11156 Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Proposed Rules 

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: Addition of Oral Fluid 

Specimen Testing for Drugs 

AGENCY: Office of the Secretary, U.S. 

Department of Transportation (DOT). 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The U.S. Department of 

Transportation is proposing to amend 

the transportation industry drug testing 

program procedures regulation to 

include oral fluid testing. This will give 

employers a choice that will help 

combat employee cheating on urine 

drug tests and provide a more 

economical, less intrusive means of 

achieving the safety goals of the 

program. The proposal includes other 

provisions to update the Department’s 

regulation, and to harmonize, as needed, 

with the new Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs using Oral Fluid established 

by the U.S. Department of Health and 

Human Services. 

DATES: Comments to the notice of 

proposed rulemaking should be 

submitted by March 30, 2022. Late-filed 

comments will be considered to the 

extent practicable. 

ADDRESSES: To ensure that you do not 

duplicate your docket submissions, 

please submit them by only one of the 

following means: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov and follow 

the online instructions for submitting 

comments. 

• Mail: Docket Management Facility, 

U.S. Department of Transportation, 1200 

New Jersey Ave. SE, West Building 

Ground Floor Room W12–140, 

Washington, DC 20590–0001. 

• Hand delivery: West Building 

Ground Floor, Room W–12–140, 1200 

New Jersey Ave. SE, between 9 a.m. and 

5 p.m., Monday through Friday, except 

Federal holidays. The telephone number 

is 202–366–9329. 

Instructions: To ensure proper 

docketing of your comment, please 

include the agency name and docket 

number DOT–OST–2021–0093 or the 

Regulatory Identification Number (RIN), 

2105–AE94 for the rulemaking at the 

beginning of your comments. All 

comments received will be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. 

FOR FURTHER INFORMATION CONTACT: 

Patrice M. Kelly, JD, 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. Purpose 

The Department of Transportation 

(DOT) is issuing this notice of proposed 

rulemaking (NPRM) to revise part 40 of 

title 49 of the Code of Federal 

Regulations (Part 40), ‘‘Procedures for 

Transportation Workplace Drug and 

Alcohol Testing Programs’’ to add the 

oral fluid testing procedures to the 

existing urine drug testing procedures 

for safety-sensitive transportation 

employees subject to drug testing under 

Part 40 (hereinafter referred to as 

‘‘employees’’). This action is based on 

the Department of Health and Human 

Services’ (HHS) establishment of the 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs using 

Oral Fluid (OFMG) for Federal 

workplace drug testing programs. HHS 

determined that oral fluid testing 

conducted in accordance with the 

OFMG provides ‘‘the same scientific 

and forensic supportability of drug test 

results as the Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs using Urine . . . .’’ (84 FR 

57554). The OFMG final rule was 

published on October 25, 2019, and 

became effective January 1, 2020. 

In addition to adding oral fluid as a 

drug testing method and harmonizing 

with pertinent OFMG sections, we also 

propose to clarify certain Part 40 

provisions that cover urine drug testing 

procedures; to remove provisions that 

no longer are necessary; to add 

clarifying language to other provisions 

such as updated definitions and web 

links, as appropriate; and to update 

provisions to reflect issues that have 

arisen in recent practice. 

II. 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 HHS Mandatory 

Guidelines, including amendments, into 

the Department’s regulations for testing 

and laboratory requirements for 

aviation, rail, motor carrier, and transit 

testing. Additional authority at 5 U.S.C. 

7301 note and Executive Order 12564, 

establish 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. Effective January 1, 2020, 

the OFMG allowed the option to use 

oral fluid specimens for Federal drug 

testing. As described in the OFMG 

rulemaking, the advantage of every oral 

fluid collection is that it will be directly 

observed, as opposed to most urine 

collections, which are unobserved. 

While directly observed urine specimen 

collections have long been the most 

effective method for preventing 

individuals from cheating on their drug 

tests by substituting or adulterating their 

specimens, directly observed urine 

collection may only be done in certain 

circumstances due to employee privacy 

concerns (see 49 CFR 40.67). Unlike 

directly observed urine collections, an 

oral fluid collection is much less 

intrusive on the tested employee’s 

privacy. By providing the option of 

collecting an oral fluid specimen, DOT 

is broadening options for the testing of 

safety-sensitive employees in the 

transportation industries. As discussed 

below, oral fluid collection can also 

reduce costs of compliance with Part 40. 

III. Background 

On November 21, 1988, the 

Department first published its drug 

testing program procedures regulation, 

Part 40, as an interim final rule (53 FR 

47002). The Department based the 

scientific requirements in that rule on 

the 1988 HHS Mandatory Guidelines for 

Federal Agency Employee Drug Testing 

Programs (53 FR 11970, Apr. 11, 1988), 

which set forth the scientific procedures 

for laboratories to analyze urine 

specimens for the presence of specified 

drugs at the HHS-required cutoff levels 

for the initial and confirmation tests for 

each specific drug in urine testing. 

These cutoff levels for urine were 

established at levels to show prohibited 

use of the specified drugs. 

When the Department adopted its first 

drug testing final rule, we established a 

procedure for urine collections 

generally to take place with visual and 

aural privacy afforded to each 

employee, unless suspicious activity 

under 49 CFR 40.25(f)(14), (16) and (23) 

(53 FR 47002, Nov. 21, 1988) called for 


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a direct observed collection (i.e., bodyto-bottle observation). In December of 

2000, the Department comprehensively 

rewrote Part 40 into plain language. The 

direct observation provisions for urine 

were placed in 49 CFR 40.67, with the 

body-to-bottle observation requirement 

remaining unchanged. (65 FR 79462, 

Dec. 19, 2000). 

Urine collections are potentially 

invasive searches and seizures of private 

citizens, subject to scrutiny under the 

Fourth Amendment of the United States 

Constitution. Consequently, the 

Department has always approached the 

collection of urine from transportation 

safety-sensitive employees with a 

concern for employee privacy, which 

must be balanced carefully against the 

Department’s need to protect 

transportation safety. The Department 

protects individual rights by ensuring 

visual and aural privacy for employees 

undergoing urine testing. Allowing 

directly observed collections only for 

‘‘cause’’ (i.e., suspicious activity at the 

collection site or as determined by the 

laboratory testing of a specimen) is 

another protection. Yet, because the vast 

majority of DOT-regulated urine drug 

collections are unobserved, the program 

remains vulnerable to cheating by 

employees at the collection site, which 

can result in adulteration or 

substitution. 

In June 2008, the Department added 

provisions to strengthen directly 

observed collection requirements to 

include more effective observation 

procedures and expanded the 

circumstances that would warrant a 

direct observation procedure to address 

cheating on drug tests. (73 FR 35961, 

June 25, 2008). Although the 2008 final 

rule was challenged in court and 

initially stayed, the stay was lifted, and 

the final rule was reinstated. (74 FR 

37949, July 30, 2019). This action was 

based on the unanimous decision of the 

United States Court of Appeals for the 

District of Columbia Circuit. The court’s 

decision affirmed the Department’s 

enhanced direct observation procedures 

to prevent the use of prosthetic devices 

used for cheating and to expand direct 

observation to tests of people who had 

already violated the rules (e.g., returnto-duty and follow-up tests for persons 

who had tested positive or refused to 

test). See BNSF Railway Company v. 

Department of Transportation, 566 F.3d 

200 (D.C. Cir. 2009). 

Before the Department’s move to 

expand the direct observation 

procedures, HHS was aware of the 

potential for cheating on urine tests and 

had begun its own rulemaking to 

explore alternative testing methods. In 

2004, HHS solicited public comment 

upon the following alternative testing 

methods, all of which would be directly 

observed: oral fluid, hair, and sweat 

testing. (69 FR 19673, Apr. 13, 2004). 

HHS stated: ‘‘Addition of these 

specimens to the Federal Workplace 

Drug Testing Program would 

complement urine drug testing and aid 

in combating the threat from industries 

devoted to subverting drug testing 

through adulteration, substitution, and 

dilution.’’ (Id. at 19675). HHS noted that 

there were problems with all three of 

the proposed alternative matrices but 

asked for additional scientific 

information and sought information on 

appropriate levels for proficiency testing 

for these alternatives. 

While the science supporting oral 

fluid testing did not meet the standards 

of HHS in 2004, science and research 

studies have now reached a point where 

HHS is able to determine that oral fluid 

testing is an appropriate alternative 

testing method for identifying illicit 

drug use in the Federal workplace. As 

such, HHS proposed adding oral fluid 

testing to the Federal employee 

workplace testing program (80 FR 

28054, May 15, 2015) and finalized this 

proposal, which became effective for 

Federal employee workplace testing on 

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

2019). 

The Department is proposing to add 

oral fluid testing as an alternative 

testing method because, as noted above, 

it has been determined by HHS to be 

scientifically viable for Federal 

workplace programs and because it 

provides a directly observed collection 

for every test. The collection of oral 

fluid is less invasive than directly 

observed urine collection and, therefore, 

is consistent with the careful balancing 

of an individual’s right to privacy with 

the Department’s strong interest in 

preserving transportation safety by 

deterring illicit drug use. 

The Department’s testing statutes 

specifically require that the Department 

incorporate the HHS Mandatory 

Guidelines, which are scientific and 

technical guidelines that ‘‘establish 

comprehensive standards for all aspects 

of laboratory-controlled substances 

testing’’ to ensure full reliability and 

accuracy in testing. Because HHS has 

published its final OFMG, thereby 

approving oral fluid testing as a reliable 

means of detecting illicit drug use for 

Federal employees, the Department is 

proposing to allow, but not require, oral 

fluid specimen testing as an alternative 

method under Part 40, for use by DOTregulated employers for required 

transportation industry workplace 

testing. Specifically, we are seeking 

comments as to whether there are 

circumstances where either urine or oral 

fluid should be mandatory. We are also 

proposing to amend some of our 

provisions that pertain to both urine and 

oral fluid testing to harmonize with 

pertinent sections of the urine and oral 

fluid HHS Mandatory Guidelines. We 

are proposing to clarify certain existing 

Part 40 provisions that cover the 

handling of urine specimens, remove 

provisions that are no longer necessary 

(such as erroneous compliance dates), 

add clarifying language to other 

provisions (such as updated definitions 

and web links where necessary), and 

modify a few substantive provisions to 

address issues that have arisen in 

practice (such as whether a test 

cancelled by a medical review officer 

(MRO) can ever be uncancelled, and 

whether a Substance Abuse Professional 

(SAP) should be allowed to conduct 

evaluations virtually). 

IV. Principal Policy Considerations 

Oral Fluid as an Alternative Drug 

Testing Method for Workplace Testing 

Since 2004, when HHS previously 

considered oral fluid testing, the 

scientific viability of that testing has 

advanced. In its 2019 final rule, HHS 

stated that ‘‘[t]he scientific basis for the 

use of oral fluid as an alternative 

specimen for drug testing has now been 

broadly established and the advances in 

the use of oral fluid in detecting drugs 

have made it possible for this alternative 

specimen to be used in Federal 

programs with the same level of 

confidence that has been applied to the 

use of urine.’’ (84 FR 57554; Oct. 25, 

2019). Importantly, HHS stated that its 

‘‘OFMG provide the same scientific and 

forensic supportability of drug test 

results as the Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs using Urine . . . .’’ Id. 

In its 2019 OFMG, HHS recognized 

that products have emerged that can 

help people to adulterate a urine 

specimen. HHS emphasized that 

establishing oral fluid as a testing 

method would allow Federal agencies 

greater flexibility to address testing 

needs while minimizing the opportunity 

for specimen adulteration or 

substitution. (84 FR 57554, 57571; Oct. 

25, 2019). 

Adulterating and substituting 

unobserved urine specimens is not a 

new issue to drug testing. In upholding 

the Office of Drug and Alcohol Policy 

and Compliance’s (ODAPC) 2008 final 

rule allowing additional direct 

observation procedures, the U.S. Court 

of Appeals for the District of Columbia 

Circuit recognized the ‘‘cheating’’ 

problem: ‘‘especially in light of 


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evidence of a growing proliferation of 

products that facilitate cheating on drug 

tests, the Department solicited comment 

on additional procedures to strengthen 

testing integrity.’’ BNSF Railway v. US 

Department of Transportation, 566 F.3d 

at 202. 

In the BNSF court case, the D.C. 

Circuit upheld directly observed urine 

collections under the specific 

circumstances imposed by the 

Department because of the imminent 

threat of individuals cheating on drug 

tests. The court acknowledged that ‘‘the 

Department determined that it was ‘not 

practicable’ to ignore the cheating 

problem.’’ Id. at 204. The court also 

accepted that oral fluid testing was not 

an acceptable method because HHS had 

not yet approved any specimen testing 

except urine. Id. at 205. With all of this 

considered, the court upheld the 

Department’s direct observation 

procedures. Id. at 208–209. If the 

proposal to allow oral fluid testing is 

adopted, we could allow the use of oral 

fluid testing in lieu of observed urine 

tests to assist in addressing the cheating 

problem acknowledged in the BNSF 

case. 

While the Department does not have 

data on how much cheating is 

occurring, the problem exists and poses 

a direct threat to transportation safety. 

The court in BNSF noted: 

‘‘Acknowledging that it had no statistics 

on the rates of actual use of such 

devices, the Department inferred their 

use from the anecdotal evidence of their 

availability.’’ Because the successful use 

of a cheating device would produce a 

negative drug test result, this would not 

show up in statistical reports as 

‘‘cheating.’’ Thus, the court agreed with 

DOT that ‘‘it was ‘illogical’ to require 

statistical evidence of cheating. Given 

that people presumably buy cheating 

devices to use them, we think this 

approach quite reasonable . . .’’ 

Consequently, the court recognized that 

the DOT could not base the rulemaking 

on statistical data on cheating. The court 

concluded, ‘‘ ‘It is one thing to set aside 

agency action under the Administrative 

Procedure Act because of failure to 

adduce empirical data that can readily 

be obtained. It is something else to insist 

upon obtaining the unobtainable. BNSF, 

566 F.3d at 204 (internal citations 

omitted)). 

The Department recognizes that the 

court upheld directly observed urine 

tests in specific circumstances covered 

in the regulation. In this rulemaking, the 

Department is proposing, as an option to 

employers, a specimen collection 

methodology that is inherently a 

directly observed collection and a much 

less invasive form of direct observation 

drug test collection. 

In evaluating the progress of science 

of oral fluid testing and its scientific 

viability, HHS also looked at its forensic 

defensibility in workplace testing. 

Specifically, HHS addressed concerns 

about passive exposure as the result of 

someone else’s drug use (e.g., from 

second-hand smoke) in the context of 

cutoffs or metabolites used in oral fluid 

testing, particularly with regard to 

marijuana. (84 FR 57557, 57558; Oct. 25, 

2019). HHS concluded that a 4 ng/mL 

screening test cutoff for THC would 

detect use of marijuana while 

eliminating possibilities of positive tests 

resulting from passive exposure, as 

directed by the SUPPORT for Patients 

and Communities Act, Public Law 115– 

271, 8107(b). (See 84 FR at 57558; Oct. 

25, 2019). 

HHS has verified the science, set the 

cutoffs for testing, and begun the 

laboratory certification process for oral 

fluid testing. Pursuant to the statutory 

directive to incorporate HHS’s scientific 

and technical guidelines, the 

Department proposes to offer oral fluid 

testing to DOT-regulated employers as 

an alternative to urine testing. 

Using Oral Fluid Testing as an 

Alternative Method Can Reduce Costs 

We recognize that oral fluid testing is 

generally less expensive than urine 

testing. We understand that an oral fluid 

test can cost between $10 to $20 less 

than a urine testing (e.g., about $50 for 

a typical urine testing process, vs. about 

$35 for an oral fluid testing process, 

with the largest part of the difference 

being attributable to the collection 

process). We are seeking public 

comment on the costs of oral fluid 

testing as compared to urine testing so 

that we can affirm or adjust that cost 

assumption. 

We also seek public comment on 

whether DOT-regulated employers 

would continue to utilize the services of 

external qualified collectors for oral 

fluid, or whether employers would train 

their own company personnel to 

become qualified collectors for oral 

fluid testing purposes. If companies 

train internal personnel instead of 

contracting with external providers, 

would this be due to costs, convenience 

or other reasons, and what would be the 

cost implications of the two 

approaches? 

In addition to flexibility for 

employers, there are potential cost 

savings in the ‘‘shy bladder’’ collection 

procedures and related medical 

examinations. Currently there are 

situations in which a urine specimen 

collection is attempted but not 

completed. For example, when an 

employee is unable to provide a 

sufficient quantity of urine, Part 40 

provides an alternative process with 

multiple steps. The employee receives 

up to three hours of time to provide a 

sufficient specimen and is urged to 

consume up to 40 ounces of fluids. If 

after three hours these procedures do 

not result in a sufficient urine specimen, 

the employee must be medically 

evaluated to determine whether there is 

an adequate medical explanation why 

the employee could not provide 

sufficient urine. (49 CFR 40.193 and 

40.195). This involves much time on the 

part of the collector, employee, 

employer, MRO, and physician. In 

addition, there are the costs of medical 

examinations for individuals who have 

short-term and long-term medical 

conditions that cause, or are claimed to 

cause, an inability to provide a 

sufficient urine specimen. 

Since the Part 40 comprehensive 

rewrite in the late 1990s, groups 

representing individuals with 

‘‘Paruresis’’ have raised concerns that a 

urine collection is problematic for 

individuals with this condition. Also, 

employees who are undergoing dialysis 

treatments or who have significant 

prostate issues could have difficulty 

providing a urine specimen and may 

require referrals to evaluating 

physicians to determine the legitimacy 

of their medical inability to provide a 

urine specimen. With the above in 

mind, collecting an oral fluid specimen 

may eliminate the need for a medical 

evaluation and result in a shorter 

employee visit to the collection site. 

Allowing Alternative Specimens 

Provides Flexibility to Employers 

In proposing oral fluid testing, the 

Department is not requiring employers 

to use oral fluid testing instead of urine 

testing, or for every test reason (e.g., preemployment, random, etc.). Instead, we 

are proposing to offer employers the 

flexibility in the type of specimen they 

collect. That flexibility will provide 

several benefits. For example, when an 

employer determines that a DOT postaccident or a reasonable cause/ 

suspicion test is needed, oral fluid 

collections could be done at the scene 

of the accident or the incident. The 

collection could be done by any oral 

fluid collector qualified under Part 40– 

either an external contractor or a DOTregulated company employee. There are 

fewer requirements for oral fluid 

collection sites, as discussed below. The 

ready availability of collectors and the 

reduced expectations for collection site 

requirements should facilitate prompt, 

less expensive collections for postVerDate Sep<11>2014 17:43 Feb 25, 2022 Jkt 256001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 E:\FR\FM\28FEP2.SGM 28FEP2

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accident and reasonable cause/ 

suspicion testing. We would appreciate 

public comments on these matters. 

Understanding Windows of Detection 

In proposing oral fluid testing, the 

Department is offering an alternative 

specimen for drug testing; however, we 

are not proposing to eliminate urine 

drug testing. Each specimen type offers 

different benefits to assist employers in 

detecting and deterring illegal drug use, 

and no single specimen type is perfect 

for every situation. It is important to 

understand the benefits and limitations 

of each method. 

There are different windows of 

detection that employers should 

consider when deciding whether to use 

a urine test or an oral fluid test as the 

preferred form of testing for any specific 

test reason. We have reviewed various 

scientific sources referenced below to 

compile the list of windows of 

detection, and we invite public 

comment, especially from oral fluid 

device manufacturers and laboratories, 

as to the accuracy of the information 

presented in the chart below. Any 

additional public comments pertaining 

to the accuracy and completeness of the 

table below would also be appreciated. 

Category of drug 1

Oral fluid 

testing window 

of detection 

Urine testing 

window of 

detection 

Amphetamines ............................................................................................................................................... 1–3 days 2 ............... 1–9 days 2. 

Methamphetamines ....................................................................................................................................... 1–4 days 2 ............... 2–4 days 2. 

Cocaine .......................................................................................................................................................... 1–4 days 2 3 ............. 1–5 days 2 3. 

Opioids ........................................................................................................................................................... 1–2 days 2 ............... 2–4 days 2. 

Marijuana ....................................................................................................................................................... Up to 24 hours 2 4 .... 3–67 days 2 5. 

Phencyclidine (PCP) ...................................................................................................................................... 1–3 days 6 ............... Up to 5 days 6. 

1 Detection windows in the sources are dependent on amount of drug ingested, situations such as regular heavy use, and cutoff concentrations 

used. 2 Cone E.J., Huestis MA. Ann N.Y. Acad Sci. 2007;1098:51–103, pp. 35–37, 42, 45–51, 54 https://www.ncbi.nlm.nih.gov/pmc/articles/ 

PMC2700061/pdf/nihms118888.pdf. 3 Jufer R., Walsh S.L., Cone E.J., et al. J Anal Toxicol. 2006;30(7):458–462, 460. https://academic.oup.com/jat/article/30/7/458/711502. 4 Newmeyer M.N., Desrosiers N.A., Lee D., et al. Drug Test Anal. 2014;6(10):1002–1010 https://www.ncbi.nlm.nih.gov/pmc/articles/ 

PMC4169757/pdf/nihms578748.pdf. 5 Huestis M.A., Mitchell J.M., Cone EJ. J Anal Toxicol. 1996;20(6):441–452 https://academic.oup.com/jat/article/20/6/441/777647. 6 Cook C.E., Brine D.S., Jeffcoat A.R., et al. Clinical Pharmacology and Therapeutics. 1982; 31(5)625–634—While the authors did not report 

oral fluid concentrations, they did report correlation between plasma levels and oral fluid levels. As PCP was detectable in plasma for 72 h (last 

time point) it is reasonable to assume PCP can also be detected in oral fluid that long. 

If an employer is looking to detect 

recent drug use, (i.e., reasonable cause/ 

suspicion, post-accident), an employer 

may find that the more immediate 

window of detection associated with 

oral fluid is acceptable. However, if an 

employer is looking to detect a pattern 

of intermittent drug use through preemployment, random, return-to-duty, 

follow-up testing, the delayed windows 

of detection in urine may be preferable. 

We seek comment on whether oral fluid 

or urine should be mandated, or 

prohibited, for certain test reasons, 

based on windows of detection. Should 

an employer and its service agent be 

allowed to opt for a different 

methodology if the first test cannot be 

completed because of an insufficient 

specimen or other reason? Because there 

is no drug testing that determines 

impairment, oral fluid is being 

introduced to detect use, as urine has 

done throughout the history of the DOTregulated drug testing program. 

Substance Abuse Professional Remote 

Evaluations 

During the COVID–19 public health 

emergency, the Department recognized 

that it might not be possible or advisable 

for a SAP to meet face-to-face with a 

client. As a result, we issued a guidance 

document on April 4, 2020 to allow 

remote evaluations for a period of time, 

and we extended the guidance several 

times. The Department’s COVID 

guidance was issued in 2020–2021 and 

can be viewed at: 

www.transportation.gov/odapc/ 

Statement_of_Enforcement_Discretion_

SAPs_and_Service_Agents. We said 

that, while a remote evaluation may not 

provide as much information as an inperson meeting, it is preferable to not 

having a SAP evaluation at all. To make 

a remote evaluation as effective as 

possible, the guidance document 

recommended certain technical 

parameters and added that SAPs should 

document the format of the assessment 

in the final SAP report. We also said 

that we would not view a remote 

evaluation as being an act of serious 

noncompliance meriting resort to the 

Public Interest Exclusion (PIE) process. 

Based on informal contacts with the 

SAP community, we believe this 

guidance has been well received, with a 

considerable use of remote evaluations 

by SAPs since the inception of the 

guidance. Moreover, it is plausible that 

telehealth will become a regular part of 

medical practice in a wide variety of 

fields in the future. 

To make remote evaluations or 

assessments a regular option for the 

SAP’s practice under Part 40, we are 

proposing amendments to several 

sections of the regulation. Consistent 

with guidance issued in the context of 

the COVID–19 public health emergency, 

this proposal would give SAPs the 

option of choosing to conduct 

evaluations remotely in lieu of face-toface meetings. Part 40 currently requires 

all SAP assessments to be done face-toface. An in-person evaluation provides 

SAPs with the opportunity to 

objectively evaluate ‘‘non-verbals’’— 

physical cues to internal feelings, 

thoughts, and behaviors. It allows the 

SAP to be aware of the client’s 

appearance, posture, carriage, ability to 

make eye contact, and ability to relate 

in person, as well as other physical 

characteristics that might be indicative 

of problems associated with alcohol 

abuse and/or drug use. 

