[Federal Register Volume 87, Number 39 (Monday, February 28, 2022)]
[Proposed Rules]
[Pages 11156-11186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02364]



[[Page 11155]]

Vol. 87

Monday,

No. 39

February 28, 2022

Part II





 Department of Transportation





-----------------------------------------------------------------------





49 CFR Part 40





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

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

[[Page 11156]]


-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket DOT-OST-2021-0093]
RIN 2105-AE94


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

AGENCY: Office of the Secretary, U.S. Department of Transportation 
(DOT).

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The U.S. Department of Transportation is proposing to amend 
the transportation industry drug testing program procedures regulation 
to include oral fluid testing. This will give employers a choice that 
will help combat employee cheating on urine drug tests and provide a 
more economical, less intrusive means of achieving the safety goals of 
the program. The proposal includes other provisions to update the 
Department's regulation, and to harmonize, as needed, with the new 
Mandatory Guidelines for Federal Workplace Drug Testing Programs using 
Oral Fluid established by the U.S. Department of Health and Human 
Services.

DATES: Comments to the notice of proposed rulemaking should be 
submitted by March 30, 2022. Late-filed comments will be considered to 
the extent practicable.

ADDRESSES: To ensure that you do not duplicate your docket submissions, 
please submit them by only one of the following means:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for submitting 
comments.
     Mail: Docket Management Facility, U.S. Department of 
Transportation, 1200 New Jersey Ave. SE, West Building Ground Floor 
Room W12-140, Washington, DC 20590-0001.
     Hand delivery: West Building Ground Floor, Room W-12-140, 
1200 New Jersey Ave. SE, between 9 a.m. and 5 p.m., Monday through 
Friday, except Federal holidays. The telephone number is 202-366-9329.
    Instructions: To ensure proper docketing of your comment, please 
include the agency name and docket number DOT-OST-2021-0093 or the 
Regulatory Identification Number (RIN), 2105-AE94 for the rulemaking at 
the beginning of your comments. All comments received will be posted 
without change to http://www.regulations.gov, including any personal 
information provided.

FOR FURTHER INFORMATION CONTACT: Patrice M. Kelly, JD, Office of Drug 
and Alcohol Policy and Compliance, 1200 New Jersey Avenue SE, 
Washington, DC 20590; telephone number 202-366-3784; 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Purpose

    The Department of Transportation (DOT) is issuing this notice of 
proposed rulemaking (NPRM) to revise part 40 of title 49 of the Code of 
Federal Regulations (Part 40), ``Procedures for Transportation 
Workplace Drug and Alcohol Testing Programs'' to add the oral fluid 
testing procedures to the existing urine drug testing procedures for 
safety-sensitive transportation employees subject to drug testing under 
Part 40 (hereinafter referred to as ``employees''). This action is 
based on the Department of Health and Human Services' (HHS) 
establishment of the Mandatory Guidelines for Federal Workplace Drug 
Testing Programs using Oral Fluid (OFMG) for Federal workplace drug 
testing programs. HHS determined that oral fluid testing conducted in 
accordance with the OFMG provides ``the same scientific and forensic 
supportability of drug test results as the Mandatory Guidelines for 
Federal Workplace Drug Testing Programs using Urine . . . .'' (84 FR 
57554). The OFMG final rule was published on October 25, 2019, and 
became effective January 1, 2020.
    In addition to adding oral fluid as a drug testing method and 
harmonizing with pertinent OFMG sections, we also propose to clarify 
certain Part 40 provisions that cover urine drug testing procedures; to 
remove provisions that no longer are necessary; to add clarifying 
language to other provisions such as updated definitions and web links, 
as appropriate; and to update provisions to reflect issues that have 
arisen in recent practice.

