Part II

 
CONTENT

Federal Register: March 31, 2008 (Volume 73, Number 62)

Rules and Regulations

Page 16965-17235

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr31mr08-14

Page 16965

Part II

Nuclear Regulatory Commission

10 CFR Part 26

Fitness for Duty Programs; Final Rule

Page 16966

NUCLEAR REGULATORY COMMISSION 10 CFR Part 26

RIN 3150-AF12

Fitness for Duty Programs

AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its regulations for Fitness for Duty (FFD) programs to update these requirements and enhance consistency with advances in other relevant

Federal rules and guidelines, including the U.S. Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace

Drug Testing Programs, and other Federal drug and alcohol testing programs that impose similar requirements on the private sector. The amendments require nuclear power plant licensees and other entities, including facilities possessing Category 1A material, to strengthen the effectiveness of their FFD programs. In addition, the amendments require nuclear power plant licensees and other entities to enhance consistency between with the FFD programs with NRC's access authorization requirements for nuclear power plants. The amendments also require nuclear power plant licensees to ensure against worker fatigue adversely affecting public health and safety and the common defense and security by establishing clear and enforceable requirements for the management of worker fatigue. The final rule ensures that individuals who are subject to these regulations are trustworthy and reliable, as demonstrated by avoiding substance abuse; are not under the influence of drugs or alcohol while performing their duties; and are not mentally or physically impaired from any other cause that would in any way adversely affect their ability to perform their duties safely and competently.

This final rule also grants, in part, a petition for rulemaking

(PRM-26-1) submitted by Virginia Electric and Power Company (now

Dominion Virginia Power) on December 30, 1993, by relaxing several required FFD program audit frequencies, and partially grants a petition for rulemaking (PRM-26-2) submitted by Barry Quigley on December 28, 1999.

DATES: This final rule is effective April 30, 2008. However, licensees and other applicable entities may defer implementation of this rule, except for Subparts I and K, until March 31, 2009. Subpart I must be implemented by licensees and other applicable entities no later than

October 1, 2009. Licensees and other applicable entities shall comply with the requirements of Subpart K as of April 30, 2008.

FOR FURTHER INFORMATION CONTACT: David Diec, Office of Nuclear Reactor

Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555- 0001, telephone (301) 415-2834, Timothy McCune, Office of Nuclear

Security and Incident Response, telephone (301) 415-6474, Dr. David R.

Desaulniers, Office of New Reactors, telephone (301) 415-1043, or Dr.

Valerie Barnes, Office of Nuclear Regulatory Research, telephone (301) 415-5944. All of the above contacts may also be reached by e-mail to

FITNESSFORDUTY@NRC.GOV.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background

A. Drug and Alcohol Testing Provisions, and General Fitness-for-

Duty Program Provisions

B. Worker Fatigue Provisions

C. Combined Part 26 Rulemaking

D. Public Input Accepted Since 2000 ``Affirmed Rule''

II. Petitions and Request for Exemption

A. Petition for Rulemaking PRM-26-1

B. Petition for Rulemaking PRM-26-2

C. Request for Exemption under 10 CFR 26.6

III. Abbreviations

IV. Discussion of Final Action

A. Overview

B. Goals of the Rulemaking Activity

C. Overview of Final Rule

D. Inclusion of Worker Fatigue Provisions in 10 CFR Part 26

V. Summary of Public Comments Submitted on Proposed Rule

VI. Section-by-Section Analysis of Substantive Changes

VII. Availability of Documents

VIII. Criminal Penalties

IX. Agreement State Compatibility

X. Plain Language

XI. Voluntary Consensus Standards

XII. Finding of No Significant Environmental Impact: Environmental

Assessment

XIII. Paperwork Reduction Act Statement

XIV. Regulatory Analysis

A. Aggregate Analysis

B. Screening Review for Disaggregation

C. Disaggregation of Worker Fatigue Provisions

XV. Regulatory Flexibility Act Certification

XVI. Backfit Analysis

A. Consideration of Fuel Fabrication Facilities and Gaseous

Diffusion Plants

B. Aggregate Backfit Analysis

C. Screening Review for Disaggregation

XVII. References

List of Subjects in 10 CFR Part 26

I. Background

A. Drug and Alcohol Testing Provisions, and General Fitness-for-Duty

Program Provisions

On June 7, 1989, the Commission announced the adoption of a new rule, 10 CFR Part 26, Fitness for Duty Programs (54 FR 24468), that required each licensee authorized to operate or construct a nuclear power reactor to implement an FFD program for all personnel having unescorted access to the protected area of its plant. A subsequent final rule published in the Federal Register on June 3, 1993 (58 FR 31467), expanded the scope of Part 26 to include licensees authorized to possess, use, or transport formula quantities of Strategic Special

Nuclear Materials (SSNM).

At the time the FFD rule was published in 1989, the Commission directed the NRC staff to continue to analyze licensee programs, assess the effectiveness of the rule, and recommend appropriate improvements or changes. The NRC staff reviewed information from several sources including inspections, periodic reports by licensees on FFD program performance, reports of significant FFD events, industry-sponsored meetings, and current research literature, as well as initiatives by industry, the Substance Abuse and Mental Health Services Administration of the Department of HHS (SAMHSA, formerly the National Institute on

Drug Abuse), and SAMHSA's Drug Testing Advisory Board, and recommended improvements and changes.

As a result, the NRC published proposed amendments to the FFD rule in the Federal Register on May 9, 1996 (61 FR 21105). The 90-day public comment period for the proposed rule closed on August 7, 1996. The NRC staff reviewed and considered public comments on the proposed rule, and submitted a final rule to the Commission in a Commission paper (SECY- 00-0159), dated July 26, 2000. The Commission affirmed the rule in a

Staff Requirements Memorandum (SRM-M001204A) dated December 4, 2000.

The affirmed rule was sent to the Office of Management and Budget (OMB) to obtain a clearance under the Paperwork Reduction Act. The request for comments on the clearance was published in the Federal Register on

February 2, 2001 (66 FR 8812). OMB and NRC received public comments that objected to some aspects of the rule. In SECY-01-0134, dated July 23, 2001, the NRC staff recommended withdrawing the request for clearance and preparing a new proposed rule. In a Staff

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Requirements Memorandum (SRM-SECY-01-0134) dated October 3, 2001, the

Commission approved the staff's recommendation to withdraw the request for clearance and prepare a new proposed rule.

B. Worker Fatigue Provisions

The NRC's ``Policy on Factors Causing Fatigue of Operating

Personnel at Nuclear Reactors'' (referred to in this document as NRC's

Policy on Worker Fatigue) was first published in the Federal Register on February 18, 1982 (47 FR 7352), and later issued through Generic

Letter (GL) 82-12, ``Nuclear Power Plant Staff Working Hours,'' on June 15, 1982 (referred to in this document as GL 82-12). In GL 82-12, the

NRC requested licensees to revise the administrative section of their technical specifications to ensure that plant administrative procedures were consistent with the work-hour guidelines. Those guidelines were:

(1) An individual should not be permitted to work more than 16 consecutive hours (excluding shift turnover time);

(2) An individual should not be permitted to work more than 16 hours in any 24-hour period, nor more than 24 hours in any 48-hour period, nor more than 72 hours in any 7-day period (all excluding shift turnover time);

(3) A break of at least 8 hours should be allowed between work periods (including shift turnover time); and

(4) Except during extended shutdown periods, the use of overtime should be considered on an individual basis and not for the entire staff on a shift.

Further, the guidelines permitted deviations from these limits in very unusual circumstances if authorized by the plant manager, his deputy, or higher levels of management in some cases. The NRC's Policy on Worker Fatigue was incorporated, directly or by reference, and with variations in wording and detail, into the technical specifications of all but three nuclear power plant sites who implemented the concept using other administrative controls.

When 10 CFR Part 26 was issued on June 7, 1989 (54 FR 24468), it focused on establishing requirements for preventing and detecting personnel impairment from drugs and alcohol. However, consistent with

SRM-SECY-88-129, dated July 18, 1988, several requirements addressed other causes of impairment, including fatigue. Those requirements included general performance objectives [Sec. 26.10(a) and (b)] that provided for ``reasonable assurance that nuclear power plant personnel

* * * are not under the influence of any substance, legal or illegal, or mentally or physically impaired from any cause'' and ``early detection of persons who are not fit to perform activities within the scope of this part.'' A requirement was also included in Sec. 26.20(a) for licensee policies to ``address other factors that could affect fitness for duty such as mental stress, fatigue and illness.''

In a letter dated February 25, 1999, Congressmen Dingell, Klink, and Markey expressed concerns to former NRC Chairman Shirley Ann

Jackson that low staffing levels and excessive overtime may present a serious safety hazard at some commercial nuclear power plants. The

Union of Concerned Scientists (UCS) expressed similar concerns on March 18, 1999, in a letter from David Lochbaum to Chairman Jackson, and in the UCS report ``Overtime and Staffing Problems in the Commercial

Nuclear Power Industry,'' dated March 1999. In a letter dated May 18, 1999, to the Congressmen, the Chairman stated that the NRC staff would assess the need to revise the policy.

On September 28, 1999, the Commission received a petition for rulemaking (PRM-26-2) from Barry Quigley. (The petition is discussed in greater detail in Section II.B of this document.) The petition requested that the NRC amend 10 CFR Parts 26 and 55 to establish clear and enforceable work-hour limits to mitigate the effects of fatigue for nuclear power plant personnel performing safety-related work.

The UCS petitioned the NRC on April 24, 2001, under 10 CFR 2.206, to issue a Demand for Information (DFI) to specified licensees. The petition asserted that Wackenhut Corporation has the contractual right to fire security guards who refuse to report for mandatory overtime, and that this contractual right conflicts with 10 CFR Part 26. The NRC denied the DFI request (ADAMS Accession No. ML013230169), but addressed the concerns of the petition through the NRC's generic communication process. On May 10, 2002, the NRC issued NRC Regulatory Issue Summary

(RIS) 2002-07, ``Clarification of NRC Requirements Applicable to Worker

Fatigue and Self-Declarations of Fitness-for-Duty.'' The RIS addressed the applicability of 10 CFR Part 26 to worker fatigue, the potential for sanctions related to worker FFD concerns to have adverse implications for maintaining a work environment conducive to reporting

FFD concerns, and the protections afforded workers by 10 CFR 50.7,

``Employee Protection.''

On January 10, 2002, in SRM-SECY-01-0113, the Commission approved a rulemaking plan, ``Fatigue of Workers at Nuclear Power Plants,'' dated

June 22, 2001 (referred to in this document as SECY-01-0113). Under the approved plan, the NRC initiated a rulemaking to incorporate fatigue management into 10 CFR Part 26 in order to strengthen the effectiveness of FFD programs at nuclear power plants in ensuring against worker fatigue adversely affecting public health and safety and the common defense and security by establishing clear and enforceable requirements for the management of worker fatigue.

During the development of the fatigue management requirements, the

NRC observed an increase in concerns (e.g., allegations, media and public stakeholder reports) related to the workload and fatigue of security personnel following the terrorist attacks of September 11, 2001. Subsequent to an NRC review of the control of work hours for security force personnel, and public interactions with stakeholders, the Commission issued Order EA-03-038 on April 29, 2003, requiring compensatory measures related to fitness-for-duty enhancements for security personnel at nuclear power plants, including work hour limits.

The compensatory measures imposed by Order EA-03-038 were similar to the guidelines of the NRC's Policy on Worker Fatigue. The compensatory measures differed from the Policy guidelines in a few areas in which the NRC believed it was necessary to address previously identified deficiencies in the guidelines, including the need to address cumulative fatigue from prolonged periods of extended work hours, matters unique to security personnel and stakeholder input obtained through public meetings concerning the worker fatigue rulemaking and the order. The NRC imposed the requirements in the order to provide the Commission with reasonable assurance that the public health and safety and common defense and security continue to be adequately protected. The provisions specified in 10 CFR Part 26,

Subpart I, Managing Fatigue, for security force personnel replace the requirements imposed by the order. Differences between the requirements in Subpart I and the requirements imposed by the order, and the rationale for those differences, are discussed in Section IV.D of this document.

C. Combined Part 26 Rulemaking

On March 29, 2004, in COMSECY-04-0014, the NRC staff informed the

Commission of the status of both

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rulemaking activities. The NRC staff also noted that because both rulemaking activities were being completed in parallel, the draft proposed fatigue rule language was based on the draft language in the proposed overall revision to Part 26, rather than on the former language in Part 26. Therefore, meaningful public comment could be confounded by the simultaneous promulgation of two draft rules which are somewhat interdependent, and staff action to address a comment on one proposed rule could easily impact the other proposed rule, creating a high potential for the need to issue one or both proposed rules. In

SRM-COMSECY-04-0014, dated May 25, 2004, the Commission directed the staff to combine the rulemaking related to nuclear power plant worker fatigue with the ongoing Part 26 rulemaking activity. This combined final rule withdraws the proposed rule published on May 9, 1996.

D. Public Input Accepted Since 2000 ``Affirmed Rule''

In preparing this rule, the NRC considered comments received by OMB on the prior Part 26 final rule affirmed by the Commission in an SRM dated December 4, 2000. The NRC also considered feedback received from industry, as well as other interested parties and members of the public. The NRC held 11 stakeholder meetings on the drug and alcohol testing portions of the rule during 2001-2004, and 13 stakeholder meetings on the fatigue portions of the rule during 2002-2003.

Following the Commission's decision to combine the two rulemaking efforts, the NRC held one stakeholder meeting on the combined rule in

July, 2004, and two subsequent meetings on the fatigue provisions of the combined rule in August and September 2004.

Throughout the time the meetings were being held, drafts of proposed rule language, regulatory and backfit analysis data, and other pertinent information were made available to the public on the

Internet, as announced in the Federal Register on February 15, 2002 (67

FR 7093). The NRC received feedback from stakeholders both through the public meetings and the NRC's Web site. Address questions about our rulemaking Web site to Carol Gallagher (301) 415-5905; e-mail cag@nrc.gov.

These interactions with stakeholders were a significant benefit to the NRC in developing the language for the final rule in a manner to ensure it is clearly understandable, will be consistently interpreted, and does not result in unintended consequences. Many of the stakeholders' comments directly resulted in changes. When a comment was included in a provision, the comment is discussed in Section VI of this document.

Many comments were received during the years the meetings were held. The draft proposed rule language was changed and re-posted to the

Web numerous times.

Following the publication of the August 25, 2005 (70 FR 50442) proposed rule, the NRC proposed a 4-month period to accept public comment submissions. However, the NRC accepted comments for several months after the proposed deadline for the submission of public comments. These comments are discussed in Section V of this document.

The NRC also held several public meetings after the proposed rule was published to increase stakeholder involvement in the rulemaking.

These meetings were held on September 21, 2005 (ADAMS Accession No.

ML052420363), November 7 and 9, 2005 (ADAMS Accession No. ML052990048),

December 15, 2005 (ADAMS Accession No. ML053400002), and March 29-30, 2006 (ADAMS Accession No. ML060650535).

II. Petitions and Request for Exemption

A. Petition for Rulemaking PRM-26-1

On December 30, 1993, Virginia Electric and Power Company (now

Dominion Virginia Power) submitted a Petition for Rulemaking (PRM-26-1) requesting relaxation of the required 1-year audit frequency of licensee FFD programs and the program elements of contractors and vendors (C/Vs) that are relied upon by licensees. The petition requested that the first sentence of former 10 CFR 26.80(a) be amended to read:

Each licensee subject to this Part shall audit the fitness-for- duty program nominally every 24 months * * *. In addition, audits must be conducted, nominally every 24 months, of those portions of fitness-for-duty programs implemented by contractors and vendors.

In a letter dated March 14, 1994, the NRC informed the petitioner that the petition would be addressed in a proposed rulemaking that was under development. The NRC has periodically communicated with the petitioner regarding the status of this rulemaking since that time.

Section 26.41(b) of the final rule partially grants two aspects of the petition. The required audit frequency for licensees and other entities who are subject to 10 CFR Part 26 has been reduced from the nominal 1-year frequency in the former rule to a nominal 2-year frequency. Further, audits of C/V services that are performed on site and under the direct daily supervision or observation of licensee personnel will be conducted as part of the 2-year audits of the licensee or other entity's FFD program, under Sec. 26.41(b).

Section 26.41(c)(1) of the final rule partially denies two aspects of the petition. The nominal annual audit requirement for HHS-certified laboratories has been retained. In addition, the annual audit requirement has been retained for FFD program elements provided by C/Vs whose personnel ``are off site or are not under the direct daily supervision or observation of licensee personnel.''

The bases for these changes to the audit requirements in the rule are addressed in the subsequent sections of this supplementary information.

B. Petition for Rulemaking PRM-26-2

On September 28, 1999, Barry Quigley submitted a Petition for

Rulemaking (PRM-26-2) requesting that the NRC amend 10 CFR Parts 26 and 55 to establish clear and enforceable work hour limits to mitigate the effects of fatigue for nuclear power plant personnel performing safety- related work. The PRM was published for public comment on December 1, 1999, (64 FR 67202). As described in detail in Attachment 3 to SECY-01- 0113, the petition requested the NRC to:

(1) Add enforceable working hour limits to 10 CFR Part 26;

(2) Add a criterion to 10 CFR 55.33(a)(1) to require evaluation of known sleeping disorders;

(3) Revise the NRC Enforcement Policy to include examples of working hour violations that warrant various NRC sanctions; and

(4) Revise NRC Form 396 to include self-disclosure of sleeping disorders by licensed operators.

The NRC received 176 comment letters in response to the petition.

The majority of the comments (157) were in favor of a rule. These comments were principally from individuals and public interest groups.

Comments received from licensees, the Nuclear Energy Institute (NEI) and Winston and Strawn, a law firm representing several utilities, were opposed to PRM-26-2. A summary of the comments and responses is available in SECY-01-0113 as Attachment 2. This document may be obtained from the NRC's Web site, http://www.nrc.gov, by selecting the electronic reading room and then collections of documents by type. It is also available in the NRC's Agencywide Documentation and Management

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System (ADAMS) under Package Accession Number ML010180224.

Although the NRC received many comments concerning the specific requirements proposed in PRM-26-2, in general, letters in support of the rulemaking--

(1) Cited the importance of ensuring that personnel who perform safety-related functions are not impaired by fatigue;

(2) Expressed concern that the NRC does not have a regulation limiting working hours and the perception that the NRC lacks the authority to enforce the guidelines in the NRC's Policy on Worker

Fatigue;

(3) Asserted that the guidelines are ambiguous and that licensees interpret the guidelines as not applicable when the plant is in an outage;

(4) Asserted that ``the NRC appears to look the other way'' when licensee work scheduling practices appear inconsistent with the guidelines; and

(5) Expressed the concern that utility restructuring and cost competition will cause reductions in staffing levels and increased working hours and fatigue.

Further, several commenters noted that the Federal Government has established work-hour limits for personnel in other industries and suggested that similar limits should apply to nuclear power plant workers.

In general, comments that opposed the petition expressed the opinion that existing regulatory requirements (i.e., technical specifications and 10 CFR Part 26) are adequate to ensure that personnel are not impaired by fatigue, that the requirements would impose an unnecessary and excessive burden that could not be justified through a backfit analysis, and that industry performance data refute the petitioner's argument that a rule is necessary to prevent fatigued personnel from performing safety-related work.

The NRC evaluated the merits of PRM-26-2, the comments received in response to the PRM, and assessed the Policy on Worker Fatigue. The NRC concluded that the petitioner proposed a comprehensive set of requirements that could reasonably be expected to effectively address fatigue from individual and programmatic causes. However, the NRC concluded that it is possible to achieve these objectives through alternative requirements that are more flexible, more directly focused on risk, and more aligned and integrated with current regulatory requirements. Therefore, the final rule grants, PRM-26-2, in part. A detailed discussion of the principal findings that led to the decision to grant, in part, PRM-26-2 through rulemaking are included in Section

IV.D of this document. In addition, for item 3 of PRM-26-2, the NRC revised Inspection Procedure (IP) 71130.08, ``Fitness For Duty

Programs'' on February 19, 2004, to reflect the requirements of Order

EA-03-038, dated April 29, 2003, which required compensatory measures related to fitness-for-duty enhancements for security personnel at nuclear power plants, including work hour limits. The NRC will similarly revise this inspection procedure following issuance of the final rule. The self-disclosure of sleeping disorders by licensed operators (item 4) is being addressed by the NRC as a separate effort from this rule through changes to Regulatory Guide 1.134, ``Medical

Evaluation of Licensed Personnel at Nuclear Power Plants.''

C. Request for Exemption Under 10 CFR 26.6

The former rule required random drug and alcohol testing for personnel with unescorted access to the protected area of a nuclear power plant. By letter dated March 13, 1990, the International

Brotherhood of Electrical Workers (IBEW) Local 1245 requested an exemption from random testing for clerical, warehouse, and maintenance workers at the Diablo Canyon Nuclear Power Plant (Diablo Canyon) under the provisions of 10 CFR 26.6. The NRC denied the request and IBEW

Local 1245 sought judicial review. In 1992, the Ninth Circuit Court of

Appeals affirmed the NRC's denial of the request (IBEW, Local 1245 v.

NRC, No. 90-70647, 9th Cir., June 11, 1992). In its opinion, the court said that random testing may well be impermissible for clerical workers at Diablo Canyon who perform no safety-sensitive work and have no access to vital areas. However, in the record before the court at that time, IBEW Local 1245 had not established that such a group existed. On

January 26 and December 6, 1993, IBEW Local 1245 renewed its request for exemption, specifically asking that the NRC exempt from 10 CFR Part 26 requirements for random drug testing, clerical employees at Diablo

Canyon who are members of Local 1245 of the IBEW and who have unescorted access to the protected area (PA) only, but not to the radiologically controlled areas (RCAs) or vital areas (VAs) and who are not required to staff the plant's emergency response center (ERC). The

PA is the area inside the security fence of a nuclear power plant, which surrounds the entire plant, and the immediately surrounding area, whereas the VAs enclose key safety systems and are located within the

PA. The RCAs contain elevated levels of radiation or contamination and are generally located within the PA. The ERC is located off site and is where the licensee evaluates and coordinates licensee activities related to an emergency, and communicates to Federal, State and local authorities responding to radiological emergencies. The NRC requested public comment on the issue in the Federal Register of May 11, 1994 (59

FR 24373). Comments were received from the nuclear industry, which largely opposed a reduction in the scope of random testing, and from elements of the IBEW, including Local 1245, which favored it. In SRM-

SECY-04-0229, dated January 10, 2005 (available on the NRC Web site at http://www.nrc.gov/reading-rm/doc-collections/commission/srm/), the

Commission denied the IBEW exemption request because it--

(1) Would endanger the common defense and security (as a result of increasing the likelihood of an insider threat); and

(2) Was not in the public interest (because reducing the scope of random drug testing could increase the risk to public health and safety due to a greater risk of both sabotage (insider threat due to vulnerability to coercion) and of an accident (impaired worker)).

Consequently, this final rule maintains the former requirement for random drug and alcohol testing for all personnel with unescorted access to the PA at a nuclear power plant.

III. Abbreviations

The following abbreviations and acronyms are used in this Statement of Considerations.

AEA Atomic Energy Act

ASDs Alcohol screening devices

BAC Blood alcohol concentration

CPL Conforming products list

C/V Contractor/vendor

DOT Department of Transportation

EAP Employee assistance program

EBT Evidential breath testing device

EPRI Electric Power Research Institute

FFD Fitness for duty

GC/MS Gas chromatography/mass spectrometry

HHS Department of Health and Human Services

IBEW International Brotherhood of Electrical Workers

ITAAC Inspections, Tests, Analyses, and Acceptance Criteria

KAs Knowledge and abilities

LOD Limit of detection

LOQ Limit of quantitation mg/dL Milligrams per deciliter

MRO Medical Review Officer

NEI Nuclear Energy Institute ng/dL Nanograms per deciliter

NHTSA National Highway Transportation Safety Administration

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NRC Nuclear Regulatory Commission

NSF National Sleep Foundation

OMB Office of Management and Budget

PDFFDI Potentially disqualifying fitness-for-duty information pH potential of hydrogen

POGO Project on Government Oversight

PROS Professional Reactor Operator Society

QA/QC Quality assurance/quality control

SAE Substance Abuse Expert

SAMHSA Substance Abuse and Mental Health Services Administration

SSNM Strategic special nuclear material

THC Tetrahydrocannabinol, delta-9-tetrahydrocannabinol-9-carboxylic acid

UCS Union of Concerned Scientists 6-AM 6-acetylmorphine

IV. Discussion of Final Action

A. Overview

A review of FFD program experience confirms that the former regulatory approach of 10 CFR Part 26 was fundamentally sound and provided a means of deterrence and detection of substance abuse at licensee facilities. FFD Program Performance Reports through 2005 are published on the NRC's Web site, http://www.nrc.gov/reactors/operating/ ops-experience/fitness-for-duty-programs/performance-reports.html.

Nonetheless, the NRC believes that revisions were needed to improve the effectiveness and efficiency of FFD programs; enhance consistency with advances in similar rules and guidelines, including HHS' Mandatory

Guidelines for Federal Workplace Drug Testing Programs (herein called the HHS Guidelines) and other Federal drug and alcohol testing programs that place similar requirements on the private sector; strengthen the effectiveness of FFD programs at nuclear power plants in ensuring against worker fatigue adversely affecting public health and safety and the common defense and security by establishing clear and enforceable requirements for the management of worker fatigue; enhance consistency with the NRC's access authorization requirements; improve clarity in the organization and language of the rule; and improve Part 26 by eliminating or modifying unnecessary requirements.

B. Goals of the Rulemaking Activity

The NRC is amending 10 CFR Part 26, Fitness For Duty Programs. The goals are to:

(1) Update and enhance the consistency of 10 CFR Part 26 with advances in other relevant Federal rules and guidelines, including the

HHS Guidelines and other Federal drug and alcohol testing programs

(e.g., those required by the U.S. Department of Transportation [DOT]) that impose similar requirements on the private sector;

(2) Strengthen the effectiveness of FFD programs at nuclear power plants in ensuring against worker fatigue adversely affecting public health and safety and the common defense and security by establishing clear and enforceable requirements for the management of worker fatigue;

(3) Improve the effectiveness and efficiency of FFD programs;

(4) Improve consistency between FFD requirements and access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003;

(5) Improve Part 26 by eliminating or modifying unnecessary requirements;

(6) Improve clarity in the organization and language of the rule; and

(7) Protect the privacy and other rights (including due process) of individuals who are subject to Part 26.

Each of these goals is expected to result in substantial improvements in FFD programs. Many changes in the final rule relate to each goal. The major changes for each subpart and the reasons for those changes are described in Section IV.C of this document. For each of the many specific changes, detailed discussions are included in Section VI.

However, the following discussion provides a description of each goal, a basis for the need to accomplish that goal, and several examples of changes to the former rule that will contribute to meeting the goal.

Goal 1--Update and enhance the consistency of 10 CFR Part 26 with advances in other relevant Federal rules and guidelines, including HHS

Guidelines and other Federal drug and alcohol testing programs (e.g., those required by the DOT that impose similar requirements on the private sector.) Goal 1 is central to this rulemaking activity. Many changes are included in the final rule to maintain consistency with advances in the conduct of FFD programs, including changes in the HHS

Guidelines. The 1994, 1998, and 2004 revisions to the HHS Guidelines differ substantially from the 1988 version of the HHS Guidelines, upon which the former rule was based.

The President of the United States designated HHS as the agency responsible for the Federal workplace drug testing program. HHS' SAMHSA is responsible for maintaining the HHS drug testing guidelines based on the most recent research and the accumulation of lessons learned from the Federal drug testing program, as well as others who are regulated.

The NRC has historically relied on HHS to establish the technical requirements for urine specimen collection, testing, and evaluation, and has only deviated from HHS' guidelines for considerations that are specific to the nuclear industry. Updating Part 26 to be consistent with the most recent HHS Guidelines ensures that NRC regulations continue to be scientifically and technically sound.

Further, the HHS-certified laboratories that Part 26 requires licensees to use for drug testing are required by HHS to follow the HHS

Guidelines in order to retain their certification. Basing Part 26 on older versions of the HHS Guidelines, or deviating from those

Guidelines, increases the cost of drug testing for the nuclear industry. Therefore, updating Part 26 to increase consistency with the

HHS Guidelines not only ensures that Part 26 is based on the best scientific and technical information available, but also avoids imposing an unnecessary and costly regulatory burden on the nuclear industry.

One example of an improvement from enhancing consistency with the

HHS Guidelines is that several cutoff levels for detection of various drugs have been updated, including a revised lower cutoff level for the marijuana metabolite THC. The lower cutoff level will provide greater assurance that individuals who use marijuana are identified.

Additionally, a revision to the HHS Guidelines, published in the

Federal Register on April 13, 2004 (69 FR 19643) as a final rule, includes requirements for specimen validity tests to determine whether a urine specimen has been adulterated, diluted, or substituted. This final rule adopts significant portions of the final HHS specimen validity testing provisions. The new validity testing requirements will substantially improve the effectiveness of the measures to guard against subversion of the testing process that are contained in former

Part 26.

Several other provisions for drug testing are under consideration by HHS and were published as a proposed rule for public comment in the

Federal Register on April 13, 2004 (69 FR 19672). One change to 10 CFR

Part 26 that is included from the proposed HHS Guidelines is permission for licensees to use validity screening tests to determine whether a urine specimen must be

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subject to further testing at an HHS-certified laboratory because it may have been adulterated, diluted, or substituted, in lieu of the instrumented validity testing required in the April 13, 2004, final version of the HHS Guidelines. Although the HHS Guidelines that would permit Federal drug testing programs to use validity screening tests for initial testing of urine specimens are not yet final, some NRC licensees desired the flexibility to use these testing methods. A technical basis for use of those methods is included in section VI.

However, the NRC is not including other provisions in the proposed HHS

Guidelines at this time. Those provisions include permitting the drug testing of specimens other than urine (e.g., hair, saliva, sweat), requirements for split specimen procedures for all specimens, and HHS certification of instrumented initial test facilities, which would be analogous to licensee testing facilities. Should such provisions be included in final HHS Guidelines in the future, the NRC will consider incorporating them into 10 CFR Part 26 at that time.

In addition to the changes to 10 CFR Part 26 that incorporate the recent revisions to the HHS Guidelines, the DOT revised its Procedures for Transportation Workplace Drug and Alcohol Testing Programs (49 CFR

Part 40, 65 FR 41944; August 9, 2001) to include the use of oral fluids

(i.e., saliva) as acceptable specimens for initial alcohol screening tests. This final rule also reflects the new oral fluids testing technology to provide FFD programs with increased flexibility in administering initial alcohol tests.

Because the HHS Guidelines do not establish requirements for alcohol testing, NRC relies on the DOT regulations, in part, to ensure that the alcohol testing provisions of Part 26 remain scientifically sound and legally defensible. Because the DOT programs test a much larger number of individuals in comparison to the number of alcohol tests that are conducted under Part 26, basing the NRC's alcohol testing regulations on portions of the DOT regulations reflects the lessons learned from that larger population.

Goal 2--Strengthen the effectiveness of FFD programs at nuclear power plants in ensuring against worker fatigue adversely affecting public health and safety and the common defense and security by establishing clear and enforceable requirements for the management of worker fatigue. This goal is central to this rulemaking activity.

Subpart I, Managing Fatigue, adds clear and enforceable requirements for licensee management of worker fatigue to 10 CFR Part 26. The requirements reduce the potential for worker fatigue and therefore, strengthen the effectiveness of FFD programs at nuclear power plants and substantially increase the protection of public health and safety and the common defense and security. Section VI of this document discusses the specific reasons for each worker fatigue provision.

Section IV.D provides a detailed discussion of the overall basis for establishing fatigue management requirements for FFD programs, and the benefits expected to result.

Goal 3--Improve the effectiveness and efficiency of FFD programs.

The NRC has gained experience in the actual implementation of FFD programs since Part 26 was originally promulgated. The NRC is making many changes throughout Part 26 based on that experience in order to improve the industry's programs, specifically to increase both the effectiveness of the programs in achieving the goals of Part 26 and the efficiency of program operations. Increasing the effectiveness and efficiency of FFD programs will enhance the protection of public health and safety and the common defense and security.

One example of a change related to Goal 3 is the reduction in the period within which pre-access testing must be performed from 60 days, in former Sec. 26.24(a)(1), to 30 days or less, in Subpart C [Granting and Maintaining Authorization]. This change improves the effectiveness of the pre-access test in detecting drug and alcohol use by individuals who are applying for authorization to have the types of access or perform the duties that require them to be subject to Part 26. Reducing the number of breath specimens required for alcohol testing from two each for initial and confirmatory testing, in former Section 2.4(g)(18) in Appendix A to Part 26, to one specimen for the initial test and one for the confirmatory test also increases the efficiency of FFD programs without compromising the accuracy and validity of alcohol test results.

Another example of rule changes related to Goal 3 is establishing a regulatory framework for the management of worker fatigue that appropriately balances the need for flexibility to manage plant exigencies with the need for more readily enforceable requirements and efficient NRC oversight of licensee compliance with the requirements and performance objectives of the rule.

Goal 4--Improve consistency between FFD requirements and the access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003. Part 26 and the access authorization requirements each contain provisions that require establishing the trustworthiness and reliability of personnel before granting unescorted access to the protected areas of nuclear power plants. The NRC determined that, because both sets of requirements share this same goal, revising Part 26 was necessary to clarify the relationship between these requirements, particularly for licensee access authorization decisions regarding personnel who move between sites with some interruption in their status of having unescorted access to a nuclear power plant. In addition, some requirements in former Part 26 addressed the granting of temporary unescorted access. In response to the terrorist attacks of September 11, 2001, on the World Trade Center and the Pentagon, and the current threat environment, the Commission took action to curtail the use of temporary unescorted access at commercial nuclear power plants.

Temporary unescorted access was eliminated by orders issued January 7, 2003, which imposed enhancements to existing access authorization programs. Therefore, it was necessary to revise the related provisions in Part 26.

Goal 5--Improve 10 CFR Part 26 by eliminating or modifying unnecessary requirements. The final rule incorporates a number of changes to eliminate or modify unnecessary requirements. The experience

NRC has gained over the years since Part 26 was promulgated has enhanced the agency's understanding of implementation issues experienced by the industry, and the NRC is now eliminating or modifying some provisions, while at the same time maintaining protection of public health and safety and the common defense and security.

For example, because of inconsistencies in how licensees interpreted the FFD and access authorization requirements for conducting employment inquiries, many licensees contacted an individual's previous employers twice--once to obtain the information required under Part 26 and once to obtain the information required for access authorization. The revisions to Part 26 clarify that licensees may obtain information to satisfy FFD suitable inquiry requirements and related access authorization requirements at the same time when conducting an employment inquiry.

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Goal 6--Improve clarity in the organization and language of the rule. The final rule is organized to facilitate implementation, as compared to the former rule, which has generated many questions from licensees. Therefore, in the final rule, the NRC has substantially reorganized the requirements to eliminate redundancies, to group related requirements, and to present requirements in the order in which they apply to licensees' FFD processes. In addition, the NRC has made many language changes to improve clarity. This substantial reorganization, which substantially reduces the likelihood of variations in FFD programs across the industry through differing interpretations of the rule, improves the protection of public health and safety and the common defense and security. The final rule is clearer in both organization and language, and is expected to result in more uniform implementation, and, consequently, more consistency in achieving the Part 26 goals.

In contrast to certain NRC regulations, Part 26 includes a considerable number of detailed requirements. In the public meetings held during the development of the final rule, industry representatives indicated that they consider this level of detail necessary to help protect individual privacy and ensure consistency in implementing the requirements. Additionally, industry representatives indicated that this high level of detail can help to avoid unnecessary litigation between licensees and individual personnel regarding worker non- compliance with specific drug and alcohol testing performance steps.

Such litigation would be more likely if those specific performance steps were not required by NRC rule. The level of detail and the enhanced clarity in the new language and organization included in Part 26 have eliminated the need for a guidance document for provisions pertaining to drug and alcohol testing. Industry representatives commented that a guidance document would not have the same weight as a rule, and that both licensees and individuals should be protected fully with rigor and specificity in a rule. Therefore, industry desired the rule to be more specific and detailed, in lieu of a guidance document.

Goal 7--Protect the privacy rights and other rights (including due process) of individuals who are subject to 10 CFR Part 26. This goal was an implicit objective of the former rule, and the final rule continues to protect the privacy and other rights of individuals

(including due process) who are subject to 10 CFR Part 26. The NRC,

DOT, and HHS have all gained experience in implementing workplace drug and alcohol testing programs. This experience has led the DOT and HHS to modify many of their requirements for such testing to more clearly protect privacy and other rights of individuals. Many of the changes to

Part 26 related to this goal are based on either DOT or HHS requirements. The NRC believes the protection of individual rights to be of the highest importance and is making changes to Part 26 to ensure that those rights are protected through rule language developed using the best available information. One example of such a change is that the final rule prohibits any testing of ``Bottle B, the second portion of a split urine specimen, or retesting an aliquot of a specimen'' without the donor's permission.

C. Overview of Final Rule

The final rule is divided into subparts that contain related requirements. Each subpart is assigned a descriptive title to aid users in locating rule provisions and to simplify cross-referencing within the final rule. By grouping related requirements and presenting them generally in the order in which they apply to licensees' and other entities' FFD processes, the final rule improves the ease of implementing the rule. For example, the final rule adds Subpart K [FFD

Programs for Construction] to consolidate FFD requirements for new reactor construction. Also, the provisions that were contained in

Subparts J [Recordkeeping and Reporting Requirements] and K

Inspections, Violations, and Penalties

of the proposed rule are now contained in Subparts N and O, respectively, of the final rule.

The major topics addressed in each subpart and the reasons that the

NRC made major changes to the former rule are described below. A detailed cross-reference table between the former and final Part 26 provisions is included at the end of this notice.

Subpart A Administrative Provisions

The first subpart, Subpart A, replaces the General Provisions portion of the former rule, but continues to address the same subject matter. Thus, Subpart A addresses the purpose and scope of the rule, provides definitions of important terms used in the final rule, and updates former provisions related to requests for specific exemptions, interpretations of the rule, and communications with the NRC. The final rule also adds a section to Subpart A that consolidates FFD program applicability requirements for categories of individuals.

Subpart B Program Elements

Subpart B of the final rule reorganizes and amends former

Sec. Sec. 26.10 through 26.29. These sections of the former rule specified the performance objectives that FFD programs were required to meet and the FFD program elements that licensees and other entities were required to implement to meet the performance objectives. However, the final rule does not include former Sec. 26.27 [Management actions and sanctions to be imposed] in Subpart B for two reasons. First, the final rule is reorganized to be consistent with the order in which licensees and other entities implement their programs. Because Subpart

B is focused on establishing the framework of FFD programs, it would be premature to present requirements related to implementing the FFD program (i.e., imposing sanctions on an individual for violating the

FFD policy) at this point in the rule. Second, the subject matter of former Sec. 26.27 is sufficiently important and complex that a separate subpart is warranted. Therefore, the final rule presents requirements related to management actions and sanctions in Subpart D

Management Actions and Sanctions to be Imposed

.

Subpart C Granting and Maintaining Authorization

Subpart C of the final rule substantially amends former FFD requirements related to the process that licensees and other entities must follow in determining whether an individual is trustworthy and reliable, as demonstrated by avoiding substance abuse, and can be expected to perform his or her job duties safely and competently. The final rule introduces the concept of (authorization( to Part 26 to refer to the status of an individual who the licensee or other entity has determined can be trusted to avoid substance abuse, and, therefore, may be permitted to have the types of access or perform the duties described in Sec. 26.4 [FFD program applicability to categories of individuals], as a result of the process described in this subpart. For example, in the case of nuclear power plant personnel, a licensee may permit an individual who is ``authorized'' under Part 26 to have unescorted access to protected areas in nuclear power plants if the individual's job requires such access.

The NRC has published other requirements, such as 10 CFR 73.56, that establish additional steps that licensees and other entities must take as part of the process of determining whether to grant unescorted access to an

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individual or permit an individual to maintain unescorted access to protected areas. These additional requirements focus on aspects of an individual's character and reputation other than substance abuse, and, among other steps, require the licensee or other entities who are subject to the rule to conduct a psychological assessment of the individual, perform a credit and criminal history check, and interview individuals who have knowledge of the applicant for authorization.

However, historically there have been some inconsistencies and redundancies between the Part 26 requirements related to granting and maintaining unescorted access and the other related regulations, particularly the NRC's access authorization requirements for nuclear power plant personnel. The inconsistencies have led to many implementation questions from licensees, as well as inconsistencies in how licensees have implemented the requirements. The redundancies have imposed an unnecessary burden on licensees in other cases. Therefore, a central goal of adding Subpart C to the final rule is to eliminate those inconsistencies and redundancies to ensure that licensees and the other entities who are subject to the rule have clear and easily interpretable requirements to follow when determining whether to grant or maintain an individual's unescorted access under Part 26 and also under other, related requirements, including, but not limited to, the

January 7, 2003 access authorization orders issued by the NRC to nuclear power plant licensees.

The requirements in Subpart C are based on several fundamental changes to the NRC's approach to the authorization requirements in former Part 26. The primary concern, which Subpart C is designed to address, is the necessity of increasing the rigor of the authorization process to provide reasonable assurance that any individual who is granted and maintains authorization is trustworthy and reliable, as demonstrated by avoiding substance abuse. The necessity for increased rigor in the authorization process is discussed in Section VI of this document with respect to Sec. 26.23(a) in terms of the increased insider threat since the terrorist attacks of September 11, 2001. One change to former Part 26 authorization requirements that reflects this concern is the elimination of temporary access authorization requirements in the second sentence of former Sec. 26.27(a)(4). Other changes are discussed in Section VI with respect to the specific provisions that incorporate them.

A second, related change to the NRC's approach to authorization requirements, which has informed Subpart C, is an increased concern with the sharing of information about individuals between licensees and other entities. At the time the former Part 26 was developed, the industry structure was different and personnel transfers between licensees (i.e., leaving the employment of one licensee to work for another licensee) with interruptions in authorization were less common.

Most licensees operated plants at a single site and maintained an FFD program that applied only to that site. When an individual left employment at one site and began working for another licensee, the individual was subject to a different FFD program that often had different requirements. Because some licensees were reluctant to share information about previous employees with the new employer, licensees often did not have access to the information the previous licensee had gathered about the individual and were required to gather the necessary information again. The additional effort to collect information that another licensee held created an unnecessary burden on both licensees.

But, because few individuals transferred, the burden was not excessive.

However, since 1989, the industry has undergone significant consolidation and developed new business practices to use its workforce more efficiently. Industry efforts to better use expertise and staffing resources have resulted in the development of a large transient workforce within the nuclear industry that travels from site to site as needed, such as roving outage crews. Although the industry has always relied on C/Vs for special expertise and staff for outages, the number of transient personnel who work solely in the nuclear industry has increased and the length of time they are on site has decreased.

Because the former FFD regulations were written on the basis that individual licensees would maintain independent, site-specific FFD programs and shared limited information, and that the majority of nuclear personnel would remain at one site for years, the former regulations did not adequately address the transfer of personnel between sites.

These changes in the industry have increased the need for information sharing among licensees and C/Vs. The increased insider threat since September 11, 2001, has also heightened the need for information sharing among licensees and C/Vs to ensure that licensees and other entities have information that is as complete as possible about an individual when making an authorization decision. To address this need, the access authorization orders issued by the NRC to nuclear power plant licensees on January 7, 2003, mandated increased sharing of information. In addition, Subpart C requires licensees and other entities to collect and share greater amounts of information than under the former rule, subject to the protections of individuals' privacy that are specified in Sec. 26.37 [Protection of information]. As a result, individuals who are subject to the rule will establish a detailed ``track record'' within the industry that will follow them if they change jobs and move to a new position that requires them to be granted authorization by another licensee or entity who is subject to the rule. This increased information sharing contributes to providing reasonable assurance that individuals who are granted and maintain authorization under Part 26 are trustworthy and reliable when individuals move between FFD programs.

However, a consequence of increased information sharing is that one violation of any licensee's FFD policy has greater potential to end an individual's career. Although an individual who has an active substance abuse problem cannot be permitted to have unescorted access to protected areas, the NRC continues to affirm that individuals who pursue treatment, stop abusing drugs or alcohol, and maintain sobriety for an extended period of time should regain the public's trust. The length of time that an individual must maintain sobriety in order to demonstrate that he or she can again be trusted with the public's health and safety and the common defense and security has been a matter of debate since Part 26 was originally under development. However, the research literature continues to indicate that individuals who maintain sobriety past the first 3 years following treatment have substantially reduced recidivism rates (i.e., relapsing into substance abuse) than during the first 3 years after treatment. There is also a further drop in recidivism rates after 5 years of sobriety.

Despite these research findings, some individuals who have had one confirmed positive test result have been prevented from working in operating nuclear power plants. The increased information sharing required under Subpart C has the potential to result in a greater number of these individuals being banned from working in the industry.

Therefore, the NRC has added several requirements to Subpart C to

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minimize these consequences for individuals who are able to demonstrate that they are effectively coping with a substance abuse problem.

Additional requirements for protecting information to be gathered about individuals under Part 26 are specified in Sec. 26.37. The detailed changes to former requirements are discussed in Section VI with respect to the specific provisions that incorporate these requirements.

In general, the authorization requirements in Subpart C are structured according to whether an individual who has applied for authorization has previously held authorization under Part 26. If an individual has not established a ``track record'' in the industry, the final rule requires licensees and other entities to meet an extensive set of requirements before granting authorization to the individual. If an individual has established a favorable track record in the industry, the amount of original information gathering that the final rule requires licensees and other entities to complete before granting authorization to the individual is reduced. The need for original information gathering in these instances is reduced because licensees and other entities will have access to all of the information that previous FFD programs have collected about the individual under the final rule.

For individuals who have established a favorable track record in the industry, the steps that licensees and other entities are required to complete in order to grant authorization to an individual also depends upon the length of time that has elapsed since the individual's last period of authorization was terminated and the amount of supervision to which the individual was subject during the interruption. (The term ``interruption'' refers to the interval of time between periods during which an individual holds authorization under

Part 26.) In general, the more time that has elapsed since an individual's last period of authorization ended, the more steps that the final rule requires licensees and other entities to complete before granting authorization to the individual. However, if the individual was subject to behavioral observation under a Part 26 program or continued to be subject to random drug and alcohol testing during the interruption, the final rule requires licensees and other entities to complete fewer steps in order to grant authorization to the individual.

There are several reasons that the final rule requires fewer steps in the authorization process for these individuals.

First, individuals who have established a favorable work history in the industry have demonstrated their trustworthiness and reliability from previous periods of authorization, so they pose less potential risk to public health and safety and the common defense and security than individuals who are new to the industry. Much is known about these individuals. Not only were they subject to the initial background screening requirements before they were initially granted authorization; but, while they were working under a Part 26 program, they were watched carefully through on-going behavioral observation, repeatedly attained negative results from random drug and alcohol tests, and demonstrated the ability to consistently comply with the many procedural requirements that are necessary to perform work safely at operating power reactor facilities.

Second, individuals who have established a favorable work history in the industry and whose authorization has been interrupted for only a short period are unlikely to develop an active substance abuse problem during the interruption. The shorter the period of time since the individual's last period of authorization ended, the less likely it is that the individual has developed an active substance abuse problem or undergone other significant changes in lifestyle or character that would diminish his or her trustworthiness, reliability, and ability to perform work safely and competently.

Further, if the individual was also subject to supervision under some elements of a Part 26 program (e.g., behavioral observation, a requirement to report any arrests, random drug and alcohol testing) during the period that his or her authorization was interrupted, the higher the assurance that the individual does not have an active substance problem. And, it is less likely that the individual could have undergone significant changes in lifestyle or character that would be undetected.

Therefore, the final rule establishes categories of requirements for granting authorization to an individual that vary, based upon whether the individual has previously held authorization under Part 26; whether the individual's last period of authorization was terminated favorably or unfavorably; how long it has been since the individual last held authorization under Part 26; and whether the individual was subject to any elements of a Part 26 program during the interruption period. Section 26.55 [Initial authorization] establishes authorization requirements for individuals who have not previously held authorization under Part 26 and individuals who have not held authorization within the past 3 years. Section 26.57 [Authorization update] establishes authorization requirements for individuals who previously held authorization under Part 26, whose last period of authorization was terminated favorably more than 1 year ago but less than 3 years ago.

Section 26.59 [Authorization reinstatement] establishes authorization requirements for individuals who previously held authorization under

Part 26 and whose last period of authorization was terminated favorably within the past year. Section 26.69 [Authorization with potentially disqualifying fitness-for-duty information] defines the steps that licensees and other entities must take in granting authorization to an individual about whom potentially disqualifying FFD information has been disclosed or discovered.

The time periods used to establish these categories of authorization requirements are consistent with the categories established in the access authorization orders issued by the NRC to nuclear power plant licensees on January 7, 2003. Basing the requirements on elapsed time is consistent with the programs of other

Federal agencies who have similar needs to control access to sensitive information and protected areas. In addition, these time periods have been used successfully within nuclear power plant access authorization programs since 1989 and have met the NRC's goal of ensuring that individuals who are granted unescorted access are trustworthy and reliable. Therefore, the final rule incorporates these time periods within Part 26.

In general, the steps that are required under this part to grant authorization to an individual who has recently held authorization and whose most recent period of authorization was terminated favorably are less extensive than the steps required for applicants for authorization who are new to the industry or those who have not recently held authorization. In addition, the NRC has strengthened the requirements for a rigorous evaluation process contained in the former Sec. 26.27(e) that licensees and other entities are required to meet before granting authorization to an individual about whom potentially disqualifying FFD information has been disclosed or discovered (see

Sec. 26.69). The final rule requires licensees and other entities to obtain and review a written self-disclosure from the applicant and an employment history, and ensure that a suitable inquiry and pre-access drug and alcohol testing are completed before granting authorization to an individual,

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with certain exceptions. The exceptions to the self-disclosure and employment history, suitable inquiry, and pre-access testing requirements are specified in Sec. Sec. 26.61 [Self-disclosure and employment history], 26.63 [Suitable inquiry], and 26.65 [Pre-access drug and alcohol testing], respectively. The final rule also requires licensees and other entities to ensure that applicants are subject to random testing, as specified in Sec. 26.67 [Random drug and alcohol testing of individuals who have applied for authorization].

Subpart D Management Actions and Sanctions

Subpart D of the final rule replaces former Sec. 26.27(b) and (c) and divides the former provisions into two separate sections that specify requirements for responding to FFD policy violations in Sec. 26.75 [Sanctions], and indications of impairment in Sec. 26.77

Management actions regarding possible impairment

. The final rule adds a new Sec. 26.73 [Applicability] to specify the entities and individuals to whom the requirements of the subpart apply. The former rule has been reorganized to generally reflect the order in which the requirements apply to licensees' and other entities' FFD processes, and to group related requirements into separate sections. Therefore, the

NRC has made these changes to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

In general, subpart D includes three significant changes from the related provisions in the former rule that are each intended to provide a stronger deterrent to engaging in the unwanted actions specified in the subpart. First, the final rule increases the severity of the minimum sanctions that are required if an individual violates a licensee's or other entity's FFD policy. The more stringent sanctions are necessary in order to strengthen the effectiveness of the rule in providing reasonable assurance that individuals who are subject to this part are trustworthy and reliable, as demonstrated by avoiding substance abuse, and by increasing the assurance that only individuals who are fit for duty are permitted to have the types of access or perform the duties listed in Sec. 26.4.

Second, the final rule requires licensees and other entities who are subject to the rule to impose the same sanctions for an FFD violation involving the abuse of alcohol as required for the abuse of illegal drugs. Impairment caused by alcohol abuse creates a risk to public health and safety that is fundamentally similar to the risk posed by the use of illegal drugs. However, some licensees have imposed lesser sanctions for alcohol violations, an approach that is inconsistent with the NRC's intent. Therefore, the final rule rectifies this situation by explicitly requiring the same minimum sanctions for abuse of alcohol as formerly required for the use of illegal drugs.

Third, the final rule adds the sanction of permanent denial of authorization for any individuals who subvert or attempt to subvert the testing process. The former rule permitted licensees and other entities to have flexibility in establishing sanctions for actions such as refusing to submit to testing and attempting to subvert the testing process by submitting an adulterated or substitute specimen. As a result, different FFD programs imposed different sanctions and some individuals were granted authorization or permitted to maintain authorization when they committed such acts. However, acts to defeat the testing process indicate that an individual is not trustworthy and reliable, and suggest that the individual may be engaging in substance abuse that could pose a risk to public health and safety and the common defense and security. Therefore, the final rule establishes a minimum sanction that all FFD programs must impose to deter attempts to subvert the testing process, as well as provide reasonable assurance that individuals who are granted and maintain authorization can be trusted to comply with the rules and regulations to which they are subject.

These three changes have been made to meet Goal 3 of this rulemaking to improve the effectiveness of FFD programs. The NRC has made other changes to former Sec. 26.27(b) and (c) in subpart D primarily to eliminate or modify unnecessary requirements and clarify the intent of former provisions.

Subpart E Collecting for Testing

Subpart E of the final rule reorganizes and amends the requirements related to collecting specimens for drug and alcohol testing that were contained in former Sec. 26.24 [Chemical and alcohol testing] and interspersed throughout former Appendix A to Part 26. The subpart groups the related requirements and presents them in the order in which they would be implemented by FFD programs. The final rule also eliminates some redundancies in the provisions of the former rule that were related to specimen collections. The NRC has made these changes to meet Goal 6 of the rulemaking to improve clarity in the organization and language of the rule.

In general, the procedures in this subpart are more detailed than those in Appendix A to the former rule and NRC regulations that are based on a risk-informed, performance-based approach, for several reasons. First, the more detailed procedures in subpart E will increase the consistency of Part 26 drug and alcohol specimen collection procedures with those of other Federal agencies and therefore, take advantage of the scientific and technical advances that have been made in workplace drug and alcohol testing programs since the former Part 26 was promulgated, as discussed in Section IV.B of this document. Second, the final rule permits FFD programs to accept and rely upon other FFD programs that are implemented under this part, as well as the programs of other Federal and State agencies, to a much greater extent than is permitted under the former rule. The permission to rely on other programs improves the effectiveness and efficiency of FFD programs

(Goal 3 of the rulemaking) and improves the rule by eliminating or modifying unnecessary requirements (Goal 5 of the rulemaking). For example, under Sec. 26.69(b)(6), the final rule permits licensees and other entities to rely on another Part 26 program's drug and alcohol followup testing of an individual who has violated an FFD policy and is consequently required to have at least 15 followup tests within the 3- year period following the violation, and is transferring from one licensee's site to another.

The final rule requires the receiving licensee or entity to continue the followup testing program. However, the final rule permits the licensee or other entity to accept the followup testing that was completed by the previous FFD program when determining the remaining number of followup tests to which the individual must be subject and the period of time during which the individual must continue to be subject to followup testing. Therefore, because the final rule permits this reliance on other programs, more detailed requirements for conducting the activities on which other FFD programs may rely, including drug and alcohol testing, are necessary to provide greater assurance that all Part 26 programs meet minimum standards. Third, the final rule incorporates a greater level of detail in the specimen collection procedures of the final rule for the reasons discussed in

Section IV.B.

The NRC has made other major changes to the former rule's requirements for collecting specimens for drug and alcohol testing to incorporate specimen validity testing

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requirements from the HHS Guidelines into Part 26 (Goal 1 of this rulemaking) and modify former alcohol testing requirements to improve the efficiency of FFD programs (Goal 3 of the rulemaking), while continuing to protect or enhance individuals' rights to privacy and due process under the rule (Goal 7 of the rulemaking).

Subpart F Licensee Testing Facilities

Subpart F of the final rule presents detailed requirements for conducting initial urine specimen validity and drug tests at licensee testing facilities, as permitted in Sec. 26.24(d)(1) of the former rule and Sec. 26.31(d)(3)(ii) of the final rule. The subpart is entitled, ``Licensee Testing Facilities,'' for brevity, but permits other entities who are subject to the rule to establish and operate drug testing facilities under the final rule.

The NRC has added this subpart to the final rule to group together in a single subpart the rule's requirements that are related to licensee testing facilities, which were intermixed with requirements related to drug testing at HHS-certified laboratories in Appendix A to

Part 26 in the former rule. The final rule presents the requirements that are applicable to licensee testing facilities and HHS-certified laboratories in two separate subparts because the provisions of the former rule were not always clear with respect to which requirements applied to which type of testing facility. Also, the final rule includes the requirements that apply to both types of facilities in both subparts so that it is unnecessary for licensees and other entities who do not operate licensee testing facilities to be concerned with any provisions in subpart F. Although many of the requirements in this subpart are redundant with similar requirements in subpart G

Laboratories Certified by HHS

, these changes meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

The most important change in subpart F to the former requirements for licensee testing facilities is the addition of new requirements for licensee testing facilities to conduct initial urine specimen validity testing, based on similar provisions contained in the most recent revision to the HHS Guidelines (69 FR 19643; April 13, 2004). The reasons for requiring initial urine specimen validity testing are discussed with respect to Sec. 26.31(d)(3)(ii). The NRC believes that it is necessary for licensee testing facilities to conduct specimen validity testing because Part 26 permits licensees and other entities to make authorization decisions based on initial drug test results from such facilities. Thus, the rule permits licensees and other entities to grant authorization to an individual who has negative initial test results from pre-access testing without further analysis of the urine specimen by an HHS-certified laboratory. If the initial test results from the licensee testing facility are inaccurate because the urine specimen was adulterated or substituted, the licensee or other entity could grant authorization to an individual who poses a risk to public health and safety and the common defense and security. Similarly, if an individual who has been selected for random testing submits an adulterated or substituted specimen that is not detected by initial tests at the licensee testing facility, the individual would be permitted to maintain authorization if the results of drug testing are negative. Therefore, in order to increase the likelihood that individuals who may be using drugs and attempting to defeat the testing process are detected, and to ensure that they are not permitted to be granted or maintain authorization, the NRC has concluded that it is necessary to require licensee testing facilities to conduct urine specimen validity tests.

However, in consideration of the increased costs and burden that are associated with instrumented initial validity testing, subpart F permits licensee testing facilities to use commercially available validity screening tests of urine specimens, which may be a less expensive alternative than the instrumented initial validity tests required in the current HHS Guidelines. As discussed in Section VI with respect to Sec. 26.5 [Definitions], the final rule uses the term

``validity screening test'' to refer to these commercially available tests. The term ``initial validity test'' refers to instrumented validity testing.

At the same time that the HHS published its regulations to require specimen validity testing, which have been incorporated in the final rule, HHS also published a proposed revision to the Guidelines (69 FR 19673; April 13, 2004) that would permit the use of validity screening devices for the detection of substitution and the presence of adulterants in urine specimens. These devices include non-instrumented devices with visually-read endpoints as well as semi-automated or automated instrumented testing devices with machine-read end points.

Specimen validity tests conducted with these devices use colorimetric assays, which is the same scientific principle as the initial tests conducted at HHS-certified laboratories. Non-instrumented specimen validity devices for urine testing have been shown to detect adulterants in urine specimens and creatinine concentrations on tests that were conducted on specimens that were spiked with drug analytes.

However, the results from the preliminary studies are variable.

Therefore, the proposed HHS Guidelines include extensive performance testing requirements for these devices, which subpart F also incorporates. Such performance testing is necessary to ensure that validity test results based on using these devices are accurate.

Subpart G Laboratories Certified by the Department of Health and Human

Services

Subpart G presents together in a single subpart requirements related to the HHS-certified laboratories that are used by licensees and other entities who are subject to Part 26 for validity and drug testing. The requirements in this subpart group together the former requirements in Appendix A to Part 26 as they relate to HHS-certified laboratories. However, the final rule updates the former requirements to be consistent with the HHS Guidelines that were published in the

Federal Register on April 13, 2004 (69 FR 19643). The most important changes to the former rule's requirements for HHS-certified laboratories are the incorporation of extensive requirements for urine specimen validity testing.

Subpart H Determining Fitness-for-Duty Policy Violations and

Determining Fitness

Subpart H in the final rule reorganizes, clarifies, and enhances former requirements related to the decisions that medical review officers (MROs) and other healthcare professionals must make under Part 26 to provide input to licensees' and other entities' management decisions with respect to granting and permitting an individual to maintain authorization under Subpart C and also with respect to imposing sanctions and taking actions to prevent an individual from performing duties that require an individual to be subject to this part under Subpart D. The former requirements, which were interspersed throughout the rule, are grouped together in Subpart H to make them easier to locate within the final rule, consistent with Goal 6 of this rulemaking to improve clarity in the organization and language of the rule. The subpart also makes several significant changes to the former requirements.

In general, Subpart H includes more detailed requirements for determining

Page 16977

FFD policy violations and conducting determinations of fitness than were included in the former rule. The NRC has added these more detailed requirements in response to implementation questions that the NRC has received from licensees since Part 26 was first promulgated, lessons learned from NRC inspections of FFD programs, and the experience of other Federal agencies that similarly require workplace drug and alcohol testing. However, the NRC's primary concern in establishing more detailed requirements is to enhance the consistency in how FFD policy violations and fitness are determined among Part 26 programs.

The final rule permits licensees and other entities to rely on the determinations made by other Part 26 programs to a greater extent than the former rule. For example, Sec. 26.63(b) of the final rule permits licensees and other entities to rely upon a previous licensee's or other entity's determinations of fitness, as well as their reviews and resolutions of potentially disqualifying FFD information, from previous periods of authorization. The reasons for adding these permissions were discussed previously in this section, with respect to Subpart C.

However, to ensure that all licensees' and other entities' determinations of FFD policy violations and fitness can be relied upon by other FFD programs, it is necessary to enhance the former requirements and establish clear minimum standards for those processes.

Therefore, the subpart includes greater detail to meet Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

Under the final rule, licensees and other entities continue to be prohibited from imposing sanctions on an individual who has a positive confirmatory drug test result from testing at the HHS-certified laboratory until the MRO has had an opportunity to discuss the result with the individual and determines that there is no legitimate medical explanation for the positive result(s). The final rule extends this requirement to the review of positive confirmatory validity test results, consistent with the addition of requirements to conduct validity testing throughout the final rule, as discussed in Section VI with respect to Sec. 26.31(d)(3)(I). An MRO review of adulterated or substituted validity test results from an HHS-certified laboratory before a licensee or other entity imposes sanctions on an individual is necessary for the same reasons that an MRO review is required of positive drug test results. That is, there may be legitimate medical reasons for the adulterated or substituted test result and the test result may not indicate that the donor has violated the FFD policy, which in this case would mean that he or she has not attempted to subvert the testing process. The NRC added a requirement for the MRO to review adulterated or substituted validity test results to meet Goal 7 of this rulemaking to protect the privacy and other rights (including due process) of individuals who are subject to Part 26 and ensure that the individuals are afforded accurate and consistent testing. The HHS

Guidelines also require the MRO to review adulterated and substituted validity test results. Therefore, adding this requirement to the final rule also meets Goal 1 of this rulemaking to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines.

Another significant change that the final rule makes to former requirements is the establishment of a new position within FFD programs--the ``substance abuse expert'' (SAE). The SAE is responsible for performing a determination of fitness, which is determining whether there are indications that an individual may be in violation of the licensee's or other entity's FFD policy or is otherwise unable to safely and competently perform his or her duties, in those instances in which an individual may not be fit for duty for reasons related to drug or alcohol abuse. The NRC has added the SAE position for several reasons.

First, some MROs who provide services under Part 26 have indicated that they do not feel qualified to assess the presence and severity of substance abuse disorders, make treatment recommendations, and determine when an individual who has had a substance abuse disorder may again be able to safely and competently perform duties under this part.

The focus of MRO responsibilities under Part 26 and other Federal workplace drug testing programs is on the medical evaluation of positive, adulterated, substituted, or invalid test results, which requires a knowledge of substance abuse. However, some MROs do not have the extensive knowledge of substance abuse disorders that is necessary to make determinations of fitness and treatment recommendations as required under this part. Therefore, the final rule permits MROs to serve as SAEs if they meet the qualifications for this role that are established in this subpart. But, the rule requires licensees and other entities to rely on other healthcare professionals who have the necessary qualifications to conduct determinations of fitness if the

MRO does not meet the SAE qualification requirements.

Second, the NRC believes that healthcare professionals other than licensed physicians may have the requisite knowledge and skills to serve as SAEs under the rule. Therefore, the final rule defines the position of SAE in terms of the knowledge and skills required, and permits healthcare professionals other than licensed physicians to serve in this role.

Third, under the final rule, FFD programs are permitted to accept determinations of fitness and treatment plans from other Part 26 programs, if an individual who has had a substance abuse problem will be granted authorization by another licensee or entity. Consequently, detailed requirements for the qualifications and responsibilities of the SAE are necessary to ensure consistency among FFD programs.

Detailed requirements for the qualifications and responsibilities of the SAE are necessary because of the key role the SAE plays in assuring the common defense and security and public health and safety when making a determination of fitness on which licensees and other entities will rely when making authorization decisions. It is critical that SAEs understand the potential impact on the common defense and security and public health and safety when determining that an individual who has had an active substance abuse problem has resolved the problem and is again worthy of the public's trust. A sophisticated understanding of substance abuse problems and the types of adverse behaviors they may involve, including knowledge of the research literature and clinical experience, is necessary to inform the SAE's clinical judgments in these circumstances.

The NRC has adapted many of the provisions in the subpart from related DOT requirements regarding the ``substance abuse professional''

49 CFR Part 40, subpart O; 65 FR 41944; August 9, 2001

. The SAE role is not defined in former Part 26.

Subpart I Managing Fatigue

Subpart I of the final rule strengthens the effectiveness of FFD programs at nuclear power plants in ensuring against worker fatigue adversely affecting public health and safety and the common defense and security by establishing clear and enforceable requirements for the management of worker fatigue. Because the overall rationale for including Subpart I, Managing Fatigue, in Part 26, is detailed

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and extensive, this discussion is presented separately in Section IV.D.

Subpart J [Reserved]

As a result of adding Subpart K [FFD Programs for Construction] to the final rule, several subparts of the proposed rule have been renumbered. The provisions contained in Subpart J of the proposed rule have been moved to Subpart N of the final rule.

Subpart K FFD Programs for Construction

As a result of reorganizating the final rule, the NRC has moved the provisions contained in Subpart K of the proposed rule [Inspections,

Violations, and Penalties] to Subpart O of the final rule.

The final rule adds a new Subpart K to revise and increase the level of detail of FFD requirements contained in Sec. 26.3(e) of the proposed rule pertaining to FFD programs for new reactor construction.

The NRC has added this subpart to the final rule to clarify the requirements applicable to entities conducting construction activities in response to public comments that raised concerns with the proposed requirements. A detailed description of these public comments, as well as a summary of the features and objectives of Subpart K can be found in Section V of this document. A detailed section-by-section analysis of the provisions of Subpart K can be found in Section VI of this document.

Subpart L [Reserved]

Subpart M [Reserved]

Subpart N Recordkeeping and Reporting Requirements

As a result of reorganizing the proposed rule, the NRC has moved the provisions contained in Subpart J of the proposed rule

Recordkeeping and Reporting Requirements

to this subpart of the final rule. The NRC has added Subpart N to the final rule to reorganize the former rule's requirements for maintaining records and submitting reports to the NRC. The subpart combines and amends two sections of the former rule: Section 26.71 [Recordkeeping requirements] and Sec. 26.73

Reporting requirements

, and incorporates the record retention requirements of former Sec. Sec. 26.21(b), 26.22(c), and 26.80(c). The final rule adds a new Sec. 26.709 [Applicability]. The NRC has made these changes to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule, by grouping related requirements together in the subpart.

Major changes to the former rule's requirements for recordkeeping and reporting reflect the addition of requirements for specimen validity testing to the final rule, the addition of requirements for managing worker fatigue at nuclear power plants, and a relaxation of the required frequency with which Part 26 programs must submit FFD program performance reports to the NRC from bi-annually to annually.

Subpart O Inspections, Violations, and Penalties

As a result of reorganizing the proposed rule, the NRC has moved the provisions contained in Subpart K of the proposed rule

Inspections, Violations, and Penalties

to this subpart of the final rule. The NRC added Subpart O to the final rule to combine into one subpart former Sec. Sec. 26.70 [Inspections], 26.90 [Violations], and 26.91 [Criminal penalties]. The NRC has grouped these sections together in one subpart because they each establish requirements related to the

NRC's oversight of the implementation of FFD programs. Section 26.821

Inspections

retains the requirements in former Sec. 26.70. Section 26.823 [Violations] retains the requirements in former Sec. 26.90

Violations

. Section 26.825 [Criminal penalties] retains the requirements in former Sec. 26.91 [Criminal penalties].

D. Inclusion of Worker Fatigue Provisions in 10 CFR Part 26

The NRC has determined that the effectiveness of FFD programs in ensuring against worker fatigue adversely affecting public health and safety and the common defense and security should be strengthened by establishing clear and enforceable requirements for the management of worker fatigue at nuclear power plants. Subpart I, Managing Fatigue, of the final rule includes these requirements and establishes an integrated approach to fatigue management for nuclear power plant workers, with fatigue prevention, detection, and mitigation as the fundamental components. The requirements in Subpart I provide a substantial increase in the protection of public health and safety and common defense and security. In establishing the provisions of this final rule, the NRC has taken into consideration the effects of fatigue; the specific work practices of the nuclear power industry that contribute to and mitigate fatigue; the inadequacy of the former regulatory framework; the excessive hours formerly worked by many nuclear power workers; and the practices of other industries and countries for regulating work hours. In addition, the NRC held many public meetings with the nuclear industry and the public to discuss provisions for the final rule.

The NRC has determined that an integrated approach is necessary to effectively manage worker fatigue because individuals experience fatigue for many reasons, including long work hours, inadequate rest, and stressful or strenuous working conditions. Shiftwork, home-life demands, and sleep disorders can all contribute to inadequate sleep and excessive fatigue. Individual differences in workers' tolerance of these conditions also influence worker fitness for duty. As a consequence, fatigue is a complex phenomenon that requires an integrated approach to manage effectively. The requirements in Subpart

I were developed on the premise that fatigue management requires the collaboration of individual workers and licensees.

Each of the requirements in Subpart I is discussed in detail in

Section VI. However, because Subpart I presents an integrated fatigue management approach, this section discusses the principal findings that led to the NRC's decision to include fatigue management provisions in

Part 26, as well as supporting information on the causes and problems with worker fatigue in the nuclear power industry.

The Commission approved a rulemaking plan to include worker fatigue provisions for nuclear power plants in 10 CFR Part 26 on January 10, 2002, (SRM-SECY-01-0113), as described in Section I. Since that time, the NRC has continued to analyze the need for work-hour provisions in the final rule. The considerations listed in the numbered paragraphs that follow summarize the NRC's considerations concerning the appropriate regulatory action to address the potential for worker fatigue to affect public health and safety and the common defense and security. These considerations include:

(1) The research literature demonstrating the substantive effects of fatigue and decreased alertness on an individual's ability to safely and competently perform his or her duties;

(2) The conditions that contribute to worker fatigue in the U.S. nuclear power industry;

(3) With the exception of orders limiting the work hours of security personnel, the NRC's former regulatory framework did not include consistent or readily enforceable requirements to address worker fatigue;

(4) Reviews of industry control of work hours have repeatedly identified practices that were inconsistent with the NRC's Policy on

Worker Fatigue, including excessive use of extended

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work weeks and the overuse of work-hour limit deviations;

(5) The former regulatory framework included requirements that were inadequate and incomplete for effective fatigue management;

(6) Ensuring effective management of worker fatigue through rulemaking substantially enhances the effectiveness of FFD programs, but additional orders are not presently warranted to ensure adequate protection of public health and safety or the common defense and security; and

(7) Addressing the fatigue of workers in safety-critical positions through regulation is consistent with practices in foreign countries and other industries in the U.S.

Each of these considerations is discussed in greater detail below.

(1) Fatigue and decreased alertness can substantively degrade an individual's ability to safely and competently perform his or her duties.

The NRC previously noted in its ``Policy Statement on the Conduct of Nuclear Power Plant Operations,'' dated January 24, 1989 (54 FR 3424), that ``nuclear power plant operators on each shift must have knowledge of those aspects of plant status relevant to their responsibilities to maintain their working environment free of distractions, and using all their senses, be alert to prevent or mitigate any operational problems.'' The degradation in an individual's cognitive functioning resulting from inadequate rest includes, but is not limited to, a reduced ability to sustain attention; maintain situational awareness; make timely and conservative decisions; communicate; and work effectively as a team member. These degradations in performance, if exhibited by individuals performing risk-significant functions, can adversely affect the safety and security of a nuclear power plant.

The NRC evaluated the research available on the degradation of worker abilities that are important to safe plant operation. The research supports the fatigue management provisions in subpart I. Many of the specific research citations are listed in detail in section VI.

The following is a discussion of the fundamental concerns associated with worker fatigue, and some of the overall research that forms the basis for the integrated fatigue management approach in Subpart I.

Many studies have shown that fatigue impairs human alertness and performance (e.g., Alluisi and Morgan, 1982; Rosa, 1991; Scott, 1990;

Dinges, 1992; Dinges, 1995; Dawson and Reid, 1997; Bobko, et al., 1998;

Harrison and Horne, 2000; Williamson and Feyer, 2000). The lack of adequate days off and extended workdays (overtime) can result in a cumulative sleep debt (i.e., the difference between the amount of sleep an individual needs and the amount of sleep that individual actually obtains) and performance impairment (Webb and Agnew, 1974; Baker, et al., 1994; Colquhoun, et al., 1996; Tucker, et al., 1999; Williamson and Feyer, 2000; Department of Transportation (DOT), May 2, 2000, 65 FR 25546). Across a broad range of industries, studies concerning extended work hours suggest that fatigue-induced personnel impairment can increase human error probabilities by a factor of more than 2 to 3 times (Hanecke, et al., 1998; Colquhoun, et al., 1996; Akerstedt, 1995;

U.S. DOT, 49 CFR parts 350, et al., Final Rule, May 2, 2000; 65 FR 25544).

Studies of the nuclear power industry indicate that normal daily variations in alertness associated with human circadian rhythms (i.e., physiological processes that vary on an approximate 24-hour cycle) may be responsible for daily variations in the incidence of personnel errors at nuclear power plants (Bobko, et al., 1998; Dorel, 1996;

Maloney, 1992). The findings of these studies are consistent with the results of a survey of more than 100 nuclear power plant shift supervisors--over 90 percent stated that they notice times of day, and days in the schedule, during which control room operators are less alert, less vigilant, or make more mistakes (Baker, et al., 1990 [EPRI

NP-6748]). These studies suggest that despite controls, such as standardized work practices and independent verification, to ensure correct and reliable human performance, factors that influence alertness may increase the incidence of human errors in nuclear power plants.

Fatigue has generalized effects on human performance capabilities, and is associated with performance decrements at a base level, across a variety of tasks (Dinges, 1995). Fatigue can impair both physical and cognitive (i.e., mental) functioning.

Generally, cognitive task performance is affected more readily by fatigue than physical or psychomotor tracking performance (Krueger, 1989; 1991). General cognitive fatigue decreases an individual's ability to remain alert, process complex information, and correctly grasp a complex set of circumstances. Fatigue has been shown to cause memory problems, slowed responses, lapses and false responses

(Williams, et al., 1959; Morgan, et al., 1974; Dinges, 1992; Dinges, 1995). Many of the cognitive tasks performed by nuclear power plant personnel that are important to the protection of public health and safety and the common defense and security rely on their ability to sustain attention, analyze problems, make rapid, accurate decisions, and communicate and work as a team. The following effects of fatigue on cognitive abilities are the primary focus of the fatigue management requirements:

(a) Sustaining attention--Vigilance and attention to detail are fundamental for plant safety, whether an individual is operating or maintaining equipment important to plant safety, performing surveillance procedures in the plant, monitoring system status in the control room, or monitoring plant security systems or barriers. Tasks requiring sustained attention (e.g., vigilance tasks) are among the most susceptible to fatigue-induced degradation (Monk and Carrier, 2003). The sensitivity to fatigue of vigilance tasks is one of the primary reasons that tests, such as the psychomotor vigilance task

(Dinges, et al., 1997; Doran, et al., 2001), are standard measurement tools used in studies of the effects of sleep deprivation and fatigue.

Of particular note are research findings showing that, in operational settings, individuals may experience periods of sleep up to a few seconds (called microsleeps), during which they fail to respond to external stimuli, and are completely unaware that these episodes have occurred (Cabon, et al., 2003; Priest, et al., 2001; Summala, et al., 1999).

(b) Decision-making--Conservative decision-making is central to safe nuclear power plant operations. Fatigue is associated with more risky strategies and decreases in the effort individuals exert in decision-making (Schellekens, et al., 2000). Furthermore, Harrison and

Horne (2000) reviewed the impact of sleep deprivation on decision- making and reported that, contrary to popular belief, sleep deprivation impairs decision-making even if individuals try to compensate for lack of sleep when responding to heightened stimulation. As noted by Cabon, et al. (2003), studies have shown reductions in aircrew alertness, even during the critical descent phase. These findings suggest that the alerting stimuli of off-normal conditions (e.g., landing an airplane, acknowledging control room annunciators) may not fully negate the effects of fatigue on performance. The National Transportation Safety

Board (NTSB) reviewed the performance of flight crews involved in 37 major accidents and found that those crew members who had been awake longer than 12 hours before their accidents made more errors overall, and specifically more tactical decision

Page 16980

errors, than did crew members who had been awake for less time (NTSB, 1994).

(c) Problem solving--Perseveration is a term used to describe poor problem solving performance, characterized by an individual or group of individuals maintaining a faulty diagnosis or mitigation plan despite contrary information. An example of perseveration from the nuclear power industry was the initial response by plant operators to events at

Three Mile Island Unit 2 in 1979. The operators' initial response was based on a faulty diagnosis of the plant condition (the operators failed to recognize they were dealing with a loss of coolant accident), which the operators maintained throughout the first 2 hours of the event in the face of numerous conflicting indications. Many factors contributed to human performance problems during the Three Mile Island accident and the NRC is not suggesting that operator fatigue was a contributing factor. However, fatigue is one factor that has been found to contribute to this type of performance degradation (Harrison and

Horne, 2000), which may have serious consequences for public health and safety. Sleep-deprived workers fail to appropriately allocate attention, set task priorities, or sample for sources of potentially faulty information (Hockey, 1970; Krueger, 1989). Mental fatigue also contributes to decreased originality and flexibility in problem solving and sub-optimal planning (Van der Linden, et al., 2003; Lorist, et al., 2000; Horne, 1988).

(d) Communication and teamwork--Fatigue affects skills important to written and oral communication and teamwork. Fatigue degrades speech articulation, verbal fluency, grammatical reasoning (the ability to process oral and written instructions), and memory (Harrison and Horne, 1997; 1998). Studies of individuals in simulated combat and command and control conditions have shown that fatigue slows the encoding, decoding, and transcription of information (Banderet, 1981; Angus and

Heslegrave, 1985). Fatigued individuals also tend to be less communicative and have greater difficulty performing multiple tasks concurrently, as demonstrated in simulated aircraft cockpit tasks requiring monitoring and communications (Pascoe, et al., 1995; Harrison and Horne, 2000). These effects have been found in the analysis of incidents and accidents. In a study of major aircraft accidents, crews that had been awake longer (an average of 13.8 hours for captains and 13.4 hours for first officers) made significantly more procedural and tactical decision errors than crews that had been awake for a shorter period (an average of 5.3 hours for captains and 5.2 hours for first officers) (NTSB, 1994). Similar to control room personnel in nuclear power plants, aircraft cockpit crews make extensive use of secondary checks to verify that decisions and performance are correct, and to mitigate the consequences of errors. Although the difference was not statistically significant, analysis of the crew errors indicated that crews that had been awake longer made nearly 50 percent more errors in failing to challenge a faulty action or inaction by another crew member. These studies highlight how fatigue cannot only degrade the fitness of an individual, but also the overall performance of a crew.

Although fatigue has long been widely recognized as causing degraded performance, recent research has helped characterize the magnitude of these effects relative to a historical FFD concern: impairment from alcohol intoxication. Part 26 prohibited the use of alcohol on site and within several hours before a tour of duty, and established alcohol testing requirements for personnel on duty. The NRC established these requirements based on the recognition that alcohol can have significant adverse effects on a worker's ability to safely and competently perform his or her duties. Recent studies have shown that fatigue can cause performance degradations that are comparable to the levels observed from blood alcohol concentrations (BACs) in excess of those that would result in a positive breath alcohol test under the provisions of Part 26. In those studies, individuals who were awake for 17-19 hours had cognitive and psychomotor performance comparable to individuals with a BAC of 0.05 percent (Dawson and Reid, 1997;

Williamson and Feyer, 2000). Part 26 establishes breath alcohol cutoff level below 0.05 percent. The NRC considers the insight that fatigue can impair a worker at levels comparable to those prohibited for alcohol to be particularly significant.

(2) Conditions that contribute to worker fatigue are prevalent in the U.S. nuclear power industry.

Fatigue may result from an individual remaining awake continuously for an excessive period of time, or from the individual obtaining an inadequate amount or quality of sleep, or both. Conditions that contribute to worker fatigue include:

(a) Extended work shifts with five or more consecutive work days--

Although the effects of shift length on worker performance are influenced by the nature of the task, various studies have shown that task performance declines after 12 hours on a task (Rosa, 1991;

Folkard, 1997; Dawson and Reid, 1997). Other studies have shown that the relative risk of having an accident increases dramatically after 9 consecutive hours on the job (Colquhoun, et al., 1996; Hanecke, et al., 1998; U.S. DOT, 49 CFR parts 350, et al., Final Rule; 65 FR 25544; May 2, 2000). The effects of extended working hours on worker performance can be exacerbated when many extended shifts are scheduled in succession. The National Institute for Occupational safety and Health published a report in 2004 (Caruso et al., 2004) that reviewed 52 recent reports examining the association between long work hours and illness, injuries, health behaviors, and performance. NIOSH reported that ``a pattern of deteriorating performance on psychophysiolgical tests as well as injuries while working long hours was observed across study findings, particularly when 12-hour shifts combined with more than 40 hours of work a week.''

The use of 12-hour shifts has become increasingly common at U.S. nuclear power plants. Schedules that include 5 or more 12-hour shifts in succession during routine operations are sometimes popular with workers because they allow a long sequence of days off. However, scheduling more than 4 consecutive 12-hour shifts is not a recommended means of managing fatigue (Baker, et al., 1990 [EPRI NP-6748]; NUREG/

CR-4248, ``Recommendations for NRC Policy on Shift Scheduling and

Overtime at Nuclear Power Plants''). As noted in the 2000 Sleep in

America Poll, ``waking up unrefreshed'' was more likely to be reported by individuals working more than 60 hours per week (58 percent vs. 42 percent of those working 41-60 hours per week and 39 percent of those working 31-40 hours) (National Sleep Foundation, 2000).

During the public meetings described in the preamble to the proposed rule, industry stakeholders noted that the use of 6 or more consecutive 12-hour shifts is now standard practice during plant outages. In SECY-01-0113, the NRC staff reported that more than 80 percent of the authorizations written by licensees to exceed the technical specification work-hour limits during outages were for exceeding 72 hours (e.g., six 12-hour shifts) in a 7-day period. The

NRC's more recent review of deviations authorized at six plants for refueling outages during 2003 and 2004 also indicated that deviations from the limit of 72 hours in 7 days continue to account for more than 80 percent of the

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deviations authorized. During the public meetings, industry stakeholders also reported that, during outages, some licensees have scheduled personnel for three or more weeks of consecutive 12-hour shifts without intervening days off.

(b) Extensive Overtime--Many research studies report that excessive working hours cause worker fatigue (Akerstedt, 1995b; Rosa, 1995;

Buxton, et al., 2002). The U.S. nuclear power industry makes extensive use of overtime, creating a combined effect of long work hours with reduced break periods. As noted in SECY-01-0113, at approximately one- fourth of the sites, more than 20 percent of the personnel covered by working hour limits work more than 600 hours of overtime annually. This amount of overtime is more than two to three times the level permitted for personnel at some foreign nuclear power plants and more than twice the level recommended by an expert panel Commissioned by the NRC in 1985 (NUREG/CR-4248). In SECY-01-0113, the NRC also noted that some licensees authorized hundreds to several thousand deviations from the limits of 16 hours of work in any 24-hour period, 24 hours of work in any 48-hour period, 72 hours of work in a 7-day period, and from the minimum break requirement of 8 hours between work periods. The NRC also noted the continued excessive use of such deviations in its survey of six plants in 2004.

(c) Shiftwork--The nuclear power industry is a round-the-clock operation requiring individuals to be awake and working at times when they would normally be asleep. Although individuals can function in these circumstances, human alertness and task performance are cyclically affected by a daily biological clock, which runs on about a 24-hour (circadian) cycle, as it assists in timing numerous physiological and psychological phenomena (such as core body temperature, the daily release of various hormones, mood swings, and wake-sleep cycle) (Liskowsky, et al., 1991). The circadian trough, or lowest levels of function reflected in, for example, alertness, performance, subjective mood, and body temperature, occurs around 3 a.m. to 5 a.m., with many human functions showing reduced levels between 12 a.m. and 6 a.m. Sleepiness is most severe between 3 and 5 a.m., with a less marked but significant expression again between 3 and 5 p.m.

There is substantial scientific literature on circadian variations in alertness that clearly demonstrates the significant roles that worker fatigue, sleep loss, and circadian rhythms play in contributing to errors and accidents (Kryger, et al., 1994; Akerstedt, 1995a;

Dinges, 1995; Folkard, 1997; Comperatore and Krueger, 1990; Miller and

Mitler, 1997). These findings range from reduced response speed on a variety of tasks, to missing warning signals, to minor hospital incidents and accidents (Krueger, 1994). In addition, as previously described in this section, circadian variations have also been noted in studies of the incidence of personnel errors at nuclear power plants

(Bobko, et al., 1998; Dorel, 1996; Maloney, 1992) and noted in observations by a large number of nuclear power plant shift supervisors

(Baker, et al., 1990 [EPRI NP-6748]).

In addition to causing individuals to perform work at periods of depressed alertness, shiftwork also conflicts with circadian variations in alertness by requiring individuals to sleep during naturally occurring periods of increased cognitive arousal. Circadian rhythms, and naturally occurring tendencies for sleep and wakefulness, do not fully adapt to shiftwork schedules. In addition, daylight, noise and the ``regular day'' schedules of other family members challenge the ability of shiftworkers to obtain adequate rest. As a result, shiftworkers generally obtain less sleep, and report a higher incidence of sleepiness and sleep-related complaints. For example, in a survey of 1,154 U.S. adults, the National Sleep Foundation (NSF) found that shiftworkers, on average, get less sleep (6 hours, 30 minutes) than regular day workers (6 hours, 54 minutes). Almost half of the shiftworkers they surveyed obtained less than 6.5 hours of sleep per

``night'' during the work-week, 30-90 minutes less than recommended by most sleep experts. In comparison to regular day workers, shiftworkers were more likely to be sleepy at work 2 or more days per week (34 percent vs. 23 percent) (National Sleep Foundation, 2000). Many studies have demonstrated that decreased performance and increased errors and accidents are associated with night work and are affected by varying sleep schedules and durations of sleep periods (e.g., Balkin, et al., 2000).

The challenge for shiftworkers to remain alert during the early morning hours of a shift can be exacerbated by extended shift lengths, overtime, and the inability of many shiftworkers to obtain adequate sleep during the day (Hanecke, 1998). The powerful drive for sleep that is associated with circadian factors, and the fact that shiftwork is a daily influence on the alertness of all shiftworkers at nuclear power plants, has been demonstrated by a number of recent events. For example, there have been instances of operators falling asleep in the control rooms at the Pilgrim nuclear power station (2004) and the test and research reactor at the Massachusetts Institute of Technology

(2003), as well as a security officer falling asleep at the Braidwood nuclear power plant while driving a patrol vehicle (2004), despite these individuals recognizing the potential safety and disciplinary consequences.

(d) Early start times and extended commutes --Although many plant personnel do not work rotating shifts, start times before 7 a.m. can interfere with a worker's ability to obtain adequate rest if the schedule is not aligned with his or her circadian cycle and naturally occurring tendency for sleep and wakefulness. Such start times typically cause workers to wake before 6 a.m., thereby reducing the amount of sleep that can be obtained between midnight and 6 a.m., the most effective time period for most people to sleep. In addition, long commutes to remote work sites such as nuclear power plants, which are frequently located in rural areas and distanced from major population centers, contribute to the potential for fatigue associated with early start times.

(e) Sleep disorders--Sleep disorders, such as sleep apnea, insomnia, and restless leg syndrome (i.e., a condition that is characterized by uncomfortable or unpleasant sensations in the legs, causing an overwhelming urge to move them, often contributing to difficulty in staying or falling asleep), are conditions that can significantly reduce the quantity and quality of sleep that individuals are able to obtain, affect an individual's ability to remain alert, and ultimately degrade an individual's ability to safely and competently perform his or her duties (Kryger, et al., 1994; Lewis and Wessely, 1992). These factors are not effectively addressed by limits on working hours in the absence of other fatigue management practices. Although the NRC does not have data for the incidence of sleep disorders that are specific to U.S. nuclear power plant workers, in the general U.S. population, these conditions are not uncommon. For example, the prevalence of sleep apnea is estimated to be 4 percent for adult males and 2 percent for adult females (Strollo and Rogers, 1996). The incidence of sleep apnea may in fact be higher for shiftworkers at power plants, as this condition is more common in middle-age adult males than in the general population. A survey by the NSF of 1,154 adults living in households in the continental U.S.

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found self-reports of sleep apnea were more common from shiftworkers than regular day workers (15 percent vs. 9 percent) (National Sleep

Foundation, 2000). Similarly, the NSF found that shiftworkers reported a higher incidence of insomnia (66 percent vs. 55 percent) than regular day workers.

Although worker motivation can mitigate to a limited degree the effects of fatigue, fatigue has a physiological basis, including changes in glucose metabolism in the brain (Wu, et al., 1991; Thomas, et al., 2000). These changes are beyond the individual's control. In addition, several studies have suggested caution with regard to the abilities of individuals to self-monitor their capacity to safely and competently perform their duties when fatigued (Dinges, et al., 1997;

Belenky, et al., 2003; Akerstedt, 2003). These studies note that individuals experience microsleeps without being aware of their lapses in attention and underestimate their propensity for uncontrolled sleep episodes. As a consequence, a worker's motivation to remain alert does not provide reasonable assurance that an individual will be able to safely and competently perform his or her duties.

Considering the above factors, fatigue can have a significant adverse effect on worker abilities. Further, the likelihood of a nuclear power plant worker being impaired from fatigue is not trivial, and potentially greater than the likelihood of impairment from drugs and alcohol, which the NRC requires licensees to address through their

FFD programs. Therefore, the NRC believes that regulatory action is warranted to ensure that fatigue is adequately addressed through licensee FFD programs. Further, the NRC asserts that rulemaking is the appropriate regulatory action for the following reasons:

(3) With the exception of orders limiting the work hours of security personnel, the NRC's former regulatory framework did not include consistent or readily enforceable requirements to address worker fatigue.

The principal components of the former regulatory framework for matters pertaining to working hours and fatigue for non-security personnel were (a) NRC's Policy on Worker Fatigue, as issued on June 15, 1982, in GL 82-12, and (b) plant technical specifications related to this policy statement, and (c) certain limited requirements of 10

CFR Part 26.

As part of the assessment of PRM-26-2, in which Barry Quigley petitioned for rulemaking to establish enforceable requirements addressing fatigue of workers at nuclear power plants, the NRC reviewed and assessed the implementation and enforceability of the NRC's former regulatory framework applicable to worker fatigue, including licensee technical specifications for the administrative control of work hours.

