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.

    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

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

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

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

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

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

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

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

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

Subpart H, Split Specimen Tests

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

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

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

    The Department proposed edits to Sec.  40.191(a) to add what can
constitute a refusal in an oral fluid collection to part 40's existing
refusals provisions. The revisions included wording changes to take
oral fluid testing into account (e.g., in paragraph (a)(8)), ``fail to
permit an inspection of the employee's oral cavity, or fail to remove
objects from his or her mouth''), as well as specifying situations that
are applicable only to urine testing (e.g., in paragraph (a)(9)),
``fail to comply with an instruction to permit inspection to allow the
observer to determine whether there is a prosthetic device in use'').
    Like the pre-employment urine and alcohol collection processes, the
oral fluid pre-employment collection process generally would not begin
until the device is unwrapped. If an employee does not appear for a
pre-employment drug test or leaves the collection site before receiving
or unwrapping the device, this is not a refusal under Sec.
40.191(a)(1) and (2). However, as in urine testing, certain blatant
conduct by the employee at the collection site could constitute a
refusal before the collection device is chosen under Sec.
40.191(a)(8). For example, if an employee arriving for a pre-employment
test engages in

disruptive or combative conduct at the collection site, a collector
could report a refusal event to the employer for determination under
Sec.  40.191(a)(8). Also, if the employee shows they are possessing or
wearing a prosthetic or other device that could be used to interfere
with the collection process, and this becomes evident before the
specimen container is unwrapped, a collector could report a refusal
event to the employer for determination under Sec.  40.191(a)(10).
    Importantly, when an employee is undergoing a pre-employment test
and the collector switches to an alternate device, it is considered a
continuation of the original collection and is not subject to the pre-
employment exception for leaving the collection site before the second
device is opened. For example, if a collector begins with one specimen
methodology (e.g., urine) and switches to oral fluid (e.g., because the
employee was unable to provide a sufficient specimen), the employee
must not leave the collection site without refusal consequences.
    In addition, we would like to remind employers that, under the
existing Sec.  40.23(g), if they receive a cancelled test result on a
pre-employment test, the employer must direct the employee to provide
another specimen immediately. This second specimen collection is a
continuation of the original pre-employment test. This means, as we
said in our 2001 final rule on refusals, ``once the collection has
commenced, the donor has committed to the process and must complete
it.'' 66 FR 41948 (Aug. 9, 2001). As such, the employee must take the
second pre-employment test and does not have the ability to decide not
to continue this pre-employment testing requirement. In our 2003 final
rule on the Drug and Alcohol Management Information System (MIS), we
referred to the second test as ``the subsequent collection'' and we
reminded employers to report only one pre-employment test result (68 FR
43950, Jul. 25, 2003). Accordingly, the employer would count the second
test result as the result of record for this pre-employment test on the
DOT's MIS form.
    We have revised drug testing refusals Sec.  40.191(d) and added a
new Sec.  40.261(c)(1) to alcohol testing refusals to clarify an often-
misunderstood point about who has the authority to determine if conduct
at the collection site constitutes a refusal to test. Employers often
automatically treat as a refusal any situation in which the collection
site notes a refusal in the remarks section of the CCF. This is not
correct. The new Sec.  40.191(d) emphasizes the role of the collector
in a refusal is to notify the employer about the circumstances the
collector believes constitute a refusal, but the employer must decide
whether a refusal occurred. The new Sec.  40.261(c)(1) specifically
spells out the respective responsibilities of the alcohol testing
service agent(s) in reporting and the DER in making decisions about
whether a situation during an alcohol test constitutes a refusal to
test.
    Under the long-existing Sec.  40.355(i), making collection site
refusal decisions is a ``non-delegable'' duty of the actual employer.
Service agents, such as collectors, BATs or STTs, are not and never
have been authorized to make this decision. The service agent's role is
to provide information to the employer concerning the circumstances of
the event. Then the employer, who must make the ultimate decision
should, as a matter of responsible decision-making, contact the
collector or BAT to gather information and consider anything the
employee brings to the employer's attention. Taking the entirety of the
circumstances into account, the employer should then make the decision
about whether a refusal occurred. The employer also has the discretion
to consider information from the employee to determine if the evidence
satisfactorily excuses the employee's conduct. For FMCSA-regulated
owner-operators, C/TPAs stand in the shoes of those employers for the
purposes of determining whether the individual refused a test (Sec.
382.705(b)(6)).
    In this final rule, we emphasize the already existing employer's
role in making determinations about collection site and other non-MRO-
determined refusals (e.g., failure to appear for a test, failure to
take an additional test, etc.). We think it bears repeating that
refusals are violations that cannot be overturned in a decision about
personnel actions. An arbitration, grievance, State court or other non-
Federal forum cannot overturn the employer's determination of a refusal
on a DOT-regulated test. When a case proceeds to one of those forums,
it is because the employee wants an adverse personnel action reversed.
None of those forums has jurisdiction over DOT-regulated Federal drug
or alcohol testing, the determination of a refusal under part 40, or
the regulatory consequences that exist to ensure transportation safety
is served. In the part 40 final rule from December 2000, (65 FR 79470-
71), we said, as has been true from the beginning, all the Department
requires is that an employee who violates the rule not perform safety-
sensitive functions until and unless he or she successfully completes
the return-to-duty process. Decisions about discipline and termination
are left to the discretion of the employer or labor-management
negotiations. Where employer policy, or labor-management negotiations,
have delegated personnel decisions of this kind to an arbitrator, the
Department intends that the arbitrator's decision determines the
personnel action that the employer takes. The Supreme Court has
affirmed these principles. Eastern Associated Coal Corporation v.
United Mine Workers of America, District 17, et al., 531 U.S. 57
(2000). Of course, an arbitrator cannot order an employer to return an
employee to the performance of safety-sensitive functions until the
employee has successfully completed the return-to duty process. Nor can
an arbitrator or an employer change the laboratory's findings about a
specimen or an MRO's decision about whether there is a legitimate
medical explanation for a test result.
    Therefore, we have added a second sentence to Sec. Sec.  40.191(c)
and 40.261(b), to remind the employee and employer that the
consequences specified under DOT agency regulations for a violation
cannot be overturned or set aside by an arbitration, grievance or State
court tasked with adjudicating the personnel decisions the employer
decides to take against the employee. As we said in the December 2000
preamble, the employee must successfully complete the federally
required return-to-duty process regardless of what the decision is on
the personnel action. This ensures safety is not compromised.
Importantly, a refusal is a willful violation of the Department's drug
and alcohol safety regulations and is completely separate and apart
from employment decisions the employer makes.
    Some commenters asked for examples of what would not be grounds for
an employer to determine a refusal. Of course, the universe of examples
is too vast to capture. However, here are a few examples that are not
meant to be exhaustive, they are only a tiny fraction of what is
possible. Example 1: An employee provides an insufficient quantity of
urine, begins the ``shy bladder'' process, but the process is cut short
because the collection site sent the employee away because they were
closing before the employee had three hours to produce a sufficient
urine specimen per Sec.  40.193(b)(2). If the collection site
nevertheless reports this to the employer as a refusal, the employer
could determine there was no possibility the employee could have
completed the test, and therefore could conclude there was no refusal.
Example