II. Authority for This Rulemaking

    This rulemaking is promulgated under the authority originally 
enacted in the Omnibus Transportation Employee Testing Act (OTETA) of 
1991, codified at 49 U.S.C. 45102 and 45104 (aviation industry 
testing), 49 U.S.C. 20140 (rail), 49 U.S.C. 31306 (motor carrier), and 
49 U.S.C. 5331 (transit). OTETA requires that the Department 
incorporate the HHS Mandatory Guidelines, including amendments, into 
the Department's regulations for testing and laboratory requirements 
for aviation, rail, motor carrier, and transit testing. Additional 
authority at 5 U.S.C. 7301 note and Executive Order 12564, establish 
HHS as the agency that establishes scientific and technical guidelines 
for Federal workplace drug testing programs and standards for 
certification of laboratories engaged in such drug testing.
    While DOT has discretion concerning many aspects of its regulations 
governing testing in the transportation industries' regulated programs, 
DOT follows the HHS Mandatory Guidelines for the laboratory and 
specimen testing procedures. Effective January 1, 2020, the OFMG 
allowed the option to use oral fluid specimens for Federal drug 
testing. As described in the OFMG rulemaking, the advantage of every 
oral fluid collection is that it will be directly observed, as opposed 
to most urine collections, which are unobserved. While directly 
observed urine specimen collections have long been the most effective 
method for preventing individuals from cheating on their drug tests by 
substituting or adulterating their specimens, directly observed urine 
collection may only be done in certain circumstances due to employee 
privacy concerns (see 49 CFR 40.67). Unlike directly observed urine 
collections, an oral fluid collection is much less intrusive on the 
tested employee's privacy. By providing the option of collecting an 
oral fluid specimen, DOT is broadening options for the testing of 
safety-sensitive employees in the transportation industries. As 
discussed below, oral fluid collection can also reduce costs of 
compliance with Part 40.

III. Background

    On November 21, 1988, the Department first published its drug 
testing program procedures regulation, Part 40, as an interim final 
rule (53 FR 47002). The Department based the scientific requirements in 
that rule on the 1988 HHS Mandatory Guidelines for Federal Agency 
Employee Drug Testing Programs (53 FR 11970, Apr. 11, 1988), which set 
forth the scientific procedures for laboratories to analyze urine 
specimens for the presence of specified drugs at the HHS-required 
cutoff levels for the initial and confirmation tests for each specific 
drug in urine testing. These cutoff levels for urine were established 
at levels to show prohibited use of the specified drugs.
    When the Department adopted its first drug testing final rule, we 
established a procedure for urine collections generally to take place 
with visual and aural privacy afforded to each employee, unless 
suspicious activity under 49 CFR 40.25(f)(14), (16) and (23) (53 FR 
47002, Nov. 21, 1988) called for

[[Page 11157]]

