[Federal Register Volume 88, Number 84 (Tuesday, May 2, 2023)]
[Rules and Regulations]
[Pages 27596-27653]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08041]



[[Page 27595]]

Vol. 88

Tuesday,

No. 84

May 2, 2023

Part II





Department of Transportation





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Federal Aviation Administration





Office of the Secretary





Federal Railroad Administration





Federal Motor Carrier Safety Administration





Federal Transit Administration





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14 CFR Part 120

49 CFR Parts 40, 219, 240, et al.





Procedures for Transportation Workplace Drug and Alcohol Testing 
Programs: Addition of Oral Fluid Specimen Testing for Drugs; Final Rule

  Federal Register / Vol. 88 , No. 84 / Tuesday, May 2, 2023 / Rules 
and Regulations  

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 120

Office of the Secretary

49 CFR Part 40

Federal Railroad Administration

49 CFR Parts 219, 240, and 242

Federal Motor Carrier Safety Administration

49 CFR Part 382

Federal Transit Administration

49 CFR Part 655

[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 of Transportation (OST), Federal 
Aviation Administration (FAA), Federal Motor Carrier Safety 
Administration (FMCSA), Federal Railroad Administration (FRA), and 
Federal Transit Administration (FTA); U.S. Department of Transportation 
(DOT).

ACTION: Final rule.

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SUMMARY: This final rule amends the U.S. Department of Transportation's 
regulated industry drug testing program to include oral fluid testing. 
This additional methodology for drug testing will give employers a 
choice that will help combat employee cheating on urine drug tests and 
provide a less intrusive means of achieving the safety goals of the 
program. In order for an employer to implement oral fluid testing under 
the Department's regulation, the U.S. Department of Health and Human 
Services will need to certify at least two laboratories for oral fluid 
testing, which has not yet been done. The final rule includes other 
provisions to update the Department's regulation and to harmonize, as 
needed, with the Mandatory Guidelines for Federal Workplace Drug 
Testing Programs using Oral Fluid established by the U.S. Department of 
Health and Human Services. In addition, this rule amends the FAA, 
FMCSA, FRA and FTA regulations to ensure consistency within the 
Department of Transportation and by removing or adjusting references to 
the word ``urine'' and/or add references to oral fluid, as well as 
removing or amending some definitions for conformity and to make other 
miscellaneous technical changes or corrections.

DATES: This final rule is effective on June 1, 2023.

FOR FURTHER INFORMATION CONTACT: For OST, 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; 
[email protected]. For FAA, Nancy Rodriguez-Brown, Deputy Director, 
Office of Aerospace Medicine, Drug Abatement Division, AAM-800, FAA, 
800 Independence Avenue SW, Washington, DC 20591 (telephone: 202-267-
8442; [email protected]). For FMCSA, Bryan Price, Chief, Drug and 
Alcohol Programs Division, Office of Safety Programs, FMCSA, 1200 New 
Jersey Avenue SE, Washington, DC 20590-0001 (telephone: 202-366-2995; 
email: [email protected]). For FRA, Gerald Powers, Drug and Alcohol 
Program Manager, Office of Railroad Safety--Office of Program 
Management, FRA RRS-25, 1200 New Jersey Avenue SE, Washington, DC 
20590-0001 (telephone: 202-493-6313; email: [email protected]). For 
FTA, Iyon Rosario, Senior Drug and Alcohol Program Manager, Office of 
Transit Safety and Oversight (TSO), FTA, 1200 New Jersey Avenue SE, 
Washington, DC 20590-0001 (telephone: 202-366-2010; email: 
[email protected]).

SUPPLEMENTARY INFORMATION: 

I. Authority for This Rulemaking

    This rulemaking is promulgated under the authority originally 
enacted in the Omnibus Transportation Employee Testing Act (OTETA) of 
1991, codified at 49 U.S.C. 45102 and 45104 (aviation industry 
testing), 49 U.S.C. 20140 (rail), 49 U.S.C. 31306 (motor carrier), and 
49 U.S.C. 5331 (transit). OTETA requires that the Department 
incorporate the Department of Health and Human Services' (HHS) 
Mandatory Guidelines, including amendments, into the Department's 
regulations for testing and laboratory requirements for aviation, rail 
(except for rail post-accident testing),\1\ 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.
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    \1\ As will be discussed further below, post-accident 
toxicological testing conducted under FRA authority is not subject 
to the OTETA mandate and therefore does not follow Part 40 
procedures. See 49 U.S.C. 20140(f), 40.1(c), 219.205(a), and 
219.701(a)-(b).
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    On October 25, 2019, HHS published a final rule establishing the 
Mandatory Guidelines for Federal Workplace Drug Testing Programs using 
Oral Fluid (OFMG), which became effective January 1, 2020. (84 FR 
57554, Oct. 25, 2019). As of the time of the publication of this final 
rule, there have been no laboratories yet certified by HHS for oral 
fluid testing.

II. Background

    On November 21, 1988, the Department first published its drug 
testing program regulation, ``Procedures for Transportation Workplace 
Drug and Alcohol Testing Programs'', part 40 of Title 49 of the Code of 
Federal Regulations (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 use of the 
specified prohibited 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) called for 
a direct observed collection (i.e., body-to-bottle observation). (53 FR 
47002, Nov. 21, 1988). In December 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 of private citizens are potentially invasive 
searches and seizures 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

[[Page 27597]]

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 privacy for employees undergoing 
urine testing. Allowing directly observed urine collections only for 
``cause'' (e.g., suspicious activity at the collection site, previous 
violations, or irregularities determined by the laboratory testing of a 
specimen), but not for all urine collections under part 40, is another 
protection for employees undergoing testing.
    In June 2008, the Department strengthened direct observation 
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, 
Jun. 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, Jul. 30, 2019). The United States Court of 
Appeals for the District of Columbia Circuit unanimously 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., return-to-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 on 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 
the point where HHS has been able to determine that oral fluid testing 
is an appropriate alternate testing method for identifying illicit drug 
use in the Federal workplace. The scientific viability of oral fluid 
testing has greatly advanced since 2004 to the point where HHS 
determined, in 2019, that the methodology is accurate and appropriate 
for Federal employee testing.
    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 evaluating the progress of science of oral fluid testing and its 
scientific viability, HHS also looked at its forensic defensibility in 
workplace testing. Specifically, in its preamble to the OFMG, 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 marijuana use 
while eliminating possibilities of positive tests resulting from 
passive exposure, as directed by the SUPPORT for Patients and 
Communities Act, Public Law 115-271, Sec.  8107(b). (See 84 FR at 
57558; Oct. 25, 2019).
    We recognize 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, 
but directly observed urine collection may only be done in certain 
circumstances due to employee privacy concerns (see 49 CFR 40.67). All 
oral fluid collections are directly observed because they are always 
collected in front of the collector. Unlike a directly observed urine 
collection, an oral fluid collection is much less intrusive on the 
tested employee's privacy. Therefore, adding oral fluid testing as an 
option 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.
    OTETA specifically requires the Department to follow the HHS 
Mandatory Guidelines, which are the scientific and technical guidelines 
that establish comprehensive standards for all aspects of laboratory-
controlled substances testing to ensure full reliability and accuracy 
in testing. Consequently, the Department published a notice of proposed 
rulemaking (NPRM) that proposed to revise part 40 to add the oral fluid 
testing procedures to its existing urine drug testing procedures for 
safety-sensitive transportation employees subject to drug testing under 
part 40 (hereinafter referred to as ``employees''). (87 FR 11156; Feb. 
28, 2022). In response to public comments requesting an extension of 
the comment period, we provided additional time through April 29, 2022. 
(87 FR 16160; Mar. 22, 2022).
    Like HHS in its OFMG, we proposed, and are now including in this 
final rule, the option for employers to use either urine or oral fluid 
testing (except for FRA post-accident toxicological testing).\2\ By 
providing the option for an employer to choose collecting an oral fluid 
specimen or a urine specimen, DOT is broadening options for the testing 
of safety-sensitive employees in the transportation industries.
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    \2\ Because FRA post-accident toxicological testing requirements 
in part 219, subpart C are not subject to the OTETA mandate and do 
not follow Part 40 procedures, this rule does not allow oral fluid 
testing for FRA post-accident toxicological testing, which still 
requires urine and blood specimens, as well as body fluid and tissue 
specimens for post-mortem tests. See Sec. Sec.  40.1(c), 
219.203(a)(1), 219.205(a), and 219.207(a).
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    Importantly, in order for an employer to implement oral fluid 
testing there must be at least two HHS-certified laboratories for oral 
fluid testing. There must be one HHS-certified laboratory to conduct 
the screening and confirmation drug testing on the primary specimen. 
There must be a different HHS-certified laboratory to conduct the split 
specimen drug testing on the secondary specimen, if the employee 
requests split specimen testing for a non-negative result. As of the 
date of the publication of this final rule, HHS has not yet certified 
any laboratories to conduct oral fluid testing. The following is a link 
to HHS-certified laboratories: https://www.samhsa.gov/workplace/drug-testing-resources/certified-lab-list As a reminder, if the employee 
requests the testing of their split specimen and there is not a second 
HHS-certified laboratory to test it, then the positive/adulterated/
substituted test result would be cancelled per Sec.  40.187(e) because 
there

[[Page 27598]]

would not be a way for the employee to have their split specimen tested 
and this would undermine the fairness and accuracy of the underlying 
test. Thus, for the reasons set forth above, oral fluid testing under 
part 40 cannot be fully implemented until HHS certifies at least two 
laboratories.
    The Department has amended some provisions of part 40 to harmonize 
with pertinent sections of the urine and oral fluid HHS Mandatory 
Guidelines. We have clarified certain existing part 40 provisions that 
cover the handling of urine specimens, removed provisions that are no 
longer necessary (such as erroneous compliance dates), added clarifying 
language to other provisions (such as updated definitions and web links 
where necessary), and modified 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) can conduct evaluations virtually 
and across State lines). We have also modified some proposed revisions 
and added some new provisions to part 40, in response to public 
comments. This final rule also makes changes to the regulations of some 
DOT agencies, to ensure harmonization within the Department with the 
part 40 regulation.
    There were 417 commenters, most of whom provided multiple 
substantive and valuable points within each comment. The Department 
appreciates the time and effort the commenters expended in providing 
literally thousands of meaningful points. As we explained in our final 
rule in December of 2000, what matters the most is not a count of how 
many commenters favored or opposed a particular proposal. Instead, the 
Department's ``central concern is with the substance of the comments. 
In discussing comments on this rule and our response to them, we will 
focus on the substance of positions that commenters expressed, and on 
why we did or did not make changes in response to various comments.'' 
(65 FR 79462, Dec. 19, 2000). Similarly, in this preamble, with 
thousands of substantive comments, we have not ``counted the number of 
comments supporting a given position except in the most general way, 
believing that doing so would distract from the discussion of 
substantive issues.'' Id. However, we have attempted to meaningfully 
address all comments, including the questions and concerns expressed 
therein.
    As the final part of this Background section, we are providing 
readers with a Redesignation Table to provide what sections in the 
existing part 40 are changing and what their new redesignations are.

Redesignation Table

    Beginning with subpart D (see below), the Department is 
redesignating (i.e., renumbering and reordering) numerous sections of 
part 40 to provide a more easily followed flow for users of the 
regulation provisions specific to oral fluid drug testing.

                  Redesignations of Sections in Part 40
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                Old section                          New section
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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.
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III. Principal Policy Considerations

Oral Fluid as an Alternate Drug Testing Method for Workplace Testing

    When the HHS finalized its OFMG in 2019, it opened oral fluid 
testing to Federal agencies as an alternate methodology to choose and 
not as a replacement for urine drug testing. Similarly, the Department 
has determined that oral fluid testing will be an option for regulated 
employers and not a replacement for urine testing.
    The commenters expressed many different opinions on whether oral 
fluid testing should be mandated in some or all circumstances; whether 
it should be purely the employer's choice; whether it should be the 
employee's choice; and whether it should be the collector's choice. 
There were suggestions to allow only oral fluid testing for reasonable 
suspicion and post-accident testing. Some commenters wanted to see oral 
fluid testing prohibited for pre-employment and random testing because 
they preferred the potentially longer windows of detection of urine 
versus oral fluid testing. Individuals who were concerned with 
paruresis wanted the employee to be able to choose oral fluid for every 
test and some of those commenters wanted urine testing banned. Some 
commenters were concerned that, if we mandated oral fluid testing in 
any circumstances, then every collector would need to be trained in 
oral fluid collections and every collection site would need to purchase 
oral fluid testing kits at an additional expense to such small 
businesses. The commenters who opposed oral fluid testing generally 
said they were concerned that oral fluid specimens would be used for 
DNA testing, or the commenters wanted drug testing of safety sensitive 
employees to stop.
    As discussed earlier, HHS has determined oral fluid drug testing, 
like urine drug testing, is accurate and defensible. With both drug 
testing methodologies being scientifically accurate and forensically 
defensible, there is no reason to eliminate either methodology. 
Similarly, we see no reason to mandate either methodology. However, we 
will discuss below, in reference to problem collection scenarios 
covered by Sec.  40.67 (direct observation collections) and Sec.  
40.193 (insufficient specimen ``shy bladder'' cases), that we strongly 
suggest employers consider moving to an oral fluid testing methodology. 
Employers should communicate to their consortium/third party 
administrator (C/TPA) and to their collection sites whether they want 
to utilize urine testing, oral fluid testing, or some combination of 
both. Employers should also provide their service agents with the 
specific instances that would trigger a different methodology (e.g., an 
insufficient oral fluid collection should immediately become a urine 
collection or vice-versa).
    If we were to mandate an alternate methodology be used, but the 
collection kit was not available at the collection site, the test would 
likely not occur at that site. If no test occurs, that would not be in 
the best interest of safety.
    Those who commented that not every collection site will offer oral 
fluid testing have a valid point. It is possible a collection site will 
make a business decision not to offer oral fluid testing because of 
costs or training issues. Although it is the ultimate duty of the 
employer to ensure their collection sites are able and available to 
perform testing in accordance with part 40, it would be helpful for 
collections sites to notify their DOT-regulated clients that they will 
not offer oral fluid collections.
    It is also important to remember that under Sec.  40.209(b)(3), if 
an unqualified collector were to conduct a collection, it would not 
cancel the test. As we said in our 2000 preamble to Sec.  40.209, ``a 
test is

[[Page 27599]]

not invalidated because a collector has not fulfilled a training 
requirement. For example, suppose someone collects a specimen correctly 
but has not completed required training or retraining. The test would 
not be cancelled because the training requirement was not met.'' 65 FR 
79472. To reflect this point, we have updated Sec.  40.209(b)(3) to add 
a reference to Sec.  40.35 for oral fluid collector training, in 
addition to the existing reference to Sec.  40.33 for urine collector 
training. Although it would not cancel the test result if the collector 
has not been trained in accordance with part 40, the collector, other 
service agents, and employer involved might be found in noncompliance 
as the result of the failure to meet training requirements.
    Since the inception of DOT-regulated alcohol testing in 1994, we 
have allowed screening testing to be conducted using saliva testing 
devices, and we have required all confirmation testing to be conducted 
on an evidential breath testing (EBT) device. See 49 CFR 40.231. A 
facility that conducts alcohol saliva screening but that does not have 
an EBT must work expeditiously with the employer to ensure that the 
confirmation test takes place on an EBT.
    Similarly, if a collection site only offers urine collections and 
an insufficient specimen is presented or if a direct observation 
collection is triggered, that collection site is expected to work 
expeditiously with the employer to ensure that the oral fluid 
collection occurs if the employer wants an oral fluid collection 
performed for an employee. Collection sites need to make business 
decisions about whether they will offer urine collections, oral fluid 
collections or both. Thus, not every collector needs to be trained on 
both urine and oral fluid collections unless they offer both.
    The Owner-Operator Independent Drivers Association (OOIDA) asked 
that we ``continue educating industry stakeholders about the scientific 
and forensic supportability of oral fluid testing . . . (and) about how 
oral fluid testing would be implemented and administered.'' OOIDA 
reminded us that State and local law enforcement execute roadside 
testing, and OOIDA wanted us to differentiate and address concerns in 
the trucking industry about the differences between roadside oral fluid 
drug tests and DOT's regulated laboratory tests.
    The Department will continue educating industry stakeholders, as we 
have always done, for urine testing and for part 40 compliance. 
Traditionally, State and local law enforcement have implemented their 
own testing entirely outside DOT-regulated drug testing and will 
continue to do so. Often, law enforcement entities have chosen point-
of-collection testing (POCT) devices that provide initial screening 
test results, instead of laboratory-based screening testing. The POCT 
testing can cover the same drugs for which we test and more (or fewer) 
substances. The cutoff levels of the drugs being tested for in POCT 
devices differ widely among POCT devices. Thus, the differences are 
varying and may be significant. We will educate our regulated 
industries about DOT's regulated oral fluid testing alone. However, we 
welcome our industry partners to continue to educate their memberships 
about the differences they are encountering beyond DOT-regulated 
testing.
    In buffered collections, the employee's oral fluid is collected on 
a device and then the device is subdivided into Bottles A and B, which 
contain a buffering solution. The buffering solution draws the oral 
fluid from the device, so that the liquid can be analyzed by the 
laboratory for the drugs for which we test. OOIDA raised concerns about 
whether drugs sufficiently enter the buffering solution. In its 
oversight of laboratory testing under the OFMG, HHS sets the standards 
for the devices and recovery of drug from the same. These are assessed 
two times: first, by the manufacturer and second, during laboratory 
validation of the collection device. While HHS does not certify or 
validate the collection devices or the buffer, the NLCP laboratory 
inspection process does ensure accuracy of the results obtained by the 
laboratories as evidenced by each laboratory's method of validation 
documentation which must specify the collection device(s) used. HHS 
will approve each specific HHS-certified oral fluid laboratory to use 
only one or more specific devices for which the laboratory can ensure 
the accuracy of the results. For further discussion of this subject, 
see the HHS final rule on oral fluid testing at 84 FR 57559, 57584 
(Oct. 25, 2019).
    Also, OOIDA stated they do not want hair testing in the DOT 
regulated program. It is important to note hair testing is outside the 
scope of this rulemaking, as we will discuss further in this preamble.
    Finally, in response to the commenters who opposed the proposal to 
allow oral fluid testing due to concerns about DNA information or who 
oppose the principle of drug testing of safety-sensitive employees, we 
disagree on both points. As for DNA testing, part 40 already prohibits 
the DNA testing of any specimen collected for a DOT-regulated test. In 
fact, this rulemaking proposed to update the prohibitions on DNA 
testing contained in Sec. Sec.  40.13(c) and (e) (now Sec. Sec.  
40.13(c) and (f)) to ensure that they extend to oral fluid testing.
    As for the commenters who generally opposed drug testing, they 
offered no data to support why eliminating drug testing would be in the 
best interest of transportation safety. Instead, they merely said that 
transportation safety-sensitive employees should be permitted to use 
marijuana. However, it is important to remember that the beginning of 
DOT-regulated testing in 1988 was prompted by marijuana-related 
accidents that occurred in 1985 (two New York City subway accidents) 
and 1987 (one railroad accident in Chase, Maryland).

Whether Using Oral Fluid Testing as an Alternate Method Can Reduce 
Costs

    In the proposal for this rulemaking, we stated that oral fluid 
testing is generally less expensive than urine testing. We said an oral 
fluid test can cost between $10 to $20 less than a urine test (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 asked for public 
comment on the costs of oral fluid testing as compared to urine testing 
to affirm or adjust this cost assumption.
    The majority of commenters on this point said the cost of an oral 
fluid test would be more expensive than a urine test, but that there 
were other, mostly unquantifiable benefits that oral fluid testing 
would bring. Specifically, those benefits included: eliminating the 
costs of shy bladder evaluations; alleviating the burden on individuals 
who cannot produce a sufficient urine specimen due to a psychological 
and/or physical medical condition; opening transportation safety-
sensitive employment possibilities to many who have disabilities 
rendering them unable to produce an adequate urine specimen; and the 
thwarting of cheating. Many commenters said these benefits would 
outweigh the additional costs of conducting an oral fluid specimen 
collection.
    Several commenters who conduct non-DOT collections said 
laboratories currently conducting oral fluid testing charge about $4.00 
per buffered collection device, versus urine collection devices that 
are provided at no charge. A number of commenters in the laboratory and 
manufacturing businesses explained the need to charge because the 
buffering solutions included

[[Page 27600]]

in the oral fluid collection tubes are an added expense. Urine specimen 
collection devices are empty plastic containers, with no solutions 
involved, and are thus less expensive to provide and need no Food and 
Drug Administration (FDA) approval. In addition, the oral fluid 
collection kits expire, often as soon as twelve months after 
manufacturing because of the limited shelf life of the buffering 
solution and sometimes the collection pads themselves, which are 
included in the collection kits. Collection sites noted that they not 
only pay the $4.00 per oral fluid collection kit, but then they must 
discard each kit that expires before it is used. Of course, urine 
collection kits do not expire.
    We proposed the use of a single oral fluid collection device that 
would be subdivided in the presence of the donor, as required by OTETA. 
Some commenters expressed appreciation that DOT would use a single 
device versus two separate devices. Those commenters noted that even if 
the single device were to be subdivided, it might cost more than $4.00, 
but was not likely to be the same expense as two separate kits at $4.00 
each, which could have different expiration dates. Some commenters 
suggested the new devices would cost no more than $4.00 each, giving 
the new devices appeal in the non-DOT oral fluid market, also. They 
said the oral fluid device manufacturers and the laboratories would 
want to keep up with the DOT's requirements for DOT-regulated testing 
and they would not want to price themselves out of the market for non-
DOT testing, since many in the non-DOT market would follow DOT's 
requirements, as they now do.
    We had a tremendous number of comments from individuals who have an 
inability to provide a sufficient quantity of urine due to a 
psychological condition known as paruresis. Individuals in this group 
told stories of losing their careers due to an inability to provide a 
sufficient quantity of urine. Others said they chose not to pursue 
transportation safety-sensitive careers because of the requirements of 
urine testing. Some commenters told of aspirations of becoming 
commercial truck drivers or airline pilots, once the perceived barrier 
of urine testing is removed. With the option of oral fluid testing 
methodology, these individuals emphasized their marketability in the 
transportation workplace would increase.
    While part 40 has a process for a medical evaluation to be 
conducted to determine if one's inability to provide urine is 
legitimate under Sec.  40.193, the commenters noted the process was 
arduous for them and expensive. In addition, such individuals often do 
not have a diagnosis of a pre-existing psychological condition that 
would substantiate their inability to provide a sufficient quantity of 
urine. We received comments from the International Paruresis 
Association (IPA), who thoroughly explained the condition of paruresis. 
The IPA and the individual commenters applauded DOT for proposing to 
allow oral fluid testing. Many asked for the Department to end urine 
testing or to allow employees to choose the methodology that would be 
used for their testing. By allowing the employee to choose the 
methodology, they believed those with paruresis could receive a 
reasonable accommodation without needing to disclose their disability 
to their respective employer or prospective employer.
    We asked for public comment about the number of shy bladder 
evaluations that are occurring and how much they cost. We did not 
receive any public comment to add clarity to those points.
    Overall, the commenters did not provide specific data on the 
numbers we sought clarification on through the public notice and 
comment process, but they did provide many comments about the 
qualitative improvements to DOT drug testing that would be added 
through the adoption of oral fluid testing. Consequently, we adjusted 
our approach to the economic analysis for this rule. Instead of the 
quantitative economic analysis we began in the NPRM, we have conducted 
a qualitative analysis for this final rule.
    As discussed above under Oral Fluid as an Alternate Methodology 
section, we have decided to make oral fluid testing available to 
employers as an alternate methodology to urine testing. We are not 
eliminating urine testing. We are including oral fluid testing as an 
option available to employers. Whether an oral fluid or urine test is 
administered is the employer's choice and not the choice of the 
employee, for the reasons explained in this preamble.

Who will perform the oral fluid collection?

    Recognizing that employers often utilize the services of external 
qualified collectors for urine testing, we asked for comment as to 
whether this would continue for oral fluid testing, or if employers 
would train their own company personnel to become qualified collectors 
for oral fluid testing purposes. We also specifically asked if 
companies thought they would train internal personnel instead of 
contracting with external providers, whether this would this be due to 
costs, convenience or other reasons, and what would be the cost 
implications of the two approaches.
    The majority of commenters disagreed with the concept of employers 
conducting their own collections. The commenters cited concerns such as 
invasion of privacy by supervisors and a lack of professionalism if an 
employer's own staff conducted oral fluid collections. Other commenters 
said allowing a co-worker to conduct oral fluid collections would lead 
to fraud because an employee with a substance use disorder might 
influence the objectivity of a colleague who is collecting. Some 
employers said that they would not want to incur the training costs or 
liability for their corporate employees to conduct collections. Some 
commenters wondered if internal collectors would thwart the testing 
process so that their fellow employees would not test positive. A few 
external collectors worried that in-house collections would lead to 
less demand for external collectors, thereby driving up costs for those 
who still want to use external collectors. One collection company 
polled its clients and found that 90 percent of their clients would 
continue to use external collectors.
    Even those who favored internal collections agreed that there 
should be limitations on internal collectors within an employer's 
organization. They supported the proposal to make it clear that 
employees, relatives, and close friends of the employees cannot conduct 
collections, consistent with existing guidance in the Department's 
Urine Specimen Collection Guidelines, which can be found at: https://www.transportation.gov/odapc/urine-specimen-collection-guidelines.
    Interestingly, many of those commenters appeared not to realize 
that employers have been allowed to collect urine specimens in-house 
for more than 30 years. For example, some of the large employers in the 
transportation industries have on-site clinics and regularly conduct 
many urine collections, including those requiring direct observation 
collections. Thus, we were asking more about whether oral fluid 
collections would occur externally or in-house, and were separately 
proposing the existing constraints regarding employees, relatives, and 
close friends of the employees as we have in urine testing.
    We have amended Sec.  40.31 to separately specify the requirements 
for collectors of urine and oral fluid specimens, respectively. We have 
adopted wording to require oral fluid collectors to be qualified. The 
final rule clarifies that employees, relatives, and

[[Page 27601]]

close friends of the employees cannot conduct collections, consistent 
with existing guidance in the Department's Urine Specimen Collection 
Guidelines.

Allowing Alternate Specimens Provides Flexibility to Employers

    The Department proposed to offer employers flexibility in the type 
of specimen they collect. This final rule provides flexibility to 
employers in most situations, although we strongly encourage employers 
to consider having an alternate methodology ready and available to plan 
for contingencies (e.g., an employee's inability to produce a 
sufficient specimen as a permanent, long-term, or short-term condition; 
direct observation urine collections that could be handled easily by 
switching to oral fluid testing; reasonable accommodation requests; 
etc.).
    In addition, when an employer offers both oral fluid and urine 
testing, this can afford flexibility and other benefits. For example, 
when an employer determines that a DOT post-accident or a reasonable 
cause/suspicion test is needed, an oral fluid collection could be done 
at the scene of the accident or the workplace without the need to 
provide access to a bathroom. Oral fluid testing allows the collection 
to be done by any oral fluid collector qualified under part 40--either 
an external contractor or an employee the DOT-regulated employer 
dispatches to the scene of the accident or incident. In addition, 
offering both urine and oral fluid testing would permit an employer and 
its service agent to efficiently deal with situations when an employee 
cannot provide a sufficient specimen. Finally, having the flexibility 
of both options allows an employer and its service agent the ability to 
perform a directly observed collection as an oral fluid test, without 
concerns about the gender of the observer.

Understanding Windows of Detection

    As discussed earlier, like urine testing, oral fluid testing is 
scientifically accurate and forensically defensible. As our scientific 
authority for drug testing under OTETA, HHS has determined that oral 
fluid testing, set at the cutoffs established by HHS, meets the 
requirements for accurate Federal drug testing.
    Urine and oral fluid specimen testing each offer different benefits 
and limitations in assisting employers in detecting and deterring 
illegal drug use, and no single specimen type is perfect for every 
situation. In an effort to assist employers in understanding some 
benefits and limitations to each methodology, we reviewed and 
referenced various scientific sources in compiling a table of the 
windows of detection. This table provided information regarding the 
specific timeframe in which an oral fluid or a urine drug test could 
identify the presence of the drugs for which we test. We asked for 
public comment on the accuracy and completeness of the information in 
the windows of detection table we provided.
    We received a few public comments on the actual information in the 
table. A couple of commenters believed that the windows of detection we 
had listed for oral fluid testing were too long. Several commenters 
suggested that we remove the table from the final rule, saying that it 
caused confusion. Another commenter cautioned that windows of detection 
should be interpreted carefully because the results depend on study 
design and context. They noted that the window of detection ``for a 
single dose may differ from those observed in individuals who are 
regular users. In addition, route of administration has significant 
impact on concentrations and detection of drugs in oral fluid over 
time.'' That commenter, a laboratory, also noted, ``in general, 
detection windows in oral fluid are shorter than those in urine, but it 
should not be inferred that the cutoffs are equivalent''. Another 
laboratory cautioned against including a windows of detection table in 
the final rule because ``the Federal Register is not updated each time 
a new scientific reference becomes available that may or may not 
support the duration and literature referenced was very limited and not 
very recently published.'' Quest Diagnostics discussed the complexity 
in understanding windows of detection due to ``numerous variables in 
play including: drug dose, drug purity, route of administration, time 
since dosing, individual metabolic rate variability and hydration state 
(for urine).'' As the study of oral fluid continues, Quest Diagnostics 
noted ``more data will be forthcoming as oral fluid testing is 
instituted across the United States that will provide more detailed 
information about oral fluid detection windows which will make these 
stated detection windows obsolete and likely misleading.''
    Many commenters relied on the shorter windows of detection for oral 
fluid testing listed in the table from the preamble to the NPRM to 
reach the assumption that oral fluid test results are more akin to 
impairment tests. That is not a correct assumption. While oral fluid 
testing may provide a better indicator of an employee's recent use of 
the drug, it also detects frequent users. Furthermore, there is no 
definitive drug impairment test. Importantly, the DOT testing program 
is a deterrence-based program to prevent illegal drug use, not an 
impairment testing program.
    We agree with the commenters who cautioned against including a 
windows of detection table in the final rule. Any information that is 
accurate today in a table of windows of detection may not be accurate 
shortly thereafter, as oral fluid testing is deployed by DOT-regulated 
employers and related research on the windows of detection continues. 
For the reasons stated above, we have removed the windows of detection 
table and we note that oral fluid windows of detection will likely be 
shorter than for urine. Employers, working in conjunction with their 
service agents, should determine whether urine or oral fluid collection 
is best for their program and in what contexts.

Substance Abuse Professional Issues

    For more than twenty years, part 40 has been clear that all 
evaluations with a Substance Abuse Professional (SAP) must be face-to-
face and in-person. During the COVID-19 public health emergency, we 
realized conducting face-to-face in-person evaluations may not be 
possible or advisable for certain individuals. As a result, the 
Department issued a notice of enforcement discretion on April 4, 2020, 
to allow SAPs to conduct, for a specified period of time, what we 
called ``face-to-face remote evaluations''. We extended that notice 
several times from 2020-2022, and on December 20, 2022, we extended the 
notice to remain in effect until the effective date of this final rule. 
(https://www.transportation.gov/odapc/Statement_of_Enforcement_Discretion_SAPs)
    To make a remote evaluation as effective as possible, within the 
notice of enforcement discretion we provided, we said the technology 
the SAP uses should permit a real-time two-way audio and visual 
communication and interaction between the SAP and the employee. We said 
the SAP should determine if the quality of the technology (e.g., speed 
of the internet connection, clarity of the display, application being 
used, etc.) is sufficient for the SAP to gather all the visual (e.g., 
non-verbal physical cues) and audible information you would normally 
observe in an in-person face-to-face interaction. In other words, the 
SAP must be able to objectively evaluate verbal, non-verbal and 
physical characteristics to a sufficient extent through the chosen 
technology. We added that SAPs should document the format of the 
assessment in the final

[[Page 27602]]

SAP report. We also stated we would not consider a remote evaluation to 
be an act of serious noncompliance meriting resort to the Public 
Interest Exclusion (PIE) process.
    We proposed amendments to several sections of subpart O of part 40 
to make the notice of enforcement discretion permanent. We proposed and 
are adopting modifications to Sec.  40.291(a)(1) to allow the SAP to 
conduct the evaluations either in-person or remotely, with criteria 
based on those from the COVID-19 notice as conditions for remote 
evaluations. First, the revisions require the technology used to permit 
real-time two-way audio and visual interaction between the SAP and the 
employee (i.e., a conversation without video would not meet this 
criterion). Second, the quality of the technology (e.g., speed of the 
internet connection, clarity of the display) must be sufficient to 
allow the SAP to gather all the visual and audible information the SAP 
would normally observe in a face-to-face in-person interaction. In 
addition, the technology must incorporate sufficiently robust security 
to protect the confidentiality of the conversation. Third, a SAP can 
only use the technology in question if the SAP's State-issued license 
authorizes the SAP to do so (e.g., a State license may permit a 
practitioner to work only with clients in the State of licensure).
    On a second but related topic, we asked for public comment about 
whether a SAP's respective ``qualifying credential'' (i.e., State 
license or other credential under Sec.  40.281) would allow them to 
evaluate individuals who live in a different State from where the SAP 
is licensed. We asked if this was already allowed, especially since 
virtual video evaluations are often done outside of the DOT-regulated 
context. We also asked for public comment about what steps a SAP, who 
is remotely evaluating an individual outside of the SAP's locality, 
could take to ensure a working knowledge of quality programs and 
qualified counselors available to the employee when recommending a 
course of treatment and/or education.
    The comments we received on SAP remote evaluations and crossing 
``State lines'' were thought-provoking and abundant. There were many 
supporting, opposing, qualifying and suggesting improvements to the 
proposals. We will discuss them in-depth.
    Regarding remote SAP evaluations, the majority of commenters 
enthusiastically supported the proposal. Many commenters who identified 
themselves as qualified SAPs who have practiced for years said remote 
evaluations offered unforeseen benefits. Several said they had learned 
to use technology to better study the employee's mannerisms, facial 
expressions, and nonverbal cues as effectively as they could for their 
in-person consultations. One SAP admitted to not being receptive to 
remote evaluations before the COVID-19 public health emergency, but 
acknowledged that ``everything has changed, including people's 
receptivity to virtual interactions . . . even extensive treatment is 
often virtual.'' That same SAP acknowledged reading comments from other 
SAPs who do not support virtual evaluations, but strongly disagreed 
with those fellow commenters because of the advances in telehealth and 
the skills SAPs are developing for evaluating clients virtually as 
effectively as in-person. Specifically, this SAP and many others 
recognized that they had built skill in assessing eye movement, 
involuntary body twitches, and other aspects of nonverbal indicators 
that are key to accurate and complete evaluations. One SAP pointed out 
there would be no difference between a virtual and an in-person 
evaluation if the technology is ``sufficient to allow the SAP to gather 
all visual and audible information that would be apparent in a face-to-
face interaction.'' One commenter wanted DOT to gather more information 
on the effectiveness of remote evaluations, believing the SAP will miss 
too many details if the evaluation is not conducted in-person. However, 
with the advances in telehealth and the robust comments by the many 
SAPs who took the time to comment, we believe that we have reliable 
information from practicing SAPs who are confident that face-to-face 
remote evaluations are as effective as in-person face-to-face 
evaluations.
    In addition, several practicing SAPs said they learn more about the 
employee and circumstances in virtual assessments in the home of the 
employee, because the SAP can ``speak to family members and obtain 
other collateral information that is not always readily available in 
the office setting.'' Some said that the employees seem to be more 
relaxed and communicative when they can participate from the comfort of 
their home. Several SAPs believed it is less stressful for employees in 
remote areas to be able to see a SAP without having to travel to the 
SAP's office. Many SAPs expressed gratitude about the reduction in cost 
to the employees, who often needed to travel significant distances to 
see the SAP in-person. Several SAPs said that this innovation that 
arose temporarily during 2020-2022 should be finalized because it 
created access to evaluation for many employees who were at a loss for 
where to go to seek help, especially for those who live in remote rural 
areas.
    Some SAPs mentioned multiple ``safety'' factors as a reason to 
allow remote evaluations. One said, ``If someone has been removed from 
safety-sensitive duties . . . meeting remotely keeps them off the road 
further lessening the potential for harm to the public.'' Another SAP 
pointed out that, after an employee was ``drinking and driving, does it 
really make sense to say `hey I know you were under the influence while 
driving, but can you get in your car and come see me?' '' Some of the 
SAPs said that there are occasional personal safety issues with 
employees who are angry because of their non-negative results or 
refusals. One commenter who has been involved with SAP evaluations and 
training for more than 30 years said, ``virtual assessments have 
increased personal safety for SAPs dealing with belligerent 
employees.'' Multiple SAP commenters noted the personal safety issues 
are significantly lessened when the contact between the employee and 
the SAP can be conducted virtually.
    A number of SAPs noted a reduction in cost for themselves. Although 
there was an initial cost of setting up the details for conducting 
remote evaluations generally (e.g., subscribing to HIPAA-compliant 
software platforms, obtaining the right equipment for audio and visual 
interactions), the costs of not needing to conduct evaluations in a 
formal office setting was a significant cost savings. One SAP asked if 
we could allow post office boxes for the SAP's address because many 
SAPs no longer maintain a professional office space outside their home.
    Regarding the use of a post office box instead of a physical 
address, we will not consider that change at this time. While many SAPs 
conduct a significant number of evaluations virtually, we are still 
maintaining the option for in-person evaluations. In some situations, 
in-person evaluations may be the best choice and we want to ensure that 
SAPs consider that. Also, having a physical location where DOT can 
inspect, audit, or investigate a SAP and their records is important, 
and we require this of service agents in part 40. If the SAP chooses to 
run their operations from their home, they must furnish the address 
from that place of business on their letterhead. If using one's home 
address is not acceptable to an individual SAP, they must continue to 
provide a physical commercial location address for part 40 purposes.

