Conforming Amendments and Technical Corrections to Department Rules Implementing the Transportation Industry Drug Testing Program
| Published date | 23 April 2019 |
| Citation | 84 FR 16770 |
| Record Number | 2019-06986 |
| Section | Rules and Regulations |
| Court | Federal Transit Administration |
Federal Register, Volume 84 Issue 78 (Tuesday, April 23, 2019)
[Federal Register Volume 84, Number 78 (Tuesday, April 23, 2019)]
[Rules and Regulations]
[Pages 16770-16775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06986]
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DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 120
Office of the Secretary of Transportation
49 CFR Parts 40
Pipeline and Hazardous Materials Safety Administration
49 CFR Part 199
Federal Transit Administration
49 CFR Part 655
RIN 2105-AE78
Conforming Amendments and Technical Corrections to Department
Rules Implementing the Transportation Industry Drug Testing Program
AGENCY: Office of the Secretary of Transportation (OST), Federal
Aviation Administration (FAA), Federal Transit Administration (FTA),
and Pipeline and Hazardous Materials Safety Administration (PHMSA);
U.S. Department of Transportation (DOT).
ACTION: Final rule.
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SUMMARY: This final rule makes minor technical corrections to the OST,
FAA, FTA, and PHMSA regulations governing drug testing for safety-
sensitive employees to ensure consistency with the recent amendments
made to the Department of Transportation's regulation, ``Procedures for
Transportation Workplace Drug and Alcohol Testing Programs,'' which
added requirements to test for oxycodone, oxymorphone, hydrocodone, and
hydromorphone to DOT-regulated drug testing programs. The changes to
the Department's regulation make it necessary to refer to these
substances, as well as the previously covered drugs morphine, 6-
acetylmorphine, and codeine, by the more inclusive term ``opioids,''
rather than ``opiates.'' This rule amends the term in the FAA, FTA, and
PHMSA regulations to ensure that all DOT drug testing rules are
consistent with one another and with the Mandatory Guidelines for
Federal Workplace Drug Testing Programs. In addition, this rule makes a
conforming amendment to include the term ``opioids'' in the wording of
the Department's annual information collection requirement and
clarifications to section 40.26 and Appendix H regarding the
requirement for employers to follow the Department's instructions for
the annual information collection.
DATES: This rule is effective on April 23, 2019.
FOR FURTHER INFORMATION CONTACT: For OST, Patrice M. Kelly, Director,
Office of Drug and Alcohol Policy and Compliance, 1200 New Jersey
Avenue SE, Washington, DC 20590 (telephone: 202-366-3784; email:
[email protected]). For FTA, for program issues, contact Iyon
Rosario, Office of Transit Safety and Oversight (TSO), FTA, 1200 New
Jersey Avenue SE, Washington, DC 20590-0001 (telephone: 202-366-2010;
email: [email protected]). For legal issues, contact Bruce Walker,
Office of Chief Counsel (TCC), FTA, 1200 New Jersey Avenue SE,
Washington, DC 20590-0001 (telephone: 202-366-9109; email:
[email protected]). For FAA, Rafael Ramos, Office of Aerospace
Medicine, Drug Abatement Division, AAM-800, FAA, 800 Independence
Avenue SW, Washington, DC 20591 (telephone 202-267-8442; facsimile 202-
267-5200; email: [email protected]). For PHMSA, Wayne Lemoi, Drug
and Alcohol Program Manager, PHMSA Office of Pipeline Safety (telephone
909-937-7232, email [email protected]).
SUPPLEMENTARY INFORMATION:
Background
On January 23, 2017, the Department of Health and Human Services
(HHS) published its final version of its Mandatory Guidelines for
Federal Workplace Drug Testing Programs using Urine (HHS Mandatory
Guidelines) (82 FR 7920). In that final rule, HHS added four semi-
synthetic opioid substances (hydrocodone, hydromorphone, oxycodone, and
oxymorphone) to the drugs for which laboratories test under the HHS
Mandatory Guidelines. That rule became effective October 1, 2017.
By statute, the Department of Transportation is required to follow
the HHS Mandatory Guidelines for the
[[Page 16771]]
drugs for which it tests in the transportation industry drug testing
program. Consequently, the Department issued a notice of proposed
rulemaking (NPRM) on January 23, 2017 (82 FR 7771). In that NPRM, the
Department proposed to revise 49 CFR part 40 (part 40) to harmonize
with certain parts of the revised HHS Mandatory Guidelines. The
Department received 69 comments on the NPRM from various stakeholders,
which were addressed in the final rule published on November 13, 2017.
