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[Federal Register Volume 89, Number 236 (Monday, December 9, 2024)]
[Proposed Rules]
[Pages 97579-97581]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28561]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket DOT-OST-2021-0093]
RIN 2105-AF28

Procedures for Transportation Workplace Drug and Alcohol Testing 
Programs

AGENCY: Office of the Secretary, Department of Transportation (DOT).

ACTION: Notice of proposed rulemaking.

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SUMMARY: The U.S. Department of Transportation (DOT) proposes to revise 
its drug testing procedures rule, which became effective on June 1, 
2023, to provide interim provisions to require the conduct of directly 
observed urine tests in situations where oral fluid tests are currently 
required, but oral fluid testing is not yet available.

DATES: Comments must be received on or before January 8, 2025.

ADDRESSES: Submit your comments, identified by Docket ID No. DOT-OST-
2021-0093, at https://www.regulations.gov/. Follow the online 
instructions for submitting comments. Once submitted, comments cannot 
be edited or removed from Regulations.gov. DOT may publish any comment 
received to its public docket. Do not submit electronically any 
information you consider to be Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. For 
additional submission methods and general guidance on making effective 
comments, please visit https://www.transportation.gov/regulations/rulemaking-process.

FOR FURTHER INFORMATION CONTACT: Bohdan Baczara, Deputy Director, 
Office of Drug and Alcohol Policy and Compliance, 1200 New Jersey 
Avenue SE, Washington, DC 20590; telephone number 202-366-3784; 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Why is DOT proposing this rule?

    DOT proposes to revise its drug testing regulation, Procedures for 
Transportation Workplace Drug and Alcohol Testing Programs (49 CFR part 
40), to address unforeseen circumstances rendering it impossible to 
comply with requirements in the final rule.

II. General Information

    DOT published a final rule amending the procedures for its drug 
testing program (49 CFR part 40) on May 2, 2023 (88 FR 27596) (May 2023 
Final Rule). The May 2023 Final Rule went into effect on June 1, 2023. 
The May 2023 Final Rule authorized oral fluid drug testing as an 
additional methodology for employers to use as a means of achieving the 
safety goals of the program. In the May 2023 Final Rule, we required an 
oral fluid test to be conducted in certain circumstances where an 
observed collection is required. However, because oral fluid testing is 
not yet available, DOT proposes to amend DOT's regulations to require 
the conduct of directly observed urine collections in those 
circumstances for an interim period. This rulemaking would correct the 
inadvertent factual impossibility created by the May 2023 Final Rule.

Section 40.67 When and how is a directly observed urine collection 
conducted?

    DOT regulations at Sec.  40.67 require that a collection be 
directly observed in certain circumstances, e.g., if the original 
sample was invalid without adequate medical explanation or the test is 
for a return to duty. In the May 2023 Final Rule, DOT codified a 
procedure requiring the directly observed collection to be an oral 
fluid test rather than a urine test in certain situations. However, 
oral fluid testing cannot be implemented until the Department of Health 
and Human Services (HHS) certifies at least two laboratories, one to 
serve as a primary laboratory, and a second to serve as a split 
specimen laboratory. Because no oral fluid laboratories have been 
certified, it is not yet possible to comply with this provision.
    In the interim, it is necessary to ensure that directly observed 
collections can still be conducted when required. DOT proposes to 
require directly observed urine collections in the situations specified 
in Sec.  40.67(g)(3) if an oral fluid collection is not yet available. 
We emphasize that the responsibility of ensuring the collection takes 
place has always been a requirement the employer must satisfy. If a 
directly observed urine collection is required, the burden--as is 
currently the case--remains on the employer to provide an observer as 
specified in Sec.  40.67(g) if the collection site cannot do so.
    We intend this provision to require directly observed urine tests 
in situations where an oral fluid collection is required, but is not 
yet available, to be a temporary, short-term solution because there are 
currently no certified oral fluid laboratories. This provision will 
sunset one year after HHS publishes a Federal Register notice that it 
certified the second oral fluid drug testing laboratory. So that all 
are aware of the date when this provision will sunset, we will publish 
a Federal Register document specifying the date the second oral fluid 
laboratory is certified by HHS. If, during the interim period, a 
collection site is able to conduct an oral fluid collection (HHS has 
certified at least two oral fluid drug testing laboratories, and both a 
qualified oral fluid collector and a conforming oral fluid collection 
device are available at the collection site), an oral fluid collection 
would be required to be conducted.
    In the May 2023 Final Rule, we added Sec.  40.67(g)(3) to address 
situations where an observer who meets the regulatory requirements 
cannot be found at the collection site, but mistakenly used the term 
``collector'' instead of ``observer'' in the regulatory text of that 
section. In this rule, we propose to correct the error.