The most important proposed change 

regarding SAP evaluations is to 

§ 40.291(a)(1). The amendment would 

replace the current requirement for a 

face-to-face meeting with an option: The 

SAP could do the evaluation either faceto-face or remotely. If the evaluation is 

to be done remotely, there would be 

three criteria that the process would 

need to meet, to ensure that the SAP can 

still objectively evaluate ‘‘non-verbals’’ 

and physical characteristics to a 

sufficient extent. These criteria are also 

based on the provisions of the 

Department’s guidance document. 

First, the technology used must 

permit real-time two-way audio and 

visual interaction between the SAP and 

the employee. A phone conversation not 


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including video would not meet this 

criterion. 

Second, the quality of the technology 

(e.g., speed of the internet connection, 

clarity of the display), would have to be 

sufficient to allow the SAP to gather all 

the visual and audible information the 

SAP would normally observe in a faceto-face interaction. In addition, the 

technology would have to have 

sufficiently robust security to protect 

the confidentiality of the conversation. 

Third, a SAP could only use the 

technology in question if the SAP’s 

State-issued license authorizes the SAP 

to do so. The SAP’s use of the 

technology would have to stay within 

the parameters of that authority (e.g., a 

State license may permit a practitioner 

to work only with clients in the State of 

licensure). We are also seeking public 

comment, especially from SAPs, 

regarding whether their respective State 

license would allow them to evaluate 

individuals who live in a different State 

from where the SAP is licensed. Is this 

already allowed? Now that virtual video 

evaluations are often done outside of the 

DOT-regulated context, would 

evaluation of individuals not in one’s 

State of licensure be allowed? For a SAP 

remotely evaluating an individual 

outside of the SAP’s locality, what steps 

could ensure a working knowledge of 

quality programs and qualified 

counselors available to the employee? 

While we continue to believe that 

face-to-face interactions are the ‘‘gold 

standard’’ for the SAP evaluations, we 

also believe that the remote evaluation 

option may have considerable merit, 

and we seek comment on the proposed 

approach, as well as on the specific 

technical parameters under which SAPs 

would perform remote virtual 

evaluations. We welcome comments 

regarding the experience of both SAP 

and employees under the COVID–19 

guidance. We also seek comment on 

whether remote virtual evaluations and 

assessments should be limited to certain 

circumstances, e.g., natural disasters, 

pandemic situations, and where there 

are few or no SAPs available. 

Other Matters of Interest 

As noted above, the Department 

works closely with HHS on matters 

concerning workplace drug testing. On 

September 10, 2020, HHS published a 

notice of proposed Mandatory 

Guidelines proposing to add hair testing 

to the drug testing specimen types 

authorized for the Federal employee 

testing program. (85 FR 56108). Because 

HHS is still considering amendments to 

its Mandatory Guidelines to permit hair 

testing, comments to DOT concerning 

the use of hair testing are not relevant 

at this time. 

In addition, we are proposing to 

amend § 40.67 to address situations 

where a same gender observer is not 

available for the collection of urine 

specimens. Specifically, we request 

public comment on allowing direct 

observations by any licensed or certified 

medical professional legally authorized 

to take part in a medical examination in 

the jurisdiction where the collection 

takes place. 

Currently, per § 40.141(b), MROs must 

personally contact pharmacies to verify 

a prescription that an employee has 

cited as a potential legitimate medical 

explanation for a laboratory-confirmed 

positive test. We believe it would 

increase efficiency and assist MRO 

office workflow if MRO staff were able 

to make these inquiries. The Department 

seeks comment on whether this change 

is advisable and what the estimated cost 

savings would be. 

In addition to the above, we request 

comments on whether there are 

situations in which a test, once 

cancelled, should be ‘‘uncancelled’’ if 

circumstances dictate (e.g., a test is 

cancelled because paperwork is missing 

or delayed, but the paperwork is later 

found and provided to the MRO). Or, 

alternatively, should a test, once 

cancelled, remain cancelled to ensure 

finality? We specifically seek comment 

from MROs on the practicality of 

administering such a process, and from 

employers on the effect that an 

‘‘uncancelled’’ test would have when 

administering their drug testing 

program. To be clear, this would not 

apply to those specimens ‘‘rejected’’ by 

the laboratory because of a fatal flaw 

and ultimately reported by the MRO as 

cancelled. We have proposed language 

in § 40.207(d) to address this 

circumstance. We have also included a 

requirement for a party seeking to 

reverse a cancellation to consult ODAPC 

if the decision is being made more than 

60 days after the cancellation, which is 

the same consultation requirement we 

have in § 40.149(a)(4), where we allow 

an MRO to reopen a verified test after 

60 days. Providing this information 

helps ODAPC to provide advice to 

MROs regarding what to consider and 

potential concerns. 

V. Section-by-Section Analysis 

In drafting the proposed oral fluid 

amendments to Part 40, the Department 

is not creating a separate subpart of Part 

40 concerning oral fluid testing. Since 

many of the provisions of Part 40 can be 

applied to specimen types in addition to 

urine, we have sought to integrate 

provisions concerning oral fluid testing 

within the current Part 40 structure. 

However, since the provisions 

applicable to Alcohol Testing, SAPs, the 

PIE process, and some other provisions 

would not change based on which 

specimen types are authorized, we are 

not proposing changes to those 

provisions. 

Consistent with changes made in the 

substantive provisions of the rule, we 

propose to modify some section titles as 

well as adding new sections. In many 

cases, the modifications revise current 

titles specifying urine testing so that 

they address oral fluid and potential 

future testing matrices. 

40.3 What do the terms used in this 

part mean? 

In addition to proposing to delete the 

definition of ‘‘screening drug test’’ 

because the term is not used in Part 40, 

the proposed rule would delete the 

definition of ‘‘Invalid drug test’’ because 

that is a term that HHS does not use, as 

such. 

The term ‘‘invalid result’’ is an HHS 

term with a very specific meaning and 

HHS does not have a defined term of 

‘‘Invalid drug test.’’ The term ‘‘invalid’’ 

is sometimes misunderstood in 

arbitrations, courtrooms, and other 

settings to incorrectly suggest a lack of 

certainty about the underlying testing 

event. A laboratory reporting an invalid 

result to the MRO does not mean that 

the underlying drug testing event was 

not valid. For example, when the 

laboratory reports that there was an 

‘‘invalid result,’’ it is not a 

characterization of the employer’s 

authority to conduct the testing, the 

collection process, etc. The ‘‘invalid 

result’’ refers only to the fact that the 

laboratory has not been able to complete 

testing or obtain a valid drug test result 

(e.g., because of an unidentified 

adulterant, an interfering substance, or 

an abnormal physical characteristic). 

Also, for consistency with HHS 

terminology, we are removing the 

defined term ‘‘invalid drug test’’ in the 

definitions section, § 40.3, and are 

updating §§ 40.123(c), 40.129(a) and 

40.129(d) to use the term ‘‘invalid 

result’’. 

The proposal would add definitions 

of seven terms as part of our effort to 

harmonize Part 40 with the HHS 

Guidelines and to update Part 40 as 

needed. An ‘‘alternative specimen’’ is an 

authorized specimen of a type other 

than the one previously collected. For 

example, in a case where the initial 

collection was urine, oral fluid would 

be an alternative specimen. The ‘‘cutoff’’ 

is the quantitative point distinguishing 

a need for further testing or whether a 

laboratory result, for example, is 


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positive or negative (e.g., 2 ng/ml is the 

confirmatory test cutoff for a positive vs. 

negative oral fluid result reported by the 

laboratory for THC). We are also 

proposing to add definitions for ‘‘oral 

fluid specimen’’ and ‘‘urine specimen.’’ 

‘‘Specimen’’ is the generic term for any 

fluid, breath or material collected from 

someone for a drug or alcohol test. We 

are proposing to add ‘‘Undiluted (neat) 

oral fluid’’, using the same language 

HHS uses in Section 1.5 of its Oral Fluid 

Mandatory Guidelines. We have also 

added a definition for the FMCSA’s 

Commercial Driver’s License (CDL) Drug 

and Alcohol Clearinghouse 

(Clearinghouse). 

We are also proposing to add a new 

definition for ‘‘SSN or Employee ID 

No.’’, and some minor changes to rule 

language in §§ 40.14, 40.45, 40.97, 

40.163 and 40.311 for the following 

reasons. Since its inception in 1988, 

Part 40 has required program 

participants to use the donor’s Social 

Security Number (SSN) or an employee 

identification (ID) number in various 

sections. For example, the employer 

must supply the collection site with the 

‘‘Donor SSN, Employee I.D., or CDL 

State and No.’’ as referenced on the 

Federal Drug Testing Custody and 

Control Form (CCF). For the Alcohol 

Testing Form (ATF), the employer must 

supply the donor’s ‘‘SSN or Employee 

ID No.’’ In addition to the unique 

specimen ID number on the CCF and the 

specimen seals, having the SSN or 

employee ID number on the form assists 

the MRO in matching the Copy 1 of the 

CCF from the laboratory with their copy, 

Copy 2 of the CCF. The SSN or the 

employee ID number may be used by 

the employer to, for example, run 

random selection lists and ensure that 

test results are associated with the 

correct employee. The SAP is required 

to utilize the SSN on the SAP initial and 

final reports to the employer. 

In the Federal Motor Carrier Safety 

Administration’s (FMCSA) Commercial 

Driver’s License Clearinghouse final 

rule (81 FR 87686; Dec. 5, 2016), which 

required the creation of the Drug and 

Alcohol Clearinghouse database 

(Clearinghouse), the FMCSA amended 

49 CFR 382.123(a) and (b) to require 

that, for FMCSA-regulated drivers 

undergoing DOT-regulated testing, the 

employer use a Commercial Driver’s 

License (CDL) number and State of 

issuance, instead of the SSN or other 

employee ID number, on the CCF and 

Alcohol Testing Form (ATF) for all drug 

and alcohol tests conducted under part 

382. It is important to note that the 

Clearinghouse final rule did not affect or 

otherwise allow use of the CDL number 

for a CDL driver operating under 

another DOT agency’s regulation and 

subject to a test not under Part 382 (e.g., 

employers of CDL drivers under 

PHMSA or FTA). Under this proposal, 

those employers could also use the CDL 

numbers, which could potentially 

increase efficiency and reduce 

confusion. 

We are proposing to create a 

definition of ‘‘SSN or Employee No.’’ in 

§ 40.3 that would conform to and 

explicitly acknowledge this existing 

requirement for CDL holders regulated 

by the FMCSA and to allow the use of 

the CDL number for the drivers being 

tested under the regulations of the other 

DOT agencies. 

In addition, we are proposing the 

changes because some employers 

already consider an employee’s ID 

number to be the individual’s personal 

driver’s license number, State-issued 

identification number, or other Stateissued or federally issued identification 

number. We believe that it would be 

less confusing to explicitly state that it 

is allowable to use these forms of ID, 

which can be verified by viewing the 

actual ID. 

With increasing concerns of identity 

theft, SAPs, employers and others have 

indicated that the use of one’s SSN is 

becoming increasingly difficult and 

risky. Some corporations are only 

allowing the use of 4 or 6 digits of the 

SSN, and others prohibit the use of the 

SSN entirely. We are proposing the 

additional options of other official 

identifications issued by State or 

Federal authorities to also address these 

concerns. 

Consequently, we are proposing to 

create a new definition ‘‘SSN or 

Employee No.’’ that will allow a 

collector, MRO, SAP, BAT, STT or other 

service agent or employer to utilize only 

the CDL number and State of issuance 

for FMCSA-regulated drivers tested 

under Part 382, and to allow the CDL 

number to be used as an option on tests 

conducted under the authority of the 

other DOT Agencies. The definition 

would also allow any other State-issued 

or federally- issued identification 

number to fulfill Part 40 requirement for 

a unique identification number. 

We are proposing to modify seventeen 

definitions. For the most part, the 

changes are not substantive, and would 

simply conform Part 40’s wording with 

that of the HHS guidelines. For 

example, ‘‘collection container’’ refers 

to vessels used in all collections, 

whether of urine or oral fluid. In the 

definition of ‘‘specimen bottle,’’ we 

propose noting that the term could 

include terms like ‘‘tube’’ or ‘‘vial’’ used 

in oral fluid testing. 

§ 40.13 How do DOT drug and alcohol 

tests relate to non-DOT tests? 

The Department is proposing minor 

changes to paragraphs (b), (c), and (d) of 

this section to clarify them in the 

context of oral fluid testing. For 

example, paragraph (d) is made 

applicable only to urine testing since 

oral fluid testing is not part of the 

normal medical examination procedure 

to which the paragraph applies. 

We propose to redesignate paragraphs 

the current paragraphs (e) and (f), as 

new paragraphs (f) and (g), and would 

add a new paragraph (e) emphasizing 

that a drug or alcohol test administered 

as directed by a medical examiner, 

exclusively as part of a medical 

examination required for an employee 

to qualify for a certificate or license, is 

not a DOT drug or alcohol test under 

Part 40 and related DOT agency drug 

and alcohol testing rules. For example, 

if a certified medical examiner decided 

to give a motor carrier driver a drug test 

as part of an examination for medical 

card purposes, that would be a ‘‘nonDOT test.’’ An employer could request 

a required DOT pre-employment test be 

conducted when the medical 

examination is being conducted, as 

currently permitted under 49 U.S.C. 

31306(d). 

We added a new paragraph (h) to 

further emphasize that DOT drug and 

alcohol tests are authorized to be 

conducted only on safety-sensitive 

employees as designated in the agency 

drug and alcohol testing regulations and 

must not be conducted on non-regulated 

persons. (See Section II of this proposed 

rule for a discussion of DOT’s testing 

authorities.) DOT testing is a legal 

warrantless search and seizure 

permitted by the Fourth Amendment of 

the Constitution. The DOT’s strong 

interest in maintaining transportation 

safety, when weighed against an 

individual’s right to privacy, allows 

DOT’s regulated testing to pass 

Constitutional scrutiny. See Bluestein v. 

Skinner, 908 F.2d 451 (9th Cir. 1990); 

Skinner v. Railway Labor Executives’ 

Assn., 489 U.S. 682 (1989); Treasury 

Employees v. Von Raab, 489 U.S. 656 

(1989). However, there is no Federal 

transportation safety interest in using 

this testing for individuals other than 

safety-sensitive employees. 

Consequently, DOT testing cannot be 

conducted on employees not regulated 

by the DOT agencies. DOT regulations 

also do not allow company-authorized 

non-DOT testing to satisfy an 

employer’s obligation to meet its 

minimal annual testing rate for DOT 

testing. 


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§ 40.14 What information must 

employers provide to collectors? 

Paragraph (b) in this section would be 

modified for clarity and to recognize 

that, in the motor carrier industry, 

FMCSA requires the CDL to be used for 

purposes of the Drug and Alcohol 

Clearinghouse (Clearinghouse) (see 49 

CFR 382.705). A new paragraph (k) 

would be inserted for ‘‘the specimen 

type to be collected’’ and a new 

paragraph (l) is proposed to specify if a 

urine test is to be directly observed. 

§ 40.21 May an employer stand down 

an employee before the MRO has 

completed the verification process? 

Where there is a stand down waiver 

in place, the proposed rule would add 

a new paragraph (c)(2)(vii)(C) of this 

section to explain that an employer, 

after receiving a verified negative result, 

must not send an employee back in for 

another test using a different specimen 

type. We have clarified that the 

employer can send and employee in for 

an alternative specimen collection if the 

MRO cancelled the tested (e.g., per the 

requirements of § 40.159). The authority 

to stand down an employee is very 

limited and requires an employer to 

obtain an actual waiver from the DOT 

agency before implementing a stand 

down policy. The waiver authorizes the 

employer to ‘stand down’ an employee 

from performing safety-sensitive 

functions based on a laboratory 

confirmed positive result until the MRO 

issues the employer a verified result, 

which may be negative. We are 

proposing that an employer cannot 

conduct another test on the employee 

after an MRO verifies the test as 

negative. We want to prevent 

harassment of employees who 

ultimately have an MRO-verified 

negative result and we do not want 

employers to attempt to conduct a 

second test to see if the window of 

detection could later impact the result. 

§ 40.23 What actions do employers 

take after receiving verified test results? 

The proposed rule would make minor 

conforming changes in the language of 

this section to account for the proposed 

use of oral fluid testing. In the 

introductory language of paragraph (f), 

the specification of urine testing would 

be deleted because the paragraph would 

apply to oral fluid as well as urine 

testing. In paragraphs (f)(1) and(5), 

language would be added emphasizing 

that oral fluid collection is always 

directly observed. In the event of an 

invalid specimen, the subsequent direct 

observation collection could either be 

an oral fluid collection or a urine 

collection under direct observation. 

§ 40.25 Must an employer check on the 

drug and alcohol testing record of 

employees it is intending to use to 

perform safety-sensitive duties? 

In January 2020, FMCSA 

implemented its Clearinghouse 

regulation requiring FMCSA-regulated 

employers that employ drivers subject 

to the CDL testing requirements of 49 

CFR part 382 to query the Clearinghouse 

drug and alcohol database for 

information about an employee’s past 

violations of the drug and alcohol 

testing rules. Until January 2023, 

FMCSA-regulated employers have dual 

requirements: Query the Clearinghouse 

and continue to follow the procedure of 

§ 40.25, as set forth in § 382.413. 

Beginning January 6, 2023, FMCSAregulated employers will rely solely on 

querying the Clearinghouse with respect 

to present or former FMCSA-regulated 

employers of an FMCSA-regulated 

applicant, in accordance with 

§ 382.413(b). For example, after January 

6, 2023, a motor carrier vetting a 

prospective employee would check the 

Clearinghouse to determine whether the 

driver’s previous FMCSA-regulated 

employer(s) reported drug and alcohol 

testing program violations by that 

driver. To conform the requirements of 

§ 40.25 with these existing FMCSA 

requirements, we are proposing to add 

a paragraph stating if an applicant’s past 

employment was with an employer 

regulated by, for example, the Federal 

Transit Administration or the Federal 

Aviation Administration (FAA), the 

gaining motor carrier employer would 

continue to use § 40.25 to check on that 

individual’s past compliance with the 

Department’s rules, since drug or 

alcohol violations incurred while the 

driver was employed by a DOT modal 

administration other than FMCSA will 

not have been recorded in the 

Clearinghouse. We are proposing to add 

a new paragraph (a)(3) to this section to 

remind employers that when hiring an 

employee subject to both FMCSA and 

another DOT agency’s drug and alcohol 

testing program, they must query the 

Clearinghouse and request the 

information about the employee listed 

in paragraphs (b) through (j) of this 

section from any other DOT agency for 

whom the employee previously worked. 

§ 40.26 What form must an employer 

use to report Management Information 

System (MIS) data to a DOT agency? 

The proposed rule would make a 

simple editorial change, substituting a 

reference to appendix J for a reference 

to appendix H. This conforms to a redesignation of the appendix letters but 

would make no substantive changes to 

the section or form. 

§ 40.29 and similar sections 

In the current Part 40, there are 

several sections (§§ 40.29, 40.37, 40.113, 

40.169, 40.189, 40.217, and 40.313) that 

list, for readers’ information, other 

sections of the regulation touching a 

given topic (e.g., employer 

responsibilities in § 40.29). These lists 

of cross-references were intended to 

assist readers in finding other relevant 

information. However, in the 20 years 

since these sections were placed in Part 

40, electronic search tools have become 

much more sophisticated and 

ubiquitous. Under these circumstances, 

the Department proposes removing 

them as no longer necessary. The 

Department seeks comment on whether 

users continue to find the crossreference lists helpful enough to retain. 

§ 40.31 Who may collect specimens for 

DOT drug testing? 

The provisions of this section would 

be updated to separately specify the 

requirements for collectors of urine and 

oral fluid specimens, respectively. We 

proposed adding wording to require oral 

fluid collectors to be qualified. In 

addition, we added wording to make it 

clear that employees, relatives, and 

close friends of the employees cannot 

conduct collections, consistent with 

existing guidance in the Department’s 

Specimen Collection Guidelines. The 

Department seeks comment on these 

proposed revisions. 

§ 40.33 What training requirements 

must a collector meet for urine 

collection? 

The proposed rule would change the 

title of § 40.33 to reflect its focus on 

urine collectors. We are also proposing 

a change to § 40.33(f) to clarify that 

damage to a specimen resulting in it 

being cancelled does not require 

retraining of the collector, unless the 

error actually occurred during the 

collection process. We understand that 

some MROs are requiring collector 

retraining when a specimen is cancelled 

because the damage occurred during the 

transportation process. When a 

specimen is damaged by a delivery 

truck, sort facility, or other part of the 

transportation process, or is lost in 

transit, it would not be the result of an 

error by the collector during the 

collection process. Consequently, we are 

proposing language to clarify a collector 

is not subject to the time and costs of 

retraining for errors outside the 

collection process. 


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§ 40.35 What training requirements 

must a collector meet for oral fluid 

collection? 

The proposed rule would renumber 

existing § 40.35 to become § 40.36, and 

add a new section § 40.35 concerning 

training for oral fluid collectors. Our 

intent is to parallel, as closely as 

possible, our existing training 

requirements for urine specimen 

collectors. We seek comment on any 

differences that may exist between the 

training for collectors for each specimen 

type. We anticipate, in many cases, that 

collectors may be cross-trained in the 

two modes of collection. 

In discussing who is authorized to 

monitor the mock collections exercise 

for oral fluid collectors, the proposed 

rule retains the provision applicable to 

urine collector training, which states 

that someone who has performed DOT 

collections for at least a year is 

qualified. However, since the oral fluid 

collection process is new to the DOT 

testing regime, there initially will not be 

anyone who has collected DOT oral 

fluid specimens for a year. The 

Department seeks comment on how best 

to address this transition issue. For 

example, would it be sufficient for a 

monitor, during the first year or two 

under the DOT oral fluid testing 

process, to have had experience in oral 

fluid collections in non-DOT oral fluid 

testing? Should only someone who has 

been through a ‘‘train the trainer’’ 

course be able to monitor the mock 

collections test until there are oral fluid 

collectors with a year of experience in 

DOT oral fluid collections? What role, if 

any, should oral fluid device 

manufacturers play in the process? 

Redesignation Table 

Beginning with subpart D (see below), 

the Department is proposing to 

redesignate (i.e., renumber and reorder) 

numerous sections of Part 40 to provide 

a more easily followed flow for users of 

the regulation provisions specific to oral 

fluid drug testing. For the convenience 

of the reader, we are displaying these 

proposed redesignations in the 

preamble section of the NPRM. 

The Department recognizes that 

practitioners have likely become 

accustomed to particular section 

numbers for drug testing procedures 

under the present regulation. While we 

believe that the reorganization will 

create a logical structure for the rule, we 

seek comment on whether the 

reorganization would cause any 

significant degree of confusion for 

practitioners, and if so, how confusion 

could be mitigated. 

For the convenience of the reader, we 

are including this redesignation table to 

show what the renumbering would be, 

if the proposed changes are adopted: 

PROPOSED REDESIGNATIONS THE FOLLOWING SECTIONS OF PART 40 AS

FOLLOWS

Old section New section 

40.35 ......................... 40.36. 

40.41 ......................... 40.42. 

40.45 ......................... 40.40. 

40.47 ......................... 40.41. 

40.49 ......................... 40.44. 

40.51 ......................... 40.45. 

40.73 ......................... 40.79. 

40.85 ......................... 40.82. 

40.87 ......................... 40.85. 

40.89 ......................... 40.86. 

40.91 ......................... 40.87. 

40.93 ......................... 40.88. 

40.95 ......................... 40.89. 

40.96 ......................... 40.90. 

40.99 ......................... 40.84. 

Appendix B ................ Appendix D. 

Appendix C ............... Appendix E. 

Appendix D ............... Appendix F. 

Appendix E ................ Appendix G. 

Appendix F ................ Appendix H. 

Appendix G ............... Appendix I. 

Appendix H ............... Appendix J. 

Subpart D—Collection Sites, Forms, 

Equipment and Supplies Used in DOT 

Collections 

As a starting point, it is important to 

remember that oral fluid drug testing 

and saliva alcohol testing are 

completely distinct. The devices, 

procedures and outcomes are never 

interchangeable. In Part 40, we are only 

proposing the provisions applicable to 

oral fluid testing procedures in subpart 

D. The saliva alcohol testing provisions 

in subparts K–L remain unchanged. 