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

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

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

    We proposed the addition of oral fluid testing to paragraph (a),
adding insufficient specimen provisions for oral fluid testing,
parallel to the existing insufficient urine specimen procedures. Due to
the differences between the two types of specimen collections, the oral
fluid insufficient specimen collection procedure is shorter in duration
than the insufficient urine specimen collection procedure (e.g., in an
oral fluid collection, there is no need for a three-hour wait period).
In paragraph (e), we proposed adding examples of conditions that might
succeed as medical explanations of providing an insufficient quantity
of oral fluid (e.g., autoimmune diseases), as well as examples that
would not constitute a valid medical explanation (e.g., unsupported
assertions of dehydration). Although one commenter opposed listing any
examples of conditions that could be legitimate medical explanations
because MROs should be able to ascertain legitimate conditions, we have
kept the examples as proposed. In addition, another commenter said MROs
are not qualified to assess the legitimacy of shy bladders or dry
mouth, but we disagree and will continue to have MROs, who are fully
qualified physicians, assess the legitimacy of the conditions
underlying an individual's inability to provide a sufficient specimen
under any approved testing methodology.
    With an alternate specimen methodology now available, an employer
may authorize a collector to use a different type of specimen
collection process in an insufficient quantity case. If a urine
specimen is insufficient, the collector could follow up with an oral
fluid collection, or vice-versa. In a case involving an insufficient
urine specimen, following the insufficient urine specimen procedures
would become unnecessary since an oral fluid collection would be
performed. We asked for public comment on these changes and whether
allowing a donor to rinse with up to 8 ounces of water is an
appropriate amount of fluid for rinsing for the purposes of both
Sec. Sec.  40.72(b) and 40.193(b)(2). We also asked for comment about
the questions of who would decide what methodology to use after an
insufficient specimen occurs, and when and how such a decision would be
made. Since so many oral fluid tests occur each year in non-DOT
testing, we were eager to learn from those with experience on what we
should know.
    We received robust public comment on the above-mentioned subjects
and have discussed these in detail in the Principle Policy section of
this final rule. As explained in the Principle Policy section, the
Department will not mandate the use of the same or the alternate
testing methodology for an insufficient urine specimen (``shy
bladder'') or an insufficient oral fluid specimen (``dry mouth'').
While not required, it would be prudent for an employer to offer more
than one methodology to address such scenarios.
    The Department agrees there are several advantages to switching
from a urine collection to an oral fluid collection when an employee
has presented an insufficient specimen. For example, once an employee
provides an insufficient urine specimen, they would have up to three
hours to provide a sufficient specimen (during which time the employee
should be monitored). If at the end of the three-hour period, the
employee still did not provide a sufficient specimen, the employee is
required to prove (via a medical evaluation by a referral physician)
they have a medical condition to explain their inability to provide a
sufficient specimen.
    We also acknowledge the commenters' concerns that shy bladder
situations merit attention, as we have articulated in our discussion of
Sec.  40.193 below. Employers have legal obligations separate and apart
from part 40 for providing reasonable accommodations for employees with
disabilities. If an individual has a condition rendering that person
unable to produce urine falling within the parameters of a disability,
this should not be considered to be an effort to evade a test.
    Whether the reason for failing to provide a sufficient specimen is
substantiated by a medical condition or not, there is a cost (e.g.,
lost work) to the employer for having the employee wait for up to three
hours. Similarly, there is a cost for the medical evaluation which, in
most instances, is at the employee's expense. The availability of oral
fluid

