87792 Federal Register / Vol. 89, No. 214 / Tuesday, November 5, 2024 / Rules and Regulations 

1There were duplicate comments filed for both 

the DFR and the NPRM that are included in the 

docket in www.regulations.gov. 

the Captain of the Port Sector Columbia 

River or a designated representative. 

DATES: The regulations in 33 CFR 

165.1315 will be enforced from 7 p.m. 

until 8:30 p.m., each day on December 

6 and 7, 2024. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this notice of 

enforcement, call or email Lieutenant 

Commander Jesse Wallace, Waterways 

Management Division, Sector Columbia 

River, Coast Guard; telephone 503–572– 

3524, email SCRWWM@USCG.MIL. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce a safety zone in 33 

CFR 165.1315 for the City of Richland 

Lighted Boat Parade Fireworks Display, 

in Richland, WA, from 7 p.m. until 8:30 

p.m., each day on December 6 and 7, 

2024 on the Columbia River. The safety 

zone will include all navigable waters 

within a 450-yard radius of the 

fireworks launch site location of 

approximately 46°16′29′′ N; 119°16′10′′ 

W. 

The special requirements listed in 33 

CFR 165.1315 apply to the activation 

and enforcement of the safety zone. 

During the enforcement period, as 

reflected in § 165.1315(e), no person 

may enter or remain in the safety zone 

unless authorized by the Captain of the 

Port Sector Columbia River or a 

designated representative. Additionally, 

each person in the safety zone must 

comply with the lawful order or 

directions of the Captain of the Port 

Sector Columbia River or designated 

representative. 

In addition to this notification of 

enforcement in the Federal Register, the 

Coast Guard plans to provide 

notification of this enforcement period 

via the Local Notice to Mariners and 

marine information broadcasts. 

Dated: October 25, 2024 

J.W. Noggle, 

CAPTAIN, U.S. Coast Guard, Captain of the 

Port Sector Columbia River. 

[FR Doc. 2024–25644 Filed 11–4–24; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF TRANSPORTATION 

Office of the Secretary 

49 CFR Part 40 

[Docket DOT–OST–2021–0093] 

RIN 2105–AE94 

Procedures for Transportation 

Workplace Drug and Alcohol Testing 

Programs 

AGENCY: Office of the Secretary, 

Department of Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: The U.S. Department of 

Transportation (DOT) revises its drug 

and alcohol testing procedures, as 

amended by a final rule published on 

May 2, 2023, to provide temporary 

qualification requirements for mock oral 

fluid monitors, provide for consistent 

requirements by identifying which 

individuals may be present during an 

oral fluid collection, and clarify how 

collectors are to document that a 

sufficient volume of oral fluid was 

collected. 

DATES: This final rule is effective on 

December 5, 2024. 

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. Authority for This Rulemaking 

This rulemaking is promulgated 

under the authority originally enacted 

in the Omnibus Transportation 

Employee Testing Act (OTETA) of 1991, 

codified at 49 U.S.C. 45102 and 45104 

(aviation industry testing), 49 U.S.C. 

20140 (rail), 49 U.S.C. 31306 (motor 

carrier), and 49 U.S.C. 5331 (transit). 

OTETA requires that the Department 

incorporate the Department of Health 

and Human Services’ (HHS) Mandatory 

Guidelines, including amendments, into 

the Department’s regulations for testing 

and laboratory requirements for 

aviation, rail (except for rail postaccident testing), motor carrier, and 

transit testing. Additional authority at 5 

U.S.C. 7301 note and Executive Order 

12564, specify HHS as the agency that 

establishes scientific and technical 

guidelines for Federal workplace drug 

testing programs and standards for 

certification of laboratories engaged in 

such drug testing. While DOT has 

discretion concerning many aspects of 

its regulations governing testing in the 

transportation industries’ regulated 

programs, DOT follows the HHS 

Mandatory Guidelines for the laboratory 

and specimen testing procedures. 

On October 25, 2019, HHS published 

a final rule establishing the Mandatory 

Guidelines for Federal Workplace Drug 

Testing Programs using Oral Fluid 

(OFMG), which became effective 

January 1, 2020. (84 FR 57554, Oct. 25, 

2019). As of the time of the publication 

of this final rule, there have been no 

laboratories yet certified by HHS for oral 

fluid testing. 

II. Background 

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 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. 

We have determined instances in 

which the text of various aspects of the 

procedures as amended by the May 

2023 final rule need to be further 

amended due to unforeseen 

circumstances that have rendered it 

impossible to comply with requirements 

for mock oral fluid collection observers, 

for consistency with regard to privacy 

during the specimen collection, and to 

clarify the means by which collectors 

document that a sufficient volume of 

oral fluid was collected. 

To address the issues identified 

above, DOT published a direct final rule 

(DFR) on June 21, 2024. (89 FR 5189) 

DOT published the DFR without a prior 

proposed rule because we viewed the 

DFR as a noncontroversial action and 

anticipated no adverse comments on 

any of the provisions of the rule. The 

DFR was to become effective on August 

5, 2024, unless DOT received adverse 

comments on the provisions of the DFR. 

DOT noted that if adverse comments 

were received, it would publish a timely 

withdrawal in the Federal Register 

informing the public that the provisions 

of the rule on which adverse comments 

were received would not take effect. 

On the same day, DOT published a 

notice of proposed rulemaking (NPRM) 

containing the same amendments in the 

DFR that served as the proposed rule to 

amend Part 40 if adverse comments 

were received on any of the provisions 

in the DFR (89 FR 52002). DOT noted 

that if adverse comments were received, 

DOT would address the public 

comments received in a subsequent 

final rule based on the NPRM. DOT 

stated that it would not institute a 

second comment period on the NPRM. 

DOT received adverse comments to 

each of the provisions in the DFR and 

NPRM, and DOT published a notice 

withdrawing the DFR in the Federal 

Register on August 1, 2024 (89 FR 

62665). 