To accommodate the addition of 

provisions pertaining to oral fluid drug 

testing, the Department is proposing to 

reorganize subpart D. Sections applying 

to the DOT drug testing process 

generally, regardless of specimen type, 

would come first. Renumbered §§ 40.40 

and 40.41 would contain the content of 

present §§ 40.45 and 40.47, concerning 

the use of the Federal Drug Testing 

Custody and Control Form (CCF) in all 

DOT collections. We note that HHS 

revised the CCF in August 2020. The 

2020 CCF and instructions for 

completing the CCF for both urine and 

oral fluid collections are available on 

the HHS website, https://

www.samhsa.gov. The DOT has posted 

the 2020 CCF on our website, https://

www.transportation.gov/odapc, and we 

will post instructions for oral fluid 

collections upon promulgation of any 

final rule to allow oral fluid for DOTregulated drug testing. 

The above sections would no longer 

contain the words ‘‘urine’’ and 

‘‘urination,’’ because these sections now 

would apply to oral fluid collections 

and would include ‘‘any other 

appropriate contact information’’ to 

permit the inclusion of email addresses 

or other means of contacting the 

appropriate parties. The Department is 

considering removing requirements 

related to fax numbers on the CCF, 

allowing the fax number if the parties 

have one. We seek comment on whether 

specifying the use of fax numbers 

remains relevant. We are proposing to 

add a provision allowing the Designated 

Employer Representative’s (DER) name 

and contact information to be 

preprinted on the CCF. We specifically 

seek comments from the laboratories on 

the availability of space on the CCF to 

pre-print the information, as well as the 

logistics and timeliness of sending out 

updated CCFs with the new DER 

information. To recognize the 

responsibility of collectors, as well as 

collection site operators, for proper 

collections, we would add ‘‘collectors’’ 

to the title of § 40.43. 

In the proposed reorganization of the 

subpart, §§ 40.42–40.45 would cover 

urine testing (renumbered § 40.42 in the 

proposed rule contains the material now 

found in § 40.41, while renumbered 

§§ 40.44 and 40.45 contain the material 

now found in §§ 40.49 and 40.51). Then 

we would add new §§ 40.47–40.51, 

covering oral fluid testing. These 

provisions largely parallel their urine 

testing counterparts. We seek comment 

on the content of the new oral fluid 

provisions, including whether it would 

be useful to address any additional 

differences between the urine and oral 

fluid testing procedures. 

We are proposing to modify 

renumbered § 40.40 to clarify what 

address and telephone number a 

collector must provide on the CCF. In 

January of 2002, ODAPC issued a 

Question and Answer (Q&A) explaining 

that the collection site address should 

not be a corporate or ‘‘main office’’ 

address. In addition, the Q&A stated 

that the collector’s telephone number on 

the CCF should be the number to 

directly reach the individual collector 

and/or the collector’s supervisor and not 

a corporate ‘‘toll free’’ number to a call 

center. Under the proposal, if an MRO, 

laboratory, employer or any DOT staff 

need to speak with the collector, the 

telephone number provided on the CCF 

must give access directly to that 

collector. This proposal would codify 

requirements for the collection site 

address and collector’s telephone 

number, which would render the Q&A 

unnecessary. 


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11164 Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Proposed Rules 

In § 40.48(c)(1), we use the term ‘‘dry 

mouth.’’ This is shorthand, similar to 

the term ‘‘shy bladder’’ used for urine 

collections, for a situation in which an 

employee is unable to produce a 

sufficient specimen. 

§ 40.49 What materials are used to 

collect oral fluid? 

We are proposing to add this section 

to require that collection devices meet 

the requirements being set forth in a 

new appendix B. The devices meeting 

the requirements in appendix B would 

be allowed for DOT-regulated 

collections. It is important to note that 

not all of the devices that HHS would 

allow for the OFMG will be allowed for 

DOT-regulated collections under 49 CFR 

part 40. Each collection must include a 

split that is subdivided from the original 

specimen collection. See 49 U.S.C. 

45104(5) (aviation industry testing), 49 

U.S.C. 20140(c)(5) (rail), 49 U.S.C. 

31306(c)(5) (motor carrier), and 49 

U.S.C. 5331(d)(5) (transit). All the 

devices meeting the requirements in 

appendix B will allow a single specimen 

to be subdivided in the presence of the 

donor. For example, a device could 

allow two specimens to be collected 

simultaneously using a single collection 

device that directs the oral fluid into 

two separate collection tubes; or a 

device could collect a specimen with a 

single pad, which can be subdivided 

into two separate collection tubes. We 

are seeking public comment as to 

whether there are other device types we 

should mention that allow one single 

specimen to be collected and then 

subdivided in the donor’s presence. 

We are also seeking public comment 

as to whether the devices should be 

sufficiently transparent so the collector 

can observe whether there is anything 

unusual about the specimen collected 

and take action to perform a recollection, if appropriate. 

§ 40.61 What are the preliminary steps 

in the drug testing collection process? 

In paragraphs (b)(1) and (3), the term 

‘‘drug testing’’ or ‘‘drug test’’ would be 

used in place of ‘‘urine,’’ since the 

provision applies to the testing of either 

specimen type. We propose to split the 

existing (b)(3) into (b)(3) and a revised 

(b)(4). The proposed revision to (b)(3) 

prohibits collection of any kind of 

specimen from an unconscious donor. 

The proposed revision to (b)(4) includes 

the remaining sentences of the current 

(b)(3), with a change to the final 

sentence of proposed paragraph (b)(4). 

The final sentence in (b)(4), if adopted, 

would be changed to emphasize that an 

employer must decide whether a given 

circumstance constitutes a refusal. In 

paragraph (f)(5)(i), we would note that, 

when a directly observed test is needed, 

either a directly observed urine 

collection or oral fluid collection would 

suffice. In (f)(5)(i), we propose to remind 

the collector to note on the CCF whether 

a directly observed urine or oral fluid 

test will be conducted. 

In addition, we are proposing changes 

to §§ 40.61(e) and § 40.73(a)(1) 

(proposed to be redesignated as 

§ 40.79(a)(1) because HHS made changes 

to the CCF. The DOT requires its 

regulated entities to use HHS’s OMBapproved CCF. 

DOT worked closely with HHS on the 

revised CCF, which incorporates 

changes necessary as a result of HHS’s 

establishment of scientific and technical 

guidelines for the inclusion of oral fluid 

specimens in the Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs. The majority of changes to 

the CCF were made to allow the 

collection of oral fluid specimens, 

which are not currently authorized in 

the DOT drug testing. The revisions also 

include other changes to improve the 

clarity and presentation of the form. 

However, because of the revisions to 

the CCF, it is necessary for DOT to 

amend two sections of Part 40. 

Specifically, the instructions for 

completing the old CCF were provided 

on the back of Copy 5 of that form. 

These instructions are not provided on 

the revised CCF, and instead, 

instructions for completing the form can 

be found on the HHS and DOT (Office 

of Drug and Alcohol Policy and 

Compliance) websites. Consequently, 

we are proposing to amend the rule text 

in 49 CFR 40.61(e) to reflect the 

repositioning of the instructions. Also, 

we are proposing to amend § 40.73(a)(1) 

(proposed to be redesignated as 

§ 40.79(a)(1)) to note that the employee 

needs to provide all information 

required in Step 5 of the revised CCF. 

This information includes the donor’s 

printed name and signature, date of the 

collection, date of birth, daytime and 

evening phone numbers, and email 

address. 

§ 40.63 What steps does the collector 

take in the collection process before the 

employee provides a urine specimen? 

We are proposing to modify § 40.63(a) 

to remind collectors to ensure that all 

items in Step 1 of the CCF are 

completed. Specifically, we propose to 

add a parenthetical to remind collectors 

to check the box for the DOT agency in 

Step 1.D, and to write an address for the 

actual collection site in Step 1.G. 

§ 40.65 What does the collector check 

for when the employee presents a urine 

specimen? 

The proposed rule would make two 

changes to the current regulation to 

ensure that when an immediate recollection under direct observation is 

needed (e.g., because the temperature of 

a urine specimen is out of range or there 

were signs of tampering), regardless of 

whether the first specimen was urine or 

oral fluid, the required directly observed 

collection could be either urine or oral 

fluid. For example, if a directly 

observed collection is needed after a 

urine collection, the second could be 

either an oral fluid collection 

(inherently directly observed) or a urine 

collection carried out under the direct 

observation procedures set forth in 

§ 40.67. After the second collection is 

done, each specimen collected must be 

sent to the appropriate laboratory (i.e., a 

laboratory certified by HHS for that 

specimen type). 

We are asking for public comment 

about how communication would take 

place between the employer and the 

collection site to ensure that an alternate 

methodology is or even should be 

available. Who should decide whether 

to collect an alternative specimen? 

Should the collector be the one to 

determine whether to collect an 

alternate specimen when a situation 

allows for it? Should the employer and 

the service agents communicate in 

advance to ensure that the alternate 

specimen type is authorized, if the 

employer wants one—with devices and 

laboratories designated? Could this be 

accomplished through the contract 

between the employer and the service 

agent? Are there other means of 

communication to facilitate the 

collection site process? 

§ 40.67 When and how is a directly 

observed urine collection conducted? 

In addition to altering the title of the 

section to refer only to urine collections, 

the proposed rule would make a 

substantive change to paragraph (g), 

regarding who may act as the observer 

in a directly observed urine collection. 

The paragraph would retain the general 

requirement that the observer have the 

same gender as the employee, but make 

an exception for licensed or certified 

medical professionals or those who are 

legally authorized to take part in a 

medical examination in the jurisdiction 

where the collection takes place. It is 

commonplace in medical settings for 

opposite-gender personnel to take part 

in examining a patient (e.g., a female 

doctor, physician’s assistant, nurse, 

Emergency Medical Technician, or an 


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individual who holds a ‘‘Persons-InCharge Medical Care’’ U.S. Coast Guard 

designation who might be examining a 

male patient). To reduce the 

circumstances in which an observed 

urine collection might be delayed for 

lack of a same-gender observer, we 

propose that an opposite-gender 

medical professional, if available, could 

perform this task. The donor would not 

be permitted to decline the direct 

observed collection by an opposite 

gender medical professional and such a 

refusal would fall under § 40.191(a)(4), 

if the proposal is adopted. We seek 

comment on whether there should be 

any limitations on the types of medical 

professionals who could perform this 

function. In addition, we would 

appreciate comments on whether there 

are religious or other concerns that 

should be considered in the regulatory 

language proposed. 

We want to clarify that the collector 

does not enter the reason for the direct 

observation in the ‘‘Remarks’’ section of 

the CCF if the employer is sending the 

employee in for a required directly 

observed collection (e.g., a return-toduty test, a follow-up test, a test where 

the MRO has instructed the employer to 

send an employee in for a directly 

observed collection). The ‘‘Remarks’’ 

section needs to be used only when the 

collector moves to a directly observed 

collection and the employer did not 

know about it in advance. Thus, we are 

proposing to amend § 40.67(e)(2) to 

change a cross-reference to ‘‘§ 40.67(b)’’ 

to become a cross-reference to 

‘‘§ 40.67(c)(2)-(4)’’. This is because 

§ 40.67(e)(2) is an instruction to 

collectors to follow through with an 

entry on the ‘‘Remarks’’ line on a CCF 

when an event under § 40.67(c) takes 

place. This has nothing to do with 

§ 40.67(b), so this cross-reference is 

being corrected. We are proposing to 

make a technical amendment to 

§ 40.67(c)(1) to strike the reference to 

paragraph (b) because it is an incorrect 

reference. 

§ 40.69 How is a monitored urine 

collection conducted? 

The proposed rule would add new 

introductory language emphasizing that 

a monitored collection would be 

conducted if a urine collection takes 

place in a multi-stall restroom and the 

collector cannot secure all sources of 

water and other substances that could 

be used for adulteration and 

substitution (49 CFR 40.42(f)(2)(ii)). 

§ 40.71 How does the collector prepare 

the urine specimens? 

The proposed rule would make a 

minor clarifying change, instructing the 

collector of a urine specimen to check 

both the boxes for ‘‘urine’’ and ‘‘split 

specimen’’ on the CCF. 

§ 40.72–§ 40.74 

These three new proposed sections 

would establish the collection 

procedures for oral fluid testing, 

consistent with the HHS OFMG and 

parallel, in many respects, to the 

administrative aspects of urine 

collections. For information on the 

parallel HHS provisions and the HHS 

rationale for putting them into effect, 

please see the OFMG, (84 FR 57554, 

Oct. 25, 2019). 

At several points in these sections 

(e.g., § 40.72(a)(2)), the proposed rule 

emphasizes the proper relationship 

between collection sites and employers 

in cases involving conduct that could be 

considered a refusal. In each case, the 

collector does not make a unilateral, 

final decision, but rather provides 

information on the circumstances to the 

employer, who per § 40.355(i), has the 

non-delegable duty to make decisions in 

these cases. 

The oral fluid specimen collector is 

expected to follow both the Part 40 

requirements for collections, as well as 

the manufacturer’s instructions on how 

to collect the specimen. The collector 

must check the expiration date on each 

device. Each device will have its own 

instructions and, therefore, these are not 

specifically covered in the proposed 

regulatory text. When we refer to 

conducting the collection ‘‘correctly’’ in 

these sections, we mean using the oral 

fluid device in the manner described by 

its manufacturer. 

Subpart F 

The proposed rule would reorganize 

subpart F (49 CFR 40.81–40.97), which 

addresses drug testing laboratories, to 

create a logical progression of urine 

drug testing, oral fluid drug testing, and 

provisions common to both. This 

reorganization involves renumbering 

several provisions and, in some cases, 

adding language to specify where a 

provision applies only to urine drug 

testing. For example, the title of 

renumbered § 40.86 (§ 40.89 in the 

current regulation) would be changed to 

read ‘‘§ 40.86 What is urine validity 

testing, and are laboratories required to 

conduct it?’’ 

In several places in the text of § 40.97, 

several requirements are specified to 

apply only to urine testing, as they have 

no application to oral fluid testing. We 

restated § 40.97 in its entirety, given the 

number of individual changes made for 

this purpose. 

These editorial changes are not 

intended to modify the substance of the 

provisions in question. However, we 

would call readers’ attention to two 

proposed substantive changes. First, in 

renumbered § 40.84 (§ 40.99 in the 

current regulation), laboratories would 

be required to keep non-negative 

specimens for only 90 days, rather than 

the present one-year requirement. This 

change is intended to reduce storage 

burdens on laboratories. We are not 

aware of any reason a laboratory would 

need to keep the actual specimen 

beyond 90 days. This change would not 

affect the 2-year record retention 

requirement that HHS has set for 

documentation supporting the 

laboratory’s analysis of a non-negative 

specimen. This would not change a 

litigation hold placed upon the 

specimen and the paperwork. We seek 

comment on this change, as well as the 

more general question of whether 

interested parties find the 

reorganization of the Subpart F useful. 

The most notable new portion of this 

subpart, consisting of §§ 40.91–40.93, 

concerns cutoff concentrations and 

validity testing for oral fluid specimens. 

These three new sections are drawn 

from the HHS OFMG and are intended 

to be consistent with the HHS 

provisions. For information on the 

parallel HHS provisions and the HHS 

rationale for putting them into effect, 

see the OFMG (84 FR 57554). 

In § 40.111, we propose to add 

language to paragraphs (a) and (d) to 

clarify that in their statistical reports to 

employers and DOT, laboratories need 

to submit reports to employers for the 

specimens for which the laboratory 

tests. 

In addition, we added language in 

§ 40.111 to clarify that a laboratory 

withdrawing from National Laboratory 

Certification Program (NLCP) program 

certification is required to file with both 

employers and the DOT an aggregate 

statistical summary for the last period in 

which it conducted DOT-regulated 

testing. This data is important to the 

Department because it helps DOT 

identify trends regarding non-negative 

results (e.g., positives, adulterated, 

substituted and invalid) and cancelled 

tests. 

Subpart G—Medical Review Officers 

For the most part, MROs would 

continue to do their jobs as they have 

under the current regulation. However, 

the Department is proposing a few 

changes to the MRO provisions. 

Specifically, in § 40.121, we would 

delete the word ‘‘urine’’ from paragraph 

(c)(1)(i), because training for MROs 

should also include oral fluid testing. 

We seek comment on whether existing 

and/or new MROs should receive 


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additional training specifically with 

respect to their role in oral fluid testing 

and, if so, what subjects it should cover. 

In § 40.127, concerning MRO reviews 

of negative results, we propose 

specifying that MROs need not review 

more than 500 negative results ‘‘of all 

specimen types combined’’ in any 

quarter. This is to clarify that, by adding 

oral fluid testing to the regulation, we 

do not intend to increase MROs’ 

negative test result review requirements. 

In § 40.129(d), we propose deleting 

‘‘drug test report’’ and adding the word 

‘‘result’’ following ‘‘invalid test.’’ In 

§ 40.135(d), we propose deleting the 

word ‘‘test’’ and adding the word 

‘‘result.’’ This would keep the language 

of that paragraph internally consistent 

and consistent with the definition of the 

term ‘‘invalid result’’ in § 40.3. 

In § 40.139(b), we are proposing to 

add the cutoffs for oral fluid laboratoryconfirmed results. This is important 

because there are different cutoffs for 

the MRO to consider when the 

specimen is oral fluid versus urine. 

These cutoffs trigger a clinical 

examination for the use of the naturally 

occurring opiates, codeine and 

morphine. In addition, in § 40.139(c), 

we propose to delete a reference to 

‘‘urine,’’ since the provision would 

apply to all DOT drug tests. 

The proposed rule would make two 

clarifying changes to § 40.145. In 

§ 40.145(g)(3), we would delete the 

word ‘‘urine’’ and substitute ‘‘drug,’’ 

since in this context we would apply 

the requirement to test in an HHScertified laboratory to any such test, 

whether urine or oral fluid. In paragraph 

(h) we would add the word ‘‘urine’’ after 

‘‘substituted’’. 

In § 40.151, we propose clarifying the 

language of paragraph (a) to direct 

MROs not to accept the result of any 

drug test not collected and tested under 

Part 40 procedures. In talking to 

employees who contact ODAPC 

following a positive drug test, we often 

hear, ‘‘I went to my own doctor the next 

day and took another test and it was 

negative.’’ This paragraph emphasizes 

that MROs cannot accept such a claim, 

which does not overturn the MRO’s 

decision. We also deleted language 

referring to DNA tests since use of those 

tests is prohibited elsewhere in the 

regulation (see 49 CFR 40.153(e) and 

40.331(f)). In paragraph (b), we would 

change ‘‘urine’’ container to 

‘‘collection’’ container in recognition of 

the advent of oral fluid testing. In 

paragraph (g), we deleted reference to 

‘‘MDEA’’, since it had been removed in 

a previous rulemaking (82 FR 52229 

(Nov. 13, 2017)), in response to HHS 

deleting MDEA from the drug testing 

panel. MDEA is a Schedule I drug in the 

amphetamines class that was previously 

a required confirmatory test analyte 

under the HHS Guidelines, but which 

HHS removed. 

In § 40.151, we also propose a 

technical amendment to paragraph (i), 

replacing the wording ‘‘with no 

detectable creatinine’’ with ‘‘when the 

creatinine level is below the laboratory’s 

limit of detection.’’ This would ensure 

consistency with the requirement for 

laboratories to provide a numerical 

value for a substituted result (see 49 

CFR 40.97(e)(2)). Also, it is our 

understanding that all HHS/NLCPcertified laboratories must have an 

established limit of detection for 

creatinine of 1mg/dL or less. Therefore, 

when a laboratory reports a creatinine 

concentration level at less than its limit 

of detection, MROs can be assured that 

it falls below the creatinine 

concentration of 2mg/dL for a 

substituted specimen and that an 

individual cannot physiologically 

produce such a urine specimen. 

In § 40.159, in paragraph (a)(1) we 

propose to correct the reference to 

§ 40.96(c) to become § 40.96(b) and we 

propose adding a new sentence to 

paragraph (a)(5)(ii), which would 

require re-collection when an invalid 

test is cancelled. The added sentence 

would direct that an alternative 

specimen be collected if practicable 

(e.g., oral fluid, if the specimen was 

urine). This could result in a more 

efficient process and reduce the 

likelihood of multiple invalid 

specimens resulting from use of the 

same specimen type. 

In § 40.163(c)(2), we propose a small 

change, substituting ‘‘employee’’ for 

‘‘donor.’’ In § 40.163(e), we are also 

making minor wording changes to 

clarify what records the MRO needs to 

retain after having reported a result and 

to clarify that when completing Copy 2 

of the CCF, either the MRO must sign 

and date it (for both negatives and nonnegatives) or MRO staff must stamp and 

date it (for negatives only). 

§ 40.177 What does the second 

laboratory do with the split specimen 

when it is tested to reconfirm the 

presence of a drug or drug metabolite? 

In § 40.177, we propose adding a 

reference to the sections pertaining to 

oral fluid testing. 

§ 40.179 What does the second 

laboratory do with the split specimen 

when it is tested to reconfirm an 

adulterated test result? 

In § 40.179, the proposed rule would 

change referenced section numbers in 

accordance with renumbering and new 

oral fluid provisions elsewhere in the 

regulations. 

§ 40.181 What does the second 

laboratory do with a urine split 

specimen when it is tested to reconfirm 

a substituted test result? 

In § 40.181, the proposed rule would 

change referenced section numbers in 

accordance with renumbering and new 

oral fluid provisions elsewhere in the 

regulations. In addition, § 40.181 would 

be changed to refer only to urine testing, 

since the creatinine and specific gravity 

apply only to urine testing. 

§ 40.187 What does the MRO do with 

split specimen laboratory results? 

In § 40.187, the proposed rule would 

change references to appendix D to 

appendix F in accordance with the 

redesignations. 

§ 40.191 What is a refusal to take a 

DOT drug test, and what are the 

consequences? 

This proposed provision carries 

through the main points of Part 40’s 

existing refusals provision, the main 

addition being a provision describing 

what can constitute a refusal in an oral 

fluid collection. The proposed section 

would make a variety of small wording 

changes to take oral fluid testing into 

account (e.g., in paragraph (a)(8)), ‘‘fail 

to permit an inspection of the 

employee’s oral cavity or fail to remove 

objects from his or her mouth’’), as well 

as specifying situations that are 

applicable only to urine testing (e.g., in 

paragraph (a)(9)), ‘‘fail to comply with 

an instruction to permit inspection to 

allow the observer to determine whether 

there is a prosthetic device in use’’). 

Like the pre-employment urine 

collection process, the oral fluid preemployment collection process 

generally would not begin until the 

device is unwrapped. If an employee 

does not appear for a pre-employment 

drug test or leaves the collection site 

before receiving or unwrapping the 

device, this is not a refusal under 

§ 40.191. However, as in urine testing, 

certain blatant conduct by the employee 

at the collection site could constitute a 

refusal before the collection device is 

unwrapped. For example, if an 

employee arriving for a pre-employment 

test, engages in disruptive or combative 

conduct at the collection site, a collector 

could report a refusal to the employer 

for determination. 

In addition, it is important to note 

that when an employee is undergoing a 

pre-employment test and the collector 

switches to an alternate device, it is 

considered a continuation of the 

original collection and is not subject to 


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the pre-employment exception for 

leaving the collection site before the 

second device is opened. For example, 

if a collector begins with one specimen 

methodology (e.g., urine) and switches 

to oral fluid (e.g., because the employee 

was unable to provide a sufficient 

specimen), the employee must not leave 

the collection site without refusal 

consequences. 

The proposed rule would revise 

§ 40.191(d) and add a new paragraph 

(c)(1) to § 40.261 to clarify an oftenmisunderstood point about who has the 

authority to declare that conduct at the 

collection site constitutes a refusal to 

test. The Department has received many 

inquiries in which employers have 

automatically treated as a refusal any 

situation in which the collection site 

notes a refusal in the remarks section of 

the CCF. This is not correct. 