III. Regulatory Notices and Analyses

Executive Orders 12866, 13563, and 14094

    This proposed rule is a non-significant rule for purposes of 
Executive Order (E.O.) 12886, as supplemented by E.O. 13563 and amended 
by E.O. 14094, and will not impose any significant costs or have any 
significant impacts. Given the uncertainty of testing costs and lack of 
data on other aspects of testing, DOT did not estimate cost savings or 
other benefits for the May 2023 Final Rule that permitted oral fluid 
testing as an alternative to urine testing in most scenarios. In the 
regulatory analyses for the May 2023 Final Rule, DOT stated that ``Oral 
fluid testing is optional in all but very rare cases . . .'' However, 
and because oral fluid testing is not yet

[[Page 97580]]

available, this proposed rule requires that a directly observed urine 
collection be conducted in those ``very rare cases'' where an oral 
fluid test is required but is not available. As an amendment to 
establish a temporary requirement to conduct directly observed urine 
collections in situations where oral fluid collections are required but 
oral fluid testing is not yet available, which was the requirement in 
existence before issuance of the May 2023 Final Rule, this proposed 
rule will not affect a significant number of drug tests, and as such, 
will not impose any significant costs or have any significant impacts 
on the DOT testing program.

Regulatory Flexibility Act and Small Business Regulatory Enforcement 
Fairness Act (SBREFA)

    The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.) 
requires Federal agencies to consider the effects of their regulatory 
actions on small businesses and other small entities and minimize any 
significant economic impact. The term ``small entities'' comprises 
small businesses and not-for-profit organizations that are 
independently owned and operated and are not dominant in their fields, 
and governmental jurisdictions with a population of less than 50,000. 
For this rulemaking, potentially affected small entities include drug 
testing companies (U.S. Small Business Administration (SBA) North 
American Industry Classification System (NAICS) Sector 54 
(Professional, Scientific and Technical Services), Code 541380 (Testing 
Laboratories and Services)) as well as DOT-regulated entities (SBA 
NAICS Sectors 48-49 (Transportation and Warehousing)).
    The Department does not expect that the proposed rule would have a 
significant economic impact on a substantial number of small entities. 
The proposed rule, if adopted, would establish a temporary requirement 
to conduct directly observed urine collections in situations where oral 
fluid collections are required but oral fluid testing is not yet 
available. Urine testing was the requirement in existence before 
issuance of the May 2023 Final Rule, and regulated entities are 
therefore familiar with the procedure for directly observed urine 
tests. Because oral fluid testing is not yet available for use in DOT's 
drug testing programs, regulated entities also likely still have the 
collection devices and other equipment necessary to conduct urine 
testing. In addition, the temporary procedures proposed in this 
rulemaking would be used only in the specific circumstances in Sec.  
40.67(g) where urine testing is currently required and would thus not 
affect a significant number of drug tests. As a result, the temporary 
amendments would not, if adopted, impose significant costs. For these 
reasons, I certify that the proposed rule would not have a significant 
economic impact on a substantial number of small entities within the 
meaning of the Regulatory Flexibility Act. DOT requests comment on its 
certification and the expected economic impacts of the proposed rule.

Unfunded Mandates

    The Secretary has examined the impact of this proposed rule under 
the Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L. 104-4). This 
proposed rule does not trigger the requirement for a written statement 
under sec. 202(a) of the UMRA because this rulemaking does not impose a 
mandate that results in an expenditure of $200 million or more by 
either State, local, and Tribal governments in the aggregate or by the 
private sector in any one year.

Environmental Impact

    The DOT has analyzed the environmental impacts of this action 
pursuant to the National Environmental Policy Act of 1969 (NEPA) (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, October 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). This proposed 
rule would amend the transportation industry drug testing program 
procedures regulation to establish a temporary requirement to conduct 
directly observed urine collections in situations where oral fluid 
collections are required but oral fluid testing is not yet available. 
This action is covered by the categorical exclusion listed at 23 CFR 
771.118(c)(4), ``[p]lanning and administrative activities that do not 
involve or lead directly to construction, such as: . . . promulgation 
of rules, regulations, directives . . .'' The Department does not 
anticipate any environmental impacts, and there are no extraordinary 
circumstances present in connection with this rulemaking.