[[Page 27603]]

    In not allowing SAPs to use post office boxes, we are being 
consistent with our Question and Answer from September of 2001, which 
reads, in pertinent part, as follows: ``May the MRO's address entered 
on the CCF be a post-office box number only? . . . No. The address must 
contain at least a number and street address. . . . The post-office box 
can be included, but not in lieu of the number and street address.'' 
https://www.transportation.gov/odapc/part40QA/40-311 We are also adding 
this reminder to Sec.  40.40(c)(2), to note MRO addresses must not be 
simply a post office box.
    The SAP commenters who favored allowing remote evaluations agreed 
the technology must provide real-time audio and visual interaction 
between the SAP and the employee. We agree that an audio call, alone, 
will not satisfy the requirements of part 40 or the expectations of 
these professionals.
    Technology security concerns were on the mind of some commenters, 
also. Many SAPs suggested that we require a HIPAA-compliant software or 
platform for these audio-visual interactions. Commenters also 
recommended using high-level platforms to ensure confidentiality, and 
not merely commercial platforms that are available for video calls.
    It is important to note that HIPAA does not apply to the DOT 
testing, which involves searches and seizures under the Fourth 
Amendment of the United States Constitution. However, we recognize SAPs 
may be required by the State that licenses the SAP to follow HIPAA as 
part of their clinical evaluations. While we will not require specific 
software and we will not reference HIPAA compliance as a criteria, we 
have specified in Sec.  40.291(a)(1)(ii) of the final rule the 
performance standard that the technology must provide ``security to 
protect the confidentiality of the communication.'' We also added 
language to Sec.  40.291 to explain that the technology needs to be at 
the expected level of confidentiality and security as is required for 
substance abuse evaluations. It is important to note that this is a 
performance standard. We did not prescribe exact measures, which may 
currently be appropriate, because those standards will change, and we 
want to ensure the most effective standards continue to be applied.
    Often, the individual State's licensing and/or private 
credentialing authority set ethical and confidentiality criteria for 
licensed professionals who are performing their duties via virtual 
platforms. Some of the SAP commenters have noted that there are 
additional ethical guidelines and standards that they follow in order 
to provide remote evaluation services. Sometimes these additional 
requirements are set by the qualifying credential authorities, other 
times these are guidelines the SAPs follow because they are recommended 
by the professional organizations with which they affiliate. We urge 
SAPs to continue to follow their respective codes of ethics and 
confidentiality. The ethics of using video technology is an evolving 
field, and we expect SAPs to keep up with their ethical requirements as 
this aspect of their profession continues to improve and evolve.
    One SAP suggested that we make telehealth education part of SAP 
training. We will not require that because not all SAPs will offer 
remote evaluations. Also, SAP training should continue to focus upon 
part 40 requirements and not about generally how to practice more 
effectively.
    SAPs who opposed the proposal varied in wanting to see remote 
evaluations prohibited versus allowed in special circumstances. Some 
commenters only wanted to see remote evaluations when there is a 
pandemic, while others would support remote evaluations in a national 
crisis or in situations where the employee was located hundreds of 
miles from the nearest SAP. Other SAPs disliked remote evaluations 
because ``paperwork and payment'' are better collected in person. Some 
SAP commenters were concerned about employees ``shopping for less 
expensive SAPs'' outside their own high-cost zip code. Conversely, one 
commenter who favored the remote evaluation option said that this 
reduction in cost for the out-of-work employee was exactly why the 
Department should allow an employee to seek a SAP outside their home 
area. Also, SAPs who opposed remote evaluations said it would be 
difficult to find qualified and appropriate treatment resources outside 
the SAP's local area, while other SAPs said this would not be a problem 
because of the ability to search for treatment resources on the 
internet. Those SAPs who suggested using the internet also said the SAP 
would then call the treatment facility to establish communication and 
determine if the treatment resource was appropriate for the employee's 
needs.
    One employer's association provided a reply to other commenters who 
wanted the SAP to justify why a remote evaluation is being held instead 
of an in-person evaluation. The employer's association recommended 
allowing the SAP to choose remote or in-person without the need to 
justify one over the other ``because `DOT cannot predict and codify the 
wide range of circumstances that could reasonably justify remote SAP 
evaluation, nor could employers effectively determine whether a 
particular circumstance is appropriate if the DOT applies an ambiguous 
standard, like `extraordinary circumstances'.'' Reply comments such as 
this are very helpful to us as regulators, and we thank this commenter 
and others who took the time to read and respond to the comments of 
others.
    Commenters who favored and those who opposed the proposal were 
almost unanimous in wanting in-person evaluations to continue as an 
option. That option should be decided by the SAP, many of the 
commenters said.
    We had proposed and agree with allowing SAPs the option of choosing 
to conduct face-to-face evaluations remotely in lieu of in-person 
meetings, and never proposed for the in-person evaluations to be 
eliminated. We have decided to adopt the proposed provision with minor 
modifications. We agree with the commenters and will permit both 
evaluations in-person or via virtual technology meeting the 
requirements of part 40. The choice of which option to use will be the 
decision of the SAP, without any need to justify the use of one or the 
other.
    With SAPs being permitted to conduct remote evaluations, we 
anticipated the issue of SAPs providing evaluations across State lines 
would be something we needed to address. On this subject, we received a 
few favorable comments, but most commenters disagreed with the 
Department taking action in this area.
    Some commenters had no objections to a SAP providing part 40 
services outside the State in which the SAP is licensed. One of these 
commenters noted the MROs are licensed in one State but are permitted 
to provide MRO services under part 40 in all 50 States, the U.S. 
Territories, Canada and Mexico. Other commenters said they had no 
objections to allowing SAPs to practice across State lines, as long as 
part 40 clarified that the SAP could specifically do so as a qualified 
SAP under part 40. Some told us their certifications as ``national'' or 
``international'' drug and alcohol counselors, which they received 
through larger organizations that administer the SAP examinations, 
already allow them to practice throughout the United States. Also, 
several commenters, who are practicing SAPs, told us their licensing 
States already allowed them to practice across State lines. 
Consequently, within the parameters of their own State's licensure, 
they have been conducting

[[Page 27604]]

SAP evaluations of DOT-regulated employees for approximately two years. 
Another SAP told us the licensure from their State ``does not permit me 
to conduct assessments across state lines, however, I have an 
additional certification for telemental health (BC-TMH). Together, my 
credentials permit me to practice both counseling and my SAP 
assessments remotely.'' One commenter asserted that ``SAP is a federal 
qualification and I believe we should be permitted by federal 
designation to see a DOT-governed employee from anywhere.'' Another 
commenter stated, ``As a federal program, drug testing requirements for 
transportation workers already span jurisdictions; it follows that an 
SAP should likewise be able to conduct evaluations across jurisdictions 
. . .'' An MRO association characterized the SAP as ``not a treatment 
provider, just as the MRO is not a treatment provider for donors. . . . 
Thus, performing a substance abuse assessment and recommending 
treatment and a plan, the SAP would unlikely be in violation of any 
state practice act.''
    The commenters who opposed allowing practice across State lines 
said there was value in State licensing and overseeing counselors who 
provide services to individuals within the State. Others who disfavored 
the proposal raised the argument addressed above about a distant SAP 
not knowing the treatment facilities that offer the appropriate 
treatment for an individual employee.
    The commenters have made it clear that there is much confusion 
about whether a SAP can practice across State lines. It is also clear 
that this is an evolving topic, having nothing to do with part 40. The 
States, individually, are addressing needs that have arisen during the 
past two years and the resulting evolution of telehealth options. The 
SAP certification organizations (see Sec.  40.283) should make their 
own determinations about whether those individuals who hold their 
respective qualifying credential can practice throughout the United 
States. SAPs should continue to keep informed about the permissions and 
jurisdictional limitations of their qualifying credentials. If a State 
licensing authority or DOT-recognized credentialing organization 
decides that it is appropriate for one or more of their authorized 
practitioner categories that qualifies a person to be a SAP to practice 
across State lines, DOT will defer to that granting authority.
    With that said, in the short-term, the current inconsistency as to 
where a SAP can practice remotely is creating problems for some DOT-
regulated employees who are seeking SAP services. With an in-person SAP 
evaluation, the employee sits in the SAP's own office, and there is no 
question that the SAP is licensed to practice in their own office. 
Unique to a remote SAP evaluation, an employee may not be located in 
the same geographic jurisdiction where the SAP is authorized to 
practice, thereby making the SAP's underlying qualifying credential not 
valid for that particular evaluation. Under the DOT COVID-19 notice 
allowing remote evaluations, we stated: ``You may only utilize the 
technology if your State-issued license authorizes you to do so and 
within the parameters of that authority.'' Consequently, any SAP who 
evaluates an employee outside the parameters of the SAP's State-issued 
license or other credential is acting without authority and violating 
part 40. To address this, we have added a new Sec.  40.281(f) to create 
a limitation on an otherwise qualified SAP under this part who conducts 
evaluations outside the geographic limitations applicable to their 
credential.
    Some otherwise qualified SAPs have acted outside their authority 
and created problems for employees who received evaluations under the 
DOT COVID-19 notice. When we have learned that a qualified SAP 
evaluated an employee outside the SAP's authorized geographic 
jurisdiction, we have asked the employee to seek the services of a 
different SAP who is qualified and can conduct the evaluation as 
permitted by their credential. There has been no other option under 
part 40 until this final rule.
    However, we acknowledge the costs of having an out-of-work employee 
seek and pay for a second SAP evaluation is an unfair and unintended 
consequence of allowing remote evaluations. Therefore, we are adding a 
new Sec.  40.297(c) to notify the otherwise qualified SAP (see Sec.  
40.281(a) through (d)) that they must not perform evaluations outside 
the geographic jurisdiction of their credential(s). If the SAP who made 
the evaluation exceeds their geographic jurisdiction, the employee will 
not be required to seek the evaluation of a second SAP. The evaluation 
and assessment of the SAP is still valid for the employee, even if the 
SAP has failed to follow Sec.  40.297(c) by exceeding their geographic 
jurisdiction. The employer must carry out the follow-up testing plan of 
the SAP, even though the SAP was acting outside their geographic 
jurisdiction. We have added a new Sec.  40.303(d) to let employers know 
they can utilize such evaluations and follow-up plans, if they choose 
to return the employee to work. We believe that these new sections, 
along with new Sec.  40.281(f), address the unintended consequences of 
costs and stress to employees.
    The new Sec. Sec.  40.281(f) and 40.297(c) also require that a 
qualified SAP must not evaluate any employee outside the jurisdiction 
in which the SAP can practice. In other words, the intention is to 
prohibit the SAP from crossing geographic lines without authority and 
to relieve the employee from the need to pay the cost of seeking a new 
SAP evaluation. If the SAP engages in evaluations outside the limits of 
their credential, then this activity could constitute serious 
noncompliance and the SAP could be subject to a PIE.
    Finally, as a compliance reminder: Every SAP is expected to be 
aware of the specific requirements of their State or credentialing 
authority and may not be authorized to practice across State lines. 
Some of the SAPs who commented that they have national and 
international credentials through certain organizations may not be 
correct and should check with those organizations who, previously, have 
told us their credentials are not nationwide. It will benefit both the 
SAP and every DOT-regulated employee they evaluate to know what their 
geographic jurisdiction is.

Using Identification Numbers Other Than a Social Security Number or 
Employee Identification Number

    Since the inception of the DOT's drug testing program, the Federal 
Drug Testing Custody and Control Form (CCF) has included a space for 
the Social Security Number or Employee Identification Number (SSN or 
Employee ID No.). We proposed to add a new definition for ``SSN or 
Employee ID No.'', and some minor changes to rule language that 
mentioned ``SSN'' in Sec. Sec.  40.14, 40.45, 40.97, 40.163, and 
40.311. The rationale for the change includes privacy concerns and 
identity theft considerations that arose over the years since the 1988 
inception of part 40. Also prompting these amendments was a final rule 
in 2016, in which the Federal Motor Carrier Safety Administration 
(FMCSA) changed the information Commercial Driver's License (CDL) 
holders and Commercial Learner's Permit (CLP) holders must provide on 
the CCF and Alcohol Testing Form (ATF). Specifically, in 2016, FMCSA 
amended 49 CFR 382.123(a) and (b) to require FMCSA-regulated drivers 
undergoing DOT-regulated testing and their employers to use the CDL 
number and State of issuance,

[[Page 27605]]

instead of the SSN or other employee ID number, on the CCF and ATF for 
all drug and alcohol tests conducted under 49 CFR part 382 (part 382). 
See FMCSA's Commercial Driver's License Drug and Alcohol Clearinghouse 
(Clearinghouse) final rule (81 FR 87686; Dec. 5, 2016). 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 the Pipeline and Hazardous Materials Safety 
Administration (PHMSA) or FTA).
    To address the concerns about using SSNs and to conform to the 
existing requirement for CDL numbers to be used for employees regulated 
by FMCSA, we proposed changing the provisions of part 40 requiring the 
use of the employee's SSN or an employee ID number. We proposed a 
definition of the term ``SSN or Employee ID No.'' in Sec.  40.3, as 
well as amendments to sections pertaining to the CCF and/or the Alcohol 
Testing Form (ATF), and in SAP reports. We proposed to require CDL 
numbers for FMCSA-regulated employees, for consistency with part 382. 
We proposed to add that identification numbers issued by States or the 
Federal government would also be allowed for employees not regulated by 
the FMCSA.
    We received several public comments on this issue. The majority of 
those commenters favored allowing alternate identification numbers, 
citing concerns about the employee's security, privacy, and wanting to 
protect employees from potential identity theft. Some commenters 
suggested we only allow the last four digits of the SSN to be used. 
Those opposed to the proposed changes thought the only modification to 
part 40 should be to allow FMCSA-regulated employees to use their CDL 
numbers. Those commenters thought allowing others to use their driver's 
license number would result in violations unrelated to FMCSA-required 
testing erroneously being reported to the FMCSA's Clearinghouse. 
Finally, some of the commenters asked what to do when presented with a 
form of identification that has ``expired''.
    Switching to using the last four digits of the SSN would not 
resolve the concerns about privacy and identity fraud adequately 
because some part of the SSN would still be used. In addition, for 
laboratories that receive thousands, and in some cases tens of 
thousands, of CCFs each day, it is not uncommon for those labs to 
receive multiple CCFs with the same last four digits.
    We acknowledge the concerns about violations being incorrectly 
entered into the FMCSA Clearinghouse if an employee who is not 
regulated by the FMCSA provides their driver's license number. Some 
States use the same number format for a CDL as for any private driver's 
license number issued by the State. In some States, the CDL holder does 
not have a separate private license for driving their own car--only the 
CDL is issued. However, the essence of the concern is not so much about 
the number being used as it is about the entry of incorrect data into 
the FMCSA's Clearinghouse by program participants.
    We have weighed the various considerations raised by the commenters 
and have adopted the proposed language in each section because the 
confusion the commenters are concerned about can be addressed with the 
program participants who may incorrectly enter data into the FMCSA's 
Clearinghouse. We will not remove the option for an employee to provide 
their SSN because that specific term currently appears on the CCF. In 
the future, if that term is ever removed from the CCF, which belongs to 
HHS, we would consider amending these part 40 provisions to exclude the 
SSN.
    The new definition ``SSN or Employee No.'' will allow a collector, 
MRO, SAP, Breath Alcohol Technician (BAT), Screening Test Technician 
(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 
also allows any other State- or federally issued identification number 
to fulfill the part 40 requirement for a unique identification number.
    Since States often do not differentiate between CDL numbers and 
private driver's license numbers, we will continue to remind employers 
and collectors to be very specific about the exact DOT agency 
regulation under which the employee will be tested. An employer 
directly, or through its service agent, must check the block for the 
``Specific DOT Agency'' on Step 1.D. of the CCF. The name of each 
agency is provided in Step 1.D. (i.e., FMCSA, FAA, FRA, FTA, PHMSA, 
USCG). When the employer sends the employee to the collection site, the 
employer must be clear with the collector as to what specific DOT 
agency regulates the test, as required by Sec.  40.14(g). The 
collector, in turn, is expected to ensure that the correct DOT agency 
is checked, unless the employer has already checked the box. If unsure, 
without delaying conducting the actual test, the collector should 
contact the employer to ask what specific DOT agency regulates the 
test. Checking the correct block in Step 1.D.'s ``Specific DOT Agency'' 
block is as important as checking the correct box for the ``Reason for 
Test'' in Step 1.E. Employers and collectors are, and should be, aware 
that not knowing the correct reason for the test may subject an 
employee wrongfully to a direct observation collection or may fail to 
ensure that an employee is subject to a direct observation when they 
need to be observed. Similarly, checking the wrong box in Step 1.D. 
will have potentially incorrect consequences if the employee has a non-
negative result. We will continue to educate and remind employers and 
collectors to appreciate the need for identifying the correct DOT 
agency on the testing form.
    If an employee is wrongfully identified as an FMCSA-regulated 
employee during the collection process, the MRO is likely to discover 
this in the verification interview for a non-negative result. For 
example, during the verification interview some MROs simply ask the 
employee what they do for the employer. In any case, if the MRO finds 
the FMCSA box was incorrectly checked, the MRO must not report the 
verified non-negative result to the FMCSA's Clearinghouse. The only 
employees whose results are ever reported to the FMCSA's Clearinghouse 
are those employees who have taken an FMCSA-regulated test.
    Similarly, if the employer is determining whether or not a 
collection site refusal has taken place and finds that the FMCSA box 
was incorrectly checked, the employer must not report the refusal to 
the FMCSA's Clearinghouse. Since only the employer or the MRO can enter 
a violation into the FMCSA's Clearinghouse, these are the only program 
participants who can correct their own entries, including when they 
have incorrectly identified an employee as an FMCSA-regulated 
individual when they are not.
    Finally, we recognize the issue of employees using expired forms of 
identification at the collection site has been an ongoing problem. As 
we have advised for several years, we want collectors to know it is 
acceptable to accept an expired photo ID issued by a Federal, State, or 
local government agency, if the ID has not been expired for more than 1 
year. This information is contained in the current Office of Drug and 
Alcohol (ODAPC) Urine Collection Guidelines and will be added to the 
ODAPC Oral Fluid Specimen Collection Guidelines.

[[Page 27606]]

Medical Review Officer Reversal of Test Cancellations

    In part 40, there are many instances where an MRO would cancel a 
drug test result. These are set forth in Sec.  40.133 (when verifying 
an invalid result without a donor interview), Sec.  40.145 (if there is 
a legitimate explanation for an adulterated or substituted result), 
Sec.  40.159 (for various specific explanations for an invalid result), 
Sec.  40.161 (after laboratory rejection of a fatal flaw or an 
uncorrected flaw); Sec.  40.187 (if a split fails to reconfirm or 
bottle B is unavailable for testing); Sec.  40.191 (if there is a 
refusal to go for a medical examination where there is no contingent 
offer of employment on a pre-employment test); Sec.  40.193 (where 
there is an acceptable medical explanation for an insufficient 
specimen); Sec.  40.195 (if a medical examination reveals clinical 
evidence of drug use), and Sec.  40.199 (after the laboratory reports a 
fatal flaw). We did not propose any of these types of cancellations as 
grounds for reversing a cancelled test.
    Instead, the proposal addressed situations where a test is 
cancelled due to paperwork errors, which would be correctable flaws, 
but which were not corrected before the MRO sent the cancellation to 
the employer. Those are specifically found in Sec. Sec.  40.203 and 
40.205. In the preamble to the NPRM and in the proposed regulatory 
language of Sec.  40.207(d), we gave the example of the MRO reversing 
the cancellation of a test where the missing or delayed paperwork is 
subsequently found and provided to the MRO. We also said that we did 
not intend for MROs to reverse the cancellation of a test that was 
rejected for testing by a laboratory.
    There were several comments on this proposal. The commenters 
supportive of the proposal understood this as an administrative fix to 
allow an MRO to uncancel a test result involving a correctible error 
the MRO decided was not timely corrected. Many of those who opposed the 
proposal were concerned about DOT allowing MROs to reverse 
cancellations that were related to the fairness and accuracy of the 
test. Those were not the intended cancelled tests subject to the 
proposed change. Even so, we understand the questions in the preamble 
for public comment could have led commenters to conclude otherwise. The 
comments received have helped to shape a better final rule for this 
provision, which we have adopted with modifications.
    Some MROs and other service agents said they already thought MROs 
could reverse a cancelled test. They did not see a need for a change 
because reversing cancelled tests was already part of their MRO 
practice. It is for exactly this reason we needed to consider modifying 
the regulation because these MROs had no authority to reverse 
cancellations. 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. We proposed a new paragraph Sec.  40.207(d) to allow 
an MRO to reverse the cancellation of a test in very specific and 
limited circumstances.
    The American Trucking Association supported the change as a useful 
``administrative fix'' that would save money for random tests. They 
gave a solid example of the impact of the problem when they said: ``the 
employee is sent for a random test; the paperwork for the collection 
site is lost, so the MRO cancels the test; the paperwork is recovered, 
and the test is counted toward the employer's random testing 
requirement.'' As such, the proposal is a ``rational administrative fix 
that will not have a detrimental impact on safety . . . to address 
situations in which administrative errors require a driver to retake a 
drug test unnecessarily.''
    The Association of American Railroads and American Short Line and 
Regional Railroad Association supported the proposal. They said this 
``proposed amendment would be helpful in situations where an employer 
requires a negative result (e.g., a pre-employment, return-to-duty or 
follow-up test), and would avoid the burdens and inconvenience of 
requiring an employee to travel for, or otherwise accommodate a test, 
more than once.''
    Several consortia/third party administrators (C/TPAs) agreed with 
the proposal. One C/TPA referred to ``circumstances that missing 
paperwork is located after the MRO has cancelled the result. This would 
allow the MRO to then report the result.'' To illustrate the benefits 
of the proposal, the commenter described a frequently occurring 
scenario they encounter: ``a delay in receiving information that was 
inadvertently omitted from the custody and control form. In these 
situations, if the test has already been cancelled, a driver must be 
sent back to the collection facility to provide a new sample 
constituting a significant additional cost for motor carriers and 
drivers. Allowing un-cancelling of tests is a commonsense solution to 
an unintended consequence.''
    Some who supported the proposal wanted the Department to ensure it 
would be used in narrow circumstances. They supported reversals of 
cancellations only in tests cancelled for administrative errors that 
are correctible flaws. We added language to the final rule, in the form 
of a parenthetical, to note correctible flaws arising under Sec. Sec.  
40.203 and 40.205 would be examples of what is reversible.
    Several commenters, including the National Drug and Alcohol 
Screening Association (NDASA), C/TPAs, collector trainers, and a 
transit agency noted an existing issue within part 40: an MRO cannot 
cancel a test without having Copy 1 and Copy 2 of the CCF in the MRO's 
possession, per Sec. Sec.  40.129(b), 40.161(a) and (c). These 
commenters said, if the reason the MRO is cancelling the test is 
because the CCF paperwork is missing, then part 40 should allow the MRO 
to cancel the test without holding either or both Copies 1 and 2 of the 
CCF. One commenter recommended we allow the MRO to cancel the test by 
noting on the bottom of Copy 1 that Copy 2 is missing. Another 
commenter suggested allowing the ``MRO to issue a report that the test 
is cancelled if the MRO has not received a legible [CCF].''
    In response to the concerns from these commenters about an MRO's 
inability to cancel a test without the proper paperwork, we have made 
changes to part 40. In Sec.  40.129(b), as a logical outgrowth of the 
comments, we have struck the words ``test cancelled'' so that cancelled 
tests do not require both Copies 1 and 2, as the other verified non-
negative results listed would require. We have modified Sec. Sec.  
40.161(a) and (c) to allow an MRO to use either copy or to issue a 
report, if Copy 1, Copy 2, or both are missing. Also, we have made a 
technical amendment to insert quotation marks around ``rejected for 
testing'' and the word ``laboratory'' in Sec.  40.161(c). As in 
Sec. Sec.  40.127(c)(1) and 40.129(b)(1), we remind the MRO of the 
obligation to try to obtain Copy 2 or any other CCF copy containing the 
employee's signature before cancelling a test. If a copy of the CCF 
with the employee's signature cannot be obtained, then the MRO can use 
the report format set forth in Sec.  40.163(c)(1) through (9).
    The commenters who opposed the proposal to allow an MRO to uncancel 
a test included organized labor (e.g., the Transportation Trades 
Department (TDD), the Airline Pilots Association (ALPA), and the 
National Air Traffic Controllers Union), Quest Diagnostics, and others. 
One commenter thought this would affect so few tests that it was not 
worth doing. Another opposing commenter objected to allowing 
laboratories to cancel tests and requested that the proposal restrict 
the MROs to a 30-day window for reversing a cancelled test. Another 
commenter

[[Page 27607]]

said the proposal will ``undermine the finality of these MRO 
administrative determinations, and raise practical concerns with 
undoing such actions.'' That commenter also wanted DOT to create a 
process for appealing MRO decisions, which is outside the scope of this 
rulemaking. One commenter said the proposal ``could in effect increase 
the frequency of drug testing beyond what is reasonable and justified. 
We are also concerned that it would create administrative burdens to 
the employees being tested who would not have the same finality they 
currently have if a test is canceled.'' Another commenter was concerned 
that, ``If an individual is told the test is cancelled, they may decide 
not to take steps to protect themselves (that they would otherwise have 
done had they been notified of an `uncancelled' test), only to later 
learn that the test has been `uncancelled'.''
    We see no reason to limit the MRO's reversal to 30 days, but have 
maintained the proposed requirement for an MRO to consult ODAPC if the 
reversal of the cancellation occurs more than 60 days after the test 
was cancelled. We do not have exact data on the number of cancelled 
tests this will impact each year because, as we said earlier and the 
commenters supported, many MROs were already reversing cancellations 
because they mistakenly thought they had this authority.
    Quite often the cancellations occur when an MRO is unable to get 
the information needed from the collection site. Often, MROs cannot 
reach the collector. Sometimes, the MROs must contact a general call 
center and wait days, or longer, to reach the collector who did not 
send the needed paperwork (i.e., Copy 2 or a memorandum of correction). 
This delay in reaching the collector should be eliminated by the change 
to Sec.  40.40 to require the collector to provide the telephone number 
where they can be reached more directly and promptly. Ensuring the MROs 
and their staffs have timely access to the collectors is likely to 
result in fewer cancellations. So, this is effectively a two-pronged 
approach to addressing the cancellation problem.
    Allowing an MRO to reverse a result cancelled for administrative 
reasons will not increase the frequency of drug testing because there 
currently are many reasons an employee may be called back for a second 
test when an MRO cancels a test. Also, reversing the cancellation of a 
test would not reduce the finality of an employee's expectations 
because, if a second test is needed because of the reversal of the 
cancellation, an employee would not necessarily know if and when to 
expect a second test. Examples of this include when a split specimen is 
lost or damaged, then the employee must come back in for another test; 
or when a laboratory reports an invalid result and the MRO tells the 
employee to report for another collection. At times, if a negative 
result is needed (i.e., pre-employment, return-to-duty, or follow-up), 
a cancelled test actually causes an employee to return for an 
unanticipated second test. This final rule will reduce the instances of 
those second tests.
    An employee must make themselves available for an additional test 
when the employer directs them to go. Thus, the finality of a test has 
never been tied to the employee's expectations.
    As for the concern that an employee ``may decide not to take steps 
to protect themselves'', we respectfully submit that the employee would 
not lose the right to have a split specimen tested or to request a 
litigation hold on the actual urine specimen. We hope this information 
eases that concern.
    Another industry association and a C/TPA opposed the proposal 
because the employer may perform another test after the first is 
cancelled on a pre-employment, return-to-duty or follow-up test. On a 
similar note, another commenter said ``the ability to `un-cancel' a 
test will cause significant confusion, particularly for those cases 
where a negative result is required (e.g., for a pre-employment test) 
and the donor has likely already submitted to a second test.'' To avoid 
this problem, some commenters suggested only allowing an MRO to 
uncancel a test when the ``cancelled test did not qualify for 
recollection, [then] the MRO should have the option to invoke the same 
consultation requirement we have in [Sec.  ] 40.149(a)(4).''
    We believe part 40 already addresses these concerns. In a test 
where a negative result is not required (i.e., random, reasonable 
cause/suspicion, or post-accident), the employer has no authority to 
send the employee for a second test after the first test is cancelled, 
unless the result of the first test was cancelled due to an invalid 
result. In a test where a negative test result is required (i.e., pre-
employment, return-to-duty, or follow-up), the employee should have 
been sent for a second test after the cancellation. Under Sec.  40.162, 
an MRO is provided clear directions for handling multiple verified 
results for the same testing event, which the MRO can apply to 
reconciling a second test result with the reversed cancellation.
    In the proposal, we 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. This is the same consultation 
requirement we have in Sec.  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. We received several supportive comments on this 
part of the proposal and have finalized it, as proposed.

V. Section-by-Section Analysis

    The Department made a deliberate decision not to create a separate 
subpart of part 40 or to designate another part of Title 49 of the 
United States Code to house oral fluid testing. Since many of the 
provisions of part 40 can be applied to urine, oral fluid and other 
potential future testing matrices, we proposed to integrate new 
provisions concerning oral fluid testing within the current part 40 
structure. In other sections, we proposed to revise current sections 
and their titles to specify they would only apply to urine testing.

Sec.  40.3 What do the terms used in this part mean?

    We proposed to delete the definition of ``screening drug test'' 
because the term is not used in part 40. For consistency with HHS 
terminology, we have removed the defined term ``invalid drug test'' in 
the definitions section, Sec.  40.3, and have updated the wording in 
the definition of ``invalid result'' to be consistent with the current 
language in the HHS mandatory guidelines for both urine and oral fluid. 
We have also updated Sec. Sec.  40.123(c) and 40.129(a) and (d) to use 
the term ``invalid result''.
    To harmonize part 40 with the HHS Guidelines and to update part 40, 
we have added seven defined terms. We have added ``alternate specimen'' 
as an authorized specimen of a type other than the one previously 
collected (e.g., in a case where the initial collection was urine, oral 
fluid would be an alternate specimen). ``Cutoff'' is the quantitative 
point distinguishing a need for further testing or whether a laboratory 
result, for example, is 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 have added definitions for 
``oral fluid specimen'' and ``urine specimen.'' We have added a 
sentence to the definition of ``oral fluid specimen'' to explicitly 
state that an oral fluid collection is a direct observation collection. 
``Specimen'' is the generic term for any fluid, breath or material 
collected from someone for a

[[Page 27608]]

drug or alcohol test. We have added ``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). For the reasons explained in the Principal Policy 
section, we added a new definition for ``SSN or Employee ID No.''.
    We have modified seventeen definitions in Sec.  40.3. For the most 
part, the changes are not substantive, and 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 added that the term 
could include ``tube'' or ``vial'' used in oral fluid testing.
    One commenter requested we change the definition of ``split 
specimen'' to allow two separate specimen collections. This would be 
inconsistent with OTETA's requirement for a single specimen to be 
collected from and subdivided in the presence of the tested individual. 
Thus, we have adopted the proposed definition of ``split specimen'' 
with no changes.
    Most of the comments were supportive of the proposed changes. Thus, 
we have adopted the proposed changes to Sec.  40.3.

Sec.  40.13 How do DOT drug and alcohol tests relate to non-DOT tests?

