Fitness for duty programs: Conformance with HHS testing guidelines, etc.,

As Enacted ( Federal Register)

Cited authorities 9

Cited in

[Federal Register: August 26, 2005 (Volume 70, Number 165)]

[Proposed Rules]

[Page 50441-50677]

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

[DOCID:fr26au05-37]

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Part II

Nuclear Regulatory Commission

10 CFR Part 26

Fitness for Duty Programs; Proposed Rule

[[Page 50442]]

NUCLEAR REGULATORY COMMISSION

10 CFR Part 26

RIN 3150-AF12

Fitness for Duty Programs

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations for Fitness for Duty (FFD) programs to update the rule and enhance consistency with advances in other relevant Federal rules and guidelines, including the U.S. Department of Health and Human Services Mandatory Guidelines for Federal Workplace Drug Testing Programs (HHS Guidelines), and other Federal drug and alcohol testing programs that impose similar requirements on NRC licensees. The proposed amendments would require nuclear power plant licensees to strengthen the effectiveness of their FFD programs 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; and ensure consistency with the NRC's access authorization requirements for nuclear power plants. The proposed rule would ensure 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 proposed rule would also grant, 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 would partially grant a petition for rulemaking (PRM-26-2) submitted by Barry Quigley on December 28, 1999.

DATES: Submit comments on the rule by December 27, 2005. Submit comments specific to the information collections aspects of this rule by September 26, 2005. Comments received after the above dates will be considered if it is practical to do so, but assurance of consideration cannot be given to comments received after these dates.

ADDRESSES: You may submit comments on the rule by any one of the following methods. Please include the following number (RIN 3150-AF12) in the subject line of your comments. Comments on rulemakings submitted in writing or in electronic form will be made available to the public in their entirety on the NRC rulemaking Web site. Personal information will not be removed from your comments.

Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff.

E-mail comments to: SECY@nrc.gov. If you do not receive a reply e- mail confirming that we have received your comments, contact us directly at (301) 415-1966. You may also submit comments via the NRC's rulemaking Web site at http://ruleforum.llnl.gov. Address questions

about our rulemaking Web site to Carol Gallagher (301) 415-5905; e-mail cag@nrc.gov.

Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland, between 7:30 A.M. and 4:15 P.M. on Federal workdays.

Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at (301) 415-1101.

You may submit comments on the information collections by the methods indicated in the Paperwork Reduction Act Statement.

Publicly available documents related to this rulemaking may be examined and copied for a fee at the NRC's Public Document Room (PDR), Public File Area O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland. Copyrighted documents may be viewed at the NRC's PDR, but may not be copied. The draft Regulatory Analysis and other documents related to this rulemaking, including comments can be viewed and downloaded electronically via the NRC rulemaking Web site at http://ruleforum.llnl.gov .

Publicly available documents created or received at the NRC after November 1, 1999, are available electronically at the NRC's Electronic Reading Room at http://www.nrc.gov/NRC/ADAMS/index.html. From this

site, the public can gain entry into the NRC's Agencywide Document Access and Management System (ADAMS), which provides text and image files of NRC's public documents. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC Public Document Room (PDR) Reference staff at 1-800- 397-4209, 301-415-4737 or by e-mail to pdr@nrc.gov.

FOR FURTHER INFORMATION CONTACT: Rebecca L. Karas, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-3711, Timothy S. McCune, Office of Nuclear Security and Incident Response, telephone (301) 415-6474, or Dr. David R. Desaulniers, Office of Nuclear Reactor Regulation, telephone (301) 415-1043. All of the above contacts may also be reached by e-mail to FITNESSFORDUTY@NRC.GOV.

SUPPLEMENTARY INFORMATION:

Table of Contents

Background
1. Drug and Alcohol Testing Provisions, and General Fitness-for- Duty Program Provisions
2. Work Fatigue Provisions
3. Combined Part 26 Rulemaking II. Petitions and Request for Exemption
4. Petition for Rulemaking PRM-26-1
5. Petition for Rulemaking PRM-26-2
6. Request for Exemption under 10 CFR 26.6 III. Abbreviations IV. Discussion of Proposed Action
7. Overview
8. Goals of the Rulemaking Activity
9. Overview of Proposed Rule
10. Inclusion of Worker Fatigue Provisions in 10 CFR Part 26 V. Summary of Public Interactions and Comments
11. Public Comments Submitted to OMB on 2000 Final Rule and Responses
12. Key Stakeholder Comments not Incorporated into Proposed Rule and Responses VI. Section-by-Section Analysis of Substantive Changes VII. Issues for Public Comment 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
13. Aggregate Analysis
14. Screening Review for Disaggregation
15. Disaggregation of Worker Fatigue Provisions XV. Regulatory Flexibility Act Certification XVI. Backfit Analysis
16. Consideration of Fuel Fabrication Facilities and Gaseous Diffusion Plants
17. Aggregate Backfit Analysis
18. Screening Review for Disaggregation XVII. References
Background
1. 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 a FFD program for all
  
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  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 literature, as well as initiatives by industry, the Substance Abuse and Mental Health Services Administration (SAMHSA, formerly the National Institute on Drug Abuse [NIDA]) 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 rulemaking 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 (responses to those comments are included in Section V of this document). 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 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.
2. 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 revised work-hour guidelines. Those guidelines were:
  
  (1) An individual should not be permitted to work more than 16 hours straight (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 seven 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. 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.
  
  Soon thereafter, the Commission received a petition for rulemaking (PRM-26-2), dated September 28, 1999, from Barry Quigley. (The petition is discussed in greater detail in Section II. B.) 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, pursuant to 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 (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). In accordance with 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
  
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  adversely affecting public health and safety and the common defense and security by establishing clear and enforceable requirements for the management worker fatigue.
  
  During the development of proposed 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. Following 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 use of extended work hours, matters unique to security personnel, and stakeholder input obtained through public meetings concerning the proposed worker fatigue rulemaking and the Order. The requirements in the Order were imposed 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 proposed 10 CFR Part 26, Subpart I, Managing Fatigue, for security force personnel would replace the requirements imposed by Order. Differences between the proposed requirements in Subpart I and the requirements imposed by Order, and the rationale for those differences, are discussed in Section IV. D.
3. Combined Part 26 Rulemaking
  
  On March 29, 2004, in COMSECY-04-0014, the NRC staff informed the Commission of the status of both 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 current 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 repropose one or both 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 proposed rule withdraws the proposed rule published on May 9, 1996.
Petitions and Request for Exemption
1. 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 the FFD program and 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 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.
  
  Proposed Sec. 26.41(b) would partially grant two aspects of the petition. That is, the required audit frequency for licensees and other entities who are subject to 10 CFR Part 26 would be reduced from the nominal 1-year frequency in the current 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 would be conducted as part of the 2-year audits of the licensee or other entity's FFD program, under proposed Sec. 26.41(b).
  
  Proposed Sec. 26.41(c)(1) would partially deny two aspects of the petition. That is, the nominal annual audit requirement for HHS- certified laboratories would be retained. In addition, the annual audit requirement would be 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 audit requirements in the proposed rule are addressed in the subsequent sections of this supplementary information.
2. 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 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 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
  
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  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 proposed 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 has evaluated the merits of PRM-26-2, the comments received in response to the PRM, and assessed the Policy on Worker Fatigue. The NRC has 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 believes 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. The proposed rule would therefore grant, in part, PRM-26- 2. 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 plans to similarly revise the same documents during preparation of the final Part 26 rule. The self-disclosure of sleeping disorders by licensed operators (item 4) is being addressed by the NRC as a separate effort from this proposed rule through changes to Regulatory Guide 1.134, ``Medical Evaluation of Licensed Personnel at Nuclear Power Plants.''
3. Request for Exemption under 10 CFR 26.6
  
  The current rule requires 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 offsite 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 proposed rule would maintain the current requirement for random drug and alcohol testing for personnel with unescorted access to the PA at a nuclear power plant.
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 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 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

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SSNM Strategic special nuclear material THC Tetrahydrocannabinol, delta-9-tetrahydrocannabinol-9-carboxylic acid UCS Union of Concerned Scientists 6-AM 6-acetylmorphine
Discussion of Proposed Action
1. Overview
  
  A review of FFD program experience confirms that the regulatory approach of 10 CFR Part 26 is fundamentally sound and continues to provide a means of deterrence and detection of substance abuse at licensee facilities. NRC Information Notice 2003-04, ``Summary of Fitness-for-Duty Program Performance Reports,'' dated February 6, 2003, provides the latest published summary of program performance. 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 ADAMS under Accession No. ML030350473.
  
  Nonetheless, the NRC believes that revisions are needed to improve the effectiveness and efficiency of FFD programs; enhance consistency with advances in similar rules and guidelines, including 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.
2. Goals of the Rulemaking Activity
  
  The Nuclear Regulatory Commission (NRC) proposes to amend 10 CFR Part 26, Fitness for Duty Programs. The proposed 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 U.S. Department of Health and Human Services Mandatory Guidelines for Federal Workplace Drug Testing Programs 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.
  
  (7) Protect the privacy and due process rights 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 proposed rule relate to each goal. The major changes for each subpart, and the reasons for those changes, are described in Section IV. C and D of this document. For each of the many specific changes that are being proposed, 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 proposed changes to the rule that would 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 the U.S. Department of Health and Human Services Mandatory Guidelines for Federal Workplace Drug Testing Programs (referred to in this document as 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. Goal 1 is central to this rulemaking activity. Many changes are included in the proposed 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 Guidelines, upon which the current rule is based.
  
  The President of the United States designated HHS as the agency responsible for the Federal workplace drug testing program, and HHS' Substance Abuse and Mental Health Services Administration (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 HHS' most recent 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 would be 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 instrumented specimen validity tests to determine whether a urine specimen has been adulterated, diluted, or substituted. This proposed rule would adopt 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 current 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 proposed change to 10 CFR Part 26 that was included from the proposed HHS Guidelines is permission for licensees to use non-instrumented validity testing devices to determine
  
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  whether a urine specimen must be 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 non-instrumented validity testing devices 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 proposing to include 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 proposed changes to 10 CFR Part 26 that incorporate the recent revisions to the HHS Guidelines, the Department of Transportation (DOT) revised its Procedures for Transportation Workplace Drug and Alcohol Testing Programs [49 CFR 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. The proposed rule would also reflect 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. Proposed Subpart I, Managing Fatigue, would add clear and enforceable requirements for licensee management of worker fatigue to 10 CFR Part 26. The proposed requirements would 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 discusses the specific reasons for each proposed 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 proposing 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 proposed reduction in the period within which pre-access testing must be performed from 60 days, in current Sec. 26.24(a)(1), to 30 days or less, in proposed Subpart C [Granting and Maintaining Authorization]. This proposed change would improve the effectiveness of the pre-access test in detecting drug and alcohol use by individuals who are applying for authorization to perform the types of job duties that require them to be subject to Part 26 (see proposed Sec. 26.25 [Individuals subject to the fitness-for-duty program]). Reducing the number of breath specimens required for alcohol testing from two each for initial and confirmatory testing, in current Section 2.4(g)(18) in Appendix A to Part 26, to one specimen for the initial test and one for the confirmatory test, if required, in proposed Sec. 26.91(d), would increase the efficiency of FFD programs without compromising the accuracy and validity of alcohol test results.
  
  Another example would be establishing a regulatory framework for the management of worker fatigue that appropriately balances the need for flexibility to manage plant exigencies and worker individual differences relative to fatigue 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 access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003. Current FFD and access authorization requirements each contain provisions that relate to establishing the trustworthiness and reliability of personnel prior to granting unescorted access to the protected areas of nuclear power plants. The NRC has determined that, because both sets of requirements share this same goal, revising Part 26 would 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 Part 26 address 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 compensatory measures on existing access authorization programs. Therefore, it is necessary to revise the related provisions in Part 26.
  
  Goal 5--Improve 10 CFR Part 26 by eliminating or modifying unnecessary requirements. The proposed rule would incorporate a number of changes to eliminate or modify unnecessary requirements. The experience NRC has gained over the years since Part 26 was promulgated have enhanced the agency's understanding of implementation by the industry, and the NRC now proposes to eliminate or modify some provisions, while at the same time maintaining the protection of public health and safety and the common defense and security.
  
  For example, because of inconsistencies in 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. Proposed revisions to Part 26 would clarify that licensees may obtain information to satisfy FFD
  
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  suitable inquiry requirements and related access authorization requirements at the same time when conducting an employment inquiry.
  
  Goal 6--Improve clarity in the organization and language of the rule. The proposed rule is organized to facilitate implementation, as compared to the current rule which has generated many questions from licensees. Therefore, in the proposed 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 would apply to licensees' FFD processes. In addition, the NRC has proposed many language changes to improve clarity. The NRC has undertaken this substantial reorganization to improve the protection of public health and safety and the common defense and security by substantially reducing the likelihood of variations in FFD programs across the industry through differing interpretations of the rule. The proposed 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 this proposed 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 proposed Part 26 have eliminated the need for a guidance document. In the public meetings described in Section V, 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. Industry therefore desired the rule to be more specific and detailed, in lieu of a guidance document.
  
  Goal 7--Protect the privacy and due process rights of individuals who are subject to 10 CFR Part 26. This goal is an implicit objective of the current rule, and the proposed rule would also continue to protect the privacy and due process rights of individuals 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 DOT and HHS to modify many of their requirements for such testing to more clearly protect privacy and due process rights of individuals. Many of the proposed 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 proposes 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 ``Bottle B'', the second portion of a split urine specimen, would now only be tested with the donor's written permission.
3. Overview of Proposed Rule
  
  The proposed rule would be divided into subparts that contain related requirements. This proposed change would be made to improve the ease of implementing the rule by grouping related requirements and presenting them generally in the order in which they would apply to licensees' and other entities' FFD processes. Each subpart would be assigned a descriptive title to aid users in locating rule provisions and to simplify cross-referencing within the proposed rule. The major topics addressed in each subpart and the reasons that the major changes are being proposed are described below. A detailed cross-reference table between the current and proposed Part 26 provisions is included at the end of this notice. Subpart A Administrative Provisions
  
  The first subpart, proposed Subpart A [Administrative Provisions], would replace the General Provisions portion of the current rule, but continue to address the same subject matter. Thus, Subpart A would address the purpose and scope of the rule, provide definitions of important terms used in the proposed rule, and update current provisions related to requests for specific exemptions, interpretations of the rule, and communications with the NRC. Subpart B Program Elements
  
  Subpart B [Program Elements] of the proposed rule would reorganize and amend current Sec. Sec. 26.10-26.29, which specify the performance objectives that FFD programs would be required to meet and the FFD program elements that licensees and other entities must implement to meet the performance objectives. However, the proposed rule would not include current Sec. 26.27 [Management actions and sanctions to be imposed] in Subpart B for two reasons. First, at the public meetings described in Section V. B, stakeholders requested that the rule be reorganized to be consistent with the order in which licensees and other entities would implement their programs. Because Subpart B would be 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 proposed rule. Second, the stakeholders suggested, and the NRC staff concurred after consideration, that the subject matter of current Sec. 26.27 is sufficiently important and complex that a separate subpart is warranted. Therefore, the proposed rule would present requirements related to management actions and sanctions in proposed Subpart D
  
  [Management Actions and Sanctions to be Imposed] . Subpart C Granting and Maintaining Authorization
  
  Subpart C [Granting and Maintaining Authorization] of the proposed rule would substantially amend current 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 proposed rule would introduce 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 perform the job duties described in proposed Sec. 26.25
  
  [Individuals subject to the fitness-for-duty program] , as a result of the process described in this subpart. For example, in the case of nuclear power plant personnel, an individual who is ``authorized'' under Part 26 may be permitted 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 authorization to an individual or permit an individual to
  
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  maintain authorization. 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, a credit and criminal history check, and interview individuals who have knowledge of the applicant for authorization. However, as discussed in Section IV. B, historically there have been some inconsistencies and redundancies between the Part 26 requirements related to granting and maintaining authorization 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, in other cases, imposed an unnecessary burden on licensees. Therefore, a central goal of adding Subpart C to the proposed 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 authorization under Part 26 and also under other, related requirements, including, but not limited to, the access authorization orders issued by the NRC to nuclear power plant licensees on January 7, 2003.
  
  The requirements in proposed Subpart C are based upon several fundamental changes to the NRC's approach to the authorization requirements in current 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 IV. C with respect to proposed Sec. 26.23(a) in terms of the increased insider threat since the terrorist attacks of September 11, 2001. One change to current Part 26 authorization requirements that reflects this concern is the elimination of temporary access authorization requirements in the second sentence of current Sec. 26.27(a)(4). Other changes are discussed in Section IV with respect to the specific provisions that would incorporate them.
  
  A second, related change to the NRC's approach to authorization requirements, which has informed proposed Subpart C, is an increased concern with the sharing of information about individuals between licensees and other entities. At the time the current 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 so 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 upon 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 current FFD regulations were written on the basis that individual licensees would maintain independent, site-specific FFD programs and would share limited information, and that the majority of nuclear personnel would remain at one site for years, the regulations do 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, proposed Subpart C would require licensees and other entities to collect and share greater amounts of information than under the current rule, subject to the protections of individuals' privacy that would be specified in proposed Sec. 26.37 [Protection of information]. As a result, individuals who are subject to the rule would establish a detailed ``track record'' within the industry that would 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 would contribute to providing reasonable assurance that individuals who are granted and maintain authorization 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 hold authorization, 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 and there is 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 that would be required under Subpart C has the potential to result in a greater number of such individuals being banned from working in the industry. Therefore, several requirements would be added to
  
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  proposed Subpart C to minimize such consequences for individuals who are able to demonstrate that they have resolved a substance abuse problem. Additional requirements for protecting information that would be gathered about individuals under proposed Part 26 would be specified in proposed Sec. 26.37 [Protection of information]. The detailed changes to current requirements are discussed in Section VI with respect to the specific provisions that would incorporate them.
  
  In general, the authorization requirements in proposed Subpart C would be 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 proposed rule would require 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 proposed rule would require licensees and other entities to complete before granting authorization to the individual would be reduced. The need for original information gathering in these instances would be reduced because, under the proposed rule, licensees and other entities would have access to all of the information that previous FFD programs had collected about the individual.
  
  For individuals who have established a favorable track record in the industry, the steps that licensees and other entities would be required to complete in order to grant authorization to an individual would also depend 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 proposed rule would require 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 proposed rule would require licensees and other entities to complete fewer steps in order to grant authorization to the individual. There are several reasons that the proposed rule would require 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 would be 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 would have 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.
  
  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, the less likely it would be that the individual could have undergone significant changes in lifestyle or character that would be undetected.
  
  Therefore, the proposed rule would establish categories of requirements for granting authorization to an individual that would 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. Proposed Sec. 26.55 [Initial authorization] would establish 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. Proposed Sec. 26.57 [Authorization update] would establish 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. Proposed Sec. 26.59 [Authorization reinstatement] would establish authorization requirements for individuals who previously held authorization under Part 26 and whose last period of authorization was terminated favorably within the past year. Proposed Sec. 26.69
  
  [Authorization with potentially disqualifying fitness-for-duty information] would define 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 would be 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 proposed 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 proposed rule would incorporate these time periods within Part 26.
  
