[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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