a direct observed collection (i.e., body-to-bottle observation). In 
December of 2000, the Department comprehensively rewrote Part 40 into 
plain language. The direct observation provisions for urine were placed 
in 49 CFR 40.67, with the body-to-bottle observation requirement 
remaining unchanged. (65 FR 79462, Dec. 19, 2000).
    Urine collections are potentially invasive searches and seizures of 
private citizens, subject to scrutiny under the Fourth Amendment of the 
United States Constitution. Consequently, the Department has always 
approached the collection of urine from transportation safety-sensitive 
employees with a concern for employee privacy, which must be balanced 
carefully against the Department's need to protect transportation 
safety. The Department protects individual rights by ensuring visual 
and aural privacy for employees undergoing urine testing. Allowing 
directly observed collections only for ``cause'' (i.e., suspicious 
activity at the collection site or as determined by the laboratory 
testing of a specimen) is another protection. Yet, because the vast 
majority of DOT-regulated urine drug collections are unobserved, the 
program remains vulnerable to cheating by employees at the collection 
site, which can result in adulteration or substitution.
    In June 2008, the Department added provisions to strengthen 
directly observed collection requirements to include more effective 
observation procedures and expanded the circumstances that would 
warrant a direct observation procedure to address cheating on drug 
tests. (73 FR 35961, June 25, 2008). Although the 2008 final rule was 
challenged in court and initially stayed, the stay was lifted, and the 
final rule was reinstated. (74 FR 37949, July 30, 2019). This action 
was based on the unanimous decision of the United States Court of 
Appeals for the District of Columbia Circuit. The court's decision 
affirmed the Department's enhanced direct observation procedures to 
prevent the use of prosthetic devices used for cheating and to expand 
direct observation to tests of people who had already violated the 
rules (e.g., return-to-duty and follow-up tests for persons who had 
tested positive or refused to test). See BNSF Railway Company v. 
Department of Transportation, 566 F.3d 200 (D.C. Cir. 2009).
    Before the Department's move to expand the direct observation 
procedures, HHS was aware of the potential for cheating on urine tests 
and had begun its own rulemaking to explore alternative testing 
methods. In 2004, HHS solicited public comment upon the following 
alternative testing methods, all of which would be directly observed: 
oral fluid, hair, and sweat testing. (69 FR 19673, Apr. 13, 2004). HHS 
stated: ``Addition of these specimens to the Federal Workplace Drug 
Testing Program would complement urine drug testing and aid in 
combating the threat from industries devoted to subverting drug testing 
through adulteration, substitution, and dilution.'' (Id. at 19675). HHS 
noted that there were problems with all three of the proposed 
alternative matrices but asked for additional scientific information 
and sought information on appropriate levels for proficiency testing 
for these alternatives.
    While the science supporting oral fluid testing did not meet the 
standards of HHS in 2004, science and research studies have now reached 
a point where HHS is able to determine that oral fluid testing is an 
appropriate alternative testing method for identifying illicit drug use 
in the Federal workplace. As such, HHS proposed adding oral fluid 
testing to the Federal employee workplace testing program (80 FR 28054, 
May 15, 2015) and finalized this proposal, which became effective for 
Federal employee workplace testing on January 1, 2020 (84 FR 57554, 
Oct. 25, 2019).
    The Department is proposing to add oral fluid testing as an 
alternative testing method because, as noted above, it has been 
determined by HHS to be scientifically viable for Federal workplace 
programs and because it provides a directly observed collection for 
every test. The collection of oral fluid is less invasive than directly 
observed urine collection and, therefore, is consistent with the 
careful balancing of an individual's right to privacy with the 
Department's strong interest in preserving transportation safety by 
deterring illicit drug use.
    The Department's testing statutes specifically require that the 
Department incorporate the HHS Mandatory Guidelines, which are 
scientific and technical guidelines that ``establish comprehensive 
standards for all aspects of laboratory-controlled substances testing'' 
to ensure full reliability and accuracy in testing. Because HHS has 
published its final OFMG, thereby approving oral fluid testing as a 
reliable means of detecting illicit drug use for Federal employees, the 
Department is proposing to allow, but not require, oral fluid specimen 
testing as an alternative method under Part 40, for use by DOT-
regulated employers for required transportation industry workplace 
testing. Specifically, we are seeking comments as to whether there are 
circumstances where either urine or oral fluid should be mandatory. We 
are also proposing to amend some of our provisions that pertain to both 
urine and oral fluid testing to harmonize with pertinent sections of 
the urine and oral fluid HHS Mandatory Guidelines. We are proposing to 
clarify certain existing Part 40 provisions that cover the handling of 
urine specimens, remove provisions that are no longer necessary (such 
as erroneous compliance dates), add clarifying language to other 
provisions (such as updated definitions and web links where necessary), 
and modify a few substantive provisions to address issues that have 
arisen in practice (such as whether a test cancelled by a medical 
review officer (MRO) can ever be uncancelled, and whether a Substance 
Abuse Professional (SAP) should be allowed to conduct evaluations 
virtually).