  In general, the steps that would be required to grant authorization to an individual who has recently held authorization and whose most recent period of authorization was terminated favorably would be 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 requirements for a rigorous evaluation process contained in the current Sec. 26.27(e) would be strengthened and licensees and other entities would be required to meet them before granting authorization to an individual about whom potentially disqualifying FFD information has been disclosed or
  
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  discovered (see proposed Sec. 26.69). The proposed rule would require 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, with certain exceptions. The proposed exceptions to the self-disclosure and employment history, suitable inquiry, and pre-access testing requirements would be specified in proposed Sec. Sec. 26.61 [Self- disclosure and employment history], 26.63 [Suitable inquiry], and 26.65
  
  [Pre-access drug and alcohol testing] , respectively. The proposed rule would also require licensees and other entities to ensure that applicants are subject to random testing, as specified in proposed Sec. 26.67 [Random drug and alcohol testing of individuals who have applied for authorization]. Subpart D Management Actions and Sanctions
  
  Subpart D [Management Actions and Sanctions] of the proposed rule would replace current Sec. 26.27(b) and (c) and divide the current provisions into two separate sections that specify requirements for responding to FFD policy violations in proposed Sec. 26.75
  
  [Sanctions] , and indications of impairment in proposed Sec. 26.77
  
  [Management actions regarding possible impairment] . The current rule would be reorganized in response to stakeholder requests that were made during the public meetings discussed in Section V. The stakeholders requested that the proposed rule generally reflect the order in which the requirements apply to licensees' and other entities' FFD processes and that related requirements be grouped into separate sections. Therefore, this change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule.
  
  In general, proposed Subpart D would include three significant changes from the related provisions in the current rule that are each intended to provide a stronger deterrent to engaging in the unwanted actions specified in the proposed subpart. First, the proposed rule would increase 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 would be 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 perform the job duties listed in proposed Sec. 26.25 [Individuals subject to the fitness-for-duty program].
  
  Second, the proposed rule would require 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. Some licensees, however, have imposed lesser sanctions for alcohol violations, an approach that is inconsistent with the NRC's intent. Therefore, the proposed rule would rectify this situation by explicitly requiring the same minimum sanctions for abuse of alcohol as currently required for the use of illegal drugs.
  
  Third, the proposed rule would add the sanction of permanent denial of authorization for any individuals who subvert or attempt to subvert the testing process. The current rule permits 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 have imposed different sanctions and some individuals have been granted authorization or permitted to maintain authorization when they have 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 proposed rule would establish 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 would be made to meet Goal 3 of this rulemaking, which is to improve the effectiveness of FFD programs, as discussed in Section IV. B. Other changes to current Sec. 26.27(b) and (c) in proposed Subpart D would be made primarily to eliminate or modify unnecessary requirements and clarify the intent of current provisions. Subpart E Collecting Specimens for Testing
  
  Subpart E [Collecting specimens for testing] of the proposed rule would reorganize and amend the requirements related to collecting specimens for drug and alcohol testing that are contained in current Sec. 26.24 [Chemical and alcohol testing] and interspersed throughout current Appendix A to Part 26. The proposed subpart would group the related requirements and present them in the order in which they would be implemented by FFD programs. The proposed rule would also eliminate some redundancies in the provisions of the current rule that are related to specimen collections, as is discussed in Section VI, with respect to the specific provisions. These proposed changes would be made to meet Goal 6 of the rulemaking, which is to improve clarity in the organization and language of the rule, as discussed in Section IV. B.
  
  In general, the procedures in this subpart would be more detailed than those in Appendix A to the current rule, and also those NRC regulations that are based upon a risk-informed, performance-based approach, for several reasons. First, the more detailed procedures in proposed Subpart E would increase the consistency of Part 26 drug and alcohol specimen collection procedures with those of other Federal agencies and therefore would take advantage of the scientific and technical advances that have been made in workplace drug and alcohol testing programs since the current Part 26 was promulgated, as discussed in Section IV. B. Second, the proposed rule would permit Part 26 FFD programs to accept and rely upon other Part 26 programs, as well as the programs of other Federal and State agencies, to a much greater extent than is permitted under the current rule. The proposed permission to rely on other programs would improve the effectiveness and efficiency of FFD programs (Goal 3 of the rulemaking) and improve 10 CFR Part 26 by eliminating or modifying unnecessary requirements (Goal 5 of the rulemaking). For example, under proposed Sec. 26.69(b)(6), the proposed rule would permit licensees and other entities to rely upon 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 three-year period following the violation, and is transferring from one licensee's site to another. The proposed rule would require the receiving licensee or other entity to continue the followup testing
  
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  program. However, the proposed rule would permit 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 proposed rule would permit such reliance on other programs, more detailed requirements for conducting the activities upon 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, at the public meetings discussed in Section V, industry stakeholders requested a greater level of detail in the specimen collection procedures of the proposed rule for the reasons discussed in Section IV. B.
  
  Other major changes to the current rule's requirements for collecting specimens for drug and alcohol testing would be made to incorporate specimen validity testing requirements from the HHS Guidelines into Part 26 (Goal 1 of this rulemaking) and modify current 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 [Licensee Testing Facilities] of the proposed rule would present 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 current rule and Sec. 26.31(d)(3)(i) of the proposed rule. The proposed subpart would be entitled, ``Licensee Testing Facilities,'' for brevity, but other entities who are subject to the proposed rule would be permitted to establish and operate such facilities under the proposed rule.
  
  This new subpart would be added to group together in a single subpart the proposed requirements that are related to licensee testing facilities, which are intermixed with requirements related to drug testing at HHS-certified laboratories in Appendix A to Part 26 in the current rule. During the public meetings discussed in Section V, stakeholders requested that the proposed rule present the requirements that would be applicable to licensee testing facilities and HHS- certified laboratories in two separate subparts because, the stakeholders noted, it is not always clear which requirements apply to which type of testing facility in the current rule. The stakeholders also requested that any requirements that apply to both types of facilities would be included in both subparts so that it would be unnecessary for licensees and other entities who do not operate licensee testing facilities to review or implement any provisions in Subpart F. Although many of the requirements in this subpart would be redundant with similar requirements in proposed Subpart G [Laboratories Certified by the Department of Health and Human Services], the proposed rule would implement these recommendations to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule.
  
  The most important changes in proposed Subpart F to the current requirements for licensee testing facilities would be the addition of new requirements for licensee testing facilities to conduct 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 urine specimen validity testing are discussed in Section VI with respect to proposed Sec. 26.31(d)(3)(I). As discussed in Section V, stakeholders have objected to the addition of requirements for licensee testing facilities to conduct validity testing. However, 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, licensees and other entities are permitted 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 would not be 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, proposed Subpart F would permit licensee testing facilities to use non- instrumented validity testing devices to conduct ``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 proposed Sec. 26.5 [Definitions], the proposed rule would use the term, ``validity screening test,'' to refer to testing using these non- instrumented devices. The term, ``initial validity test,'' would refer to instrumented validity testing.
  
  At the same time that the HHS published its final regulations to require specimen validity testing, which would be incorporated in the proposed 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 proposed Subpart F would also incorporate. 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 [Laboratories Certified by the Department of Health and Human Services] in the proposed rule would present together in a single subpart requirements related to the HHS-certified laboratories that are used by
  
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  licensees and other entities who are subject to Part 26 for validity and drug testing. The requirements in this subpart would group together the current requirements in Appendix A to Part 26, as they relate to HHS-certified laboratories. However, the current requirements would be updated 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 current rule's requirements for HHS-certified laboratories would be the incorporation of extensive requirements for urine specimen validity testing. Subpart H Determining Fitness-for-Duty Policy Violations and Determining Fitness
  
  Subpart H [Determining Fitness-for-Duty Policy Violations and Determining Fitness] in the proposed rule would reorganize, clarify, and enhance current requirements related to the decisions that 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 proposed Subpart C [Granting and Maintaining Authorization] and also with respect to imposing sanctions and taking actions to prevent an individual from performing the job duties that require an individual to be subject to this part under proposed Subpart D [Management Actions and Sanctions]. The current requirements, which are interspersed throughout the rule, would be grouped together in the proposed subpart to make them easier to locate within the proposed rule, consistent with Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule, as discussed in Section IV. B. The proposed subpart would also make several significant changes to current requirements.
  
  In general, proposed Subpart H would include more detailed requirements for determining FFD policy violations and conducting determinations of fitness than are included in the current rule. These more detailed requirements would be added 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 proposed rule would permit licensees and other entities to rely on the determinations made by other Part 26 programs to a greater extent than the current rule. For example, proposed Sec. 26.63(b) would permit 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, for previous periods of authorization. The reasons for adding these permissions were discussed previously in this section, with respect to proposed Subpart C [Granting and Maintaining Authorization]. However, in order 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 current requirements and establish clear minimum standards for those processes. Therefore, the proposed subpart would include greater detail to meet Goal 3 of this rulemaking, which is to improve the effectiveness and efficiency of FFD programs.
  
  Under the proposed rule, licensees and other entities who are subject to the rule would 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 proposed rule would extend this requirement to the review of non-negative validity test results, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed in Section VI with respect to proposed Sec. 26.31(d)(3)(i). An MRO review of non-negative confirmatory validity test results 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 non-negative 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. Requiring the MRO to review non- negative validity test results would be added to meet Goal 7 of this rulemaking, which is to protect the due process rights of individuals who are subject to Part 26. The HHS Guidelines also require the MRO to review non-negative validity test results. Therefore, adding this requirement to the proposed rule would also 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.
  
  Another significant change that the proposed rule would make to current requirements is establishing a new position within FFD programs--the ``substance abuse expert'' (SAE). The SAE would be 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 SAE position would be added 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 non- negative 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 proposed rule would permit MROs to serve as SAEs if they meet the qualifications for this role that would be established in this subpart. But, licensees and other entities would be required to rely on other healthcare professionals who have the necessary qualifications to conduct determinations of fitness if the MRO does not meet the proposed SAE qualification requirements.
  
  Second, during the meetings discussed in Section V, stakeholders requested that healthcare professionals, other than a licensed physician, be permitted to make determinations of fitness under the proposed rule. The stakeholders indicated that the costs of using only licensed physicians are prohibitive and noted that a license to practice medicine does not guarantee that a physician is knowledgeable about substance abuse disorders. The NRC concurs that healthcare professionals
  
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  other than licensed physicians may have the requisite knowledge and skills to serve as SAEs under the proposed rule. Therefore, the proposed rule would define the position of SAE in terms of the knowledge and skills required, and permit healthcare professionals other than licensed physicians to serve in this role.
  
  Third, under the proposed rule, FFD programs would be 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 would play in assuring the common defense and security and public health and safety when making a determination of fitness upon 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 judgements in these circumstances.
  
  Many of the provisions in the proposed subpart would be adapted 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 current Part 26. Subpart I Managing Fatigue
  
  Subpart I [Managing Fatigue] of the proposed rule would 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. Because the overall rationale for including Subpart I, Managing Fatigue, in Part 26, is detailed and extensive, this discussion is presented separately in Section IV. D. Subpart J Recordkeeping and Reporting Requirements
  
  Subpart J [Recordkeeping and Reporting Requirements] would be added to the proposed rule to reorganize the current rule's requirements for maintaining records and submitting reports to the NRC. The new subpart would combine and amend two sections of the current rule: Section 26.71
  
  [Recordkeeping requirements] and Sec. 26.73 [Reporting requirements], and would incorporate the record retention requirements of current Sec. Sec. 26.21(b), 26.22(c), and 26.80(c). This proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule, by grouping related requirements together in the proposed subpart.
  
  Major changes to the current rule's requirements for recordkeeping and reporting would reflect (1) the addition of requirements for specimen validity to the proposed rule; (2) the addition of requirements for managing worker fatigue at nuclear power plants; and (3) 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 K Inspections, Violations, and Penalties
  
  Subpart K [Inspections, Violations, and Penalties] would be added to the proposed rule to combine into one subpart current Sec. Sec. 26.70 [Inspections], 26.90 [Violations] and 26.91 [Criminal penalties]. These sections would be grouped together in one subpart because they each establish requirements related to the NRC's oversight of the implementation of FFD programs. Proposed Sec. 26.221 [Inspections] would retain the requirements in current Sec. 26.70. Proposed Sec. 26.223 [Violations] would retain the requirements in current Sec. 26.90 [Violations]. Proposed Sec. 26.225 [Criminal penalties] would retain the requirements in current Sec. 26.91 [Criminal penalties].
4. 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. Subpart I, Managing Fatigue, of the proposed rule would include these requirements and establish an integrated approach to fatigue management, with fatigue prevention, detection, and mitigation as the fundamental components. As discussed further in this section, the proposed requirements in Subpart I would provide a substantial increase in the protection of public health and safety and common defense and security. In determining the provisions of this proposed 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 current regulatory framework; the excessive hours currently worked by many nuclear power workers; and the 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 proposed rule. These interactions are discussed in detail in Section V of this document.
  
  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 worker tolerances to these conditions also influence worker fitness for duty. As a consequence, fatigue is a complex phenomenon that requires an integrated approach to be managed effectively. The requirements in proposed Subpart I were developed based upon the premise that fatigue management requires the collaboration of individual workers and licensees.
  
  Each of the proposed requirements in Subpart I are discussed in detail in Section VI. However, because proposed Subpart I presents an integrated fatigue management approach, this section discusses the principal findings that led to the 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 proposed rule. The considerations listed in the numbered paragraphs that follow summarize the NRC's considerations
  
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  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 prevalence of 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 current regulatory framework does 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 work hours and work-hour limit deviations;
  
  (5) The current regulatory framework includes requirements that are inadequate and incomplete for effective fatigue management;
  
  (6) Ensuring effective management of worker fatigue through rulemaking would 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; 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. Such 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 has 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., Proposed 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 safeguards 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 clear decisions, and communicate and work as a team. The following effects of fatigue on cognitive abilities are the primary focus of the proposed 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 a cornerstone of safe nuclear power plant operations. Fatigue has been associated with more risky strategies and decreases in the effort individuals exert (Schellekens, et al., 2000). Furthermore, Harrison and Horne (2000) reviewed the impact of sleep deprivation on decision-making and
  
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  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 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 degrading performance, recent research has helped characterize the magnitude of these effects relative to a historical FFD concern: impairment from alcohol intoxication. The current provisions in 10 CFR Part 26 prohibit the use of alcohol on site and within several hours before a tour of duty, and establish 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 current provisions of 10 CFR 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 a breath alcohol cutoff level of 0.04 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 is 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., Proposed Rule, May 2, 2000, 65 FR 25544). The effects of extended working hours on worker performance can be exacerbated when many extended shifts are scheduled in succession.
  
  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 Section V, 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
  
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  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 indicates that deviations from the limit of 72 hours in 7 days continue to account for more than 80 percent of the deviations authorized. During these 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 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 a 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. 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 is specific to U.S. nuclear power plant workers, in the general U.S. population, such 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
  
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  general population. A survey by the NSF of 1,154 adults living in households in the continental U.S. 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), and such changes are beyond the individual's control. In addition, several studies have suggested caution with regard to the ability of individuals to self-monitor their abilities 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, the NRC believes that 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 currently 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 believes 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 current regulatory framework does not include consistent or readily enforceable requirements to address worker fatigue.
  
  The principal components of the current regulatory framework for matters pertaining to working hours and fatigue for non-security personnel are (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 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 current regulatory framework applicable to worker fatigue, including licensee technical specification requirements 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 proposed 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, the policy is enforceable only to the extent that the guidelines have been incorporated into a license condition or technical specification requirements. For the three nuclear power plant sites who have not incorporated the guidelines from the NRC's Policy on Worker Fatigue into a license condition or technical specification requirement, 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 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 is 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 results in inconsistent interpretation and implementation of technical specification requirements 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 working 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 capability. --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 be 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 is not implemented consistently from one nuclear power plant to another. Work hours included within the limits at some nuclear power plants are not 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 Sec. 26.10 require 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.''
  
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  Although 10 CFR Part 26 contains specific requirements pertaining to alcohol and drug usage, it does not include prescriptive requirements regarding fatigue. Rather, Sec. 26.20 uses 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 is 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, make it difficult for the NRC to enforce worker fatigue requirements and working 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 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 includes 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 have 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.
  
  The Nuclear Energy Institute (NEI) conducted a survey in the summer of 2000 concerning industry control of work hours for personnel subject to the technical specification requirements (letter dated August 29, 2000, from J.W. Davis, NEI, to G.T. 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 increased from 7 percent in 1997 to 11 percent in 1999. The percentage of licensed operators working in excess of 600 hours increased from 13 percent in 1997 to more than 16 percent in 1999. The NRC believes these percentages 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 are reported in detail in Appendix 3 of the draft Regulatory Analysis. The analysis is available as discussed above under the ADDRESSES heading. Single copies may be obtained from the contact listed above under the FOR FURTHER INFORMATION CONTACT heading. The NRC believes that licensee use of deviations and overtime at some sites is excessive, and does not represent the intent of the NRC's Policy on Worker Fatigue.
  
  In addition to excessive work hours and work hour guideline 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 proposed rule would establish requirements to address this need.
  
  (5) The current regulatory framework includes requirements that are inadequate and incomplete for effective fatigue management.
  
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  1. 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 consequence, implementation has been varied across the industry.
  2. Certain policy guidelines and technical specification requirements are inadequate for 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 would be revised to a 10 hour break. The basis for the need to revise this break period is described in detail in Section VI with respect to proposed Sec. 26.199(d)(2)(I).
    
    Further, the specific work hour guidelines of the policy, and most technical specification requirements for the administrative control of work hours, are principally focused on acute fatigue, and do 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, continuous task demands, or other issues 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 or night 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 current regulatory framework for addressing cumulative fatigue became particularly apparent in the months following the terrorist attacks of September 11, 2001. As described in Section VI with respect to proposed Sec. 26.199(f)(2), 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 are 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, would establish controls to address cumulative fatigue. Limits to mitigate cumulative fatigue for security personnel were implemented by Order EA-03-038. The proposed rule would codify, with limited changes, these requirements. Changes to those limits that would be imposed by this rule are discussed in detail in Section VI, which also includes a detailed discussion of the proposed limits and other controls to mitigate cumulative fatigue for non-security personnel.
  3. The existing regulatory framework does not effectively ensure that fatigue from causes other than work hours is 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 ability 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). Proposed Subpart I, Managing Fatigue, would require a comprehensive fatigue management program. One example would be the strengthening of FFD training requirements concerning worker fatigue. This would 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.
    
    (6) Ensuring effective management of worker fatigue through rulemaking would 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 are ensured under the current regulatory framework, including Order EA-03-038 (for security personnel), the NRC's Policy on Worker Fatigue, and licensee technical specification requirements. Licensee FFD programs currently include 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 current 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) ensure adequate protection of public health and safety and the common defense and security. However, there are substantial limitations to the current regulatory framework, as detailed in this section. Therefore, although the current regulatory framework provides adequate protection, including work hour controls in 10 CFR Part 26 would provide a substantial increase in public health and safety and the common defense and security. The NRC is proposing to incorporate worker fatigue provisions into 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 current and proposed Federal limits on work hours for nuclear plant workers in eight other countries, as well as six other industries in the United States and Canada. Although many factors influence specific regulatory limits, and requirements for other industries should be considered in context, the NRC found that the NRC's current 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. With the exception of Spain, which has limits consistent with the NRC's Policy on Worker Fatigue, each of the other eight countries has
    
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    more stringent requirements. The more stringent requirements have largely 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). Dissatisfied 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) prohibit work after the end of the fourteenth hour after the driver began work; and (3) require long break recovery periods to prevent cumulative fatigue (68 FR 22456-22517; April 28, 2003).
    
    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 in paragraph D(1)(d) of 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 job 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 industries, in its use of automated safety systems to protect against the
    
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    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. Current NRC requirements, such as the minimum on-site 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 proposed rule would differ from other Federal agencies' requirements with respect to specific work hour requirements and would require 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 proposed 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 proposed 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 current regulatory framework, the excessive hours currently worked by many nuclear power plan 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 proposed rule. These interactions are discussed in detail in Section V. The specific basis for each provision of the fatigue management portions of the proposed rule are discussed in Section VI.
    
    The proposed 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 would 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.
Summary of Public Interactions and Comments

In preparing this proposed rule, the NRC has considered comments received by OMB and the NRC on the prior Part 26 final rule affirmed by the Commission in a SRM dated December 4, 2000, and subsequently submitted to the Office of Management and Budget (OMB) for a clearance under the Paperwork Reduction Act. Those comments and responses to them are provided in Section V. A.

