Federal Register / Vol. 89, No. 236 / Monday, December 9, 2024 / Proposed Rules 97579 

SUPPLEMENTARY INFORMATION: EPA has 

explained the reasons for this action in 

the preamble to the direct final rule. For 

additional information, see the direct 

final rule published in the ‘‘Rules and 

Regulations’’ section of this issue of the 

Federal Register. 

Authority: This proposed rule is issued 

under the authority of sections 2002(a), 

7004(b), and 9004 of the Solid Waste 

Disposal Act, as amended, 42 U.S.C. 6912, 

6991c, 6991d, and 6991e. 

Dated: November 22, 2024. 

Meghan A. McCollister, 

Regional Administrator, EPA Region 7. 

[FR Doc. 2024–28139 Filed 12–6–24; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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; 

ODAPCwebmail@dot.gov. 

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 § 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 § 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 § 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 

§ 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 nonsignificant 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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
97580 Federal Register / Vol. 89, No. 236 / Monday, December 9, 2024 / Proposed Rules 

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 § 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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 89, No. 236 / Monday, December 9, 2024 / Proposed Rules 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 

■ 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. 

■ 2. In § 40.67: 

■ a. In paragraph (g)(3) introductory 

text, remove the word ‘‘collector’’ and 

add in its place ‘‘observer’’; and 

■ b. Add paragraph (g)(4). 

The addition reads as follows: 

§ 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 


ddrumheller on DSK120RN23PROD with PROPOSALS1