    The Department has made minor changes to paragraphs (b), (c), and 
(d) of this section for clarification in the context of oral fluid 
testing. For example, paragraph (d) is applicable only to urine 
testing, since oral fluid testing is not part of the normal medical 
examination procedure to which the paragraph applies.
    We have redesignated the current paragraphs (e) and (f) as new 
paragraphs (f) and (g). We have added a new paragraph (e) to specify 
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 ``non-DOT 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 have 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. DOT-regulated tests must not be conducted on non-
regulated persons (i.e., those who do not perform DOT-regulated safety-
sensitive duties). DOT testing is a legal warrantless search and 
seizure permitted by the Fourth Amendment of the Constitution and is 
only applicable to regulated persons. 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). 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. Companies do not have the authority to conduct DOT-regulated 
testing on non-regulated employees. DOT regulations also do not allow 
non-DOT testing to satisfy an employer's obligation to meet its minimal 
annual random testing rate for DOT testing.
    Some individual commenters supported the proposed modifications to 
paragraphs (d), (e), and (f). Other commenters noting the changes to 
Sec.  40.13 were also supportive. We have finalized the proposed 
changes.

Sec.  40.14 What information must employers provide to collectors?

    We received one comment in support of the modification we proposed 
to Sec.  40.14(b). We have adopted this change to add 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).
    We have adopted our proposal to add a new paragraph (k) for ``the 
specimen type to be collected''. We had proposed to add paragraph (l) 
to specify if a urine test is to be directly observed. Although there 
were no comments on paragraphs (k) and (l), we have decided to remove 
the proposed paragraph (l) because it is redundant with current 
paragraph (i).

Sec.  40.21 May an employer stand down an employee before the MRO has 
completed the verification process?

    Under part 40 and the corresponding DOT agency regulations, an 
employer can request a waiver to ``stand down'' an employee from 
performing safety-sensitive functions based on a laboratory confirmed 
non-negative result (i.e., positive, adulterated, substituted or any 
combination thereof) until the MRO issues the employer a verified 
result. 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.
    As with any laboratory-confirmed positive, the MRO may verify the 
final result as negative (e.g., if an employee offers a legitimate 
medical explanation such as a legal prescription). We proposed to add a 
new paragraph (c)(2)(vii)(C) of this section to prevent the employer to 
send an employee back in for another test using a different specimen 
type after receiving a verified negative result. We did not want the 
employer to order a second test using a different methodology to see if 
the window of detection could later impact the result. If the MRO 
cancelled the test (e.g., per the requirements of Sec.  40.159), then 
the employer can send an employee in for an alternate specimen 
collection.
    We received one comment on this proposal. The combined commenter, a 
C/TPA and MRO practice, asked us to clarify in the final rule preamble 
that this applies to more than laboratory positives. Specifically, it 
also applies to laboratory-confirmed adulterated and substituted 
results. We have made this distinction in the preamble, as it already 
exists in Sec.  40.21(b). Other than making this change, we have 
finalized the changes as proposed.

Sec.  40.23 What actions do employers take after receiving verified 
test results?

    We proposed minor changes in this section to account for the use of 
oral fluid or urine in the event of an invalid specimen. In Sec.  
40.23(f), we proposed flexibility in allowing the subsequent direct 
observation collection to either be an oral fluid collection or a urine 
collection under direct observation. In paragraphs (f)(1) and (5), we 
offered language to acknowledge a urine collection would need to be 
directly observed. As written, it is clear oral fluid collections are 
directly observed.
    We received two comments. One commenter supported allowing the 
employer to choose an alternate specimen type for the directly observed 
collection. The other commenter said an employee could deliberately 
cause their urine test to be invalid, then refrain from drug use for a 
few days and test negative on an oral fluid test. This commenter was 
concerned employees

[[Page 27609]]

would use the windows of detection for the different methodologies to 
their advantage.
    While we recognize the concern of the second commenter, we want to 
emphasize that oral fluid is a scientifically valid form of testing for 
the DOT-regulated drug testing program. Our program is deterrence-
based. With established cutoffs, we do not seek to detect the presence 
of every drug, we only seek to detect drugs at their cutoffs and deter 
illegal drug use. Since HHS has determined oral fluid testing is 
scientifically viable and forensically defensible, we are willing to 
leave it to the determination of the individual employers to select the 
methodology acceptable to them under given circumstances. For this 
reason, we encourage employers to look at all aspects of using urine 
drug testing versus oral fluid drug testing as their choice for a 
particular test, in accordance with part 40.
    In consideration of the comments and for the reasons set forth 
above, we have finalized the proposed changes to Sec.  40.23.

Sec.  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?

    Beginning January 6, 2020, FMCSA implemented its Clearinghouse 
regulation, set forth in part 382, subpart G. As part of those 
requirements, FMCSA-regulated employers with drivers subject to the 
drug and alcohol use and testing regulations set forth in part 382 to 
query the Clearinghouse drug and alcohol database for information about 
an employee's past drug and alcohol violations that occurred while the 
driver was employed by another FMCSA-regulated employer. The 
Clearinghouse regulations apply only to employers and employees subject 
to the requirements of part 382.
    Until January 2023, FMCSA-regulated employers had dual 
requirements. They had to conduct a pre-employment query of the 
Clearinghouse, as required by Sec.  382.701(a), and continue to follow 
the procedure of Sec.  40.25, as set forth in Sec.  382.413, to request 
a prospective employee's drug and alcohol violation information from 
previous DOT-regulated employers.
    We have added Sec.  40.25(a)(2) to reflect that, beginning January 
6, 2023, the requirements changed for FMCSA-regulated employers, who 
now must rely solely on querying the Clearinghouse, in accordance with 
Sec.  382.413(b), to determine whether an applicant violated FMCSA's 
drug and alcohol testing regulations while employed by other FMCSA-
regulated employers. For example, after January 6, 2023, a motor 
carrier vetting a prospective employee is required to check the 
Clearinghouse to determine whether the driver's previous FMCSA-
regulated employer(s) reported drug and alcohol testing program 
violations by that driver.
    However, since the Clearinghouse does not include drug and alcohol 
violations committed by employees of other DOT agency-regulated 
employers, FMCSA-regulated employers must continue to comply with the 
requirements of Sec.  40.25 when hiring an employee who has been 
employed by another DOT agency-regulated employer.
    Under the new Sec.  40.25(a)(3), we remind FMCSA-regulated 
employers to request the information about the employee listed in 
paragraph (b)-(j) of this section from any other DOT agency-regulated 
employer for whom the employee previously worked, if the employee was 
subject to another DOT agency's drug and alcohol testing program. If an 
applicant's past employment was with an employer regulated by, for 
example, the FTA or the FAA, the gaining motor carrier employer must 
continue to comply with the requirements of Sec.  40.25 by requesting 
the required information directly from those employers, in accordance 
with Sec.  382.413(c). This is necessary since drug or alcohol 
violations incurred while the driver was employed by a DOT agency other 
than FMCSA will not have been recorded in the Clearinghouse.
    Although FMCSA-regulated employers must query the Clearinghouse for 
an employee's drug and alcohol testing information, employers regulated 
by the other DOT agencies do not have access to the Clearinghouse but 
must find out this important safety information for employees who 
previously worked for motor carriers. For example, if an FAA-regulated 
employer sends a Sec.  40.25 inquiry to a motor carrier, the motor 
carrier must respond to that inquiry in accordance with Sec.  40.25(h). 
Thus, the Clearinghouse will address motor carrier inquiries, but each 
FMCSA-regulated employer is required to retain the records and be ready 
to respond to Sec.  40.25 inquiries from other DOT-regulated employers.
    We did not receive any substantive public comments on these 
changes, which merely conform to FMCSA's requirements. We have 
finalized the proposed changes.

Sec.  40.26 What form must an employer use to report Management 
Information System (MIS) data to a DOT Agency?

    We proposed a simple editorial change, substituting a reference to 
appendix J for a reference to appendix H. This conforms to a re-
designation of the appendix letters but would make no substantive 
changes to the section or form. We did not receive any public comments 
on this change. We have adopted this change as proposed.

Sec.  40.29 And Similar Sections

    We proposed deleting several sections (Sec. Sec.  40.29, 40.37, 
40.113, 40.169, 40.189, 40.217, and 40.313), which listed other 
sections of part 40 touching on a given topic (e.g., employer 
responsibilities in Sec.  40.29). These lists of cross-references were 
intended to assist readers in finding other relevant information before 
part 40 was searchable electronically. In the more than 20 years since 
we placed these sections into part 40, electronic search tools have 
become sophisticated and ubiquitous, making these sections no longer 
necessary.
    A small number of commenters said they liked these cross 
references, but the majority of commenters said that the cross-
references have outlived their usefulness because of electronic search 
options. One commenter said, ``Please continue to make decisions about 
organization of part 40 based on logic, without regard to previous 
editions of the rule. Those of us who look at it every day need to do 
our jobs and learn the new numbers.'' Another commenter noted, ``it 
would not be a burden if the cross referencing was removed because the 
titles of the Subparts clearly identify the subject matter and the 
title/s of the section/s under those Subparts are worded in the format 
of a question with the answers found in that section.''
    Therefore, we have adopted the changes. We removed the cross-
reference sections of Sec. Sec.  40.29, 40.37, 40.113, 40.169, 40.189, 
40.217, and 40.313, as proposed.

Sec. Sec.  40.31 and 40.35--Collectors and Their Qualifications--

    We have updated Sec.  40.31 to include oral fluid collectors who 
can collect DOT drug testing specimens. We have added a new Sec.  40.35 
to separately specify the requirements for collectors of urine and oral 
fluid specimens, respectively. Adding this section required renumbering 
existing Sec.  40.35 to become Sec.  40.36. We have paralleled the new 
Sec.  40.35 as closely as possible to our existing training 
requirements for urine specimen collectors in Sec.  40.33. We have 
added language to parallel Sec.  40.213(b) for training on the specific 
devices.

[[Page 27610]]

    In addition, we have included a clarification for both urine and 
oral fluid collectors prohibiting relatives, close friends, and certain 
employees (e.g., co-worker or immediate supervisor) from conducting 
collections. This is consistent with existing guidance in the 
Department's Urine Specimen Collection Guidelines. We received 
substantive public comment on these changes. Several comments supported 
the following proposed wording: ``a collector must not be related to 
the employee being tested (e.g., spouse, ex-spouse, relative) or a 
close personal friend.'' Other commenters, including Quest 
Laboratories, NDASA, and the Substance Abuse Program Administrator's 
Association (SAPAA) agreed with the exact wording proposed. An aviation 
employer, Flight Safety International, said they thought the list of 
specific relationships listed is too limited and would prefer the 
following wording: ``the collector shall have no conflict of interest 
with regard to the donor's result''.
    On SAP commenter asked that we not allow supervisors or managers to 
serve as collectors. The Aircraft Mechanics Fraternal Association asked 
us to clarify whether management is included in the category of those 
prohibited from collecting a specimen. The Passenger Vessel Association 
supported the existing prohibition on collections by immediate 
supervisors in the current Sec.  40.31(d) is sufficient. This commenter 
said: ``While the limitations proposed in 49 CFR 40.31(d) are 
problematic for vessels that are often operated by a small number of 
crew members with a strict supervisor/subordinate organization, that 
same paragraph finishes with caveat `unless no other collector is 
available and you are allowed to do so under DOT Agency drug and 
alcohol regulations,'. . .'', which this commenter supported.
    We agree with the Passenger Vessel Association and other 
commenters, who supported the wording of the newly renumbered Sec.  
40.31(d). We did not change this long-standing provision cautioning 
against collection by the immediate supervisor of the employee being 
tested, which is now found in Sec.  40.31(d) (formerly in Sec.  
40.31(c)).
    Regarding the qualifications for oral fluid collectors in Sec.  
40.35, those who commented generally supported the proposal and we 
have, therefore, adopted it as proposed. One C/TPA wanted to see 
training similar to urine specimen collectors plus completing the 
manufacturer's training for each oral fluid testing device the 
collector will use. A large C/TPA and MRO practice said all collectors 
should be trained and qualified to perform both oral fluid and urine 
testing, and device-specific training should come from the 
manufacturer. One commenter, who performs a large number of trainings 
annually, said we should look at this the way we view alcohol testing 
training, which means there needs to be comprehensive part 40 training 
plus device-specific training. One commenter suggested we call any 
qualified oral fluid collector a ``Drug Screening Collector Technician 
(DSCT)'' to be consistent with Breath Alcohol Technicians and Screening 
Test Technicians. This commenter also recommended having oral fluid 
collectors: join the ODAPC list serve; be trained to all steps of the 
CCF, and in problem collections, fatal flaws, and collection site 
integrity; undergo five error-free mock collections; and have a 
requirement to requalify every five years. Similarly, NDASA and several 
C/TPAs wanted oral fluid collector training to include all of the 
proposed training elements, which mirrored the urine collector training 
with additions specific to oral fluid collections. SAPAA also commented 
in favor of device-specific training. Several commenters said there 
should not be five error-free mock collections per device.
    Regarding creating a model training course for oral fluid testing 
and urine testing similar to the one we have for alcohol testing, we 
did not propose to create and require such model courses in this 
rulemaking. However, we will take the requests of these commenters into 
consideration in formulating future guidance.
    We asked for comment about who should be considered appropriate for 
monitoring the mock collections necessary to qualify an oral fluid 
collector. We modeled the criteria for the oral fluid monitor after 
what we have set for urine collections in Sec.  40.33(c): one who has 
regularly conducted DOT drug test collections for a period of at least 
one year; has conducted collector training under this part for at least 
one year; or has successfully completed a ``train the trainer'' course. 
The commenters supported keeping the same requirements for the mock 
collection monitors for oral fluid as for urine. Several commenters 
noted it would be inadvisable for the Department to allow individuals 
who have been collecting only non-DOT specimens to automatically 
qualify to train oral fluid collectors under part 40 but did not 
provide a reason for their rationale. Other commenters asked if virtual 
training and virtual mock collections were permissible. Both have been 
allowed for urine collector initial training, error correction training 
and for requalification training. Consequently, both will be permitted 
for oral fluid collector initial training, error correction training 
and for requalification training.
    One commenter asked about whether there must be two or three 
individuals involved in the mock proficiency demonstrations. Whether 
they are in-person or virtual, we have always required at least two 
individuals to interact during the mock collections, while a best 
business practice is to have a third person act as the donor, so that 
the trainee could have the experience of ``collecting from an 
employee'' without actually collecting a specimen during the training. 
We believe this is an extremely important requirement because 
collectors must deal with real people and real specimen collections. If 
the monitor and trainee are the only participants in the mock 
proficiency collections, then the monitor must also perform the role of 
the donor--by interacting meaningfully with the collector trainee to 
make certain the trainee gets the experience of both uneventful and 
problem collections. The easiest way to achieve this result is for 
there to be a third person playing the part of the donor. However, if 
there are only the monitor and the trainee, but the monitor 
meaningfully plays the roles of the cooperative and uncooperative 
donors, the intent of part 40 is fulfilled.
    There were comments recommending oral fluid collectors be trained 
by the manufacturer(s) of the respective oral fluid device(s) the 
collector intends to use. Some recommended collectors take the 
manufacturer's online course to get qualified to use each specific 
device. Others distrusted having specific device training done through 
the manufacturer's website because they said that would increase costs. 
One commenter said not to allow manufacturers to train for their own 
devices because the manufacturer would introduce bias, but a third-
party conducting training would not have that bias. One commenter 
suggested the collector instructor take the manufacturer's device-
specific training and use that as the basis for training others. 
Similarly, a couple of commenters recommended using specific training 
approved by the manufacturer for its own device. Labcorp strongly 
encouraged us to require ``collectors to complete manufacturers' 
training on each collection device that will be used for DOT-regulated 
collections as individual devices have unique features with

[[Page 27611]]

respect to proper placement in the mouth, timing, and specimen 
sufficiency indicators.'' One C/TPA said train the trainer courses will 
be widely available, as they are for urine testing, and oral fluid 
device manufacturers may take the lead on this. Other commenters 
discussed the user-friendly nature of the devices (i.e., they usually 
come with instructions for use or those instructions can easily be read 
on the manufacturer's website prior to the collection).
    We agree with the commenters who were hesitant about specifically 
requiring the manufacturer's training be used. Considering the user-
friendly nature of the devices and that instructors will be teaching 
oral fluid collectors to use each device the collector is expected to 
deploy, we amended the proposed language. We have adopted the 
requirement for a collector to obtain ``training to proficiency in the 
operation of the particular oral fluid collection device(s) you will be 
using.''
    The collector must demonstrate proficiency for each device. We 
acknowledge several commenters did not want proficiency demonstrations 
for each device on which a collector is instructed. However, we 
disagree because the point of the initial proficiency demonstration is 
to prove the collector was trained on a particular device to full 
proficiency. If the collector will use more than one device, then the 
collector needs to prove initial proficiency on each device.
    The collector must check the expiration date of the device in each 
mock collection because using an expired device or failing to enter the 
``Split Specimen Device Expiration Date'' on Step 4 of the CCF would be 
a fatal flaw under Sec.  40.199. Since the collector will use an oral 
fluid device that will collect a single specimen, which is then 
subdivided in the presence of the donor, only one device is to be used. 
The collector must make the entry on the option marked ``Split Specimen 
Device Expiration Date'' instead of the option marked ``Primary/Single 
Specimen Device Expiration Date''. We have been clear that part 40 does 
not allow the use of a ``primary'' collection device, meaning one of 
two collection devices. In addition, part 40 does not allow for a 
``single specimen'' collection device because all devices must be 
capable of collecting both a primary and split specimen. For DOT-
regulated collections, all devices will collect a split and have an 
expiration date. The collector will enter the expiration date of the 
single device in Step 4 of the CCF, on the line marked ``Split Specimen 
Device Expiration Date,'' which appears directly above Step 5A. The 
collector would not fill in the ``Primary/Single Specimen Device 
Expiration Date'' in addition to the ``Split Specimen Device Expiration 
Date'' on the CCF.
    We consider proficiency demonstrations to be extremely important. 
It is one thing to receive instruction on how to use a device, but 
demonstrating proficiency is literally where the ``rubber hits the 
road.'' If a collector cannot demonstrate proficiency on a device, then 
the instruction received on the use of the device will not remain with 
the collector in real world collections.

Sec.  40.33 What training requirements must a collector meet for urine 
collection?

    There were no comments to changing the title of Sec.  40.33 to 
reflect its focus on urine collectors. We also proposed a change to 
Sec.  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. When a 
specimen is damaged by a delivery truck, sort facility, or other part 
of the transportation process, or is lost in transit, it is not the 
result of an error by the collector during the collection process. 
However, when such damage during the transportation process occurred, 
some MROs had required collector retraining.
    Our proposal to clarify that a collector is not subject to the time 
and costs of retraining for errors outside the collection process, such 
as in transportation process events, was met with only supportive 
comments. In response to the following, we have adopted the change to 
Sec.  40.33(f).
    One commenter, NDASA, said, ``Unnecessary error correction has been 
required for far too many circumstances that are beyond the control of 
the collector, costing time and cancelled tests.'' A combined MRO and 
C/TPA comment supported the proposal, saying ``Previously this was too 
subtle of a distinction and collectors have been unnecessarily 
subjected to error correction training when a situation was not their 
fault. An example is when a bottle leaks in transit where fault is 
difficult to assign.'' In further agreement, Quest Diagnostics said, 
``Similar to urine collections, problems that occur during shipping 
that are out of the collector's control should not be held against the 
collector.'' LabCorp also agreed with this proposed change.

Subpart D--Collection Sites, Forms, Equipment and Supplies Used in DOT 
Urine and Oral Fluid Collections

    Some commenters appeared to be confused about testing oral fluid 
specimens for drugs versus testing saliva for alcohol misuse. Oral 
fluid drug testing and saliva alcohol testing are completely distinct 
from each other. The devices, procedures and outcomes are never 
interchangeable. The provisions applicable to oral fluid testing 
procedures were proposed as additions in subpart D. The saliva alcohol 
testing provisions in subparts K through L remain unchanged.
    We proposed to reorganize subpart D to accommodate the addition of 
provisions pertaining to oral fluid drug testing. Sections applying to 
the DOT drug testing process generally, regardless of specimen type, 
come first. Renumbered Sec. Sec.  40.40 and 40.41 contain the content 
of previous Sec. Sec.  40.45 and 40.47, concerning the use of the 
official ``Federal Drug Testing Custody and Control Form'', which we 
continue to refer as the ``CCF'' in all DOT collections. 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. Some commenters specifically requested 
ODAPC to provide Specimen Collection Guidelines for both oral fluid and 
urine, in one combined document. Since not every collector intends to 
perform both types of collections, we will provide an ODAPC Oral Fluid 
Specimen Collection Guidelines document, separate from our Urine 
Specimen Collection Guidelines, after the publication of this final 
rule.
    We proposed changes to the sections of subpart D, including the 
title of the subpart, which contain the word ``urine'' or a derivative 
of that word, if those sections would apply to both urine and oral 
fluid testing. We added the words ``and Oral Fluid'' to the title of 
this section to emphasize subpart D applies both forms of DOT-regulated 
drug testing collections. We proposed the language ``any other 
appropriate contact information'' to permit the inclusion of email 
addresses or other means of contacting the appropriate parties in the 
redesignated Sec.  40.44(c)(2). We asked for public comment regarding 
removing requirements related to fax numbers on the CCF, allowing the 
fax number if the parties have one, or whether fax numbers were still 
relevant.
    We proposed a provision allowing the Designated Employer 
Representative's (DER) name and contact information to

[[Page 27612]]

be preprinted on the CCF. We asked the laboratories about 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 have 
added ``collectors'' to the title of Sec.  40.43.
    As amended, the newly reorganized Sec. Sec.  40.42-40.45 covers 
urine testing (renumbered Sec.  40.42 in the amended rule contains the 
material previously found in Sec.  40.41, while renumbered Sec. Sec.  
40.44 and 40.45 contain the material previously found in Sec. Sec.  
40.49 and 40.51). To parallel with their urine testing counterparts, 
new Sec. Sec.  40.47-40.51 have been added to address oral fluid 
testing, specifically.
    We proposed to modify renumbered Sec.  40.40 to clarify what 
address and telephone number a collector must provide on the CCF. In 
January 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. With the modification 
to Sec.  40.40, 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 and/or the collector's 
supervisor during the collection site's business hours. The collector 
must not provide a number for a call center. Since this amendment makes 
the collection site address and collector's telephone number part of 
the regulatory requirements, we will withdraw the January 2002 Q&A 
because it is now unnecessary.
    If CCFs had already been printed before this final rule was 
published, the call center number may be on the forms. Service agents 
(i.e., C/TPAs and collectors) and employers can use these preprinted 
forms, but they need to cross out the incorrect telephone number and 
write in the correct telephone number and/or collection site address. 
There is no need to incur the cost of destroying these CCFs, but we 
would expect they will no longer be generated with the call center 
telephone numbers or incorrect addresses after this final rule becomes 
effective. However, we want to remind collectors and collections sites 
that they have the responsibility to keep their information current 
with the laboratories.
    We did not receive comments strongly opposing the addition of email 
addresses, but there were strong proponents for and against using fax 
numbers. Some commenters said fax machines are outmoded by more secure 
electronic equipment. LabCorp supported removing the fax number 
requirement. One commenter said fax machines tend to produce less 
legible and sometimes illegible copies of the recipient because some 
labs use lighter ink on their CCFs. One commenter specifically 
supported replacing the requirement for fax numbers on the CCF with the 
option and space to include a either a fax number or email address to 
transmit the CCF to others. In support of using fax numbers, one 
commenter said faxes are ``still a consistent use of transmitting 
information in a secure manner. Not all organizations are set up with 
secure transmittal methods and fax still remains more secure than email 
and is used between clinics, labs and MROs as well as with employers.'' 
A large C/TPA and MRO practice supported the continued use of faxes: 
``While some collection sites are getting rid of fax numbers, we do not 
have widely available access to their email addresses. Fax is still 
commonly used to communicate between collectors, MROs and labs. 
Confidential communications with collection site should be encrypted 
yet some of their systems will not allow for this. Faxing still plays a 
role in our business world and systems are available to keep the 
information secure in transit.'' Another C/TPA commenter wanting us to 
keep fax numbers echoed, ``maximizing the usage of electronic mail and 
other digital means for document transfer is the most efficient method 
of communication available today. However, fax communications are still 
prevalent in the industry, and at this point still an unfortunate 
necessity.''
    In response to the comments, we have decided to keep the option of 
including a fax number on the CCF, but not require its use. Since many 
entities no longer use fax machines, it would be an unintended cost to 
require them to reinstate them. Consequently, in Sec.  40.40(c)(2), we 
finalized the following proposed language: ``Fax numbers may be 
included, but are not required.''
    There were only opposing comments on the idea of including the 
DER's name and contact information pre-printed on the CCFs. 
Laboratories, C/TPAs, MROs, and collector trainers said that DERs 
change too frequently to pre-print a specific name on the CCF, and to 
fill that information in on the CCF at the time of the collection. One 
commenter said that, even on an electronic CCF, it can be confusing to 
need to change the actual DER's name if it is pre-set in the electronic 
system. Many commenters said pre-printing this would be a waste of 
money and time because the pre-printed DER names and contact 
information would need to be crossed out and the correct information 
written over the cross-outs. This would lead to further confusion.
    Consequently, we have not included any requirement for pre-printing 
the DER's name. It was interesting and informative for us to know that 
using an electronic system would have difficulties adapting to changing 
DERs.
    We asked for public comment on the use of the term ``dry mouth'' in 
Sec.  40.48(c)(1). We explained ``dry mouth'' 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. We 
received no comments on this point, although many commenters had 
already adopted the term ``dry mouth'' in their own comments.
    One commenter with a nationwide collection network said ``multiple 
oral tests can be conducted simultaneously when in a controlled/
supervised environment. All while ensuring the integrity of the 
individual tests.'' That was the only comment opposing the proposal to 
require the collector to only collect from one employee at a time. We 
are concerned the distraction of conducting multiple collections at the 
same time could compromise the security of the collection and 
potentially impact the fairness and accuracy of the oral fluid test. 
Consequently, we have adopted this provision to allow the collector to 
conduct only one collection at a time.

Sec.  40.49 What materials are used to collect oral fluid?

    The Department proposed that all oral fluid collection devices must 
meet the requirements being set forth in a new appendix B, which is 
consistent with OTETA's requirement that the specimen must be 
subdivided from the original specimen in the presence of the employee 
being tested. 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). Importantly, we noted not all the 
devices HHS would allow for the OFMG will be allowed for DOT-regulated 
collections under 49 CFR part 40 because many would not be consistent 
with OTETA.

[[Page 27613]]

    Some commenters said DOT and HHS should not allow different 
devices. One commenter said HHS should only use devices meeting the 
needs of the DOT program. Another commenter said laboratories charge 
four dollars per oral fluid collection device, and since every 
collection would require two devices to create a split specimen, they 
thought DOT's proposal would save money by mandating a single device, 
even though it was a sub-dividable device.
    Although we discussed the requirements of OTETA in the preamble to 
the NPRM, one commenter did not realize it was a statutory requirement, 
saying DOT did not have data to support using a single specimen 
collection device that gets subdivided. An industry association said it 
could not find the language in OTETA. One commenter said there was no 
need to subdivide the specimens, simply use a single collection device, 
as is done in non-DOT testing. A couple of commenters misunderstood 
OTETA's requirements and thought that a single specimen subdivided was 
a concept that DOT created separately from the statute. Several 
commenters suggested the mouth could be the collection container, 
thereby allowing separate specimens could be collected from different 
parts of the mouth to collect a subdivided specimen. Others said the 
Department did not understand OTETA's requirements and were thereby 
creating an obstacle that would delay oral fluid testing because the 
Food and Drug Administration (FDA) could take one to two years to 
approve new devices. Incidentally, some of these same commenters 
participated in the public comment period for proposed changes to the 
HHS OFMG and said it would not be a problem to change the devices and 
obtain FDA approval in under one year, even on an annual basis, if 
needed. (See 87 FR 20522, Apr. 7, 2022). That inconsistency was 
notable, when compared to the comments some of the same commenters 
filed to this docket.
    When Congress passed OTETA in 1991, it designated DOT as the agency 
to interpret and carry out the requirements of the statute. The 
Secretary of Transportation, with certain delegations to the aviation, 
rail, motor carrier and transit administrations, was charged with 
continuing its existing drug testing regulations, but enhancements were 
articulated in OTETA. One of those enhancements was to require ``that 
each specimen sample be subdivided, secured, and labelled in the 
presence of the tested individual.'' Id. The Senate Committee Report 
explained the testing programs were to include ``procedures designed to 
safeguard individual rights and testing procedures which shall . . . 
Provide that each specimen sample be subdivided, secured, and labeled 
in the presence of the tested individual . . .'' Senate Report: Omnibus 
Transportation Employee Testing Act of 1991, S. Rpt. 102-54, pp. 20-21 
(May 2, 1991). In addition, the Senate Report explained, ``These 
safeguards are critical to the success of any testing program. They are 
designed to ensure that an individual's basic rights to privacy are 
protected and that there is accountability and accuracy of testing.'' 
Id.
    Having a single specimen collected and subdivided in the presence 
of the tested individual is the core issue in the decisions we have 
made regarding what device features would be acceptable in the DOT oral 
fluid testing program. Congress clearly articulated collecting a single 
specimen that is subdivided in the presence of the tested individual is 
a critical safeguard for the individual and it provides assurance of 
the accountability and accuracy of the testing program. Furthermore, 
the safeguard of a single specimen subdivided in the presence of the 
individual being tested is a right OTETA ensured for individuals being 
tested. As we said in our 2000 preamble to the plain language rewrite 
of part 40, ``When Congress guarantees a right to employees (and we 
believe we must treat all DOT-regulated employees in our program alike, 
even if they are not covered by the Omnibus Act), our obligation as a 
Federal agency is to faithfully execute that legislative decision.'' 
(65 FR 79467 Dec. 19, 2000).
    Requiring a device that permits a single specimen to be collected 
and subdivided in the presence of the donor is both a statutory 
requirement and a reasonable expectation. The Department is acting 
within its authority to carry out such reasonable and clear 
requirements in legislation entrusted to it.
    Assuming in the alternative that the statute is not considered to 
be clear on its face, the DOT is the Federal agency charged by Congress 
to interpret OTETA and we are utilizing our ability to interpret the 
statutory authority vested in us. The precedent for this ability to 
interpret statutes has been supported for almost forty years in the 
cases following Chevron v. Natural Resources Defense Council, 467 U.S. 
837 (1984). In Chevron, the leading case on the authority of agencies 
to interpret statutes through rulemaking, the Supreme Court articulated 
the following standard:

    When a court reviews an agency's construction of the statute it 
administers, it is confronted with two questions. First, always, is 
the question of whether Congress has directly spoken to the precise 
question at issue. If the intent of Congress is clear, that is the 
end of the matter; for the court, as well as the agency, must give 
effect to the unambiguously expressed intent of Congress. If, 
however, the court determines Congress has not directly addressed 
the precise question at issue, the court does not simply impose its 
own construction of the statute, as would be necessary in the 
absence of an administrative interpretation. Rather, if the statute 
is silent or ambiguous with respect to the specific issue, the 
question for the court is whether the agency's answer is based on a 
permissible construction of the statute. (Id. at 842-43).

    In applying the Chevron analysis, courts will strike down an agency 
regulation or interpretation when there is something in the statute 
specifically precluding the action the agency had taken. Actually, 
OTETA confirms the Department's broad authority to carry out its drug 
and alcohol testing responsibilities. When the intent of Congress is 
clear, as is the case here, no further inquiry is necessary.
    Thus, the Department is acting within its statutory authority to 
carry out such reasonable requirements in legislation entrusted to it. 
The statute unambiguously provides that samples for drug testing must 
be subdivided, or ``split.'' To the extent that that the statute 
requires interpretation, the DOT's implementation of the statute is 
reasonable and is, therefore, entitled to deference. See Chevron v. 
Natural Resources Defense Council, 467 U.S. 837 (1984).
    Consequently, as we proposed, all 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, which 
directs the oral fluid into two separate collection tubes; or a 
specimen could be collected with a single device, which is inserted 
into the mouth and can be subdivided into two separate collection 
tubes. We would also allow a device to have two pads joined together 
for the collection in the same part of the mouth, as long as they can 
be separated in the presence of the employee being tested. We do not 
agree with the creative suggestion of allowing the mouth to be the 
collection container.
    We have made slight modifications to the proposed rule language in 
Appendix B to encompass this broader intention of what is acceptable 
under OTETA. We think it is reasonable to allow a device with either 
one or two pads that can be subdivided and sealed in the presence

[[Page 27614]]

of the employee to be consistent with OTETA.
    One commenter who is a collector pointed out that there is already 
at least one patented device that would meet the requirements of OTETA. 
This commenter said she has experience using that device and it is far 
superior to others on the market. She noted problems with other oral 
fluid collection devices ``such as: inadequate specimen for multiple 
drug confirmations; sample-adequacy indicators are not reliable 
indicators of specimen volume as donors attempting to `beat' the test 
often suck on the device to draw saliva out of the paddle or swab; 
absorbent material in paddles/swabs have no consistency in sample 
volume collected; there is no standardization of oral fluid collection 
devices that a offers a reproducible, sufficient (1 mL) sample . . .'' 
As manufacturers develop new devices capable of being subdivided in the 
presence of the donor, we expect that any such problematic issues with 
oral fluid collection devices will be resolved.
    We have included below, in the Section-by-Section analysis of 
Appendix B, more comments regarding the specifics of what we proposed 
for collection device kits. A full discussion of the specific comments 
can be found there.

Sec.  40.61 What are the preliminary steps in the drug testing 
collection process?