The NRC has also considered feedback received from industry, as well as other interested parties and members of the public in preparing this proposed rule. The NRC held 11 stakeholder meetings on the drug and alcohol testing portions of the rule during 2001-2004, and held 13 stakeholder meetings on the fatigue portion of the rule during 2002- 2003. Subsequent to the Commission's decision to combine the two rulemaking efforts, the NRC held 1 stakeholder meeting on the combined rule in July, 2004, and 2 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 (67 FR 7093) on February 15, 2002. Feedback was received from stakeholders both through the public meetings and the NRC's rulemaking Web site at http://ruleforum.

llnl.gov. Summaries of these meetings, and any comments provided through the Web site are available at http://ruleforum. llnl.gov/cgi-

bin/rulemake?source= BQ--PETITION&st= plan for meetings and comments on the fatigue portions of the rulemaking prior to 2004, and at http://ruleforum. llnl.gov/cgi-bin/ rulemake?source=Part26-- risk&st=risk for

meetings and comments on the drug and alcohol testing portions of the rulemaking, and on the fatigue portions of the rulemaking subsequent to the Commission's decision to combine the rulemakings in 2004. 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 proposed rule in a manner to ensure it was clearly understandable, could be consistently interpreted, and did not result in unintended consequences. Many of the stakeholders' comments directly resulted in proposed changes. Where a comment was included in a proposed provision, the comment is discussed in Section VI.

Many comments were received during the years the meetings were held, and the draft proposed rule language was

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changed and re-posted to the web numerous times. Each comment received during these meetings, but not included in the proposed rule text, is not discussed and responded to in detail, given that the NRC is issuing a new proposed rule for formal public comment. However, the most significant comments that were not incorporated are discussed in Section V. B of this document.
1. Public Comments Submitted to OMB on 2000 Final Rule and Responses
The comments below were received by OMB and the NRC on the prior Part 26 final rule affirmed by the Commission in a SRM dated December 4, 2000, and subsequently submitted to OMB for a clearance under the Paperwork Reduction Act. The NRC's responses follow each comment.

Industry Comment 1: Rule should allow combining partial samples to get the required volume for HHS analysis. Otherwise, it [the Regulatory Analysis] should reflect an added expense with a reduced gain.

Response: New provisions in Sec. 26.109, ``Urine specimen quantity,'' prohibit licensees from combining partial samples because this practice may falsely lower the concentration of a drug or adulterant. Further, HHS and DOT do not permit this practice. Additionally, comments on the previous proposed rule objected to combining specimens for the same reason. However, the proposed rule would lower the required specimen quantity from a minimum of 60 milliliters (mL) to 30 mL. NRC discussions with representatives of HHS- certified laboratories have indicated that advances in testing technologies allow accurate and reliable testing of 15 mL specimens. The NRC has proposed 30 mL, which would allow the HHS laboratory sufficient specimen quantity for retesting, if needed. Because the required specimen quantity has been reduced by at least one-half, there should be few instances in which a donor is unable to produce the necessary quantity and, therefore, few instances in which additional costs would be incurred.

Industry Comment 2: Medical professionals other than a licensed physician should be allowed to determine if a history of substance abuse ``raises a concern.''

Response: The proposed rule in Sec. 26.187 would add a position called the ``Substance Abuse Expert'' (SAE), adapted from the related DOT regulations. The SAE need not be a licensed physician, but would be required to have extensive expertise, such as a licensed or certified social worker, psychologist, or others listed in Sec. 26.187(b), and additional qualifications specifically related to substance abuse disorders. The SAE would be authorized to make a determination of fitness in at least circumstances: (1) when an individual has violated the substance abuse provisions of a licensee's or C/V's FFD policy, including, but not limited to a first positive drug test result; (2) when there is a concern that an individual may be impaired by the use of a substance; or (3) for an applicant for authorization when the self-disclosure, the suitable inquiry, or other sources of information identify potentially disqualifying FFD information (PDFFDI) about the applicant.

Industry Comment 3: Reevaluate NRC's regulatory analysis indicating a $27 million savings in light of industry's estimate of a $8 million cost increase.

Response: A detailed reevaluation of the drug and alcohol provisions, based in part on data obtained from NEI, still indicates a savings to industry of $116 million-$183 million (7 percent--3 percent discount rate) present value. The evaluation of the proposed Part 26 provisions as a whole, including the proposed worker fatigue provisions, indicates a cost to industry of $469 million-$730 million (7 percent--3 percent discount rate) present value. A draft regulatory analysis was provided to industry and other stakeholders during the public meetings held in 2004. Comments received have been considered in developing the regulatory analysis for this proposed rule.

Industry Comment 4: New rule requires audits of [HHS] certified labs.

Response: The proposed rule includes additional language in proposed Sec. 26.41 to clarify the NRC's intent that audits of certified labs may be shared among licensees and that licensees are not required to audit areas that are covered by the HHS certification process. Additionally, organizations that do not routinely provide FFD services to a licensee or C/V, such as local hospitals or a substance abuse treatment facility, would be exempt from the annual audit requirement.

Industry Comment 5: Rule includes FFD personnel in program.

Response: The NRC continues to agree with the original intent of the rule, which was that personnel who administer FFD programs must be covered by 10 CFR Part 26. However, during meetings, stakeholders discussed the numerous logistical difficulties associated with covering FFD program personnel. As a result, the proposed rule includes a number of related language adjustments.

Specifically, new language in proposed Sec. 26.25(a)(4) would clarify the NRC's intent that FFD program personnel must be subject to the program. Proposed Sec. 26.25(a)(4)(I) through (v) would be added to identify the FFD program personnel who must be subject to the FFD program, based upon their job responsibilities. Proposed Sec. 26.25(b)(1) would exempt individuals who may provide an FFD service to a licensee or other entity in special circumstances, and who meet all of the following three criteria: (1) They are not employed by the licensee or C/V, (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 or other entity's facility. Personnel who meet the three criteria specified in proposed Sec. 26.25(b)(1) would be exempt 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.

In addition, new language in Sec. 26.31(b)(2) would permit FFD program personnel who are distant from a licensee site to be tested at a local facility that meets DOT requirements, including audits. Permitting these FFD program personnel to be tested at local collection sites that follow similar procedures would be adequate to meet the goal of ensuring their continuing honesty and integrity, while addressing some logistical concerns posed by stakeholders.

Industry Comment 6: The term, ``history of substance abuse,'' is pejorative and may incorrectly label some workers in the nuclear industry as substance abusers.

Response: Based upon further discussions with stakeholders, the NRC developed a greater appreciation for the connotations of the term, ``history of substance abuse,'' and agreed that the term has too many pejorative implications. Therefore, the proposed rule would entirely eliminate the use of this term. The rule language no longer discusses this issue in terms of an individual's personal characteristics. Rather, the language focuses on the type of information that would trigger a determination of fitness. This information is referred to as ``potentially disqualifying FFD information'' (PDFFDI), which is consistent with terminology used in access authorization programs.

Industry Comment 7: History of substance abuse creates a new class of workers and no relief.

Response: As noted above, the concept, ``history of substance abuse,''

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has been eliminated in the proposed rule. The proposed rule would provide relief to individuals with PDFFDI in three ways. First, individuals would be required to self-disclose PDFFDI that is related to events that occurred only within the past 5 years. This provision provides relief from the current rule, which requires individuals to self-disclose certain adverse events every time they apply for authorization, no matter how long ago the adverse events occurred. Second, licensees would be permitted to accept a determination of fitness conducted by a previous licensee and a favorable termination of authorization for an individual who had any PDFFDI that was addressed and resolved under a previous Part 26 program. This provision also provides relief from the current rule, which requires the licensee to conduct a determination of fitness for any individual who has ever been denied access or had access terminated unfavorably, no matter how long ago the event occurred or whether there is evidence that the individual has been rehabilitated. Licensees would be permitted to conduct another determination of fitness, but would not be required to do so, if the individual's last period of authorization was terminated favorably. Third, licensees would be permitted to accept responsibility for continuing any treatment and followup testing plans that a previous licensee implemented for an individual, rather than conducting a new determination of fitness and developing new treatment and testing plans. These provisions protect the rights of individuals who have successfully resolved or are resolving a substance abuse-related problem as well as reduce the regulatory burden on the individuals and licensees.

Industry Comment 8: History of substance abuse creates a tracking burden.

Response: As noted above, the concept, ``history of substance abuse,'' would be eliminated in the proposed rule. Further, the current rule requires licensees to maintain records and share information related to denials and unfavorable terminations of authorization in Sec. 26.27(a)(3). Therefore, the proposed rule's requirements for licensees to maintain records and share information related to PDFFDI would not create a new tracking burden and are consistent with the access authorization Order.

Industry Comment 9: Change the opiate cutoff level of 300 ng/mL to the HHS standard of 2000 ng/mL.

Response: The proposed rule now includes the 2000 ng/mL HHS cutoff level for opiates. Discussions with HHS indicate that the HHS staff's rationale for changing the cutoff level to 2000 ng/ML provides sufficient protection for public health and safety from individuals who may be abusing opiates.

Industry Comment 10: It is impossible to complete all suitable inquiries within 72 hours.

Response: Consistent with the access authorization Order, which the Commission issued to nuclear power reactor licensees on January 7, 2003, the proposed rule would eliminate provisions for routine temporary access. Therefore, the proposed rule would eliminate the requirement in the Affirmed Rule for a 72-hour turnaround on a suitable inquiry prior to granting temporary access.

Industry Comment 11: Rule requires verification of all employment periods, including less than 30 days.

Response: The proposed rule incorporates feedback received through stakeholder meetings. The revised provisions specify employers required to be addressed during the suitable inquiry for several different cases, including applicants for initial authorization, updated authorization, or reinstated authorization. The employers required to be addressed vary for each of these situations, and are specified in proposed Sec. Sec. 26.63 and 26.69. In developing this proposed section, the NRC took into account documented substance abuse recidivism rates (highest within the first year following treatment, continuing at a somewhat lower rate for 3 years post-treatment, and decreasing again at 5 years) and stakeholder feedback.

Stakeholders have indicated that employers are generally reluctant to provide any information other than dates of employment, but that more recent employers are more likely to disclose adverse information than employers from previous years. Therefore, the NRC has determined that requiring every employer from the past 5 years to be contacted for all persons is both unnecessary and an unwarranted regulatory burden. Thus, for initial authorization, the employment check is to be conducted with every employer, regardless of the length of employment, for the past year, and with each employer by whom the individual claims to have been employed the longest in each calendar month for the previous 2 years. For authorization updates, the employment check is to be conducted with every employer, regardless of the length of employment, for the past year, and with each employer by whom the individual claims to have been employed the longest in each calendar month for the remaining time since authorization was terminated. For authorization reinstatements, the employment check is to be conducted with each employer by whom the individual claims to have been employed the longest in each calendar month since authorization was terminated. For individuals who have had a substance abuse problem, however, Sec. 26.69 requires a suitable inquiry for the applicable period specified by Sec. 26.63, as well as obtaining any records that other licensees or other entities may have developed relating to any potentially disqualifying FFD information about the individual.

Industry Comment 12: Allow credit for prior licensee's suitable inquiry.

Response: Proposed Sec. 26.63(b) would permit licensees to rely upon suitable inquiry information that was gathered by other licensees and entities. However, for all applicants for authorization, the suitable inquiry would be more thorough than previous industry practices, in order to increase the likelihood that PDFFDI would be identified, if it existed, and to provide reasonable assurance that individuals are trustworthy and reliable as demonstrated by the avoidance of substance abuse. For individuals who have established a recent, favorable work history within the industry, as demonstrated by having held authorization that was terminated favorably within the past 3 three years, the period of time addressed in the suitable inquiry would be reduced from the past 5 five years in every case, to the past 3 three years or less, depending upon how recently the applicant held authorization. If PDFFDI within the past 5 five years is identified regarding an applicant and the information had not been addressed and favorably resolved by a previous licensee or other entity, the suitable inquiry requirements would be more extensive, as described in proposed Sec. 26.69.

Industry Comment 13: Allow credit for prior licensee's medical determination of fitness.

Response: The NRC has clarified the qualification requirements for the medical personnel who may conduct a determination of fitness and believe that these clarifications will provide greater consistency in the determinations made across licensees. Therefore, a requirement for each new licensee to perform another determination of fitness for authorization reinstatements (authorization interrupted for 365 days or less) and authorization updates

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(authorization interrupted for >365 days to ,'' or may dilute an aliquot of the specimen to obtain an accurate quantitative result when the concentration is above the upper limit of the linear range.

Sec. 26.165 Testing split specimens and retesting single specimens.

(a) Split specimens. (1) If a specimen has been split into Bottle A and Bottle B at the collection site, and the specimen was not initially tested at a licensee testing facility, then the HHS-certified laboratory shall perform initial and confirmatory validity and drug testing, if required, of the specimen in Bottle A.

(2) If a specimen was initially tested at a licensee testing facility and non-negative results were obtained, then the HHS-certified laboratory shall perform initial and confirmatory testing, if required, of the specimen in Bottle A.

(3) At the licensee's or other entity's discretion, Bottle B must either be forwarded to the laboratory or maintained in secure storage by the licensee or other entity. If the specimen in Bottle A is free of any evidence of drugs or drug metabolites, and is a valid specimen, then the licensee, other entity, or laboratory may discard the specimen in Bottle B.

(4) If initial and confirmatory test results from the specimen in Bottle A are positive for one or more drugs or drug metabolites, or if validity testing at the HHS-certified laboratory shows that the specimen has been subject to adulteration, substitution, or other means of subversion, the laboratory shall report the results to the MRO. Within 3 business days (Monday through Friday, excluding holidays) of being notified by the MRO that the donor's specimen yielded a non- negative test result, the donor may request that the split specimen in Bottle B be tested by another HHS-certified laboratory. The MRO shall inform the donor of this option, and the specimen in Bottle B may be tested only at the donor's request. The donor shall provide his or her written permission for the testing of Bottle B and neither the licensee, MRO, NRC, nor any other entity may order testing of Bottle B without the donor's written permission.

(5) If the donor requests that the specimen in Bottle B be tested, the HHS-certified laboratory shall forward Bottle B to a second HHS- certified laboratory that did not test the specimen in Bottle A as soon as reasonably practical and not more than one business day following the day of the donor's request.

(6) The HHS-certified laboratory that tests the specimen in Bottle B shall provide quantitative test results to the MRO and the MRO shall provide them to the donor.

(b) Donor request to MRO for a retest of a single specimen. (1) For a drug-positive, adulterated, or substituted result reported on a single specimen of 30 mL or more which the donor submitted to the licensee or other entity, a donor may request (through the MRO) that an aliquot from the single specimen be tested by a second HHS-certified laboratory to verify the result reported by the first laboratory. The MRO shall inform the donor of the option for a retest and the donor shall request the retest within 3 business days after notification by the MRO of the non-negative test result. The donor shall provide his or her written permission for the retest and neither the licensee, MRO, NRC, nor any other entity may order retesting of the specimen without the donor's written permission, except as provided in Sec. 26.185(m).

(2) For a single specimen that the laboratory has reported as invalid, a donor may not request that an aliquot from the single specimen be tested by a second HHS-certified laboratory. If the donor requests testing of the specimen, the HHS-certified laboratory shall forward the specimen to a second HHS-certified laboratory that did not test the specimen as soon as reasonably practical and not more than one business day following the day of the donor's request.

(c) Retesting a specimen for drugs. (1) The second laboratory shall use its standard confirmatory drug test when retesting an aliquot of a single specimen or testing Bottle B of a split specimen for the drug(s) or drug metabolite(s) for which the first laboratory reported a positive result(s).

(2) Because some drugs or drug metabolites may deteriorate during storage, the retest by the second laboratory is not subject to a specific drug cutoff level, but must provide data sufficient to confirm the presence of the drug(s) or drug metabolite(s) down to the assay's LOD.

(3) If the second laboratory fails to reconfirm the presence of the drug(s) or drug metabolite(s) for which the first

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laboratory reported a positive result(s), the second laboratory shall attempt to determine the reason for not reconfirming the first laboratory's findings by conducting specimen validity tests. The second laboratory shall conduct the same specimen validity tests it would conduct on a single specimen or the specimen in Bottle A of a split specimen.

(4) The second laboratory shall report all results to the licensee's or other entity's MRO.

(d) Retesting a specimen for adulterants. A second laboratory shall use the appropriate confirmatory validity test and criteria specified in Sec. 26.161(c) to reconfirm an adulterant result when retesting an aliquot from a single specimen or when testing Bottle B of a split specimen. The second laboratory may only conduct the confirmatory validity test needed to reconfirm the adulterant result reported by the first laboratory.

(e) Retesting a specimen for substitution. A second laboratory shall use its confirmatory creatinine and confirmatory specific gravity tests, when retesting an aliquot of a single specimen or testing Bottle B of a split specimen, to reconfirm that the creatinine concentration was less than 2 mg/dL and the specific gravity was less than or equal to 1.0010 or equal to or greater than 1.0200. However, the second laboratory shall apply the cutoff levels for a substituted result in this part and shall report the results as non-confirmed if the second laboratory's results exceed the original test cutoff parameters. The second laboratory may only conduct the confirmatory creatinine and specific gravity tests to reconfirm the substitution result reported by the first laboratory.

(f) Management actions and sanctions. (1) If the MRO confirms a non-negative test result(s) from the first HHS-certified laboratory and the donor requests testing of Bottle B of a split specimen or retesting of an aliquot from a single specimen, the licensee or other entity shall administratively withdraw the individual's authorization on the basis of the first confirmed non-negative test result until the results of testing Bottle B or retesting an aliquot of the single specimen are available and have been reviewed by the MRO. If the MRO reports that the results of testing Bottle B or retesting the aliquot of a single specimen confirm any of the original non-negative test result(s), the licensee or other entity shall impose the appropriate sanctions specified in Subpart D of this part. If the results of testing Bottle B or retesting the aliquot of a single specimen are negative, the licensee or other entity--

(i) May not impose any sanctions on the individual;

(ii) Shall eliminate from the tested individual's personnel and other records any matter that could link the individual to the temporary administrative action;

(iii) May not disclose the temporary administrative action in response to a suitable inquiry conducted under the provisions of Sec. 26.63 or to any other inquiry or investigation required in this chapter. To ensure that no records have been retained, access to the system of files and records must be provided to personnel conducting reviews, inquiries into allegations, or audits under the provisions of Sec. 26.41, or to NRC inspectors; and

(iv) Shall provide the tested individual with a written statement that the records specified in Sec. Sec. 26.213 and 26.215 have not been retained and shall inform the individual in writing that the temporary administrative action that was taken will not be disclosed and need not be disclosed by the individual in response to requests for self-disclosure of potentially disqualifying FFD information.

(2) If a donor requests that Bottle B be tested or that an aliquot of a single specimen be retested, and either Bottle B or the single specimen are not available due to circumstances outside of the donor's control (including, but not limited to, circumstances in which there is an insufficient quantity of the single specimen to permit retesting, either Bottle B or the original single specimen is lost in transit to the second HHS-certified laboratory, Bottle B has been lost), the MRO shall cancel the test. The licensee or other entity shall eliminate from the donor's personnel and other records any matter that could link the donor to the original non-negative test result(s) and any temporary administrative action, and may not impose any sanctions on the donor for a cancelled test. If the original specimen was collected for random, for-cause, or post-event testing, the licensee or other entity shall document only that the test was performed and cancelled. If the original specimen was collected for pre-access or followup testing, the MRO shall direct the licensee or other entity to collect another specimen for testing as soon as reasonably practical. If test results from the second specimen collected are non-negative and the MRO determines that the donor has violated the FFD policy, the licensee or other entity shall impose the appropriate sanctions specified in Subpart D of this part, but may not consider the original confirmed non-negative test result in determining the appropriate sanctions.

Sec. 26.167 Quality assurance and quality control.