This review was documented in detail in Attachment 1 to SECY-01-0113.

The NRC continued this evaluation during development of this final rule, and the principal findings include:

(a) NRC's Policy on Worker Fatigue--NRC guidance documents do not prescribe requirements. Guidance documents establish policy or provide advice on meeting a regulatory requirement. As a result, a policy is enforceable only to the extent that the guidelines have been incorporated into a license condition or technical specifications. For the three nuclear power plant sites that have not incorporated the guidelines from the NRC's Policy on Worker Fatigue into a license condition or technical specification, the guidelines are unenforceable.

These plant sites have implemented the concept using other administrative controls that the NRC has determined to be adequate.

However, had the NRC determined that the controls were inadequate, it would have had no basis for taking enforcement action.

(b) Technical Specifications--For those licensees who have incorporated the NRC's Policy on Worker Fatigue into a license condition or technical specifications, consistent enforcement has been complicated by the following factors:

--The language in plant technical specifications is largely advisory

(e.g., an individual should not be permitted to work more than 16 hours straight) and key terms have not been defined. This deficiency has resulted in inconsistent interpretation and implementation of technical specifications by licensees, as well as difficulty for the NRC in enforcing the requirements. For example, many technical specifications use the terms, ``routine heavy use of overtime,'' ``unforeseen problems,'' and ``temporary basis.'' The NRC has not defined any of these terms and has not consistently pursued enforcement on the basis of the amount or frequency of overtime authorized.

--The technical specifications have inconsistent levels of detail from one nuclear power plant licensee to another. Only three-quarters of the licensees' technical specifications include the quantitative work-hour limit guidelines of the NRC's Policy on Worker Fatigue.

--The technical specifications contain varying scopes of requirements.

Some plant technical specifications require periodic reviews of overtime approvals to ensure that excessive hours have not been assigned, while other technical specifications contain no equivalent requirements. Although the observed variability in the controls does not by itself present a safety concern, such variability is inconsistent with establishing a uniform level of assurance that personnel are not in a fatigued condition that could significantly reduce their mental alertness and decision-making capabilities.

--Licensees have inconsistently interpreted the scope of personnel who must be subject to the technical specification work-hour limits. The

NRC's Policy on Worker Fatigue applies to personnel who are performing safety-related functions. The NRC's review of work-hour data gathered by NEI regarding the work hours of personnel subject to the technical specifications (Nuclear Energy Institute, 2000) identified variation in the numbers and types of personnel covered by these controls. A limited number of sites may not have been applying work-hour controls to all personnel performing safety-related functions. At least two nuclear plant sites do not apply the work hour controls to any maintenance personnel even though GL 83-14, ``Definition of `Key Maintenance

Personnel' (Clarification of GL 82-12),'' issued March 7, 1983, defined key maintenance personnel to include individuals who work on safety- related equipment.

--The basic measure used to determine whether an individual's work hours are within or above the technical specification limits has not been implemented consistently from one nuclear power plant to another.

Work hours included within the limits at some nuclear power plants have not been included at others, effectively creating substantively different work-hour limits among plants.

(c) 10 CFR Part 26, ``Fitness for Duty Programs''--The general performance objectives of former Sec. 26.10 required that licensees provide ``reasonable assurance that nuclear power plant personnel * * * are not * * * mentally or physically impaired from any cause, which in any way adversely affects their ability to perform their duties.''

Although former 10 CFR Part 26 contained specific requirements pertaining to alcohol and drug usage, it did not include prescriptive

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requirements regarding fatigue. Rather, former Sec. 26.20 used general, non-mandatory language to state that the FFD policy ``should'' address other factors that can affect a worker's ability to safely and competently perform his or her duties, ``such as mental stress, fatigue, and illness.'' As a result, it has been difficult for the NRC to justify a violation of the regulation based on a licensee's failure to limit overtime hours. In addition, without a numerical limit on overtime hours, or a provision limiting overtime, a range of overtime practices could be viewed as ``reasonable,'' and therefore in compliance with the regulation.

In summary, the broad and non-prescriptive provisions of Part 26, and the technical specifications and license conditions pertaining to fatigue, in the absence of clearly defined terms or measures of fatigue, have made it difficult for the NRC to enforce worker fatigue requirements and work-hours limits in an effective, efficient, and uniform manner that ensures that all licensees provide reasonable assurance that workers are able to safely and competently perform their duties. The NRC believes that a consistent fatigue management program and its uniform implementation across the industry is essential, and the most effective regulatory mechanism is to incorporate worker fatigue requirements into 10 CFR Part 26.

(4) Reviews of industry control of work hours have repeatedly identified practices that were inconsistent with the NRC's Policy on

Worker Fatigue, including excessive use of work hours and work hour limit deviations.

The policy states, in part, ``Enough plant operating personnel should be employed to maintain adequate shift coverage without routine heavy use of overtime.'' Surveys and expert panels have suggested that tolerance for overtime is generally limited to 300-400 hours of overtime per year (ADAMS Accession No. ML05270310; NUREG/CR-4248).

Baker, et al. (1994) reviewed the hours worked by nuclear power plant operations, technical, and maintenance personnel during 1986, four years after the NRC issued its policy. Based on a sample of 63 percent of U.S. nuclear power plants operating at that time, Baker and colleagues found that operations personnel averaged more than 500 hours of overtime annually at 20 percent of the plants, and more than 700 hours of overtime at 9 percent of the plants. Technical personnel averaged more than 500 hours of overtime annually at 30 percent of the plants, and more than 700 hours of overtime at 18 percent of the plants. Maintenance personnel averaged more than 500 hours of overtime annually at 80 percent of the plants and more than 700 hours of overtime at 14 percent of the plants.

The NRC's Policy on Worker Fatigue included provisions for licensees to authorize deviations from the NRC's work and rest guidelines for individual workers in ``very unusual circumstances.'' On

June 10, 1991, following several NRC inspections noting concerns related to licensee work hour control, the NRC issued Information

Notice (IN) 91-36, Nuclear Power Plant Staff Working Hours, to alert licensees of potential problems resulting from inadequate controls to prevent excessive working hours. The conditions cited in the notice included an event attributed to fatigue, excessive use of deviations and overtime, and overtime deviations authorized after the fact.

Subsequent NRC reviews completed in 1999 and 2001 identified continued problems with industry control of work hours. In 1999, the NRC reviewed licensee event reports and NRC inspection reports from January 1994 through April 1999. The NRC found that only a few events of limited risk significance had been attributed to fatigue. However, the staff found several instances each year in which licensee use of overtime appeared to be inconsistent with the general objectives or specific guidelines of the NRC's Policy on Worker Fatigue.

NEI conducted a survey in the summer of 2000 concerning industry control of work hours for personnel subject to the technical specifications (letter dated August 29, 2000, from J. W. Davis, NEI, to

G. M. Tracy, NRC, ADAMS Accession No. ML003746495). Forty-seven sites responded to the survey, providing data from 1997-1999. The NRC staff's review of the data is documented in Attachment 1 to SECY-01-0113. The

NRC evaluated the results of the survey concerning overtime and found that 8 of 36 sites providing data had more than 20 percent of the personnel covered by the policy working in excess of 600 hours of overtime per year. Considering all plants that provided data, the percentage of personnel working in excess of 600 hours of overtime per year increased from 7 percent in 1997 to 11 percent in 1999. The percentage of licensed operators working in excess of 600 hours of overtime per year increased from 13 percent in 1997 to more than 16 percent in 1999. The NRC considers these percentages to represent excessive use of overtime in the nuclear industry.

The NRC also reviewed the data collected by NEI concerning deviations, which showed that approximately one-third of the respondents were authorizing more than a thousand, to as many as 7,500, deviations in a year to exceed the policy guidelines. The frequency of deviations did not appear to be consistent with either the specific guidelines or the general objective of the policy. As previously described in this section, the policy permits deviations from the guidelines in ``very unusual circumstances.''

Subsequent to the Commission's decision to initiate rulemaking for worker fatigue, the NRC staff also obtained data from six sites in 2004. Those data indicated that between 95 and 603 deviations, with an average of 311 deviations, were issued for individuals. The data were provided by the six sites for each plant's most recent refueling outage and one month of power operation, and therefore do not reflect the total number of deviations issued for individuals during all of 2004, except for one of the six sites that provided its deviation data (101 deviations) for all of 2004. Data on the deviations from 2004 in this sample are reported in detail in Appendix 3 of the Regulatory Analysis.

The NRC believes that licensee use of deviations and overtime at some sites has been excessive, and has been inconsistent with the intent of the NRC's Policy on Worker Fatigue.

In addition to excessive work hours and work-hour guidelines deviations, the NRC has recently identified other concerns related to licensee policies and practices applicable to worker fatigue. On May 10, 2002, the NRC issued Regulatory Issue Summary (RIS) 2002-007,

``Clarification of NRC Requirements Applicable to Worker Fatigue and

Self-Declaration of Fitness-for-Duty.'' The NRC issued the RIS following several allegations made to the NRC regarding the appropriateness of licensee actions or policies related to individuals declaring they are not fit due to fatigue. These concerns indicate a need to ensure that individuals and licensees clearly understand their responsibilities with respect to self-declarations of worker fatigue.

The final rule establishes requirements to address this need.

(5) The former regulatory framework included requirements that were inadequate and incomplete for effective fatigue management.

(a) The NRC's Policy on Worker Fatigue did not establish clear expectations for the control of work hours. As previously noted in this section, the NRC did not define key terms of the policy, and, as a

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consequence, implementation has been varied across the industry.

(b) Certain policy guidelines and technical specifications were inadequate to provide reasonable assurance that individuals remain capable of safely and competently performing their duties. For example, the requirement for an 8-hour break between work periods has been revised to a 10-hour break. The basis for this revision to increase the length of this break period is described in detail in Section VI with respect to Sec. 26.205(d)(2)(i).

In addition, although the policy established an objective of a nominal 40-hour work week, the specific work hour guidelines of the policy and most technical specifications for the administrative control of work hours have principally focused on acute fatigue. These guidelines did not adequately address the longer term control of work hours and the cumulative fatigue that can result from prolonged periods of extended work hours. Acute fatigue results from restricted sleep, sustained wakefulness, or continuous task demands over the past 24 hours or more. Cumulative fatigue results from inadequate rest over consecutive sleep-wake periods when the worker obtains less sleep than he or she requires. An individual incurs a sleep debt for each day during which the worker obtains insufficient sleep. If the individual continues to obtain insufficient sleep, this debt accumulates over successive days, resulting in increasing fatigue and impairment

(Belenky, et al., 2003).

The inadequacy of the former regulatory framework for addressing cumulative fatigue became particularly apparent in the months following the terrorist attacks of September 11, 2001. The NRC received numerous allegations from nuclear security officers that certain licensees required them to work excessive amounts of overtime over long periods due to the post-September 11, 2001, threat environment. These individuals questioned their readiness and ability to perform their required job duties due to the adverse effects of cumulative fatigue.

The NRC reviewed the actual hours worked by security personnel and determined that, in the majority of cases, individual work hours did not exceed the guidelines specified in the NRC's Policy on Worker

Fatigue, but the review confirmed that individuals had been working up to 60 hours per week for extended periods. The concerns expressed by individuals regarding their FFD, in light of work schedules that did not exceed the specific guidelines of the policy, as well as relevant technical research supporting the basis for cumulative fatigue, led the

NRC to conclude that the work hour guidelines of the policy were inadequate for addressing cumulative fatigue. The NRC obtained additional worker feedback supporting this conclusion through a review of worker fatigue concerns and work hours during a long-term outage at the Davis Besse nuclear plant (NRC Inspection Report 05000346/2004003, dated March 31, 2004, ADAMS Accession No. ML040910335).

The comprehensive fatigue management approach in Subpart I,

Managing Fatigue, establishes controls to address cumulative fatigue.

Limits to mitigate cumulative fatigue for nuclear power plant security personnel were implemented by Order EA-03-038. The final rule codifies, with changes, these requirements. Changes to those limits that have been imposed by this rule are discussed in detail in Section VI, which also includes a detailed discussion of the limits and other controls to mitigate cumulative fatigue for other personnel who perform safety- related duties at nuclear power plants.

(c) The former regulatory framework did not effectively ensure that fatigue from causes other than work hours was addressed. Work hour controls are necessary, but not sufficient, to effectively manage worker fatigue. As a consequence, training and fatigue assessments are essential. Worker fatigue, and its effects on worker alertness and performance, can result from many causes in addition to work hours

(e.g., stress, sleep disorders, daily living obligations) (Rosa, 1995;

Presser, 2000). In addition, there are substantial individual differences in the abilities of individuals to work for extended periods without performance degradation from fatigue (Gander, 1998; Van

Dongen, et al., 2004a; Van Dongen, et al., 2004b; Jansen, et al., 2003). Subpart I, Managing Fatigue, requires a comprehensive fatigue management program. One example is the strengthening of FFD training requirements concerning worker fatigue. The training requirements will improve the effectiveness of behavioral observation and the assessment of worker fatigue, self-declaration as a means for early detection of fatigue, worker self-management of fatigue, the ability of workers to obtain adequate rest on a shiftwork schedule, and licensee use of effective fatigue counter-measures.

(6) Ensuring effective management of worker fatigue through rulemaking will substantially enhance the effectiveness of FFD programs, but additional orders are not presently warranted to ensure adequate protection of public health and safety or the common defense and security.

Adequate protection of public health and safety and the common defense and security were ensured under the former regulatory framework, including Order EA-03-038 (for security personnel), the

NRC's Policy on Worker Fatigue, and licensee technical specifications.

Licensee FFD programs included behavioral observation programs to identify individuals whose behavior indicates they may not be fit to safely and competently perform their duties, and ensure that those individuals are removed from duty until any question regarding their fitness has been resolved. The former work-hour controls, in conjunction with licensee behavioral observation programs, automatic reactor protection systems and other administrative controls on worker activities (e.g., post-maintenance testing, peer checks, independent verifications) ensured adequate protection of public health and safety and the common defense and security. However, there were substantial limitations to the former regulatory framework, as detailed in this section. Therefore, although the previous regulatory framework provided adequate protection, including work-hour controls in 10 CFR Part 26 provides a substantial increase in public health and safety and the common defense and security. The NRC has incorporated worker fatigue provisions in Part 26 in light of the substantial increase in safety and security that is expected to result.

(7) Addressing fatigue of workers in safety-critical positions through regulation is consistent with practices in foreign countries and other industries in the U.S.

The NRC reviewed the limits on work hours for nuclear plant workers in eight other countries, as well as six other industries in the United

States and Canada. These are summarized in Attachment 1 of SECY-01- 0113. Although many factors influence specific regulatory limits, and requirements for other industries should be considered in context, the

NRC found that the NRC's former guidelines are the least restrictive among those reviewed.

The work hours of nuclear power plant personnel in other countries are largely based on labor laws or union agreements that apply to multiple industries. With the exception of Spain, which has limits consistent with the NRC's Policy on Worker Fatigue, each of the other eight countries has more stringent requirements. The more stringent requirements have largely

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preempted the need in those countries for regulation of work hours based on nuclear safety concerns.

The Department of Transportation (DOT) has established regulatory limits on the work hours of pilots, air traffic controllers, and maintenance personnel in the commercial aviation industry (14 CFR parts 121 and 135); in the maritime industry (46 U.S.C. 8104; 46 CFR parts 15.705, 15.710 and 15.111); in the rail industry (49 U.S.C. 211; 49 CFR

Part 228); and for drivers of heavy trucks in the commercial trucking industry (49 CFR Part 395). The DOT recognized that fatigue can substantively degrade the ability of individuals to perform these duties and, therefore, promulgated regulatory requirements for each of these modes of transportation in keeping with the department's mission to protect public safety. In the late 1980s and early 1990s, the

National Transportation Safety Board (NTSB) identified equipment operator fatigue as a significant issue affecting all transportation modes (Beal and Rosekind, 1995). As a result, DOT classified operator fatigue management as a DOT ``Flagship Initiative'' and several proactive fatigue management activities ensued across the transportation industries (e.g. U.S. DOT, 1995; Rogers, 1996, 1997;

Hartley, 1998; Carroll, 1999).

In 1999, the NTSB evaluated DOT's decade of efforts on operator fatigue (NTSB, 1999). Not satisfied that enough was being done, NTSB subsequently offered DOT three recommendations: (1) expedite a coordinated research program on the effects of fatigue, sleepiness, sleep disorders, and circadian factors on transportation safety; (2) develop and disseminate educational materials for transportation industry personnel and management regarding shift work, work rest schedules, and proper regimens of health, diet, and rest; and (3) review and upgrade regulations governing hours of service for all transportation modes to assure they are consistent and incorporate the results of the latest research on fatigue and sleep issues (NTSB, 1999).

On April 28, 2003, the DOT issued revised hours-of-service regulations to require motor carriers to provide drivers with better opportunities to obtain sleep. Among other provisions, the regulations

(1) increase the required off-duty time from 8 to 10 consecutive hours;

(2) limit driving time to 11 cumulative hours following 10 consecutive hours off duty; (3) prohibit work after the end of the fourteenth hour after the driver began work; and (4) require long break recovery periods to prevent cumulative fatigue (68 FR 22456-22517; April 28, 2003, as amended by 70 FR 50071; August 25, 2005).

Nuclear power plant licensees in the U.S. have sometimes asserted that the characteristics of the work tasks in nuclear power plants differ from other occupations that have work hour controls (e.g. transportation equipment operators); therefore information from other occupations may not be applicable. In addition, licensees have suggested that the level of automation in nuclear power plants provides an important barrier to human errors resulting from fatigue, and that the amount of control room crew interaction and oversight of operators' actions assures that fatigue-induced errors will be detected and corrected before they have an opportunity to impact plant operations.

The NRC concurs that requirements for other industries should be considered in context. Nevertheless, the fact that other Federal agencies with a safety mission have established regulations to address fatigue is relevant for several reasons.

First, the human need for sleep and the deleterious effects of sleep deprivation have a physiological basis (e.g., changes in brain glucose metabolism) that is independent of the nature of the work being performed (Wu, et al., 1991). Second, circadian variations in alertness and performance, and the underlying changes in physiological processes, have been observed in individuals performing a wide range of tasks across many industries (Kecklund, et al., 1997). For all individuals, time since awakening, the time of day, and the amount of prior sleep that an individual obtains relative to his or her sleep needs are primary determinants of fatigue and the need for sleep.

The NRC acknowledges that task characteristics and time on task may exacerbate the effects of fatigue on the ability of individuals to remain alert. For example, a concern for task-specific effects is reflected in the DOT hours-of-service regulations for commercial truck drivers, which establish a daily limit on driving time of 11 hours per day. This limit is in addition to the requirements prohibiting driving after 14 hours on duty and mandating minimum 10-hour break periods, which reflect the human physiological need for rest that is necessary to maintain performance (68 FR 22456-22517; April 28, 2003).

By comparison to driving a truck, the characteristics of some jobs in nuclear power plants (e.g., reactor operator) permit greater freedom of movement and social interaction, which may serve to temporarily mitigate the effects of fatigue on alertness. However, there is no evidence to indicate that worker motivation or the stimulating effects of the job or environment alter the underlying physiological processes.

Although crew interactions and other job characteristics may serve to bolster worker alertness temporarily, environmental stimulation only masks individuals' physiological need for sleep. Removing the stimulation (e.g., transitioning from the activity of shift turnover to monitoring steady state plant operations during a night shift) will increase the potential for lapses in attention and uncontrolled sleep episodes among individuals who may be partially sleep deprived or otherwise fatigued.

Another consideration regarding the relevance of other regulations limiting work hours is that adverse fatigue effects are observed across a broad range of cognitive functions in addition to alertness. Whereas crew interactions may help sustain alertness, sleep deprivation and sustained periods of wakefulness continue to degrade other cognitive functions (e.g., memory and decision making) and elements of performance that are important to safe nuclear plant operations, such as communications and following written and oral instructions. For example, as discussed earlier in this section, studies of crew performance in critical phases of commercial aircraft flight (e.g., take-off and landings) and in simulated battle command station operations have shown fatigue-related degradations in performance despite the stimulation of the interactions, the intense level of activity, and the implications of degraded performance for the loss of human life. Regulations limiting work hours in other industries that use operating crews (e.g., aviation) and allow greater freedom of movement than trucking (e.g. maritime) are consistent with this understanding of the broad effects of fatigue on cognitive performance.

There is no reason to believe that nuclear power plant workers' physiological processes and the adverse effects of fatigue on their abilities to perform their tasks would differ. In addition, the notion that human performance practices in the nuclear industry prevent fatigue-related performance decrements from resulting in human errors is not supported by studies that have shown circadian variations in performance at nuclear power plants (Bobko, et al., 1998; Dorel, 1996;

Maloney, 1992).

The NRC acknowledges that the nuclear power industry is perhaps unique, relative to many other

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industries, in its use of automated safety systems to protect against the consequences of equipment failure and human error. Nevertheless, reliable human performance remains an essential element in the protection of public health and safety and the common defense and security. NRC requirements, such as the minimum onsite staffing requirements of 10 CFR 50.54(m) and minimum security staffing requirements in site security plans, are predicated on the expectation that all personnel in these positions are fit for duty and are able to safely and competently perform their duties. As a consequence, the NRC does not consider the use of automated safety systems to be an appropriate basis for permitting conditions that could allow fatigue to degrade the important line of defense of reliable human performance.

Further, despite automated systems, the contribution of human error to risk in operating events continues to be notable (NUREG/CR-6753,

``Review of Findings for Human Error Contribution to Risk in Operating

Events'').

Because the NRC concurs that task characteristics are an appropriate consideration, the final rule differs from other Federal agencies' requirements with respect to specific work hour requirements and requires licensees to consider task characteristics when authorizing any waiver from the work hour controls. Nevertheless, the

NRC believes that it remains relevant that other Federal agencies with public safety missions have chosen to address worker fatigue through regulation.

In summary, the NRC believes that the requirements in Subpart I will provide a substantial increase in the protection of public health and safety and common defense and security. In determining the provisions of this final rule, the NRC has taken into consideration the effects of fatigue on human performance, the specific work practices of the nuclear power industry that both mitigate and contribute to fatigue, the inadequacy of the former regulatory framework, the excessive hours formerly worked by many nuclear power plant personnel, and the relevant research and practices of other industries and countries for regulating work hour limits. In addition, many public meetings were held with the nuclear industry and the public to discuss draft provisions for the final rule. The specific basis for each provision of the fatigue management portions of the final rule are discussed in Section VI.

The requirements for managing fatigue will provide a substantial increase in the protection of public health and safety and common defense and security by:

(1) Establishing specific, integrated, comprehensive, and enforceable requirements for the effective prevention, detection, and mitigation of worker fatigue;

(2) Ensuring that personnel who perform functions that are significant to the protection of public health and safety or the common defense and security are subject to appropriate work hour controls, including: individuals performing risk significant operations or maintenance duties; health physics, chemistry, and fire brigade duties important to emergency response; and individuals performing security duties important to maintaining the security of the plant;

(3) Establishing work hour controls that provide increased assurance that workers will have adequate opportunity for rest and that deviations from the work hour limits will only be authorized as necessary for plant safety or security and following appropriate assessment of the worker's ability to safely and competently perform his or her duties;

(4) Ensuring that work hour deviations are only permitted when necessary for plant safety or security, and following assessment of the worker's ability to safely and competently perform his or her duties;

(5) Establishing controls to prevent cumulative fatigue that can result from consecutive weeks of extended work hours;

(6) Ensuring workers are provided with sufficient break periods to provide for adequate opportunity for sleep to mitigate acute and cumulative fatigue;

(7) Ensuring that, in addition to work hours, other factors that can affect worker fatigue and the ability of workers to remain alert are adequately addressed through licensee FFD programs;

(8) Encouraging effective fatigue management by permitting licensees to use alternate measures for prevention and mitigation of fatigue; and

(9) Strengthening FFD training requirements concerning worker fatigue. This will improve behavioral observation and assessment of worker fatigue; self-declaration as a means for early detection of fatigue; worker self-management of fatigue; the ability of workers to obtain adequate rest on a shiftwork schedule; and licensee use of effective fatigue counter-measures.

E. Subsequent Rulemakings

On August 28, 2007 (72 FR 49352), the Commission issued a final rule amending its regulations by revising the provisions, particularly 10 CFR Part 52, applicable to the licensing and approval processes for future nuclear power plants. The Part 52 final rule also clarified portions of the former Part 26 to explicitly extend the applicability of sections of the former Part 26 to a combined license holder after the date that the NRC makes the finding under Sec. 52.103(g), a combined license holder before the date that the NRC makes the finding under Sec. 52.103(g), a manufacturing license holder under Subpart F of 10 CFR Part 52, and a person authorized to conduct the construction activities under Sec. 50.10(e)(3). The Part 52 final rule accomplished this by:

(1) Revising the former Sec. 26.2(a) to refer to combined license holders after the date that the NRC makes the finding under Sec. 52.103(g);

(2) Revising the former Sec. 26.2(c) to refer to a holder of a combined license before the date that the NRC makes the finding under

Sec. 52.103(g), a holder of a manufacturing license under Subpart F of

Part 52, and a person authorized to conduct the activities under Sec. 50.10(e)(3);

(3) Revising the former Sec. 26.10(a) to refer to the personnel of a holder of a manufacturing license and those authorized to conduct the activities under Sec. 50.10(e)(3); and

(4) Revising the former Appendix A to Part 26, paragraph 1.1(1) to include a reference to a holder of a combined license after the date that the NRC makes the finding under Sec. 52.103(g).

The Part 52 final rule changes to Part 26 went into effect on

September 27, 2007. Each of the Part 26 provisions revised by the Part 52 final rule has been modified by this final rule, as discussed in section VI of this document.

On October 9, 2007 (72 FR 57416), the Commission issued a final rule amending its regulations applicable to limited work authorizations

(LWAs), which allow certain construction activities on production and utilization facilities to commence before a construction permit or combined license is issued. The LWA final rule modified the scope of activities that are considered construction for which a construction permit, combined license or LWA is necessary, specified the scope of construction activities that may be performed under a LWA, and changed the review and approval process for LWA requests. By making these changes in the LWA final rule, the Commission also revised the scope of

Part 26 by clarifying which entities could be subject to Part 26. The extent to which the LWA final rule impacted

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Part 26 is discussed in section VI in this document.

V. Summary of Public Comments Submitted on Proposed Rule

Description of Public Comments and Public Meetings

The NRC received 81 written public comments on the proposed Part 26 published on August 26, 2005. The NRC also considered six comments submitted on a previous working draft of the proposed rule that NRC posted on its Web site on May 19, 2005, but which were received too late to consider at that time. These 87 written comments contained more than 350 pages of material. The stakeholders who submitted these 87 comments are as follows: 25 (29 percent) from nuclear energy industry representatives, including several substantive comments from NEI; five

(6 percent) from other organizations; seven (8 percent) from unions; 21

(24 percent) from individuals who work in the nuclear energy industry

(i.e. operators, maintenance workers); 15 (17 percent) from other individuals; and 14 (16 percent) from anonymous commenters.

The NRC considered comments contained in the transcript of a public meeting held on September 21, 2005, in which 28 individuals, including

NRC staff, spoke. Four written comments were submitted anonymously at this meeting. The NRC also considered comments from several other public meetings: November 7 and 9, 2005 (ADAMS Accession No.

ML052990048) to provide clarification on the proposed rule; and

December 15, 2005 (ADAMS Accession No. ML053400002) regarding NEI's proposed alternative approach to the work-hour portions of the proposed rule.

The written comments received on the proposed rule addressed many issues that were of stakeholder concern. The NRC analyzed all of these comments as part of the process for developing this final rule. In particular, commenters raised several important concerns relating to fatigue management, the application of FFD requirements to entities involved in new plant construction and manufacturing activities, and validity testing of urine specimens. These concerns are discussed in some detail below. As discussed in Section VI, commenters also raised numerous other smaller issues that led the NRC to modify many final rule provisions. Finally, many comments resulted in minor changes to the proposed rule to improve clarity in the rule's organization and language, consistent with Goal 6 of this rulemaking. Virtually all of the comments supported the objectives of the proposed rule.

Public Comment on Subpart I

The NRC has reorganized the overall structure of the proposed rule and renumbered several subparts. This necessitated renumbering the affected sections of Subpart I [Managing Fatigue].

Subpart I contains requirements for the management of worker fatigue at nuclear power plants. Most comments recommended modifications to Subpart I to address specific concerns with the proposed rule language or certain provisions of the rule. However, the vast majority of the stakeholders commenting on Subpart I expressed their general support for the NRC's objective of establishing a set of clear and enforceable requirements to address the management of worker fatigue at nuclear power plants. Commenters supported the fatigue provisions for various reasons. In particular, commenters expected that the rule would increase the clarity of work hour requirements, reduce forced overtime, provide reasonable assurance that the risk of fatigue- related events is managed, increase staffing levels, and prevent worker injuries. Those who opposed the rule asserted that it would place an unnecessary burden on licensees, reduce worker income, and make it more difficult for licensees to attract supplemental workers during outages.

The NRC received several substantive comments that addressed specific provisions in proposed Sec. 26.199 [Work hour controls]. This section would have established requirements for the control of work hours for a limited scope of personnel at a nuclear power plant. In general, the individuals who would have been subject to these requirements perform functions that most directly affect the protection of public health and safety and common defense and security. The provisions that were the subject of these comments were proposed Sec. 26.199(d)(2)(ii), which would have required a minimum 24-hour break in any 7-day period; proposed Sec. 26.199(d)(2)(iii), which would have required a minimum 48-hour break in any 14-day period; and proposed

Sec. 26.199(f) [Collective work hour limits], which would have required licensees to control the average work hours of specified duty groups (e.g., operations, security). The NRC also received substantive comments on the reporting requirements in Subpart I of the proposed rule. Specifically, the comments concerned the proposed Sec. 26.197(e)

Reporting

which would have required licensees to provide information concerning the implementation of certain work hour requirements as part of an annual FFD program report.

Proposed Requirements for a Minimum 24-Hour Break in Any 7-Day Period

Section 26.199(d)(2)(ii) of the proposed rule would have required a minimum 24-hour break in any 7-day period. Commenters noted that licensees who currently use 8-hour schedules often include periods of 7 consecutive work days in their schedules. These schedules limit the frequency of shift rotations and enable licensees to conduct training on a Monday-through-Friday schedule. The commenters also asserted that the requirement for a minimum 24-hour break in any 7-day period would substantially reduce licensee flexibility in scheduling 8-hour shifts and would cause them to switch to 12-hour shifts. The NRC agrees that the proposed requirement for a minimum 24-hour break in any 7-day period would have adversely affected licensee scheduling of 8-hour shifts as described in the comments and has revised the maximum number of work days that the rule permits between breaks.

Section 26.205(d)(2)(ii) of the final rule replaces proposed Sec. 26.199(d)(2)(ii) and requires a minimum 34-hour break in any 9-day period. In revising the requirement, the NRC considered that, although the final rule permits more consecutive work shifts for 8-hour and 10- hour shift schedules, the additional flexibility allows licensees to more readily optimize their 8-hour shift schedules to minimize the transitions between day, evening, and night shifts that can lead to worker fatigue. Although this relaxation also allows more consecutive shifts for individuals on 10-hour shifts, these individuals typically do not work a rotating schedule and therefore do not experience the disruption of their circadian cycle that exacerbates the cumulative fatigue effects of consecutive work shifts. The rule also establishes minimum day of requirements in Sec. 26.205(d)(3) that effectively limit within each shift cycle the number of times individuals can work the 8 consecutive work days allowed by Sec. 26.205(d)(2)(ii). The scheduling of 12-hour shifts is unaffected by this requirement because

Sec. 26.205(d)(1)(iii) effectively limits the scheduling of 12-hour shifts to not more than 6 consecutive days. The final rule also provides the licensee with sufficient flexibility to accommodate other

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practical considerations, such as scheduling training on a Monday- through-Friday basis, and allows a contingency day for 8-hour shift schedules that include a series of seven consecutive 8-hour shifts.

The final rule also revises the minimum duration of the break period from 24 hours, as specified in Sec. 26.199(d)(2)(ii) of the proposed rule, to a minimum of 34 hours. The revision more clearly reflects the NRC's intent to require a periodic ``day off'' in which individuals have the opportunity for two consecutive sleep periods without an intervening work period. The 34-hour break duration provides this opportunity, supports use of forward rotating and fixed shifts, and allows for the possibility that individuals may work 26 hours in a 48-hour period contiguous to the break.

Proposed Requirement for a Minimum 48-Hour Break in Any 14-Day Period and Collective Work Hour Limits

Section 26.199(d)(2)(iii) of the proposed rule would have required a minimum 48-hour break in any 14-day period. This requirement would have provided periodic breaks to prevent and mitigate cumulative fatigue. Although this requirement would have also been applicable when a reactor was operating, the NRC considered it particularly important for the control of work hours during outages. During these periods, successive weeks of extended work hours (i.e., up to 72 hours per week) are common. However, the NRC received substantive comments regarding this provision.

Several commenters expressed concern that a mandatory 48-hour break would limit the ability of licensees to provide adequate coverage for unplanned maintenance (e.g., to quickly restore inoperable equipment).

Several commenters also stated that the break requirements would encourage supplemental workers to seek jobs in other industries that offer more overtime. Therefore, commenters were concerned that this unintended consequence of the break requirements would harm the licensees' ability to attract and retain qualified workers. Other commenters stated that, although the recovery concept is scientifically supported, the approach used to prevent cumulative fatigue should consider existing work schedules and scheduling practices. Commenters also asserted that a 48-hour break during a series of night shifts would adversely affect the circadian cycle of those workers who had adjusted to the night shift. These commenters stated that for workers on the night shift, having 1 day off provides an additional rest period and allows the worker to maintain a consistent pattern of work and sleep habits, thus reducing the risk of accidents on the job. However, two days off may interfere with a worker's sleep cycle, requiring the individual to readjust to the night shift after a 2-day break.

Commenters also asserted that a 1-day break in any 7-day period is more than adequate when combined with other rule provisions to address cumulative fatigue.

The NRC considered public comments on the proposed 48-hour break requirement in conjunction with public comments on the collective work hour limits of the proposed rule. The collective work hour limits in proposed Sec. 26.199(f) would have required licensees to control the average work hours of specified groups of personnel that perform the same job function. In general, this provision would have required licensees to ensure that the collective work hours of individuals within each group did not average more than 48 hours per week, when averaged over a period of up to 13 weeks. The objective of the collective work hour limits, like the 48-hour break requirement, was to prevent cumulative fatigue. In contrast to the 48-hour break requirement, the collective work hour limits would typically have been applicable only when a reactor was operating. Thus, the 48-hour break requirement in conjunction with the 24-hour break requirement of proposed Sec. 26.199(d)(2)(i) would have been the principal mechanism to address cumulative fatigue during outages, and collective work hour limits would have been the principal means of preventing cumulative fatigue while a plant was operating.

Some commenters stated that the collective work hour limits would be an ineffective means for addressing fatigue because it is experienced on an individual basis. That is, the collective work hour limits could not ensure that each individual would be protected from cumulative fatigue. One commenter stated that the collective work hour controls would allow licensees to force individuals to work overtime.

Other commenters stated that licensees may be able to manipulate the collective work hour calculations. Still other commenters asserted that the collective work hour controls were unnecessary to mitigate the effects of cumulative fatigue and that they would limit licensee flexibility to increase work hours for a job-duty group based on operational needs. These commenters stated that other rule provisions, such as the work scheduling requirement, individual work hour limits, individual break requirements, and the provisions concerning fatigue assessments and the self-declaration process, adequately address the possibility of cumulative fatigue.

The NRC agrees, in part, with certain comments on the proposed 48- hour break requirement and the collective work hour limits of the proposed rule, and has revised the final rule accordingly. To address cumulative fatigue during periods when a plant is operating, the NRC replaced the proposed rule requirement for a minimum 48-hour break in

Sec. 26.199(d)(2)(iii) and the collective work hour limits in Sec. 26.199(f) with the requirements in Sec. 26.205(d)(3) of the final rule. This section requires that each individual subject to the work hour requirements has a minimum average number of days off per week while the plant is operating. This provision addresses comments on the proposed 48-hour break requirement and collective work hour limits as follows:

The minimum day-off requirements of Sec. 26.205(d)(3) address cumulative fatigue on an individual basis. In contrast to the proposed collective work hour limits, the final rule provides more uniform assurance of worker FFD and addresses the concern that, although duty groups could have met the collective work hour requirements, individuals in those groups may have worked excessive hours.

The minimum day-off requirements of Sec. 26.205(d)(3) establish limits that in most circumstances are tailored to the duration of the shifts that individuals work (e.g., individuals on 8- hour shifts must average at least 1 day off per week; individuals on 10-hour shifts must average 2 days off per week). As a consequence, in contrast to the single set of break requirements in the proposed rule, the final rule provides a better correlation between the number of hours an individual works and the amount of restorative rest required by the rule.

The minimum day-off requirements of Sec. 26.205(d)(3) establish a flexible approach to addressing cumulative fatigue. This provision requires a minimum average number of days off per week, averaged over a shift cycle of up to 6 weeks. Accordingly, the rule does not require that individuals meet the average each week, but does ensure that individuals receive a minimum number of days off over the course of the shift cycle. As a consequence, the NRC has established a requirement that accommodates a wide range of scheduling practices and short-term fluctuations in workload. The

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requirement also allows licensees considerable flexibility in accommodating individual worker preferences concerning the timing and distribution of days off.

The minimum day-off requirements of Sec. 26.205(d)(3) establish limits that are practical and likely to impose less administrative burden on licensees than would have been required by the collective work hour limits in the proposed rule.\1\ By establishing limits that require the control of work hours on an individual basis, licensees need not define and track membership in duty groups. In addition, the requirements in the final rule largely adopt an approach proposed by NEI as an industry-recommended alternative to the group work hour controls. Thus, the NRC expects that licensees will consider the administrative requirements of this work hour control method to be less burdensome.

\1\ Although the NRC believes that the minimum day off requirements of Sec. 26.205(d)(3) will impose less administrative burden on licensees than the collective work hour limits of the proposed rule, the NRC has conservatively retained the administrative burden estimate of the collective work hour limits for Sec. 26.205(d)(3) of the final rule.

To address cumulative fatigue during periods when a plant is in a unit or planned security system outage, the NRC has replaced the proposed rule requirements for a minimum 48-hour break (Sec. 26.199(d)(2)(iii)) and the collective work hour limits applicable to security personnel during outages (Sec. 26.199(f)(2)(i)) with the requirements in Sec. 26.205(d)(4) and (d)(5) of the final rule.

Section 26.205(d)(4) requires that licensees provide individuals who perform the operations, health physics or chemistry, and fire brigade duties described in Sec. 26.4(a)(1) through (a)(3) of the final rule a minimum of 3 days off in each successive 15-day period of a unit outage. Section 26.205(d)(4) also requires that licensees provide individuals who perform the maintenance duties described in Sec. 26.4(a)(4) at least 1 day off in any 7-day period. Section 26.205(d)(5) applies to individuals who perform the security duties described in

Sec. 26.4(a)(5) of the final rule and requires a minimum of 4 days off in each successive 15-day period of a unit outage or planned security system outage. These final rule provisions address those comments on the 48-hour break and collective work hour requirements applicable to outage periods as follows:

The minimum day-off requirements of Sec. 26.205(d)(4) do not mandate that licensees schedule 2 consecutive days off as would have been required by the 48-hour break requirement. As a result, licensees are better able to establish schedules that minimize the potential for disrupting the circadian cycle of individuals who are on fixed night shifts.

The minimum day-off requirements of Sec. 26.205(d)(4) allow licensees substantial flexibility in scheduling the required days off within the 15-day outage periods. As a result, licensees are able to implement a range of scheduling options to meet known outage schedule demands and have the flexibility to revise schedules as necessary to address emergent needs.

The minimum day-off requirements of Sec. 26.205(d)(4) allow licensees to use a predictable, repeating schedule. The requirements permit a schedule of four consecutive 12-hour shifts followed by 1 day off. This 5-day sequence can repeat three times in each 15-day period creating a schedule that is predictable and repeatable, characteristics typically desired by workers and schedulers. This schedule limits the number of consecutive work shifts to prevent cumulative fatigue and includes sufficient periodic days off to mitigate fatigue. For individuals performing the maintenance duties described in Sec. 26.4(a)(4) the requirement permits a predictable, repeating schedule of 6 consecutive work days followed by 1 day off.

The minimum day-off requirements of Sec. 26.205(d)(4), in conjunction with the other requirements in Sec. 26.205 [Work hours], allow a maximum workweek of 72 hours and an average workweek of 67.2 to 72 hours for a period of up to 60 days. As a result, the requirements allow licensees to offer substantial amounts of overtime within these limits to attract supplemental workers for outage activities. The NRC acknowledges that some individuals may want to work more than 72 hours, or even more than 84 hours, per week. However, the NRC notes that the work hour limits of Sec. 26.205 apply only to those duties that the agency believes have the most direct impact on the protection of public health and safety and common defense and security. As a result, the requirements do not prevent individuals from working more than 72 hours per week, unless those individuals are performing (1) duties on structures, systems, and components (SSCs) that a risk-informed evaluation process has shown to be significant to public health and safety, (2) critical emergency or fire response duties, or (3) duties as members of the site security force that are necessary for the execution of the site security plan.

Several commenters recommended that the 8-week exclusion period be extended to 10 weeks to accommodate extended outages for activities such as reactor vessel head and steam generator replacements. In conjunction with these comments, industry stakeholders asserted at public meetings held for this rulemaking that cumulative fatigue was not a concern during these extended outages because individuals often had periods when they were not required to work the extended work hours typically associated with outages. In response to this comment, the NRC includes a provision in Sec. 26.205(d)(6) of the final rule which allows licensees to extend the 60-day exception for individuals by 1 week for each 7-day period the individual worked not more than 48 hours during the outage. Thus, the rule allows the outage exception to be extended when directly justified by an individual's actual work history. In light of the significant work hours allowed by the requirements, as discussed in the preceding paragraph, the NRC considers this approach to be better justified for the management of worker fatigue than the proposal for a blanket extension of the outage exclusion to 10 weeks.

Section 26.205(d)(5) of the final rule applies to individuals who perform the security duties described in Sec. 26.4(a)(5) and requires a minimum of 4 days off in each successive 15-day period of a unit outage or planned security system outage. This minimum days-off requirement is comparable to the work hour limits imposed for security personnel by order EA-03-038 and the 60-hour collective work hour average that the proposed rule would have required. The NRC replaced the collective work hour limits for security personnel with the requirements in Sec. 26.205(d)(5) of the final rule for the following three reasons:

(1) In addition to other commenters, security personnel expressed concerns about the effectiveness of the collective work hour controls to fully protect against impairment from fatigue for all personnel in a group.

(2) Elimination of the 48-hour break requirement sets aside a key requirement for preventing an excessive number of consecutive work days that would have otherwise been allowed under the collective work hour limits. As a result, the NRC concluded that the collective work hour limits, absent the 48-hour break requirement, would not provide reasonable assurance that nuclear power plant security personnel would be protected from cumulative fatigue from excessive work hours.

(3) Revision of the outage requirements to a minimum of 4 days off in a 15-day period avoids the potential confusion and additional

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burden of two different approaches and accounting systems (i.e., minimum day off requirements and collective work hour limits) for the control of personnel work hours at a site.

The NRC believes that the minimum day-off requirements of Sec. 26.205(d)(3) through (d)(6) of the final rule address the range of comments on the rule, several of which expressed opposing views regarding the need to relax the requirements or to make them more restrictive.

The NRC does not agree with the comments that asserted that the proposed requirements to address cumulative fatigue were unnecessary and that a 1-day break in any 7-day period is more than adequate when combined with the other rule provisions (e.g., self-declaration and training) to address cumulative fatigue. The NRC has concluded that, given a broad range of considerations, a 1-day break in any 7-day period is an appropriate requirement for individuals performing the maintenance duties described in Sec. 26.4(a)(4) for a limited time period during unit outages. The NRC has also concluded that additional days off are necessary for individuals performing other duties described in Sec. 26.4(a) to ensure that those individuals are not impaired by the cumulative fatigue that would result if they routinely worked the maximum work hours that would otherwise be allowed by the requirements in Sec. 26.205(d)(1) and (d)(2). Accordingly, the final rule requires more than a 1-day break in any 7-day period for individuals performing the duties described in Sec. 26.4(a)(1) through

(a)(3) and (a)(5) during unit outages. For periods when the plant is operating, the final rule requires that all individuals working 10 or 12-hour shifts receive on average more than one day off per week. The rule requires only one day off per week on average for individuals working 8-hour shifts because individuals on 8-hour shifts could not be practically scheduled at the maximum work hours allowed by the requirements in Sec. 26.205(d)(1) and (d)(2).

The NRC acknowledges the important role of self-declaration and training in fatigue management, as noted by some commenters, but also recognizes the inherent limitations of these provisions to effectively address fatigue, particularly during periods of outage schedule conditions. As noted by Michael T. Coyle, NEI, comment letter 49, and supported by several other commenters, ``for many supplemental workers the availability of overtime is a key factor in where they decide to work.'' The NRC also recognizes that outages are periods when individuals may perceive increased schedule pressure and is aware that at least one site offered bonuses for perfect attendance during outages. Self-declaration would likely cause individuals to forfeit a portion of that overtime and possibly a bonus. As a result, despite the best efforts of licensees to emphasize safety and worker

FFD, the NRC anticipates that self-declaration and training in methods to obtain adequate rest may not be implemented as effectively or consistently during outage periods as during periods of routine plant operation, and therefore, they are not a substitute for work hour controls that effectively prevent cumulative fatigue.

In asserting that a 1-day break is more than adequate to address cumulative fatigue, industry stakeholders have cited the basis for the

Federal Motor Carrier Safety Administration's (FMCSA) minimum 34-hour break provision for commercial motor vehicle (CMV) operators. The NRC reviewed the FMCSA regulations (49 CFR Part 395), associated statements of considerations (65 FR 25540 (May 2, 2000); 70 FR 49978 (Aug 25, 2005), the findings of an expert panel commissioned by the FMCSA

(Belenky et al., 1998), a petition for review of the final rule (Brief of Public Citizen, et al., Owner-Operator Independent Drivers Ass'n,

Inc. v. Federal Motor Carrier Safety Admin., 494 F.3d 188 (D.C. Cir.

July 24, 2007) (No. 06-1035) (``FMCSA'')), and the decision of the court with regard to the petition. FMCSA. The NRC concluded that, for a limited range of conditions, the studies cited by FMCSA support a 34- hour break as an appropriate minimum rest period. However, the NRC staff does not agree that the basis cited by the FMCSA supports a requirement that would routinely allow 72 hours of work for all nuclear power plant workers performing functions important to the protection of public health and safety before such a break is required. The NRC notes that:

(1) The FMCSA regulations for CMV operators include requirements that prohibit driving after 60 hours of duty in 7 days. By contrast the

NEI proposal would allow 72 hours of work in a 7-day period, excluding turnover.

(2) The statement of considerations for the FMCSA regulation establishes that long work weeks with minimum break periods are the exception for CMV operators. The FMCSA sets forth this information as a premise for the adequacy of the 34-hour break. By contrast, application of the industry proposed requirement to the control of work hours during unit outages would allow licensed operators \2\ and other plant personnel to work regularly occurring periods of multiple consecutive 72-hour work weeks with minimum break periods. The NRC notes that a federal appeals court vacated the 2005 provision of the FMCSA requirements that would have permitted a 34-hour break to restart the weekly limits. Among the reasons cited by the court was that FMCSA's operator-fatigue model did not ``account for cumulative fatigue due to the increased weekly driving and working hours permitted by the 34-hour restart provision.'' FMCSA at 206.

\2\ At multi-unit sites with common control rooms, all licensed operators would be subject to the limits applicable to unit outages, including operators responsible for operating units.

(3) Contrary to the NEI assertion that a 34-hour break is ``more than adequate'' the expert panel commissioned by the FMCSA described the 34-hour break as ``absolutely minimal.'' Further, the expert panel noted that a fundamental assumption for the adequacy of the 34-hour break is that it will provide two consecutive nights of uninterrupted sleep between midnight and 6 a.m. Given common outage scheduling practices, the NRC believes that no workers on night shifts and few workers on day shifts would meet this assumption.

In addition, the NRC does not agree with industry stakeholder comments that an opportunity for 8 hours of sleep between shifts prevents cumulative fatigue. This argument is contrary to common experience in that it implies workers should be able to work 12 hours per day, without degradation in their performance, for an unlimited number of days. To the contrary, the National Institute for

Occupational Safety and Health (NIOSH) found that ``up to five consecutive 12/14-hour shifts * * * creates the potential for excessive fatigue, even when 8 hours of sleep per day are obtained'' (2000 NIOSH 3). Similarly, the NRC notes that it has received increased reports of excessive fatigue following extended periods of 12-hour shifts, such as in the months following the terrorist attacks of September 11, 2001, and during the extended head replacement outage at Davis Besse (NRC

Inspection Report 05000346/2004003, dated March 31, 2004, ADAMS

Accession No. ML040910335). The NRC found that workers typically did not average more than 60 work hours per week during these periods. As a result, even if a 34-hour break was adequate to mitigate cumulative fatigue from 72 or more hours of work, the 1 day off in a 7-day

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period that the industry's proposed would not ensure that breaks would be provided on a sufficient frequency to prevent weekly occurrences of cumulative fatigue. A NIOSH review (Caruso, et al., 2004) of 52 recent reports examining the association between long work hours and illness, injuries, health behaviors, and performance, reported ``a pattern of deteriorating performance on psychophysiological tests as well as injuries while working long hours was observed across study findings, particularly when 12-hour shifts combined with more than 40 hours of work a week.''

Considering the limitations of the technical basis cited by the industry and its applicability to outage scheduling practices and operating experience and technical literature indicating that 1 day off in 7 days is not adequate for recovery when individuals are working in excess of 60 hours per week, the NRC concluded that the industry proposal would not effectively prevent cumulative fatigue for individuals performing the operations, health physics, chemistry, fire brigade and security duties described in Sec. 26.4(a)(1) through

(a)(3) and (a)(5) for multiple consecutive weeks of extended work hours. The NRC considers the minimum day off requirements of the final rule provide adequate flexibility to accommodate emergent work and a range of scheduling practices while supporting reasonable assurance of worker FFD. By limiting the use of the maximum work hours and minimum break guidelines to a ``temporary basis,'' the requirements of Sec. 26.205(d)(3) through (d)(6) are consistent with the NRC's long-standing

``Policy on Factors Causing Fatigue of Operating Personnel at Nuclear

Reactors.''

Proposed Reporting Requirements

Many comments addressed the reporting requirements for the fatigue provisions. Section 26.197(e) of the proposed rule would have required licensees to submit, as part of the annual FFD program report required under Sec. 26.717 [Fitness-for-duty program performance data] of the final rule, information concerning the licensee's implementation of the work hour controls and management of worker fatigue. The proposed rule would have required the annual report to include a summary of the waivers the licensee approved during the calendar year, information pertaining to instances of job duty groups exceeding a collective work hour average of 48 hours in any averaging period during the calendar year, and information pertaining to instances of fatigue assessments conducted during the calendar year.

Several commenters from industry asserted that the reporting requirements in the proposed Sec. 26.197(e) should be deleted from the rule because they would not provide new or unique information to the

NRC, would be unnecessary to protect public health and safety, would be unnecessary to facilitate NRC oversight of the revised rule, and would be unduly burdensome. One commenter further stated that the NRC's proposed FFD rule and supporting materials did not demonstrate that the industry would fail to comply with the requirements of the revised rule without the imposition of these reporting requirements. The commenter asserted that the existing regulatory process is adequate to ensure compliance with the rule. Some commenters believed that the reporting requirement would create a significant duplication in licensee efforts, noting that proposed Sec. 26.199(j) required periodic reviews by licensees to assess the effectiveness of the work hour controls, and that these reviews are documented and trended under the licensee's corrective action program which is periodically inspected by the NRC.

Some commenters stated that the reports the rule would require would not be a meaningful indicator of licensee performance in managing work hours because a number of valid conditions may warrant waivers of work hour controls. Two commenters suggested that the rule require licensees to report the number of workers covered under Sec. 26.199(a)

Individuals subject to work hour controls

of the proposed rule to provide appropriate context for the annual reporting of waivers.

Several commenters from industry also stated that the NRC did not meet its obligation under the Paperwork Reduction Act with respect to the information collection requirements proposed in Sec. 26.197(e).

They argued that the NRC failed to adequately justify the need for these provisions to achieve the objectives of the proposed FFD rule and failed to objectively support its estimate of the burden placed on affected licensees. The commenters asserted that the annual report would require at least 30 clerical hours to develop and 20 management hours to review.

In response to public comments on the reporting requirements, the

NRC revised certain requirements for the inclusion of fatigue management information in the annual FFD program report. The NRC also made conforming changes to the reporting requirements as part of changes to other provisions of the rule.

Section 26.203(e) [Reporting] of the final rule presents the reporting requirements associated with licensee implementation of

Subpart I. This section does not retain the requirements in proposed

Sec. 26.197(e)(2) for the reporting of information pertaining to the control of collective work hours because the final rule does not include collective work hour controls. In addition, the agency revised the requirements in proposed Sec. 26.197(e)(1) and (e)(2) in response to comments that the required information would not provide a meaningful indication of licensee performance in managing work hours because a number of valid conditions may warrant waivers of work hour controls. Through its review of authorized waivers from the work hour limits in plant technical specifications, the NRC has found that waivers are most frequently associated with outage activities.

Accordingly, the NRC has revised the final rule to require licensees to report whether a waiver of the work hour requirements in Sec. 26.205 was associated with an outage activity.

As a result of these revisions, the NRC will be better able to interpret a licensee's changes in waiver use over time and understand why certain annual reports for a given licensee may indicate a heightened level of waiver use relative to the licensee's previous reports. The NRC recognizes that outages are not the only cause of waivers; however, the agency expects that most other causes of waiver use will be for substantially shorter periods of time or involve smaller groups of workers and that these other conditions would not have a substantive effect on overall waiver use. For unique causes that may have more substantive effects (e.g., licensee response to hurricanes), the NRC is likely to be aware of or able to identify these conditions if they were to significantly affect waiver use. The NRC notes that the frequency of waiver use (i.e., how often individuals exceed the work hour limits while performing functions important to safety and security) indicates the potential for worker fatigue to affect the performance of these functions, regardless of whether a waiver is the result of an activity associated with an outage or a cause that is beyond the licensee's control.

In addition to requiring an indication of whether a waiver was associated with an outage activity, the NRC revised the annual report requirement to require a frequency distribution of waivers for each of the five duty groups described in Sec. 26.4(a) of the final rule. As a result, the annual report would include, for

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example, a table that shows the number of operators who received just one waiver during the year, the number of operators who received two waivers during the year, and so on. The NRC incorporated this requirement in the final rule in response to comments that the rule should also require licensees to report the number of workers covered under Sec. 26.199(a) of the proposed rule to provide an appropriate context for the annual reporting of waivers. The NRC understood that the intent of this comment was to provide a basis for evaluating the number of waivers from the work hour controls relative to the number of individuals subject to those controls. The NRC chose not to require licensees to report the number of individuals covered under Sec. 26.4(a) of the final rule because that number will vary throughout the course of the reporting period, particularly when the reporting period includes a unit outage. In addition, the NRC believes that the required distribution of waivers more effectively provides context to the waiver use information by indicating whether the waivers were concentrated among individuals performing a certain duty and whether the waiver use in a duty group was associated with relatively few individuals or distributed among many individuals.

The NRC does not agree with comments that the requirements for including fatigue management information should be deleted from the rule because they would not provide new or unique information to the

NRC, would be unnecessary to protect public health and safety, would be unnecessary to facilitate NRC oversight of the revised rule, and would be unduly burdensome. In choosing to retain reporting requirements for waiver use, the NRC considered several aspects of the work hour requirements in the final rule. First, the NRC established the work hour limits in the final rule at levels such that the potential for fatigue is substantive for individuals working in excess of those limits. Second, the rule permits licensees to authorize waivers of the limits only for circumstances in which the additional work hours are necessary to prevent or mitigate a condition adverse to safety or security. Finally, the rule only requires a waiver if the individual is operating or maintaining an SSC that a risk-informed evaluation process has shown to be important to the protection of public health and safety or if the individual is performing specified functions that are essential to an effective response to a fire, plant emergency, or implementation of the site security plan. As a result, information concerning licensee use of waivers indicates (1) the number of hours worked on risk-significant activities by individuals who are at increased potential for impairment, and (2) how often a licensee must mitigate or prevent a condition adverse to safety while relying on individuals who are at increased potential for impairment. The NRC considers this unique information, not otherwise reported, to be relevant to the agency's mission.

The NRC similarly considered the need to retain reporting requirements regarding fatigue assessments and any management actions in response to the fatigue assessments. The NRC concluded that the fatigue assessment information that would have been reported under the requirements of the proposed rule is more the purview of a licensee's corrective action program, and would have been more detailed than the program performance data for drug and alcohol testing required under

Sec. 26.717(c) of the final rule. Accordingly, the final rule requires licensees to report a summary of corrective actions, if any, resulting from the licensee's analysis of waiver and fatigue assessment data. As a consequence, the required reports will provide information that will focus more on licensee performance in managing worker fatigue and will enable NRC to review licensee reporting of waivers in the context of associated corrective actions.

The NRC expects that the information provided by licensees in response to the annual reporting requirements in Subpart I will facilitate NRC oversight of the implementation of the requirements through the following means:

Consistency, efficiency, and continuity of NRC oversight--

Information provided through the annual FFD program performance reports concerning fatigue management will enable the NRC to achieve a higher level of consistency and efficiency in the oversight of the implementation of the requirements in Subpart I and in the enforcement of those requirements. Without the reporting requirements, the NRC's inspection of licensee FFD programs would likely be limited to individual inspectors evaluating licensee fatigue management for a sample of workers at a site for a limited time period. These assessments would necessarily be conducted without the benefit of broader contextual information from the site or the industry normative information that would be available through the annual reports. In contrast, the annual reports will help ensure a common perspective and maintain consistency among inspectors conducting the oversight process.

In addition, the annual reports can enhance the efficiency of the NRC inspection process by providing information necessary to allow the agency to focus inspection resources on duty groups (e.g., security or maintenance) that may warrant review. The reports will enable the NRC to be better focused in preparing for the inspection, reduce the burden of onsite inspection hours, and potentially reduce the total number of hours required for a baseline inspection. Further, the annual reporting will also help to achieve a more complete and continuous assessment of licensee performance because the NRC intends to conduct the baseline inspection of FFD programs only once every 2 years.

Evaluation of rule implementation for lessons learned--

Although the NRC and stakeholders have made extensive efforts to ensure clear and enforceable requirements that are effective and practical for the management of worker fatigue, the rule introduces the potential for unintended consequences and lessons learned. In addition, changes in the size and composition of the nuclear industry may have unforeseen implications for site staffing and fatigue management. The NRC expects that the site-specific and normative information obtained through the annual reports can provide important insights regarding opportunities to amend the rule to improve its effectiveness or reduce unnecessary burden. The NRC notes that information provided by the FFD program performance reports was the basis for reducing the random testing rate for drugs and alcohol required in a previous amendment to Part 26.

Consistent interpretation of waiver criterion--The final rule provides licensees the discretion to use waivers to exceed the work hour limits, thereby allowing levels of work hours that could adversely affect worker FFD. The principal basis for allowing waivers is to reduce the additional staffing burden that licensees would otherwise incur if waivers were not available to address exigent circumstances. The annual reporting of waiver use in conjunction with the corrective action summaries will enable the NRC to ensure that licensees use this discretion in a manner consistent with the objectives of the rule and not as a means to compensate for a lack of adequate staffing. Further, although the use of waivers is limited to conditions when the work hours are ``necessary to prevent or mitigate a condition adverse to safety or security,'' the NRC recognizes the potential for licensees to develop different

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interpretations regarding this criterion. Some industry commenters on the proposed rule took exception to the NRC's characterization of high levels of waiver use at some sites as abuse. These commenters suggested that differences in licensee waiver practices could be attributed to the policy being subject to a number of interpretations during the many years that it has been in effect. Regardless of the cause of the differences in licensee use of work hour control waivers, the NRC considers it prudent to address, through rulemaking, the lessons learned from past implementation of the policy and provide a level of oversight through the annual reporting requirement that will ensure consistent implementation of the waiver criteria in the future.

In addition to the reasons cited in the preceding paragraphs explaining the need for reporting requirements to ensure the effective and efficient oversight of the implementation of the rule, the NRC considers the reporting requirements to be justified and beneficial for the following additional reasons:

Consistency with other Part 26 requirements and performance objective--The final rule retains the requirement of the former rule that licensees must report the results of drug and alcohol testing and the performance objective for reasonable assurance that individuals are not impaired from any cause (Sec. Sec. 26.719

Reporting requirements

and 26.23(b) of the final rule). In addition, several studies discussed in detail in Section IV.D of this document have demonstrated that worker fatigue can produce levels of impairment that are comparable to blood alcohol concentrations above the levels permitted by this rule. Further, given the frequency of worker concerns regarding fatigue and the work scheduling practices that are common during outages, the incidence of impairment from fatigue is likely to be greater than the very low incidence of drug and alcohol use that is detected through testing. Therefore, the NRC considers the reporting of information pertaining to licensee management of worker fatigue to be consistent with the requirements for reporting information pertaining to drug and alcohol testing, the performance objective of this rulemaking for licensees to implement a comprehensive FFD program, and the NRC's belief that the management of worker fatigue is no less important to worker FFD than the effective detection and deterrence of drug and alcohol use.

Public confidence--Public interest groups such as the UCS and the Project on Government Oversight have commented at public meetings that relevant information regarding worker fatigue is withheld to either protect alleger identity or, in the case of security personnel, plant security. In addition, several public media articles have been published during the past 2 years reporting instances of guards sleeping and guards fearing repercussions for refusing forced and excessive overtime. Information submitted by licensees in the annual reports will be publicly available and will reassure public stakeholders that the NRC is appropriately cognizant of licensee actions regarding fatigue management and that the NRC's oversight of these activities is transparent to all stakeholders.

The burden is limited and justified--Section 26.203(e) of the final rule requires licensees to report information concerning fatigue management as part of the annual FFD program report. As a result, the burden associated with this reporting requirement is an incremental change to the reporting requirement for drug and alcohol testing. In addition, the fatigue management information required by

Sec. 26.203(e) of the final rule is largely information that licensees will have already generated to demonstrate compliance with other provisions of Subpart I. As a result, the burden associated with the report will be largely associated with compiling the information in an appropriate form and reviewing that compilation. The NRC has reviewed the public comments suggesting that the agency underestimated the number of clerical and management hours associated with this requirement and has taken these comments into consideration in estimating the burden of the reporting requirements in Sec. 26.203(e) of the final rule. Nevertheless, the NRC considers the burden associated with the annual reporting requirements to be justified for the reasons described in this and the preceding paragraphs.

The NRC also considered comments that the reporting requirement ignores significant duplication in licensee efforts. The NRC agrees that Sec. 26.205(e) of the final rule requires licensees to periodically review and assess the effectiveness of the work hour controls and that the licensee's corrective action program, which is routinely inspected by the NRC, will document and trend these reviews.

However, as noted previously, the NRC considers the annual reports to be a limited burden that will enable the NRC to provide more effective and consistent oversight and achieve other objectives for the effective implementation of the requirements in Subpart I.

Public Comments on FFD Programs for Construction and Manufacturing

In response to substantive public comments and industry efforts to develop guidance on the subject, the NRC has added Subpart K to the final rule to clarify Sec. 26.3(e) of the proposed rule, which contained requirements for combined license holders, combined license applicants, construction permit holders, construction permit applicants, as well as manufacturing license holders under Part 52.

Subpart K's FFD program is intended to provide reasonable assurance that individuals involved in the construction of a nuclear power plant who perform specified duties at the site are fit for duty, trustworthy, and reliable, commensurate with the potential risks to public health and safety and the common defense and security that their activities and access to certain information would pose.

Proposed Sec. 26.3(e) would have retained and updated the requirements of Sec. 26.2(c) of the former rule. However, proposed

Sec. 26.3(e) would not have revised the basic approach taken in former

Sec. 26.2(c). The former rule specified the regulations in Part 26 that applied to licensees holding permits to construct a nuclear power plant. Section 26.2(c) of the former rule required each construction permit holder with a plant under active construction to comply with

Sec. Sec. 26.10 [General performance objectives], 26.20 [Written policy and procedures], 26.23 [Contractors and vendors], 26.70

Inspections

, and 26.73 [Reporting requirements] of the former rule.

This provision also explained that permit holders with plants under active construction were required to implement a chemical testing program, including random tests, and make provisions for employee assistance programs (EAPs), imposition of sanctions, appeals procedures, the protection of information, and recordkeeping.

Proposed Sec. 26.3(e) would have explicitly reflected the NRC's combined licensing procedure for nuclear power plants under 10 CFR Part 52, ``Early Site Permits; Standard Design Certifications; and Combined

Licenses for Nuclear Power Plants.'' It would have specified the entities that are regulated by the NRC (specifically, combined license holders before the Commission has made the finding under Sec. 52.103

Operation under a combined license

, combined license applicants who have received authorization to construct under Sec. 50.10(e)(3), construction permit

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holders under Part 50, ``Domestic Licensing of Production and

Utilization Facilities,'' construction permit applicants who have received authorization to construct under Sec. 50.10(e)(3), and holders of manufacturing licenses under Part 52) who would be responsible for meeting certain Part 26 requirements. (The Part 52 final rule amended Sec. 26.2(c) of the former rule to include in Sec. 26.2(c) combined license holders before the date that the Commission makes the finding under Sec. 52.103(g), holders of manufacturing licenses, and persons authorized to conduct the activities under Sec. 50.10(e)(3).)

The proposed rule would have replaced the cross-references to other sections of the former rule with updated cross-references to the related sections in the proposed rule (i.e., Sec. Sec. 26.23

Performance objectives

, 26.41 [Audits and corrective action], and 26.189 [Determination of fitness]). The proposed rule would also have stipulated that the specified entities should implement a drug and alcohol testing program, including random testing, and make provisions for EAPs, imposition of sanctions, procedures for the objective and impartial review of authorization decisions, protection of information, and recordkeeping. However, the proposed rule did not specify in detail how the FFD programs of the entities listed in proposed Sec. 26.3(e) were to address these topics or the categories of workers who would be subject to the programs.

Some comments received during the public comment period stated that the proposed rule did not clearly describe the type of FFD programs the

NRC expected under proposed Sec. 26.3(e). Commenters stated that because the proposed rule required FFD programs for construction to comply with a few specific sections of the rule, it would have imposed virtually all of the rule's requirements on FFD programs for construction, because it would be difficult to ensure compliance with the referenced sections of the rule without applying the entire rule.

Other comments received from industry representatives during the public comment period indicated that the NRC should not require FFD programs for construction that are more rigorous than industrial safety programs implemented during construction of other large, commercial facilities because construction activities do not pose risks to public health and safety or the common defense and security until nuclear fuel arrives on site. In response to these comments, the NRC staff gathered additional information about FFD programs for construction in other industries, developed a new Subpart K, ``FFD Programs for Construction,'' and revised other sections of the rule to clarify the scope of requirements for construction activities.

The results of the NRC staff's benchmarking activities indicated that, as a result of the higher incidence of substance problems among construction workers than other occupational groups, pre-employment, for-cause, and post-accident drug and alcohol testing are increasingly common at large, commercial construction projects and some labor union coalitions have implemented drug and alcohol testing and substance abuse treatment-referral programs for their members. In addition, the staff also identified several private-sector entities in the petrochemical and steel manufacturing industries that require drug and alcohol testing, including random testing, for construction workers on large projects, as well as employment history evaluations and other background checks. Where safety and/or security during construction are critical, large construction projects initiated by some Federal agencies (e.g., the Department of Energy) require drug and alcohol testing, including random testing, extensive background checks, and continuous behavioral observation for the most sensitive construction tasks. The NRC concluded that (1) implementing FFD requirements for new nuclear power plant construction activities is consistent with the practices of other industries, and (2) taking a graded approach to FFD requirements, by imposing requirements that are commensurate with the potential risks to public health and safety and the common defense and security that the results of construction activities may pose when a plant begins operations, is consistent with the approach implemented by other government agencies when constructing facilities that have the potential to affect public health and safety or the common defense and security.

The NRC also determined that some of the requirements in proposed

Sec. 26.3(e) would be difficult to implement. For example, much of the nuclear power plant construction workforce will likely be transient and rapidly changing. As a result, it may be challenging to conduct random drug and alcohol testing in a manner that would meet all of the random testing requirements Part 26 includes for operating plants. In addition, some new reactors will be constructed near an operating plant that has readily accessible FFD program resources, such as a specimen collection and alcohol testing site, a licensee testing facility, an

FFD training program, and expert staff (e.g., a substance abuse expert,

MRO, or EAP representative). However, other new reactors may be constructed at locations that are distant from the FFD program resources of an operating plant. Therefore, the NRC concluded that applying some of the requirements in the proposed rule would be overly burdensome, such as requiring random testing of all construction workers, the requirement for all nuclear power plant construction workers to have access to an EAP, and the proposed requirement for a determination of fitness process performed by a substance abuse expert under Sec. 26.189 of the final rule.

To streamline administration of the FFD program for construction, add flexibility, and implement an approach that is commensurate with the potential risks resulting from new plant construction, the final rule requires two different levels of FFD requirements for workers in different job roles. Because of their important oversight responsibilities, the first category of workers, specified in Sec. 26.4(e), includes any individual whose duties, once construction activities begin, require him or her to perform the following activities at the location where the nuclear power plant will be constructed and operated: serve as security personnel required by the

NRC; perform quality assurance, quality control, or quality verification activities related to safety- and security-related construction activities; based on a designation under Sec. 26.406 by a licensee or other entity, monitor the fitness of the individuals specified in Sec. 26.4(f); witness or determine inspections, tests, and analyses certification required under Part 52; supervise or manage the construction of safety- or security-related SSCs; or direct or implement the licensee's or other entity's access authorization program. These individuals must be subject to a full FFD program that meets the same requirements as FFD programs for operating plants

(including random drug and alcohol testing at the 50 percent annual rate, behavioral observation training, and a suitable inquiry/ employment history check but excluding the requirements of Subpart I) when they are performing duties at the location where the nuclear power plant is being constructed and will operate. However, individuals who serve as security personnel required by the NRC must meet the requirements applicable to security personnel in Sec. 26.4(a)(5) at the time the licensee or other entity

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receives special nuclear material in the form of fuel assemblies.

A new definition of ``supervises or manages'' in Sec. 26.5 explains that these terms mean the exercise of control over work activity by an individual who is not directly involved in the execution of the work activity, but who either makes technical decisions for that activity without subsequent technical review, or is ultimately responsible for the correct performance of that work activity. The reference to security personnel is modified by the addition of the words ``required by the NRC'' to clarify that the FFD requirements are meant to apply to security personnel who perform duties specified by

NRC regulations and orders, while other security personnel, if any, are not covered by the requirements.

By contrast to the requirements for those individuals listed under

Sec. 26.4(e), Sec. 26.4(f) provides that the FFD program in Subpart K applies only to individuals who are constructing or directing the construction of safety- or security-related SSCs. Section 26.5 explains that ``construction or construction activities'' means the tasks involved in building a nuclear power plant that are performed at the location where the nuclear power plant will be constructed and operated, and that these tasks include fabricating, erecting, integrating, and testing safety- and security-related SSCs and the installation of their foundations, including the placement of concrete.

At a minimum, these individuals must be subject to an FFD program that meets the requirements of Subpart K, which emphasizes performance objectives and does not incorporate all of the requirements of Part 26, unless the licensee or other entity chooses to subject them to an FFD program that meets the Part 26 requirements for operating plants, except the fatigue management requirements in Subpart I of the final rule. The rule adds new definitions of ``safety-related SSCs'' and

``security-related SSCs'' (described further in Section VI.A of this

SOC) that clarify the intended coverage of Sec. 26.4(f).

If a licensee or other entity specified in Sec. 26.3(c) of the final rule chooses to implement an FFD program for construction under

Subpart K, the entity must submit to the NRC a description of the FFD program and its implementation as part of the license, permit, or limited work authorization application. The description must include a written FFD policy that will be given to all individuals covered by the program and FFD procedures. The program must include pre-assignment, for-cause, and post-accident drug and alcohol testing. Subpart K requires an FFD program for construction to include sanctions for FFD policy violations, a system of files and procedures to protect personal information, and procedures for reviewing determinations that an individual has violated the FFD policy. The entity who elects to implement a program under Subpart K must conduct periodic audits, maintain records, provide reports to the NRC, and develop and apply procedures for suitability and fitness evaluations to determine whether to assign individuals to constructing safety- and security-related

SSCs. The program description will be evaluated as a part of the application for the license, permit, or limited work authorization and the NRC's finding on the application will include a finding on the FFD program description. Before work begins on the foundations, including placement of concrete, for the safety- or security-related SSCs under the license, permit, or limited work authorization, the entity will be required to implement the FFD program that it has described in its application.

To detect and deter substance abuse by individuals who are constructing safety- and security-related SSCs, Subpart K of the final rule permits a licensee or other entity listed in Sec. 26.3(c) of the final rule to subject these individuals either to random testing for drugs and alcohol or a fitness monitoring program. Subpart K also permits FFD programs for construction to--

(1) Collect specimens other than urine for drug testing and/or rely on collection sites at local hospitals or clinics that conduct testing under U.S. DOT procedures, rather than those specified in Subpart E,

``Collecting Specimens for Testing,'' of Part 26;

(2) Rely on healthcare professionals other than a substance abuse expert to evaluate an individual's fitness;

(3) Designate the persons who will perform fitness monitoring, if the entity elects this option, and adjust the number of fitness monitors performing monitoring and the frequency of monitoring to accommodate the stage of construction and local conditions; and

(4) Establish the random testing rate and limit the selection of individuals for testing to only those who are present and constructing safety- or security-related SSCs on a given day, if the entity elects this option.

In the course of its analysis and development of Subpart K of the final rule, the NRC published a Federal Register notice (71 FR 13782;

March 17, 2006) that described the NRC's alternative concepts for FFD programs during construction and announced a meeting to obtain stakeholder feedback. The concepts described included a requirement for

FFD policies and procedures on a limited set of topics; pre-access drug and alcohol testing, for-cause drug and alcohol testing, and post-event testing for accidents; requirements for protection of information; requirements for collecting specimens and conducting alcohol tests; the option to test specimens at a licensee testing facility; initial and confirmatory testing of urine specimens for drugs and validity at an

HHS-certified laboratory; a review of drug test results by an MRO; and annual reports of FFD program performance. The notice listed fatigue management requirements, random drug and alcohol testing, the requirement for an EAP, and the determination of fitness process described in the proposed Part 26 rule as concepts the NRC was not currently pursuing for FFD programs for construction. These concepts, along with draft guidance for construction programs being prepared by nuclear industry representatives, were discussed at the public meeting held on March 29, 2006.

On October 24, 2006, the NRC published the entire draft final rule text of 10 CFR Part 26 on the NRC's rulemaking Web site and, on

November 7, 2006, held a second public meeting with stakeholders to present the technical basis for Subpart K and to describe the fitness monitoring option included in Subpart K as an alternative to random drug and alcohol testing of construction workers. The NRC staff described four primary reasons for imposing regulatory requirements for

FFD programs during construction: (1) The quality of work could be adversely affected by construction workers who are impaired by substance abuse where studies indicate that members of this group have the highest rates of substance abuse problems among occupational groups in the U.S. (e.g., SAMHSA's NHSDA covering the years 2000-2001 and

SAMHSA's National Survey on Drug Use and Health covering the years 2002-2004), (2) individuals who have become addicted to illegal drugs are susceptible to coercion and will interact with others involved in the drug trade, (3) past experience has demonstrated that errors during construction can adversely affect subsequent plant operations (NUREG/

CR-6819, Vols. 1-4, ``Common-Cause Failure Event Insights,'' (May 2003) and NUREG-1837, ``Regulatory Effectiveness Assessment of Generic Issue 43 and Generic Letter 88-14,'' (October, 2005)), and (4) quality assurance by design uses

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a sampling process. The staff stated that, despite having a high degree of confidence in the effectiveness of quality assurance/quality control programs (required under 10 CFR Part 50) and the inspections, tests, analyses, and acceptance criteria (ITAAC) programs (required under 10

CFR Part 52) to detect construction errors, it is prudent to require an

FFD program during construction to provide reasonable assurance that impaired construction workers do not introduce faults in safety- or security-related SSCs that may cause the SSCs to fail when the plant is operational. In addition, the staff expressed concern that some construction personnel who have substance abuse problems will have access to sensitive information that could be useful to an adversary, as well as physical access to safety- and security-related SSCs that may provide opportunities for malicious acts.

The staff acknowledged, in part, that the full defense-in-depth approach of the FFD program for operating plants is not appropriate for all construction workers because many construction activities do not have the potential to impact subsequent plant operations, and, before fuel arrives on site, do not impose immediate radiological risks. The staff stated that, therefore, the rule's requirements for construction require a full FFD program for only a limited number of personnel who have critical oversight responsibilities for verifying that safety- and security-related SSCs are constructed properly. For workers who will construct the safety- and security-related SSCs, the FFD program requirements in Subpart K are less stringent. For example, Subpart K does not require a suitable inquiry/employment history check for these workers. In addition, the staff acknowledged the many complex logistical challenges associated with implementing FFD requirements during construction. Therefore, the Subpart K requirements provide a licensee or other entity listed in Sec. 26.3(c) of the final rule greater flexibility in implementing FFD programs for construction than the rule permits for FFD programs at operating plants.

The staff also stated that the NRC has decided to defer adopting requirements for reactor manufacturing facilities in the final rule.

Although proposed Sec. 26.3(e) would have covered these facilities, and the Part 52 final rule amended Sec. 26.2(c) of the former rule to include holders of manufacturing licenses, the NRC has concluded that it needs additional information before proceeding with FFD requirements for these facilities.

Stakeholder responses to the staff's presentation varied. Industry stakeholders asserted that Part 26 requirements during nuclear power plant construction are not warranted until shortly before fuel arrives on site. Some industry commenters indicated that, because there are no immediate radiological risks to public health and safety or the common defense and security during the construction of new plants, the NRC should not require FFD programs for construction that are more rigorous than the industrial safety programs implemented during construction of other large, commercial facilities. Industry stakeholders also asserted that NRC requirements for FFD programs during construction are unnecessary because the NRC-mandated quality assurance processes will detect any errors in construction and are adequate to protect public health and safety and the common defense and security, and the industry will voluntarily implement FFD programs during construction for industrial safety and business reasons. Industry stakeholders also commented that the fitness monitoring program, which is permitted under

Subpart K in lieu of random drug and alcohol testing of workers who are constructing safety- and security-related SSCs, is an unfamiliar concept and asked several implementation questions. The staff indicated that it will work with stakeholders to develop a guidance document that would provide examples of acceptable means to implement an FFD program under Subpart K, including fitness monitoring.

A representative from a public interest group stated that the

Subpart K requirements are necessary for FFD during construction.

However, this representative questioned the staff's concerns about construction workers having unfettered access to sensitive information as partial justification for the FFD requirements before fuel receipt.

This individual stated that safety considerations alone, independent of any potential security concerns, warrant regulations for FFD programs for construction before fuel receipt.

Based on the staff's assessment of the potential risks to public health and safety and the common defense and security that the results of construction activities may pose when a plant begins operations, the staff concluded that--

(1) Relying on voluntary FFD programs would not ensure that all workers who construct safety- and security-related SSCs or provide oversight of those construction activities are subject to a program;

(2) Relying on voluntary FFD programs that include only pre- employment, for-cause, and post-accident testing would not provide the on-going detection and deterrence of substance abuse that is achieved by either random testing or a fitness monitoring program;

(3) The extensive programs required for operating plants are not warranted for all nuclear power plant construction activities, but consistent implementation of FFD programs that provide on-going detection and deterrence of substance abuse is warranted; and

(4) Public confidence in new plant construction will be enhanced by a program to provide reasonable assurance that individuals who construct safety- and security-related SSCs are fit for duty.

The NRC believes that the requirements for FFD programs for construction in Subpart K of the final rule (1) provide reasonable assurance that individuals who are responsible for constructing and assuring the quality of safety- and security-related SSCs are fit for duty, trustworthy, and reliable, commensurate with the potential risk to public health and safety and the common defense and security, (2) permit licensees and other entities the flexibility to implement programs that are appropriate for local circumstances and the challenges created by a large and transient workforce, and (3) ensure that the privacy and other rights (including due process) of individuals who are subject to the requirements will be protected.

Public Comment on Drug and Alcohol Testing Provisions

The NRC received several detailed comments on the drug and alcohol testing provisions contained in Subparts E, F, and G. Most significantly, no comments disagreed with NRC's proposed inclusion of specimen validity testing of all urine specimens collected under Part 26 provisions. Most comments related to improving the clarity and intent of the proposed rule. Many comments received were of a technical nature and addressed inconsistencies between the NRC's proposed rule and requirements in other federal testing programs, mainly the HHS's

Mandatory Guidelines for Federal Workplace Drug Testing and DOT drug and alcohol testing regulations (49 CFR Part 40). The NRC, in large part, agrees with many of the comments and has made clarifying revisions to the final rule.

Stakeholder commenters raised several concerns relating to the drug and

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alcohol provisions of the proposed rule. First, numerous comments were received on the validity testing provisions for screening and initial validity tests conducted at licensee testing facilities. Some stakeholders disagreed with the NRC's proposal to permit licensee testing facilities to use point-of-collection type tests to conduct validity screening tests. The NRC considered the comments, but has retained in the final rule the proposed provision to allow licensee testing facilities to use point-of-collection type tests to conduct validity screening tests. However, in response to the comments received, the NRC has revised the performance testing provisions in

Sec. 26.137 to ensure that the functional capabilities of the performance testing of screening tests meet the criteria of the final rule. In addition, another set of comments pointed out that the proposed rule did not afford licensee testing facilities the opportunity to conducting specific gravity testing on specimens, which is a required component of reporting specimens as dilute, substituted, or invalid. The NRC continues to believe that any specimen that has a creatinine concentration below 20 mg/dL must be forwarded for additional testing at an HHS certified laboratory (including specific gravity testing). Finally, the NRC received numerous comments on the use of the term ``non-negative.'' Some commenters believed that the term created significant confusion with respect to understanding specimen test results. The NRC agrees with the commenters and has replaced the term ``non-negative test result'' in the final rule with the term ``positive'' (for drug test results) and the term

``adulterated, substituted, and invalid'' (for validity test results).

In addition, the NRC has replaced the term ``non-negative test result'' with the new term ``questionable validity'' for licensee testing facility test results that indicate that a specimen may be adulterated, substituted, dilute, or invalid.

VI. Section-by-Section Analysis of Substantive Changes

The final rule is organized into twelve subparts that are comprised of related requirements, as follows:

Subpart A--Administrative Provisions

Subpart B--Program Elements

Subpart C--Granting and Maintaining Authorization

Subpart D--Management Actions and Sanctions to be Imposed

Subpart E--Collecting Specimens for Testing

Subpart F--Licensee Testing Facilities

Subpart G--Laboratories Certified by the Department of Health and

Human Services

Subpart H--Determining Fitness-for-Duty Policy Violations and

Determining Fitness

Subpart I--Managing Fatigue

Subpart J--[Reserved]

Subpart K--FFD Programs for Construction

Subpart L--[Reserved]

Subpart M--[Reserved]

Subpart N--Recordkeeping and Reporting Requirements

Subpart O--Inspections, Violations, and Penalties

A detailed cross-reference table between the former and final Part 26 provisions is included at the end of this document.

The NRC has deleted Appendix A of the former rule and moved the detailed requirements for conducting drug and alcohol testing that were contained in Appendix A to 10 CFR Part 26 to Subpart E [Collecting

Specimens for Testing], Subpart F [Licensee Testing Facilities], and

Subpart G [Laboratories Certified by the Department of Health and Human

Services] of the final rule.

Subpart A--Administrative Provisions

Section 26.1 Purpose

Section 26.1 of the final rule amends the language of the corresponding section of the former rule. The final rule deletes the term ``certain aspects'' and adds the term ``implementation'' to the phrase in the former rule which stated, ``for the establishment and maintenance of * * * fitness-for-duty programs,'' in order to convey more accurately that the final rule includes requirements for implementing FFD programs, in addition to requirements for establishing and maintaining such programs. The NRC has moved the portion of former

Sec. 26.1 that referred to the entities who are subject to the rule to

Sec. 26.3 [Scope] in order to meet Goal 6 of the rulemaking to improve clarity in the organization and language of the final rule, by consolidating related requirements into one section.

Section 26.3 Scope

The NRC has reorganized, renumbered, and amended Sec. 26.3 relative to both former Sec. 26.2 [Scope], as modified by the Part 52 final rule, and proposed Sec. 26.3 [Scope] based upon the NRC's consideration of issues raised by public comments on the proposed rule.

In general, the final rule retains and clarifies most of the provisions pertaining to the scope of the former and proposed rules. However, one public comment stated that the proposed rule was confusing with regard to the entities and individuals who are subject to the different requirements of this part. Therefore, the final rule amends this section of the proposed and former rules and adds a new Sec. 26.4 [FFD program applicability to categories of individuals], as discussed with respect to that section, to clarify the rule text. Also, the final rule makes a substantive change to the proposed rule by adding Sec. 26.3(c), which modifies the requirements of proposed Sec. 26.3(e) pertaining to combined license holders and applicants and construction permit holders and applicants. As in Sec. 26.3(e) of the proposed rule, Sec. 26.3(c) of the final rule specifies the requirements to which these entities are subject. However, the final rule modifies these requirements and moves them to a new Subpart K [FFD Programs for

Construction]. These changes are discussed in more detail with respect to Sec. 26.3(c).

Section 26.3(a) of the final rule specifies that licensed nuclear power reactor operators and combined license holders after the

Commission has made the finding in Sec. 52.103(g) shall comply with the requirements of this part, with the exception of Subpart K. The

Part 52 final rule modified former Sec. 26.2(a) to expressly require combined license holders after the Commission has made the finding in

Sec. 52.103(g) to comply with the requirements of Part 26.

The final rule clarifies that the regulations contained in Subpart

K do not apply to the licensees and other entities specified in Sec. 26.3(a) because only entities specified in Sec. 26.3(c) are permitted to implement an FFD program under the more flexible program requirements in Subpart K. The final rule also adds a requirement that licensees who receive their operating license under Sec. 50.57 after the date of publication of the final rule in the Federal Register and holders of a combined license under Part 52 after the Commission has made the finding in Sec. 52.103(g) must implement an FFD program meeting all of the requirements of Part 26 except Subpart K before receipt of special nuclear material in the form of fuel assemblies. The

NRC believes that once fuel assemblies have arrived on site, the full range of potential risks to public health and safety and the common defense and security that Part 26 is designed to avert are possible.

Therefore, the NRC believes that a more rigorous FFD program must be in place at this time.

Section 26.3(b) of the final rule combines Sec. 26.3(b) and (c) of the proposed rule. This section retains the requirement in the first sentence of former Sec. 26.2(a) that licensees who are authorized to possess, use, or transport formula quantities of are subject to the regulations in this part. Section 26.3(b) also retains the requirements of former

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Sec. 26.2(d) and specifies that corporations and entities other than a corporation are subject to the regulations of this part because there may be entities who are organized as firms, partnerships, limited liability companies, or associations who may also obtain a certificate or approved compliance plan under Part 76 and elect to engage in activities involving formula quantities of SSNM.

However, the entities specified in this paragraph are not subject to the requirements contained in Subpart I [Managing Fatigue] for the reasons that are discussed with respect to Sec. 26.201

Applicability

. With respect to the proposed rule, the final rule adds a specification that the entities listed in Sec. 26.3(b) are not subject to the requirements contained in Subpart K, because the requirements of Subpart K apply only to the entities specified in Sec. 26.3(c). The provision also eliminates the cross reference to Sec. 26.25(a)(3) of the proposed rule because the final rule has moved the proposed provisions in Sec. 26.25 to Sec. 26.4 of the final rule for increased clarity in the rule's organization.

Section 26.3(c) of the final rule retains but modifies the provisions of former Sec. 26.2(c) and proposed Sec. 26.3(e). Proposed

Sec. 26.3(e) would have retained and updated the requirements of Sec. 26.2(c) of the former rule before Part 26 was amended by the Part 52 final rule. However, proposed Sec. 26.3(e) did not revise the basic approach taken in former Sec. 26.2(c), and specified the regulations in Part 26 that applied to the entities listed in proposed Sec. 26.3(e). Section 26.3(c) of the final rule specifies that the entities listed are subject to the requirements of Part 26, except Subpart I.

The NRC received a public comment, discussed in detail in Section V of this document, that argued that proposed Sec. 26.3(e) was unclear regarding the type of FFD program the NRC expected from the licensees specified in this paragraph. The NRC acknowledged these concerns, and for the reasons discussed in Section V of this document, the final rule amends the requirements of proposed Sec. 26.3(e) and moves them to a separate Subpart K. The specific requirements applicable to the entities specified in Sec. 26.3(c) are discussed in this document with respect to Subpart K.

Like the proposed rule, the final rule specifies the requirements that are applicable to combined license holders before the Commission has made the finding under Sec. 52.103(g) and to construction permit holders. Section 26.3(c)(2) and 26.3(c)(4) specifies that combined license holders before the Commission has made the finding under Sec. 52.103(g) and construction permit holders, respectively, are subject to the requirements of Part 26, except for Subpart I.

The final rule, however, to be consistent with the LWA final rule, amends the proposed rule with respect to combined license applicants and construction permit applicants. Section 26.3(c)(1) and (c)(3) addresses combined license applicants and construction permit applicants, respectively. Although the proposed rule specified combined license applicants and construction permit applicants who have

``received the authorization to construct under Sec. 50.10(e)(3),'' revisions to Part 50 in the LWA final rule have changed the content and applicability of Sec. 50.10(e)(3). As a result, the Part 26 final rule specifies combined license applicants and construction permit applicants who ``have been issued a limited work authorization under

Sec. 50.10(e), if the limited work authorization authorizes the applicant to install the foundations, including the placement of concrete, for safety- and security-related [SSCs] under the limited work authorization.'' Similarly, in Sec. 26.3(c)(5), the final rule, with respect to the proposed rule, adds a new specification for early site permit holders ``who have been issued a limited work authorization under Sec. 50.10(e), if the limited work authorization authorizes the early site permit holder to install the foundations, including the placement of concrete, for safety- and security-related SSCs under the limited work authorization.'' (The final rule contains definitions of safety- and security-related SSCs in Sec. 26.5, and those definitions are discussed with respect to that section.)

The LWA final rule modified the scope of activities that are considered construction for which a construction permit, combined license, or LWA is necessary, and specified the scope of construction activities that may be performed under an LWA. Under an LWA, entities are allowed to perform some or all of the following activities: driving of piles, subsurface preparation, placement of backfill, concrete, or permanent retaining walls within an excavation, and installation of the foundation, including placement of concrete, any of which are for an

SSC of a production or utilization facility for which either a construction permit or combined license is otherwise required under 10

CFR 50.10(c).

The NRC has concluded that if the entity is authorized under the

LWA to perform only the driving of piles, subsurface preparation, or placement of backfill, concrete or permanent retaining walls within an excavation for safety- and security-related SSCs, it will not be required to comply with Part 26. Entities who are authorized under the

LWA to perform installation of the foundation, including placement of concrete, for safety- or security-related SSCs, however, will be required to comply with Part 26 and establish either an FFD program under Subpart K of Part 26 or an FFD program that complies with all of

Part 26 except Subparts I and K.