III. Comments to the DFR and NPRM 

DOT received 15 unique comments to 

the DFR, and 18 unique comments to 

the NPRM.1 These comments included 


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2We noted that the knowledge, skills, and 

abilities in § 40.35(c)(i) require regularly conducting 

DOT drug test collections (in this case, for oral 

fluids) for at least one year. This is not possible 

because until HHS certifies an oral fluid 

laboratory(ies) with a device that meets DOT’s 

requirements per appendix B of part 40, oral fluid 

is not a permissible means of collection. We 

determined that, in contrast to paragraphs (c)(ii) 

and (c)(iii), there is no way for an individual to 

otherwise possess the knowledge, skills, and 

abilities in paragraph (c)(i) such that the individual 

could competently observe mock collections. As a 

result, we stated that those who want to act as 

monitors specified in subparagraph (c)(2)(i) must 

still become qualified collectors and meet the oneyear requirement of regularly conducting DOT oral 

fluid drug test collections before they can act as 

monitors. 

three that expressed concerns about, or 

opposed the use of, oral fluid testing 

generally, and one that was not related 

to the subject rulemaking. DOT 

considered and responded to comments 

expressing the same concerns about and 

opposing oral fluid testing in the May 

2023 final rule establishing oral fluid 

testing as an additional test 

methodology for employers. These 

comments are therefore outside of the 

scope of this rulemaking, which makes 

only technical corrections to the May 

2023 final rule, and are not addressed in 

this final rule. 

A. Comments in Support of the 

Amendments 

The Substance Abuse Program 

Administrators Association (SAPAA), a 

nonprofit trade association with a 

membership encompassing third-party 

administrators, in-house program 

administrators, medical review officers 

(MROs), HHS-certified laboratories, 

substance abuse professionals (SAP), 

manufacturers of testing devices, and 

collection sites/collectors, supported 

each of the changes to Part 40 as 

outlined in the DFR and NPRM. SAPAA 

stated that the changes ‘‘emphasize the 

necessity of aligning the regulations 

with practical implementation realities 

and reflect the successful introduction 

of similar guidelines in the past,’’ and 

that ‘‘nothing in these changes would 

negatively impact the ability to train 

DOT oral fluid collectors once 

collection devices are commercially 

available; and, in fact, would facilitate 

that process.’’ 

Airlines for America (A4A) 

commented, stating that it generally 

supports DOT’s efforts in the DFR and 

NPRM to address the issues identified 

regarding the May 2023 final rule. A4A 

suggested that DOT extend the sunset 

date for the regulatory relief under 

§ 40.35(c)(3) to 18 months, instead of 12 

months as proposed. A4A also 

requested that DOT clarify the intent of 

§ 40.35(c)(2)(ii), specifically with 

respect to whether the qualified 

collector under that section is required 

to have conducted oral fluid training 

under Part 40 for a period of at least one 

year. Finally, A4A suggested that DOT 

permit an employee to orally waive the 

prohibition on others ‘‘actually 

witnessing the testing process.’’ 

DOT received one comment 

supporting the clarifying language to 

§ 40.73(c)(2) regarding how collectors 

are to specify that a sufficient volume of 

oral fluid was collected. That 

commenter stated that the amendment 

‘‘brings uniformity to all collectors, 

maintains consistent results, and 

promotes more efficient workflow and 

data from collectors.’’ 

B. Comments in Opposition to the 

Amendments 

DOT received comments from two 

individuals opposing the proposed 

amendment to § 40.73(a)(1) regarding 

who may witness the oral fluid testing 

process. 

DOT received comments opposing the 

DFR and the NPRM from the National 

Drug and Alcohol Screening Association 

(NDASA), a nonprofit association with a 

membership that includes laboratories, 

employers’ substance abuse program 

administrators, compliance auditors, 

consortia/third party administrators (C/ 

TPA), specimen collection facilities, 

collectors, breath alcohol technicians, 

screening test technicians, laboratories, 

MROs, and SAPs. In addition, several 

other organizations and individuals 

provided comments opposing the DFR 

and NPRM by either (1) citing to 

NDASA’s comments as the basis for 

their opposition, or (2) attaching a copy 

of NDASA’s comments as their docket 

submittal. 

In discussing comments on this rule 

and our response to them, we focus on 

the substance of positions that 

commenters expressed, and on why we 

did or did not make changes in 

response. We address each of the 

substantive comments provided to the 

DFR and the NPRM in the discussion of 

the amendments to Part 40 in the 

following section. 

IV. Amendments to Part 40 

A. Section 40.35 What training 

requirements must a collector meet for 

oral fluid collection? 

The May 2023 final rule established 

requirements for oral fluid collector 

qualifications in § 40.35 that mirrored as 

closely as possible existing urine 

collector qualifications in § 40.33. All of 

the qualification training requirement 

categories (i.e., basic information, 

qualification training, initial proficiency 

demonstration, refresher training, error 

correction training, and documentation) 

are identical. Regarding the mock 

collections specified in § 40.35(c), we 

required oral fluid collectors to 

demonstrate proficiency in collections 

by completing five consecutive errorfree mock collections for each device 

they will use. These mock collections 

must be monitored and evaluated by a 

‘‘qualified collector’’ who has 

demonstrated the necessary knowledge, 

skills, and abilities by additionally: (i) 

regularly conducting DOT drug test 

collections for a period of at least one 

year; (ii) conducting collector training 

under this part for at least one year; or 

(iii) successfully completing a ‘‘train the 

trainer’’ course. 

At this time, however, individuals 

wanting to be oral fluid collectors are 

not able to be qualified because there 

are no currently qualified oral fluid 

collectors per § 40.35(c)(2) with the 

additional qualifications at 

§ 40.35(c)(2)(i), (ii), or (iii) to monitor 

and evaluate the trainee’s mock 

collections. In the NPRM, we stated that 

we did not intend to create a factual 

impossibility, and that we meant for the 

oral fluid monitors for the mock 

proficiency demonstrations to be 

proficient as oral fluid collectors. 