The Department's final rule, among other things, added the four
semi-synthetic opioid substances (hydrocodone, hydromorphone,
oxycodone, and oxymorphone) to the Department's drug testing program
(82 FR 52229). The Department's final rule became effective on January
1, 2018. These testing requirements are now codified at 49 CFR 40.85(d)
and 40.87.
Before the 2017 HHS and DOT rulemakings, laboratories under the HHS
Mandatory Guidelines and Part 40 tested for codeine, 6-acetylmorphine,
and morphine, properly referred to as ``opiates.'' The four substances
added in the DOT 2017 final rule are semi-synthetic substances, closely
related to opiates but chemically distinct. For this reason, it is more
accurate to refer to all six substances under the more inclusive term
``opioids.''
DOT Management Information System Form
The 2017 DOT final rule changed the terminology from ``opiates'' to
``opioids'' throughout part 40, with one minor exception in the DOT's
Management Information System (MIS) Form. Specifically, we did not
change the term ``opiates'' to ``opioids'' within the MIS Form in order
to avoid any confusion on what employers were to report for the 2017
calendar year MIS reporting period. Since testing for the semi-
synthetic opioids began in calendar year 2018, employers would not need
to report that data until after January 1, 2019. Therefore, we are now
updating the MIS Form to be consistent with the rest of part 40. The
costs for the additional opioid testing were addressed in the final
rule dated November 13, 2017.
In addition, in our November 13, 2017, final rule (82 FR 52243), we
moved the instructions to the MIS data collection form from Appendix H
to our website. We did so to provide greater flexibility to make
changes and/or updates to the MIS instructions. We did not intend for
this to suggest that employers were no longer required to use the MIS
instructions as they have been required to do by part 40 and the
respective DOT Agency regulations since 2003. Therefore, we are making
a technical amendment to Sec. 40.26 and Appendix H to part 40 to
clarify the requirement for employers to use the MIS instructions.
Discussion
The Department's 2017 final rule was promulgated under the
authority of the Omnibus Transportation Employee Testing Act (OTETA) of
1991 (Pub. L. 102-143, Title V, 105 Stat. 952). The OTETA sets the
requirements for DOT's reliance on the HHS Mandatory Guidelines for
scientific testing issues. Section 503 of the Supplemental
Appropriations Act, 1987 (Pub. L. 100-71, 101 Stat 391, 468), 5 U.S.C.
7301, and Executive Order 12564 establish HHS as the agency that
directs scientific and technical guidelines for Federal workplace drug-
testing programs and standards for certification of laboratories'
regulated programs. While the Department has discretion concerning many
aspects of the regulations governing testing in the transportation
industries' regulated programs, we must follow the HHS Mandatory
Guidelines for the drugs for which we require testing.
The final rule follows that same mandate with respect to 49 CFR
part 40 (OST), 14 CFR part 120 (FAA), and 49 CFR part 655 (FTA), all of
which are directly subject to the OTETA mandate to conform to the HHS
Mandatory Guidelines. Although PHMSA is not one of the agencies
mentioned in OTETA, PHMSA's drug testing rule (49 CFR part 199) has
always incorporated part 40 procedures, and it is important for all DOT
drug testing regulations, and their terminology, to remain consistent.
For this reason, we are changing the definition of ``prohibited drug''
in part 199 to directly reference part 40 and not the Controlled
Substances Act.
In the OST rule, in Appendix H, the MIS form, in Section III,
``Drug Testing Data,'' the word ``opiates'' in Column 7 is being
changed to ``opioids.''
In the FAA rule, the FAA is revising the definition of ``prohibited
drug'' in Sec. 120.7(m) to mean any of the drugs specified in part 40.
The FAA is also revising Sec. Sec. 120.107 and 120.109 to replace the
list of drugs and drug metabolites with the term ``prohibited drug.''
These changes will harmonize part 120, in pertinent part, with part 40.
In Sec. 120.109(c) the words ``can not'' are being corrected to
``cannot.''
In the FTA rule, the FTA is replacing the term ``opiates'' with
``opioids'' in 49 CFR 655.21(b)(3).