Under the long-existing § 40.355(i), 

making collection site refusal decisions 

is a ‘‘non-delegable’’ duty of the actual 

employer. Service agents, such as 

collectors, BATs or STTs, are not 

authorized to make this decision. Their 

role is to provide information to the 

employer concerning the circumstances 

of the event. Then the employer, who as 

a matter of prudence would contact the 

employee and the collector or BAT to 

gather information, should make the 

decision, taking the entirety of the 

circumstances into account. The 

employer would have the discretion to 

consider circumstances that may 

satisfactorily excuse the employee’s 

conduct. For FMCSA-regulated owneroperators, C/TPAs stand in the shoes of 

employers for the purposes of 

determining whether the individual 

refused a test (49 CFR 382.705(b)(6)). 

For example, we have heard multiple 

times about situations in which an 

employee provides an insufficient 

quantity of urine, begins the ‘‘shy 

bladder’’ procedure, but the procedure 

is cut short because the collection site 

closes before the employee has had 

three hours to produce a sufficient urine 

specimen, as allowed by § 40.193(b)(2). 

If the collection site nevertheless reports 

the matter to the employer as a refusal, 

the employer has discretion to 

determine that there was no intent on 

the part of the employee to evade the 

process. If the employer determines that 

a refusal did not occur, the employer 

would treat the test as an 

administratively closed non-event. 

FMCSA-regulated employers would 

have the discretion not report such nonevents to the Clearinghouse as refusals. 

The same thinking might apply in a 

situation in which a documented family 

medical emergency led the employee to 

leave the collection site. 

For random tests administratively 

closed as a non-event by the employer, 

no further action is required. For those 

testing events that require a ‘‘negative’’ 

test result (e.g., return-to-duty, followup), the employer would send the 

employee back for another collection. In 

all cases, the employer should 

document exactly what happened to 

explain why the employer concluded a 

refusal did not occur. 

§ 40.193 What happens when an 

employee does not provide a sufficient 

amount of specimen for a drug test? 

The most important change that this 

section would make is the addition of 

oral fluid testing to paragraph (a), 

adding insufficient specimen provisions 

for oral fluid testing, parallel to, but 

briefer than, the existing provisions of 

dealing with insufficient urine 

specimens. Because of the differences 

between the two types of specimen 

collections, the insufficient specimen 

collection procedure is shorter in 

duration than the insufficient urine 

specimen collection procedure (e.g., in 

an oral fluid collection, there would not 

be a need for a three-hour wait period). 

In paragraph (e), the proposed rule 

would add examples of conditions that 

might succeed as medical explanations 

of providing an insufficient quantity of 

oral fluid (e.g., autoimmune diseases), 

as well as examples that would not 

constitute a valid medical explanation 

(e.g., unsupported assertions of 

dehydration). We seek comment on 

what sort of evidence is needed to avoid 

an assertion being viewed as 

‘‘unsupported’’ for this purpose. We 

note that because alternative specimens 

will be available, using a different type 

of specimen in an insufficient quantity 

case may be an option. That is, if a urine 

specimen is insufficient, the collector 

could follow up with an oral fluid 

collection, or vice-versa. In such a case, 

following the insufficient urine 

specimen procedures would become 

unnecessary. The Department seeks 

comment on both this concept and 

whether specific language to this effect 

should be included in the regulatory 

text. 

We also seek public comment, 

especially from device manufacturers, 

regarding whether allowing a donor to 

rinse with up to 8 ounces of water is an 

appropriate amount of fluid for rinsing 

for the purposes of both §§ 40.72(b) and 

40.193(b)(2). Should we allow more or 

less? Would measuring less than 8 

ounces be difficult for collectors? 

We also seek comment on whether a 

qualified collector should be able to 

make a decision about what 

methodology to use after an insufficient 

specimen occurs, or whether this should 

be a decision left to the employer, 

depending, for example on the 

employer’s contract with a C/TPA, 

laboratory, or collection site. In 

addition, when following an insufficient 

specimen collection, consistent with the 

HHS OFMG, the collector would 

complete a new CCF for the alternative 

specimen collection. Is this an 

appropriate way of handling such 

situations, or would it be better to 

continue the current practice and use 

the original CCF with relevant crossouts and notations in the remarks 

section? 

§ 40.195 What happens when an 

individual is unable to provide a 

sufficient amount of specimen for a preemployment follow-up or return-to-duty 

test because of a permanent or longterm medical condition? 

The only textual change in § 40.195 in 

the proposed rule is in the title, where 

the more general ‘‘specimen’’ is 

substituted for ‘‘urine,’’ in view of the 

addition of oral fluid testing to the 

program. 

§ 40.197 What happens when an 

employer receives a report of a dilute 

urine specimen? 

The only textual change in § 40.197 in 

the proposed rule is in the title, where 

the word urine would be inserted 

because this section concerns situations 

that arise only in urine testing. 

§ 40.199 What problems always cause 

a drug test to be cancelled? 

Section 40.199, the ‘‘fatal flaws’’ 

section of the rule, would be expanded 

by adding a new fatal flaw for use of an 

expired oral fluid collection device, in 

paragraph (b)(8). In paragraph (b)(7) of 

§ 40.199, the term ‘‘urine’’ would be 

replaced with ‘‘specimen,’’ reflecting 

the addition of oral fluid testing to the 

program. 

§ 40.201 What problems always cause 

a drug test to be cancelled and may 

result in a requirement for another 

collection? 

In paragraph (b)(7) of § 40.199 and 

paragraph (f) of § 40.201, the term 

‘‘urine’’ would be replaced with 

‘‘specimen,’’ reflecting the addition of 

oral fluid testing to the program. 

§ 40.207 What is the effect of a 

cancelled drug test? 

Throughout the history of Part 40, 

there has not been a regulatory 

provision that allows an MRO to 

‘‘uncancel’’ a test that the MRO has 

cancelled. New paragraph (d) is 

proposed so that an MRO can reverse 


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11168 Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Proposed Rules 

the cancellation of a test. Currently, 

§§ 40.203, 40.205, and 40.208 address 

situations that require a test to be 

cancelled by an MRO, if there is not 

corrective action. For example, if an 

MRO does not receive a timely 

memorandum for the record from a 

collector regarding required information 

that was omitted from the CCF, the 

MRO may cancel the test. Once an MRO 

cancels a test due to an uncorrected 

correctible error, there is currently no 

authority for the MRO to reverse that 

cancellation decision. So, if the 

memorandum for the record arrives, but 

the MRO staff misses it, the cancelled 

test cannot be reversed without this 

proposed rule change. That inability has 

created additional cost for the employer, 

inconvenience for the employee, and 

also confusion because some MROs 

think they already have this authority. 

Adding this provision will reduce costs 

and confusion. In addition, for those 

testing events for which an employer 

needs a negative result (i.e., preemployment, return-to-duty or followup), an employee must go in and re-take 

the test, if the MRO cannot un-cancel it 

after the error is corrected. 

§ 40.210 What kinds of drug tests are 

permitted under the regulations? 

This proposed revision notes that oral 

fluid and/or urine specimens can be 

collected, and must be tested at HHScertified laboratories. No other 

specimen methodologies are currently 

permitted. 

We are proposing that an employer 

can use one or the other, but not both 

urine and oral fluid methodologies at 

the beginning of the testing event. For 

example, if an employee is sent for a 

test, either a urine or oral fluid 

specimen can be collected, but not both 

simultaneously. However, if there is a 

problem in the collection that 

necessitates a second collection (e.g., 

insufficient quantity of urine, 

temperature out of range, or insufficient 

oral fluid), we want to propose that a 

second methodology could be used to 

complete the collection process for the 

testing event. If we adopt this provision, 

would the employer and/or its service 

agent be the correct one(s) to make the 

decision as to which methodology to 

use in the second collection? 

§ 40.225 What form is used for an 

alcohol test? 

This proposed revision would make a 

conforming change to § 40.225 and 

redesignate appendix G to be appendix 

I. 

§ 40.261 What is a refusal to take an 

alcohol test, and what are the 

consequences? 

We are proposing to add a new 

paragraph (c)(1) to this section, parallel 

to the proposed § 40.191(b) for drug 

testing. It spells out the respective 

responsibilities of the service agent(s) 

and the DER in making decisions about 

whether a situation during an alcohol 

test constitutes a refusal to test. In a 

situation in which there is not an 

employee signature, at Step 2 of the 

ATF (see paragraph (a)(6) of this 

section), but a result is nonetheless 

forwarded to the employer, we 

recommend that the employer take a 

case-by-case approach, for example not 

treating as a refusal a situation in which 

there is no signature but there is an 

affidavit from an STT or BAT explaining 

the situation. 

§ 40.283 How does a certification 

organization obtain recognition for its 

members as SAPs? 

In § 40.283, there is a conforming 

change redesignating aappendix E to 

aappendix G. 

§ 40.285 When is a SAP evaluation 

required? 

In § 40.285, the word ‘‘urine’’ would 

be removed if oral fluid testing is added. 

§ 40.345 In what circumstances may a 

C/TPA act as an intermediary in the 

transmission of drug and alcohol testing 

information to employers? 

A conforming change, from aappendix 

F to aappendix H, would be made in 

§ 40.345. 

§ 40.355 What limitations apply to the 

activities of service agents? 

In § 40.355(n) (Example 3), the word 

‘‘urine’’ would be removed in light of 

the addition of oral fluid testing. 

§ 40.291 What is the role of the SAP in 

the evaluation, referral, and treatment 

process of an employee who has 

violated DOT agency drug and alcohol 

testing regulations? 

As discussed in the Principal Policy 

Considerations section, the Department 

is proposing to permit substance abuse 

professionals (SAPs) to conduct 

evaluations or assessments remotely. 

The proposed rule would amend 

§§ 40.291(a)(1) and (3) to remove the 

requirement that SAP evaluations be 

only ‘‘face-to-face’’ and to explain what 

is required for remote evaluations. 

Specifically, the technology must be 

able to allow real-time audio and visual 

interaction between the SAP and the 

employee. Telephone calls, therefore, 

would not be acceptable. In addition, 

the proposal would require that the 

quality of the technology be sufficient to 

allow the SAP to gather all visual and 

audible information that would be 

apparent in a face-to-face interaction. 

§ 40.293 What is the SAP’s function in 

conducting the initial evaluation of an 

employee? 

The proposal would remove the 

words ‘‘face-to-face’’ from paragraph (a) 

this provision. This change, if adopted, 

would allow remote evaluations. 

§ 40.301 What is the SAP’s function in 

the follow-up evaluation of an 

employee? 

The proposal would remove the 

words ‘‘face-to-face’’ from paragraph 

(b)(2) this provision. It would also add 

the words ‘‘meeting the requirements of 

§ 40.291(a)(1) of this part’’, if adopted. 

This proposed change would allow 

remote evaluations. 

§ 40.311 What are the requirements 

concerning SAP reports? 

The proposal would add the words 

‘‘and format (i.e., face-to-face or 

remote)’’ to § 40.311(c)(4), (d)(4), and 

(e)(4). In addition, we would amend 

§ 40.311 to direct SAPs to note on their 

SAP reports whether a given evaluation 

occurred face-to-face or remotely. 

We also propose to change ‘‘SSN’’ to 

‘‘SSN or employee ID number’’ in 

paragraphs § 40.311(c)(1), (d)(1) and 

(e)(1) for consistency of terms in Part 40 

and to allow the use of additional 

identification numbers in SAP reports, 

instead of solely the Social Security 

Number. 

§ 40.365 What is the Department’s 

policy concerning starting a PIE 

proceeding? 

We propose to amend § 40.365 to say 

that a PIE could occur because a SAP 

failed to conduct an evaluation using 

the means provided in § 40.291(a)(1), 

rather than because there was no faceto-face evaluation. 

§ 40.327 When must the MRO report 

medical information gathered in the 

verification process? 

In § 40.327, we would add a 

clarification that MROs are not to use 

the CCF to transmit information about 

safety concerns to employers or other 

authorized parties. Rather, a separate 

communication (e.g., secure email, 

letter) is to be used. The communication 

should specify whether the MRO’s 

safety concern relates to the use of a 

medication, the type of medical 

condition for which such a medication 

is typically prescribed, or some 

combination of the two. The purpose of 


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providing this information is to allow 

the employer and/or any third parties to 

focus on the MRO’s specific concern, 

rather than having to make an openended inquiry. The Department seeks 

comment on this matter. This 

clarification would echo the 

Department’s 2017 final rule preamble 

discussion that medical information is 

sent apart from the verified result 

report. (82 FR 52229, 52236; Nov. 13, 

2017). 

Appendices 

Appendix A, concerning urine 

collection kits, would remain 

unchanged. The proposed rule would 

add a new aappendix B, establishing 

standards for oral fluid collection kits, 

based on material in the HHS OFMG 

and consistent with OTETA 

requirements for a split specimen. The 

Department seeks comments on the 

details of the proposed standards. 

The remainder of the appendices 

would be renumbered and reordered. 

For a summary of these changes, see the 

redesignation table immediately 

preceding the discussion of subpart D in 

section V of the preamble. The 

Department seeks comment on the new 

organization of the appendices. 

Current aappendix B, concerning 

semi-annual reports by laboratories to 

employers, would become aappendix D. 

The new version of the appendix would 

break out matters to be reported with 

respect to urine and oral fluid testing 

respectively. Current aappendix C, 

regarding semi-annual reports by 

laboratories to the Department, would 

become aappendix E. Meanwhile, the 

aappendix C slot would be reserved. 

In the redesignated aappendix E (the 

former aappendix C), the Department 

proposes to amend the data elements 

that HHS/NLCP certified laboratories 

would submit to DOT semi-annually. 

Specifically, we propose to require 

laboratories to continue to provide the 

DOT with the drug testing data but to be 

broken out by specimen type (i.e., urine 

and oral fluid), DOT agency (i.e., 

FMCSA, FAA, FRA, FTA, PHMSA, U.S. 

Coast Guard) and test reason (i.e., preemployment, random, reasonable 

suspicion/cause, post-accident, returnto-duty, other, and follow-up). The 

proposal would require each laboratory 

to submit multiple data summaries as 

opposed to the one data summary they 

now provide. By providing the 

additional data elements, we hope to 

evaluate the efficacy of testing by oral 

fluid versus urine. We also hope to get 

a better understanding of any trends in 

drug testing by specimen type, DOT 

agency and/or test reason(s). 

We do not anticipate that providing 

the amended data summaries will prove 

to be burdensome to the laboratories. It 

is our understanding that most, if not all 

of the HHS/NLCP-certified laboratories 

capture these data elements either as a 

result of implementing the electronic 

Federal Drug Testing Custody and 

Control Form, or in their Laboratory 

Information Management System, as 

part of tracking the specimens and 

reporting out test results to the Medical 

Review Officer. We would appreciate 

information from laboratories as to 

whether adding the new data elements 

would increase their costs or otherwise 

impose a quantifiable burden of what 

the costs of adding the new data 

elements would be. 

Current aappendix D, concerning 

reports on split specimen failures to 

reconfirm, would become aappendix F. 

We propose to add the ‘‘specimen type’’ 

as another element to the information 

the MRO currently provides so we can 

track the two specimen types. Current 

aappendix E, on SAP equivalency 

requirements for certification 

organizations, would become aappendix 

G. 

Current aappendix F, concerning drug 

and alcohol testing information can be 

transmitted by C/TPAs, would become 

appendix H. Current appendix G, the 

Alcohol Testing Form, would become 

aappendix I. Finally, aappendix H, the 

MIS data collection form, would be 

found in aappendix J. 

VI. Regulatory Analyses and Notices 

Executive Order 12866 

The Secretary has examined the 

impact of the proposed Part 40 

amendments under Executive Order 

12866, which directs Federal agencies to 

assess all costs and benefits of available 

regulatory alternatives and, when 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). This 

examination draws upon the evaluation 

performed by HHS in its final guidelines 

concerning oral fluid testing, published 

October 25, 2019 (84 FR 57554), as well 

as data reflecting the Department’s 

experience in implementing its existing 

drug testing program. 

According to Executive Order 12866, 

a regulatory action is ‘‘significant’’ if it 

meets any one of a number of specified 

conditions, including having an annual 

effect on the economy of $100 million; 

adversely affecting in a material way a 

sector of the economy, competition, or 

jobs; or if it raises novel legal or policy 

issues. The proposed amendments do 

modify existing regulatory requirements 

and allow an activity that was formerly 

prohibited, but they do not meet the 

Executive Order’s criteria for being a 

significant rule. Consequently, OMB has 

determined that this document proposes 

a nonsignificant rule. 

Need for Regulation 

The Department believes that this 

proposed rule is needed because it 

makes several improvements in the 

integrity and effectiveness of an 

important safety program, as well as 

potentially reducing some costs to 

regulated parties. The reasons for this 

belief include the following: 

Enhanced Flexibility 

The proposed rule, consistent with 

the HHS OFMG, would revise the 

requirement to collect only a urine 

specimen, which has existed since Part 

40 was first published in 1988. Urine 

drug testing is subject to issues related 

to an employee’s inability to produce a 

sufficient urine specimen. In such 

situations, the employee’s inability to 

provide a sufficient urine specimen 

creates delays in getting a result to the 

employer because of the requirement to 

have the employee evaluated by a 

medical professional to assess the 

employee’s inability to provide a 

sufficient specimen. 

When the proposed amendments to 

Part 40 permitting oral fluid testing are 

used by a transportation employer, the 

employer will be authorized to collect 

an oral fluid specimen from an 

individual who is unable to provide a 

sufficient urine specimen. This added 

flexibility will reduce the need for the 

Medical Review Officer (MRO) to 

arrange a medical evaluation of an 

employee’s inability to provide a 

specimen. Therefore, the proposed 

amendments would provide flexibility 

to address workplace drug testing needs 

of transportation employers by 

permitting the selection of the specimen 

type best suited for their needs and 

authorizing collection of an alternative 

specimen type when an employee is 

unable to provide a sufficient urine 

specimen. The added flexibility will 

also benefit employees, who should be 

able to provide one of the specimen 

types, thereby facilitating the drug test 

required for their employment. 

Enhanced Versatility 

Urine collection requires use of a 

collection facility, secured restrooms, 

and other special requirements. An oral 

fluid collection does not require an 

enclosure, the way that a urine 

collection does. With oral fluids, there 


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is more flexibility regarding the 

collection site. Specifically, an 

acceptable oral fluid collection site must 

allow the collector to observe the 

employee, maintain control of the 

collection device(s) during the process, 

maintain record storage, and protect 

employee privacy. This would provide 

employers with more flexibility about 

where to conduct a collection. For 

example, especially in the railroad and 

pipeline industries, where selected 

employees may be part of ‘‘travelling 

gangs’’ or in remote locations (e.g., away 

from locations with traditional brickand-mortar buildings) an enclosure is 

often difficult to find for collecting 

DOT-regulated specimens. 

Having oral fluid testing as an option 

available to an employer provides 

flexibility for the employer to choose 

whether urine or oral fluid testing is 

better due to logistics, costs, and the 

specific facts of a situation. Among 

other things, when a problematic 

situation occurs at a collection site (e.g., 

a urine specimen is out of temperature 

range), the ensuing directly observed 

test could be conducted using oral fluid. 

Choosing the oral fluid testing option in 

such situations can save the employer 

significant time and money. 

Decreased Numbers of Substituted and 

Adulterated Tests 

All unobserved specimen collections 

are at risk for substitution and 

adulteration. Per HHS’s OFMG 

preamble, information from the drug 

testing industry indicates that 0.05 to 

3% of urine specimens collected for 

drug use detection are determined to be 

substituted or adulterated. (84 FR 

57571; Oct. 25, 2019). All oral fluid 

collections will occur under direct 

observation, which should substantially 

reduce the risks of specimen 

substitution and adulteration that has 

been associated with urine specimen 

collections, most of which are 

unobserved. With the above in mind, 

and to harmonize with HHS, we are 

proposing changes to §§ 40.91 and 40.93 

to authorize laboratories to conduct 

specimen validity testing (e.g., testing 

for a biomarker such as albumin or 

immunoglobulin G, IgG or for a specific 

adulterant). 

Time and Cost Savings 

Collecting an oral fluid specimen can 

require less time than collecting a urine 

specimen, and thereby reduce the 

employee’s time away from the 

workplace and costs to the employer. 

First, most urine collections take place 

in separate facilities dedicated to 

collections, requiring employees to 

travel from their workplace to those 

facilities and back. Their time away 

from their workplace is a cost to their 

employers. On the other hand, most oral 

fluid collections are likely to take place 

at or near the workplace, making this 

travel time and cost unnecessary. 

The Department does not currently 

have data on the percentage of urine 

collections that are conducted in 

dedicated collection facilities, or the 

percentage of oral fluid collections that 

would likely be conducted on-site. We 

request that commenters submit 

information that would help the 

Department approximate a calculation 

of the travel time savings that could 

result from making oral fluid testing 

available as an alternative to urine 

testing. 

Second, some urine collection events 

involve the employee’s inability to 

provide a sufficient specimen. In these 

cases, the current regulation affords the 

employee up to three hours to make a 

second attempt at providing a sufficient 

urine specimen. This wait period can be 

avoided by immediately switching to an 

oral fluid collection, saving up to three 

hours of time in such cases. From 2018 

MIS data, about 334 insufficient 

specimen collections resulted in 

refusals, a number that does not include 

those instances in which the situation is 

resolved without a refusal being 

declared. The Department seeks 

comment on the incidence of ‘‘shy 

bladder’’ situations, to get a better sense 

of how much time and costs would be 

saved by eliminating them by the use of 

oral fluid testing. 

In addition, fewer insufficient 

specimen situations would mean fewer 

medical evaluations, which could also 

result in time and cost savings. The 

option to collect a urine specimen in the 

event that the employee cannot provide 

an oral fluid specimen (and vice versa) 

will avoid the need for the MRO to 

arrange for a medical evaluation of an 

employee’s inability to provide a 

sufficient specimen. We seek comment 

on what degree of time and cost savings 

might result from this proposal. 

We also note that urine testing is 

subject to other events that may involve 

additional testing. For instance, if an 

initial urine specimen is out of 

temperature range, or the color or odor 

of a specimen may indicate an attempt 

to tamper with a specimen, there must 

be an immediate re-collection under 

direct observation. Many of these 

situations may well evolve into a ‘‘shy 

bladder’’ situation as, having just 

voided, the employee may be unable to 

produce another specimen quickly. 

These subsequent collections involve 

time and other costs. We seek comment 

on how frequently such subsequent 

collections occur, and how much time 

they add to the process. 

Reduced Need for Collection Site 

Security Measures 

Urine testing requires that access to 

water sources or to any potential 

adulterants or substituting products be 

secured and prohibited. This requires 

securing of the collection site to ensure 

the integrity of the unobserved testing 

process and protection against cheating. 

We are proposing substantially fewer 

steps for oral fluid collection site 

integrity and security because all oral 

fluid specimen collection is directly 

observed. 

Providing urine is a bodily function 

that requires more privacy than having 

the employee place a collection device 

in the employee’s mouth, in accordance 

with the collector’s instructions. 

Consequently, oral fluid testing is less 

intrusive and time-consuming than even 

unobserved urine testing. 

Versatility in Detection 

Adding oral fluid as an alternate 

specimen type would allow an 

employer to select the specimen type 

based on the circumstances of the test. 

For example, in a reasonable suspicion/ 

cause or post-accident test, an oral fluid 

test may show the presence of an active 

drug, which may indicate recent use of 

the drug, and which might not be 

detected in a urine drug test. 

An oral fluid drug test can detect 

marijuana use in the past 24 hours, 

while a urine drug test detects use 

ranging from 3–67 days prior to 

collection (see preamble 

‘‘Understanding Windows of 

Detection’’). Thus, oral fluid testing may 

give employers more interpretative 

insight into recent drug use. 

Lower Likelihood of Adulteration, 

Substitution or Cheating 

Urine was the original specimen of 

choice for workplace drug testing, and 

urine testing is expected to remain an 

established and reliable component of 

DOT’s drug testing program. However, a 

major challenge to urine drug testing 

has been the proliferation and use of 

available commercial products used to 

adulterate or substitute an employee’s 

urine specimen. Due to individual 

privacy rights, most urine collections 

are unobserved, allowing the 

opportunity to use such products. As 

under HHS Urine Mandatory 

Guidelines, laboratories have developed 

procedures to identify adulterated and/ 

or substituted specimens, manufacturers 

have developed new products to avoid 

detection. The use of these products is 

expected to continue. Like HHS, DOT 


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believes that oral fluid testing is likely 

to be less susceptible to these problems 

because the oral fluid collection is a 

directly observed collection. 