(a) Quality assurance program. Each HHS-certified laboratory shall have a quality assurance program that encompasses all aspects of the testing process, including, but not limited to, specimen accessioning, chain of custody, security and reporting of results, initial and confirmatory testing, certification of calibrators and controls, and validation of analytical procedures. The performance characteristics (e.g., accuracy, precision, LOD, limit of quantitation (LOQ), specificity) of each test must be validated and documented for each test. Validation of procedures must document that carryover does not affect the donor's specimen results. Periodic re-verification of analytical procedures is required. Quality assurance procedures must be designed, implemented, and reviewed to monitor the conduct of each step of the testing process.

(b) Calibrators and controls required. Each analytical run of specimens for which an initial or confirmatory validity test, or an initial or confirmatory drug test, is being performed must include the appropriate calibrators and controls.

(c) Quality control requirements for performing initial and confirmatory validity tests. (1) Requirements for performing creatinine tests.

(i) The creatinine concentration must be measured to 1 decimal place on both the initial and the confirmatory creatinine tests.

(ii) The initial creatinine test must have a calibrator at 2 mg/dL.

(iii) The initial creatinine test must have a control in the range of 1-1.5 mg/dL, a control in the range of 3-20 mg/dL, and a control in the range of 21-25 mg/dL.

(iv) The confirmatory creatinine test (performed on those specimens with a creatinine concentration less than 2 mg/dL on the initial test) must have a calibrator at 2 mg/dL, a control in the range of 1-1.5 mg/ dL, and a control in the range of 3-4 mg/dL.

(2) Requirements for performing specific gravity tests.

(i) The refractometer must report and display the specific gravity to 4 decimal places, and must be interfaced with a laboratory information management system (LIMS), or computer, and/or generate a hard copy or digital electronic display to document the numerical result.

(ii) The initial and confirmatory specific gravity tests must have a calibrator or control at 1.0000.

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(iii) The initial and confirmatory specific gravity tests must have the following controls:

(A) One control targeted at 1.0020;

(B) One control in the range of 1.0040-1.0180; and

(C) One control equal to or greater than 1.0200 but not greater than 1.0250.

(3) Requirements for performing pH tests.

(i) Colorimetric pH tests that have the dynamic range of 2-12 to support the 3 and 11 pH cutoffs and pH meters must be capable of measuring pH to 1 decimal place. Dipsticks, colorimetric pH tests, and pH paper that have a narrow dynamic range and do not support the 2-12 pH cutoffs may be used only to determine whether initial validity tests must be performed. At a minimum, pH screening tests must have the following controls:

(A) One control below the lower decision point in use;

(B) One control between the decision points in use; and

(C) One control above the upper decision point in use.

(ii) An initial colorimetric pH test must have the following calibrators and controls:

(A) One calibrator at 3;

(B) One calibrator at 11;

(C) One control in the range of 2-2.8;

(D) One control in the range 3.2-4;

(E) One control in the range of 4.5-9;

(F) One control in the range of 10-10.8;

(G) One control in the range of 11.2-12.

(iii) If a pH screening test is not used, an initial pH meter test must have the following calibrators and controls:

(A) One calibrator at 4;

(B) One calibrator at 7;

(C) One calibrator at 10;

(D) One control in the range of 2-2.8;

(E) One control in the range 3.2-4;

(F) One control in the range of 10-10.8; and

(G) One control in the range of 11.2-12.

(iv) If a pH screening test is used, an initial or confirmatory pH meter test must have the following calibrators and controls when the screening result indicates that the pH is below the lower decision point in use:

(A) One calibrator at 4;

(B) One calibrator at 7;

(C) One control in the range of 2-2.8; and

(D) One control in the range 3.2-4.

(v) If a pH screening test is used, an initial or confirmatory pH meter test must have the following calibrators and controls when the screening result indicates that the pH is above the upper decision point in use:

(A) One calibrator at 7;

(B) One calibrator at 10;

(C) One control in the range of 10-10.8; and

(D) One control in the range of 11.2-12.

(4) Requirements for performing oxidizing adulterant tests.

(i) Initial tests for oxidizing adulterants must include a calibrator at the appropriate cutoff concentration for the compound of interest, a control without the compound of interest (i.e., a certified negative control), and at least one control with one of the compounds of interest at a measurable concentration.

(ii) A confirmatory test for a specific oxidizing adulterant must use a different analytical method than that used for the initial test. Each analytical run must include an appropriate calibrator, a control without the compound of interest (i.e., a certified negative control), and a control with the compound of interest at a measurable concentration.

(5) Requirements for performing nitrite tests. The initial and confirmatory nitrite tests must have a calibrator at the cutoff concentration, a control without nitrite (i.e., certified negative urine), one control in the range of 200-400 mcg/mL, and one control in the range of 500-625 mcg/mL.

(6) Requirements for performing ``other'' adulterant tests.

(i) The initial and confirmatory tests for any ``other'' adulterant that may be identified in the future must satisfy the requirements in Sec. 26.161(a).

(ii) The confirmatory test for ``other'' adulterants must use a different analytical principle or chemical reaction than that used for the initial test.

(iii) The initial and confirmatory tests for ``other'' adulterants must include an appropriate calibrator, a control without the compound of interest (i.e., a certified negative control), and a control with the compound of interest at a measurable concentration.

(d) Quality control requirements for performing initial drug tests. (1) Any initial drug test performed by an HHS-certified laboratory must use an immunoassay that meets the requirements of the Food and Drug Administration for commercial distribution. Non-instrumented immunoassay testing devices that are pending HHS/Substance Abuse and Mental Health Services Administration (SAMHSA) review and approval may not be used for initial drug testing under this part.

(2) HHS-certified laboratories may perform multiple initial drug tests for the same drug or drug class, provided that all tests meet the cutoffs and quality control requirements of this part.

(3) Each analytical run of specimens for initial testing must include--

(i) Sample(s) certified to contain no drug (i.e., negative urine samples);

(ii) At least one control fortified with a drug or drug metabolite targeted at 25 percent above the cutoff;

(iii) At least one control fortified with a drug or drug metabolite targeted at 75 percent of the cutoff;

(iv) A sufficient number of calibrators to ensure and document the linearity of the assay method over time in the concentration area of the cutoff (after acceptable values are obtained for the known calibrators, those values will be used to calculate sample data);

(v) A minimum of 10 percent of the total specimens in each analytical run must be quality control samples; and

(vi) One percent of each run, with a minimum of at least one sample, must be the laboratory's blind quality control samples to appear as routine specimens to the laboratory analysts.

(e) Quality control requirements for performing confirmatory drug tests. (1) Confirmatory tests for drugs and drug metabolites must be performed using gas chromatography/mass spectrometry (GC/MS) or other confirmatory test methodologies that HHS-certified laboratories are permitted to use in Federal workplace drug testing programs for this purpose.

(2) At least 10 percent of the samples in each analytical run of specimens must be calibrators and controls. Each analytical run of specimens that are subjected to confirmatory testing must include--

(i) Sample(s) certified to contain no drug (i.e., negative urine samples);

(ii) Positive calibrator(s) and control(s) fortified with a drug or drug metabolite;

(iii) At least one control fortified with a drug or drug metabolite targeted at 25 percent above the cutoff; and

(iv) At least one calibrator or control that is targeted at or below 40 percent of the cutoff.

(f) Blind performance testing. Each licensee and other entity shall submit blind performance test samples to the HHS-certified laboratory.

(1) During the initial 90-day period of any contract with an HHS- certified laboratory (not including rewritten or renewed contracts), each licensee or other entity shall submit blind performance test samples to each HHS-certified laboratory with whom it contracts in the amount of at least 20 percent of the total number of specimens submitted (up to a maximum of 100 blind performance specimens) or

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30 blind performance test samples, whichever is greater.

(2) Following the initial 90-day period, the number of blind performance test samples submitted per quarter must be a minimum of 1 percent of all specimens (up to a maximum of 100) or 10 blind performance test samples, whichever is greater. Both during the initial 90-day period and quarterly thereafter, licensees and other entities should attempt to submit blind performance test samples at a frequency that corresponds to the submission frequency for other specimens.

(3) Approximately 15 percent of the blind performance test samples submitted to the laboratory must be positive for one or more drugs per sample so that all of the drugs for which the FFD program is testing are included each quarter. The positive samples must be spiked only with those drugs for which the FFD program is testing and spiked with concentrations between 60-80 percent of the initial cutoff values for the panel of drugs established herein, or of any lower cutoff values established by the licensee or other entity. To challenge the HHS- certified laboratory's ability to determine specimen validity, the licensee or other entity shall submit blind samples each quarter that are appropriately adulterated, diluted, or substituted, in the amount of 5 percent of the specimens submitted that quarter or at least 3 samples per quarter (one each that is adulterated, diluted, or substituted), whichever is greater.

(4) Approximately 80 percent of the blind performance test samples submitted to the laboratory each quarter must be blank (i.e., certified to contain no drug).

(5) Licensees and other entities shall use only blind performance test samples that have been certified by the supplier to be negative (i.e., as certified by immunoassay and confirmatory testing), drug positive [i.e., certified by immunoassay and confirmatory testing to contain one or more drug(s) or drug metabolite(s)], adulterated (i.e., certified to be adulterated with a specific adulterant using an appropriate confirmatory validity test), or substituted (i.e., the creatinine concentration and specific gravity satisfy the criteria for a substituted specimen using confirmatory creatinine and specific gravity tests, respectively). The supplier shall also provide the expiration date for each blind performance test sample to ensure that each quality control sample will give the expected result when it is submitted and correctly tested by a laboratory before the expiration date. In addition--

(i) Drug performance testing samples must satisfy, but are not limited to, one of the following criteria:

(A) The drug or drug metabolite concentration in the sample must be at least 20 percent above the designated cutoff for either the initial drug test or the confirmatory drug test, depending upon which is to be evaluated;

(B) For retest samples, the drug or drug metabolite concentration may be as low as 40 percent of the cutoff;

(C) For routine samples, the drug or drug metabolite concentration may be below the cutoff for special purposes;

(D) A negative sample may not contain the target drug analyte at a concentration greater than 10 percent of the confirmatory cutoff; and

(E) Samples may be fortified with interfering substances.

(ii) Validity performance testing samples must satisfy, but are not limited to, one of the following criteria:

(A) The nitrite concentration must be at least 20 percent above the cutoff;

(B) The pH must be less than 2.75 or greater than 11.25;

(C) The concentration of an oxidant will be at a level sufficient to challenge a laboratory's ability to identify and confirm the oxidant;

(D) The creatinine concentration must be between 0 and 20 mg/dL; and

(E) The specific gravity must be less than or equal to 1.0050 or between 1.0170 and 1.0230.

(g) Errors in testing. The licensee or other entity shall ensure that the HHS-certified laboratory investigates any testing errors or unsatisfactory performance discovered in blind performance testing, in the testing of actual specimens, or through the processing of reviews, as well as any other errors or matters that could adversely reflect on the testing process.

(1) Whenever possible, the investigation must determine relevant facts and identify the root cause(s) of the testing or process error. The licensee or other entity, and the HHS-certified laboratory, shall take action to correct the causes of any errors or unsatisfactory performance that are within their control. Sufficient records shall be maintained to furnish evidence of activities affecting quality. The licensee or other entity shall assure that the cause of the condition is determined and the corrective action taken to preclude repetition. The identification of the significant condition, the cause of the condition, and the corrective action taken shall be documented and reported to appropriate levels of management.

(2) Should a false positive error occur on a blind performance test sample or on a regular specimen, the licensee or other entity shall require the laboratory to take corrective action to minimize the occurrence of the particular error in the future. If there is reason to believe that the error could have been systematic, the licensee or other entity may also require review and re-analysis of previously run specimens.

(3) Should a false positive error occur on a blind performance test sample and the error is determined to be technical or methodological, the licensee or other entity shall instruct the laboratory to provide all quality control data from the batch or analytical run of specimens that included a false positive sample. In addition, the licensee or other entity shall require the laboratory to retest all specimens that analyzed as positive for that drug or metabolite, or as non-negative in validity testing, from the time of final resolution of the error back to the time of the last satisfactory performance test cycle. This retesting must be documented by a statement signed by the laboratory's certifying scientist. The licensee or other entity and the NRC also may require an onsite review of the laboratory, which may be conducted unannounced during any hours of operation of the laboratory.

(h) Accuracy. Volumetric pipettes and measuring devices must be certified for accuracy or be checked by gravimetric, colorimetric, or other verification procedures. Automatic pipettes and dilutors must be checked for accuracy and reproducibility both before being placed in service and periodically thereafter.

(i) Calibrators and controls. Laboratory calibrators and controls must be prepared using pure drug reference materials, stock standard solutions obtained from other laboratories, or standard solutions that are obtained from commercial manufacturers and are properly labeled as to content and concentration. Calibrators and controls may not be prepared from the same stock solution. The standards and controls must be labeled with the following dates: When received; when prepared or opened; when placed in service; and when scheduled for expiration.

Sec. 26.169 Reporting results.

(a) The HHS-certified laboratory shall report test results to the licensee's or other entity's MRO within 5 business days after receiving the specimen from the licensee or other entity. Before reporting any test result to the MRO, the laboratory's certifying scientist shall certify the result as correct. The report must identify the substances for which testing was performed; the results of the validity and drug tests; the cutoff levels

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for each; any indications of tampering, adulteration, or substitution that may be present; the specimen identification number assigned by the licensee or other entity; and the specimen identification number assigned by the laboratory.

(b) The HHS-certified laboratory shall report as negative all specimens that are negative on the initial or confirmatory drug and validity tests. Specimens that test as non-negative on the confirmatory analysis must be reported to the MRO as positive for a specific drug(s) or drug metabolite(s), or as meeting the criteria for an adulterated, substituted, or dilute specimen.

(c) If licensees or other entities specify cutoff levels for drugs or drug metabolites that are more stringent than those specified in this part, the laboratory need only conduct the more stringent tests and shall report the results of the initial and confirmatory tests only for the more stringent cutoff levels.

(d) For a specimen that is found to be dilute, adulterated, or substituted, the laboratory shall report the specimen as dilute, adulterated, or substituted and, when applicable, shall provide the MRO with the numerical values that support the reported result. The MRO may not disclose the numerical values to the licensee or other entity, except as permitted in Sec. 26.37(b). If the numerical values for creatinine are below the LOD, the laboratory shall report to the MRO ``creatinine none detected'' (i.e., substituted) along with the numerical values. For a specimen that has an invalid result, the laboratory shall contact the MRO and both will decide whether testing by another certified laboratory would be useful in being able to report a positive or adulterated result. Such contact may occur through any secure electronic means (e.g., telephone, fax, e-mail). If no further testing is necessary, the laboratory shall report the invalid result to the MRO.

(e) The laboratory shall report all non-negative test results for a specimen to the MRO. For example, a specimen may be both adulterated and positive for one or more specific drugs.

(f) The laboratory shall provide numerical values for non-negative confirmatory test results when the MRO requests such information. The MRO's request may be either a general request covering all such results or a specific case-by-case request. When the concentration of a drug, metabolite, or adulterant exceeds the linear range of the standard curve, the laboratory may report to the MRO that the quantitative value ``exceeds the linear range of the test,'' that the quantitative value is ``equal to or greater than ,'' or may report an accurate quantitative value above the upper limit of the linear range that was obtained by diluting an aliquot of the specimen. The MRO may not disclose quantitative test results to the licensee or other entity, but shall report only whether the specimen was drug-positive (and for which analyte), adulterated, substituted, invalid, or negative, except as permitted under Sec. 26.37(b). This paragraph does not preclude either the laboratory or the MRO from providing program performance data, as required under Sec. 26.217.

(g) The laboratory shall routinely provide quantitative values for confirmatory opiate test results for morphine or codeine that are greater than or equal to 15,000 ng/mL, even if the MRO has not requested quantitative values for the test result.

(h) The laboratory may transmit results to the MRO by various electronic means (e.g., teleprinters, facsimile, or computer) in a manner designed to ensure the confidentiality of the information. The laboratory may not provide results verbally by telephone. The licensee or other entity, directly or through the HHS-certified laboratory, shall ensure the security of the data transmission and ensure only authorized access to any data transmission, storage, and retrieval system.

(i) For negative test results, the HHS-certified laboratory may fax, courier, mail, or electronically transmit a computer-generated electronic report and/or a legible image or copy of the completed custody-and-control form to the MRO. However, for non-negative results, the laboratory shall fax, courier, mail, or electronically transmit a legible image or copy of the completed custody-and-control form to the MRO.

(j) For a specimen that has a non-negative result, the laboratory shall retain the original custody-and-control form and transmit to the MRO a copy of the original custody-and-control form signed by a certifying scientist.

(k) The HHS-certified laboratory shall provide to the licensee's or other entity's official responsible for coordination of the FFD program an annual statistical summary of urinalysis testing, which may not include any personal identifying information. In order to avoid sending data from which it is likely that information about a donor's test result can be readily inferred, the laboratory may not send a summary report if the licensee or other entity has fewer than 10 specimen test results in a 1-year period. The summary report must include test results that were reported within the year period. The laboratory shall send the summary report to the licensee or other entity within 14 calendar days after the end of the 1-year period covered by the report. The statistics must be presented either for the cutoff levels specified in this part or for any more stringent cutoff levels that the licensee or other entity may specify. The HHS-certified laboratory shall make available quantitative results for all specimens tested when requested by the NRC, licensee, or other entity for whom the laboratory is performing drug-testing services. If the FFD program tests for additional drugs beyond those listed in Sec. 26.31(d), the summary must include drug test results for the additional drugs. The summary report must contain the following information:

(1) Total number of specimens received;

(2) Number of specimens reported as--

(i) Negative, and

(ii) Negative and dilute;

(3) Number of specimens reported as positive on confirmatory tests by drug or drug metabolite for which testing is conducted, including, but not limited to--

(i) Marijuana metabolite;

(ii) Cocaine metabolite;

(iii) Opiates (total);

(A) Codeine,

(B) Morphine, and

(C) 6-AM;

(iv) Phencyclidine;

(v) Amphetamines (total);

(A) Amphetamine, and

(B) Methamphetamine;

(4) Total number of specimens reported as adulterated;

(5) Total number of specimens reported as substituted;

(6) Total number of specimens reported as drug positive and dilute; and

(7) Total number of specimens reported as invalid.

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

Sec. 26.181 Purpose.

This subpart contains requirements for determining whether a donor has violated the FFD policy and for making a determination of fitness.

Sec. 26.183 Medical review officer.

(a) Qualifications. The MRO shall be knowledgeable of this part and of the FFD policies of the licensees and other entities for whom the MRO provides services. The MRO shall be a physician

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holding either a Doctor of Medicine or Doctor of Osteopathy degree who is licensed to practice medicine by any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico. By [insert date 2 years after publication of the final rule in the Federal Register], the MRO shall have passed an examination administered by a nationally recognized MRO certification board or subspecialty board for medical practitioners in the field of medical review of Federally mandated drug tests.

(b) Relationships. The MRO may be an employee of the licensee or other entity or a contractor. However, the MRO may not be an employee or agent of, or have any financial interest in, an HHS-certified laboratory or a contracted operator of a licensee testing facility for whom the MRO reviews drug test results. Additionally, the MRO may not derive any financial benefit by having the licensee or other entity use a specific drug testing laboratory or licensee testing facility operating contractor and may not have any agreement with such parties that may be construed as a potential conflict of interest.

(c) Responsibilities. The primary role of the MRO is to review and interpret non-negative test results obtained through the licensee's or other entity's testing program and to identify any evidence of subversion of the testing process. The MRO is also responsible for identifying any issues associated with collecting and testing specimens, and for advising and assisting FFD program management in planning and overseeing the overall FFD program.

(1) In carrying out these responsibilities, the MRO shall examine alternate medical explanations for any non-negative test result. This action may include, but is not limited to, conducting a medical interview with the donor, reviewing the donor's medical history, or reviewing any other relevant biomedical factors. The MRO shall review all medical records that the donor may make available when a non- negative test result could have resulted from responsible use of legally prescribed medication, a documented condition or disease state, or the demonstrated physiology of the donor.

(2) The MRO may only consider the results of tests of specimens that are collected and processed in accordance with this part, including the results of testing split specimens, in making his or her determination, as long as those split specimens have been stored and tested in accordance with the procedures described in this part.