To facilitate the training of oral fluid 

collectors, we proposed to amend the 

regulation to authorize individuals to 

monitor mock oral fluid collections 

without meeting the requirement of 

being a qualified oral fluid collector 

specified in § 40.35. To ensure the 

proficiency of the collection monitor, 

we proposed that this regulatory 

flexibility would apply only to those 

individuals meeting the knowledge, 

skills, and abilities in § 40.35(c)(2)(ii) or 

(iii).2 With regard to the knowledge, 

skills, and abilities in § 40.35(c)(2)(ii), 

we proposed to waive the requirement 

that individuals conducting oral fluid 

collector training have at least one year 

of experience conducting collector 

training, but stated that we expect those 

individuals to have a thorough 

understanding of Part 40 and to be well 

versed in the course content they are 

teaching. The course content must meet 

the requirements in § 40.35(b), and 

individuals conducting training should 

maintain good records (for example, the 

course content for the instructor and 

student, the duration of the training, the 

dates the course was taught, who 

attended the course and any certificate 

of successful completion provided to 

students, etc.) to demonstrate that they 

conducted the training. We noted that 

this is no different than what would be 

expected of those conducting urine 


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collection training today. Individuals 

conducting this training would be 

eligible to observe oral fluid mock 

collections during the period of 

regulatory relief. 

We proposed that the regulatory relief 

would sunset one year after HHS 

published a Federal Register notice that 

it certified the first oral fluid drug 

testing laboratory. We stated that we 

would publish a Federal Register 

document specifying the date the first 

oral fluid laboratory was certified by 

HHS and the effective date that 

individuals observing mock collections 

(i.e., monitors) would need to comply 

with the qualified collector 

requirements in § 40.35(c)(2) established 

in the May 2023 final rule so that all 

would be aware of the effective date of 

the regulatory flexibility. 

Comments 

NDASA (and the other commenters 

that echoed NDASA’s comments) 

objected to the proposed change to 

§ 40.35(c), expressing concern that DOT 

was ‘‘lowering its standards’’ by not 

requiring the monitor of the mock oral 

fluid collections to be a qualified oral 

fluid collector under the requirements 

of § 40.35. Instead, NDASA 

recommended that DOT retain the 

language of § 40.35(c)(2) as currently 

written, which it contends would 

permit qualified urine collectors under 

§ 40.33 to serve as monitors for the 

required mock oral fluid collections. 

Specifically, NDASA recommended 

leaving § 40.35(c)(2) unchanged 

because, as it currently reads, a monitor 

must be a ‘‘qualified collector.’’ Under 

the current Part 40, the only qualified 

collectors are urine collectors who meet 

the requirements of § 40.33. Therefore, if 

the Direct Final Rule does not become 

effective, current qualified urine 

collectors who have taken a train the 

trainer class would be able to be the 

monitors of the initial proficiency 

demonstrations required under 

§ 40.35(c). 

NDASA and others also objected to 

language in the preamble stating that 

individuals conducting oral fluid 

collector training under § 40.35(c)(2)(ii) 

‘‘should maintain good records (for 

example, the course content for the 

instructor and student, the duration of 

the training, the dates the course was 

taught, who attended the course and any 

certificate of successful completion you 

may have provided students, etc.) to 

demonstrate that they conducted the 

training.’’ NDASA states that it is the 

responsibility of those receiving the 

training, and not of the trainer, to retain 

proof of their training and its sufficiency 

with Part 40. NDASA believes that the 

preamble language imposes (1) new 

‘‘processes and requirements,’’ and (2) 

an ‘‘additional and arguably redundant 

record-keeping requirement for 

monitors or trainers’’ that were not 

properly evaluated through regulatory 

and cost analyses. 

As noted above, A4A recommended 

that DOT extend the sunset date for the 

regulatory relief under § 40.35(c)(3) to 

18 months, instead of 12 months as 

proposed. 

DOT Response 

While the training and qualification 

requirements for urine collectors and 

oral fluid collectors in Part 40 are 

similar, they are also unique because of 

the differences in the collection site, 

collection equipment and supplies used, 

and the collection process for urine and 

oral fluid specimens. The intent to have 

separate training and qualification 

requirements for urine collectors and 

oral fluid collectors is evident when 

looking at the manner in which Part 40 

was amended in the May 2023 rule that 

authorized—for the first time—the use 

of a specimen other than urine in the 

DOT drug testing program. In the May 

2023 final rule, DOT stated that it had 

‘‘amended § 40.31 to separately specify 

the requirements for collectors of urine 

and oral fluid specimens, respectively.’’ 

(88 FR at 27600) (emphasis added). 

Specifically, § 40.31(b) states that ‘‘A 

urine collector must meet training 

requirements of § 40.33,’’ and § 40.31(c) 

states that ‘‘An oral fluid collector must 

meet training requirements of § 40.35.’’ 

In the May 2023 final rule, DOT 

established requirements for oral fluid 

collector qualifications in a new § 40.35 

that mirrored the existing urine 

collector qualifications in § 40.33 as 

closely as possible. The qualification 

training requirements in the new § 40.35 

for oral fluid collectors directly parallel 

those in the longstanding § 40.33 for 

urine collectors (i.e., Basic Information, 

Qualification Training, Initial 

Proficiency Demonstration, Refresher 

Training, Error Correction Training, and 

Documentation). 

While §§ 40.33 and 40.35 mirror each 

other to the extent possible, there are 

provisions in each section that are 

unique and tailored specifically to the 

particular specimen type (urine or oral 

fluid), recognizing the distinct 

differences between a urine collection 

and an oral fluid collection (i.e., training 

on ‘‘shy bladder’’ collections for urine 

in § 40.33(b)(2), and training on ‘‘dry 

mouth’’ collections for oral fluid in 

§ 40.35(b)(4); completion of a urine 

mock collection for a scenario in which 

the urine temperature is not within the 

acceptable range in § 40.33(c)(1), and 

completion of an oral fluid mock 

collection for a scenario in which the 

employee has something in the 

employee’s mouth that might interfere 

with the collection in § 40.35(c)(1)). 