IV. Principal Policy Considerations

Oral Fluid as an Alternative Drug Testing Method for Workplace Testing

    Since 2004, when HHS previously considered oral fluid testing, the 
scientific viability of that testing has advanced. In its 2019 final 
rule, HHS stated that ``[t]he scientific basis for the use of oral 
fluid as an alternative specimen for drug testing has now been broadly 
established and the advances in the use of oral fluid in detecting 
drugs have made it possible for this alternative specimen to be used in 
Federal programs with the same level of confidence that has been 
applied to the use of urine.'' (84 FR 57554; Oct. 25, 2019). 
Importantly, HHS stated that its ``OFMG provide the same scientific and 
forensic supportability of drug test results as the Mandatory 
Guidelines for Federal Workplace Drug Testing Programs using Urine . . 
. .'' Id.
    In its 2019 OFMG, HHS recognized that products have emerged that 
can help people to adulterate a urine specimen. HHS emphasized that 
establishing oral fluid as a testing method would allow Federal 
agencies greater flexibility to address testing needs while minimizing 
the opportunity for specimen adulteration or substitution. (84 FR 
57554, 57571; Oct. 25, 2019).
    Adulterating and substituting unobserved urine specimens is not a 
new issue to drug testing. In upholding the Office of Drug and Alcohol 
Policy and Compliance's (ODAPC) 2008 final rule allowing additional 
direct observation procedures, the U.S. Court of Appeals for the 
District of Columbia Circuit recognized the ``cheating'' problem: 
``especially in light of

[[Page 11158]]

evidence of a growing proliferation of products that facilitate 
cheating on drug tests, the Department solicited comment on additional 
procedures to strengthen testing integrity.'' BNSF Railway v. US 
Department of Transportation, 566 F.3d at 202.
    In the BNSF court case, the D.C. Circuit upheld directly observed 
urine collections under the specific circumstances imposed by the 
Department because of the imminent threat of individuals cheating on 
drug tests. The court acknowledged that ``the Department determined 
that it was `not practicable' to ignore the cheating problem.'' Id. at 
204. The court also accepted that oral fluid testing was not an 
acceptable method because HHS had not yet approved any specimen testing 
except urine. Id. at 205. With all of this considered, the court upheld 
the Department's direct observation procedures. Id. at 208-209. If the 
proposal to allow oral fluid testing is adopted, we could allow the use 
of oral fluid testing in lieu of observed urine tests to assist in 
addressing the cheating problem acknowledged in the BNSF case.
    While the Department does not have data on how much cheating is 
occurring, the problem exists and poses a direct threat to 
transportation safety. The court in BNSF noted: ``Acknowledging that it 
had no statistics on the rates of actual use of such devices, the 
Department inferred their use from the anecdotal evidence of their 
availability.'' Because the successful use of a cheating device would 
produce a negative drug test result, this would not show up in 
statistical reports as ``cheating.'' Thus, the court agreed with DOT 
that ``it was `illogical' to require statistical evidence of cheating. 
Given that people presumably buy cheating devices to use them, we think 
this approach quite reasonable . . .'' Consequently, the court 
recognized that the DOT could not base the rulemaking on statistical 
data on cheating. The court concluded, `` `It is one thing to set aside 
agency action under the Administrative Procedure Act because of failure 
to adduce empirical data that can readily be obtained. It is something 
else to insist upon obtaining the unobtainable. BNSF, 566 F.3d at 204 
(internal citations omitted)).
    The Department recognizes that the court upheld directly observed 
urine tests in specific circumstances covered in the regulation. In 
this rulemaking, the Department is proposing, as an option to 
employers, a specimen collection methodology that is inherently a 
directly observed collection and a much less invasive form of direct 
observation drug test collection.
    In evaluating the progress of science of oral fluid testing and its 
scientific viability, HHS also looked at its forensic defensibility in 
workplace testing. Specifically, HHS addressed concerns about passive 
exposure as the result of someone else's drug use (e.g., from second-
hand smoke) in the context of cutoffs or metabolites used in oral fluid 
testing, particularly with regard to marijuana. (84 FR 57557, 57558; 
Oct. 25, 2019). HHS concluded that a 4 ng/mL screening test cutoff for 
THC would detect use of marijuana while eliminating possibilities of 
positive tests resulting from passive exposure, as directed by the 
SUPPORT for Patients and Communities Act, Public Law 115-271, 8107(b). 
(See 84 FR at 57558; Oct. 25, 2019).
    HHS has verified the science, set the cutoffs for testing, and 
begun the laboratory certification process for oral fluid testing. 
Pursuant to the statutory directive to incorporate HHS's scientific and 
technical guidelines, the Department proposes to offer oral fluid 
testing to DOT-regulated employers as an alternative to urine testing.