(d) MRO staff. Individuals who provide administrative support to the MRO may be employees of a licensee or other entity, employees of the MRO, or employees of an organization with whom a licensee or other entity contracts for MRO services.

(1) Direction of MRO staff activities. MROs shall be directly responsible for all administrative, technical, and professional activities of individuals who are serving MRO staff functions under his or her direction.

(i) The duties of MRO staff must be maintained independent from any other activity or interest of a licensee or other entity, in order to protect the integrity of the MRO function and donors' privacy.

(ii) An MRO's responsibilities for directing MRO staff must include, but are not limited to, ensuring that--

(A) The procedures being performed by MRO staff meet NRC regulations and HHS' and professional standards of practice;

(B) Records and other donor personal information are maintained confidential by MRO staff and are not released to other individuals or entities, except as permitted under this part;

(C) Data transmission is secure; and

(D) Drug test results are reported to the licensee's or other entity's designated reviewing official only in accordance with the requirements of this part.

(iii) The MRO may not delegate any of his or her responsibilities for directing MRO staff to any other individual or entity, except another MRO.

(2) MRO staff responsibilities. MRO staff may perform routine administrative support functions, including receiving test results, reviewing negative test results, and scheduling interviews for the MRO.

(i) The staff under the direction of the MRO may receive, review, and report negative test results to the licensee's or other entity's designated representative.

(ii) The staff reviews of non-negative drug test results must be limited to reviewing the custody-and-control form to determine whether it contains any errors that may require corrective action and to ensure that it is consistent with the information on the MRO's copy. The staff may resolve errors in custody-and-control forms that require corrective action(s), but shall forward the custody-and-control forms to the MRO for review and approval of the resolution.

(iii) The staff may not conduct interviews with donors to discuss non-negative drug test results nor request medical information from a donor. Only the MRO may request and review medical information related to a non-negative drug test result or other matter from a donor.

(iv) Staff may not report nor discuss any non-negative test results received from the HHS-certified laboratory with any individuals other than the MRO and other MRO staff.

Sec. 26.185 Determining a fitness-for-duty policy violation.

(a) MRO review required. A non-negative drug test result does not automatically identify an individual as having used drugs in violation of the NRC's regulations, or the licensee's or other entity's FFD policy, or as having attempted to subvert the testing process. An individual who has a detailed knowledge of possible alternate medical explanations is essential to the review of the results. The MRO shall review all non-negative test results from the HHS-certified laboratory to determine whether the donor has violated the FFD policy before reporting the results to the licensee's or other entity's designated representative.

(b) Reporting of initial test results prohibited. Neither the MRO nor MRO staff may report non-negative initial test results to the licensee or other entity that are received from the HHS-certified laboratory.

(c) Discussion with the donor. Before determining that a non- negative test result or other occurrence is an FFD policy violation and reporting it to the licensee or other entity, the MRO shall give the donor an opportunity to discuss the test result or other occurrence with the MRO, except as described in paragraph (d) of this section. After this discussion, if the MRO determines that a non-negative test result or other occurrence is an FFD policy violation, the MRO shall immediately notify the licensee's or other entity's designated representative.

(d) Donor unavailability. The MRO may determine that a non-negative test result or other occurrence is an FFD policy violation without having discussed the test result or other occurrence directly with the donor in the following three circumstances:

(1) The MRO has made and documented contact with the donor and the donor expressly declined the opportunity to discuss the test result or other occurrence that may constitute an FFD policy violation;

(2) A representative of the licensee or other entity, or an MRO staff member, has successfully made and documented contact with the donor and has instructed him or her to contact the MRO, and more than one business day has elapsed since the date on which the

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licensee's representative or MRO's staff member successfully contacted the donor; or

(3) The MRO, after making all reasonable efforts and documenting the dates and time of those efforts, has been unable to contact the donor. Reasonable efforts include, at a minimum, three attempts, spaced reasonably over a 24-hour period, to reach the donor at the day and evening telephone numbers listed on the custody-and-control form.

(e) Additional opportunity for discussion. If the MRO determines that the donor has violated the FFD policy without having discussed the non-negative test result or other occurrence directly with the donor, the donor may, upon subsequent notification of the MRO determination and within 30 days of that notification, present to the MRO information documenting the circumstances, including, but not limited to, serious illness or injury, which unavoidably prevented the donor from being contacted by the MRO or a representative of the licensee or other entity, or from contacting the MRO in a timely manner. On the basis of this information, the MRO may reopen the procedure for determining whether the donor's test result or other occurrence is an FFD policy violation and permit the individual to present information related to the issue. The MRO may modify the initial determination based on an evaluation of the information provided.

(f) Review of invalid specimens. (1) If the HHS-certified laboratory reports an invalid result, the MRO shall consult with the laboratory to determine whether additional testing by another HHS- certified laboratory may be useful in determining and reporting a drug- positive, adulterated, or substituted test result. If the MRO and the laboratory agree that further testing would be useful, the HHS- certified laboratory shall forward the specimen to a second laboratory for additional testing.

(2) If the MRO and the laboratory agree that further testing would not be useful and there is no technical explanation for the result, the MRO shall contact the donor and determine whether there is an acceptable medical explanation for the invalid result. If there is an acceptable medical explanation, the MRO shall report to the licensee or other entity that the test result is not an FFD policy violation, but that a negative test result was not obtained. If the medical reason for the invalid result is, in the opinion of the MRO, a temporary condition, the licensee or other entity shall collect a second urine specimen from the donor as soon as reasonably practical and rely upon the MRO's review of the test results from the second collection. The second specimen collected for the purposes of this paragraph may not be collected under direct observation. If the medical reason for the invalid result would similarly affect the testing of another urine specimen, the MRO may authorize an alternative method for drug testing. Licensees and other entities may not impose sanctions for an invalid test result due to a medical condition.

(3) If the MRO and the laboratory agree that further testing would not be useful and there is no legitimate technical or medical explanation for the invalid test result, the MRO shall require that a second collection take place as soon as practical under direct observation. The licensee or other entity shall rely upon the MRO's review of the test results from the directly observed collection.

(g) Review of dilute specimens. (1) If the HHS-certified laboratory reports that a specimen is dilute and that drugs or drug metabolites were detected in the specimen at or above the cutoff levels specified in this part or the licensee's or other entity's more stringent cutoff levels, and the MRO determines that there is no legitimate medical explanation for the presence of the drugs or drug metabolites in the specimen, the MRO shall determine that the drug test results are positive and that the donor has violated the FFD policy.

(2) If the MRO has reason to believe that the donor may have diluted a specimen in a subversion attempt, the MRO may require the laboratory to conduct confirmatory testing of the specimen at the LOD for any drugs or drug metabolites as long as each drug class is evaluated in accordance with Sec. 26.31(c)(1)(ii). For purposes of this paragraph, the following circumstances are the exclusive grounds constituting a reason to believe that the donor may have diluted the specimen in a subversion attempt:

(i) The donor has presented, at this or a previous collection, a urine specimen that the HHS-certified laboratory reported as being substituted, adulterated, or invalid to the MRO and the MRO determined that there is no adequate technical or medical explanation for the result;

(ii) The donor has presented a urine specimen of 30 mL or more that falls outside the required temperature range, even if a subsequent directly observed collection was performed; and

(iii) The collector observed conduct clearly and unequivocally indicating an attempt to dilute the specimen.

(3) If the dilute specimen was collected under direct observation as required under Sec. 26.69, the MRO may require the laboratory to conduct confirmatory testing at the LOD for any drugs or drug metabolites, as long as each drug class is evaluated in accordance with Sec. 26.31(c)(1)(ii).

(4) If the drugs detected in a dilute specimen are any opium, opiate, or opium derivative (e.g., morphine/codeine), or if the drugs or metabolites detected indicate the use of prescription or over-the- counter medications, before determining that the donor has violated the FFD policy under paragraph (a) of this section, the MRO or his/her designee, who shall also be a licensed physician with knowledge of the clinical signs of drug abuse, shall conduct the clinical examination for abuse of these substances that is required in paragraph (j) of this section. An evaluation for clinical evidence of abuse is not required if the laboratory confirms the presence of 6-AM (i.e., the presence of this metabolite is proof of heroin use) in the dilute specimen.

(h) Review of substituted specimens. (1) If the HHS-certified laboratory reports a specimen as substituted (i.e., the creatinine concentration is less than 2 mg/dL and the specific gravity is less than or equal to 1.0010 or equal to or greater than 1.0200), the MRO shall contact the donor and offer the donor an opportunity to provide a legitimate medical explanation for the substituted result. The burden of proof resides solely with the donor, who must provide legitimate medical evidence within 5 business days that he or she produced the specimen for which the HHS-certified laboratory reported a substituted result. Any medical evidence must be submitted through a referral physician who is experienced and qualified in the medical issues involved. Claims of excessive hydration, or claims based upon unsubstantiated personal characteristics, including, but not limited to, race, gender, diet, and body weight, are not acceptable evidence without medical studies which demonstrate that the donor did produce the laboratory result.

(2) If the MRO determines that there is no legitimate medical explanation for the substituted test result, the MRO shall report to the licensee or other entity that the specimen was substituted.

(3) If the MRO determines that there is a legitimate medical explanation for the substituted test result and no drugs or drug metabolites were detected in the specimen, the MRO shall report to the licensee or other entity that no FFD policy violation has occurred.

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(i) Review of adulterated specimens. (1) If the HHS-certified laboratory reports a specimen as adulterated with a specific substance, the MRO shall contact the donor and offer the donor an opportunity to provide a legitimate medical explanation for the adulterated result. The burden of proof resides solely with the donor, who must provide legitimate medical evidence within 5 business days that he or she produced the adulterated result through normal human physiology. Any medical evidence must be submitted through a referral physician experienced and qualified in the medical issues involved.

(2) If the MRO determines there is no legitimate medical explanation for the adulterated test result, the MRO shall report to the licensee or other entity that the specimen is adulterated.

(3) If the MRO determines that there is no legitimate medical explanation for the adulterated test result and no drugs or drug metabolites were detected in the specimen, the MRO shall report to the licensee or other entity that no FFD policy violation has occurred.

(j) Review for opiates, prescription and over-the-counter medications. (1) If the MRO determines that there is no legitimate medical explanation for a positive confirmatory test result for opiates and before the MRO determines that the test result is a violation of the FFD policy, the MRO or his/her designee, who shall also be a licensed physician with knowledge of the clinical signs of drug abuse, shall determine that there is clinical evidence, in addition to the positive test result, that the donor has illegally used opium, an opiate, or an opium derivative (e.g., morphine/codeine). This requirement does not apply if the laboratory confirms the presence of 6-AM (i.e., the presence of this metabolite is proof of heroin use), or the morphine or codeine concentration is equal to or greater than 15,000 ng/mL and the donor does not present a legitimate medical explanation for the presence of morphine or codeine at or above this concentration. The MRO may not determine that the consumption of food products is a legitimate medical explanation for the presence of morphine or codeine at or above this concentration.

(2) If the MRO determines that there is no legitimate medical explanation for a positive test result for drugs other than opiates that are commonly prescribed or included in over-the-counter preparations (e.g., benzodiazepines in the first case, barbiturates in the second) and are listed in the licensee's or other entity's panel of substances to be tested, the MRO shall determine whether there is clinical evidence, in addition to the positive test result, of abuse of any of these substances or their derivatives.

(3) If the MRO determines that the donor has used another individual's prescription medication, including a medication containing opiates, and no clinical evidence of drug abuse is found, the MRO shall report to the licensee or other entity that the donor has misused a prescription medication. If the MRO determines that the donor has used another individual's prescription medication and clinical evidence of drug abuse is found, the MRO shall report to the licensee that the donor has violated the FFD policy.

(4) In determining whether a legitimate medical explanation exists for a positive test result for opiates, prescription or over-the- counter medications, the MRO may consider the use of a medication from a foreign country. The MRO shall exercise professional judgment consistently with the following principles:

(i) There can be a legitimate medical explanation only with respect to a drug that is obtained legally in a foreign country;

(ii) There can be a legitimate medical explanation only with respect to a drug that has a legitimate medical use. Use of a drug of abuse (e.g., heroin, PCP) or any other substance that cannot be viewed as having a legitimate medical use can never be the basis for a legitimate medical explanation, even if the drug is obtained legally in a foreign country; and

(iii) Use of the drug can form the basis of a legitimate medical explanation only if it is used consistently with its proper and intended medical purpose.

(5) The MRO may not consider consumption of food products, supplements, or other preparations containing substances that may result in a positive drug test result, including, but not limited to supplements containing hemp products or coca leaf tea, as a legitimate medical explanation for the presence of drugs or drug metabolites in the urine specimen above the cutoff levels specified in Sec. 26.163 or a licensee's or other entity's more stringent cutoff levels.

(6) The MRO may not consider the use of any drug contained in Schedule I of section 202 of the Controlled Substances Act [21 U.S.C. 812] as a legitimate medical explanation for a positive confirmatory drug test result, even if the drug may be legally prescribed and used under State law.

(k) Results consistent with legitimate drug use. If the MRO determines that there is a legitimate medical explanation for a positive drug test result, and that the use of a drug identified through testing was in the manner and at the dosage prescribed, and the results do not reflect a lack of reliability or trustworthiness, then the donor has not violated the licensee's or other entity's FFD policy. The MRO shall report to the licensee or other entity that no FFD policy violation has occurred. The MRO shall further evaluate the positive test result and medical explanation to determine whether use of the drug and/or the medical condition poses a potential risk to public health and safety as a result of the individual being impaired while on duty. If the MRO determines that such a risk exists, he or she shall ensure that a determination of fitness is performed.

(l) Retesting authorized. Should any question arise as to the accuracy or validity of a non-negative test result, only the MRO is authorized to order retesting of an aliquot of the original specimen. Retesting must be performed by a second HHS-certified laboratory. The MRO is also the only individual who may authorize a reanalysis of an aliquot of the original specimen or an analysis of any split specimen (Bottle B) in response to a written request from the donor tested.

(m) Result scientifically insufficient. Based on the review of inspection and audit reports, quality control data, multiple specimens, and other pertinent results, the MRO may determine that a non-negative test result is scientifically insufficient for further action and may declare that a drug or validity test result is not an FFD policy violation, but that a negative test result was not obtained. In this situation, the MRO may request retesting of the original specimen before making this decision. The MRO is neither expected nor required to request such retesting, unless in the sole opinion of the MRO, such retesting is warranted. The MRO may request that the reanalysis be performed by the same laboratory, or that an aliquot of the original specimen be sent for reanalysis to another HHS-certified laboratory. The licensee testing facility and the HHS-certified laboratory shall assist in this review process, as requested by the MRO, by making available the individual(s) responsible for day-to-day management of the licensee testing facility or the HHS-certified laboratory, or other individuals who are forensic toxicologists or who have equivalent forensic experience in urine drug testing, to provide specific consultation as required by the MRO.

(n) Evaluating results from a second laboratory. After a second laboratory tests an aliquot of a single specimen or the split (Bottle B) specimen, the MRO

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shall take the following actions if the second laboratory reports the following results:

(1) If the second laboratory reconfirms any drug-positive test results, the MRO may report an FFD policy violation to the licensee or other entity;

(2) If the second laboratory reconfirms any non-negative validity test results, the MRO may report an FFD policy violation to the licensee or other entity;

(3) If the second laboratory does not reconfirm the drug-positive test results, the MRO shall report that no FFD policy violation has occurred; or

(4) If the second laboratory does not reconfirm the non-negative validity test results, the MRO shall report that no FFD policy violation has occurred.

(o) Re-authorization after a first violation for a drug-positive test result. The MRO is responsible for reviewing drug test results from an individual whose authorization was terminated or denied for a first violation of the FFD policy involving a confirmed positive drug test result and who is being considered for re-authorization. In order to determine whether subsequent positive confirmatory drug test results represent new drug use or remaining metabolites from the drug use that initially resulted in the FFD policy violation, the MRO shall request from the HHS-certified laboratory, and the laboratory shall provide, quantitation of the test results and other information necessary to make the determination. If the drug for which the individual first tested positive was marijuana and the confirmatory assay for delta-9- tetrahydrocannabinol-9-carboxylic acid yields a positive result, the MRO shall determine whether the confirmatory test result indicates further marijuana use since the first positive test result, or whether the test result is consistent with the level of delta-9- tetrahydrocannabinol-9-carboxylic acid that would be expected if no further marijuana use had occurred. If the test result indicates that no further marijuana use has occurred since the first positive test result, then the MRO shall declare the drug test result as negative.

(p) Time to complete MRO review. The MRO shall complete his or her review of non-negative test results and, in those instances in which the MRO determines that the donor has violated the licensee's or other entity's FFD policy, notify licensee or other entity's designated representative within 10 days of an initial non-negative test result. The MRO shall notify the licensee or other entity of the FFD policy violation in writing and in a manner designed to ensure the confidentiality of the information.

Sec. 26.187 Substance abuse expert.

(a) Implementation. By [insert date 2 years after publication of the final rule in the Federal Register], substance abuse experts (SAEs) upon whom licensees and other entities rely to make determinations of fitness under this part shall meet the requirements of this section.

(b) Credentials. An SAE shall have at least one of the following credentials:

(1) A licensed physician;

(2) A licensed or certified social worker;

(3) A licensed or certified psychologist;

(4) A licensed or certified employee assistance professional; or

(5) An alcohol and drug abuse counselor certified by the National Association of Alcoholism and Drug Abuse Counselors Certification Commission (NAADAC) or by the International Certification Reciprocity Consortium/Alcohol and Other Drug Abuse (ICRC).

(c) Basic knowledge. An SAE shall be knowledgeable in the following areas:

(1) Demonstrated knowledge of and clinical experience in the diagnosis and treatment of alcohol and controlled-substance abuse disorders;

(2) Knowledge of the SAE function as it relates to the public's interests in the job duties performed by individuals who are subject to this part; and

(3) Knowledge of this part and any changes thereto.

(d) Qualification training. SAEs shall receive qualification training on the following subjects:

(1) Background, rationale, and scope of this part;

(2) Key drug testing requirements of this part, including specimen collection, laboratory testing, MRO review, and problems in drug testing;

(3) Key alcohol testing requirements of this part, including specimen collection, the testing process, and problems in alcohol tests;

(4) SAE qualifications and prohibitions;

(5) The role of the SAE in making determinations of fitness and the return-to-duty process, including the initial evaluation, referrals for education and/or treatment, the followup evaluation, continuing treatment recommendations, and the followup testing plan;

(6) Procedures for SAE consultation and communication with licensees or other entities, MROs, and treatment providers;

(7) Reporting and recordkeeping requirements of this part; and

(8) Issues that SAEs confront in carrying out their duties under this part.

(e) Continuing education. During each 3-year period following completion of initial qualification training, the SAE shall complete continuing education consisting of at least 12 continuing professional education hours relevant to performing SAE functions.

(1) This continuing education must include material concerning new technologies, interpretations, recent guidance, rule changes, and other information about developments in SAE practice pertaining to this part, since the time the SAE met the qualification training requirements of this section.

(2) Continuing education activities must include documented assessment tools to assist in determining that the SAE has learned the material.

(f) Documentation. The SAE shall maintain documentation showing that he or she currently meets all requirements of this section. The SAE shall provide this documentation upon request to NRC representatives, licensees, or other entities who are relying upon or contemplating relying upon the SAE's services.

(g) Responsibilities and prohibitions. The SAE shall evaluate individuals who have violated the substance abuse provisions of an FFD policy and make recommendations concerning education, treatment, return to duty, followup drug and alcohol testing, and aftercare. The SAE is not an advocate for the licensee or other entity, or the individual. The SAE's function is to protect public health and safety and the common defense and security by professionally evaluating the individual and recommending appropriate education/treatment, follow-up tests, and aftercare.