Beyond the training and qualification 

requirements for collectors in §§ 40.33 

and 40.35, DOT established separate 

requirements for urine and oral fluid 

collections in Subpart D of Part 40, 

‘‘Collection Sites, Forms, Equipment 

and Supplies Used in DOT Urine and 

Oral Fluid Collections’’ (see §§ 40.40– 

40.51), and in Subpart E of Part 40, 

‘‘Specimen Collections’’ (see §§ 40.61– 

40.79). 

Given the above, DOT clarifies that 

under the May 2023 final rule, a 

qualified urine collector (§ 40.33) is not 

a qualified oral fluid collector (§ 40.35), 

and vice-versa. 

Section 40.35(c)(2) requires that a 

‘‘qualified collector’’ monitor and 

evaluate an individual’s performance in 

a series of mock oral fluid collections 

before that individual becomes a 

qualified oral fluid collector. And, per 

§ 40.35(c)(2)(i), (ii), and (iii), the 

qualified collector that will serve as the 

monitor for the mock collections is 

additionally required to have 

demonstrated knowledge, skills, and 

abilities by (1) ‘‘regularly conducting 

DOT drug test collections for a period of 

at least one year’’; or (2) ‘‘conducting 

collector training under Part 40 for at 

least one year’’; or (3) ‘‘successfully 

completing a ‘train the trainer’ course.’’ 

As currently written, § 40.35(c)(2) 

does not expressly state that the 

qualified collector needs to be a 

qualified oral fluid collector. Similarly, 

§§ 40.35(c)(2)(i), (ii), and (iii) do not 

expressly require the qualified collector 

that will serve as the monitor to have: 

(1) regularly conducted DOT oral fluid 

drug test collections for a period of at 

least one year; (2) conducted oral fluid 

collector training under Part 40 for at 

least one year; or (3) successfully 

completed an oral fluid ‘‘train the 

trainer’’ course. 

However, and while § 40.35(c)(2) and 

§ 40.35(c)(2)(i), (ii), and (iii) do not 

expressly state that the qualified 

collector for the oral fluid mock 

collections must be a qualified oral fluid 

collector and have specific experience 

in oral fluid collections or training, DOT 

believes that this is the only reasonable 

interpretation of the requirement as 

written based on (1) the manner in 

which § 40.35 is drafted and, more 

importantly, (2) the fact that a qualified 

urine collector is not a qualified oral 

fluid collector and, therefore, lacks the 

knowledge needed to monitor and attest 

in writing that the mock oral fluid 

collections are error-free. Qualified 


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3 DOT also notes that § 40.209, ‘‘What procedural 

problems do not result in the cancellation of a test 

and do not require corrective action?,’’ provides a 

list of matters that never result in the cancellation 

of a test. Included in that list at § 40.209(b)(3) is 

‘‘The collection of a specimen by a collector who 

is required to have been trained (see § 40.33 or 

40.35), but who has not met this requirement.’’ As 

noted in the December 19, 2000 final rule (65 CFR 

79462), this section is based on a ‘‘general 

principle’’ that ‘‘tests cannot be cancelled based on 

an error that does not have a significant adverse 

effect on the right of the employee to have a fair 

and accurate test. The point of this proposal was to 

prevent administrative or judicial decisions 

invalidating drug tests that were fair and accurate, 

but had certain de minimis irregularities.’’ [65 FR 

79503] DOT went further, and specifically with 

respect to the issue of collector training and 

qualifications, stated ‘‘One of the points we make 

in this section is that a urine collection or an 

alcohol test must not be cancelled solely because 

the collector, BAT, or STT has not met training 

requirements. Such a test would be cancelled only 

if there were a fatal flaw or other circumstances 

requiring cancellation.’’ [Id.] [Emphasis added]. 

This means that if a collector properly conducts a 

urine test in accordance with the provisions of Part 

40 (or an oral fluid test when laboratories have been 

approved) without having met the requirements of 

§ 40.33, the test is not permitted to be cancelled. 

Simply stated, if an individual is not a qualified 

urine or oral fluid collector and that person collects 

a specimen by following Part 40 ‘‘to the letter,’’ the 

collection is a good collection and is not to be 

cancelled. In a similar vein, DOT believes that in 

these beginning stages of oral fluid testing, it is 

appropriate for individuals who are conducting 

collector training, and who are well versed in the 

course content that they are teaching (i.e., their 

instruction follows Part 40 procedures), to be 

qualified to serve as monitors for mock oral fluid 

collections. 

urine collectors do not have the specific, 

detailed knowledge, skills, and abilities 

directly related to oral fluid devices and 

collections to serve as appropriate 

monitors for mock oral fluid collections. 

If DOT had intended to permit qualified 

urine collectors to serve as monitors for 

oral fluid mock collections, it would 

have affirmatively stated so in the 

regulatory text. 

DOT acknowledged in its June 2024 

DFR that it had inadvertently created a 

factual impossibility given the current 

language of § 40.35. There are no 

currently qualified oral fluid collectors 

per § 40.35(c)(2) who meet the 

additional qualifications at 

§ 40.35(c)(2)(i), (ii) or (iii) to monitor 

and evaluate the trainee’s mock 

collections; therefore, no one can be a 

qualified oral fluid collector at this time. 

To best facilitate the timely training of 

oral fluid collectors, DOT continues to 

believe that it is appropriate to 

authorize individuals to monitor mock 

oral fluid collections without meeting 

the requirement of being a qualified oral 

fluid collector, specified in § 40.35 as 

proposed in the NPRM. As discussed 

above, qualified urine collectors are not 

qualified oral fluid collectors, and they 

are similarly not qualified to monitor 

and evaluate a trainee’s performance in 

oral fluid mock collections merely 

because they are qualified in urine 

collections. As qualified urine collectors 

are not qualified to serve in this role, 

and because there are no qualified oral 

fluid collectors to serve in the same role, 

this rule permits individuals who are 

not qualified oral fluid collectors to 

serve as monitors for oral fluid mock 

collections provided that they meet 

certain requirements. 