    We proposed changes to Sec.  40.61(a) to remind C/TPAs for motor 
carrier owner/operators of the C/TPA's respective nondelegable duty to 
make a determination of whether a refusal has occurred when an employee 
fails to timely report for a test that is not for pre-employment. We 
received only supportive comments. We have adopted the changes and have 
added similar language to this section to remind employers of their 
duty to make a determination on refusals. We have added language in the 
final rule to reiterate the responsibility for the employer or C/TPA of 
the owner/operator to make the actual refusal determination required 
under Sec. Sec.  40.191(a)(1) and 40.355(i) and (j).
    There were no comments regarding modifying Sec.  40.61(b)(1) and 
(3), to use the term ``drug testing'' or ``drug test'' in place of 
``urine,'' since the provision applies to the testing of either 
specimen type. We have adopted these changes as proposed.
    We proposed to split the existing Sec.  40.61(b)(3) into (b)(3) and 
a revised (b)(4), and there were no comments. We have revised Sec.  
40.61(b)(3) to prohibit collection of any kind of specimen from an 
unconscious donor. The revision to Sec.  40.61(b)(4) includes the 
remaining sentences of the current Sec.  40.61(b)(3), with a change to 
the final sentence of proposed subparagraph Sec.  40.61(b)(4). The 
final sentence in Sec.  40.61(b)(4) emphasizes the actual employer must 
decide whether a given circumstance constitutes a refusal, as is 
required by Sec.  40.355(i). When a directly observed test is needed, 
either a directly observed urine collection or oral fluid collection 
will suffice, and the collector will note on the CCF whether a directly 
observed urine or oral fluid test was conducted under Sec.  
40.61(f)(5)(i).
    There was a comment to Sec.  40.61(f)(5)(i). The commenter said the 
``collector should have clear instructions on when the type of sample 
can be switched. Ideally the collector would get instruction from the 
DER, however the DER is rarely available when a problem collection 
arises.'' We agree that this instruction should come from the DER. That 
instruction should be provided in advance of the tests when possible. 
These are the kinds of details employers and collection sites should be 
discussing in their regular course of business. We disagree that it 
should be a regulatory requirement.
    DOT-regulated entities are required to use HHS's OMB-approved CCF. 
DOT worked closely with HHS on the current CCF, which incorporated 
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 have not been authorized in the DOT drug 
testing until this final rule and will not be fully implemented until 
HHS certifies at least two laboratories.
    In response to the HHS revisions to the CCF, we proposed changes to 
Sec. Sec.  40.61(e) and 40.79(a)(1) (formerly Sec.  40.73(a)(1)). 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. Instead, instructions for completing the form can be found on the 
HHS and DOT (ODAPC) websites. We proposed amending Sec.  40.61(e) to 
instruct the collector to tell the employee they can find instructions 
for completing the CCF on specific HHS and DOT websites. We received 
the following comments to these changes.
    Airlines for America (A4A) supported the amendment to require the 
collector to ``notify the employee that instructions for . . . the CCF 
can be found at the HHS . . . and DOT . . . websites.'' Quest 
Diagnostics suggested, ``a printed and legible copy of the instructions 
for completing the CCF should be available to both the donor and 
collector to follow as part of the collection process during all 
collections. Provision of a printed copy should be a collector's 
responsibility in the event electronic access is not available.'' While 
we agree with the spirit of this latter comment and would encourage 
collectors to have a legible copy of the CCF instructions available, we 
envision it as a good business practice and not a regulatory provision. 
To require paper copies of this to be provided to each donor seems to 
be an unnecessary paperwork burden to employers and their collection 
personnel. Having a laminated copy available at the collection site is 
also a good idea. As long as these directions are available 
electronically through the DOT and HHS websites, they will be available 
to all employees. We have finalized Sec.  40.61(e) as proposed.
    We received a comment from a labor organization asking for a new 
requirement to be added to Sec.  40.61(b). Specifically, they asked us 
``to add a requirement that for union represented employees to be 
informed by the collector that the employee being tested has the right 
to have a union representative present during the process.'' It is 
unlikely that collectors would know this information. We consider this 
comment outside the scope of this rulemaking, but it can be addressed 
in individual collective bargaining agreements between unions and their 
employers.
    Also, we proposed amending redesignated Sec.  40.79(a)(1) to note 
the employee must 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 (if the donor has one they are willing 
to share).
    One commenter asked that we not require the collector to make a 
remark on the CCF if the donor's email address, date of birth, or 
telephone numbers are not in Step 5 of the CCF. This commenter said 
requiring this notation as a remark on the CCF ``could have a 
catastrophic impact on the collection process, expose employers to 
privacy complaints, create unnecessary test cancelations, increase 
administrative costs, and add another point of potential conflict 
between the donor and collector.'' The commenter thought the 
requirement to provide two phone numbers and an email address would be 
a violation of the employee's privacy

[[Page 27615]]

rights. However, the commenter did not have an issue with providing the 
donor's name, SSN and date of birth.
    We disagree that additional information on the CCF is a violation 
of the employee's privacy. If the information required in Step 5 of the 
CCF is not properly completed by the employee, the collector has a duty 
to attempt to get the employee to provide the information or note in 
the remarks section that this was not done. As with all problems at the 
collection site, it is best to document them as soon as possible.
    One commenter, NDASA, asked about situations in which the employee 
does not have a second phone number. This commenter asked that we allow 
the collector to write ``Not applicable'' or some derivation of that 
phrase on the CCF, to note the absence of the second number was not 
available and not simply an oversight. That is a reasonable suggestion 
and common-sense approach. We have not included this in the regulatory 
text. Instead, we will include it in our collection guidance. We have 
finalized Sec.  40.79(a)(1) as proposed.

Sec.  40.63 What steps does the collector take in the collection 
process before the employee provides a urine specimen?

    We proposed to modify Sec.  40.63(a) to remind collectors to ensure 
that all items in Step 1 of the CCF are completed. Specifically, we 
proposed 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.
    Quest Diagnostics commented in support of ``the reminder to 
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.'' 
Similarly, industry trade associations supported the change. There were 
no opposing comments. We have adopted the changes as proposed.

Sec.  40.65 What does the collector check for when the employee 
presents a urine specimen?

    We proposed to modify Sec.  40.65 to ensure that when an immediate 
re-collection under direct observation is needed (e.g., because the 
temperature of a urine specimen is out of range or there are 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 Sec.  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 asked for public comment about who should 
make the decision as to the methodology for the second collection.
    ARCpoint Labs, a nationwide network of collection sites, commented 
that the collector should be the one ``to determine the type of second 
collection that is performed. This will allow maximum flexibility based 
on environment, oral/urine kits available for that client, and the 
collectors experience.'' This commenter also pointed out that moving 
from a urine collection to an oral fluid for the purpose of obtaining a 
directly observed collection would remove the need to conduct a more 
invasive urine direct observation.
    Conversely, Labcorp, which is an HHS-certified laboratory and owner 
of a large network of collection sites, opposed ``allowing the 
collector to independently determine when an alternate specimen should 
be collected or requiring that the collector contact the employer each 
time an alternate specimen type is collected.'' Labcorp also said the 
identification of what specimen type is used and when it should be used 
should not be in the regulation and should be in the agreement between 
the employer and the collection site. A C/TPA requested that a 
``collector should have clear instructions on when the type of sample 
can be switched.'' Similarly, the New York City Department of 
Transportation recommended advance communication between the DER and 
the service agent ``to ensure that an alternate methodology is 
authorized with devices and laboratories as designated. In the event an 
alternate methodology is needed, the collector should contact the 
employer (DER) and/or service agent (TPA/MRO) immediately. They will 
make the decision on which device to use.''
    We agree there should be clear communication between the employer 
and their service agent(s) who conduct the collection to ensure there 
is a process set up in advance. That process would determine whether 
the collection would either continue with the same methodology as the 
collection began or switch to the alternate methodology to complete the 
second test (e.g., under direct observation or to complete the test 
when there is a shy bladder scenario). As Labcorp noted, moving to oral 
fluid for a directly observed collection is less invasive than moving 
to a urine collection under direct observation.
    When there is a need to determine whether an alternate specimen 
should be used, it is advisable for an employer to have a standing 
order in place to deal with such situations. The different specimen 
type could be chosen by the employer (through a standing order or a 
discussion with the collector) or its service agent (i.e., if there is 
no standing order and the collector cannot contact the DER) to complete 
the collection process for the testing event.
    As several commenters supported, this should all be discussed and 
arranged in advance. We do not believe this is something the Department 
should regulate. The employer and its service agents are in the best 
position to assess the costs and logistics of the collection, set up 
the appropriate contracts with collectors and laboratories, and 
determine the most effective way to conduct a second collection under 
direct observation. The proposed language sets up the performance 
standard for the second collection to be accomplished without 
interfering in these contractual relationships between employers and 
their service agents. Consequently, we have finalized the proposed 
language without further changes.

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

    We proposed to modify the title of the section to add the word 
``urine''. This clarifies its applicability solely to how and when 
directly observed urine collections will occur. We received no comments 
on this point and have adopted the change to the title.
    One commenter asked why we did not include permission for an 
employer to send an employee in for an immediate recollection if the 
employer discovered a direct observation should have been conducted but 
was not. The commenter pointed out the employer could do this only when 
the service agent noted this for the employer. We agree with this 
commenter and, as a logical outgrowth, we have added a Sec.  
40.67(a)(4) to permit this and to tie in the action expected of the 
employer when a service agent notifies the employer under Sec.  
40.67(n) that a required direct observation was not done.
    We proposed minor changes to Sec.  40.67(c) and (d). We received a 
public comment requesting an additional modification to the proposed 
Sec.  40.67(d). That commenter asked for a language change to have the 
collector inform the employee a direct observation is

[[Page 27616]]

necessary because the specimen did not meet Federal guidelines. We will 
not make that change because we believe it will cause confusion between 
the HHS guidelines and DOT's regulation, part 40. We have finalized the 
changes to Sec.  40.67(c) and (d).
    In the most substantive proposed change to Sec.  40.67, we offered 
an amendment to Sec.  40.67(g) to address situations where a same 
gender observer is not available for the collection of urine specimens. 
We requested and received public comment on whether a licensed or 
certified medical professional legally authorized to take part in a 
medical examination in the jurisdiction where the collection takes 
place should be permitted to be opposite gender observers. We explained 
that we were proposing this option to reduce the circumstances in which 
an observed urine collection might be delayed for lack of a same-gender 
observer.
    We received a significant number of comments on proposed Sec.  
40.67(g). Some commenters thought that it would be a good idea to allow 
certain specified medical professionals to be direct observers 
regardless of gender because a same-gender observer is not always 
present in a collection site, and others mentioned how transgender and 
nonbinary gender individuals pose a challenge for finding a same-gender 
observer.
    The majority of commenters on this subject opposed the proposal. 
The opposing comments included concerns about sexual advances, stress 
to donors, and accusations of assault that would lead to liability for 
medical professional serving as the observer. Some commenters asked 
that we leave the same gender direct observation provision exactly as 
it is in Sec.  40.67.
    While we acknowledge the concerns of the commenters who opposed the 
proposal, we agree with the commenters who wanted to see some changes 
made to accommodate situations where a same-gender observer cannot be 
easily provided and in the less common situations of transgender and 
nonbinary gender individuals who will be subject to a direct 
observation collection. Oral fluid testing offers a completely 
appropriate solution for all of these scenarios because every oral 
fluid collection is a directly observed collection without the need for 
a same gender individual to perform that observation.
    Consequently, we have not added the proposed provision to allow a 
different gender direct observer who is a medical professional. If a 
directly observed urine collection is required, the burden remains on 
the employer to provide the same-gender observer if the collection site 
cannot do so, or to permit an oral fluid test. The responsibility of 
ensuring the collection takes place has always been the employer's 
requirement. If the employer has a standing order that all directly 
observed collections will be conducted as oral fluid, then there is no 
need for the collector to call the DER. Otherwise, the collector will 
use the telephone number listed on the CCF where the DER can be reached 
at any time of the day or night the testing is being conducted. If a 
collector cannot find a same-gender observer, the collector needs to 
let the DER know that one must be immediately provided for the 
collection, unless an oral fluid standing order exists.
    In the case where the employee identifies as transgender or 
nonbinary gender, the burden remains on the actual employer to ensure 
the direct observed collection will take place. We have added Sec.  
40.67(g)(3) to require that when a same gender collector cannot be 
found, unless the employer has a standing order to allow oral fluid 
testing in such situations, the collector must contact the DER and 
either conduct an oral fluid test because the collection site is able 
to do so or send the employee to a collection site acceptable to the 
employer for the oral fluid test. Even if an employer does not usually 
utilize oral fluid testing, that employer should have agreements or 
arrangements either directly, or through its C/TPA, for oral fluid 
testing to be used for directly observed collections of transgender or 
nonbinary employees. In the alternative, the employer could establish 
in-house collections for such situations. We encourage employers to 
arrange for oral fluid testing in advance, in order to plan for such 
contingencies.
    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-to-duty 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 would be used 
only when the collector moves to a directly observed collection and the 
employer did not know about it in advance (e.g., temperature out-of-
range, or signs of tampering). Thus, we have amended Sec.  40.67(e)(2) 
to change a cross-reference to Sec.  40.67(b) to become a cross-
reference to Sec.  40.67(c)(2) through (4). This is because Sec.  
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 Sec.  
40.67(c) takes place. This has nothing to do with Sec.  40.67(b), so 
this cross-reference has been corrected. We also proposed to make a 
technical amendment to Sec.  40.67(c)(1) to strike the reference to 
paragraph (b) because it is an incorrect reference. There were no 
comments opposing any of these edits to Sec.  40.67, so we have adopted 
them, as proposed.

Sec.  40.69 How is a monitored urine collection conducted?

    There were no comments on the proposed new introductory language in 
Sec.  40.69(a) to emphasize a monitored collection will be conducted if 
the collector is using a multi-stall restroom and the collector cannot 
secure all sources of water and other substances that could be used for 
adulteration and substitution (Sec.  40.42(f)(2)(ii)). Also, there were 
no comments about the proposed edits to Sec.  40.69(e) to update cross-
references in part 40 that were renumbered. We have adopted these 
changes as proposed.

Sec.  40.71 How does the collector prepare the urine specimens?

    The final rule makes a minor clarifying change, instructing the 
collector of a urine specimen to check both the boxes for ``urine'' and 
``split specimen'' on the CCF. We received one comment, which requested 
we add the words ``after the collection'' for the purpose of reminding 
the collector to check the boxes under Step 2 after the collection 
takes place. We agree this would be helpful. We have adopted the change 
to Sec.  40.71(b)(1), with this modification.

Sec. Sec.  40.72-40.74--Collection Procedures for Oral Fluid Testing

    These three new sections establish the collection procedures for 
oral fluid testing. They are consistent with the HHS OFMG (84 FR 57554, 
Oct. 25, 2019).
    There were many substantive points discussed in the comments that 
were extremely helpful to the Department. Commenters in the medical 
field, collectors experienced in non-DOT collections, laboratories, 
associations, and others discussed practical tips, potential problems 
and other factors for us to consider. In response to those comments, we 
made the following changes explained below.
    The American College of Occupational Medicine (ACOEM) questioned 
whether oral fluid collectors would be well-enough trained to determine 
whether a donor is ``cheeking'', which they said is ``a practice of 
hiding medication or

[[Page 27617]]

contraband in the mouth between the cheek and gums.'' This association, 
with a membership of very knowledgeable health care professionals, 
warned of ``substitute saliva (complete with the proper amount of 
albumin or immunoglobulin biomarker) which is far easier to conceal and 
maintain at body temp than 30 cc of urine'' and the rise of other 
products to cheat oral fluid testing. They also asked whether 
collectors would ``be trained to carefully examine the entire mouth, 
i.e., using a dental mirror, to assure that the donor has not concealed 
an adulterant or substitute saliva sample in their mouth?'' ACOEM also 
encouraged us to include such instructions in our Oral Fluid Collection 
Guidelines to ``make sure that the proper initial inspection process of 
the oral cavity is included.''
    To ensure proper training can be done, we must first ensure the 
regulatory text is clear and provides the necessary details. 
Consequently, we chose to address the substantive concerns about 
substituting and adulterating tests here, in Sec.  40.72(a), instead of 
the collector training provisions of the regulation.
    We agree with ACOEM about the potential for adulterating, 
substituting, or otherwise interfering with an oral fluid test exists, 
even though all oral fluid tests will be directly observed. The final 
rule requires the employee to open their mouth and allow the collector 
to fully inspect the oral cavity. The collector is required to check 
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. In 
Sec.  40.72(a), we have provided the examples of ``candy, gum, food, or 
tobacco'', which is not an exclusive list because there could be more 
items that are inadvertently present in a donor's mouth. However, we 
also included in Sec.  40.72(a) that the collector needs to be checking 
for anything that could be used to adulterate, substitute, or alter the 
specimen. As this commenter suggested, we will provide further guidance 
on inspecting the oral cavity within our oral fluid collection 
guidelines to remind collectors to conduct oral fluid testing in well-
lit areas and recommend, as a best business practice, the collector 
have a flashlight available for oral cavity inspection.
    In response to the concerns of ACOEM and other commenters, we have 
amended the proposed Sec.  40.72(a)(1) and created a new Sec.  
40.72(a)(2). Specifically, we have added ``If the collector finds 
indication(s) of anything identified above, the collector will ask the 
employee to lift their tongue and/or separate their cheek from their 
gum to permit full inspection.'' Although we do not believe every oral 
cavity inspection will require the employee to lift their tongue and/or 
separate their check from their gum, we want to provide this as an 
option for the collector to utilize within their discretion. We also 
added a sentence to allow the employee to cleanse their hands if they 
need to touch their own mouth to allow further inspection by the 
collector.
    On the specific subject of tobacco, one commenter asked how oral 
fluid testing ``interacts chemically with employees who will use 
tobacco products via dip, smoke or chew prior to testing and of course 
various mouth washes to cover up.'' The HHS looked at this specific 
subject when formulating its OFMG. See 84 FR 57565 (Oct.25, 2019). The 
dark brown juice resulting from some forms of tobacco use can cause 
discoloration that may interfere with initial testing. This is part of 
the reason why there is a wait period prior to collection, so the 
employee can clear their mouth of any material that might stain the 
collected oral fluid.
    In Sec.  40.72(a)(3), the Department continues to emphasize the 
actual employer must make the refusal determination after the 
collection site notes the circumstances in the Remarks section of the 
CCF and reports these to the DER. Determining whether a refusal has 
occurred is a non-delegable duty of the employer per Sec.  40.355(i). 
The collector will provide information to the employer to reach a 
determination about whether a refusal has occurred.
    We asked for public comment about whether the collector or the 
laboratory should check the expiration date on the device used. The 
comments, including laboratories, industry associations, C/TPAs and 
collectors were overwhelmingly in support of having the collector check 
the date and record it, as in the proposed language in Sec.  
40.72(d)(3). Many pointed out the collector could discard an expired 
device and proceed with a new device at the collection site, with no 
impact on the collection. Conversely, if the laboratory were 
responsible for checking the expiration date on the oral fluid 
collection device and the device were expired, then the test would need 
to be cancelled. Consequently, in this final rule, we have required the 
collector to check the expiration date on the device and document it on 
the CCF.
    It is important to note the CCF is a document designed by HHS and 
is not customized to the DOT-regulated drug testing process. HHS allows 
two separate devices to be used to collect a primary and a secondary 
specimen. For the reasons set forth in the Principle Policy section 
regarding the requirements for a single specimen to be collected and 
subdivided in the presence of the donor, the collector will not use two 
separate devices. Consequently, we have added a new Sec.  40.72(d)(5) 
to specify the collector must enter the expiration date of the device 
being used on the CCF line marked in Step 4 of the CCF.
    We chose the option designated as ``Split Specimen Device 
Expiration Date'' instead of the option marked ``Primary/Single 
Specimen Device Expiration Date'' for entry of the DOT-regulated test's 
expiration date because part 40 does not allow the use of a ``primary'' 
collection device, meaning one of two collection devices, nor does it 
allow for a ``single specimen'' collection device because all devices 
must be capable of collecting a primary and split specimen. 
Consequently, to avoid confusion, we require the collector to enter the 
device expiration date only in the second option in Step 4 of the CCF 
because it is entitled, ``Split Specimen Device Expiration Date'' and 
all devices will collect a split and have a single expiration date.
    Some commenters asked whether an expired collection device would be 
a fatal flaw. We had proposed that in Sec.  40.199(b)(8). We have 
adopted that change, as proposed. We have also added a new Sec.  
40.199(b)(9) to create a fatal flaw when the collector fails to note 
the expiration date for the device in Step 4 of the CCF and the 
laboratory confirms that the device was expired.
    A commenter suggested we include a new provision to allow 
corrective action when a collector checked the expiration date on the 
device but forgot to check the box in Step 2 of the CCF to indicate the 
device was not expired. The documentation to prove the collector 
checked the expiration date is the collector's notation in Step 4 of 
the CCF, where the collector will document the expiration date for the 
oral fluid collection device. Consequently, we agree with the spirit of 
the suggestion and have amended Sec.  40.208 to add the situation where 
a collector has entered the collection device expiration and merely 
forgot to check the box in Step 2. We have also added language to 
address when the collector enters the expiration date in the wrong 
spot, as the ``Primary Specimen Expiration Date'', instead of entering 
the date as the ``Split Specimen Device Expiration Date'' in Step 4 of 
the CCF. By adding these points to Sec.  40.208, we have made these 
omissions the basis for creating a memorandum for the record, but the 
absence of this corrective

[[Page 27618]]

documentation will not cause the cancellation of the test.
    Commenters, including laboratories and oral fluid device 
manufactures, supported the provision in Sec.  40.72(b) to have the 
employee rinse with 8 ounces of water, if something was in the mouth. 
Several of these commenters noted a rinse with 8 ounces of water for 
the purpose of clearing the mouth is consistent with current 
instructions and practices in non-DOT testing.
    More than one commenter was hesitant to say consuming water would 
remedy a dry mouth responsible for an insufficient specimen volume. 
Quest Diagnostics said, ``the use of water may, but is unlikely, to 
have a material impact on the amount of oral fluid collected.''
    The commenters were supportive of the 10-minute wait and offered 
comments to enhance the proposal. A4A suggested ``DOT provide a 
mechanism or guidance regarding the performance-based documentation of 
the 10-minute period so that collectors may demonstrate compliance with 
the wait time.'' Since Sec.  40.72 requires the 10-minute wait occur in 
every collection, the Department will not require the collector to 
document this on the CCF. However, the commenter raises a fair point 
about addressing this in guidance. Consequently, in the ODAPC Oral 
Fluid Specimen Collection Guidelines, we will include more suggestions 
for best business practices for a collector to use to demonstrate their 
compliance.
    A commenter asked whether the collector failing to give the 
employee water and wait 10 minutes in a ``dry mouth situation'' would 
be a ``fatal flaw.'' It would not be a fatal flaw because fatal flaws 
are laboratory issues. Similarly, in urine testing, we did not classify 
failure of a collector to make fluids available to an employee during 
the shy bladder process in Sec.  40.193 as a ``fatal flaw'' in Sec.  
40.199.
    Regarding proposed Sec.  40.73, one commenter questioned what we 
meant by referring to conducting collections ``correctly''. We 
recognize there are differences among the various oral fluid collection 
kits on the market today and those that will be developed in the 
future. We expect all oral fluid specimen collectors to follow both the 
part 40 requirements for collections, as well as the manufacturer's 
instructions on how to collect the specimen. Each device will have its 
own instructions, and when we refer to conducting the collection 
``correctly'' in this section, we mean using the oral fluid device in 
the manner described by its manufacturer. The oral fluid collection 
must be done under the observation of the collector. In addition, the 
employee must properly position the device. We have added a new Sec.  
40.73(c)(1) to reflect these requirements.
    We received a comment from Quest Diagnostics regarding Sec.  40.74. 
Specifically, this commenter ``agrees with the requirement for a 
minimum of 1 mL of neat saliva for both the ``A'' and ``B'' (split) 
specimens.'' In addition, after further consultations with HHS, we 
realized we had drafted this provision too narrowly. There may be 
scientifically valid and forensically defensible devices that HHS 
determines do not need a minimum measure of 1 mL of neat saliva. 
Therefore, we have added the following language to Sec.  40.74(b), ``or 
an otherwise sufficient amount of oral fluid to permit an HHS-certified 
laboratory to analyze the specimen(s).'' With this additional language 
added, we have adopted the amended Sec.  40.74.
    As an overall concern, a commenter suggested we refer to the 
individual being tested as the ``donor'' and not the ``employee'' in 
Sec. Sec.  40.72-40.74. To be consistent with the urine collection 
procedures, we will continue to refer to the individual being tested as 
the ``employee.''

Subpart F

    We are reorganizing subpart F (Sec. Sec.  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 Sec.  
40.86 would be changed to read ``Sec.  40.86 What is urine validity 
testing, and are laboratories required to conduct it?'' We have made a 
technical amendment to the second footnote in the newly renumbered 
Sec.  40.86.
    As an outgrowth of the public comments, we have added new fatal 
flaws for the laboratories in Sec.  40.83(c)(8) and (9). We have not 
included a requirement for the laboratories to enter the expiration 
date on the CCF, as the CCF currently indicates and as commenters 
objected to in response to the NPRM. Instead, the laboratory must 
reject a specimen if the collector used an expired device at the time 
of collection or the collector failed to enter the expiration date in 
Step 4 of the CCF, but only if the laboratory confirms the device was 
expired. This mirrors the fatal flaws added to Sec.  40.199(b)(8) and 
(9). Importantly, it is not the Department's expectation that every 
laboratory must check every vial for an expiration date. Instead, the 
laboratory will check the vials only when the collector has not entered 
the expiration date on the CCF or has entered an expired date. In those 
hopefully infrequent instances, by checking the date on the vials and 
ensuring that the expiration date has not passed, the laboratory is 
saving the test and not declaring it a fatal flaw.
    In addition, we asked for comment on decreasing the amount of time 
laboratories would be required to keep non-negative specimens from 1 
year to 90 days, as required by Sec.  40.84 (formerly Sec.  40.99). We 
explained the change was intended to reduce storage burdens on 
laboratories. The proposed change would not have affected the 2-year 
record retention HHS requires for documentation supporting the 
laboratory's analysis of a non-negative specimen and it would not have 
changed a litigation hold placed upon the specimen and the paperwork.
    We received many comments on this proposal, with the vast majority 
of those opposing the change. Several commenters in favor of the change 
said employees challenge the results within 90 days and those 
commenters recognized that the litigation hold would mean that the 
specimen would be retained for what is sometimes years. Others said 
that they appreciated the cost and logistical benefits of having 
laboratories retain the specimens for a shorter time but suggested 180 
days instead of 90 days. Those commenters said the introduction of oral 
fluid collections will pose additional costs on the laboratories for 
housing two different kinds of specimens under different preservation 
methods, so a reduction in time was welcomed.
    Those opposing the change cited many substantive arguments for why 
they thought reducing the time to 90 days would disadvantage employees 
who want to challenge their result. The most persuasive of the opposing 
comments noted how an employee who has a non-negative test result needs 
more time to understand the process and retain counsel who, in turn, 
would formally place a litigation hold upon the specimen.
    We agree with the commenters that 90 days may be too short for the 
specimen retention where there is no litigation hold. Although we did 
not propose 180 days as the hold period, we acknowledge that it is a 
logical outgrowth of the comments. We could adopt that period of time. 
However, it would be more helpful if we had further insight from public 
comment on that specific point. Although multiple

[[Page 27619]]

commenters suggested 180 days would be better, we did not receive any 
rationale for the 180 days. Consequently, we have not made any change 
at this time to the one-year retention period for non-negative test 
result and have withdrawn the proposed language. In a future 
rulemaking, it is possible we may consider posing a 180-day retention 
period instead of a one-year period, but we would want full public 
comment on such a proposal.
    The most notable new portions of subpart F are Sec. Sec.  40.91-
40.93, which cover cutoff concentrations and specimen validity testing 
(SVT) 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).
    One commenter questioned whether HHS had set the correct cutoffs to 
be as sensitive to the presence of the drugs for which we test as the 
urine cutoffs are sensitive. While this commenter acknowledged DOT must 
follow HHS for the science, including the cutoffs for screening and 
confirmation for oral fluid testing, the commenter was concerned about 
whether there could be a lack of equivalence between the urine and oral 
fluid test results and the ultimate fairness of any difference between 
the two methodologies.
    OTETA requires the DOT to follow HHS on the science of drug 
testing, as the commenter noted, and we must defer to HHS for their 
scientific determinations. We consulted with HHS regarding this 
commenter's concerns and were told there were many variable factors 
that impact the ability to detect a person's drug use. Those factors 
include biological differences, route of administration, diet and, for 
urine, hydration status. In addition, whether someone is an occasional 
drug user or a chronic drug user will impact detection, regardless of 
methodology. For example, someone's body mass index (BMI) may impact 
their urine test results for marijuana because THC adheres to fat 
cells. So, someone with a lower BMI may be less likely to test positive 
on a urine test than someone with a higher BMI. We have always accepted 
the impact on drug testing of the various factors mentioned above. 
Similarly, we acknowledge these factors will impact both urine and oral 
fluid testing in the future. Since the DOT-regulated testing program is 
deterrence-based, we acknowledge our focus is on prevention. When an 
employee abstains from using drugs because they know they will be drug 
tested, the true result is a benefit to both the individual and to 
transportation safety. There may be some situations where urine testing 
may not detect the same drug use as oral fluid does, or vice versa. 
However, HHS has set the cutoffs for both methodologies to ensure 
accuracy and fairness. In this approach, HHS and DOT have made the 
decision to forfeit detecting every single possible positive test 
result in favor of ensuring accuracy and fairness to each employee 
tested. Far from a possible ``arbitrary and capricious'' approach 
suggested by the commenter, it is our carefully weighed decision to 
ensure accurate and fair testing.
    Quest Diagnostics submitted a comment in support of the SVT 
provisions of Sec. Sec.  40.92 and 40.93. This commenter agrees with 
allowing SVT, as long as DOT is consistent with HHS requirements and 
``the specific analyte(s) or whether it is performed at all should be 
left to the discretion of the laboratory.''
    In the text of Sec.  40.97, several requirements for laboratories 
are specified to apply only to urine testing, as they have no 
application to oral fluid testing. We restated Sec.  40.97 in its 
entirety, given the number of individual changes made for this purpose. 
We did not receive any comments opposing these editorial changes, which 
were not intended to modify the substance of the provisions in 
question. We have finalized those changes.
    We proposed a new data element in Sec.  40.97(c)(1)(i)(I) to 
require a laboratory to report the collection device expiration date in 
a laboratory results report for the MRO. An industry association and a 
major laboratory opposed the addition of this data element. We disagree 
with the commenters and have included this data element because it 
applies only in the circumstance where a laboratory wants to report 
negative results to an MRO in report format. If the laboratory chooses 
to use Copy 1 of the CCF, the collection device expiration date is 
included on the CCF and no additional data element is needed. If a 
laboratory chooses to issue a report for one or more negative results, 
then the data elements in Sec.  40.97(c)(1) must be included.
    An additional major laboratory wanted the collector and not the 
laboratory to check the expiration date, saying that having the 
laboratory check the expiration date would be another 20,000 hours of 
work for laboratories each year. We agree, as we stated in the preamble 
for Sec.  40.72(d)(3), the collectors and not the laboratories will 
have that responsibility. However, we see two different issues on the 
expiration date, neither of which should generate 20,000 hours of 
laboratory staff time annually. The first issue is who will be 
responsible for checking the expiration date? This will be the 
collector per Sec.  40.72(d)(3). The second issue on the expiration 
date is its importance as a data element, but only if the laboratory 
chooses to generate its own report to the MRO instead of reporting the 
result on Copy 1 of the CCF. An expired device could be the grounds for 
a fatal flaw, but if the laboratory sends a report instead of sending 
the MRO Copy 1 of the CCF, on which the collector has already provided 
the expiration date of the device, the MRO would not know about the 
fatal flaw. Thus, if the laboratory wants to generate a report instead 
of using Copy 1 of the CCF, then the expiration date needs to be 
included to ensure the MRO gets the same data as if Copy 1 of the CCF 
were transmitted by the laboratory. Since the report is optional for 
laboratories, they could choose to revert to Copy 1 of the CCF for 
reporting each negative result to the MROs with no burden at all.
    In Sec.  40.111, we proposed 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. Also, we proposed language in Sec.  40.111 
to state a laboratory withdrawing from National Laboratory 
Certification Program (NLCP) certification is required to file with 
both employers and the DOT an aggregate statistical summary for the 
last semi-annual reporting 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. We received 
one supportive comment regarding these changes and have adopted them as 
proposed.