(1) The SAE is authorized to make determinations of fitness in at least the following three circumstances:

(i) When potentially disqualifying FFD information has been identified regarding an individual who has applied for authorization under this part;

(ii) When an individual has violated the substance abuse provisions of a licensee's or other entity's FFD policy; and

(iii) When an individual may be impaired by alcohol, prescription or over-the-counter medications, or illegal drugs.

(2) Upon determining the best recommendation for assisting the individual, the SAE shall serve as a referral source to assist the individual's entry into an education and/or treatment program.

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(i) To prevent the appearance of a conflict of interest, the SAE may not refer an individual requiring assistance to his or her private practice or to a person or organization from whom the SAE receives payment or in which the SAE has a financial interest. The SAE is precluded from making referrals to entities with whom the SAE is financially associated.

(ii) There are four exceptions to the prohibitions contained in the preceding paragraph. The SAE may refer an individual to any of the following providers of assistance, regardless of his or her relationship with them:

(A) A public agency (e.g., treatment facility) operated by a state, county, or municipality;

(B) A person or organization under contract to the licensee or other entity to provide alcohol or drug treatment and/or education services (e.g., the licensee's or other entity's contracted treatment provider);

(C) The sole source of therapeutically appropriate treatment under the individual's health insurance program (e.g., the single substance abuse in-patient treatment program made available by the individuals' insurance coverage plan); or

(D) The sole source of therapeutically appropriate treatment reasonably available to the individual (e.g., the only treatment facility or education program reasonably located within the general commuting area).

Sec. 26.189 Determination of fitness.

(a) A determination of fitness is the process whereby it is determined 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. A determination of fitness must be made by a licensed or certified professional who is appropriately qualified and has the necessary clinical expertise, as verified by the licensee or other entity, to evaluate the specific fitness issues presented by the individual. A professional called upon by the licensee or other entity may not perform a determination of fitness regarding fitness issues that are outside of his or her specific areas of expertise. The types of professionals and the fitness issues for which they are qualified to make determinations of fitness include, but are not limited to, the following:

(1) An SAE who meets the requirements of Sec. 26.187 may determine the fitness of an individual who may have engaged in substance abuse and shall determine an individual's fitness to be granted authorization following an unfavorable termination or denial of authorization under this part, but may not be qualified to assess the fitness of an individual who may have experienced mental illness, significant emotional stress, or other mental or physical conditions that may cause impairment but are unrelated to substance abuse, unless the SAE has additional qualifications for addressing those fitness issues;

(2) A clinical psychologist may determine the fitness of an individual who may have experienced mental illness, significant emotional stress, or cognitive or psychological impairment from causes unrelated to substance abuse, but may not be qualified to assess the fitness of an individual who may have a substance abuse disorder, unless the psychologist is also an SAE;

(3) A psychiatrist may determine the fitness of an individual who is taking psychoactive medications in accordance with one or more valid prescription(s), but may not be qualified to assess potential impairment attributable to substance abuse, unless the psychiatrist has had specific training to diagnose and treat substance abuse disorders;

(4) A physician may determine the fitness of an individual who may be ill, injured, fatigued, taking medications in accordance with one or more valid prescriptions, or using over-the-counter medications, but may not be qualified to assess the fitness of an individual who may have a substance abuse disorder, unless the physician is also an SAE; and

(5) As a physician with specialized training, the MRO may determine the fitness of an individual who may have engaged in substance abuse or may be ill, injured, fatigued, taking medications in accordance with one or more valid prescriptions, and/or using over-the-counter medications, but may not be qualified to assess an individual's fitness to be granted authorization following an unfavorable termination or denial of authorization under this part, unless the MRO is also an SAE.

(b) A determination of fitness must be made in at least the following circumstances:

(1) When there is an acceptable medical explanation for a non- negative test result, but there is a basis for believing that the individual could be impaired while on duty;

(2) Before making return-to-duty recommendations after an individual's authorization has been terminated unfavorably or denied in accordance with a licensee's or other entity's FFD policy;

(3) Before an individual is granted authorization when potentially disqualifying FFD information is identified and has not previously been evaluated by another licensee or entity who is subject to this part; and

(4) When potentially disqualifying FFD information is otherwise identified and the licensee's or other entity's reviewing official concludes that a determination of fitness is warranted under Sec. 26.69.

(c) A determination of fitness that is conducted ``for cause'' must be conducted through face-to-face interaction between the subject individual and the professional making the determination. Electronic means of communication may not be used.

(1) If there is neither conclusive evidence of an FFD policy violation nor a significant basis for concern that the individual may be impaired while on duty, then the individual must be determined to be fit for duty.

(2) If there is no conclusive evidence of an FFD policy violation but there is a significant basis for concern that the individual may be impaired while on duty, then the subject individual must be determined to be unfit for duty. This result does not constitute a violation of this part nor of the licensee's or other entity's FFD policy, and no sanctions may be imposed. However, the professional who made the determination of fitness shall consult with the licensee's or other entity's management personnel to identify the actions required to ensure that any possible limiting condition does not represent a threat to workplace or public health and safety. Licensee or other entity management personnel shall implement the required actions. When appropriate, the subject individual may also be referred to the EAP.

(d) Neither the individual nor licensees and other entities may seek a second determination of fitness if a determination of fitness under this part has already been performed by a qualified professional employed by or under contract to the licensee or other entity. After the initial determination of fitness has been made, the professional may modify his or her evaluation and recommendations based on new or additional information from other sources including, but not limited to, the subject individual, another licensee or entity, or staff of an education or treatment program. Unless the professional who made the initial determination of fitness is no longer employed by or under contract to the licensee or other entity, only that professional is authorized to modify the evaluation and recommendations. When reasonably practicable, licensees and other entities shall assist in arranging for consultation between the new

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professional and the professional who is no longer employed by or under contract to the licensee or other entity, to ensure continuity and consistency in the recommendations and their implementation.

Subpart I--Managing Fatigue

Sec. 26.195 Applicability.

The requirements in this subpart apply only to the licensees and other entities identified in Sec. 26.3(a) and (d).

Sec. 26.197 General provisions.

(a) Policy. Licensees shall establish a policy for the management of fatigue and incorporate it into the written policy required in Sec. 26.27(b).

(b) Procedures. In addition to the procedures required in Sec. 26.27(c), licensees shall develop, implement, and maintain procedures that--

(1) Describe the process to be followed when any individual who is subject to an FFD program under Sec. 26.25(a)(1) or (2) makes a self- declaration that he or she is not fit to safely and competently perform his or her duties for any part of a working tour as a result of fatigue. The procedure must--

(i) Describe the individual's and licensee's responsibilities related to self-declaration;

(ii) Describe requirements for establishing controls and conditions under which an individual may be permitted or required to perform work after that individual declares that he or she is not fit due to fatigue; and

(iii) Describe the process to be followed if the individual disagrees with the results of a fatigue assessment that is required under Sec. 26.201(a)(2);

(2) Describe the process for implementing the work hour controls required under Sec. 26.199 for the individuals who are performing the duties listed in Sec. 26.199(a);

(3) Describe the process to be followed in conducting fatigue assessments under Sec. 26.201; and

(4) Describe the sanctions, if any, that the licensee may impose on an individual following a fatigue assessment.

(c) Training and examinations. Licensees shall add the following KAs to the content of the training that is required in Sec. 26.29(a) and the comprehensive examination required in Sec. 26.29(b):

(1) Knowledge of the contributors to worker fatigue, circadian variations in alertness and performance, indications and risk factors for common sleep disorders, shiftwork strategies for obtaining adequate rest, and the effective use of fatigue countermeasures; and

(2) Ability to identify symptoms of worker fatigue and contributors to decreased alertness in the workplace.

(d) Recordkeeping. Licensees shall retain the following records for at least 3 years or until the completion of all related legal proceedings, whichever is later:

(1) Records of work hours for individuals who are subject to the work hour controls in Sec. 26.199;

(2) The documentation of waivers that is required in Sec. 26.199(d)(3)(iv), including the bases for granting the waivers;

(3) The documentation of work hour reviews that is required in Sec. 26.199(j)(3);

(4) The documentation of fatigue assessments that is required in Sec. 26.201(g); and

(5) Documentation of the collective work hours of each job duty group, as calculated in accordance with Sec. 26.199(b)(2).

(e) Reporting. Licensees shall include the following information in the annual FFD program performance report required under Sec. 26.217:

(1) A summary of the number of instances during the previous calendar year in which the licensee waived any of the work hour controls specified in Sec. 26.199(d)(1) and (d)(2) for individuals within each job duty group in Sec. 26.199(a). The report must include--

(i) Only those waivers under which work was performed; and

(ii) Each work hour control that was waived in Sec. 26.199(d)(1) and (d)(2), including all of the work hour controls that were waived for any single extended work period for which it was necessary to waive more than one work hour control;

(2) The collective work hours of any job duty group listed in Sec. 26.199(a) that exceeded an average of 48 hours per person per week in any averaging period during the previous calendar year, in accordance with Sec. 26.199(f)(3) and (f)(5). The report must also include--

(i) The dates that defined the averaging period(s) during which collective work hours exceeded 48 hours per person per week;

(ii) The job duty group that exceeded the collective work hours limit; and

(iii) The conditions that caused the job duty group's collective work hours to exceed the collective work hours limit; and

(3) The number of fatigue assessments conducted during the previous calendar year, the conditions under which each fatigue assessment was conducted (i.e., self-declaration, for cause, post-event, followup), and the management actions, if any, resulting from each fatigue assessment.

Sec. 26.199 Work hour controls.

(a) Individuals subject to work hour controls. Any individual who performs duties within the following job duty groups is subject to the requirements of this section:

(1) Operating or on-site directing of the operation of systems and components that a risk-informed evaluation process has shown to be significant to public health and safety;

(2) Performing maintenance or on-site directing of the maintenance of structures, systems, and components that a risk-informed evaluation process has shown to be significant to public health and safety;

(3) Performing Health Physics or Chemistry duties required as a member of the on-site emergency response organization minimum shift complement;

(4) Performing the duties of a Fire Brigade member who is responsible for understanding the effects of fire and fire suppressants on safe shutdown capability; and

(5) Performing security duties as an armed security force officer, alarm station operator, response team leader, or watchperson, hereinafter referred to as security personnel.

(b) Calculating work hours. (1) Individual work hours. For the purposes of this subpart, licensees shall calculate an individual's work hours as the amount of time that an individual performs any duties for a licensee who is subject to this subpart, including all within- shift break times and rest periods during which there are no reasonable opportunities or accommodations appropriate for restorative sleep, but excluding shift turnover.

(i) Shift turnover includes only those activities that are necessary to safely transfer information and responsibilities between two or more individuals between shifts. Shift turnover activities may include, but are not limited to, discussions of the status of plant equipment, and the status of ongoing activities, such as extended tests of safety systems and components. Licensees may not exclude work hours worked during turnovers between individuals within a shift period due to rotations or relief within a shift. Activities that licensees may not exclude from work hours calculations also include, but are not limited to, shift holdovers to cover for late arrivals of incoming shift members; early arrivals of individuals for meetings, training, or pre-shift briefings for special evolutions;

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and holdovers for interviews needed for event investigations.

(ii) Other than shift turnover, only that portion of a break or rest period during which there is a reasonable opportunity and accommodations for restorative sleep may be excluded from the licensee's calculation of an individual's work hours.

(iii) Licensees need not calculate the work hours of an individual who is qualified to perform the job duties listed in paragraph (a) of this section but has not performed such duties during the applicable calculation period. However, if the individual begins or resumes performing any of the job duties listed in paragraph (a) of this section, the licensee shall include in the calculation of the individual's work hours all work hours worked, including hours worked performing duties that are not listed in paragraph (a) of this section, and control the individual's work hours in accordance with the requirements of paragraph (d) of this section.

(2) Collective work hours. For the purposes of this subpart, licensees shall calculate collective work hours as the average number of work hours worked among each group of individuals who perform the duties listed in paragraph (a) of this section, within an averaging period that may not exceed 13 weeks, as follows:

(i) Licensees may define broad job duty groups comprised of individuals who perform the job duties listed in paragraph (a) of this section, or may define smaller groups of individuals who perform similar duties. The groups must collectively include all individuals who perform the job duties listed in paragraph (a) of this section;

(ii) Licensees shall include in the average for each job duty group the work hours of any individual who performs the job duties of the group at the licensee's site, except if, during the averaging period the individual worked less than 75 percent of the group's normally scheduled hours;

(iii) The days included in an averaging period must be consecutive or separated only by days that licensees are permitted to exclude from the collective work hour calculation under Sec. 26.199(f)(1) through (f)(3) and (f)(5), (h), and (i);

(iv) Licensees shall include within an averaging period all days that are not excluded from collective work hour controls under Sec. 26.199(f)(1) through (f)(3) and (f)(5), (h), and (i); and

(v) Licensees may not include in the collective work hour calculation for an averaging period any work hours that are included in a collective work hour calculation for any other averaging period.

(c) Work hours scheduling. Licensees shall schedule the work hours of individuals who are subject to this section consistent with the objective of preventing impairment from fatigue due to the duration, frequency, or sequencing of successive shifts.

(d) Work hour controls for individuals. Licensees shall control the work hours of individuals, as follows:

(1) Except as permitted under paragraph (d)(3) of this section, licensees shall ensure that any individual's work hours do not exceed the following limits:

(i) 16 work hours in any 24-hour period;

(ii) 26 work hours in any 48-hour period; and

(iii) 72 work hours in any 7-day period.

(2) Licensees shall ensure that individuals have adequate rest breaks. For the purposes of this subpart, a break is defined as an interval of time that falls between successive work periods, during which the individual does not perform any duties for the licensee other than shift turnover. At a minimum, licensees shall ensure that individuals who are subject to this section have the following breaks:

(i) A 10-hour break between successive work periods or an 8-hour break between successive work periods when a break of less than 10 hours is necessary to accommodate a crew's scheduled transition between work schedules or shifts;

(ii) A 24-hour break in any 7-day period; and

(iii) A 48-hour break in any 14-day period, except during the first 14 days of any plant outage if the individual is performing the job duties listed in paragraph (a)(1) through (a)(4) of this section.

(3) Licensees may grant a waiver of the individual work hour controls in paragraphs (d)(1) and (d)(2) of this section, as follows:

(i) In order to grant a waiver, the licensee shall meet both of the following requirements:

(A) An operations shift manager determines that the waiver is necessary to mitigate or prevent a condition adverse to safety, or a security shift manager determines that the waiver is necessary to maintain the security of the facility, or a site senior-level manager with requisite signature authority makes either determination; and

(B) A supervisor, who is qualified to direct the work to be performed by the individual and trained in accordance with the requirements of Sec. Sec. 26.29 and 26.197(c), assesses the individual face to face and determines that there is reasonable assurance that the individual will be able to safely and competently perform his or her duties during the additional work period for which the waiver will be granted. At a minimum, the assessment must address the potential for acute and cumulative fatigue considering the individual's work history for at least the past 14 days, the potential for circadian degradations in alertness and performance considering the time of day for which the waiver will be granted, the potential for fatigue-related degradations in alertness and performance to affect risk-significant functions, and whether any controls and conditions must be established under which the individual will be permitted to perform work;

(ii) To the extent practicable, licensees shall rely upon the granting of waivers only to address circumstances that could not have been reasonably controlled;

(iii) Licensees shall ensure that the timing of the face-to-face supervisory assessment that is required in paragraph (d)(3)(i)(B) of this section supports a valid assessment of the potential for worker fatigue during the time the individual will be performing work under the waiver. Licensees may not perform the face-to-face assessment more than four hours before the individual begins performing any work under the waiver; and

(iv) Licensees shall document the bases for individual waivers. The documented basis for a waiver must include a description of the circumstances that necessitate the waiver, a statement of the scope of work and time period for which the waiver is approved, and the bases for the determinations required in paragraph (d)(3)(i) of this section.

(e) Self-declarations during extended work hours. If an individual is performing, or being assessed for, work under a waiver of the requirements contained in paragraphs (d)(1) and (d)(2) of this section and declares that, due to fatigue, he or she is unable to safely and competently perform his or her duties, the licensee shall immediately stop the individual from performing any duties listed in paragraph (a) of this section, except if the individual is required to continue performing those duties under other requirements of this chapter. If the subject individual must continue performing the duties listed in paragraph (a) of this section until relieved, the licensee shall immediately take action to relieve the individual. Following the self- declaration or relief

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from performing the duties listed in paragraph (a) of this section, as applicable, the licensee--

(1) May reassign the individual to duties other than those listed in paragraph (a) of this section, but only if the results of a fatigue assessment, conducted in accordance with the requirements of Sec. 26.201, indicate that the individual is fit to safely and competently perform those other duties; and

(2) Shall permit or require the individual to take a rest break of at least 10 hours before the individual returns to performing any duties listed in paragraph (a) of this section.

(f) Collective work hour limits. In addition to controlling individuals' work hours in accordance with paragraph (d) of this section, licensees shall control the collective work hours of each group of individuals who are performing similar job duties, as listed in paragraph (a) of this section. Licensees shall ensure that the collective work hours of each job duty group do not exceed an average of 48 hours per person per week in any averaging period, except as follows:

(1) The licensee need not impose the collective work hour controls required in this paragraph on the job duty groups specified in paragraphs (a)(1) through (a)(4) of this section during the first 8 weeks of a plant outage;

(2) For job duty groups comprised of security personnel--

(i) The group work hour average(s) may not exceed 60 hours per person per week during the first 8 weeks of a plant outage or a planned security system outage;

(ii) The group work hour average(s) may not exceed 60 hours per person per week during the actual conduct of force-on-force tactical exercises (i.e., licensee exercises and NRC-observed exercises);

(iii) The licensee need not impose any collective work hour controls for the first 8 weeks of an unplanned security system outage or an increased threat condition;

(iv) If an increase in threat condition occurs while the site is in any plant outage or a planned security system outage and the increased threat condition persists for a period of 8 weeks or less, the licensee need not impose collective work hour controls on security personnel for the duration of the increased threat condition. However, if during any such outage, the threat condition returns to the least significant threat condition that was in effect at any time within the past 8 weeks, then the licensee shall limit the collective work hours of security personnel to an average of 60 hours per person per week for the first 8 weeks of the outage for the periods prior to and following the increased threat condition, and shall limit the collective work hours of security personnel to an average of 48 hours per person per week following the first 8 weeks of the outage;

(v) If additional increases in threat condition occur during an unplanned security system outage or increased threat condition, the relaxation of the collective work hour limits that is permitted in paragraph (f)(2)(iii) of this section may be extended with each increase in the threat condition, but only for a period that is the shorter of either the duration of the increased threat condition or 8 weeks;

(vi) If the threat condition decreases during an unplanned security system outage or increased threat condition, the applicability of the relaxation of the collective work hour limits that is permitted in paragraph (f)(2)(iii) of this section must based upon the date upon which the current threat condition was last entered as a result of an increase;

(3) The collective work hours of any job duty group listed in paragraph (a) of this section may exceed an average of 48 hours per person per week in one averaging period if all of the following conditions are met:

(i) The circumstances that cause the group's collective work hours to exceed 48 hours per person per week cannot be reasonably controlled;

(ii) The group's collective work hours do not exceed 54 hours per person per week; and

(iii) The additional work hours that result in the group's collective work hours exceeding 48 hours per person per week are worked only to address the circumstances that the licensee could not have reasonably controlled.

(4) The collective work hours of any job duty group may not exceed 48 hours per person per week if the collective work hours for the job duty group exceeded 48 hours per person per week--

(i) In the previous averaging period; or

(ii) In any other averaging period that ended within the past 26 weeks.

(5) Licensees may also exceed any collective work hour limits in this paragraph if the licensee has received prior approval from the NRC of a written request that includes, at a minimum,--

(i) A description of the specific circumstances that require the licensee to exceed the applicable collective work hour limit, the job duty group(s) affected, and the collective work hours limit(s) to be exceeded;

(ii) A statement of the period of time during which it will be necessary to exceed the collective work hour limit(s); and

(iii) A description of the fatigue mitigation strategies, including, but not limited to, rest break requirements and work hour limits, that the licensee will implement to ensure that the individuals affected will be fit to safely and competently perform their duties.