Specifically, to ensure the proficiency 

of collection monitors, this regulatory 

flexibility—consistent with what we 

proposed in the NPRM—will apply only 

to those individuals meeting the 

knowledge, skills, and abilities in 

§ 40.35(c)(2)(ii) or (iii). With regard to 

the knowledge, skills, and abilities in 

§ 40.35(c)(2)(ii), we are waiving the 

requirement that individuals conducting 

oral fluid collector training have at least 

one year of experience conducting 

collector training, but we expect those 

individuals to have a thorough 

understanding of Part 40 and to be well 

versed in the course content they are 

teaching. The course content must meet 

the requirements in § 40.35(b), and 

individuals conducting training should 

maintain good records (for example, the 

course content for the instructor and 

student, the duration of the training, the 

dates the course was taught, who 

attended the course, any certificate of 

successful completion provided to the 

students, etc.) to demonstrate that they 

conducted the training. This is no 

different than what would be expected 

of those conducting urine collection 

training today. Individuals conducting 

Part 40 oral fluid training would be 

eligible to observe oral fluid mock 

collections during the period of 

regulatory relief.3

As noted above, DOT specified in the 

preamble to the June 2024 DFR and 

NPRM that individuals conducting 

training should maintain good records 

to demonstrate that they conducted the 

training; however, DOT did not include 

regulatory text in the DFR, or propose 

regulatory text in the NPRM, regarding 

record retention requirements or 

expectations for oral fluid collector 

trainers. DOT also does not require in its 

Part 40 regulations that such records 

should or must be maintained—for 

trainers of urine collectors, breath 

alcohol technicians, or oral fluid 

collectors. Instead, the preamble 

language in the June 2024 DFR and 

NPRM stating that individuals 

conducting oral fluid collector training 

should keep certain records of these 

training sessions was based on our 

expectation that individuals conducting 

collector training would normally be 

retaining those records as a business 

best practice. NDASA and others 

objected to the same preamble language 

in the NPRM, contending that the 

preamble language imposed new 

standards and documentation retention 

requirements for monitors of mock 

collections. 

The commenters are correct in stating 

that Part 40 requires urine and oral fluid 

collectors and breath alcohol 

technicians to maintain documentation 

showing that they meet all of the 

requirements to collect DOT specimens 

(see § 40.33(g), 40.35(g), and 40.213(g), 

respectively). In this final rule, DOT is 

not establishing any new regulatory 

requirement that monitors, trainers, 

and/or trainees retain specific records of 

the training materials used to qualify the 

trainees. 

A4A recommended extending the 

sunset provision from 12 months, as 

proposed, to 18 months because it 

believes that 12 months is insufficient 

for the industry to establish the 

necessary number of qualified collectors 

to train all other collectors in the oral 

fluid collecting process. A4A contends 

that ‘‘This difficulty is exacerbated for 

airlines, which operate globally and in 

remote locations . . . that make it 

unreasonable to expect the 

establishment of the necessary cadre of 

qualified collectors exactly one year 

after publication that can train other 

collectors.’’ 

DOT does not believe that it is 

necessary to extend the sunset date 

beyond 12 months, as proposed. In its 

comments, NDASA stated that it alone 

has trained ‘‘several hundred’’ trainers 

through its train-the-trainer course since 

the issuance of DOT’s oral fluid rule in 

May 2023. This—coupled with the 

regulatory flexibility established in this 

rule—will ensure that there are a 

sufficient number of qualified oral fluid 

collectors within the first year of 

laboratories being certified without the 

need for an extended sunset date. 

As noted above, while §§ 40.35(c)(2) 

and 40.35(c)(2)(i), (ii), and (iii) do not 

expressly state that the qualified 

collector for the oral fluid mock 

collections must be a qualified oral fluid 

collector and have specific experience 

in oral fluid collections or training, DOT 

believes that this is the only reasonable 

interpretation of the requirement as 

written based on: (1) The manner in 

which § 40.35 is drafted, and more 

importantly, (2) the fact that a qualified 

urine collector is not a qualified oral 

fluid collector, and therefore, lacks the 

knowledge needed to monitor and attest 

in writing that the mock oral fluid 

collections are error-free. To clarify this, 

and consistent with our stated intent, 

we have amended the language in those 


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87796 Federal Register / Vol. 89, No. 214 / Tuesday, November 5, 2024 / Rules and Regulations 

sections to specifically refer to ‘‘oral 

fluid’’ where necessary. For the same 

reasons, we have similarly amended the 

language in § 40.33(c)(2) and 

§§ 40.33(c)(2)(i), (ii), and (iii) regarding 

urine mock collections to refer 

specifically to ‘‘urine’’ where necessary. 

B. Section 40.73 How is an oral fluid 

specimen collected? (persons allowed in 

the testing room) 

DOT intended in the May 2023 final 

rule that the procedures for oral fluid 

testing parallel the alcohol testing 

procedures found in § 40.223(b), which 

requires the breath alcohol technician 

(BAT) or screening test technician (STT) 

to prohibit anyone other than the BAT 

or STT, the employee, or a DOT 

representative from witnessing the 

testing process. Such a provision also 

affords privacy to the employee being 

tested. 

In the NPRM, DOT proposed to 

correct the inadvertent omission of this 

provision from its oral fluid testing 

requirements. Specifically, we proposed 

to add a new paragraph to the regulation 

instructing the oral fluid collector not to 

allow anyone other than the collector, 

the employee being tested, or a DOT 

agency representative to witness the 

testing process. This instruction 

parallels the alcohol testing procedure 

found in § 40.223(b) and would afford 

the employee privacy during testing. 

Comments 

Two individuals opposed the 

proposed amendment, stating that 

restricting who may be present during 

the testing process to the collector, the 

employee, or a DOT agency 

representative is too restrictive and will 

hinder the ability of collection sites to 

train new staff and monitor for ongoing 

quality assurance. And, as noted earlier, 

A4A recommended that because the oral 

fluid testing process does not include 

immediate testing results or require 

exposure of private body parts, DOT 

‘‘should empower the employee to 

orally waive the prohibition on others 

‘actually witness[ing] the testing 

process.’ ’’ A4A believes that doing so 

may materially improve the efficiency of 

the collection process. 