In the PHMSA rule, 49 CFR 199.5, pipeline operators are required to
conduct their anti-drug programs according to the requirements of part
199 and the DOT Procedures in part 40. Moreover, the regulations
explain that the terms and concepts used in part 199 have the same
meaning as in the DOT Procedures in part 40. The ODAPC final rule,
dated November 13, 2017, changed the definition of ``drug'' in 49 CFR
40.3 to: ``The drugs for which tests are required under this part and
DOT Agency regulations are marijuana, cocaine, amphetamines,
phencyclidine (PCP), and opioids.'' As a conforming amendment, PHMSA is
changing the definition of ``prohibited drug'' in part 199 to align it
with the recently changed definition of ``drugs'' in part 40. Instead
of referencing the Controlled Substances Act, the definition of
``prohibited drug'' will now reference part 40. This change will also
conform with the requirement under part 40 that the drug test panel
includes the four semi-synthetic opioids (i.e., hydrocodone, oxycodone,
hydromorphone, oxymorphone) in addition to the three natural opiates
(i.e., heroin, morphine, codeine) previously included in DOT drug
tests.
Regulatory Analyses and Notices
Good Cause for Immediate Adoption Without Prior Notice and Comment
Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with prior notice
and comment for rules when the agency for ``good cause'' finds that
those procedures are ``impracticable, unnecessary, or contrary to the
public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without seeking comment prior to the
rulemaking.
As discussed above, this final rule revises the terminology in the
respective OST, FAA, FTA, and PHMSA drug testing rules to conform to
the Department of Transportation's final rule requiring testing for
semi-synthetic opioids. Also, as discussed above, OST, FAA, and FTA are
statutorily required to incorporate the Department of Health and Human
Services (HHS) scientific and technical guidelines, including mandatory
guidelines establishing the list of controlled substances which
individually may be tested. While PHMSA is not subject to the OTETA
mandate to follow the HHS Mandatory Guidelines, the PHMSA rule already
required compliance with part 40. The terminological changes involved
will not make substantive changes in the obligations of regulated
parties but clarify those parties' obligations. For these reasons, we
find that it is
[[Page 16772]]
unnecessary to seek public comment before issuing this final rule.
There will be no additional costs associated with any of these
changes, which are all administrative. Each of these changes removes
inconsistencies and harmonizes with changes made to the HHS Mandatory
Guidelines in January of 2017 that were incorporated into 49 CFR part
40 on November 13, 2017. Any costs associated with the substantive
rulemaking changes to add the semi-synthetic opioids were accounted for
in the final rule dated November 13, 2017 (82 FR 52229).
Similarly, section 553(d)(3) of the APA requires that agencies
publish a rule not less than 30 days before its effective date, except
as otherwise provided by the agency for good cause found and published
with the rule. DOT finds that, for the same reasons stated above, there
is good cause to make these amendments effective immediately.
Executive Order 12866 and 13563
Executive Order 12866 and 13563 direct agencies to assess all costs
and benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). Executive Order 13563
emphasizes the importance of quantifying both costs and benefits, of
reducing costs, of harmonizing rules, and of promoting flexibility.
This final rule implements changes that are administrative in nature.
All agencies involved have determined that this action is not a
significant regulatory action under section 3(f) of Executive Order
12866, nor is it significant within the meaning of Department of
Transportation regulatory policies and procedures.
This rule provides technical corrections to the cited regulations
harmonizing them with part 40. The only entities affected by this rule
are those aviation, transit, and pipeline entities already subject to
DOT drug testing rules and the changes made to part 40 by the final
rule dated November 13, 2017. This rule does not require any additional
costs associated with compliance. Accordingly, it has not been reviewed
by the Office of Management and Budget.
This rule is not expected to impose any new compliance costs, and
would not adversely affect, in any material way, any sector of the
economy. There are no significant changes to the existing program with
the publication of this rulemaking. Additionally, this rule does not
interfere with any action planned by another agency and does not
materially alter the budgetary impact of any entitlements, grants, user
fees, or loan programs. Consequently, a full regulatory evaluation is
not required.
Executive Order 13771
This rule is not an Executive Order 13771 regulatory action because
this rule is not significant under Executive Order 12866.