Subpart G--Medical Review Officers

    With the addition of oral fluid testing, for the most part, MROs 
would continue to do their work as they have done under the current 
regulation. Conferring with laboratories, verifying test results by 
interviewing donors, and the other aspects of the MROs remain the same 
because this final rule adds an additional methodology, but does not 
change the basics of the MRO's role. We asked for public comment on 
whether existing and/or new MROs should receive additional training 
specifically with respect to their role in oral fluid testing and, if 
so, what subjects should such training cover. While we agree it

[[Page 27620]]

is important for MROs to learn about the science of oral fluid drug 
testing, the commenters said this is already covered in MRO training.
    Several very experienced MROs and practices weighed in on this 
subject. One large MRO practice did not want to see additional 
training, but the other commenters did. An active MRO and MRO trainer 
said, ``Yes training is needed, especially in light of detection 
windows, cutoffs and collection processes.'' Corporate Medical Services 
commented, ``MRO training should be enhanced to include Oral Fluid 
Specimen information during initial training and recertification 
training, but that the training should not be required prior to 
reviewing oral specimen for MROs who are currently certified.'' The 
American Association of Medical Review Officers (AAMRO) said they 
already instruct on non-DOT oral fluid testing in their online training 
and their current materials follow the HHS final rule on oral fluid 
testing. They intend to incorporate any requirements of this DOT final 
rule. AAMRO said, ``key areas of concentration will be on managing `shy 
mouth' and understanding the factors that can result between 
conflicting urine and oral fluid confirmed results.'' Vault Health 
Workforce Screening, another MRO practice wants to see oral fluid 
testing addressed in MRO training and certification. This commenter 
also noted ``[t]he MRO is required to subscribe to ODAPC's list serve. 
Through this they are notified of the new regulation once finalized. 
This would provide them the information on the collection and 
laboratory process that additional training prior to their re-
certification should not be needed.'' We appreciate that perspective on 
the usefulness of the ODAPC list serve.
    Additional commenters on this subject included SAPAA and Quest 
Diagnostics, who both said there should be additional training required 
for MROs to include the following, ``differences in laboratory 
procedures (e.g., cut-off levels) between urine and oral fluid testing, 
the differences between the detection of parent drugs vs. metabolites 
where urine and oral fluid differ, differences in windows of detection, 
and any additional requirements for the interpretation and reporting of 
codeine and morphine positive results in oral fluid testing.'' Quest 
Diagnostics urged the Department to require MRO training, echoing the 
SAPAA comment and adding ``While it would not be practical to 
immediately augment the training of all MROs, the recognized 
certification and/or training entities should consider making available 
oral fluid modules to augment the training of currently certified MROs 
without having to wait for the next recertification cycle.''
    We agree with the commenters who said MROs should be trained on the 
various aspects of oral fluid testing. We particularly like the 
approach of suggesting the MRO training organizations offer oral fluid 
modules to augment the training of MROs who are already current on 
their training certification requirements. As Vault Health Workforce 
Screening noted, the MROs will be notified through the ODAPC list 
serve, and mandatory training for MROs is not needed before their next 
certification date.
    We only proposed to modify a few MRO provisions in subpart G. 
Specifically, in Sec.  40.121, we have deleted the word ``urine'' from 
subparagraph (c)(1)(i) because future training for MROs should also 
include familiarization with oral fluid testing. By removing the word 
``urine'' from Sec.  40.121(c)(1)(i), we have opened the section on MRO 
qualification training to include oral fluid matters. We will not 
require MROs to undergo recertification training, but strongly suggest 
MROs seek supplemental information about oral fluid testing by the time 
HHS certifies at least two laboratories to conduct oral fluid testing.
    In Sec.  40.127, concerning MRO reviews of negative results, we 
proposed 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. We 
received only supportive comments on this proposal and have included it 
in this final rule.
    In Sec.  40.129(d), we proposed deleting ``drug test report'' and 
adding the word ``result'' following ``invalid test.'' In Sec.  
40.135(d), we proposed 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 Sec.  40.3. In Sec.  40.139(b), we proposed to add the 
cutoffs for oral fluid laboratory-confirmed 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 Sec.  40.139(c), we proposed to delete a 
reference to ``urine,'' since the provision would apply to all DOT drug 
tests. We received no comments on these changes and have adopted them 
as proposed.
    We proposed a change to the MRO's responsibilities regarding 
contacting the pharmacy to verify the authenticity of a prescription in 
accordance with Sec.  40.141(b). For more than twenty years, MROs have 
been required to 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 proposed to 
allow MRO staff to make these inquiries. This would increase 
efficiency, lower costs, and assist MRO office workflow. No part of the 
MRO's verification interview of the donor would be changed, only the 
subsequent checking with the pharmacy to authenticate the prescription. 
The proposal only addressed the communication between the MRO's staff 
and the pharmacy to ensure that the prescription the donor provided is 
or is not authentic.
    We received several comments in support of this proposal to change 
Sec.  40.141(b). Most of the commenters agreed that this would increase 
efficiency and decrease costs because MRO time would not be spent 
waiting to speak with pharmacists. One MRO practice characterized 
calling the pharmacy as ``an administrative task to `confirm' the 
information that was presented to the MRO during the interview.'' AAMRO 
suggested the MRO provide their staff ``with an outline or script and 
form for documentation. It would also be a good idea for the MRO to 
monitor a number of these calls to assure the staff call is 
appropriate.'' ACOEM was unsure this change would be effective because 
pharmacists are already hesitant to speak with the MROs, who are actual 
physicians. If a pharmacist does not want to speak with the MRO, they 
would be less likely to speak with staff. Instead, this commenter 
wanted the Department to instruct pharmacies that HIPAA does not apply, 
and they must communicate with the MRO.
    We agree with the suggestion that MROs should conduct some 
oversight of their staff by providing instructions on what to say and 
occasionally monitoring some of these staff calls. We have added 
language to Sec.  40.141(b) to set a performance standard for MROs to 
ensure oversight and quality control measures. While HIPAA does not 
apply to MROs, who are functioning in DOT-regulated drug testing, a 
search and seizure process under the Fourth Amendment to the U.S. 
Constitution, pharmacists are functioning under HIPAA because they are 
providing healthcare services, often covered by

[[Page 27621]]

insurance. Thus, we cannot direct pharmacists to comply. However, as 
always, under Sec.  40.137(c), the burden of proof is on the employee 
to establish a legitimate medical explanation. If the pharmacist will 
not speak with the MRO or the MRO staff, then the MRO practice needs to 
let the donor know to authorize the pharmacist to communicate the 
information needed to verify the authenticity of the prescription. If 
the donor does not do this, then the MRO must report the verified non-
negative result because the MRO could not authenticate the 
prescription, thus the donor did not provide a legitimate medical 
explanation that could be authenticated per Sec.  40.137(c). Of course, 
the MRO has the discretion to reopen the verification within 60 days, 
if the employee is able to provide them access to the pharmacy. After 
60 days, the MRO must continue to notify ODAPC before reopening the 
verification.
    We have adopted two clarifying changes to Sec.  40.145 on which we 
received no comments. In Sec.  40.145(g)(3), we have deleted the word 
``urine'' and substituted ``drug,'' since in this context we apply the 
requirement to test in an HHS-certified laboratory to any such test, 
whether urine or oral fluid. In Sec.  40.145(h), have added the word 
``urine'' after ``substituted''.
    In Sec.  40.151(a), we proposed clarifying the language to direct 
MROs not to accept the result of any drug test not collected and tested 
under part 40 procedures. If an employee goes to their own doctor the 
next day and requests a drug test, the MRO must not consider the 
results of that non-DOT test. We also proposed to delete language 
referring to DNA tests since use of those tests is prohibited elsewhere 
in the regulation (see Sec. Sec.  40.153(e) and 40.331(f)). In Sec.  
40.151(b), we proposed to change ``urine'' container to ``collection'' 
container in recognition of the advent of oral fluid testing. In Sec.  
40.151(g), we proposed to delete the reference to ``MDEA'', since it 
was removed in a previous rulemaking (82 FR 52229 (Nov. 13, 2017)), 
after HHS deleted MDEA from the drug testing panel. MDEA is a Schedule 
I drug in the amphetamines class and was previously a required 
confirmatory test analyte before HHS removed it from the HHS Mandatory 
Guidelines.
    In Sec.  40.151(i), we proposed a technical amendment to replace 
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 Sec.  
40.97(e)(2)). Also, it is our understanding that all HHS-certified 
laboratories must have an established limit of detection for creatinine 
of 1mg/dL or less. Thus, when a laboratory reports a creatinine 
concentration level at less than its limit of detection, MROs can be 
assured it falls below the creatinine concentration of 2mg/dL for a 
substituted specimen and an individual cannot physiologically produce 
such a urine specimen.
    We received only one comment regarding our proposed changes to 
Sec.  40.151. SAPAA said it ``appreciates the clarification language as 
it will allow the MRO to point to a clearer explanation in the 
regulations when they receive donor objections.'' With this supportive 
comment and no others, we adopted all proposed changes to Sec.  40.151.
    In Sec.  40.159(a)(1) we proposed to correct the reference to Sec.  
40.96(c) to become Sec.  40.96(b) and we proposed adding a new sentence 
to Sec.  40.159(a)(5)(ii), which would require re-collection when an 
invalid test is cancelled. The added sentence would direct that an 
alternate 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.
    We received a comment from a C/TPA and MRO practice regarding Sec.  
40.159(a)(5)(ii), in which they said, ``We agree with the concept of 
changing specimen methodology if possible, but feel that it is the 
employer's decision to do so.'' An industry association specifically 
supported the new sentence in Sec.  40.159(a)(5)(ii), ``which would 
require recollection when an invalid test is canceled. However, 
clarification that the proposed addition applies only to results 
canceled without a valid medical explanation or where a negative result 
is required is needed.'' Since Sec.  40.159(a)(5) already makes this 
clarification, no further rule language is needed and we have adopted 
it as proposed.
    In Sec.  40.163(c)(2), we proposed a small change, substituting 
``employee'' for ``donor.'' In Sec.  40.163(e), we also proposed 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 
non-negatives) or MRO staff must stamp and date it (for negatives 
only).
    A C/TPA and MRO practice specifically agreed with the changes to 
Sec.  40.163(e) saying, ``We agree with stressing that the MRO needs to 
sign and date the CCF copy 2 for non-negative results. The MRO staff 
may stamp negative test results. All tests must have signed/stamped MRO 
copy.''
    We have adopted the changes to Sec.  40.163 as proposed.

Subpart H, Split Specimen Tests

    We proposed a change to Sec.  40.177 to add a reference to the 
sections pertaining to oral fluid testing. In Sec.  40.179, we proposed 
to change referenced section numbers in accordance with renumbering and 
new oral fluid provisions elsewhere in the regulations. In Sec.  
40.181, we proposed changing referenced section numbers in accordance 
with renumbering and new oral fluid provisions elsewhere in the 
regulations. Another change to Sec.  40.181 is to refer only to urine 
testing, since the creatinine and specific gravity apply only to urine 
testing. In Sec.  40.187, we proposed to change references to Appendix 
D to Appendix F in accordance with the redesignations. We received no 
substantive comments regarding these changes and have adopted them, as 
proposed.

Sec.  40.191 What is a refusal to take a DOT drug test, and what are 
the consequences?

Sec.  40.261 What is a refusal to take an alcohol test, and what are 
the consequences?

    The Department proposed edits to Sec.  40.191(a) to add what can 
constitute a refusal in an oral fluid collection to part 40's existing 
refusals provisions. The revisions included 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 and alcohol collection processes, the 
oral fluid pre-employment 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 Sec.  
40.191(a)(1) and (2). However, as in urine testing, certain blatant 
conduct by the employee at the collection site could constitute a 
refusal before the collection device is chosen under Sec.  
40.191(a)(8). For example, if an employee arriving for a pre-employment 
test engages in

[[Page 27622]]

disruptive or combative conduct at the collection site, a collector 
could report a refusal event to the employer for determination under 
Sec.  40.191(a)(8). Also, if the employee shows they are possessing or 
wearing a prosthetic or other device that could be used to interfere 
with the collection process, and this becomes evident before the 
specimen container is unwrapped, a collector could report a refusal 
event to the employer for determination under Sec.  40.191(a)(10).
    Importantly, 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 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.
    In addition, we would like to remind employers that, under the 
existing Sec.  40.23(g), if they receive a cancelled test result on a 
pre-employment test, the employer must direct the employee to provide 
another specimen immediately. This second specimen collection is a 
continuation of the original pre-employment test. This means, as we 
said in our 2001 final rule on refusals, ``once the collection has 
commenced, the donor has committed to the process and must complete 
it.'' 66 FR 41948 (Aug. 9, 2001). As such, the employee must take the 
second pre-employment test and does not have the ability to decide not 
to continue this pre-employment testing requirement. In our 2003 final 
rule on the Drug and Alcohol Management Information System (MIS), we 
referred to the second test as ``the subsequent collection'' and we 
reminded employers to report only one pre-employment test result (68 FR 
43950, Jul. 25, 2003). Accordingly, the employer would count the second 
test result as the result of record for this pre-employment test on the 
DOT's MIS form.
    We have revised drug testing refusals Sec.  40.191(d) and added a 
new Sec.  40.261(c)(1) to alcohol testing refusals to clarify an often-
misunderstood point about who has the authority to determine if conduct 
at the collection site constitutes a refusal to test. Employers often 
automatically treat as a refusal any situation in which the collection 
site notes a refusal in the remarks section of the CCF. This is not 
correct. The new Sec.  40.191(d) emphasizes the role of the collector 
in a refusal is to notify the employer about the circumstances the 
collector believes constitute a refusal, but the employer must decide 
whether a refusal occurred. The new Sec.  40.261(c)(1) specifically 
spells out the respective responsibilities of the alcohol testing 
service agent(s) in reporting and the DER in making decisions about 
whether a situation during an alcohol test constitutes a refusal to 
test.
    Under the long-existing Sec.  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 and never 
have been authorized to make this decision. The service agent's role is 
to provide information to the employer concerning the circumstances of 
the event. Then the employer, who must make the ultimate decision 
should, as a matter of responsible decision-making, contact the 
collector or BAT to gather information and consider anything the 
employee brings to the employer's attention. Taking the entirety of the 
circumstances into account, the employer should then make the decision 
about whether a refusal occurred. The employer also has the discretion 
to consider information from the employee to determine if the evidence 
satisfactorily excuses the employee's conduct. For FMCSA-regulated 
owner-operators, C/TPAs stand in the shoes of those employers for the 
purposes of determining whether the individual refused a test (Sec.  
382.705(b)(6)).
    In this final rule, we emphasize the already existing employer's 
role in making determinations about collection site and other non-MRO-
determined refusals (e.g., failure to appear for a test, failure to 
take an additional test, etc.). We think it bears repeating that 
refusals are violations that cannot be overturned in a decision about 
personnel actions. An arbitration, grievance, State court or other non-
Federal forum cannot overturn the employer's determination of a refusal 
on a DOT-regulated test. When a case proceeds to one of those forums, 
it is because the employee wants an adverse personnel action reversed. 
None of those forums has jurisdiction over DOT-regulated Federal drug 
or alcohol testing, the determination of a refusal under part 40, or 
the regulatory consequences that exist to ensure transportation safety 
is served. In the part 40 final rule from December 2000, (65 FR 79470-
71), we said, as has been true from the beginning, all the Department 
requires is that an employee who violates the rule not perform safety-
sensitive functions until and unless he or she successfully completes 
the return-to-duty process. Decisions about discipline and termination 
are left to the discretion of the employer or labor-management 
negotiations. Where employer policy, or labor-management negotiations, 
have delegated personnel decisions of this kind to an arbitrator, the 
Department intends that the arbitrator's decision determines the 
personnel action that the employer takes. The Supreme Court has 
affirmed these principles. Eastern Associated Coal Corporation v. 
United Mine Workers of America, District 17, et al., 531 U.S. 57 
(2000). Of course, an arbitrator cannot order an employer to return an 
employee to the performance of safety-sensitive functions until the 
employee has successfully completed the return-to duty process. Nor can 
an arbitrator or an employer change the laboratory's findings about a 
specimen or an MRO's decision about whether there is a legitimate 
medical explanation for a test result.
    Therefore, we have added a second sentence to Sec. Sec.  40.191(c) 
and 40.261(b), to remind the employee and employer that the 
consequences specified under DOT agency regulations for a violation 
cannot be overturned or set aside by an arbitration, grievance or State 
court tasked with adjudicating the personnel decisions the employer 
decides to take against the employee. As we said in the December 2000 
preamble, the employee must successfully complete the federally 
required return-to-duty process regardless of what the decision is on 
the personnel action. This ensures safety is not compromised. 
Importantly, a refusal is a willful violation of the Department's drug 
and alcohol safety regulations and is completely separate and apart 
from employment decisions the employer makes.
    Some commenters asked for examples of what would not be grounds for 
an employer to determine a refusal. Of course, the universe of examples 
is too vast to capture. However, here are a few examples that are not 
meant to be exhaustive, they are only a tiny fraction of what is 
possible. Example 1: An employee provides an insufficient quantity of 
urine, begins the ``shy bladder'' process, but the process is cut short 
because the collection site sent the employee away because they were 
closing before the employee had three hours to produce a sufficient 
urine specimen per Sec.  40.193(b)(2). If the collection site 
nevertheless reports this to the employer as a refusal, the employer 
could determine there was no possibility the employee could have 
completed the test, and therefore could conclude there was no refusal. 
Example

[[Page 27623]]

2: When an employee leaves a collection site due to a documented family 
medical emergency, the employer could determine the employee's 
departure from the collection site did not constitute a refusal. 
Example 3: If an employer sends an employee to report for a DOT-
regulated test, but the collection site is closed or is about to close 
and sends the employee away, the employer would take this into 
consideration in determining that a refusal did not occur. Example 4: 
If an employer requests an applicant take a pre-employment test, and 
the employee does not show for the test, this is not a refusal under 
part 40 and the employer would appropriately not consider this to be a 
refusal to test. In all of the examples above, an employer would not 
report a ``refusal'' in response to a records request made by a 
prospective employer under Sec.  40.25. Similarly, an FMCSA-regulated 
employer would not report a ``refusal'' to the Clearinghouse.
    If the employer determines that a refusal did not occur, the 
employer would treat the test as an administratively closed non-event. 
The employer would not ``cancel'' the test and would not enter it on 
the MIS report required by DOT. For random, post-accident and 
reasonable cause/suspicion tests administratively closed as a non-event 
by the employer, no further action is required, and the employee would 
not be sent back in for another test. For those testing events that 
require a ``negative'' test result (e.g., return-to-duty, follow-up, 
pre-employment), the employer would send the employee back for another 
collection. In all cases, the employer should document the event and 
the evidence relied upon to explain why the employer concluded a 
refusal did not occur.
    The Aircraft Owners and Pilots Association (AOPA) said it 
``supports the change to Sec.  40.191 that clarifies the employer does 
not need to automatically treat as a refusal any situation in which the 
collection site notes a refusal in the remarks section.'' AOPA also 
asked for clarification in the regulation to indicate ``what the 
testing center must explain to an individual.''
    For decades, it has been a requirement of Federal law, per 
Sec. Sec.  40.191(a)(2) and 40.261(a)(2), for an employee to ``remain 
at the testing site until the testing process is complete.'' With this 
explicit statement of the requirement to remain at the testing site, we 
have never put additional requirements on the collector to explain to 
the employee what the employee's legal requirements are. ODAPC has 
provided guidance stating the following: ``There is no requirement for 
a collector to inform an employee that the failure to remain at the 
collection site is a refusal. Therefore, if the collector does not 
inform an employee that failure to remain at the collection site is a 
refusal, it does not mean that the collector has given the employee 
permission to leave the collection site. If an employee leaves prior to 
the completion of the testing process, the employer must decide whether 
the employee's actions constitute a refusal.'' https://www.transportation.gov/sites/dot.gov/files/docs/resources/partners/drug-and-alcohol-testing/323471/july-2014-part-40-questions-and-answers.pdf. In response to AOPA's comment for clarification, we have 
added the following to Sec.  40.191(a)(2) and (3), ``The collector is 
not required to inform an employee that the failure to remain at the 
collection site is a refusal. If an employee leaves prior to the 
completion of the testing process, per Sec.  40.355(i) the employer 
must decide whether the employee's actions constitute a refusal.'' For 
consistency and as a logical outgrowth of the comment, we have also 
amended Sec.  40.261(a)(2) and (3) to add the same language.
    Two commenters asked for specificity about Sec.  40.191(a)(2) 
because it deems one ground for determining a refusal is an employee's 
failure to remain at a ``testing site'' until the process is complete. 
One commenter noted part 40 does not state ``what constitutes a 
`testing site' for this purpose. Is it the waiting room? Is it the 
building? Is it the building and grounds?'' Another commenter asked for 
more explanation from the Department about whether it would be a 
refusal for an employee to step out of a waiting room or to leave a 
building during a collection.
    Since part 40 covers the regulated industries of aviation, motor 
carriers, transit, railroads, pipelines and is applied to the maritime 
industry, it would be nearly impossible to define what a ``testing 
site'' is for every industry and in every circumstance. It could be the 
clinic in a major airline's hub, the area around a portable toilet in 
an oil field, an occupational health clinic offering drug tests, or 
somewhat of an improvised collection site near the scene of an 
accident. In recognition of the differences among and between these 
transportation industry employers and the testing sites they and their 
contractors use, we will continue to defer to the respective employers 
to make the determination about what is reasonable to construe as the 
``testing site'' in a particular circumstance, as they determine 
whether or not their employee's behavior constituted a failure to 
remain at that testing site.
    One commenter opposed the changes to Sec. Sec.  40.191(d)(1) and 
40.261(c), saying collectors should be the ones to determine whether or 
not a collection site refusal has occurred. This commenter said most 
employers ``do not know what to do when the collector informs them that 
there was an attempt to tamper during the collection. The only witness 
to the tampering is often only the collector.'' Conversely, another 
commenter who is a seasoned collector and collector trainer said, 
``Thank you for clarifying that collectors do not have the authority to 
make these. I appreciate the two very common and distressing examples 
(collection site closing, family emergency for employee) and the 
clarification that employers have discretion in these cases.''
    Several commenters were pleased with the additional clarity we 
proposed to add to Sec. Sec.  40.191(d)(1) and 40.261(c) to remind 
employers that making collection site refusal decisions continues to be 
their ``non-delegable'' duty. Quest Diagnostics, which includes 
multiple HHS-certified laboratories and more than a thousand collection 
sites in the United States, said it ``appreciates the clarification 
that it is only the employer who can make the determination that a 
donor refused to take a DOT drug test. While a collector can inform the 
donor that an employer may view the donor's action as a refusal to 
test, that decision rests with the employer.''
    One commenter noted the importance of the employer making ``the 
determination regarding a test refusal after seeking comments from the 
collectors involved in the process.'' Other supportive commenters 
requested we go further and not say ``the collector could report a 
refusal to the employer for determination . . .'' A collector training 
company said this language ``implies that the collector has the ability 
to make the determination. They suggest better language would be: 
``note the actions that may constitute a refusal on the Remarks line . 
. .' [and they want] ``more directive language'' for employers who must 
make refusal determinations. Several commenters asked us to amend this 
proposed rule text ``to be clear the collector will `notify' an 
employer of the employee's actions'', so the employer will make the 
determination of whether or not a refusal has occurred. One commenter 
asked for more directive language for employers who must make refusal 
determinations.
    In response to the comments, we have amended Sec. Sec.  
40.191(d)(1) and 40.261(c)

[[Page 27624]]

to include the language some requested to more clearly indicate that 
collectors do not determine refusals. Both sections now state, ``As the 
collector, you must note the actions that may constitute a refusal in 
the `Remarks' line (Step 2), and sign and date the . . . [CCF for drug 
testing or ATF for alcohol testing].'' We think we have been 
sufficiently directive to employers in adding the following to 
Sec. Sec.  40.191(d)(1) and 40.261(c)(2): ``the employer has the sole 
responsibility to decide whether a refusal occurred.''
    More than one commenter asked for guidance on how a collection site 
should handle an employee who is sent back to the collection site after 
the employer determines that a refusal did not occur. Because every 
collector is different and every employee is different, this would be 
difficult for the Department to include in guidance. What collection 
site(s) an employer uses would be up to the employer. If another 
collection site is available for the subsequent collection, the 
employer might want to choose this collection site for the second 
collection.
    Another commenter asked for advice about ``What actions by the 
donor prior to selecting the collection device constitutes a refusal in 
a Pre-employment setting? Which do not?'' The preamble to the final 
rule establishing exceptions for refusal determinations when a donor 
leaves a collection site in pre-employment tests merits reiterating. It 
stated that i]n the pre-employment test context, there can be 
situations in which an employee could legitimately leave a collection 
site before the test actually commences (e.g., there is a long wait for 
the test and the employee has another obligation). By the commencement 
of the test, we mean the actions listed in Sec.  40.63(c), in which the 
collector or employee selects a collection container. Once the 
collection has commenced, the donor has committed to the process, and 
must complete it. If the employee then leaves before the process is 
complete, or takes another action listed in this section as a refusal, 
the consequences of a refusal attach. However, if the employee leaves 
the site before the test commences, then the employee is in the same 
situation as someone who does not appear at all for the pre-employment 
test. The consequences of a refusal do not attach in this situation 
(Sec.  40.191(a)(2) and (3)). 68 FR 41948 (Aug. 9, 2001).
    However, in a pre-employment situation there could be a refusal to 
test prior to selecting a collection container. In Sec.  40.191(a)(8) 
and (10), there are no exceptions for pre-employment tests. These 
sections address conduct at the collection site that is disruptive or 
that involves bringing in substituting or adulterating products. 
Consequently, there could be refusals reported to an employer for a 
pre-employment applicant. Here are some specific examples, although not 
an exhaustive list: refusing to empty one's pockets; refusing to wash 
one's hands; acting disruptively at the collection site; threatening or 
attempting to bribe collection site personnel; bringing to a collection 
site a bag of urine or any device that could be used to substitute or 
adulterate a urine specimen.

Sec.  40.193 What happens when an employee does not provide a 
sufficient amount of specimen for a drug test?

    We proposed the addition of oral fluid testing to paragraph (a), 
adding insufficient specimen provisions for oral fluid testing, 
parallel to the existing insufficient urine specimen procedures. Due to 
the differences between the two types of specimen collections, the oral 
fluid insufficient specimen collection procedure is shorter in duration 
than the insufficient urine specimen collection procedure (e.g., in an 
oral fluid collection, there is no need for a three-hour wait period). 
In paragraph (e), we proposed adding 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). Although one commenter opposed listing any 
examples of conditions that could be legitimate medical explanations 
because MROs should be able to ascertain legitimate conditions, we have 
kept the examples as proposed. In addition, another commenter said MROs 
are not qualified to assess the legitimacy of shy bladders or dry 
mouth, but we disagree and will continue to have MROs, who are fully 
qualified physicians, assess the legitimacy of the conditions 
underlying an individual's inability to provide a sufficient specimen 
under any approved testing methodology.
    With an alternate specimen methodology now available, an employer 
may authorize a collector to use a different type of specimen 
collection process in an insufficient quantity case. If a urine 
specimen is insufficient, the collector could follow up with an oral 
fluid collection, or vice-versa. In a case involving an insufficient 
urine specimen, following the insufficient urine specimen procedures 
would become unnecessary since an oral fluid collection would be 
performed. We asked for public comment on these changes and 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 
Sec. Sec.  40.72(b) and 40.193(b)(2). We also asked for comment about 
the questions of who would decide what methodology to use after an 
insufficient specimen occurs, and when and how such a decision would be 
made. Since so many oral fluid tests occur each year in non-DOT 
testing, we were eager to learn from those with experience on what we 
should know.
    We received robust public comment on the above-mentioned subjects 
and have discussed these in detail in the Principle Policy section of 
this final rule. As explained in the Principle Policy section, the 
Department will not mandate the use of the same or the alternate 
testing methodology for an insufficient urine specimen (``shy 
bladder'') or an insufficient oral fluid specimen (``dry mouth''). 
While not required, it would be prudent for an employer to offer more 
than one methodology to address such scenarios.
    The Department agrees there are several advantages to switching 
from a urine collection to an oral fluid collection when an employee 
has presented an insufficient specimen. For example, once an employee 
provides an insufficient urine specimen, they would have up to three 
hours to provide a sufficient specimen (during which time the employee 
should be monitored). If at the end of the three-hour period, the 
employee still did not provide a sufficient specimen, the employee is 
required to prove (via a medical evaluation by a referral physician) 
they have a medical condition to explain their inability to provide a 
sufficient specimen.
    We also acknowledge the commenters' concerns that shy bladder 
situations merit attention, as we have articulated in our discussion of 
Sec.  40.193 below. Employers have legal obligations separate and apart 
from part 40 for providing reasonable accommodations for employees with 
disabilities. If an individual has a condition rendering that person 
unable to produce urine falling within the parameters of a disability, 
this should not be considered to be an effort to evade a test.
    Whether the reason for failing to provide a sufficient specimen is 
substantiated by a medical condition or not, there is a cost (e.g., 
lost work) to the employer for having the employee wait for up to three 
hours. Similarly, there is a cost for the medical evaluation which, in 
most instances, is at the employee's expense. The availability of oral 
fluid

[[Page 27625]]

drug testing means the costs associated with the three-hour wait and 
the medical evaluation could be avoided while still affording the 
employee the opportunity to provide a specimen.
    Some commenters opposed allowing an insufficient urine collection 
to go to an oral fluid collection. These commenters were concerned 
employees who had used drugs several days before the test would 
withhold their urine in the hopes of having an oral fluid with a 
shorter window of detection. Some commenters wanted the decision of 
whether to proceed with another urine collection or to change to an 
oral fluid collection left to the discretion of the collector after the 
initial insufficient urine specimen. Since the collector could assess 
the facts at the collection site, the collector would be the better 
judge of the best method of testing to deploy.
    The majority of the commenters supported the option of changing to 
a different collection methodology if the employee demonstrates (at the 
onset) that she or he cannot provide a sufficient specimen. For the 
reasons outlined above, the Department agrees with those commenters in 
theory, but we have not mandated that change in drug testing 
methodologies.
    For employers including oral fluid drug testing in their DOT-
regulated drug testing program, the Department will allow the employer 
to switch to an oral fluid collection when an employee does not provide 
a sufficient urine specimen on their first attempt. Similarly, the 
Department will allow the employer to switch to a urine collection when 
an employee does not provide a sufficient oral fluid specimen on their 
first attempt. Under Sec.  40.193, the employer has this option and the 
employer should communicate this option to the collector or the 
collection site in advance of any collection. The employer will need to 
ensure the collector is a qualified urine and/or oral fluid collector.
    In either scenario when there is a successful collection under 
Sec.  40.193, there is no requirement for the employer to send the 
employee for an evaluation of the first insufficient specimen type. In 
the rare circumstance when the employee is not able to provide a 
sufficient oral fluid specimen after the insufficient urine specimen or 
vice a versa, the employee would be required to only have an evaluation 
for the collection of the specimen type attempted under Sec.  40.193. 
To be clear, the employer must send the employee for only a dry mouth 
medical evaluation if the employee has not provided a sufficient oral 
fluid specimen following an insufficient urine specimen. The MRO will 
only proceed with the dry mouth evaluation and not proceed with the shy 
bladder evaluation. Similarly, the employer must not send the employee 
for a dry mouth evaluation if the employee has not provided a 
sufficient urine specimen following an insufficient oral fluid 
specimen. The MRO will only proceed with the shy bladder evaluation and 
not proceed with the dry mouth evaluation. Only a shy bladder medical 
evaluation is to be done at that point. The final rule reflects this 
requirement.
    Employers should strongly consider having oral fluid as an 
alternate methodology available for employees who need a reasonable 
accommodation because of a physiological or pre-existing psychological 
condition that renders the employee unable to provide a urine specimen. 
Similarly, if an employee needs a reasonable accommodation for dry 
mouth, it is advisable for the employer to have urine testing 
available.
    In situations where the employee provides a suspect urine specimen 
(e.g., temperature out of range, excess foaming, etc.), which leads to 
a successful oral fluid specimen collection, or vice versa, the 
collector would send both specimens to the respective laboratories for 
testing. In this scenario, the MRO would report the multiple verified 
results from one testing event in accordance with Sec.  40.162. For 
example, if there were two negative results, a single negative result 
would be reported to the employer; if there were a negative and a 
verified non-negative result, only the verified non-negative result 
would be reported.
    In addition, we asked for public comment as to whether the 
collector should use the same CCF when switching collection 
methodologies from urine to oral fluid or vise-a-versa. Some commenters 
thought this would be more efficient. Others thought it was too 
confusing to list a urine collection on the same form as an oral fluid 
collection is listed, even if there is an explanation in the ``Remark'' 
space on the CCF.
    We agree with the commenters who said documenting the insufficient 
first specimen on the same CCF used for the second collection with a 
different methodology is likely to cause confusion. The laboratory for 
the urine collection might not be the same laboratory listed on the CCF 
for the subsequent oral fluid collection. If the specimen from the 
second collection is sent to the wrong laboratory, it will add 
confusion and delay, as the specimen will need to be rerouted to the 
correct laboratory. Not all HHS-certified laboratories for urine 
collections will be HHS-certified for oral fluid collections, and vice-
versa.
    For example, the CCF is designed for the collector to complete and 
document either an oral fluid or a urine collection process (e.g., Step 
2 identifies the specimen type, the specimen labels can be used for 
either type of specimen container). The CCF from a urine-only testing 
laboratory contains account and billing information only for the 
employer's urine drug testing account. The CCF from an oral fluid-only 
drug testing laboratory will contain account and billing information 
for the employer's oral fluid drug testing account. The CCF from a 
laboratory that conducts both urine and oral fluid drug testing would 
contain account and billing information for the employer's urine and 
oral fluid drug testing accounts. The collector will use a new CCF when 
switching collection processes. The rule text will reflect the need for 
the collector to ensure a correct CCF is used. The rule text will also 
reflect the requirement to document, in the ``Remarks'' section of the 
CCF, the reason for the changed collection process. It will not be a 
fatal flaw or correctable flaw if the collector does not make notes in 
the ``Remarks'' section.
Oral Fluid Insufficient Specimen (``Dry Mouth'') Specifics
    Since oral fluid testing and ``dry mouth'' for insufficient oral 
fluid specimens are new concepts for DOT-regulated testing, the 
commenters asked many relevant questions. We appreciate the time people 
took to call out the details because their thoughts and concerns have 
made this a better final rule.
    Some commenters asked exactly how ``dry mouth'' will be determined. 
The commenters also wanted to know how many attempts and/or how much 
time would a donor be given before the collector would end the 
collection and send it on to the DER to provide the contact information 
for an evaluation by a referral physician.
    In Sec.  40.48(c)(1), we use the term ``dry mouth'' to indicate an 
insufficient oral fluid specimen. 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. An 
employee may tell a collector they think their mouth is dry before the 
collection begins. If the employee states their mouth is dry, then 
Sec.  40.72(b)(1) requires the collector to give the employee up to 8 
ounces of water to rinse their mouth. The employee may drink the water. 
The collector must then wait 10 minutes

[[Page 27626]]

before beginning the specimen collection. Incidentally, the commenters 
who responded to our question whether 10 minutes was an appropriate 
waiting time responded unanimously in support of this amount of time. 
Apparently, it is the industry standard.
    It is a dry mouth scenario if the oral fluid device indicates the 
employee has not provided a sufficient specimen. If dry mouth occurs 
after the initial collection is attempted, this will begin a one-hour 
period to allow a sufficient specimen. Also, this necessitates a second 
oral fluid collection within one hour, or the employer could have a 
standing order to require the collector to move on to an alternate 
methodology (i.e., urine) to complete the collection process for the 
testing event.
    Some commenters asked how many attempts at providing an oral fluid 
specimen should be made before a finding of dry mouth is determined and 
a referral physician is needed. We were asked to consider conducting 
research concerning dry mouth. Some commenters wondered if we would 
require a specific period of time for attempts for an oral fluid 
collection. In addition, we were asked to describe or define what we 
meant in Sec.  40.193(b)(2)(i) by requiring that the employee ``remain 
at the collection site, in a monitored area designated by the 
collector, during the wait period.''
    We proposed procedures to go into effect 15 minutes after an 
employee fails to produce a sufficient specimen and the procedures 
would continue for one hour. We have adopted this proposal in Sec.  
40.193(b)(2)(i). If an employer has provided for an alternate 
methodology to be used in oral fluid insufficient specimen situations, 
then the collector would move on to the alternate methodology, which is 
currently urine. If the employer does not have this option, then the 
collector would follow the steps set forth in Sec.  40.193(b)(2)(i) 
when the employee demonstrates an inability to provide a specimen after 
15 minutes of using the collection device. As in urine testing, the 
time clock begins after the 15 minutes and when the employee attempts 
but is unable to provide a sufficient quantity of specimen. If the 
employee states they could provide a specimen after drinking some 
fluids, the collector must 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). The employee is not required to drink during the hour and their 
choice not to drink is not a refusal. The collector must provide a full 
hour for the employee to attempt another oral fluid collection. If the 
employee still cannot provide a sufficient specimen, then the collector 
must note this in the ``Remarks'' line in Step 2 of the CCF, and 
immediately contact the DER to begin the referral physician process for 
the dry mouth medical evaluation.
    We will not be conducting our own studies on dry mouth but will 
continue to follow HHS for the science of oral fluid testing, as 
required by OTETA. In addition, a referral physician would evaluate the 
employee to obtain and provide to the MRO information about whether a 
``medical condition has, or with a high degree of probability could 
have, precluded the employee from providing a sufficient amount of 
specimen'', per Sec.  40.193(d)(1). We rely on the referral physician 
and the MRO to remain versed in the current medical studies to make 
these important determinations, as they have done for more than 30 
years in shy bladder urine testing cases.
    To ``monitor'' an employee during a wait period in an oral fluid 
collection, we mean the employee must be supervised or observed for 
security and integrity of the collection process. This ensures they 
cannot take any actions to interfere with the integrity of the specimen 
they are required to provide. It does not need to be the actual 
collector who monitors the employee during the wait period. In fact, in 
Sec.  40.48(c)(1), we say that the collector can conduct a collection 
for another employee during this wait period.