Costs and Benefits 

Using data obtained from the Federal 

Workplace Drug Testing Programs and 

HHS-certified laboratories, HHS 

estimated that approximately 7% (or 

10,500) of the 150,000 specimens tested 

in the Federal employee program per 

year would be oral fluid specimens and 

93% would continue to be urine 

specimens. HHS further estimated that 

subsequent transition to oral fluid 

testing would be gradual and steady 

over the course of four years, when it 

could account for about 30% of all tests. 

If, as the Department believes based 

on industry experience, the cost of a 

urine test is approximately $50, while 

the cost of an oral fluid test is $35, this 

means that each oral fluid test that is 

done in place of a urine test results in 

a saving of $15. By this calculation, oral 

fluid testing would cost $14.7 million in 

the first year and $63 million after the 

four-year transition period. This 

represents a potential savings of $6.3 

million the first year and $27 million in 

the fourth year, compared to a scenario 

in which all the tests in question were 

urine tests. The Department seeks 

comment on whether the assumptions 

behind these calculations make sense 

and whether and how we should modify 

them. 

It is possible that, over time, the 

proportion of tests conducted using oral 

fluid could increase beyond this 

projection, as employers take advantage 

of the lower costs and greater flexibility 

associated with oral fluid testing. If so, 

then the cost savings of these 

amendments would increase. We do not 

have data on which to base an estimate 

of how large and how quickly this trend 

might become. The Department seeks 

comment on this matter. 

Employers and C/TPAs choosing to 

use oral fluid in their drug testing 

programs may incur collector training 

costs. Based on an average of the limited 

number of published training costs for 

oral fluid collectors in the non-DOT 

drug testing industry, oral fluid 

collection training would cost about 

$348 per collector trained. 

The Department estimates that there 

are about 25,000 collectors currently 

participating in the DOT-regulated urine 

drug testing program. We assume, per 

HHS’s projection, that after the first year 

of oral fluid testing, 7% of tests would 

use oral fluid and around 7% of 

collectors would be trained in oral fluid 

collection by that point. Seven percent 

of 25,000 collectors is 1,750. Their 

training would cost $609,000. By the 

same logic, by the end of the fourth 

year, 30% of those 25,000 collectors, or 

7,500, would have been trained in 

collecting oral fluid. The cost for oral 

fluid testing training an additional 23% 

of the 25,000 collectors, or 5,750 

individuals, in years 2–4 would be 

$2,001,000. The Department seeks 

information and comment on this 

approach and these projections. 

As noted in the time savings 

discussion above, in a ‘‘shy bladder’’ 

situation, a collector can switch from 

urine to oral fluid collection. Likewise, 

in a ‘‘dry mouth’’ situation, a collector 

can switch from oral fluid to urine 

collection. This flexibility minimizes 

the required waiting period involved in 

‘‘shy bladder/dry mouth’’ situations at 

the collection site. It also avoids costs 

and time expenses of subsequent 

medical evaluations to determine 

whether there is a medical explanation 

of employee’s inability to provide a 

sufficient specimen. As noted above, we 

are seeking information on the number 

and costs of such evaluations. Table 1 

summarizes the quantified economic 

effects of the proposed rule. The 

proposed rule has annual net cost 

savings (benefits) of $5,61,000 in the 

first year, increasing to $24,999,000 in 

the fourth and subsequent years. 

TABLE 1—ECONOMIC EFFECTS OF PROPOSED RULE

Year Costs Cost savings Net cost savings 

1 ....................................................................................................................................... $609,000 $6,300,000 $5,691,000 

2 ....................................................................................................................................... $957,000 $11,475,000 $10,518,000 

3 ....................................................................................................................................... $1,305,000 $11,475,000 $10,170,000 

4 and beyond ................................................................................................................... $2,001,000 $27,000,000 $24,999,000 

Regulatory Flexibility Act and SBREFA 

This rule does affect small entities, 

including employees, small 

transportation companies and collection 

sites. DOT anticipates, however, that 

there will be an overall reduction in 

costs if drug testing is expanded to 

provide the option of oral fluid testing 

under Part 40. The added flexibility to 

use either specimen type will permit 

employers to select the specimen type 

best suited for their needs and to 

authorize collection of an alternative 

specimen type when an employee is 

unable to provide the specimen type 

originally authorized. This added 

flexibility will also benefit employees, 

who should be able to provide one of 

the specimen types, thereby facilitating 

the completion of drug tests required for 

their employment. For these reasons, 

and as explained in more detail in the 

preamble to this proposed rule, the 

Secretary has determined 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 (5 U.S.C. 605(b)). 

Consequently, an initial regulatory 

flexibility analysis is not required for 

this proposed rule. 

The Secretary has determined that 

this NPRM is not a ‘‘major rule’’ for the 

purpose of congressional review. For the 

purpose of congressional review, a 

major rule is one which is likely to 

cause an annual effect on the economy 

of $100 million or more; a major 

increase in costs or prices; significant 

effects on competition, employment, 

productivity, or innovation; or 

significant effects on the ability of U.S.- 

based enterprises to compete with 

foreign-based enterprises in domestic or 

export markets. The proposed rule does 

none of these things, and hence does not 

constitute a major rule under the Small 

Business Regulatory Enforcement 

Fairness Act (SBREFA) of 1996. 

Unfunded Mandates 

The Secretary has examined the 

impact of the proposed rule under the 

Unfunded Mandates Reform Act 

(UMRA) of 1995 (Pub. L. 104–4). This 

notice 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 $100 million 

(adjusted annually for inflation) or more 

by either State, local, and tribal 

governments in the aggregate or by the 

private sector in any one year. In fact, 

by providing a lower cost alternative to 

urine drug testing, the NPRM would 

reduce costs to regulated parties, 

including State and local entities (e.g., 


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public transit authorities, public works 

departments) whose employees are 

subject to testing. 

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). The purpose of 

this rulemaking is to amend the 

transportation industry drug testing 

program procedures regulation to 

include oral fluid testing. 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 agency 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, public works departments); 

however, as noted above, this proposal 

would reduce costs of the Department’s 

drug testing program and provide 

additional flexibility for regulated 

parties. Accordingly, the Secretary has 

determined that the proposed rules do 

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. Nor will they 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. 

Information Collection/Record Keeping 

Requirements 

The proposed rule would not impose 

additional information collection 

burdens. In August 2020, OMB 

approved the revised CCF (OMB Control 

No. 0930–0158). It is a single CCF that 

can be used for either urine or oral fluid 

testing. Collectors, laboratories, MROs 

and other parties in the DOT drug 

testing program are required to use the 

2020 CCF for urine testing. Upon 

issuance of any final rule authorizing 

oral fluid testing, the 2020 CCF will be 

required for oral fluid testing. 

Notwithstanding any other provision 

of law, no person is required to, nor 

shall any person be subject to a penalty 

for failure to comply with, a collection 

of information subject to the 

requirements of the PRA unless that 

collection of information displays a 

currently valid OMB control number. 

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, the Department proposes to 

amend 49 CFR part 40 as follows: 

PART 40—PROCEDURES FOR 

TRANSPORTATION WORKPLACE 

DRUG AND ALCOHOL TESTING 

PROGRAMS 

■ 1. The authority for part 40 continues 

to read as follows: 

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

20140, 31306, and 54101 et seq. 

■ 2. In § 40.3: 

■ a. Remove the definitions of ‘‘Invalid 

drug test’’ and ‘‘Screening drug test’’; 

■ b. Remove the definition of ‘‘Initial 

drug test (also known as ‘‘Screening 

drug text’’) and add a definition for 

‘‘Initial drug test’’ in its place; 

■ c. Remove the definition of ‘‘Limit of 

Quantification’’ and add a definition for 

‘‘Limit of Quantification (LOQ)’’ in its 

place; 

■ d. Add in alphabetical order 

definitions for ‘‘Alternative specimen’’, 

‘‘Commercial Driver’s License Drug and 

Alcohol Clearinghouse 

(Clearinghouse)’’, ‘‘Cutoff’’, ‘‘Oral Fluid 

Specimen’’, ‘‘Specimen’’, ‘‘SSN or 

Employee ID No.’’, ‘‘Undiluted (neat) 

oral fluid’’, and ‘‘Urine Specimen’’; and 

■ e. Revise the definitions of 

‘‘Collection container’’, ‘‘Collection 

site’’, ‘‘Confirmatory drug test’’, ‘‘Initial 

drug test’’, ‘‘Initial specimen validity 

test’’, ‘‘Invalid Result’’, ‘‘Laboratory’’, 

‘‘Limit of Detection (LOD)’’, ‘‘Limit of 

Quantitation (LOQ)’’, ‘‘Non-negative 

specimen’’, ‘‘Primary specimen’’, 

‘‘Reconfirmed’’, ‘‘Shipping container’’, 

‘‘Specimen bottle’’, ‘‘Split specimen’’, 

‘‘Split specimen collection’’, and 

‘‘Substituted specimen’’. 

The additions and revisions read as 

follows: 

§ 40.3 What do the terms used in this part 

mean? 

* * * * * 

Alternative specimen. An authorized 

specimen, other than the type of 

specimen previously collected or 

attempted to be collected. 

* * * * * 

Collection container. A container 

used to collect a specimen. 

Collection site. A place selected by 

the employer where employees present 

themselves for the purpose of providing 

a specimen for a drug test. 

* * * * * 

Commercial Driver’s License Drug and 

Alcohol Clearinghouse (Clearinghouse). 

A database, administered by the Federal 

Motor Carrier Safety Administration, 

containing records of commercial motor 

vehicle drivers’ violations of controlled 


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substances and alcohol testing program 

requirements, as set forth in part 382 of 

this title, as well as their return-to-duty 

status. 

* * * * * 

Confirmatory drug test. A second 

analytical procedure performed on a 

different aliquot of the original 

specimen to identify and quantify a 

specific drug or drug metabolite. 

* * * * * 

Cutoff. The analytical value (e.g., drug 

or drug metabolite concentration) used 

as the decision point to determine a 

result (e.g., negative, positive, 

adulterated, invalid, or substituted) or 

the need for further testing. 

* * * * * 

Initial drug test. The first test used to 

differentiate a negative specimen from 

one that requires further testing for 

drugs or drug metabolites. 

Initial specimen validity test. The first 

test used to determine if a specimen is 

adulterated, diluted, substituted, or 

invalid. 

Invalid result. The result reported by 

a laboratory for a specimen in which the 

laboratory has not been able to complete 

testing or obtain a valid drug test result 

(e.g., because of an unidentified 

adulterant, an interfering substance, or 

an abnormal physical characteristic). 

Laboratory. Any U.S. laboratory 

certified by HHS under the National 

Laboratory Certification Program as 

meeting the minimum standards set by 

HHS; or, in the case of foreign 

laboratories, a laboratory approved for 

participation by DOT under this part. 

Limit of Detection (LOD). The lowest 

concentration at which the analyte (e.g., 

drug or drug metabolite) can be 

identified. 

Limit of Quantitation (LOQ). For 

quantitative assays, the lowest 

concentration at which the identity and 

concentration of the analyte (e.g., drug 

or drug metabolite) can be accurately 

established. 

* * * * * 

Non-negative specimen. A specimen 

that is reported as adulterated, 

substituted, positive (for drug(s) or drug 

metabolite(s)), or invalid. 

* * * * * 

Oral Fluid Specimen. A specimen that 

is collected from an employee’s oral 

cavity and is a combination of 

physiological fluids produced primarily 

by the salivary glands. 

* * * * * 

Primary specimen. In drug testing, the 

specimen bottle that is opened and 

tested by a first laboratory to determine 

whether the employee has a drug or 

drug metabolite in his or her system; 

and for the purpose of specimen validity 

testing. The primary specimen is the 

portion of the donor’s subdivided 

specimen designated as the primary 

(‘‘A’’) specimen by the collector to 

distinguish it from the split (‘‘B’’) 

specimen, as defined in this section. 

* * * * * 

Reconfirmed. The result reported for 

a split (Bottle B) specimen when the 

second HHS-certified laboratory 

corroborates the original result reported 

for the primary (Bottle A) specimen. 

* * * * * 

Shipping container. A container that 

is used for transporting and protecting 

specimen bottles and associated 

documents from the collection site to 

the laboratory. 

Specimen. Fluid, breath, or other 

material collected from an employee at 

the collection site for the purpose of a 

drug or alcohol test. 

Specimen bottle. The bottle that, after 

being sealed and labeled according to 

the procedures in this part, is used to 

hold a primary (‘‘A’’) or split (‘‘B’’) 

specimen during transportation to the 

laboratory. In the context of oral fluid 

testing, it may be referred to as a ‘‘vial,’’ 

‘‘tube,’’ or ‘‘bottle.’’ 

Split specimen. In drug testing, the 

specimen that is sent to a first laboratory 

and stored with its original seal intact, 

and which is transported to a second 

laboratory for retesting at the 

employee’s request following MRO 

verification of the primary specimen as 

positive, adulterated or substituted. 

Split specimen collection. A 

collection in which the single specimen 

collected is divided into two separate 

specimen bottles, the primary specimen 

(Bottle A) and the split specimen (Bottle 

B). 

SSN or Employee ID No. This number 

serves as a unique identifier that must 

be used on the Federal Drug Testing 

Custody and Control Form (CCF) or 

Alcohol Testing Form (ATF) for a donor, 

on the MRO’s reports, on SAP reports, 

or on other documents that are required 

under this part. For all purposes of this 

part, this term means: Only the 

Commercial Driver’s License (CDL) 

Number and State of issuance for 

drivers tested under the authority of the 

Federal Motor Carrier Safety 

Administration (FMCSA); and, for all 

drivers and other safety-sensitive 

employees tested under the authority of 

the other DOT agencies, this can be the 

individual’s actual Social Security 

Number, a unique identifier issued by 

the employer, a State-issued 

identification card number, a Stateissued driver’s license number 

(including a CDL number) or any other 

State-issued or federally-issued 

identification number. 

* * * * * 

Substituted specimen. An employee’s 

specimen not consistent with a normal 

human specimen, as determined by 

HHS (e.g., a urine specimen, with 

creatinine and specific gravity values 

that are so diminished, or so divergent 

that they are not consistent with normal 

human urine). 

* * * * * 

Undiluted (neat) oral fluid. An oral 

fluid specimen to which no other solid 

or liquid has been added. For example: 

A collection device that uses a diluent 

(or other component, process, or method 

that modifies the volume of the testable 

specimen) must collect at least 1 mL of 

undiluted (neat) oral fluid. 

Urine specimen. Urine collected from 

an employee at the collection site for the 

purpose of a drug test. 

* * * * * 

■ 3. In § 40.13, revise paragraphs (b), (c), 

and (d), redesignate paragraphs (e) and 

(f) as paragraphs (f) and (g), respectively, 

add new paragraph (e), and add 

paragraph (h). 

The revisions and additions to read as 

follows: 

§ 40.13 How do DOT drug and alcohol 

tests relate to non-DOT tests? 

* * * * * 

(b) DOT tests must take priority and 

must be conducted and completed 

before a non-DOT test is begun. When 

conducting a urine DOT drug test, you 

must discard any excess urine left over 

from a DOT test and collect a separate 

urine void for the subsequent non-DOT 

test. 

(c) Except as provided in paragraph 

(d) of this section, you must not perform 

any tests on DOT specimens other than 

those tests specifically authorized by 

this part or DOT agency regulations. For 

example, you must not test a DOT 

specimen for additional drugs. In 

addition, a laboratory is prohibited from 

making a DOT specimen available for a 

DNA test or other types of specimen 

identity testing. 

(d) When a DOT urine drug test 

collection is conducted as part of a 

physical examination required by DOT 

agency regulations, it is permissible to 

conduct medical tests related to this 

physical examination (e.g., for glucose) 

on any specimen remaining in the 

collection container after the DOT 

portion has been sealed into the 

specimen bottles. 

(e) A non-DOT drug or alcohol test 

administered, as part of a physical 

examination, is not a DOT drug or 

alcohol test for purposes of this part and 


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related DOT agency drug and alcohol 

testing rules, if that test was performed 

to determine if an employee is 

medically qualified for a license or 

certificate. Consequently, the results of 

such a test do not have consequences 

under this part. 

* * * * * 

(h) No one is permitted to conduct a 

DOT drug or alcohol test on an 

individual who is not a DOT-regulated 

employee, as defined by the DOT 

agency regulations. 

■ 4. In § 40.14, revise paragraph (b) and 

add paragraphs (k) and (l) to read as 

follows: 

§ 40.14 What information must employers 

provide to collectors? 

* * * * * 

(b) SSN or Employee ID No.’’; 

* * * * * 

(k) Specimen type to be collected (i.e., 

oral fluid or urine). 

(l) If a urine specimen is to be 

collected under direct observation. 

■ 5. In § 40.21: 

■ a. In paragraph (c)(2)(vii)(B), remove 

the word ‘‘and’’ from the end; 

■ b. Redesignate paragraph (c)(2)(vii)(C) 

as paragraph (c)(2)(vii)(D); and 

■ c. Add a new paragraph (c)(2)(vii)(C). 

The addition reads as follows: 

§ 40.21 May an employer stand down an 

employee before the MRO has completed 

the verification process? 

* * * * * 

(c) * * * 

(2) * * * 

(vii) * * * 

(C) For a verified negative result, the 

employee will not be required to submit 

an alternative specimen for the same 

testing action. For a cancelled result, the 

employee could be required to submit 

an alternative specimen on a recollection; and 

* * * * * 

■ 6. In § 40.23, revise paragraphs (f) 

introductory text and (f)(1) and (5) to 

read as follows: 

§ 40.23 What actions do employers take 

after receiving verified test results? 

* * * * * 

(f) As an employer who receives a 

drug test result indicating that the 

employee’s test was cancelled because it 

was invalid and that a second collection 

must take place under direct 

observation— 

(1) You must immediately direct the 

employee to provide a new specimen 

under direct observation (either an oral 

fluid specimen or a urine specimen 

under direct observation). 

* * * * * 

(5) You must ensure that the collector 

conducts the collection under direct 

observation (either an oral fluid 

specimen or a urine specimen under 

direct observation). 

* * * * * 

■ 7. In § 40.25, revise paragraph (a) to 

read as follows: 

§ 40.25 Must an employer check on the 

drug and alcohol testing record of 

employees it is intending to use to perform 

safety-sensitive duties? 

(a)(1) Yes, as an employer, you must, 

after obtaining an employee’s written 

consent, request the information about 

the employee listed in paragraphs (b) 

through (j) of this section. This 

requirement applies only to employees 

seeking to begin performing safetysensitive duties for you for the first time 

(i.e., a new hire, an employee 

transferring into a safety-sensitive 

position). If the employee refuses to 

provide this written consent, you must 

not permit the employee to perform 

safety-sensitive functions. 

(2) If you are an employer regulated 

by FMCSA, beginning January 6, 2023, 

you are not required to comply with the 

requirements of this section when 

checking an employee’s testing history 

with other employers regulated by 

FMCSA. You must continue to comply 

with the requirements of section 40.25 

when checking an employee’s testing 

history with employers regulated by a 

DOT operating administration other 

than FMCSA. 

(3) If you are an employer regulated 

by FMCSA, with a prospective 

employee subject to drug and alcohol 

testing with a DOT agency other than 

FMCSA, you must continue to request 

the information about the employee 

listed in in paragraphs (b) through (j) of 

this section. For example, if you are an 

employer regulated by both FMCSA and 

PHMSA, and you are hiring an 

employee to perform functions 

regulated by both DOT Agencies, then 

you must query FMCSA’s Clearinghouse 

to satisfy FMCSA’s requirements and 

you must request the information listed 

in in paragraphs (b) through (j) of this 

section to satisfy PHMSA’s 

requirements. 

* * * * * 

§ 40.26 [Amended] 

■ 8. In § 40.26, remove ‘‘Appendix H’’ 

and add in its place ‘‘Appendix J’’. 

§ 40.29 [Removed] 

■ 9. Remove § 40.29. 

■ 10. In § 40.31, 

■ a. Revise the section heading; 

■ b. Revise paragraphs (b); 

■ c. Redesignate paragraphs (c) and (d) 

as paragraphs (d) and (e) 

■ d. Add new paragraph (c); 

■ e. Revise newly redesignated 

paragraph (d); and 

■ f. Add paragraph (f). 

The revisions and additions read as 

follows: 

§ 40.31 Who may collect specimens for 

DOT drug testing? 

* * * * * 

(b) A urine collector must meet 

training requirements of § 40.33. 

(c) An oral fluid collector must meet 

the training requirements of § 40.35. 

(d) To avoid the appearance of a 

conflict of interest, if you are the 

immediate supervisor of the employee 

being tested, you must not act as the 

collector when that employee is tested, 

unless no other collector is available 

and you are permitted to do so under 

DOT agency drug and alcohol 

regulations. 

* * * * * 

(f) Employees are not permitted to be 

their own collector. 

(1) An employee who is a qualified 

collector is not permitted to be their 

own collector; another qualified 

collector must perform the collection in 

accordance with this part. 

(2) To avoid a potential conflict of 

interest, a collector must not be related 

to the employee being tested (e.g., 

spouse, ex-spouse, relative) or a close 

personal friend. 

■ 11. In § 40.33, revise the section 

heading, introductory text, and 

paragraph (f) to read as follows: 

§ 40.33 What training requirements must a 

collector meet for urine collection? 

To be permitted to act as a urine 

collector in the DOT drug testing 

program, you must meet each of the 

requirements of this section: 

* * * * * 

(f) Error correction training. If you 

make a mistake in the collection process 

that causes a test to be cancelled (i.e., a 

fatal or uncorrected flaw), you must 

undergo error correction training. This 

training must occur within 30 days of 

the date you are notified of the error that 

led to the need for retraining. Errors that 

cause cancellation but occur outside the 

collection process (e.g., when a 

specimen is crushed or otherwise 

damaged during the transportation 

process, or is lost in transit), the 

cancellation would not be the result of 

an error by the collector during the 

collection process and does not require 

the collector to be retrained. 

* * * * * 

§ 40.35 [Redesignated as § 40.36] 

■ 12. Redesignate § 40.35 as § 40.36. 

■ 13. Add a new § 40.35 to read as 

follows: 


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§ 40.35 What training requirements must a 

collector meet for oral fluid collection? 

To be permitted to act as an oral fluid 

collector in the DOT drug testing 

program, you must meet each of the 

requirements of this section: 

(a) Basic information. You must be 

knowledgeable about this part, the 

current applicable guidelines and DOT 

agency regulations applicable to the 

employers for whom you perform 

collections. DOT agency regulations, 

guidelines, and other materials are 

available from ODAPC (Department of 

Transportation, 1200 New Jersey 

Avenue SE, Washington, DC 20590, 

202–366–3784, or on the ODAPC 

website (https://

www.transportation.gov/odapc). You 

must keep current on any changes to 

these materials. You must subscribe to 

the ODAPC list-serve at: https://

www.transportation.gov/odapc/getodapc-email-updates. 

(b) Qualification training. You must 

receive qualification training meeting 

the requirements of this paragraph. 

Qualification training must provide 

instruction on the following subjects: 

(1) The oral fluid collection device 

manufacturer’s training for each device 

the collector will use for DOT-regulated 

collections; 

(2) All steps necessary to complete a 

collection correctly and the proper 

completion and transmission of the 

CCF; 

(3) ‘‘Problem’’ collections (e.g., 

situations like ‘‘dry mouth’’ and 

attempts to tamper with a specimen); 

(4) Fatal flaws, correctable flaws, and 

how to correct problems in collections; 

and 

(5) The collector’s responsibility for 

maintaining the integrity of the 

collection process, ensuring the privacy 

of employees being tested, ensuring the 

security of the specimen, and avoiding 

conduct or statements that could be 

viewed as offensive or inappropriate. 

(c) Initial proficiency demonstration. 

Following your completion of 

qualification training under paragraph 

(b) of this section, you must 

demonstrate proficiency in collections 

under this part by completing five 

consecutive error-free mock collections. 

(1) The five mock collections must 

include one uneventful collection 

scenario, one insufficient specimen 

quantity scenario; one scenario in which 

the employee has something in their 

mouth that might interfere with the 

collection; one scenario in which the 

employee attempts to tamper with the 

specimen; and one scenario in which 

the employee refuses to sign the CCF. 

(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.’’ This person 

must be a qualified collector who has 

demonstrated necessary knowledge, 

skills, and abilities by— 

(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. 

(d) Schedule for qualification training 

and initial proficiency demonstration. 