DOT Response 

Part 40 outlines the steps that must be 

taken to protect the security of urine, 

oral fluid, and alcohol testing sites, 

including identifying who is considered 

to be an ‘‘authorized person’’ who is 

permitted to enter the testing site (see 

§ 40.43(e)(1), § 40.48(d)(1), and 

§ 40.223(a)(1), respectively). In each 

case, these authorized persons are 

limited to the individual being tested, 

the collector/BAT/STT and other 

collection/testing site workers, DERs, 

employee and employer representatives 

authorized by the employer (e.g., 

representatives authorized pursuant to 

an employer policy or collective 

bargaining agreement), and DOT agency 

representatives. 

However, who may enter the testing 

site differs from who is permitted to 

actually witness the collection/testing 

process. Beyond identifying who is an 

‘‘authorized person’’ that is permitted to 

enter a drug or alcohol testing site, Part 

40 identifies who may actually witness 

the collection/testing process for drug 

and alcohol tests. Prior to the approval 

of oral fluid testing, this was limited to 

urine drug testing and alcohol testing. 

Because of the privacy concerns 

associated with urine testing, 

§ 40.43(e)(2) expressly prohibits the 

collector from permitting anyone to 

enter the urination facility in which 

employees provide specimens (i.e., 

actually witness the collection process) 

except for the observer in a directly 

observed collection or the monitor in a 

monitored collection. While alcohol 

tests are observed tests, § 40.223(b) has 

long prohibited BATs and STTs from 

permitting any person besides the BAT 

or STT, the employee, or a DOT agency 

representative to ‘‘actually witness the 

testing process.’’ 

While Part 40 limits who is an 

‘‘authorized person’’ that may be at the 

testing site, those authorized persons 

include other collection site workers. 

DOT understands the concerns 

articulated by the commenters, but we 

believe that limiting who may actually 

witness the oral fluid testing process, 

similar to what has been done for 

decades for alcohol testing, will not 

unduly restrict a collection site from 

conducting training or monitoring for 

ongoing quality assurance given that 

other collection site workers (including 

other collectors) may be present at the 

testing site. Oral fluid drug tests, like 

alcohol tests, are observed tests. As 

noted in the NPRM, it was our intention 

in the May 2023 final rule that the 

procedures for oral fluid testing parallel 

the alcohol testing procedure found in 

§ 40.223(b), which requires the BAT or 

STT to prohibit anyone other than the 

BAT or STT, the employee, or a DOT 

representative to witness the testing 

process. 

We do not believe that there would be 

any material efficiency gains to be 

realized in the oral fluid testing process 

by permitting employees to orally waive 

the prohibition on others actually 

witnessing the testing process, as 

suggested by A4A. We believe that it is 

important to maintain consistency in 

the DOT drug and alcohol testing 

program and process and will continue 

to limit who may witness the oral fluid 

testing process to the collector, the 

employee, and a DOT agency 

representative. As noted above and in 

the NPRM, limiting who may actually 

witness the oral fluid testing process 

also affords privacy to the employee 

being tested even though we recognize 

that the privacy interest for oral fluid is 

not as heightened as for urine testing. 

Given the above, we have retained the 

amendment to § 40.73(a)(1) as proposed 

in the NPRM. 

C. Section 40.73 How is an oral fluid 

specimen collected? (specification of the 

collection of a sufficient amount of oral 

fluid) 

The current § 40.73(c)(2) requires the 

oral fluid collector to ensure that a 

sufficient specimen volume is collected. 

To be more specific and provide our 

interpretation of how collectors ensure 

that a sufficient volume is collected, we 

proposed to require the collector to also 

check the ‘‘Volume Indicator(s) 

Observed’’ box in Step 2 of the CCF. 

Specifically, we proposed to add 

language to § 40.73(c)(2) to instruct the 

collector to document in Step 2 of the 

CCF that they observed the volume 

indicator(s) during the collection. 

Comments 

NDASA provided the only comment 

on this issue and stated that the 

collector should not be relying on the 

volume indicator until after the 

specimen is collected. As such, NDASA 

recommended revising the proposed 

language to read as follows: ‘‘After the 

employee provides a sufficient 

specimen, check the ‘‘Volume 

[I]ndicator(s) Observed’’ box in Step 2 of 

the Federal CCF to document that you 

observed the volume indicator(s).’’ 

DOT Response 

DOT agrees with this editorial 

suggestion, and has incorporated the 

revised language as suggested. 

D. Other Comments 

While acknowledging that the 

language of the regulatory provisions of 

the DFR/NPRM does not prevent 

qualified trainers from beginning to 

train oral fluid collectors before HHS 

certifies a laboratory to conduct oral 

fluid testing, NDASA contends that the 

preamble to the DFR sets an ‘‘artificial 

barrier’’ to NDASA members and other 

qualified trainers from doing so, thereby 

‘‘causing a detrimental financial burden 

to small businesses.’’ Specifically, 

NDASA stated ‘‘Delaying collector 

training until after laboratories are HHSVerDate Sep<11>2014 16:29 Nov 04, 2024 Jkt 265001 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 E:\FR\FM\05NOR1.SGM 05NOR1

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Federal Register / Vol. 89, No. 214 / Tuesday, November 5, 2024 / Rules and Regulations 87797 

4Section 40.35(b)(2) requires oral fluid collectors 

to be trained to proficiency ‘‘in the operation of the 

particular oral fluid collection device(s) you will be 

using.’’ 

certified will cause small businesses 

that have met the train the trainer 

requirements to suffer the loss of 

training revenue.’’ In addition, NDASA 

anticipates that if the process of training 

collectors and conducting those 

collectors’ proficiency demonstrations is 

delayed until after HHS certifies 

laboratories for oral fluid testing, that 

there will be a ‘‘rush on the market’’ to 

obtain approved oral fluid collection 

devices causing: (1) potential shortages 

of inventory, and (2) price increases 

because demand may exceed supply, 

and concluded that ‘‘small businesses 

will bear the brunt of these problems 

and costs.’’ 