The NRC based its decision to distinguish the installation of the foundation, including placement of concrete, from the other activities listed under Sec. 50.10(d)(1) on the following considerations. First, until the NRC broadened the concept of construction because of its early interpretation of the National Environmental Policy Act, construction requiring NRC approval in the form of a construction permit was defined in Sec. 50.10 as ``pouring the foundation for, or the installation of, any portion of the permanent facility on the site.'' Thus, installation of the foundation has in the past been identified by the agency as a key step in construction.

Second, the NRC concluded that installation of the foundation is different in kind from the other activities listed under Sec. 50.10(d)(1). A common meaning of ``foundation'' is the underlying base or support for a building or the substructure of a building. Therefore, the foundation is an integral component of the fabric of a safety- or security-related SSC, while piles, backfill, and retaining walls are not. The foundation must be installed properly on the first attempt, as any flaws in the foundation or voids or concrete will be difficult to detect and impossible to correct without complete re-installation of the foundation. The individuals who install foundations for safety- and security-related SSCs must therefore be fit-for-duty and trustworthy and reliable. Thus, the installation of foundations has a closer and more significant nexus with public health and safety and common defense and security, and the individuals who construct or direct the construction of such SSCs should be subject to an FFD program.

Third, the public can be expected to view installation of foundations as different from, and more important than, other activities under an LWA because of the integral nature of foundations with the SSCs and the nexus with public health and safety and common defense and security. An FFD program that provides reasonable

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assurance that the individuals who perform installation of foundations of safety- or security-related SSCs are trustworthy and reliable and fit to perform their duties will enhance public confidence in the NRC's regulatory processes and the safety and security of newly constructed nuclear power plants.

Further, Sec. 26.3(c) of the final rule explains that if the licensees and other entities specified in Sec. 26.3(c)(1) through (5) receive special nuclear material in the form of fuel assemblies, then those entities must comply with all of the requirements of Part 26.

This requirement is consistent with the requirement in Sec. 26.3(a) that licensees who receive their operating license under Sec. 50.57 after the date of publication of the final rule in the Federal Register and holders of a combined license under Part 52 after the Commission has made the finding in Sec. 52.103(g) must comply with the requirements of Part 26, except Subpart K, before the receipt of special nuclear material in the form of fuel assemblies. Under both

Sec. 26.3(a) and (c), no later than when fuel arrives on site, the applicable licensees and other entities must implement an FFD program that complies with the requirements of Part 26 for the reasons discussed with respect to Sec. 26.3(a).

The NRC has decided to defer adopting requirements for reactor manufacturing facilities. Although these facilities would have been covered under proposed Sec. 26.3(e) and were temporarily included in the former Sec. 26.2(c) as amended by the Part 52 final rule, the agency has concluded that it needs additional information before going forward with FFD requirements for such facilities, particularly when

FFD requirements are closely linked to issues of access authorization and physical security. The NRC is considering, but has not yet completed, regulatory requirements on those subjects for reactor manufacturing facilities. Any industry stakeholders with a potential interest in pursuing a license for a reactor manufacturing facility should ensure that they engage in early discussions with the NRC so that suitable requirements can be developed in a timely manner.

Section 26.3(d) of the final rule retains the meaning of a portion of former Sec. 26.23(a)(1), but amends some of the terminology used in the former rule. Like the proposed rule, the final rule requires that a

C/V FFD program must meet the standards of Part 26 if licensees and other entities specified in paragraphs (a) through (c) of Sec. 26.3 rely upon the C/V's FFD program or program elements to meet the requirements of Part 26. The provision adds C/Vs to the list of entities who are subject to Part 26 in Sec. 26.3 to more clearly convey that C/Vs may be directly subject to NRC inspection and enforcement actions than the former rule language implied. The former rule text presented the applicability of the rule's requirements to a

C/V's FFD program in terms of the contractual relationship between a licensee and the C/V. For example, former Sec. 26.23(a)(1) stated,

``The contractor or vendor is responsible to the licensee [emphasis added] for adhering to the licensee's fitness-for-duty policy, or maintaining and adhering to an effective fitness-for-duty program; which meets the standards of this part.'' This paragraph, and others in the former rule, could be interpreted as implying that a C/V is accountable to the licensee but not to the NRC, should significant weaknesses be identified in the C/V's FFD program upon which a licensee relies. However, this interpretation would be incorrect. Therefore,

Sec. 26.3(d) of the final rule includes C/V FFD programs and program elements upon which the licensees and other entities specified in paragraphs (a) through (c) of this section rely within this section to convey more accurately that C/Vs are directly accountable for meeting the applicable requirements of Part 26, not only through their contractual relationships with the licensees and other entities who are subject to the rule. This clarification also is necessary to maintain the internal consistency of the final rule because some provisions of the rule apply only to C/Vs, including, but not limited to Sec. 26.717(g). The final rule makes this change to meet Goal 6 of the rulemaking to improve the clarity in the organization and language of the rule.

The phrases ``program elements'' and ``licensees and other entities specified in paragraphs (a) through (c) of this section'' are used in

Sec. 26.3(d) of the final rule because C/Vs need only meet the requirements of Part 26 for those FFD program elements upon which licensees and other entities rely to meet the requirements of the rule.

For example, a C/V may choose to implement all of the program elements that are required for a full FFD program under the final rule except drug and alcohol testing. In this case, the final rule does not require the C/V to address drug and alcohol testing in the C/V's FFD policy, procedures, and training program; establish contracts with drug-testing laboratories; collect specimens for drug and alcohol testing; or meet any other requirements in the final rule that relate to conducting drug and alcohol testing. However, if a C/V chooses to conduct drug and alcohol testing under some or all of the conditions specified in Sec. 26.31(c) [Conditions for testing], such as for cause testing, and a licensee or other entity specified in Sec. 26.3(a) through (c) relies upon the results of the C/V's tests in determining whether to grant authorization to an individual (see Subpart C [Granting and Maintaining

Authorization]), then the use of these phrases in the provision would be correctly interpreted to mean that the C/V's drug and alcohol testing program element must meet the final rule's requirements related to drug and alcohol testing when conducting the tests on which the licensee or other entity relies. In contrast, if a C/V implements an

FFD program element that is addressed in this part, but that program element is not relied upon by a licensee or other entity specified in paragraphs (a) through (c) of this section, then the provision does not require the C/V to meet the applicable Part 26 requirements for that

FFD program element. Section 26.3(d) requires C/Vs to meet the requirements of Subpart I of the final rule, if any nuclear power reactor licensees specified in Sec. 26.3(a) through (c) rely upon a C/

V's fatigue management program element to meet the requirements of

Subpart I. The applicability of Subpart I to C/Vs is discussed with respect to Sec. 26.201.

The NRC has either eliminated or moved to other places of the final rule other provisions of former Sec. 26.23 [Contractors and vendors].

The NRC has moved the former requirement for licensees to retain written agreements with C/Vs in the second sentence of Sec. 26.23 to

Subpart N [Recordkeeping and Reporting Requirements] of the final rule.

The NRC has moved the requirement in former Sec. 26.23(a)(1) to

Subpart C of the final rule. That provision requires that individuals who have violated an FFD program must not be assigned to work within the scope of this part without the knowledge and consent of the licensee. The NRC has addressed the audit requirement contained in former Sec. 26.23(b) in Sec. 26.41(d) [Contracts] of the final rule.

By moving the former requirements to different sections of the final rule and grouping related requirements together in one section or subpart that addresses similar topics, the NRC has met Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

The NRC has amended and moved the requirements of proposed Sec. 26.3(e) to

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Sec. 26.3(c) and Subpart K of the final rule. The requirements contained in proposed Sec. 26.3(e) are discussed in this document with regard to those sections.

Section 26.3(e) of the final rule, like the proposed rule, retains the second sentence of former Sec. 26.2(b) and addresses entities who are not subject to the rule. The NRC has moved the first sentence of former Sec. 26.2(b), which addressed individuals who are not subject to the rule, to Sec. 26.4(i) of the final rule for organizational clarity.

Section 26.4 FFD Program Applicability to Categories of Individuals

In the proposed rule, the NRC moved the provisions in former Sec. 26.2 that specified the individuals whose duties require them to be subject to the rule and exempt certain other individuals to Sec. 26.25

Individuals subject to the fitness-for-duty program

. However, the NRC has deleted Sec. 26.25 from the final rule, and has amended, reorganized, and moved all of the provisions in proposed Sec. 26.25 to a new Sec. 26.4 to group related applicability requirements together in one section.

The provisions moved into new Sec. 26.4 include the second sentence of former Sec. 26.2(a), the first sentence of former Sec. 26.2(b), and the portion of the second sentence of former Sec. 26.2(d) that pertained to personnel. The NRC determined that separating into two different sections the requirements that address the entities who are subject to the rule and the requirements that address the individuals who must be subject to the rule makes the two sets of provisions easier to locate within the final rule without compromising the intended meaning of these provisions. Also, moving the applicability requirements for individuals into Subpart A [Scope] from

Subpart B [Program Elements], where they were located in the proposed rule, is appropriate because some categories of individuals who are subject to the rule are not subject to Subpart B of the final rule. The applicability requirements in Sec. 26.4 clearly specify the categories of individuals who are subject to Part 26. The NRC determined that grouping all of the applicability requirements into one subpart of the final rule increases the ease of locating these provisions, consistent with Goal 6 of this rulemaking to improve clarity in the organization of the rule.

Section 26.4(a) of the final rule retains portions of proposed

Sec. 26.25(a)(1). Proposed Sec. 26.25(a)(1) amended portions of former Sec. 26.2(a) and (d) and described the individuals whose duties require them to be subject to Part 26. The final rule specifies that the persons who are granted unescorted access to nuclear power reactor protected areas by the licensees and other entities in Sec. 26.3(a) and (c), as applicable, and who perform the duties in Sec. 26.4(a)(1) through (a)(5) shall be subject to an FFD program that meets the requirements of this part, except Subpart K but including Subpart I.

The NRC has moved the categories of individuals specified in Sec. 26.199(a)(1) through (a)(5) of the proposed rule to Sec. 26.4(a)(1) through (a)(5) of the final rule in order to group together all related applicability requirements for individuals in one section. This change is consistent with Goal 6 of this rulemaking to improve clarity in the organization and language of the rule. Additional concerns regarding the reasons why individuals performing these duties shall be subject to the fatigue management provisions of Subpart I are discussed with respect to Sec. 26.205(a) [Individuals subject to work hour controls].

The final rule clarifies that these individuals may not be subject to the more flexible FFD program described in Subpart K because they may be granted unescorted access by the licensees in Sec. 26.3(a), to whom all of the requirements of this part, except Subpart K, apply, and entities in Sec. 26.3(c), as applicable, to whom all of the requirements of this part apply.

Section 26.4(b) of the final rule retains portions of and amends proposed Sec. 26.25(a)(1). The final rule adds Sec. 26.4(b) to clarify that individuals who are granted unescorted access to nuclear power reactor protected areas by the licensees and other entities in

Sec. 26.3(a) and (c), as applicable and who do not perform the duties described in Sec. 26.4(a), shall be subject to an FFD program that meets all of the requirements of Part 26, except Sec. 26.205 [Work hours] through Sec. 26.209 [Self-declarations] and Subpart K. Section 26.4(b) does not permit these individuals to be subject to an FFD program that meets the more flexible requirements of Subpart K because they may be granted unescorted access to protected areas by the licensees in Sec. 26.3(a), to whom all of the requirements of this part, except Subpart K, apply, and the entities in Sec. 26.3(c), as applicable, to whom all of the requirements of this part apply. This paragraph does not require the individuals in this paragraph to be subject to an FFD program that meets the requirements of Sec. 26.205 through Sec. 26.209 for the reasons discussed with regard to Sec. 26.205(a).

Section 26.4(c) of the final rule retains and amends proposed Sec. 26.25(a)(2). Proposed Sec. 26.25(a)(2) amended portions of former

Sec. 26.2(a) and (d) and described the individuals whose duties require them to be subject to Part 26. Section 26.4(c) of the final rule states that all persons who are required by a licensee or other entity in Sec. 26.3(a), and, as applicable, (c) to physically report to the licensee's Technical Support Center or Emergency Operations

Facility shall be subject to an FFD program that meets all of the requirements of this part, except Sec. 26.205 through Sec. 26.209 and

Subpart K. Section 26.4(c) of the final rule does not permit these individuals to be subject to an FFD program that meets the more flexible requirements of Subpart K because they may be granted unescorted access by the licensees in Sec. 26.3(a), to whom all of the requirements of this part, except Subpart K, apply, and the entities in

Sec. 26.3(c), as applicable, to whom all of the requirements of this part apply. This paragraph also does not require the specified individuals to be subject to an FFD program that meets the requirements of Sec. 26.205 through Sec. 26.209 for the reasons discussed with regard to Sec. 26.205(a).

Section 26.4(d) of the final rule retains and amends portions of proposed Sec. 26.25(a)(3). Proposed Sec. 26.25(a)(3) amended the portions of former Sec. 26.2(a) and (d) and described the individuals whose duties require them to be subject to Part 26. Section 26.4(d) of the final rule specifies that any individual whose duties for the licensees and other entities in Sec. 26.3(b) require him or her to have the types of access or perform the activities in paragraphs (d)(1) through (d)(5) shall be subject to an FFD program that meets all of the requirements of this part, except Subparts I and K. Section 26.4(d) of the final rule does not require these individuals to be subject to an

FFD program that meets the requirements of Subparts I or K, which is consistent with the provisions of the proposed rule.

The NRC has added Sec. 26.4(e) to the final rule to specify that individuals whose duties when construction activities begin require them to have the types of access or perform the activities specified in

Sec. 26.4(e)(1) through (e)(6) at the location where the nuclear power plant will be constructed and operated must be subject to a rigorous

FFD program that complies with the requirements of Part 26, except for the requirements of Subparts I and K. These individuals have direct responsibility for assuring the quality and security of construction activities and, thereby, the safety and security of the completed nuclear power plant. The NRC considers

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it prudent that these personnel are verified to be trustworthy and reliable, as demonstrated by the avoidance of substance abuse, and fit for duty with an FFD program that is equivalent to the program required for an operating plant, which includes a 50 percent random testing rate and a suitable inquiry and employment history check. These individuals include all individuals whose duties at the location where the nuclear power plant will be constructed and operated require them to: (1) Serve as security personnel required by the NRC, until the licensee or other entity receives special nuclear material in the form of fuel assemblies, at which time individuals who serve as security personnel required by the NRC must meet the requirements applicable to security personnel in Sec. 26.4(a)(5); (2) perform quality assurance, quality control, or quality verification activities related to safety- and security-related construction activities; (3) based on a designation under Sec. 26.406 by a licensee or other entity, monitor the fitness of the individuals specified in Sec. 26.4(f) (and thus has also received fitness monitoring training); (4) witness or determine inspections, tests, and analyses certification required by Part 52; (5) supervise or manage the construction of safety- or security-related

SSCs; or (6) direct, as defined in Sec. 26.5, or implement the access authorization program. Section 26.4(e)(5) specifies that an individual who ``supervises or manages the construction of safety- or security- related SSCs'' must be subject to an FFD program that complies with the requirements of Part 26, except the requirements of Subparts I and K.

The NRC has added this provision based upon information from stakeholders at public meetings at which the conceptual framework for

Subpart K was discussed. The NRC has included a definition of

``supervises or manages'' in the final rule, which means ``exercises control over a work activity by an individual who is not directly involved in the execution of the work activity.'' The final rule specifies that this requirement applies only to those individuals who supervise or manage the construction of safety- or security-related

SSCs ``at the location where the nuclear power plant will be constructed and operated'' (i.e., only those individuals whose activities at the site where the nuclear power plant will be constructed and operated may negatively impact public health and safety and the common defense and security).

Section 26.4(e)(6)(i) through (e)(6)(vii) specifies that individuals who direct or implement the licensee's or other entity's access authorization program during construction must be subject to an

FFD program that complies with the requirements of Part 26, except the requirements of Subparts I and K. The NRC expects that, in the absence of an order or regulation requiring a specific access authorization program during construction, an access authorization program during construction would require individuals to perform the same duties and activities as would a licensee's access authorization program under

Sec. 73.55 and Sec. 73.56 when the plant is operating. These duties and activities include having access to the information used by the licensee or other entity to make access authorization determinations, including information stored in electronic format, as specified in

(e)(6)(i); making access authorization determinations, as specified in

(e)(6)(ii); issuing entry-control picture badges in accordance with access authorization determinations, as specified in (e)(6)(iii); conducting background investigations or psychological assessments used by the licensee or other entity to make access authorization determinations, as specified in (e)(6)(iv); adjudicating reviews or appeals of access authorization determinations, as specified in

(e)(6)(v); auditing the access authorization program, as specified in

(e)(6)(vi); or performing any of the activities or having any of the duties listed in Sec. 26.4(e)(6) for any C/V upon whom the licensee's or other entity's access authorization program will rely, as specified in (e)(6)(vii). Section 26.4(e)(6)(iv) includes the following exception for individuals who conduct background investigations or psychological assessments used by the licensee or other entity to make access authorization determinations: ``He or she shall be subject to behavioral observation only when he or she is present at the location where the nuclear power plant will be constructed and operated, and licensees and other entities may rely on a local hospital or other organization that meets the requirements of 49 CFR Part 40, `Procedures for Department of Transportation Workplace Drug and Alcohol Testing

Programs' (65 FR 41944; August 9, 2001) to collect his or her specimens for drug and alcohol testing.'' The requirements for persons conducting background checks and psychological assessments are relaxed for reasons similar to requirements for MROs and certain FFD program personnel, as described in detail with respect to Sec. 26.31(b)(1)(v) and (b)(2).

The NRC has added the requirements of Sec. 26.4(e)(6) in accordance with Goal 1 of this rulemaking, which is to update and enhance the consistency of 10 CFR Part 26 with advances in other relevant Federal rules and guidelines.

Section 26.4(e)(1) includes the phrase ``until the licensees or other entities receive special nuclear material in the form of fuel assemblies, at which time individuals who serve as security personnel required by the NRC must meet the requirements applicable to security personnel in paragraph (a)(5) of this section'' to clarify that, once fuel is received on site, security personnel must be subject to all the requirements of this part, except the requirements of Subpart K, and including the requirements of Subpart I. The individuals listed in

Sec. 26.4(e)(2) through (6), once construction activities begin and until a licensee or other entity specified in Sec. 26.3(a) or (c) grants them unescorted access to the nuclear power plant protected areas, must be subject to the requirements of this part, except the requirements of Subparts I and K. However, once the individuals listed in Sec. 26.4(e)(2) through (6) are granted unescorted access to the nuclear power plant protected areas, they must be subject to the requirements of Sec. 26.4(b), which require them to be subject to the requirements of this part, except those in (Sec. Sec. 26.205 through 26.209 and Subpart K.

The NRC has added Sec. 26.4(f) to the final rule to specify the individuals involved in the construction of a new reactor plant who, at the licensee's or other entity's discretion, must be subject to either a more flexible FFD program under Subpart K, or a more rigorous FFD program that meets the requirements in the other portions of Part 26, except Subparts I and K. These individuals include any individual who is constructing or directing the construction of safety- or security- related SSCs at the location where the nuclear power plant will be constructed and operated. However, if and when a licensee or entity specified in Sec. 26.3(a) or (c) grants these individuals unescorted access to the nuclear power plant protected area, these individuals must be subject to the requirements of Sec. 26.4(a) or (b), as applicable. As specified by the definition of (constructing or construction activities' in Sec. 26.5, these tasks include fabricating, erecting, integrating, and testing safety- or security- related SSCs and the installation of their foundations, including the placement of concrete. The final rule also contains a definition of

``directing'' in Sec. 26.5, which means

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the exercise of control over a work activity by an individual ``who is directly involved in the execution of the work activity.'' This definition is distinguished from the term ``supervises or manages,'' used in Sec. 26.4(e)(5), which means the exercise of control over a work activity by an individual ``who is not directly involved in the execution of the work activity.'' The NRC determined that it is necessary to impose FFD requirements on individuals who are constructing or directing the construction of safety- or security- related SSCs because (1) the quality of work could be adversely affected by construction workers who are impaired by substance abuse where studies indicate that members of this group have the highest rates of substance abuse problems among occupational groups in the U.S.

(e.g., SAMHSA's NHSDA covering the years 2000-2001 and SAMHSA's

National Survey on Drug Use and Health covering the years 2002-2004),

(2) individuals who have become addicted to illegal drugs are susceptible to coercion and will interact with others involved in the drug trade, (3) past experience has demonstrated that errors during construction can adversely affect subsequent plant operations (NUREG/

CR-6819, Vols. 1-4, ``Common-Cause Failure Event Insights,'' (May 2003) and NUREG-1837, ``Regulatory Effectiveness Assessment of Generic Issue 43 and Generic Letter 88-14,'' (October 2005)), and (4) quality assurance by design uses a sampling process. Despite having a high degree of confidence in the effectiveness of quality assurance and

ITAAC programs to detect construction errors, the NRC believes it is prudent to require an FFD program during construction to provide reasonable assurance that impaired construction workers or individuals directing construction workers do not introduce faults in safety- or security-related SSCs that may cause the SSCs to fail to perform their intended functions when the plant is operating. In addition, the NRC is concerned that some construction personnel who have substance abuse problems will have access to sensitive information that could be useful to an adversary, as well as physical access to safety- and security- related SSCs that may provide opportunities for malicious acts.

Therefore, the NRC is requiring individuals who are directly involved in constructing safety- and security-related SSCs to be subject to an

FFD program.

Section 26.4(g) of the final rule contains the provisions in proposed Sec. 26.25(a)(4). Proposed Sec. 26.25(a)(4) clarified the

NRC's original intent that FFD program personnel must be subject to the

FFD program. Although former Section 2.3 in Appendix A to Part 26 required licensees to carefully select and monitor individuals who are responsible for administering the drug and alcohol testing program based upon the highest standards of honesty and integrity, some licensees' testing programs did not include all of the FFD program personnel who the NRC originally intended to be subject to testing. The final rule clarifies the NRC's original intent because the actions of these individuals have an ongoing effect on public health and safety and the common defense and security as a result of their responsibility to ensure that FFD programs are effective. In addition, these individuals' actions affect the confidence that the public, management, and individuals who are subject to testing have in the integrity of the program and the accuracy and reliability of test results. Individuals who are involved in the day-to-day operations of an FFD program are in a position to permit substance abusers to remain undetected. For example, specimen collectors could inadvertently commit errors when testing others as a result of being impaired from drug or alcohol abuse or intentionally omit testing an individual because of motives associated with maintaining a collector's substance abuse or empathy with an abuser. Further, several reported incidents have confirmed the need to assure that FFD program personnel meet the highest standards of honesty, integrity, reliability, and trustworthiness. For example, one licensee added specimen collectors to the testing pool after investigating an allegation and determining that two collectors were substance abusers. In another instance, a contracted MRO who was not in the testing pool was reported to be an alcoholic and an abuser of prescription drugs. Some MROs who provide their services to other

Federally regulated industries also have been identified as substance abusers. Therefore, the revision to former Sec. 26.2(a) fulfills the

NRC's original objective and requires licensees and other entities to extend their programs to include FFD personnel who (1) can link test results with the individual who was tested before an FFD policy violation determination is made, including, but not limited to, the

MRO, as specified in Sec. 26.4(g)(1); (2) make determinations of fitness, as specified in Sec. 26.4(g)(2); (3) make authorization decisions, as specified in Sec. 26.4(g)(3); (4) are involved in selecting or notifying individuals for testing, as specified in Sec. 26.4(g)(4); or (5) are involved in the collection or on-site testing of specimens, as specified in Sec. 26.4(g)(5).

Although job titles and responsibilities may differ among different

Part 26 FFD programs, examples of FFD program personnel who are subject to Part 26 under the final rule include, but are not limited to, the following: The FFD program manager under Sec. 26.4(g)(1) through

(g)(5); the MRO and MRO staff under Sec. 26.4(g)(1); the licensee's or other entity's reviewing officials under Sec. 26.4(g)(3); specimen collectors under Sec. 26.4(g)(5); SAEs who are under contract to or employed by the FFD program under Sec. 26.4(g)(2); and licensee testing facility personnel under Sec. 26.4(g)(5). In some cases, information technology personnel who design and implement software programs for selecting individuals for random testing also may be subject to the rule under Sec. 26.4(g)(4) if such personnel have knowledge of who was selected for random testing before the individual is notified or the ability to affect the selection of specific individuals for random testing.

Section 26.4(g) of the final rule amends the proposed rule to clarify the requirements that the FFD programs specified in this paragraph must meet. The section specifies that FFD program personnel who are involved in the day-to-day operations of the program, as defined by the procedures of the licensees or other entities, and whose duties require them to have the types of access and perform the activities in Sec. 26.4(g)(1) through (g)(5) shall be subject to an

FFD program that meets all of the requirements of Part 26, except

Subparts I and K, and at the licensees's discretion, Subpart C. The final rule clarifies that the procedures referenced are those of the licensees and other entities specified in Sec. 26.3(a) through (c) and, as applicable, (d). Licensees may use different FFD program personnel for a Subpart K program, in which case, those FFD program personnel would be subject to a full program under the rule. However, individuals specified in Sec. 26.4(i)(1) are not subject to an FFD program under Part 26. The term ``as applicable'' in this provision specifies that entities listed in Sec. 26.3(d) must subject FFD program personnel to all of the requirements of this part if they perform the activities specified in Sec. 26.4(g). The final rule also clarifies that the FFD programs for FFD program personnel performing the listed activities in Sec. 26.4(g) must meet all the requirements of Part 26, except Subparts

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I and K, which is consistent with the provisions of proposed rule. The final rule clarifies that the licensees and other entities may subject

FFD program personnel to an FFD program that meets the requirements of

Subpart C, for the reasons discussed with respect to Sec. 26.31(b).

These clarifications are consistent with Goal 6 of this rulemaking to improve clarity in the organization and language of the final rule.

Section 26.4(h) retains and amends the requirements contained in proposed Sec. 26.25(d). Proposed Sec. 26.25(d) clarified that individuals who have applied for authorization or perform duties that require them to be subject to Part 26 also would be subject to some provisions of Part 26. The former Part 26 required an applicant for authorization to provide a written statement related to his or her past activities under this part in former Sec. 26.27(a)(1); provide permission to the licensee to conduct a suitable inquiry in former

Sec. 26.27(a)(2); and submit to pre-access testing in former Sec. 26.24(a)(1). Although the proposed rule used general terms, such as

``applicable requirements of this part'' and ``applicable protections of this part,'' the final rule clarifies the requirements to which the individuals specified in this paragraph are subject. The final rule requires that individuals who have applied for authorization to have the types of access or perform the activities described in Sec. 26.4(a) through (d) shall be subject to the requirements in Sec. Sec. 26.31(c)(1), 26.35(b), 26.37, 26.39 and the applicable requirements of

Subparts C, and E [Collecting Specimens for Testing] through H

Determining Fitness-for-Duty Violations and Determining Fitness

.

These clarifications ensure the internal consistency of the final rule and meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.4(i)(1) through (i)(3) contains the provisions of proposed Sec. 26.25(b)(1) through (b)(3). The final rule groups together in one paragraph the former rule's provisions that identify individuals who would not be subject to the rule. This change has been made to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

The NRC has added Sec. 26.4(i)(1) to the final rule as a result of extensive discussions with industry stakeholders at the public meetings mentioned in the Section I.D of this document. Industry stakeholders expressed strong concern that the related language in the affirmed rule

(which was discussed in the preamble to the proposed rule) that delineated the FFD program personnel who must be subject to Part 26 was too broad. Stakeholders agreed that FFD program personnel who work on site and are involved in the day-to-day operations of the FFD program should be subject to the rule. However, the stakeholders noted that the language used in the affirmed rule was so vague that it could be interpreted as requiring, for example, that offsite human resources staff at a licensee's or other entity's corporate offices, who may have access to some FFD information about individuals, must be covered, as well as any medical or treatment personnel and their managers, at a hospital or substance abuse treatment facility who provide an occasional FFD program service. These interpretations of the intent of the affirmed rule provisions would be incorrect.

The stakeholders also strongly disagreed with the requirement in the affirmed rule that some FFD program personnel who maintain offices at locations other than a licensee's or other entity's facilities and are not involved in day-to-day program operations, such as EAP counselors and some contract MROs, should be subject to the rule. The stakeholders indicated that they believe the honesty and integrity of such off-site personnel is maintained through their professions' oversight and standards, with the result that requiring these individuals to be subject to the rule would create a significant and unnecessary regulatory burden. Stakeholders stated that the regulatory burden would result from the significant logistical difficulties involved in ensuring that these individuals are subject to behavioral observation and drug and alcohol testing, and excessive costs to hire additional MRO(s) to review any positive, adulterated, substituted, or dilute drug test results from MRO(s) who serve the FFD program.

Based on the stakeholders' input, lessons learned from FFD program experience since the rule was first implemented, the experience gained by other Federal agencies and their regulated industries, and the continuing need to ensure that FFD program personnel meet the highest standards of honesty and integrity, the NRC added Sec. 26.4(i)(1) to the final rule. The provision excludes from the rule individuals who may be called upon to provide an FFD program service to a licensee or other entity in special circumstances and who meet all of the following criteria:

(1) They are not employed by the licensee or other entity;

(2) They do not routinely provide services to the licensee's or other entity's FFD program; and

(3) They do not normally work at a licensee's or other entity's facility.

Examples of individuals who are not subject to the rule under this provision may include, but are not limited to, a nurse at a local hospital who collects a single specimen for a post-event test from an individual who has been injured, and a counselor at a residential substance abuse treatment facility who performs behavioral observation of a patient while the individual is in residence. Personnel who meet the three criteria specified in the paragraph are excluded from the FFD program because the limited nature of their involvement with the FFD program makes it unlikely that they would be subject to coercion or influence attempts to subvert the testing process and the NRC is not aware of any reports indicating that these types of individuals have been involved in any adverse incidents.

However, Sec. 26.4(g) of the final rule requires MROs and SAEs to be subject to Part 26 (see the discussion of Sec. 26.187 [Substance abuse expert] in Section VI of this document for a detailed description of the SAE's roles and responsibilities under the FFD program), as well as any EAP counselor who serves as the SAE for a licensee's or other entity's FFD program. Individuals who serve in these positions play the key roles of determining whether a positive, adulterated, or substituted drug test result is an FFD policy violation (i.e., the MRO under Sec. 26.185) and whether an individual is fit to safely and competently perform the duties that require the individual to be subject to this part (i.e., the SAE). Although the NRC recognizes the significant logistical difficulties and costs that may be associated with covering these individuals, the NRC concluded that MROs and SAEs play such critical roles in the effective functioning of an FFD program that ensuring their continuing honesty and integrity by requiring them to be subject to the rule is warranted.

Section 26.4(i)(2) and (i)(3) retains the first sentence of former

Sec. 26.2(b) but divides it into two paragraphs. This organizational change makes it easier to locate these requirements within the rule text and to support cross-referencing to these paragraphs from other portions of the rule. The NRC has moved the second sentence of former

Sec. 26.2(b) to Sec. 26.3(e) of the final rule, rather than retain it in this provision, because it addressed entities who would not be subject to the rule, rather than individuals. The NRC has made these

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changes to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

The final rule adds a new Sec. 26.4(i)(4), which specifies that

FFD program personnel of a program that is regulated by another Federal agency or State upon which a licensee or other entity relies to meet the requirements of this part, as permitted in Sec. 26.4(j), Sec. 26.31(b)(2), and Sec. 26.405(e)(3) are not subject to a licensee's or other entity's program if the FFD program personnel are not employed by the licensee or other entity and their normal workplace is not at the licensee's or other entity' facility.

Section 26.4(j) contains the provisions of proposed Sec. 26.25(c).

This provision provides that persons who are covered by a program regulated by another Federal agency or State need not also be covered by duplicate elements of a licensee's or other entity's FFD program.

Duplicate testing and training requirements applicable to an appreciable number of individuals working at nuclear facilities have become an increasing problem as the facilities have implemented the

DOT's drug and alcohol testing requirements [49 CFR Part 40, 65 FR 41944, August 9, 2001]. This revision reduces the burden on some individuals who are currently subject to Federal and State programs with requirements that duplicate those of Part 26. Minor differences in specific program requirements for conducting drug and alcohol testing would be unlikely to adversely affect the ability of a licensee's or other entity's FFD program to meet the performance objectives of this part. The licensee or other entity continues to be responsible for implementing any Part 26 program elements that may not be addressed by the alternate Federal or State program. These program elements may include, but are not limited to, providing behavioral observation and initiating for cause testing, if necessary, when an individual who is covered by an alternate program is on site at a licensee's or other entity's facility and is performing the duties that require the individual to be subject to the rule, as well as immediate removal from duty of persons whose fitness may be questionable.

Section 26.4(j)(1) through (j)(5) of the final rule contains the provisions in proposed Sec. 26.25(c)(1) through (c)(4) and (c)(6). The final rule lists the necessary characteristics of an alternative

Federal or State program that, under the final rule, licensees and other entities may rely upon to satisfy the requirements of this part for an individual who is subject both to Part 26 and an alternative program. Paragraphs 26.4(j)(1) and (j)(3) permit licensees and other entities to rely on the alternative program to meet the final rule's drug testing requirements if the alternative program tests for the drugs and drug metabolites that are specified in the final rule at or below the cutoff levels established in the final rule and an HHS- certified laboratory conducts the program's specimen validity and drug testing. Similarly, Sec. 26.4(j)(2) permits licensees and other entities to rely on the alternative program to meet the final rule's alcohol testing requirements if the alternative program's alcohol testing procedures and devices meet the final rule's requirements and the alternative program uses cutoff levels that are at least as stringent as those specified in Sec. 26.103(a). Section 26.4(j)(4) permits the licensee or other entity to rely on an alternative program's FFD training if that training addresses the knowledge and abilities listed in Sec. 26.29(a)(1) through (a)(10). If the licensee or other entity relies on the alternative program, Sec. 26.4(j)(5) requires the licensee or other entity to ensure that the alternative program informs the licensee or other entity of any FFD violations.

The final rule deletes the provision that was contained in proposed

Sec. 26.25(c)(5). The proposed provision allowed individuals subject to Part 26 and to a Federal agency- or State-regulated program to be covered only by those elements of an FFD program that are not included in the Federal agency or State program if an impartial and objective procedure is provided for the review and reversal of any findings of an

FFD policy violation. The NRC has deleted this provision because it recognizes that it would be impractical to require a licensee to ensure that a Federal agency or State program would include an impartial and objective procedure for the review and reversal of any findings of an

FFD policy violation. Such assurance would be beyond the licensee's ability to obtain or provide because the licensee would not control the

Federal agency or State program. Therefore, this change is consistent with Goal 5 of this rulemaking to improve Part 26 by eliminating or modifying unnecessary requirements.

These provisions are consistent with the former and final rules' approaches to permitting licensees and other entities to rely on C/V

FFD programs and program elements to meet the requirements of this part if the C/V's program or program element meets the requirements of this part, as discussed with respect to Sec. 26.21 [Fitness-for-duty programs]. In general, permitting licensees and other entities to rely on FFD programs and program elements that are implemented by others, when those programs or program elements meet the requirements of this part, fulfills the rule's performance objectives and improves Part 26 by eliminating or modifying unnecessary requirements, which is Goal 5 of this rulemaking. However, an important difference between the final rule's permission for licensees and other entities to rely on the programs of other Federal and State agencies, compared to the final rule's permission for licensees and other entities to rely on C/V programs, is that the final rule does not require licensees and other entities to audit the alternate Federal and State programs under Sec. 26.41 [Audits and corrective action]. Auditing Federal and State programs is unnecessary because these programs are subject to other, equally effective audit and inspection requirements. Relieving licensees and other entities who are subject to this part from an audit requirement also is in keeping with Goal 5 of this rulemaking.

Section 26.5 Definitions

Section 26.5 amends former Sec. 26.3 [Definitions] to (1) clarify some definitions; (2) make the listed terms and their definitions more consistent with those used by other Federal agencies (including SAMHSA and DOT); (3) define new terms used in other sections of the rule; and

(4) move definitions into this section from former Section 1.2 in

Appendix A to 10 CFR Part 26, which contained definitions of important terms used in Appendix A to Part 26. The rule also eliminates six terms in former Sec. 26.3 and Section 1.2 in Appendix A to Part 26 because they are fully defined in the provisions of the final rule or are not used in the final rule. In addition, the rule eliminates redundant definitions of some terms, which appear in both former Sec. 26.3 and

Section 1.2 in Appendix A to Part 26. Finally, the NRC has revised some definitions to make them simpler and easier to understand, consistent with the NRC's commitment to using plain language. For example, some definitions in the former rule included requirements that were also contained in other sections of the rule. In these instances, the final rule eliminates the embedded requirements from within the definitions, but retains the definitions in this section. The NRC has moved these requirements to the related sections of the final rule for organizational clarity.

The final rule modifies several definitions of the proposed rule due to public comment or to increase clarity in the language of the rule, consistent with Goal 6 of the rulemaking. These changes

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are discussed below. Otherwise, the final rule adopts the definitions of this section as proposed, without change.

The NRC has made the majority of the changes to this section as a result of adding new requirements for urine drug testing, including specimen validity testing, to the rule. The rule incorporates advances in the science and technology of urine drug testing that are based on the most recent revision to the HHS Guidelines, as published in the

Federal Register on April 13, 2004 (69 FR 19643). These changes require adding terms to Sec. 26.5, modifying a number of the terms that were used in the former rule, and revising the definitions of some terms in the former rule that are also used in the final rule, as described in the following paragraphs.

The final rule modifies several terms that are used in the former and proposed rules to describe the results of drug and alcohol testing, in order to reduce the number of terms, increase consistency with terms used by other Federal agencies, and address the addition of urine specimen validity testing requirements. The final rule has deleted the term ``non-negative'' from the proposed rule. The NRC has added the term ``non-negative'' to the proposed rule to refer to any adverse test result from the different types of urine testing that are required under the final rule. However, the NRC received a public comment that requested clarification of ``non-negative'' with respect to

``positive'''' in the proposed rule. Therefore, the NRC has deleted

``non-negative'' from the final rule and replaced it with more specific terminology. The final rule uses the term ``positive'' to refer to results from drug and alcohol testing indicating the presences of drugs or drug metabolites in a urine specimen or the presence of alcohol above the cutoff levels established in this part in breath or oral fluids specimens. The final rule uses the terms ``adulterated, dilute, substituted, or invalid,'' as appropriate, to refer to results of validity tests of urine specimens indicating that the specimen may not be normal human urine. Consequently, the NRC has replaced the term

``non-negative'' in the following definitions in this section:

``confirmed test result,'' ``cutoff level,'' and ``Medical Review

Officer (MRO).''

The final rule, with respect to both the former and proposed rules, adds the term ``positive result'' to specify what positive results mean for drug and alcohol testing. The definition clarifies that, when the laboratory has conducted the special analysis permitted in Sec. 26.163(a)(2), a result reported by an HHS-certified laboratory that a specimen contains a drug or drug metabolite below the cutoff concentration is also a positive result.

The final rule also changes the former term ``confirmed positive test'' to ``confirmed test result'' to clarify that this term refers to the results of the MRO's review of both drug and validity tests of urine specimens, rather than to a type of testing. The final rule also removes the reference to testing of blood specimens for alcohol that is contained in the former definition of ``confirmed positive test'' from the definition of ``confirmed test result'' because blood specimens are no longer collected at the donor's request for confirmatory alcohol testing, as discussed with respect to Sec. 26.83(a). With respect to the proposed rule, the final rule specifies that a confirmed test result demonstrates that an individual has used drugs ``and/or'' alcohol. The NRC has made these changes to meet Goal 6 of this rulemaking, as it relates to improving clarity in the language of the final rule.

The final rule adds several terms to refer to urine specimens that have characteristics that are inconsistent with those expected of normal human urine, as identified through validity testing. The terms include ``adulterated specimen,'' ``dilute specimen,'' ``substituted specimen,'' and ``invalid result.'' The final rule also adds the term

``oxidizing adulterant'' to refer to one class of substances that may be used to adulterate urine specimens. These new terms and definitions have been adapted from the HHS Guidelines.

With respect to the proposed rule, the final rule adds the term

``questionable validity'' to mean the results of validity screening or initial validity tests at a licensee testing facility indicating that a urine specimen may be adulterated, substituted, dilute, or invalid. The

NRC has added this term based on the consideration identified by a commenter that licensee testing facilities may not be able to determine whether a specimen is substituted, dilute, or meets some of the invalid criteria because they are not required to test for specific gravity of a specimen. This term replaces the term ``suspect specimens'' in the former rule. Therefore, the NRC has made this change to improve clarity in the language of the rule, consistent with Goal 6 of this rulemaking.

The final rule also adds several terms that are associated with new requirements for maintaining quality control of urine specimen validity and drug testing, such as the term ``quality control sample.'' The final rule also adds definitions of the terms ``calibrator,''

``control,'' and ``standard'' to distinguish among the types of quality control samples that are associated with urine specimen testing in

Subparts F [Licensee Testing Facilities] and G [Laboratories Certified by the Department of Health and Human Services] of the final rule.

The final rule changes certain terms that describe drug and alcohol tests to reflect the addition of urine specimen validity testing requirements. The changes include replacing the term ``initial or screening test'' with more specific terms to distinguish between drug testing and testing for urine specimen validity. The NRC has added the terms ``validity screening test,'' ``initial drug test,'' and ``initial validity test'' to refer to the first tests of a urine specimen that are performed to determine whether a urine specimen is free of drugs and drug metabolites and has the expected characteristics of normal urine, or whether further testing of the specimen is required. The final rule modifies the proposed definition of ``validity screening test'' to clarify that both non-instrumented tests, in which the endpoint result is obtained by visual evaluation, and instrumented

(machine read) tests are acceptable methods to determine the need for initial validity testing of urine specimen. The NRC has made these changes to improve clarity in the language of the rule, consistent with

Goal 6 of this rulemaking.

The final rule also modifies the definition of ``initial or screening test'' in the former rule to eliminate the requirement that the test must be performed using immunoassay techniques because the NRC addresses that requirement in other sections of the rule. The final rule replaces the general term ``confirmatory test'' in the former rule with the more specific terms, ``confirmatory drug or alcohol test'' and

``confirmatory validity test.'' In addition, the definitions of these terms in the final rule do not include requirements for the methods to be used in performing confirmatory tests because these requirements are addressed in other sections of the rule. Therefore, the NRC has removed the requirement that confirmatory drug testing be performed using gas chromatography/mass spectrometry (GC/MS) testing from the definition.

The final rule also eliminates the reference to GC/MS testing of blood samples for confirmatory alcohol testing in the definition of

``confirmatory drug or alcohol test'' because the final rule does not allow donors the option to provide a blood sample for alcohol confirmatory testing, as discussed with respect to Sec. 26.83(a).

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The final rule also adds two terms that refer to testing for very low levels of drugs, drug metabolites, or adulterants in a urine specimen, ``limit of detection (LOD)'' and ``limit of quantitation

(LOQ).'' The NRC has adapted the definitions of these terms from the

HHS Guidelines.

In addition, the final rule modifies the definitions of two terms in the former and proposed rules to be consistent with the new drug and alcohol testing terminology that is used throughout the rule. The final rule amends the definition of ``cutoff level'' in the former rule to clarify that the term is also applicable to the interpretation of results from specimen validity testing. The final rule further modifies this definition to refer to test results as ``positive,'' ``of questionable validity,'' and ``adulterated, substituted, dilute, or invalid'' to account for validity tests results from a licensee testing facility. The final rule amends the definition of ``Medical Review

Officer (MRO)'' to refer to a ``drug and validity'' test result, rather than a ``positive'' test result, to clarify that the MRO reviews validity test results in addition to drug test results.

The rule also adds six terms that are related to the requirements contained in Subpart C. The term ``potentially disqualifying FFD information'' refers to the types of information that licensees and other entities who are subject to the rule consider when deciding whether to grant or maintain an individual's authorization to have the types of access or perform the duties that are listed in Sec. 26.4.

The final rule also adds definitions for four terms that are used within the definition of ``potentially disqualifying FFD information,'' including ``substance abuse,'' ``legal action,'' ``employment action,'' and ``reviewing official.'' The NRC has also added the term ``best effort'' to refer to the actions that a licensee or other entity who is subject to the rule must take to obtain the information that is necessary to complete a suitable inquiry and employment history check, as discussed with respect to Sec. 26.63(a).

The final rule, with respect to the proposed rule, also adds a definition of the term ``authorization'' in response to public comment.

The final rule uses the term, ``authorization,'' to refer to an individual's status as having been determined by a licensee or other entity to be eligible to perform the duties or have the types of access listed in Sec. 26.4(a) through (e), and at the licensee's or other entity's discretion, Sec. 26.4(f) and (g) of the final rule. The agency selected this term to differentiate ``authorization'' under Part 26 from the terms, ``unescorted access authorization'' and ``unescorted access,'' that are used by nuclear power plant licensees to refer to individuals who are subject to both Part 26 and related access authorization requirements under 10 CFR 73.56 [Personnel access authorization requirements for nuclear power plants]. The NRC created a new term because some categories of individuals who are subject to Part 26 are not required to meet the additional requirements of 10 CFR 73.56. For example, the NRC has not promulgated access authorization requirements in Sec. 73.56 for FFD program personnel. Therefore, the final rule uses the term ``authorization'' to refer to the determination that these categories of individuals may perform the duties or have the types of access specified in Sec. 26.4 to distinguish the requirements in this part from the additional requirements that a licensee or other entity must meet in order to grant individual ``unescorted access authorization'' or ``unescorted access'' to nuclear power plant protected areas.

The final rule adds a definition of ``maintenance'' to clarify the scope of duties described as maintenance in Sec. 26.4(a)(4) of the final rule. The definition also distinguishes duties performed by individuals covered by Sec. 26.4(a)(4) from duties performed by individuals that are subject to different work hour limits, such as the duties described in Sec. 26.4(a)(1) through (3). Specifically, the definition clarifies that Sec. 26.205(a) requires that individuals identified in Sec. 26.4(a)(4) (i.e., individuals who are maintaining or providing onsite direction for the maintenance of systems and components that ``a risk informed evaluation process has shown to be significant to public health and safety'') must be subject to the work hour requirements. These requirements apply to those individuals who perform the following maintenance activities within the licensee's owner-controlled area: modification, surveillance, post-maintenance testing, and corrective and preventive maintenance. This definition is similar to the language used in GL 83-14, ``Definition of `Key

Maintenance Personnel,' (Clarification of Generic Letter 82-12)'' and 10 CFR 50.65, ``Requirements for Monitoring the Effectiveness of

Maintenance at Nuclear Power Plants.'' The definition of

``maintenance'' in Sec. 26.5 of the final rule excludes the term

``calibration,'' found in GL 83-14, because the NRC considers

``calibration'' to be part of ``preventive maintenance'' and, therefore, within the definition of ``maintenance.''

The final rule also adds several terms that are necessary to implement the requirements of Subpart I. These terms include

``fatigue,'' ``acute fatigue,'' and ``cumulative fatigue,'' which refer to the degradation in an individual's cognitive (mental) and motor

(physical) functioning resulting from inadequate rest within the past 24 hours or over successive days and weeks, respectively. The rule also uses the term ``alertness'' to refer to an individual's ability to remain awake and sustain attention, which is adversely affected by fatigue. The new term ``circadian variation in alertness and performance'' defines a factor that licensees would consider when conducting a fatigue assessment under Sec. 26.211 [Fatigue assessments]. The final rule also adds the term ``increased threat condition'' to refer to circumstances in which the rule provides licensees with some flexibility in implementing the work hour controls of Sec. 26.205. With respect to the proposed rule, the final rule modifies the term ``increased threat condition'' to clarify that any increase in the protective measure level is relative to the lowest protective measure applicable to the site during the previous 60 days.

The final rule, with respect to the proposed rule, adds a definition of ``shift cycle'' to mean a series of consecutive work shifts and days off that is planned by the licensee or other entity to repeat regularly, thereby constituting a continuous shift schedule.

Similarly, the final rule adds ``8-hour shift schedule,'' ``10-hour shift schedule,'' and ``12-hour shift schedule'' to define these schedules in terms of allowable hours of a workday averaged over a shift cycle.

Also, the NRC has added the term ``unit outage'' to the final rule to clarify that the specific reactor unit has to be disconnected from the electrical grid to be declared in an outage. This term was added in response to stakeholder comment raised at a public meeting on whether, for purposes of implementing the work hour controls, a unit was considered to be in an outage if reactor power was reduced for repair or maintenance of a system or component, but the reactor was not shutdown. Consequently, the NRC defined unit outage as the reactor being disconnected from the electrical grid. This definition provides a clearly identifiable plant state for applying the work hour controls in

Sec. 26.205(d)(4) and (d)(5).

The term ``directing'' clarifies new requirements for MRO staff under Sec. 26.183(d) and the scope of individuals who would be subject to work hour controls in Sec. 26.205. The NRC has

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revised this definition in response to public comment regarding the lack of clarity of the term ``directing'' as used in Subpart I in the proposed rule and the scope of personnel that should be subject to work hour controls. Specific comments included remarks regarding the scope of engineering functions that should or should not be subject to work hour controls. The revised definition in the final rule clarifies the

NRC's expectations that a limited scope of personnel providing technical input would be subject to the requirements of Sec. 26.205.

The definition explicitly states the criteria that the term

``directing'' refers to an individual who is ``directly involved in the execution of the work activity'' or ``is ultimately responsible for the correct performance of that work activity'' as opposed to, for example, the planning, development or scheduling of the activity, and that the technical input does not receive ``subsequent technical review.'' The

NRC believes that, in the context of Subpart I, the revised definition more clearly focuses on activities that have the potential to substantively and immediately affect safety. These changes are consistent with the changes that the NRC has made to the final rule in

Subpart I and meet Goal 6 of this rulemaking as it relates to improving clarity in the language of the rule.

Similarly, with respect to the proposed rule, the NRC has added the term ``supervises or manages'' to the final rule. The definition of

``supervises or manages'' explicitly states the criteria that the term refers to an individual who is ``not directly involved in the execution of the work activity,'' but who either makes technical decisions without technical review, or is ``ultimately responsible for the correct performance of that work activity,'' as opposed to, for example, the planning, development or scheduling of the activity, and that the technical input does not receive ``subsequent technical review.'' This definition is intended to clearly focus on activities that have the potential to substantively and immediately affect safety.

These changes are consistent with the changes that the NRC has made to the final rule in Subpart I and meet Goal 6 of this rulemaking as it relates to improving clarity in the language of the rule.

The final rule, with respect to the proposed rule, also adds several terms that are necessary to interpret and implement the requirements in Subpart K. The final rule includes definitions of

``constructing or construction activities,'' ``safety-related SSCs,'' and ``security-related SSCs.'' The NRC has added these definitions in response to public comments that recommended that the NRC reconsider the proposed requirements for licensees or other entities who will build new nuclear power plants. The NRC defined these terms to clarify the point in the construction process at which an FFD program for construction is required, the physical location where the FFD program for construction must be implemented, and to specify the individuals who are subject to an FFD program for construction in terms of the duties they will perform.

The former rule in Sec. 26.2(c) imposed FFD requirements on construction permit holders ``with a plant under active construction'' but did not define that term. The proposed rule in Sec. 26.3(e) would have required an FFD program for construction following NRC authorization to construct. However, the NRC recognizes that there may be a period of time that elapses between the authorization to construct and the commencement of specific construction activities that have the potential to affect public health and safety and the common defense and security when the nuclear power plant begins operations. Therefore, the

NRC has added a definition of ``constructing and construction activities'' to clarify that an FFD program for construction is not required until a licensee or other entity begins ``fabricating, erecting, integrating, and testing safety- and security-related SSCs, and the installation of their foundations, including the placement of concrete.''

In addition, this definition specifies that the FFD program for construction applies only to construction activities that are performed at the location where the new plant will be constructed and operated.

The NRC added this phrase to the definition of construction activities to clarify that any fabrication, integration, or testing of safety- or security-related SSCs that is not performed within or near the licensee's or other entity's owner-controlled area in which the new plant will be operated would not be subject to Subpart K. For example, fabricating, integrating, and testing safety- or security-related SSCs at a vendor's or manufacturer's facility that is located in another city or state or outside of the U.S. would not be subject to Subpart K, whereas producing the concrete to be used for the foundation of the reactor building in a facility located on the site where the nuclear power plant will be constructed and operated would be subject to

Subpart K (although the construction of the cement mixing facility would not). The NRC anticipates that the focus of the Subpart K program on construction activities involving safety- and security-related SSCs at the location where the new plant will be constructed and operated will lead licensees and other entities to ensure that the program covers all those individuals who perform construction activities within the footprint of the new power reactor (e.g., the exterior boundary of the reactor building once it is completed) as well as the nearby areas where safety- and security-related SSCs will be installed and operated when the plant begins operations.

The former rule and the proposed rule also did not specify the individuals who would be subject to an FFD program for construction.

The NRC recognizes that there will be other construction work performed at the location where a new plant will be constructed and operated that will not have the potential to affect public health and safety and the common defense and security when the nuclear power plant begins operations, such as constructing a building that will be used only for training or administration purposes. The NRC does not intend that individuals who are performing these other construction activities must be subject to the FFD program. Therefore, the final rule also includes definitions of safety- and security-related SSCs to clarify that only those individuals who are constructing (i.e., fabricating, erecting, integrating, testing, and installing foundations of) these specific

SSCs must be subject to a Subpart K program. Thus, as one example of a safety-related SSC, the rule requires individuals who are constructing the containment structure that surrounds the reactor to be subject to an FFD program because the containment is relied on to mitigate the consequences of accidents that could result in potential offsite exposure. Similarly, individuals who are constructing security-related

SSCs, such as the central and secondary alarm stations, physical barriers, communications systems, guard towers, surveillance and detection systems, or installing locks and illumination systems, that will be necessary to implement the physical security and safeguards contingency plans that are required under 10 CFR Part 73 also are subject to an FFD program for construction.

The development of the revised requirements contained in Subpart K

(described in Sections V and VI of this document) compelled the NRC to define these terms in the final rule. Adding definitions of these terms satisfies Goal 6 of this rulemaking as it relates to improving clarity in the language of the rule.

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The final rule also adds many terms related to other revisions to the former rule. Specifically, the final rule adds ``analytical run'' for use in establishing amended performance testing requirements for licensee testing facilities in Sec. 26.137 [Quality assurance and quality control]. For consistency with the use of the term in the related regulations of other Federal agencies, the term ``donor'' replaces the former terms that are used to refer to an individual from whom a specimen is collected for drug or alcohol testing. The new term

``nominal'' refers to the leeway in the time periods within which certain requirements must be met, such as the requirement for annual

FFD refresher training in Sec. 26.29(c)(2). The term ``other entity'' refers to organizations who are subject to Part 26, but who are not licensed by the NRC, including, but not limited to, the organizations who hold the NRC certificates or permits listed in Sec. 26.3. The terms ``formula quantity'' and ``strategic special nuclear material''

(SSNM) have been defined consistently with the definitions of the same terms in 10 CFR 70.4. The term ``subversion and subvert the testing process'' clarifies the language of provisions related to urine specimen validity testing, as discussed with respect to Sec. 26.31(d)(3)(i), and sanctions in Sec. 26.75(b) that are imposed on individuals who are subject to Part 26.

Section 26.5 of the final rule also retains and amends a number of other definitions formerly contained in Sec. 26.3 and Section 1.2 in

Appendix A to Part 26, as described in the following paragraphs.

The rule revises the former definition of ``aliquot'' to clarify that an aliquot is a representative sample of a urine specimen that may be used for testing. The amended definition is consistent with the same definition in the HHS Guidelines.

The final rule simplifies the former definition of ``blood alcohol concentration (BAC)'' by deleting references to the instruments that licensees and other entities are permitted to use for alcohol testing.

The text of Sec. 26.91 [Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use] specifies acceptable devices for alcohol testing under the final rule.

The final rule revises the definition of ``category IA material'' to conform with the former definition contained in 10 CFR 74.4.

The final rule expands the definition of ``chain of custody'' to indicate that the terms ``chain of custody'' and ``custody and control'' are synonymous.

The NRC has modified the definition of ``collection site'' in the final rule to include a reference to oral fluids as specimens that are acceptable for initial alcohol testing. The basis for permitting the use of oral fluids for initial alcohol testing is discussed in Section

VI of this document with respect to Sec. 26.83(a).

The final rule replaces the term ``collection site person'' with the term ``collector'' to simplify the terminology used to refer to individuals who collect specimens for testing and for consistency with the terminology used by other Federal agencies. In addition, the definition no longer includes the qualifications required for collectors because they are specified in Sec. 26.85 [Collector qualifications and responsibilities].

The final rule adds the term ``contractor/vendor (C/V),'' combining the definitions of ``contractor'' and ``vendor'' in the former rule, because the final rule does not distinguish between the two types of entities.

The final rule updates the definition of ``HHS-certified laboratory'' to reference the most recent version of the HHS Mandatory

Guidelines for Federal Workplace Drug Testing Programs.

In addition, the final rule simplifies the definition of ``licensee testing facility'' by eliminating the reference to collecting specimens for alcohol testing in the former definition, because alcohol testing typically occurs at a collection site rather than at the licensee testing facility. Also, with respect to the proposed rule, the NRC has clarified this definition in the final rule to be consistent with the inclusion of specimen validity testing at licensee testing facilities.

Finally, the final rule eliminates six terms that were defined in former Sec. 26.3 and Section 1.2 in Appendix A to Part 26.

Specifically, the rule eliminates ``followup testing,'' ``random test,'' ``suitable inquiry,'' ``reason to believe,'' and ``split specimen'' because the text of the rule defines them in the section where each term is used. The rule also eliminates the term ``permanent record book'' in former Section 1.2 in Appendix A to Part 26 because laboratories now use other mechanisms to maintain testing records.

Therefore, this term is no longer used in the rule.

Section 26.7 Interpretations

Section 26.7 in the final rule retains former Sec. 26.4

Interpretations

but moves the qualifying phrase, ``other than a written interpretation by the General Counsel,'' to the end of the sentence to improve its clarity. The NRC has made this change in keeping with the Commission's commitment to using plain language in its regulations and to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the final rule.

Section 26.8 Information Collection Requirements: OMB Approval

Section 26.8 in the final rule amends former Sec. 26.8

Information collection requirements: OMB approval

to reflect the modified sections of the final rule in which recordkeeping requirements are incorporated.

Section 26.9 Specific Exemptions

Section 26.9 in the final rule revises former Sec. 26.6

Exemptions

to include the citation of 10 CFR 50.12 and 70.17. The NRC has made this change in the final rule to ensure consistency between

Part 26 and these related requirements.

Section 26.11 Communications

New Sec. 26.11 in the final rule improves consistency with similar sections in other parts of 10 CFR and ensures that communications with the NRC are addressed and, therefore, processed properly.

Subpart B--Program Elements

Throughout Subpart B, the final rule makes minor clarifications to the proposed rule because of public comment, to make conforming changes, and to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

The final rule also makes more substantive changes to the proposed rule in this subpart because of public comment or to improve clarity in the organization and language of the rule. The substantive changes in this subpart can be found in Sec. Sec. 26.21; 26.27(b)(3), (c)(1),

(c)(2)(ii), (c)(3), and (c)(3)(ii); 26.29(c)(2); 26.31(d)(1)(ii),

(d)(1)(iii), (d)(2)(i)(A), (d)(2)(v), (d)(3)(i), and (d)(3)(iii); 26.35(b); 26.37(a), (b)(5) and (d); 26.39(c) and (e); and 26.41(a).

These changes are discussed in detail below. However, other than the changes mentioned above, the final rule adopts the provisions of this subpart as proposed, without change.

Section 26.21 Fitness-for-Duty Program

The final rule modifies the proposed rule's text in this section to specify which entities and individuals are subject to the requirements of this subpart. This section requires that the licensees and other entities specified in Sec. 26.3(a) through (c) must establish, implement, and maintain FFD programs that, at a minimum, comprise the program elements contained in this subpart. This new statement serves as

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an introduction to the remaining text of the final rule and eliminates the need for the phrase ``[licensees and other entities] who are subject to this subpart'' (or a derivation of this phrase) from several provisions in this subpart. These changes are consistent with Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

The NRC has also added a sentence to this section to specify which individuals are subject to FFD programs. The sentence in the final rule includes cross-references to provisions in Sec. 26.4 [FFD program applicability to categories of individuals], which eliminates the need for the phrase ``[individuals] who are subject to this part'' (or a derivation of this phrase) from several provisions in this subpart.

This change is consistent with Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

The third sentence of the section of the final rule is based on former Sec. 26.23(b). This provision retains permission for licensees and other entities to rely upon the FFD program or program elements of a C/V to meet the requirements of this part, if the FFD program or program element of a C/V meets the applicable requirements of this part. The other requirements contained in former Sec. 26.23

Contractors and vendors

are discussed with respect to Sec. 26.23

Performance objectives

.

Section 26.23 Performance Objectives

Section 26.23 amends former Sec. 26.10 [General performance objectives] as described in the following paragraphs.

The final rule divides the performance objectives contained in

Sec. 26.10(a) into two provisions (Sec. 26.23(a) and (b), respectively) to clarify that the performance objective of assuring that personnel are trustworthy and reliable is separate and distinct from the performance objective of assuring that personnel are fit for duty.

Section 26.23(a) of the final rule requires that FFD programs provide reasonable assurance that persons who are subject to this part are trustworthy and reliable as demonstrated by the avoidance of substance abuse and the adverse behaviors that accompany it. The NRC has placed an increased emphasis on the trustworthiness and reliability of individuals who have access to certain types of sensitive information, certain types of radiological materials, and protected areas in nuclear power plants since September 11, 2001. These are the same individuals who are subject to the final rule. Because these individuals have unimpeded access to sensitive information and safety equipment and systems, their trustworthiness and reliability are essential. This level of emphasis is necessary to reduce the risk of an insider threat, maintain public health and safety, and provide for the common defense and security in the post-September 11, 2001, threat environment. Substance abuse by these individuals presents an unacceptable risk to public health and safety and the common defense and security in several ways.

First, by increasing an individual's vulnerability to coercion, substance abuse increases the likelihood that such individuals may pose an insider threat. Under 10 CFR 73.1 [Purpose and scope], a passive insider is defined as an individual who obtains or attempts to obtain safeguards or other relevant information, such as a nuclear power plant's physical configuration and design, and who does not have a functional or operational need to know this information. Section 73.1 defines an active insider as a knowledgeable individual who, while within the protected area of a nuclear power plant in an unescorted status, takes direct action to facilitate entrance and exit, disable alarms and communications, and/or participates in a violent attack. An individual who uses illegal drugs may be coerced into cooperating, actively or passively, with a terrorist in an attempt to commit radiological sabotage if, for example, the terrorist were to threaten the individual with revealing his or her illegal drug use or was somehow able to withhold drugs from an individual who is addicted.

Second, an individual's judgment and self-control are impaired while an individual is abusing drugs or alcohol. When an individual is intoxicated from abusing any of the substances for which testing is conducted under Part 26, including alcohol, the individual is more likely to inadvertently reveal sensitive information that terrorists could use in a radiological sabotage attempt than when he or she is not intoxicated.

Third, the use of illegal drugs establishes that an individual is willing to disobey the law, thus indicating that the individual will disregard other rules and regulations. The use of illegal drugs raises questions about the individual's trustworthiness and reliability in terms of scrupulously following the regulations, procedures, and other requirements, such as safeguards requirements, that ensure the protection of public health and safety.

Many provisions of the former rule provided means to identify and reduce the risks posed by any individuals whose substance abuse casts doubt on their trustworthiness and reliability. In combination with other measures the NRC has taken since September 11, 2001, a number of the changes to the former rule provide further assurance that individuals who are subject to the rule are trustworthy and reliable.

Changes to strengthen the effectiveness of the final rule in assuring individuals' trustworthiness and reliability include, but are not limited to, the following:

(1) Adding requirements for specimen validity testing to identify individuals who are willing to attempt to subvert the testing process, and may be willing to subvert other rules and regulations that are important for public health and safety and the common defense and security;

(2) Increasing the rigor of the evaluations that licensees and other entities must perform before granting authorization to an individual who has previously violated Part 26 requirements to ensure that the individual has ceased abusing drugs or alcohol; and

(3) Imposing more stringent sanctions on individuals who violate

Part 26 requirements, including, but not limited to, permanently denying authorization to any individual who attempts to subvert the drug and alcohol testing process.

The NRC believes that implementation of these provisions of the final rule, in addition to related measures the agency has taken in the post-September 11, 2001, threat environment, provides an increased level of requirements appropriate for the new threat environment, as well as reasonable assurance that individuals who are subject to the rule are trustworthy and reliable.

Section 26.23(b) of the final rule retains the performance objective of providing reasonable assurance that personnel are fit for duty, which appeared in former Sec. 26.10(a). The use of the term

``reasonable'' to describe the level of assurance required by the rule reflects the NRC's awareness that many different factors may affect an individual's fitness at any particular moment in time. Some of these factors may be difficult for the licensee or other entity to detect and many (such as a transitory illness) may not warrant management action or the imposition of sanctions because they do not pose a significant risk to public health and safety.

As mentioned above, the level of requirements associated with achieving reasonable assurance of trustworthiness and reliability is greater than that associated with achieving reasonable assurance that individuals are not

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impaired. Another example of this relates to the sanctions that the final rule requires licensees and other entities to impose on individuals who demonstrate questionable trustworthiness and reliability compared to the management actions licensees are expected to take with individuals who may be impaired. For example, if an individual demonstrates dishonesty by attempting to bring a substitute urine specimen to the collection site with a clear intent to subvert the testing process or demonstrates a willingness to break the law by possessing illegal drugs on site, the final rule (under Sec. 26.75(b) and 26.75(c), respectively) requires the licensee or other entity to terminate the individual's authorization. Terminating the individual's authorization is necessary to provide reasonable assurance that the individual could pose no further risk to public health and safety or the common defense and security. In contrast, the final rule does not require a licensee or other entity to terminate an individual's authorization if he or she is mentally or physically impaired while on duty from such transitory causes as illness or emotional stress resulting from a family problem.

For example, an individual who arrives at work with a severe migraine headache may suffer impairment on the job that would adversely affect the individual's ability to perform his or her duties safely and competently while the headache persists. The final (and former) rule

(under Sec. 26.77(b)(3) and former Sec. 26.27(b)(1), respectively) require the licensee or other entity to take action to prevent the individual from performing the duties that require the individual to be subject to this part if the individual's fitness is questionable. These actions could include, for example, assigning the individual to other duties until medication brings the headache under control or sending the individual home until the headache resolves. Such actions `meet the performance objective of providing reasonable assurance that the individual is fit when he or she resumes his or her normal duties.

However, it would be unreasonable for a licensee's FFD policy to impose sanctions on the individual, such as terminating his or her authorization. Sanctions could have no deterrent effect on the recurrence of the individual's headache, which is one purpose of including requirements for minimum sanctions in Part 26. In addition, there would not be any continuing risk to public health and safety from permitting the individual to resume his or her duties after the headache is resolved.

Another difference between the performance objectives of providing

``reasonable'' assurance of trustworthiness and reliability and

``reasonable'' assurance that the individuals who are subject to the final rule are fit for duty lies in the severity of the enforcement actions that the NRC would be likely to take against an FFD program that failed to meet these performance objectives. The NRC's enforcement actions would be severe in the case of an FFD program that, for example, granted authorization to an individual who had previously had his or her authorization permanently denied under Sec. 26.75(b) but would take less severe enforcement action in the case of an FFD program that failed to remove an individual who was experiencing impairment related to family stress from his or her duties under Sec. 26.77(b)(3).

Section 26.23(c) of the final rule retains the performance objective in former Sec. 26.10(b) to ``provide reasonable measures for the early detection of persons who are not fit to perform activities within the scope of this part.'' However, the final rule replaces the phrase ``perform activities within the scope of this part'' with the phrase ``perform the duties that require them to be subject to the FFD program.'' The final rule requires that certain individuals must be subject to an FFD program based on their duties. These duties include performing activities, such as measuring, guarding, or transporting

Category IA material. They also include having access to certain locations, material, and sensitive information, such as nuclear power plant protected areas, Category IA material, procedures and records for safeguarding SSNM, and the drug test results of an individual before the MRO reviews those results. Therefore, the phrase ``perform the duties that require them to be subject to the FFD program'' is more accurate. Replacing the former phrase with the more accurate phrase is consistent with Goal 6 of the rulemaking to improve clarity in the organization and language of the rule.

Section 26.23(d) of the final rule amends former Sec. 26.10(c) to require that FFD programs must provide reasonable assurance that the workplaces subject to this part are free from the presence and effects of illegal drugs and alcohol. The final rule revises the former performance objective to ``have a goal of achieving a drug-free workplace and a workplace free of the effects of such substances'' for several reasons. First, the terms ``drug-free'' and ``free from the effects of such substances'' do not accurately capture the NRC's intent with respect to this performance objective. These terms could be misunderstood as requiring FFD programs to have the goal of preventing any drugs and their effects from being present in the workplace, which could include medications that individuals who are subject to the rule may take to treat health problems. Therefore, the final rule replaces

``drug-free'' and ``free of the effects of such substances'' with the more specific phrase ``free from the presence and effects of illegal drugs and alcohol'' to refer to the specific substances that are proscribed. This revision clarifies that the NRC does not intend for

FFD programs to prohibit individuals from taking the medications they need to maintain their health or bringing those medications to the workplace. The NRC has made this change to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

The final rule also replaces the phrase ``have a goal of'' in the former rule with the phrase ``provide reasonable assurance'' which more accurately captures the intent of this performance objective. The NRC has eliminated the phrase ``have a goal of'' because Sec. 26.23(d) is a performance objective and, therefore, the phrase is unnecessary. The

NRC has made this change to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule without changing the intended meaning of the performance objective.

Section 26.23(e) of the final rule adds a provision to require licensees and other entities to provide reasonable assurance that the effects of fatigue and degraded alertness on individuals' abilities to safely and competently perform their duties are managed commensurate with maintaining public health and safety. This new performance objective, consistent with Goal 2 of this rulemaking to strengthen the effectiveness of FFD programs at nuclear power plants in ensuring against worker fatigue adversely affecting public health and safety and the common defense and security by establishing clear and enforceable requirements for the management of worker fatigue, specifies the objective of the requirements concerning worker fatigue that the NRC has added to the final rule. Worker fatigue cannot be measured or controlled with precision. Also, licensees and other entities do not have direct control over all matters that may influence worker fatigue.

Therefore, Sec. 26.23(e) establishes a ``reasonable assurance'' criterion for the performance objective. Worker fatigue

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can result from many causes (e.g., work hours, sleep disorders, demands outside the workplace). In addition, individuals differ in their responses to conditions that cause fatigue. As a consequence, work-hour limits alone do not address all causes of fatigue, nor do they prevent fatigue related to work hours for all workers. Contemporary methods for addressing worker fatigue (e.g., Rogers, 1996, 1997; Hartley, 1998;

Carroll, 1999) are commonly referred to as ``fatigue management'' programs and use diverse methods (e.g., training, behavioral observation, fatigue countermeasures) in addition to work-hour controls to prevent, detect, and mitigate fatigue. Accordingly, Sec. 26.23(e) establishes a performance objective of reasonable assurance that the effects of fatigue and degraded alertness on individuals' abilities to safely and competently perform their duties are ``managed'' commensurate with maintaining public health and safety. The performance objective permits licensees and other entities to apply risk-informed fatigue management controls for individuals consistent with the significance of their work activities to the protection of public health and safety.

Section 26.25 [Reserved]

The final rule has amended and moved the requirements from proposed

Sec. 26.25 [Individuals subject to the fitness-for-duty program] to

Sec. 26.4 of the final rule. This change is discussed in detail in this document with regard to Sec. 26.4.

Section 26.27 Written Policy And Procedures

Section 26.27 of the final rule reorganizes and amends former Sec. 26.20 [Written policy and procedures. The final rule divides into separate paragraphs the requirements related to the FFD policy and FFD program procedures that are intermixed within the former section. This organizational change makes the requirements related to the FFD policy and procedures easier to locate within this section, consistent with

Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.27(a) of the final rule amends the first paragraph of former Sec. 26.20. The former provision required licensees to establish and implement written policies and procedures designed to meet the performance objectives and specific requirements of this part and to retain superseded copies of the policies and procedures. The final rule replaces the term ``licensee'' in the former rule with the phrase ``licensees and other entities'' because entities other than licensees are subject to this requirement, as discussed with respect to

Sec. 26.3 [Scope]. The final rule adds the term ``maintain'' to the former requirement to ``establish and implement'' written policies and procedures to reflect the fact that licensees and other entities who are subject to Part 26 must occasionally revise FFD program policies and procedures to keep them current when FFD program personnel or other aspects of the FFD program change. The final rule replaces ``specific'' with the term ``applicable'' in the final sentence because all the requirements in Part 26 do not apply to all the licensees and other entities who are subject to the rule, as discussed with respect to

Sec. 26.3. The final rule also eliminates ``designed to'' from this sentence because it is unnecessary. The NRC has moved the records retention requirements contained in the second sentence of the former provision to Sec. 26.713(d) in Subpart N [Recordkeeping and Reporting

Requirements] of the final rule. Subpart N groups together the recordkeeping and reporting requirements that are interspersed throughout the former rule. The NRC has made these changes to the organization and language of former Sec. 26.20 to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.27(b) of the final rule amends former Sec. 26.20(a).

The former provision established requirements for the written FFD policy, and the final rule expands the list of topics that the FFD policy must address as a result of discussions with stakeholders during the public meetings mentioned in Section I.D. Stakeholders noted that the list of topics in the former rule is incomplete because it does not include many topics about which individuals who are subject to the policy should be aware in order to be able to comply with the policy.

Therefore, the final rule adds topics to the policy content requirements in former Sec. 26.20(a) to ensure that FFD policies will be complete. The NRC has made this change to meet Goal 7 of this rulemaking to protect the rights (including due process) of individuals who are subject to Part 26.

Section 26.27(b) of the final rule also adds requirements for the written FFD policy to be clear, concise, and readily available to all individuals who are subject to the policy because neither the former nor final rules require licensees and other entities to provide site- specific FFD training to individuals. However, FFD policies may vary between licensees and other entities with respect to, for example, the sanctions that are applied for confirmed positive, adulterated, or substituted test results, the cutoff levels used in drug or alcohol testing, or the time periods within which an individual who has been selected for random testing must report to the collection site.

Under this final rule, the written FFD policy continues to be the primary means by which a licensee or other entity communicates local variations in FFD policy. In the past, however, a few individuals challenged determinations that they had violated a licensee's FFD policy on the basis that they were not aware of the specific provisions of the policy to which they were subject. Therefore, the final rule adds requirements that the FFD policy must be clear, concise, and readily available in order to promote individuals' awareness of the site-specific FFD policy to which they are subject. The NRC has made this change to meet Goal 7 of this rulemaking to protect the rights

(including due process) of individuals who are subject to Part 26.

The final rule also adds examples of acceptable methods to make the written policy ``readily available'' to individuals who are subject to the FFD policy, including, but not limited to, posting the policy in various work areas throughout the licensee's or other entity's facilities, providing individuals with brochures, or allowing individuals to print the policy from a computer. The NRC has added these examples to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.27(b)(1) amends the second sentence of former Sec. 26.20(a). Former Sec. 26.20(a) required that ``the policy must address the use of illegal drugs and abuse of legal drugs (e.g., alcohol, prescription and over-the-counter drugs).'' Section 26.27(b)(1) of the final rule expands this sentence to require the FFD policy to describe the consequences of onsite or offsite use, sale, or possession of illegal drugs in Sec. 26.27(b)(i); the abuse of legal drugs and alcohol in Sec. 26.27(b)(ii); and the misuse of prescription and over- the-counter drugs in Sec. 26.27(b)(iii). The final rule replaces the phrase ``must address'' in the former sentence with the phrase ``must describe the consequences of.'' The updated phrase clarifies the information that the policy must convey to ensure that individuals who are subject to the policy are aware of the consequences of these actions, as specified in the licensee's or other entity's FFD policy.

The NRC has made these changes to meet Goal 6 of this

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rulemaking to improve clarity in the organization and language of the rule.

The final rule adds Sec. 26.27(b)(2) that requires the FFD policy to state the time period specified by the licensee or other entity within which individuals must report to the collection site after being notified that they have been selected for random testing. The provision does not establish a time limit because there are a variety of circumstances among the different licensees and other entities who are subject to this rule that make it impractical to establish a universal time limit. However, adding the requirement for the licensee's or other entity's FFD policy to establish and convey a time limit is necessary because some programs have not done so. As a result, circumstances have arisen in which individuals who were selected for random testing intentionally delayed reporting to the collection site in order to take steps to subvert the testing process, such as obtaining an adulterant to bring to the collection site or drinking large amounts of liquid to be able to provide a dilute specimen. Furthermore, the longer that an individual who has abused illegal drugs or alcohol is able to delay providing specimens for testing, the more likely it is that the concentrations of an illegal drug or alcohol in the individual's urine, breath, or oral fluids will decrease because of metabolism. As a result, the concentrations may fall below the cutoff levels for those substances by the time the specimens are collected and the individual's substance abuse would not be detected. Therefore, the requirement to establish a time limit within which individuals must report for random testing after notification meets Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs. The final rule also requires the FFD policy to convey this time limit to ensure that individuals are aware of it, given that a failure to appear for testing within the prescribed time limit may lead to the imposition of sanctions under the FFD policy. The NRC has made this change to meet

Goal 7 of this rulemaking to protect the rights (including due process) of individuals who are subject to Part 26.

Section 26.27(b)(3) adds a requirement that the FFD policy inform individuals of the consequences of refusing to be tested and attempting to subvert the testing process. With respect to the proposed rule, the final rule clarifies that the written policy statement must also describe the actions that constitute a refusal to provide a specimen for testing. This change, in response to a public comment, clarifies the intent of the provision, consistent with Goal 6 of the rulemaking to improve clarity in the language and organization of the rule. This provision ensures that persons who are subject to the rule are aware of

Sec. 26.75(b), which requires licensees and other entities to impose the sanction of permanent denial of authorization for these actions.

Section 26.27(b)(3) protects the due process rights of individuals who are subject to drug and alcohol testing under this part by ensuring that they are informed, in advance, of the licensee's or other entity's policies to which they are subject. Therefore, adding this requirement to the final rule meets Goal 7 of this rulemaking to protect the rights

(including due process) of individuals who are subject to Part 26.

Section 26.27(b)(4)(i) amends former Sec. 26.20(a)(1). Former

Sec. 26.20(a)(1) required the FFD policy to prohibit the consumption of alcohol within an abstinence period of at least 5 hours preceding

``any scheduled working tour.'' The final rule replaces the phrase

``any scheduled working tour'' with the phrase ``the individual's arrival at the licensee's or other entity's facility'' as a result of stakeholder comments on the language in the former rule at the public meetings mentioned in Section I.D. The stakeholders commented that the former phrase lacked clarity and could be misinterpreted as meaning,

``any working tour scheduled by the licensee or other entity.'' If the phrase was so interpreted, individuals who are subject to the rule may believe that, if they work on a weekend or work overtime that is not part of their normally scheduled working tour, the rule would permit them to consume alcohol within the 5-hour period before they arrive at work, which would be incorrect. Therefore, the revised language of the final rule clarifies that the pre-work abstinence period applies to the 5 hours before an individual arrives at the licensee's or other entity's facility for any purpose, except if an individual is called in to perform an unscheduled working tour, as discussed with respect to

Sec. 26.27(c)(3). The NRC has made this final change to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.27(b)(4)(ii) retains former Sec. 26.20(a)(2) without change.

The NRC has added Sec. 26.27(b)(5) to the final rule to require that the FFD policy inform individuals that abstinence from alcohol during the 5 hours preceding any scheduled tour of duty may not be sufficient to ensure that an individual is fit for duty upon reporting to work. Some individuals who have complied with the 5-hour abstinence requirement could have BACs above the cutoff levels specified in Sec. 26.103 [Determining a confirmed positive test result for alcohol] preceding a scheduled tour of duty, depending on the amount of alcohol and food that the individual consumed before the abstinence period began, body weight, and other factors. By ensuring that individuals who are subject to this part are aware that the required 5-hour abstinence period may be insufficient to ensure they have a BAC below the cutoff levels in this part when arriving at the licensee's or other entity's facility, this provision to meet Goal 7 of this rulemaking to protect the rights (including due process) of individuals who are subject to alcohol testing under Part 26.

Section 26.27(b)(6) amends the last sentence of former Sec. 26.20(a). That sentence required the FFD policy to address other factors that could affect individuals' abilities to perform their duties safely and competently, such as mental stress, fatigue, and illness. The final rule adds a requirement for the FFD policy also to address the use of prescription and over-the-counter medications that could cause impairment at work. For example, some licensees or other entities may require individuals to self-report to the FFD program their use of any prescription medications that are labeled with a warning indicating that use of the medication may cause impairment. The licensee's or other entity's FFD policy may require that an individual who is taking a medication that can cause impairment must be temporarily reassigned to duties that the individual can perform without posing a risk to the individual or public health and safety while he or she is taking the medication. Therefore, the final rule requires licensees and other entities to include such information in the FFD policy to ensure that individuals are aware of the actions they may be required to take when using these substances, consistent with

Goal 7 of this rulemaking with respect to protecting the rights

(including due process) of individuals who are subject to the policy.

The addition of this requirement also increases the internal consistency of the rule because other portions of the final rule establish requirements related to using prescription and over-the- counter medications. For example, Sec. 26.29(a)(6) requires FFD training to address use of prescription and over-the-counter medication. Also, Sec. 26.185(j)(2) requires the MRO to determine whether a positive confirmatory drug test result that results from using a prescription or over-the-counter medication represents

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substance abuse. Therefore, the requirement for the FFD policy to address the use of prescription and over-the-counter medications that could cause impairment at work also meets Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.27(b)(7) amends former Sec. 26.20(b). Former Sec. 26.20(b) required the FFD policy to describe programs that are available to individuals desiring assistance in dealing with drug, alcohol, or other problems that may adversely affect their performance of their duties. Section 26.27(b)(7) of the final rule adds fatigue as one of the problems for which individuals may be seeking assistance because sleep disorders (e.g., sleep apnea, insomnia, restless leg syndrome) can substantially affect individuals' abilities to obtain sufficient quality sleep. Poor quality sleep causes fatigue that may degrade an individual's ability to safely and competently perform his or her duties. Sleep disorders affect a sizeable portion of the U.S. work force. According to polls conducted by NSF, about two-thirds of

U.S. adults report experiencing one or more symptoms associated with insomnia, sleep apnea, or restless leg syndrome at least a few nights a week (National Sleep Foundation, 2003) and nearly one out of five (19 percent) report making occasional or frequent errors because of sleepiness (National Sleep Foundation, 2000). Section 26.27(b)(7) ensures that individuals are aware of the services that are available for diagnosing and treating sleep disorders that can adversely affect their job performance. The NRC has made this change to meet Goal 2 of this rulemaking to strengthen the effectiveness of FFD programs at nuclear power plants by reducing the potential for worker fatigue to adversely affect public health and safety and the common defense and security, through establishing clear and more readily enforceable requirements concerning the management of worker fatigue. In addition, the final rule replaces the phrase ``adversely affect the performance of activities within the scope of this part'' in the former provision with the phrase ``could adversely affect an individual's ability to safely and competently perform the duties that require an individual to be subject to this part'' for the reasons discussed with respect to

Sec. 26.23(c).

Section 26.27(b)(8) retains the requirement in former Sec. 26.20(d) that the FFD policy must specify the consequences of violating the policy. The NRC has moved the former requirements that were related to the procedures that the licensee or other entity would implement if an individual violates the FFD policy to Sec. 26.27(c) of the final rule, which addresses FFD program procedures, for organizational clarity.

Section 26.27(b)(9) adds a requirement that licensees' and other entities' FFD policies must describe the individual's responsibility to report legal actions, as defined in Sec. 26.5 [Definitions]. The new requirement to report legal actions is discussed with respect to Sec. 26.61 [Self-disclosure and employment history]. The final rule requires the FFD policy to address the reporting of legal actions to ensure that individuals are aware of this and are not at risk of sanctions for failing to report any legal actions. Thus, the NRC has made this change to meet Goal 7 of this rulemaking to protect the rights (including due process) of individuals who are subject to the policy.

Section 26.27(b)(10) adds a requirement for the FFD policy to describe the responsibilities of managers, supervisors, and escorts to report FFD concerns. The former rule implied that managers and supervisors have the responsibility to report FFD concerns in Sec. 26.22(a)(5), which required managers and supervisors to be trained in procedures ``for initiating appropriate corrective action.'' Similarly, the last phrase of former Sec. 26.22(b) required that escorts be trained in procedures ``for reporting problems to supervisory or security personnel'' and, therefore, also implied that escorts have a reporting responsibility. However, the former rule did not explicitly state that the FFD policy must convey this requirement. Therefore, the final rule adds Sec. 26.27(b)(10) to enhance the internal consistency of the rule. The NRC has made this change to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.27(b)(11) adds a requirement for the FFD policy to state that individuals who are subject to the rule must report FFD concerns, consistent with Sec. 26.33 [Behavioral observation]. Section 26.33 requires individuals who are subject to the rule to perform behavioral observation and to report an FFD concern if they detect behaviors that may indicate possible use, sale, or possession of illegal drugs; use or possession of alcohol on site or while on duty; or impairment from fatigue or any cause that, if left unattended, may constitute a risk to the health and safety of the public. Section 26.29 [Training] requires individuals to be trained in behavioral observation. The agency has added these requirements to enhance the effectiveness of Part 26 by ensuring the early detection of individuals who are not fit to perform the duties that require them to be subject to this part. This is one of the performance objectives that FFD programs must meet, as discussed with respect to Sec. 26.23(c). This provision also improves consistency between FFD requirements and access authorization requirements established in 10 CFR 73.56 [Personnel access authorization requirements for nuclear power plants] as supplemented by orders to nuclear power plant licensees dated January 7, 2003, as discussed in Section IV.B of this document. The specific requirement in

Sec. 26.27(b)(11) for licensees' and other entities' FFD policies to state that individuals must report FFD concerns is necessary to ensure that individuals are aware of their responsibility to report concerns

(and that sanctions may be imposed if they do not) to meet Goal 7 of this rulemaking to protect the rights (including due process) of individuals who are subject to the policy.

Section 26.27(c) of the final rule combines the requirements related to procedures contained in former Sec. 26.20(c) through (e), and adds other requirements, as described in the following paragraphs.

Section 26.27(c)(1) retains the requirements in former Sec. 26.20(c). The NRC has replaced the phrase in the proposed rule

``privacy and due process rights of an individual who provides a specimen'' with the phrase ``privacy and other rights (including due process) of an individual who provides a specimen'' in the final rule.

The NRC has made this change in response to a public comment that stated the proposed phrase may be interpreted to limit individuals' protected rights to due process. This phrase clarifies the requirement for ``protecting the employee'' contained in former Sec. 26.20(c). For example, individuals' privacy rights under the final rule include, but are not limited to, requirements for the protection of personal information that is collected about the individual and individual privacy during specimen collections. Other examples of individuals' rights under the final rule include, but are not limited to, the right to an objective and impartial review of a determination that the individual has violated the FFD policy, the right to advance knowledge of rule provisions and FFD policy requirements that affect the individual, and the right to request testing of a split specimen or retesting an aliquot of a single specimen, if the individual questions a confirmed positive, adulterated, or substituted test result.

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The NRC has made this change to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.27(c)(2)(i) and (c)(2)(ii) divides former Sec. 26.20(d) into separate paragraphs that address different topics. Section 26.27(c)(2)(i) retains the former requirement that licensees and other entities must have procedures that specify the immediate and followup actions that must be taken if an individual is determined to have been involved in the use, sale, or possession of illegal drugs. Like the former provision, Sec. 26.27(c)(2)(ii) requires licensees' and other entities' procedures to specify the immediate and followup actions to be taken if an individual is determined to have consumed alcohol to excess before the mandatory prework abstinence period, or while on duty, as determined by a test that measures BAC. With respect to the proposed rule, the final rule also adds the phrase ``or consumed any alcohol during the mandatory prework abstinence period'' to clarify the prohibition against any alcohol consumption, not only excess consumption, during the pre-work abstinence period. The NRC has made these changes to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.27(c)(2)(iii) and (c)(2)(iv) adds requirements that licensees and other entities must prepare written procedures for implementing the FFD program that describe immediate and followup actions for attempted subversion of the testing process. Section 26.27(c)(2)(iii) requires procedures to specify immediate and followup actions if an individual has attempted to subvert the testing process by adulterating, substituting, or diluting specimens (in vivo or in vitro), or by any other means. Section 26.27(c)(2)(iv) requires procedures to address the actions to be taken if an individual has refused to provide a specimen for testing. The final rule adds these provisions for consistency with Sec. 26.75(b). Section 26.75(b) requires licensees and other entities to terminate an individual's authorization and, thereafter, permanently deny authorization to any individual who has committed or attempted any act to subvert the testing process, including refusing to provide a specimen and providing or attempting to provide a substituted or adulterated specimen for any test required under Sec. 26.31(c). Adding the requirements for procedures to address these circumstances meets Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.27(c)(2)(v) adds a requirement that the written procedures must describe immediate and followup actions for individuals who have had drug- or alcohol-related legal actions taken against them, as defined in Sec. 26.5. This provision supports related provisions in

Sec. 26.69(d). Section 26.69(d), in general, requires licensees and other entities to take certain steps if an individual has had drug- or alcohol-related legal actions taken against them while they are maintaining authorization to perform the duties that require them to be subject to this part. Adding the requirement for procedures to address these circumstances ensures the internal consistency of the final rule and meets Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

The NRC has reorganized Sec. 26.27(c)(3) of the final rule, with respect to the proposed rule, to clarify which provisions apply to

``emergencies'' and which apply to ``unscheduled working tours.'' The

NRC received a public comment that suggested the term ``emergency'' may be too limiting. However, the NRC believes the term ``emergency'' accurately reflects NRC's intent and has retained this term in the final rule. Section 26.27(c)(3) amends former Sec. 26.20(e). The provision requires licensees and other entities to have procedures to describe the process that the licensee or other entity will use to ensure that individuals who are called in to perform an unscheduled working tour are fit for duty.

The final rule retains and modifies the other requirements of former Sec. 26.20(e), as described in the following paragraphs.

Section 26.27(c)(3)(i) retains former Sec. 26.20(e)(1). The provision requires the individual who is called in to state whether the individual considers himself or herself fit for duty and whether he or she has consumed alcohol within the pre-duty abstinence period stated in the FFD policy. The final rule adds the requirement to state whether he or she considers himself or herself to be fit for duty, in addition to stating whether he or she has consumed alcohol because the NRC recognizes that conditions other than the consumption of alcohol may cause an individual to be unable to safely and competently perform duties, including, but not limited to, fatigue (as discussed with respect to Subpart I [Managing Fatigue]). The NRC received a comment suggesting that individuals who are called in should only be required to report if they are not fit for duty or have consumed alcohol during the pre-duty abstinence period. The NRC believes that this alternative would be less protective of public health and safety, as an affirmative obligation to provide a statement may dissuade individuals who would be tempted to remain silent. Requiring individuals to report other conditions that may cause them to be impaired when called in under

Sec. 26.27(c)(3)(i), strengthens the effectiveness of FFD programs by providing the licensee or other entity with more complete information about the individual's condition to determine whether there is a need to establish controls and conditions under which the individual may safely perform work, as required under Sec. 26.27(c)(3)(iii).