Using Oral Fluid Testing as an Alternative Method Can Reduce Costs

    We recognize that oral fluid testing is generally less expensive 
than urine testing. We understand that an oral fluid test can cost 
between $10 to $20 less than a urine testing (e.g., about $50 for a 
typical urine testing process, vs. about $35 for an oral fluid testing 
process, with the largest part of the difference being attributable to 
the collection process). We are seeking public comment on the costs of 
oral fluid testing as compared to urine testing so that we can affirm 
or adjust that cost assumption.
    We also seek public comment on whether DOT-regulated employers 
would continue to utilize the services of external qualified collectors 
for oral fluid, or whether employers would train their own company 
personnel to become qualified collectors for oral fluid testing 
purposes. If companies train internal personnel instead of contracting 
with external providers, would this be due to costs, convenience or 
other reasons, and what would be the cost implications of the two 
approaches?
    In addition to flexibility for employers, there are potential cost 
savings in the ``shy bladder'' collection procedures and related 
medical examinations. Currently there are situations in which a urine 
specimen collection is attempted but not completed. For example, when 
an employee is unable to provide a sufficient quantity of urine, Part 
40 provides an alternative process with multiple steps. The employee 
receives up to three hours of time to provide a sufficient specimen and 
is urged to consume up to 40 ounces of fluids. If after three hours 
these procedures do not result in a sufficient urine specimen, the 
employee must be medically evaluated to determine whether there is an 
adequate medical explanation why the employee could not provide 
sufficient urine. (49 CFR 40.193 and 40.195). This involves much time 
on the part of the collector, employee, employer, MRO, and physician. 
In addition, there are the costs of medical examinations for 
individuals who have short-term and long-term medical conditions that 
cause, or are claimed to cause, an inability to provide a sufficient 
urine specimen.
    Since the Part 40 comprehensive rewrite in the late 1990s, groups 
representing individuals with ``Paruresis'' have raised concerns that a 
urine collection is problematic for individuals with this condition. 
Also, employees who are undergoing dialysis treatments or who have 
significant prostate issues could have difficulty providing a urine 
specimen and may require referrals to evaluating physicians to 
determine the legitimacy of their medical inability to provide a urine 
specimen. With the above in mind, collecting an oral fluid specimen may 
eliminate the need for a medical evaluation and result in a shorter 
employee visit to the collection site.

Allowing Alternative Specimens Provides Flexibility to Employers

    In proposing oral fluid testing, the Department is not requiring 
employers to use oral fluid testing instead of urine testing, or for 
every test reason (e.g., pre-employment, random, etc.). Instead, we are 
proposing to offer employers the flexibility in the type of specimen 
they collect. That flexibility will provide several benefits. For 
example, when an employer determines that a DOT post-accident or a 
reasonable cause/suspicion test is needed, oral fluid collections could 
be done at the scene of the accident or the incident. The collection 
could be done by any oral fluid collector qualified under Part 40-
either an external contractor or a DOT-regulated company employee. 
There are fewer requirements for oral fluid collection sites, as 
discussed below. The ready availability of collectors and the reduced 
expectations for collection site requirements should facilitate prompt, 
less expensive collections for post-

[[Page 11159]]

accident and reasonable cause/suspicion testing. We would appreciate 
public comments on these matters.

Understanding Windows of Detection

    In proposing oral fluid testing, the Department is offering an 
alternative specimen for drug testing; however, we are not proposing to 
eliminate urine drug testing. Each specimen type offers different 
benefits to assist employers in detecting and deterring illegal drug 
use, and no single specimen type is perfect for every situation. It is 
important to understand the benefits and limitations of each method.
    There are different windows of detection that employers should 
consider when deciding whether to use a urine test or an oral fluid 
test as the preferred form of testing for any specific test reason. We 
have reviewed various scientific sources referenced below to compile 
the list of windows of detection, and we invite public comment, 
especially from oral fluid device manufacturers and laboratories, as to 
the accuracy of the information presented in the chart below. Any 
additional public comments pertaining to the accuracy and completeness 
of the table below would also be appreciated.