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

before beginning the specimen collection. Incidentally, the commenters
who responded to our question whether 10 minutes was an appropriate
waiting time responded unanimously in support of this amount of time.
Apparently, it is the industry standard.
    It is a dry mouth scenario if the oral fluid device indicates the
employee has not provided a sufficient specimen. If dry mouth occurs
after the initial collection is attempted, this will begin a one-hour
period to allow a sufficient specimen. Also, this necessitates a second
oral fluid collection within one hour, or the employer could have a
standing order to require the collector to move on to an alternate
methodology (i.e., urine) to complete the collection process for the
testing event.
    Some commenters asked how many attempts at providing an oral fluid
specimen should be made before a finding of dry mouth is determined and
a referral physician is needed. We were asked to consider conducting
research concerning dry mouth. Some commenters wondered if we would
require a specific period of time for attempts for an oral fluid
collection. In addition, we were asked to describe or define what we
meant in Sec.  40.193(b)(2)(i) by requiring that the employee ``remain
at the collection site, in a monitored area designated by the
collector, during the wait period.''
    We proposed procedures to go into effect 15 minutes after an
employee fails to produce a sufficient specimen and the procedures
would continue for one hour. We have adopted this proposal in Sec.
40.193(b)(2)(i). If an employer has provided for an alternate
methodology to be used in oral fluid insufficient specimen situations,
then the collector would move on to the alternate methodology, which is
currently urine. If the employer does not have this option, then the
collector would follow the steps set forth in Sec.  40.193(b)(2)(i)
when the employee demonstrates an inability to provide a specimen after
15 minutes of using the collection device. As in urine testing, the
time clock begins after the 15 minutes and when the employee attempts
but is unable to provide a sufficient quantity of specimen. If the
employee states they could provide a specimen after drinking some
fluids, the collector must urge the employee to drink (up to 8 ounces)
and wait an additional 10 minutes before beginning the next specimen
collection (a period of up to one hour must be provided, or until the
donor has provided a sufficient oral fluid specimen, whichever occurs
first). The employee is not required to drink during the hour and their
choice not to drink is not a refusal. The collector must provide a full
hour for the employee to attempt another oral fluid collection. If the
employee still cannot provide a sufficient specimen, then the collector
must note this in the ``Remarks'' line in Step 2 of the CCF, and
immediately contact the DER to begin the referral physician process for
the dry mouth medical evaluation.
    We will not be conducting our own studies on dry mouth but will
continue to follow HHS for the science of oral fluid testing, as
required by OTETA. In addition, a referral physician would evaluate the
employee to obtain and provide to the MRO information about whether a
``medical condition has, or with a high degree of probability could
have, precluded the employee from providing a sufficient amount of
specimen'', per Sec.  40.193(d)(1). We rely on the referral physician
and the MRO to remain versed in the current medical studies to make
these important determinations, as they have done for more than 30
years in shy bladder urine testing cases.
    To ``monitor'' an employee during a wait period in an oral fluid
collection, we mean the employee must be supervised or observed for
security and integrity of the collection process. This ensures they
cannot take any actions to interfere with the integrity of the specimen
they are required to provide. It does not need to be the actual
collector who monitors the employee during the wait period. In fact, in
Sec.  40.48(c)(1), we say that the collector can conduct a collection
for another employee during this wait period.

Sec.  40.195 What happens when an individual is unable to provide a
sufficient amount of specimen for a pre-employment follow-up or return-
to-duty test because of a permanent or long-term medical condition?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Sec.  40.285 When is a SAP evaluation required?

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

Sec.  40.291 What is the role of the SAP in the evaluation, referral,
and treatment process of an employee who has violated DOT Agency drug
and alcohol testing regulations?

    As discussed in the Principal Policy section of this final rule,
the Department proposed to permit SAPs to conduct evaluations or
assessments remotely by amending Sec.  40.291(a)(1) and (3) to remove
the requirement that SAP evaluations be only ``face-to-face'' and to
explain what is required for remote evaluations. The changes we adopted
are fully discussed and resolved in the Principal Policy section.

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

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

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

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

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

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

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

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

Sec.  40.311 What are the requirements concerning SAP reports?