Therefore, the NRC has adopted the proposed provision as final. The NRC has made these changes to meet Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

Section 26.27(c)(3)(ii) specifies the procedures to follow if the individual has consumed alcohol in the pre-duty abstinence period and is called in for an unscheduled working tour, including an unscheduled working tour to respond to an emergency. Section 26.27(c)(3)(ii)(A) retains former Sec. 26.20(e)(2). The provision requires that an individual who reports that he or she has used alcohol and is called in must be subject to a determination of fitness by breath analysis. The

NRC has added a new Sec. 26.27(c)(3)(ii)(B) to the final rule to permit the licensee or other entity to assign the individual to duties that require him or her to be subject to this part, if the results of the determination of fitness indicate that the individual is fit to safely and competently perform his or her duties. The NRC has also added a new Sec. 26.27(c)(3)(ii)(C) to the final rule to prohibit the licensee or other entity from assigning the individual to duties that require him or her to be subject to this part, if the individual is not required to respond to an emergency and the results of the determination of fitness indicate that the individual may be impaired.

The NRC has also added Sec. 26.27(c)(3)(ii)(D) that retains a portion of former Sec. 26.20(e)(3). The provision requires the procedures to state that consumption of alcohol during the 5-hour abstinence period required in paragraph (b)(4)(i) of this section may not by itself preclude a licensee or other entity from using individuals who are needed to respond to an emergency. This provision also retains and modifies a portion of former Sec. 26.20(c)(3). It states that if the determination of fitness indicates that an individual who has been called in for an unscheduled working tour to

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respond to an emergency may be impaired, the procedure must require the establishment of controls and conditions under which the individual who has been called in can perform work if necessary.

The NRC has added Sec. 26.27(c)(3)(ii)(E) to the final rule to clarify that licensees and other entities may not impose sanctions if an individual is called in for an unscheduled working tour for having consumed alcohol during the preduty abstinence period specified in the

FFD policy. This change ensures that, if an individual who is called in unexpectedly has a confirmed positive test result for alcohol, he or she would not be subject to the sanctions that are otherwise required under this part for a confirmed positive alcohol test result. The NRC believes that sanctions for the consumption of alcohol in these circumstances would be inappropriate because the individual would have been unaware that he or she would be called in to work. The revision is also consistent with the original intent of the rule. Therefore, the

NRC has made these changes to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.27(c)(4) adds a requirement that FFD procedures must describe the process to be followed when another individual's behavior raises an FFD concern and the process for reporting the concern. As discussed with respect to Sec. 26.27(b)(11), this provision is consistent with Sec. 26.33, which establishes a requirement that all individuals must perform behavioral observation and report any FFD concerns. This provision is also consistent with Sec. 26.29, which requires individuals to be trained to perform behavioral observation.

The NRC has added this requirement to meet Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs and Goal 4 to improve consistency between FFD requirements and access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003.

Section 26.27(d) of the final rule retains the requirements of former Sec. 26.20(f) without changes.

Section 26.29 Training

Section 26.29 of the final rule combines and amends former Sec. 26.21 [Policy communications and awareness training] and Sec. 26.22

Training of supervisors and escorts

. This section clarifies that all individuals subject to this subpart must receive the same scope of training, to include, for example, behavioral observation, whereas former Sec. 26.22 required that only supervisors and escorts must receive behavioral observation training. Increasing the number of individuals who are trained in behavioral observation enhances the effectiveness of FFD programs by increasing the likelihood of detecting potential impairment, consistent with Goal 3 of this rulemaking.

Section 26.29(a) of the final rule combines the training topics listed in former Sec. Sec. 26.21(a)(1) through (a)(5), 26.22(a)(1) through (a)(5), and 26.22(b). The agency has rewritten the required training topics in terms of knowledge and abilities (KAs) to be consistent with terminology used by licensees and other entities in other required training programs. This change meets Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.29(a)(1) combines former Sec. 26.21(a)(1) with the latter portion of former Sec. 26.21(a)(5). Consistent with the former training requirements, the provision requires licensees and other entities to ensure that individuals who are subject to this subpart have knowledge of the FFD policy and procedures that apply to them, the methods used to implement the policy and procedures, and the consequences of violating the policy and procedures.

Section 26.29(a)(2) retains the requirement in former Sec. 26.22(a)(1) that licensees and other entities must ensure that individuals understand their roles and responsibilities under the FFD program, such as avoiding substance abuse and reporting for testing within the time limit specified in FFD program procedures.

Section 26.29(a)(3) amends the terminology used in former Sec. 26.22(a)(2). Former Sec. 26.22(a)(2) required FFD training to address the roles and responsibilities of others, such as the personnel, medical, and EAP staffs. The final rule replaces the references to the

``personnel'' function and ``medical'' staff in former Sec. 26.22(a)(2) with ``human resources'' and ``FFD'' staff, respectively.

The final rule also moves the reference to the MRO into this section from former Sec. 26.21(a)(3). These updates to the terminology in this section are consistent with other terms used throughout the final rule to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.29(a)(4) and (a)(5) amends former Sec. 26.21(a)(4) and

(a)(2), respectively, by changing some of the language used in the former provisions. Former Sec. 26.21(a)(4) required FFD training to inform individuals who are subject to the rule of any EAPs that are available to them. The final rule eliminates the reference to EAPs

``provided by the licensee'' in the former provision and amends it as

``EAP services available to the individual'' because other entities are also subject to this requirement under the final rule. Section 26.29(a)(5) amends former Sec. 26.21(a)(2) by replacing the phrase

``abuse of drugs and misuse of alcohol'' with ``abuse of illegal and legal drugs and alcohol'' for greater accuracy in describing the required knowledge. The NRC has made these changes to meet Goal 6 of this rulemaking to improve clarity in the language of the rule.

Section 26.29(a)(6) retains the portion of former Sec. 26.21(a)(3) that required licensees to ensure that individuals understand the effects of prescription and over-the-counter drugs and dietary factors on job performance. The final rule adds a requirement for FFD training to address the effects of alcohol, illness, mental stress, and fatigue on job performance, in order to ensure that individuals understand the bases for the licensee's or other entity's FFD policy regarding these conditions. The NRC has moved the requirement in the last sentence of former Sec. 26.20(a) to Sec. 26.27(b)(6) of the final rule because that section addresses FFD policy requirements. The NRC has made these changes to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.29(a)(7) retains the portion of former Sec. 26.21(a)(3) that required licensees and other entities to ensure that individuals who are subject to the rule understand the effects of prescription and over-the-counter drugs and dietary factors on drug and alcohol test results. Examples of medications, supplements, and dietary factors that can affect drug and alcohol test results may include, but are not limited to, ingesting foods containing poppy seeds, drinking coca tea, using some liquid or inhalant cold and cough preparations containing alcohol or codeine, and taking supplements containing hemp oil.

Section 26.29(a)(8) and (a)(9) of the final rule retains the requirements in former Sec. 26.22(a)(3) and (a)(4), respectively, without changes.

Section 26.29(a)(10) amends former Sec. 26.22(a)(5). The provision retains the former requirement for FFD training to address the licensee's or other entity's process for initiating appropriate corrective action if an individual has an FFD concern about another person, including referral to the EAP. The final rule adds a requirement for FFD training

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to ensure that individuals understand their responsibility to report

FFD concerns to the person(s) who are designated to receive such reports in FFD program procedures. This change is consistent with Sec. 26.33, which requires individuals to perform behavioral observation and report any FFD concerns, as discussed with respect to Sec. 26.27(b)(11). The change is also consistent with Sec. 26.27(c)(4), which requires procedures for implementing the requirement. The NRC has added this group of interrelated requirements to meet Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs and Goal 4 to improve consistency between FFD requirements and access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003.

Section 26.29(b) of the final rule adds a requirement that individuals must demonstrate attainment of the KAs specified in Sec. 26.29(a) by passing a comprehensive examination. The NRC has added this requirement because in several instances since Part 26 was first promulgated, individuals were able to overturn determinations that they had violated a licensee's FFD policy on the basis that they had not understood the information they received during FFD training and could not be expected to comply with the requirements of the policy.

Therefore, the final rule requires individuals to demonstrate their attainment of the KAs listed in Sec. 26.29(a) to ensure that the FFD training has been effective. The final rule requires remedial training for those who fail to achieve a passing score of 80 percent on the examination. Section 26.29(b) also requires the examination to include at least one question for each KA. These requirements are modeled on other required training programs that have been successful in ensuring that examinations are valid and individuals have achieved an adequate understanding of the subject matter. Establishing a method to ensure that individuals understand the requirements with which they must comply meets Goal 3 of this rulemaking to improve the effectiveness of

FFD programs.

The provision also permits the use of various media for administering the comprehensive examination, in order to achieve the efficiencies associated with computer-based training and testing, for example, and other new training delivery technologies that may become available. Permitting the use of various media to administer the examination meets the portion of Goal 3 of this rulemaking to improve the efficiency of FFD programs. The permission also meets Goal 5 to improve Part 26 by eliminating or modifying unnecessary requirements through providing flexibility in the methods that licensees and other entities may use to administer the required examination.

Section 26.29(c) of the final rule combines and amends the portions of former Sec. Sec. 26.21(b) and 26.22(c) that required FFD training for individuals who are subject to this section before they are permitted to perform duties that require them to be subject to this part.

Section 26.29(c)(1) requires that all personnel who are subject to this section must complete FFD training before the licensee or other entity grants initial authorization to the individual, as defined in

Sec. 26.55 [Initial authorization]. The final rule also requires that an individual's training must be current before the licensee or other entity grants an authorization update or reinstatement to the individual, as defined in Sec. 26.57 [Authorization update] and Sec. 26.59 [Authorization reinstatement], respectively. The provision also eliminates the requirement in former Sec. 26.22(c) to upgrade training for newly assigned supervisors within 3 months of a supervisory assignment because all personnel will receive the same scope of training and be required to complete the training before a licensee or other entity grants authorization to any individual. These changes are consistent with the requirements related to granting and maintaining authorization that are established in Subpart C [Granting and

Maintaining Authorization] of the final rule, as discussed in this document with respect to that subpart. The changes also meet Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

Section 26.29(c)(2) retains and combines the requirements for annual refresher training in former Sec. Sec. 26.21(b) and 26.22(c).

Former Sec. 26.21(b) addressed individuals who are subject to this part and former Sec. 26.22(c) addressed supervisors and escorts. The final rule combines the former requirements because all personnel receive the same scope of training under the final rule. The final rule specifies that individuals must complete the refresher training every 12 months, or more frequently when the need is indicated. With respect to the proposed rule, the final rule gives some examples of situations that indicate a need to conduct the refresher training more frequently than every 12 months, but this list is not inclusive of all situations that may indicate this need. Adding these examples clarifies the NRC's intent and meets Goal 6 of the rulemaking to clarify the language of the rule. The final provision permits individuals who pass a comprehensive annual examination that demonstrates their continued understanding of the FFD program requirements to be excused from the refresher training that the provision otherwise requires. The examination is necessary to meet the examination requirements specified in Sec. 26.29(b) [Comprehensive examination]. Individuals who do not pass must undergo remedial training. Permitting individuals to pass a comprehensive examination rather than take refresher training each year ensures that they are retaining their FFD KAs while reducing some costs associated with meeting the annual refresher training requirement.

Therefore, this change meets Goal 5 of this rulemaking to improve Part 26 by eliminating or modifying unnecessary requirements.

Section 26.29(c)(3) permits licensees and other entities to use various media, in addition to traditional classroom instruction, for presenting initial and refresher training for the same reasons discussed with respect to the portion of Sec. 26.29(b) that permits licensees and other entities to use various media to administer the comprehensive examination. The requirements for a licensee or other entity to monitor the completion of training and provide access to an instructor or subject matter expert ensures that individuals who are trained using different media achieve the same understanding as persons who are trained in a classroom setting with an instructor present. This flexibility may reduce the costs associated with presenting initial and refresher training only in a classroom setting. Therefore, this change meets Goal 5 of this rulemaking to improve Part 26 by eliminating or modifying unnecessary requirements.

To meet the annual refresher training requirement for individuals,

Sec. 26.29(d) of the final rule permits licensees and other entities to accept the training of individuals who have been subject to another training program that meets the requirements of this section. Licensees and other entities are also permitted to accept a passing result from a comprehensive examination that was administered by another training program that meets the requirements of this section in lieu of refresher training, if the examination meets the requirements of Sec. 26.29(b). This requirement meets Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

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Section 26.31 Drug and Alcohol Testing

Section 26.31 of the final rule renames former Sec. 26.24

Chemical and alcohol testing

. The final rule, in general, replaces the former term ``chemical testing'' with ``drug testing'' because the testing for chemicals that is required in the rule is performed only in the context of urine drug testing. Therefore, the term ``drug testing'' more accurately conveys the nature of the testing that is performed.

The NRC has made these changes to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.31(a) [General] of the final rule retains but updates the language in former Sec. 26.24(a) to be consistent with the new terminology used throughout the rule as discussed in Sec. 26.5. The

NRC has made this change to meet Goal 6 of this rulemaking to improve clarity in the language of the rule.

Section 26.31(b) [Assuring the honesty and integrity of FFD program personnel] of the final rule amends former Section 2.3 in Appendix A to

Part 26. Other than making minor clarifications to the rule text as explained below, the NRC has adopted the requirements of paragraph (b) of this section as proposed, without change.

Section 26.31(b)(1) amends the first paragraph of former Section 2.3 in Appendix A to Part 26. This paragraph required licensees to carefully select and monitor persons responsible for administering the testing program to ensure that they meet the highest standards of honesty and integrity. The final rule replaces the former list of individuals who are subject to this requirement with a cross-reference to Sec. 26.4(g) of the final rule, which specifies in detail the FFD program personnel who must be subject to the FFD program. This cross- reference avoids repeating the list of personnel in this provision.

The provision also adds a reference to factors, other than a personal relationship with an individual who is subject to testing, that have the potential to cause an individual to be subject to influence attempts or may adversely affect the honesty and integrity of

FFD program personnel. In addition to a personal relationship with an individual who is subject to testing, factors that could cause an individual to be compromised may include, but are not limited to, a substance abuse problem or financial problems. Therefore, the final rule adds a reference to these additional factors to more accurately characterize the scope of potential concerns that licensees and other entities must consider when selecting and monitoring the honesty and integrity of FFD program personnel. The NRC has made these changes to meet Goal 6 of this rulemaking to improve clarity in the language of the rule.

Section 26.31(b)(1)(i) amends former Section 2.3(2) in Appendix A to Part 26 in response to implementation questions regarding the former requirements. The provision clarifies that the background investigations, credit and criminal history checks, and psychological evaluations that are required for persons who are granted unescorted access to protected areas in nuclear power plants are acceptable when determining the honesty and integrity of FFD program personnel. The final rule retains the term ``appropriate'' in the former rule for two reasons. First, it indicates that FFD program personnel who are employed by entities who are subject to the rule but are not nuclear power plants, may meet the requirements through investigations, checks, and evaluations that provide the information needed to determine the honesty and integrity of FFD program personnel, but the investigations, checks, and evaluations may differ from those required under nuclear power plant access authorization programs. In addition, the final rule retains the term ``appropriate'' because it has particular relevance to the requirement for licensees and other entities to conduct criminal history checks for FFD program personnel. In some cases, licensees and other entities cannot legally obtain the same type of criminal history information about FFD program personnel as they are able to obtain for other individuals who are subject to Part 26. Therefore, the term

``appropriate'' is used to indicate that local criminal history checks for FFD program personnel who do not have unescorted access to nuclear power plant protected areas are acceptable. The NRC has made these changes to meet the portion of Goal 6 of this rulemaking that pertains to improving clarity in the language of the rule.

The NRC has relaxed the requirement in former Section 2.3(2) in

Appendix A to Part 26 for appropriate background checks and psychological evaluations to be conducted at least once every 3 years to require that credit and criminal history checks and updated psychological assessments be conducted nominally every 5 years. The final rule relaxes the former requirement for several reasons. First, the NRC is not aware of any instances in which licensees and other entities have identified new information about FFD program personnel from updating the background checks and psychological assessments that had not already been identified through other avenues, including self- reports by FFD program personnel, drug and alcohol testing, and behavioral observation. However, the NRC continues to believe that the required updates provide an independent method to verify the ongoing honesty and integrity of FFD program personnel that is necessary because of the critical importance of FFD program personnel in assuring program effectiveness. Therefore, the final rule retains the former requirement for updated background checks and psychological assessments, but reduces the required frequency of these updates from every 3 years to every 5 years under the final rule. The NRC has made this change to meet Goal 5 of this rulemaking to improve Part 26 by eliminating or modifying unnecessary requirements. In addition, the frequency for these updates increases the consistency of Part 26 with access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003, which is Goal 4 of this rulemaking.

Section 26.31(b)(1)(ii) amends and clarifies former Section 2.3(1) in Appendix A to Part 26 in response to the many implementation questions that have arisen after the regulation was published. The former rule prohibited individuals who have a personal relationship with the individual being tested (i.e., a donor), such as the donor's

``supervisors, coworkers, and relatives,'' from performing any

``collection, assessment, or evaluation procedures'' involving the individual being tested. The NRC included the restriction on

``supervisors, coworkers, and relatives'' in the former rule to provide examples of the ``personal relationships'' referenced in the introductory paragraph of former Section 2.3 in Appendix A to Part 26.

Some licensees have misinterpreted the restriction on coworkers in the former rule as meaning that no one who is an employee of the same corporation may be involved in collection, assessment, or evaluation procedures. However, in a large corporation, many individuals employed by the same corporation will not have personal relationships with FFD program personnel, specifically, or with other individuals who are subject to testing, in general. Therefore, in Sec. 26.31(b)(1)(ii), the phrase ``in the same work group'' clarifies that the example regarding coworkers pertains to individuals who report to the same manager. For example, FFD program

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personnel report to the FFD program manager and would be considered

``coworkers in the same work group'' to whom the restriction applies.

In addition, the section adds a reference to determinations of fitness

(discussed with respect to Sec. 26.189 [Determination of fitness]) to provide a clarifying example of the assessment and evaluation procedures that FFD program personnel are prohibited from performing if the FFD program staff member has a personal relationship with the subject individual. The NRC has made these changes to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.31(b)(1)(iii) relaxes the prohibition on individuals who have ``personal relationships'' with the donor from performing specimen collection procedures in former Section 2.3(1) in Appendix A to Part 26. The NRC acknowledges that the former restriction imposed an unnecessary burden when the objective of ensuring the integrity of specimen collections in these circumstances could be achieved by other means. Therefore, in Sec. 26.31(b)(1)(iii), individuals who have a personal relationship with a donor are permitted to collect specimens, if another individual who does not have a personal relationship with the donor and is not a supervisor, a coworker in the same work group, or a relative of the donor monitors the collection and preparation of the specimens for shipping. The section also provides examples of the types of individuals who may monitor the integrity of specimen collection procedures in these circumstances, including but not limited to, security force or quality assurance personnel. By permitting monitored collections in these circumstances while continuing to assure the integrity of specimen collections from FFD program personnel, this provision meets Goal 5 of this rulemaking to improve Part 26 by eliminating or modifying unnecessary requirements. The final rule retains the prohibition for individuals who have personal relationships with the donor from performing assessment and evaluation procedures because monitoring of these activities by qualified personnel is not feasible.

If a directly observed collection is required, Sec. 26.31(b)(1)(iv) of the final rule adds a prohibition for an individual who has a personal relationship with the donor from acting as a urine collector or observer. This prohibition is necessary to minimize embarrassment to the donor (and the collector) during a directly observed collection. The NRC has added this provision to meet Goal 7 of this rulemaking, relating to protecting the privacy rights of individuals who are subject to Part 26.

Section 26.31(b)(1)(v) amends former Section 2.3(3) in Appendix A to Part 26 to require that MROs who are on site at a licensee's or other entity's facility must be subject to behavioral observation. For the purposes of Sec. 26.31(b)(1)(v), a ``facility'' includes, but is not limited to, a licensee's or other entity's corporate offices and any medical facilities that the licensee or other entity operates. The

NRC has added this requirement because MROs are ``persons responsible for administering the testing program,'' but some FFD programs have not included MROs in the behavioral observation element of their programs.

However, the final rule limits the behavioral observation of MROs to those times when they are on site at a licensee's or other entity's facility in order to permit licensees and other entities to continue relying on the services of MROs who normally work independently, often alone, in offices at a geographical distance from the licensee's or other entity's facilities so that behavioral observation is impractical. Limiting the requirement for behavioral observation of

MROs to those instances in which the MRO is working on site at a licensee's or other entity's facility is adequate to ensure the continuing honesty and integrity of these MROs because MROs who work off site would not interact on a daily basis with other individuals who are subject to the FFD program. Therefore, off site MROs would be less likely to be subject to potential influence attempts than MROs who normally work on site because they are generally inaccessible. The final rule continues to require all MROs to be subject to the other FFD program elements that are required in this subpart. These elements include drug and alcohol testing and regular psychological assessments and background investigations, which permit licensees and other entities to monitor the honesty and integrity of off site MROs. The NRC has added this relaxation to meet Goal 5 of this rulemaking to improve

Part 26 by eliminating or modifying unnecessary requirements.

A new Sec. 26.31(b)(2) provides another relaxation from the former rule related to collecting specimens from FFD program personnel. The provision permits FFD program personnel to submit specimens for testing at collection sites that meet the requirements of 49 CFR Part 40,

``Procedures for Department of Transportation Workplace Drug and

Alcohol Testing Programs'' (65 FR 41944; August 9, 2001). As discussed with respect to Sec. 26.31(b)(1), some FFD program personnel, such as contract MROs and EAP staff members, normally work at locations that are so distant from a licensee's collection site(s) as to make it impractical for them to be randomly tested at a licensee's or other entity's collection site. Permitting these FFD program personnel to be tested at local collection sites that follow similar procedures is adequate to meet the goal of ensuring their continuing honesty and integrity. Therefore, the NRC has added this provision to meet Goal 5 of this rulemaking to improve Part 26 by eliminating or modifying unnecessary requirements.

Section 26.31(c) [Conditions for testing] replaces former Sec. 26.24(a)(1) through (a)(4). The provision lists the situations in which testing is required in separate paragraphs, such as ``pre-access,''

``for cause,'' and ``post-event'' testing to clarify that each situation for which testing is required stands on its own. The former provision in Sec. 26.24(a)(3), in particular, has led to confusion and misinterpretation of the requirements, to be corrected as noted below.

Subparts E [Collecting Specimens for Testing], F [Licensee Testing

Facilities], and G [Laboratories Certified by the Department of Health and Human Services] address the specific requirements for conducting the testing. The final rule reorganizes and amends former Sec. 26.24(a)(1) through (a)(4) to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.31(c)(1) [Pre-access] amends former Sec. 26.24(a)(1).

Former Sec. 26.24(a)(1) required pre-access testing within 60 days before the initial granting of unescorted access to protected areas or assignment to duties within the scope of this part. Section 26.31(c) of the final rule introduces the concepts of ``initial authorization,''

``authorization update,'' and ``authorization reinstatement,'' which refer to categories of requirements that licensees and other entities must meet in order to assign an individual to duties that require the individual to be subject to Part 26. Section 26.65 [Pre-access drug and alcohol testing] in Subpart C of the final rule specifies detailed requirements for conducting pre-access testing.

Section 26.31(c)(2) [For cause] and (c)(3) [Post event] clarifies and amends former Sec. 26.24(a)(3), as follows:

Section 26.31(c)(2) continues to require for-cause testing in response to any observed behavior or physical

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condition indicating possible substance abuse. The final rule also retains the former requirement for testing if the licensee or other entity receives credible information that an individual is engaging in substance abuse. Section 26.3 defines the term ``substance abuse.''

Section 26.31(c)(3) [Post event] amends the portion of former Sec. 26.24(a)(3) that required drug and alcohol testing when an event involving a failure in individual performance leads to significant consequences. The final rule amends the former provision because it has been subject to misinterpretation and numerous questions from licensees.

The phrase ``if there is reasonable suspicion that the worker's behavior contributed to the event'' in former Sec. 26.24(a)(3) has been subject to misinterpretation. The location of this phrase at the end of the list of conditions under which post-event testing must be performed has led some licensees to conclude that this phrase applies only to events involving actual or potential substantial degradations of the level of safety of the plant. Other licensees have misinterpreted the term ``reasonable suspicion'' as meaning

``reasonable suspicion of substance abuse'' or some other ``illegal'' or ``disreputable'' activity. Neither of these interpretations is consistent with the intent of this provision. Therefore, to clarify the intent of the provision, the final rule eliminates the phrase ``if there is reasonable suspicion that the worker's behavior contributed to the event'' from the end of the list of significant events that require post-event testing and, instead, requires post-event testing as soon as practical after significant events (as listed in Sec. 26.31(c)(3)(i) through (c)(3)(iii)) involving a human error that may have caused or contributed to the event. The final rule uses the term ``human error'' rather than the former term ``worker's behavior'' to emphasize that post-event testing is required for acts that unintentionally deviated from what was planned or expected in a given task environment (see

NUREG/CR-6751, ``The Human Performance Evaluation Process: A Resource for Reviewing the Identification and Resolution of Human Performance

Problems'') as well as failures to act (i.e., errors of omission).

Therefore, testing is required regardless of whether there was

``reasonable suspicion'' that the individual was abusing drugs or alcohol for the consequences listed in the section.

In addition, the NRC has added the second sentence of Sec. 26.31(c)(3) to clearly delineate the scope of individuals who must be subject to post-event testing. Some licensees have misinterpreted the former provision as requiring the testing of all individuals who are involved in a significant event, including individuals whose behavior played no causal or contributing role in the event. For example, these licensees' FFD programs would require testing an individual who was exposed to radiation in excess of regulatory limits, even if other individuals' actions (or failures to act) were responsible for the event and the individual who suffered the exposure was a bystander.

Therefore, the second sentence of the provision clarifies the original intent of this section by stating that only the individual(s) who committed the error(s) is subject to post-event testing.

Section 26.31(c)(3)(i) provides a threshold for the types of workplace personal injuries and illnesses for which post-event testing is required in response to implementation questions related to former

Sec. 26.24(a)(3). Some licensees have misinterpreted the former provision as requiring post-event testing for any personal injury, no matter how minor. This section clarifies the type of personal injuries and illnesses for which post-event testing would be required by establishing a threshold that is based on the general criteria contained in 29 CFR 1904.7, ``General Recording Criteria,'' of the regulations of the Occupational Safety and Health Administration (OSHA) for recording occupational injuries and illnesses. As defined in the

OSHA standard and the final rule, these include any injuries and illnesses which result in death, days away from work, restricted work, transfer to another job, medical treatment beyond first aid, loss of consciousness, or other significant injury or illness as diagnosed by a physician or other licensed health care professional. In the case of a significant injury or illness diagnosed by a physician or health care professional, a serious injury or illness does not need to result in death, days away from work, restricted work, transfer to another job, medical treatment beyond first aid, or loss of consciousness. The final rule adds this clarification to reduce the number of unnecessary post- event tests performed for minor injuries and illnesses and meet Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

Section 26.31(c)(3)(i) also includes the qualifying phrase,

``within 4 hours after the event,'' with reference to the recordable personal injuries and illnesses that would trigger post-event testing.

The NRC acknowledges that in some cases it is difficult to detect illnesses and injuries that meet the threshold for post-event testing at the time they occur. For example, if an individual has been injured on site but does not report the injury to the licensee or other entity and waits for several days to seek treatment from his or her private physician, the licensee or other entity may not learn of the injury.

The extent of an injury may be unclear at the time it occurs and may appear to fall below the threshold for post-event testing until several days have passed. In these examples, if the licensee or other entity learns after several days that the injury would have met the threshold for post-event testing, it would be too late for post-event testing to be of any value in determining whether the individual's use of drugs or alcohol may have contributed to the event. If alcohol or drug use had contributed to the event, testing several days later would be unlikely to detect it because of the effects of metabolism. Further, it would be difficult to prove that any positive test results reflected the individual's condition at the time the event occurred rather than subsequent drug or alcohol use. Therefore, the final rule limits post- event testing to situations in which the licensee or other entity can determine that an injury or illness meets the threshold within four hours after the event has occurred, and can conduct the testing within a time frame that will provide useful information about the individual's condition at the time of the event. However, the section should not be misinterpreted as requiring post-event testing to be completed within four hours after the event. Section 26.31(c)(3) defines the time period after the event within which testing must be completed as ``as soon as practical.'' The NRC has made this change to meet Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

Section 26.31(c)(3)(ii) retains the relevant language in the corresponding portion of former Sec. 26.24(a)(3) without change.

Section 26.31(c)(3)(iii) retains the relevant language in the corresponding portion of former Sec. 26.24(a)(3). However, as discussed with respect to Sec. 26.31(c), the final rule eliminates the former qualifying phrase ``if there is reasonable suspicion that the worker's behavior contributed to the event.'' The NRC has eliminated this phrase because it is preferable to determine the need for post- event testing using an objective standard based on the severity of the underlying event. The experience of the DOT with post-accident testing, for example, is that it is more effective to separate completely ``for cause''

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concepts (such as ``reasonable suspicion'' of substance abuse) from post-event testing. Under the final rule's approach, if one of the events occurs that is defined in the regulations as requiring post- event testing, then that testing should be carried out irrespective of the presence or absence of any ``reasonable suspicion'' of substance abuse.

Section 26.31(c)(4) [Followup] retains the intent of former Sec. 26.24(a)(4) but amends its language. The final rule eliminates the former phrase ``to verify an individual's continued abstention from the use of substances covered under this part'' because it could be misinterpreted as limiting the substances for which followup testing is permitted to only those listed in Sec. 26.31(d)(1) [Substances tested]. The final rule revises this phrase as ``to verify continued abstinence from substance abuse'' to clarify that FFD programs are permitted to conduct followup testing for any substances an individual may have abused, subject to certain additional requirements discussed with respect to Sec. 26.31(d)(1)(i). Section 26.69 [Authorization with potentially disqualifying fitness-for-duty information] establishes detailed requirements for conducting followup testing, where they apply to licensees' and other entities' processes for granting and maintaining authorization. The final rule makes these changes to meet

Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.31(c)(5) [Random] simplifies former Sec. 26.24(a)(2) to define random testing as one of the conditions under which testing is required. The NRC has moved the detailed requirements for implementing random testing that were contained in former Sec. 26.24(a)(2) to Sec. 26.31(d) [General requirements for drug and alcohol testing] of the final rule. The NRC has made these changes to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

The NRC has added Sec. 26.31(d) to the final rule to better organize requirements related to the general administration of drug and alcohol testing. The final rule presents more detailed requirements for conducting drug and alcohol testing in Subparts E, F, and G. The NRC has made these changes to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.31(d)(1) [Substances tested] retains the list of drugs for which testing must be conducted in former Section 2.1(a) in

Appendix A to Part 26, but clarifies that for some drugs the testing is conducted to detect drug metabolites. The NRC has moved the provisions detailing the circumstances in which testing for these substances must be performed (i.e., pre-access, post-event, random) to Sec. 26.31(c) for organizational clarity. In addition, the section adds adulterants to the list of substances for which testing must be conducted, consistent with the addition of specimen validity testing requirements to the final rule, as discussed with respect to Sec. 26.31(d)(3)(i).

Section 26.31(d)(1)(i) retains the permission in the second sentence of former Sec. 26.24(c) for licensees and other entities to consult with local law enforcement agencies or other sources of information to identify drugs that may be abused by individuals in the geographical locale of the FFD program.

Section 26.31(d)(1)(i)(A) retains the permission in former Sec. 26.24(c) for licensees and other entities to add to the panel of drugs for which testing is required in Sec. 26.31(d)(1). Additional drugs may include, but are not limited to, ``designer drugs,'' such as ecstasy or ketamine, and illegal drugs that are popular in some geographical areas, such as lysergic acid diethylamide-25 (LSD). The provision also requires that any additional drugs must be listed on

Schedules I-V of section 202 of the Controlled Substances Act [21

U.S.C. 812], which is consistent with the definition of ``illegal drugs'' in former Sec. 26.3.

Section 26.31(d)(1)(i)(B) retains the last sentence in former Sec. 26.24(c). The provision requires licensees and other entities to establish appropriate cutoff levels for any additional substances for which testing will be conducted.

Section 26.31(d)(1)(i)(C) retains the requirement in former Section 2.1(c) in Appendix A to Part 26. The provision specifies that licensees and other entities must establish rigorous testing procedures for any additional drugs.

Section 26.31(d)(1)(i)(D) further clarifies the requirement in

Sec. 26.31(d)(1)(i)(C) for ``rigorous testing procedures.'' The provision replaces the portion of former Section 1.1(2) in Appendix A to Part 26 that required licensees to obtain written approval from the

NRC to test for additional drugs. The purpose of the former requirement was to provide an opportunity for the NRC to verify that the assays and cutoff levels licensees use in testing for additional drugs are scientifically sound and legally defensible. However, the former requirement also imposed a reporting burden. The final provision eliminates this reporting requirement and replaces it with requirements for an independent forensic toxicologist who has no relationships that could be construed as potential conflicts of interest to conduct the review that the NRC currently performs. The final rule requires the independent forensic toxicologist to certify, in advance and in writing, that the assay to be used in testing for any additional drugs or drug metabolites, and the cutoff levels to be applied, are scientifically sound and legally defensible. This section also specifies the required qualifications for the forensic toxicologist.

Certification of the assay and cutoff levels are not required in two circumstances: (1) If the HHS Guidelines are revised to permit use of the assay and the cutoff levels in Federal workplace drug testing programs and the licensee or other entity uses the cutoff levels established in the HHS Guidelines for drug or drug metabolites; and (2) if the licensee and other entity received written approval of the NRC to test for the additional drug or drug metabolites before the implementation date of the final rule, which is 365 days after the date the final rule is published in the Federal Register. Certification by a toxicologist is unnecessary in these two circumstances because it would be redundant. By eliminating or modifying unnecessary requirements, while continuing to ensure that any drug testing conducted under Part 26 is scientifically sound and legally defensible, this provision meets

Goal 5 of this rulemaking.

Section 26.31(d)(1)(ii) amends former Section 2.1(b) in Appendix A to Part 26. The provision permits licensees and other entities, when conducting for-cause, post-event, and followup testing, to test for any drugs listed on Schedules I-V of the Controlled Substances Act that the licensee or other entity suspects the individual may have abused, as follows:

The section adds a reference to post-event testing for consistency with the intent of former Section 2.1(b) in Appendix A to Part 26, which permitted testing for any illegal drugs during a for-cause test.

The former rule included post-event testing within the definition of for-cause testing. The final rule uses a distinct term ``post-event'' testing to refer to the testing that is required following certain events as discussed with respect to Sec. 26.31(d)(3). Therefore, it is necessary to add a reference to post-event testing to this section to retain the full intent of the former provision.

The section also adds a reference to followup testing, which permits the

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licensee or other entity to test for an additional drug if an individual who is subject to followup testing is suspected of having abused it. For example, if an SAE, in the course of performing a determination of fitness under Sec. 26.189 found that an individual was abusing barbiturates, this provision would permit followup testing to verify that the individual is abstaining from such abuse. The NRC has made this change to strengthen the followup testing element of FFD programs by ensuring that followup testing would detect continued drug abuse. Therefore, this provision is consistent with Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

The section retains the limitation in former Section 2.1(b) in

Appendix A to Part 26 that permitted testing only for illegal drugs that the individual is suspected of having abused and extends that limitation to followup testing. The final rule extends this limitation to followup testing to protect donors' rights to privacy, which is the same reason that the limitation was established in the former rule with respect to for-cause testing. Licensees and other entities are prohibited from conducting a wide spectrum of tests for any drugs without suspicion that the individual had abused them because such tests could reveal personal medical information about the individual that is irrelevant to the performance objectives of this part, as discussed with respect to Sec. 26.23. Thus, extending the former limitation on for-cause testing to followup testing meets Goal 7 of this rulemaking to protect the privacy rights and other rights

(including due process) of individuals who are subject to Part 26.

The final rule replaces the term ``illegal drugs'' in former

Section 2.1(b) in Appendix A to Part 26 with a specific reference to the drugs that are listed on Schedules I-V of the Controlled Substances

Act. These schedules list drugs with abuse potential and include many drugs with legitimate medical uses that are not ``illegal'' when used with a valid prescription for medical purposes. Therefore, replacing the term ``illegal drugs'' with the reference to Schedules I-V of the

Controlled Substances Act (CSA) more accurately characterizes the specific drugs for which testing is permitted. The NRC has made this change to meet Goal 6 of this rulemaking to improve clarity in the language of the rule.

Section 26.31(d)(1)(ii) also applies the new requirements in Sec. 26.31(d)(1)(i)(D) related to testing for drugs that are not included in the FFD program's panel of drugs to for-cause, post-event, and followup testing. The section requires that a forensic toxicologist certify the assays and cutoff levels to be used in testing for the additional drugs. The provision provides consistency with Sec. 26.31(d)(1)(i)(D) and ensures that the testing is scientifically sound and legally defensible. The NRC has made this change to protect donors' rights as it relates to minimizing the possibility of false positive test results. The provision also strengthens the effectiveness of FFD programs by ensuring that tests for additional drugs that are conducted for cause, post-event, or as part of a followup program will accurately detect drugs that an individual may have abused. Therefore, the NRC has made this change to meet Goal 7 of this rulemaking to protect the rights (including due process) of individuals who are subject to Part 26 and Goal 3 to improve the effectiveness and efficiency of FFD programs.

The NRC has added the last sentence of Sec. 26.31(d)(1)(ii) to prohibit inappropriate practices that some FFD programs have implemented. The NRC is aware that some FFD programs have directed their HHS-certified laboratories to test specimens that are collected for for-cause, post-event, or followup testing at the assay's LOD without first subjecting the specimens to initial testing. In addition, if a drug or drug metabolite is detected at the LOD, the MROs in these programs have confirmed the test result as an FFD policy violation even if the quantitative test result falls below the FFD program's established confirmatory cutoff level. Although these practices may increase the likelihood of detecting drug abuse, they are inconsistent with one of the bases for establishing cutoff levels for drug testing.

This basis is to minimize the likelihood of false positives that could result in the imposition of sanctions on an individual who has not abused drugs. It also subjects individuals who are undergoing for- cause, post-event, or followup testing to unequal treatment when compared to individuals who are subject to random and pre-access testing, in which the established cutoff levels must be applied.

Therefore, the final rule specifically prohibits these practices, but adds, with respect to the proposed rule, an exception for a situation in which the specimen is dilute and the licensee or other entity has requested the HHS-certified laboratory to evaluate the specimen under

Sec. Sec. 26.163(a)(2) and 26.185(g)(3). The NRC has made these changes to meet Goal 7 of this rulemaking as it relates to protecting the rights of individuals (including due process) who are subject to

Part 26, by requiring that individuals who are subject to for-cause, post-event, and followup testing must be subject to the same testing procedures and cutoff levels as others who are tested under this part.

With respect to the proposed rule, the NRC has added Sec. 26.31(d)(1)(iii) to the final rule to require the licensee or other entity to document the additional drug(s) for which testing will be performed in written policies and procedures. A public comment suggested that licensees and other entities should not screen for drugs in addition to those listed in paragraph (d)(1) of this section without identifying them in advance. The NRC agrees that informing individuals of the substances for which testing will routinely occur and the cutoff levels to be applied may deter abuse of those substances. Information about the drugs for which testing will occur, and their potential effects on job performance, is also an important part of the FFD training that individuals must receive under Sec. 26.29, to assist individuals in meeting their responsibilities under the rule. This added provision is also consistent with Sec. 26.31(d)(3)(iii)(A) that requires licensees and other entities to document more stringent cutoff levels for drug testing than those specified in Sec. 26.163 in written policies and procedures. However, the NRC does not agree that a licensee should be prohibited from testing for drugs in addition to those listed in the rule without identifying them in advance. Although deterring substance abuse is an important goal of the rule, detecting substance abuse is equally important. Therefore, both the former and final rules permit licensees to add drugs to the panel of substances for which they routinely test, as well as to conduct tests to detect any drugs listed on Schedules I-IV of the CSA in followup, post-event, and for-cause testing that the individual is suspected of abusing. The

NRC has added this requirement to meet Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs and Goal 6 to improve clarity in the organization and language of the rule.

Section 26.31(d)(2) [Random testing] reorganizes and amends the requirements for conducting random testing. These requirements appeared in former Sec. 26.24(a)(2), as described in the following paragraphs.

Section 26.31(d)(2)(i) adds a requirement for licensees and other entities to administer random testing in a manner that provides reasonable assurance that individuals are unable to

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predict the time periods during which specimens will be collected. The

NRC has added this provision because the NRC is aware of instances when individuals who believed they would have a positive test result if tested have been able to determine the days on which collections were being conducted. This determination then gave them the opportunity to leave work under the guise of illness in order to avoid the possibility of being tested. The ability to detect that specimens are being or will be collected for random testing also provides an opportunity for individuals to be prepared to subvert the testing by procuring an adulterant or urine substitute and keeping it available on their persons during the periods that specimens are collected. However, the

NRC also recognizes that it is impossible to ensure that individuals are unable to detect the periods when specimens are being collected. At a minimum, coworkers will be suspicious that collections are occurring if they observe an individual leaving the work site and returning within a short time, even if the supervisor and individual do not discuss the reason for the individual's short absence. Therefore, the section requires licensees and other entities to conduct random testing in a manner that would provide ``reasonable assurance'' that individuals are unable to predict when specimens will be collected, rather than requiring them to ``ensure'' that the period of time during which specimens will be collected cannot be detected. However, licensees and other entities are required to minimize the likelihood that individuals who are subject to testing know that they are more likely to be called for testing at certain times than others.

Within this context, Sec. 26.31(d)(2)(i)(A) adds a requirement that licensees and other entities take reasonable steps to either conceal from the workforce that collections will be performed during a scheduled collection period, or create the appearance that specimens are being collected during a portion of each day on at least 4 days in each calendar week at each site. With respect to the proposed rule, the final rule clarifies that in the latter instance, the portions of each day and the days of the week must vary in a manner that cannot be predicted by donors. The NRC, after publishing the proposed rule, recognized the need for additional clarity in this provision to illustrate the NRC's intent. Therefore, the NRC has made this change to meet Goal 6 of this rulemaking to improve clarity in the language of the rule.

Section 23.31(d)(2)(i)(A) requires licensees and other entities to take reasonable steps to minimize the cues that persons may use to detect that specimens will be collected at a certain time. These cues may include, but are not limited to, the presence of a mobile collection facility on site and the presence of collectors at the site only on days that collections occur, or having the lights on in a designated collection site and occupying it only when the collection site is in use. A reasonable step to minimize cues associated with activities inside a collection site could be covering any outside windows so that a passerby cannot detect whether the collection site is occupied. Other steps to meet the requirement could include, but would not be limited to, stationing a mobile collection facility on site for some part of the day on 4 days each week or assigning individuals to staff the designated collection site during periods that specimens are not being collected during some portion of each day on at least 4 days in each calendar week. Maintaining the appearance that the collection site is active on more than half of the days in each week makes it more difficult for individuals to plan to subvert the testing process by leaving work when they believe specimens are being collected. By reducing the opportunities for individuals to subvert the testing process by having advanced warning that specimens are being collected, the requirements in Sec. 26.31(d)(2)(i) and paragraph (A) of this section meet Goal 3 of this rulemaking to improve the effectiveness of

FFD programs.

Section 26.31(d)(2)(i)(B) amends the third sentence of former Sec. 26.24(a)(2). This sentence required that specimens must be collected

``at various times during the day.'' The final rule expands the former requirement to require licensees and other entities to collect specimens on an unpredictable schedule, including weekends, backshifts, and holidays, and at various times during a shift. The purpose of the former and final provisions is to ensure that individuals cannot predict the times they will be tested, as well as prevent them from perceiving that there are ``safe'' periods during which they will not be tested, which may lead them to believe they could engage in substance abuse without fear of detection. Varying the time periods during which specimens are collected on an unpredictable schedule also increases the rule's effectiveness in deterring substance abuse, which meets Goal 3 of this rulemaking to improve the effectiveness of FFD programs.

Section 26.31(d)(2)(ii) retains the third sentence of former Sec. 26.24(a)(2). Section 26.31(d)(2)(ii) states that random testing must be administered on a nominal weekly frequency. The former requirement to collect specimens for random testing at ``various times during the day'' is retained in Sec. 26.31(d)(2)(i)(B).

Section 26.31(d)(2)(iii) requires individuals who are selected for random testing to report to the collection site as soon as reasonably practicable after they have been notified that they have been selected for testing within the time period established in the FFD policy. The necessity for the FFD policy to establish a time limit within which individuals must report for testing is discussed with respect to Sec. 26.27(b)(2). Section 26.31(d)(2)(iii) further clarifies this requirement by emphasizing the individual's responsibility to report as soon as reasonably practicable after notification. For example, in order to cover all of the possible situations when it may not be possible for an individual to immediately report for testing after notification (which could include the time required to travel to a collection site or to change clothes and be monitored for contamination after working under a radiation work permit), the FFD policy may permit individuals up to two hours to report for testing after notification.

However, if no legitimate work, travel, or other demands would prevent an individual from immediately reporting for testing, the provision requires the individual to report as soon as he or she is notified.

This provision strengthens FFD programs by further reducing opportunities for individuals to subvert the testing process and, therefore, meets Goal 3 of this rulemaking to improve the effectiveness of FFD programs.

Section (d)(2)(iv) retains the portion of the first sentence of former Sec. 26.24(a)(2) that required licensees to ensure that individuals subject to testing have an equal probability of being selected and tested. The final rule splits proposed Sec. 26.31(d)(2)(iv) into two paragraphs after the first sentence of the proposed paragraph, and renumbers the subsequent paragraphs to accommodate this change. This reorganization is an effort to clarify the requirements of this section, consistent with Goal 6 of this rulemaking to improve clarity in organization and language of the rule.

As a result of this renumbering, Sec. 26.31(d)(2)(v) of the final rule amends the first sentence of former Sec. 26.24(a)(2) to clarify that individuals who are off site when selected for testing and not reasonably available for testing when selected, must be tested at the earliest

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reasonable and practical opportunity. However, the final rule, with respect to the proposed rule, adds a clarification that individuals who are on site and not reasonably available for testing also must be tested at the earliest reasonable and practical opportunity. The NRC has made this change in response to a public comment, which suggested that the second sentence of proposed Sec. 26.31(d)(2)(iv) could be interpreted as requiring individuals who are on site but not reasonably available for testing to be tested immediately. The commenter gave the example of an individual who is suited up for work in a radiologically controlled area from which he or she could not exit to be tested in a reasonable period of time. The NRC notes that in these cases, individuals who are on site but not reasonably be available for testing are required to report to the collection site as soon as reasonably practical after notification (emphasis on ``notification''), under

Sec. 26.31(d)(2)(iii). In the given example, the supervisor would only notify the individual about testing after he or she is out of containment and has changed back to street clothes. If this were to occur at the end of the shift when collectors have left the site, this individual would not be notified that he or she must report for testing until the next time both the donor and the collectors are available to collect specimens for testing. Because there would be no known reason that this individual will test positive at the time of collection, any possible delays in testing should not compromise the performance objectives of the FFD program. However, the FFD program is responsible for preventing potential abuses brought on by such delays, which could include a supervisor protecting known substance abusers through improper notifications or delaying testing until completion of a critical job. Therefore, based on this analysis, the NRC has clarified this provision to reflect the public comment and clarify the NRC's intent, consistent with Goal 6 of this rulemaking to improve clarity in the language of the rule.

The requirements of Sec. 26.31(d)(2)(v) prohibit licensees and other entities from returning the names of the individuals who are offsite when selected for testing or who are on site and not reasonably available for testing when selected to the random testing pool without conducting a test, as has been the practice of some licensees.

Returning these individuals' names to the random testing pool without conducting a test ensures that they are immediately eligible for another unannounced test, as required in Sec. 26.31(d)(2)(vi), but does not ensure that all individuals who are subject to this part have an equal probability of being tested. Therefore, the requirement that individuals who are off site when selected for testing or who are on site and not reasonably available for testing when selected must be tested at the earliest reasonable and practical opportunity meets Goal 3 of this rulemaking to improve the effectiveness of FFD programs.

The section includes the phrase ``at the earliest reasonable and practical opportunity when both the donor and collectors are available to collect specimens for testing'' to clarify that licensees and other entities are not required to call an individual back to the site if he or she is off site when selected for testing. In addition, the provision does not require licensees and other entities to make special arrangements to ensure that a collector is available to collect the specimens as soon as the individual returns to the site. The NRC is aware that some licensees have called in individuals and collectors in the past under these circumstances. However, these practices may permit individuals to predict that they will be subject to testing when they return to the site. This prediction would provide them with an opportunity to take actions to subvert the testing process, as discussed with respect to Sec. 26.31(d)(2)(i). Therefore, the provision requires licensees and other entities to collect specimens from an individual who is off site when selected for testing or on site and not reasonably available for testing, in a manner that also ensures that the individual does not have advance notification that he or she has been selected for testing. The NRC has made this change to meet

Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

Section 26.31(d)(2)(vi) of the final rule, renumbered from

(d)(2)(v) in the proposed rule, retains the second sentence of former

Sec. 26.24(a)(2). This provision requires that an individual who has completed a test is immediately eligible for another random test.

Section 26.31(d)(2)(vii) of the final rule, renumbered from

(d)(2)(vi) in the proposed rule, amends the last sentence of former

Sec. 26.24(a)(2). The NRC has made this change in response to licensee implementation questions with respect to the meaning of the term

``workforce'' in the former rule. These questions related to whether

``workforce'' means all individuals who are employed by the licensee, including individuals who are not subject to Part 26, all individuals at a site, or all individuals who are subject to the licensee's FFD program. This provision clarifies that the number of random tests that must be performed in a year must equal 50 percent of the population of individuals who are subject to random testing under the FFD program. If a common FFD program covers several sites, the ``population'' would include all individuals who are subject to the common FFD program. The population also includes individuals who have applied for authorization and who are subject to random testing under Sec. 26.67 [Random drug and alcohol testing of individuals who have applied for authorization].

The NRC has made this change to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

The NRC has added Sec. 26.31(d)(3) [Drug testing] to the final rule to group requirements in one section that are related to the general administration of drug testing. The NRC has made this change because requirements that address this topic were dispersed throughout the former rule. Grouping them together in a section makes them easier to locate within the final rule. This reorganization meets Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.31(d)(3)(i) combines and modifies some of the requirements in former Section 1.1(3) in Appendix A to Part 26, former

Sec. 26.24(f), the first sentence of former Section 2.8(e)(1) in

Appendix A, and former Section 2.8(a) and (b) in Appendix A to Part 26.

These former provisions required licensees and other entities to use only HHS-certified laboratories to perform drug testing, except if initial tests were performed at a licensee testing facility. However, the final rule has clarified the first sentence of this section, with respect to the proposed rule, to include validity tests, validity screening tests, and initial validity tests. The NRC has retained other detailed requirements in these sections, but they are presented in the appropriate sections in Subparts E, F, and G of the final rule. The agency has made these changes to meet Goal 6 of this rulemaking to improve the organizational clarity of the rule.

In addition, Sec. 26.31(d)(3)(i) requires that specimens sent to the HHS-certified laboratory by the licensee or other entity must be subject to initial validity and drug testing by the laboratory.

However, the final rule clarifies the language of the proposed rule to require that any specimens that yield ``positive initial drug test results or are determined by initial validity testing to be of

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questionable validity'' must be subject to confirmatory testing by the laboratory. The final rule deletes the term ``non-negative'' from the proposed rule and adds the term ``questionable validity'' for the reasons discussed with respect to Sec. 26.5. The NRC has made these changes to meet Goal 6 of this rulemaking to improve the organizational clarity of the rule.

Specimen validity testing refers to testing conducted by a laboratory to identify attempts to tamper with a specimen. Attempts to tamper with a specimen may include:

(1) Adulteration, which means putting a substance into a specimen that is designed to mask or destroy the drug or drug metabolite that the specimen may contain or to adversely affect the assay reagent;

(2) Dilution, which means adding a liquid that, in contrast to an adulterant, would not be detected by validity testing, to the urine specimen to decrease the concentration of a drug or metabolite below the cutoff concentration; and

(3) Substitution, which means replacing a valid urine specimen with a drug-free specimen.

When HHS published its Notice of Final Revisions to the HHS

Guidelines (66 FR 43876; August 21, 2001) to establish requirements for specimen validity testing performed by HHS-certified laboratories, HHS reported that the number of adulterated and substituted urine specimens has been increasing among the specimens tested under the Federal agency workplace drug testing program and the DOT regulations (49 CFR Part 40). Program experience gained after Part 26 was first promulgated has also indicated an increasing number of adulterated and substituted urine specimens submitted to HHS-certified laboratories from Part 26 testing programs.

Although former Part 26 contained a number of requirements related to specimen validity (e.g., the fifth sentence of former Sections 2.1(e), 2.4(f)(2), 2.4(g)(14) through (g)(16), and 2.7(d) in Appendix A to Part 26), the methods available to tamper with specimens have become more sophisticated after the rule was first published and more sophisticated methods of detecting tampering are necessary. Therefore, the final rule incorporates new requirements for HHS-certified laboratories to conduct specimen validity tests that are consistent with similar provisions contained in the most recent revision to the

HHS Guidelines (69FR 19643; April 13, 2004). The NRC has added these new requirements for specimen validity testing to strengthen FFD programs by improving current laboratory procedures to detect specimens that are diluted, adulterated, or substituted. This change is consistent with Goal 1 of this rulemaking to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. Detecting specimen tampering is necessary to identify individuals who may attempt to hide drug abuse. Attempts to tamper with a specimen provide clear evidence that the individual is not trustworthy and reliable. Also, these individuals' drug use may pose a risk to public health and safety and the common defense and security, as discussed with respect to Sec. 26.23.

Section 26.31(d)(3)(ii) amends the first sentence of former Sec. 26.24(d)(1). This sentence permits licensees and other entities to conduct initial testing of urine specimens at a licensee testing facility, provided that the licensee testing facility staff possesses the necessary training and skills for the tasks assigned, the staff's qualifications are documented, and adequate quality controls for the testing are implemented. The final rule adds permission for licensees and other entities to perform initial validity testing at a licensee testing facility for the reasons discussed with respect to Sec. 26.31(d)(3)(i). Subpart F establishes detailed requirements related to specimen validity testing at licensee testing facilities.

Section 26.31(d)(3)(iii) is based upon the portions of former

Section 2.7(e)(1) and (f)(2) in Appendix A to Part 26. These former sections established the cutoff levels for initial and confirmatory drug testing, respectively, which licensees must apply under the former rule. However, the final rule requires FFD programs to apply the updated cutoff levels specified in Sec. 26.163(a)(1) for initial drug testing and Sec. 26.163(b)(1) for confirmatory drug testing. The final rule clarifies the language of the proposed rule by adding that either the licensee testing facility or HHS-certified lab conducts the initial drug testing and the HHS-certified laboratory conducts the confirmatory testing. Consistent with the first sentence of former Sec. 26.24(b), the second sentence of this provision permits FFD programs to implement more stringent cutoff levels than specified in the rule, but establishes additional requirements related to lower cutoff levels, as is discussed with respect to paragraphs (d)(3)(iii)(A) through (C). The

NRC has relocated the permission in the first sentence of former Sec. 26.24(b) to implement a broader panel of drugs to Sec. 26.31(d)(1), as discussed with respect to that section. The NRC has made these changes to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.31(d)(3)(iii)(A) retains the third and fourth sentences of former Sec. 26.24(b) regarding management actions and sanctions for confirmed positive drug test results based on any lower cutoff levels established by the FFD program. The final rule adds a requirement that the FFD program's written policy and procedures must document the FFD program's lower cutoff levels in the written policy and procedures to ensure that individuals who are subject to testing are aware of the cutoff levels that would be applied to their drug test results in order to protect their rights. The NRC has made this change to meet Goal 7 of this rulemaking to protect the privacy and other rights (including due process) of individuals who are subject to Part 26.

Section 26.31(d)(3)(iii)(B) requires the uniform application of the

FFD program's cutoff levels for drugs and drug metabolites, including any more stringent cutoff levels in all tests conducted under this part and equally to all individuals who are subject to testing, except as permitted under Sec. Sec. 26.31(d)(1)(ii), 26.163(a)(2) for dilute specimens, and Sec. 26.165(c)(2) for retesting specimens. As discussed with respect to Sec. 26.31(d)(1)(ii), some FFD programs have adopted the practice of testing specimens at the assay's LOD for for-cause, post-event, and followup tests, which results in some individuals receiving unequal treatment under the rule. Therefore, the NRC has added the section to meet Goal 7 of this rulemaking to protect the privacy and other rights (including due process) of individuals who are subject to Part 26.

The NRC has added Sec. 26.31(d)(3)(iii)(C) to the final rule to specify requirements for establishing more stringent cutoff levels.

Before implementing the more stringent cutoff levels, licensees and other entities are required to obtain certification from a forensic toxicologist that the more stringent cutoff levels are technically sound and legally defensible, with two exceptions. Certification by a forensic toxicologist is not required if: (1) If the HHS Guidelines are revised to lower the cutoff levels for the drug or drug metabolites in

Federal workplace drug testing programs and the licensee or other entity implements the cutoff levels published in the HHS guidelines; or

(2) if the licensee or other entity received written approval of the

NRC to test for lower cutoff levels before the implementation date of this rule, which is 365 days after the date the final rule

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is published in the Federal Register. Certification by a toxicologist is unnecessary in these two circumstances because it would be redundant. The NRC has made this change to meet Goal 5 of this rulemaking to improve Part 26 by eliminating or modifying unnecessary requirements, while continuing to protect donors' right to accurate and reliable drug testing.

Section 26.31(d)(4) [Alcohol testing] updates former Sec. 26.24(g) that contained general requirements for conducting alcohol testing. The update reflects other changes that have been made in the final rule.

The NRC has amended the former cross-reference to Section 2.7(o)(3) in

Appendix A to Part 26 to refer to Sec. 26.91(a) in Subpart E, which contains detailed requirements for conducting alcohol testing. The NRC has added the reference to oral fluids as acceptable specimens for initial alcohol testing to this section. The basis for adding oral fluids as acceptable specimens for initial alcohol testing is discussed with respect to Sec. 26.83 [Specimens to be collected]. The NRC has changed the BAC at which a confirmatory test is required to 0.02 percent (from 0.04 percent) in the provision for consistency with the revised alcohol cutoff levels in Sec. 26.99 [Determining the need for a confirmatory test for alcohol] and Sec. 26.103 [Determining a confirmed positive test result for alcohol]. The basis for the revised alcohol cutoff levels is discussed with respect to those sections of the final rule. The agency has deleted reference to blood testing for alcohol because the final rule no longer permits donors to request blood testing for alcohol, as discussed with respect to Sec. 26.83(a) of the final rule.

The NRC has added Sec. 26.31(d)(5) [Medical conditions] to the final rule to address circumstances when it may be impossible or inadvisable to test an individual using the procedures specified in this part. Circumstances have arisen under Part 26, as well as the programs of other Federal agencies, when an individual's medical condition has made it inadvisable to implement testing procedures under the relevant requirements. Therefore, Sec. 26.31(d)(5)(i) permits alternative specimen collection and evaluation procedures for rare instances when it would be difficult or hazardous to the donor to collect breath, oral fluids, or urine specimens, including, but not limited to, required post-event testing when an individual has been seriously injured. Only the MRO is permitted to authorize an alternative evaluation procedure that may include, but is not limited to blood testing for alcohol. Section 26.31(d)(5)(ii) clarifies that necessary medical treatment may not be delayed in order to conduct drug and alcohol testing. These sections are consistent with the requirements of other Federal agencies and meet Goal 1 of this rulemaking to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines.

Section 26.31(d)(6) [Limitations of testing] retains and amends former Section 2.1(d) in Appendix A to Part 26. This former section stated that specimens collected under Part 26 may only be designated or approved for testing as described in this part and may not be used for any other analysis or test without the permission of the tested individual. The final rule adds examples of the types of analyses and tests that are prohibited without the donor's written permission.

Although the NRC is not aware of any instances when such unauthorized testing has occurred in FFD programs under this part, the technology for performing these analyses and tests has become increasingly available since the regulation was first promulgated. The NRC has added these examples to meet Goal 7 of this rulemaking to protect the privacy and other rights (including due process) of individuals who are subject to Part 26.

Section 26.33 Behavioral Observation

The NRC has added Sec. 26.33 to the final rule to emphasize that behavioral observation is a required element of FFD programs. The first sentence of Sec. 26.33 requires behavioral observation of individuals subject to this subpart. The second sentence retains former Sec. 26.22(a)(3), (a)(4), and (b), which stated that the individuals who perform behavioral observation must be trained. The third sentence of the section requires that individuals must report FFD concerns arising from behavioral observation to the appropriate personnel designated in the FFD program procedures. The NRC has added these requirements to the final rule to strengthen the behavioral observation element of FFD programs by increasing the likelihood that the licensees and other entities detect and appropriately address impairment and other adverse behaviors. These changes are consistent with Goal 3 of the rulemaking to improve the effectiveness and efficiency of FFD programs.

Section 26.35 Employee Assistance Programs

Section 26.35 amends former Sec. 26.25 [Employee assistance programs].

Section 26.35(a) retains the former provision without change and specifies that licensees and other entities shall maintain EAPs that offer confidential assessment, short-term counseling, referral services, and treatment monitoring to individuals who have problems that could adversely affect the individuals' abilities to safely and competently perform their duties. The provision also requires that the

EAP be designed to achieve early intervention and provide for confidential assistance.

The NRC has added Sec. 26.35(b) to the final rule to clarify that licensees and other entities are not required to provide EAP services to C/V employees, including those who are working at a licensee's or other entity's facility. With respect to the proposed rule, the final rule clarifies that licensees and other entities are not required to provide EAP services to C/V employees whose work location is a licensee's or other entity's facility. This provision is consistent with the interpretation of the former rule in item 13.1.4 of NUREG- 1354. The final rule continues to require that C/V employees who are subject to Part 26 must have access to an EAP, and that licensees and other entities who rely upon the FFD program of a C/V continue to be required to ensure that the EAP of a C/V meets the requirements of this part.

The provision also states that licensees and other entities need not provide EAP services to individuals who have applied for but have not yet been granted authorization under Subpart C. Licensees and other entities are not required to provide an EAP to applicants for authorization because these individuals would not yet be performing duties that could affect public health and safety or the common defense and security. The NRC has added this clarification because applicants are subject to other requirements under the final rule as discussed with respect to Sec. 26.4(h).

Section 26.35(c) amends the last sentence of former Sec. 26.25.

The provision emphasizes that the identity and privacy of an individual who seeks EAP services must be protected and clarifies the conditions under which EAP personnel may or must violate an individual's confidentiality. The final rule permits EAP personnel to communicate information about an individual by name to the licensee or other entity under only two conditions: (1) If the individual waives the right to privacy, or (2) EAP personnel determine that the individual's condition or actions pose or have posed an immediate threat to himself or herself or others. By clarifying the NRC's intent

Page 17026

with respect to EAP confidentiality, the provision meets Goal 6 of this rulemaking to improve clarity in the language of the rule because the former provision has been misinterpreted.

The last sentence of former Sec. 26.25 required confidentiality for individuals who seek EAP services, except if EAP professionals determine that the individual's condition ``constitutes a hazard to himself or herself or others.'' Some licensees have over-interpreted this phrase and routinely require EAP staff to report individuals who self-refer for any reason, which is not the intent of this provision.

The NRC is also aware that some individuals who are subject to the rule have misinterpreted this phrase as meaning that no self-referral to the

EAP would remain confidential and that EAP staff always report self- referrals to licensee management. This perception appears to be widely shared, including by individuals who are subject to FFD programs that have not misinterpreted the former rule and who correctly permit EAP staff to make the determination of whether to report an individual's condition to licensee management.

A key purpose of requiring EAPs under Part 26 is to encourage individuals and their family members to self-refer for any type of problem that could potentially impair job performance, so that early intervention may be offered to prevent the problem from adversely affecting the individuals' job performance. Upon assessment, it is not uncommon for EAP staff to find that a developing substance abuse problem is contributing to a financial or family problem for which an individual has sought assistance. As a result, the EAP provides an important means to detect and achieve early resolution of developing substance abuse and other problems, which if left untreated could have the potential to adversely affect an individual's ability to safely and competently perform his or her duties. The knowledge or perception among individuals who are subject to the rule that self-referrals to the EAP will be reported to management and will routinely result in the loss of authorization represents a significant barrier to the effectiveness of the EAP element of FFD programs. Therefore, the section amends the last sentence of former Sec. 26.25 to clarify that an individual's use of the licensee's or other entity's EAP must remain confidential, except in very limited circumstances.

The NRC has added Sec. 26.35(c)(1) to the final rule to prohibit licensees and other entities from requiring the EAP to routinely report the names of individuals who self-refer to the EAP and the nature of assistance the individuals sought. The provision is necessary to eliminate some licensees' practices of requiring these reports, protect individuals' privacy, and strengthen the EAP element of FFD programs by eliminating a former barrier to self-referrals in some FFD programs.

The term ``routinely'' is used to indicate that the final rule permits

EAP personnel to report individuals' names and the nature of their problems if the individuals have waived the right to privacy in writing or EAP personnel determine that an individual's condition or actions pose or have posed an immediate risk to public health and safety or the common defense and security. The provision does not prohibit EAPs from reporting program utilization statistics or aggregated data that characterize the types of problems for which the program has provided services because this type of information does not compromise individuals' privacy.

The NRC has added Sec. 26.35(c)(2) to the final rule to provide further clarity in the language of the rule with respect to the conditions under which EAP personnel are excepted from the confidentiality requirement in Sec. 26.35(c) and required to report a concern about an individual to the licensee or other entity. The NRC is confident that EAP personnel have the qualifications and training necessary to continue to make the professional judgments required under the regulations in these circumstances. However, the final rule includes more detail with respect to the conditions and actions that an

EAP professional is required to report to ensure that licensees, other entities, and individuals who are subject to the rule better understand the intent of the former and final provisions. The final rule requires

EAP personnel to report a concern about a specific individual to licensee or other entity management only when they have substantive reasons to believe that an individual's condition or actions pose or have posed an immediate hazard to themselves or others. The phrase

``substantive reasons to believe'' is used to clarify that casual and/ or contextually appropriate comments made by an individual during a counseling session are not a sufficient basis for reporting to the licensee or other entity. For example, an individual's statement that he or she is concerned about becoming an alcoholic would not constitute a substantive reason to believe that the individual's condition poses an immediate hazard. In contrast, this stated concern, in addition to evidence that the individual's personal relationships, financial condition, and/or health are suffering from his or her alcohol consumption, and any indications that the individual has been impaired while in a work status, would constitute substantive reasons to believe that the individual's condition poses an immediate hazard and must be reported.

The NRC has added Sec. 26.35(c)(2)(i) through (iii) to the final rule to provide several examples of conditions and actions that require

EAP personnel to provide a report about an individual who has self- referred to licensee or other entity management. Section 26.35(c)(2)(i) requires reporting if the EAP staff has substantive reasons to believe that an individual may harm himself or herself or others, including, but not limited to, plans threatening suicide, radiological sabotage, or physical violence against others. Section 26.35(c)(2)(ii) requires reporting if the EAP staff has substantive reasons to believe that an individual has been impaired from drugs or alcohol while in a work status and is likely to be impaired in the future, as discussed with respect to Sec. 26.35(c)(2). Section 26.35(c)(2)(iii) requires reporting if the EAP staff has substantive reasons to believe that an individual has committed any of the acts that would require a report to the NRC under Sec. 26.719(b)(1) through (b)(3), including but not limited to, the use, sale, distribution, possession, or presence of illegal drugs, or the consumption or presence of alcohol within a protected area or while performing duties that require the individual to be subject to this part. The examples included in these sections are illustrative, and do not represent an exhaustive list of the conditions and actions that EAP staff may encounter that would be reported to licensee or other entity management under the final rule.

For additional clarity, the NRC has added Sec. 26.35(c)(3) to the final rule to cross-reference the provisions in the final rule that specify the actions that licensees and other entities would take after receiving a report from EAP personnel that an individual's condition or actions pose or have posed an immediate hazard to himself or herself or others. As discussed with respect to (Sec. Sec. 26.69(d) and 26.77(b) of the final rule, those provisions require the licensee or other entity to take immediate action to prevent the individual from performing any duties that require the individual to be subject to this part, ensure that a determination of fitness is performed by a professional who has specific qualifications and

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training to address the nature of the individual's problem, and either terminate the individual's authorization or ensure that the condition is resolved before permitting him or her to return to performing duties under this part.

These changes to former Sec. 26.25 are consistent with Goal 7 of this rulemaking to protect the privacy and other rights (including due process) of individuals who are subject to Part 26, as well as Goal 3 to improve the effectiveness and efficiency of FFD programs.

Section 26.37 Protection of Information

Section 26.37 amends former Sec. 26.29 that contained requirements for protecting the personal information that must be collected under

Part 26. In general, this section of the final rule groups requirements related to the protection of personal information that were dispersed throughout the former rule to aid in locating these requirements in the final rule. The NRC has moved the records retention requirement in former Sec. 26.29(a) to Subpart N of the final rule. The NRC has made these changes to meet Goal 6 of this rulemaking to improve clarity in the organization of the rule.

Section 26.37(a) combines and retains the first sentence of former

Sec. 26.29(a) and the second sentence of former Section 3.1 in

Appendix A to Part 26. The final rule modifies the language of the proposed rule to require licensees and other entities to establish, use, and maintain a system of files and procedures that protects the individuals' privacy. The NRC, after publishing the proposed rule, recognized the need for more clarity in the language of this provision to illustrate the NRC's intent. Therefore, this change meets Goal 6 of the rulemaking to improve clarity in the language of the rule.

Section 26.37(b) amends former Sec. 26.29(b) and divides it into several sections for clarity. The first sentence of the section amends the first sentence of former Sec. 26.29(b) that prohibited licensees and other entities from disclosing personal information collected under this part to any individuals other than those listed in the sentence.

The final rule continues to permit disclosure of the personal information to the listed individuals and adds permission for the licensee or entity to disclose the personal information to others if the licensee or other entity has obtained a signed release for such a disclosure from the individual. The NRC has added the permission to release the personal information to individuals who are not listed in the section with the written consent of the subject individual because some licensees have misinterpreted the former requirement as prohibiting them from releasing the personal information under any circumstances, except to the parties listed in this section. In some instances, such failures to release information have inappropriately inhibited an individual's ability to obtain information that was necessary for a review or appeal of the licensee's determination that the individual had violated the FFD policy. Therefore, the NRC has added the explicit permission for licensees and other entities to release personal information when an individual consents to the release, in writing, to meet Goal 7 of this rulemaking to protect the privacy rights and other rights (including due process) of individuals who are subject to Part 26.

Section 26.37(b)(1) through (b)(8) lists the individuals to whom licensees and other entities are permitted to release personal information about an individual. Section 26.37(b)(3), (b)(4), and

(b)(8) retains unchanged the permission for the release of information to NRC representatives, appropriate law enforcement officials under court order, and other persons as required by court order. Section 26.37(b)(1), (b)(2), (b)(5), (b)(6), and (b)(7) amends the related requirements contained in former Sec. 26.29(b) to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule. The specific changes to former Sec. 26.29(b) include the following:

Section 26.37(b)(1) retains the permission for the release of information to the subject individual and his or her designated representative. The provision adds requirements for the individual to designate his or her representative in writing and specify the FFD matters to be disclosed. The NRC has made these changes in response to implementation questions from licensees. Licensees have sought guidance from the NRC related to the way an individual must ``designate'' a representative.

Section 26.37(b)(2) retains the permission for the release of information to the licensee's or other entity's MROs. The final rule also permits the release of information to MRO staff members for consistency with Sec. 26.183(d), which permits MRO staff to serve some

MRO functions under the direction of the MRO. MRO staff require access to the personal information in order to perform their duties. The role of MRO staff in FFD programs is discussed with respect to Sec. 26.183(d) of the final rule.

Section 26.37(b)(5) amends the former reference to licensee representatives who have a need to have access to the information in performing assigned duties. The former rule referred only to individuals who are performing audits of FFD programs. As a result, some licensees have misinterpreted the former rule as limiting the release of personal information only to such individuals. This was not the intent of the provision. Rather, the NRC intended that licensees and other entities were permitted to release information to their representatives who must have access to the personal information in order to perform assigned duties.

With respect to the proposed rule, the final rule modifies proposed

Sec. 26.37(b)(5) to clarify the NRC's intent that the only licensee or other entity representatives who may have access to the personal information collected under this part are persons who have a need for that information to implement the requirements of the rule. The NRC made this change to provide greater assurance that personal information, such as medical records that an individual has submitted to the MRO to document prescription medication for a ``shy bladder'' situation, is not released to persons who do not have assigned duties under the FFD program that specifically require access to that information. Reviewing officials, MROs, SAEs, and other FFD program personnel, as well as auditors, require access to some personal information about individuals in order to perform their assigned duties to implement the FFD program. Human resources personnel may need to know that an individual has violated the FFD policy, if the licensee or other entity terminates an individual's employment in response to an

FFD policy violation, but do not need access to the personal information collected about the individual under the FFD program to carry out the process of terminating the individual's employment. The

NRC has determined that this additional clarification is necessary to provide further protection of the privacy of persons who are subject to the rule.

Section 26.37(b)(6) and (b)(7) amends the portion of former Sec. 26.29(b) that referred to ``persons deciding matters on review or appeal.'' The NRC has amended the provision in response to implementation questions from licensees, including whether the rule covers persons deciding matters in judicial proceedings or only the internal appeals process specified in former Sec. 26.28 [Appeals], as well as whether

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information could be released in a judicial proceeding that the subject individual did not initiate. The final rule clarifies that the permission includes individuals who are presiding in a judicial or administrative proceeding, but only if the subject individual in Sec. 26.37(b)(6) initiates the proceeding. Section 26.37(b)(7) covers

``persons deciding matters under review in Sec. 26.39'' [Review process for fitness-for-duty policy violations], as discussed with respect to that section. The NRC has made these changes to meet Goal 6 of this rulemaking relating to improving clarity in the organization and language of the rule.

The NRC has added Sec. 26.37(c) to the final rule to require the disclosure of relevant information to licensees and other entities, including C/Vs, and their authorized representatives who have a legitimate need for the information and a signed release from an individual who is seeking authorization under this part. This provision clarifies former Sec. 26.29(b) because some licensees have misinterpreted the former provision as prohibiting the release of information to C/Vs who have licensee-approved FFD programs and conduct suitable inquiries on behalf of licensees and other entities. The NRC has made this change to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.37(d) through (f) retains several requirements related to the protection of information in the former rule but moves them into this section for organizational clarity. Section 26.37(d) combines requirements in former Sec. 26.29(b) and Section 3.2 in Appendix A to

Part 26 as they relate to an individual's access to records that are necessary for a review of an FFD policy violation. However, the final rule modifies the language of the proposed rule by specifying that it is the FFD program that is required to promptly provide all requested records. The NRC has made this change to meet Goal 6 of the rulemaking to improve clarity in the language of the rule. The final rule also adds ``collection site'' and ``SAE'' to the list of entities who must provide records to an individual or his or her designated representative. The final rule also expands the proposed language to specify the types of records that must be provided. The examples given for the types of records that must be provided to the individual are illustrative, but are not comprehensive of all the types of records that must be provided upon request. The agency has made these changes in response to public comment, to clarify the rule language, to ensure that individuals and representatives can verify the accuracy of FFD records, and to meet Goal 7 of this rulemaking to protect the privacy and other rights (including due process) of individuals subject to Part 26. Section 26.37(e) and (f) retains former Section 3.1 in Appendix A to Part 26 and the last sentence of former Sec. 26.29(b), respectively.

Section 26.39 Review Process for Fitness-for-Duty Policy Violations

Section 26.39 amends former Sec. 26.28 and separates it into several sections. The change from the former section heading eliminates the implication that the internal management review is a legal proceeding. The agency has added several requirements to clarify and strengthen individuals' rights during the review, consistent with Goal 7 of this rulemaking, as described in the following paragraphs.

Former Sec. 26.28 required that individuals who are subject to the rule have an opportunity for a management review of a determination that the individual has violated the licensee's or other entity's FFD policy. Section 26.39(a) retains the requirement that the review must be impartial and adds a requirement that the review must be objective.

The NRC has added the requirement for an objective review because some licensees have permitted the same individuals who were involved in the initial determination that an individual violated the FFD policy to provide the review that was required under former Sec. 26.28. The impartiality of individuals who are reviewing their own decisions is questionable and calls into question the effectiveness of the review process. Therefore, the requirement for the review to be both impartial and objective emphasizes the NRC's intent that the review process be effective.

In keeping with revisions to several other sections that are intended to counter subversion of the testing process, Sec. 26.39(a) extends this opportunity to request a review to all FFD violations, including, but not limited to, violations based upon confirmed positive, adulterated, or substituted, or invalid test results. The section also clarifies that applicants for authorization must be given the opportunity for a review. Experience with implementing this section of Part 26 has indicated that some licensees did not provide a review process to individuals who tested positive on pre-access tests.

However, the factors that could produce false positive test results among licensee and C/V employees (e.g., administrative or testing errors) are equally likely to occur during pre-access testing of applicants for authorization. If applicants are not provided with a review process, it is possible that some of them would be effectively barred from the industry based on test results erroneously determined to be a violation of the licensee's or other entity's FFD policy.

Providing applicants with the opportunity to request a review also enhances program credibility.

Section 26.39(b) specifies that FFD procedures must describe the contents and purpose of the notice that licensees and other entities would be required to provide to an individual who has violated an FFD policy. The provision also requires that the procedures must state that the individual may submit additional relevant information as part of the review process. This clarification is necessary because experience with implementing former Sec. 26.28 has indicated that individuals do not understand the purpose of the review process and their associated rights in some cases.

Section 26.39(c) specifies that the procedure must ensure that the individual who conducts the review is not associated with the administration of the FFD program. The final rule modifies the proposed rule by requiring that only one representative of the licensee's or other entity's management shall conduct the review. The final rule allows only one individual to conduct the review in response to a public comment that stated that the review process required by this section should be consistent with that required by 10 CFR 73.56(e)

(personnel access authorization) because this would simplify licensee procedures and would improve the consistency between FFD requirements and access authorization requirements. In specifying that the reviewer may not be anyone associated with the administration of the FFD program, including anyone who made the initial determination that the individual violated the FFD policy, the final rule strengthens the impartiality and objectivity of the review process in order to further enhance individuals' rights. The NRC has made these changes to meet

Goal 3 of the rulemaking to increase the effectiveness and efficiency of FFD programs, and Goal 7 to protect the privacy and other rights

(including due process) of individuals who are subject to Part 26.

Section 26.39(d) adds a requirement that any records associated with the FFD policy violation must be deleted or corrected, as appropriate, if the policy violation decision is overturned. This requirement is necessary because the final rule permits licensees and other entities to share and rely on information

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gathered by other Part 26 programs to a greater extent than is currently possible. Therefore, incorrect records related to an FFD policy violation could significantly inhibit an individual from further employment under a Part 26 program if this information is transmitted to other licensees and entities who are considering whether to grant authorization to an individual. The requirement to delete or correct any records associated with an FFD policy violation that has been overturned will protect individuals from such potential adverse consequences.

Section 26.39(e) of the final rule amends the last sentence of former Sec. 26.28. This sentence stated that licensees and other entities are not required to provide a review procedure to C/V employees and applicants when the C/V is administering its own drug and alcohol testing. The final rule amends the former paragraph in response to implementation questions from licensees who have asked whether the former provision excuses them from providing a review process for C/V employees at any time, including situations when the FFD policy violation was determined as a result of testing conducted by the licensee. The final rule revises this sentence to clarify that the licensee or other entity need not provide a review process if the C/V's drug and alcohol testing program identified the FFD violation to be reviewed. If the licensee's drug and alcohol testing determined the FFD violation, the licensee is required to provide the impartial and objective review. The final rule modifies the proposed rule to state that the licensee need not provide a review procedure to a C/V subcontractor when the FFD policy violation was determined under a C/

V's program. These changes are consistent with Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.41 Audits and Corrective Action

Section 26.41 of the final rule renames and amends former Sec. 26.80 [Audits]. The NRC has added the phrase ``and corrective action'' to the section heading to emphasize the NRC's intent that licensees and other entities must ensure that corrective actions are taken in response to any adverse findings resulting from an audit. In addition, the final rule reorganizes the audit requirements in former Sec. 26.80, and moves several audit and inspection requirements into this section that were addressed in Appendix A to Part 26. The NRC has made these changes to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.41(a) [General] of the final rule amends the last sentence in former Sec. 26.80(a). This sentence stated that licensees retain responsibility for the effectiveness of C/V programs and the implementation of appropriate corrective action. The final rule revises this requirement to include HHS-certified laboratories, as well as any

C/V FFD program elements and FFD programs that the licensee or other entity relies upon, consistent with the intent of the former requirement. The final rule has added a phrase to the proposed rule that requires licensees to be responsible for the continuing effectiveness of any FFD program services a subcontractor provides to the C/V. The NRC has made these changes to meet Goal 6 of this rulemaking to improve clarity in the language of the rule.

Section 26.41(b) [FFD program] of the final rule amends the required audit frequency in former Sec. 26.80(a). (Other provisions of

Sec. 26.41 address the other requirements contained in former Sec. 26.80(a), as discussed with respect to the sections of the final rule that address those topics.) The final rule decreases the former 12- month FFD program audit frequency to a nominal 24-month frequency, which grants a petition for rulemaking (PRM-26-1) submitted by Virginia

Power on December 30, 1993. Experience with implementing Part 26 has shown that annual audits of the entire FFD program are unnecessary to ensure continued program effectiveness and, therefore, place an unnecessary burden on those entities who are subject to the rule. The

NRC decreased the audit frequency to 24 months to relieve this burden and to be consistent with the NRC's schedule for inspecting FFD programs. The change is consistent with Goal 5 of this rulemaking to improve Part 26 by eliminating or modifying unnecessary requirements.

Although the final rule decreases the required audit frequency, licensees and other entities are required to monitor program performance indicators and operating experience, consistent with a performance-based approach, and audit FFD program elements more frequently than every 24 months as needed. In determining the need for more frequent audits, the final rule requires licensees and other entities to consider FFD performance, including but not limited to, the frequency, nature, and severity of discovered problems, testing errors, personnel or procedural changes, and previous audit findings. The provision is intended to promote performance-based rather than compliance-based audit activities and clarify that programs must be audited following a significant change in personnel, procedures, or equipment as soon as reasonably practicable. The NRC recognizes that

FFD programs evolve and new issues and problems continue to arise.

Turnover of FFD program personnel and contracted services personnel, such as specimen collectors, exacerbates this concern. Licensee audits have identified problems that were associated in some way with personnel changes, such as new personnel not understanding their duties or procedures, the implications of actions that they took or did not take, or changes in processes. The purpose of these focused audits is to ensure that changes in personnel, procedures, or equipment do not adversely affect the operation of the particular program element or function in question. Accordingly, the audit requirement ensures that any programmatic problems that may result from significant changes in personnel, procedures, or equipment are detected and corrected on a timely basis. By requiring more frequent audits of FFD program performance that may require closer monitoring than a nominal 24-month frequency would provide, these changes meet Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

Section 26.41(c) [C/Vs and HHS-certified laboratories] of the final rule amends the audit and inspection requirements that are contained in the second sentence of former Sec. 26.80(a) and the third sentence of

Section 2.7(m) in Appendix A to Part 26, as follows:

Section 26.41(c)(1) further amends the requirement in former Sec. 26.80(a) for annual audits of C/V FFD programs and program elements and

HHS-certified laboratories. The former annual audit frequency is retained only for those portions of C/V FFD programs whose personnel work off site and are not under the daily supervision of FFD program personnel. The activities of C/V personnel who work on site and are under the daily supervision of FFD program personnel are audited under

Sec. 26.41(b). Retention of the annual audit requirement for C/Vs whose personnel work off site meets Goal 3 of this rulemaking to improve the effectiveness and efficiency of FD programs. The provision is necessary to ensure that the services provided continue to be effective because other means of monitoring their effectiveness, such as daily oversight, are unavailable. The section also retains the annual audit requirement for HHS-certified laboratories. The NRC has retained this audit frequency because of the key role

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the laboratories play in the overall effectiveness of Part 26 programs.

Retention of these annual audit requirements in the section denies the petition for rulemaking (PRM-26-1) submitted by Virginia Power on

December 30, 1993.

Section 26.41(c)(2) relaxes some requirements related to annual audits and inspections of the HHS-certified laboratories that licensees and other entities rely upon for drug testing services. The final rule permits licensees and other entities who are subject to the rule to rely upon the inspections of HHS laboratories that are performed for

HHS-certification reviews and no longer requires licensees and other entities to audit the effectiveness of services that HHS inspectors review. The former rule contained a number of requirements that are inconsistent with the requirements for drug testing under other

Federally mandated programs. For example, the former rule permitted donors to request confirmatory alcohol testing of a blood specimen at an HHS-certified laboratory, which other Federal agencies do not permit. Also, some of the cutoff levels established in the former rule are higher, in the case of testing for marijuana metabolite, or lower, in the case of testing for opiates, than those of other Federal agencies. These programmatic discrepancies have made licensee audits of

HHS-certified laboratories necessary to ensure the effectiveness of the unique drug and alcohol testing services required for Part 26 programs because HHS inspections do not address these services. The final rule eliminates the majority of these discrepancies. Therefore, the annual audits of HHS-certified laboratories by licensees that have been necessary under the former rule would be redundant under the final rule, except in certain conditions described below. The NRC has made these changes to meet Goal 5 of this rulemaking to improve Part 26 by eliminating or modifying unnecessary requirements.

Section 26.41(c)(2) continues to require licensees and other entities to conduct annual audits of any services provided to the licensee or other entity that the annual HHS-certification review did not address. The NRC has retained this annual audit requirement because

Sec. 26.31(d) retains the permission in the former rule for licensees and other entities to establish lower cutoff levels and test for drugs in addition to those for which testing is required under this part. If a licensee or other entity chooses to implement more stringent cutoff levels or a broader panel of drugs than required under the final rule, the licensee or other entity is required to ensure that annual audits of the HHS-certified services related to those cutoff levels and drug tests are performed.

The NRC has added the last sentence of Sec. 26.41(c)(2) to clarify the scope of the former audit requirements. The final rule does not require licensees and other entities to audit organizations that do not routinely provide FFD services to the licensee or other entity, such as local hospitals or a substance abuse treatment facility. It is unnecessary to audit these organizations because the FFD program would use their services infrequently, there would be a reasonable expectation of quality, and weaknesses in these services could be identified through other means. For example, Sec. 26.187 [Substance abuse expert] requires the SAE to monitor the substance abuse treatment of individuals who require it and the SAE would have the qualifications and information necessary to assess the quality of the treatment services an individual receives. The SAE has the authority to seek other services on behalf of the FFD program if he or she identifies weaknesses in a treatment program. Therefore, the NRC has made these changes to meet Goal 5 of this rulemaking to improve Part 26 by eliminating or modifying unnecessary requirements.

Section 26.41(d) [Contracts] of the final rule incorporates and amends the requirements of former Section 2.7(m) in Appendix A to Part 26 and others that addressed contractual relationships to permit licensees and other entities access to the HHS-certified laboratories for the purposes of conducting the audits and inspections required under the rule. The portions of former Section 2.7(m) in Appendix A to

Part 26 that related to NRC inspections of HHS-certified laboratories have been moved to Sec. 26.821 [Inspections] in Subpart O

Inspections, violations, and penalties

of the final rule, consistent with Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.41(d)(1) amends the second sentence of former Section 2.7(m) in Appendix A to Part 26. The former section required licensee contracts with HHS-certified laboratories for drug testing and alcohol confirmatory testing, as well as contracts for collection site services, to permit the licensee to conduct unannounced inspections.

The final rule retains the former requirement with respect to HHS- certified laboratories and expands it to require that contracts with any C/V (which would include collection services providers) must permit the licensee or other entity to conduct audits at any time, including unannounced times, and to review all information and documentation that is reasonably relevant to the audits. The provision extends the former requirement to any C/V with whom the licensee or other entity contracts for FFD program services to enhance the effectiveness of the licensees' and other entities' audits should unannounced audits appear to be necessary. For example, a licensee or other entity may receive allegations that an offsite C/V is falsifying records or that a contract MRO or SAE is using drugs. The licensee or other entity may determine that an unannounced audit would provide the most effective means to investigate these allegations. This provision ensures that the licensee's or other entity's contract with the C/V permits the unannounced audit as well as access to any information necessary to conduct the audit. Therefore, the NRC has made this change to meet Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

The NRC had added Sec. 26.41(d)(2) to ensure that licensees' and other entities' contracts with C/Vs and HHS-certified laboratories permit the licensee or other entity to obtain copies of and take away any documents that auditors may need to assure that the C/V, its subcontractors, or the HHS-certified laboratory are performing their functions properly and that staff and procedures meet applicable requirements. This provision responds to several incidents when parties under contract to licensees did not permit Part 26 auditors to remove documents from a premises of a C/V that were necessary to document audit findings, develop corrective actions, and ensure the effectiveness of the corrective actions. Therefore, the new requirement meets Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs. The provision permits HHS-certified laboratories to reasonably limit the use and dissemination of the documentation that auditors copy and take off site. This change meets

Goal 7 of this rulemaking to protect the privacy of individuals who are subject to Part 26 and protects the trade secrets of HHS-certified laboratories who are subject to auditing under the final rule.

Section 26.41(d)(3) amends the third sentence of former Section 2.7(m) in Appendix A to Part 26. This sentence required licensees and other entities to carry out inspections and evaluations of the procedural aspects of an HHS-certified laboratory drug testing operations before awarding a contract to the laboratory. The final rule adds a cross-reference to Sec. 26.41(g). Section

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26.41(g) permits licensees and other entities to forego the otherwise required pre-award evaluation under certain specific circumstances, as discussed with respect to that section.

Section 26.41(e) [Conduct of audits] of the final rule retains the requirements in former Sec. 26.80(b).

Section 26.41(f) [Audit results] of the final rule retains the portion of former Sec. 26.80(c) that required licensees and other entities to document audit findings and recommendations, report them to senior management, and document corrective actions taken in response to any identified adverse conditions. The final rule adds two requirements. The second sentence of Sec. 26.41(f) specifies the required content of audit reports, including identification of any conditions that are adverse to the proper performance of the FFD program, the cause of the condition(s), and recommended corrective actions. The third sentence of the section requires licensees and other entities to review the audit findings and take corrective actions, including reauditing of indicated deficient areas, to preclude, within reason, repetition of the condition. The final rule adds these two sentences for consistency with Criterion XVI in Appendix B to 10 CFR

Part 50 [Domestic licensing of production and utilization facilities] to indicate that the corrective action programs of licensees and other entities must include FFD audit reports. Some licensees have handled

FFD audit reports outside of their normal corrective action programs that address other conditions adverse to quality. As a result, some corrective actions for FFD program weaknesses have not been timely or effective. Therefore, the final rule adds these requirements to meet

Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

The NRC has deleted the last sentence of former Sec. 26.80(c) that referred to the requirements for auditing HHS-certified laboratories in

Appendix A to Part 26 because it is redundant with Sec. 26.41(c). The

NRC has made this change to meet Goal 6 of this rulemaking to improve clarity in the organization of the rule.

Section 26.41(g) [Sharing of audits] of the final rule responds to licensees' implementation questions related to the third and fourth sentences in former Sec. 26.80(a) that permitted licensees and other entities to accept audits of C/Vs that other FFD programs conduct. The section clarifies the former permission to accept and rely on others' audits in response to implementation questions that the NRC has received from licensees with respect to the sharing of audits, as documented in Section 17 of NUREG-1354, and items 11.4 and 11.5 of

NUREG-1385, ``Fitness for Duty in the Nuclear Power Industry: Responses to Implementation Questions.''