(g) Successive plant outages. If two or more plant outages occur at the licensee's site and the interval(s) between successive outages is less than 2 weeks, the licensee shall apply the requirements in paragraphs (d)(2)(iii), (f)(1), (f)(2)(i), and (f)(2)(iv) of this section based upon the number of days that have elapsed since the first plant outage in the series began.

(h) Common defense and security. Licensees need not meet the requirements of this section when informed in writing by the NRC that these requirements, or any subset thereof, are waived for security personnel in order to assure the common defense and security, for the duration of the period defined by the NRC.

(i) Plant emergencies. Licensees need not meet the requirements of paragraphs (c) through (f) of this section during declared emergencies, as defined in the licensee's emergency plan.

(j) Reviews. Licensees shall review the control of work hours for individuals who are subject to this subpart for each averaging period. Licensees shall complete this review within 30 days of the end of the averaging period. If any outages or increased threat conditions occurred since the licensee completed the most recent review, the licensee shall include in the review an assessment of the control of work hours during the outages or increased threat conditions. Licensees shall--

(1) Review the work hours and performance of individuals to assess the effectiveness of the licensee's work hour controls in achieving the objective of reasonable assurance that fatigue due to work hours does not compromise individuals' abilities to safely and competently perform their duties. At a minimum, the licensee's review must address--

(i) Individuals who were granted more than one waiver during the review period;

(ii) Individuals who were assessed for fatigue in accordance with Sec. 26.201 during the review period;

(iii) Individuals who performed the job duties listed in paragraph (a) of this section whose average work hours per week exceeded 54 hours during any averaging period for which the

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collective work hour limit is 48 hours in this section; and

(iv) Any security personnel whose average work hours per week exceeded 66 hours in any averaging periods for which the collective work hours limit in this section is 60 hours per person per week;

(2) Review individuals' hours worked and the waivers under which work was performed to assess staffing adequacy for all jobs subject to the work hour controls of this section;

(3) Document the methods used to conduct these reviews and the results of the reviews; and

(4) Record, trend, and correct, under the licensee's corrective action program, any problems identified in maintaining control of work hours consistent with the specific requirements and performance objectives of this part.

Sec. 26.201 Fatigue assessments.

(a) Licensees shall ensure that fatigue assessments are conducted under the following conditions:

(1) For-cause. In addition to any other test or determination of fitness that may be required under Sec. Sec. 26.31(c) and 26.77, a fatigue assessment must be conducted in response to an observed condition of impaired individual alertness creating a reasonable suspicion that an individual is not fit to safely and competently perform his or her duties, except if the condition is observed during an individual's break period. If the observed condition is impaired alertness with no other behaviors or physical conditions creating a reasonable suspicion of possible substance abuse, then the licensee need only conduct a fatigue assessment. If the licensee has reason to believe that the observed condition is not due to fatigue, the licensee need not conduct a fatigue assessment;

(2) Self-declaration. A fatigue assessment must be conducted in response to an individual's self-declaration to his or her supervisor that he or she is not fit to safely and competently perform his or her duties for any part of a working tour because of fatigue, except if, following the self-declaration, the licensee permits or requires the individual to take a rest break of at least 10 hours before the individual returns to duty;

(3) Post-event. A fatigue assessment must be conducted in response to events requiring post-event drug and alcohol testing as specified in Sec. 26.31(c). Licensees may not delay necessary medical treatment in order to conduct a fatigue assessment; and

(4) Followup. If a fatigue assessment was conducted for cause or in response to a self-declaration, and the licensee returns the individual to duty following a rest break of less than 10 hours in duration, the licensee shall reassess the individual for fatigue as well as the need to implement controls and conditions before permitting the individual to resume performing any job duties.

(b) Either a supervisor or a staff member of the FFD program, who is trained in accordance with the requirements of Sec. 26.29 and Sec. 26.197(c), shall conduct the fatigue assessment face to face with the individual whose alertness may be impaired.

(1) In the case of a fatigue assessment conducted for cause, the individual who observed the condition of impaired alertness may not conduct the fatigue assessment.

(2) In the case of a post-event fatigue assessment, the individual who conducts the fatigue assessment may not have--

(i) Performed or directed the work activities during which the event occurred;

(ii) Performed, within 24 hours before the event occurred, a fatigue assessment of the individuals who were performing or directing the work activities during which the event occurred; and

(iii) Evaluated or approved a waiver of the limits specified in Sec. 26.199(d)(1) and (2) for any of the individuals who were performing or directing the work activities during which the event occurred, if the event occurred while such individuals were performing work under that waiver.

(c) A fatigue assessment must provide the information necessary for management decisions and actions in response to the circumstance that initiated the assessment.

(1) At a minimum, the fatigue assessment must address the following factors:

(i) Acute fatigue;

(ii) Cumulative fatigue; and

(iii) Circadian variations in alertness and performance.

(2) Individuals shall provide complete and accurate information that may be required by the licensee to address the factors listed in paragraph (c)(1) of this section. Licensees shall limit any inquiries to obtaining from the subject individual only the personal information that may be necessary to assess the factors listed in paragraph (c)(1) of this section.

(d) The licensee may not conclude that fatigue had not or will not degrade the individual's ability to safely and competently perform his or her duties solely on the basis that the individual's work hours have not exceeded any of the limits specified in Sec. 26.199(d)(1) or that the individual has had the minimum rest breaks required in Sec. 26.199(d)(2), as applicable.

(e) Following a fatigue assessment, the licensee shall determine and implement the controls and conditions, if any, that are necessary to permit the individual to resume performing duties for the licensee, including the need for a rest break.

(f) Licensees shall document the results of any fatigue assessments conducted, the circumstances that necessitated the fatigue assessment, and any controls and conditions that were implemented.

Subpart J--Recordkeeping and Reporting Requirements

Sec. 26.211 General provisions.

(a) Each licensee and other entity who is subject to this part shall maintain records and submit certain reports to the NRC. Records that are required by the regulations in this part must be retained for the period specified by the appropriate regulation. If a retention period is not otherwise specified, these records must be retained until the Commission terminates the facility's license, certificate, or other regulatory approval.

(b) All records may be stored and archived electronically, provided that the method used to create the electronic records meets the following criteria:

(1) Provides an accurate representation of the original records;

(2) Prevents the alteration of any archived information and/or data once it has been committed to storage; and

(3) Permits easy retrieval and re-creation of the original records.

Sec. 26.213 Recordkeeping requirements for licensees and other entities.

(a) Each licensee and other entity who is subject to this part shall retain the following records for at least 5 years after the licensee or other entity terminates or denies an individual's authorization or until the completion of all related legal proceedings, whichever is later:

(1) Records of self-disclosures, employment histories, and suitable inquiries that are required under Sec. Sec. 26.55, 26.57, 26.59, and 26.69 that result in the granting of authorization;

(2) Records pertaining to the determination of a violation of the FFD policy and related management actions;

(3) Documentation of the granting and termination of authorization; and

(4) Records of any determinations of fitness conducted under Sec. 26.189.

(b) Each licensee and other entity who is subject to this part shall retain the

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following records for at least 3 years or until the completion of all related legal proceedings, whichever is later:

(1) Records of FFD training and examinations conducted under Sec. 26.29; and

(2) Records of audits, audit findings, and corrective actions taken under Sec. 26.41.

(c) Licensees and other entities shall ensure the retention and availability of records pertaining to any 5-year denial of authorization under Sec. 26.75(c), (d), or (e)(2) and any permanent denial of authorization under Sec. 26.75(b) and (g) for at least 40 years or until, upon application, the NRC determines that the records are no longer needed.

(d) Licensees and other entities shall retain any superseded versions of the written FFD policy and procedures required under Sec. Sec. 26.27, 26.39, and 26.197(b) for at least 5 years or until completion of all legal proceedings related to an FFD violation that may have occurred under the policy and procedures, whichever is later.

(e) Licensees and other entities shall retain written agreements for the provision of services under this part for the life of the agreement or until completion of all legal proceedings related to an FFD policy violation that involved those services, whichever is later.

(f) Licensees and other entities shall retain records of the background investigations, credit and criminal history checks, and psychological assessments of FFD program personnel, conducted under Sec. 26.31(b)(1)(ii), for the length of the individual's employment by or contractual relationship with the licensee or other entity, or until the completion of all related legal proceedings, whichever is later.

(g) If a licensee's or other entity's FFD program includes tests for drugs in addition to those specified in this part, as permitted under Sec. 26.31(d)(1), or uses more stringent cutoff levels than those specified in this part, as permitted under Sec. 26.31(d)(3), the licensee or other entity shall retain documentation certifying the scientific and technical suitability of the assays and cutoff levels used, as required under Sec. 26.31(d)(1)(i) and (d)(3)(iii)(C), respectively, for the period of time during which the FFD program follows these practices or until the completion of all related legal proceedings, whichever is later.

Sec. 26.215 Recordkeeping requirements for collection sites, licensee testing facilities, and laboratories certified by the Department of Health and Human Services.

(a) Collection sites providing services to licensees and other entities, licensee testing facilities, and HHS-certified laboratories shall maintain and make available documentation of all aspects of the testing process for at least 2 years or until the completion of all legal proceedings related to a determination of an FFD violation, whichever is later. This 2-year period may be extended upon written notification by the NRC or by any licensee or other entity for whom services are being provided.

(b) Documentation that must be retained includes, but is not limited to, the following:

(1) Personnel files, including training records, for all individuals who have been authorized to have access to specimens, but are no longer under contract to or employed by the collection site, licensee testing facility, or HHS-certified laboratory;

(2) Chain-of-custody documents (other than forms recording specimens with negative test results and no FFD violations or anomalies, which may be destroyed after appropriate summary information has been recorded for program administration purposes);

(3) Quality assurance and quality control records;

(4) Superseded procedures;

(5) All test data (including calibration curves and any calculations used in determining test results);

(6) Test reports;

(7) Records pertaining to performance testing;

(8) Records pertaining to the investigation of testing errors or unsatisfactory performance discovered in blind performance testing, in the testing of actual specimens, or through the processing of appeals and MRO reviews, as well as any other errors or matters that could adversely reflect on the integrity of the testing process, investigation findings, and corrective actions taken, where applicable;

(9) Performance records on certification inspections;

(10) Records of preventative maintenance on licensee testing facility instruments;

(11) Records that summarize any test results that the MRO determined to be scientifically insufficient for further action;

(12) Either printed or electronic copies of computer-generated data;

(13) Records that document the dates, times of entry and exit, escorts, and purposes of entry of authorized visitors, maintenance personnel, and service personnel who have accessed secured areas of licensee testing facilities and HHS-certified laboratories; and

(14) Records of the inspection, maintenance, and calibration of EBTs.

Sec. 26.217 Fitness-for-duty program performance data.

(a) Licensees and other entities shall collect and compile FFD program performance data for each FFD program that is subject to this part.

(b) The FFD program performance data must include the following information:

(1) The random testing rate;

(2) Drugs for which testing is conducted and cutoff levels, including results of tests using lower cutoff levels and tests for drugs not included in the HHS panel;

(3) Populations tested (i.e., individuals in applicant status, permanent licensee employees, C/Vs);

(4) Number of tests administered and results of those tests sorted by population tested (i.e., individuals in applicant status, permanent licensee employees, C/Vs);

(5) Conditions under which the tests were performed, as defined in Sec. 26.31(c);

(6) Substances identified;

(7) Number of subversion attempts by type; and

(8) Summary of management actions.

(c) Licensees and other entities who have a licensee-approved FFD program shall analyze the data at least annually and take appropriate actions to correct any identified program weaknesses. Records of the data, analyses, and corrective actions taken must be retained for at least 3 years or until the completion of any related legal proceedings, whichever is later.

(d) Any licensee or other entity who terminates an individual's authorization or takes administrative action on the basis of the results of a positive initial drug test for marijuana or cocaine shall also report these test results in the annual summary by processing stage (i.e., initial testing at the licensee testing facility, testing at the HHS-certified laboratory, and MRO determinations). The report must also include the number of terminations and administrative actions taken against individuals for the reporting period.

(e) Licensees and other entities shall submit the FFD program performance data (for January through December) to the NRC annually, before March 1 of the following year.

(f) Licensees and other entities may submit the FFD program performance data in a consolidated report, as long as the report presents the data separately for each site.

(g) Each C/V who maintains a licensee-approved drug and alcohol testing program is subject to the reporting requirements of this section and shall submit the required

[[Page 50671]]

information either directly to the NRC or through the licensee(s) or other entities to whom the C/V provided services during the year. Licensees, other entities, and C/Vs shall share information to ensure that the information is reported completely and is not duplicated in reports submitted to the NRC.

Sec. 26.219 Reporting requirements.

(a) Required reports. Each licensee and entity who is subject to this part shall inform the NRC of significant violations of the FFD policy, significant FFD program failures, and errors in drug and alcohol testing. These events must be reported under this section, rather than under the provisions of 10 CFR 73.71.

(b) Significant FFD policy violations or programmatic failures. The following significant FFD policy violations and programmatic failures must be reported to the NRC Operations Center by telephone within 24 hours after the licensee or other entity discovers the violation:

(1) The use, sale, distribution, possession, or presence of illegal drugs, or the consumption or presence of alcohol within a protected area;

(2) Any acts by any person licensed under 10 CFR Parts 52 and/or 55 to operate a power reactor, as well as any acts by SSNM transporters, FFD program personnel, or any supervisory personnel who are authorized under this part, if such acts--

(i) Involve the use, sale, or possession of a controlled substance;

(ii) Result in a determination that the individual has violated the licensee's or other entity's FFD policy (including subversion as defined in Sec. 26.5); or

(iii) Involve the consumption of alcohol within a protected area or while performing the job duties that require the individual to be subject to this part;

(3) Any intentional act that casts doubt on the integrity of the FFD program; and

(4) Any programmatic failure, degradation, or discovered vulnerability of the FFD program that may permit undetected drug or alcohol use or abuse by individuals within a protected area, or by individuals who are assigned to perform job duties that require them to be subject to this part.

(c) Drug and alcohol testing errors. (1) Within 30 days of completing an investigation of any testing errors or unsatisfactory performance discovered in blind performance testing at either a licensee testing facility or an HHS-certified laboratory, in the testing of actual specimens, or through the processing of reviews under Sec. 26.39 and MRO reviews under Sec. 26.185, as well as any other errors or matters that could adversely reflect on the integrity of the random selection or testing process, the licensee or other entity shall submit to the NRC a report of the incident and corrective actions taken or planned. If the error involves an HHS-certified laboratory, the NRC shall ensure that HHS is notified of the finding.

(2) Should a false positive error occur on a blind performance test sample submitted to an HHS-certified laboratory, the licensee or other entity shall notify the NRC within 24 hours after discovery of the error.

(3) Should a false negative error occur on a quality assurance check of validity screening devices, as required in Sec. 26.137(b)(2) and (3), the licensee or other entity shall notify the NRC within 24 hours after discovery of the error.

(d) Indicators of programmatic weaknesses. Licensees and other entities shall document, trend, and correct non-reportable indicators of FFD programmatic weaknesses under the licensee's or other entity's corrective action program, but may not track or trend drug and alcohol test results in a manner that would permit the identification of any individuals.

Subpart K--Inspections, Violations, and Penalties

Sec. 26.221 Inspections.

(a) Each licensee and other entity who is subject to this part shall permit duly authorized NRC representatives to inspect, copy, or take away copies of its records and to inspect its premises, activities, and personnel as may be necessary to accomplish the purposes of this part.

(b) Written agreements between licensees or other entities and their C/Vs must clearly show that--

(1) The licensee or other entity is responsible to the NRC for maintaining an effective FFD program in accordance with this part; and

(2) Duly authorized NRC representatives may inspect, copy, or take away copies of any licensee's, other entity's, or C/V's documents, records, and reports related to implementation of the licensee's or other entity's FFD program under the scope of the contracted activities.

Sec. 26.223 Violations.

(a) An injunction or other court order may be obtained to prohibit a violation of any provision of--

(1) The Atomic Energy Act of 1954, as amended;

(2) Title II of the Energy Reorganization Act of 1974; or

(3) Any regulation or order issued under these Acts.

(b) A court order may be obtained for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act of 1954, for violations of--

(1) Section 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Act;

(2) Section 206 of the Energy Reorganization Act of 1974;

(3) Any rule, regulation, or order issued under these sections;

(4) Any term, condition, or limitation of any license issued under these sections; or

(5) Any provisions for which a license may be revoked under section 186 of the Atomic Energy Act of 1954.

Sec. 26.225 Criminal penalties.

(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all of the regulations in Part 26 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.

(b) The regulations in Part 26 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: Sec. Sec. 26.1, 26.3, 26.5, 26.7, 26.8, 26.9, 26.11, 26.51, 26.81, 26.121, 26.151, 26.181, 26.195, 26.223, and 26.225.

Dated at Rockville, Maryland, this 2nd day of August 2005.

For the Nuclear Regulatory Commission. Annette Vietti-Cook, Secretary of the Commission.

Appendix--Tables 1 and 2

Note: This appendix will not appear in The Code of Federal Regulations.

Note: The Proposed Rule constitutes a complete revision of Part 26. Substantial changes frequently have been made between the new section in the proposed rule and the derivation listed in Table 1.

[[Page 50672]]

Table 1.--Derivation Table for Part 26

New section

Based on

26.1................................... 26.1 first sentence. 26.3(a)................................ 26.2(a). 26.3(b)................................ 26.1 (2nd sentence) and 26.2(a) (1st sentence). 26.3(c)................................ 26.2(d). 26.3(d)................................ 26.23(a)(1). 26.3(e)................................ 26.2(c). 26.3(f)................................ 26.2(b). 26.5................................... 26.3 and Appendix A Subpart 1.2. 26.7................................... 26.4. 26.8................................... 26.8. 26.9................................... 26.6. 26.11.................................. NEW. 26.21.................................. 26.23(b). 26.23(a)............................... 26.10(a). 26.23(b)............................... 26.10(a). 26.23(c)............................... 26.10(b). 26.23(d)............................... 26.10(c). 26.23(e)............................... NEW. 26.25(a)(1)............................ 26.2(a) and 26.2(d). 26.25(a)(2)............................ 26.2(a) and 26.2(d). 26.25(a)(3)............................ 26.2(a) and 26.2(d). 26.25(a)(4)............................ NEW. 26.25(b)(1)............................ NEW. 26.25(b)(2)............................ 26.2(b). 26.25(b)(3)............................ 26.2(b). 26.25(c)............................... NEW. 26.25(d)............................... NEW. 26.27(a)............................... 26.20 1st paragraph. 26.27(b)(1)............................ 26.20(a). 26.27(b)(2)............................ NEW. 26.27(b)(3)............................ NEW. 26.27(b)(4)(i)......................... 26.20(a)(1). 26.27(b)(4)(ii)........................ 26.20(a)(2). 26.27(b)(5)............................ NEW. 26.27(b)(6)............................ 26.20(a). 26.27(b)(7)............................ 26.20(b). 26.27(b)(8)............................ 26.20(d). 26.27(b)(9)............................ NEW. 26.27(b)(10)........................... NEW. 26.27(b)(11)........................... NEW. 26.27(c)............................... 26.20(d). 26.29.................................. 26.21. 26.31.................................. 26.24. 26.33.................................. 26.22. 26.35.................................. 26.25. 26.37.................................. 26.29. 26.39.................................. 26.27. 26.41.................................. 26.80. 26.51.................................. 26.1. 26.53.................................. NEW. 26.55(a)............................... 26.27(a). 26.55(b)............................... NEW. 26.57(a)............................... NEW. 26.57(b)............................... NEW. 26.59.................................. NEW. 26.61(a)............................... 26.27(a)(1). 26.61(b)............................... 26.27(a)(2). 26.61(c)............................... NEW. 26.61(d)............................... 26.27(a)(4). 26.63(a)............................... NEW. 26.63(b)............................... NEW. 26.63(c)............................... NEW. 26.63(d)............................... 26.27(a)(3). 26.63(e)............................... NEW. 26.63(f)(1)............................ 26.71(c) and 26.27(b)(2)(vii). 26.63(f)(2)............................ NEW. 26.63(f)(3)............................ NEW. 26.65(a)............................... NEW. 26.65(b)............................... NEW. 26.65(c)(1)............................ 26.24(a)(1). 26.65(c)(2)............................ NEW. 26.65(d)............................... NEW.