Sec.  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?

    The only change we proposed in Sec.  40.195 was in the title, where 
the more general ``specimen'' is substituted for ``urine,'' in view of 
the addition of oral fluid testing to the program. However, there were 
several commenters who wanted an oral fluid test conducted whenever 
there is a permanent or long-term medical situation.
    Section 40.195 is the mechanism for an MRO to rule out the drug use 
of an employee who has been found under the clinical evaluation in 
Sec.  40.193 to have permanent or long-term medical condition that 
renders that employee otherwise unable to produce a sufficient amount 
of urine required to yield a negative drug test result. A negative drug 
test result is required for a pre-employment, return-to-duty, or 
follow-up test. Historically, Sec.  40.195 has not applied to random, 
post-accident, reasonable cause, or reasonable suspicion tests.
    We anticipate most employers will embrace oral fluid testing for 
employees they know have permanent or long-term medical conditions that 
affect one's ability to urinate. However, we have not mandated that 
employers use oral fluid testing for employees with such medical 
conditions. It would be prudent for an employer to consider various 
cost factors for an oral fluid test versus a urine test in a shy 
bladder scenario. In addition, if an alternate methodology is not used, 
then when a negative drug test result is needed, there is the cost of 
having yet another evaluation for clinical evidence of drug use so that 
the MRO can determine whether a ``negative'' result can be issued under 
Sec.  40.195. While an employer may not want to use two different 
testing methodologies on a regular basis, the situations of an 
inability to provide a sufficient specimen for either a urine test or 
an oral fluid test are excellent reasons for an employer to have a 
second methodology in place to plan for such contingencies.
    One commenter acknowledged Sec.  40.195 ``has long provided relief 
to employees with permanent or long-term medical conditions preventing 
the provision of a sufficient urine specimen in the cases of pre-
employment, follow-up, or return-to-duty tests, in which a negative 
test is required.'' This commenter urged the Department to go further 
to allow an employee to bypass a urine specimen collection by producing 
documentation of their ``long-term medical conditions preventing giving 
a complete specimen [regardless of test type].''
    While the Department agrees with the spirit of this commenter's 
point, we do not agree with allowing an employee to produce 
documentation to avoid a urine specimen collection. Individuals who are 
unable to produce a sufficient urine specimen, regardless of whether 
their condition is short-term or long-term, have the potential to 
undergo an oral fluid specimen collection instead of a urine 
collection, as long as their employer allows oral fluid testing. 
Prudent employers should take this into consideration when determining 
what testing methodologies to allow.

Sec.  40.197 What happens when an employer receives a report of a 
dilute urine specimen?

    The only textual change in Sec.  40.197 in the proposed rule is in 
the title, where the word ``urine'' would be inserted because this 
section concerns situations

[[Page 27627]]

that arise only in urine testing. We received no comments regarding 
this change and have adopted it as proposed.

Sec.  40.199 What problems always cause a drug test to be cancelled?

    We proposed to add a new fatal flaw for use of an expired oral 
fluid collection device, in Sec.  40.199(b)(8). In Sec.  40.199 (b)(7) 
of, we proposed to replace the term ``urine'' with ``specimen,'' to 
reflect the addition of oral fluid testing to the program.
    OraSure, a long-established oral fluid device manufacturer, agreed 
that the use of an expired device should be a fatal flaw. Quest 
Diagnostics also agreed with the addition of the new fatal flaw and 
said ``the use of an expired device (at the time of collection) should 
be considered a fatal flaw and collector error.''
    We have adopted the proposed changes to Sec.  40.199 without 
further change.

Sec.  40.201 What problems always cause a drug test to be cancelled and 
may result in a requirement for another collection?

    In Sec. Sec.  40.199(b)(7) and 40.201(f), we proposed to replace 
the term ``urine'' with ``specimen,'' reflecting the addition of oral 
fluid testing to the program. We received no comments on this proposal 
and have finalized it as proposed.

Sec.  40.210 What kinds of drug tests are permitted under the 
regulations?

    The proposal acknowledged that oral fluid and/or urine specimens 
can be collected, and must be tested at HHS-certified laboratories. No 
other specimen methodologies are currently permitted. Furthermore, we 
proposed an employer can use one or the other, but not both urine and 
oral fluid methodologies at the beginning of the testing event. We 
offered an example ``if an employee is sent for a test, either a urine 
or oral fluid specimen can be collected, but not both simultaneously.''
    ALPA agrees ``with DOT's proposal to require an employer to use one 
or the other methodology at the beginning of a testing event--but not 
both simultaneously.'' A consortium and MRO practice also supported 
``using one method of testing at the beginning of the testing event, 
not both simultaneously.''
    In Sec.  40.210, we also discussed what to do if a problem arises 
that would require a second collection. Such problems would include 
when the employee provides a specimen that is an insufficient quantity 
of urine, has a temperature out of range, or is an insufficient oral 
fluid quantity. We asked for comment on whether the employer and/or its 
service agent would be the correct one(s) to make the decision as to 
which methodology to use in the second collection.
    One commenter suggested using urine first in all collections and to 
use oral fluid testing if a second collection is needed. Another 
commenter said it would be easier to finish the testing event by using 
the same methodology for the second collection. The International 
Paruresis Association cautioned against continuing with a second urine 
collection after the employee produced an insufficient urine specimen 
unless the employee requested this. Another commenter asked ``how 
things would proceed when the alternate specimen was available only at 
a different collection site. How would the change of venue be handled? 
Would someone have to accompany or supervise the employee in transit 
between Site 1 and Site 2?'' Questions such as these are valid and will 
be best handled in the collection guidelines for both urine and oral 
fluid.
    The remaining comments on this provision delved into the choices 
between having the employer and service agent make the choice as to 
what to do when a second collection is needed. NDASA said the employer 
should decide what methodology to use for the initial specimen ``and 
only in cases where an alternative is required to complete the 
collection, should the service agent make a determination.'' The New 
York City Department of Transportation commented in support of allowing 
either the employer or service agent to make a decision about the 
second collection. An MRO practice, Cynergy, said the employer's 
``policy should dictate what is permitted if there is a problem in the 
collection that necessitates a second collection.''
    Under Sec.  40.210 we have retained the flexibility for either the 
employer, the service agent, or both working together, to decide what 
methodology to use for a second collection after a problematic first 
collection. We think the ideal is for the employer's policy to dictate 
what methodology should be used for the first test and for the second 
test, should a problem arise. However, if there is no standing order 
and the collector cannot contact the DER, then the service agent will 
need to make the decision as to the methodology to be used for the 
second test. Thus, we have adopted Sec.  40.210 with minor changes to 
emphasize the flexibility discussed above.

Sec.  40.225 What form is used for an alcohol test?

    We made a conforming change to Sec.  40.225 and redesignated 
appendix G to be appendix I. We received no comments on this change.

Sec.  40.283 How does a certification organization obtain recognition 
for its members as SAPs?

    In Sec.  40.283, we made a conforming change redesignating appendix 
E to appendix G. We no comments received on this change.

Sec.  40.285 When is a SAP evaluation required?

    In Sec.  40.285, the word ``urine'' would be removed if oral fluid 
testing is added. Having received no comments on this change, we have 
finalized it.

Sec.  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 section of this final rule, 
the Department proposed to permit SAPs to conduct evaluations or 
assessments remotely by amending Sec.  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. The changes we adopted 
are fully discussed and resolved in the Principal Policy section.

Sec.  40.293 What is the SAP's function in conducting the initial 
evaluation of an employee?

    For the reasons discussed in the Principal Policy section of this 
final rule, we have removed the words ``face-to-face'' from paragraph 
(a) this provision to remote evaluations. In the context of remote 
evaluations and other issues of concern to SAPs, many commenters raised 
points that we have decided merit changes to Sec.  40.293, as a logical 
outgrowth of their comments.
    Specifically, some commenters expressed concerns about SAPs who are 
conducting remote assessments without following the requirements of 
subpart O of part 40. The commenters said some SAPs are not evaluating 
employees individually and are simply taking their money. The 
commenters asserted these purportedly noncompliant SAPs are regularly 
or even exclusively requiring employees to complete online education, 
regardless of the substance abuse issues the individual employee 
presents. Additional commenters said some SAPs offer low pricing for 
their services online and, before evaluating employees, allegedly 
promise the employees will only need to complete online education to 
satisfy the return-to-duty requirements, when some of these employees 
actually may need treatment

[[Page 27628]]

after an assessment and clinical evaluation is performed.
    We appreciate that these concerns are serious, but we believe they 
potentially apply to all SAPs, not only those SAPs who conduct remote 
assessments. It is important to break out the individual points raised 
by the commenters, in order to explain what is already addressed in the 
existing subpart O of part 40, what we will not address through 
regulatory changes, and what we can address through rulemaking, as a 
logical outgrowth of these comments.
    First, under Sec.  40.293(a), each SAP must perform an assessment 
and clinical evaluation for each employee. Any SAP who is not 
performing an assessment and clinical evaluation for an individual 
employee is in direct violation of Sec.  40.293(a). There is no 
modification to Sec.  40.293(a) needed because the current regulatory 
language is clear.
    Second, if a SAP prescribes online education for most or all of the 
individual employees that SAP evaluates, then the SAP would be in 
violation of Sec.  40.293(b) through (d). These sections discuss the 
appropriate education and/or treatment the SAP would determine is 
necessary for each employee. In the final rule establishing subpart O, 
the Department said: ``For someone who performs safety-sensitive 
transportation functions, the very fact of a violation indicates a 
disregard of safety that must be addressed, corrected, and monitored in 
order to ensure safe performance of those functions in the future.'' 65 
FR 79470 (Dec. 19, 2000). As a gatekeeper of transportation safety, the 
SAP has an essential duty to evaluate each employee and consider the 
employee's violation(s) in order to determine what help that individual 
needs and how to best address safety through getting the employee the 
help they need for their unique circumstances. If the SAP were to 
prescribe the same education and/or treatment requirement for every 
employee, the SAP would be violating part 40 and failing to fulfill 
their role as a gatekeeper of safety and enormous responsibility to the 
public.
    The Department recently became aware that some SAPs were providing 
return-to-duty timelines to employees who violated the DOT drug and/or 
alcohol regulations before conducting the required initial assessment 
and evaluation of the employee. In response, we issued a list serve to 
remind SAPs of their regulatory responsibilities and the SAP's role in 
evaluating each individual employee and directing that employee to get 
the specific help the employee needs. https://content.govdelivery.com/accounts/USDOT/bulletins/3304b9a.
    The SAP process was carefully designed to utilize the clinical 
evaluation and assessment skills and expertise of the SAP practitioner 
to evaluate each specific individual employee. The SAP must address the 
employee's needs for rehabilitation for the sake of the employee and 
give the employee the tools the employee needs to return to the 
performance of safety-sensitive duties. Consistent with sound clinical 
and established SAP standards of care in clinical practice, and 
utilizing reliable alcohol and drug abuse assessment tools, the SAP 
must conduct an assessment and evaluation, either in-person or 
remotely. As stated in ODAPC's SAP Guidelines, ``The evaluation should 
be comprised of a review of the employee's psychosocial history, an in-
depth review of the employee's drug and alcohol use history (with 
information regarding onset, duration, frequency, and amount of use; 
substance(s) of use and choice; emotional and physical characteristics 
of use; and associated health, work, family, personal, and 
interpersonal problems); and an evaluation of the employee's current 
mental status.'' https://www.transportation.gov/odapc/substance-abuse-professional-guidelines.
    In accordance with Sec.  40.293, the SAP must provide a 
comprehensive assessment and clinical evaluation unique to the 
employee. As required by Sec.  40.293(b), the SAP must make a 
recommendation for education and/or treatment that will, to the 
greatest extent possible, protect public safety in the event that the 
employee returns to the performance of safety-sensitive functions. 
Providing estimated return-to-duty dates without such individual 
assessments and recommendations unique to the individual is yet another 
concern recently arising.
    As a logical outgrowth of the proposal to add an option for remote 
evaluations and, in response to the concerns about some SAPs failing to 
individually evaluate, assess and recommend education or treatment, and 
a follow-up testing plan unique to the needs of each and every employee 
evaluated, we have added a new paragraph to Sec.  40.293(e). This 
additional paragraph requires a SAP to use their professional judgment 
to individualize their assessment, clinical evaluation, education and/
or treatment recommendations, and follow-up testing recommendations 
unique to each employee. In the regulatory text, we provided the 
example of not having the SAP require the same and/or substantially 
similar education, treatment and/or follow-up testing plan for most of 
the employees you assess. If the SAP prescribes the same treatment for 
every marijuana positive as a result of the SAP's personal philosophy 
about marijuana use and not as a result of evaluating and clinically 
assessing the needs of the individual employee, then the SAP is not 
exercising their professional judgment. If the SAP requires only online 
training for every employee who comes to the SAP, then the SAP is not 
individualizing their assessment and, actually, may not even be making 
an evaluation and assessment. Thus, this would certainly not fall 
within the bounds of using their professional judgment.
    The SAP has highly respected roles and serious responsibilities 
under the DOT's regulations. The SAP is the key to ensuring the 
employee receives the education or treatment they need to have 
meaningful rehabilitation and treatment. In addition, the SAP has the 
extremely important responsibility of being the gatekeeper for 
transportation safety. The SAP is required to use their professional 
judgment to evaluate and assess the employee and direct the employee to 
get the individualized help they need. When the SAP role is carried out 
faithfully, the employee gets the help they need toward the road to 
recovery and toward being able to return to safety-sensitive functions 
in a way that will not pose a threat to safety. In short, the 
individualized evaluations and assessments carried out through the 
SAP's professional judgment as a safety gatekeeper ensure employees get 
the help they need, and transportation safety is protected and 
preserved.
    Finally, as to costs a SAP advertises or charges, the Department 
will continue to remain silent, as we do on other questions of who pays 
and how much one would pay for services rendered to meet the 
requirements of part 40. Any SAP can charge a fee they determine is 
appropriate. Since the Department remains silent on all pricing issues, 
the marketplace controls what SAPs can reasonably charge and what 
individual employees with part 40 violations are willing to pay. We do 
not see a reason to intervene in this free market, which has been 
working successfully for more than 20 years.

Sec.  40.301 What is the SAP's function in the follow-up evaluation of 
an employee?

    As discussed in Principal Policy section of this final rule, we 
have removed the words ``face-to-face'' from paragraph (b)(2) this 
provision. We have added the words ``meeting the

[[Page 27629]]

requirements of Sec.  40.291(a)(1) of this part'' to allow remote 
evaluations.

Sec.  40.307 What is the SAP's function in prescribing the employee's 
follow-up tests?

    In the SAP comments, there were discussions about follow-up 
testing, and as a logical outgrowth, we are clarifying several points. 
A follow-up testing plan contains the SAP's recommendation for the 
number and duration of follow-up tests to be conducted by the employer. 
The SAP can recommend drug follow-up testing and alcohol follow-up 
testing for a single drug violation or a single alcohol violation if 
the SAP determines that is necessary.
    However, the SAP has no authority to determine the dates when the 
testing is to be done, that is up to the employer. The SAP can indicate 
the follow-up tests should be done close in time to certain triggering 
events for the employee (e.g., birthdays, anniversaries of deaths, long 
weekends, etc.) or the SAP can choose not to make such suggestions.
    The key to successful follow-up testing is that it is not announced 
to the employee in advance. If the employer, the SAP, or another 
service agent provides the follow-up testing plan to the employee, the 
employee can anticipate how many tests will take place and ``plan'' the 
period of time they need to abstain from illegal drug use or alcohol 
misuse to successfully complete their follow-up tests. Thus, it was 
always the intent that no one provide the follow-up testing schedule to 
the employee. We have added a new paragraph (g) to clarify this.

Sec.  40.311 What are the requirements concerning SAP reports?

    For the reasons discussed in the Principal Policy section of this 
final rule, we have adopted the proposal to add the words ``and format 
(i.e., face-to-face or remote)'' to Sec.  40.311(c)(4), (d)(4), and 
(e)(4). In addition, we have amended Sec.  40.311 to direct SAPs to 
note on their SAP reports whether a given evaluation occurred face-to-
face or remotely.
    Also as discussed in the Principal Policy section, we have adopted 
the proposal to change ``SSN'' to ``SSN or employee ID number'' in 
Sec.  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 SSN.

Sec.  40.327 When must the MRO report medical information gathered in 
the verification process?

    In Sec.  40.327, we proposed to add a clarification requiring MROs 
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 or letter) must be used and will 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 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 
open-ended inquiry. This clarification echoes 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).
    Several commenters, including NDASA and multiple MRO practices, 
supported this clarification. The Drug and Alcohol Testing Association 
(DATIA) commented in support of the proposal, saying: ``The MRO must 
take appropriate steps to balance public safety concern and the right 
to privacy of the individual that is subject to testing. We support 
fully the Department's 2017 final rule preamble discussion that medical 
information or any other communication regarding a safety sensitive 
concern should be processed and reported separately from the standard 
result report.''
    Another major industry association opposed the proposal and 
appeared to be confused about what is currently required. The 
association said MROs should continue to report a significant safety 
risk with a negative test result. However, MROs have not been permitted 
to report the two simultaneously since 2017. Under Sec.  40.135(e), 
MROs have been required to wait five business days between reporting a 
negative test result and reporting a significant safety risk they have 
determined under Sec.  40.327 regarding an employee who does not hold 
DOT-regulated medical certification. See 82 FR 52236 (Nov. 13, 2017).
    One MRO practice thought the clarification would allow the MRO ``to 
discuss specifics with the DER, avoiding more vague references to 
safety concerns thus enabling a more focused fitness for duty 
process.'' This commenter supported the proposal.
    There is no duty of confidentiality between the MRO and the 
employee, as every MRO must declare to each employee. Instead, per 
Sec.  40.135(d), the MRO is ``required to provide third parties drug 
testing information and medical information affecting the performance 
of safety-sensitive duties that the employee gives . . .'' Under Sec.  
40.135(d)(2), this includes ``information on medicines or other 
substances affecting the performance of safety-sensitive duties that 
the employee reports using or medical conditions the employee reports 
having.'' Thus, with informed consent, the employee provides such 
information to the MRO who can share it with the employer. However, 
what the employer does with such information may impact the Americans 
with Disabilities Act or other Federal, State or local civil rights 
laws and responsibilities. These are matters outside the jurisdiction 
of the DOT. Employers should consult with their counsel to understand 
how they can use such information received by the MRO without violating 
the Americans with Disabilities Act, the Rehabilitation Act of 1973, or 
other State or Federal laws. We are adopting Sec.  40.327 as proposed.

Sec.  40.345 In what circumstances may a C/TPA act as an intermediary 
in the transmission of drug and alcohol testing information to 
employers?

    As a conforming change, we have updated the reference from appendix 
F to appendix H, Sec.  40.345. There were no comments on this point.

Sec.  40.355 What limitations apply to the activities of service 
agents?

    In Sec.  40.355(n) (Example 3), we have removed the word ``urine'' 
to allow the section to apply to both approved methodologies for 
testing. We received no comments on this proposed change.
    We received one comment regarding Sec.  40.355(a), which we had not 
proposed to change. The commenter asked us to include the term 
``treatment provider'' in list of the entities that must not require an 
employee to sign a consent form. The commenter noted the term 
``treatment provider'' is included in the DOT's HIPAA statement 
(https://www.transportation.gov/odapc/hipaa-statement), and in the 
Release of Information section of the DOT's Substance Abuse Guidelines 
(https://www.transportation.gov/odapc/substance-abuse-professional-guidelines). In the HIPAA statement, we say ``SAPs need no written 
authorizations from employees to conduct SAP evaluations, to confer 
with employers, to confer with MROs, to confer with appropriate 
education and

[[Page 27630]]

treatment providers, or to provide SAP reports to employers.'' We state 
this because SAPs are performing a role as a safety official within the 
bounds of part 40 and not as a health care provider. Thus, it would not 
be appropriate for us to instruct treatment providers, who are likely 
covered under HIPAA when they accept insurance payments, to communicate 
with third parties without the consent of their patient/client. It 
would also be outside the jurisdiction of the Department to do this. On 
page 10 of the SAP Guidelines, we instruct SAPs to provide information 
to treatment providers, but we lack jurisdiction to require treatment 
providers to provide information to SAPs.
    Section 40.355(a) would not restrict a SAP from asking an employee 
to execute a HIPAA waiver with the treatment provider to provide the 
SAP with information about treatment progression and conclusion. That 
information is essential to the SAP being able to determine whether the 
employee has successfully complied with the education and/or treatment. 
Without this information, the SAP cannot complete the follow-up 
evaluation of the employee. It is in the best interests of the employee 
to execute such a release for the treatment provider to communicate. If 
the employee does not provide the appropriate releases and the 
information is not conveyed to the SAP, then the employee will not be 
permitted to return to work. We think this natural progression of the 
process has been successful and we have not made the suggested change.

Sec.  40.365 What is the Department's policy concerning starting a PIE 
proceeding?

    We proposed to amend Sec.  40.365 to say a PIE could occur because 
a SAP failed to conduct an evaluation using the means provided in Sec.  
40.291(a)(1), rather than because there was no face-to-face evaluation. 
NDASA and several other commenters concurred with the change. We have 
adopted it as proposed.

Appendices

    Appendix A, concerning urine collection kits remains unchanged. We 
have added a new Appendix B, establashing standards for oral fluid 
collection kits, based on material in the HHS OFMG and consistent with 
OTETA requirements for a split specimen. The remainder of the 
appendices have been renumbered and reordered, as explained below. For 
a summary of these changes, see the redesignation table.

Appendix B

    Appendix B describes the requirements for the contents of an oral 
fluid collection kit. Where we could conform to the HHS OFMG, we did 
so. We differed from HHS in some aspects of the collection kits because 
OTETA requires a single collection that must be subdivided in the 
presence of the employee. This necessitated unique requirements for 
DOT-regulated entities. For a full discussion of the comments in 
support of and opposing our approach in appendix B, as well as the 
Department's responses, see the section-by-section analysis above for 
Sec.  40.49.
    In viewing the public comments and in consultation with HHS, we 
restructured appendix B, section 1(a) to address future devices that 
may be invented, as well as neat collection devices that currently 
exist in what we now have as appendix B, section 1(a)(1). We have a new 
appendix B, section 1(a)(2), similar to what we proposed, for devices 
utilizing a buffering solution. We have removed some specific language 
from the proposal regarding quantities of specimens and percentages of 
undiluted (neat) oral fluid because these do not need to be included in 
part 40. An oral fluid collection device will not be permitted to be 
used in the DOT-regulated drug testing program unless HHS has approved 
a certified laboratory to deploy a particular device. In other words, 
unless HHS has approved an HHS-certified laboratory to use a particular 
oral fluid collection device, that device will not be used. So, it is 
unnecessary and inconsistent for part 40 to create device or volume 
specifications separate from those of HHS. This is part of the 
scientific aspect of drug testing we defer to HHS.
    Alere Toxicology provided comments including language edits with 
which we agree and have added to the final rule language, with slight 
modification. Specifically, this commenter recommended a change in 
appendix B, section 1(a) of ``specimen bottle or tube'' instead of 
merely ``specimen bottle.'' They also suggested a change to appendix B, 
section 1(a) to add ``a single pad or dual pads'' for a description of 
the single collection which can be subdivided into two separate 
collection tubes. We have added these to appendix B, section 1(a)(2) 
and have included a slight modification to make it clear that the dual 
pads must be joined for insertion together into the same spot in the 
mouth. This further clarifies details about the single collection 
device that would be subdivided in the presence of the donor, which we 
must require under OTETA.
    We appreciate ALPA's comments, in which they supported the way we 
have described neat and wet collections in appendix B, section 1(a). 
They believe we have met OTETA on the requirements for these devices.
    OraSure requested ``additional language should be added allowing 
for the use of a single device, consisting of 2 cotton fiber pads, 
placed back-to-back or side by side, which after the collection, can be 
split into an A & B samples.'' We agree and the language added to 
appendix B section 1(a)(2) described above should address this. OraSure 
asked us to leave room to allow entirely different types of devices 
``that could be pad based or non-pad-based devices so long as they 
meet'' what we are asking for under OTETA. This is a reasonable 
request, and we have added the new appendix B, section 1(a)(1) to 
include devices that we have not contemplated as of this time.
    Both buffered and undiluted (neat) specimen collection devices must 
have an expiration date. For clarity, we have added a parenthetical to 
appendix B, section 1(e) to indicate the expiration date is the 
shortest expiration date of any component. We recognize that this date 
could be more than a decade after an undiluted (neat) specimen 
collection device is manufactured. However, we proposed and there were 
no dissenting comments regarding the need for an expiration date. We 
want to ensure the integrity of the testing process and that collectors 
will always enter the device expiration regardless of whether the 
device is a buffered collection device or an undiluted (neat) specimen 
collection device.
    We asked for public comments specifically regarding whether 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 re-collection, if appropriate. We proposed language in 
appendix B, section 1(c) to ensure that transparency.
    Several commenters including DATIA, OraSure, Quest Diagnostics, the 
New York City Department of Transportation, and others commented in 
favor of this proposal. Many commenters said the tubes should be 
sufficiently transparent, or at least semi-transparent, to assist 
collectors in detecting adulteration. Alere San Diego also agreed, 
saying ``the tube . . . should be sufficiently transparent to allow the 
collector the ability to ensure the sample is visible.'' We agree with 
these commenters.
    In addition, some commenters wanted to see a minimum volume 
indicator built into the device or vials to ensure

[[Page 27631]]

the collector has gathered enough specimen for the laboratory to 
process. One commenter noted that there are at least two devices 
already on the market with an indicator showing whether enough fluid 
was collected. We agree with these commenters and have finalized the 
proposed language.
    In appendix B, section 1(h), we proposed to require the tamper-
evident bottle seals for bottles A and B ``not conceal printed 
information.'' NDASA urged that we not require the use of ``clear 
security labels'' because it would be a cost increase. In addition, 
NDASA said ``clear label materials are an untested technology, without 
evidence of how a clear label product could affect the collection 
device and its components. For the collector to verify the expiration 
date during the collection process and then adhere paper-based security 
seals which are already in use and industry standard, should suffice in 
the collection process.'' Quest Diagnostics also strongly stated we 
should not require transparent seals ``because of high costs of 
manufacturing the transparent seals (estimated at an increase of 
$300,000 annually) and the intended purpose would be for the lab to be 
better able to read the expiry dates, which the collectors should do.'' 
In addition, Quest Diagnostics noted, ``the current seals stand up to 
heat of travel and freezing in the lab, transparent labels may not do 
as well.''
    We appreciate these concerns and observations. We will only require 
that the seals not conceal the printed information on Bottles A and B 
and that the seals not be damaged by the employee initialing or the 
collector signing them. This creates a performance standard, and we are 
not requiring more specific details for compliance with this provision.
    We have amended the proposed appendix B, section 1(i) to state the 
oral fluid collection device ``must be approved by HHS for use by the 
specific HHS-certified laboratory that will test the specimen gathered 
by this device.'' As discussed above, if HHS approves the use of a 
particular device by an HHS-certified laboratory, we defer to that 
approval.

Appendix D

    The resdesignated appendix D (the former appendix B) concerns semi-
annual reports laboratories provide to employers. The new appendix D 
sets forth matters to be reported with respect to urine and oral fluid 
testing respectively. No comments were received on these changes, and 
they are adopted as proposed.

Appendix E

    In the redesignated appendix E (the former appendix C), the 
Department proposed to amend the data elements that HHS-certified 
laboratories submit to DOT semi-annually. With this change, 
laboratories will 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, the US Coast 
Guard) and test reason (i.e., pre-employment, random, reasonable 
suspicion/cause, post-accident, return-to-duty, other, and follow-up). 
The proposal required each laboratory to submit multiple data summaries 
as opposed to the one data summary they now provide. The additional 
data elements will assist the Department in evaluating the efficacy of 
testing by oral fluid versus urine. In addition, we anticipate 
developing a better understanding of any trends in drug testing by 
specimen type, DOT agency and/or test reason(s).
    There were very few comments to the proposed biannual reporting 
changes. One DOT-regulated employer opposed the concept of collecting 
data from laboratories at all because the collectors make errors on the 
test type and the DOT agency they list on the CCF. This employer 
thought these mistakes would make the data unreliable. We also received 
public comments suggesting there would be cost associated with adding 
the proposed data elements, but no costs were quantified by the 
commenters.
    While any change to searches set up for data collection may have an 
initial cost, the changes to the redesignated appendix C fall within 
data elements already collected by the laboratories. We did not ask for 
new data to be collected. It is our understanding that most, if not all 
of the HHS-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.
    The Department has required laboratories to submit data biannually 
since 2018. This data has proven to be effective in analyzing drug use 
trends. Even though there could be some potential collector errors, 
there is still great utility for this data collection. Due to this 
value to DOT and since no quantifiable burdens were identified with 
adding the new data elements, we have adopted the changes as proposed.

Appendix F

    Current appendix D, concerning reports on split specimen failures 
to reconfirm, will become appendix F under this final rule. We proposed 
to add the ``specimen type'' as another element to the information the 
MRO currently provides so we can track the two specimen types. We 
received no comments on this proposal, other than to agree with the 
redesignation of the appendices, and have adopted the changes to 
appendix D.

Appendix G

    Current appendix E, on SAP equivalency requirements for 
certification organizations, would become appendix G. We received no 
comments on this proposal, other than to agree with the redesignation 
of the appendices, and have adopted it as proposed.

Appendix H

    Current appendix F, concerning drug and alcohol testing information 
can be transmitted by C/TPAs, would become appendix H. We received no 
comments on this proposal, other than to agree with the redesignation 
of the appendices, and have adopted it as proposed.

Appendix I

    Current appendix G, the Alcohol Testing Form, would become appendix 
I. We received no comments on this proposal, other than to agree with 
the redesignation of the appendices, and have adopted it as proposed.