Section 26.41(g) amends the former provision to incorporate specific permission for licensees and other entities to jointly conduct audits as well as rely on one another's audits. The NRC has also added a reference to HHS-certified laboratories to indicate the applicability of these permissions to licensees' and other entities' audits of HHS- certified laboratories. These changes are consistent with the guidance issued by the NRC in the documents referenced above and current licensee practices. Therefore, the NRC has made these changes to meet

Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

The NRC has added Sec. 26.41(g)(1) and (g)(2) to the final rule to require licensees and other entities to identify any areas that were not covered by a shared or accepted audit and ensure that any unique services used by the licensee or other entity that were not covered by the shared audit are audited. For example, an FFD program may use lower cutoff levels for drug testing than the FFD program(s) that conducted a shared audit with the result that the shared audit did not address the

HHS-certified laboratories' procedures for testing at the first FFD program's lower cutoff levels. In this case, the first FFD program is not permitted to rely on the shared audit with respect to the lower cutoff levels and is required to ensure that the HHS-certified laboratories' procedures for testing at the lower cutoff levels are audited separately (or in conjunction with other FFD programs that use the same cutoff levels). These provisions are consistent with the guidance issued by the NRC in the documents referenced above and current licensee practices. Therefore, the NRC has made these changes to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.41(g)(3) retains the portion of the third sentence of former Sec. 26.80(a) that stated that licensees and other entities need not re-audit the same C/V for the same period of time. This provision extends this permission to audits of HHS-certified laboratories, which is consistent with the guidance issued by the NRC in the documents referenced above and current licensee practices.

Therefore, the NRC has made this change to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.41(g)(4) retains the fourth sentence of former Sec. 26.80(a). This provision requires licensees and other entities to retain copies of the shared audit reports.

The NRC has added Sec. 26.41(g)(5) to the final rule. The provision permits licensees and other entities to immediately obtain drug testing services from another HHS-certified laboratory, subject to certain conditions, if the laboratory used by the licensee or other entity loses its certification. Within 3 months of obtaining services from the replacement laboratory, the section requires the licensee or other entity to ensure that an audit is conducted of any aspects of the laboratory's services that the licensee or other entity use that have not been audited within the past 12 months by another licensee or entity who is subject to this subpart. This provision enhances the effectiveness of FFD programs by ensuring that drug testing will not be interrupted or delayed if an HHS-certified laboratory loses its certification as some licensees have experienced. The reliability of drug testing services provided by the replacement laboratory is ensured by the auditing and inspection activities of other licensees and entities who have been using the services of the replacement laboratory, as well as the audit conducted by the licensee or other entity of any services that have not been audited by other licensees or entities who are subject to this part. The NRC has made this change to meet Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

Subpart C--Granting and Maintaining Authorization

Throughout Subpart C, the final rule makes minor clarifications to the proposed rule based on public comment, to accommodate conforming changes, and to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

One clarification that the final rule makes in numerous sections in this subpart is to state that licensees or other entities subject to this subpart shall ``ensure'' that a requirement under this subpart has been met. This language differs from that of the proposed rule, which stated that the licensee or other entity shall explicitly perform the activity (i.e., obtain, review, conduct, complete) to meet the requirement. For example, in Sec. 26.55(a)(1), the proposed rule stated that the licensee or other entity shall ``obtain and review a self-disclosure.'' The final rule states that the licensee or other entity shall ``ensure that a self-disclosure has been obtained

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and reviewed.'' This modified language clarifies the NRC's intent that licensees or other entities may rely on other entities to assist in performing the activities necessary to meet the requirements of this subpart. For example, many licensees rely on contractors to conduct the suitable inquiry required under Sec. 26.63. However, the final rule retains the language of the proposed rule in Sec. 26.69(b) for the reasons discussed with respect to that paragraph. In another change from the proposed rule text, the NRC has eliminated the term ``non- negative'' and replaced it with the phrase ``positive, adulterated, or substituted'' for the reasons discussed with respect to Sec. 26.5

Definitions

.

The final rule also makes more substantive changes to the proposed rule in this subpart because of public comment or to improve clarity in the organization and language of the rule. The substantive changes in this subpart can be found in Sec. Sec. 26.51; 26.53(d) through (i); 26.57(b); 26.61(c) and (d); 26.63(c), (c)(3), (d) and (f); 26.65(c),

(c)(2), (d)(1)(i), (d)(2)(ii), (e) and (f); and 26.69(c), (c)(1) and

(e)(1). These changes are discussed in detail below. However, other than the changes mentioned above, the final rule adopts the provisions of this subpart as proposed, without change.

Section 26.51 Applicability

The final rule amends Sec. 26.51 of the proposed rule to describe the applicability of the subpart. The NRC has changed the heading of this section from ``Purpose'' to ``Applicability'' because the NRC has revised the content of the section to specify the licensees, entities, and categories of individuals to whom the requirements Subpart C apply by using cross-references to the relevant paragraphs in Sec. Sec. 26.3 [Scope] and 26.4 [FFD program applicability to categories of individuals]. The NRC made this change in response to public comments requesting this clarification in the rule text and to meet Goal 6 of this rulemaking.

Section 26.53 General Provisions

The NRC has added Sec. 26.53 to the final rule to provide an overview of the requirements and process for determining when individuals may be granted and maintain authorization. With respect to the proposed rule, paragraph (e) has been added to this section to specify the requirements for relying on the FFD program of a C/V when granting or maintaining authorization. Paragraph (f) specifies that licensees and other entities may not rely on FFD programs under Subpart

K [FFD programs for Construction] of this rule to meet the requirements of this subpart. The reasons for adding these paragraphs are discussed with respect to the specific paragraphs.

Section 26.53(a) of the final rule introduces four new terms to

Part 26: ``Initial authorization,'' ``authorization update,''

``authorization reinstatement,'' and ``authorization with potentially disqualifying FFD information.'' The final rule uses these terms to describe categories of requirements for granting authorization. These categories are based on whether an applicant has previously held authorization under Part 26 and the length of time that has elapsed after the individual's last period of authorization ended, and are described in Sec. 26.55 [Initial authorization], Sec. 26.57

Authorization update

, Sec. 26.59 [Authorization reinstatement], and

Sec. 26.69 [Authorization with potentially disqualifying fitness-for- duty information]. Section 26.53(a) directs licensees or other entities to use the criteria for granting authorization to individuals found in

Sec. Sec. 26.55, 26.57, 26.59, or 26.69, depending on which of these sections applies to the individual seeking authorization. The former rule in Sec. 26.27 [Management actions and sanctions to be imposed] discussed actions that the licensee must take before initially granting access or assigning specified duties to an individual, but did not use the concepts of ``initial authorization,'' ``authorization update,''

``authorization reinstatement,'' or ``authorization with potentially disqualifying FFD information.'' The final rule uses these concepts to focus the requirements for authorization more precisely on whether the individual has an established record (i.e. authorization history) in the industry. The NRC also uses these concepts to specify the amount of original information-gathering activities licensees or other entities are required to perform, according to whether previous FFD programs have collected information about the individual. In addition, the NRC uses similar concepts in access authorization requirements found in 10

CFR 73.56 [Personnel access authorization requirements for nuclear power plants] and access authorization orders issued by the agency to nuclear power plant licensees. The NRC has incorporated these concepts into Part 26 to increase the consistency between the related regulations in accordance with Goal 4 of this rulemaking.

Section 26.53(b) of the final rule defines the meaning of the term

``interruption'' which is used in Sec. 26.57 and Sec. 26.59 to refer to the interval of time between periods during which an individual holds authorization under Part 26. Licensees and other entities shall calculate an interruption in authorization as the total number of days falling between the day the individual's last period of authorization ended and the day the licensee or other entity grants authorization to the individual. Section 26.53(b) also specifies that if potentially disqualifying FFD information is disclosed or discovered about an individual, licensees and other entities must implement the applicable requirements in Sec. 26.69 in order to grant or maintain an individual's authorization, rather than relying on the requirements in

Sec. Sec. 26.55, 26.57, or 26.59.

Section 26.53(c) of the final rule references the FFD training requirements in Sec. 26.29 [Training] and the fatigue training requirements in Sec. 26.203(c) [Training and examinations] to clarify that all individuals who are subject to Subpart C must meet the applicable requirements for initial or refresher FFD training, as appropriate, before the licensee or other entity may grant authorization to the individuals. This provision references the training requirements for organizational clarity because they apply to the authorization process. As discussed in the preamble to the proposed rule, stakeholders requested that the regulation present requirements in the order in which they would apply to licensees' and other entities' FFD processes. The NRC has added this paragraph to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.53(d) of the final rule permits licensees and other entities to rely on other licensees' or entities' FFD programs and program elements to meet the requirements of this subpart for granting and maintaining authorization. Section 26.53(d) expands upon a section of the former rule that similarly permitted licensees and other entities to accept and rely on other FFD programs and program elements.

Specifically, former Sec. 26.24(a)(1) permitted licensees to accept results from drug and alcohol tests that were administered under another Part 26 program within the past 60 days. Consistent with the principle of permitting licensees to accept and rely on other Part 26 programs in their authorization decisions, guidance contained in NUREG- 1385, ``Fitness for Duty in the Nuclear Power Industry: Responses to

Implementation Questions,'' also indicates that licensees may

``accept'' an authorization granted by a previous licensee for individuals

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who transfer between licensees with only a short break in authorization.

The final rule substantially increases the specificity of the requirements that licensees or other entities must meet for granting authorization and establishes detailed minimum standards that all programs must meet. The agency designed these detailed minimum standards to address recent changes in industry practices that have resulted in a more transient workforce. Because the FFD programs of licensees and other entities will be substantially more consistent than in the past under these detailed standards, permitting licensees and other entities to rely on other FFD programs to meet the rule's requirements is reasonable and appropriate. Section 26.53(d) eliminates unnecessary redundancies in the steps required to grant authorization to an individual who is transferring from one FFD program to another, consistent with Goal 5 of this rulemaking to improve Part 26 by eliminating or modifying unnecessary requirements. With respect to the proposed rule, the final rule specifies that the receiving FFD program shall ensure that the program elements to which the individual is subject under the transferring FFD program remain current. The NRC has made this change to the proposed rule in recognition of the need for additional consistency between the final rule and the access authorization requirements. Therefore, this change helps meet Goal 4 of this rulemaking to improve consistency between FFD requirements and access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003.

In response to public comment, the final rule adds paragraph (e) to

Sec. 26.53 to clarify the relationship between licensees' and other entities' FFD programs and those of C/Vs. Section 26.53(e) retains the permission in former Sec. 26.23 [Contractors and vendors] for licensees to rely upon C/Vs' FFD programs that have been formally reviewed and approved by the licensee. The paragraph also permits the licensees and other entities in Sec. 26.3(a) through (c) to rely on a

C/V's FFD program elements that meet the requirements of Part 26. For example, some C/Vs ensure that their employees receive initial and refresher FFD training so that, when the employee is assigned to work on a contract that requires him or her to have unescorted access to a nuclear power plant protected area, it is unnecessary for the licensee to provide FFD training to the C/V's employee in order to grant unescorted access to this individual. The final rule adds this permission to rely on a C/V's FFD program elements to codify a long- standing industry practice that has been endorsed by the NRC and to provide clarity in the language of the rule.

Section 26.53(e)(1) permits a C/V to grant, maintain, deny, or unfavorably terminate an individual's authorization under the C/V's FFD program. As defined in Sec. 26.5, granting authorization in this case means that a C/V has determined that the individual has met the requirements in this subpart and is eligible to have the types of access and perform the duties specified in Sec. 26.4. Maintaining authorization under a C/V's FFD program means that the individual continues to meet the requirements of this subpart and be eligible to perform the duties specified in Sec. 26.4. However, the second sentence of Sec. 26.53(e)(1) retains the intent of the provisions in former Sec. 26.23 that placed responsibility on licensees for ensuring that individuals who are ``performing activities within the scope of this part'' meet the requirements in Part 26. However, the final rule updates the terminology used to convey this intent and adds cross- references to other sections of the rule for clarity and consistency with other rule changes.

Section 26.53(e)(2) further clarifies the relationship between authorization under a C/V's FFD program and authorization under the FFD programs of licensees and other entities in Sec. 26.3(a) through (c).

This provision addresses circumstances when a C/V's FFD program determines that an individual does not meet the requirements of this subpart to be granted or maintain authorization and denies or unfavorably terminates the individual's authorization under the C/V's program. The rule requires that if the C/V's FFD program denies or unfavorably terminates the authorization of an individual who is performing the duties for a licensee that are listed in the specified sections of Sec. 26.4, the C/V must inform the affected licensee or other entity of the denial or unfavorable termination. In this case, the licensee or other entity shall, on the day the licensee receives the information from the C/V, deny or unfavorably terminate the individual's authorization or implement the applicable process in Sec. 26.69 to maintain the individual's authorization. For example, if a C/

V's employee is convicted of selling illegal drugs and reports the conviction to the C/V, the C/V would unfavorably terminate this individual's authorization under the C/V's FFD program. If the individual was also assigned to a contract that required him or her to have unescorted access to the protected area of a nuclear power plant at the time he or she was convicted, this provision requires the C/V to inform the FFD program of the licensee or other entity of the conviction. The licensee would then either terminate the individual's unescorted access on the day that the licensee or other entity receives the information from the C/V or, in unlikely circumstances, may implement the process established in Sec. 26.69(d) for determining whether an individual may maintain authorization after potentially disqualifying FFD information is disclosed or discovered. This provision codifies a long-standing industry practice that has been endorsed by the NRC and adds clarity in the rule language. The NRC has also added this requirement in recognition of the need for additional consistency between the final rule and the access authorization requirements. Therefore, this change helps meet Goal 4 of this rulemaking to improve consistency between FFD requirements and access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003.

The final rule has added Sec. 26.53(e)(3) to the final rule to explicitly permit the licensees and other entities in Sec. 26.3(a) through (c) to rely on a C/V's FFD program and program elements, or a combination of program elements from the licensee's or other entity's

FFD program and the C/V's FFD program, to satisfy the requirements of

Subpart C for maintaining an individual's authorization. This paragraph repeats the language in Sec. 26.53(d), which permits licensees and other entities to rely on one another's FFD programs and program elements, but applies it to C/V FFD programs and program elements for additional clarity in the language of the rule. The final rule also clarifies that the receiving licensee's or other entity's FFD program shall ensure that the program elements to which the individual is subject under the C/V's FFD program remain current. The NRC has made this change to the proposed rule in recognition of the need for additional consistency between the final rule and the access authorization requirements. Therefore, this change helps meet Goal 4 of this rulemaking to improve consistency between FFD requirements and access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003.

The NRC has also added Sec. 26.53(f) to the final rule to prohibit licensees and

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other entities from relying on an FFD program that has been implemented under Subpart K of this part when granting authorization to an individual. This prohibition is necessary because Subpart K permits the licensees and other entities specified in Sec. 26.3(c) greater flexibility in establishing and implementing an FFD program than is permitted in Subpart C. For example, Subpart K does not require the licensees and other entities in Sec. 26.3(c) to conduct a suitable inquiry of individuals who are permitted to perform the duties described in Sec. 26.4(f). Therefore, in order to grant authorization to such an individual to have the types of access or perform the duties in Sec. 26.4(a) or (b), for example, a licensee in Sec. 26.3(a) would be required to ensure that a suitable inquiry has been completed under

Sec. 26.63. However, this new provision would permit a licensee or other entity to rely on the program elements of a Subpart K FFD program if the program elements meet the applicable requirements of Subpart C.

For example, if a Subpart K program included suitable inquiry requirements and implemented them under Sec. 26.63, a licensee or other entity could rely on those suitable inquiry results when granting authorization under Subpart C. This section satisfies Goal 3 of this rulemaking by improving the effectiveness and efficiency of FFD programs.

The NRC has added 26.53(g) to the final rule to require licensees and other entities to identify any FFD violation to any licensee who has relied or intends to rely on the FFD program element that is determined to be in violation of this part. The NRC has made this change to the proposed rule in recognition of the need for additional consistency between the final rule and the access authorization requirements. Therefore, this change helps meet Goal 4 of this rulemaking to improve consistency between FFD requirements and access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003.

In the final rule, the NRC has added a new provision in Sec. 26.53(h) to prohibit licensees and other entities from initiating any actions under Subpart C, such as beginning to gather information about the individual's authorization history from other licensees or entities, without the knowledge and consent of the individual who is applying for authorization. The new provision in the final rule also informs individuals that they may withdraw consent at any time, and specifies the actions that licensees and other entities must take if an individual withdraws his or her consent. The NRC has added this provision to provide additional protection of individuals' privacy by ensuring that licensees and other entities do not gather personal information about an individual without his or her permission. The requirements to inform the individual that he or she may withdraw consent and for licensees and other entities to inform the individual of what information will be documented and shared with other licensees or entities following a withdrawal of consent are necessary to protect individuals' other rights under the rule, including due process.

Therefore, this provision meets Goal 7 of this rulemaking to protect the privacy and other rights (including due process) of individuals subject to Part 26. This provision meets Goal 4 of this rulemaking to improve consistency between FFD requirements and access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003.

The NRC has added Sec. 26.53(i) to the final rule to require licensees and other entities specified in Sec. 26.3(a) and, as applicable, (c) and (d), to inform individuals applying for authorizations of the actions related to providing and sharing personal information that are sufficient cause for denial or unfavorable termination of authorization. The actions that are sufficient cause for denial or unfavorable termination of authorization include refusal to provide written consent, as specified in Sec. 26.53(i)(1), and refusal to provide or the falsification of any personal information required under this subpart, including the failure to report any previous denial or unfavorable termination of authorization, as specified in Sec. 26.53(i)(2). These provisions were moved from Sec. 26.63(d) and Sec. 26.61(d) of the proposed rule, respectively. The NRC has added Sec. 26.53(i)(3) and (i)(4) to specify that a refusal to provide written consent for the sharing of personal information with other licensees or other entities, as required in Sec. 26.53(h), and a failure to report any legal actions, respectively, are also sufficient cause for denial or unfavorable termination of authorization. Also, the NRC has made these changes to the proposed rule in recognition of the need for additional consistency between the final rule and the access authorization requirements. Therefore, this change helps meet Goal 4 of this rulemaking to improve consistency between FFD requirements and access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003.

Section 26.55 Initial Authorization

The NRC has added Sec. 26.55 to the final rule, which defines the category of ``initial authorization'' requirements as applying both to individuals who have not previously held authorization under Part 26 and those whose authorization has been interrupted for a period of 3 years or more and ended favorably.

Two considerations support the mandate for individuals whose last period of authorization ended 3 or more years previously to satisfy the same requirements as individuals who have never previously held authorization. In general, the longer the period of time since the individual's last period of authorization ended, the greater the possibility that the individual has developed an active substance abuse problem or undergone significant changes in lifestyle or character that would diminish his or her trustworthiness, reliability, and ability to perform work safely and competently. Therefore, it is reasonable to require a full and extensive screening identical to that given an individual who has not held authorization, and has not been subject to drug and alcohol testing and behavioral observation, for 3 years or more. For similar reasons, access authorization requirements also require that individuals who have not held authorization for 3 years or more must be subject to the same screening as individuals who have not previously held authorization. Therefore, mandating that individuals whose last period of authorization ended 3 or more years previously must satisfy the same requirements as individuals who have never held authorization increases the consistency of Part 26 with the related access authorization requirements, consistent with Goal 4 of this rulemaking.

Section 26.55(a)(1) requires the licensee or other entity, before granting initial authorization to an individual, to ensure that a self- disclosure has been obtained and reviewed in accordance with the applicable requirements of Sec. 26.61 [Self-disclosure and employment history]. As discussed with respect to Sec. 26.61, the self-disclosure and employment history requirements mandate that the individual report violations, if any, involving drugs or alcohol and the individual's current and past employment history. The requirement is similar to that in Sec. 26.27(a)(1) of the former rule that a

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written statement must be obtained from the individual addressing the topics that are specified in former Sec. 26.27(a)(1). The discussion of Sec. 26.61 in this document compares the topics required to be addressed in the written statement under the former rule with the topics that are addressed in the self-disclosure under this final rule.

As discussed with respect to Sec. 26.61(b)(3), an applicant for initial authorization must address in the self-disclosure the shorter period of either the past 5 years or the interval of time that has elapsed since the individual's eighteenth birthday.

Section 26.55(a)(2) requires the licensee or other entity to ensure that a suitable inquiry has been completed under the applicable requirements of Sec. 26.63 [Suitable inquiry] before granting initial authorization to an individual. The requirement is similar to that in

Sec. 26.27(a)(2) of the former rule that a suitable inquiry must be completed addressing the topics that are specified in Sec. 26.27(a)(2). The discussion of Sec. 26.63 in this document compares the topics that the suitable inquiry must address under the former rule with the topics that it addresses under the final rule. Section 26.63(f)(1) specifies that the suitable inquiry for an initial authorization must address the shorter period of either the past 3 years or the interval of time that has elapsed since the individual's eighteenth birthday.

Section 26.55(a)(3) requires the licensee or other entity to ensure that the individual has been subject to pre-access drug and alcohol testing under the applicable requirements of Sec. 26.65 [Pre-access drug and alcohol testing] before granting initial authorization to an individual. Former Sec. 26.24(a)(1) required testing within the 60 days before initially granting unescorted access to protected areas or assignment to activities within the scope of Part 26. The discussion of

Sec. 26.65 in this document compares the pre-access drug and alcohol testing requirements for initial authorization in this rule to the requirements in the former rule. Section 26.65 requires the licensee or other entity to ensure that the individual had negative drug and alcohol test results from testing that had been completed within the past 30 days before granting authorization to the individual.

Section 26.55(a)(4) requires the licensee or other entity also to ensure that the individual has been subject to random drug and alcohol testing under the applicable requirements of Sec. 26.67 [Random drug and alcohol testing of individuals who have applied for authorization].

Former Sec. 26.64(a)(2) required unannounced drug and alcohol tests imposed in a statistically random and unpredictable manner. The discussion of Sec. 26.67 in this document compares the random drug and alcohol testing requirements for initial authorization in this rule to the requirements in the former rule.

Section 26.55(b) of the final rule mandates that the licensee or other entity must meet the requirements in Sec. 26.69 to grant authorization to the individual, if potentially disqualifying FFD information is disclosed or discovered about the individual who is applying for authorization that another licensee or other entity has not previously evaluated.

Section 26.57 Authorization Update

The NRC has added Sec. 26.57 to the final rule, which defines the category of ``authorization update'' requirements for granting authorization to individuals whose authorization has been interrupted for more than 365 days but less than 3 years and whose last period of authorization was terminated favorably.

As noted in the discussion of Subpart C in Section IV.C, the requirements for granting an authorization update are less stringent than the requirements for granting initial authorization. The requirements are less stringent because (1) the individual who is applying for an authorization update will have a more recent history of successful performance within the industry, and (2) the licensee or other entity will have access to information about the individual from the licensee or other entity who last granted authorization to him or her because of the increased information-sharing requirements of the final rule. However, the requirements in the final rule for an authorization update focus on gathering and evaluating information from the interruption period because the licensee or other entity will not have information about the individual's activities during the period of the interruption. For example, in the case of an individual whose last period of authorization ended 2 years ago, the licensee or other entity will focus on gathering information about the individual's activities within the 2-year interruption period. If an individual's last period of authorization ended 13 months ago, the licensee or other entity will focus on gathering information about the individual's activities within those 13 months.

Section 26.57(a) of the final rule, like Sec. 26.55(a), requires the licensee or other entity before granting authorization to ensure that:

(1) A self-disclosure has been obtained and reviewed under the applicable requirements of Sec. 26.61;

(2) A suitable inquiry has been completed under the applicable requirements of Sec. 26.63;

(3) The individual has been subject to pre-access drug and alcohol testing under the applicable requirements of Sec. 26.65; and

(4) The individual has been subject to random drug and alcohol testing under the applicable requirements of Sec. 26.67.

However, Sec. 26.61(b)(3)(iii) and (c)(3) limits the period of time to be addressed in the self-disclosure and employment history to the interruption period. If an individual's last period of authorization ended 2 years ago, the self-disclosure and employment history would cover only the past 2 years. Similarly, Sec. 26.63(f)(2) provides that the suitable inquiry for an authorization update must cover the interruption period. The final rule requires the self- disclosure, employment history, and suitable inquiry to address only the interruption period because the licensee or other entity may obtain information from earlier periods in the individual's history from the licensee or other entity who had last granted authorization to the individual.

The NRC has added Sec. 26.57(b) to specify that if potentially disqualifying FFD information is disclosed or discovered about the individual who is applying for authorization, the licensee or other entity may not grant authorization to the individual, except under

Sec. 26.69.

Section 26.59 Authorization Reinstatement

The NRC has added Sec. 26.59 to the final rule, which establishes two categories of authorization reinstatement requirements for individuals whose authorization has been interrupted for a short period and whose last period of authorization was terminated favorably.

One category of authorization reinstatement requirements applies to individuals whose authorization has been interrupted for more than 30 days but no more than 365 days in Sec. 26.59(a), and the other to individuals whose authorization has been interrupted for 30 or fewer days in Sec. 26.59(c). The steps for reinstating an individual's authorization after an interruption of 365 or fewer days are less stringent than those required for initial authorization or an authorization update because these individuals will have a recent, positive record within the industry and pose little risk to public health and

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safety or the common defense and security.

The requirements that are related to an individual whose authorization has been interrupted for more than 30 days but no more than 365 days are more extensive than the requirements for granting authorization to an individual whose authorization has been interrupted for 30 or fewer days. The requirements for the 31-365-day category are consistent with those contained in the access authorization orders issued by the NRC to nuclear power plant licensees dated January 7, 2003. However, the requirements for individuals whose authorization has been interrupted for 30 or fewer days are more stringent than those contained in those orders. Under the access authorization orders, licensees are required to obtain and review a self-disclosure and employment history from the applicant before reinstating the individual's authorization. Under this amendment, licensees and other entities are also required to subject the individual to the possibility of selection for pre-access testing under Sec. 26.65(e) [Authorization reinstatement after an interruption of 30 or fewer days]. The NRC has determined that this additional requirement is necessary to meet the final rule's performance objective of providing reasonable assurance that individuals are trustworthy and reliable by extending the deterrent effect of pre-access testing to individuals who have had an interruption in authorization of 30 or fewer days in length.

For individuals whose authorization has been interrupted for 31-365 days, Sec. 26.59(a)(1) requires the licensee or other entity to ensure that a self-disclosure and employment history has been obtained and reviewed in order to reinstate authorization. Consistent with the requirements for authorization updates in Sec. 26.57, the final rule in Sec. 26.61(b)(3)(iii) and (c)(3) limits the period of time to be addressed in the self-disclosure and employment history to the period of the interruption in authorization. A self-disclosure and employment history for earlier periods of time is unnecessary because the granting licensee or other entity will have access to information about the individual from the licensee or other entity who recently terminated the individual's authorization.

Section 26.59(a)(2) permits the licensee or other entity to reinstate an individual's authorization without first ensuring that a suitable inquiry has been completed, in contrast to the requirements for an initial authorization and an authorization update. The final rule permits this because these individuals will have a recent, positive record within the industry and pose little risk to public health and safety or the common defense and security. As is required for an authorization update, this provision limits the period of time to be addressed by the suitable inquiry to the interruption period in

Sec. 26.63(f)(3). However, this provision requires licensees and other entities to ensure that the suitable inquiry is completed within 5 business days after reinstating the individual's authorization. If the suitable inquiry is not completed within the 5-day period, the licensee or other entity can maintain the individual's authorization for up to 10 business days following the day authorization was reinstated, but only if the licensee or other entity is unaware of any potentially disqualifying information about the individual. If the suitable inquiry is not completed within 10 business days, the rule requires the licensee or other entity to administratively withdraw the individual's authorization until the suitable inquiry is completed.

Section 26.59(a)(3) requires the licensee or other entity to ensure that the individual whose authorization has been interrupted for 31-365 days has been subject to pre-access drug and alcohol testing, and Sec. 26.59(a)(4) requires the licensee or other entity to ensure that the individual whose authorization has been interrupted for 31-365 days is subject to random testing. Section 26.65(d) [Authorization reinstatement after an interruption of more than 30 days] establishes pre-access drug and alcohol testing requirements for authorization reinstatements. Section 26.67 specifies the requirements for the random testing of individuals who are applying for an authorization reinstatement.

The NRC has added Sec. 26.59(b) to the final rule to ensure that any administrative withdrawal of authorization required under Sec. 26.59(a)(2) is not reported or recorded as an unfavorable termination of authorization until the suitable inquiry is completed and it indicates that authorization should not be granted. This provision ensures that a temporary administrative withdrawal of authorization caused by a licensee's or other entity's delay in completing the suitable inquiry is not treated as an unfavorable termination caused by an FFD violation. The final rule specifies that the individual may not be required to disclose the administrative action in response to requests for self-disclosure of potentially disqualifying FFD information. With respect to the proposed rule, the final rule clarifies that the individual is required to disclose the administrative action if the individual's authorization was subsequently denied or terminated unfavorably. The NRC has made this change to the proposed rule in recognition of the need for additional consistency between the final rule and the access authorization requirements. Therefore, this change helps meet Goal 4 of this rulemaking to improve consistency between FFD requirements and access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003.

Section 26.59(b) is necessary to meet Goal 7 of this rulemaking to protect the privacy and other rights (including due process) of individuals who are subject to Part 26 by ensuring that they are not subject to any adverse consequences for the licensee's or other entity's delay in completing the suitable inquiry.

Section 26.59(c) of the final rule establishes authorization requirements for individuals whose authorization has been interrupted for 30 or fewer days. Section 26.59(c)(1) requires the licensee or other entity to ensure that a self-disclosure has been obtained and reviewed with certain exceptions that are specified in Sec. 26.61. The licensee or other entity is permitted to forego conducting a suitable inquiry for individuals whose authorization has been interrupted for such a short period. Section 26.59(c)(2) permits licensees and other entities also to forego pre-access drug and alcohol testing of individuals whose authorization has been interrupted for 5 or fewer days. However, pre-access testing may be required under Sec. 26.65(e) for individuals whose authorization has been interrupted for 6 to 30 days. Sections 26.61 and 26.65 specify the exceptions to the self- disclosure and pre-access testing requirements in this provision, respectively.

Section 26.61 Self-Disclosure and Employment History

The NRC has added Sec. 26.61 to the final rule to replace former

Sec. 26.27(a)(1) for the reasons discussed in Section IV.C. The final rule replaces the term ``written statement'' in the former rule with the phrase ``self-disclosure and employment history'' to more accurately characterize the requirement. The NRC has made this change to meet Goal 6 of this rulemaking to improve clarity in the language of the rule.

The NRC has added Sec. 26.61(a) to the final rule to require licensees and other entities to ensure that a written self-disclosure and employment history has

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been obtained from every applicant before granting authorization to the individual, except in two circumstances, as follows.

Section 26.61(a)(1) permits the licensee or other entity to forego obtaining a self-disclosure and employment history if all three of the following conditions are met:

(1) The individual previously held authorization under Part 26;

(2) The individual's last period of authorization was terminated favorably; and

(3) The individual has been subject to a behavioral observation and arrest-reporting program that meets the requirements of this part throughout the time the individual's authorization was interrupted.

The information to be obtained from the self-disclosure and employment history is unnecessary in these circumstances because it will already be available to the granting licensee or other entity from the FFD program that had been implementing the behavioral observation and arrest-reporting program during the interruption in the individual's authorization. A requirement for licensees and other entities to conduct another suitable inquiry is redundant and imposes an unnecessary burden.

Section 26.61(a)(2) permits licensees and other entities to forego obtaining an employment history from applicants for an authorization reinstatement whose authorization has been interrupted for 30 or fewer days. The employment history information is unnecessary in this case because the final rule does not require licensees or other entities to conduct a suitable inquiry for individuals who have had such a short break in authorization.

The NRC has added Sec. 26.61(b) to the final rule to specify the required content of the written self-disclosure. Affirmative responses to any of the questions in Sec. 26.61(b)(1) are considered potentially disqualifying FFD information, as defined in Sec. 26.5. The final rule expands the scope of the questions to be asked from those required in former Sec. 26.27(a)(1) in order to provide greater assurance that individuals will disclose information indicating an active substance abuse problem or an increased risk of recidivism into an active substance abuse problem after treatment. Former Sec. 26.27(a)(2) required information about whether the applicant ``tested positive for drugs or use of alcohol that resulted in on-duty impairment.'' Section 26.61(b)(1) requires information about whether the applicant used, sold, or possessed illegal drugs, subverted or attempted to subvert a drug or alcohol testing program, or refused to take a drug or alcohol test. Both former Sec. 26.27(a)(2) and Sec. 26.61(b)(1) require information on whether the applicant has been subject to a plan for substance abuse treatment (except for a self-referral). Both require information about previous denials or terminations of authorization.

The NRC has added Sec. 26.61(b)(2) to the final rule to require the applicant to disclose the circumstances surrounding any potentially disqualifying FFD information and the resolution of the matter. For example, Sec. 26.61(b)(1) requires an applicant to report an arrest on drug-related charges, while Sec. 26.61(b)(2) requires the applicant to report the outcome of the arrest (e.g., charges, a conviction, a finding of not guilty, the dropping of the charges).

Section 26.61(b)(3) defines the time period that the self- disclosure must address. The final rule establishes a time limit on the number of years in the past for which an individual is required to report and account for potentially disqualifying FFD information. One purpose of the self-disclosure is to identify indicators of an active substance abuse problem or an increased risk of recidivism into an active substance abuse problem after treatment. The relevant research literature indicates that post-treatment recidivism (i.e., relapse) rates decrease after 3 years of no further substance abuse, and a larger decrease occurs in the recidivism rate after 5 years. If the applicant discloses no indicators of a substance abuse problem within the past 5 years (or since the applicant's eighteenth birthday, in the case of an applicant who is less than 23 years of age), an applicant for initial authorization (see Sec. 26.55) is not required to disclose earlier events related to substance abuse. For applicants who held authorization within the past 3 years, the self-disclosure addresses only the time interval after the individual's last period of authorization ended. However, the licensee or other entity shall obtain further information about the applicant over the past 5 years by reviewing the information made available by licensees or other entities who granted authorization to the applicant in the past. This includes information developed as part of previous suitable inquiries (see Sec. 26.63) as well as information from the period(s) during which the individual was subject to other FFD programs.

Section 26.61(c) in the final rule modifies this provision as proposed. The proposed rule specified that applicants must provide information about current and past employers, which the licensee or other entity then uses for the suitable inquiry if a suitable inquiry is required under Sec. 26.63. However, the final rule requires the individual to provide a list of employers to include the employer by whom he or she claims to have been employed on the day before he or she completes the employment history. The agency has also made this change in Sec. 26.63(c). The NRC has made this change in response to a public comment, which stated that a licensee or other entity has the ability to ensure that a suitable inquiry has been conducted only of those employers that are listed in the self-disclosure or employment history.

The NRC believes that this revision provides more specificity in cases when an individual's current employer changes after he or she submits the self-disclosure. This change is consistent with Goal 6 of the rulemaking to improve clarity in the organization and language of the rule.

The NRC has moved the provision in proposed Sec. 26.61(d) to Sec. 26.53(i)(2) of the final rule to meet Goal 6 of this rulemaking to improve clarity in the organization of the rule.

Section 26.63 Suitable Inquiry

The NRC has added Sec. 26.63 to the final rule. This section amends former Sec. 26.27(a)(2) and the requirements related to conducting a suitable inquiry that are contained within the definition of the term ``suitable inquiry'' in former Sec. 26.3. The former rule defined a suitable inquiry as a ``best-effort verification of employment history for the past 5 years, but in no case less than 3 years, obtained through contacts with previous employers to determine if a person was, in the past, tested positive for illegal drugs, subject to a plan for treating substance abuse, removed from, or made ineligible for activities within the scope of 10 CFR Part 26, or denied unescorted access at any other nuclear power plant or other employment in accordance with a fitness-for-duty policy.'' In general, the NRC intends that the changes to the former requirements better focus the suitable inquiry on indicators of an active substance problem and/or an increased risk of recidivism into an active substance abuse problem following treatment, as discussed in Section IV.C; increase the consistency in implementing suitable inquiries among FFD programs by providing more detailed requirements, also as discussed in Section

IV.C; and improve Part 26 by eliminating or modifying unnecessary

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requirements, which is Goal 5 of this rulemaking.

For all authorization categories, the suitable inquiry required by the final rule is more thorough than previous industry practices to increase the likelihood that any potentially disqualifying FFD information is identified and provide reasonable assurance that individuals are trustworthy and reliable, as demonstrated by avoiding substance abuse. For individuals who have established a recent, favorable work history under Part 26, as demonstrated by having held authorization that was terminated favorably within the past 3 years, the NRC has reduced the period of time addressed in the suitable inquiry from the past 5 years in every case, to the past 3 years or fewer, depending on how recently the applicant held authorization. If potentially disqualifying FFD information within the past 5 years is identified regarding an applicant and a previous licensee or other entity has not addressed and favorably resolved it, the suitable inquiry requirements are more extensive, as described in Sec. 26.69.

The NRC has added Sec. 26.63(a) to the final rule to require licensees and other entities to ensure that a suitable inquiry has been conducted to verify the information provided by the applicant in the self-disclosure and employment history obtained under Sec. 26.61 and to determine if additional potentially disqualifying FFD information is available regarding the applicant. The provision also establishes the circumstances in which a licensee or other entity is permitted to forego the suitable inquiry in order to grant authorization to individuals. A licensee or other entity is permitted to forego the suitable inquiry if the individual previously held authorization under

Part 26, his or her last period of authorization was terminated favorably, and the individual was subject to a behavioral observation and arrest-reporting program that meets the requirements of this part throughout the period during which the individual's authorization was interrupted. The information to be obtained from a suitable inquiry is unnecessary in these circumstances because it will already be available to the granting licensee or other entity from the Part 26 program that implemented the behavioral observation and arrest-reporting program during the interruption in authorization.

The final rule adds Sec. 26.63(b) to the final rule to permit licensees and other entities to rely on suitable inquiry information that was gathered by previous licensees and other entities who are subject to this subpart. This provision reduces the number of redundant suitable inquiries that licensees and other entities must conduct when the suitable inquiries would address the same employers and same time periods. The provision also permits licensees and other entities to accept the results of determinations of fitness that were performed under a previous Part 26 program, rather than requiring each new licensee and other entity to reevaluate the same information that was reviewed and resolved under the same requirements in another Part 26 program. The NRC has made this change to meet Goal 5 of this rulemaking to improve Part 26 by eliminating or modifying unnecessary requirements.

With respect to the proposed rule, the final rule adds a cross- reference to Sec. 26.189 [Determination of fitness] in Sec. 26.63(b) to specify that licensees and other entities may only rely on determinations of fitness that were conducted under Sec. 26.189. This change is necessary because the licensees and other entities specified in Sec. 26.3(c) have greater latitude in conducting fitness evaluations under Subpart K than is permitted under Sec. 26.189.

However, as discussed with respect to Sec. 26.53(f), a licensee or other entity who is subject to this subpart is permitted to rely on a determination of fitness conducted under a Subpart K program if the determination of fitness met the requirements in Sec. 26.189.

The NRC has added Sec. 26.63(c) to the final rule, which specifies requirements for conducting suitable inquiries. Licensees and other entities shall ensure that a ``best effort'' is demonstrated to complete the suitable inquiry. The ``best effort'' criterion recognizes licensees' and other entities' status as commercial entities with no legal authority to require the release of the information from other private employers and educational institutions. Because of privacy and potential litigation concerns, some private employers and educational institutions may be unable or unwilling to release qualitative information about a former employee or student. For example, a former employer may verify the dates that the company employed an individual, but may be unwilling to reveal that the individual had been in treatment for drug or alcohol abuse while employed with the company.

Therefore, the ``best effort'' criterion requires licensees and other entities to ensure that suitable inquiry information is sought from the primary source (e.g., a company, private employer, or educational institution that the applicant has listed on his or her employment history), but recognizes that it may not be forthcoming. The ``best effort'' criterion in the paragraph is consistent with the ``best- efforts basis'' in former Sec. 26.27(a)(2). However, the final rule provides more detailed requirements in response to questions that the

NRC has received from licensees about implementing a suitable inquiry on a ``best effort'' basis after Part 26 was first promulgated. Also, the final rule modifies the proposed rule to more clearly specify which employers must be questioned as discussed with respect to Sec. 26.61(c).

The NRC has added Sec. 26.63(c)(1) to the final rule, which specifies the type of information that the licensee or other entity must seek from employers regarding the applicant for authorization.

This provision requires the licensee or other entity to ascertain the reason that the individual's employment was terminated, his or her eligibility for rehire, and other information that could reflect on the individual's fitness to be granted authorization. The requirement to obtain this information is consistent with long-standing industry practices related to granting access authorization and related requirements in the access authorization requirements established in 10

CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003.

Section 26.63(c)(2) specifies the type of information that licensees and other entities must seek when an applicant's claimed periods of employment include military service. The NRC has added this requirement for consistency with related requirements in the access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003.

The NRC has added Sec. 26.63(c)(3) to the final rule to address circumstances in which a primary source of information refuses to provide the necessary suitable inquiry information or indicates an inability or unwillingness to provide it within 3 days of the request.

Licensees and other entities are required to document that the request for information was directed to the primary source and the nature of the response (i.e., a refusal, inability, or unwillingness). If a licensee or other entity encounters the circumstances addressed in

Sec. 26.63(c)(3), the provision requires the licensee or other entity to seek suitable inquiry information from an alternate source to the extent of the alternate source's ability to provide the information. An alternate source may include, but is not limited to, a co-

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worker or supervisor at the same company who had personal knowledge of the applicant, if such an individual could be located. However, the final rule prohibits the licensee or other entity from using the alternate source of suitable inquiry information to meet any other access authorization requirements for a character reference. The provision permits licensees and other entities to grant authorization, if warranted, when a response has been obtained from an alternate source without waiting more than 3 days after the request for information was directed to a primary source. With respect to the proposed rule, the final rule clarifies that the licensee shall evaluate and document the response if it is received. The NRC has made this change to the proposed rule in recognition of the need for additional consistency between the final rule and the access authorization requirements. Therefore, this change helps meet Goal 4 of this rulemaking to improve consistency between FFD requirements and access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003. These alternative methods of meeting the suitable inquiry requirement are necessary because some employers are unwilling or unable to provide suitable inquiry information.

The NRC has added Sec. 26.63(d) to the final rule, which requires licensees and other entities to share suitable inquiry information that they have collected when contacted by another licensee or entity who has a release signed by the applicant for authorization that permits the sharing of that information. This provision restates the permission to release suitable inquiry information in former Sec. 26.29(b) as a requirement that licensees and other entities must share the information necessary to conduct the suitable inquiry. With respect to the proposed rule, the final rule clarifies this provision as a result of a public comment that disagreed with the use of the word

``presentation'' in the proposed provision. The NRC concurred with the comment and believes that current practices in the industry allow for verification of a signed release without the licensee presenting the actual document. Therefore, the NRC has made this change to meet Goal 6 of the rulemaking to improve clarity in the organization and language of the rule. Also, the final rule expands the list of the types of information that licensees and other entities must make available and on which the denial or unfavorable determination of authorization was based. The NRC has made this change because after publishing the proposed rule, it recognized the need for additional clarity to reflect the NRC's intent beyond what the proposed rule contained.

Section 26.63(d) clarifies that the information must also be released to C/Vs who have licensee-approved FFD programs when the C/V has obtained the required signed release from the applicant. This clarification is necessary because some licensees have misinterpreted former Sec. 26.29(b) as prohibiting the release of suitable inquiry information to C/Vs who have licensee-approved FFD programs. The provision also imposes the requirement on licensees and other entities who may be implementing an FFD program under Subpart K of this part.

The NRC has made this change for consistency with the new requirements in Subpart K of this rule and to meet Goal 3 of the rulemaking to improve the effectiveness and efficiency of FFD programs.

The NRC has moved the portion of proposed Sec. 26.63(d) that specified that a failure of an individual to authorize the release of information for the suitable inquiry is sufficient cause for a denial of authorization to Sec. 26.53(i)(1) of the final rule. The NRC has made this change to meet Goal 6 of the rulemaking to improve clarity in the organization and language of the rule.

The NRC has added Sec. 26.63(e) to the final rule to permit licensees and other entities to use electronic means to obtain the suitable inquiry information. This permission is consistent with access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003. The paragraph also adds cross-references to the applicable records retention requirements in Sec. 26.711 [General provisions] and Sec. 26.713 [Recordkeeping requirements for licensees and other entities] in

Subpart N [Recordkeeping and Reporting Requirements] to the final rule to ensure that licensees and other entities are aware of the applicability of these requirements to the suitable inquiry information obtained electronically. These changes are consistent with Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

The NRC has added Sec. 26.63(f) to the final rule, which specifies the period(s) of time that the suitable inquiry must address for applicants for initial authorization, authorization update, and authorization reinstatement. The final rule specifies that the suitable inquiry requirements in this provision apply only to those individuals about whom no potentially disqualifying FFD information is known at the time the suitable inquiry is initiated. The NRC added this provision to meet Goal 6 of the rulemaking to improve clarity in the organization and language of the rule.

Section 26.63(f) specifies the following additional requirements for conducting the suitable inquiry for these authorization categories.

Section 26.63(f)(1) [Initial authorization] requires licensees and other entities to conduct a suitable inquiry to address the 3-year period preceding the date the individual applies for authorization. The

NRC has reduced the period of time that the suitable inquiry must address for applicants for initial authorization who do not disclose any potentially disqualifying FFD information. The NRC has reduced the period of time to be addressed in the suitable inquiry from 5 years in the former regulation to 3 years to better focus the suitable inquiry on identifying indicators of an active substance abuse problem or an increased risk of recidivism following treatment. If an applicant for initial authorization discloses no potentially disqualifying FFD information from the past 5 years and none is identified through the suitable inquiry or other means, it is unlikely that the applicant has an active substance abuse problem. Therefore, seeking a full 5 years of information about the individual would be unlikely to provide useful data and imposes an unnecessary burden. Industry experience has shown that employers are often reluctant to disclose adverse information to other private employers about former employees. Also, the longer it has been since an individual was employed, the less likely it is that a former employer will disclose useful information. Therefore, rather than retaining the requirement for a 5-year suitable inquiry in all cases, the final rule increases the thoroughness of the suitable inquiry over the past 3 years.

Section 26.63(f)(1) requires the licensee or other entity to ensure that the suitable inquiry has been conducted with every employer by whom the applicant claims to have been employed within the past year.

This requirement leads to a more rigorous suitable inquiry than was common industry practice before the issuance of the January 7, 2003, access authorization orders, which imposed additional compensatory measures related to access authorization. The purpose of contacting every employer is to ensure that the licensee or other entity sought information related to any active substance abuse problem. For the earlier years of the suitable inquiry period, the

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provision requires the licensee or other entity to ensure that the suitable inquiry has been conducted with every employer by whom the applicant claims to have been employed the longest within each calendar month. Contacting these employers increases the likelihood that the employers would have knowledge of the applicant and may provide more useful information than contacting employers who employed the applicant only briefly.

The NRC has added Sec. 26.63(f)(2) [Authorization update] to the final rule, which specifies the period of time that the suitable inquiry must address for applicants for an authorization update (i.e., those who held authorization within the past 3 years and whose last period of authorization was terminated favorably, but who have not held authorization within the past year). The paragraph requires the licensee or other entity to ensure that the suitable inquiry has been conducted in the same manner as described in Sec. 26.63(f)(1).

However, for an authorization update, the suitable inquiry addresses only the period during which the individual's authorization was interrupted, rather than the full 3 years that is required for initial authorization. A 3-year period for the suitable inquiry is unnecessary for these individuals because the licensee or other entity will have access to the information about the individual that was gathered by the licensee or other entity under whose program the individual had been granted and successfully maintained authorization within the past 3 years.

Section 26.63(f)(3) [Authorization reinstatement after an interruption of more than 30 days] specifies the period of time that the suitable inquiry must address for applicants who held authorization within the past year and whose last period of authorization was terminated favorably, but who have not held authorization within the past 30 days. The final rule requires licensees and other entities to ensure that the suitable inquiry has been conducted with the employer by whom the applicant claims to have been employed the longest in each calendar month of the interruption. This provision does not require licensees and other entities to ensure that every employer by whom the individual claimed to have been employed during the interruption is contacted for the reasons discussed with respect to Sec. 26.59(a)(2).

Because these individuals have had only a short break in authorization, a sampling of employers from the interruption period is sufficient to determine if any indications exist that the individual has developed a previously undetected substance abuse or other problem that would adversely affect his or her fitness to have authorization reinstated.

The time periods and approach to conducting the suitable inquiry established in Sec. 26.63(f)(1) through (f)(3) are consistent with those established in the access authorization orders issued to nuclear power plant licensees dated January 7, 2003.

Section 26.65 Pre-Access Drug and Alcohol Testing

Section 26.65 of the final rule amends former Sec. 26.24(a)(1).

The former provision required drug and alcohol ``testing within 60 days prior to the initial granting of unescorted access to protected areas or assignment to activities within the scope of this part.'' The final rule amends the former pre-access drug and alcohol testing requirement for individuals who are seeking authorization under Part 26 to strengthen the effectiveness of FFD programs.

The NRC has added Sec. 26.65(a) [Purpose] to the final rule to describe the purpose of the section and identify the individuals to whom the requirements in the section apply. The pre-access testing requirements in this section cover applicants for authorization who have never held authorization under Part 26 or have held authorization under Part 26 and whose most recent period of authorization was terminated favorably, and about whom no potentially disqualifying FFD information has been discovered or disclosed that was not reviewed and favorably resolved by another licensee or entity who is subject to

Subpart C. Requirements for granting authorization to individuals whose previous periods of authorization were terminated unfavorably or denied, or about whom new potentially disqualifying FFD information has been discovered or disclosed, are contained in Sec. 26.69.

The NRC has added Sec. 26.65(b) [Accepting tests conducted within the past 30 days] to the final rule to permit licensees and other entities to forego pre-access testing of an individual who has negative results from drug and alcohol tests that were performed under the requirements of Part 26 within the 30-day period before the licensee or other entity grants authorization to the individual, including tests that were conducted before the individual applied for authorization from the licensee or other entity. For example, if an individual was subject to random testing under another Part 26 program and was selected for testing under the other program before applying for authorization from the granting licensee or other entity, the final rule permits the granting licensee or other entity to accept negative test results from the random test in lieu of performing a pre-access test, if the random test was conducted within 30 days before the day authorization is granted to the individual. A requirement for the licensee or other entity to conduct pre-access testing in these circumstances is redundant and unnecessary.

The NRC has added Sec. 26.65(c) [Initial authorization and authorization update] to the final rule, which establishes pre-access testing requirements for individuals who are applying for initial authorization and an authorization update. The final rule, with respect to the proposed rule, has added a specification that before granting initial authorization, any pre-access drug and alcohol tests must be conducted within the 30-day period preceding the day the licensee or other entity grants authorization to the individual. Under former Sec. 26.24(a)(1), licensees and other entities were permitted to complete pre-access testing within the 60-day period before authorization is granted. The inclusion in the final rule of a shorter time period within which pre-access testing must be conducted, if required, increases the likelihood of detecting an active substance abuse problem among applicants for unescorted access to nuclear power plants and others who are subject to Part 26 by increasing the number of pre- access tests that are performed. In addition, the decreased time period for pre-access testing increases the likelihood that recent drug use, particularly marijuana, is detected before the concentration of metabolites in an individual's body could decrease below the cutoff levels prescribed in the final rule. Also, the final rule's provision for a decreased time period within which pre-access testing must be performed provides greater assurance that individuals subject to this part are trustworthy and reliable, as demonstrated by the avoidance of substance abuse, as discussed with respect to Sec. 26.23(a).

The final rule requires negative results from pre-access testing before the licensee or other entity grants authorization to the individual, except in the two circumstances described in Sec. 26.65(c)(1) and (c)(2). Pre-access testing in these two circumstances is unnecessary because there is sufficient opportunity to detect substance abuse without the testing. In Sec. 26.65(c)(1), licensees and other entities are permitted to forego pre-access testing if the applicant had been subject to drug and alcohol testing (including random testing), behavioral observation, and

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arrest-reporting requirements under a Part 26 FFD program throughout the period the individual's authorization was interrupted.

In proposed Sec. 26.65(c)(2), licensees and other entities were permitted to forego pre-access testing of an applicant who had negative results from Part 26 drug and alcohol tests that were performed within the past 30 days and who was subject to behavioral observation and arrest-reporting requirements during the time interval between the day the specimens were collected and the day the licensee or other entity grants authorization to the individual. However, the NRC received a public comment regarding this provision, which stated that licensees should be able to rely on drug and alcohol tests that were conducted before the individual applied for authorization if the individual has been subject to a behavioral observation and arrest-reporting program, and random drug and alcohol testing, during the time period following the drug and alcohol tests. The NRC agrees that pre-access testing within 30 days before authorization is granted is unnecessary in these circumstances and has removed reference to Sec. 26.65(b) in this provision. This amendment clarifies that licensees may rely on drug and alcohol tests that were conducted at any time before the individual applied for authorization, provided that the individual has been subject to a random drug and alcohol testing program, a behavioral observation program, and an arrest-reporting program that meet the applicable requirements of this part. The NRC has made this change under Goal 5 of the rulemaking to improve the rule by eliminating or modifying unnecessary requirements.

The NRC has added Sec. 26.65(d) [Authorization reinstatement after an interruption of more than 30 days] and (e) [Authorization reinstatement after an interruption of 30 or fewer days] to the final rule, which establish requirements for the pre-access testing of individuals who are applying for an authorization reinstatement. The requirements for pre-access testing of these individuals are less stringent than the requirements for initial authorization and an authorization update. The provision relaxes the pre-access testing requirements in former Sec. 26.24(a)(1), which mandated that all applicants for authorization must be subject to pre-access testing within 60 days before granting authorization. Less stringent pre-access testing requirements are appropriate because these individuals have met the rigorous criteria for initial authorization, established a recent record of successfully maintaining authorization under Part 26, and had only a short break in authorization.

Section 26.65(d) of the final rule specifies pre-access testing requirements for individuals whose authorization has been interrupted for more than 30 days but no more than 1 year. Section 26.65(d)(1)(i) requires the licensee or other entity to administer an alcohol test and collect a urine specimen for drug testing. The final rule, with respect to the proposed rule, clarifies that before granting initial authorization, any required pre-access drug and alcohol tests must be conducted within the 30-day period preceding the day the licensee or other entity grants authorization to the individual. The licensee or other entity is permitted to reinstate the individual's authorization if the alcohol test results are negative before the drug test results are available. Section 26.65(d)(1)(ii) permits the licensee or other entity to maintain the individual's authorization for 5 business days after reinstatement without receiving the drug test results. However, if the licensee or other entity does not receive negative drug test results within 5 business days of reinstating the individual's authorization, the final rule requires the licensee or other entity to administratively withdraw the individual's authorization until negative drug test results are received. These requirements ensure that individuals whose authorization has been interrupted for more than 30 days are subject to pre-access drug and alcohol testing to deter substance abuse and to detect any current substance abuse problem.

However, the provisions do not unduly delay authorization reinstatement because these individuals' recent successful histories of maintaining authorization under Part 26 indicate that they are at low risk of engaging in substance abuse.

Section 26.65(d)(2) permits licensees and other entities to forego pre-access testing of these applicants for reinstatement in the circumstances discussed with respect to Sec. 26.65(c)(1) and (c)(2).

The discussion with regard to Sec. 26.65(c)(2) also specifies the reasons for the changes from the proposed rule in Sec. 26.65(d)(2)(ii).

The NRC has added Sec. 26.65(e)(1) to the final rule to permit licensees and other entities to forego pre-access testing of applicants whose authorization has been interrupted for 5 or fewer days. This provision is consistent with current licensee practices and recommendations regarding short breaks in authorization in NUREG-1385 and other access authorization requirements. The final rule also has moved the provisions from paragraph (e)(3) of the proposed rule into this paragraph of the final rule to improve clarity in the organization of the final rule, consistent with Goal 3 of the rulemaking. This provision permits licensees and other entities also to forego subjecting an individual to the possibility of selection for pre-access testing if the applicant has been subject to the drug and alcohol testing (including random testing), behavioral observation, and arrest- reporting elements of a Part 26 FFD program throughout the interruption in the individual's authorization. The NRC believes that being subject to these program elements during the interruption period is sufficient to deter substance abuse and provide assurance that substance abuse would be detected. Section 26.65 enhances the deterrent effect of pre- access testing for individuals who have had a very short break in authorization without imposing the burden of requiring that every individual must be tested.

Section 26.65(e)(2) of the final rule requires licensees and other entities to subject applicants whose authorization has been interrupted for 6 to 30 days to the possibility of selection for pre-access testing in order to deter any potential for substance abuse. However, this provision specifies that the licensee or other entity may forego subjecting an individual to the possibility of being selected for pre- access testing if the applicant has been subject to the drug and alcohol testing (including random testing), behavioral observation, and arrest-reporting elements of a Part 26 FFD program throughout the interruption in the individual's authorization.

Section 26.65(e)(2)(i) requires the licensee or other entity to subject the applicant to a one-time chance of being selected for testing at a probability of approximately 4 percent. This probability approximates the likelihood that individuals who are subject to random testing at the 50-percent annual testing rate in Sec. 26.31(d)(2)(vii) are selected for testing at some point within a 30-day period. Section 26.65(e)(2)(ii) clarifies that if an applicant is not selected for pre- access testing under the preceding section, the licensee or other entity is not required to perform a pre-access test. Section 26.65(e)(2)(iii)(A) and (B) specifies requirements for conducting the pre-access testing if an individual is selected for testing under Sec. 26.65(e)(2)(i). The licensee or other entity shall complete an alcohol test and collect a specimen for drug testing before reinstating the individual's authorization. In order to maintain the individual's reinstated authorization,

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the final rule requires that the licensee or other entity must receive negative drug test results within 5 business days after reinstatement or administratively withdraw the individual's authorization until negative drug test results are received.

The NRC has deleted from the final rule Sec. 26.65(f) [Time period for testing] of the proposed rule. The proposed provision mandated that specimens that are collected for any pre-access testing required in this section must be collected within the 30-day period preceding the day the licensee grants authorization to an individual. The NRC received a public comment that stated that licensees currently conduct pre-access drug and alcohol testing within the 30-day period preceding the date the licensee grants authorization and that proposed Sec. 26.65(f) only requires licensees to collect a sample in this timeframe.

The NRC agrees with the comments and, therefore, has deleted this provision from the final rule to increase efficiency, consistent with

Goal 5 of the rulemaking to eliminate unnecessary requirements.

However, the NRC has added requirements to Sec. 26.65(c) and (d)(1)(i) to specify that any pre-access testing required in this section must be conducted within the 30-day period preceding the day upon which the licensee grants authorization to an individual, consistent with the proposed rule's intent. Under former Sec. 26.24(a)(1), licensees and other entities were permitted to complete pre-access testing within the 60-day period before authorization is granted. The reason why the final rule shortens this time period to 30 days is discussed with respect to

Sec. 26.65(c).

The NRC has added Sec. 26.65(f) [Administrative withdrawal of authorization] (changed from Sec. 26.65(g) in the proposed rule because of renumbering) to the final rule to ensure that the licensee or other entity does not record or report as an unfavorable termination any administrative withdrawal of authorization that may be required under paragraphs (d)(1)(ii) or (e)(2)(iii)(B) of this section. The time a licensee or other entity receives drug test results is not under the applicant's control and does not reflect on the applicant's fitness, trustworthiness, or reliability, if the licensee or other entity is unable to obtain drug test results within the 5 days permitted and must administratively withdraw the individual's authorization. Therefore, subjecting the individual to the severe consequences associated with a record of an unfavorable termination is inappropriate, except if the individual's authorization was subsequently denied or terminated unfavorably by a licensee or entity. However, if the drug test results are positive, adulterated, or substituted and the licensee or other entity terminates the individual's authorization for cause, the termination is then recorded as unfavorable. However, with respect to the proposed rule, the final rule adds a clarification that the individual is required to disclose administrative action if the individual's authorization was subsequently denied or terminated unfavorably. The NRC has made this change to the proposed rule in recognition of the need for additional consistency between the final rule and the access authorization requirements. Therefore, this change helps meet Goal 4 of this rulemaking to improve consistency between FFD requirements and access authorization requirements established in 10

CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003.

The NRC has added Sec. 26.65(g) [Sanctions] (changed from Sec. 26.65(h) in the proposed rule because of renumbering) to the final rule, which specifies the minimum sanctions to be imposed on an individual whose pre-access test results the MRO confirms as an FFD policy violation. Section 26.65(g)(1) and (g)(2) contains cross- references to the relevant sanctions specified in Subpart D [Management

Actions and Sanctions To Be Imposed] to clarify that those sanctions apply to applicants for authorization. For example, if the MRO determines that an individual has submitted an adulterated urine specimen for a pre-access drug test, the licensee or other entity is required to impose the sanction for an attempt to subvert the testing process (i.e., permanent denial of authorization) in Sec. 26.75(b).

The NRC has added Sec. 26.65(g)(3) to the final rule to permit licensees and other entities to grant authorization to an individual whose confirmed positive, adulterated, or substituted test result is a first drug- or alcohol-related violation under a Part 26 program, consistent with former Sec. 26.27(b)(2). However, the final rule permits authorization to be granted only under the stringent requirements contained in Sec. 26.69.

Section 26.67 Random Drug and Alcohol Testing of Individuals Who Have

Applied for Authorization

The NRC has added Sec. 26.67 to the final rule, which extends former random testing requirements to individuals who have applied for authorization under Part 26 but who have not yet been granted authorization. The NRC has added the requirements in this section to the access authorization requirements that were established by orders to nuclear power plant licensees dated January 7, 2003, to enhance the effectiveness of FFD programs by increasing the likelihood that substance abuse will be detected before authorization is granted and to deter the potential for substance abuse among applicants. Therefore, the NRC has made these changes to meet Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

The NRC has added Sec. 26.67(a) to the final rule, which requires licensees and other entities to conduct random testing of applicants under the requirements of Sec. 26.31(d)(2). The licensee or other entity must add applicants for authorization to the FFD program's normal population of individuals who are subject to random testing, select individuals for testing at the 50-percent annual rate, and otherwise subject applicants to the same random testing requirements as individuals who currently hold authorization under Part 26. An applicant is subject to random testing beginning when the licensee or other entity collects the specimens for any required pre-access test and continues thereafter, if the licensee or other entity grants authorization to the individual.

Licensees and other entities are permitted to forego random testing of applicants in the two circumstances described in Sec. 26.67(a)(1) and (a)(2). Section 26.67(a)(1) permits a licensee or other entity to discontinue random testing of any applicant to whom the licensee or other entity does not grant authorization for any reason, including a termination or denial of authorization or a withdrawal of the application for authorization by the individual or the individual's employer, in the case of a C/V. Section 26.67(a)(2) addresses the circumstance described in Sec. 26.65(b), in which the licensee or other entity is permitted to meet pre-access testing requirements by relying on negative test results from specimens collected under another

Part 26 program within 30 days before granting authorization to the individual. Under Sec. 26.67(a)(2), the licensee or other entity shall begin subjecting the applicant to random testing when the licensee or other entity takes the first formal action to process the individual's application for authorization.

The formal actions may include, but are not limited to, the time when the licensee or other entity receives the individual's signed consent form and begins creating a record of the

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individual's application that would be accessible to other licensees and entities; conducts a psychological evaluation; begins a suitable inquiry; or takes other actions that are required under NRC regulations to grant authorization. The first formal action that the licensee or other entity takes to process an individual's application for authorization will vary, depending on the licensee's FFD and access authorization program procedures, whether the applicant's FFD training is up-to-date, and other factors. These considerations make it impractical to establish a single point in the authorization process established in the rule when random testing must begin. Therefore, the provision requires the licensee or other entity to begin subjecting the individual to random testing when the licensee or other entity takes the first formal action, but does not define a specific formal action that would initiate random testing of applicants in all cases.

The NRC has added Sec. 26.67(b) to the final rule, which permits licensees and other entities to grant authorization to an individual before random testing is completed if the individual has met all of the requirements for authorization but has been selected for one or more random tests while in applicant status. The final rule does not require the testing to be completed before the licensee or other entity grants authorization to the individual because the primary purpose of randomly testing applicants is to deter substance abuse rather than to provide information for the authorization decision. Pre-access testing provides the necessary information for authorization decision making.

Section 26.67(c) of the final rule cross-references the minimum sanctions to be imposed on an individual whose drug or alcohol results from random testing are confirmed as positive, adulterated, or substituted. The final rule also makes a minor language clarification to the proposed rule by modifying the term ``non-negative'' of this section. Section 26.67(c)(1) and (c)(2) refers to the relevant sanctions specified in Subpart D. Section 26.67(c)(3) continues to permit licensees and other entities to grant authorization to an individual whose confirmed positive, adulterated, or substituted test result is a first drug- or alcohol-related violation under a Part 26 program, consistent with former Sec. 26.27(b)(2). However, the final rule permits authorization to be granted only under the stringent requirements contained in Sec. 26.69.

Section 26.69 Authorization With Potentially Disqualifying Fitness-for-

Duty Information

The NRC adds Sec. 26.69 to the final rule to replace and clarify the requirements contained in former Sec. 26.27(b)(4). Former Sec. 26.27(b)(4) established requirements for granting authorization to an individual who has violated an FFD policy and had his or her authorization terminated unfavorably or denied for a period of 3 or more years under the former rule. Consistent with Goal 6 of this rulemaking to improve clarity in the organization and language of the rule, this section of the final rule addresses problems that have arisen in implementing the former rule and clarifies the NRC's intent with respect to several situations that the former rule did not address.

The NRC has added Sec. 26.69(a) [Purpose] to the final rule to describe the purpose of the section and the applicants who are subject to these requirements. The provision requires licensees and other entities to meet the applicable requirements in this section before granting authorization to an individual or permitting an individual to maintain his or her authorization when potentially disqualifying FFD information is obtained about the individual through any means and a previous licensee or other entity has not assessed and favorably resolved the information. Section 26.63(b) permits licensees and other entities to rely on the results of determinations of fitness that previous licensees or other entities conducted, rather than requiring each new licensee or other entity to reevaluate the same information that was reviewed and resolved under another Part 26 program. However, if the potentially disqualifying FFD information was not previously reviewed and favorably resolved by another FFD program under this subpart, licensees and other entities must implement the requirements contained in this section.

Section 26.69(a) also revises the language contained in former

Sec. 26.27(b)(2) to recognize that licensees and other entities may decide not to grant authorization to the subject individual and so, in that case, are not required to implement these requirements. At the public meetings discussed in Section I.D, stakeholders noted that some individuals have misinterpreted the former rule as requiring licensees to provide individuals who have violated an FFD policy with the opportunity to seek treatment for a substance abuse problem and to have authorization reinstated. However, although the NRC continues to affirm that individuals who pursue treatment and maintain sobriety may be considered for authorization, both the former and final rules assign the responsibility for making authorization decisions to the licensee or other entity. Therefore, the paragraph clarifies that granting or maintaining the authorization of an individual about whom potentially disqualifying FFD information has been disclosed or discovered is ``at the licensee's or other entity's discretion.''

The NRC has added Sec. 26.69(b) [Authorization after a first confirmed positive drug or alcohol test result or a 5-year denial of authorization] to the final rule to define requirements for granting authorization at the licensee's or other entity's discretion to an individual who had confirmed positive drug or alcohol test results and whose authorization was previously terminated unfavorably or denied for 5 years. The requirements in this section apply to:

(1) An applicant who had a first confirmed positive test result on a pre-access test and was consequently denied authorization by a licensee;

(2) An individual who is returning to duty following the 14-day assessment period required in Sec. 26.75(e)(1) (The NRC has moved the provisions in former Sec. 26.26(b)(2) to Sec. 26.75(e)(1));

(3) An individual whose authorization was terminated unfavorably under another Part 26 program and who had an interruption in authorization that was longer than 14 days; and

(4) An individual whose authorization was denied for 5 years under the requirements of Sec. 26.75(c), (d), (e)(2), or (f).

This provision replaces and strengthens the requirements contained in former Sec. 26.27(b)(2) and expands them to address confirmed positive alcohol test results, which were excluded from this process in former Sec. 26.27(b)(5). The paragraph includes confirmed positive alcohol test results for the reasons discussed with respect to Sec. 26.75(e).

The NRC has retained the language of the proposed rule to state that the licensee or other entity shall perform the activities listed in paragraphs (b)(1) through (b)(6) of this section. In the situations presented in this section, the NRC believes that the licensees or other entities will likely conduct these tasks themselves because another licensee has not reviewed and resolved the individual's situation.

Therefore, the licensees will have to collect more original data about the individual, rather than relying on that collected by another licensee. However, by retaining

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the language of the proposed rule in this section, the NRC does not intend to require that the licensees or other entities must conduct these tasks themselves in these situations. The NRC maintains that the licensee may rely on information collected by others to meet the requirements of Sec. 26.69 if that is the most reasonable way to proceed. For example, if the licensee or other entity uses a background screening company, they would most likely continue to have the company perform the employment history required in this section.

Section 26.69(b)(1) requires the licensee or other entity to obtain and review a self-disclosure and employment history from the applicant to verify that it does not contain any previously undisclosed potentially disqualifying FFD information. The final rule has added

``employment history,'' with respect to the proposed rule, to state the intent that both a self-disclosure and employment history shall be reviewed. When an individual's last period of authorization was terminated unfavorably or denied, licensees and other entities are not permitted to forego obtaining a self-disclosure and employment history under any circumstances because it is important to review the individual's activities during the interruption period. The period of time the self-disclosure must address is the shorter of either the past 5 years or the intervening period after the individual last held authorization.

Section 26.69(b)(2) increases the scope of the suitable inquiry by requiring the licensee or other entity to conduct the suitable inquiry with every employer by whom the applicant claims to have been employed during the period of time addressed in the individual's employment history. The final rule replaces ``self-disclosure'' in the proposed rule with ``employment history'' to clarify that the time period covered is that which the employment history addresses. This extensive suitable inquiry is necessary to determine if any indications exist that the individual has continued to engage in substance abuse. The final rule also requires licensees and other entities to obtain and review any records that other licensees or entities may have developed related to any potentially disqualifying FFD information about the individual from the past 5 years. These records may include, but are not limited to, the results of past suitable inquiries or other investigations, records of arrests or convictions, drug and alcohol test results, treatment records, and the results of determinations of fitness. The SAE uses this information to assess the individual's fitness and the licensee's or other entity's reviewing official uses it to determine whether authorization is warranted.

Section 26.69(b)(3) applies only to individuals whose authorization was denied for 5 years under the former rule or under Sec. 26.75(c),

(d), (e)(2), or (f) of the final rule. The paragraph requires the licensee or other entity to verify, before granting authorization, that the individual had not abused alcohol or drugs during the 5-year interruption, at a minimum. The requirement is consistent with the portion of former Sec. 26.27(b)(4) that required licensees to obtain

``satisfactory medical assurance that the person has abstained from drugs for at least 3 years.'' However, the final rule extends the requirement to 5 years to ensure that such an individual is at the lowest risk of recidivism into an active substance abuse problem before the licensee or other entity grants authorization to the individual.

Section 26.69(b)(4) amends the requirement in former Sec. 26.27(b)(2). The former provision mandated that an individual who has a first confirmed positive test result must be referred to the EAP for assessment and counseling before the licensee or other entity may grant authorization to the individual. The final rule makes several changes to the former provision. First, the final rule replaces the term

``management and medical assurance of fitness'' which was used in former Sec. 26.27(b)(2) and (b)(4), with the term ``determination of fitness'' to improve the accuracy of the language in the final rule.

The final rule does not use ``management'' because the licensee's or other entity's reviewing official [see the discussion of Sec. 26.69(c)(3) and the definition of ``reviewing official'' in Sec. 26.5] is the individual who licensees and other entities currently designate to make authorization decisions and the reviewing official may not be a manager. In addition, the final rule permits professionals other than a licensed physician to conduct a determination of fitness, for the reasons discussed with respect to Sec. 26.189. The NRC has made these change to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Consistent with the intent of the former requirement, the provision requires the licensee or other entity to ensure that an SAE has conducted a determination of fitness, as defined in Sec. 26.189, as part of the authorization decision. Section 26.187 [Substance abuse expert] requires that an SAE must perform determinations of fitness that are conducted for authorization decisions. Section 26.187 also defines the role, responsibilities, and required qualifications of an

SAE. Therefore, Sec. 26.69(b)(4) requires that the individual must be referred to an SAE for a determination of fitness. However, the final rule does not require the SAE to be an EAP employee. Permitting licensees and other entities to rely on a professional who meets the required qualifications for an SAE rather than only on EAP personnel, more appropriately focuses this requirement on ensuring that the professional who performs the assessment and treatment planning is qualified, rather than on the professional's organizational affiliation. The NRC received a comment requesting that the rule rely on a Substance Abuse Professional (SAP) to meet the requirement of this section. The NRC acknowledges that the SAP training and credentialing process emphasizes knowledge about the SAP role in programs under 10

CFR Part 40, ``Domestic Licensing of Source Material.'' However, although an SAP under Part 40 meets many of the criteria established in the rule, thorough knowledge of Part 26 requirements is also necessary.

Therefore, the NRC has not modified the proposed provision in the final rule.

Section 26.69(b)(4)(i) through (b)(4)(iii) replaces and strengthens the requirement in former Sec. 26.27(b)(2). The former provision stated that ``any rehabilitation program deemed appropriate must be initiated during such suspension period.'' The final rule requires that the individual must be in compliance with or have successfully completed treatment and follow-up testing plans, rather than simply started treatment, in order for the licensee or other entity to grant authorization to the individual and maintain the individual's authorization after it has been granted.

The NRC has added Sec. 26.69(b)(5) to the final rule to impose more stringent pre-access testing requirements on an individual who is being considered for authorization following an unfavorable termination or denial of authorization than those required for individuals whose last period of authorization was terminated favorably. The provision requires negative results from an alcohol test performed within 10 business days before authorization is granted. Similarly, the provision requires negative results from a urine specimen that was collected under direct observation for drug testing within 10 business days before authorization is granted. The provision prohibits the licensee or other entity from granting authorization to the individual before the drug test results are reported to the

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licensee's or other entity's MRO. The MRO may then determine whether the drug test results indicate that the individual has not engaged in any further drug abuse [see the discussion of Sec. 26.69(f)].

Completing drug and alcohol testing within 10 business days before granting authorization rather than the 30 days that is permitted in

Sec. 26.65 for the other authorization categories provides evidence that the individual has abstained from abusing proscribed substances during the interruption period and that the individual is able to safely and competently perform duties under this part when authorization is reinstated, if the individual's authorization has been interrupted for the 14-day assessment period required under former

Sec. 26.27(b)(2) and retained in Sec. 26.75(e)(1). Requiring direct observation of the urine specimen collection is necessary to provide added assurance that the specimen is valid and yields accurate drug test results.

Section 26.69(b)(6) applies only to individuals whose authorization has been unfavorably terminated or denied for at least 14 days for a first confirmed positive drug or alcohol test result. The provision replaces the third sentence of former Sec. 26.27(b)(4). This sentence established requirements and a schedule for followup drug and alcohol testing for an individual whose authorization was denied for 3 years under the former rule. The final rule applies the requirement for followup testing to individuals who have had a first confirmed positive test result for drugs or alcohol. This requirement provides greater deterrence of further drug and alcohol use than former Sec. 26.27(b)(4), which required this followup testing only for the more serious FFD violations that result in a denial of authorization for 3 years or longer. The more stringent requirement provides higher assurance that individuals who are subject to this part are trustworthy, reliable, and fit for duty.

Section 26.69(b)(6) amends the former fixed schedule for followup testing by requiring licensees and other entities to subject the individual to the possibility of being selected for followup testing, during any period in which he or she holds authorization under Part 26, for a period of 3 calendar years after the individual's authorization is restored following termination or denial for the first confirmed positive drug or alcohol test result. The rule requires licensees and other entities to ensure that the individual is subject to unannounced testing at least 15 times within the 3-year period and to verify that the individual's test results are negative. Either random or followup tests, which are both unannounced, may be used to meet this final requirement. The final rule requires licensees and other entities to distribute the unannounced tests over the 3-year period, with at least one unannounced test conducted each quarter.

The NRC has added Sec. 26.69(b)(6)(i) through (b)(6)(iii) to the final rule to address circumstances when an individual is not continuously subject to a Part 26 program during the 3 years following the restoration of authorization. Section 26.69(b)(6)(i) requires that an individual who intermittently holds authorization over the 3-year period must be subject to unannounced testing at least once in each quarter during which the individual is authorized. Section 26.69(b)(6)(ii) permits the licensee or other entity to extend the followup testing period to 5 years, if the requirement for 15 tests over the 3-year period has not been met because the individual has not been authorized a sufficient number of times or for sufficient periods of time during the first 3 years to meet the final 15-test requirement.

Section 26.69(b)(6)(iii) permits the licensee or other entity to have an SAE conduct a determination of fitness to determine whether further followup testing is required, if an individual is unable to meet the 15-test requirement after 5 years because of brief and infrequent periods of authorization. The revision of these requirements increase the flexibility with which licensees and other entities may implement followup testing, but retains the former effectiveness of followup testing in detecting and deterring substance abuse.

The NRC has added Sec. 26.69(b)(7) to the final rule, which requires the licensee or other entity to verify that the results of all drug and alcohol tests that are administered to the individual under a

Part 26 program following the restoration of the individual's authorization indicate no further drug or alcohol abuse. The provision does not specify that the drug test results must be negative because the metabolites of some drugs, such as marijuana, may be present in an individual's urine for several weeks after the individual has stopped using the drug. If an individual is tested again soon after the original test that resulted in an FFD violation was conducted, the specimen may yield positive results which would not, in fact, reflect new drug use. Therefore, if subsequent drug test results show the presence of the same drug or drug metabolites in the individual's urine as detected in the original confirmed positive test result, the MRO, under Sec. 26.185(o), is required to determine whether the results indicate new drug use or are consistent with results that are expected from the drug use that resulted in the previous confirmed positive test result. The rule adds this requirement in response to inconsistencies in the way some MROs have implemented former requirements related to return-to-duty drug testing. Some MROs have been inappropriately reluctant to declare a second drug test result as negative if any concentration of the drug or drug metabolites that resulted in a first confirmed positive drug test result are detected in the specimen. The change permits an individual who has not engaged in further drug use after a first confirmed positive drug test result to regain authorization at the licensee's discretion rather than be incorrectly denied authorization for 5 years on the basis of a subsequent FFD policy violation, under Sec. 26.75(e)(2).

The NRC has added Sec. 26.69(c) [Granting authorization with other potentially disqualifying FFD information] to the final rule to establish requirements for granting authorization to an individual about whom potentially disqualifying FFD information is discovered or disclosed that was not a confirmed positive, adulterated, substituted, or invalid drug or alcohol test result or 5-year denial of authorization. For example, this type of potentially disqualifying FFD information may include, but is not limited to:

(1) A report of an arrest for an alcohol-related traffic violation;

(2) Information from the suitable inquiry that a previous private- sector employer terminated an individual's employment because of drug- or alcohol-related job performance problems; or

(3) Information obtained from the suitable inquiry or other sources of information indicating that the individual is known to abuse illegal drugs or alcohol or is experiencing significant mental or emotional stress.

This provision is necessary because the former rule did not address the authorization process in these circumstances and the NRC is aware that licensees and other entities have handled these circumstances inconsistently. Therefore, the final rule adds these requirements to establish the NRC's intent with respect to these circumstances and increase consistency between Part 26 programs.

The NRC has added a second sentence to Sec. 26.69(c) in the final rule to clarify that if potentially disqualifying FFD information is obtained about an

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individual by any means, the licensee shall perform the activities in paragraphs (c)(1) through (c)(5) of this section before granting authorization to the individual. The NRC has made this change to meet

Goal 6 of the rulemaking to improve clarity in the organization and language of the rule.

The NRC has added Sec. 26.69(c)(1) to the final rule, which requires the licensee or other entity to obtain and review the individual's self-disclosure and employment history. The final rule has added the term ``employment history'' to clarify that the licensee must obtain and review that in addition to the self-disclosure. The final rule also modifies the language of the proposed rule by eliminating reference to Sec. 26.31(b)(3) and instead adding paragraphs (c)(1)(i) through (c)(1)(iii) to Sec. 26.69 to specify exactly the time period that the self-disclosure and employment history must address. The NRC has made this change in response to a public comment suggesting that this provision needed clarification and to meet Goal 6 of the rulemaking to improve clarity in the organization and language of the rule.

Section 26.69(c)(2) requires the licensee or other entity to conduct a suitable inquiry with every employer for the period that the employment history addresses. In this section, the final rule deletes

``self-disclosure'' and replaces it with the phrase ``employment history required under paragraph 26.63(a) through (e)'' to clarify the time period addressed. If the potentially disqualifying FFD information was identified during the course of conducting a suitable inquiry under

Sec. 26.63(f) so that the suitable inquiry was partially completed,

Sec. 26.69(c)(2) requires the licensee or other entity to conduct a more complete suitable inquiry by contacting every employer that the individual listed during the interruption period. The provision also requires that if the individual held authorization within the past 5 years, the licensee or entity shall obtain and review any records that other licensees or entities who are subject to this part may have developed with regard to potentially disqualifying FFD information about the individual from the past 5 years. The final rule, with respect to the proposed rule, has added the phrase ``if the individual held authorization within the past 5 years'' to meet Goal 6 of the rulemaking to improve clarity in the language of the rule. This more complete suitable inquiry is necessary to ensure that the licensee or other entity has more information about the individual than is required for individuals whose last period of authorization was terminated favorably in order to make an appropriate authorization decision.

The NRC has added Sec. 26.69(c)(3) to the final rule, which uses the term ``reviewing official'' to refer to the employee whom the licensee or other entity designates to make authorization decisions as discussed with respect to Sec. 26.5. This provision permits the reviewing official to grant or deny authorization based upon his or her review of the circumstances associated with the potentially disqualifying FFD information. Because of the variety of circumstances that may arise, the provision also grants discretion to the reviewing official in deciding whether a determination of fitness is required rather than requiring a determination of fitness in every case.

However, if the reviewing official requests a determination of fitness and the professional who performs it recommends any form of treatment or drug and alcohol testing, including the collection of urine specimens under direct observation, Sec. 26.69(c)(4) requires the licensee or other entity to implement the treatment and testing recommendations.

The NRC has added Sec. 26.69(c)(5) to the final rule to require pre-access and random testing of the applicant for authorization. This provision requires the licensee or other entity to verify that the results of pre-access drug and alcohol tests are negative before granting authorization to the individual, to provide evidence that the individual is avoiding substance abuse.

The NRC has added Sec. 26.69(d) [Maintaining authorization with other potentially disqualifying FFD information] to the final rule, which establishes requirements for maintaining an individual's authorization when new potentially disqualifying FFD information is disclosed or discovered that was not a confirmed positive drug or alcohol test result, or 5-year denial of authorization, if the reviewing official determines that maintaining authorization is warranted. A self-disclosure, suitable inquiry, and pre-access testing are not required because the individual would not be applying for authorization. However, the provision requires the reviewing official to consider the circumstances related to the information and, at his or her discretion, ensure that a professional with the appropriate qualifications makes a determination of fitness. The provision mandates that the licensee or other entity must implement any treatment or testing requirements resulting from the determination of fitness. The

NRC has added the provision because the former rule did not address maintaining an individual's authorization in these circumstances. Also, the NRC is aware that licensees and other entities have handled these circumstances inconsistently. Therefore, the final rule adds these requirements to establish the NRC's intent with respect to these circumstances and to increase consistency between Part 26 programs.

The NRC has added Sec. 26.69(e) [Accepting followup testing and treatment from another Part 26 program] to the final rule to establish continuity of care requirements for individuals who were subject to a followup testing and/or a substance abuse treatment plan under one Part 26 program and transfer to another FFD program, or leave and then return to the same FFD program.

Section 26.69(e)(1) requires the receiving licensee or other entity to continue the testing and treatment plan to which the individual was subject under the previous FFD program. However, with respect to the proposed rule, the final rule clarifies that the licensee or other entity who imposed the treatment and/or followup testing plan shall ensure that information documenting the treatment and/or followup testing plan is identified to any subsequent licensee or other entity who seeks to grant authorization to the individual. The NRC has made this change to clarify the intent of the provision and in recognition of the need for additional consistency between the final rule and the access authorization requirements. Therefore, this change helps meet

Goal 4 of this rulemaking to improve consistency between FFD requirements and access authorization requirements established in 10

CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003.

Section 26.69(e)(1) of the final rule also adds a specification that if it is impractical for the individual to comply with the treatment plan that was developed under another FFD program, the granting FFD program shall ensure that an SAE develops a comparable treatment plan. The NRC has made this change because it received a public comment stating that the proposed provision that required the licensee to assume responsibility for overseeing the continuation of treatment and follow-up testing for an employee who had a positive test result under another FFD program could be burdensome, especially if the individual is applying for authorization at a new site that makes it impossible to use the same treatment providers.

Section 26.69(e)(2) permits the receiving licensee or other entity to

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accept and rely on any followup testing that was completed while the individual was subject to the previous Part 26 program to determine how long followup testing must continue. For example, if an individual met all of the requirements for authorization by a new licensee but had completed only 2 of the 3 years of followup testing required under a previous Part 26 program, the granting licensee would then administer the final year of the followup testing. However, the licensee is not required to conduct another 3 full years of followup testing after the individual was authorized. If the transferring individual successfully completed any followup testing and treatment program required under the first FFD program, a previous determination of fitness indicated that the individual is fit for duty, and the individual's authorization by the first licensee or other entity was terminated favorably, this provision permits the receiving licensee or other entity to accept the previous determination of fitness and does not require the granting licensee to develop and implement an additional testing and treatment plan.

The NRC has added Sec. 26.69(f) [Sanctions] to the final rule to clarify the minimum sanctions to be imposed on an individual who has confirmed positive, adulterated, or substituted drug and alcohol test results on any tests that may be required under this section. Section 26.69(f)(1) and (f)(2) cross-references the relevant sanctions specified in Subpart D to establish that those sanctions apply to individuals about whom potentially disqualifying FFD information has been discovered or disclosed.

Section 26.71 Maintaining Authorization

The NRC has added Sec. 26.71 to the final rule to state the requirements for maintaining authorization under this part and has adopted the provisions in this section as proposed without change.

Section 26.71(a) of the final rule provides that individuals may maintain authorization under the conditions listed in Sec. 26.71(a)(1) through (a)(4), as follows:

Section 26.71(a)(1) establishes that an individual must comply with the licensee's or other entity's FFD policies to which the individual is subject. This requirement relates, although it does not refer to

Sec. 26.27 [Written policy and procedures] that requires the licensee or other entity to prepare a clear and concise statement of its FFD policy and make that policy readily available to all individuals who are subject to the policy. The final rule requires that all individuals who are subject to the FFD policy must have information on the expectations of them and the consequences that may result from a lack of adherence to the policy. Section 26.71 also requires that in order to maintain authorization, an individual must report any legal actions as defined in Sec. 26.5. Finally, although not explicitly specified in

Sec. 26.71(a)(1), Sec. 26.33 [Behavioral observation] requires individuals to report any FFD concern to the personnel designated in the FFD policy.

Section 26.71(a)(2) establishes that an individual may maintain authorization if the individual remains subject to a drug and alcohol testing program that complies with the requirements of Part 26, including random testing. Licensees and other entities who are subject to Part 26 are responsible for implementing drug and alcohol testing programs that comply with the requirements in Sec. 26.31 [Drug and alcohol testing]. The failure of a licensee or other entity to maintain a program would terminate the authorizations of individuals who have been granted authorization by the licensee or other entity (see the discussion of Sec. 26.71(b)). Section 26.31 also places certain responsibilities on individuals who are subject to the testing program.

In particular, under Sec. 26.31(d)(2)(iii), individuals who are selected for random testing are required to report to the collection site as soon as reasonably practicable after notification within the time period specified in FFD program procedures, as well as to cooperate in the testing process. In appropriate circumstances, an individual's failure to report or cooperate could be the basis for terminating the individual's authorization.

Section 26.71(a)(3) establishes that an individual may maintain authorization if the individual remains subject to a behavioral observation program that complies with the requirements of Part 26.

Behavioral observation, as required by Sec. 26.33, is performed by individuals, including coworkers, who have been trained to detect behaviors that may indicate possible use, sale, or possession of illegal drugs; use or possession of alcohol on site or while on duty; or impairment from fatigue or any cause that, if left unattended, might constitute a threat to the health and safety of the public or the common defense and security.

Section 26.71(a)(4) establishes that a condition for maintaining authorization is the individual's successful completion required of FFD training, according to the schedule in Sec. 26.29(c). As specified in

Sec. 26.29(c)(1), the final rule requires the individual to complete training before the licensee or other entity grants initial authorization. Thereafter, as specified in Sec. 26.29(c)(2), the rule requires individuals to complete refresher training or pass a comprehensive examination on a nominal 12-month frequency. Section 26.29(d) provides that licensees and other entities may accept the training of individuals who have been subject to another Part 26 program and have either had initial or refresher training or successfully passed a comprehensive examination within the past 12 months that meets the requirements of Sec. 26.29.

Section 26.71(b) of the final rule requires a licensee or other entity to terminate an individual's authorization if the individual is not subject to an FFD program that meets the requirements of Part 26 for more than 30 (consecutive) days. The requirements of the paragraph permits an individual to be away from all elements of a Part 26 program for this period of time in order to accommodate vacations and significant illnesses when the individual is not reasonably available for behavioral observation or to collect specimens for random drug and alcohol testing. The NRC has added this paragraph to the final rule in response to stakeholder requests, and it is consistent with related requirements in the access authorization orders issued to nuclear power plant licensees on January 7, 2003.

Subpart D--Management Actions and Sanctions To Be Imposed

Throughout this subpart, the final rule makes minor clarifications to the proposed rule due to public comment, to accommodate conforming changes, and to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule. The final rule makes other substantive changes in Sec. Sec. 26.73; 26.75(e)(1) and (h); and 26.77(b)(2) that are discussed with regard to those sections.

Otherwise, the final rule has adopted the provisions in this section as proposed without change.

Section 26.73 Applicability

The NRC has added Sec. 26.73 to the final rule to describe the applicability of the subpart. The new Sec. 26.73 specifies, by using applicable cross-references to Sec. Sec. 26.3 [Scope] and 26.4 [FFD program applicability to categories of individuals], the licensees and other entities, as well as individuals, to whom the requirements of this subpart apply.

Section 26.75 Sanctions

The first sentence of Sec. 26.75(a) of the final rule introduces the purpose of the section, which is to define the minimum

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sanctions that licensees and other entities must impose when an individual has violated the drug and alcohol provisions of an FFD policy. The second sentence of the paragraph restates the second sentence of former Sec. 26.27(b). This sentence permits licensees and other entities to impose more stringent sanctions than those specified in the final rule. The final rule adds a cross-reference to paragraph

(h) of this section, which establishes limits on the sanctions that licensees and other entities may impose for positive, adulterated, substituted, or invalid drug test results. Adding a cross-reference to paragraph (h) of this section clarifies that the blanket permission to impose more stringent sanctions granted in this paragraph has one exception, as discussed with respect to paragraph (h) of this section.