Regulatory Flexibility Act
The requirements of the Regulatory Flexibility Act (RFA) do not
apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt
a rule without prior notice and comment. Because this rule adopts
Departmental regulatory requirements pursuant to part 40, the involved
agencies have determined that there is good cause to adopt the rule as
a final rule; therefore, RFA analysis is not required. Additionally,
this administrative action will result in no significant economic
impact nor impose any additional cost to small entities that are
subject to alcohol misuse and controlled substance testing requirements
of the cited regulations.
Paperwork Reduction Act
This rule does not provide a new collection of information that is
subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
Under the provisions of the Paperwork Reduction Act, the affected
agencies may not conduct or sponsor, and a person is not required to
respond to or may not be penalized for failing to comply with, a
collection of information unless it displays a currently valid OMB
control number.
Executive Order 13132, Federalism
Executive Order 13132 sets forth principles and criteria that
agencies must adhere to in formulating and implementing policies that
have Federalism implications. That is, regulations that have
substantial direct effects on the States, or on the distribution of
power and responsibilities among the various levels of government.
Federal agencies must closely examine the statutory authority
supporting any action that would limit the policymaking discretion of
the States, and to the extent practicable, must consult with State and
local officials before implementing any such action.
The agencies involved have reviewed this rule under the threshold
criteria of Executive Order 13132 on Federalism and certify that the
rule would not have Federalism implications as defined by the Executive
Order. The rule would not significantly affect the rights, roles, and
responsibilities of States, and would not involve preemption of State
law, nor would it limit State policymaking discretion.
Unfunded Mandates Reform Act
This rule is not an unfunded Federal mandate within the meaning of
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, March 22,
1995, 109 Stat. 48). This rule will not result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $148.1 million or more in any one year (2 U.S.C.
1532).
Executive Order 13175 (Tribal Consultation)
The agencies involved have analyzed this action under Executive
Order 13175, and determined that this rule would not have substantial
direct effects on one or more Indian Tribes; would not impose
substantial direct compliance costs on Indian Tribal governments; and
would not preempt Tribal law.
National Environmental Policy Act
The Department has analyzed the environmental impacts of this
action pursuant to the National Environmental Policy Act of 1969 (42
U.S.C. 4321 et seq.) and has determined that it is categorically
excluded pursuant to DOT Order 5610.1C, Procedures for Considering
Environmental Impacts (44 FR 56420, Oct. 1, 1979). Categorical
exclusions are actions identified in an agency's NEPA implementing
procedures that do not normally have a significant impact on the
environment and therefore do not require either an environmental
assessment (EA) or environmental impact statement (EIS). See 40 CFR
1508.4. In analyzing the applicability of a categorical exclusion, the
agency must also consider whether extraordinary circumstances are
present that would warrant the preparation of an EA or EIS. Id.
Paragraph 4(c)(5) of DOT Order 5610.1C incorporates by reference the
categorical exclusions for all DOT Operating Administrations. This
action is covered by the categorical exclusion listed in the Federal
Transit Administration's implementing procedures, ``[p]lanning and
administrative activities that do not involve or lead directly to
construction, such as: . . . promulgation of rules, regulations,
directives . . .'' 23 CFR 771.118(c)(4). The purpose of this rulemaking
is to make minor technical corrections to the Department's drug-testing
regulations. The Department does not anticipate any environmental
impacts and there are no extraordinary
[[Page 16773]]
circumstances present in connection with this rulemaking.
International Compatibility and Cooperation
In keeping with U.S. obligations under the Convention on
International Civil Aviation (ICAO), it is FAA policy to conform to
ICAO Standards and Recommended Practices to the maximum extent
practicable. The FAA has determined that its portion of this final rule
does not conflict with any international agreement of the United
States.
List of Subjects
14 CFR Part 120
Air carriers, Alcoholism, Alcohol abuse, Aviation safety, Drug
abuse, Drug testing, Operators, Reporting and recordkeeping
requirements, Safety, Safety-sensitive, Transportation.
49 CFR Part 40
Administrative practice and procedures, Alcohol abuse, Alcohol
testing, Drug abuse, Drug testing, Laboratories, Reporting and
recordkeeping requirements, Safety, Transportation.
49 CFR Part 655
Mass transportation, Alcohol testing, Drug testing, Reporting and
recordkeeping requirements, Safety, Transportation.
49 CFR Part 199
Alcohol testing, Drug testing, Pipeline safety, Reporting and
recordkeeping requirements, Safety, Transportation.