You must meet the requirements of 

paragraphs (b) and (c) of this section 

before you begin to perform collector 

functions. 

(e) Refresher training. No less 

frequently than every five years from the 

date on which you satisfactorily 

complete the requirements of 

paragraphs (b) and (c) of this section, 

you must complete refresher training 

that meets all the requirements of 

paragraphs (b) and (c) of this section. 

(f) Error correction training. If you 

make a mistake in the collection process 

that causes a test to be cancelled (i.e., a 

fatal or uncorrected flaw), you must 

undergo error correction training. This 

training must occur within 30 days of 

the date you are notified of the error that 

led to the need for retraining. 

(1) Error correction training must be 

provided and your proficiency 

documented in writing by a person who 

meets the requirements of paragraph 

(c)(2) of this section. 

(2) Error correction training is 

required to cover only the subject matter 

area(s) in which the error that caused 

the test to be cancelled occurred. 

(3) As part of the error correction 

training, you must demonstrate your 

proficiency in the collection procedures 

of this part by completing three 

consecutive error-free mock collections. 

The mock collections must include one 

uneventful scenario and two scenarios 

related to the area(s) in which your 

error(s) occurred. The person providing 

the training must monitor and evaluate 

your performance and attest in writing 

that the mock collections were ‘‘errorfree.’’ 

(g) Documentation. You must 

maintain documentation showing that 

you currently meet all requirements of 

this section. You must provide this 

documentation on request to DOT 

agency representatives and to employers 

and C/TPAs who are using or 

negotiating to use your services. 

§ 40.37 [Removed] 

■ 14. Remove § 40.37. 

Subpart D [Amended] 

■ 15. In the heading for subpart D, 

remove the word ‘‘Urine’’. 

§ 40.41 [Redesignated as § 40.42] 

■ 16. Redesignate § 40.41 as § 40.42. 

§ 40.45 [Redesignated as § 40.40] 

■ 17. Redesignate § 40.45 as § 40.40. 

■ 18. In newly redesignated § 40.40: 

■ a. Revise the section heading and 

paragraphs (a) and (b), (c) introductory 

text, and (c)(1) through (4); and 

■ b. Amend paragraph (d) by removing 

the words ‘‘social security number 

(SSN) or other employee identification 

(ID) number’’ and adding in their place 

‘‘SSN or Employee ID No.’’. 

The revisions read as follows: 

§ 40.40 What form is used to document a 

DOT collection? 

(a) The Federal Drug Testing Custody 

and Control Form (CCF) must be used 

to document every collection required 

by the DOT drug testing program. You 

may view this form on the Department’s 

website (http://www.transportation.gov/ 

odapc) or the HHS website (http://

www.workplace.samhsa.gov). 

(b) You must not use a non-Federal 

form or an expired CCF to conduct a 

DOT collection. As a laboratory, C/TPA 

or other party that provides CCFs to 

employers, collection sites, or other 

customers, you must not provide copies 

of an expired CCF to these participants. 

You must also affirmatively notify these 

participants that they must not use an 

expired CCF. 

(c) As a participant in the DOT drug 

testing program, you are not permitted 

to modify or revise the CCF except as 

follows: 

(1) You may include, in the area 

outside the border of the form, other 

information needed for billing or other 

purposes necessary to the collection 

process. 

(2) The CCF must include the names, 

addresses, telephone numbers and any 

other appropriate contact information 

(e.g., an email address of the employer 

and the MRO), including the DER’s 

name and contact information. All of 

this information must be preprinted, 

typed, or handwritten. Fax numbers 

may be included, but are not required. 

The MRO information must include the 

physician’s name and address, as 

opposed to only a generic clinic, health 

care organization, or company name. 

This information is required, and an 

employer, collector, service agent or any 

other party is prohibited from omitting 

it. In addition, a C/TPA’s name, address, 


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telephone and fax numbers, and any 

other appropriate contact information 

should be included, but is not required. 

The employer may use a C/TPA’s 

address in place of its own, but must 

continue to include its name, telephone 

and fax numbers, and any other 

appropriate contact information. 

(3) As an employer you may preprint 

the box in Step 1–D of the CCF for the 

DOT agency under whose authority the 

test will occur. 

(4) As a collector, you may use a CCF 

with your name, address, telephone 

number, and fax number preprinted, but 

under no circumstances may you sign 

the form before the collection event. If 

a collection takes place at a clinic, the 

actual address of the clinic should be 

used, not a corporate address of the 

collection company. If the collection 

takes place onsite at the employer, the 

employer’s address must be noted as the 

collection site address. If the collection 

takes place in a ‘‘mobile unit’’ or at an 

accident site, the collector must enter 

the actual location address of the 

collection or as near an approximation 

as possible. The collector must ensure 

that the required collector telephone 

number is the number that the 

laboratory, MRO, or employer may use 

to directly contact the individual 

collector and/or the collector’s 

supervisor. 

* * * * * 

§ 40.47 [Redesignated as § 40.41] 

■ 19. Redesignate § 40.47 as § 40.41. 

§ 40.41 [Amended] 

■ 20. In newly redesignated § 40.41, in 

paragraph (a), remove the word ‘‘urine’’ 

wherever it appears. 

■ 21. In § 40.43, revise the section 

heading to read as follows: 

§ 40.43 What steps must operators of 

collection sites and collectors take to 

protect the security and integrity of urine 

collections? 

* * * * * 

§ 40.49 [Redesignated as § 40.44] 

■ 22. Redesignate § 40.49 as § 40.44. 

§ 40.51 [Redesignated as § 40.45] 

■ 23. Redesignate § 40.51 as § 40.45. 

■ 24. Add §§ 40.47, 40.48, 40.49, and 

40.51 to subpart D to read as follows: 

* * * * * 

Sec. 

40.47 Where does an oral fluid collection 

for a DOT drug test take place? 

40.48 What steps must operators of 

collection sites and collectors take to 

protect the security and integrity of oral 

fluid collections? 

40.49 What materials are used to collect 

oral fluid specimens? 

40.51 What materials are used to send oral 

fluid specimens to the laboratory? 

* * * * * 

§ 40.47 Where does an oral fluid collection 

for a DOT drug test take place? 

(a) An oral fluid collection for a DOT 

drug test must take place in a collection 

site meeting the requirements of this 

section. 

(b) If you are operating an oral fluid 

collection site: 

(1) You must ensure that it meets the 

security requirements of § 40.48; 

(2) The site may be a permanent or 

temporary facility located either at the 

work site or at a remote site; 

(3) The site may be in a medical 

facility, a mobile facility (e.g., a van), a 

dedicated collection facility, or any 

other location meeting the requirements 

of this section; and 

(4) You must have all necessary 

personnel, materials, equipment, and 

facilities that include privacy and 

supervision to provide for the 

collection, temporary storage, and 

shipping of specimens to a laboratory, 

and a suitable clean surface for writing. 

(c) If a collection site is not accessible 

and there is an immediate requirement 

to collect an oral fluid specimen (e.g., an 

accident investigation), another site may 

be used for the collection, if the 

collection is performed by a collector 

who has been trained to collect oral 

fluid specimens in accordance with this 

part and the manufacturer’s procedures 

for the collection device. 

§ 40.48 What steps must operators of 

collection sites and collectors take to 

protect the security and integrity of oral 

fluid collections? 

(a) Collectors and operators of 

collection sites must take the steps 

listed in this section to prevent 

unauthorized access that could 

compromise the integrity of collections. 

(b) As a collector, you must do the 

following before each collection to deter 

tampering with specimens: 

(1) Ensure that access to collection 

materials and specimens is effectively 

restricted; 

(2) Ensure that undetected access 

(e.g., through a door not in your view) 

is not possible; and 

(3) Secure facility against access 

during the procedure to ensure privacy 

to the employee and prevent distraction 

of the collector. Limited-access signs 

must be posted. 

(c) As a collector, you must take the 

following additional steps to ensure 

security during the collection process: 

(1) To avoid distraction that could 

compromise security, you are limited to 

conducting a collection for only one 

employee at a time. However, during the 

time one employee is in the period for 

drinking fluids in a ‘‘dry mouth’’ 

situation (see § 40.72(b)(1)), you may 

conduct a collection for another 

employee as long as the employee with 

‘‘dry mouth’’ remains supervised. 

(2) To the greatest extent practicable, 

keep an employee’s collection container 

within view of both you and the 

employee between the time the 

employee has provided the oral fluid 

specimen and the specimen is sealed. 

(3) Ensure you are the only person in 

addition to the employee who handles 

the specimen before it is sealed with 

tamper-evident seals. 

(4) In the time between when the 

employee gives you the specimen and 

when you seal the specimen, remain 

within the collection site. 

(5) Maintain personal control over 

each specimen and CCF throughout the 

collection process. 

(d) If you are operating a collection 

site, you must implement a policy and 

procedures to prevent unauthorized 

personnel from entering any part of the 

site in which oral fluid specimens are 

collected or stored. 

(1) Only employees being tested, 

collectors and other collection site 

workers, DERs, employee and employer 

representatives authorized by the 

employer (e.g., employer policy, 

collective bargaining agreement), and 

DOT agency representatives are 

authorized persons for purposes of 

paragraph (e) of this section. 

(2) You must ensure that all 

authorized persons are under the 

supervision of a collector at all times 

when permitted into the site. 

(3) You or the collector may remove 

any person who obstructs, interferes 

with, or causes a delay in the collection 

process. 

(e) If you are operating a collection 

site, you must minimize the number of 

persons handling specimens. 

§ 40.49 What materials are used to collect 

oral fluid specimens? 

For each DOT drug test, you must use 

a collection device meeting the 

requirements of appendix B of this part. 

§ 40.51 What materials are used to send 

oral fluid specimens to the laboratory? 

(a) Except as provided in paragraph 

(b) of this section, you must use a 

shipping container that adequately 

protects the specimen bottles from 

damage in the transport of specimens 

from the collection site to the 

laboratory. 

(b) You are not required to use a 

shipping container if a laboratory 

courier hand-delivers the specimens 


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Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Proposed Rules 11177 

from the collection site to the 

laboratory. 

Subpart E—[Amended] 

■ 25. In the heading for subpart E, 

remove the word ‘‘Urine’’. 

■ 26. In § 40.61, revise the section 

heading and paragraphs (a), (b)(1) 

introductory text, (b)(3) and (4), (e), and 

(f)(5)(i) to read as follows: 

§ 40.61 What are the preliminary steps in 

the drug testing collection process? 

* * * * * 

(a) When a specific time for an 

employee’s test has been scheduled, or 

the collection site is at the employee’s 

work site, and the employee does not 

appear at the collection site at the 

scheduled time, contact the DER to 

determine the appropriate interval 

within which the DER has determined 

the employee is authorized to arrive. If 

the employee’s arrival is delayed 

beyond that time, you must notify the 

DER that the employee has not reported 

for testing. In a situation where a C/TPA 

has notified an owner/operator or other 

individual employee to report for testing 

(other than for a pre-employment test) 

and the employee does not appear, the 

C/TPA must determine whether the 

employee has refused to test (see 

§ 40.191(a)(1)). 

(b) * * * 

(1) If the employee is also going to 

take a DOT alcohol test, you must 

ensure, to the greatest extent 

practicable, that the alcohol test is 

completed before the drug testing 

collection process begins. 

* * * * * 

(3) You must not collect a specimen 

from an unconscious employee to 

conduct a drug test under this part. 

(4) You must not catheterize a 

conscious employee for purposes of a 

urine test. However, you must inform an 

employee who normally voids through 

self-catheterization that the employee is 

required to provide a specimen in that 

manner. If an employee normally voids 

through self-catheterization, but 

declines to do so for the urine test, the 

collector should notify the DER of the 

circumstances, so that the employer can 

determine whether the situation 

constitutes a refusal to test by the 

employee. 

* * * * * 

(e) Explain the basic collection 

procedure to the employee, and notify 

the employee that instructions for 

completing the CCF can be found at the 

HHS (www.samhsa.gov/workplace) and 

DOT (www.transportation.gov/odapc) 

websites. 

(f) * * * 

(5) * * * 

(i) Determine if the material appears 

to be brought to the collection site with 

the intent to alter the specimen, and, if 

it is, either conduct a directly observed 

urine collection using direct observation 

procedures (see § 40.67) or an oral fluid 

specimen collection, make a note on the 

CCF and continue with collection 

process; or 

* * * * * 

■ 27. In § 40.63, revise paragraph (a) to 

read as follows: 

§ 40.63 What steps does the collector take 

in the collection process before the 

employee provides a urine specimen? 

* * * * * 

(a) Ensure all items under Step 1 of 

the CCF are complete and accurate (e.g., 

if Step 1.D is not checked, put a check 

mark for the ‘‘Specify DOT Agency’’ 

under the authority of which the test 

will take place; if the address where the 

collection is actually taking place is not 

in Step 1.G, update that.) 

* * * * * 

■ 28. In § 40.65, revise the section 

heading and paragraphs (b)(5) and (6), 

and (c)(1) to read as follows: 

§ 40.65 What does the collector check for 

when the employee presents a urine 

specimen? 

* * * * * 

(b) * * * 

(5) If the specimen temperature is 

outside the acceptable range, you must 

immediately conduct a new urine 

collection using direct observation 

procedures (see § 40.67) or an oral fluid 

collection. 

(6) In a case where a specimen is 

collected under direct observation 

because of the temperature being out of 

range, you must process both the 

original specimen and the specimen 

collected using direct observation 

(including oral fluid) and send the two 

sets of specimens to their respective 

laboratories. This is true even in a case 

in which the original specimen has 

insufficient volume and the temperature 

is out of range. You must also, as soon 

as possible, inform the DER and 

collection site supervisor that a 

collection took place under direct 

observation and the reason for doing so. 

* * * * * 

(c) * * * 

(1) If it is apparent from this 

inspection that the employee has 

tampered with the specimen (e.g., blue 

dye in the specimen, excessive foaming 

when shaken, or smell of bleach), you 

must immediately conduct a new urine 

collection using direct observation 

procedures (see § 40.67) or an oral fluid 

collection. 

* * * * * 

■ 29. In § 40.67: 

■ a. Revise the section heading; 

■ b. In paragraph (c)(1), remove 

‘‘paragraphs (a) and (b)’’ and add 

‘‘paragraph (a)’’ in its place; 

■ c. Revise paragraph (d)(2); 

■ d. In paragraph (e)(2), remove 

‘‘§ 40.67(b)’’ and add in its place 

‘‘§ 40.67(c)(2) through (4)’’; and 

■ e. Revise paragraph (g). 

The revisions and additions read as 

follows: 

§ 40.67 When and how is a directly 

observed urine collection conducted? 

* * * * * 

(d) * * * 

(2) As the collector, you must explain 

to the employee the reason, if known, 

under this part for a directly observed 

collection. 

* * * * * 

(g) As the collector, you must ensure 

that the observer is the same gender as 

the employee unless the observer is a 

medical professional (e.g., nurse, doctor, 

physician’s assistant, technologist, 

technician licensed or certified to 

practice in the jurisdiction in which the 

collection takes place). The observer can 

be a different person from the collector 

and need not be a qualified collector. 

■ 30. In § 40.69, revise the section 

heading, redesignate paragraphs (a) 

through (g) as paragraphs (b) through 

(h); add new paragraph (a), and revise 

newly redesignated paragraph (e) to 

read as follows: 

§ 40.69 How is a monitored urine 

collection conducted? 

(a) As stated in § 40.42(f)(2), if you are 

conducting a urine collection in a multistall restroom and you cannot secure all 

sources of water and other substances 

that could be used for adulteration and 

substitution, you must conduct a 

monitored collection. This is the only 

circumstance in which you must 

conduct a monitored collection. 

* * * * * 

(e) As the monitor, you must not 

watch the employee urinate into the 

collection container. If you hear sounds 

or make other observations indicating 

an attempt to tamper with a specimen, 

there must be an additional collection 

under direct observation. See 

§§ 40.63(e), 40.65(c), and 40.67(c)(2)(3)). 

* * * * * 

■ 31. In § 40.71, revise the section 

heading and paragraph (b)(1) to read as 

follows: 

§ 40.71 How does the collector prepare the 

urine specimen? 

* * * * * 


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11178 Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Proposed Rules 

(b) * * * 

(1) Check the box on the CCF (Step 2) 

indicating that this was a ‘‘Urine’’ and 

‘‘Split’’ specimen collection. 

* * * * * 

§ 40.73 [Redesignated as § 40.79] 

■ 32. Redesignate § 40.73 as § 40.79. 

■ 33. Add new §§ 40.72 through 40.74 

to read as follows: 

* * * * * 

Sec. 

40.72 What steps does the collector take in 

the collection process before the 

employee provides an oral fluid 

specimen? 

40.73 How is an oral fluid specimen 

collected? 

40.74 How does the collector prepare the 

oral fluid specimens? 

* * * * * 

§ 40.72 What steps does the collector take 

in the collection process before the 

employee provides an oral fluid specimen? 

(a) The collector requests that the 

employee open the employee’s mouth, 

and the collector inspects the oral cavity 

to ensure that it is free of any items that 

could impede or interfere with the 

collection of an oral fluid specimen 

(e.g., candy, gum, food, or tobacco) or 

could be used to adulterate, substitute, 

or alter the specimen. 

(1) If the employee claims that he or 

she has a medical condition that 

prevents opening his or her mouth for 

inspection, the collector follows the 

procedure described in § 40.193(a). 

(2) If the collector observes materials 

brought to the collection site or the 

employee’s conduct clearly indicates an 

attempt to adulterate, substitute, or alter 

the specimen, the collector must 

terminate the collection, note the 

circumstances in the Remarks section of 

the CCF, and report the circumstances 

to the DER, so that the employer can 

decide whether to deem the situation a 

refusal in accordance with § 40.191(a). 

(b) If an item is present that might 

impede or interfere with the collection 

of an oral fluid specimen, the collector 

must request the employee remove the 

item. 

(1) If the employee removes any item 

that could impede or interfere with the 

collection of an oral fluid specimen, the 

employee has abnormally colored 

saliva, or the employee claims to have 

‘‘dry mouth,’’ then the collector must 

give the employee water, up to 8 

ounces, to rinse their mouth. The 

employee may drink the water. The 

collector must then wait 10 minutes 

before beginning the specimen 

collection. 

(2) If the employee refuses to remove 

the item or rinse, the collector must 

terminate the collection, note the 

circumstances in the Remarks section of 

the CCF, and report the information to 

the DER to test as described in 

§ 40.191(a)(8) (failure to cooperate), so 

that the employer can decide whether to 

deem the situation a refusal. 

(c) If there is nothing of concern in the 

oral cavity and no ‘‘dry mouth’’ 

condition, the collector starts the 10- 

minute wait period and proceeds with 

the steps below before beginning the 

specimen collection as described in 

§ 40.73. 

(d) During the 10-minute wait: 

(1) Review with the employee the 

procedures required for a successful oral 

fluid specimen collection as stated in 

the manufacturer’s instructions for the 

specimen collection device. 

(2) Complete all items under Step 1 of 

the CCF, and for clarification: 

(i) In Step 1.D of the CCF, the 

collector must put a check mark for the 

‘‘Specify DOT Agency’’ under whose 

authority the test will take place. 

(ii) In Step 1.G of the CCF for the 

‘‘Collection Site Address’’, the collector 

must provide the address where the 

collection took place. 

(3) The collector will complete Step 2 

of the CCF. 

(i) Check ‘‘Oral Fluid’’, 

(ii) For ‘‘Oral Fluid: Split Type’’ check 

‘‘Subdivided,’’ and 

(iii) Check ‘‘Each Device Within 

Expiration Date?’’ after ensuring that 

each device is within its expiration date. 

(4) The collector must instruct the 

employee to use hand sanitizer, put on 

gloves, or wash and dry his or her 

hands. 

(e) The collector will provide, or the 

employee may select, a specimen 

collection device that is clean, unused, 

and wrapped/sealed in original 

packaging. The collector must open the 

specimen collection device in view of 

the employee. 

(f) To the greatest extent practicable, 

the collector must keep the employee’s 

unwrapped collection device within 

view of both you and the employee, 

between the time the employee has 

provided a specimen and the specimen 

is sealed. 

§ 40.73 How is an oral fluid specimen 

collected? 

(a) The collector must be present and 

maintain visual contact with the 

employee during the procedures 

outlined in this section. 

(b) The collector must note any 

unusual behavior or appearance of the 

employee on the CCF. If the collector 

detects any conduct that clearly 

indicates an attempt to tamper with a 

specimen (e.g., an attempt to bring into 

the collection site an adulterant or oral 

fluid substitute), the collector must 

terminate the collection and report the 

information to the DER so that the 

employer can decide whether to deem 

the situation a refusal. 

(c) The employee and collector must 

complete the specimen collection in 

accordance with the manufacturer 

instructions for the collection device. 

(1) 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. 

(i) If there is a failure to collect the 

specimen, the collector must start the 

process again, beginning with § 40.72(e), 

using a new specimen collection device, 

and noting the failed collection attempt 

on the CCF. 

(ii) If the employee states that he or 

she is unable to provide an oral fluid 

specimen during the collection process, 

or after multiple failures to collect the 

specimen, the collector follows the 

procedure in § 40.193. 

(2) The collector must inspect the 

specimen for unusual color, presence of 

foreign objects or material, or other 

signs of tampering. If it is apparent from 

this inspection that the employee has 

tampered with the specimen, you must 

conduct a new collection. 

(i) Document any unusual 

characteristics referenced above in the 

Remarks section of the CCF. 

(ii) Proceed with obtaining the new 

oral fluid specimen from the donor. 

Note on the new CCF that this is another 

collection for the same testing event. 

(i.e., Document in the remarks section 

that this is Specimen 2 of 2 and include 

the Specimen ID number of the other 

specimen. Make the same notation on 

the CCF of the suspect specimen.) 

§ 40.74 How does the collector prepare the 

oral fluid specimens? 

(a) The collector follows the 

manufacturer’s instructions to package 

the split specimen collections. 

(b) A volume of at least 1 mL of 

undiluted (neat) oral fluid is collected 

for the specimen designated as ‘‘Tube 

A’’ and a volume of at least 1 mL of 

undiluted (neat) oral fluid is collected 

for the specimen designated as ‘‘Tube 

B’’. 

(c) In the presence of the employee, 

the collector places a tamper-evident 

seal from the CCF over the cap of each 

specimen container, taking care not to 

obstruct the expiration date on the 

collection containers. The collector 

must record the date of the collection on 

the tamper-evident seals, after they are 

affixed to the specimen containers. 


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Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Proposed Rules 11179 

(d) The collector instructs the 

employee to initial the tamper-evident 

seals on each specimen container. If the 

employee declines to do so, the 

collector must note this in the 

‘‘Remarks’’ line of the CCF (Step 2) and 

complete the collection process. 

§§ 40.75–40.78 [Reserved] 

■ 34. Add reserved §§ 40.75 through 

40.78. 

■ 35. In newly redesignated § 40.79, 

revise paragraph (a)(1) to read as 

follows: 

§ 40.79 How is the collection process 

completed? 

* * * * * 

(a) * * * 

(1) Direct the employee to read and 

sign the certification statement on Copy 

2 of the CCF and provide all information 

required in Step 5. If the employee 

declines to sign the CCF or to provide 

any of the required information, you 

must note this in the ‘‘Remarks’’ line 

(Step 2) of the CCF and complete the 

collection. If the employee declines to 

fill out any information, you must, as a 

minimum, print the employee’s name in 

the appropriate place. 

* * * * * 

§ 40.81 [Amended] 

■ 36. In § 40.81, in paragraph (a), 

remove the words ‘‘all testing’’ and add 

in their place the words ‘‘each specimen 

testing methodology performed’’. 

§ 40.83 [Amended] 

■ 37. In § 40.83: 

■ a. In paragraph (c)(7), remove the 

word ‘‘urine’’ and add in its place the 

word ‘‘specimen’’; 

■ b. In paragraph (f) introductory text, 

add the word ‘‘urine’’ before the word 

‘‘specimen’’; 

■ c. In paragraph (g) introductory text, 

remove the cross-reference ‘‘40.45(a)’’ 

and adding in its place ‘‘40.40(a)’’; 

■ d. a. In paragraphs (h)(1)(i), (iii), and 

(iv), remove the word ‘‘urine’’ and add 

in its place the word ‘‘specimen’’; and 

■ e. In paragraph (h)(2) removing the 

cross-reference ‘‘(g)(1)’’ and adding in 

its place ‘‘(h)(1)’’. 