NDASA stated that ‘‘There is no need 

to wait for laboratories to be certified by 

the HHS National Laboratory 

Certification Program (NLCP) before the 

training of individuals to collect oral 

fluid specimens can begin.’’ In addition, 

NDASA stated that delaying collector 

training until after HHS certifies 

laboratories will ‘‘create a shortage of 

properly trained and qualified oral fluid 

collectors from being able to collect 

specimens for possibly months after the 

first laboratories are certified.’’ Finally, 

NDASA stated that delaying training 

and qualification of oral fluid collectors 

until after HHS certifies laboratories 

will further delay full implementation 

of the oral fluid rule provisions, 

including § 40.67(g)(3), which requires 

oral fluid collections to be conducted in 

specified scenarios. 

DOT Response 

The purpose of the amendment to 

§ 40.35 is to facilitate the timely 

qualification of oral fluid collectors. 

However, oral fluid specimens cannot 

be collected, and DOT oral fluid testing 

cannot be implemented, until HHS 

certifies at least two laboratories, one to 

serve as a primary laboratory, and a 

second to serve as a split specimen 

laboratory, and until there is a device 

that meets DOT requirements per 

Appendix B of Part 40. As part of the 

laboratory application and certification 

process, a specific oral fluid collection 

device will be identified and approved 

for use by that laboratory by HHS and 

NLCP. To date, HHS has not yet 

certified any laboratories for oral fluid 

drug testing with a device that meets 

DOT standards. It follows that no oral 

fluid collection devices meeting DOT’s 

device standards have been approved as 

part of the HHS/NLCP lab certification. 

At the same time, DOT acknowledges 

that oral fluid collection devices are 

currently available and are being used 

for non-DOT oral fluid drug testing 

purposes. Further, NDASA states that 

there is an oral fluid collection device 

that has been approved for use by the 

Food and Drug Administration (FDA), 

and that several laboratories expect to 

use that same device when submitting 

applications to HHS/NLCP for 

certification at some point in the future. 

DOT anticipated that oral fluid 

trainers and prospective oral fluid 

collectors would wait until a specific 

oral fluid collection device meeting 

DOT’s standards had been approved by 

HHS/NLCP as part of the official 

laboratory certification process before 

conducting and obtaining training on 

how to use that specific device. 

Otherwise, trainers and prospective 

collectors would be risking the 

expenditure of significant time and 

costs to become trained in the operation 

of an oral fluid collection device that 

may not ultimately be approved as part 

of a laboratory’s certification by HHS/ 

NLCP. 

DOT did not intend to prevent 

individuals from training on devices to 

collect oral fluid specimens before HHS 

certifies a laboratory and use of an 

associated oral fluid collection device. 

As noted above, training on an oral fluid 

collection device that has not been 

approved for use as part of an official 

HHS laboratory certification package 

comes with the risk that the device may 

not be ultimately included and 

approved for use by a laboratory by 

HHS.4 This risk is borne entirely by the 

trainer and prospective collector, as 

DOT does not have any role in 

determining which particular oral fluid 

collection device is submitted by a 

laboratory to HHS as part of the 

laboratory’s approval/certification. 

Because there is no regulatory 

requirement to wait until the first 

laboratory is certified by HHS before 

beginning training on the use of oral 

fluid collection devices, there is no 

detrimental financial burden or loss of 

training revenue to those small 

businesses that have taken train-thetrainer courses. Additionally, while 

NDASA expressed concern that: (1) 

sufficient quantities of approved oral 

fluid collection devices may not be 

available if training is delayed until 

after laboratories have been certified, 

and (2) suppliers of those devices may 

increase the price of those devices 

because demand may exceed supply, 

DOT does not believe there will be any 

issues regarding market availability or 

cost of the devices for training purposes. 

Importantly, and as discussed above, 

DOT makes it clear that while training 

on the use of an oral fluid collection 

device can take place at any time— 

including prior to the certification by 

HHS of an oral fluid drug testing 

laboratory—mock collections (and 

therefore, qualification of oral fluid 

collectors) cannot take place unless/ 

until DOT provides regulatory flexibility 

with respect to the qualifications of the 

monitors for the required mock 

collections, which DOT accomplishes in 

this final rule. Therefore, because 

§ 40.35(b)(2) requires oral fluid 

collectors to be trained to proficiency in 

the operation of the particular oral fluid 

collection device(s) that the collector 

will be using, an individual becoming a 

qualified oral fluid collector on a 

specific oral fluid device before a 

laboratory is certified by HHS to use 

that device risks having to (1) receive 

training to proficiency on another 

device, and (2) complete the mock 

collections on that other device if the 

laboratory is not ultimately certified by 

HHS to use the device that the collector 

was originally trained on and qualified 

to use. 

IV. Regulatory Notices and Analyses 

This 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 

impacts beyond those analyzed in the 

May 2, 2023 final rule. DOT has 

determined that the regulatory analyses 

conducted for the May 2, 2023 final rule 

remain applicable to this action. DOT 

makes these statements on the basis 

that, as a series of technical 

amendments that correct or clarify 

existing regulatory provisions, 

specifically to establish temporary 

requirements to qualify an initial group 

of mock oral fluid collection observers, 

establish privacy requirements during 

an oral fluid collection, and clarify how 

collectors are to document that a 

sufficient volume of oral fluid was 

collected, this action will not impose 

any significant costs or have impacts 

beyond those analyzed in the May 2, 

2023 final rule. 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. DOT will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 


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87798 Federal Register / Vol. 89, No. 214 / Tuesday, November 5, 2024 / Rules and Regulations 

States. This rule does not constitute a 

major rule as defined in 5 U.S.C. 804(2). 