The NRC has made these changes to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

The NRC has added Sec. 26.75(b) to the final rule to require licensees and other entities to permanently deny authorization to individuals who refuse to be tested or who in any way subvert or attempt to subvert the testing process. This sanction is necessary because acts to subvert the testing process reflect a sufficiently egregious lack of trustworthiness and reliability to warrant permanent denial of authorization. An individual's willingness to subvert or attempt to subvert the testing process provides strong evidence that the individual will also be willing to disregard other rules and regulations, such as safeguards requirements, which ensure the protection of public health and safety and the common defense and security. In addition, if an individual succeeds in subverting the testing process in order to hide substance abuse, the individual may pose an undetected and unacceptable risk to public health and safety or the common defense and security by performing the duties that require him or her to be subject to this part while impaired. Therefore, by deterring acts to defeat the testing process as well as preventing any individuals who engage in them from posing any further risk to public health and safety and the common defense and security, this change meets Goal 3 of this rulemaking to improve the effectiveness of FFD programs.

The final rule specifies three examples of actions that are considered subversion or an attempt to subvert the testing process.

These include refusing to provide a specimen and providing or attempting to provide a substituted or adulterated specimen. However, these examples are not intended to be exhaustive. For example, if a licensee or other entity determines that several individuals colluded to notify potential donors that they would be selected for random testing on a particular day, so that the potential donors could plan to avoid work on that day or take other actions to ensure that their illegal drug use would not be detected, the NRC expects the licensee or other entity to permanently deny authorization to all of the individuals who were involved in the collusion.

The final rule does not include submitting a dilute specimen as an example of a subversion attempt without additional evidence that the donor had diluted the specimen in order to mask the presence of drugs or drug metabolites in the specimen, for the reasons discussed with respect to Sec. 26.185(g). Submitting a dilute specimen, in itself, does not necessarily indicate an attempt to subvert the testing process because there are many legitimate causes for a dilute specimen, including drinking liquids in order to provide a specimen of sufficient quantity, as permitted in Section 2.4(g)(11) in Appendix A of the former rule and in Sec. 26.109(b)(1) of the final rule. Therefore, the final rule does not require licensees and other entities to apply the sanction of permanent denial of authorization for submitting a dilute specimen, unless there is other evidence that the donor had diluted the specimen in an attempt to subvert the testing process.

The NRC used the phrase ``for any test required under this part'' in Sec. 26.75(b) in the proposed rule to indicate that applicants for authorization who subvert or attempt to subvert a pre-access or random test are also subject to permanent denial of authorization. However, the NRC has changed this phrase in the final rule to ``for any test required under 26.31(c).'' This change clarifies the intent of the provision and is consistent with Goal 6 of this rulemaking to improve clarity in the organization and language of the rule. Although these individuals would not yet be performing any duties that could affect public health and safety or the common defense and security, an attempt to subvert the testing process while in an applicant status provides strong evidence that the individual cannot be trusted to perform those duties. Therefore, it is necessary to ensure that any applicant who subverts or attempts to subvert the testing process is denied authorization.

Section 26.75(c) of the final rule amends former Sec. 26.27(b)(3).

Former Sec. 26.27(b)(3) established sanctions for the sale, use, or possession of illegal drugs within a protected area of any nuclear power plant, within a facility that is licensed to possess or use formula quantities of SSNM, or within a transporter's facility or vehicle. The final rule retains the former sanction of a 5-year denial of authorization in these instances and adds two other instances in which a 5-year denial of authorization is required.

First, the final rule requires licensees and other entities to impose a 5-year denial of authorization on any individual who is determined to have consumed alcohol within a protected area of any nuclear power plant, within a facility that is licensed to possess or use formula quantities of SSNM, or within a transporter's facility or vehicle. This change from the former rule is necessary because consuming alcohol causes impairment, which poses the same risks to public health and safety as impairment from illegal drugs. Extending the scope of the former sanction to alcohol consumption is also consistent with the revised FFD program performance objective in Sec. 26.23(d), which is to provide reasonable assurance that the workplaces subject to this part are free from the presence and effects of alcohol as well as illegal drugs. Therefore, by reducing the risk to public health and safety and the common defense and security that the onsite use of alcohol poses, this change meets Goal 3 of this rulemaking to improve the effectiveness of FFD programs.

Second, the final rule adds the phrase ``or while performing the duties that require the individual to be subject to this part'' to address circumstances in which an individual may be performing the duties that require him or her to be subject to this part but is not doing so within the protected area of a nuclear power plant, within a facility that is licensed to possess or use formula quantities of SSNM, or within a transporter's facility or vehicle. As one example, many nuclear power plant licensees' designated collection sites are located outside of the plant's protected area. The intent of the former rule was to prohibit the presence, sale, and use of alcohol or illegal drugs by FFD program personnel at a collection site that is located outside of the protected area, but the former rule did not specifically address such circumstances. The majority of licensees have appropriately interpreted the intent of the former rule, but the final rule adds this phrase to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

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In addition, the final rule deletes the list of activities in the paragraph of the former rule that an individual is prohibited from performing. The final rule replaces this list with the summary term

``authorization'' for consistency with the use of this term throughout the final rule. As discussed with respect to Sec. 26.4, the NRC presents the list of duties that require individuals to maintain authorization and to be subject to this part once in that section, rather than repeatedly throughout the rule, for consistency with Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.75(d) of the final rule amends a portion of former Sec. 26.27(c) that required licensees or other entities to record as a removal ``for cause'' an individual's resignation that occurs before the licensee removes the individual for violating the FFD policy. This portion of the former provision has raised implementation questions from licensees regarding the appropriate action to take in these circumstances. Licensees have questioned whether the former requirement was intended to deny authorization to an individual for some period of time, as required under former Sec. 26.27(b)(2) through (b)(4), permanently deny authorization to the individual, or merely to record the resignation. Therefore, the final rule clarifies the intent of the former provision as follows:

The final rule establishes the sanction of a 5-year denial of authorization for an individual who resigns before a licensee or other entity terminates the individual's authorization or denies authorization to an applicant for a first violation of the FFD policy involving a confirmed positive drug or alcohol test result. The paragraph establishes a 5-year denial of authorization because the confirmed positive drug or alcohol test result in combination with such a resignation, is a strong indication that the individual has an active substance abuse problem. However, because the individual resigned or withdrew his or her application for authorization, the individual would not be available for the SAE to evaluate the seriousness of his or her substance abuse problem and devise an appropriate treatment plan, as required under Sec. 26.189 [Determination of fitness]. Therefore, prohibiting the individual from being granted authorization for a 5- year period gives the individual an opportunity to seek treatment and establish a 5-year history of sobriety, which is required to regain authorization under Sec. 26.69 [Authorization with potentially disqualifying fitness-for-duty information]. This prohibition also ensures that such an individual is not granted authorization without having demonstrated that he or she has overcome the substance abuse problem. Therefore, the NRC has made this change to meet Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

In addition, for any type of FFD policy violation, this provision requires the licensee or other entity to record the fact that the individual had resigned or withdrawn his or her application for authorization, the nature of the FFD policy violation, and the sanction that would have been imposed if the individual had not resigned or withdrawn. Recording this information is necessary to ensure that any licensees or other entities who may consider granting authorization to the individual in the future are aware of the individual's behavior and the nature of the FFD policy violation. Subsequent licensees and other entities will then be able to ensure that the minimum requirements of this section are met. For example, if the FFD policy violation was a third confirmed positive drug or alcohol test result, Sec. 26.75(g) prohibits a subsequent licensee or other entity from granting authorization to the individual under any circumstances. The NRC has made this change to meet Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

The NRC has moved the portion of former Sec. 26.27(c) that referred to a refusal to provide a specimen for testing to Sec. 26.75(b) of the final rule to meet Goal 6 of this rulemaking, regarding organizational clarity.

Section 26.75(e) of the final rule amends former Sec. 26.27(b)(2) and expands its scope to include alcohol. The NRC no longer excludes the abuse of alcohol from the sanctions specified in this section for several reasons. First, although the possession and use of alcohol are legal for adults and do not adversely reflect on an individual's trustworthiness and reliability, a perceived need to conceal an untreated active alcohol abuse problem could cause an individual to be vulnerable to influence to act in ways that are adverse to the common defense and security. Second, alcohol-related impairment in the nuclear workplace poses an undue potential risk to public health and safety that is comparable to the risk imposed by impairment from the use of drugs. Third, some licensees have not imposed appropriately stringent sanctions on individuals who have abused alcohol in a manner that could cause the individual to be impaired while performing the duties that require individuals to be subject to this part. Therefore, in order to deter individuals from abusing alcohol and ensure that individuals who may be impaired from alcohol are not permitted to perform the duties that require individuals to be subject to this part, this final rule imposes the same sanctions for abusing alcohol as those required for abusing drugs. The NRC has made this change to meet Goal 3 of this rulemaking to improve the effectiveness of FFD programs.

Section 26.75(e)(1) retains but amends the intent of the second sentence of former Sec. 26.27(b)(2). The former Sec. 26.27(b)(2) stated that licensees and other entities must remove an individual from performing activities under this part for at least 14 days following a first confirmed positive test result. However, the final rule requires licensees and other entities to immediately unfavorably terminate the individual's authorization for at least 14 days from the date of the unfavorable termination, rather than ``remove'' the individual. With respect to the proposed rule, the final rule adds a clarification that the 14-day termination begins on the date of the unfavorable termination. The NRC has made this change because after publishing the proposed rule, it recognized the need for additional clarity in this provision to illustrate the NRC's intent. At the public meetings discussed in Section I.D, the stakeholders indicated that the term

``remove'' is confusing because it could be interpreted as requiring licensees and other entities to terminate the individual's employment, which is not the intent of this paragraph. The stakeholders suggested using the phrase ``terminate the individual's authorization'' to more accurately characterize the required action. This change is consistent with Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

The stakeholders also requested that the agency eliminate from

Sec. 26.75(e)(1) the requirements in the former paragraph related to referring the individual to the EAP for assessment and counseling. The stakeholders noted that many licensees terminate an individual's employment at the same time that they terminate the individual's authorization after a first confirmed positive test result. They suggested that if the licensee or other entity terminates the individual's employment and does not intend to provide the individual with an opportunity to regain authorization, it is inappropriate to require the licensee or other entity to provide assessment and counseling services to the individual. However, some licensees have interpreted the

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former provision as requiring them to provide EAP services to individuals whom they no longer employ. The NRC concurs that the intent of the former rule is for licensees and other entities to provide assessment and counseling services only in those instances when the licensee or other entity desires to reinstate the individual's authorization. Therefore, the NRC has made this change, consistent with

Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

The final rule also moves the requirements in former Sec. 26.27(b)(2) that were related to permitting the individual to regain authorization to Subpart C [Granting and Maintaining Authorization] of the final rule instead of retaining them in Sec. 26.75(e)(1) because

Sec. 26.75(e)(1) addresses sanctions for FFD policy violations, rather than FFD requirements for granting authorization. Subpart C addresses the requirements for granting authorization to an individual after his or her authorization has been terminated unfavorably for a first confirmed positive drug or alcohol test result in Sec. 26.69(b). The

NRC has made this change to meet Goal 6 of this rulemaking to improve organizational clarity in the rule.

Section 26.75(e)(2) increases the length of the period for which licensees and other entities must deny an individual's authorization for a second confirmed positive drug or alcohol test result from 3 years in former Sec. 26.27(b)(vii) to 5 years in the final rule. This change provides greater assurance that individuals who have had a second confirmed positive drug or alcohol test result are able to abstain from substance abuse for at least 5 years before a licensee or other entity may again consider granting authorization to them. The 5- year period is based on the research literature indicating that individuals who abstain from substance abuse for 5 years after treatment are less likely to relapse than individuals who have been able to abstain for 3 years. In addition, the more stringent sanction for a second confirmed positive drug or alcohol test result provides greater deterrence to recidivism than the former 3-year period. The NRC has made this change to meet Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

Section 26.75(f) of the final rule amends former Sec. 26.27(b)(5).

Former Sec. 26.27(b)(5) stated that the sanctions for confirmed positive drug test results in former Sec. 26.27 [Written policy and procedures] did not apply to the misuse of alcohol, valid prescriptions, and over-the-counter drugs, but required licensee FFD policies to establish sanctions that are sufficient to deter the misuse of those substances. The final rule requires the same minimum sanctions for alcohol abuse as those required for drug abuse. Impairment caused by alcohol abuse creates a risk to public health and safety that is fundamentally similar to the risk posed by the use of illegal drugs.

However, some licensees have imposed lesser sanctions for alcohol violations, an approach that is inconsistent with the NRC's intent.

Therefore, the final rule rectifies this situation by explicitly requiring the same minimum sanctions for the abuse of alcohol as currently required for the use of illegal drugs. The NRC has made this change to meet Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs and Goal 6 to improve clarity in the organization and language of the rule.

In addition, Sec. 26.75(f) of the final rule requires licensees and other entities to impose the same sanctions as mandated for the abuse of illegal drugs if the MRO determines that the misuse of prescription drugs or over-the-counter medications resulting in a positive drug or alcohol test result represents substance abuse. The

MRO makes this determination under Sec. 26.185(j). Misuse of prescription and over-the-counter medications may include, for example, the use of a spouse's or other family member's prescription medications that may cause impairment, such as some pain relievers, or the excessive use of some over-the-counter cold and cough preparations containing alcohol or other active ingredients that may cause impairment. However, an individual who has a substance abuse problem may use the same substances. For example, an individual who has become addicted to opiates may use a spouse's or other family member's codeine tablets or other opiates that were prescribed for pain relief to assist the addicted individual in avoiding withdrawal symptoms. Under this provision, if the MRO determines that an individual's use of a prescription or over-the-counter medication represents substance abuse, the licensee or other entity is required to impose the minimum sanctions specified in this section for a confirmed positive drug or alcohol test result, as appropriate. If the MRO determines that the misuse of a prescription or over-the-counter medication does not represent substance abuse, the final rule requires the licensee or other entity to impose the sanctions for substance misuse that the licensee or other entity specifies in the FFD policy.

The final rule also retains but revises the requirement in the last sentence of former Sec. 26.27(b)(5). Section 26.75(f) retains the former requirement that sanctions for the misuse of prescription and over-the-counter drugs must be sufficient to ``deter abuse of legally obtainable substances'' because such misuse may lead to impairment on the job. However, the final rule eliminates the phrase ``as a substitute for abuse of prescribed drugs'' in the last sentence of former Sec. 26.27(b)(5) because it unnecessarily limited the circumstances in which sanctions for the misuse of prescription and over-the-counter drugs must be imposed. The NRC has made these changes to meet Goal 3 of the rulemaking to improve the effectiveness and efficiency of FFD programs, and Goal 6 to improve clarity in the organization and language of the rule.

Section 26.75(g) of the final rule amends former Sec. 26.27(b)(4).

The NRC has moved the portions of the former paragraph that established requirements for granting authorization to an individual who has violated the licensee's or other entity's FFD policy to Sec. 26.69 in

Subpart C of the final rule for organizational clarity because Sec. 26.75(g) only addresses sanctions for FFD policy violations. This provision retains the portion of the former paragraph that required licensees and other entities to permanently deny authorization to an individual who has repeatedly violated a licensee's or other entity's

FFD policy. The final rule requires the permanent denial of an individual's authorization if he or she has another confirmed positive drug or alcohol test result after he or she has had authorization denied for 5 years under other paragraphs in this section. Requiring this more stringent sanction meets Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs because this provides reasonable assurance that individuals are trustworthy and reliable, as demonstrated by avoiding substance abuse, and increases the assurance that only individuals who are fit for duty are permitted to perform the duties listed in Sec. 26.4.

Section 26.75(h) and (i) of the final rule amends former Sec. 26.24(d)(2). The former provision permitted licensees to temporarily suspend an individual's authorization or take other administrative action if an individual has a positive drug test result for marijuana or cocaine metabolites that is identified through initial testing at the licensee testing facility. For organizational clarity, consistent with Goal 6 of this rulemaking, the final rule divides the former paragraph into two paragraphs to separate the requirements related to the conditions under which licensees and other entities may and

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may not take action on the basis of initial test results.

Section 26.75(h) prohibits licensees and other entities from taking administrative actions or imposing sanctions on an individual based on a positive test result from any initial drug test result reported by an

HHS-certified laboratory. This section also permits licensees and other entities to take administrative actions on the basis of positive initial drug test results for marijuana and cocaine from a licensee testing facility. However, in order for the licensee or other entity to take action, the final rule requires that the urine specimen that yields a positive, adulterated, or substituted drug test result(s) must also appear to be a valid specimen, based on the results of validity screening or initial validity test results at the licensee testing facility. In addition, this section prohibits licensees and other entities from imposing sanctions or taking other actions in response to adulterated, substituted, or invalid screening or initial validity test results from a specimen in which no drug metabolites were detected. The

NRC has added this prohibition because the procedures, instruments, and devices used in conducting validity screening and initial validity tests have not yet been proven to be sufficiently accurate and reliable to support management actions or sanctions without confirmatory testing. Permitting licensees and other entities to take actions on the basis of validity screening or initial validity test results risks imposing substantial burdens on individuals from false positive, adulterated, substituted, or invalid test results. Therefore, the NRC has added this prohibition to meet Goal 7 of this rulemaking to protect the privacy and other rights (including due process) of individuals who are subject to Part 26.

With respect to the proposed rule, the final rule adds a provision that the licensee or other entity may not subject an individual to administrative action based upon validity testing results indicating that a specimen is of questionable validity. This change is based on analysis of public comment, which is discussed with respect to the term

``questionable validity'' in Sec. 26.5 [Definitions].

Section 26.75(i)(1) through (i)(4) retains the requirements in former Sec. 26.24(d)(2)(i) through (iv) that established the conditions under which licensees and other entities may take administrative actions on the basis of a positive initial drug test result for marijuana or cocaine metabolites from a licensee testing facility. The final rule adds a requirement for specimen validity testing (see the discussion of Sec. 26.31(d)(3)(i) with respect to the addition of validity testing requirements in this rule and the requirement that the specimen for which action will be taken must appear to be valid, based on validity screening or initial validity test results from the licensee testing facility). The final rule also revises the terminology used in the former provision to be consistent with the terminology used throughout the final rule (see the discussion of Sec. 26.5 with respect to the new terminology adopted in the final rule) and updates the cross-references to other sections of the rule to be consistent with the organization of the final rule. The NRC has made these changes to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.77 Management Actions Regarding Possible Impairment

The NRC has added Sec. 26.77 [Management actions regarding possible impairment], which amends the requirements of former Sec. 26.27(b)(1). The former section required licensees and other entities to remove impaired workers, or those whose fitness may be questionable, from performing activities within the scope of this part. The former provision also permitted licensees and other entities to return the individuals to duty only after the individuals were determined to be fit to safely and competently perform their duties. The final rule retains the intent of the former provision, but the terminology used in the section is consistent with the terminology used throughout the final rule. The NRC has updated cross-references to other sections of the rule, consistent with Goal 6 of this rulemaking to improve clarity in the organization and language of the rule. In addition, the agency has added several new requirements.

The NRC has added Sec. 26.77(a) to the final rule to introduce and describe the purpose of the section, which is to prescribe the management actions that licensees and other entities must take when an individual shows indications that he or she is not fit to safely and competently perform their duties. The NRC has added this paragraph to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.77(b) of the final rule retains the portion of former

Sec. 26.27(b)(1) that required the licensee or other entity to take immediate action to prevent an individual from performing the duties that require him or her to be subject to this part if an individual appears to be impaired, or his or her fitness is questionable. This section of the final rule adds cross-references to Sec. Sec. 26.27(c)(3), 26.207, and 26.209 (updated from the proposed rule) because those provisions provide exceptions to the requirement for immediate action. Section 26.27(c)(3) permits licensees and other entities to use individuals who have consumed alcohol if they are needed to respond to an emergency and the licensee or other entity establishes controls and conditions under which the individual may perform work safely. Sections 26.207 and 26.209 contain the provisions for waivers and exceptions and self-declarations, which exempt individuals from the work hour controls of Subpart I [Managing Fatigue] under certain circumstances. The NRC has added the cross-references to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

The final rule also revises some terminology used in the former provision in response to stakeholder requests during the public meetings discussed in Section I.D. The stakeholders indicated that, because the former rule requires them to ``remove'' individuals whose fitness may be questionable, some FFD programs have interpreted the former paragraph as requiring them to terminate the individual's authorization. This was not the intent of the former provision. In this instance, the intent of the rule was for licensees and other entities to prevent the individual from performing the duties that would require the individual to be subject to this part in order to ensure that any potential impairment could not result in errors or lapses in judgment that may pose a risk to public health and safety or the common defense and security until the cause of the problem could be identified and resolved. Therefore, the final rule replaces the phrase, ``removed from activities within the scope of this part,'' with the phrase, ``prevent the individual from performing the duties,'' and makes other minor changes to the wording of the former requirement to clarify the intent of the provision. The NRC has made these changes to meet Goal 6 of this rulemaking to improve clarity in the language of the rule.

Section 26.77(b)(1) retains the intent of former Sec. 26.24(a)(3).

This provision requires licensees and other entities to conduct drug and alcohol testing for cause. The final rule requires for-cause testing based upon a ``reasonable suspicion'' that the individual may be impaired from possible substance abuse. Reasonable suspicion of substance abuse could be based upon an observed

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behavior, such as unusual lack of coordination or slurred speech, or a physical condition, such as the smell of alcohol. If the only basis for a reasonable suspicion is the smell of alcohol, then alcohol testing is required. However, the final rule does not require the licensee or other entity to perform a drug test unless other physical or behavioral indicators of possible impairment are present.

The stakeholder comments received during the public meetings discussed in Section I.D reported that many of the for cause tests they perform are initiated as a result of a security officer or other person reporting that an individual smells of alcohol without behavioral indications of impairment. They also noted that the very large majority of the for-cause drug tests that they conduct in these circumstances yields negative results, including those instances in which the alcohol test results are positive. The stakeholders suggested that the former requirement to conduct drug tests in these circumstances imposes a significant burden because the drugs tests impose costs, not only for collecting and testing the urine specimens, but also because they cannot permit the individual to resume performing his or her duties until the drug test results are available, which may take several days.

The stakeholders argued that the burden is unnecessary because the drug tests yield positive results so infrequently and, therefore, do not serve their intended purpose of detecting drug abuse. Based on these stakeholders' arguments and the FFD program performance data that support them, the NRC concurs that drug testing is unnecessary when the smell of alcohol is the only indication that for cause testing is required, and has eliminated it from the final rule. The final rule continues to require drug testing if there are behavioral or physical indications of impairment in addition to the smell of alcohol.

The NRC has added Sec. 26.77(b)(2) to apply only to nuclear power plant licensees and C/Vs who are subject to Subpart I. With respect to the proposed rule, the final rule modifies the language of this provision to improve its clarity and to more clearly specify the NRC's intent. This section permits these entities to forego drug and alcohol testing and the determination of fitness process required by Sec. 26.189 if a fatigue assessment conducted under Sec. 26.211 confirms that the individual's observed behavior or physical condition is solely a result of fatigue. This section applies only to licensees and C/Vs who are subject to Subpart I because licensees not subject to Subpart I would not have the requisite training to evaluate whether the observed behavior is caused by fatigue. The NRC has made this change to meet

Goal 2 of this rulemaking to ensure against worker fatigue at nuclear power plants and Goal 3 to improve the effectiveness and efficiency of

FFD programs.

The NRC has added Sec. 26.77(b)(3) to specify the actions that licensees and other entities must take when there are indications that an individual may be impaired, other than behavior or a physical condition that creates a reasonable suspicion of substance abuse (or fatigue, in the case of licensees who are subject to Subpart I).

Consistent with former Sec. 26.27(b)(1), the final rule permits the licensee or other entity to return the individual to duty only after identifying and resolving the cause of the impairing condition and making a determination of fitness indicating that the individual is fit to safely and competently perform his or her duties (see the discussion of Sec. 26.189 for more details regarding the determination of fitness process). This section does not require licensees and other entities to unfavorably terminate an individual's authorization for illness, fatigue, temporary mental and emotional stress, or other conditions that may affect an individual's fitness, but prohibits the licensee or other entity from assigning the impaired individual to perform the duties that require him or her to be subject to this subpart until a determination is made that the individual is fit to return to duty. The

NRC has made this change to meet Goal 2 of this rulemaking to ensure against worker fatigue at nuclear power plants and Goal 3 to improve the effectiveness and efficiency of FFD programs.

Section 26.77(c) of the final rule updates former Sec. 26.27(d) to be consistent with current NRC notification procedures.

Subpart E--Collecting Specimens for Testing

Throughout Subpart E, the final rule makes minor clarifications to the proposed rule because of public comment, to accommodate conforming changes, and to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule. The final rule also makes more substantive changes to the proposed rule in this subpart because of public comment or to improve clarity in the organization and language of the rule. The substantive changes in this subpart can be found in Sec. Sec. 26.81; 26.85(c)(1), (c)(2), and (e); 26.87(e); 26.89(a)(2) and (c); 26.91(e)(4); 26.109(b)(1); and 26.111(a), (c) and

(d). These changes are discussed in detail below. However, other than the changes mentioned above, the final rule adopts the provisions of this subpart as proposed without change.

Section 26.81 Purpose and Applicability

This added section describes the purpose of Subpart E, which is to establish requirements for collecting specimens for drug and alcohol testing. The new section assists in locating provisions within the rule and is consistent with Goal 6 of the rulemaking to improve clarity in the organization and language of the rule.

The NRC revised the title of this section from ``Purpose'' in the proposed rule to ``Purpose and applicability'' in the final rule to reflect other modifications to this paragraph that the agency has made in response to public comments that the applicability of the proposed rule's requirements was unclear. This paragraph specifies that the requirements of Subpart E apply to the licensees and other entities in

Sec. 26.3(a) through (d) to the extent that a C/V conducts drug and alcohol testing on which a licensee or other entity in Sec. 26.3(a) through (d) relies. The provision further specifies the applicability of Subpart E's requirements by also listing the categories of individuals who are subject to the subpart. These include the categories of individuals listed in Sec. 26.4(a) through (e). In addition, licensees and other entities may choose to conduct specimen collections and alcohol testing under the requirements of this subpart for the categories of individuals specified in Sec. 26.4(f) and (g).

However, Sec. Sec. 26.4(j), 26.31(b)(2), and Subpart K [FFD Programs for Construction] permit licensees and other entities to rely on specimen collections and alcohol testing that are conducted under the requirements of 49 CFR Part 40, ``Procedures for Transportation

Workplace Drug Testing Programs'' (65 FR 41944; August 9, 2001), for the reasons discussed with respect to those sections. In these instances, Sec. 26.81 permits the specimen collections and alcohol testing to be performed under DOT's procedures, rather than those contained in Subpart E, for individuals who are subject to another

Federal or State FFD program in Sec. 26.4(j), FFD program personnel in

Sec. 26.31(b)(2), and the categories of individuals identified in

Sec. 26.4(f). These changes meet Goal 6 of the rulemaking to improve clarity in the organization and language of the rule.

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Section 26.83 Specimens To Be Collected

The NRC has added Sec. 26.83, which specifies the types of specimens that licensees and other entities must collect for initial and confirmatory drug and alcohol testing.

Section 26.83(a) requires licensees and other entities to collect either breath or oral fluids (i.e., saliva) for initial alcohol tests.

The final rule continues to require collecting only breath specimens for confirmatory alcohol testing. The final rule permits the use of oral fluids (i.e., saliva) for initial alcohol tests because devices for testing oral fluids for alcohol have matured sufficiently to provide valid and reliable initial test results. Circumstances may arise, such as collecting a specimen of oral fluids from a donor who has impaired lung functioning, in which the use of these devices is more efficient than collecting breath specimens for both donors and the

FFD program. Therefore, the permission to collect oral fluids for initial alcohol testing meets Goal 3 of this rulemaking to improve the efficiency of FFD programs. Additionally, other Federally mandated alcohol testing programs permit the use of these devices for initial alcohol testing. Therefore, adding permission to collect oral fluids for initial alcohol testing to the final rule is consistent with Goal 1 of the rulemaking to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines.

The final rule eliminates the use of blood as a specimen for alcohol testing at the donor's discretion, which was permitted in former Sec. 26.24(g) and Section 2.2(d)(4) in Appendix A to Part 26.

The final rule eliminates the former provisions related to blood alcohol testing for several reasons. Since the former rule was first promulgated, licensees have repeatedly raised questions related to the proper interpretation of a confirmatory alcohol test result using an evidential breath testing device (EBT) and an alcohol test result derived from a blood specimen when the results from the two types of testing differ. Specifically, if a confirmatory alcohol test result using an EBT is positive, but the result from testing a blood specimen is negative, licensees have asked which test result they should rely on in determining whether the donor has violated the FFD policy. Although the NRC's original intent was that the result from the blood test was to be definitive, delays in obtaining a blood specimen sometimes resulted in blood test results that fell below the alcohol cutoff level of 0.04 percent BAC due to alcohol metabolism during the period of the delay. Some licensees have been reluctant to apply sanctions for a positive alcohol test result in these instances even though alcohol metabolism over time explains the lower test result from the blood sample. Further, experience has shown that few donors request testing of a blood sample. Data gathered from a sampling of representative FFD programs show that individuals requested an average of fewer than one blood test per program within the period reviewed (January-May 2002).

Additionally, the use of EBTs for confirmatory alcohol tests has consistently withstood legal challenge. The added protection of donors' rights that the NRC envisioned when promulgating the provisions for voluntary testing of blood specimens has not been realized in practice.

The former requirement has also been costly for licensees. Licensees must ensure that an individual who is trained to draw blood is available to do so should a donor request blood testing. Based on information provided by stakeholders at the public meetings discussed in the preamble to the proposed rule, the NRC determined that the costs associated with retaining this provision are not justified because of the very few instances in which donors have requested blood alcohol testing. Therefore, the agency has deleted from the final rule references to collecting and testing blood specimens for alcohol.

Section 26.83(b) retains, but makes explicit, the implied requirement in the first sentence of former Sec. 26.24(b) (and other provisions that are interspersed throughout the former rule) for licensees and other entities to collect only urine specimens for drug testing. When the former rule was promulgated, it was unnecessary to establish an explicit requirement to collect and test only urine specimens for drugs in Part 26 programs because methods for testing other specimens were not available and the HHS Guidelines only addressed testing urine specimens. Since that time, methods for testing alternate specimens, such as oral fluids, sweat, and hair, have become commercially available and HHS has published proposed revisions to its guidelines (69 FR 19673; April 13, 2004) that would permit the use of alternate specimens for drug testing in Federal workplace drug testing programs. The NRC is considering permitting the use of alternate specimens for drug testing when HHS has published final revisions to its guidelines related to these types of specimens. The revised HHS

Guidelines will establish acceptable collection procedures and testing methods. However, HHS has not yet published final guidelines for collecting and testing these alternate specimens. Therefore, it is necessary to add Sec. 26.83(b) to the final rule to clarify that the

NRC intends to continue prohibiting the collection and drug testing of specimens other than urine in this rulemaking except as permitted under

Sec. 26.31(d)(5) [Medical conditions]. The reasons are as discussed with respect to that section.

Section 26.85 Collector Qualifications and Responsibilities

This added section replaces the collector qualifications and training requirements specified in the definition of ``collection site person'' in the former rule and in former Sections 1.2, 2.2(d), and 2.4(b) in Appendix A to Part 26. This section retains the intent of the former provisions, but the final rule groups the requirements together to improve organizational clarity. In addition, the final rule amends the former collector qualifications and training requirements to increase the consistency of Part 26 with the requirements of other

Federal agencies and incorporates the lessons learned from those programs as discussed with respect to Goal 1 of this rulemaking.

Section 26.85(a) [Urine collector qualifications] provides more detailed requirements for urine collector qualifications and training than are contained in the former definition of ``collection site person'' and former Section 2.2(d) in Appendix A to Part 26. The final rule requires urine collectors to be knowledgeable of the requirements of this part, the FFD policy and procedures of the licensees or other entities for whom they perform collections, and to keep current on any changes to urine collection procedures. These changes increase the consistency of urine collector qualification requirements with those of other Federal workplace drug testing programs as well as consistency in urine collection procedures among FFD programs that are subject to this subpart.

Section 26.85(a) retains the requirements in former Section 2.2(d) that urine collectors must receive training to perform their duties and demonstrate proficiency in applying the requirements of this section before serving as a collector. Section 26.85(a)(1) through (a)(4) lists the topics that the final rule requires collector training to address.

Section 26.85(a)(1) requires collectors to be trained in the steps that are necessary to complete a collection correctly and the proper

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completion and transmission of the custody-and-control form to the licensee testing facility or HHS-certified laboratory, as appropriate.

Section 26.85(a)(2) requires training in methods to address ``problem'' collections. These may include, but are not limited to, collections involving ``shy bladder'' (see the discussion of proposed Sec. 26.119

Determining ``shy'' bladder

for an explanation of this term and the procedures involved) and attempts by a donor to tamper with a specimen.

Section 26.85(a)(3) requires the training to instruct collectors on correcting collection problems. These may include, but are not limited to, a donor refusing to cooperate with the collection process or an incident in which a urine specimen is spilled. Section 26.85(a)(4) requires training so that a collector is knowledgeable in maintaining the integrity of the specimen collection and transfer process, and ensuring that donors' privacy and modesty are maintained. The NRC added these requirements to meet Goal 1 of this rulemaking to update and enhance the consistency of Part 26 with advances in other relevant

Federal rules and guidelines.

Section 26.85(a)(4) retains the portion of former Section 2.2(d)(1) in Appendix A to Part 26 that required collector training to emphasize the collector's responsibility for maintaining the integrity of the specimen collection and transfer process, carefully ensuring the modesty and privacy of the donor, and avoiding any conduct or remarks that might be construed as accusatorial or otherwise offensive or inappropriate.

The NRC added Sec. 26.85(b) [Alcohol collector qualifications] to specify requirements related to alcohol collector qualifications and training. Portions of this section are the same as the requirements for urine collectors in Sec. 26.85(a), including the first three sentences of Sec. 26.85(b), and (b)(4) and (b)(5). The agency added these requirements here for the same reasons discussed with respect to the first three sentences of Sec. 26.85(a), and (a)(3) and (a)(4), respectively. The final rule repeats the requirements that are applicable to both urine and alcohol collectors in each of these paragraphs because some FFD programs may not train collectors to perform both types of collections. Repeating the requirements makes it easier to locate the requirements that apply to urine or alcohol collectors and meets Goal 6 of the rulemaking to improve clarity in the organization of the rule.

Section 26.85(b)(1) and (b)(3) requires alcohol collectors to receive training that addresses the alcohol testing requirements of this part and methods to address ``problem'' collections. These include, but are not limited to, collections involving ``shy lung'' problems or attempts by a donor to tamper with a specimen. In contrast to Sec. 26.85(a)(2), which addresses ``shy bladder'' problems in urine collections, the final rule does not incorporate the related DOT procedures for evaluating ``shy lung'' problems in alcohol collections.

During the public meetings discussed in the preamble to the proposed rule, stakeholders requested that the proposed rule incorporate DOT's

``shy bladder'' procedures, but did not believe that adding DOT's ``shy lung'' procedures to the final rule is necessary. The stakeholders reported that donors have not experienced problems related to ``shy lung,'' based on their experience implementing the breath testing requirements of Part 26 since the rule was first promulgated.

Therefore, Sec. 26.85(b)(3) requires alcohol collectors to be able to implement the ``shy lung'' procedures established by any FFD program for whom the collectors are providing collection services, but does not establish requirements for responding to ``shy lung'' problems in the rule.

The final rule adds Sec. 26.85(b)(2) to require alcohol collectors to be trained in the operation of the particular alcohol testing device(s) (i.e., the ASDs and EBTs) to be used in conducting alcohol tests, consistent with the most recent version of the manufacturers' instructions. The final rule adds this requirement because the NRC is aware that some FFD programs did not implement device manufacturers' recommended changes to instructions for using the testing devices.

Although the NRC staff is not aware of any testing errors or instances in which donors have challenged the results of alcohol tests that were not performed in accordance with the most recent version of the device manufacturer's instructions, the final rule adds this requirement to ensure that alcohol test results continue to be accurate and cannot be challenged on this basis. The changes are also consistent with the alcohol collector training requirements of other Federal agencies.

Section 26.85(c) [Alternative collectors] amends the last sentence of former Section 2.2(d)(2) in Appendix A to Part 26. The former provision permitted medical personnel to perform specimen collections without receiving the required training for non-medical collectors. The final rule permits medical personnel to conduct specimen collections for the purposes of this subpart only under the conditions specified in

Sec. 26.85(c)(1) through (c)(5). These conditions may include, but are not limited to, the collection of specimens for post-event testing by a nurse or medical technician at a hospital. The final rule limits the circumstances in which an untrained medical professional, technologist, or technician may perform collections for a licensee or other entity because the experience of other Federal agencies has shown that medical personnel who are untrained in specific collection procedures have committed errors in collections that resulted in unnecessary legal challenges to test results. At the same time, the NRC is also aware that licensees and other entities may occasionally have to rely on these individuals to collect specimens for drug and alcohol testing, as discussed with respect to Sec. 26.4(i)(1). Therefore, the final rule permits untrained medical personnel to collect specimens to facilitate the collection of specimens for testing in rare circumstances in which a qualified collector could not reasonably be expected to be available, but otherwise requires medical personnel who do not meet the criteria specified in Sec. 26.85(c)(1) through (c)(5) to receive the same training as non-medical collectors. The NRC made this change to meet

Goal 3 of the rulemaking to improve the effectiveness and efficiency of

FFD programs, by reducing the likelihood of errors and legal challenges to test results. In addition, the final rule also makes minor changes to the organization of this paragraph in response to a public comment indicating a lack of clarity in the same provision in the proposed rule.

The NRC has eliminated former Section 2.2(d)(4) in Appendix A to

Part 26, which required that donors must be informed of the option to request blood testing. The agency eliminated the former requirement because the final rule no longer permits donors to request blood testing for alcohol, as discussed with respect to Sec. 26.83(a).

Section 26.85(d) amends former Section 2.7(o)(5) [Personnel available to testify at proceedings] in Appendix A to Part 26. This section required the licensee testing facility and HHS-certified laboratory to make available qualified individuals to testify in administrative or disciplinary proceedings related to drug and alcohol test results. The final rule adds an explicit requirement for collection site personnel to be available to testify at proceedings because the former provision implied, but did not explicitly state this requirement. When the rule was first published, licensee testing facilities and collection sites were

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typically co-located at a site. However, this is no longer the case. In some current FFD programs, alcohol testing and urine specimen collections occur at the collection site, but initial testing of urine specimens is performed at a licensee testing facility that may not be co-located with the collection site. Therefore, the NRC has added this paragraph to retain the former rule's original intent that licensees and other entities must make available collection site personnel to testify, as needed, in administrative and/or legal proceedings related to an alcohol or drug test result. For organizational clarity, the final rule moves the requirements in the former paragraph that addressed the availability of personnel to testify in proceedings related to drug test results from the licensee testing facility to

Sec. 26.139(c) of Subpart F [Licensee Testing Facilities] and those related to HHS-certified laboratories to Sec. 26.153(f)(2) of Subpart

G [Laboratories Certified by the Department of Health and Human

Services].

The NRC added Sec. 26.85(e) to the final rule in response to a public comment noting that the proposed rule did not include a requirement for licensees and other entities to ensure that personnel files are maintained for collectors. The new paragraph establishes requirements for personnel files for collectors to document their training and other qualifications for the positions they hold. This documentation may be necessary in administrative and/or legal proceedings related to an alcohol or drug test result.

Section 26.87 Collection Sites

The NRC has reorganized requirements related to specimen collection sites in the former rule and grouped them together in this section.

Requirements related to collection sites were distributed among several different sections in Appendix A to Part 26 of the former rule. The agency made this change to improve organizational clarity in the rule.

Section 26.87(a) amends former Section 2.4(a) in Appendix A to Part 26. This former section required FFD programs to designate collection sites and ensure that they are fully equipped to collect specimens for testing. The final rule deletes references to blood specimens because the final rule no longer provides donors with the option to request blood testing for alcohol for the reasons discussed with respect to

Sec. 26.83(a). The final rule adds a requirement for collection sites to be capable of alcohol testing that the former section implied but did not explicitly state. The agency made this change to meet Goal 6 of this rulemaking to improve clarity in the language of the rule. This section retains the permission in the former rule for licensees and other entities to use properly equipped mobile collection facilities.

Section 26.87(b) revises the first sentence of former Section 2.4(f) in Appendix A to Part 26 to require visual privacy for donors while the donor and collector are viewing the results of an alcohol test and retains the former requirement for individual privacy during urine specimen collections, except if the urine specimen collection must be conducted under direct observation. The new requirement for visual privacy while viewing alcohol test results increases the consistency of Part 26 with the alcohol testing procedures of other

Federal agencies and assures greater privacy for donors who are subject to FFD programs that did not provide visual privacy under the former rule. The NRC made this change to meet Goal 7 of this rulemaking to protect the privacy of individuals who are subject to Part 26. For organizational clarity, the final rule moves the former requirements in

Section 2.4(f) in Appendix A to Part 26 that are related to collecting a specimen under direct observation to Sec. 26.115 [Collecting a urine specimen under direct observation].

Section 26.87(c) retains only the portion of former Section 2.7(m) in Appendix A to Part 26 that required licensees' and other entities' contracts for collection site services to permit unfettered NRC, licensee, and other entity access to collection sites for unannounced inspections. The final rule moves the portions of the former section that apply to HHS-certified laboratories to Sec. 26.153(f) of Subpart

G for organizational clarity. In addition, Sec. 26.87(c) adds a requirement that licensees' and other entities' contracts for collection site services must permit unfettered NRC, licensee, and other entity access to all information and documentation that is reasonably relevant to inspections and audits. The final rule adds this requirement for access to documentation for consistency with the HHS

Guidelines, which also require collection sites to provide information and documentation as part of inspections and audits. Therefore, this change meets Goal 1 of this rulemaking to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. The agency also added the term ``audit'' to this section because, although the NRC conducts inspections, licensees and other entities are required to conduct audits under Sec. 26.41 [Audits and corrective action]. Adding this term to this paragraph increases the clarity of its language, consistent with Goal 6 of the rulemaking.

Section 26.87(d) revises former Section 2.4(c) in Appendix A to

Part 26 to clarify requirements for assuring collection site security and the integrity of specimen collection procedures. For organizational clarity, the final rule groups requirements related to assuring the security of a licensee's or other entity's designated collection site in this paragraph. For the same reason, the final rule moves to Sec. 26.87(f) the requirements contained in former Section 2.4(c) in

Appendix A to Part 26 that address assuring collection security when a designated collection site is inaccessible and there is an immediate requirement to collect a urine specimen. Section 26.87(d) includes other clarifying changes to former Section 2.4(c) in Appendix A to Part 26, in response to stakeholder requests at the public meetings discussed in Section IV.D.

Section 26.87(d)(1) retains the first sentence of former Section 2.4(e) in Appendix A to Part 26 and permits only authorized personnel to have access to any part of a collection site in which specimens are collected and stored. For organizational clarity, the final rule moves this requirement to this section because it addresses the topic of collection site security.

Section 26.87(d)(2) amends the second sentence of former Section 2.4(c) in Appendix A to Part 26. The former provision required collection sites to be secure, and the final rule adds examples of acceptable methods to assure collection site security. The NRC added these examples in response to stakeholder requests during the public meetings discussed in the preamble to the proposed rule. The stakeholders noted that the requirement that collection sites ``must be secure'' has raised many implementation questions. Therefore, the final rule adds examples of acceptable means to ensure collection site security, including, but not limited to, physical measures to control access, such as locked doors, alarms, or visual monitoring of the collection site when it is not occupied. The agency made this change to meet Goal 6 of this rulemaking to improve clarity in the language of the rule.

Section 26.87(d)(3) amends the third sentence in former Section 2.4(c) in Appendix A to Part 26. The former provision required that the portion of any facility that is not dedicated solely to drug and alcohol testing must be secured during testing. The final rule

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retains that requirement and combines it with the third sentence of former Section 2.4(c)(1) in Appendix A to Part 26. The provision requires the protection of the facility against unauthorized access during the collection. The final rule replaces the phrase, ``in the case of a public restroom,'' in the last sentence of former Section 2.4(c)(1) in Appendix A to Part 26, with the phrase, ``if a collection site cannot be dedicated solely to collecting specimens,'' to clarify that a specimen may be collected at locations other than public restrooms. The NRC makes these changes to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

The agency has added Sec. 26.87(e) to specify the steps that licensees and other entities must take to deter dilution and adulteration of specimens during urine collections. This section retains and amends portions of former Section 2.4(g) in Appendix A to

Part 26.

Section 26.87(e)(1) relaxes the former requirement in Section 2.4(g)(1) of Appendix A to Part 26 to use a bluing agent in any source of standing water, such as a toilet bowl or tank. The final rule permits licensees and other entities to use colors other than blue.

However, the final rule prohibits use of a yellow coloring agent because it precludes the collector's ability to determine whether a donor had diluted the specimen with water from a source of standing water in the stall or room in which the donor provides a specimen. The relaxation does not affect the accuracy of drug tests but gives FFD programs increased flexibility in the choice of coloring agents. The agency made this change in response to stakeholder requests during the public meetings discussed in the preamble to the proposed rule and to meet Goal 5 of this rulemaking to improve Part 26 by eliminating or modifying unnecessary requirements.

Section 26.87(e)(2) retains the second sentence of former Section 2.4(g)(1) in Appendix A to Part 26, which requires sources of standing water to be secured, but shortens it without changing the intended meaning of the requirement. The agency made this change to improve clarity in the language of the rule.

The final rule adds Sec. 26.87(e)(3) to require that chemicals or products that could be used to adulterate a urine specimen must be secured or removed from the collection site. The paragraph also requires the collector to inspect the enclosure to ensure that no potential adulterants are available before the donor enters the stall or enclosure. The agency intends these requirements to prevent possible donor attempts to subvert the testing process by adulterating a urine specimen with materials that are available at the collection site. This provision meets Goal 3 of this rulemaking to improve the effectiveness of FFD programs. The provision is also consistent with the related requirements of other Federal agencies.

Section 26.87(f) reorganizes former Section 2.4(c)(1), portions of

Section 2.4(c)(2), and Section 2.4(g)(10) in Appendix A to Part 26 to prescribe acceptable procedures for collecting specimens at locations other than a designated collection site in unusual circumstances, such as a specimen collection for post-event testing at a hospital. The final rule groups these requirements together in a single paragraph and separates them from those related to collecting specimens at a designated collection site in Sec. 26.87(d) and (e) to make it easier to locate these requirements within the rule. The NRC made this change to improve organizational clarity in the rule.

Section 26.87(f)(1) amends former Section 2.4(c)(1) in Appendix A to Part 26, which established requirements for securing a location that is not a designated collection site but will be used for a specimen collection(s). The final rule requires either an individual to guard access to a public rest room while the collection is occurring or the posting of a sign to ensure that no unauthorized personnel enter the area during the collection. The former rule required only the posting of a sign. However, stationing an individual to guard access is at least as effective. The final rule permits an individual to guard access to the collection area in response to stakeholder requests for this flexibility during the public meetings discussed in the preamble to the proposed rule. This change meets Goal 5 of this rulemaking to improve Part 26 by eliminating or modifying unnecessary requirements.

Section 26.87(f)(2) retains the third sentence of former Section 2.4(g)(10) in Appendix A to Part 26 that requires using a water- coloring agent, if possible, to deter a possible dilution or adulteration attempt when a collection must occur at a location other than the licensee's or other entity's designated collection site.

Section 26.87(f)(3) retains the requirement in the second sentence of former Section 2.4(g)(10) that the collector must be the same gender as the donor in the exceptional event of a specimen collection occurring at a location other than the FFD program's designated collection site. However, if a collector of the same gender is unavailable, the rule permits another person of the same gender who is instructed in the requirements of Subpart E [Collecting Specimens for

Testing] to assist in the collection. The provision requires either the collector or the observer to remain outside the area in which the donor will provide the urine specimen to protect the donor's privacy and the integrity of the collection process. The rule requires documentation of the observer's identity on the custody-and-control form so that the observer may be located should any subsequent questions arise with respect to the collection in a review under Sec. 26.39 [Review process for fitness-for-duty policy violations] or legal proceedings. The flexibility to rely on a person of the same gender as an observer, if a collector of the same gender is unavailable, is consistent with the procedures of other Federal agencies and reduces potential embarrassment to the donor. Therefore, this change meets Goal 1 of this rulemaking to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines, and Goal 7 to protect the privacy of individuals who are subject to Part 26.

Section 26.87(f)(4) requires the collector, once he or she is in possession of the donor's specimen, to inspect the area in which the specimen donation occurred for any evidence of a subversion attempt by the donor. This paragraph amends the fifth and sixth sentences of former Section 2.4(g)(10) in Appendix A to Part 26 that described the required sequence of actions during a specimen collection and specified that a donor is permitted to flush the toilet after a specimen donation. The final rule eliminates the option for the donor to flush the toilet and directs the collector to instruct the donor not to flush the toilet. The change reduces the possibility that a donor could dispose of evidence of a subversion attempt by flushing it down the toilet. Section 26.87(f)(4) directs the collector to inspect the toilet bowl and area once he or she receives the specimen from the donor. The final rule adds these provisions to reduce the opportunities for a donor to subvert the testing process at a location that is not a designated collection site to meet Goal 3 of this rulemaking to improve the effectiveness of FFD programs. The requirements also meet Goal 1 to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines.

Section 26.87(f)(5) amends the portions of former Section 2.4(c)(2) in Appendix A to Part 26 that defined requirements for maintaining control of

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specimens that are not collected at a designated collection site. The final rule permits an ``authorized individual,'' including, for example, a security officer or hospital medical technician, to maintain physical custody and control of specimens, rather than only the collector, as the former rule required. The licensee or other entity must designate the ``authorized individual'' and ensure that he or she is instructed in his or her responsibilities for maintaining custody and control of the specimen. The authorized individual's custody of the specimen must be documented on the custody-and-control form to ensure that the individual may be located should any subsequent questions arise with respect to the collection in a review under Sec. 26.39 or legal proceedings. This change continues to ensure specimen integrity and security, but responds to industry experience, as described by stakeholders at the public meetings discussed in the preamble to the proposed rule. The stakeholders reported that it is sometimes difficult in unusual circumstances, such as the hospital setting, for the collector to maintain physical custody of the specimen until it is prepared for transfer, storage, or shipping. Therefore, the NRC made this change to meet Goal 5 of this rulemaking, to improve Part 26 by eliminating or modifying unnecessary requirements, while also continuing to meet Goal 7 to protect the privacy and other rights

(including due process) of individuals who are subject to Part 26.

Section 26.89 Preparing To Collect Specimens for Testing

This added section describes the preliminary steps that the collector and donor must take before specimens will be collected for drug and alcohol testing. This section reorganizes and amends portions of the former Appendix A to Part 26, and adds several new requirements.

The final rule presents these requirements in a new section to facilitate locating them within the final rule to meet Goal 6 of this rulemaking to improve clarity in the organization of the rule.

Section 26.89(a) provides more detailed requirements than those contained in former Section 2.4(g)(3) in Appendix A to Part 26 for actions to be taken if an individual does not appear for testing. The former rule required the collector to contact an ``appropriate authority'' to determine the actions to take if a donor does not appear for testing. At the public meetings discussed in the preamble to the proposed rule, some stakeholders indicated that the lack of specificity in the former rule with respect to the actions that the ``appropriate authority'' must take in these circumstances has led some FFD programs to interpret this provision as requiring the imposition of the sanctions for a ``refusal to test'' on an individual who fails to appear, including situations in which there is clear evidence that the individual had not been informed that he or she was required to appear for testing or was otherwise not at fault for the failure. This was not the NRC's intent. Therefore, under this new provision, when informed that an individual who was selected for testing has not appeared at the required time, FFD program management must ensure that the circumstances are investigated and determine whether the individual's absence or tardiness represents an attempt to avoid testing and, therefore, subvert the testing process. The final rule requires the licensee or other entity to impose the sanctions specified in Sec. 26.75(b) for a refusal to test only if the investigation identifies evidence that the individual's failure to appear for testing was a subversion attempt. If the investigation does not identify evidence of a subversion attempt, the final rule prohibits the licensee or other entity from imposing sanctions and requires testing the individual at the earliest reasonable and practical opportunity after the individual is located. The NRC has added these more detailed requirements to strengthen the rule's effectiveness in preventing subversion by ensuring that a failure to appear for testing is investigated to increase the likelihood of detecting a willful attempt to avoid testing. In addition, the requirements prevent an individual from being subject to a permanent denial of authorization, as required under Sec. 26.75(b), if the individual's failure to appear is determined to be outside of the individual's control or otherwise not a result of a willful attempt to avoid testing. The agency has made these changes to meet Goal 3 of this rulemaking to improve the effectiveness of FFD programs, and Goal 7 to protect the privacy and other rights (including due process) of individuals who are subject to Part 26.

Section 26.89(b) reorganizes and expands former Section 2.4(g)(2) in Appendix A to Part 26, which required the collector to ensure that an individual who arrives at the collection site for testing is positively identified. The final rule adds more detailed requirements for the reasons discussed with respect to each requirement.

Section 26.89(b)(1) retains the requirement in former Section 2.4(g)(2) in Appendix A to Part 26 for the collector to positively identify the donor before beginning a collection. This section specifies the types of photo identification that the licensee or other entity may accept to establish a donor's identity.

Section 26.89(b)(2) amends the portion of former Section 2.4(g)(2) in Appendix A to Part 26 that directed the collector to stop the collection if the individual cannot be positively identified. The amended provision directs the collector to proceed with the collection and inform FFD program management that the donor did not present acceptable photo identification. This paragraph requires FFD management to take the necessary steps to determine whether the lack of identification is an attempt to subvert the testing process. However, the provision retains the former requirement for the collector to delay the collection until the individual can be identified if it is a pre- access test. The NRC has made these changes for several reasons.

First, lessons learned from implementing the former rule have indicated that the large majority of failures to present acceptable identification result from miscommunication or other errors that are easily resolved. However, stopping or delaying the specimen collection may alter test results (e.g., if an individual has consumed alcohol, the individual's alcohol test result would show a lower BAC after a delay or may not be detected if testing is not conducted). Therefore, collecting the specimens first and then resolving the individual's identity ensures that test results are available and accurate from donors who are currently authorized and whose identity the licensee or other entity has previously confirmed. Therefore, this change meets

Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

Second, the former requirement to stop the collection without investigating the reasons that the individual is unable to present acceptable identification does not ensure that an attempt by an individual to subvert the testing process is detected. For example, an individual who has engaged in substance abuse could delay specimen collection by claiming to have ``forgotten'' his or her photo identification in his or her car or locker. Permitting the individual to leave the collection site to obtain his or her identification provides an opportunity for the individual to obtain an adulterant or substitute urine that he or she could then use to subvert the testing process. Steps that FFD program management could take to investigate

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the reasons that the individual did not present acceptable identification in this instance could include assigning a security officer to accompany the individual to his or her car or locker to verify the individual's claim, as well as to ensure that the individual does not have the opportunity to bring an adulterant or substitute urine back to the collection site. Therefore, the new requirement strengthens the effectiveness of FFD programs in detecting attempts to subvert the testing process.

The final rule modifies the proposed rule to permit an individual's supervisor, except for pre-access tests, to positively identify an individual who appears for testing without acceptable photo identification. The NRC made this change in response to a public comment, which noted that under many FFD programs, supervisors are trusted to notify donors that they have been selected for random testing, and, therefore, it is reasonable to trust supervisors also to verify a donor's identity. The change increases the consistency of Part 26 with access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated

January 7, 2003 (Goal 4 of this rulemaking).

Section 26.89(b)(3) retains the former requirement to delay the specimen collection until the individual presents acceptable identification if it is a pre-access test, at the request of stakeholders during the public meetings discussed in the preamble to the proposed rule. The stakeholders noted that the former requirement to delay pre-access testing until the individual presents acceptable photo identification does not present a risk to public health and safety or the common defense and security from a possible subversion attempt because the individual does not yet have access to sensitive information, radiological materials, or safety systems and equipment.

Furthermore, stakeholders noted that retaining the former provision saves licensees and other entities from the expense associated with collecting and testing a specimen from the wrong individual. Therefore, the NRC believes it is reasonable to retain the former requirement as it relates to pre-access tests.

Section 26.89(b)(4) updates former Section 2.4(g)(4) and 2.4(g)(23)(ii) in Appendix A to Part 26, in which, before any specimens are collected, donors were required to list the prescription and over- the-counter medications they had used within the 30 days before testing. To be consistent with the privacy requirements of the

Americans with Disabilities Act [Pub. L. 101-336, July 26, 1990], the final rule eliminates the requirement to list medications prior to specimen collection and testing. The final rule requires donors to provide medication information to the MRO only in the event of positive, adulterated, substituted, or invalid confirmatory validity and/or drug test result to enhance their rights to privacy under the rule. This revised requirement is also consistent with the procedures of other Federal agencies and meets Goal 1 of this rulemaking to update and enhance the consistency of Part 26 with advances in other relevant

Federal rules and guidelines.

Section 26.89(b)(4) also adds a requirement for the collector to explain the testing procedure to the donor. Former Section 2.2(d)(3) in

Appendix A to Part 26 required providing individuals who are subject to testing with standard written instructions setting forth their responsibilities. However, the NRC is aware that individuals typically receive these instructions as part of the training that is required under former Sec. 26.21 [Policy communications and awareness training] rather than at the collection site before starting the specimen collection process. This was not the intent of Section 2.2(d)(3) in

Appendix A to Part 26. Rather than retaining and clarifying the former provision for standard written instructions that some individuals may have difficulty comprehending, the final rule adopts the related practices of other Federal agencies, which require the collector to explain the testing procedure to the donor. This change ensures that individuals are informed of the testing process in which they must participate and their responsibilities. It also meets Goal 7 of this rulemaking to protect the privacy and other rights (including due process) of individuals who are subject to Part 26, and Goal 1, by enhancing the consistency of Part 26 with the requirements of other

Federal agencies.

The NRC added Sec. 26.89(c) to ensure that the donor is aware of his or her responsibilities to cooperate with the specimen collection process. This paragraph responds to reports from stakeholders at the public meetings discussed in the preamble to the proposed rule that some donors have attempted to obstruct or delay the collection process on the basis that the former rule implied, but did not explicitly state, the donor's responsibility to cooperate with the collection process. Therefore, the new provision eliminates that basis for obstructing or delaying collections, which improves the effectiveness and efficiency of FFD programs, consistent with Goal 3 of this rulemaking.

This section also requires the collector to inform the donor that a failure to cooperate in the specimen collection process is considered a refusal to test and may result in a permanent denial of authorization under Sec. 26.75(b). In response to public comment, the final rule adds examples to those in the proposed rule describing behavior that may be determined to be a refusal to test. In addition to leaving the collection site before the collection is complete, the final rule adds behaving in a confrontational manner that disrupts the testing process; admitting to the collector that the donor has substituted, diluted, or adulterated the specimen; or the collector finds that the donor has a device, such as a prosthetic appliance, the purpose of which is to interfere with providing an actual urine specimen. Other examples could include a donor refusing to permit the collector to examine the contents of the donor's pockets or the donor refusing to wash his or her hands when directed by the collector. The final rule does not provide an exhaustive list of behaviors that comprise a refusal to test because they are too numerous to list. However, the NRC has added these examples for increased clarity in the rule. Informing donors of the potential consequences of failing to cooperate in the collection process, in advance, is consistent with Goal 7 of this rulemaking to protect the privacy and other rights (including due process) of individuals who are subject to Part 26. The requirements of this section also meet Goal 1 to improve the consistency of NRC requirements with those of other Federal agencies.

Section 26.89(d) retains the last two sentences of former Section 2.4(e) in Appendix A to Part 26. These provisions require the collector to conduct only one urine specimen collection at a time and define the point at which the collection process ends, which is when the donor has left the collection site. The NRC has retained these provisions in this paragraph because they relate to the topic of this section, which is preparing for specimen collections, to ensure that collectors are aware of this requirement before they begin collecting any specimens. The change improves the organizational clarity of the rule.

Section 26.91 Acceptable Devices for Conducting Initial and

Confirmatory Tests for Alcohol and Methods of Use

This added section amends requirements in the former rule that addressed alcohol testing devices and

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methods of use. The requirements in the former rule that are related to this topic appeared in former Sec. 26.24(g) and Sections 2.4(g)(18) and 2.7(o)(3)(ii) in Appendix A to Part 26. This section combines these requirements, amends the former requirements, and adds others. The final rule groups these requirements in one section to meet Goal 6 of this rulemaking to improve clarity in the organization of the rule.

The agency added Sec. 26.91(a) [Acceptable alcohol screening devices] to permit the use of alcohol screening devices (ASDs) for initial testing and establish requirements for the ASDs that may be used. Acceptable ASDs include alcohol saliva analysis devices and breath testing devices that are listed on the most recent version of

NHTSA's Conforming Products List (CPL) for ASDs (66 FR 22639; May 4, 2001, and subsequent amendments). Former Section 2.7(o)(3)(ii) in

Appendix A to Part 26 limited FFD programs to using only evidential- grade breath testing devices. However, permitting FFD programs to use

ASDs listed on NHTSA's CPL for initial alcohol testing is consistent with other Federal agencies' procedures for workplace alcohol testing.

Therefore, the change meets Goal 1 of this rulemaking to update and enhance the consistency of Part 26 with advances in other relevant

Federal rules and guidelines.

Further, permitting the use of some ASDs for initial alcohol testing provides increased flexibility in conducting initial alcohol tests. Licensees and other entities may find that, over time, it is less expensive to use a particular ASD than to continue using EBTs for all initial alcohol tests. The option to use alcohol saliva analysis devices also may reduce the burden of alcohol testing for some donors, such as individuals who have impaired lung functioning. The final rule's permission to use ASDs that are listed on NHTSA's CPL for ASDs for initial alcohol testing meets Goal 5 of this rulemaking to improve

Part 26 by eliminating or modifying unnecessary requirements by increasing FFD programs' flexibility in administering initial alcohol tests.

Section 26.91(b) [Acceptable evidential breath testing devices] amends former Section 2.7(o)(3)(ii) in Appendix A to Part 26 and establishes new requirements for the EBTs that licensees and other entities must use for confirmatory alcohol breath testing. The new section requires licensees and other entities to use EBTs that are listed on the most recent version of NHTSA's CPL for evidential breath testing devices without an asterisk (67 FR 62091; October 3, 2002, and subsequent amendments) when conducting confirmatory alcohol tests, and permits licensees and other entities to use these EBTs for conducting initial alcohol tests. The EBTs that are listed without an asterisk incorporate many improvements in EBT technology and have been shown to accurately detect BACs at the 0.02 percent level. Therefore, they are the appropriate instruments to use for confirmatory testing at the revised alcohol cutoff levels specified in Sec. 26.103 [Determining a confirmed positive test result for alcohol].

Further, because these EBTs have been shown to provide valid, reliable, and legally defensible results in other Federal programs that also require workplace alcohol testing, the new requirement to use these EBTs permits two additional changes to the alcohol testing procedures contained in former Section 2.4(g)(18) in Appendix A to Part 26: (1) Collecting only one breath specimen for the initial alcohol test and one for the confirmatory test in Sec. Sec. 26.95(c) and 26.101(c), rather than the two specimens that were required for each test under the former rule; and (2) conducting both the initial and confirmatory tests (if a confirmatory test is required) using the same

EBT in Sec. 26.101(d). As discussed further with respect to Sec. Sec. 26.95(c) and 26.101(c) and (d), these changes to the former alcohol testing requirements improve the efficiency of alcohol testing while continuing to provide valid, reliable, and legally defensible results that are necessary to protect donor's rights under workplace alcohol testing programs. The use of these improved EBTs is similarly required for confirmatory alcohol testing and permitted for initial testing under 49 CFR Part 40. Therefore, this change meets Goal 1 of this rulemaking to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines; Goal 3 to improve the efficiency of FFD programs; and Goal 5 to improve Part 26 by eliminating or modifying unnecessary requirements.

The NRC added Sec. 26.91(c) [EBT capabilities] to specify the required capabilities of the EBTs that licensees and other entities may use for initial alcohol testing and must use for confirmatory alcohol tests. The EBT capabilities listed in Sec. 26.91(c)(1) through (c)(3) are necessary to ensure that a confirmatory alcohol test result can be uniquely associated with the instrument used, the time of testing, and the donor. These capabilities are necessary to establish an unimpeachable chain of custody for confirmatory alcohol test results as well as permit the accurate identification of any test results that may have been affected by instrument malfunctions that are discovered later through additional quality assurance checks. The EBT capabilities listed in Sec. 26.91(c)(4) and (c)(5) ensure that test results will be accurate by requiring collectors to verify before each test that the instrument is functioning properly and there will be no carryover effects from previous testing. With respect to the proposed rule, the final rule revises the language of proposed Sec. 26.91(c)(6) to clarify that EBTs must have the capability to support a calibration check using an external standard in response to public comments that the intended meaning of the proposed provision was unclear. Commenters were unfamiliar with the meaning of the term, ``external calibration check,'' and stated that the proposed provision implied that the EBT itself must be capable of performing an external calibration check to be acceptable for testing under this part. This was not the NRC's intent. As discussed with respect to Sec. 26.91(e)(1), EBT manufacturers must submit a quality assurance plan to NHTSA that, among other attributes, specifies the minimum frequency with which the EBT must be subject to an external calibration check. An external calibration check simulates delivering a breath sample with a known alcohol concentration to the EBT to verify that the EBT is reading within acceptable limits. The external standards used for the calibration checks are typically either wet bath (i.e., a solution of ethanol in water) or dry gas (i.e., a mixture of pressurized gas, usually ethanol in nitrogen) and are delivered to the EBT through a regulator or other device that simulates a human breath exhalation.

Calibrating devices may be included in an EBT ``kit'' or sold separately. Section 26.91(c)(6) of the final rule clarifies that EBTs used for confirmatory alcohol testing must be capable of being calibrated using external standards, rather than implying that the EBTs must be self-calibrating with external standards. The capabilities specified in Sec. 26.91(c)(4) through (c)(6) improve the effectiveness and efficiency of confirmatory alcohol testing by limiting the need to cancel test results due to instrument errors, as required under Sec. 26.91(e)(3). Using EBTs that have the required capabilities for confirmatory alcohol tests protects donors' rights to accurate test results, provides greater assurance that test results will withstand any legal challenges, and improves FFD

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programs' abilities to identify tests that instrument errors may have affected. Therefore, these requirements meet Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

The NRC added Sec. 26.91(d) [Quality assurance and quality control of ASDs] to establish quality assurance and quality control requirements for ASDs. These requirements are necessary to ensure that initial tests that are conducted using an ASD do not yield false negative test results. If an ASD provides a false negative test result, the test would not detect a donor who has an alcohol concentration that exceeds the cutoff levels established in this part, and the donor may be permitted to perform duties while impaired, potentially creating an unacceptable risk to public health and safety or the common defense and security. The final rule continues to require confirmatory testing if initial alcohol test results are positive, so false positive test results from an ASD lead to confirmatory testing, which provides accurate test results. False positive test results from initial testing reduce the efficiency of FFD programs and inconvenience donors by causing them to be subject to unnecessary confirmatory testing, but do not pose any risks to public health and safety or the common defense and security. However, confirmatory testing is not required if the result of an initial alcohol test result is negative. Therefore, the quality assurance and quality control requirements contained in this paragraph are necessary to maintain the effectiveness of FFD programs, which is Goal 3 of this rulemaking.

The agency added Sec. 26.91(d)(1) to require FFD programs to implement the most recent version of the quality assurance plan that a manufacturer has submitted to NHTSA for any ASD that the licensee or other entity uses for initial alcohol testing. To obtain NHTSA approval for an ASD, the manufacturer of the device must submit a quality assurance plan that (1) specifies the methods that must be used for quality control checks, (2) the temperatures at which the ASD must be stored and used, (3) the shelf life of the device, (4) environmental conditions (e.g., temperature, altitude, humidity) that may affect the

ASD's performance, (5) instructions for its use and care, (6) the time period after specimen collection within which the device must be read, where applicable, and (7) the manner in which the reading is made. This paragraph requires licensees and other entities who intend to use an

ASD to obtain and implement the most recent version of the manufacturer's quality assurance plan to ensure that the ASD will not provide false negative test results from improper storage or use. As discussed with respect to Sec. 26.91(d), the new provision is necessary to maintain the effectiveness of FFD programs that rely on

ASDs for initial alcohol testing.

The NRC added Sec. 26.91(d)(2) to prohibit licensees and other entities from using an ASD that fails the quality control checks that are specified in the most recent version of the manufacturer's quality assurance plan or that has passed its expiration date. This prohibition is necessary to ensure that test results from using the ASD are accurate both to protect public health and safety and donors' rights to accurate test results under the rule.

The NRC added Sec. 26.91(d)(3) to require licensees and other entities to follow the device use and care requirements that are specified in Sec. 26.91(e) for any ASD that tests breath specimens.

The agency added this requirement because some ASDs test specimens of oral fluids while others test breath specimens, and some ASDs that test breath specimens also appear on NHTSA's CPL for evidential breath testing devices (67 FR 62091: October 3, 2002, and subsequent amendments). Those ASDs that do test breath specimens and are used for confirmatory testing have more detailed quality assurance and quality control provisions because their results must be legally defensible.

Section 26.91(e) [Quality assurance and quality control of EBTs] establishes new quality assurance and quality control requirements for

EBTs. The new requirements are consistent with those of other Federal agencies that require workplace alcohol testing and, therefore, update and enhance the consistency of Part 26 with advances in other relevant

Federal rules and guidelines.

Section 26.91(e)(1) adds a requirement that licensees and other entities must implement the most recent version of the manufacturer's instructions for the use and care of the EBT consistent with the quality assurance plan submitted to NHTSA for the EBT, including the required frequency for conducting calibration checks using external standards (``external calibration checks''). An EBT manufacturer is required to submit to NHTSA a quality assurance plan that addresses methods used to perform external calibration checks on the EBT, the tolerances within which the EBT is regarded as being in proper calibration, and the intervals at which these checks must be performed.

The final rule requires licensees and other entities to perform calibration checks using external standards at the manufacturer's recommended intervals, at a minimum. These calibration intervals take into account factors such as frequency of use, environmental conditions

(e.g., temperature, humidity, altitude), and type of operation (e.g., stationary or mobile). Therefore, this provision is intended to ensure that the EBT will not provide false test results from improper storage or use.

Section 26.91(e)(2) adds a requirement for licensees and other entities to use only calibration devices appearing on NHTSA's CPL for

``Calibrating Units for Breath Alcohol Tests'' when conducting external calibration checks. This requirement is necessary to ensure that the calibrating units used by licensees and other entities meet minimum standards and provide accurate results.

The final rule adds Sec. 26.91(e)(3) to address circumstances in which an EBT fails an external calibration check. This section requires the licensee or other entity to take the EBT out of service and prohibits its use until it has been repaired and passes an external calibration check. An EBT that has failed an external calibration check must be taken out of service to avoid inaccurate reporting of breath alcohol test results that could result either in the imposition of sanctions on a donor who has not abused alcohol or the failure to identify a donor who has.

The NRC moved and amended the requirement in proposed Sec. 26.91(e)(3) to cancel any positive confirmatory alcohol test results that were obtained from an EBT that fails an external calibration check and also to cancel the results of any tests that were conducted with that EBT subsequent to its last successful external calibration check.

The final rule retains this requirement in Sec. 26.91(e)(4)(i), but presents it as one of two options licensees and other entities must implement if an EBT fails an external calibration check. The final rule adds a second option for handling circumstances in which an EBT fails an external calibration check in Sec. 26.91(e)(4)(ii). This new section permits licensees and other entities to conduct an external calibration check of the EBT after each positive confirmatory alcohol test result. If the EBT fails the check, the provision requires the collector to cancel the donor's test result and perform another initial and confirmatory alcohol test, if necessary, using a different EBT. The requirements to cancel tests from an EBT that has failed an external calibration check are necessary to protect donors' right to accurate testing under the rule because

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positive test results from an EBT that has failed an external calibration check are questionable and donors should not be subject to sanctions on the basis of these test results.

The NRC added Sec. 26.91(e)(4)(ii) in response to a public comment on proposed Sec. 26.91(e)(3). The commenter stated that canceling donors' positive confirmatory test results from an EBT that fails an external calibration check may not adequately protect donors' rights under the rule, if a licensee or other entity performs external calibration checks at the manufacturers' recommended intervals. The commenter noted that most EBT manufacturers' recommended intervals for conducting external calibration checks are 1 month, which could result in several canceled tests, if an EBT has yielded false positive test results that are only discovered when the EBT fails the monthly check.

However, if the licensee or other entity has already imposed sanctions on a donor for a positive confirmatory alcohol test result from the

EBT, the donor will experience the adverse consequences of those sanctions, which may include job loss, before the licensee or other entity identifies the instrument malfunction and cancels the donor's confirmed positive test result.

The NRC considered several options to address this concern, including requiring more frequent external calibration checks, but could not identify a technical basis for establishing schedules that would be more appropriate for every EBT on the NHTSA list than those recommended by the EBT manufacturers. Further, the agency recognizes that canceling tests imposes a burden on licensees and other entities as well as on donors and expects that licensees and other entities will likely choose to conduct external calibration checks more often than recommended by the EBT manufacturers to avoid canceling multiple tests.

Therefore, the final rule retains the proposed requirement as an option in Sec. 26.91(e)(4)(i), but adds a second option for handling circumstances in which an EBT fails an external calibration check in

Sec. 26.91(e)(4)(ii). Under the latter provision, it is unnecessary for a licensee or other entity to cancel any previous donors' confirmed positive alcohol test results from using the EBT because the licensee or other entity will perform the external calibration check after every positive confirmatory test result and no other donors will have been affected by false positive test results from an EBT that fails the check. Under this option, a donor will not be subject to adverse consequences for a false positive test result because the malfunction will be detected before the licensee or other entity imposes any sanctions. The NRC has added this provision to meet Goal 7 of the rulemaking to protect donors' privacy and other rights (including due process) under the rule.

The final rule renumbers as Sec. 26.91(e)(5) the provision contained in Sec. 26.91(e)(4) of the proposed rule. This section requires an EBT manufacturer or a maintenance representative or other individual who is certified by the manufacturer, a State health agency, or other appropriate State agency to inspect, maintain, and calibrate the EBT. This new provision ensures that qualified personnel perform inspection, maintenance, and calibration of EBTs (1) to ensure that the

EBTs used in Part 26 programs continue to provide accurate test results, and (2) because the experience of other Federal agencies that require workplace alcohol testing has demonstrated that such stringent

EBT inspection, maintenance, and calibration requirements are necessary to withstand legal challenges to alcohol test results. The final rule adds ``or other individual who is certified'' to the proposed provision because some licensees and other entities may choose to obtain the required certification for their FFD program personnel or other employees, and the NRC does not intend to prohibit this practice.

Section 26.93 Preparing for Alcohol Testing

This added section expands on former Section 2.4(g)(18) in Appendix

A to Part 26, which specified procedures for alcohol testing. The final rule provides more detailed procedures than the former paragraph to increase the consistency of these procedures with those of other

Federal workplace alcohol testing programs as well as consistency among the alcohol testing procedures of Part 26 programs. The agency added more detailed requirements for the reasons discussed in Section IV.B.

Section 26.93(a) contains more detailed procedures for implementing the requirement in the first sentence of former Section 2.4(g)(18) in

Appendix A. That provision instructed collectors to delay alcohol breath testing for 15 minutes if the donor has engaged in any of the activities listed (e.g., smoking, regurgitation of stomach contents from vomiting). Section 26.93(a)(1) through (a)(6) requires the collector to provide the donor with more detailed information about mouth alcohol and the testing process than was required under the former rule and document that the information is provided. Providing more detailed requirements for the 15-minute waiting period improves the effectiveness and efficiency of the alcohol testing process by reducing false positive test results that are due to residual mouth alcohol or other substances that could potentially trigger a false positive result. Section 26.93(a)(1) retains the former requirement for the collector to ask the donor about behaviors such as eating and drinking that may have occurred within the 15 minutes before an alcohol test and adds a requirement for the collector to advise the donor to avoid these activities during the collection process. Section 26.93(a)(2) permits alcohol testing to proceed if the donor states that none of the activities listed in Sec. 26.93(a)(1) has occurred, while

Sec. 26.93(a)(3) retains the former requirement for a 15-minute waiting period before a donor may be tested if he or she had engaged in the activities listed in Sec. 26.93(a)(1). Section 26.93(a)(4) adds a requirement for the collector to explain that it is to the donor's benefit to avoid the activities listed in Sec. 26.93(a)(1) during the collection process. Section 26.93(a)(5) adds a requirement for the collector to explain to the donor that initial and confirmatory alcohol tests will be conducted at the end of the waiting period regardless of whether the donor has engaged in any of the activities listed in Sec. 26.93(a)(1). Section 26.93(a)(6) adds a requirement for the collector to document that he or she has communicated the instructions to the donor. The additional requirements for the collector to communicate with the donor about the potential effects on test results of the activities listed in Sec. 26.93(a)(1) ensure that donors clearly understand the reasons for avoiding those activities and the potential consequences of engaging in them to protect their rights to accurate test results under the rule. The requirement for the collector to document that the instructions were communicated to the donor ensures that the collector does not inadvertently omit the instructions and, therefore, improves the legal defensibility of the collection procedure, should a donor challenge it.

The final rule adds Sec. 26.93(b) to require collectors to minimize delays in administering for-cause drug and alcohol tests and complete alcohol testing before collecting a specimen for drug testing.

These requirements decrease the likelihood that a donor's test results will fall below the program's cutoff levels as a result of metabolic

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processes over time, which could prevent the detection of proscribed alcohol consumption and drug use. Delays between the time at which a donor reports for testing and the time at which testing occurs continue to be permitted for tests conducted under conditions other than for cause, because, in contrast to for-cause testing, there is no reason to believe that an individual may have used drugs or alcohol in violation of the FFD policy. Therefore, there is no basis for a concern that metabolic processes may cause inaccurate test results. The new provision is consistent with the related regulations of other Federal agencies.

Section 26.95 Conducting an Initial Test for Alcohol Using a Breath

Specimen

Section 26.95 replaces portions of former Section 2.4(g)(18) in

Appendix A to Part 26 that specified procedures for conducting an initial test for alcohol. Collectors follow the procedures in this section when using ASDs that test breath specimens and EBTs. The new section increases the consistency of Part 26 with the procedures of other Federal agencies for workplace alcohol testing. Consistent with other agencies' procedures, the final rule eliminates the requirement in former Section 2.4(g)(18) in Appendix A to Part 26 for collecting a second breath specimen for the initial alcohol test. The experience of other Federal agencies indicates that the former Part 26 requirement for two breath specimens is unnecessary to obtain a valid, reliable, and legally defensible test result if the procedures specified in the new section are followed. Therefore, the final rule amends the former procedures to reduce the burden on FFD programs and donors that is associated with collecting two breath specimens for the initial alcohol test, while continuing to ensure that breath alcohol testing provides accurate results.

The agency added Sec. 26.95(a) to require the collector to start breath testing as soon as reasonably practical after the donor indicates that he or she has not engaged in any activities that may result in the presence of mouth alcohol or after the 15-minute waiting period, if required. The final rule adds the phrase, ``as soon as reasonably practical,'' to this paragraph in response to stakeholder comments at the public meetings discussed in the preamble to the proposed rule. The intent of the provision is for the collector to conduct the initial alcohol test as soon as the individual has received the instructions specified in Sec. 26.93 [Preparing for alcohol testing] to ensure the accuracy of the test result. Delays in conducting the test increase the possibility that the donor may inadvertently engage in a behavior that could result in the presence of mouth alcohol as well as permit the donor's metabolism to lower the alcohol concentration in the specimen if the donor has consumed alcohol. However, the stakeholders noted that when preparing for outages, in which it is sometimes necessary to test large numbers of individuals, collectors often provide the instructions in Sec. 26.93 to groups of donors at the same time and it is not feasible to test each one immediately after providing the instructions. Therefore, the final rule adds the phrase, ``as soon as reasonably practical,'' to permit reasonable delays in testing associated with outage planning.

Section 26.95(b)(1) permits the donor to select a mouthpiece to be used for his or her test, at the collector's discretion. The rule does not require the collector to permit the donor to select the mouthpiece.

However, this practice may increase the donor's confidence in the integrity of the testing process by assuring the donor that the selection of the mouthpiece is random if he or she is concerned that a collector may attempt to subvert the testing process by selecting a mouthpiece that had been contaminated with alcohol or other means of tampering with the testing device. The NRC is not aware of any instances in Part 26 programs in which a donor has accused a collector of altering an alcohol testing device. However, the experience of other

Federal agencies who similarly require workplace alcohol testing indicates that taking steps to reduce potential donor concerns about the integrity of the testing process increases donors' willingness to participate in the testing procedures and reduces the potential for legal challenges.

In Sec. 26.95(b)(2), the NRC has added a requirement for the collector to open the mouthpiece packaging and insert it into the device in view of the donor for the same reason described with respect to Sec. 26.95(b)(1).

Section 26.95(b)(3) requires the donor to blow into the mouthpiece for at least 6 seconds in order to obtain an adequate breath sample.

The NRC deleted the requirement to obtain the specimen from the end of the breath exhalation in former Section 2.4(g)(18) in Appendix A to

Part 26 because it is unnecessary, based on improvements to breath- testing technology.

Section 26.95(b)(4) requires the collector to show the test result to the donor. This requirement is consistent with current industry practices and is intended to increase donor confidence in the integrity of the testing process by ensuring that both the donor and the collector have access to the same information about the donor's test result. The requirement is consistent with Goal 7 of this rulemaking to protect the privacy and other rights (including due process) of individuals who are subject to Part 26, by ensuring that donors are aware of the information used by the collector to determine whether an alcohol test result is positive or negative.

Section 26.95(b)(5) requires the collector to ensure that the test result record can be associated with the donor and is maintained securely, consistent with the many provisions throughout the former and final rules that the chain of custody must be maintained for specimens and the associated documentation of test results. Sections 26.129

Assuring specimen security, chain of custody, and preservation

and 26.159 [Assuring specimen security, chain of custody, and preservation] establish similar requirements for urine specimens at licensee testing facilities and HHS-certified laboratories, respectively.

The NRC has added Sec. 26.95(c) to require the collection of only one breath specimen for the initial test unless problems in the collection require repetition of the collection. Problems in the collection may include, but are not limited to, device malfunctions or a donor's inability to provide an adequate breath specimen on the first try. If a repeat collection is required, the collector must rely on the result from the first successful collection in determining the need for confirmatory alcohol testing. If the procedures specified in this paragraph are followed, relying on one breath specimen for the initial test, rather than the two required in the former rule, increases the consistency of Part 26 collection procedures with those of other

Federal agencies, in accordance with Goal 1 of this rulemaking. The new requirement also reduces the time required for breath specimen collections without compromising the accuracy, validity, or reliability of the test results. Therefore, the provision also meets Goal 3 to improve the efficiency of FFD programs.

Section 26.97 Conducting an Initial Test for Alcohol Using a Specimen of Oral Fluids

The NRC added this section to establish requirements for conducting initial alcohol tests using an ASD for testing oral fluids specimens.

The final rule permits licensees and other entities to rely on ASDs that test oral fluids for

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the reasons discussed with respect to Sec. 26.83(a). The procedures for conducting alcohol testing of oral fluids with an ASD incorporate the related requirements from 49 CFR Part 40 and have been added to the final rule to ensure that initial alcohol tests of oral fluids provide accurate and legally defensible test results.

The agency has added Sec. 26.97(a) to specify the procedures that the collector must follow in using an ASD for testing oral fluids.

Section 26.97(a)(1) requires the collector to check the expiration date on the device and show it to the donor. Because some devices degrade during storage, this step is necessary to assure both the donor and the collector that the device can be expected to function properly.

Section 26.97(a)(2) requires the collector to open an individually wrapped or sealed package containing the device in the presence of the donor for the reasons discussed with respect to Sec. 26.95(b)(1).

Section 26.97(a)(3) requires the collector to offer the donor a choice of using the device or having the collector use it. If the donor chooses to use the device, the collector must provide instructions for its proper use. The final rule requires the collector to offer the donor the choice of using the device to increase the donor's confidence in the integrity of the testing process, as discussed with respect to

Sec. 26.95(b)(1).

Section 26.97(a)(4) requires the collector to gather oral fluids in the proper manner if the donor chooses not to use the device, or in cases in which a second test is necessary because the device failed to activate. In addition, the collector is required to wear single-use examination or similar gloves while doing so and change them following each test. Section 26.97(a)(5) requires the collector to follow the manufacturer's instructions to ensure that the device has activated.

The NRC has added the requirements in these sections to ensure that the collection is properly conducted. The requirement to use single-use examination gloves ensures that the collector and donor are protected from possible infection from exposure to body fluids.

The NRC added Sec. 26.97(b) to specify the procedures that the collector must follow if the first attempt to conduct the test using the ASD fails for any reason, including, but not limited to, the ASD failing to activate or because the device is dropped on the floor.

Section 26.97(b)(1) requires the collector to discard the device and conduct another test using a new device that has been under the collector's control if the first attempt fails. The final rule requires the second device to have been under the collector's control to ensure that the donor or another individual has no opportunity to substitute the new device with another that has been altered to provide a false negative test result. This provision is necessary to protect the integrity of the collection process.

Section 26.97(b)(2) requires the collector to record the reason for the new test. This requirement ensures that the information is available, should any questions arise with respect to the collection procedure in a review conducted under Sec. 26.39 or legal proceedings.

Section 26.97(b)(3) requires the collector to offer the donor the choice of using the device or having the collector use it, unless the collector concludes that the donor was responsible for the new test needing to be conducted. The final rule requires the collector to offer the donor the choice of using the device for the reasons discussed with respect to Sec. 26.95(b)(1). The requirement for the collector to use the device if he or she concludes that the donor was responsible for the second test needing to be conducted enhances the efficiency of the collection procedure by ensuring that the second collection is conducted properly.

Section 26.97(b)(4) requires the collector to repeat the collection procedures outlined in Sec. 26.97(a) for the second collection.

If the second collection attempt fails, Sec. 26.97(c) directs the collector to use an EBT to perform the initial alcohol test instead.

The final rule requires the collector to use an EBT to perform the initial test after two failed attempts at testing oral fluids specimens to ensure that a valid test result is obtained to enhance the efficiency of the collection procedure by changing the method used to conduct the test.

If the specimen collection using the ASD for testing oral fluids is successful, Sec. 26.97(d) instructs the collector to follow the device manufacturer's instructions for reading the result and show the result to the donor. The final rule prohibits the collector from reading the result sooner than instructed by the device manufacturer because some devices require several minutes after specimen collection to provide an accurate result, but no more than 15 minutes in all cases. The requirement for the collector to show the test result to the donor is intended to increase donor confidence in the integrity of the testing process by ensuring that both the donor and the collector have access to the same information about the donor's test result. This paragraph also requires the collector to record the test result and document that an ASD was used to ensure that the information is available, should any questions arise with respect to the collection procedure in a review conducted under Sec. 26.39 or legal proceedings.

To protect collectors and donors from any possible biohazards, the final rule adds Sec. 26.97(e) to prohibit the reuse of any devices, swabs, gloves, and other materials used in collecting oral fluids.

Section 26.99 Determining the Need for a Confirmatory Test for Alcohol

Section 26.99 amends the requirements in former Sec. 26.24(g) and the portion of Section 2.7(e)(1) in Appendix A to Part 26 that addressed cutoff levels for alcohol testing. The final rule amends the former requirements for consistency with a new approach to determining positive alcohol test results in Sec. 26.103. The NRC adopted the new approach because some licensees have not taken appropriate action when a donor has obtained alcohol test results just below the 0.04 percent

BAC cutoff level after the donor has been at work for several hours. A

BAC below 0.04 percent after the donor has been at work for several hours allows very little doubt that the donor has had an unacceptably high BAC, and has probably been impaired, at some time during the work period. Therefore, the final rule establishes new cutoff levels for alcohol testing in Sec. Sec. 26.99 and 26.103 that take into account the average rate at which individuals metabolize alcohol over time. In

Sec. 26.99(a), the agency decreased the cutoff level for the initial alcohol test result from 0.04 to 0.02 percent BAC and requires a confirmatory alcohol test if a donor's initial test result is 0.02 percent BAC or higher. In addition, Sec. 26.99(b) requires the collector to record the time at which the initial alcohol test result is obtained, so that the length of time during which the donor has been in a work status can be calculated to determine whether a confirmatory test result is positive, in accordance with Sec. 26.103. These changes to the initial alcohol test cutoff level and testing procedure are necessary to support the provisions of Sec. 26.103, which require the collector to declare an alcohol test as positive if the donor's confirmatory test result is 0.03 percent or higher after the donor has been on duty for 1 hour, or 0.02 percent or higher after the donor has been on duty for 2 hours. The revised lower cutoff level for the initial test of 0.02 percent BAC permits licensees and other entities to identify donors who

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have had a BAC of 0.04 percent or higher while in a work status, and to initiate confirmatory testing for those individuals.

Section 26.101 Conducting a Confirmatory Test for Alcohol

The NRC added this section to provide detailed procedures for conducting confirmatory breath alcohol tests. These procedures incorporate the related requirements from 49 CFR Part 40, which the NRC has added to the final rule to ensure that confirmatory breath alcohol tests provide accurate and legally defensible test results when using the EBTs that are required in Sec. 26.91(b) [Acceptable evidential breath testing devices] and relying on one breath specimen for confirmatory testing, as is required in Sec. 26.91(c).

Section 26.101(a) requires licensees and other entities to conduct the confirmatory test as soon as possible following the initial alcohol test, and in all cases, no later than 30 minutes after the initial test. The final rule adds this requirement to reduce the possibility that alcohol metabolism will cause a confirmatory test to provide a result falling below the applicable cutoff level. Former Section 2.4(g)(18) in Appendix A to Part 26 did not require conducting a confirmatory test as soon as possible after obtaining a positive initial alcohol test result, although licensees follow this practice.

However, the agency had added a 30-minute limit because some FFD program personnel may be tested under DOT procedures, as permitted in

Sec. 26.31(b)(2), and an EBT that is suitable for confirmatory testing may not be immediately available at the collection site, such that transport to another collection site is required. The 30-minute interim period is unnecessary at licensees' and other entities' collection sites because licensees' and other entities' collection sites must have the capability to conduct confirmatory tests with an EBT, as required under Sec. 26.87(a). Therefore, except in these unusual circumstances, licensees and other entities are expected to continue their current practice of conducting the confirmatory test immediately after a donor's initial test result is determined to be positive.

The NRC added Sec. 26.101(b) to specify procedures for conducting a confirmatory alcohol test.

Sections 26.101(b)(1) and (b)(2) require the collector to conduct an air blank before beginning the confirmatory test and verify that the air blank reading is 0.00. These steps are necessary to ensure that the

EBT is functioning properly before the test begins.

Section 26.101(b)(3) requires the collector to take the EBT out of service if a second air blank test reading is above 0.00. This step is necessary because a reading above 0.00 on an air blank test indicates that the EBT is not functioning properly and may provide inaccurate test results.

The NRC has added Sec. 26.101(b)(4) through (b)(7) to specify requirements for handling the EBT's mouthpiece; reading the test number displayed on the EBT; blowing into the EBT; and showing, recording, and documenting the result displayed on the EBT, respectively. The need for these steps is the same as for those discussed with respect to the related steps in Sec. 26.95 [Conducting an initial test for alcohol using a breath specimen]. However, the final rule does not permit the donor to insert the mouthpiece into the EBT for the confirmatory test because it is necessary to ensure that the confirmatory test is conducted strictly in accordance with the proper procedures to produce a result that meets evidential standards. Meeting evidential standards is necessary if any questions arise with respect to the collection procedure in a review conducted under Sec. 26.39 or legal proceedings.