[[Page 50673]]

26.65(e)............................... NEW. 26.65(f)............................... NEW. 26.65(g)............................... NEW. 26.65(h)............................... Appendix A Subpart B 2.9(c) and 26.27(a)(2). 26.67(a)............................... NEW. 26.67(b)............................... NEW. 26.67(c)............................... Appendix A Subpart B 2.9(c) and 26.27(a)(2). 26.69(a)............................... NEW. 26.69(b)(1)............................ 26.27(b)(4). 26.69(b)(2)............................ NEW. 26.69(b)(3)............................ 26.27(b)(4). 26.69(b)(4)............................ NEW. 26.69(b)(5)............................ NEW. 26.69(b)(6)............................ 26.27(b)(4). 26.69(b)(7)............................ 26.27(b)(4). 26.69(c)(1)............................ 26.27(a)(3). 26.69(c)(2)............................ NEW. 26.69(c)(3)............................ 26.27(a)(3). 26.69(c)(4)............................ NEW. 26.69(c)(5)............................ NEW. 26.69(d)............................... NEW. 26.69(e)............................... NEW. 26.69(f)............................... 26.27(a)(2). 26.71.................................. NEW. 26.75(a) (1st sentence)................ NEW. 26.75(a) (2nd sentence)................ 26.27(b) (1st sentence). 26.75(b)............................... NEW. 26.75(c)............................... 26.27(b)(3). 26.75(d)............................... 26.27(c). 26.75(e)............................... 26.27(b)(2). 26.75(f)............................... 26.27(b)(5). 26.75(g)............................... 26.27(b)(4). 26.75(h)............................... 26.24(d)(2). 26.77(a)............................... NEW. 26.77(b)(1)............................ 26.27(b)(1). 26.77(b)(2)............................ NEW. 26.77(b)(3)............................ NEW. 26.77(c)............................... 26.27(d). 26.81.................................. NEW. 26.83(a)............................... NEW. 26.83(b)............................... 26.24(b). 26.85(a)............................... Appendix A Subpart B 2.2(d). 26.85(b)............................... NEW. 26.85(c)............................... Appendix A Subpart B 2.2(d)(2) (last sentence). 26.87(a)............................... Appendix A Subpart B 2.4(a). 26.87(b)............................... Appendix A Subpart B 2.4(f) (1st sentence). 26.87(c)............................... Appendix A Subpart B 2.7(m). 26.87(d)............................... Appendix A Subpart B 2.4(c). 26.87(d)(1)............................ Appendix A Subpart B 2.4(e). 26.87(d)(2)............................ Appendix A Subpart B 2.4(c) (2nd sentence). 26.87(d)(3)............................ Appendix A Subpart B 2.4(c). 26.87(e)............................... Appendix A Subpart B 2.4(g)(1). 26.87(f)(1)............................ Appendix A Subpart B 2.4(c). 26.87(f)(2)............................ Appendix A Subpart B 2.4(c). 26.87(f)(3)............................ Appendix A Subpart B 2.4(c). 26.87(f)(4)............................ NEW. 26.87(f)(5)............................ Appendix A Subpart B 2.4(c)(2). 26.89.................................. NEW. 26.91.................................. NEW. 26.93.................................. Appendix A Subpart B 2.4 and new material. 26.95.................................. NEW. 26.97.................................. NEW. 26.99.................................. Appendix A Subpart B 2.4 and new material. 26.101................................. Appendix A Subpart B 2.4 and new material. 26.103................................. NEW. 26.105................................. Appendix A Subpart B 2.4 and new material. 26.107................................. Appendix A Subpart B 2.4 and new material. 26.109................................. NEW. 26.111................................. NEW. 26.113................................. Appendix A Subpart B 2.4 and new material. 26.115................................. Appendix A Subpart B 2.4 and new material. 26.117................................. Appendix A Subpart B 2.4 and new material.

[[Page 50674]]

26.119................................. Appendix A Subpart B 2.4 and new material. 26.121................................. NEW. 26.123................................. NEW. 26.133................................. Appendix A Subpart B 2.7(e)(1). 26.125(a).............................. Appendix A Subpart B 2.6(a). 26.125(b).............................. Appendix A Subpart B 2.6(b). 26.125(c).............................. Appendix A Subpart B 2.6(c). 26.127(a).............................. Appendix A Subpart B 2.2 1st paragraph. 26.127(b).............................. Appendix A Subpart B 2.2(a) and 2.4(d). 26.127(b).............................. Appendix A Subpart B 2.4(d). 26.127(c).............................. Appendix A Subpart B 2.7(o)(1). 26.127(d).............................. Appendix A Subpart B 2.2(d). 26.127(e).............................. Appendix A Subpart B 2.7(o)(3)(iii). 26.129(a).............................. Appendix A Subpart B 2.4(c) and 2.7(a)(1). 26.129(b).............................. Appendix A Subpart B 2.2(b). 26.129(c).............................. Appendix A Subpart B 2.7(b)(2). 26.129(d).............................. Appendix A Subpart B 2.7(a)(2). 26.129(e).............................. Appendix A Subpart B 2.7(d) 1st sentence. 26.129(f).............................. Appendix A Subpart B 2.7(c). 26.129(g).............................. Appendix A Subpart B 2.4(i). 26.129(h).............................. NEW. 26.131................................. Appendix A Subpart B 2.4(e). 26.133................................. Appendix A Subpart B 2.7. 26.135................................. Appendix A Subpart B 2.7(j). 26.137................................. Appendix A Subpart B 2.8(a). 26.137(e)(4-5)......................... Appendix A Subpart B 2.8(b). 26.137(e)(6-8)......................... Appendix A Subpart B 2.8(c). 26.137(f).............................. Appendix A Subpart B 2.8(e)(6). 26.137(g).............................. Appendix A Subpart B 2.7(o). 26.137(h).............................. Appendix A Subpart B 2.7(o). 26.139(a).............................. Appendix A Subpart B 2.7(g)(2). 26.139(b).............................. 26.24(d)(1). 26.139(c).............................. Appendix A Subpart B 2.7(o)(5). 26.139(d).............................. Appendix A Subpart B 2.7(g)(6). 26.139(e).............................. Appendix A Subpart B 2.7(g)(7). 26.139(f).............................. NEW. 26.151................................. NEW. 26.153(a).............................. 26.24(f) and Appendix A Subpart D 4.1. 26.153(b).............................. Appendix A Subpart B 2.7(l)(2). 26.153(c).............................. Appendix A Subpart B 2.7(k). 26.153(d).............................. Appendix A Subpart A 1.1(2). 26.153(f)(5)........................... Appendix A Subpart B 2.3(1). 26.153(f) 1st paragraph................ Appendix A Subpart B 2.3 1st paragraph. 26.155................................. Appendix A Subpart B 2.5. 26.157(a).............................. Appendix A Subpart B 2.2 1st paragraph. 26.157(b).............................. Appendix A Subpart B 2.2(a) and 2.4(d). 26.157(c).............................. Appendix A Subpart B 2.7(o)(1). 26.157(d).............................. Appendix A Subpart B 2.2(d). 26.157(e).............................. Appendix A Subpart B 2.7(o)(3)(iii). 26.159(a).............................. Appendix A Subpart B 2.4(c) and 2.7(a)(1). 26.159(b).............................. Appendix A Subpart B 2.2(b). 26.159(c).............................. Appendix A Subpart B 2.7(b)(2). 26.159(d).............................. Appendix A Subpart B 2.7(a)(2). 26.159(e).............................. Appendix A Subpart B 2.7(a)(2). 26.159(f).............................. Appendix A Subpart B 2.4(i). 26.159(g).............................. NEW. 26.161................................. NEW. 26.163................................. Appendix A Subpart B 2.7(e)(1) (substantially revised). 26.165................................. Appendix A Subpart B 2.7(j) (substantially revised). 26.167(a) through (g).................. Appendix A Subpart B 2.8 (substantially revised). 26.167(h).............................. Appendix A Subpart B 2.7(o)(3)(i). 26.167(i).............................. Appendix A Subpart B 2.8(d). 26.169................................. Appendix A Subpart B 2.7(g) (substantially revised). 26.181................................. NEW. 26.183(a).............................. 26.3 and Appendix A Subpart A 1.2 and Appendix. A Subpart B 2.9(b). 26.183(b).............................. NEW. 26.183(b)1st sentence.................. Appendix A Subpart B 2.9(b) 1st sentence. 26.183(c).............................. 26.3 and Appendix A Subparts A 1.2,B 2.4 (J),B 2.9(a), and b 2.9(b). 26.183(d).............................. NEW. 26.185(a).............................. Appendix A Subpart B 2.9(a). 26.185(b).............................. Appendix A Subpart B 2.9(a) last sentence. 26.185(c).............................. Appendix A Subpart B 2.9(c).

[[Page 50675]]

26.185(d).............................. NEW (more detailed than Appendix A Subpart B 2.9(c)). 26.185(e).............................. NEW. 26.185(f).............................. NEW. 26.185(g).............................. NEW. 26.185(h).............................. NEW. 26.185(i).............................. NEW. 26.185(j)(1)........................... Appendix A Subpart B 2.9(d). 26.185(j)(2)........................... Appendix A Subpart B 2.9(d). 26.185(j)(3)........................... NEW. 26.185(j)(4)........................... NEW. 26.185(j)(5)........................... NEW. 26.185(j)(6)........................... NEW. 26.185(k).............................. Appendix A Subpart B 2.9(f). 26.185(l).............................. Appendix A Subpart B 2.9(e). 26.185(m).............................. Appendix A Subpart B 2.9(g). 26.185(n).............................. NEW. 26.185(o).............................. NEW. 26.185(p).............................. 26.24(e). 26.187................................. NEW. 26.189................................. NEW. 26.195................................. NEW. 26.197................................. NEW. 26.199................................. NEW. 26.201................................. NEW. 26.211(a).............................. NEW. 26.211(b).............................. NEW. 26.213(a)(1)........................... 26.71(a). 26.213(a)(2)........................... 26.71(b). 26.213(a)(3)........................... NEW. 26.213(a)(4)........................... NEW. 26.213(b)(1)........................... 26.21(b), 26.22(c), and 26.80(c). 26.213(b)(2)........................... 26.21(b), 26.22(c), and 26.80(c). 26.213(c).............................. 26.71(c). 26.213(d).............................. 26.2. 26.213(e).............................. 26.23(a). 26.213(f).............................. NEW. 26.213(g).............................. NEW. 26.215(a).............................. Appendix A Subpart B 2.7(n). 26.215(b).............................. NEW. 26.217(a).............................. 26.71(d). 26.217(b).............................. 26.71(d). 26.217(c).............................. 26.71(d). 26.217(d).............................. 26.71(d). 26.217(e).............................. 26.71(d). 26.217(f).............................. 26.71(d). 26.217(g).............................. NEW. 26.219(a).............................. NEW. 26.219(b)(1)........................... 26.73(a)(1). 26.219(b)(2)(i)........................ 26.73(a)(2)(i). 26.219(b)(2)(ii)....................... 26.73(a)(2)(ii) + (iv) combined. 26.219(b)(2)(iii)...................... 26.73(a)(2)(iii). 26.219(b)(3)........................... NEW. 26.219(b)(4)........................... NEW. 26.219(c)(1)........................... Appendix A Subpart B 2.8(e)(4). 26.219(c)(2)........................... Appendix A Subpart B 2.8(e)(5). 26.219(c)(3)........................... NEW. 26.219(d).............................. NEW.

Table 2.--Distribution Table for Part 26

Current section

Replaced by:

26.1 (from beginning to ``programs'').. 26.1. 26.1 (following ``programs'').......... Deleted. 26.2(a) (first clause)................. 26.2(a) (to ``and''). 26.2(a) (balance of 1st sentence)...... 26.2(b) (from ``to'' to end). 26.2(a) (2nd sentence)................. 26.21 (1st sentence). 26.2(a) (3rd sentence to end).......... 26.25(a) (1)(2) and (3). 26.2(b) (1st sentence)................. 26.25(a). 26.2(b) (2nd sentence to end).......... 26.3(f). 26.2(c) (1st sentence)................. 26.3(e).

[[Page 50676]]

26.2(c) (from ``shall implement'' to 26.3(f). end). 26.2(d)................................ 26.3(c). 26.3................................... 26.5. 26.4................................... 26.7. 26.6................................... 26.9. 26.8................................... 26.13. 26.10(a) (from beginning through

26.23(a). ``manner''). 26.10(a) (balance of 1st sentence)..... 26.23(b). 26.10(b)............................... 26.23(c). 26.10(c)............................... 26.23(d). 26.20 (introductory paragraph, 1st 26.27(a). sentence). 26.20 (introductory paragraph, 2nd 26.213(d). sentence). 26.20 (introductory paragraph, final 26.27(b) (sentence before sentence).

``(1)''). 26.20(a)............................... 26.27(b). 26.20(b)............................... 26.27(b)(7). 26.20(c)............................... 26.27(c)(1). 26.20(d)............................... 26.27(c)(2). 26.20(e)............................... 26.27(c)(3). 26.20(f)............................... 26.27(d). 26.21(a)............................... 26.29(a). 26.21(b)............................... 26.29(c). 26.21(b) (last sentence)............... 26.213(b)(1). 26.22.................................. Deleted. 26.23(a)............................... 26.3(d) and 26.21. 26.23(b)............................... 26.21. 26.24(a) (first sentence to ``(1)'')... 26.31(a). 26.24(a) (balance of paragraph)........ 26.31(c) (substantially revised). 26.24(b)............................... Subparts E, F, and G. 26.24(c)............................... 26.31(d). 26.24(d)............................... Subparts E, F, and G. 26.24(e)............................... Subpart H. 26.24(f)............................... 26.31(d)(3) and requirements in Subpart G. 26.24(g)............................... 26.31(d)(4) and Subparts E, F, and G. 26.25.................................. 26.35. 26.27(a)............................... Subpart C. 26.27(b)............................... Subpart D. 26.27(c)............................... Subpart D. 26.27(d)............................... 26.77(c). 26.28.................................. 26.39. 26.29.................................. 26.37. 26.70.................................. 26.221. 26.71.................................. 26.211, 26.213, and 26.215. 26.73.................................. 26.219 (substantially revised). 26.80.................................. 26.41 (substantially revised). 26.90.................................. 26.223. 26.91.................................. 26.225. Appendix A Subpart A, 1.1(1)........... 26.3. Appendix A Subpart A, 1.1(2)........... 26.31(d) (substantially revised). Appendix A Subpart A, 1.1(3)........... Subparts F and G. Appendix A Subpart A, 1.2.............. 26.5. Appendix A Subpart B, 2.1(a)........... 26.31(d)(1). Appendix A Subpart B, 2.1(b)........... 26.31(d)(1). Appendix A Subpart B.2.1(c)............ Subparts E, F, and G. Appendix A Subpart B.2.1(d)............ 26.31(d)(6). Appendix A Subpart B.2.1(e)............ 26.31. Appendix A Subpart B.2.2 (Initial

Subparts F and G. paragraph). Appendix A Subpart B.2.2(a), (b), and 26.115, 26.117, 26.129, 26.159, (c).

26.169. Appendix A Subpart B.2.2(d)(1), (2), 26.85. and (3). Appendix A Subpart B.2.2(d)(4)......... Deleted. Appendix A Subpart B.2.3............... 26.31(b), and requirements in Subparts E, F, and G. Appendix A Subpart B.2.4(a)............ 26.87(a). Appendix A Subpart B.2.4(b)............ 26.85. Appendix A Subpart B.2.4(c)............ 26.87(d) and (f). Appendix A Subpart B 2.4(d)............ 26.117. Appendix A Subpart B 2.4(e)............ 26.87(d)(1). Appendix A Subpart B 2.4(f) 1st

26.87(b). sentence. Appendix A Subpart B 2.4(f)(1) through 26.95 through 26.115 and (f)(4).

Subparts F and G. Appendix A Subpart B 2.4(g)(1) through Subparts E, F, and G. (g)(24). Appendix A Subpart B 2.4(h) (1st

26.87(f)(5). sentence). Appendix A Subpart B 2.4(h) (balance of 26.113, 26.117, and 26.135. section). Appendix A Subpart B 2.4(i)............ 26.117. Appendix A Subpart B 2.4(j) (first two 26.115 and 26.185. sentences).

[[Page 50677]]

Appendix A Subpart B 2.4(j) (final Deleted. sentence). Appendix A Subpart B 2.5(a)............ 26.155(a). Appendix A Subpart B 2.5(b)............ 26.153. Appendix A Subpart B 2.5(c)............ 26.155(c). Appendix A Subpart B 2.5(d)............ 26.155(d). Appendix A Subpart B 2.5(e)............ 26.155(e). Appendix A Subpart B 2.5(f)............ 26.155(f). Appendix A Subpart B 2.6(a)............ 26.125(a). Appendix A Subpart B 2.6(b)............ 26.125(b). Appendix A Subpart B 2.6(c)............ 26.125(c). Appendix A Subpart B 2.7(a)............ 26.127, 26.129, 26.157, and 26.159. Appendix A Subpart B 2.7(b)............ 26.129(b) and 26.159(b). Appendix A Subpart B 2.7(c)............ 26.129(f) and 26.159(h). Appendix A Subpart B 2.7(d)............ 26.157 and 26.159. Appendix A Subpart B 2.7(e)............ Validity screening and initial validity test requirements in 26.131 and 26.161 and initial cutoff levels in 26.133 and 26.163(a). Appendix A Subpart B 2.7(f)............ 26.163(b). Appendix A Subpart B 2.7(g)(1) through 26.169. (5). Appendix A Subpart B 2.7(g)(6) and (7). Requirement for annual summary in 26.169(k). Appendix A Subpart B 2.7(g)(8)......... 26.215. Appendix A Subpart B 2.7(h)............ 26.159(i) and by 26.135(c). Appendix A Subpart B 2.7(i)............ Subparts F and G. Appendix A Subpart B 2.7(j)............ 26.113, 26.135, 26.165. Appendix A Subpart B 2.7(k)............ 26.153(c). Appendix A Subpart B 2.7(l)............ 26.153((f)(1) and 26.153(b). Appendix A Subpart B 2.7(m)............ 26.87(c) and 26.221. Appendix A Subpart B 2.7(n)............ 26.215(a). Appendix A Subpart B 2.7(o)(1)......... 26.127(c) and 26.157(c). Appendix A Subpart B 2.7(o)(2), (o)(3), 26.137 and 26.167. and (o)(4). Appendix A Subpart B 2.7(o)(5)......... 26.139(c) and 26.153(f)(2). Appendix A Subpart B 2.8(a)............ 26.137(a) and 26.167(a). Appendix A Subpart B 2.8(b)............ 26.137. Appendix A Subpart B 2.8(c)............ 26.167. Appendix A Subpart B 2.8(d)............ 26.137 and 26.167. Appendix A Subpart B 2.8(e)(1) to

26.137. (e)(3). Appendix A Subpart B 2.8(e)(4), (e)(5), 26.137 and 26.219. and (e)(6). Appendix A Subpart B 2.9(a) and (b) 26.183. (through ``contract employee''). Appendix A Subpart B 2.9(b) (balance of 26.185. section), (c), (d), (e), (f), and (g). Appendix A Subpart C 3.1............... 26.37(e) and 26.153(f)(3). Appendix A Subpart C 3.2............... 26.75(i)(4), 26.165(f). Appendix A Subpart D 4.1............... 26.153.

[FR Doc. 05-15576 Filed 8-25-05; 8:45 am]

BILLING CODE 7590-01-P

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