§ 40.99 [Redesignated as § 40.84] 

■ 38. Redesignate § 40.99 as § 40.84. 

§ 40.84 [Amended] 

■ 39. In newly redesignated § 40.84: 

■ a. In paragraph (a), remove the words 

‘‘one year’’ and add, in their place, the 

words ‘‘90 days’’; 

■ b. In the first sentence of paragraph (c) 

remove the words ‘‘one-year’’ and add 

in their the words ‘‘90-day’’; and 

■ c. In the last sentence of paragraph (c) 

remove the word ‘‘year’’ and add in its 

place the words ‘‘90-day period’’. 

§ 40.85 [Redesignated as § 40.82] 

■ 40. Redesignate § 40.85 as § 40.82. 

§ 40.87 [Redesignated as § 40.85] 

■ 41. Redesignate § 40.87 as § 40.85. 

§ 40.89 [Redesignated as § 40.86] 

■ 42. Redesignate § 40.89 as § 40.86. 

■ 43. In newly redesignated § 40.86, 

revise the section heading to read as 

follows: 

§ 40.86 What is urine validity testing, and 

are laboratories required to conduct it? 

* * * * * 

§ 40.91 [Redesignaed as § 40.87] 

■ 44. Redesignate § 40.91 as § 40.87. 

■ 45. In newly redesignated § 40.87, 

revise the section heading, and in the 

introductory text, remove ‘‘§ 40.89’’ and 

add in its place ‘‘§ 40.86’’. 

The revision reads as follows: 

§ 40.87 What validity tests must 

laboratories conduct on primary urine 

specimens? 

* * * * * 

§ 40.93 [Redesignated as § 40.88] 

■ 46. Redesignate § 40.93 as § 40.88. 

■ 47. In newly redesignated § 40.88, 

revise the section heading to read as 

follows: 

§ 40.88 What criteria do laboratories use to 

establish that a urine specimen is dilute or 

substituted? 

* * * * * 

§ 40.95 [Redesignated § 40.89] 

■ 48. Redesignate § 40.95 as § 40.89. 

■ 49. In newly redesignated § 40.89, 

revise the section heading to read as 

follows: 

§ 40.89 What are the adulterant cutoff 

concentrations for initial and confirmation 

urine tests? 

* * * * * 

§ 40.96 [Redesignated as § 40.90] 

■ 50. Redesignate existing § 40.96 as 

§ 40.90. 

■ 51. In newly redesignated § 40.90, 

revise the section heading to read as 

follows: 

§ 40.90 What criteria do laboratories use to 

establish that a urine specimen is invalid? 

* * * * * 

■ 52. Add new §§ 40.91 through 40.93 

to read as follows: 

Sec. 

* * * * * 

40.91 What are the cutoff concentrations for 

undiluted (neat) oral fluid drug tests? 

40.92 What is oral fluid validity testing, and 

are laboratories required to conduct it? 

40.93 What validity tests must laboratories 

conduct on primary oral fluid 

specimens? 

* * * * * 

§ 40.91 What are the cutoff concentrations 

for undiluted (neat) oral fluid drug tests? 

As a laboratory, you must use the 

cutoff concentrations displayed in table 

1 to this section for initial and 

confirmatory drug tests for oral fluid 

specimens. All cutoff concentrations are 

expressed in nanograms per milliliter 

(ng/mL). 

TABLE 1 TO § 40.91—ORAL FLUID TESTING CUTOFF CONCENTRATIONS

Initial test analyte Initial test 

cutoff 1

Confirmatory 

test analyte 

Confirmatory 

test cutoff 

concentration 

Marijuana (THC) 2 ............................................................................. 4 ng/mL 3 ....... THC .......................................................... 2 ng/mL. 

Cocaine/Benzoylecgonine ................................................................ 15 ng/mL ........ Cocaine ....................................................

Benzoylecgonine ......................................

8 ng/mL. 

8 ng/mL. 

Codeine/Morphine ............................................................................ 30 ng/mL ........ Codeine ....................................................

Morphine ..................................................

15 ng/mL. 

15 ng/mL. 

Hydrocodone/Hydromorphone ......................................................... 30 ng/mL ........ Hydrocodone ............................................

Hydromorphone ........................................

15 ng/mL. 

15 ng/mL. 

Oxycodone/Oxymorphone ................................................................ 30 ng/mL ........ Oxycodone ...............................................

Oxymorphone ...........................................

15 ng/mL. 

15 ng/mL. 

6-Acetylmorphine .............................................................................. 4 ng/mL 3 ....... 6-Acetylmorphine ..................................... 2 ng/mL. 

Phencyclidine ................................................................................... 10 ng/mL ........ Phencyclidine ........................................... 10 ng/mL. 

Amphetamine/Methamphetamine ..................................................... 50 ng/mL ........ Amphetamine ...........................................

Methamphetamine ....................................

25 ng/mL. 

25 ng/mL. 


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TABLE 1 TO § 40.91—ORAL FLUID TESTING CUTOFF CONCENTRATIONS—Continued 

Initial test analyte Initial test 

cutoff 1

Confirmatory 

test analyte 

Confirmatory 

test cutoff 

concentration 

MDMA4/MDA5 ................................................................................. 50 ng/mL ........ MDMA ......................................................

MDA .........................................................

25 ng/mL. 

25 ng/mL. 

1For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial test cutoff): 

Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The cross reactivity of the 

immunoassay to the other analyte(s) within the group must be 80 percent or greater; if not, separate immunoassays must be used for the 

analytes within the group. 

Alternate technology:Either one analyte or all analytes from the group must be used for calibration, depending on the technology. At least one 

analyte within the group must have a concentration equal to or greater than the initial test cutoff or, alternatively, the sum of the analytes present 

(i.e., with concentrations equal to or greater than the laboratory’s validated limit of quantification) must be equal to or greater than the initial test 

cutoff. 2An immunoassay must be calibrated with the target analyte. 

3Alternate technology (THC and 6–AM): The confirmatory test cutoff must be used for an alternate technology initial test that is specific for the 

target analyte (i.e., 2 ng/mL for THC, 2 ng/mL for 6–AM). 4 Methylenedioxymethamphetamine (MDMA). 

5 Methylenedioxyamphetamine (MDA). 

§ 40.92 What is oral fluid validity testing, 

and are laboratories required to conduct it? 

(a) Specimen validity testing is the 

evaluation of the specimen to determine 

if it is consistent with normal human 

oral fluid. The purpose of validity 

testing is to determine whether certain 

adulterants or foreign substances were 

added to the oral fluid, if the oral fluid 

was altered. 

(b) If a specimen exhibits abnormal 

characteristics (e.g., unusual odor or 

color), causes reactions or responses 

characteristic of an adulterant during 

initial or confirmatory drug tests (e.g., 

non-recovery of internal standard, 

unusual response), or contains an 

unidentified substance that interferes 

with the confirmatory analysis, then you 

may conduct validity testing. 

(c) If you determine that the specimen 

is invalid and HHS guidelines direct 

you to contact the MRO, you must 

contact the MRO and together decide if 

testing the primary specimen by another 

HHS-certified laboratory would be 

useful in being able to report a positive 

or adulterated test result. 

§ 40.93 What validity tests must 

laboratories conduct on primary oral fluid 

specimens? 

As a laboratory, if you conduct 

validity testing under § 40.92, you must 

conduct it in accordance with the 

requirements of this section. 

(a) You may test for a biomarker such 

as albumin or immunoglobulin G (IgG) 

or a test for a specific adulterant. 

(b) You must follow the applicable 

HHS requirements for any additional 

validity testing. 

■ 53. Revise § 40.97 to read as follows: 

§ 40.97 What do laboratories report and 

how do they report it? 

(a) As a laboratory, when reporting a 

result of any kind, you must report the 

specimen type. 

(b) You must also report the results 

for each primary specimen, which will 

fall into one of the following three 

categories. As a laboratory, you must 

report the actual results (and not the 

categories): 

(1) Category 1: Negative Results. As a 

laboratory, when you find a specimen to 

be negative, you must report the test 

result as being one of the following, as 

applicable: 

(i) Negative, or 

(ii) For urine only, negative-dilute, 

with numerical values for creatinine 

and specific gravity. 

(2) Category 2: Non-negative Results. 

As a laboratory, when you find a 

specimen to be non-negative, you must 

report the test result as being one or 

more of the following, as applicable: 

(i) Positive, with drug(s)/metabolite(s) 

noted, with numerical values for the 

drug(s) or drug metabolite(s). 

(ii) Adulterated, with adulterant(s) 

noted, with confirmatory test values 

(when applicable), and with remarks(s); 

(iii) For urine only, positive-dilute, 

with drug(s)/metabolite(s) noted, with 

numerical values for the drug(s) or drug 

metabolite(s) and with numerical values 

for creatinine and specific gravity; 

(iv) For urine only, substituted, with 

confirmatory test values for creatinine 

and specific gravity; or 

(v) For urine only, invalid result, with 

remark(s). Laboratories will report 

actual values for pH results. 

(vi) For oral fluid only, invalid result, 

with remark(s). Laboratories must report 

numerical values of the specimen 

validity test results that support a 

specimen reported as invalid. 

(3) Category 3: Rejected for Testing. 

As a laboratory, when you reject a 

specimen for testing, you must report 

the result as being Rejected for Testing, 

with remark(s). 

(c) As a laboratory, you must report 

laboratory results directly, and only, to 

the MRO at his or her place of business. 

You must not report results to or 

through the DER or a service agent (e.g., 

a C/TPA). 

(1) Negative results: You must fax, 

courier, mail, or electronically transmit 

a legible image or copy of the fully 

completed Copy 1 of the CCF which has 

been signed by the certifying scientist, 

or you may provide the laboratory 

results report electronically (i.e., 

computer data file). 

(i) If you elect to provide the 

laboratory results report, you must 

include the following elements, as a 

minimum, in the report format: 

(A) Laboratory name and address; 

(B) Employer’s name (you may 

include I.D. or account number); 

(C) Medical review officer’s name; 

(D) Specimen I.D. number; 

(E) SSN or Employee ID from Step 1C 

of the CCF, if provided; 

(F) Reason for test, if provided; 

(G) Collector’s name and telephone 

number; 

(H) Date of the collection; 

(I) For oral fluid only, collection 

device expiration date 

(J) Date received at the laboratory; 

(K) Date certifying scientist released 

the results; 

(L) Certifying scientist’s name; 

(M) Results (e.g., positive, 

adulterated) as listed in paragraph (a) of 

this section; and 

(N) Remarks section, with an 

explanation of any situation in which a 

correctable flaw has been corrected. 

(ii) You may release the laboratory 

results report only after review and 

approval by the certifying scientist. It 

must reflect the same test result 

information as contained on the CCF 

signed by the certifying scientist. The 

information contained in the laboratory 

results report must not contain 

information that does not appear on the 

CCF. 


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(iii) The results report may be 

transmitted through any means that 

ensures accuracy and confidentiality. 

You, as the laboratory, together with the 

MRO, must ensure that the information 

is adequately protected from 

unauthorized access or release, both 

during transmission and in storage (e.g., 

see § 40.351). 

(2) Non-negative and Rejected for 

Testing results: You must fax, courier, 

mail, or electronically transmit a legible 

image or copy of the fully completed 

Copy 1 of the CCF that has been signed 

by the certifying scientist. In addition, 

you may provide the electronic 

laboratory results report following the 

format and procedures set forth in 

paragraphs (b)(1)(i) and (ii) of this 

section. 

(d) In transmitting laboratory results 

to the MRO, you, as the laboratory, 

together with the MRO, must ensure 

that the information is adequately 

protected from unauthorized access or 

release, both during transmission and in 

storage. If the results are provided by fax 

or other electronic means, the electronic 

communication must be accessible only 

to authorized individuals. 

(e) You must transmit test results to 

the MRO in a timely manner, preferably 

the same day that review by the 

certifying scientist is completed. 

(f)(1) You must provide quantitative 

values for confirmed positive drug test 

results to the MRO. 

(2) You must provide numerical 

values that support the adulterated 

(when applicable) or substituted result, 

without a request from the MRO. 

(3) You must also provide the MRO 

numerical values for creatinine and 

specific gravity for the negative-dilute 

urine test result, without a request from 

the MRO. 

(g) You must provide quantitative 

values for confirmed positive morphine 

and/or codeine urine results at or below 

15,000 ng/mL, and for confirmed 

positive morphine or codeine oral fluid 

results at or below 150 ng/mL. 

■ 54. In § 40.111, revise paragraphs (a) 

and (d) to read as follows: 

§ 40.111 When and how must a laboratory 

disclose statistical summaries and other 

information it maintains? 

(a) As a laboratory, you must transmit 

an aggregate statistical summary, by 

employer, of the data listed in appendix 

D of this part with respect to each 

specimen type for which you conduct 

tests to the employer on a semi-annual 

basis. 

* * * * * 

(d) As a laboratory, you must transmit 

an aggregate statistical summary listed 

in appendix E of this part for each 

specimen type for which you conduct 

testing to DOT on a semi-annual basis. 

The summary must be sent by January 

31 of each year for July 1 through 

December 31 of the prior year. It must 

be sent by July 31 of each year for 

January 1 through June 30 of the current 

year. If you withdraw or are removed 

from NLCP’s laboratory certification 

during a reporting period, you must 

provide the aggregate statistical 

summary to the DOT-regulated 

employers and to ODAPC for the last 

period in which you conducted DOTregulated testing. 

§ 40.121 [Amended] 

■ 55. In § 40.121, in paragraph (c)(1)(i), 

remove the word ‘‘urine’’. 

§ 40.123 [Amended] 

■ 56. In § 40.123, in paragraph (c), 

remove the words ‘‘invalid drug tests 

results’’ and add in their place ‘‘invalid 

results’’. 

§ 40.127 [Amended] 

■ 57. In § 40.127, in paragraph (g)(2), 

add the words ‘‘of all specimen types 

combined’’ before the words ‘‘in any 

quarter’’. 

§ 40.129 [Amended] 

■ 58. In § 40.129, in paragraph (a) 

introductory text, remove the words 

‘‘invalid drug tests’’ and add in their 

place ‘‘invalid results’’; in paragraph (d), 

remove ‘‘drug test report’’ and add 

‘‘result’’ in its place. 

§ 40.135 [Amended] 

■ 59. In § 40.135, in paragraph (d) 

introductory text, remove the word 

‘‘test’’ and add in its place the word 

‘‘result’’. 

■ 60. In § 40.139, revise paragraph (b), 

and in paragraph (c), remove the word 

‘‘urine’’. 

The revision reads as follows: 

§ 40.139 On what basis does the MRO 

verify text results involving 6- 

acetylmorphine, codeine, and morphine? 

* * * * * 

(b) In the absence of 6–AM, if the 

laboratory confirms the presence of 

either morphine or codeine equal to or 

above 15,000 ng/mL (in urine) or equal 

to or above 150 ng/mL (in oral fluid), 

you must verify the test result as 

positive, unless the employee presents a 

legitimate medical explanation for the 

presence of the drug or drug metabolite 

in his or her system, as in the case of 

other drugs (see § 40.139). Consumption 

of food products (e.g., poppy seeds) 

must not be considered a legitimate 

medical explanation for the employee 

having morphine or codeine at these 

concentrations. 

* * * * * 

§ 40.145 [Amended] 

■ 61. In § 40.145, in paragraph (g)(3), 

remove the word ‘‘urine’’ and add the 

word ‘‘drug’’ in its place; and in 

paragraph (h) introductory text, add the 

word ‘‘urine’’ before the word ‘‘result’’. 

■ 62. In § 40.151, revise paragraphs (a), 

(b), (g), and (i) to read as follows: 

§ 40.151 What are MROs prohibited from 

doing as part of the verification process? 

* * * * * 

(a) You must not consider any 

evidence (verbal or written information) 

from any drug tests that are not 

collected or tested in accordance with 

this part. For example, if an employee 

tells you he went to his own physician, 

provided a urine specimen, sent it to a 

laboratory, and received a negative test 

result, you are required to ignore this 

test result. 

(b) It is not your function to make 

decisions about factual disputes 

between the employee and the collector 

concerning matters occurring at the 

collection site that are not reflected on 

the CCF (e.g., concerning allegations 

that the collector left the area or left 

open collection containers where other 

people could access them.) 

* * * * * 

(g) You must not accept an assertion 

that there is a legitimate medical 

explanation for the presence of PCP, 6– 

AM, MDMA, or MDA in a specimen. 

* * * * * 

(i) You must not accept, as a 

legitimate medical explanation for a 

substituted specimen, an assertion that 

an employee can produce a urine 

specimen for which the creatinine level 

is below the laboratory’s limit of 

detection. There are no physiological 

means through which a person can 

produce a urine specimen having this 

characteristic. 

■ 63. In § 40.159, revise paragraphs 

(a)(1) and (a)(5)(ii) to read as follows: 

§ 40.159 What does the MRO do when a 

drug test result is invalid? 

(a) * * * 

(1) Discuss the laboratory results with 

a certifying scientist to determine if the 

primary specimen should be tested at 

another HHS-certified laboratory. If the 

laboratory did not contact you as 

required by §§ 40.91(e) and 40.96(b), 

you must contact the laboratory. 

* * * * * 

(5) * * * 

(ii) Report to the DER that the test is 

cancelled, the reason for cancellation, 

and that a second collection must take 


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place immediately under direct 

observation. Recommend to the 

employer that an alternative specimen 

should be collected if practicable (e.g., 

oral fluid, if the specimen was urine). 

* * * * * 

■ 64. In § 40.163, in paragraph (c)(2), 

remove the words ‘‘donor SSN or 

employee ID number’’ and add in their 

place the words ‘‘SSN or employee ID 

No.’’ and revise paragraph (e). 

The revision reads as follows: 

§ 40.163 How does the MRO report drug 

test results? 

* * * * * 

(e) If you use a written report as 

provided in paragraph (c) of this section 

to report results, you must retain a copy 

of the written report. If you use the 

electronic data file to report negatives, 

as provided in paragraph (d) of this 

section, you must retain a retrievable 

copy of that report in a format suitable 

for inspection and audit by a DOT 

representative. In either case, you must 

keep the completed Copy 2 of the CCF. 

When completing Copy 2, either the 

MRO must sign and date it (for both 

negatives and non-negatives) or MRO 

staff must stamp and date it (for 

negatives only). 

* * * * * 

■ 65. In § 40.177, revise paragraphs (a) 

through (c) to read as follows: 

§ 40.177 What does the second laboratory 

do with the split specimen when it is tested 

to reconfirm the presence of a drug or drug 

metabolite? 

* * * * * 

(a) As the laboratory testing the split 

specimen, you must test the split 

specimen for the drug(s)/drug 

metabolite(s) confirmed in the primary 

specimen. 

(b) You must conduct this test 

without regard to the cutoff 

concentrations of § 40.85 or § 40.91, as 

applicable. 

(c) If the test fails to reconfirm the 

presence of the drug(s)/drug 

metabolite(s) that were reported in the 

primary specimen, you must conduct 

validity tests in an attempt to determine 

the reason for being unable to reconfirm 

the presence of the drug(s)/ 

metabolite(s). You should conduct the 

same validity tests as you would 

conduct on a primary specimen set forth 

in § 40.87 or § 40.93, as applicable. 

* * * * * 

§ 40.179 [Amended] 

■ 66. In § 40.179, in paragraph (a), 

remove ‘‘§ 40.95’’ and add in its place 

‘‘§ 40.89 or § 40.93, as applicable’’. 

■ 67. Revise § 40.181 to read as follows: 

§ 40.181 What does the second laboratory 

do with the split specimen when it is tested 

to reconfirm a substituted test result? 

As the laboratory testing a urine split 

specimen, you must test the split 

specimen using the confirmatory tests 

for creatinine and specific gravity, using 

the criteria set forth in § 40.88. 

§ 40.187 [Amended] 

■ 68. In § 40.187, in paragraphs (b)(1), 

(c)(1)(iii), and (c)(2)(iii), remove 

‘‘Appendix D’’ and add in its place 

‘‘appendix F’’, and in paragraph (e)(3), 

remove ‘‘appendix D’’ and add in its 

place ‘‘appendix F’’. 

■ 69. In § 40.191, revise paragraphs 

(a)(2) through (9) and (d)(1) to read as 

follows: 

§ 40.191 What is a refusal to take a DOT 

drug test, and what are the consequences? 

(a) * * * 

(2) Fail to remain at the testing site 

until the testing process is complete. 

Provided that an employee who leaves 

the collection site before the testing 

process commences (see § 40.63(c) or 

§ 40.72(e), as applicable) for a preemployment test is not deemed to have 

refused to test; 

(3) Fail to provide a specimen for any 

drug test required by this part or DOT 

agency regulations. Provided that an 

employee who does not provide a 

specimen because he or she has left the 

testing site before the testing process 

commences (see § 40.63(c) or § 40.72(e), 

as applicable) for a pre-employment test 

is not deemed to have refused to test; 

(4) In the case of a directly observed 

or monitored urine collection in a drug 

test, fail to permit the observation or 

monitoring of an employee’s provision 

of a specimen (see §§ 40.67(m) and 

40.69(g)); 

(5) Fail to provide a sufficient amount 

of specimen when directed, and it has 

been determined, through a required 

medical evaluation, that there was no 

adequate medical explanation for the 

failure (see § 40.193(d)(2)); 

(6) Fail or decline to take an 

additional drug test the employer or 

collector has directed you to take (see, 

for instance, § 40.197(b) as applicable); 

(7) Fail to undergo a medical 

examination or evaluation, as directed 

by the MRO as part of the verification 

process, or as directed by the DER under 

§ 40.193(c). In the case of a preemployment drug test, the employee is 

deemed to have refused to test on this 

basis only if the pre-employment test is 

conducted following a contingent offer 

of employment. If there was no 

contingent offer of employment, the 

MRO will cancel the test; 

(8) Fail to cooperate with any part of 

the testing process (e.g., refuse to empty 

pockets when directed by the collector, 

behave in a confrontational way that 

disrupts the collection process, fail to 

wash hands after being directed to do so 

by the collector, fail to remove objects 

from mouth, fail to permit inspection of 

the oral cavity, or fail to complete a 

rinse when requested); 

(9) For an observed urine collection, 

fail to follow the observer’s instructions 

to raise your clothing above the waist, 

lower clothing and underpants, and to 

turn around to permit the observer to 

determine if you have any type of 

prosthetic or other device that could be 

used to interfere with the collection 

process; 

* * * * * 

(d) * * * 

(1) As the collector, you must note the 

refusal in the ‘‘Remarks’’ line (Step 2), 

and sign and date the CCF. The collector 

does not make the final decision about 

whether the employee’s conduct 

constitutes a refusal to test; the 

employer has the sole responsibility to 

decide whether a refusal occurred, as 

stated in § 40.355(i), the employer has a 

non-delegable duty to make the decision 

about whether the employee has refused 

to test. 

* * * * * 

■ 70. Revise § 40.193 to read as follows: 

§ 40.193 What happens when an employee 

does not provide a sufficient amount of 

specimen for a drug test? 

(a) If an employee does not provide a 

sufficient amount of specimen to permit 

a drug test (i.e., 45 mL of urine in a 

single void, or 2 mL oral fluid in a 

single sampling, as applicable) you, as 

the collector, must provide another 

opportunity to the employee to do so. 

This can be done using the same 

specimen type as the original collection 

or, if you are qualified to collect an 

alternative specimen, you may use an 

alternative specimen collection for this 

purpose. 

(b)(1) As the collector, you must do 

the following when collecting a urine 

specimen: 

(i) Discard the insufficient specimen, 

except where the insufficient specimen 

was out of temperature range or showed 

evidence of adulteration or tampering 

(see § 40.65(b) and (c)). 

(ii) Urge the employee to drink up to 

40 ounces of fluid, distributed 

reasonably through a period of up to 

three hours, or until the individual has 

provided a sufficient urine specimen, 

whichever occurs first. It is not a refusal 

to test if the employee declines to drink. 

Document on the Remarks line of the 

CCF (Step 2), and inform the employee 

of the time at which the three-hour 

period begins and ends. 


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Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Proposed Rules 11183 

(iii) If the employee refuses to make 

the attempt to provide a new urine 

specimen or leaves the collection site 

before the collection process is 

complete, you must discontinue the 

collection, note that fact on the 

‘‘Remarks’’ line of the CCF (Step 2), and 

immediately notify the DER of the 

conduct as provided in section 

40.191(e)(1); the employer decides 

whether the situation is deemed to be a 

refusal. 