----------------------------------------------------------------------------------------------------------------
                                                Oral fluid testing window of          Urine testing window of
           Category of drug \1\                          detection                           detection
----------------------------------------------------------------------------------------------------------------
Amphetamines.............................  1-3 days \2\.........................  1-9 days \2\.
Methamphetamines.........................  1-4 days \2\.........................  2-4 days \2\.
Cocaine..................................  1-4 days \2\ \3\.....................  1-5 days \2\ \3\.
Opioids..................................  1-2 days \2\.........................  2-4 days \2\.
Marijuana................................  Up to 24 hours \2\ \4\...............  3-67 days \2\ \5\.
Phencyclidine (PCP)......................  1-3 days \6\.........................  Up to 5 days \6\.
----------------------------------------------------------------------------------------------------------------
\1\ Detection windows in the sources are dependent on amount of drug ingested, situations such as regular heavy
  use, and cutoff concentrations used.
\2\ Cone E.J., Huestis MA. Ann N.Y. Acad Sci. 2007;1098:51-103, pp. 35-37, 42, 45-51, 54 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2700061/pdf/nihms118888.pdf.
\3\ Jufer R., Walsh S.L., Cone E.J., et al. J Anal Toxicol. 2006;30(7):458-462, 460. https://academic.oup.com/jat/article/30/7/458/711502 jat/article/30/7/458/711502.
\4\ Newmeyer M.N., Desrosiers N.A., Lee D., et al. Drug Test Anal. 2014;6(10):1002-1010 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4169757/pdf/nihms578748.pdf.
\5\ Huestis M.A., Mitchell J.M., Cone EJ. J Anal Toxicol. 1996;20(6):441-452 https://academic.oup.com/jat/article/20/6/441/777647 article/20/6/441/777647.
\6\ Cook C.E., Brine D.S., Jeffcoat A.R., et al. Clinical Pharmacology and Therapeutics. 1982; 31(5)625-634--
  While the authors did not report oral fluid concentrations, they did report correlation between plasma levels
  and oral fluid levels. As PCP was detectable in plasma for 72 h (last time point) it is reasonable to assume
  PCP can also be detected in oral fluid that long.

    If an employer is looking to detect recent drug use, (i.e., 
reasonable cause/suspicion, post-accident), an employer may find that 
the more immediate window of detection associated with oral fluid is 
acceptable. However, if an employer is looking to detect a pattern of 
intermittent drug use through pre-employment, random, return-to-duty, 
follow-up testing, the delayed windows of detection in urine may be 
preferable. We seek comment on whether oral fluid or urine should be 
mandated, or prohibited, for certain test reasons, based on windows of 
detection. Should an employer and its service agent be allowed to opt 
for a different methodology if the first test cannot be completed 
because of an insufficient specimen or other reason? Because there is 
no drug testing that determines impairment, oral fluid is being 
introduced to detect use, as urine has done throughout the history of 
the DOT-regulated drug testing program.

