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Rule2023-08041

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

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Published

May 2, 2023

Effective

June 1, 2023

Issuing agencies

Transportation DepartmentFederal Aviation AdministrationFederal Railroad AdministrationFederal Motor Carrier Safety AdministrationFederal Transit Administration

Abstract

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.

Full Text

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<title>Federal Register, Volume 88 Issue 84 (Tuesday, May 2, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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

[[Page 27596]]

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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;
<a href="/cdn-cgi/l/email-protection#f9b6bdb8a9ba8e9c9b94989095b99d968dd79e968f">[email&#160;protected]</a>. 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; <a href="/cdn-cgi/l/email-protection#81e5f3f4e6e0e3e0f5e4ece4eff5c1e7e0e0afe6eef7">[email&#160;protected]</a>). 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: <a href="/cdn-cgi/l/email-protection#086a7a71696626787a616b6d486c677c266f677e">[email&#160;protected]</a>). 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: <a href="/cdn-cgi/l/email-protection#d5b2b0a7b4b9b1fba5baa2b0a7a695b1baa1fbb2baa3">[email&#160;protected]</a>). 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:
<a href="/cdn-cgi/l/email-protection#c7aebea8a9e9b5a8b4a6b5aea887a3a8b3e9a0a8b1">[email&#160;protected]</a>).

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).
---------------------------------------------------------------------------

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: <a href="https://www.samhsa.gov/workplace/drug-testing-resources/certified-lab-list">https://www.samhsa.gov/workplace/drug-testing-resources/certified-lab-list</a> 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
------------------------------------------------------------------------
Old section New section
------------------------------------------------------------------------
40.35..................................... 40.36.
40.41..................................... 40.42.
40.45..................................... 40.40.
40.47..................................... 40.41.
40.49..................................... 40.44.
40.51..................................... 40.45.
40.73..................................... 40.79.
40.85..................................... 40.82.
40.87..................................... 40.85.
40.89..................................... 40.86.
40.91..................................... 40.87.
40.93..................................... 40.88.
40.95..................................... 40.89.
40.96..................................... 40.90.
40.99..................................... 40.84.
Appendix B................................ Appendix D.
Appendix C................................ Appendix E.
Appendix D................................ Appendix F.
Appendix E................................ Appendix G.
Appendix F................................ Appendix H.
Appendix G................................ Appendix I.
Appendix H................................ Appendix J.
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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: <a href="https://www.transportation.gov/odapc/urine-specimen-collection-guidelines">https://www.transportation.gov/odapc/urine-specimen-collection-guidelines</a>.
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.
(<a href="https://www.transportation.gov/odapc/Statement_of_Enforcement_Discretion_SAPs">https://www.transportation.gov/odapc/Statement_of_Enforcement_Discretion_SAPs</a>)
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.''
<a href="https://www.transportation.gov/odapc/part40QA/40-311">https://www.transportation.gov/odapc/part40QA/40-311</a> 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, <a href="https://www.samhsa.gov">https://www.samhsa.gov</a>.
The DOT has posted the 2020 CCF on our website, <a href="https://www.transportation.gov/odapc">https://www.transportation.gov/odapc</a>. 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 agre

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