(iv) If the employee has not provided 

a sufficient specimen within three hours 

of the first unsuccessful attempt to 

provide the specimen, you must 

discontinue the collection, note the fact 

on the ‘‘Remarks’’ line of the CCF (Step 

2), and immediately notify the DER. You 

must also discard any specimen the 

employee previously provided, 

including any specimen that is ‘‘out of 

temperature range’’ or shows signs of 

tampering. In the remarks section of the 

CCF that you will distribute to the MRO 

and DER, note the fact that the 

employee provided an ‘‘out of 

temperature range specimen’’ or 

‘‘specimen that shows signs of 

tampering’’ and that it was discarded 

because the employee did not provide a 

second sufficient specimen. 

(2) As the collector, you must do the 

following when collecting an oral fluid 

specimen: 

(i) If the employee demonstrates an 

inability to provide a specimen after 15 

minutes of using the collection device, 

and if the donor states that he or she 

could provide a specimen after drinking 

some fluids, urge the employee to drink 

(up to 8 ounces) and wait an additional 

10 minutes before beginning the next 

specimen collection (a period of up to 

one hour must be provided, or until the 

donor has provided a sufficient oral 

fluid specimen, whichever occurs first). 

If the employee simply needs more time 

before attempting to provide an oral 

fluid specimen, the employee is not 

required to drink any fluids during the 

one-hour wait time. It is not a refusal to 

test if the employee declines to drink. 

The employee must remain at the 

collection site, in a monitored area 

designated by the collector, during the 

wait period. 

(ii) If the employee has not provided 

a sufficient specimen within one hour of 

the first unsuccessful attempt to provide 

the specimen, you must discontinue the 

collection, note the fact on the 

‘‘Remarks’’ line of the CCF (Step 2), and 

immediately notify the DER. 

(iii) Send Copy 2 of the CCF to the 

MRO and Copy 4 to the DER. You must 

send or fax these copies to the MRO and 

DER within 24 hours or the next 

business day. 

(c) As the DER, if the collector 

informs you that the employee has not 

provided a sufficient amount of 

specimen (see paragraph (b) of this 

section), you must, after consulting with 

the MRO, direct the employee to obtain, 

within five days, an evaluation from a 

licensed physician, acceptable to the 

MRO, who has expertise in the medical 

issues raised by the employee’s failure 

to provide a sufficient specimen. (The 

MRO may perform this evaluation if the 

MRO has appropriate expertise.) 

(1) As the MRO, if another physician 

will perform the evaluation, you must 

provide the other physician with the 

following information and instructions: 

(i) That the employee was required to 

take a DOT drug test, but was unable to 

provide a sufficient amount of specimen 

to complete the test; 

(ii) The consequences of the 

appropriate DOT agency regulation for 

refusing to take the required drug test; 

(iii) That the referral physician must 

agree to follow the requirements of 

paragraphs (d) through (g) of this 

section. 

(2) [Reserved] 

(d) As the referral physician 

conducting this evaluation, you must 

recommend that the MRO make one of 

the following determinations: 

(1) A medical condition has, or with 

a high degree of probability could have, 

precluded the employee from providing 

a sufficient amount of specimen. As the 

MRO, if you accept this 

recommendation, you must: 

(i) Check ‘‘Test Cancelled’’ (Step 6) on 

the CCF; and 

(ii) Sign and date the CCF. 

(2) There is not an adequate basis for 

determining that a medical condition 

has, or with a high degree of probability 

could have, precluded the employee 

from providing a sufficient amount of 

specimen. As the MRO, if you accept 

this recommendation, you must: 

(i) Check the ‘‘Refusal to Test’’ box 

and ‘‘Other’’ box in Step 6 on Copy 2 

of the CCF and note the reason next to 

the ‘‘Other’’ box and on the ‘‘Remarks’’ 

lines, as needed. 

(ii) Sign and date the CCF. 

(e) For purposes of this paragraph, a 

medical condition includes an 

ascertainable physiological condition 

(e.g., a urinary system dysfunction in 

the case of a urine test or autoimmune 

disorder in the case of an oral fluid test), 

or a medically documented pre-existing 

psychological disorder, but does not 

include unsupported assertions of 

‘‘situational anxiety’’ or dehydration. 

(f) As the referral physician making 

the evaluation, after completing your 

evaluation, you must provide a written 

statement of your recommendations and 

the basis for them to the MRO. You 

must not include in this statement 

detailed information on the employee’s 

medical condition beyond what is 

necessary to explain your conclusion. 

(g) If, as the referral physician making 

this evaluation in the case of a preemployment, return-to-duty, or followup test, you determine that the 

employee’s medical condition is a 

serious and permanent or long-term 

disability that is highly likely to prevent 

the employee from providing a 

sufficient amount of specimen for a very 

long or indefinite period of time, you 

must set forth your determination and 

the reasons for it in your written 

statement to the MRO. As the MRO, 

upon receiving such a report, you must 

follow the requirements of § 40.195, 

where applicable. 

(h) As the MRO, you must seriously 

consider and assess the referral 

physician’s recommendations in making 

your determination about whether the 

employee has a medical condition that 

has, or with a high degree of probability 

could have, precluded the employee 

from providing a sufficient amount of 

specimen. You must report your 

determination to the DER in writing as 

soon as you make it. 

(i) As the employer, when you receive 

a report from the MRO indicating that 

a test is cancelled as provided in 

paragraph (d)(1) of this section, you take 

no further action with respect to the 

employee. If the test reason was 

‘random’, the employee remains in the 

random testing pool. 

■ 71. In § 40.195, revise the section 

heading to read as follows: 

§ 40.195 What happens when an individual 

is unable to provide a sufficient amount of 

specimen for a pre-employment, follow-up, 

or return-to-duty test because of a 

permanent or long-term medical condition? 

* * * * * 

■ 72. In § 40.197, revise the section 

heading to read as follows: 

§ 40.197 What happens when an employer 

receives a report of a dilute urine 

specimen? 

* * * * * 

■ 73. In § 40.199, revise paragraph (b)(7) 

and add paragraph (b)(8) to read as 

follows: 

§ 40.199 What problems always cause a 

drug test to be cancelled? 

* * * * * 

(b) * * * 

(7) Because of leakage or other causes, 

there is an insufficient amount of 

specimen in the primary specimen 

bottle for analysis and the specimens 

cannot be re-designated (see § 40.83(h)). 


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11184 Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Proposed Rules 

(8) For an oral fluid collection, the 

collector used an expired device at the 

time of collection. 

* * * * * 

§ 40.201 [Amended] 

■ 74. In § 40.201, in paragraph (f), 

remove the word ‘‘urine’’ and add in its 

place the word ‘‘specimen’’. 

■ 75. In § 40.207, add paragraph (d) to 

read as follows: 

§ 40.207 What is the effect of a cancelled 

drug test? 

* * * * * 

(d) If a test is cancelled, only the MRO 

who cancelled the test can reverse the 

cancellation and must do so within 60 

days of the cancellation. After 60 days, 

the MRO who cancelled the test cannot 

reverse the cancellation without the 

permission of ODAPC. For example, if 

an MRO cancels a test because the MRO 

did not receive a copy of the CCF, but 

later receives a copy of the CCF, the 

MRO may reverse the decision to cancel 

the test within 60 days. After 60 days, 

the MRO must contact ODAPC for 

permission to reverse the cancellation. 

A laboratory is not authorized to reverse 

a cancellation due to a fatal flaw, as 

described in § 40.199. 

§ 40.209 [Amended] 

■ 76. In § 40.209, in paragraph (b)(7), 

remove ‘‘§ 40.41’’ and add in its place 

‘‘§ 40.42’’. 

■ 77. Revise § 40.210 to read as follows: 

§ 40.210 What kinds of drug tests are 

permitted under the regulations? 

Both urine and oral fluid specimens 

are authorized for collection and testing 

under this part. An employer can use 

one or the other, but not both at the 

beginning of the testing event. For 

example, if an employee is sent for a 

test, either a urine or oral fluid 

specimen can be collected, but not both 

simultaneously. However, if there is a 

problem in the collection that 

necessitates a second collection (e.g., 

insufficient quantity of urine, 

temperature out of range, or insufficient 

saliva), then a different specimen type 

could be chosen by the employer and its 

service agent to complete the collection 

process for the testing event. Only urine 

and oral fluid specimens screened and 

confirmed at HHS-certified laboratories 

(see § 40.81) are allowed for drug testing 

under this part. Point-of-collection 

(POC) urine, POC oral fluid drug testing, 

hair testing, or instant tests are not 

authorized. 

§ 40.225 [Amended] 

■ 78. In § 40.225, in paragraph (a), 

remove ‘‘Appendix G’’ and add in its 

place ‘‘appendix I’’. 

■ 79. In § 40.261, redesignate paragraph 

(c) as paragraph (c)(1) and add 

paragraph (c)(2). 

The addition reads as follows. 

§ 40.261 What is a refusal to take an 

alcohol test? 

* * * * * 

(c) * * * 

(2) As the BAT or STT, you must note 

the refusal in the ‘‘Remarks’’ line (Step 

3), and sign and date the ATF. The BAT 

or STT does not make the final decision 

about whether the employee’s conduct 

constitutes a refusal to test; the 

employer must decide whether a refusal 

occurred, as stated in § 40.355(i), the 

employer has a non-delegable duty to 

make the decision about whether the 

employee has refused to test. 

§ 40.283 [Amended] 

■ 80. In § 40.283, in paragraph (c), 

remove ‘‘Appendix E’’ and add in its 

place ‘‘appendix G’’. 

§ 40.285 [Amended] 

■ 81. In § 40.285, in paragraph (b), 

remove the word ‘‘urine’’. 

■ 82. In § 40.291, revise paragraphs 

(a)(1) and (3) to read as follows: 

§ 40.291 What is the role of the SAP in the 

evaluation, referral, and treatment process 

of an employee who has violated DOT 

agency drug and alcohol testing 

regulations? 

(a) * * * 

(1) Making a clinical assessment and 

evaluation to determine what assistance 

is needed by the employee to resolve 

problems associated with alcohol and/or 

drug use. This assessment or evaluation 

may be performed face-to-face or 

remotely. If a SAP is not prohibited 

from using technology within the 

parameters of the SAP’s State-issued 

license, a remote evaluation must be 

must be conducted in accordance with 

the following criteria: 

(i) The technology must permit realtime audio and visual interaction 

between the SAP and the employee; and 

(ii) The quality of the technology (e.g., 

speed of the internet connection and 

clarity of the video display) must be 

sufficient to allow the SAP to gather all 

the visual and audible information the 

SAP would otherwise gather in a faceto-face interaction, while providing 

security to protect the confidentiality of 

the communication. 

* * * * * 

(3) Conducting an evaluation to 

determine if the employee has actively 

participated in the education and/or 

treatment program and has 

demonstrated successful compliance 

with the initial assessment and 

evaluation recommendations. This 

assessment or evaluation may be 

performed face-to-face or remotely. A 

remote evaluation must be made by 

means that meet the criteria in 

paragraphs (a)(1)(i) and (ii) of this 

section. 

* * * * * 

§ 40.293 [Amended] 

■ 83. In § 40.293, in paragraph (a), 

remove the words ‘‘face-to-face’’ and 

after the words ‘‘clinical evaluation,’’ 

add the words ‘‘meeting the 

requirements of § 40.291(a)(1)’’. 

§ 40.301 [Amended] 

■ 84. In § 40.301, in paragraph (b)(2), 

remove the words ‘‘face-to-face’’ and 

after the words ‘‘clinical interview’’, add 

the words ‘‘meeting the requirements of 

§ 40.291(a)(1)’’. 

§ 40.311 [Amended] 

■ 85. In § 40.311, in paragraphs (c)(4), 

(d)(4), and (e)(4), after the word 

‘‘Date(s)’’ add the words ‘‘and format 

(i.e., face-to-face or remote)’’; in 

paragraphs (c)(1), (d)(1), and (e)(1) 

remove ‘‘SSN’’ and add in its place 

‘‘SSN or employee ID No.’’. 

■ 86. In § 40.327: 

■ a. In paragraph (a), remove the 

reference ‘‘paragraph (c)’’ and add in its 

place ‘‘paragraph (d)’’; 

■ b. Redesignate paragraph (c) as 

paragraph (d); and 

■ c. Add a new paragraph (c). 

The addition reads as follows: 

§ 40.327 When must the MRO report 

medical information gathered in the 

verification process? 

* * * * * 

(c) The MRO must not report such 

medical information using the CCF. 

Instead, the MRO must provide the 

information in a separate written 

communication (e.g., letter, secure 

email). The information must state the 

specific nature of the MRO’s safety 

concern (e.g., the effects of a medication 

the employee is taking, the employee’s 

underlying medical condition which the 

employee disclosed to the MRO). 

* * * * * 

§ 40.345 [Amended] 

■ 87. In § 40.345, in paragraph (b), 

remove ‘‘Appendix F’’ and add in its 

place ‘‘appendix H’’. 

§ 40.355 [Amended] 

■ 88. In § 40.355, in Example 3 to 

paragraph (n), remove the word ‘‘urine’’. 

§ 40.365 [Amended] 

■ 89. In § 40.365, in paragraph (b)(8), 

remove the words ‘‘face to face 

interviews’’ and add in their place the 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Proposed Rules 11185 

words ‘‘without interviews meeting the 

requirements of § 40.291(a)(1)’’. 

Appendices E Through H to Part 40 

[Redesignated as Appendices G 

Through J to Part 40] 

■ 90. Redesignate appendices E through 

H to part 40 as appendices G through J 

to part 40. 

Appendix C to Part 40 [Redesignated as 

Appendix E to Part 40] 

■ 91. Redesignate appendix C to part 40 

as appendix E to part 40. 

Appendix C to Part 40 [Reserved] 

■ 92. Add reserved appendix C to part 

40. 

Appendix D to Part 40 [Redesignated as 

Appendix F to Part 40] 

■ 93. Redesignate appendix D to part 40 

as appendix F to part 40. 

Appendix B to Part 40 [Redesignated as 

Appendix D to Part 40] 

■ 94. Redesignate appendix B to Part 40 

as appendix D to part 40. 

■ 95. Add new appendix B to part 40 to 

read as follows: 

Appendix B to Part 40—Oral Fluid 

Collection Kit Contents 

1. Oral Fluid Collection Device 

a. A single-use device made to 

simultaneously collect a total of at least 2 mL 

of undiluted (neat) oral fluid, which can be 

subdivided in the employee’s presence, into 

an ‘‘A’’ and a ‘‘B’’ split sample of at least 1 

mL ±10 percent undiluted (neat) oral fluid 

per each included specimen bottle; or a 

single-use device made to simultaneously 

collect a sufficient amount of oral fluid, 

which can be subdivided in the employee’s 

presence, into an ‘‘A’’ and a ‘‘B’’ split sample 

sufficient for laboratory testing. For example, 

when two specimens are collected 

simultaneously using a single collection 

device that directs the oral fluid into two 

separate collection tubes; or when a device 

collects a specimen with a single pad, which 

can be subdivided into two separate 

collection tubes. 

b. Must have unit markings or other 

indicators clearly noting that sufficient 

volume of oral fluid has been achieved. 

c. Must be sufficiently transparent to 

permit a visual assessment of the contents 

without opening the specimen bottle. 

d. Must be individually packaged in an 

easily visible tamper-evident system. 

e. Must have the device’s expiration date 

on the specimen bottles or vials sent to the 

laboratory. 

f. Must not include any substance that 

would interfere with an accurate analysis of 

analytes per HHS OFMG. 

g. Must include a way to seal specimens to 

prevent leakage and be engineered to 

withstand storage and shipping while 

maintaining the integrity of the specimen. 

h. Must be designed so that the required 

tamper-evident bottle seals made available on 

the CCF fit with no damage to the seal when 

the employee initials it, and the seal overlap 

will not conceal printed information. 

2. Instructions 

a. Must include the manufacturer’s 

instructions within the device’s packaging. 

The instructions must provide sufficient 

detail to allow for an error-free collection 

when instructions are followed. 

3. Leak-Resistant Plastic Bag 

a. Must have two sealable compartments or 

pouches that are leak-resistant; one large 

enough to hold two specimen bottles and the 

other large enough to hold the CCF 

paperwork. 

b. The sealing methodology must be such 

that once the compartments are sealed, any 

tampering or attempts to open either 

compartment will be evident. 

4. Absorbent Material 

Each kit must contain enough absorbent 

material to absorb the entire contents of both 

specimen bottles. Absorbent material must be 

designed to fit inside the leak-resistant 

plastic bag pouch into which the specimen 

bottles are placed. 

5. Shipping Container 

a. Must be designed to adequately protect 

the specimen bottles from damage during 

shipment of the specimens from the 

collection site to the laboratory (e.g., standard 

courier box, small cardboard box, plastic 

container). 

b. May be made available separately at 

collection sites rather than being part of an 

actual collection device sent to collection 

sites. 

c. A shipping container is not necessary if 

a laboratory courier hand-delivers the 

specimen bottles in the leak-resistant plastic 

bags from the collection site to the laboratory. 

■ 96. Revise the newly redesignated 

appendix D to read as follows: 

Appendix D to Part 40—DOT Drug 

Testing Semi-Annual Laboratory 

Report to Employers 

The following items are required on each 

laboratory report: 

Reporting Period: (inclusive dates) 

Laboratory Identification: (name and address) 

Employer Identification: (name; may include 

Billing Code or ID code) 

C/TPA Identification: (where applicable; 

name and address) 

A. Urine Specimens 

1. Urine Specimen Results Reported (total 

number) By Test Reason 

(a) Pre-employment (number) 

(b) Post-Accident (number) 

(c) Random (number) 

(d) Reasonable Suspicion/Cause (number) 

(e) Return-to-Duty (number) 

(f) Follow-up (number) 

(g) Type of Test Not Noted on CCF 

(number) 

2. Urine Specimens Reported 

(a) Negative (number) 

(b) Negative and Dilute (number) 

3. Urine Specimens Reported as Rejected 

for Testing (total number) By Reason 

(a) Fatal flaw (number) 

(b) Uncorrected Flaw (number) 

4. Urine Specimens Reported as Positive 

(total number) By Drug 

(a) Marijuana Metabolite (number) 

(b) Cocaine Metabolite (number) 

(c) Opioids (number) 

(1) Codeine (number) 

(2) Morphine (number) 

(3) 6–AM (number) 

(4) Hydrocodone (number) 

(5) Hydromorphone (number) 

(6) Oxycodone (number) 

(7) Oxymorphone (number) 

(d) Phencyclidine (number) 

(e) Amphetamines (number) 

(1) Amphetamine (number) 

(2) Methamphetamine (number) 

(3) MDMA (number) 

(4) MDA (number) 

5. Urine Adulterated (number) 

6. Urine Substituted (number) 

7. Urine Invalid Result (number) 

B. Oral Fluid Specimens 

1. Oral Fluid Specimen Results Reported 

(total number) By Test Reason 

(a) Pre-employment (number) 

(b) Post-Accident (number) 

(c) Random (number) 

(d) Reasonable Suspicion/Cause (number) 

(e) Return-to-Duty (number) 

(f) Follow-up (number) 

(g) Type of Test Not Noted on CCF 

(number) 

2. Oral Fluid Specimens Reported 

(a) Negative (number) 

(b) Negative and Dilute (number) 

3. Oral Fluid Specimens Reported as 

Rejected for Testing (total number) By 

Reason 

(a) Fatal flaw (number) 

(b) Uncorrected Flaw (number) 

4. Oral Fluid Specimens Reported as 

Positive (total number) By Drug 

(a) Marijuana (number) 

(b) Cocaine and/or Cocaine Metabolite 

(number) 

(c) Opioids (number) 

(1) Codeine (number) 

(2) Morphine (number) 

(3) 6–AM (number) 

(4) Hydrocodone (number) 

(5) Hydromorphone (number) 

(6) Oxycodone (number) 

(7) Oxymorphone (number) 

(d) Phencyclidine (number) 

(e) Amphetamines (number) 

(1) Amphetamine (number) 

(2) Methamphetamine (number) 

(3) MDMA (number) 

(4) MDA (number) 

5. Oral Fluid Adulterated (number) 

6. Oral Fluid Substituted (number) 

7. Oral Fluid Invalid Result (number) 

■ 97. Revise newly redesignated 

appendix E to part 40 to read as follows: 

Appendix E to Part 40—Drug Testing 

Semi-Annual Laboratory Report to DOT 

Mail, fax, or email to: U.S. Department of 

Transportation, Office of Drug and Alcohol 

Policy and Compliance, 1200 New Jersey 

Avenue SE, Washington, DC 20590, Fax: 

(202) 366–3897. Email: ODAPCWebMail@

dot.gov. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
11186 Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Proposed Rules 

The following items are required on each 

report: 

Reporting Period: (inclusive dates) 

Laboratory Identification: (name and address) 

1. Specimen Type: 

—oral fluid or urine 

2. DOT agency 

—FMCSA, FAA, FRA, FTA, PHMSA, or 

USCG 

3. Test Reason 

—Pre-Employment, Random, Reasonable 

Suspicion/Cause, Post-Accident, Returnto-Duty, Other, and Follow-up 

A. DOT Specimen Results Reported (total 

number) 

B. Negative Results Reported (total 

number) 

1. Negative (number) 

2. Negative-Dilute (number) 

C. Rejected for Testing Results Reported 

(total number) By Reason 

1. Fatal flaw (number) 

2. Uncorrected Flaw (number) 

D. Positive Results Reported (total number) 

By Drug 

1. Marijuana or Marijuana Metabolite 

(number) 

2. Cocaine and/or Cocaine Metabolite 

(number) 

3. Opioids (number) 

a. Codeine (number) 

b. Morphine (number) 

c. 6–AM (number) 

d. Hydrocodone (number) 

e. Hydromorphone (number) 

f. Oxycodone (number) 

g. Oxymorphone (number) 

4. Phencyclidine (number) 

5. Amphetamines (number) 

a. Amphetamine (number) 

b. Methamphetamine (number) 

c. MDMA (number) 

d. MDA (number) 

E. Adulterated Results Reported (total 

number) By Reason (number) 

F. Substituted Results Reported (total 

number) 

G. Invalid Results Reported (total number) 

By Reason (number) 

■ 98. Revise newly redesignated 

appendix F to read as follows: 

Appendix F to Part 40—Report Format: 

Split Specimen Failure To Reconfirm 

Mail, fax, or submit electronically to: U.S. 

Department of Transportation, Office of Drug 

and Alcohol Policy and Compliance, 1200 

New Jersey Avenue SE, Washington, DC 

20590, Fax: (202) 366–3897. 

Submit Electronically: https://

www.transportation.gov/odapc/mro-splitspecimen-cancellation-notification. 

The following items are required on each 

report: 

1. MRO name, address, phone number, and 

fax number. 

2. Collection site name, address, and phone 

number. 

3. Date of collection. 

4. Specimen I.D. number. 

5. Specimen type. 

6. Laboratory accession number. 

7. Primary specimen laboratory name, 

address, and phone number. 

8. Date result reported or certified by 

primary laboratory. 

9. Split specimen laboratory name, 

address, and phone number. 

10. Date split specimen result reported or 

certified by split specimen laboratory. 

11. Primary specimen results (e.g., name of 

drug, adulterant) in the primary specimen. 

12. Reason for split specimen failure-toreconfirm result (e.g., drug or adulterant not 

present, specimen invalid, split not collected, 

insufficient volume). 

13. Actions taken by the MRO (e.g., 

notified employer of failure to reconfirm and 

requirement for re-collection). 

14. Additional information explaining the 

reason for cancellation. 

15. Name of individual submitting the 

report (if not the MRO). 

Appendix H to Part 40 [Amended] 

■ 99. In newly redesignated appendix 

H, under ‘‘Drug Testing Information,’’ 

remove the reference ‘‘§ 40.129(d)’’ and 

add in its place the reference 

‘‘§ 40.129(e)’’. 

Signed in Washington, DC, on January 19, 

2022. 

Peter Paul Montgomery Buttigieg, 

Secretary of Transportation. 

[FR Doc. 2022–02364 Filed 2–25–22; 8:45 am] 

BILLING CODE 4910–9X–P 


khammond on DSKJM1Z7X2PROD with PROPOSALS2