In accordance with Compliance with 

Pay-As-You-Go Act of 2023 (Fiscal 

Responsibility Act of 2023, Pub. L. 118– 

5, D. B, Title III) and OMB 

Memorandum (M–23–21) dated 

September 1, 2023, the Department has 

determined that this final 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 

procedures, Alcohol abuse, Alcohol 

testing, Drug abuse, Drug testing, 

Laboratories, Reporting and 

recordkeeping requirements, Safety, 

Transportation. 

For the reasons stated in the 

preamble, DOT amends 49 CFR part 40 

as follows: 

PART 40—PROCEDURES FOR 

TRANSPORTATION WORKPLACE 

DRUG AND ALCOHOL TESTING 

PROGRAMS 

■ 1. The authority citation for Part 40 

continues to read as follows: 

Authority: 49 U.S.C. 102, 301, 322, 5331, 

20140, 31306, and 45101 et seq. 

■ 2. In § 40.33, revise paragraph (c)(2) to 

read as follows: 

§ 40.33 What training requirements must a 

collector meet for urine collection? 

* * * * * 

(c) * * * 

(2) Another person must monitor and 

evaluate your performance, in person or 

by a means that provides real-time 

observation and interaction between the 

instructor and trainee, and attest in 

writing that the mock collections are 

‘‘error-free.’’ This person must be a 

qualified urine collector who has 

demonstrated necessary knowledge, 

skills, and abilities by— 

(i) Regularly conducting DOT urine 

drug test collections for a period of at 

least one year; 

(ii) Conducting urine collector 

training under this part for at least one 

year; or 

(iii) Successfully completing a urine 

‘‘train the trainer’’ course. 

* * * * * 

■ 3. In § 40.35, revise paragraph (c)(2) 

and add paragraph (c)(3) to read as 

follows: 

§ 40.35 What training requirements must a 

collector meet for oral fluid collection? 

* * * * * 

(c) * * * 

(2) Another person must monitor and 

evaluate your performance, in person or 

by a means that provides real-time 

observation and interaction between 

you and the qualified collector, who 

must attest in writing that the mock 

collections are ‘‘error-free.’’ Except as 

provided in paragraph (c)(3) of this 

section, this person must be a qualified 

oral fluid collector who has 

demonstrated necessary knowledge, 

skills, and abilities by— 

(i) Regularly conducting DOT oral 

fluid drug test collections for a period 

of at least one year; 

(ii) Conducting oral fluid collector 

training under this part for at least one 

year; or 

(iii) Successfully completing an oral 

fluid ‘‘train the trainer’’ course. 

(3) As the person monitoring and 

evaluating the collector’s five mock 

collections pursuant to paragraphs (c)(1) 

and (2) of this section, you need not be 

a qualified oral fluid collector to do so 

if you meet the necessary knowledge, 

skills, and abilities in paragraph 

(c)(2)(ii) or (iii) until otherwise specified 

(one year after HHS publishes a Federal 

Register notification of the first certified 

oral fluid drug testing laboratory (HHS 

notification)). Furthermore, the one-year 

requirement in paragraph (c)(2)(ii) is not 

applicable until otherwise specified 

(one year after the HHS notification). 

* * * * * 

■ 4. In § 40.73, add paragraph (a)(1) and 

a reserved paragraph (a)(2) and revise 

paragraph (c)(2) to read as follows: 

§ 40.73 How is an oral fluid specimen 

collected? 

* * * * * 

(a) * * * 

(1) As the oral fluid collector, you 

must not allow any person other than 

you, the employee, or a DOT agency 

representative to actually witness the 

testing process. 

(2) [Reserved] 

* * * * * 

(c) * * * 

(2) The collector must ensure the 

collection is performed correctly (i.e., 

using the oral fluid device in the 

manner described by its manufacturer), 

that the collection device is working 

properly, and that a sufficient specimen 

volume is collected. After the employee 

provides a sufficient specimen, check 

the ‘‘Volume Indicator(s) Observed’’ box 

in Step 2 of the Federal CCF to 

document that you observed the volume 

indicator(s) during the collection. 

* * * * * 

Signed pursuant to authority delegated at 

49 CFR 1.27(c) in Washington, DC. 

Subash Iyer, 

Acting General Counsel. 

[FR Doc. 2024–25403 Filed 11–4–24; 8:45 am] 

BILLING CODE 4910–9X–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 679 

[Docket No. 240304–0068; RTID 0648– 

XE445] 

Fisheries of the Exclusive Economic 

Zone Off Alaska; Reallocation of 

Pacific Cod in the Bering Sea and 

Aleutian Islands Management Area 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; reallocation. 

SUMMARY: NMFS is reallocating the 

projected unused amount of Pacific cod 

from trawl catcher vessels and from 

catcher vessels greater than or equal to 

60 feet (18.3 meters (m)) length overall 

(LOA) using pot gear to catcher vessels 

less than 60 feet (18.3 m) LOA using 

hook-and-line or pot gear, Amendment 

80 vessels, and catcher/processors using 

hook-and-line gear in the Bering Sea 

and Aleutian Islands management area 

(BSAI). This action is necessary to allow 

the 2024 total allowable catch (TAC) of 

Pacific cod to be harvested. 

DATES: Effective October 31, 2024, 

through 2400 hours, Alaska local time 

(A.l.t.), December 31, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Andrew Olson, 907–586–7228. 

SUPPLEMENTARY INFORMATION: NMFS 

manages the groundfish fishery in the 

BSAI according to the Fishery 

Management Plan for Groundfish of the 

Bering Sea and Aleutian Islands 

Management Area (FMP) prepared by 

the North Pacific Fishery Management 

Council under authority of the 

Magnuson-Stevens Fishery 

Conservation and Management Act 

(Magnuson-Stevens Act). Regulations 

governing fishing by U.S. vessels in 

accordance with the FMP appear at 

subpart H of 50 CFR parts 600 and 679. 

The 2024 Pacific cod TAC specified 

for trawl catcher vessels in the BSAI is 

28,754 mt as established by the final 

2024 and 2025 harvest specifications for 

groundfish in the BSAI (89 FR 17287, 

March 11, 2024) and reallocations (89 

FR 67327, August 20, 2024 and 89 FR 

79454, September 30, 2024). 


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