In consideration of the foregoing, the Department of Transportation
and its agencies amend their regulations as follows:
Title 14--Aeronautics and Space
PART 120--DRUG AND ALCOHOL TESTING PROGRAM
0
1. The authority citation for part 120 continues to read as follows:
Authority: 49 U.S.C. 106(f), 106(g), 40101-40103, 40113, 40120,
41706, 41721, 44106, 44701, 44702, 44703, 44709, 44710, 44711,
45101-45105, 46105, 46306.
0
2. In Sec. 120.7, revise paragraph (m) to read as follows:
Sec. 120.7 Definitions.
* * * * *
(m) Prohibited drug means any of the drugs specified in 49 CFR part
40.
* * * * *
0
3. Revise Sec. 120.107 to read as follows:
Sec. 120.107 Substances for which testing must be conducted.
Each employer shall test each employee who performs a safety-
sensitive function for evidence of a prohibited drug during each test
required by Sec. 120.109.
0
4. In Sec. 120.109, revise paragraphs (a)(5) and (c) to read as
follows:
Sec. 120.109 Types of drug testing required.
* * * * *
(a) * * *
(5) Before hiring or transferring an individual to a safety-
sensitive function, the employer must advise each individual that the
individual will be required to undergo pre-employment testing in
accordance with this subpart, to determine the presence of a prohibited
drug in the individual's system. The employer shall provide this same
notification to each individual required by the employer to undergo
pre-employment testing under paragraph (a)(4) of this section.
* * * * *
(c) Post-accident drug testing. Each employer shall test each
employee who performs a safety-sensitive function for the presence of a
prohibited drug in the employee's system if that employee's performance
either contributed to an accident or cannot be completely discounted as
a contributing factor to the accident. The employee shall be tested as
soon as possible but not later than 32 hours after the accident. The
decision not to administer a test under this section must be based on a
determination, using the best information available at the time of the
determination, that the employee's performance could not have
contributed to the accident. The employee shall submit to post-accident
testing under this section.
* * * * *
Title 49--Transportation
PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL
TESTING PROGRAMS
0
5. The authority citation for part 40 continues to read as follows:
Authority: 49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and
54101 et seq.
0
6. Revise Sec. 40.26 to read as follows:
Sec. 40.26 What form must an employer use to report Management
Information System (MIS) data to a DOT agency?
As an employer, when you are required to report MIS data to a DOT
agency, you must use the U.S. Department of Transportation Drug and
Alcohol Testing MIS Data Collection Form to report that data. You must
use the form and instructions referenced at Appendix H to part 40. You
must submit the MIS report in accordance with rule requirements (e.g.,
dates for submission; selection of companies required to submit, and
method of reporting) established by the DOT agency regulating your
operation.
0
7. Revise Appendix H to part 40 to read as follows:
Appendix H to Part 40--DOT Drug and Alcohol Testing Management
Information System (MIS) Data Collection Form
The following form is the MIS Data Collection form required for use
to report calendar year MIS data. The instructions for this form are
found at https://www.transportation.gov/odapc.
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PART 199--DRUG AND ALCOHOL TESTING
0
8. The authority citation for part 199 continues to read as follows:
Authority: 49 U.S.C. 5103, 60102, 60104, 60108, 60117, and
60118; 49 CFR 1.53.
0
9. In Sec. 199.3, revise the definition of ``Prohibited drug'' to read
as follows:
Sec. 199.3 Definitions.
* * * * *
Prohibited drug means any of the substances specified in 49 CFR
part 40.
* * * * *
PART 655--PREVENTION OF ALCOHOL MISUSE AND PROHIBITED DRUG USE IN
TRANSIT OPERATIONS
0
10. The authority citation for part 655 continues to read as follows:
Authority: 49 U.S.C. 5331; 49 CFR 1.91.
0
11. Amend Sec. 655.21 by revising paragraph (b)(3) to read as follows:
Sec. 655.21 Drug testing.
* * * * *
(b) * * *
(3) Opioids;
* * * * *
Issued in Washington, DC, on Tuesday, March 19, 2019.
Elaine L. Chao,
Secretary of Transportation.
Daniel K. Elwell,
Acting Administrator, Federal Aviation Administration.
[FR Doc. 2019-06986 Filed 4-22-19; 8:45 am]
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