Appendix J

    Finally, appendix H, the MIS data collection form, would be found 
in appendix J. We received no comments on this proposal, other than to 
agree with the redesignation of the appendices, and have adopted it as 
proposed.
Miscellaneous Comments Outside the Scope
    We received many comments outside the scope of this rulemaking. 
These included a request for a new provision to say, ``if a test is 
given to an employee who per the applicable agency rule should not have 
been subjected to that test, it must be treated for all purposes as a 
non-DOT test.'' We received several comments about the PIE process. A 
few commenters wanted to see an appeal process for any positive or 
refusal verified by an MRO, as well as any employer-determined 
refusals.
    Another commenter wanted guidance or regulatory text to address how 
people should proceed if the donor or collector

[[Page 27632]]

appears to be ill at the time of the test. A standard approach cannot 
be applied because each situation is different. In Sec.  40.61(b)(2) we 
already say that medical care for the employee is to be provided before 
the drug test is administered.
    One commenter wanted us to have collectors and collection sites 
``explicitly warn employees of the consequences of non-cooperation or 
leaving a collection site prematurely, which could be done via posters 
or words in the script collectors use to begin the process with 
employees.'' The requirement to follow the DOT's regulations is a 
matter of Federal law, so the collectors are not obligated to remind 
employees of their duties under the regulations that govern their work 
responsibilities. However, we are aware that many collectors, as a best 
practice do warn employees. In addition, ODAPC has issued several 
posters that collection sites and workplaces can post to remind 
employees ``What You Can Lose if You Refuse.''
    NDASA made several suggestions that are outside the scope but are 
helpful suggestions for revisions to our collection guidelines. They 
suggested including in our guidelines the situations of ``donors who 
enter the facility claiming inability to provide a specimen before an 
attempt to provide is made, donors leaving before shy bladder is 
complete, the point at which the actual collection process begins, who 
may and may not determine a refusal to test.'' NDASA also suggested we 
``produce an updated collector training video to include all specimen 
types.'' Another helpful suggestion was to clarify if the collector can 
rely on an expired identification as proof of their identity. We will 
address that in our collection guidelines.
    We also received a comment requesting refusal training for all 
employers. This is outside the scope of part 40. Instead, the DOT 
agency regulations would need to include such requirements for their 
respective regulated employers.
    Another commenter requested a strengthening of and expansion for 
the conflict-of-interest provisions in part 40. This issue is outside 
the scope of this regulation. Also, as this commenter mentioned, ``the 
provisions that already exist in Sec.  40.101 regarding prohibited 
relationships and in other areas of part 40 that speak to improper 
actions on the part of a service provider, and retaliation for 
reporting improper actions to employers and regulators''.
    Other comments outside the scope included requests to remove urine 
testing, add hair testing, include point of collection testing (without 
laboratory-based testing included), removing marijuana testing, and 
other matters involving the science of DOT-regulated testing. As we 
have said many times, OTETA requires DOT to follow HHS for the drugs 
for which we test, the scientific and technical aspects, and that we 
must use HHS-certified laboratories for the screening and confirmation 
of our regulated specimens. Thus, these comments are outside the scope 
of this rulemaking and have not been further addressed.
Common Preamble
    While part 40 provides the regulatory provisions for how to 
administer drug and alcohol testing, the DOT agency regulations provide 
the specifics of what employers and employees are subject to testing 
and when to conduct the testing. In order to allow oral fluid drug 
testing across the DOT-regulated transportation industries, we must 
make some minor adjustments to some of the DOT agency regulations. 
Specifically, we are making conforming changes to 14 CFR part 120 
(FAA), 49 CFR part 219 (FRA), 49 CFR part 382 (FMCSA), and 49 CFR part 
655 (FTA), all of which are directly subject to the OTETA mandate to 
follow the HHS Mandatory Guidelines for the scientific and technical 
requirements for oral fluid testing under part 40. Without the changes 
explained in this Common Preamble, these DOT agencies would not be able 
to allow oral fluid testing. Consequently, this final rule addresses 
urine-specific provisions; adds, removes and modifies definitions; and 
makes other technical changes specifically set forth below. 
Incidentally, PHMSA has determined it does not need to make any changes 
to its drug testing regulations to permit oral fluid testing, thus 
there are no changes to 49 CFR part 199 in this final rule. Part 199 
utilizes the testing procedures of part 40.
FAA
    In 14 CFR part 120, the FAA has revised the definitions of 
``Alcohol'' to be consistent with part 40. The FAA has corrected the 
definition of ``Refusal to submit to drug test'' to reference covered 
employees. It is important to note this is not a change in coverage, it 
is only a technical change to phrasing. The FAA has added the 
definition of ``Alcohol misuse'' to reference the alcohol misuse 
prohibitions under subparts C or D of part 120. The FAA has removed the 
following definitions because they are unnecessary and/or already 
defined in part 40: ``Alcohol Concentration (or content)'', ``Alcohol 
use'', ``DOT agency'', ``Verified negative drug test result'', and 
``Verified positive drug test result''. Due to the removal of these 
definitions, several paragraphs of Sec.  120.7 have been redesignated 
and the definitions of ``Covered employee'' and ``Employee'' have been 
updated. In Sec. Sec.  120.119(b) and 120.219(b)(2), the FAA has 
changed references to ``Appendix H'' to become references to ``appendix 
J'' because those appendices are redesignated in part 40. In Sec. Sec.  
120.111(d) and 120.221(d), the FAA corrected references to ``employee'' 
to ``covered employee.'' All of these changes are conforming only and 
do not otherwise amend the underlying provisions of 14 CFR part 120.
Federal Railroad Adimistration (FRA)
    FRA has made the followings changes to the regulatory text in part 
219, which are solely for purpose of either conforming with part 40 or 
correcting an error in the regulatory text, and do not affect the 
substance of FRA's rule.
    In 49 CFR part 219, FRA amended Sec. Sec.  219.11(a)(2) and (h), 
219.617(b)(2), 219.619, 219.621(a), and 219.903(a) to conform with 
changes made today to part 40. FRA's revisions have generally removed 
the term ``urine'' and replaced it with references to body fluid 
specimens to capture both the existing urine specimens and the new 
alternate oral fluids specimens.
    FRA has made minor technical corrections to Sec.  219.4. To conform 
with terminology used in part 40, FRA replaced the term ``return-to-
service'' with ``return-to-duty'' in Sec.  219.4(a) and (b)(1) and (2). 
FRA has further amended Sec.  219.4(b)(2) to remove an incorrect 
reference to ``paragraph (d) of this section'' and replaced it with the 
correct reference to ``Sec.  219.104(d),'' which establishes the 
return-to-duty requirements this paragraph addresses.
    FRA has also made the following technical changes to part 240--
Qualification and Certification of Locomotive Engineers and part 242--
Qualification and Certification of Conductors. The amended provisions 
previously used the word ``urine'' when referencing certain provisions 
of part 219 that a railroad must consider when determining whether a 
person may be or remain certified as a locomotive engineer or 
conductor. These changes are solely for the purpose of conforming with 
part 40 and do not affect the substance of FRA's locomotive engineer 
and conductor certification regulations. Specifically, in part 240, FRA 
is amending Sec.  240.119(e)(4)(iv)(A) and (f)(1)(iii) to replace the 
word ``urine'' with the words ``body fluid.'' In part 242, FRA is 
amending Sec.  242.115(e)(4)(iv)(A) and (f)(1)(iii) to

[[Page 27633]]

replace the word ``urine'' with the words ``body fluid.''
    With respect to oral fluid and FRA post-accident toxicological 
testing, persons subject to part 219 should note that FRA's post-
accident toxicological testing requirements in part 219, subpart C are 
not subject to the OTETA mandate and therefore do not follow part 40 
procedures. See Sec. Sec.  40.1(c), 219.205(a), and 219.701(a) and (b). 
This final rule allowing for oral fluid testing therefore does not 
apply to FRA post-accident toxicological testing, which still requires 
urine and blood specimens, as well as body fluid and tissue specimens 
for post-mortem tests. See Sec. Sec.  219.203(a)(1), 219.205(a), and 
219.207(a).
Federal Motor Carriers S* * * Administration (FMCSA)
    In part 382, the FMCSA has amended Sec. Sec.  382.107, 382.401(b) 
and (c), 382.403(b), 382.409(b), and 382.705(a) to conform with changes 
made to part 40. The revised text includes references to oral fluid 
specimens as an alternate to urine specimens and added the term ``oral 
fluid collectors'' as necessary. The FMCSA also updated references to 
sections of part 40 (i.e., references to appendices) that were 
redesignated in the oral fluids final rule and has added references to 
a Medical Review Officer's reversal of canceled drug test results. 
These changes are conforming only and do not otherwise amend the 
underlying provisions of 49 CFR part 382.
Federal Transit Administration (FTA)
    In 49 CFR part 655, FTA has amended Sec.  655.53 to add ``oral 
fluid collector''. FTA has modified Sec.  655.71 to explicitly add 
``oral fluid specimen'' to conform with changes made today to part 40 
to add oral fluid specimens as an alternate to urine specimens, a small 
technical change is being made to correct ``breathe'' to ``breath'', 
also. In Sec. Sec.  655.47 and 655.61(a)(3), FTA revised the term 
``employee'' to read as ``covered employee.'' FTA has made technical 
changes to conform with the rest of Parts 40 and 655, including 
amending Sec.  655.5(c) to update their street address; revised Sec.  
655.15(e) by replacing ``illegal'' with ``prohibited''; and revised 
Sec.  655.44(a)(1)(i) by correcting a reference to ``part 389''. These 
changes are technical or conforming only and do not otherwise amend the 
underlying provisions of 49 CFR part 655.
Good Cause for Adoption Without Prior Notice and Comment
    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 
U.S.C. 551 et seq.) authorizes agencies to dispense with prior notice 
and comment for rules when the agency for ``good cause'' finds that 
those procedures are ``impracticable, unnecessary, or contrary to the 
public interest.'' Under this section, an agency, upon finding good 
cause, may issue a final rule without seeking comment prior to the 
rulemaking.
    The changes being made to the regulations of FAA, FMCSA, FRA, and 
FTA are all conforming technical edits to conform with the OST part 40 
regulations. Because the underlying part 40 regulations received the 
benefit of notice and comment, further public comment on the conforming 
edits is not necessary.

IV. How To Obtain Additional Information

A. Rulemaking Documents

    An electronic copy of a rulemaking document may be obtained by 
using the internet--
    1. Search regulations.gov (https://www.regulations.gov) for the 
docket number listed at the beginning of this document; or
    2. Search the Office of the Federal Register's web page (https://www.federalregister.gov) for the RIN listed at the beginning of this 
document.

V. Regulatory Analyses and Notices

Executive Order 12866 (Regulatory Planning and Review)

    The Office and Management and Budget (OMB) has determined that the 
rulemaking action is not significant under Executive Order 12866 
(``Regulatory Planning and Review''), as supplemented by Executive 
Order 13563 (``Improving Regulation and Regulatory Review''). 
Accordingly, OMB has not reviewed it under that order.
    The final rule allows transportation employers and drug test 
collection sites to use oral fluid testing instead of urine testing for 
DOT-regulated drug tests. Compared with the baseline scenario in which 
employers must use urine testing for all drug tests, the rule may 
reduce costs for employers and collection sites, improve the 
effectiveness of drug testing, and reduce burdens for individuals 
undergoing testing. Oral fluid testing is optional in all but very rare 
cases, and DOT expects that employers would adopt it only when benefits 
exceed costs.
    The extent of the benefits depends on the degree to which employers 
and collection sites adopt oral fluid testing. For non-DOT drug tests, 
an increasing number of companies utilize oral fluid testing. In 2022, 
38% of respondents to a drug testing industry survey reported that 
their company already offered oral fluid testing.\3\ An additional 48% 
expected that their company would offer oral fluid testing after SAMHSA 
and DOT establish guidelines. Some of the respondents may not be 
involved in DOT-regulated testing, but the results demonstrate industry 
interest in adopting oral fluid testing.
---------------------------------------------------------------------------

    \3\ Current Consulting Group. 2022. ``The 2022 Drug Testing 
Industry Survey.'' http://www.currentconsultinggroup.com/wp-content/uploads/2022/07/2022-Drug-Testing-Industry-Survey.pdf.
---------------------------------------------------------------------------

Cost Savings

    Allowing employers to use oral fluid testing may result in cost 
savings for employers by reducing the time individuals need to spend 
undergoing testing. Most urine collections occur in separate collection 
facilities, requiring individuals to travel to and from the facilities. 
Oral fluid collection could occur at or near the workplace, reducing 
travel time.
    Oral fluid testing may also reduce resources needed to administer 
tests. Collectors administering urine tests must secure the site to 
ensure the integrity of the testing process. Securing the site involves 
restricting access to water sources and ensuring that individuals 
cannot alter or switch urine samples. Oral fluid testing, in contrast, 
is directly observed and requires fewer resources to ensure testing 
integrity.
    Oral fluid testing may offer a less time-consuming alternate to 
existing procedures when an employee cannot produce a sufficient urine 
specimen--for example, in a ``shy bladder'' situation or when specimens 
show evidence of tampering. Currently, employers must give individuals 
up to three hours to try producing a urine specimen again. If an 
individual still cannot produce a urine sample, the employer must refer 
the individual to a physician for further evaluation. The rule would 
allow employers to switch immediately to an oral fluid collection after 
the first failed attempt. Employers could similarly switch from oral 
fluid to urine collection if, for example, an employee has a ``dry 
mouth'' situation.
    DOT estimated cost savings for employers in the NPRM but has not 
done so for the final rule. In the NPRM, DOT used testing costs from 
industry and projected adoption rates from the HHS rule on oral fluid 
guidelines to estimate annual net cost savings of $25.0 million by the 
fourth year. As detailed in ``Principal Policy Considerations,'' 
commenters disputed the information used. Some commenters asserted that 
an oral fluid test has slightly higher costs than a urine test, in

[[Page 27634]]

part because oral fluid collection kits use chemical buffering 
solutions with a limited shelf life. At the same time, economies of 
scale may lead to lower unit costs for oral fluid tests if the drug 
testing industry increases its volume of testing. Given the uncertainty 
of testing costs and lack of data on other aspects of testing, DOT has 
not estimated cost savings or other benefits for the final rule. 
Nonetheless, commenters acknowledged the potential for cost savings.

Improved Effectiveness of Testing

    Allowing employers to use oral fluid testing may improve the 
effectiveness of drug testing. Oral fluid testing can detect the recent 
use of some drugs, including marijuana and cocaine,4 5 while 
urine drug testing has a longer window of detection. More effective 
drug testing could deter employee illicit drug use and reduce safety 
risks from drug use.
---------------------------------------------------------------------------

    \4\ Edward J. Cone and Marilyn A. Huestis. 2007. 
``Interpretation of Oral Fluid Tests for Drugs of Abuse.'' Annals of 
the New York Academy of Sciences 1098, 51-103. https://doi.org/10.1196/annals.1384.037.
    \5\ Rebecca Jufer, Sharon L. Walsh, Edward J. Cone, and Angela 
Sampson-Cone. 2006. ``Effect of Repeated Cocaine Administration on 
Detection Times in Oral Fluid and Urine.'' Journal of Analytical 
Toxicology 30(7): 458-462. https://doi.org/10.1093/jat/30.7.458.
---------------------------------------------------------------------------

Reduced Burdens for Individuals Undergoing Testing

    Oral fluid testing can reduce anxiety, discomfort, and other 
burdens for individuals undergoing testing because it is less intrusive 
and time-consuming than urine testing. For example, while most DOT-
regulated urine tests are unobserved, a small number require direct 
observation. In observed tests, an observer of the same gender as the 
employee watches the employee urinate into the collection container. 
Allowing the alternative of oral fluid testing would reduce discomfort 
and other issues for individuals, including potential civil rights 
issues for transgender or non-binary individuals. Reducing the burdens 
associated with testing may also reduce barriers to transportation 
employment for individuals deterred by current testing requirements.

Regulatory Flexibility Act

    The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.) 
requires Federal agencies to consider the effects of their regulatory 
actions on small businesses and other small entities and minimize any 
significant economic impact.
    The Department does not expect that the rule would have a 
significant economic impact on a substantial number of small entities. 
The rule increases flexibility for small-entity transportation 
employers and drug test collection sites by allowing them to use oral 
fluid testing instead of urine testing to meet DOT testing 
requirements. Oral fluid testing is a voluntary option for the small 
entities. Accordingly, the Department certifies that the rule would not 
have a significant economic impact on a substantial number of small 
entities.

Unfunded Mandates

    The Secretary has examined the impact of the final 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 
section 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 final rule would reduce costs to regulated parties, including State 
and local entities (e.g., 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). This final 
rule amends 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 Department does not anticipate any environmental 
impacts, and there are no extraordinary circumstances present in 
connection with this rulemaking.

Executive Order 13132: Federalism

    The Secretary has analyzed the final 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 final rule does not contain policies that have federalism 
implications.

Executive Order 13175: Consultation and Coordination With Indian Tribal 
Governments

    Executive Order 13175 (65 FR 67249, November 9, 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 final 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.

[[Page 27635]]

Paperwork Reduction Act

    The PRA requires that DOT consider the impact of paperwork and 
other information collection burdens imposed on the public. We will 
need a new data collection section for oral fluid specimens on the U.S. 
Department of Transportation Drug and Alcohol Testing MIS Data 
collection form (OMB No. 2105-0529), which DOT-regulated employers 
currently use to report their urine drug testing data annually. There 
will be no increase in the number of tests conducted. For those 
employers choosing to use oral fluid, in addition to urine testing, 
there will simply be a redistribution of the total number of tests 
split between the drug testing methodologies the employer uses. Thus, 
for the employers who choose to use both methodologies, we expect a 
nominal increase in the burden hours because they will have one more 
simple section to fill out on the form. The information collections for 
oral fluid testing are covered by HHS under OMB Control Number 0930-
0158. Notwithstanding any other provisions of law, no person shall be 
subject to any penalty for failing to comply with a collection of 
information subject to the Paperwork Reduction Act (PRA) that does not 
display a currently valid OMB control number.

Privacy Act

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

International Compatibility and Cooperation

    In keeping with U.S. obligations under the Convention on 
International Civil Aviation (ICAO), it is FAA policy to conform to 
ICAO Standards and Recommended Practices to the maximum extent 
practicable. The FAA has determined that its portion of this final rule 
does not conflict with any international agreement of the United 
States.

List of Subjects

14 CFR Part 120

    Air carriers, Alcoholism, Alcohol abuse, Aviation safety, Drug 
abuse, Drug testing, Operators, Reporting and recordkeeping 
requirements, Safety, Safety-sensitive, Transportation.

49 CFR Part 40

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

49 CFR Part 219

    Alcohol abuse, Drug abuse, Drug testing, Penalties, Railway safety, 
Reporting and record keeping requirements, Safety, Transportation.

49 CFR Part 240

    Administrative practice and procedure, Locomotive engineer, 
Penalties, Railroad employees, Railroad operating procedures, Railroad 
safety, Reporting and recordkeeping requirements.

49 CFR Part 242

    Administrative practice and procedure, Conductors, Penalties, 
Railroad employees, Railroad operating procedures, Railroad safety, 
Reporting and recordkeeping requirements.

49 CFR Part 382

    Administrative practice and procedure, Alcohol abuse, Drug abuse, 
Drug testing, Highway safety, Motor carriers, Penalties, Safety, 
Transportation.

49 CFR Part 655

    Alcohol abuse, Alcohol testing, Drug abuse, Drug testing, Grant 
programs--transportation, Mass transportation, Reporting and 
recordkeeping requirements, Safety, Transportation.

    For the reasons stated in the preamble, the Department amends 14 
CFR chapter 1 and 49 CFR chapters I through III and VI as follows:

Title 14--Aeronautics and Space

PART 120--DRUG AND ALCOHOL TESTING PROGRAM

0
1. The authority citation for part 120 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40101-40103, 40113, 40120, 
41706, 41721, 44106, 44701, 44702, 44703, 44709, 44710, 44711, 
45101-45105, 46105, 46306.


0
2. Revise Sec.  120.7 to read as follows:


Sec.  120.7  Definitions.

    For the purposes of this part, the following definitions apply:
    (a) Accident means an occurrence associated with the operation of 
an aircraft which takes place between the time any individual boards 
the aircraft with the intention of flight and all such individuals have 
disembarked, and in which any individual suffers death or serious 
injury, or in which the aircraft receives substantial damage.
    (b) Alcohol means any substance specified in 49 CFR part 40.
    (c) Alcohol misuse means any prohibited conduct referenced under 
subpart C or D of this part.
    (d) Contractor is an individual or company that performs a safety-
sensitive function by contract for an employer or another contractor.
    (e) Covered employee means an individual who performs, either 
directly or by contract, a safety-sensitive function listed in 
Sec. Sec.  120.105 and 120.215 for an employer (as defined in paragraph 
(g) of this section). For purposes of pre-employment testing only, the 
term ``covered employee'' includes an individual applying to perform a 
safety-sensitive function.
    (f) Employee is an individual who is hired, either directly or by 
contract, to perform a safety-sensitive function for an employer, as 
defined in paragraph (g) of this section. An employee is also an 
individual who transfers into a position to perform a safety-sensitive 
function for an employer.
    (g) Employer is a part 119 certificate holder with authority to 
operate under parts 121 and/or 135 of this chapter, an operator as 
defined in Sec.  91.147 of this chapter, or an air traffic control 
facility not operated by the FAA or by or under contract to the U.S. 
Military. An employer may use a contract employee who is not included 
under that employer's FAA-mandated drug and alcohol testing program to 
perform a safety-sensitive function only if that contract employee is 
included under the contractor's FAA-mandated drug and alcohol testing 
program and is performing a safety-sensitive function on behalf of that 
contractor (i.e., within the scope of employment with the contractor.)
    (h) Hire means retaining an individual for a safety-sensitive 
function as a paid employee, as a volunteer, or through barter or other 
form of compensation.
    (i) Performing (a safety-sensitive function): an employee is 
considered to be performing a safety-sensitive function during any 
period in which he or she is actually performing, ready to perform, or 
immediately available to perform such function.
    (j) Positive rate for random drug testing means the number of 
verified positive results for random drug tests conducted under subpart 
E of this part, plus the number of refusals of random drug tests 
required by subpart E of this part, divided by the total number of 
random drug test results (i.e., positives,

[[Page 27636]]

negatives, and refusals) under subpart E of this part.
    (k) Prohibited drug means any of the drugs specified in 49 CFR part 
40.
    (l) Refusal to submit to alcohol test means that a covered employee 
has engaged in conduct including but not limited to that described in 
49 CFR 40.261, or has failed to remain readily available for post-
accident testing as required by subpart F of this part.
    (m) Refusal to submit to drug test means that a covered employee 
engages in conduct including but not limited to that described in 49 
CFR 40.191.
    (n) Safety-sensitive function means a function listed in Sec. Sec.  
120.105 and 120.215.
    (o) Violation rate for random alcohol testing means the number of 
0.04, and above, random alcohol confirmation test results conducted 
under subpart F of this part, plus the number of refusals of random 
alcohol tests required by subpart F of this part, divided by the total 
number of random alcohol screening tests (including refusals) conducted 
under subpart F of this part.


Sec.  120.111  [Amended]

0
3. Amend Sec.  120.111 in the first sentence of paragraph (d) by adding 
the word ``covered'' before the word ``employee''.


Sec.  120.119  [Amended]

0
4. Amend Sec.  120.119 in the first sentence of paragraph (b) by 
removing ``appendix H'' and adding in its place ``appendix J''.


Sec.  120.219  [Amended]

0
5. Amend Sec.  120.219 in the first sentence of paragraph (b)(2) by 
removing ``appendix H'' and adding in its place ``appendix J''.


Sec.  120.221  [Amended]

0
6. Amend Sec.  120.221 in the first sentence of paragraph (d) by adding 
the word ``covered'' before the word ``employee''.

Title 49--Transportation

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

0
7. 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.

0
8. Amend Sec.  40.3 by:
0
a. Removing the definitions of ``Invalid drug test'' and ``Screening 
drug test'';
0
b. Removing the definition of ``Initial drug test (also known as 
``Screening drug text'') and adding a definition for ``Initial drug 
test'' in its place;
0
c. Removing the definition of ``Limit of Quantification'' and adding a 
definition for ``Limit of Quantification (LOQ)'' in its place;
0
d. Adding in alphabetical order definitions for ``Alternate 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
0
e. Revising the definitions of ``Collection container'', ``Collection 
site'', ``Confirmatory drug test'', ``Initial specimen validity test'', 
``Invalid result'', ``Laboratory'', ``Limit of Detection (LOD)'', 
``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:


Sec.  40.3  What do the terms used in this part mean?

* * * * *
    Alternate 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 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 an HHS-certified in 
accordance with the criteria established by HHS when a positive, 
negative, adulterated, or substituted result cannot be established for 
a specific drug or specimen validity test.
    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. An oral fluid specimen is 
considered to be a direct observation collection for all purposes of 
this part.
* * * * *
    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

[[Page 27637]]

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 State-issued 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.
* * * * *

0
9. Amend Sec.  40.13 by revising paragraphs (b), (c), and (d), 
redesignating paragraphs (e) and (f) as paragraphs (f) and (g), 
respectively, adding new paragraph (e), and adding paragraph (h).
    The revisions and additions to read as follows:


Sec.  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/or 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.
* * * * *

0
10. In Sec.  40.14 by revising paragraph (b) and adding paragraph (k) 
to read as follows:


Sec.  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).

0
11. Amend Sec.  40.21 by:
0
a. Removing the word ``and'' from the end of paragraph (c)(2)(vii)(B);
0
b. Redesignating paragraph (c)(2)(vii)(C) as paragraph (c)(2)(vii)(D); 
and
0
c. Adding a new paragraph (c)(2)(vii)(C).
    The addition reads as follows:


Sec.  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 alternate specimen for the same testing action. 
For a cancelled result, the employee could be required to submit an 
alternate specimen on a re-collection; and
* * * * *

0
12. Amend Sec.  40.23 by revising paragraphs (f) introductory text and 
(f)(1) and (5) to read as follows:


Sec.  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).
* * * * *

0
13. Amend Sec.  40.25 by revising paragraph (a) to read as follows:


Sec.  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

[[Page 27638]]

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 safety-sensitive 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, you must comply with 
the requirements of this section by using the FMCSA's Drug and Alcohol 
Clearinghouse in accordance with 49 CFR 382.71(a). In addition, you 
must continue to comply with the requirements of this Sec.  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 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 paragraphs 
(b) through (j) of this section to satisfy PHMSA's requirements.
* * * * *


Sec.  40.26  [Amended]

0
14. Amend Sec.  40.26 in the second sentence by removing ``Appendix H'' 
and adding in its place ``appendix J''.


Sec.  40.29  [Removed]

0
15. Remove Sec.  40.29.

0
16. Amend Sec.  40.31 by:
0
a. Revising the section heading;
0
b. Revising paragraph (b);
0
c. Redesignating paragraphs (c) and (d) as paragraphs (d) and (e);
0
d, Adding new paragraph (c);
0
e. Revising newly redesignated paragraph (d); and
0
f. Adding paragraph (f).
    The revisions and additions read as follows:


Sec.  40.31  Who may collect specimens for DOT drug testing?

* * * * *
    (b) A urine collector must meet training requirements of Sec.  
40.33.
    (c) An oral fluid collector must meet the training requirements of 
Sec.  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.

0
17. Amend Sec.  40.33 by revising the section heading, introductory 
text, and paragraph (f) introductory text to read as follows:


Sec.  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.
* * * * *


Sec.  40.35  [Redesignated as Sec.  40.36]

0
18. Redesignate Sec.  40.35 as Sec.  40.36.

0
19. Add a new Sec.  40.35 to read as follows:


Sec.  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 ``DOT Oral Fluid Specimen Collection Procedures 
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/get-odapc-email-updates.
    (b) Qualification training. You must receive qualification training 
meeting the requirements of this paragraph (b). Qualification training 
must provide instruction on the following subjects:
    (1) Training on the testing procedures of this part;
    (2) Training to proficiency in the operation of the particular oral 
fluid collection device(s) you will be using.
    (3) All steps necessary to complete a collection correctly and the 
proper completion and transmission of the CCF;
    (4) ``Problem'' collections (e.g., situations like ``dry mouth'' 
and attempts to tamper with a specimen);
    (5) Fatal flaws, correctable flaws, and how to correct problems in 
collections; and
    (6) 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 for each device you will 
use.
    (1) The five mock collections for each device 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. For each of the five mock 
collections, the collector must check the expiration date of the 
device, show it to the employee, and record the date on the CCF used. 
The collector must ensure, when applying the labels, they do not cover 
the expiration dates.

[[Page 27639]]

    (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).
    (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 ``error-free.''
    (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.


Sec.  40.37  [Removed]

0
20. Remove Sec.  40.37.

0
21. Revise the heading for subpart D to read as follows:

Subpart D--Collection Sites, Forms, Equipment and Supplies Used in 
DOT Urine and Oral Fluid Collections


Sec.  40.41  [Redesignated as Sec.  40.42]

0
22. Redesignate Sec.  40.41 as Sec.  40.42.


Sec.  40.45  [Redesignated as Sec.  40.40]

0
23. Redesignate Sec.  40.45 as Sec.  40.40.

0
24. Amend newly redesignated Sec.  40.40 by:
0
a. Revising the section heading and paragraphs (a) and (b), (c) 
introductory text, and (c)(1) through (4); and
0
b. Removing the words ``social security number (SSN) or other employee 
identification (ID) number'' and adding in their place ``SSN or 
Employee ID No.'' in paragraph (d).
    The revisions read as follows:


Sec.  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 (https://www.transportation.gov/odapc) or the HHS website (https://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, company name, or 
post office box. 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, 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 during the collection site's business hours. 
The collector must not provide a number for a call center.
* * * * *


Sec.  40.47  [Redesignated as Sec.  40.41]

0
25. Redesignate Sec.  40.47 as Sec.  40.41.


Sec.  40.41  [Amended]

0
26. Amend newly redesignated Sec.  40.41 in paragraph (a) by removing 
the word ``urine'' wherever it appears.

0
27. Amend Sec.  40.43 by revising the section heading to read as 
follows:


Sec.  40.43  What steps must operators of collection sites and 
collectors take to protect the security and integrity of urine 
collections?

* * * * *


Sec.  40.49  [Redesignated as Sec.  40.44]

0
28. Redesignate Sec.  40.49 as Sec.  40.44.


Sec.  40.51  [Redesignated as Sec.  40.45]

0
29. Redesignate Sec.  40.51 as Sec.  40.45.


[[Page 27640]]



0
30. Add Sec. Sec.  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?
* * * * *


Sec.  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 
Sec.  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.


Sec.  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) Ensure the security of the facility during the collection 
process to maintain 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 Sec.  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 
this paragraph (d).
    (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.


Sec.  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.


Sec.  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 from the collection site 
to the laboratory.

0
31. Revise the heading for subpart E to read as follows:

Subpart E--Specimen Collections


0
32. Amend Sec.  40.61 by revising the section heading and paragraphs 
(a), (b)(1) introductory text, (b)(3) and (4), (e), and (f)(5)(i) to 
read as follows:


Sec.  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, the DER must determine whether 
the employee has refused to test (see Sec. Sec.  40.191(a)(1) and 
40.355(i)). 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 Sec. Sec.  
40.191(a)(1) and 40.355(j)).
    (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

[[Page 27641]]

declines to do so for the urine test, the collector should notify the 
DER of the circumstances, so that the actual 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 (https://www.samhsa.gov/workplace) and DOT (https://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 Sec.  40.67) or an oral fluid specimen 
collection, make a note on the CCF and continue with collection 
process; or
* * * * *

0
33. Amend Sec.  40.63 by revising paragraph (a) to read as follows:


Sec.  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.)
* * * * *

0
34. Amend Sec.  40.65 by revising the section heading and paragraphs 
(b)(5) and (6), and (c)(1) to read as follows:


Sec.  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 Sec.  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 Sec.  
40.67) or an oral fluid collection.
* * * * *

0
35. Amend Sec.  40.67 by:
0
a. Revising the section heading and paragraph (a) introductory text;
0
b. Adding paragraph (a)(4);
0
c. Removing ``paragraphs (a) and (b)'' and adding ``paragraph (a)'' in 
its place in paragraph (c)(1);
0
d. Revising paragraphs (c)(3) and (4);
0
e. Adding paragraph (c)(5);
0
f. Revising paragraph (d)(2);
0
f. Removing ``Sec.  40.67(b)'' and adding in its place ``paragraphs 
(c)(2) through (4) of this section'' in paragraph (e)(2); and
0
g. Revising paragraph (g).
    The revisions and additions read as follows:


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

    (a) As an employer, you must direct an immediate collection under 
direct observation with no advance notice to the employee, if:
* * * * *
    (4) You realize a collection under direct observation was required 
but was not conducted or the service agent informs you that a direct 
observation should have been collected but was not (see paragraph (n) 
of this section).
    (c) * * *
    (3) The temperature on the original specimen was out of range (see 
Sec.  40.65(b)(5));
    (4) The original specimen appeared to have been tampered with (see 
Sec.  40.65(c)(1)); or
    (5) The test reason is return-to-duty or follow-up.
    (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.
    (1) You must never permit an opposite gender person to act as the 
observer.
    (2) The observer can be a different person from the collector and 
need not be a qualified collector.
    (3) If a same gender collector cannot be found or in circumstances 
of nonbinary or transgender employees:
    (i) If the employer has a standing order to allow oral fluid 
testing in such situations, the collector will follow that order;
    (ii) If there is no standing order from the employer, the collector 
must contact the DER and either conduct an oral fluid test if the 
collection site is able to do so, or send the employee to a collection 
site acceptable to the employer for the oral fluid test.
* * * * *

0
36. Amend Sec.  40.69 by:
0
a. Revising the section heading;
0
b. Redesignating paragraphs (a) through (g) as paragraphs (b) through 
(h);
0
c. Adding new paragraph (a); and
0
d. Revising newly redesignated paragraph (e).
    The revisions and addition read as follows:


Sec.  40.69  How is a monitored urine collection conducted?

    (a) As stated in Sec.  40.42(f)(2), if you are conducting a urine 
collection in a multi-stall 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 Sec. Sec.  
40.63(e), 40.65(c), and 40.67(c)(2)(3)).
* * * * *

0
37. Amend Sec.  40.71 by revising the section heading and paragraph 
(b)(1) to read as follows:


Sec.  40.71  How does the collector prepare the urine specimen?

* * * * *
    (b) * * *
    (1) After the collection, check the box on the CCF (Step 2) 
indicating that this was a ``Urine'' and ``Split'' specimen collection.
* * * * *


Sec.  40.73  [Redesignated as Sec.  40.79]

0
38. Redesignate Sec.  40.73 as Sec.  40.79.

[[Page 27642]]


0
39. Add new Sec. Sec.  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?
* * * * *


Sec.  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 collector finds indication(s) of anything identified 
above, the collector will ask the employee to lift their tongue and/or 
separate their cheek from their gum to permit full inspection. If this 
occurs, the employee may cleanse his or her hands, but must not decline 
the collector's request for further inspection.
    (2) 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 Sec.  40.193(a).
    (3) 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 Sec.  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 Sec.  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 a 10-minute wait period and 
proceeds with the steps below before beginning the specimen collection 
as described in Sec.  40.73.
    (d) During the 10-minute wait period:
    (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 provide, or the employee may select, a 
specimen collection device that is clean, unused, and wrapped/sealed in 
original packaging.
    (i) The collector will check the expiration date on the device or 
the package containing the device and show it to the employee.
    (ii) The collector must not use the device after its expiration 
date.
    (iii) The collector must open the specimen collection device in 
view of the employee.
    (4) 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 
the device is within its expiration date.
    (5) The collector will enter the Split Specimen Device Expiration 
Date in Step 4 of the CCF. Since the collector will use one oral fluid 
device that will collect a single specimen, which is then subdivided in 
the presence of the donor, only one entry in Step 4 is to be made for 
the device expiration date.
    (6) The collector must instruct the employee to use hand sanitizer 
or wash and dry his or her hands.
    (e) To the greatest extent practicable, the collector must keep the 
employee's unwrapped collection device within view of both the 
collector and the employee, between the time the employee has provided 
a specimen and the specimen is sealed.


Sec.  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's instructions for the 
collection device.
    (1) Under the observation of the collector, the employee is 
responsible for positioning the specimen collection device for 
collection.
    (2) The collector must ensure the collection is performed correctly 
(i.e., using the oral fluid device in the manner described by its 
manufacturer), that the collection device is working properly, and that 
a sufficient specimen volume is collected.
    (3) If the employee states that he or she is unable to provide an 
oral fluid specimen or provides an insufficient specimen during the 
collection process, the collector must continue to make one attempt to 
collect, after an insufficient specimen, the collector follows the 
procedure in Sec.  40.193.
    (4) 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, the collector 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.


Sec.  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 ``Bottle

[[Page 27643]]

A'', and a volume of at least 1 mL of undiluted (neat) oral fluid is 
collected for the specimen designated as ``Bottle B'', or an otherwise 
sufficient amount of oral fluid is collected to permit an HHS-certified 
laboratory to analyze the specimen(s).
    (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.
    (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.


Sec. Sec.  40.75-40.78  [Reserved]

0
40. Add reserved Sec. Sec.  40.75 through 40.78 to subpart E.

0
41. Amend newly redesignated Sec.  40.79 by revising paragraph (a)(1) 
to read as follows:


Sec.  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.
* * * * *


Sec.  40.81  [Amended]

0
42. Amend Sec.  40.81 in paragraph (a) by removing the words ``all 
testing'' and adding in their place the words ``each specimen testing 
methodology performed''.

0
43. Amend Sec.  40.83 by:
0
a. Removing the word ``urine'' in paragraph (b);
0
b. Removing the word ``urine'' and adding in its place the word 
``specimen'' in paragraph (c)(7);
0
c. Adding paragraphs (c)(8) and (9);
0
d. Adding the word ``urine'' before the word ``specimen'' in paragraph 
(f) introductory text;
0
e. Removing ``40.45(a)'' and adding in its place ``40.40(a)'' in 
paragraph (g) introductory text;
0
f. Removing the word ``urine'' and adding in its place the word 
``specimen'' in paragraphs (h)(1)(i), (iii), and (iv); and
0
g. Removing ``(g)(1)'' and adding in its place ``(h)(1)'' in paragraph 
(h)(2).


Sec.  40.83  How do laboratories process incoming specimens?