Section 26.101(c) requires that only one breath specimen must be collected for the confirmatory alcohol test, unless problems in the collection require that the collection be repeated. If a repeat collection is required, the collector must rely on the result from the first successful collection in determining the confirmatory test result. As discussed under Sec. 26.95(c), if the specified procedures are followed, relying on one breath specimen for the initial test rather than the two required in the former rule increases the consistency of Part 26 collection procedures with those of other

Federal agencies. This also reduces the time required for breath specimen collections without compromising the accuracy, validity, or reliability of the test results. This section also prohibits licensees and other entities from combining or averaging results from more than one test in order to arrive at the confirmatory test result. These calculations, required by former Section 2.4(g)(18) in Appendix A to

Part 26, are no longer necessary because of the mandatory use of the

EBTs specified in Sec. 26.91(b). The change meets Goal 3 of this rulemaking to improve the efficiency of FFD programs.

Section 26.101(d) amends the portion of former Section 2.4(g)(18) in Appendix A of Part 26 that required using a different EBT to conduct the confirmatory alcohol test than used for initial alcohol testing.

The final rule permits the use of the same EBT for both initial and confirmatory alcohol testing, instead of requiring the use of two different EBTs. The licensee or other entity must obtain one breath specimen for initial alcohol testing and one for confirmatory testing, if necessary, but is permitted to conduct both tests using the same

EBT. The NRC has made this change because improvements in EBT technology assure that valid and reliable test results may be obtained from a single EBT if the specimen collection and quality assurance procedures in this part are followed. Reducing the number of breath specimens required for alcohol testing not only reduces the costs associated with alcohol testing, but also reduces the burden on donors that the collection process imposes. Use of the same EBT for initial and confirmatory testing is consistent with the procedures of other

Federal agencies for workplace alcohol testing.

Section 26.103 Determining a Confirmed Positive Test Result for Alcohol

Section 26.103 amends the cutoff level for determining whether a confirmatory alcohol test result is positive, as specified in former

Sec. 26.24(g) and Section 2.7(f)(2) in Appendix A to Part 26. This section establishes new cutoff levels that take into account the length of time the donor has been in a work status for the reasons discussed with respect to Sec. 26.99 [Determining the need for a confirmatory test for alcohol]. Section 26.103(a)(1) retains the 0.04 percent BAC in former Sec. 26.24(g) and Section 2.7(f)(2) in Appendix A to Part 26 as the cutoff level for a confirmed positive alcohol test result at any time regardless of the length of time the donor has been in a work status. Sections 26.103(a)(2) and (a)(3) establish new cutoff levels for positive alcohol test results that are above the 0.02 percent BAC cutoff level on the initial test and do not meet or exceed the 0.04 percent BAC cutoff level on confirmatory testing but indicate that the donor had a BAC of 0.04 percent or greater while in a work status or consumed alcohol while on duty. The cutoff levels and time periods in

Sec. 26.103(a)(2) and (a)(3) are based on the average rate at which normal metabolic processes reduce an individual's BAC over time, which is about 0.01 percent BAC per hour. Therefore, a donor whose BAC is measured as 0.03 percent after the donor has been in a work status for 1 hour would have had a BAC of approximately 0.04 percent when he or she reported for work an hour ago.

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Fitness for Duty Programs

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Through the same metabolic processes, a donor whose BAC is measured as 0.02 percent after he or she has been in a work status for 2 hours would also have had a BAC of approximately 0.04 percent when he or she reported for work 2 hours ago. These changes improve the effectiveness of FFD programs by ensuring that confirmatory alcohol testing identifies donors who have been impaired from alcohol use while on duty and, therefore, may have posed a risk to public health and safety.

The NRC added Sec. 26.103(b) to strengthen FFD programs by requiring licensees and other entities to address circumstances in which a donor's confirmatory alcohol test result is greater than 0.01 percent BAC when the individual has been in a work status for 3 hours or more, but his or her BAC falls below the cutoff levels in Sec. 26.103(a). The final rule requires the collector to declare the test as negative because NHTSA has not thoroughly evaluated some of the EBTs that licensees and other entities are permitted to use for confirmatory alcohol testing under the final rule for accurately estimating BAC levels below 0.02 percent. However, if an individual has an alcohol test result above 0.01 percent BAC and has been in a work status for 3 hours or more, the test result provides a reason to believe that the individual has been impaired while on duty. Therefore, the provision requires the licensee or other entity, after testing, to ensure that the donor's alcohol use is evaluated, a determination of fitness is performed, and the determination of fitness indicates that the donor is fit to safely and competently perform his or her duties before the individual is permitted to perform the duties that require him or her to be subject to this part. This change strengthens the effectiveness of FFD programs by ensuring that the alcohol use of individuals who may have been impaired when reporting for duty is assessed to determine whether such individuals' alcohol use is problematic and may pose a future risk to public health and safety and the common defense and security.

The NRC has deleted former Section 2.4(g)(19) in Appendix A to Part 26, which established requirements for collecting a blood specimen for alcohol testing, in its entirety because the final rule no longer permits blood testing for alcohol, at the donor's discretion, for the reasons discussed with respect to Sec. 26.83(a).

Section 26.105 Preparing for Urine Collection

This section is added to describe the preliminary steps for collecting a urine specimen for drug testing. For organizational clarity, this section reorganizes the requirements in former Section 2.4(g)(5) through (g)(7) in Appendix A to Part 26 by separating alcohol and urine specimen collection procedures into separate sections of the final rule. The section also establishes several new requirements that the agency has added to meet Goal 1 of this rulemaking to update and enhance the consistency of Part 26 with advances in other relevant

Federal rules and guidelines.

Section 26.105(a) revises former Section 2.4(g)(5) in Appendix A to

Part 26. The final rule retains the former requirement for the donor to remove any unnecessary outer garments and belongings that might conceal items or substances that could be used to tamper with a urine, breath, or blood specimen. However, the final rule eliminates the references to blood and breath specimens in the former paragraph because the final rule no longer permits donors to request blood testing for alcohol.

This paragraph also eliminates reference to breath specimens because the final rule presents requirements related to preparing for alcohol testing in a separate section (Sec. 26.93) for organizational clarity.

The NRC added Sec. 26.105(b) to require the donor to empty his or her pockets and display the items contained in them. The new requirement for the collector to examine the articles in the donor's pockets increases the likelihood of detecting items (e.g., a vial of powdered urine, bleach, a portable heating unit, a false penis or any other tube or device that may be used to replicate the function of urinary excretion) that could be used to adulterate or substitute the specimen in a subversion attempt. The rule requires the collector to use his or her judgment in determining whether an item found in the donor's pockets indicates a clear intent to attempt to subvert the testing process. For example, whereas a container of urine found in a donor's pocket would be clear evidence of an intent to subvert the testing process, a container of eye drops, which could be used to adulterate the specimen, would, in most cases, be unlikely to indicate an intent to subvert the testing process. Should the collector identify an item that indicates a possible intent to subvert the testing process, this section requires him or her to contact the FFD program manager or MRO in order to obtain direction regarding the need for a directly observed collection. If the collector identifies an item that could be used to tamper with the specimen, but does not indicate an intent to subvert testing, then the collector must secure the item and continue with the collection. The agency added these requirements to meet Goal 1 of this rulemaking to update and enhance the consistency of

Part 26 with advances in other relevant Federal rules and guidelines, as well as Goal 3 to improve the effectiveness of FFD programs, by improving the ability of the collector to identify attempts to subvert the drug testing process. Adding the requirement for the donor to permit the collector to make this examination ensures that donors understand that they must cooperate with the examination.

Section 26.105(c) retains former Section 2.4(g)(6) in Appendix A to

Part 26, which required the individual to be instructed to wash his or her hands prior to urination. The final rule makes two minor editorial changes to the former provision for clarity in the language of the final rule. The final rule clarifies that the collector is to instruct the donor to wash and dry his or her hands and replaces the term

``individual'' with the term ``donor.''

Section 26.105(d) retains former Section 2.4(g)(7) in Appendix A to

Part 26 and requires the donor to remain in the presence of the collection site person and not to have access to any source of water or other materials that could be used to tamper with the specimen. The final rule makes two minor editorial changes to the former provision for clarity in the language of the rule. The final rule replaces the term ``collection site person'' with the simpler term ``collector'' and the term ``individual'' with the term ``donor.''

The NRC added Sec. 26.105(e) to permit the donor, at the collector's discretion, to select the specimen collection container that he or she will use. Permitting the donor to select the collection kit is not required. However, this practice may increase the donor's confidence in the integrity of the testing process by assuring the donor that the selection of the collection kit is random if he or she is concerned that a collector may attempt to subvert the testing process by selecting a kit that had been contaminated with a substance that would produce a positive, adulterated, substituted, or invalid test result in order to entrap the donor. The importance of providing assurance to the donor regarding the integrity of the collection process is discussed with respect to Sec. 26.95(b)(1). This paragraph also prohibits the donor from taking collection kit materials (such as the specimen label) other than the collection container, into the private area used for urination. This prohibition ensures that a donor could not tamper

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with the other collection kit materials and thereby disrupt the chain of custody for the urine specimen.

This section is consistent with the related requirements of other

Federal agencies and so meets Goal 1 of this rulemaking to update and enhance the consistency of Part 26 with advances in other relevant

Federal rules and guidelines, as well as Goal 3 to improve the effectiveness of FFD programs, by improving the ability of the collector to identify attempts to subvert the drug testing process. The final rule adds the new provision requiring the donor to permit the collector to make this examination in response to stakeholder requests at the public meetings discussed in the preamble to the proposed rule to ensure that donors understand that they must cooperate with the examination.

Section 26.107 Collecting a Urine Specimen

Section 26.107 amends former Section 2.4(g)(8), (g)(9), and (g)(12) in Appendix A to Part 26 to update the rule's urine specimen collection procedures and incorporate advances in other relevant Federal rules and guidelines, consistent with Goal 1 of this rulemaking.

The NRC added Sec. 26.107(a)(1) to specify the instructions that the collector is required to provide to the donor. This paragraph requires the collector to instruct the donor to go into the room or stall used for urination, provide a specimen of the quantity that the licensee or other entity has predetermined, refrain from flushing the toilet, and return with the specimen as soon as the donor has completed the void. The final rule requires the collector to provide these instructions to the donor so that the donor understands his or her responsibilities with respect to the urine collection procedure. In addition, the instructions are necessary to implement other provisions of the final rule. For example, the quantity of urine that the collector instructs the donor to provide is based on the requirements of the licensee's or other entity's drug testing program, as discussed with respect to Sec. 26.109 [Urine specimen quantity]. The collector instructs the donor not to flush the toilet so that the collector may inspect the private area in which the donor voided after receiving the specimen, as discussed with respect to Sec. 26.109(c). The collector must instruct the donor to return with the specimen as soon as the donor has completed the void in order to minimize the possibility that the urine specimen cools and its temperature falls below the acceptable specimen temperature range specified in Sec. 26.111(b).

Section 26.107(a)(1) further amends former Section 2.4(g)(8) in

Appendix A to Part 26. The former provision stated that the individual may provide his or her urine specimen in the privacy of a stall or otherwise partitioned area that protects individual privacy. For clarity, this paragraph replaces ``may'' in the former rule with

``shall'' to indicate that the area in which the donor will urinate must provide for individual privacy. The final rule also adds an exception to the former requirement for privacy in the case of a directly observed collection. The agency made this change for greater accuracy in the rule language because the requirement for individual privacy does not apply in the case of a directly observed collection, as discussed with respect to Sec. 26.115.

The NRC added Sec. 26.107(a)(2) to further emphasize the requirement in former Section 2.4(g)(8) in Appendix A to Part 26 that donors must be afforded individual privacy when providing a urine specimen. The new paragraph requires that, unless the specimen is to be collected under direct observation, no one other than the donor may go into the private area in which the donor will urinate. Although the NRC is not aware of any instances in Part 26 programs in which the former requirement for individual privacy has been compromised, the experience of other Federal agencies has indicated that such emphasis is necessary.

Section 26.107(a)(3) permits the collector to set a reasonable time limit for the donor to void. Rather than establishing a specific time limit, the final rule permits the collector to rely on his or her professional judgment in order to ensure that individuals who may experience difficulty in voiding have sufficient time to provide a specimen while also permitting collectors to prevent donors from disrupting the testing process by taking an unduly long time to provide a specimen. In Sec. 26.85(a), the rule specifies new training and qualification requirements to ensure that collectors are able to exercise professional judgment appropriately. At the public meetings discussed in the preamble to the proposed rule, stakeholders reported incidents in which donors appeared to be attempting to disrupt the testing process by spending an unduly long time providing a specimen and challenged the collector's authority to set a time limit. The new paragraph clarifies that collectors have the authority to set a reasonable time limit for voiding. In addition, this paragraph increases the consistency of Part 26 with the procedures implemented by other Federal agencies in accordance with Goal 1 of this rulemaking.

Section 26.107(b) amends former Section 2.4(g)(9) in Appendix A to

Part 26. The former provision required the collector to note any unusual behavior or appearance in the permanent record book and on the custody-and-control form. This section clarifies the intent of the former requirement, which raised implementation questions from licensees, by specifying that the collector must pay careful attention to the donor during the collection process so that the collector can note any conduct that may indicate an attempt to substitute or tamper with the specimen. This section also provides examples of the types of behavior that may indicate a subversion attempt and requires the collector to contact FFD program management if he or she observes such behavior. This section requires FFD program management to determine whether a directly observed collection is necessary under Sec. 26.115.

The NRC added Sec. 26.107(c) to specify the actions to be taken by the collector and donor to complete the specimen collection procedure.

The first sentence of Sec. 26.107(c) retains the instruction in former

Section 2.4(g)(12) in Appendix A to Part 26 that prohibits the donor from washing his or her hands until the specimen has been delivered to the collector. This paragraph also adds a requirement for the collector to inspect the private area for any evidence of a subversion attempt prior to flushing the toilet. This additional requirement is consistent with existing industry practices and the procedures of other Federal agencies. It is intended to increase the likelihood of detecting subversion attempts if the donor leaves any physical evidence in the toilet bowl or private area where the donor voided, which could include, but is not limited to, an empty vial that contains an adulterant, powdered urine spilled on the floor, or the remains of an adulterant in the toilet bowel.

Section 26.109 Urine Specimen Quantity

Section 26.109 amends former Section 2.4(g)(11) in Appendix A to

Part 26. The former provision established 60 milliliters (mL) as the minimum quantity of urine that an FFD program must collect from donors and the procedures to be followed if a donor is unable to provide the specified quantity. The final rule reduces to 30 mL the basic quantity of urine to be collected.

Section 26.109(a) introduces a new term ``the predetermined quantity.'' The licensee or other entity establishes a

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predetermined quantity of urine that each donor is requested to provide, depending on the characteristics of the licensee's or other entity's testing program. The final rule requires the predetermined quantity to include at least 30 mL of urine, but licensees and other entities may request a larger quantity of urine if--

The specimen will be initially tested at a licensee testing facility;

Testing will be conducted for additional drugs beyond those required in Sec. 26.31(d)(1);

Split specimen procedures will be followed; or

The licensee's or other entity's program includes some combination of these characteristics.

The NRC has reduced the 60-mL quantity that was required in former

Section 2.4(g)(11) in Appendix A to Part 26 to 30 mL to decrease the burden on donors, while ensuring that a sufficient quantity of urine is available to complete initial validity and drug tests, confirmatory validity and drug tests (if required), and any retests that may be requested by the donor and authorized by the MRO under Sec. 26.165(b).

NRC staff discussions with representatives of HHS-certified laboratories indicated that advances in testing technologies allow for these minimum testing and retesting procedures to be completed on a 30- mL specimen. Therefore, a 60-mL specimen is no longer necessary to achieve the NRC's minimum objectives of conducting validity and drug tests on each specimen for the five classes of drugs specified in Sec. 26.31(d)(1), as well as retesting of the specimen, if required.

Section 26.109(a) also specifies the additional quantity of urine, above the basic 30 mL, to be collected when the testing program follows split specimen procedures. The rule requires licensees and other entities to collect an additional 15 mL for transfer into Bottle B of a split specimen for storage and possible testing. (As discussed with respect to Sec. 26.113(b), the final rule replaces the terms,

``primary specimen'' and ``split specimen,'' in the former rule with the terms, ``Bottle A'' and ``Bottle B,'' for clarity in the language of the rule and consistency with the terminology used by other Federal agencies.) This additional 15 mL is sufficient to permit the HHS- certified laboratory to conduct validity and drug tests of the specimen in Bottle B, at the donor's request, and is consistent with the quantity required in the related provisions of other Federal agencies.

Therefore, if a licensee's or other entity's testing program follows split specimen procedures, but does not include initial tests at the licensee testing facility or testing for additional drugs beyond those specified in Sec. 26.31(d)(1), then the predetermined quantity for this testing program is 45 mL (30 mL for basic testing + 15 mL for the split specimen). The predetermined quantity must be larger than 45 mL if the testing program also includes initial tests at a licensee testing facility and testing for additional drugs.

Section 26.109(a) also permits licensees and other entities to include in the predetermined quantity the additional amount of urine that is necessary to support testing for additional drugs beyond those specified in Sec. 26.31(d)(1). Licensees and other entities must consult with the HHS-certified laboratories they use to identify the quantity of urine required to test for the additional drugs. For example, if the licensee's or other entity's testing program does not include initial tests at a licensee testing facility and does not follow split specimen procedures, then the predetermined quantity for that testing program consists of the 30-mL basic quantity plus the additional amount of urine needed to test for additional drugs. As another example, if a licensee's or other entity's testing program includes initial tests at a licensee testing facility, follows split specimen procedures, and tests for additional drugs, then the predetermined quantity consists of the 30-mL basic quantity plus 15 mL for the split specimen plus the additional amount required by the licensee testing facility and HHS-certified laboratory to test for the additional drugs.

Section 26.109(a) also permits licensees and other entities to include in the predetermined quantity the additional amount of urine that is necessary to perform initial validity and drug tests at the licensee testing facility, if initial tests are performed there. For example, one licensee testing program currently requires an additional 10 mL of urine for initial testing at the licensee testing facility, but does not test for other drugs or follow split specimen procedures.

In this program, the predetermined quantity that collectors must request the donor to provide is 40 mL. As another example, if a licensee's or other entity's testing program includes initial tests at the licensee testing facility, does not test for additional drugs, and follows: split specimen procedures, the predetermined quantity may be 55 mL (30 mL for basic testing + 15 mL for the split specimen + 10 mL for initial testing at the licensee testing facility). If this program also tests for additional drugs, the predetermined quantity may be larger than 55 mL.

The final rule adds Sec. 26.109(b) to establish the actions that the collector must take if a donor provides a specimen that is less than the 30-mL basic quantity. NRC staff discussions with representatives of HHS-certified laboratories indicated that 30 mL is sufficient to meet the NRC's primary objectives of detecting drug use and subversion attempts through initial validity and drug testing, and for confirmatory validity and drug tests, if required, at an HHS- certified laboratory for the panel of drugs for which testing is required in Sec. 26.31(d)(1). The 30-mL quantity also ensures that sufficient urine is available for retesting the specimen for validity and for drugs and drug metabolites, should the donor request such retesting, as permitted in Sec. 26.165(b). Therefore, the 30-mL basic quantity is necessary to achieve the NRC's drug-testing objectives, although it is insufficient to permit testing for additional drugs, initial testing at licensee testing facilities, or splitting the specimen, which this part does not require.

Section 26.109(b)(1) amends the portions of former Section 2.4(g)(11) in Appendix A to Part 26 that prescribed collector actions if a donor provides an insufficient specimen. The final rule requires the collector to ``encourage'' the donor to drink a reasonable amount of liquid in order to provide a specimen of at least 30 mL, rather than

``allow'' the donor to drink additional liquid as required under the former rule. The NRC made this change to enhance the efficiency of FFD programs, consistent with Goal 3 of this rulemaking, by potentially reducing the time required to obtain a specimen of the required quantity from the donor and, thereby, to complete the collection, should the donor choose to comply. However, this paragraph establishes a limit on the amount of liquid that the individual is permitted to consume to avoid the potential for ``water intoxication,'' which is a physical response to consuming too many liquids that may cause harm to the donor. Although the limit of 24 ounces of water over a 3-hour period in the proposed rule is the same limit imposed in the HHS

Guidelines, the NRC raised the limit in the final rule to 40 ounces over a 3-hour period for consistency with the DOT limit, in response to public comment. This limit continues to be conservative to ensure that individuals who may have a medical condition that makes them more subject to water intoxication, such as some forms of renal disease, or who are taking some medications, would not be placed at risk. The final rule retains

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the former requirement in Section 2.4(g)(11) in Appendix A to Part 26 to collect successive specimens in separate containers.

The NRC added Sec. 26.109(b)(2) to require the collector to end the specimen collection process as soon as the donor provides a specimen of at least 30 mL in a subsequent attempt. This requirement reduces the burden on donors who may have some difficulty providing a urine specimen while meeting the NRC's objectives of obtaining a specimen of sufficient size to support initial and confirmatory validity and drug testing, as well as retesting of the specimen.

Section 26.109(b)(2) also specifies that the licensee or other entity may not impose any sanctions if a donor provides a subsequent specimen that is less than the licensee's or other entity's predetermined quantity, as long as the specimen quantity is at least 30 mL. Imposing sanctions for failing to provide sufficient urine to support initial testing at the licensee's testing facility, split specimen procedures, or testing for additional drugs is inappropriate, because a specimen of at least 30 mL is sufficient to meet the NRC's objectives and, therefore, could not be considered a refusal to test.

Section 26.109(b)(2) also requires the collector to forward a subsequent specimen that is greater than 30 mL, but less than the licensee's or other entity's predetermined quantity, to the HHS- certified laboratory for testing, rather than permit the specimen to be tested at the licensee testing facility. This provision is necessary to ensure that a sufficient quantity of urine is available for validity and drug testing and retesting at the HHS-certified laboratory, if required, consistent with the NRC's objectives. However, if the subsequent specimen is equal to or greater than the licensee's or other entity's predetermined quantity, the licensee or other entity is permitted to follow the FFD program's normal testing procedures.

Following normal testing procedures in this instance is permissible because there is sufficient urine to implement the FFD program's testing procedures (e.g., split specimen procedures, testing for additional drugs, initial testing at a licensee testing facility), while continuing to ensure that sufficient urine is available for testing and retesting at the HHS-certified laboratory, if required.

The agency added Sec. 26.109(b)(3) to require the implementation of ``shy bladder'' procedures if a donor is unable to provide a 30-mL specimen within 3 hours of the initial attempt to provide a specimen, for the reasons discussed with respect to Sec. 26.119. Requirements for implementing ``shy bladder'' procedures are contained in that section.

The NRC added Sec. 26.109(b)(4) to establish additional requirements for specimen collections when a donor provides a specimen of less than 30 mL.

This section eliminates the requirement in former Section 2.4(g)(11) in Appendix A to Part 26 to combine successive specimens from a donor in order to obtain a specimen of 60 mL. The final rule prohibits the practice of combining specimens to ensure that successive specimens neither contaminate nor dilute a specimen that will be tested. In addition, the prohibition increases the consistency of Part 26 with the related requirements of other Federal agencies (Goal 1 of this rulemaking).

Section 26.109(b)(4) also requires the collector to discard any specimens of less than 30 mL unless there is reason to believe that a specimen may have been altered. Examples of reasons to believe that a donor may have attempted to alter the specimen may include, but are not limited to: (1) Observation of powder (that could be an adulterant or powdered urine) spilled in the private area in which the donor urinated or on the donor's clothing; (2) unexpected sounds from the private area while the donor should be voiding, such as the sound of something being unwrapped or dropping to the floor; (3) observation that the donor's pocket appears to contain an item that was not visible before the donor entered the private area (that the donor may have previously had taped to his body); and (4) an unusual color or lack of clarity in the urine specimen. The final rule requires the collector to discard specimens of less than 30 mL when there is no reason to believe that the specimens have been subject to tampering because they are not used for testing and there is no reason to retain them.

If the collector suspects that a specimen has been altered and the suspect specimen is equal to or greater than 15 mL, the rule requires the collector to forward the suspect specimen to the HHS-certified laboratory for testing, consistent with former Section 2.4(g)(16) in

Appendix A to Part 26. NRC staff discussions with representatives of

HHS-certified laboratories indicate that 15 mL is the minimum quantity necessary for HHS-certified laboratories to perform the initial and confirmatory (if necessary) validity and drug testing required in this part, although it is insufficient to support retesting of the specimen at the donor's request. When the collector has observed donor conduct or specimen characteristics that indicate there is a reason to believe that the donor may have altered the specimen, the NRC's interest in assuring that the testing process is not subverted takes precedence over the donor's ability to request retesting of the specimen. Any results of validity testing that confirm that the specimen was adulterated or substituted, in combination with the collector's observations, provide clear evidence that a donor has tampered with the specimen and thereby attempted to subvert the testing process.

This section also amends former Section 2.4(g)(17) in Appendix A to

Part 26. The former provision required a directly observed collection whenever there is a reason to believe that a donor has or may attempt to alter a specimen. The amended provision requires the collector to contact FFD program management to determine whether a directly observed collection is required, but does not require a directly observed collection in every circumstance. At the public meetings discussed in the preamble to the proposed rule, the stakeholders requested flexibility in the decision to collect another specimen under direct observation. They noted that numerous instances have occurred in which a collector identified incontrovertible evidence that the donor intended to or had tampered with a specimen and that, in such cases, drug testing would not provide additional information that justifies the costs associated with conducting a directly observed collection and testing the additional specimen. The NRC believes that the presence of drugs and drug metabolites in a specimen that is collected under direct observation establishes a clear motive for an alleged attempt to tamper with a specimen and adds further evidence supporting the imposition of sanctions on the donor for attempting to subvert the testing process.

However, the NRC believes that such additional evidence is unnecessary when there is incontrovertible evidence that the donor intends to or has attempted to tamper with a specimen. Therefore, the final rule permits FFD program management to determine whether an additional specimen collection under direct observation must be conducted. The agency has made this change to meet Goal 3 of this rulemaking to improve the efficiency of FFD programs, by reducing the number of directly observed collections required under the rule.

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Section 26.111 Checking the Acceptability of the Urine Specimen

Section 26.111 amends former requirements for assessing specimen validity at the collection site, which appeared in Section 2.4(g)(13) through (g)(17) in Appendix A to Part 26. In general, the NRC has made changes in this section to meet Goal 1 of this rulemaking to update and enhance the consistency of Part 26 with advances in other relevant

Federal rules and guidelines. In addition, the NRC changed the heading of this section from ``Checking the validity of the urine specimen'' in the proposed rule to ``Checking the acceptability of the urine specimen,'' in response to a public comment which noted that

``acceptability'' more accurately characterizes the purpose of the requirements in this section.

Section 26.111(a) amends former Section 2.4(g)(13) in Appendix A to

Part 26. The former provision required the collector to measure the temperature of the specimen immediately after the urine specimen is collected. The new provision requires the collector to measure the temperature of any specimen that is 15 mL or more. The final rule does not mandate measuring the temperature of smaller specimens because the collector is required to discard them, as discussed with respect to

Sec. 26.109(b)(4). This paragraph also replaces former Section 2.4(g)(14) in Appendix A to Part 26, which established the acceptable specimen temperature range and required conducting a second specimen collection under direct observation if a specimen's temperature falls outside the acceptable range. The final rule increases the range of acceptable specimen temperatures from 90.5[deg]F-99.8[deg]F in the former provision to 90[deg]F-100[deg]F for consistency with the temperature range specified in the HHS Guidelines. The wider acceptable temperature range provides increased protection against false low or false high temperature readings and, therefore, protects donors from the imposition of sanctions based on inaccurate specimen temperature readings. The portion of former Section 2.4(g)(14) that specified collector actions if there is a reason to believe that the individual may have tampered with the specimen has been moved to Sec. 26.111(d) for organizational clarity.

In response to a public comment, the final rule eliminates the requirement in Sec. 26.111(a), which appeared in both the former and proposed rules, for the collector to offer the donor an opportunity to provide a measurement of body temperature. In addition, the final rule deletes Sec. 26.111(b) in the proposed rule entirely and has renumbered the paragraphs in this section accordingly. The NRC has made these changes in response to public comments, which reported that DOT's experience indicates that there are often discrepancies when comparing the temperature provided by a specimen container temperature strip and that provided by a device that measures body temperature. Further, with the increase in the range of acceptable specimen temperatures, as discussed with respect to Sec. 26.111(a), a measurement of body temperature is less useful to counter a reason to believe that the donor has altered the specimen (e.g., humans who have a body temperature at or below 90[deg]F would be suffering from severe hypothermia). Therefore, eliminating the opportunity for a donor to provide a measure of body temperature in this paragraph meets Goal 5 of this rulemaking to improve Part 26 by eliminating or modifying unnecessary requirements.

Section 26.111(b) amends former Section 2.4(g)(15) in Appendix A to

Part 26. The former provision required the collector to inspect the specimen's color, determine whether there were any signs of contaminants, and record any unusual findings in the permanent record book. The final rule amends this provision by deleting reference to the permanent record book and requiring the collector to use the custody- and-control form to record this information. The NRC has made this change because the final rule no longer requires collection sites to maintain a permanent record book, consistent with the elimination of the requirement to maintain a permanent record book in the HHS

Guidelines. The final rule also makes minor editorial revisions to the former provision by incorporating the related language from the HHS

Guidelines. The agency made these changes to meet Goal 1 of this rulemaking to update and enhance the consistency of Part 26 with the regulations of other Federal agencies.

Section 26.111(c) replaces and amends the first sentence of former

Section 2.4(g)(14) in Appendix A to Part 26. The former provision required a second specimen to be collected under direct observation if the temperature of the first specimen submitted by a donor fell outside of the acceptable specimen temperature range. The final rule eliminates the requirement for a second specimen collection under direct observation if the specimen temperature falls outside of the required range, although licensees and other entities could, at their discretion, continue this practice. Instead, the new provision requires the collector to contact the FFD program manager, if the collector has a reason to believe the donor has attempted to subvert the testing process based on observed donor behavior, the specimen temperature, unusual specimen characteristics, or other observations. The FFD program manager, at his or her discretion, may consult with the MRO to determine whether the collector's observations provide sufficient evidence that a subversion attempt has occurred to warrant the imposition of sanctions. If the MRO and/or FFD program manager determine that a subversion attempt has occurred on the basis of the collector's observations, the final rule permits the licensee or other entity to impose the sanctions for a subversion attempt in Sec. 26.75(b) without conducting a directly observed collection. However, at the FFD program manager's or the MRO's discretion, a second specimen may be collected under direct observation. The rule permits a second specimen to be collected under direct observation to provide further information to assist the MRO in determining whether or not a subversion attempt has occurred. For example, positive drug test results from a second specimen that is collected under direct observation provide additional evidence that the donor attempted to tamper with his or her first specimen to hide drug use. The NRC has made this change in response to stakeholder requests, for the reasons discussed with respect to proposed Sec. 26.109(b)(4).

The NRC also added permission in Sec. 26.111(c) for a donor to volunteer to submit another specimen under direct observation to counter any reason to believe that he or she may have altered the first specimen. The agency added this permission in response to a public comment suggesting this change and because it is consistent with Goal 7 of the rulemaking to protect donor's rights (including due process) under the rule.

Section 26.111(d) replaces and revises former Section 2.4(g)(16) in

Appendix A to Part 26. The former provision required forwarding all urine specimens that are suspected of being adulterated or diluted to the HHS-certified laboratory for testing. The final rule adds a third reason, suspicion that a specimen has been substituted, for forwarding a specimen to the HHS-certified laboratory. As discussed with respect to Sec. 26.31(d)(3)(i), substitution entails replacing a valid urine specimen with a drug-free specimen. The NRC has made this change for consistency with the addition of substitution to the final

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rule as another method of attempting to subvert the testing process for which licensees and other entities are required to impose sanctions, as discussed with respect to Sec. 26.75(b). This paragraph also adds a provision that specifically prohibits testing any suspect specimen at a licensee testing facility to (1) limit the potential for specimen degradation during the time period required to conduct testing at the licensee testing facility; (2) decrease the time required to obtain confirmatory validity test results if the specimen, in fact, has been altered; and (3) ensure that a sufficient quantity of urine is available for conducting validity tests at more than one HHS-certified laboratory if, for example, the specimen contains a new adulterant or an adulterant that the licensee's or other entity's primary laboratory is not capable of identifying (see Sec. 26.161(g)). Only suspect specimens of 15 mL or more must be sent for testing, rather than all specimens. The final rule establishes this lower limit on specimen quantity to ensure that there is sufficient urine available for the

HHS-certified laboratory to conduct all of the validity and drug tests on the specimen that are required under this part. In response to a comment, this paragraph of the final rule also adds a requirement to send specimens of 15 mL or more, collected under direct observation in accordance with Sec. 26.111(c), to an HHS-certified laboratory for initial and confirmatory testing.

Section 26.111(e) requires collectors and the HHS-certified laboratory to preserve as much of a suspect specimen as possible. The

NRC has added this requirement to provide increased assurance that a sufficient quantity of urine is available to support further testing, in the event that further testing of the specimen is necessary, and to enhance the consistency of Part 26 with the related provisions of other

Federal agencies.

The agency also added Sec. 26.111(f) to inform donors and collectors of the characteristics of a specimen that is acceptable for testing at an HHS-certified laboratory. This paragraph incorporates the related provision from the HHS Guidelines.

Section 26.113 Splitting the Urine Specimen

Section 26.113 updates former Sections 2.4(g)(20) and 2.7(j) in

Appendix A to Part 26. This section amends collection site procedures for split specimens in the former rule and groups them together in one section within the final rule for organizational clarity.

Section 26.113(a) of the final rule revises the same provision in the proposed rule, in that the NRC has deleted the phrase ``who are subject to this part'' to provide additional clarity to the language of the rule, in response to public comment. The NRC deleted this phrase because not all of the licensees and entities who are subject to Part 26 are required to meet the requirements of this section.

For organizational clarity, the NRC has added Sec. 26.113(b) to group together in one paragraph the steps that the collector and donor must follow for the split specimen collection procedure. These steps were embedded in former Section 2.4(g)(20) and portions of Section 2.7(j) in Appendix A to Part 26. The final rule also replaces the terminology used in the former rule that referred to the split specimen as an ``aliquot,'' and uses the terms, ``Bottle A'' and ``Bottle B,'' to refer to the primary and split specimen, respectively. The agency made these changes for increased clarity in the language of the rule and consistency with the terminology used in other relevant Federal rules and guidelines.

In response to a public comment, the NRC revised proposed Sec. 26.113(b)(1) to delete the option of using a specimen bottle to collect a urine specimen to eliminate the possibility of problems arising from collecting urine in two different types of containers. The final rule retains the requirement for the collector to instruct the donor to void into a specimen container to clarify that the donor is not required to divide a specimen into Bottle A and Bottle B while urinating. This paragraph incorporates the related provision in the HHS Guidelines.

Section 26.113(b)(2) amends the portions of former Section 2.7(j) in Appendix A to Part 26 that specified the amount of urine to be poured into the split specimen bottles. The rule replaces the implied requirements in the second and third sentences of Section 2.4(j), which referred to the split specimens as ``halves'' of the specimen that was collected, with updated requirements that are consistent with those established in Sec. 26.109 and the related provisions in the HHS

Guidelines. This paragraph requires the collector to ensure that Bottle

A contains 30 mL and that Bottle B contains a minimum of 15 mL of urine. As discussed with respect to Sec. 26.109, advances in urine testing technologies since the agency first promulgated Part 26 permit a reduction in the quantity of urine that must be collected from donors in order to conduct the testing this part requires. Therefore, 30 mL of urine is now a sufficient quantity for conducting all of the testing that may be required under this part and 15 mL is sufficient for conducting testing of the specimen in Bottle B.

In response to public comment, the NRC has revised this paragraph in the final rule to more clearly specify that the specimen in Bottle A must be used for drug and validity testing even if there is less than 15 mL of urine available for Bottle B. The agency added this clarification to the final rule because, in the experience of other

Federal agencies, some collection sites have discarded any specimen of less than 45 mL and conducted another collection to obtain a sufficient amount of urine to fill both Bottles A and B. Following this practice would reduce the efficiency of FFD programs and unnecessarily increase the burden on donors who are subject to testing. The final rule incorporates this clarification from the HHS Guidelines to ensure that

Part 26 programs do not adopt this inefficient and burdensome practice.

Section 26.113(b)(3) retains the portion of former Section 2.4(g)(20) in Appendix A to Part 26 that requires the donor to observe the process of splitting the specimens and maintain visual contact with the specimen bottles until they are sealed and prepared for storage or shipping.

The NRC added Sec. 26.113(c) to establish priorities for using the specimen that has been collected. The paragraph permits the licensee testing facility to test aliquots of the specimen at a licensee testing facility or to test for additional drugs beyond those required under

Sec. 26.31(d)(1), but only if the donor has provided a specimen of at least the predetermined quantity, as discussed with respect to Sec. 26.109. As discussed with respect to Sec. 26.113(b)(2), the final rule requires the collector first to ensure that 30 mL of urine is available for Bottle A and 15 mL for Bottle B. If the donor has provided more than 45 mL of urine and the additional amount is sufficient to support testing at the licensee testing facility, testing for additional drugs, or both, the final rule permits the remaining amount of urine to be subject to such testing. However, if the donor has provided only 45 mL of urine, the final rule requires that the 15 mL of urine that remains after 30 mL has been retained for Bottle A must be used for Bottle B rather than to conduct testing at the licensee testing facility or testing for additional drugs. The final rule establishes this priority because the FFD program has established the expectation among donors in this instance that the FFD program will follow split specimen procedures and

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that Bottle B will be available for retesting at the donor's request.

Reserving the 15 mL of urine for Bottle B is also consistent with the principle that is established in the last sentences of Sec. Sec. 26.135(b) and 26.165(a)(4) that control over testing of the specimen contained in Bottle B resides with the donor.

Section 26.115 Collecting a Urine Specimen Under Direct Observation

Section 26.115 groups together in one section the former rule's requirements that apply to collecting a urine specimen under direct observation. The NRC has made this organizational change because requirements that address this topic were dispersed throughout the former rule. This section also incorporates more detailed procedures for collecting specimens under direct observation that are based on related requirements from other relevant Federal rules and guidelines.

More detailed procedures are necessary because devices and techniques to subvert the testing process have been developed since Part 26 was first published that are difficult to detect in many collection circumstances, including under direct observation, such as a false penis or other realistic urine delivery device containing a substitute urine specimen and heating element that may be used to replicate urination. Therefore, the agency has made these changes to increase the likelihood of detecting attempts to subvert the testing process and increase the effectiveness of directly observed collections in assuring that a valid specimen is obtained from the donor.

Section 26.115(a) amends and combines former Section 2.4(f), 2.4(g)(17), and (g)(25) in Appendix A to Part 26. The former provisions established requirements for collecting a urine specimen under direct observation. This paragraph of the final rule assigns responsibility for approving a directly observed collection to the MRO or FFD program manager, rather than a ``higher level supervisor'' of the collector, as stated in former Section 2.4(b)(25) in Appendix A to Part 26. This change ensures that an individual who is thoroughly knowledgeable of the requirements of this part, and the emphasis that the NRC places on maintaining the individual privacy of donors, makes the decision to conduct a directly observed collection. The change is also consistent with revised requirements in the HHS Guidelines related to who may authorize a directly observed collection.

The final rule also lists the circumstances that constitute a reason to believe that a donor may dilute, substitute, adulterate, or otherwise alter a specimen, and that warrant the invasion of individual privacy associated with a directly observed collection.

Section 26.115(a)(1) amends former Section 2.4(f)(2) in Appendix A to Part 26, which stated that a directly observed collection may be performed if the last urine specimen provided by the donor yielded specific gravity and creatinine concentration results that were inconsistent with normal human urine. The new paragraph amends the former provision in several ways.

First, the final rule eliminates the limitation in the former paragraph that a specimen may be collected under direct observation if

``the last urine specimen'' provided by the individual yielded specific gravity and creatinine concentration results that are inconsistent with normal human urine. The final rule permits a directly observed collection if the donor had presented a specimen with characteristics that are inconsistent with normal human urine ``at this or a previous collection.'' The change is consistent with Sec. 26.75(b), which requires that an individual who has subverted or attempted to subvert any test conducted under Part 26 must be subject to a permanent denial of authorization. Because Sec. 26.75(b) requires permanent denial of authorization to a donor who has engaged in a subversion attempt, individuals whose last specimen had characteristics that are inconsistent with normal human urine are not subject to further testing under the rule. However, instances may arise in which a licensee or other entity is aware that an individual engaged in a subversion attempt under a drug testing program that the NRC does not regulate. If the licensee or other entity is considering granting authorization under Part 26 to the individual, then a directly observed collection is warranted to ensure that the donor does not have an opportunity to tamper with the specimen and, therefore, that drug test results will be accurate. The amended language of the new provision permits collecting a specimen under direct observation in these circumstances.

Second, the final rule updates the former provision by replacing the specific gravity and creatinine concentration values in the former paragraph with references to a urine specimen that ``the HHS-certified laboratory reported as being substituted, adulterated, or invalid to the MRO and the MRO reported to the licensee or other entity that there is no adequate medical explanation for the result.'' The NRC made this change for consistency with the addition of more detailed requirements for validity testing throughout the final rule, as discussed with respect to Sec. 26.31(d)(3)(i). Section 26.161 [Cutoff levels for validity testing] specifies the cutoff concentrations and specimen characteristics that require the HHS-laboratory to report a specimen as substituted, adulterated, or invalid. Section 26.185 [Determining a fitness-for-duty policy violation] specifies the requirements for the

MRO's review of these test results.

Section 26.115(a)(2) combines and updates former Sections 2.4(f)(1) and 2.4(g)(14) in Appendix A to Part 26. The former provisions stated that the presentation of a specimen that falls outside of the required temperature range is sufficient grounds to conduct a directly observed collection. The new paragraph retains the requirement in former Section 2.4(f)(1) in Appendix A to Part 26, which specified that a directly observed collection may be conducted at any time the specimen's temperature falls outside of the required temperature range. However, the final rule deletes the provisions of the proposed rule that addressed measuring the donor's body temperature for the reasons discussed with respect to Sec. 26.111(a).

Section 26.115(a)(3) updates former Section 2.4(f)(3) in Appendix A to Part 26. The former provision permitted a directly observed collection if a collector observed donor conduct that clearly and unequivocally demonstrates an attempt by the donor to substitute the specimen. The final rule adds references to attempts to dilute and adulterate a specimen, in addition to substitution, as behaviors that demonstrate a subversion attempt, consistent with the NRC's heightened concern in the final rule for ensuring specimen validity, as discussed with respect to Sec. 26.31(d)(3)(i). As discussed with respect to

Sec. 26.107(b), donor conduct that clearly and unequivocally demonstrates an attempt to alter a specimen may include, but is not limited to, possession of a urine specimen before the collection has occurred; possession of a vial, or vials, filled with chemicals that are subsequently determined to be urine or an adulterant; possession of a heating element; or evidence that the coloring agent used by the licensee or other entity in a source of standing water at the collection site (see Sec. 26.87(e)(1)) discolors the specimen.

Section 26.115(a)(4) updates former Section 2.4(f)(4) in Appendix A to Part 26. The former provision permitted

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directly observed collections if a donor had previously been determined to have engaged in substance abuse and the specimen was being collected as part of a rehabilitation program and/or pre-access testing following a confirmed positive test result. This paragraph updates the former requirement by adding a cross-reference to Sec. 26.69 [Authorization with potentially disqualifying fitness-for-duty information], which establishes requirements for granting or maintaining the authorization of an individual about whom potentially disqualifying FFD information has been discovered or disclosed. Several provisions in Sec. 26.69 permit or require directly observed collections, including Sec. 26.69(b)(5), which requires specimens to be collected under direct observation for pre-access drug testing of individuals who have been subject to sanctions under the rule. For organizational clarity, this paragraph replaces the former requirement with a cross-reference to

Sec. 26.69, rather than repeat the applicable requirements in this section.

Section 26.115(b) amends the requirement in former Section 2.4(g)(25) in Appendix A to Part 26 that the collector must obtain permission from a ``higher level supervisor'' before conducting a directly observed collection, as discussed with respect to Sec. 26.115(a). The NRC has added the second sentence of this paragraph to require that, once the decision has been made to conduct a directly observed collection based on a reason to believe that the donor may alter a specimen, the collection must occur as soon as reasonably practical. Although the NRC is not aware of any occasions in Part 26 programs in which a directly observed collection has been unreasonably delayed, the new requirement ensures that test results from the directly observed collection provide information about the presence or absence of drugs and drug metabolites in the donor's urine. If a collection is delayed for a day or more, metabolism may cause the concentration of drugs and drug metabolites in the donor's urine, if any are present, to fall below the cutoff levels established in this part or by the FFD program and, therefore, not be detected by testing.

Positive, adulterated, substituted, or invalid test results from a specimen collected under direct observation provide evidence to support a conclusion that the individual had attempted to subvert the testing process in order to mask drug abuse, whereas negative test results may counter the reason to believe that the individual had attempted to subvert the testing process. Therefore, conducting the directly observed collection as soon as reasonably practical ensures that test results from the specimen provide relevant and useful information. The requirement is also consistent with those of other relevant Federal rules and guidelines.

The agency added Sec. 26.115(c) to require the collector to inform the donor of the reason(s) for the directly observed collection so that the donor is aware of the nature of the concern that has initiated a directly observed collection. The final rule includes this requirement for two reasons: (1) knowing the reason for a directly observed collection may increase a donor's willingness to cooperate in the procedure in order to counter the reason to believe that the donor has or may attempt to alter the specimen, and (2) informing the donor of the reason for a directly observed collection meets Goal 7 of this rulemaking to protect the privacy and other rights (including due process) of individuals who are subject to Part 26 by ensuring that the donor is aware of the concern that has initiated the collection. This paragraph also meets Goal 1 of this rulemaking by improving consistency with the requirements of other relevant Federal rules and guidelines.

The NRC added Sec. 26.115(d) to establish recordkeeping requirements related to the directly observed collection. This provision requires the collector to record on the specimen's custody- and-control form that the specimen was collected under direct observation and the reason(s) for the directly observed collection.

This requirement ensures that the HHS-certified laboratory and the MRO have this information available when the specimen is tested and the MRO conducts his or her review of the test results, as is required under

Sec. 26.185. This information is important in an MRO's decision to request the laboratory to test a specimen that appeared to have been diluted, as permitted under Sec. 26.185(g)(2), in order to compare the results from testing the dilute specimen with those obtained from testing the specimen that was collected under direct observation.

Positive, adulterated, substituted, or invalid test results from the dilute specimen and the presence of the same drugs or drug metabolites in the specimen collected under direct observation provide evidence that the donor diluted the first specimen in an attempt to mask drug use. This section is also consistent with the requirements of other relevant Federal rules and guidelines.

Section 26.115(e) retains and combines the former requirements in

Sections 1.2, 2.4(b), 2.4(g)(14), (g)(17), and (g)(25) in Appendix A to

Part 26. These provisions required that the individual who observes the specimen collection must be of the same gender as the donor. Consistent with the former requirements, the final rule permits another individual of the same gender to serve as the observer if a qualified urine collector of the same gender is not available as long as the observer receives the instructions specified in Sec. 26.115(f). The final rule combines the former requirements in this paragraph for organizational clarity.

The NRC added Sec. 26.115(f) to specify the procedures that must be followed in conducting a directly observed collection by either a qualified collector or an individual of the same gender who may serve as the observer. These more detailed procedures are necessary because devices and techniques to subvert the testing process have been developed since Part 26 was first published that can be used under direct observation without detection. Therefore, the agency made these changes to increase the likelihood of detecting attempts to subvert the testing process and, thereby, increase the effectiveness of directly observed collections in assuring that a valid specimen is obtained from the donor.

The NRC added Sec. 26.115(f)(1) to specify that the observer must instruct the donor to adjust his or her clothing to ensure that the area of the donor's body between the waist and knees is exposed. This requirement ensures that the observer is able to detect the use of an anatomically correct urine delivery device.

The agency added Sec. 26.115(f)(2) to specify the action to be observed during the collection. This paragraph is consistent with the requirements of other Federal agencies and is intended to ensure that the urine specimen is obtained from the donor's body.

The rule adds Sec. 26.115(f)(3) to prohibit an observer who is not the collector from touching the specimen container. The new provision is consistent with the related requirements of other Federal agencies and is intended to protect the observer from any potential claims by a donor that the observer had altered the specimen.

The new Sec. 26.115(f)(4) requires the collector to record the observer's name on the custody-and-control form if the observer is not the collector. This mandate is consistent with the related requirements of other Federal agencies

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and is intended to ensure that the observer's identity is documented should future questions arise regarding the collection.

The NRC added Sec. 26.115(g) to clarify that a donor's refusal to participate in the directly observed collection constitutes a refusal to test and, therefore, is considered to be an act to subvert the testing process under Sec. 26.75(b). Former Section 2.4(j) in Appendix

A to Part 26 required the collector to inform the MRO, and the MRO to inform licensee management, if a donor failed to cooperate with the specimen collection process, including, but not limited, to a refusal to provide a complete specimen, complete paperwork, or initial the specimen bottles. The former requirement did not specifically mention that a refusal to participate in a directly observed collection is also an instance of a failure to cooperate. In addition, the former rule did not require the licensee or other entity to impose sanctions on a donor for refusing to be tested. Therefore, the final rule adds a provision that both clarifies the NRC's original intent by stating that a refusal to participate in a directly observed collection constitutes a refusal to test and updates the former requirement by adding a cross-reference to the sanction of permanent denial of authorization that is required under Sec. 26.75(b).

The agency added Sec. 26.115(h) to specify the actions that a collector must take if a directly observed collection was required but not performed. The collector must report the omission to the FFD program manager or designee, who ensures that a directly observed collection is immediately performed. Although the concentrations of any drugs, drug metabolites, or blood alcohol in the donor's specimens may fall below the cutoff levels that are specified in this part or in the licensee's or other entity's FFD policy if several days have elapsed since the directly observed collection should have occurred, testing a specimen collected several days later increases the likelihood of detecting any subsequent drug or alcohol use. In addition, the metabolites from using some drugs, such as marijuana, linger in an individual's body. Therefore, conducting a directly observed collection may result in detecting these metabolites. However, because elapsed time reduces the concentrations of drugs, drug metabolites, or alcohol in the donor's specimens, the final rule requires a directly observed collection to be performed immediately. This section uses the term

``immediately'' to indicate that the licensee or other entity may be required to call in the donor and a collector to perform the directly observed collection, if the donor and collectors are not on site when the oversight is identified. This requirement increases consistency with the related requirements of other Federal agencies and is intended to provide instructions for correcting an oversight that the former rule did not address.

Section 26.117 Preparing Urine Specimens for Storage and Shipping

A new Sec. 26.117 reorganizes and presents together in one section former requirements for safeguarding specimens and preparing them for transfer from the collection site to the licensee's testing facility or the HHS-certified laboratory for testing. The NRC made this organizational change because requirements that address these topics were dispersed throughout the former rule and grouping them together in a single section in the final rule makes them easier to locate.

Section 26.117(a) amends former Section 2.4(g)(20) in Appendix A to

Part 26, which required the donor and collector to maintain visual contact with specimens until they were sealed and labeled. The final rule eliminates reference to blood specimens because donors are no longer permitted to request blood testing for alcohol under the final rule, as discussed with respect to Sec. 26.83(a). The new paragraph also amends the requirements in the second sentence of the former provision. For organizational clarity, the final rule moves to Sec. 26.113 [Splitting the urine specimen] procedural requirements for observing the splitting of a specimen and sealing the split specimen bottles. However, this provision broadens the former requirement, which addressed only split specimens, to require the donor to observe the transfer of any specimen or aliquot that the collector transfers to a second container and the sealing of the container(s). This requirement is necessary because some FFD programs who operate licensee testing facilities may transfer an aliquot of the urine specimen to a second container for initial testing at the licensee testing facility, while preserving the primary specimen in the first or another container. The final rule requires the donor to observe these actions to ensure that the specimen or aliquot(s) that are transferred belong to the donor and that the identity and integrity of the specimen are maintained.

Section 26.117(b) retains former Section 2.4(g)(21) in Appendix A to Part 26. This provision requires the donor and collector to remain present while the procedures for sealing and preparing the specimen

(and aliquots, if applicable) for transfer are performed.

Section 26.117(c) retains the meaning of former Section 2.4(g)(22) in Appendix A to Part 26. This provision establishes requirements for labeling and sealing the specimen(s), but the final rule splits the former requirement into several sentences for increased clarity in the language of the provision.

For organizational clarity, Sec. 26.117(d) retains and combines former Section 2.4(g)(23) and 2.4(g)(23)(i) in Appendix A to Part 26.

These provisions required the donor to certify that the specimen was collected from him or her. However, the final rule deletes former

Section 2.4(g)(23)(ii), which required the donor to have an opportunity to list on the custody-and-control form any medications he or she had taken within the past 30 days for the reasons discussed with respect to

Sec. 26.89(b)(3).

The final rule deletes former Section 2.4(g)(24) in Appendix A to

Part 26, which required the collector to enter into the permanent record book all information identifying the specimen. The agency eliminated this requirement because the final rule no longer requires collection sites to maintain a permanent record book, consistent with the elimination of the requirement to maintain a permanent record book in the HHS Guidelines. Collection sites are permitted to use other means of tracking specimen identity, including, but not limited to, bar coding.

Section 26.117(e) amends former Section 2.4(g)(26) in Appendix A to

Part 26. The former provision required the collector to complete the chain-of-custody forms for both the aliquot and the split sample and certify proper completion of the collection. The final rule eliminates reference to the aliquot and split sample in the former section to clarify the intent of this requirement, which is that the collector must complete the appropriate chain-of-custody forms for all of the sealed specimen and aliquot containers, not simply those resulting from a split specimen procedure. For example, if an FFD program follows split specimen procedures and conducts initial testing at a licensee testing facility, the donor's urine specimen may be divided into Bottle

A, Bottle B, and another container that would be used for tests at the licensee testing facility. This section retains the former requirement for the collector to certify proper completion of the collection.

Section 26.117(f) amends former Section 2.4(g)(27) in Appendix A to

Part 26. The former provision stated that the specimens and chain-of- custody forms

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``are now ready for transfer'' and must be appropriately safeguarded if they are not immediately prepared for shipment. The final rule replaces the first sentence of the former provision, which stated that the specimens and forms are ready for transfer, with a requirement for the collector to package the specimens and forms for transfer to the HHS- certified laboratory or licensee testing facility. This change improves the clarity in the rule's language because it is necessary for the collector to package the specimens and chain-of-custody forms for transfer before they are ready to be transferred. This section retains the second sentence of the former provision.

Section 26.117(g) retains former Section 2.4(g)(28) in Appendix A to Part 26. This provision requires the collector to maintain control of the specimens and custody documents and ensure they are secure, if he or she must leave the workstation or collection site for any reason.

The final rule makes minor editorial changes to some of the terminology used in the former section for consistency with the terminology used throughout the final rule, as discussed with respect to Sec. 26.5

Definitions

, but retains the intended meaning of the former requirements.

Section 26.117(h) retains the requirements in former Section 2.4(c)(2) in Appendix A to Part 26 related to maintaining specimen security until the specimens are sent from the collection site to the licensee testing facility or the HHS-certified laboratory for testing.

For organizational clarity, the NRC moved the former paragraph to this section of the final rule because requirements for maintaining specimen security apply at this point in the specimen collection process.

Likewise, the agency has moved the portion of the former section that applies to situations in which it is impractical to maintain continuous physical security of a collection site to Sec. 26.87(f)(5) because

Sec. 26.87(f) addresses those circumstances.

Section 26.117(i) updates the specimen packaging requirements in former Section 2.7(i) in Appendix A to Part 26 by replacing the former section with the related provision from the HHS Guidelines. For organizational clarity, the rule moves Sec. 26.117(j) to the first sentence of the former section, which directs collection site personnel to arrange to transfer the specimens to the licensee testing facility or HHS-certified laboratory. Section 26.117(j) addresses transfer and storage requirements, while Sec. 26.117(i) addresses packaging requirements. This section also eliminates the initial phrases in the second sentence of the former provision, which listed the conditions under which specimens were transferred offsite (e.g., shipping specimens that test as ``presumptive positive'' on initial testing at the licensee testing facility, special processing of suspect specimens), because they are redundant with other portions of the final rule. For organizational clarity, the rule moves new requirements related to transferring specimens from a licensee testing facility to an HHS-certified laboratory for further testing to Sec. 26.129(g) in

Subpart F. The final rule also eliminates the third sentence of the former section, which required the collector to sign and date the tape used to seal the container. The NRC eliminated this requirement because licensees and other entities now transfer specimens using courier services who offer other means of tracking the sender and the date that a container of specimens is shipped. Program experience has shown these other means to be equally effective. This new section retains the intended meaning of the former requirements for the collector to place the specimens in a second container that minimizes the possibility of damage during shipment and seal them so that tampering will be detected. At the request of stakeholders during the public meetings discussed in the preamble to the proposed rule, the final rule adds shipping bags to the former set of examples of acceptable shipping containers that protect the specimens from damage. Also at the request of stakeholders, the final rule deletes the last sentence of the former section, which required the collector to ensure that chain-of-custody documents were attached to the container used to ship the specimens to the licensee testing facility or laboratory. The stakeholders requested this change because their practice is to seal a specimen's custody-and- control documentation inside the shipping container to ensure that it cannot be altered. The NRC endorses this practice as providing greater protection for donors and, therefore, adopts this change.

Section 26.117(j) amends and combines the first sentence of former

Section 2.4(i) in Appendix A to Part 26 with the requirements applicable to the short-term storage of specimens at collection sites in former Section 2.7(c) in Appendix A to Part 26. The NRC moved to this section the first sentence of former Section 2.4(i) in Appendix A to Part 26 for the reasons discussed with respect to Sec. 26.117(i).

Under this section, as a result of advances in testing technologies, the rule no longer requires short-term refrigerated storage of specimens within 6 hours of collection. However, the final rule continues to require licensees and other entities to protect specimens from any conditions that could cause specimen degradation. Collection site personnel are required to refrigerate specimens that are not transferred or shipped to the licensee testing facility or the HHS- certified laboratory within 24 hours of collection. The final rule also requires that any specimens that may have been substituted or adulterated must be refrigerated as soon as they are collected because some adulterants may interfere with drug testing results unless the specimen is refrigerated. The final rule establishes a time limit of 2 business days for receipt of specimens at the licensee testing facility or HHS-certified laboratory after shipment from the collection site to further protect against potential specimen degradation.

Section 26.117(k) amends the portions of former Section 2.4(h) in

Appendix A to Part 26 that required a specimen's custody-and-control form to identify every individual in the chain of custody. The final rule does not require couriers to meet the requirements in former

Section 2.4(h), which stated that each time a specimen is handled or transferred, the date and purpose of the transfer must be documented on the chain-of-custody form and every individual in the chain of custody must be identified. Couriers are not required to meet these requirements because custody-and-control forms for individual specimens are packaged inside the shipping container, where they are inaccessible to couriers, so that it is impractical to expect them to sign the forms when handling the specimen shipping containers. This new paragraph codifies licensees' and other entities' practice of relying on courier services' normal package tracking systems to maintain accountability for specimen shipping containers, which is consistent with the HHS

Guidelines and standard forensic practices. The final rule also eliminates the former requirement, contained in the last sentence of

Section 2.4(h) in Appendix A to Part 26, to minimize the number of persons handling specimens because this requirement cannot be enforced.

Section 26.119 Determining ``Shy'' Bladder

The agency has adapted a new Sec. 26.119 from the DOT Procedures at 49 CFR 40.193 [What happens when an employee does not provide a sufficient amount of urine for a drug test?] to specify procedures for determining whether a donor who does not provide a urine specimen of 30 mL within the 3 hours that is permitted for a specimen

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collection is refusing to test or has a medical reason for being unable to provide the required 30 mL specimen. This new section responds to stakeholder requests during public meetings discussed in the preamble to the proposed rule. The stakeholders reported that some donors have had difficulty providing the minimum 60 mL of urine required in former

Section 2.4(g)(11) for medical reasons, but the former rule did not establish procedures for handling such circumstances. As a result, some

FFD programs have adopted the DOT ``shy bladder'' procedures, but stakeholders preferred that the final rule incorporate the requirements to (1) clarify that the NRC accepts the procedures, (2) inform donors of the procedures that they are required to follow if they have medical reasons for being unable to provide a sufficient quantity of urine for testing, (3) enhance consistency among Part 26 programs, and (4) enhance the consistency of Part 26 procedures with the procedures that collectors must follow when conducting tests under DOT requirements.

The NRC expects that fewer donors will be subject to ``shy bladder'' problems under the final rule because Sec. 26.109 reduces the minimum quantity of urine required from 60 mL in the former rule to 30 mL.

However, because some donors' medical problems may also interfere with their ability to provide 30 mL of urine, the final rule incorporates the DOT procedures. These procedures are intended to protect the due process rights of individuals who are subject to Part 26. That is, this section establishes procedures for ensuring that there is a legitimate medical reason that a donor was or is unable to provide a urine specimen of the required quantity so that the licensee or other entity has a medical basis for not imposing sanctions on the individual. In addition, the MRO is authorized to devise alternative methods of drug testing, if it appears that the donor's medical problem prevents him or her from being able to provide sufficient urine for drug testing in future tests.

The agency has added Sec. 26.119(a) to require that a licensed physician, who has appropriate expertise in the medical issues raised by the donor's failure to provide a sufficient specimen, must evaluate a donor who was unable to provide a urine specimen of at least 30 mL.

The rule permits the MRO to perform the evaluation if the MRO possesses the appropriate expertise. If not, the rule requires the MRO to review the qualifications of the physician and agree to the selection of that physician. These requirements for the physician who performs the evaluation to be qualified in the relevant medical issues ensure that the results of the evaluation are valid.

This section also requires that the evaluation must be completed within 5 calendar days of the unsuccessful collection. The agency has established the time limit of 5 calendar days as a trade off between the need to provide the donor with sufficient time to locate a qualified physician, obtain an appointment, and for the physician to complete the evaluation (i.e, the donor's right to due process), and the public's interest in a rapid determination of whether the donor had attempted to subvert the testing process by refusing to provide a sufficient specimen. DOT's experience indicates that 5 days is sufficient to complete the evaluation.

The final rule adds Sec. 26.119(b) to specify the information that the MRO must provide to the physician who is selected to perform the evaluation if the MRO does not perform it. Sections 26.119(b)(1) and

(b)(2) require the MRO to inform the physician that the donor was required to take a drug test under Part 26 but was unable to provide a sufficient quantity of urine for testing and explain the potential consequences to the donor for a refusal to test. These requirements ensure that the evaluating physician understands the context in which he or she is being asked to perform the evaluation. Section 26.119(b)(3) also requires the MRO to inform the physician that he or she must agree to follow the procedures specified in Sec. 26.119(c) through (f) if he or she performs the evaluation. This requirement ensures that the physician understands and consents to follow the procedures specified in this section.

The NRC added Sec. 26.119(c) to describe the conclusions that the physician must provide to the MRO following the evaluation. Under Sec. 26.119(c)(1), the physician may determine that a medical condition has, or with a high degree of probability could have, precluded the donor from providing the required quantity of urine. Or, under Sec. 26.119(c)(2), the physician may determine that there is an inadequate basis for determining that a medical condition has, or with a high degree of probability could have, precluded the donor from providing a sufficient quantity of urine. The final rule limits the physician's conclusions to one of these two alternatives to ensure that the results of the evaluation are relevant to and useful for determining whether sanctions must be imposed on the donor for a refusal to test.

The agency added Sec. 26.119(d) to define the physical and psychological conditions that constitute a medical condition that could have precluded the donor from providing a 30-mL specimen as well as to provide examples of conditions that do not constitute a legitimate medical condition. Legitimate medical conditions include an ascertainable physiological condition (e.g., a urinary system dysfunction) or a medically documented pre-existing psychological disorder that precluded the donor from providing a 30-mL specimen.

Unsupported assertions of ``situational anxiety'' or dehydration are examples of conditions that could not be considered legitimate medical conditions. The final rule adds this section to provide necessary guidance to the evaluating physician.

The final rule adds Sec. 26.119(e) to require the evaluating physician to provide a written statement of his or her findings and conclusion from the evaluation. By implication, if the MRO performs the evaluation, the MRO provides this written statement. The written statement is necessary to communicate the results of the evaluation and create a record of it, should any question arise later with respect to the determination.

This section also requires that the physician must provide only the information that is necessary to support the physician's conclusion.

The NRC has added this requirement to protect the donor's privacy by ensuring that the physician documents only the medical information that is necessary to support the determination.

The NRC added Sec. 26.119(f) to require the physician to inform the MRO, in the written statement, whether any medical condition that may be identified also precludes the donor from providing specimens of 30 mL or more in future collections. This information is necessary for the MRO to determine whether to implement alternative methods of drug testing for the donor, as required under Sec. 26.119(g)(3).

The agency added Sec. 26.119(g) to prescribe the actions that the

MRO must take based on the results of the evaluation, as follows:

Section 26.119(g)(1) requires the MRO to determine that the donor did not violate the FFD policy, if the physician concluded that a medical condition could account for the insufficient specimen and the

MRO concurred with that conclusion. In this instance, the licensee or other entity does not impose sanctions on the donor because the donor had not violated the FFD policy by refusing to test.

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Section 26.119(g)(2) requires the MRO to determine that the donor had refused to be tested by failing to provide a sufficient specimen, if the physician concluded that a medical condition could not account for the insufficient specimen. In this instance, the licensee or other entity imposes the sanction of a permanent denial of authorization for an attempt to subvert the testing process, as required under Sec. 26.75(b).

Section 26.119(g)(3) requires the MRO to devise an alternative method of collecting specimens for drug testing, if the donor's medical condition, over the long-term, consistently prevents the donor from providing urine specimens of 30 mL or more. For example, the provision permits the MRO to direct the collection and testing of alternate specimens, including, but not limited to, hair, or other bodily fluids, if, in the MRO's professional judgment, the collection and analysis of these alternate specimens is scientifically defensible and forensically sound. The section grants flexibility to the MRO in exercising his or her professional judgment in determining an alternative method of conducting drug testing, rather than establishing detailed requirements that may not appropriately address the range of possible medical conditions that could arise.

Subpart F--Licensee Testing Facilities

In this subpart, the final rule replaces two terms used in the proposed rule in response to public comments. These language changes affect numerous sections within Subpart F. First, one public comment addressed a proposed provision in Sec. 26.137(b) [Performance testing and quality control requirements for validity screening tests] that permitted licensee testing facilities to use validity screening tests approved by the U.S. Food and Drug Administration (FDA). The NRC has eliminated both the requirement and the use of the term ``device'' with respect to validity screening testing because the FDA is not responsible for approving validity screening devices. The final rule has replaced the term ``device'' in ``validity screening device'' with the term ``test'' throughout Subpart F. Second, several public comments addressed the use of the term ``non-negative'' to refer to drug and validity test results and requested that the NRC eliminate the term from the final rule and instead use a more familiar term such as

``positive'' test result. Throughout Subpart F, the NRC has replaced the term ``non-negative'' with a new term to address validity screening and initial validity testing results from a licensee testing facility that indicate that a specimen may be adulterated, substituted, dilute, or invalid. The new term used for these validity testing results is

``questionable validity.'' The NRC has added a definition for

``questionable validity'' to Sec. 26.5 [Definitions]. Adding the term

``questionable validity'' addresses the commenters' concern and improves the clarity of the final rule to meet Goal 6 of this rulemaking. The NRC retained the use of ``positive'' to refer to results from initial testing for drugs that indicate the presence of a prohibited drug in the specimen.

Section 26.121 Purpose

The NRC added Sec. 26.121 to provide an overview of the contents of the proposed subpart, consistent with Goal 6 of this rulemaking to improve clarity in the organization and language of the final rule.

Section 26.123 Testing Facility Capabilities

Section 26.123 amends the second sentence of former Section 2.7(l)(2) in Appendix A to Part 26 as it related to the capabilities of licensee testing facilities. The final rule retains the former requirement for licensee testing facilities to be capable of performing initial tests for each drug and drug metabolite for which testing is conducted by the FFD program and adds a requirement for licensee testing facilities to have the capability to perform either validity screening tests, initial validity tests, or both. The agency moved the first sentence of former Section 2.7(l)(2), which established requirements for the capabilities of HHS-certified laboratories, to

Subpart G [Laboratories Certified by the Department of Health and Human

Services]. The NRC deleted the last sentence of the former paragraph, which permitted the testing of breath specimens for alcohol at the collection site, because the final rule addresses alcohol testing in

Subpart E [Collecting Specimens for Testing]. The NRC made these changes to the former provision to meet Goal 6 of this rulemaking to improve organizational clarity in the final rule.

Section 26.125 Licensee Testing Facility Personnel

Section 26.125 amends former Section 2.6 in Appendix A to Part 26

Licensee testing facility personnel

, as follows:

Section 26.125(a) retains former Section 2.6(a) in Appendix A to

Part 26. This provision requires each licensee testing facility to have one or more individuals who are responsible for the day-to-day operations of the facility and establishes requirements for those individuals' qualifications. The final rule makes minor changes in the former provision to improve consistency with amended language in the related portion of the HHS Guidelines.

Section 26.125(b) amends former Section 2.6(b) in Appendix A to

Part 26. This provision required laboratory technicians and nontechnical staff to have the necessary training and skills for the tasks assigned to them. The final rule retains the former provision and adds another. The final rule requires laboratory technicians who perform urine specimen testing to demonstrate proficiency in operating the instruments and tests used at the licensee testing facility. The

NRC added this proficiency requirement to ensure that technicians are capable of correctly using the instruments and tests that the licensee testing facility has selected for validity and drug testing. This change is necessary for several reasons. First, the final rule adds new requirements for licensee testing facilities to conduct validity testing, and the instruments and tests that the technicians will use are likely to differ from those previously used at licensee testing facilities. Therefore, additional training and proficiency testing is required to ensure that validity testing is conducted properly. Second, the final rule permits licensees and other entities to rely on drug test results from testing that was performed by another Part 26 program to a greater extent than the former rule. Therefore, it is necessary to ensure that all drug testing performed under Part 26, including tests performed at licensee testing facilities, meets minimum standards. The requirement for technicians to demonstrate proficiency, then, contributes to meeting this goal. Third, the experience of other

Federal agencies has shown that requirements for technicians to demonstrate proficiency assist in any litigation that may occur with respect to urine test results.

With respect to the proposed rule and in response to a public comment that proficiency documentation requirements were missing from the proposed rule in several locations, the final rule adds a requirement for licensee testing facilities to document the proficiency of its technicians. Although proposed Sec. 26.125(c) required licensee testing facility personnel files to include documentation of training and experience and the results of tests that establish employee competency for the position he or she holds, the final rule adds a requirement for documentation of proficiency in Sec. 26.125(b) to further clarify that this documentation is required and

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specifically applies to laboratory technicians who perform urine drug testing. The NRC made this change to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.125(c) amends former Section 2.6(c) in Appendix A to

Part 26. The provision establishes recordkeeping requirements for the personnel files of licensee testing facility staff. The final rule, with respect to the proposed rule, further clarifies the intent of the licensee testing facility personnel competency requirements by specifying that personnel must be proficient in conducting testing using the most recent instructions from instrument and test manufacturers. In addition, in response to comments received on the elimination of the former provision in Section 2.5(f) in Appendix A to

Part 26 that required licensees and other entities to maintain color blindness testing records in files for licensee testing facility personnel, the final rule reinstates the requirement. The final rule retains the color blindness testing recordkeeping requirement because some validity screening and initial validity tests require laboratory testing facility personnel to visually evaluate the color of the assay to determine the test result. Retaining records of color blindness testing is necessary to demonstrate licensee testing facility personnel competency.

Section 26.127 Procedures

Section 26.127 combines, reorganizes, and amends requirements for procedures that were interspersed throughout Appendix A to Part 26, including requirements in former Sections 2.2 [General administration of testing] and 2.7 [Laboratory and testing facility analysis procedures]. These changes improve clarity in the organization of the final rule by grouping procedural requirements for licensee testing facilities in one section, consistent with Goal 6 of this rulemaking.

Section 26.127(a) makes minor editorial changes to the first sentence of former Section 2.2 in Appendix A to Part 26. The former provision required licensee testing facilities and HHS-certified laboratories to have detailed procedures for conducting testing. The final rule deletes the reference to blood samples in the former provision because donors no longer have the option to request blood testing for alcohol, as discussed with respect to Sec. 26.83(a). For organizational clarity, the final rule moves the reference to HHS- certified laboratories to Sec. 26.157(a) in Subpart G. The final rule also deletes the former reference to procedures for specimen collections in this paragraph because procedural requirements for specimen collections are addressed in Subpart E.

Section 26.127(b) amends and combines portions of the requirements in the first sentence of former Section 2.4(d) and 2.7(a)(2) in

Appendix A to Part 26 related to the content and implementation of specimen chain-of-custody procedures. The final rule retains the portions of the former provisions that required licensee testing facilities to develop, implement, and maintain written chain-of-custody procedures to maintain control and accountability of specimens from receipt through completion of testing and reporting of results, during storage and shipping to the HHS-certified laboratory, and continuing until final disposition of the specimens. For organizational clarity, the NRC moved the former requirements related to HHS-certified laboratories to Sec. 26.157(b) in Subpart G. The final rule also removes references to custody-and-control procedures for blood specimens because donors no longer have the option to request blood testing for alcohol, as discussed with respect to Sec. 26.83(a).

Section 26.127(c) retains the portions of former Section 2.7(o)(1) in Appendix A to Part 26 that addressed the required content of procedures for licensee testing facilities and amends the former requirements. The final rule retains the portions of the former provision that required licensee testing facilities to develop and maintain procedures to specify all of the elements of the testing process, including, but not limited to, the principles of each test and the preparation of reagents, standards, and controls. The final rule presents the required topics of the procedures in a list format in

Sec. 26.127(c)(1)-(c)(12) to clarify that each topic stands on its own and to meet Goal 6 of this rulemaking to improve clarity in the organization of the rule.

Section 26.127(c) also amends former Section 2.7(o)(1) in Appendix

A to Part 26 in several ways. First, the final rule eliminates the former requirement for the procedures to be maintained in a laboratory manual as unnecessarily restrictive. The final rule permits licensee testing facilities to use other means to maintain their procedures.

Second, the agency has added a requirement for the development, implementation, and maintenance of written standard operating procedures for all laboratory instruments and validity screening tests, consistent with the addition of requirements to conduct validity testing throughout the final rule. Third, the final rule moves two portions of the former provision to other subparts of the rule that address related topics to improve clarity in the organization and language of the final rule, as follows: The agency relocated the last two sentences of former Section 2.7(o)(1) in Appendix A to Part 26, which addressed requirements for retaining copies of superceded procedures, to Sec. 26.715(a) of Subpart N [Recordkeeping and

Reporting Requirements], and the final rule moves procedural requirements for HHS-certified laboratories to Sec. 26.157(b) in

Subpart G.

Section 26.127(d) amends former Section 2.7(o)(3)(iii) in Appendix

A to Part 26. This provision required procedures for the setup and normal operation of testing instruments, a schedule for checking critical operating characteristics for all instruments, tolerance limits for acceptable function checks, and instructions for major troubleshooting and repair. The final rule extends the former requirements to non-instrumented tests (such as some validity screening tests, if the licensee testing facility uses these tests), consistent with the addition of requirements to conduct validity testing throughout the final rule. The final rule also makes three organizational changes to the former provision. The final rule presents the required topics of the procedures in a list format in Sec. 26.127(d)(1)-(d)(3) to clarify that each topic stands on its own. The

NRC relocated the former requirement to maintain records of preventative maintenance to Sec. 26.715(b)(10) in Subpart N. And, the

NRC has moved the former requirements that applied to HHS-certified laboratories to Sec. 26.157(d) in Subpart G. These changes improve clarity in the organization of the rule, consistent with Goal 6 of this rulemaking.

Section 26.127(e) reorganizes and amends former Section 2.7(o)(4) in Appendix A to Part 26. The former provision required corrective actions to be documented if systems are out of acceptable limits or errors are detected. The final rule extends the former requirement to validity screening tests if the licensee testing facility uses these tests, consistent with the addition of requirements to conduct validity testing throughout the final rule. The final rule, with respect to the proposed rule, also adds the term ``instrumented'' to clarify that a licensee testing facility must develop and implement procedures for remedial actions on testing facility equipment, instruments, and tests.

The NRC has moved the requirements in the former paragraph that applied to HHS-

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certified laboratories to Sec. 26.157(e) in Subpart G for organizational clarity.

Section 26.129 Assuring Specimen Security, Chain of Custody, and

Preservation

Section 26.129 has been added to group together in one section the requirements of the final rule that apply to licensee testing facilities with respect to the safeguarding of specimen identity, integrity, and security. The NRC made this organizational change because requirements that addressed these topics were dispersed throughout the former rule. Grouping them together in a single section makes them easier to locate within the final rule and meets Goal 6 of this rulemaking to improve clarity in the language and organization of the rule.

Section 26.129(a) retains the first four sentences of former

Section 2.7(a)(1) in Appendix A to Part 26. The provision requires licensee testing facilities to be secure and accessible only to authorized personnel. The final rule moves the requirements in the former provision that applied to HHS-certified laboratories to Sec. 26.159(a). The final rule moves the last sentence of the former paragraph, which established recordkeeping requirements, to Sec. 26.715(b)(13) in Subpart N. The NRC made these changes for organizational clarity.

Section 26.129(b) amends former Section 2.7(b)(1) in Appendix A to

Part 26. This provision established requirements for receiving specimens at the licensee testing facility and assuring their integrity and identity. For organizational clarity, the final rule moves the former requirements related to HHS-certified laboratories to Sec. 26.159(b) in Subpart G. The final rule, with respect to the proposed rule, adds Sec. 26.129(b)(1) and (b)(2) to improve the clarity of the organization of the rule. The NRC has also added several requirements to the former provision, as follows:

In Sec. 26.129(b), the final rule retains the requirement for licensee testing facility personnel to inspect specimens received for testing to determine whether there is any evidence of tampering with the specimens and to ensure that the custody-and-control documents are correct. With respect to the proposed rule, the final rule adds a requirement for licensee testing facility personnel to attempt to resolve any discrepancies in the information on specimen bottles or on the accompanying custody-and-control forms to ensure the identity and integrity of specimens and prevent specimens from being unnecessarily rejected for testing by the HHS-certified laboratory (if the specimen must be subject to additional testing) when flaws can be corrected. For example, if the collector's signature is missing on the custody-and- control form, licensee testing facility personnel will work with collection site personnel to attempt to identify the collector and obtain a memorandum for the record from the collector if possible. This requirement reduces the potential burden on donors who may otherwise be required to submit additional specimens to replace those for which the chain of custody could not be confirmed. The final rule, with respect to the proposed rule, adds a provision that specifies the procedures to be followed by licensee testing facility personnel to correct custody- and-control form errors that are identified after the specimen collection process has been completed and the donor has departed from the collection site. This addition is based on a comment received on the proposed rule requesting the addition of these procedures. The requirements also improve the efficiency of FFD programs by avoiding the need to conduct additional specimen collections when discrepancies can be corrected. The additional provision meets Goal 7 of this rulemaking to protect the privacy and other rights (including due process) of individuals who are subject to Part 26, as well as Goal 1 of this rulemaking, to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines.

Section 26.129(b)(1) adds requirements for licensee testing facility personnel to report to management any indications of specimen tampering within 8 hours of the discovery. This provision also requires licensee or other entity management personnel to initiate an investigation to determine whether tampering has occurred. Section 26.129(b)(i) requires management to take corrective actions if tampering is confirmed. The final rule adds these requirements because some licensees did not investigate or take corrective actions in response to indications of tampering with specimens under the former rule. The appropriate corrective actions that management personnel would take depend on the nature of the tampering identified as a result of the investigation. For example, if the investigation indicated that the tampering was an attempt to subvert the testing process and the persons involved were identified, management personnel would impose the sanctions in Sec. 26.75(b) for a subversion attempt. This provision also requires management personnel to correct any systematic weaknesses in specimen custody-and-control procedures that may be identified in the investigation, such as inadequate safeguarding of specimen shipping containers.

Section 26.129(b)(1)(ii) adds a prohibition on testing of any specimen if the licensee or other entity has reason to believe that the specimen was subject to tampering or altered in a manner as to affect specimen identity and integrity. In this circumstance, the MRO will cancel testing of the specimen or any test results for the specimen, and require the licensee or other entity to retest the donor who submitted the original specimen. The final rule, with respect to the proposed rule, adds an exception for split specimen collections in response to a public comment that requested additional clarification of the proposed rule's requirements for cancelling tests. For a split specimen collection, if the tamper-evident seal remains intact on either Bottle A or Bottle B of the specimen and the bottle contains at least 15 mL of urine, the final rule requires the licensee testing facility to forward the intact specimen to the HHS-certified laboratory and prohibits any testing at the licensee testing facility. This new provision serves to eliminate unnecessary additional specimen collections, thereby meeting Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

The NRC added Sec. 26.129(b)(2) in the final rule, with respect to the proposed rule, to include specific instances that would require the cancellation of the testing of a donor's urine specimen. This change has been made in response to a public comment that requested the NRC to add information in the final rule to describe the actions that must be taken if the integrity of a specimen is in question. Adding this information to the final rule meets Goal 7 of this rulemaking to protect the privacy and other rights (including due process) of individuals who are subject to Part 26, as well as Goal 1 to improve the consistency of NRC requirements with those of other Federal agencies. The provisions are modeled on similar requirements in the

DOT's drug testing program.

Although the NRC is not aware of any instances when these circumstances have arisen in Part 26 programs, the experience of other

Federal agencies indicates that specimen tampering is possible.

Therefore, the requirements in Sec. 26.129(b) are necessary to ensure that donors are not subject to sanctions for positive, adulterated, substituted, or invalid test results from a specimen that

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may not have been theirs. These changes meet Goal 7 of this rulemaking to protect the privacy and other rights (including due process) of individuals who are subject to Part 26 and ensure that the individuals are afforded accurate and consistent testing. These requirements are also consistent with the requirements of other Federal agencies.

Section 26.129(c) amends former Section 2.7(b)(2) in Appendix A to

Part 26. This provision established requirements for chain-of-custody procedures for specimens and aliquots at licensee testing facilities.

The final rule moves the requirements in the former paragraph that were related to HHS-certified laboratories to Subpart G to improve organizational clarity.

The section incorporates two additional changes to the former provision at the request of stakeholders at the public meetings discussed in Section I.D. The stakeholders requested that the NRC permit licensee testing facilities to use methods other than a custody- and-control form to maintain the chain of custody for aliquots of a specimen that are tested at the licensee testing facility. The NRC incorporated this change because methods other than a custody-and- control form, such as the use of bar coding, have been shown to be equally effective at tracking the chain of custody for an aliquot at licensee testing facilities. Adding this flexibility is consistent with

Goal 5 of this rulemaking to improve Part 26 by eliminating or modifying unnecessary requirements.

The stakeholders also requested that the section specify the conditions under which specimens and aliquots may be discarded because the former rule did not address discarding of negative specimens.

Therefore, the final rule permits licensee testing facilities to discard specimens and aliquots as soon as practical after validity screening or initial validity tests have demonstrated that the specimen is valid and initial test results for drugs and drug metabolites are negative. The clarification codifies licensee practices. This permission has no impact on donors' rights under the final rule because donors are not at risk of management actions or sanctions as a result of negative test results and, therefore, do not need the licensee testing facility to retain the specimen for additional testing for review or litigation purposes. The change has been made to meet Goal 6 of this rulemaking to improve clarity in the language of the final rule.

Section 26.129(d) updates former Section 2.7(a)(2) in Appendix A to

Part 26. This provision required licensee testing facility personnel to maintain and document the chain of custody for specimens and aliquots.

The final rule incorporates the simpler language of the related provision from the HHS Guidelines while retaining the intent of the former provision. The final rule relocates the requirements in the former section that were related to HHS-certified laboratories to Sec. 26.159(d) and (e) in Subpart G to improve organizational clarity.

Section 26.129(e) amends the first sentence of former Section 2.7(d) in Appendix A to Part 26 [Specimen processing]. That sentence required specimens that test as ``presumptive positive'' at the licensee testing facility to be shipped to the HHS-certified laboratory for further testing. The final rule replaces the term ``presumptive positive'' with terms to describe the specific test results, as appropriate (i.e., ``positive,'' ``questionable validity'') in order to address validity testing results, consistent with the addition of requirements to conduct validity testing throughout the final rule, as discussed with respect to Sec. 26.31(d)(3)(i). For organizational clarity, the agency has moved the requirements in former Section 2.7(d) in Appendix A to Part 26 that related to quality control procedures for testing at licensee testing facilities and HHS-certified laboratories to Sec. 26.137 [Quality assurance and quality control] and Sec. 26.167 [Quality assurance and quality control] of the final rule, respectively.

Section 26.129(f) clarifies and revises former Section 2.7(c) in

Appendix A to Part 26 [Short term refrigerated storage], as it related to refrigerating urine specimens to protect them from degradation. For organizational clarity, the final rule moves the former requirements that applied to HHS-certified laboratories to Sec. 26.159(h) in

Subpart G. The final rule restates portions of the former provision and adds a performance standard regarding ``appropriate and prudent actions'' to minimize specimen degradation. For the reasons discussed with respect to Sec. 26.117(j), the final rule no longer requires all specimens to be refrigerated within 6 hours after collection, but adds a requirement that any specimen that has not been tested within 24 hours of receipt at the licensee testing facility must be refrigerated.

The final rule continues to require the licensee or other entity to refrigerate any specimen (and the associated Bottle B for that specimen if the FFD program follows split specimen procedures) that yields a positive test result from initial drug testing at the licensee testing facility. The final rule also adds a requirement for refrigerating any specimen (and the associated Bottle B specimen if a split specimen collection is performed) that yields a questionable validity test result from validity screening or initial validity testing.

Refrigerating these specimens is necessary because some adulterants have been shown to interfere with drug test results more rapidly if the specimen remains at room temperature.

The final rule also updates the terminology used in the former paragraph to be consistent with the new terminology adopted throughout the final rule for referring to split specimens. Therefore, in the final rule, the licensee testing facility continues to be responsible for protecting from degradation the primary specimen (Bottle A) and the specimen in Bottle B of a split specimen if the FFD program follows split specimen procedures. The rule also requires the licensee testing facility to refrigerate any specimen that yields a positive test result or a questionable validity test result. This includes the specimen in

Bottle B associated with any aliquot that yields a positive or questionable validity test result at the licensee testing facility. The

NRC made these changes in the terminology of the paragraph to improve clarity in the language of the final rule.

The final rule separates former Section 2.4(i) in Appendix A to

Part 26 [Transportation to laboratory or testing facility] into two paragraphs, Sec. 26.129(g) and (h), for organizational clarity and amends the former provision for the reasons previously discussed with respect to Sec. 26.117(i) and (k). Section 26.129(g) and (h), which repeats the requirements for packaging and shipping specimens contained in Sec. 26.117(i) and (k) of Subpart E, applies these requirements to packaging and shipping specimens from licensee testing facilities to

HHS-certified laboratories. The basis for these requirements is discussed with respect to Sec. 26.117(i) and (k).

Section 26.131 Cutoff Levels for Validity Screening and Initial

Validity Tests

The NRC has added Sec. 26.131 to establish cutoff levels for validity screening and initial validity tests that are conducted at licensee testing facilities. The procedures, substances, and cutoff levels for initial validity testing in this section incorporate related requirements from the HHS Guidelines (69 FR 19643; April 13, 2004). The validity screening test requirements have been adapted, in large part, from the HHS proposed

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revision to the Guidelines that was also published in the Federal

Register on April 13, 2004 (69 FR 19673).

In contrast to the requirements for initial validity testing in the

HHS Guidelines, the final rule does not permit licensee testing facilities to evaluate the specific gravity of any specimens. To determine if a specimen is dilute or substituted, specific gravity testing is required. If the creatinine concentration of a specimen is less than 20 mg/dL, the final rule requires the licensee testing facility to forward the specimen to the HHS-certified laboratory to complete the testing, where the specimen's specific gravity will be measured. The final rule differs from the HHS Guidelines in this provision because the costs of the instruments (i.e., refractometers) that are required in the Guidelines for measuring specific gravity are high. Some licensee testing facilities are currently measuring the specific gravity of specimens. However, the cutoff levels established in the Guidelines require more sensitive measurement and licensee testing facilities would be required to purchase new equipment in order to test at the new HHS specific gravity cutoff levels. Therefore, the final rule requires licensee testing facilities to transfer all specimens with creatinine concentrations less than 20 mg/dL to an HHS- certified laboratory to complete the initial testing process and does not include cutoff levels for specific gravity or quality control requirements for measuring specific gravity.

Section 26.131(a) has been added to require licensee testing facilities to perform either validity screening tests, initial validity tests, or both. Consistent with related requirements for further testing of a specimen at an HHS-certified laboratory when initial drug testing at the licensee testing facility yields a positive test result, the final rule also requires licensee testing facilities to forward specimens that yield a questionable validity screening or initial validity test result to an HHS-certified laboratory for further testing. Further testing at an HHS-certified laboratory is necessary because licensee testing facilities do not have the sophisticated testing instruments required for conducting confirmatory testing that are required under the HHS Guidelines. In addition, further testing at an HHS-certified laboratory provides an independent check on test results from licensee testing facilities that is necessary to ensure that donors are afforded accurate and consistent testing under this part, consistent with Goal 7 of this rulemaking.

As discussed in Section IV.C, the primary distinction between validity screening tests and initial validity tests is that validity screening tests may be performed using non-instrumented devices, such as dipsticks, whereas initial validity tests generally rely on more complex instrumented testing technologies. The final rule permits licensee testing facilities to perform validity screening tests before performing initial validity tests but does not require them to do so because validity screening tests are unnecessary if the licensee testing facility performs initial validity testing. Licensees and other entities may choose to conduct validity screening tests, followed by initial validity testing of any specimens that are identified to be of questionable validity as a result of validity screening, potentially to reduce the number of donor specimens that must be forwarded to the HHS- certified laboratory. In addition, the rule permits licensee testing facilities to choose whether to conduct validity screening tests or initial validity testing for each type of validity testing that is required under the rule. For example, a licensee or other entity may choose to use dipsticks (a validity screening test) to evaluate a specimen's creatinine concentration and only a pH meter (a method for conducting initial validity testing) without first performing a validity screening test for pH to evaluate the specimen's pH. The NRC is permitting flexibility in the means licensee testing facilities use to conduct specimen validity testing to meet Goal 3 of this rulemaking to enhance the efficiency and effectiveness of FFD programs.

Section 26.131(b) requires licensee testing facilities to test each urine specimen for creatinine concentration, pH, and the presence of one or more oxidizing adulterants, such as nitrite or bleach. Abnormal creatinine concentrations, abnormal pH values, or the possible presence of an oxidizing adulterant indicate that a donor may have altered the specimen (e.g., adulterated the specimen or substituted another substance in place of the donor's urine) in an attempt to subvert the testing process. The final rule permits licensees and other entities to choose the oxidizing adulterant(s) for which testing will be conducted.

The requirements in this paragraph are consistent with the related requirements in the HHS Guidelines.

Because validity testing is complex and the methods for testing are relatively new, the second sentence of Sec. 26.131(b) prohibits an FFD program from establishing more stringent cutoff levels for validity screening and initial validity testing than the cutoff levels established in this provision. This prohibition is necessary to decrease the risk of obtaining false adulterated, substituted, or invalid test results and ensures that donors are not subject to sanctions on the basis of inaccurate test results.