Executive Order 13132: Federalism

    The Secretary has analyzed the proposed rule in accordance with 
Executive Order 13132: Federalism. Executive Order 13132 requires 
Federal agencies to carefully examine actions to determine if they 
contain policies that have federalism implications or that preempt 
State law. As defined in the order, ``policies that have federalism 
implications'' refer to regulations, legislative comments or proposed 
legislation, and other policy statements or actions that have 
substantial direct effects on the States, on the relationship between 
the National Government and the States, or on the distribution of power 
and responsibilities among the various levels of government.
    Most of the regulated parties under the Department's drug testing 
program are private entities. Some regulated entities are public 
entities (e.g., transit authorities and public works departments); 
however, the Secretary has determined that the proposed rule, which 
would provide temporary procedures to require the conduct of directly 
observed urine testing where oral fluid testing is not available, does 
not contain policies that have federalism implications.

Executive Order 13175: Consultation and Coordination With Indian Tribal 
Governments

    Executive Order 13175 (65 FR 67249, November 6, 2000) requires 
Federal agencies to develop an accountable process to ensure 
``meaningful and timely input by tribal officials in the development of 
regulatory policies that have tribal implications.'' ``Policies that 
have tribal implications'' as defined in the Executive order, include 
regulations that have ``substantial direct effects on one or more 
Indian tribes, on the relationship between the Federal government and 
the Indian tribes, or on the distribution of power and responsibilities 
between the Federal government and Indian tribes.'' This proposed rule 
does not have Tribal implications. The proposed rule will also not have 
substantial direct effects on Tribal governments, on the relationship 
between the Federal Government and Indian Tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian Tribes, as specified in Executive Order 13175.

Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (PRA) 
requires that DOT consider the impact of paperwork and other 
information collection burdens imposed on the public. This proposed 
rule would not require any new collection of information under the PRA. 
Notwithstanding any other provision of

[[Page 97581]]

law, no person shall be subject to any penalty for failing to comply 
with a collection of information subject to the PRA that does not 
display a currently valid Office of Management and Budget (OMB) control 
number.

Privacy Act

    Anyone is able to search the electronic form of all comments 
received in any of our dockets by the name of the individual submitting 
the comment (or signing the comment, if submitted on behalf of an 
association, business, labor union, etc.). For information on DOT's 
compliance with the Privacy Act, please visit https://www.transportation.gov/privacy.

Rule Summary

    As required by 5 U.S.C. 553(b)(4), a summary of this proposed rule 
can be found at regulations.gov, Docket DOT-OST-2021-0093, in the 
SUMMARY section of this document.

Pay-As-You-Go Act of 2023

    In accordance with Compliance with Pay-As-You-Go Act of 2023 
(Fiscal Responsibility Act of 2023, Pub. L. 118-5, div. B, title III) 
and OMB Memorandum (M-23-21) dated September 1, 2023, the Department 
has determined that this proposed rule is not subject to the Pay-As-
You-Go Act of 2023 because it will not increase direct spending beyond 
specified thresholds.

List of Subjects in 49 CFR Part 40

    Administrative practice and procedure, Alcohol abuse, Alcohol 
testing, Drug abuse, Drug testing, Laboratories, Reporting and 
recordkeeping requirements, Safety, Transportation.

    For the reasons stated in the preamble, DOT proposes to amend 49 
CFR part 40 as follows:

PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL 
TESTING PROGRAMS

0
1. The authority for 49 CFR part 40 continues to read as follows:

    Authority: 49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and 
54101 et seq.

0
2. In Sec.  40.67:
0
a. In paragraph (g)(3) introductory text, remove the word ``collector'' 
and add in its place ``observer''; and
0
b. Add paragraph (g)(4).
    The addition reads as follows:

Sec.  40.67  When and how is a directly observed urine collection 
conducted?

* * * * *
    (g) * * *
    (4) Notwithstanding paragraphs (g)(3)(i) and (ii) of this section, 
until otherwise specified (one year after HHS publishes a Federal 
Register notification of the second certified oral fluid drug testing 
laboratory), you must conduct an oral fluid collection if possible 
(i.e., HHS has certified at least two oral fluid drug testing 
laboratories, and both a qualified oral fluid collector and a 
conforming oral fluid collection device are available at the collection 
site). Otherwise, you must conduct a directly observed urine collection 
as required in this section.
* * * * *

    Signed pursuant to authority delegated at 49 CFR 1.27(c) in 
Washington, DC.
Subash Iyer,
Acting General Counsel.
[FR Doc. 2024-28561 Filed 12-6-24; 8:45 am]
BILLING CODE 4910-9X-P
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