* * * * *
    (c) * * *
    (8) For an oral fluid collection, the collector used an expired 
device at the time of collection.
    (9) For an oral fluid collection, if the collector failed to enter 
the expiration date in Step 4 of the CCF and the laboratory is unable 
to determine the expiration date by inspecting Bottles A and B.
* * * * *


Sec.  40.85  [Redesignated as Sec.  40.82]

0
44. Redesignate Sec.  40.85 as Sec.  40.82.


Sec.  40.99  [Redesignated as Sec.  40.84]

0
45. Redesignate Sec.  40.99 as Sec.  40.84.


Sec.  40.87  [Redesignated as Sec.  40.85]

0
46. Redesignate Sec.  40.87 as Sec.  40.85.

0
47. Amend newly redesignated Sec.  40.85 by revising the section 
heading and footnote 2 to read as follows:


Sec.  40.85  What are the cutoff concentrations for urine drug tests?

* * * * *
    \2\ An immunoassay must be calibrated with a target analyte.
* * * * *


Sec.  40.89  [Redesignated as Sec.  40.86]

0
48. Redesignate Sec.  40.89 as Sec.  40.86.

0
49. Amend newly redesignated Sec.  40.86 by revising the section 
heading to read as follows:


Sec.  40.86  What is urine validity testing, and are laboratories 
required to conduct it?

* * * * *


Sec.  40.91  [Redesignated as Sec.  40.87]

0
50. Redesignate Sec.  40.91 as Sec.  40.87.

0
51. Amend newly redesignated Sec.  40.87 by revising the section 
heading, and in the introductory text, removing ``Sec.  40.89'' and 
adding in its place ``Sec.  40.86''.
    The revision reads as follows:


Sec.  40.87  What validity tests must laboratories conduct on primary 
urine specimens?

* * * * *


Sec.  40.93  [Redesignated as Sec.  40.88]

0
52. Redesignate Sec.  40.93 as Sec.  40.88.

0
53. Amend newly redesignated Sec.  40.88 by revising the section 
heading to read as follows:


Sec.  40.88  What criteria do laboratories use to establish that a 
urine specimen is dilute or substituted?

* * * * *


Sec.  40.95  [Redesignated Sec.  40.89]

0
54. Redesignate Sec.  40.95 as Sec.  40.89.

0
55. Amend newly redesignated Sec.  40.89 by revising the section 
heading to read as follows:


Sec.  40.89  What are the adulterant cutoff concentrations for initial 
and confirmation urine tests?

* * * * *


Sec.  40.96  [Redesignated as Sec.  40.90]

0
56. Redesignate existing Sec.  40.96 as Sec.  40.90.

0
57. Amend newly redesignated Sec.  40.90 by revising the section 
heading to read as follows:


Sec.  40.90  What criteria do laboratories use to establish that a 
urine specimen is invalid?

* * * * *

0
58. Add new Sec. Sec.  40.91 through 40.93 to read as follows:
* * * * *
Sec.
40.91 What are the cutoff concentrations for 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?
* * * * *


Sec.  40.91  What are the cutoff concentrations for oral fluid drug 
tests?

    As a laboratory, you must use the cutoff concentrations displayed 
in the following table for initial and confirmatory drug tests for oral 
fluid specimens. All cutoff concentrations are expressed in nanograms 
per milliliter (ng/mL). The table follows:

[[Page 27644]]



                        Table 1 to Sec.   40.91--Oral Fluid Testing Cutoff Concentrations
----------------------------------------------------------------------------------------------------------------
                                                                  Confirmatory test     Confirmatory test cutoff
       Initial test analyte           Initial test cutoff \1\          analyte               concentration
----------------------------------------------------------------------------------------------------------------
Marijuana (THC) \2\...............  4 ng/mL \3\...............  THC..................  2 ng/mL.
Cocaine/Benzoylecgonine...........  15 ng/mL..................  Cocaine..............  8 ng/mL.
                                    ..........................  Benzoylecgonine......  8 ng/mL.
Codeine/Morphine..................  30 ng/mL..................  Codeine..............  15 ng/mL.
                                    ..........................  Morphine.............  15 ng/mL.
Hydrocodone/Hydromorphone.........  30 ng/mL..................  Hydrocodone..........  15 ng/mL.
                                    ..........................  Hydromorphone........  15 ng/mL.
Oxycodone/Oxymorphone.............  30 ng/mL..................  Oxycodone............  15 ng/mL.
                                    ..........................  Oxymorphone..........  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..........  25 ng/mL.
                                    ..........................  Methamphetamine......  25 ng/mL.
MDMA \4\/MDA \5\..................  50 ng/mL..................  MDMA.................  25 ng/mL.
                                    ..........................  MDA..................  25 ng/mL.
----------------------------------------------------------------------------------------------------------------
\1\ For 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.
\2\ An immunoassay must be calibrated with the target analyte.
\3\ Alternate 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).

Sec.  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.


Sec.  40.93  What validity tests must laboratories conduct on primary 
oral fluid specimens?

    As a laboratory, if you conduct validity testing under Sec.  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.

0
59. Revise Sec.  40.97 to read as follows:


Sec.  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

[[Page 27645]]

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.
    (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 Sec.  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.

0
60. Amend Sec.  40.111 by revising paragraphs (a) introductory text and 
(d) to read as follows:


Sec.  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 reporting period in which you 
conducted DOT-regulated testing.


Sec.  40.121  [Amended]

0
61. Amend Sec.  40.121 in paragraph (c)(1)(i) by removing the word 
``urine''.


Sec.  40.123  [Amended]

0
62. Amend Sec.  40.123 in paragraph (c) by removing the words ``invalid 
drug tests results'' and adding in their place ``invalid results''.


Sec.  40.127  [Amended]

0
63. Amend Sec.  40.127 in the second sentence of paragraph (g)(2) by 
adding the words ``of all specimen types combined'' before the words 
``in any quarter''.


Sec.  40.129  [Amended]

0
64. Amend Sec.  40.129 in paragraph (a) introductory text by removing 
the words ``invalid drug tests'' and adding in their place ``invalid 
results'', in paragraph (b) by removing the words ``text cancelled'', 
and in paragraph (d) by removing ``drug test report'' and adding 
``result'' in its place.


Sec.  40.135  [Amended]

0
65. Amend Sec.  40.135 in paragraph (d) introductory text by removing 
the word ``test'' after the word ``invalid'' and adding in its place 
the word ``result''.

0
66. Amend Sec.  40.139 by revising paragraph (b) and in paragraph (c) 
introductory text by removing the word ``urine''.
    The revision reads as follows:


Sec.  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 Sec.  40.137). 
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.
* * * * *

0
67. Amend Sec.  40.141 by revising paragraph (b) to read as follows:


Sec.  40.141  How does the MRO obtain information for the verification 
decision?

* * * * *
    (b) If the employee asserts that the presence of a drug or drug 
metabolite in his or her specimen results from taking prescription 
medication (i.e., a legally valid prescription consistent with the 
Controlled Substances Act), you must review and take all reasonable and 
necessary steps to verify the authenticity of all medical records the 
employee provides.
    (1) You may contact the employee's physician or other relevant 
medical personnel for further information.
    (i) If you decide to contact the employee's pharmacy to 
authenticate whether the prescription offered by the employee was 
filled by the pharmacy,

[[Page 27646]]

you or staff under your operational control can contact the pharmacy.
    (ii) If you utilize staff to perform the inquiry in paragraph 
(b)(1)(i) of this section, you must ensure operational control over the 
hiring, firing, evaluation of the staff and you must oversee the 
performance of the function of contacting a pharmacy to authenticate 
specific prescription(s) (e.g., outline or script what the staff will 
ask the pharmacy; occasionally monitor calls to assure quality control; 
or other methods to ensure the staff are properly conducting the calls 
with the pharmacies).
    (2) You may request an HHS-certified laboratory with validated 
protocols (see Sec.  40.81(c)) to conduct testing for D,L stereoisomers 
of amphetamine and methamphetamine or testing for 
tetrahydrocannabivarin (THC-V) when verifying lab results, as you 
determine necessary.


Sec.  40.145  [Amended]

0
68. Amend Sec.  40.145 in the last sentence of paragraph (g)(3) by 
removing the word ``urine'' and adding the word ``drug'' in its place 
and in paragraph (h) introductory text by adding the word ``urine'' 
before the word ``result''

0
69. Amend Sec.  40.151 by revising paragraphs (a), (b), (g), and (i) to 
read as follows:


Sec.  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.

0
70. Amend Sec.  40.159 by revising paragraphs (a)(1) and (a)(5)(ii) to 
read as follows:


Sec.  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 Sec. Sec.  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 place immediately 
under direct observation. Recommend to the employer that an alternate 
specimen should be collected if practicable (e.g., oral fluid, if the 
specimen was urine).
* * * * *

0
71. Amend Sec.  40.161 by revising paragraphs (a) and (c) to read as 
follows:


Sec.  40.161  What does the MRO do when a drug test specimen is 
rejected for testing?

* * * * *
    (a) Place a check mark in the ``Test Cancelled'' box (Step 6) on 
Copy 2 (or a legible copy of Copy 3-5) of the CCF and enter the reason 
on the ``Remarks'' line. If you do not have Copy 2 (or a legible copy 
of Copy 3-5), then enter ``Test Cancelled'' and the reason for the 
cancellation on a report in the format required under Sec.  40.163(c).
* * * * *
    (c) You may only report a test cancelled because of a ``rejected 
for testing'' laboratory result when you are in possession of a legible 
copy of Copy 1 of the CCF. In addition, you must have Copy 2 of the 
CCF, a legible copy of it, or any other copy of the CCF containing the 
employee's signature. If you do not have Copy 2 (or a legible copy of 
Copy 3-5), then enter ``Test Cancelled'' and the reason for the 
cancellation on a report in the format required under Sec.  40.163(c).

0
72. Amend Sec.  40.163 in paragraph (c)(2) by removing the words 
``donor SSN or employee ID number'' and adding in their place the words 
``SSN or employee ID No.'' and by revising paragraph (e).
    The revision reads as follows:


Sec.  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).
* * * * *

0
73. Amend Sec.  40.177 by revising paragraphs (a) through (c) to read 
as follows:


Sec.  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 Sec.  40.85 or Sec.  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 Sec.  40.87 or Sec.  40.93, as 
applicable.
* * * * *


Sec.  40.179  [Amended]

0
74. Amend Sec.  40.179 in paragraph (a) by removing ``Sec.  40.95'' and 
adding in its place ``Sec.  40.89 or Sec.  40.93, as applicable''.

0
75. Revise Sec.  40.181 to read as follows:


Sec.  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 Sec.  40.88.


Sec.  40.187  [Amended]

0
76. Amend Sec.  40.187 in paragraphs (b)(1), (c)(1)(iii), and 
(c)(2)(iii) by removing ``Appendix D'' and adding in

[[Page 27647]]

its place ``appendix F'' and in paragraph (e)(3) by removing ``appendix 
D'' and adding in its place ``appendix F''.

0
77. Amend Sec.  40.191 by revising paragraphs(a)(2) through (11), (c), 
and (d)(1) to read as follows:


Sec.  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 Sec.  40.63(c) or Sec.  
40.72(e), as applicable) for a pre-employment test is not deemed to 
have refused to test. The collector is not required to inform an 
employee that the failure to remain at the collection site is a 
refusal. If an employee leaves prior to the completion of the testing 
process, per Sec.  40.355(i) the employer must decide whether the 
employee's actions constitute a refusal;
    (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 Sec.  40.63(c) or Sec.  40.72(e), as 
applicable) for a pre-employment test is not deemed to have refused to 
test. The collector is not required to inform an employee that the 
failure to remain at the collection site is a refusal. If an employee 
leaves prior to the completion of the testing process, per Sec.  
40.355(i) the employer must decide whether the employee's actions 
constitute a refusal;
    (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 Sec. Sec.  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 Sec.  
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, Sec.  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 Sec.  40.193(c). In the case of a pre-employment 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;
    (10) Possess or wear a prosthetic or other device that could be 
used to interfere with the collection process; or
    (11) Admit to the collector or MRO that you adulterated or 
substituted the specimen.
* * * * *
    (c) As an employee, if you refuse to take a drug test, you incur 
the consequences specified under DOT agency regulations for a violation 
of those DOT agency regulations. The consequences specified under DOT 
agency regulations for a refusal cannot be overturned or set aside by 
an arbitration, grievance, State court or other non-Federal forum that 
adjudicates the personnel decisions the employer has taken against the 
employee.
    (d) * * *
    (1) As the collector, you must note the actions that may constitute 
a 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 
Sec.  40.355(i), the employer has a non-delegable duty to make the 
decision about whether the employee has refused to test.
* * * * *

0
78. Revise Sec.  40.193 to read as follows:


Sec.  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 2mL 
oral fluid in a single sampling, as applicable) you, as the collector, 
must provide another opportunity to the employee to do so. In 
accordance with the employer's instructions, this can be done using the 
same specimen type as the original collection or this can be done by a 
collector qualified to use an alternate specimen collection for this 
purpose.
    (1) If you change to an alternate specimen collection at this point 
(i.e., from urine to oral fluid; or from oral fluid to urine), the next 
collection begins under Sec.  40.61(e) for urine or Sec.  40.72 for 
oral fluid collection.
    (i) If you proceed with an alternate specimen collection, discard 
the insufficient specimen and proceed with the next specimen 
collection.
    (ii) If you proceed with an alternate specimen collection, discard 
the CCF for the insufficient specimen and begin a new CCF for the next 
specimen collection with a notation in the remarks section of the new 
CCF.
    (b)(1) As the collector, you must do the following when continuing 
with a urine specimen collection under this section:
    (i) Discard the insufficient specimen, except where the 
insufficient specimen was out of temperature range or showed evidence 
of adulteration or tampering (see Sec.  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.
    (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 Sec.  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

[[Page 27648]]

because the employee did not provide a second sufficient specimen.
    (2) As the collector, you must do the following when continuing 
with an oral fluid specimen collection under this section:
    (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.
    (3) 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 urine (see paragraph (b)(1) of 
this section) or oral fluid (see paragraph (b)(2) of this section) 
sufficient specimen, but not both. The evaluation and MRO determination 
required by this section only applies to the oral fluid or the urine 
insufficient specimen that was the final methodology at the collection 
site. (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 pre-employment, return-to-duty, or follow-up 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 Sec.  
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.

0
79. Amend Sec.  40.195 by revising the section heading to read as 
follows:


Sec.  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?

* * * * *

0
80. Amend Sec.  40.197 by revising the section heading to read as 
follows:


Sec.  40.197  What happens when an employer receives a report of a 
dilute urine specimen?

* * * * *

0
81. Amend Sec.  40.199 by revising paragraph (b)(7) and adding 
paragraphs (b)(8) and (9) to read as follows:


Sec.  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 Sec.  40.83(h)).
    (8) For an oral fluid collection, the collector used an expired 
device at the time of collection.
    (9) For an oral fluid collection, the collector failed to enter the 
expiration date in Step 4 of the CCF and the laboratory confirmed that 
the device was expired.
* * * * *


Sec.  40.201  [Amended]

0
82. Amend Sec.  40.201 in the first sentence of paragraph (f) by 
removing the word ``urine'' and adding in its place the word 
``specimen''.

0
83. Amend Sec.  40.207 by adding paragraph (d) to read as follows:


Sec.  40.207  What is the effect of a cancelled drug test?

* * * * *

[[Page 27649]]

    (d) If a test is cancelled for a correctible flaw (i.e., Sec.  
40.203 or Sec.  40.205), 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. An MRO must 
not reverse the cancellation of a test that the laboratory has reported 
as rejected for testing, as described in Sec.  40.83(g). A laboratory 
is not authorized to reverse a cancellation due to a fatal flaw, as 
described in Sec.  40.199.

0
84. Revise Sec.  40.208 to read as follows:


Sec.  40.208  What problems require corrective action but do not result 
in the cancellation of a test?

    (a) If, as a laboratory, collector, employer, or other person 
implementing the DOT drug testing program, you become aware that any of 
the following omissions listed in paragraphs (a)(1) through (3) of this 
section occurred, you must take corrective action, including securing a 
memorandum for the record explaining the problem and taking appropriate 
action to ensure the problem does not recur:
    (1) For a urine collection, the specimen temperature on the CCF was 
not checked and the ``Remarks'' line did not contain an entry regarding 
the temperature being out of range; or
    (2) For an oral fluid collection, the collector failed to check the 
box in Step 2 of the CCF that indicates ``Each Device was Within 
Expiration Date'' but the collector entered the ``Split Specimen Device 
Expiration Date'' in Step 4 of the CCF.
    (3) For an oral fluid collection, the collector erred by entering 
the expiration date as the ``Primary/Single Specimen Device Expiration 
Date'' instead of entering the date as the ``Split Specimen Device 
Expiration Date'' in Step 4 of the CCF.
    (b) The errors listed in paragraph (a) of this section do not 
result in the cancellation of the test.
    (c) As an employer or service agent, the errors listed in paragraph 
(a) of this section, even though not sufficient to cancel a drug test 
result, may subject you to enforcement action under DOT agency 
regulations or subpart R of this part.
0
85. Amend Sec.  40.209 in paragraph (b)(1) by removing ``social 
security number'' and adding in its place ``SSN or Employee ID No.'', 
in paragraph (b)(3) by removing ``(see Sec.  40.33)'' and adding in its 
place ``(see Sec. Sec.  40.33 or 40.35)'', in paragraph (b)(7) by 
removing ``Sec.  40.41'' and adding in its place ``Sec.  40.42'', and 
by adding paragraph (b)(11).
    The addition reads as follows:


Sec.  40.209  What procedural problems do not result in cancellation of 
a test and do not require correction?

* * * * *
    (b) * * *
    (11) The failure to use a new CCF for a second collection after an 
insufficient specimen was conducted under a different methodology 
(e.g., failing to use a new CCF for an oral fluid test after an 
insufficient quantity of urine was produced on a urine test.)
* * * * *

0
86. Revise Sec.  40.210 to read as follows:


Sec.  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 (i.e., through a standing order or a discussion with the 
collector) or its service agent (i.e., if there is no standing order 
and the service agent cannot contact the DER) to complete the 
collection process for the testing event. Only urine and oral fluid 
specimens screened and confirmed at HHS-certified laboratories (see 
Sec.  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.


Sec.  40.225  [Amended]

0
87. Amend Sec.  40.225 in paragraph (a) by removing ``Appendix G'' and 
adding in its place ``appendix I''.

0
88. Amend Sec.  40.261 by revising paragraphs (a)(2) and (3) and (b), 
redesignating paragraph (c) as paragraph (c)(1), and adding paragraph 
(c)(2)
    The revisions and addition read as follows.


Sec.  40.261  What is a refusal to take an alcohol test?

* * * * *
    (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 Sec.  40.243(a)) for a pre-
employment test is not deemed to have refused to test. The BAT or STT 
is not required to inform an employee that the failure to remain at the 
collection site is a refusal. If an employee leaves prior to the 
completion of the testing process, per Sec.  40.355(i) the employer 
must decide whether the employee's actions constitute a refusal;
    (3) Fail to provide an adequate amount of saliva or breath for any 
alcohol test required by this part or DOT agency regulations; Provided 
that an employee who does not provide an adequate amount of breath or 
saliva because he or she has left the testing site before the testing 
process commences (see Sec.  40.243(a)) for a pre-employment test is 
not deemed to have refused to test. The BAT or STT is not required to 
inform an employee that the failure to remain at the collection site is 
a refusal. If an employee leaves prior to the completion of the testing 
process, per Sec.  40.355(i) the employer must decide whether the 
employee's actions constitute a refusal;
* * * * *
    (b) As an employee, if you refuse to take an alcohol test, you 
incur the same consequences specified under DOT agency regulations for 
a violation of those DOT agency regulations. The consequences specified 
under DOT agency regulations for a refusal cannot be overturned or set 
aside by an arbitration, grievance, State court or other non-Federal 
forum that adjudicates the personnel decisions the employer has taken 
against the employee.
    (c) * * *
    (2) As the BAT or STT, you must note the actions that may 
constitute a 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 has the sole responsibility to decide whether a refusal 
occurred, as stated in Sec.  40.355(i), the employer has a non-
delegable duty to make the decision about whether the employee has 
refused to test.
* * * * *

0
89. Amend Sec.  40.281 by adding paragraph (f) to read as follows:

[[Page 27650]]

Sec.  40.281  Who is qualified to act as a SAP?

* * * * *
    (f) Limitation. If you are an otherwise qualified SAP under this 
part, you must abide by the geographic limitations applicable to your 
credential when performing remote evaluations. You must not conduct an 
evaluation that exceeds your geographic limitations.


Sec.  40.283  [Amended]

0
90. Amend Sec.  40.283 in paragraph (c) by removing ``Appendix E'' and 
adding in its place ``appendix G''.


Sec.  40.285  [Amended]

0
91. Amend Sec.  40.285 in paragraph (b) by removing the word ``urine''.

0
92. Amend Sec.  40.291 by revising paragraphs (a)(1) and (3) to read as 
follows:


Sec.  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. At the SAP's discretion, this assessment 
or evaluation may be performed face-to-face in-person or remotely. If a 
SAP is not prohibited from using technology within the parameters of 
the SAP's State-issued license or other credential(s), a remote 
evaluation must be must be conducted in accordance with the following 
criteria:
    (i) The technology must permit real-time 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 an in-person face-to-face interaction, while 
providing security to protect the confidentiality of the communications 
at the level expected by industry standards for remote substance abuse 
evaluations.
* * * * *
    (3) Conducting a follow-up 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 in-person or remotely. A face-to-face remote 
evaluation must meet the criteria in paragraphs (a)(1)(i) and (ii) of 
this section.
* * * * *

0
93. Amend Sec.  40.293 by:
0
a. Removing the words ``face-to-face'', and after the words ``clinical 
evaluation,'' adding the words ``meeting the requirements of Sec.  
40.291(a)(1)'' in paragraph (a);
0
b. Redesignating paragraphs (e) through (g) as paragraphs (f) through 
(h); and
0
c. Adding new paragraph (e).
    The addition reads as follows:


Sec.  40.293  What is the SAP's function in conducting the initial 
evaluation of an employee?

* * * * *
    (e) You must assess and clinically evaluate each employee on an 
individual basis and use your professional judgment to determine 
education and/or treatment, as well as a follow-up testing plan unique 
to the needs of the individual employee. For example, do not require 
the same and/or substantially similar education, treatment, and/or 
follow-up testing plan for most of the employees you assess.
* * * * *

0
94. Amend Sec.  40.297 by adding paragraph (c) to read as follows:


Sec.  40.297  Does anyone have the authority to change an SAP's initial 
evaluation?

* * * * *
    (c) The SAP, who is otherwise fully qualified under this subpart, 
must not perform evaluations outside the geographic jurisdiction for 
their credential(s). If the SAP who made the evaluation exceeds their 
geographic jurisdiction, the employee will not be required to seek the 
evaluation of a second SAP.


Sec.  40.301  [Amended]

0
95. Amend Sec.  40.301 in paragraph (b)(2) by removing the words 
``face-to-face'', and after the words ``clinical interview'', adding 
the words ``meeting the requirements of Sec.  40.291(a)(1)''.

0
96. Amend Sec.  40.305 by adding paragraph (d) to read as follows:


Sec.  40.305  How does the return-to-duty process conclude?

* * * * *
    (d) As the employer, if a SAP who is otherwise fully qualified 
under this subpart performed a remote evaluation of the employee 
outside the geographic jurisdiction for their credential(s), the 
employee who they evaluated will not be required to seek the evaluation 
of a second SAP. If you decide that you want to permit the employee to 
return to the performance of safety-sensitive functions, you will 
proceed with the requirements of paragraph (a) of this section.

0
97. Amend Sec.  40.307 by adding paragraph (g) to read as follows:


Sec.  40.307  What is the SAP's function in prescribing the employee's 
follow-up tests?

* * * * *
    (g) As the employer, SAP, or other service agent, you must not 
provide to the employee a copy of their drug and/or alcohol follow-up 
testing schedule prescribed by the SAP. No employer, SAP, or other 
service agent will indicate to the employee what the frequency or 
duration of the employee's follow-up testing schedule will be. The SAP 
can require follow-up testing for either or both drugs and alcohol for 
a drug-related or an alcohol-related violation.


Sec.  40.311  [Amended]

0
98. Amend Sec.  40.311 in paragraphs (c)(4), (d)(4), and (e)(4) after 
the word ``Date(s)'' by adding the words ``and format (i.e., face-to-
face or remote)'' and in paragraphs (c)(1), (d)(1), and (e)(1) by 
removing ``SSN'' and adding in its place ``SSN or employee ID No.''.

0
99. Amend Sec.  40.327 by:
0
a. Removing the reference ``paragraph (c)'' and adding in its place 
``paragraph (d)'' in paragraph (a) introductory text;
0
b. Redesignating paragraph (c) as paragraph (d); and
0
c. Adding a new paragraph (c).
    The addition reads as follows:


Sec.  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 that the employee disclosed to the MRO).
* * * * *


Sec.  40.345  [Amended]

0
100. Amend Sec.  40.345 in paragraph (b) by removing ``Appendix F'' and 
adding in its place ``appendix H''.


Sec.  40.355  [Amended]

0
101. Amend Sec.  40.355 in Example 3 to paragraph (n) by removing the 
word ``urine''.


Sec.  40.365  [Amended]

0
102. Amend Sec.  40.365 in paragraph (b)(8) by removing the words 
``face-to-

[[Page 27651]]

face interviews'' and adding in their place the words ``without 
interviews meeting the requirements of Sec.  40.291(a)(1)''.

Appendices E Through H to Part 40 [Redesignated as Appendices G Through 
J to Part 40]

0
103. 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]

0
104. Redesignate appendix C to part 40 as appendix E to part 40.

Appendix C to Part 40 [Reserved]

0
105. Add reserved appendix C to part 40.

Appendix D to Part 40 [Redesignated as Appendix F to Part 40]

0
106. Redesignate appendix D to part 40 as appendix F to part 40.

Appendix B to Part 40 [Redesignated as Appendix D to Part 40]

0
107. Redesignate appendix B to part 40 as appendix D to part 40.

0
108. 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 device, which can be subdivided in the employee's 
presence into an ``A'' specimen and a ``B'' split specimen bottle 
sufficient for laboratory testing, that is either of the following:
    (1) An oral fluid collection device made to collect a sufficient 
amount of oral fluid to permit an HHS-certified laboratory to 
analyze the specimen(s). For example, a device that directs the oral 
fluid into two separate collection bottles.
    (2) A device that uses buffering solution that collects a 
specimen using a single pad or dual pads joined for insertion 
together into the same region of the mouth, which can be subdivided 
into two separate collection bottles. Such a buffered device may use 
a diluent (or other component, process, or method that modifies the 
volume of the testable specimen). The volume specifications for the 
device must be consistent with those set by HHS.
    b. Must have unit markings or other indicators that demonstrate 
the adequacy of the volume of oral fluid specimen collected.
    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 sent to the laboratory (i.e., the shortest expiration date 
of any component).
    f. Must not have components that substantially affect the 
composition of drugs and/or drug metabolites in the oral fluid 
specimen and/or interfere with an accurate analysis of the specimen.
    g. Must maintain the integrity of the specimen during storage 
and transport so the specimen can be tested in an HHS-certified 
laboratory.
    h. Must be designed so that the required tamper-evident bottle 
seals made available on the CCF fit without concealing the 
expiration date on the bottles, without damage to the seal when the 
collector dates and the employee initials it.
    i. Must be approved by HHS for use by the specific HHS-certified 
laboratory that will test the specimen gathered by this device.

2. Instructions

    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 the 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, as applicable.
    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.

0
109. 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)

[[Page 27652]]

    (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)

0
110. 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: [email protected]
    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, Return-to-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)


0
111. Revise newly redesignated appendix F to part 40 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-split-specimen-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-to-reconfirm 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]

0
112. Amend newly redesignated appendix H under ``Drug Testing 
Information'' by removing the reference ``Sec.  40.129(d)'' and adding 
in its place the reference ``Sec.  40.129(e)''.

PART 219--CONTROL OF ALCOHOL AND DRUG USE

0
113. The authority citation for part 219 continues to read as follows:

    Authority: 49 U.S.C. 20103, 20107, 20140, 21301, 21304, 21311; 
28 U.S.C. 2461 note; Div. A, Sec. 412, Public Law 110-432, 122 Stat. 
4889 (49 U.S.C. 20140 note); Sec. 8102, Public Law 115-271, 132 
Stat. 3894; and 49 CFR 1.89.


Sec.  219.4  [Amended]

0
114. Amend Sec.  219.4 in paragraphs (a) introductory text and (b)(1) 
and (2) by removing the term ``return-to-service'' and adding in its 
place the term ``return-to-duty'' and in paragraph (b)(2) by removing 
``paragraph (d) of this section'' and adding ``Sec.  219.104(d)''.


Sec.  219.11  [Amended]

0
115. Amend Sec.  219.11 in paragraph (a)(2) by removing the word 
``urine'' and adding in its place ``body fluid'' and in paragraph (h) 
by removing the words ``urine or blood'' and adding in their place the 
words ``body fluid'' and by adding ``or oral fluid from a sampling'' 
after the word ``void''.


Sec.  219.617  [Amended]

0
116. Amend Sec.  219.617 in paragraph (b)(2) by removing the word 
``urine'' and adding in its place ``body fluid''.


Sec.  219.619  [Amended]

0
117. Amend Sec.  219.619 by removing the word ``urine'' and adding in 
its place ``body fluid'' in two places.


Sec.  219.621  [Amended]

0
118. Amend Sec.  219.621 in paragraph (a) by removing the word 
``urine'' and adding in its place ``body fluid''.


Sec.  219.903  [Amended]

0
119. Amend Sec.  219.903 in paragraph (a) by removing the word 
``urine'' and adding in its place ``body fluid''.

PART 240--QUALIFICATION AND CERTIFICATION OF LOCOMOTIVE ENGINEERS

0
120. The authority citation for part 240 continues to read as follows:

    Authority:  49 U.S.C. 20103, 20107, 20135, 21301, 21304, 21311; 
28 U.S.C. 2461 note; and 49 CFR 1.89.


Sec.  240.119  [Amended]

0
121. Amend Sec.  240.119 in paragraphs (e)(4)(iv)(A) and (f)(1)(iii) by 
removing the word ``urine'' and adding in its place ``body fluid''.

PART 242--QUALIFICATION AND CERTIFICATION OF CONDUCTORS

0
122. The authority citation for part 242 continues to read as follows:

    Authority:  49 U.S.C. 20103, 20107, 20135, 20138, 20162, 20163, 
21301, 21304, 21311; 28 U.S.C. 2461 note; and 49 CFR 1.89.


Sec.  242.115  [Amended]

0
123. Amend Sec.  242.115 in paragraphs (e)(4)(iv)(A) and (f)(1)(iii) by 
removing the word ``urine'' and adding in its place ``body fluid''.

PART 382--CONTROLLED SUBSTANCES AND ACOHOL USE AND TESTING

0
124. The authority citation for part 382 continues to read as follows:

    Authority:  49 U.S.C. 31133, 31136, 31301 et seq., 31502; sec. 
32934 of Public Law 112-141, 126 Stat. 405, 830; and 49 CFR 1.87.

[[Page 27653]]

Sec.  382.107  [Amended]

0
128. Amend Sec.  382.107:
0
a. In the definitions of ``Confirmation (or confirmatory) drug test'' 
and ``Confirmation (or confirmatory) validity'' by adding ``or oral 
fluid'' after the word ``urine'';
0
b. In the definition of ``Controlled substances'' by removing ``Sec.  
40.85'' and adding in its place ``Sec.  40.82'';
0
c. In paragraphs (3) and (5) to the definition of ``Refuse to submit 
(to an alcohol or controlled substances test'' by adding ``or oral 
fluid'' after the word ``urine'' each place it appears; and
0
d. In paragraph (1) to the definition of ``Screening test (or initial 
test)'' by adding ``or oral fluid'' after the word ``urine''.


Sec.  382.401  [Amended]

0
129. Amend Sec.  382.401 in paragraph (b)(3) by adding the words ``and 
MRO reversal of canceled controlled substances test results'' after the 
words ``canceled controlled substances test results'' and in paragraph 
(c)(1)(vii) by adding ``or oral fluid'' after the word ``urine''.


Sec.  382.403  [Amended]

0
130. Amend Sec.  382.403 in the third sentence of paragraph (b) by 
removing ``appendix H'' and adding in its place ``appendix J''.


Sec.  382.409  [Amended]

0
131. Amend Sec.  382.409 in paragraph (b) by adding the words ``and MRO 
reversal of cancelled controlled substances test results'' after the 
words ``test results''.


Sec.  382.705  [Amended]

0
132. Amend Sec.  382.705 in paragraph (a)(2)(vii)(D) by adding ``or 
oral fluid'' after the word ``urine''.

PART 655--PREVENTION OF ALCOHOL MISUSE AND PROHIBITED DRUG USE IN 
TRANSIT OPERATIONS

0
133. The authority citation for part 655 continues to read as follows:

    Authority:  49 U.S.C. 5331; 49 CFR 1.91.


Sec.  655.5  [Amended]

0
134. Amend Sec.  655.5 in paragraph (c) by removing ``400 Seventh 
Street SW'' and adding in its place ``1200 New Jersey Ave. SE''.


Sec.  655.15  [Amended]

0
135. Amend Sec.  655.15 in paragraph (e) by removing the word 
``illegal'' and adding in its place the word ``prohibited''.


Sec.  655.44  [Amended]

0
136. Amend Sec.  655.44 in paragraph (a)(1)(i) by removing 
``389.303(a)(1) or (b)(1)'' and adding in its place ``Sec.  382.303''.


Sec.  655.47  [Amended]

0
137. Amend Sec.  655.47 by adding the word ``covered'' before the word 
``employee''.


Sec.  655.53  [Amended]

0
138. Amend Sec.  655.53 by removing the words ``collection person'' and 
by adding ``or oral fluid collector'' after the word ``urine''.


Sec.  655.61  [Amended]

0
139. Amend Sec.  655.61 in paragraph (a)(3) by removing the words ``an 
employee'' and adding in their place the words ``a covered employee''.


Sec.  655.71  [Amended]

0
140. Amend Sec.  655.71 in paragraph (c)(1)(v) by adding the words ``or 
oral fluid'' after the word ``urine'' and removing the word ``breathe'' 
and adding in its place ``breath''.

    Signed in Washington, DC, on or around April 7, 2023.
Peter Paul Montgomery Buttigieg,
Secretary of Transportation.
    Signed in Washington, DC, on or around April 7, 2023.
Billy Nolen,
Acting Administrator, Federal Aviation Administration.
[FR Doc. 2023-08041 Filed 5-1-23; 8:45 am]
BILLING CODE 4910-9X-P