Section 26.131(b)(1)-(b)(8) specifies the criteria for determining whether the licensee testing facility must forward a specimen to an

HHS-certified laboratory for further validity testing. These criteria are incorporated from the HHS Guidelines. With respect to the proposed rule, the agency modified the requirements in the final rule in response to public comments received on the proposed specimen pH and nitrite levels. Specifically, the commenters identified that the proposed rule did not include pH and nitrite levels that would permit the licensee testing facility to detect a specimen that meets the criteria for an invalid test result in the HHS Guidelines. Therefore,

Sec. 26.131(b)(2) in the final rule establishes a pH level of less than 4.5, rather than a pH level of less than 3.0 in the proposed rule, as one criterion for determining that a specimen requires additional validity testing. The NRC also revised the nitrite concentration from equal to or greater than 500 micrograms (mcg) per mL in proposed Sec. 26.131(b)(3) to equal to or greater than 200 mcg/mL in the final rule.

These changes to the pH and nitrite criteria in the final rule are consistent with the current HHS Guidelines and meet Goal 1 of this rulemaking to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. By ensuring detection of specimens that may be invalid, these changes also meet

Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

Section 26.133 Cutoff Levels for Drugs and Drug Metabolites

Section 26.133 replaces former Section 2.7(e)(1) in Appendix A to

Part 26. That section established cutoff levels for initial testing for drugs and drug metabolites. Section 26.133 replaces and amends some cutoff levels for initial tests for drugs and drug metabolites in former Section 2.7(e)(1) in Appendix A to Part 26 to be consistent with the HHS cutoff levels for the same substances.

The NRC has decreased the initial test cutoff level for marijuana metabolites from 100 nanograms (ng) per milliliter (mL) to 50 ng/mL.

Current immunoassay techniques can now reliably detect the presence of marijuana metabolites at

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this cutoff level. As discussed in Section IV.B, this change strengthens the effectiveness of FFD programs by increasing the likelihood of detecting marijuana use.

The final rule increases the initial test cutoff level for opiate metabolites from 300 ng/mL in the former rule to 2,000 ng/mL. The change in the cutoff level for opiate metabolites substantially reduces the number of positive opiate test results that are reported to MROs by

HHS-certified laboratories that MROs ultimately verify as negative.

The final rule retains the permission in the former rule for licensees and other entities to establish more stringent cutoff levels for initial drug tests, subject to the requirements specified in Sec. 26.31(d)(3)(iii), for the reasons discussed with respect to that paragraph.

The final rule eliminates the former requirement for licensees and other entities to report drug test results for both the cutoff levels in the former rule and any more stringent cutoff levels they applied.

The NRC in the former rule required FFD programs to report test results for the cutoff levels specified in this part, when the licensee was applying more stringent cutoff levels, because it provided means for the NRC to monitor licensees' implementation of the permission to use more stringent cutoff levels. The final rule eliminates this requirement because Sec. 26.31(d)(3)(iii)(C) requires a qualified forensic toxicologist to certify the scientific and technical validity of the licensee's or other entity's testing process at any lower cutoff levels. Therefore, the reporting requirement is no longer needed to ensure licensee testing facility performance in this area. Eliminating this requirement meets Goal 5 of this rulemaking to improve Part 26 by eliminating or modifying unnecessary requirements.

Section 26.135 Split Specimens

The NRC has added Sec. 26.135 to reorganize and amend the requirements contained in former Section 2.7(j) in Appendix A to Part 26 that related to licensee testing facility handling of split specimens. The requirements in this section apply only to FFD programs that follow split specimen collection procedures. The NRC has divided the former provision into separate paragraphs in this section to indicate that each requirement stands on its own. This change has been made to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the final rule.

Section 26.135(a) amends the second, third, and fourth sentences of former Section 2.7(j) in Appendix A to Part 26. The final rule revises the terminology used in these sentences (e.g., ``Bottle A'' rather than

``primary specimen,'' ``Bottle B'' rather than ``split specimen,''

``positive or of questionable validity'' rather than ``presumptive positive'') to be consistent with terminology used in other parts of the regulation without amending the meaning of the sentences. The final rule deletes the requirement in the third sentence of former Section 2.7(j) to seal the split specimen prior to placing it in secure storage because Bottles A and B have already been sealed at the collection site, as required under Sec. 26.113(b)(3). The final rule adds a requirement to forward the Bottle A specimen to an HHS-certified laboratory if the licensee testing facility obtains a questionable validity test result. This requirement is consistent with the addition of requirements to conduct validity testing throughout the final rule, as discussed with respect to Sec. 26.31(d)(3)(i). With respect to the proposed rule, the final rule adds a requirement that Bottle B specimens must remain in secure storage under the requirements in Sec. 26.159(i) if the licensee testing facility retains Bottle B specimens rather than sending the specimens to the HHS-certified laboratory with

Bottle A specimens.

Section 26.135(b) amends the requirements in former Section 2.7(j) in Appendix A to Part 26 related to donor requests for testing of the specimen in Bottle B. The final rule adds adulterated or substituted validity test results as a basis for a donor request for testing the specimen in Bottle B consistent with the addition of requirements to conduct validity testing throughout the final rule, as discussed with respect to Sec. 26.31(d)(3)(i). The final rule, with respect to the proposed rule, imposes a requirement on the MRO to ensure that Bottle B is forwarded to a second HHS-certified laboratory that did not test the specimen in Bottle A, at the request of the donor, and to follow the procedures specified in Sec. 26.165(b). In addition, the NRC eliminated the procedures for donor requests for testing the specimen in Bottle B that were included in this provision in the proposed rule because they were incomplete and partially redundant with the related provision in Sec. 26.165(b). The NRC made these changes to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

The final rule eliminates the requirement in the fourth sentence of former Section 2.7(j) in Appendix A to Part 26 that required the licensee testing facility or HHS-certified laboratory to forward the split specimen to another HHS-certified laboratory for testing on the same day of the donor request. The final rule, with respect to the proposed rule, references the provisions in Sec. 26.165(b) pertaining to the time period (1 business day) within which licensee testing facilities must forward a specimen to a second HHS-certified laboratory following the donor request. This change responds to stakeholder feedback provided during the public meetings discussed in Section IV.D.

The stakeholders reported that implementing the former same-day requirement was often difficult for a number of reasons, including, for example, communication delays among donors, MROs, and FFD program personnel, particularly on weekends and holidays, and the time required to identify a second laboratory with the appropriate capability to test the split specimen, depending on the nature of the non-negative test result. The final rule alleviates some of these logistical difficulties

(e.g., logistical problems associated with weekends and holidays) while continuing to provide the donor with timely test results. Therefore, the NRC made this change to meet Goal 5 of this rulemaking to improve

Part 26 by eliminating or modifying unnecessary requirements.

Section 26.135(c) amends former Section 2.7(c) in Appendix A to

Part 26 that applied to storing specimens at licensee testing facilities. The NRC has amended some of the terminology used in the former provision for consistency with the terminology changes made throughout the rule. For example, the provision replaces the term

``split specimen'' with the term ``Bottle B.'' In addition, the final rule imposes the requirements for long-term frozen storage of split specimens in former Section 2.7(h) in Appendix A to Part 26 on licensees and other entities who choose to retain Bottle B of a split specimen at the licensee testing facility rather than forwarding it with Bottle A to the HHS-certified laboratory when additional testing at the HHS-certified laboratory is required. The final rule requires licensees and other entities to ensure that Bottle B of any specimen that the MRO has confirmed to be positive, adulterated, substituted, or invalid is retained in long-term frozen storage for at least 1 year.

The final rule, with respect to the proposed rule, includes a requirement that licensee testing facilities who retain Bottle B specimens must ensure that proper specimen storage conditions (i.e., frozen storage) are maintained during extended power outages. This change is based on comments received on the proposed

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rule noting the oversight. The final rule is consistent with former

Section 2.7(c) in Appendix A to Part 26, which required licensee testing facilities to have emergency power equipment available in case of a prolonged power failure. The final rule extends the former requirement to apply to Bottle B of any specimen that has yielded adulterated, substituted, or invalid validity test results, consistent with the addition of requirements to conduct validity testing throughout the final rule, as discussed with respect to Sec. 26.31(d)(3)(i). The final rule moves the portions of former Section 2.7(h) in Appendix A to Part 26 that applied to HHS-certified laboratories to Sec. 26.159(i) in subpart G to improve the organizational clarity of the final rule.

Section 26.137 Quality Assurance and Quality Control

The NRC has added Sec. 26.137 to amend former Section 2.8 in

Appendix A to Part 26 [Quality assurance and quality control] . This section adds quality control requirements for performing validity screening tests, initial validity tests, and initial tests for drugs and drug metabolites at the licensee testing facility, for the reasons discussed with respect to each paragraph. The final rule incorporates the related requirements from the HHS Guidelines to meet, in part, Goal 1 of this rulemaking to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. The NRC has relocated the portions of former Section 2.8 in Appendix A to Part 26 that established requirements for HHS-certified laboratories to

Sec. 26.167 in Subpart G of the final rule for organizational clarity.

The agency has made many changes in this section with respect to the proposed rule in response to detailed technical comments the NRC received on the proposed rule. The performance testing and quality control requirements in the final rule are consistent, in large part, with those required for initial testing at the HHS-certified laboratories.

Section Sec. 26.137(a) [Quality assurance program] amends former

Section 2.8(a) in Appendix A to Part 26, which required licensee testing facilities and HHS-certified laboratories to have a quality assurance program for all aspects of the testing process. The NRC moved the former requirements related to HHS-certified laboratories to Sec. 26.167(a) in Subpart G to improve organizational clarity. The final rule extends the former requirements for licensee testing facilities to have a quality assurance program and procedures for drug testing to validity testing at the licensee testing facility, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed Sec. 26.31(d)(3)(i).

Section 26.137(b) [Performance testing and quality control requirements for validity screening tests] establishes new requirements for performance testing and quality control of validity screening testing at the licensee testing facility. This section permits licensee testing facilities to use validity screening tests to determine whether a specimen is valid or must be subject to further validity testing.

However, any specific validity screening test that a licensee testing facility chooses to use (e.g., a validity screening test for creatinine concentration, a validity screening test for pH, a validity screening test for oxidizing adulterants) must meet the stringent performance testing requirements in this section. The requirements in this section are based on requirements that were proposed by HHS in a Notice of

Proposed Revisions to the Mandatory Guidelines dated April 13, 2004 (69

FR 19673). However, in response to detailed public comments on the proposed rule and further technical analyses, the NRC has revised several of the proposed HHS requirements that were incorporated in this section in the proposed rule, as discussed with respect to each provision the NRC has changed.

Section 26.137(b)(1) permits licensee testing facilities to use validity screening tests to determine whether a specimen is valid or must be subject to further validity testing. However, under Sec. 26.137(b)(1)(i) and (ii), the NRC requires licensee testing facilities to use only validity screening tests that either have been placed on the SAMHSA list of point-of-collection testing devices that are certified for use in the Federal Workplace Drug Testing Program as published in the Federal Register, or that meet the performance testing criteria set forth in Sec. 26.137(b)(1)(ii) for the reasons discussed with respect to that provision. With respect to the proposed rule,

Sec. 26.137(b)(1) in the final rule includes a new provision to address an unintentional omission in the proposed rule. Specifically, the NRC has added a requirement that licensee testing facilities must use an HHS-certified laboratory that has the capabilities to confirm the presence of any adulterant for which the licensee testing facility conducts validity screening tests. The inclusion of this provision is necessary because, as proposed, a licensee testing facility could have used a validity screening test that identified an adulterant that the

HHS-certified laboratory could not identify because the laboratory did not also test for the adulterant in their validity testing panel. If this was the case, a specimen with a questionable validity result from a licensee testing facility would be tested by the HHS-certified laboratory and the specimen would receive a negative or invalid validity test result, creating conflicting results. The final rule resolves this inconsistency.

In addition, the final rule eliminates the term, ``non-instrumented devices,'' that was used in proposed Sec. 26.137(b)(1). By eliminating the specific reference to non-instrumented tests and by revising the definition of ``validity screening test'' in Sec. 26.5, the NRC is permitting licensee testing facilities to use instrumented tests, in addition to non-instrumented tests, to perform validity screening testing. The NRC made this change in response to a public comment. The commenter suggested that the proposed requirement that limited licensee testing facilities to using only non-instrumented devices to perform validity screening tests was unduly restrictive. Specifically, the commenter stated that instrumented tests could successfully meet the performance testing requirements (e.g., pH testing) for some validity screening tests described in proposed Sec. 26.137(b)(1). The inclusion of instrumented tests for validity screening testing meets Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

In Sec. 26.137(b)(1)(i) of the final rule, the NRC permits licensee testing facilities to use validity screening tests that are identified, by lot number, on the SAMHSA list of point-of-collection tests approved for use in the Federal Workplace Drug Testing Program, as published in the Federal Register. The NRC is aware that SAMHSA has yet to publish a list of approved point-of-collection tests but added this permission so that licensee testing facilities may rely on that list when it is available. With respect to the proposed rule, the final rule has removed the requirement that validity screening tests must be cleared by the FDA in response to a public comment. The NRC eliminated the proposed requirement because, as the commenter pointed out, the FDA is not responsible for clearing specimen validity point-of-collection tests. The final rule also clarifies the proposed provision by adding the requirement that licensee testing facilities may only use validity screening tests from ``lots'' (i.e., batches or groups of tests that are manufactured

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from the same original materials) that are identified on the SAMHSA list when it is available. The NRC added this clarification because

SAMHSA approval will apply to all validity screening tests from the same lot but may not apply to other lots of the test that do not meet

SAMHSA's criteria for approval.

Because SAMHSA has yet to publish a list of approved validity screening tests, the NRC has added Sec. 26.137(b)(1)(ii) to permit licensee testing facilities to use validity screening tests that meet the stringent performance testing requirements established in this section. Adding these requirements to the final rule permits licensee testing facilities to conduct the required performance testing and begin using any validity screening tests that meet the criteria before

SAMHSA's list is published. The NRC is aware that the performance testing requirements in Sec. 26.137(b)(1)(ii) are stringent and that few, if any, validity screening devices are yet available that meet them. However, because individuals may be subject to a temporary administrative withdrawal of authorization on the basis of a positive initial drug test result for marijuana or cocaine from a specimen that yields negative test results from validity screening (see proposed

Sec. 26.75(i)), it is critical that any validity screening tests used in Part 26 programs provide accurate results. The proposed performance testing requirements are necessary to protect donors from inaccurate results and ensure that specimens of questionable validity are detected.

The final rule eliminates the proposed provision in Sec. 26.137(b)(1)(ii)(A) that required a licensee testing facility or HHS- certified laboratory to conduct performance testing of 100 validity screening devices from all currently available manufactured lots of the device to ensure that the devices met the performance testing criteria in proposed Sec. 26.137(b)(1)(ii)(C) before the licensee testing facility began using the validity screening test. The NRC eliminated proposed Sec. 26.137(b)(1)(ii)(A) to address public comments received suggesting that licensee testing facilities and HHS-certified laboratories may not have the experience or expertise to conduct performance testing of validity screening devices. The commenters suggested that the NRC should instead consider requiring the manufacturer of the validity screening tests to perform and document validation studies of the validity screening tests as well as conduct tests of performance testing samples that licensee testing facilities submit to the manufacturer. The NRC agrees with the commenters and has revised the proposed rule to require manufacturers to perform and document validation studies in Sec. 26.137(b)(1)(ii)(D) of the final rule. The final rule also requires licensees and others entities that intend to use validity screening tests to submit performance testing samples to the validity screening test manufacturer in Sec. 26.137(b)(1)(ii)(E) of the final rule. This change ensures that the evaluation of a validity screening test is conducted by an individual(s) endorsed by the manufacturer. If an individual with limited training were used to conduct the tests, the manufacturer may have a reason to question the test results obtained by the licensee testing facility or the HHS-certified laboratory. The NRC believes that the validity screening test manufacturer is best qualified to demonstrate the effectiveness of each test because the manufacturer is the entity with the greatest knowledge of correct testing procedures.

Another public comment received on proposed Sec. 26.137(b)(1)(ii)(A) stated that the requirement to test 100 validity screening devices was overly burdensome. The NRC agrees with the commenter, has revised the requirement, and relocated the amended provision to Sec. 26.137(b)(1)(ii)(E). The new Sec. 26.137(b)(1)(ii)(E) requires a licensee or other entity to submit three consecutive sets (at least 6 samples in each set) of performance testing samples to the validity screening test manufacturer for performance testing before the licensee testing facility begins using a validity screening to test donor specimens. Therefore, the final rule requires the licensee or other entity to submit a minium of 18 samples for each validity screening test to be used by a licensee or other entity. If a licensee or other entity chooses to use validity screening tests to conduct all of the validity testing required by this subpart

(e.g., creatinine, pH, and oxidizing adulterants), the total minimum number of performance test samples that a licensee testing facility must submit to meet the minimum performance testing requirements in the final rule is 72 samples (18 samples for a creatinine test divided into three sets, 18 samples for pH testing at levels equal to or less than 4.5 divided into three sets, 18 samples for pH testing at levels equal to or greater than 9 divided into three sets, and 18 samples for an oxidant test divided into three sets). If a licensee or other entity chooses to use a validity screening test for only one of the types of validity testing required in this subpart, the total number of performance test samples that the licensee testing facility must submit is less. For example, if a licensee or other entity chooses to use a validity screening test only for determining creatinine concentration, the total number of performance samples that the licensee testing facility must submit for testing is 18 samples divided into three sets.

The NRC believes that the revised performance testing sample requirements reduce the burden on licensees and other entities imposed by these performance testing requirements while ensuring that the validity screening tests provide accurate and consistent test results.

The agency has also relocated and revised the requirements in proposed Sec. 26.137(b)(1)(ii)(B) and (b)(1)(ii)(C). These proposed provisions established requirements for the formulation of performance testing samples and criteria for licensees and other entities to apply when evaluating performance testing results, respectively. The final rule combines these requirements in Sec. 26.137(b)(1)(ii)(E) and presents them in the rule in the sequence in which licensees and other entities would implement them for organizational clarity. The NRC has also made other changes to the provisions in proposed Sec. 26.137(b)(1)(ii) to address a public comment that stated that the performance testing standards in the proposed rule were unduly prescriptive and should instead be performance based. The NRC agrees with the commenter and has further revised the performance testing provisions in proposed Sec. 26.137(b) as is subsequently discussed with respect to each provision in the final rule.

Section 26.137(b)(1)(ii)(A) of the final rule specifies that a validity screening test that a licensee testing facility intends to use to conduct creatinine testing must be able to detect whether a specimen's creatinine concentration is less than 20 mg/dL. This provision replaces the portions of proposed Sec. 26.137(b)(1)(ii)(B) and (b)(4) that established the required creatinine measurement capabilities of validity screening devices. The NRC revised the provision in response to a public comment received on proposed Sec. 26.137(b)(4) that stated that tests currently available that could be used for validity screening testing for creatinine cannot distinguish creatinine concentrations in the proposed ranges of 5-20 and 1-5 mg/dL.

The commenter noted that current validity screening tests, at best, can detect creatinine concentration at a cutoff of 20 mg/dL. Because the rule does not require licensee testing facilities to determine

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whether a specimen meets the criteria for substitution or dilution, which depend on the results of specific gravity testing in addition to lower creatinine concentrations, the NRC agrees with the commenter that the proposed creatinine testing to lower concentrations is unnecessary.

A validity screening test that can detect creatinine concentration at a cutoff of 20 mg/dL is adequate for a licensee testing facility to determine that a specimen is of questionable validity and requires further testing at an HHS-certified laboratory. This revision avoids imposing an unnecessary burden on licensee testing facilities while ensuring that the validity screening test will support the creatinine concentration cutoff at 20 mg/dL established in Sec. 26.131(b)(1).

Section 26.137(b)(1)(ii)(B) of the final rule specifies that a validity screening test that a licensee testing facility intends to use to conduct pH testing must be able to identify specimens with pH of less than 4.5 and pH equal to or greater than 9. This provision replaces the portions of proposed Sec. 26.137(b)(1)(ii)(B) and (b)(4) that established the required pH measurement capabilities of validity screening devices. Proposed Sec. 26.137(b)(1)(ii)(B) and (b)(4) would have required pH validity screening tests to be capable of detecting pH in the ranges of 1-3 and 10-12. However, the NRC received two comments noting that the proposed pH ranges would not permit the licensee testing facility to detect a specimen that meets the criteria for an invalid test result in the HHS Guidelines (i.e., pH less than 4.5 or equal or greater than 9). Therefore, this change addresses the issue raised by the commenter and ensures that the validity screening test will support the pH cutoffs established in Sec. 26.131(b)(2) as revised in the final rule.

Section 26.137(b)(1)(ii)(C) of the final rule specifies the required performance capabilities for a validity screening test that a licensee testing facility intends to use to conduct testing for oxidizing adulterants. This provision replaces the portions of proposed

Sec. 26.137(b)(1)(ii)(B) and (b)(4) that established the required oxidizing adulterant measurement capabilities of validity screening devices. Proposed Sec. 26.137(b)(1)(ii)(B) and (b)(4) would have required oxidizing adulterant validity screening tests to be capable of detecting nitrite in the ranges of 250 mcg/mL to 400 mcg/mL and from 650 mcg/mL to 800 mcg/mL. However, one commenter on the proposed rule noted that the proposed nitrite concentrations for performance testing samples ranging from 250 mcg/mL to 400 mcg/mL and from 650 mcg/mL to 800 mcg/mL would not identify specimens that meet the invalid specimen testing criteria in the HHS Guidelines (i.e., nitrite concentration equal to or greater than 200 mcg/mL). The NRC agrees with the commenter and has revised the oxidant measurement requirements for validity screening tests to detect nitrite concentration at a cutoff of 200 mcg/ mL in Sec. 26.137(b)(1)(ii)(C) of the final rule. For completeness, the final rule also includes performance testing criteria for additional oxidant tests (i.e., chromium, halogen) that a licensee testing facility could perform to meet the requirements for testing for oxidizing adulterants in Sec. 26.131(b). Therefore, these changes improve the clarity of the performance testing requirements in this section and the consistency of the final rule with the HHS Guidelines.

At the suggestion of a commenter, the NRC has added Sec. 26.137(b)(1)(ii)(D) to the final rule. This provision requires the manufacturer of a validity screening test to conduct and document validation studies demonstrating the performance characteristics of the validity screening test around the cutoff levels established in this subpart. The commenter suggested that the majority of the burden of demonstrating the performance capabilities of validity screening tests should rest with the manufacturer rather than with licensees and other entities or HHS-certified laboratories, as required by several provisions of the proposed rule. The NRC agrees with the commenter and believes that the manufacturer of each validity screening test is the most appropriate entity to demonstrate the performance characteristics of the validity screening tests before a licensee or other entity begins using a test in an FFD program. The NRC believes it is necessary to establish requirements similar to those that exist for other types of testing performed by licensee testing facilities and HHS-certified laboratories. Both the former and final rules require licensee testing facilities and HHS-certified laboratories to validate their analytical methods before conducting drug testing of donor specimens. The requirement for manufacturers to validate their validity screening tests before providing them to licensee testing facilities is essentially parallel to these requirements for licensee testing facilities and HHS-certified laboratories. The NRC believes the validation requirement is necessary to ensure that the manufacturer has verified the performance characteristics of the validity screening test before shipment to suppliers and use by licensee testing facilities.

As discussed with respect to proposed Sec. 26.137(b)(1)(ii)(A), the NRC has revised the performance testing requirements in proposed

Sec. 26.137(b)(1)(ii)(A)-(b)(1)(ii)(C). In addition to the changes to performance testing requirements previously discussed, the final rule revises the portion of proposed Sec. 26.137(b)(1)(ii)(C) that established the percentage of total performance test samples that validity screening tests must correctly identify when licensees and other entities submit performance testing samples to the manufacturer.

In Sec. 26.137(b)(1)(ii)(E), the NRC has increased this required percentage from 80 percent in the proposed rule to 90 percent in the final rule. The more rigorous criterion for validity screening tests increases consistency among the rule's criteria for licensee testing facility drug testing performance and criteria in the HHS Guidelines for HHS-certified laboratory drug and validity testing performance. The

NRC has made this revision in the final rule to ensure that validity screening tests perform accurately and reliably and that each FFD program effectively evaluates the validity of urine specimens.

Section 26.137(b)(1)(iii) revises proposed Sec. 26.137(b)(1)(iii) to further reduce the performance testing burden on licensees and other entities who use validity screening tests. The proposed rule would have required licensees and other entities to ensure the continued effectiveness of any validity screening tests it is using, after they have been placed in service, by conducting or requesting the HHS- certified laboratory to conduct performance testing of 50 devices on a nominal annual frequency. Consistent with other changes to the performance testing requirements in Sec. 26.137(b), the final rule requires the validity screening tests' manufacturers to conduct this followup performance testing rather than licensee testing facilities or

HHS-certified laboratories as proposed. In addition, the final rule eliminates the specific requirement for testing of 50 devices annually and replaces it with a performance-based standard in response to a public comment suggesting that the specificity in the proposed provision was unnecessarily burdensome. The final rule does not specify the number of performance testing samples to be tested by the manufacturer using validity screening tests from the lot in use by the licensee testing facility. The final rule instead requires the manufacturer to test performance testing samples that are formulated around the cutoff levels for

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validity testing in this subpart. The NRC believes this standard is adequate to determine whether validity screening tests in each lot are continuing to provide accurate and consistent test results and avoids imposing unnecessarily restrictive requirements.

The NRC has eliminated proposed Sec. 26.137(b)(1)(iv) from the final rule. That provision required licensees and other entities to ensure that the manufacturer of a validity screening test that is used by the licensee testing facility informs the licensee or other entity of any changes to the device that may require additional performance and to conduct additional performance testing if recommended by the MRO or HHS-certified laboratory. This provision is no longer necessary because the revised performance testing requirements in the final rule are focused on each lot of validity screening tests the licensee testing facility intends to use. Because manufacturers cannot make changes to a validity screening test after a lot of the tests has been produced, information about changes to the tests in that lot and additional performance testing are not required.

Section 26.137(b)(2) establishes quality control requirements that licensee testing facility personnel must implement at the beginning of any 8-hour period when validity screening tests will be performed and while conducting validity screening testing. With respect to the proposed rule, the NRC has revised the quality control requirements that were in Sec. 26.137(b)(2) in the proposed rule and relocated them to Sec. 26.137(b)(2)(i). The agency made this change because the final rule adds a new Sec. 26.137(b)(2)(ii) and it is necessary to group the related requirements together for organizational clarity in the final rule.

In response to a public comment, the agency has revised Sec. 26.137(b)(2) in the final rule to require that the licensee testing facility personnel who will be or are performing validity screening testing must implement the quality control requirements in this section. The commenter reasoned that because some validity screening tests have visually read endpoints, the test result must be interpreted by the tester. Therefore, it is necessary to verify that each tester is able to interpret the quality control samples correctly before conducting tests on donor specimens and during the testing process. The

NRC agrees with this comment and made the appropriate change in the final rule.

Section 26.137(b)(2)(i) revises portions of proposed Sec. 26.137(b)(2) and requires that the quality control samples to be tested before beginning to test donor specimens in any 8-hour period must consist of one sample that is certified as negative and one that is formulated to appropriately challenge each type of validity screening test to be conducted (e.g., certified to contain an oxidizing adulterant, to have creatinine below 20 ng/mL). For example, the final rule requires that if a licensee testing facility is using a validity screening test to determine the nitrite concentration of a specimen, licensee testing facility personnel must use a certified quality control sample containing nitrite. This requirement is necessary to verify that the validity screening tests to be used are functioning properly and that licensee testing facility personnel are able to conduct the tests appropriately, as discussed with respect to Sec. 26.137(b)(2). The final rule replaces the term ``non-negative'' in the proposed rule, which was used to describe the quality control samples that licensees and other entities must use, with a requirement that the quality control samples must be formulated to challenge each validity screening test around the cutoffs for initial validity testing specified in this subpart. The NRC made this change to improve the clarity in the language of the rule, as discussed with respect to Sec. 26.5.

The final rule, with respect to the proposed rule, adds a provision to require validity screening tests to be challenged by licensee testing facility personnel after screening every 10 donor specimens in

Sec. 26.137(b)(2)(ii). Specifically, this provision requires the licensee testing facility to test at least 1 quality control sample after testing every 10 donor specimens during an 8-hour testing period and requires the quality control sample to be formulated to challenge the validity screening test(s) in use around the cutoffs specified in

Subpart F. The NRC has added this provision to enhance the consistency of quality control procedures for conducting validity screening testing with quality control procedures for conducting initial validity and drug testing at licensee testing facilities. As discussed with respect to Sec. 26.137(d) and (e), the NRC requires licensee testing facilities to test calibrators, controls, and blind quality control samples during each analytical run of initial validity and drug testing conducted at the licensee testing facility (See Sec. 26.5 for a discussion of the term, ``analytical run'') to monitor the accuracy of testing. However, because it may not be possible to conduct validity screening tests in batches (i.e., the tester may have to insert a dipstick into an aliquot of each donor's specimen manually), it is impractical to impose similar requirements for calibrators, controls and blind quality control testing each time a single validity screening test is performed. Therefore, the NRC added this provision to ensure, without imposing unrealistic requirements, that validity screening tests continue to perform reliably during any 8-hour period in which the validity screening tests are used and to increase consistency among quality control requirements for validity screening and initial validity and drug testing in this section.

The NRC has moved the requirements in proposed Sec. 26.137(b)(2) that addressed the steps that licensee testing facilities must take if a validity screening tests fails to perform correctly when testing quality control samples. For organizational clarity, the NRC relocated the proposed provisions to Sec. 26.137(f) in the final rule because

Sec. 26.137(f) establishes requirements related to the topic of the proposed provisions, errors in testing.

Section 26.137(b)(3) requires licensee testing facility personnel to submit 1 out of every 10 donor specimens that yield negative results using validity screening tests to an HHS-certified laboratory. This requirement is necessary to detect false negative test results from validity screening tests. A false negative test result in this instance is a result from a validity screening test indicating that the specimen is valid when, in fact, validity testing at the HHS-certified laboratory identifies the specimen as adulterated, substituted, or invalid. Assessing the validity screening test's rate of false negative test results is necessary because false negative results from a validity screening test could mean that some attempts to subvert the testing process may not be detected. For example, if an individual had adulterated his or her specimen and it was not detected because of a faulty device, the licensee or other entity would have no reason to terminate the individual's authorization. As a result, an individual who has demonstrated that he or she is not trustworthy and reliable would be permitted to perform duties under this part and may pose a risk to public health and safety and the common defense and security.

With respect to the proposed rule, the NRC has moved the requirements in proposed Sec. 26.137(b)(3) that addressed the steps that licensee testing facilities must take if the HHS-certified laboratory's results indicate that the validity screening test provided a false negative result. For organizational clarity, the NRC relocated the proposed provisions to Sec. 26.137(f) in the final rule

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because Sec. 26.137(f) establishes requirements related to the topic of the proposed provisions, errors in testing.

The NRC notifications required in Sec. 26.137(b)(2)and (b)(3) are necessary because false negative results from a validity screening test indicate the laboratory testing process may not be successfully detecting donor attempts to subvert the testing process through specimen adulteration or substitution. For example, if an individual had adulterated his or her specimen and it was not detected because of a faulty test, the licensee or other entity would have no reason to terminate the individual's authorization. As a result, an individual who has demonstrated that he or she is not trustworthy and reliable would be permitted to perform duties under this part and may pose a risk to public health and safety and the common defense and security.

The NRC will use the information to ensure that HHS is notified of the test failure as well as inform other licensees and entities who may also be using the test of the false negative results to prevent additional testing errors. Therefore, the notifications are necessary to protect donors from inaccurate test results, to ensure that specimens of questionable validity are detected, and to ensure that any problems with a test are detected and corrected as soon as possible.

In response to public comments, the NRC has eliminated proposed

Sec. 26.137(b)(4) that required validity screening tests to be capable of measuring a specimen's creatinine concentration to 1 decimal place.

Specificity below 20 mg/dL is unnecessary because NRC is not requiring licensee testing facilities to conduct the tests for specific gravity that are necessary for reporting substituted, dilute, or invalid validity test results, as discussed with respect to Sec. 26.137(b)(1)(ii)(A). This change reflects the current capabilities of validity screening tests and supports the intent of the NRC that licensee testing facilities need only be able to identify whether a specimen has a creatinine concentration of less than 20 mg/dL and therefore requires additional testing at an HHS-certified laboratory.

The NRC has added a new Sec. 26.137(b)(4) in the final rule to establish requirements for storing validity screening tests and requires licensee testing facilities to maintain the tests consistent with the manufacturer's storage specifications. Storing the tests as required by the manufacturer's instructions is necessary to ensure that the tests continue to function optimally. This requirement is consistent with the quality control requirements for ASDs in Sec. 26.91(d) and meets Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.

The NRC has deleted proposed Sec. 26.137(b)(5) and (b)(6) from the final rule and replaced these provisions with the performance testing requirements in Sec. 26.137(b)(1)(ii) for the reasons discussed with respect to that section.

The NRC added Sec. 26.137(c) [Validity screening test results] to specify the actions that the licensee testing facility must take if a donor's specimen yields questionable results from validity screening testing. If a specimen has a questionable validity screening test result, the final rule requires instrumented initial validity testing either at the licensee testing facility or the HHS-certified laboratory. This provision is consistent with the rule's requirements for transferring to the HHS-certified laboratory specimens with initial positive drug test results from testing at a licensee testing facility.

Further testing of a specimen of questionable validity is necessary to protect donors from inaccurate test results, as well as provide assurance that specimens of questionable validity are detected using the more sophisticated technologies required for instrumented initial validity testing in the HHS Guidelines and the final rule. The final rule, with respect to the proposed rule, eliminates the term ``non- negative'' from the heading of the provision for the reasons discussed with respect to Sec. 26.5 related to the elimination of this term throughout the final rule.

The agency added Sec. 26.137(d) [Quality control requirements for performing initial validity tests] to specify the required methods for performing initial validity tests at a licensee testing facility that are necessary to ensure that initial validity testing at the licensee testing facility provides accurate results. The requirements in this paragraph incorporate the related requirements in the HHS Guidelines as revised on April 13, 2004 (69 FR 19644). The paragraph has been added to meet Goal 1 of this rulemaking to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines.

Section 26.137(d)(1) requires licensee testing facilities to measure creatinine concentration to 1 decimal place and establishes requirements for the controls to be used in initial tests for creatinine concentration.

Section 26.137(d)(2) establishes quality control requirements for performing initial pH tests. Sections 26.137(d)(2)(i)-(d)(2)(v) specify the required calibrators and controls for initial pH testing, based on the type of testing instrument used and whether a pH validity screening test has been performed.

Section 26.137(d)(3) establishes quality control requirements for performing initial tests for oxidizing adulterants, including nitrite, and Sec. 26.137(d)(4) establishes quality control requirements for performing initial tests for ``other'' adulterants at the licensee testing facility.

Section 26.137(d)(5) requires that one of the quality control samples included in each analytical run must appear to be a donor specimen to laboratory analysts. The final rule retains the related requirement in the last paragraph of Section 2.8(c)(3) in Appendix A to

Part 26 and amends the provision to be consistent with the same requirement in the HHS Guidelines. With respect to the proposed rule, the NRC relocated this requirement from proposed Sec. 26.137(e)(7) to

Sec. 26.137(d)(5) in the final rule to clarify that the requirement to test one blind quality control sample in each analytical run applies to initial validity test runs as well as to initial drug testing if the licensee testing facility does not conduct initial validity and drug testing concurrently. However, if a licensee testing facility conducts initial validity and drug testing of specimens concurrently, the NRC intends that the licensee testing facility would include only one blind performance test sample in the analytical run to meet this requirement as well as the same requirement in Sec. 26.137(e)(6)(v) for drug testing runs. The NRC made these changes to meet Goal 6 of this rulemaking to improve clarity in the organization of the rule.

The NRC also added Sec. 26.137(d)(6) in the final rule to require licensee testing facilities to send 1 out of 10 specimens that test negative on initial validity tests to an HHS-certified laboratory for initial and, if necessary, confirmatory validity testing. The NRC added this requirement in response to public comments noting inconsistencies in the proposed rule's quality control requirements for validity screening, initial validity testing, and initial drug testing, and for the reasons discussed with respect to the addition of a similar requirement applicable to validity screening testing in Sec. 26.137(b)(3). Adding this provision ensures that licensee testing facilities can assess their rates of false negative initial validity test results and therefore meets Goal 3 of this rulemaking to improve the effectiveness of FFD programs.

Section 26.137(e) [Quality control requirements for initial drug tests]

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amends and combines portions of former Section 2.7(d), 2.7(e)(1), and 2.8(b) in Appendix A to Part 26. The former provisions established quality control requirements for performing initial tests for drugs and drug metabolites at licensee testing facilities. The final rule groups together in one paragraph the requirements that were dispersed throughout the former rule to meet Goal 6 of this rulemaking to improve clarity in the organization of the final rule.

Section 26.137(e)(1) amends the first sentence of former Section 2.7(e)(1) in Appendix A to Part 26 but retains the intent of the former provision as it applies to licensee testing facilities. This provision retains the former requirement that licensee testing facilities may use only immunoassay tests that meet the requirements of the Food and Drug

Administration for commercial distribution. The NRC has moved the requirements in the former provision related to initial drug testing at

HHS-certified laboratories to Sec. 26.167(d)(1) of Subpart G of the final rule to improve organizational clarity in the rule.

In addition, Sec. 26.137(e)(1) prohibits licensee testing facilities from relying on drug test results from any tests they may use to perform validity screening tests. The NRC added this prohibition because several non-instrumented devices are available that combine tests for the presence of drugs and drug metabolites in a urine specimen with tests for other attributes of a urine specimen, such as creatinine concentration. The final rule permits licensee testing facilities to use such combination tests as validity screening tests if the tests meet the requirements of Sec. 26.137(b)(1). However, the drug testing capabilities of these tests are not yet sufficiently accurate and sensitive to be used in Part 26 programs, in which licensees and other entities are permitted to administratively withdraw an individual's authorization on the basis of positive initial drug test results for marijuana and cocaine metabolites. The NRC may consider accepting the use of initial drug test results from non- instrumented tests in a future rulemaking, when HHS publishes a final revision to the Mandatory Guidelines that establishes requirements for their use in Federal workplace drug testing programs. At this time, however, the final rule retains the former prohibition on using such tests for drug testing at licensee testing facilities.

The NRC added Sec. 26.137(e)(2) to require licensee testing facilities to either discard specimens that yield negative results from initial tests at the licensee testing facility or pool them and use these specimens as quality control specimens, if the specimens are certified as negative and valid by an HHS-certified laboratory. This provision incorporates the related provision from the HHS Guidelines to meet Goal 1 of this rulemaking to update and enhance the consistency of

Part 26 with advances in other relevant Federal rules and guidelines.

With respect to the proposed rule, the final rule adds a sentence prohibiting licensee testing facilities from retaining any information linking donors to specimens pooled for use in the internal quality control program. The agency added this prohibition in response to a public comment requesting this addition. This change meets Goal 7 of this rulemaking to protect the privacy and other rights (including due process) of individuals who are subject to Part 26.

Section 26.137(e)(3) permits licensee testing facilities to conduct multiple tests of a single specimen for the same drug or drug class.

The NRC has revised Sec. 26.137(e)(3) in the final rule, with respect to the proposed rule, to include a more precise description of when multiple initial drug tests on a specimen (also know as rescreening) are permitted. The NRC added this information in the final rule in response to a comment received on the proposed provision requesting the addition. The requirements in the provision are consistent with a similar provision in the HHS Guidelines and, therefore, meet Goal 1 of this rulemaking to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines.

Section 26.137(e)(4) amends the first sentence of former Section 2.8(b) in Appendix A to Part 26. The former sentence stated that licensee testing facilities are not required to assess their false positive rates in drug testing. The final rule retains the intent of the former requirement, but the NRC has updated the terminology in the provision to use the new terms that are used throughout the final rule, e.g., ``initial'' rather than ``screening,'' as discussed with respect to Sec. 26.5.

Section 26.137(e)(5) amends the second sentence of former Section 2.8(b) in Appendix A to Part 26. This provision required licensee testing facilities to submit specimens that yield negative results from initial testing to the HHS-certified laboratory as a quality control check on the licensee testing facility's drug testing process. The paragraph retains the intent of the former provision but makes several changes to the specific requirements.

The paragraph uses the term ``analytical run'' rather than the former term ``test run'' to reflect changes in testing technologies that some licensee testing facilities have adopted since the former rule was published. Requirements for blind performance and other quality control testing in the former rule were based on the assumption that specimens would be tested in batches. However, many licensee testing facilities now conduct continuous testing, and no longer test specimens in batches. Therefore, the final rule uses the term,

``analytical run,'' to refer to both batch and continuous processing, as defined in Sec. 26.5. This change has been made to meet Goal 6 of this rulemaking to improve clarity in the language of the final rule.

The former rule did not establish a number or percentage of negative specimens that licensee testing facilities were required to submit to the HHS-certified laboratory for performance testing, which raised implementation questions from licensees who have wanted to know how many specimens must be submitted. Therefore, to clarify the former requirement to ``submit a sampling of specimens,'' the final rule requires licensee testing facilities to forward at least one specimen that yields negative drug test results from each analytical run to the

HHS-certified laboratory for performance testing. The final rule also establishes five percent of the specimens tested in each analytical run as the percentage of negative specimens that the licensee testing facility must submit to the HHS-certified laboratory for testing, except if five percent of an analytical run is a number less than one specimen. In the latter case, the licensee testing facility submits at least one negative specimen from the analytical run. This requirement ensures the ongoing evaluation of the accuracy of the licensee testing facility's initial drug testing without imposing a large performance testing burden.

The NRC has moved the last sentence of the former paragraph, which addressed performance testing of breath analysis equipment for alcohol testing, to Sec. 26.91(e) in Subpart E because that subpart of the final rule addresses quality control requirements for alcohol testing.

The NRC made this change to meet Goal 6 of this rulemaking to improve clarity in the organization of the final rule.

Section 26.137(e)(6) amends the requirements of former Section 2.8(c) in Appendix A to Part 26 and applies them to licensee testing facilities. The NRC is applying requirements for quality

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controls to initial drug testing at licensee testing facilities to provide greater assurance that initial drug tests performed by these facilities provide accurate results. The increased performance testing requirements in the final rule are necessary because the final rule permits licensees and other entities to rely on test results from other

Part 26 programs to a greater extent that the former rule. Therefore, it is necessary to ensure that any tests performed at licensee testing facilities meet minimum standards. This change meets Goal 3 of this rulemaking to improve the effectiveness of FFD programs.

The final rule, with respect to the proposed rule, moves the provision in proposed Sec. 26.137(e)(7) to Sec. 26.137(e)(6) in the final rule to improve organizational clarity. The NRC made this change to address a public comment received on the proposed rule that noted that because the second sentence in proposed Sec. 26.137(e)(7) discussed a quality control sample requirement, the provision would be more appropriately located in Sec. 26.137(e)(6) which describes the quality control sample requirements for each analytical run.

Section 26.137(e)(6) establishes requirements for the number of quality control samples to be included in each analytical run at the licensee testing facility. The final rule requires that a minimum of 10 percent of the specimens in each analytical run must be quality control samples. For example, if an analytical run consists of 50 donor specimens, an additional 5 quality control samples would be included in the analytical run for a total of 55 specimens tested in the run. The licensee testing facility will not send the quality control samples to the HHS-certified laboratory for confirmatory testing, but use them for internal quality control purposes only. The requirements in this paragraph incorporate the related requirements in the HHS Guidelines and meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines.

The final rule also requires licensee testing facilities to ensure that quality control samples that are positive for each drug and metabolite for which the FFD program conducts testing are included in at least one analytical run in each quarter of the calendar year. The

NRC added this provision at the request of comments received addressing inconsistences within the proposed rule. The proposed rule required quality control samples for each type of validity test, but failed to specify the required distribution of quality control samples among the drugs and metabolites for which the FFD program tests. This provision clarifies the former rule and increases the internal consistency of this subpart. Additionally, this provision provides for enhanced monitoring of the effectiveness of the licensee testing facilities' drug testing procedures to meet Goal 3 of this rulemaking to improve the effectiveness of FFD programs.

The NRC has added Sec. 26.137(e)(6)(i)-(e)(6)(iii) to describe the required characteristics of the quality control samples that the licensee testing facility must include in each analytical run of specimen testing. These provisions require each analytical run to include at least one negative quality control sample as well as quality control samples targeted at 25 percent above the cutoff and at 25 percent below the cutoff level for each drug and drug metabolite for which testing is conducted. The final rule, with respect to the proposed rule, revises the requirement that a quality control sample must be targeted at 75 percent of the cutoff level and instead, the final rule requires the calibrator to be targeted at 25 percent below the cutoff level. This change was made to improve the clarity of the language of the final rule without changing the intent of the provision. These requirements are consistent with the current HHS

Guidelines for processing quality control samples during initial drug testing.

With respect to the proposed rule, the final rule has added Sec. 26.137(e)(6)(iv) and Sec. 26.137(e)(6)(v) to further enhance quality control requirements for initial drug testing at licensee testing facilities. In response to a public comment, the NRC added Sec. 26.137(e)(6)(iv) to require that each analytical run has a sufficient number of calibrators to ensure linearity of the assay. This additional provision is consistent with the related requirement in the HHS

Guidelines. Section 26.137(e)(6)(v) requires that one sample must appear to be a donor sample to the laboratory analysts. This requirement was previously embedded in Sec. 26.137(e)(7) of the proposed rule, and the NRC moved the requirement to Sec. 26.137(e)(6)(v) of the final rule in response to a comment received that noted this move would enhance organizational clarity in the rule.

The NRC agrees with the commenter.

Section 26.137(e)(7) extends to licensee testing facilities the requirement in the third sentence of the last paragraph of former

Section 2.8(c) in Appendix A to Part 26. That provision required HHS- certified laboratories to implement procedures to ensure that carryover does not contaminate the testing of a donor's specimen and to document the procedures. The final rule extends this requirement to licensee testing facilities because it is a standard forensic practice that is necessary to ensure the integrity of the testing process.

The NRC has added Sec. 26.137(f) [Errors in testing] to require licensees and other entities who maintain testing facilities to investigate any errors or unsatisfactory performance of the testing process, identify the cause(s) of the adverse conditions, and correct them. The final rule requires the licensee or other entity to document the investigation and any corrective actions taken. The provision requires licensees and other entities to investigate any testing errors or unsatisfactory performance identified throughout the testing process or during the review process that are required under Sec. 26.91

Review process for fitness-for-duty policy violations

. The NRC intended, in the original rule, that testing or process errors discovered in any part of the program, including through the review process, be investigated as an unsatisfactory performance of a test.

This provision clarifies that intent. Thorough investigation and reporting of such test results will continue to assist the NRC, the licensees, HHS, and the HHS-certified laboratories in preventing future occurrences.

The NRC has reorganized the requirements in proposed Sec. 26.137(f) into a list format in Sec. 26.137(f)(1)-(f)(5) in the final rule to improve the organizational clarity of the rule and added new requirements to this section for the reasons discussed with respect to each provision.

Section 26.137(f)(1) requires, whenever possible, that the investigation of testing or processing errors must determine relevant facts and identify the root cause(s) of the error. Section 26.137(f)(2) requires the licensee testing facility to take action to correct the cause of any error or unsatisfactory performance within the licensee testing facility's control.

The NRC has added Sec. 26.137(f)(3) to the final rule, with respect to the proposed rule, to address instances when testing of a quality control sample at a licensee testing facility yields a false negative test result. This provision requires the licensee testing facility to forward all donor specimens from the analytical run in which the error is detected to the HHS-certified laboratory for additional testing. This requirement is necessary to ensure that licensees and other entities do not permit individuals who may have altered a specimen or

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used prohibited drugs to be granted or maintain authorization to have the types of access or perform the duties that require them to be subject to the rule. Additional testing at the HHS-certified laboratory of the donor specimens included in the analytical run during which the error is identified ensures that public health and safety and the common defense and security are not placed at risk because initial validity or drug test results from the licensee testing facility failed to identify an individual who has attempted to subvert the testing process or engaged in substance abuse. In addition, testing of these specimens at the HHS-certified laboratory may also provide the licensee testing facility with additional information regarding the cause(s) and extent of condition that resulted in the error. The NRC added this requirement to the final rule to enhance consistency of the rule's requirements for addressing errors in testing at licensee testing facilities with those required for addressing errors in testing at HHS- certified laboratories and in response to public comments received on the proposed rule noting the inconsistencies. This requirement is consistent with standard forensic practices and meets Goal 1 of this rulemaking to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines.

Section Sec. 26.137(f)(3) also requires the licensee testing facility to implement corrective actions before resuming testing of donor specimens. For example, if testing of a certified-positive quality control sample at the licensee testing facility yields false negative test results for opiates, this provision requires the licensee testing facility to stop testing donor specimens for opiates until the cause(s) of the false negative test are identified and corrected.

Similarly, if a quality control sample that has been certified to contain an adulterant at a concentration above the cutoff levels established in Subpart F for validity screening or initial validity testing yields a false negative test result, this provision requires the licensee testing facility to stop testing for that adulterant until the cause(s) of the false negative test result are identified and corrected. This requirement is necessary to prevent additional errors in testing that could permit individuals who may have altered a specimen or used prohibited drugs to be granted or maintain authorization to have the types of access or perform the duties that require them to be subject to the rule. The NRC added this requirement to the final rule to enhance consistency of the rule's requirements for addressing errors in testing at licensee testing facilities with those required for addressing errors in testing at HHS-certified laboratories and in response to public comments received on the proposed rule mentioning the inconsistencies. This requirement is consistent with standard forensic practices and meets Goal 1 of this rulemaking to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines.

The NRC has added Sec. 26.137(f)(4) to address instances where testing conducted at an HHS-certified laboratory identifies a specimen that yielded a false negative test result from the licensee testing facility. To evaluate whether tests at a licensee testing facility may be providing false negative test results, Sec. 26.137(b)(3), (d)(6), and (e)(5) require the licensee testing facility to submit some donor specimens that yield negative test results to an HHS-certified laboratory for additional testing. If, after confirmatory testing by the HHS-certified laboratory, a donor specimen yields positive, substituted, adulterated, or invalid results, Sec. 26.137(f)(4) mandates that the licensee testing facility must take corrective action(s) before resuming testing for the drug(s), drug metabolite(s), adulterant(s), or other specimen characteristics (i.e., creatinine, pH) associated with the donor specimen(s) that yielded the false negative result(s). Additionally, Sec. 26.137(f)(4) permits the licensee or other entity to re-collect and test specimens from any donor whose test results from initial testing at the licensee testing facility may have been inaccurate. The NRC added this provision to the final rule for the same reasons discussed with respect to Sec. 26.137(f)(3).

Section 26.137(f)(5) requires the licensee or other entity to document the investigation and any corrective actions taken for consistency with Criterion XVI in Appendix B to 10 CFR Part 50.

Section 26.137(g) [Accuracy] retains former Section 2.7(o)(3)(i) in

Appendix A to Part 26 as it applied to licensee testing facilities.

This provision requires checking the instruments used in testing for accuracy. The final rule moves the former requirement as it relates to

HHS-certified laboratories to Sec. 26.167(h) in Subpart G for organizational clarity.

Section 26.137(h) [Calibrators and controls] updates former Section 2.7(o)(2) in Appendix A to Part 26, which established requirements for the standards and quality control samples used for performance testing.

At the time the original paragraph was written, most laboratories prepared their own standards and controls. In the ensuing years, the number and variety of sources for materials used in performance testing have increased. This provision updates the former requirements to refer to several of the alternatives, including, but not limited to, pure drug reference materials, stock standard solutions from other laboratories, and standard solutions obtained from commercial manufacturers. The requirements in this paragraph incorporate the related requirements in the HHS Guidelines and meet Goal 1 of this rulemaking to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines.

Section 26.139 Reporting Initial Validity and Drug Test Results

The NRC has added Sec. 26.139 to combine requirements related to the reporting and management of test results from the licensee testing facility that were interspersed throughout former Appendix A to Part 26. The agency made this change to meet Goal 6 of this rulemaking to improve clarity in the organization of the final rule, by grouping related requirements together in a single section.

Section 26.139(a) amends former Section 2.7(g)(2) in Appendix A to

Part 26. That provision established requirements for the manner in which HHS-certified laboratories and licensee testing facilities must report test results to licensee management. The final rule amends the former provision by moving the former requirements that were related to reporting test results from HHS-certified laboratories to Sec. 26.169(b) of Subpart G for organizational clarity. The final rule also deletes the former reference to ``special processing'' and replaces it with reference to validity test results, consistent with the addition of requirements to conduct validity testing throughout the final rule, as discussed with respect to Sec. 26.31(d)(3)(i). The NRC made these changes to improve clarity in the language and organization of the rule consistent with Goal 6 of this rulemaking.

With respect to the proposed rule, the final rule eliminates use of the term ``non-negative'' in Sec. 26.139(a) for the reasons discussed with respect to Sec. 26.5 for eliminating this term throughout the proposed rule. Eliminating the term ``non-negative'' and replacing it with terms to describe specific results of drug and validity testing

(e.g., ``positive,'' ``adulterated''), necessitates splitting the last sentence of proposed Sec. 26.139(a) into two sentences for clarity.

Therefore, the final rule prohibits licensee testing facilities from reporting to licensee or

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other entity management any positive drug test results from initial drug testing at the licensee testing facility, except as permitted under Sec. 26.75(h). The final rule also prohibits licensee testing facilities from reporting to licensee or other entity management any validity screening and initial validity test results that indicate a specimen is of questionable validity and any positive initial drug test results from specimens that are of questionable validity. The NRC made these changes to improve clarity in the language of the rule, consistent with Goal 6 of this rulemaking.

Section 26.139(b) amends the last sentence of former Sec. 26.24(d)(1), which specified the individuals to whom results of initial tests from the licensee testing facility may be released. The NRC added the MRO's staff to the list of individuals who are permitted to have access to the results of initial tests performed at the licensee testing facility consistent with the addition of this job role to the final rule. Individuals who are serving as MRO staff members require access to initial test results from a licensee's testing facility in the course of performing their administrative duties for the MRO.

Additionally, with respect to the proposed rule, the final rule permits an SAE to access initial test results when appropriate consistent with the addition of this job role to the final rule. Omitting the SAE from this provision was an unintended oversight in the proposed rule which the NRC has corrected in the final rule.

Section 26.139(c) amends former Section 2.7(o)(5) in Appendix A to

Part 26. The NRC has moved the requirements in the former paragraph that addressed the availability of personnel to testify in proceedings related to drug test results from an HHS-certified laboratory to Sec. 26.153(f)(2) of Subpart G for organizational clarity. The final rule moves the former requirement for licensee testing facility personnel to be available to testify at any proceedings with respect to breath analysis test results to Sec. 26.85(d) [Personnel available to testify at proceedings] because the collection site and not the licensee testing facility is typically responsible for quality control of alcohol testing equipment. The agency made these changes for organizational clarity in the rule, consistent with Goal 6 of this rulemaking.

Section 26.139(d) amends the portions of former Section 2.7(g)(6) in Appendix A to Part 26 that applied to the summary report that licensee testing facilities must provide to FFD program management. The

NRC has replaced the former requirement for the licensee testing facility to prepare a monthly report of test results with a requirement for the licensee testing facility to summarize the data annually in the

FFD program performance report required under Sec. 26.717(b) of the final rule. Experience implementing the former requirement for a monthly statistical summary has indicated that the monthly summary has not been as useful to licensees for ongoing monitoring of testing program effectiveness as other mechanisms that licensees have developed. Therefore, the final rule replaces the monthly reporting requirement in former Section 2.7(g)(6) in Appendix A to Part 26 with a requirement in Sec. 26.139(f) of the final rule for FFD program management to monitor the ongoing effectiveness of the licensee testing facility testing program. This change meets Goal 5 of this rulemaking to improve Part 26 by eliminating or modifying unnecessary requirements. The NRC has moved the requirements in the former paragraph that addressed summary reports from HHS-certified laboratories to Sec. 26.169(k) of Subpart G for organizational clarity. With respect to the proposed rule, the agency changed the cross-reference to FFD program performance reporting requirements in

Sec. 26.217(b) in the proposed rule to Sec. 26.717(b) in the final rule to reflect the changes the NRC has made in the organization of the final rule.

Section 26.139(e) amends former Section 2.7(g)(7) in Appendix A to

Part 26. That provision required licensee testing facilities and HHS- certified laboratories to report test results for both the cutoff levels specified in Part 26 and any more stringent cutoff levels used by the FFD program. The NRC has relocated the former requirement related to HHS-certified laboratories to Sec. 26.169(c) of Subpart G for organizational clarity. The final rule requires licensees and other entities who operate testing facilities, and have adopted more stringent cutoff levels for initial tests for drugs and drug metabolites than those specified in Sec. 26.133 [Cutoff levels for drugs and drug metabolites], to conduct tests and report test results based only on their more stringent cutoff levels. The basis for the former requirement to conduct tests and report test results for the cutoff levels specified in this part, when the licensee is using more stringent cutoff levels, was a method by which the NRC monitored licensee implementation of the permission to use more stringent cutoff levels. The final rule eliminates this requirement, because Sec. 26.31(d)(3)(iii)(C) requires a qualified forensic toxicologist to certify the scientific and technical suitability of the licensee's or other entity's testing process at any lower cutoff levels. Therefore, the testing and reporting requirements in the former rule are no longer needed to monitor licensee testing facility performance in this area.

The final rule continues to require licensee testing facilities to report test results (and the cutoff levels used) from testing for additional drugs and drug metabolites, beyond those specified in Sec. 26.31(b)(1).

Section 26.139(f) has been added to require FFD program management to monitor the ongoing effectiveness of the licensee testing facility testing program. The final rule provides examples of the types of information and possible program performance indicators that licensees and other entities may use for program monitoring. The final rule also requires FFD program management to make adjustments to the testing program in response to information gained from the ongoing monitoring.

These requirements replace the monthly summary report required under former Section 2.7(g)(7) in Appendix A to Part 26 to strengthen FFD programs by ensuring that licensees monitor licensee testing facility performance on an ongoing basis and correct any weaknesses as they are identified. The paragraph is also consistent with the NRC's performance-based approach to regulation. This change meets Goal 3 of this rulemaking to improve the effectiveness of FFD programs, as discussed in Section IV.B.

Subpart G--Laboratories Certified by the Department of Health and Human

Services

Section 26.151 Purpose

The NRC has added Sec. 26.151 to introduce the purpose of the subpart, which is to establish requirements for the HHS-certified laboratories that licensees and other entities must use for testing urine specimens for validity and the presence of drugs and drug metabolites. Adding this paragraph meets Goal 6 of this rulemaking to improve clarity in the organization and language of the rule. The majority of the requirements in this subpart are based on the former requirements in Appendix A to Part 26, as they relate to HHS-certified laboratories. However, the rule substantially updates the former requirements to be consistent with the HHS Guidelines.

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Section 26.153 Using Certified Laboratories for Testing Urine Specimens

The NRC added Sec. 26.153 to group into one section requirements related to the use of HHS-certified laboratories by licensees and other entities who are subject to the rule.

Section 26.153(a) combines and updates former requirements for licensees and other entities to use HHS-certified laboratories for initial and confirmatory drug testing of urine specimens. The paragraph relocates and combines former Sec. 26.24(f) and former Sections 1.1(3) and 4.1(a) in Appendix A to Part 26. These provisions required licensees and other entities to use HHS-certified laboratories for drug testing. The NRC made this change to eliminate redundancies in the former rule and improve organizational clarity. The paragraph updates the former citations for the HHS Guidelines because the guidelines have been amended several times since the former rule was published. In addition, the provision provides current contact information for obtaining information about the certification status of HHS-certified laboratories because the contact information has changed since the former rule was published. The paragraph also adds a requirement for licensees and other entities to use HHS-certified laboratories for initial and confirmatory validity testing, consistent with the addition of urine specimen validity testing requirements to the rule, as discussed with respect to Sec. 26.31(d)(3)(i). The rule also updates the cross-reference to former Sec. 26.24(d), which permitted licensee testing facilities to conduct initial drug tests, to reference the related provision in the final rule, Sec. 26.31(d)(3)(ii).

Section 26.153(b) amends the first sentence of former Section 2.7(l)(2) in Appendix A to Part 26. The former provision required HHS- certified laboratories to have the capability, at the same laboratory premises, of performing initial and confirmatory tests for any drug and drug metabolite for which service is offered and confirmatory testing of blood for alcohol concentrations. The former requirement for HHS- certified laboratories to be capable of conducting confirmatory alcohol testing of blood has been deleted for the reasons discussed with respect to Sec. 26.83(a). The paragraph adds a requirement for HHS- certified laboratories to have the capability to perform both initial validity and confirmatory validity tests at the same premises for consistency with the addition of requirements to perform validity testing to the rule, as discussed with respect to Sec. 26.31(d)(3)(i).

The second sentence of former Section 2.7(l)(2) in Appendix A to Part 26, which established requirements for the capabilities of licensee testing facilities, has been moved to Sec. 26.123 of Subpart F

Licensee Testing Facilities

for organizational clarity. The agency deleted the last sentence of the former paragraph, which permitted the testing of breath specimens for alcohol at the collection site, because the rule addresses alcohol testing in Subpart E [Collecting Specimens for Testing]. These organizational changes to the former paragraph have been made to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.

Section 26.153(c) amends the first sentence of former Section 2.7(k) in Appendix A to Part 26. The former provision prohibited HHS- certified laboratories from subcontracting unless authorized by the licensee. The rule extends this restriction to subcontracting for specimen validity testing for consistency with the addition of requirements to perform validity testing to the rule, as discussed with respect to Sec. 26.31(d)(3)(i). The second sentence of former Section 2.7(k) has been deleted from the paragraph for several reasons: First, the requirement to have the capability to test for marijuana, cocaine, opiates, phencyclidine, and amphetamines has been deleted because it is redundant with Sec. 26.31(d)(1). The requirement to be capable of testing whole blood has been deleted because the rule no longer permits donors to request confirmatory alcohol testing of blood for the reasons discussed with respect to Sec. 26.83(a). Finally, the requirement for laboratories to be capable of using gas chromatography/mass spectrometry (GC/MS) has been eliminated because HHS-certified laboratories would be permitted to use other methods of confirmatory testing, consistent with related revisions to the HHS Guidelines.

Section 26.153(d) amends former Section 4.1(b) in Appendix A to

Part 26, which required licensees and C/Vs to use only HHS-certified laboratories who agree to follow the same rigorous testing, quality control, and chain-of-custody procedures when testing for more stringent cutoff levels, additional drugs to those for which testing required under Part 26, and blood. The final rule eliminates reference to testing for blood in this provision because the rule no longer permits donors to request confirmatory alcohol testing of blood for the reasons discussed with respect to Sec. 26.83(a).

Section 26.153(e) amends the third sentence of former Section 2.7(m) in Appendix A to Part 26. That sentence required licensees to conduct an inspection and evaluation of a laboratory's drug testing operations before using the laboratory's services. Some licensees have incorrectly interpreted the former regulation as requiring licensee employees to perform the pre-award inspection and evaluation. In many cases, however, appropriately qualified licensee employees may not be available to perform the inspection and evaluation, and the use of contracted experts may be necessary to achieve the NRC's intent. The paragraph revises the former requirement to indicate that licensees and other entities are responsible ``to ensure'' that the inspection and evaluation is performed, in order to clearly indicate that the use of expert contractors is acceptable. In addition, the rule clarifies that the pre-award inspection and evaluation must be performed by qualified individuals.

Section 26.153(e) also permits a licensee or other entity to begin using the services of another HHS-certified laboratory immediately, without a pre-award evaluation and inspection, in the event that the licensee's or other entity's primary laboratory loses its certification. To be considered acceptable, the rule requires that the replacement laboratory must be in use by another Part 26 program. The rule adds this provision to ensure that testing can continue, in the event that the HHS-certified laboratory on whom a licensee or other entity relies loses its certification, as some licensees have experienced. Related requirements for auditing the replacement laboratory are specified in Sec. 26.41(g)(5).

The agency added Sec. 26.153(f) to require that licensees' and other entities' contracts with HHS-certified laboratories must require the laboratories to implement the applicable requirements of this part.

Because the NRC does not regulate HHS-certified laboratories, this revision would ensure that the agency has a legal basis for requiring

HHS-certified laboratories to comply with this part when conducting testing for licensees and other entities.

Section 26.153(f)(1) retains the requirement in former Section 2.7(l)(1) in Appendix A to Part 26. The former requirement stated that

HHS-certified laboratories must comply with applicable State licensor requirements. The final rule replaces the term ``HHS-certified laboratories'' with the term ``laboratory facilities'' to clarify that

State requirements apply to laboratory facilities rather than to the

HHS-

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certified laboratory as a corporate entity. The clarification is necessary because some HHS-certified laboratories are operated by large national corporations with facilities in several different States, and only the facilities in a specific State are required to meet the requirements of that State. The NRC made this change for clarity in the language of the rule as well as consistency with the HHS Guidelines.

Section 26.153(f)(2) amends former Section 2.7(o)(5) in Appendix A to Part 26. The former regulation required HHS-certified laboratories to make available qualified personnel to testify in proceedings based on urinalysis results reported by the laboratory. The NRC moved the reference to licensee testing facilities to Sec. 26.139(c) in Subpart

F for organizational clarity. The requirement for qualified personnel to be available to testify in proceedings related to breath analysis results has been moved to Sec. 26.85(d) in Subpart E for organizational clarity and because responsibility for testifying with respect to breath analysis results resides with the licensee's or other entity's collection site personnel.

Section 26.153(f)(3) updates former Section 3.1 in Appendix A to

Part 26, which required HHS-certified laboratories to protect donors' records. The former requirement for licensee testing facilities to protect donors' records has been subsumed within the second sentence of

Sec. 26.37(a) for organizational clarity. The cross-reference to former Sec. 26.29 has been updated to reference Sec. 26.39 in the final rule.

Section 26.153(f)(4) updates former Section 3.2 in Appendix A to

Part 26. Specifically, the rule adds a reference to Sec. 503 of Pub. L. 100-71 to document the basis for this requirement. The paragraph adds a requirement for a donor to have access to records relating to his or her validity test results for consistency with the addition of validity testing requirements to the rule, as discussed with respect to Sec. 26.31(d)(3)(i). The paragraph deletes the former reference to records related to alcohol test results because the final rule will no longer require HHS-certified laboratories to be capable of testing blood specimens for alcohol, as discussed with respect to Sec. 26.83(a).

With respect to the proposed rule, the NRC has added a phrase to the provision to clarify that a donor's designated representative is also permitted to have access to records relating to the donor's validity test results. The NRC made this change in response to a public comment requesting the clarification.

The NRC added Sec. 26.153(f)(5) to clarify that HHS-certified laboratories must avoid relationships with a licensee's or other entity's MRO(s) that may be construed as a potential conflict of interest. The final rule, with respect to the proposed rule, adds a reference to provisions added in the final rule at Sec. 26.183(b) to specify specific conflict of interest relationships. The NRC added the provisions in Sec. 26.183(b) in response to a comment on the proposed rule requesting the NRC to consider using the examples of MRO conflict of interest relationships specified in DOT's drug and alcohol testing regulations. The paragraph responds to the experiences of other Federal agencies regarding apparent conflicts of interest involving laboratories and MROs. Although the NRC is not aware of any situations of this type in Part 26 programs, the integrity of the MRO function is sufficiently important that incorporating this requirement is warranted to prevent potential conflict of interest concerns. The paragraph is consistent with the related provision in the HHS Guidelines.

Section 26.153(f)(6) amends the requirements in the first two sentences of former Section 2.7(m) in Appendix A to Part 26, which required HHS-certified laboratories to permit the NRC, licensees, and other entities to conduct inspections at any time, including unannounced inspections. The rule deletes, for organizational clarity, the existing references to collection site services and licensee testing facilities, which are covered under Subpart F. The paragraph also deletes reference to confirmatory testing of blood specimens for alcohol because HHS-certified laboratories are no longer testing blood specimens for alcohol, as discussed with respect to Sec. 26.83(a).

A new Sec. 26.153(g) requires licensees and other entities to provide a memorandum for the record to the HHS-certified laboratories that they use to document why the licensee or other entity is using a non-Federal custody-and-control form. Under the HHS Guidelines, laboratories may reject any specimen that is submitted for testing with a non-Federal custody-and-control form unless the licensee or other entity provides a memorandum for the record. The paragraph is necessary to prevent licensee and other entity specimens from being rejected.

Section 26.155 Laboratory Personnel

Section 26.155 updates former Section 2.5 in Appendix A to Part 26 to be consistent with revisions to the HHS Guidelines.

Section 26.155(a) [Day-to-day management of the HHS-certified laboratory] amends former Section 2.5(a)(1) in Appendix A to Part 26, which required the HHS-certified laboratory to have a qualified individual to assume responsibility for day-to-day management of the

HHS-certified laboratory. Specifically, the paragraph replaces the term

``qualified individual'' with the term ``responsible person'' for consistency with terminology that other Federal agencies use to refer to this job role. The final rule retains the majority of Section 2.5(a)(2) in Appendix A to Part 26 and establishes qualification requirements for the responsible person. The provisions in Sec. 26.155(a)(1)(i)-(a)(1)(iv) retain former Section 2.5(a)(2)(i)-

(a)(2)(iv) in Appendix A to Part 26, with minor grammatical changes that are consistent with similar changes to the related provisions in the HHS Guidelines.

Section 26.155(a)(2) and (a)(3) establishes minimum day-to-day management responsibilities of the responsible person and retains former Section 2.5(a)(4) and (a)(5) in Appendix A to Part 26.

Section 26.155(a)(4) retains former Section 2.5(a)(5) in Appendix A to Part 26, which relates to the responsible person's responsibility to maintain the HHS-certified laboratory procedures in a manual. With respect to the proposed rule, the final rule includes a provision that

HHS-certified laboratories' procedures be maintained in a manual of standard operating procedures. The proposed rule eliminated the former requirement in Section 2.5(a)(5) to provide flexibility to HHS- certified laboratories in how laboratory operating procedures were maintained. However, based on a comment received on the proposed rule, the NRC has reinstituted the former requirement that laboratory procedures be maintained in a manual to improve consistency with the

HHS Guidelines, meeting Goal 1 of this rulemaking. The paragraph retains the former requirements in the second and third sentences of

Section 2.5(a)(5) in Appendix A to Part 26, and requires the responsible person to review, sign, and date the procedures when they are first placed in use, changed, or a new individual assumes responsibility for management of the laboratory. The responsible person must also maintain copies of the procedures. The final rule updates the former cross-reference to Section 2.7(o) in Appendix A to Part 26 to reference Sec. 26.157, consistent with the organizational changes made to the rule.

Section 26.155(a)(5) and (a)(6) retains former Section 2.5(a)(6) and (a)(7) in

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Appendix A to Part 26. These provisions define the responsible person's responsibilities with respect to maintaining a quality assurance program and taking remedial actions to maintain satisfactory laboratory operations.

Section 26.155(b) [Certifying scientist] amends former Section 2.5(b) in Appendix A to Part 26 to be consistent with changes made to the related requirement in the HHS Guidelines. Consistent with the HHS

Guidelines, the rule provides more detailed requirements with respect to the individual who certifies test results at the HHS-certified laboratory before they are transmitted to the licensee or other entity's MRO.

In Sec. 26.155(b)(1), a new job title, ``certifying scientist,'' replaces the term ``qualified individual(s)'' in the first sentence of former Section 2.5(b) in Appendix A to Part 26 for consistency with a related change in the HHS Guidelines. The final rule, with respect to the proposed rule, replaces the phrase ``attest the validity of'' with

``certify'' test results, as this is a more accurate description of the responsibilities of a certifying scientist. The NRC made this change in response to a comment received on the proposed rule. Section 26.155(b)(2) specifies the required qualifications of individuals who serve as certifying scientists. Section 26.155(b)(3) permits laboratories to use more than one certifying scientist with differing responsibilities.

Section 26.155(c) [Day-to-day operations and supervision of analysts] retains former Section 2.5(c) in Appendix A to Part 26. The rule makes minor language changes to the former paragraph to increase the consistency of the language in this provision with that of the related provision in the HHS Guidelines.

Section 26.155(d) [Other personnel] and (e) [Training] retains former Section 2.5(d) and (e) in Appendix A to Part 26, respectively.

Section 26.155(f) [Files] updates former Section 2.5(f) in Appendix

A to Part 26. The revisions are consistent with related requirements in the HHS Guidelines.

Section 26.157 Procedures

Section 26.157 reorganizes and amends requirements for HHS- certified laboratories' procedures. The requirements for procedures were interspersed throughout former Appendix A to Part 26, including requirements contained in former Sections 2.2 and 2.7 in Appendix A to

Part 26. The NRC has combined procedural requirements for the laboratories into a single section to improve organizational clarity in the rule.

In Sec. 26.157(a), the agency has made minor editorial changes to the first sentence of former Section 2.2 in Appendix A to Part 26, but retains the former requirement for HHS-certified laboratories to have detailed procedures for conducting testing. The rule deletes the former reference to blood samples because donors no longer have the option to request blood testing for alcohol, as discussed with respect to Sec. 26.83(a). Reference to licensee testing facilities has been moved to

Sec. 26.127(a) in Subpart F for organizational clarity. The rule also deletes reference to procedures for specimen collections, because the

NRC relocated procedural requirements for specimen collections to

Subpart E in the final rule.

Section 26.157(b) combines and amends portions of the requirements in the first sentence of former Sections 2.4(d) and 2.7(a)(2) in

Appendix A to Part 26 related to the content and implementation of specimen chain-of-custody procedures. The regulation retains the portions of the former paragraphs that required HHS-certified laboratories to develop, implement, and maintain written chain-of- custody procedures to maintain control and accountability of specimens from receipt through completion of testing and reporting of results, during storage and shipping to another HHS-certified laboratory, and continuing until final disposition of the specimens. The former requirements related to licensee testing facilities have been moved to

Sec. 26.127(b) in Subpart F for organizational clarity. The rule also removes references to custody-and-control procedures for blood specimens because donors no longer have the option to request blood testing for alcohol, as discussed with respect to Sec. 26.83(a).

The NRC has amended the portions of former Section 2.7(o)(1) in

Appendix A to Part 26 that address the required content of procedures for HHS-certified laboratories. Section 26.157(c) retains the portions of the former provision that required laboratories to develop and maintain written procedures to specify all of the elements of the testing process, including, but not limited to, the principles of each test and the preparation of reagents, standards, and controls. The paragraph presents the required topics of the procedures in a list format in Sec. 26.157(c)(1) through (c)(12) to clarify that each topic stands on its own. For organizational clarity, two portions of the former provision have been moved to other subparts of the rule that address related topics. The NRC relocated requirements for licensee testing facility procedures to Sec. 26.127(c) in Subpart F. In addition, the rule moves the last two sentences of former Section 2.7(o)(1), which specify records retention requirements, to Sec. 26.715(b)(4) of Subpart N [Recordkeeping and Reporting Requirements].

Section 26.157(d) amends former Section 2.7(o)(3)(iii) in Appendix

A to Part 26. The final (and former) provision requires procedures for the setup and normal operation of testing instruments; a schedule for checking critical operating characteristics for all instruments; tolerance limits for acceptable function checks; and instructions for major troubleshooting and repair. The rule makes three changes to the former provision for organizational clarity. The paragraph presents the required topics of the procedures in a list format in Sec. 26.157(d)(1)-(d)(3) to clarify that each topic stands on its own. The former requirement to maintain records of preventative maintenance has been relocated to Sec. 26.715(b)(10) in Subpart N. And, the rule moves the former requirements that apply to licensee testing facilities to

Sec. 26.127(d) in Subpart F.

Section 26.157(e) amends former Section 2.7(o)(4) in Appendix A to

Part 26, but continues to require documented corrective actions if systems are out of acceptable limits or errors are detected. The requirements in the former paragraph that apply to licensee testing facilities have been moved to Sec. 26.127(e) in Subpart F for organizational clarity.

Section 26.159 Assuring Specimen Security, Chain of Custody, and

Preservation

The NRC added Sec. 26.159 to present in one section the requirements of the rule that apply to HHS-certified laboratories with respect to the safeguarding of specimen identity, integrity, and security. This organizational change consolidates requirements that were dispersed throughout the former rule.

Section 26.159(a) amends former Section 2.7(a)(1) in Appendix A to

Part 26. This provision retains the first three sentences of former

Section 2.7(a)(1) in Appendix A to Part 26, which required HHS- certified laboratories to be secure and accessible only to authorized personnel. For organizational clarity, the NRC moved the requirements that apply to licensee testing facilities to Sec. 26.129(a) in Subpart

F. The last sentence of the former paragraph, which establishes recordkeeping requirements, has been moved to Sec. 26.715(b)(13) in

Subpart N. In addition, the NRC has

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revised the last sentence of the former paragraph to increase clarity in the requirement and expands the list of persons who are authorized to have access to the laboratory to include representatives of the

Secretary of HHS and emergency responders. This change increases the consistency of Part 26 with the related provision in the HHS

Guidelines.

Section 26.159(b) amends former Section 2.7(b)(1) in Appendix A to

Part 26. That provision established requirements for receiving specimens at the HHS-certified laboratory and assuring their integrity and identity. The final rule makes several organizational changes to the former rule by dividing the provision into paragraphs Sec. 26.159(b)(1) and (b)(2) for increased organizational clarity.

Section 26.159(b)(1) retains the former requirement for the HHS- certified laboratory to report evidence of tampering to licensees' or other entities' management within 24 hours of discovery, as well as the requirement for the laboratory to document any evidence of tampering on the specimen's custody-and-control form. The rule moves the former requirements related to licensee testing facilities to Sec. 26.129(b) in Subpart F for organizational clarity. With respect to the proposed rule, the final rule adds several requirements to the provision.

The NRC has renumbered as Sec. 26.159(b)(1)(i), but retained without change, the portion of proposed Sec. 26.159(b)(1) that required licensee or other entity management personnel to ensure that an investigation is initiated if any indications of specimen tampering are identified, and take corrective actions if tampering is confirmed.

The appropriate corrective actions will depend on the nature of the tampering identified as a result of the investigation. For example, if the investigation indicates that the tampering was an attempt to subvert the testing process and the persons involved are identified, the rule requires licensee and other entity management personnel to impose the sanctions in Sec. 26.75(b) for a subversion attempt.

Section 26.159(b)(1)(ii) requires the licensee and other entity to collect another specimen as soon as possible, if the licensee or other entity has reason to question the integrity and identity of a specimen.

With respect to the proposed rule, the final rule eliminates the need to collect another specimen if a split specimen collection was performed, either the Bottle A or Bottle B seal remains intact, and the intact specimen contains at least 15 mL of urine. If this circumstance arises and the licensee testing facility has retained the specimen in

Bottle B and it is intact, the rule requires the licensee testing facility to forward the intact specimen for testing to the HHS- certified laboratory. The NRC added this provision to the final rule in response to public comments on the related provision in the proposed rule. The commenters requested the NRC to include this provision from

DOT's procedures. The NRC agreed with the commenters' suggestion because eliminating the recollection when an intact specimen is available reduces the burden on donors that a recollection would impose.

The final rule, with respect to the proposed rule, establishes a new section, Sec. 26.159(b)(2) to specify the exclusive grounds requiring an MRO to cancel a test. The NRC added this section in response to public comments received on the proposed rule that requested this clarification. Section 26.159(b)(2)(i) requires the MRO to cancel a test if the custody and control form does not contain information to identify the specimen collector and the collection site cannot provide conclusive evidence of the collector's identity. Section 26.159(b)(2)(ii) requires the MRO to cancel a test if the identification numbers on the specimen bottle seal(s) do not match the identification numbers on the custody-and-control form. Section 26.159(b)(2)(iii) requires the MRO to cancel a test if a specimen bottle seal is broken or shows evidence of tampering and an intact specimen, as specified in paragraph (b)(1)(ii) of this section, does not exist. Section 26.159(b)(2)(iv) requires the MRO to cancel a test if the specimen appears to have leaked out of its sealed bottle and there is less than 15 mL remaining, and an intact specimen, as specified in paragraph (b)(1)(ii) of this section, does not exist.

Section 26.159(b)(2)(v) requires the MRO to cancel a test if the provisions of Sec. 26.165(f)(2) apply. The NRC incorporated these requirements from the related DOT procedures.

Section 26.159(c) updates and combines former Section 2.7(b)(2) in

Appendix A to Part 26 with portions of former Sections 2.7(n) and 3.1 in Appendix A to Part 26. These regulations in the former rule established requirements for chain-of-custody procedures for specimens and aliquots at licensee testing facilities and HHS-certified laboratories. For organizational clarity, the NRC has relocated the requirements in the former paragraphs that are related to licensee testing facilities to Sec. 26.129(c) in Subpart F. The final rule retains the requirements in former Sections 2.7(n) and 3.1 in Appendix

A to Part 26, which require the laboratory to maintain the original specimen and custody-and-control form in secure storage at the HHS- certified laboratory. The NRC made these changes to reduce redundancies and improve the organizational clarity of the rule.

Section 26.159(d) and (e) updates the portions of former Section 2.7(a)(2) in Appendix A to Part 26 that established requirements for

HHS-certified laboratory personnel to maintain and document the chain of custody for specimens and aliquots, by replacing the former paragraph with two related provisions from the HHS Guidelines.

Paragraph (d) in this section requires the laboratory's internal custody-and-control form to allow for identification of the donor, documentation of the testing process and transfers of custody of the specimen. The agency added the phrase, ``within the laboratory,'' to paragraph (e) of this section to clarify that the requirement to document each instance of handling and transfer of specimens applies to internal laboratory activities and does not apply to transfers involving couriers. For organizational clarity, the rule relocates the requirements in the former paragraph that are related to licensee testing facilities to Sec. 26.129(d) and (e) in Subpart F.

Section 26.159(f) and (g) separates former Section 2.4(i) in

Appendix A to Part 26 into two paragraphs, for the reasons discussed with respect to the similar provisions of Sec. 26.117(i) and (k) and

Sec. 26.129(g) and (h). The paragraphs repeat the requirements for packaging and shipping positive, adulterated, substituted, or invalid specimens that have been presented in Sec. 26.117(i) and (k) of

Subpart E and Sec. 26.129(g) and (h) in Subpart F, but apply them to packaging and shipping specimens from one HHS-certified laboratory to another. The bases for these requirements are discussed with respect to

Sec. 26.117(i) and (k). With respect to the proposed rule, the final rule clarifies Sec. 26.159(f) to ensure that a copy of the custody- and-control form, rather than the original custody-and-control form, is included with an aliquot of a single specimen or Bottle B of a split specimen that is transferred to a second HHS-certified laboratory for testing. The NRC made this change in response to a public comment on this provision that noted the proposed provision was inconsistent with the related requirement in the HHS Guidelines.

Section 26.159(h) replaces former Section 2.7(c) in Appendix A to

Part 26. The former provision established requirements for refrigerating urine

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specimens at the HHS-certified laboratory and licensee testing facility to protect them from degradation. The rule replaces the former paragraph with the simplified language of the related provision in the

HHS Guidelines. The NRC moved the requirements related to short-term refrigerated storage at licensee testing facilities to Sec. 26.129(f) in Subpart F for organizational clarity. The final rule, with respect to the proposed rule, adds the Fahrenheit temperature level that is equivalent to the Celsius temperature level included in the proposed rule to improve the clarity of the final rule.

In Sec. 26.159(i), the NRC amends former Section 2.7(h) in

Appendix A to Part 26. The former requirement established requirements for long-term frozen storage of positive urine specimens at HHS- certified laboratories and licensee testing facilities. For organizational clarity, the NRC moved the requirements related to long- term storage of specimens by licensee testing facilities to Sec. 26.135(c) in Subpart F. The rule adds requirements for storing specimens that yield adulterated, substituted, or invalid test results from specimen validity testing, consistent with the addition of requirements to conduct validity testing throughout the rule, as discussed with respect to Sec. 26.31(d)(3)(i). The NRC has eliminated the reference to ``administrative or disciplinary proceedings'' in the first sentence of the former paragraph because there are other circumstances in which it may be necessary to have a specimen available for retesting, including, but not limited to, retesting an aliquot of an invalid specimen at a second HHS-certified laboratory under Sec. 26.161(g). The rule also updates the terminology used in the former paragraph by adding a reference to ``Bottle B'' of a split specimen. As discussed with respect to Sec. 26.5 [Definitions], these changes in terminology are intended to improve clarity in the language of the rule.

The NRC added Sec. 26.159(j) to incorporate related changes to the

HHS Guidelines. The final rule permits the HHS-certified laboratory to discard negative specimens. This paragraph also permits laboratories to pool specimens that are certified to be negative for drugs and drug metabolites and valid, as well as use them as quality control samples, as permitted under the HHS Guidelines. With respect to the proposed rule, the final rule prohibits the laboratory from retaining any information linking donors to specimens that are pooled for use in the laboratory's internal quality control program. The NRC added this prohibition in response to a public comment received on the proposed rule. This addition meets Goal 7 of this rulemaking to protect the privacy and other rights (including due process) of individuals who are subject to Part 26.

Section 26.161 Cutoff Levels for Validity Testing

A new Sec. 26.161 establishes maximum cutoff levels and methods for conducting specimen validity testing at HHS-certified laboratories, consistent with the addition of requirements to conduct validity testing throughout the rule, as discussed with respect to Sec. 26.31(d)(3)(i). The rule incorporates these requirements from the HHS

Guidelines as revised on April 13, 2004, (69 FR 19644) to meet, in part, Goal 1 of this rulemaking to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. This section prohibits licensee and other entities from using more stringent validity test cutoff levels to ensure consistency among licensees and other entities and reduce the likelihood of false adulterated, substituted, or invalid test results, and ensure that donors are not subject to sanctions on the basis of inaccurate test results. The prohibition supports Goal 7 of this rulemaking to protect the privacy and other rights (including due process) of individuals who are subject to Part 26.

The NRC added Sec. 26.161(a) to specify that HHS-certified laboratories must conduct initial and, if necessary, confirmatory validity testing using two different aliquots of a urine specimen. This provision incorporates the related provision from the HHS Guidelines.

With respect to the proposed rule, the final rule revises the provision to clarify that confirmatory testing of a second aliquot is required if initial validity test results indicate that the specimen may be adulterated, substitute, dilute, or invalid. The final rule also adds a requirement that licensees and other entities must ensure that the HHS- certified laboratory is capable of conducting, and conducts, confirmatory testing for at least one oxidizing adulterant and any other adulterants for which the licensee's or other entity's FFD program conducts testing. The agency made these changes in response to public comments and to improve clarity in the language of the rule.

The agency added Sec. 26.161(b) to establish requirements and cutoff levels for initial validity tests to be performed at HHS- certified laboratories. With respect to the proposed rule, the final rule renumbers these paragraphs to improve the organization and clarity of the rule. Section 26.161(b)(1) through (b)(5) establishes requirements for initial validity tests that HHS-certified laboratories must conduct on a primary specimen. The primary specimen is either a single specimen submitted by an FFD program that does not follow split specimen procedures, or the specimen contained in Bottle A of a split specimen. For initial validity tests of each specimen, HHS-certified laboratories will determine the creatinine concentration of each specimen under Sec. 26.161(b)(1). If the creatinine concentration is less than 20 mg/dL, the laboratory will determine the specimen's specific gravity under Sec. 26.161(b)(2). Section 26.161(b)(3) requires the laboratory to determine each specimen's pH. Section 26.161(b)(4) requires the laboratory to test the specimen for the presence of oxidizing adulterants, and Sec. 26.161(b)(5) requires additional validity testing, depending on the characteristics of the specimen.

With respect to the proposed rule, the final rule deletes proposed

Sec. 26.161(b)(2). The proposed paragraph specified the results from initial validity testing that would indicate the need for the HHS- certified laboratory to conduct confirmatory validity testing. The NRC deleted this paragraph in the final rule because the criteria it contained repeated the criteria embedded in Sec. 26.161(c)-(f). In addition, the HHS Guidelines do not include these criteria separately.

Therefore, this revision increases the consistency of Part 26 with the related provisions in the HHS Guidelines.

The final rule adds Sec. 26.161(c) to establish criteria for HHS- certified laboratories to apply in determining whether to report to a licensee's or other entity's MRO that a specimen is adulterated.

Section 26.161(c)(1) through (c)(8) specifies results from initial and confirmatory validity testing that indicate that a specimen is adulterated. The paragraphs also specify the appropriate testing devices and instruments to be used for initial and confirmatory validity tests. In general, the paragraphs require the HHS-certified laboratory to report to the MRO that a urine specimen is adulterated if it meets any one of the following criteria: (1) It is confirmed to contain a substance that should not be present at all in normal human urine; (2) it is confirmed to contain a substance which, although it could be present in normal human urine, is found to be at a concentration that appears to be inconsistent with human physiology; or

(3) it presents an acid/base balance (pH) that appears to be inconsistent with human life. The paragraphs address several substances

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that some donors have used to try to defeat drug tests through ``in vitro'' contamination (i.e., adding the substance to a urine specimen).

These adulterants include substances that create a urine pH inconsistent with human life, oxidizing adulterants, chromium (VI), halogens, glutaraldehyde, pyridine, and surfactants. These substances, when either placed into an already voided urine specimen or used in place of a urine specimen, generally either attempt to defeat the chemistry of the test or destroy a drug that is present. The NRC recognizes that this list will be updated and/or modified as new substances and formulas are introduced, and methods to detect them have been developed and implemented by HHS-certified laboratories. Section 26.161(c)(8) recognizes that new adulterants will be found and, therefore, requires HHS-certified laboratories to use appropriate testing methods when conducting initial and confirmatory testing for new adulterants for which cutoff levels and criteria have not yet been established.

Section 26.161(d) and (e) establishes cutoff levels and criteria for a determination by the laboratory that a specimen has been substituted or is dilute, respectively. In Sec. 26.161(d), the HHS- certified laboratory will report to the MRO that a specimen is substituted if it contains less than 2 mg/dL of creatinine and the specific gravity is less than or equal to 1.0010 or equal to or greater than 1.0200. These low creatinine concentrations combined with the highly skewed specific gravity values indicate that the specimen is not human urine. In Sec. 26.161(e), the HHS-certified laboratory is required to report to the MRO that a specimen is dilute if the creatinine concentration is equal to or greater than 2 mg/dL but less than 20 mg/dL and the specimen specific gravity is greater than 1.0010 but less than 1.0030.

The NRC added Sec. 26.161(f)(1) through (f)(12) to establish the criteria that HHS-certified laboratories apply when determining that a specimen is invalid. In 1998, HHS established criteria for what were termed ``unsuitable'' specimens (Program Document 35, September 28, 1998). An unsuitable specimen was defined as one that contained an interfering substance but the laboratory could not determine the nature of the substance with scientific certainty. In these circumstances, the laboratory could not achieve a ``valid'' test result. The HHS recognized that in some cases, an interfering substance could be a legitimately ingested medication (some non-steroidal anti-inflammatory drugs have been known to interfere with the chemistry of some of the initial tests). However, it was also recognized that many of these problem specimens actually contained an adulterant that the laboratory could not specifically identify with ``scientific certainty'' which is the requirement for reporting a specimen as adulterated. Therefore, the

HHS adopted the term ``invalid specimen'' to mean that the laboratory has determined that valid test results cannot be obtained from a specimen or an unknown substance interfered with the confirmatory test.

The rule adopts the term ``invalid specimen'' with the same meaning.

The rule adds Sec. 26.161(g) to address circumstances in which an

HHS-certified laboratory suspects that a specimen is adulterated but cannot identify the adulterant. The paragraph permits the laboratory to transfer the specimen to a second HHS-certified laboratory for additional testing, if the first HHS-certified laboratory cannot identify a possible adulterant in the specimen using their standard testing technologies and the licensee's or other entity's MRO concurs with the additional testing. Personnel at the first HHS-certified laboratory will consult with the licensee's or other entity's MR