Substance Abuse Professional Remote Evaluations

    During the COVID-19 public health emergency, the Department 
recognized that it might not be possible or advisable for a SAP to meet 
face-to-face with a client. As a result, we issued a guidance document 
on April 4, 2020 to allow remote evaluations for a period of time, and 
we extended the guidance several times. The Department's COVID guidance 
was issued in 2020-2021 and can be viewed at: www.transportation.gov/odapc/Statement_of_Enforcement_Discretion_SAPs_and_Service_Agents. We 
said that, while a remote evaluation may not provide as much 
information as an in-person meeting, it is preferable to not having a 
SAP evaluation at all. To make a remote evaluation as effective as 
possible, the guidance document recommended certain technical 
parameters and added that SAPs should document the format of the 
assessment in the final SAP report. We also said that we would not view 
a remote evaluation as being an act of serious noncompliance meriting 
resort to the Public Interest Exclusion (PIE) process.
    Based on informal contacts with the SAP community, we believe this 
guidance has been well received, with a considerable use of remote 
evaluations by SAPs since the inception of the guidance. Moreover, it 
is plausible that telehealth will become a regular part of medical 
practice in a wide variety of fields in the future.
    To make remote evaluations or assessments a regular option for the 
SAP's practice under Part 40, we are proposing amendments to several 
sections of the regulation. Consistent with guidance issued in the 
context of the COVID-19 public health emergency, this proposal would 
give SAPs the option of choosing to conduct evaluations remotely in 
lieu of face-to-face meetings. Part 40 currently requires all SAP 
assessments to be done face-to-face. An in-person evaluation provides 
SAPs with the opportunity to objectively evaluate ``non-verbals''--
physical cues to internal feelings, thoughts, and behaviors. It allows 
the SAP to be aware of the client's appearance, posture, carriage, 
ability to make eye contact, and ability to relate in person, as well 
as other physical characteristics that might be indicative of problems 
associated with alcohol abuse and/or drug use.
    The most important proposed change regarding SAP evaluations is to 
Sec.  40.291(a)(1). The amendment would replace the current requirement 
for a face-to-face meeting with an option: The SAP could do the 
evaluation either face-to-face or remotely. If the evaluation is to be 
done remotely, there would be three criteria that the process would 
need to meet, to ensure that the SAP can still objectively evaluate 
``non-verbals'' and physical characteristics to a sufficient extent. 
These criteria are also based on the provisions of the Department's 
guidance document.
    First, the technology used must permit real-time two-way audio and 
visual interaction between the SAP and the employee. A phone 
conversation not

[[Page 11160]]

including video would not meet this criterion.
    Second, the quality of the technology (e.g., speed of the internet 
connection, clarity of the display), would have to be sufficient to 
allow the SAP to gather all the visual and audible information the SAP 
would normally observe in a face-to-face interaction. In addition, the 
technology would have to have sufficiently robust security to protect 
the confidentiality of the conversation.
    Third, a SAP could only use the technology in question if the SAP's 
State-issued license authorizes the SAP to do so. The SAP's use of the 
technology would have to stay within the parameters of that authority 
(e.g., a State license may permit a practitioner to work only with 
clients in the State of licensure). We are also seeking public comment, 
especially from SAPs, regarding whether their respective State license 
would allow them to evaluate individuals who live in a different State 
from where the SAP is licensed. Is this already allowed? Now that 
virtual video evaluations are often done outside of the DOT-regulated 
context, would evaluation of individuals not in one's State of 
licensure be allowed? For a SAP remotely evaluating an individual 
outside of the SAP's locality, what steps could ensure a working 
knowledge of quality programs and qualified counselors available to the 
employee?
    While we continue to believe that face-to-face interactions are the 
``gold standard'' for the SAP evaluations, we also believe that the 
remote evaluation option may have considerable merit, and we seek 
comment on the proposed approach, as well as on the specific technical 
parameters under which SAPs would perform remote virtual evaluations. 
We welcome comments regarding the experience of both SAP and employees 
under the COVID-19 guidance. We also seek comment on whether remote 
virtual evaluations and assessments should be limited to certain 
circumstances, e.g., natural disasters, pandemic situations, and where 
there are few or no SAPs available.
Other Matters of Interest
    As noted above, the Department works closely with HHS on matters 
concerning workplace drug testing. On September 10, 2020, HHS published 
a notice of proposed Mandatory Guidelines proposing to add hair testing 
to the drug testing specimen types authorized for the Federal employee 
testing program. (85 FR 56108). Because HHS is still considering 
amendments to its Mandatory Guidelines to permit hair testing, comments 
to DOT concerning the use of hair testing are not relevant at this 
time.
    In addition, we are proposing to amend Sec.  40.67 to address 
situations where a same gender observer is not available for the 
collection of urine specimens. Specifically, we request public comment 
on allowing direct observations by any licensed or certified medical 
professional legally authorized to take part in a medical examination 
in the jurisdiction where the collection takes place.
    Currently, per Sec.  40.141(b), MROs must personally contact 
pharmacies to verify a prescription that an employee has cited as a 
potential legitimate medical explanation for a laboratory-confirmed 
positive test. We believe it would increase efficiency and assist MRO 
office workflow if MRO staff were able to make these inquiries. The 
Department seeks comment on whether this change is advisable and what 
the estimated cost savings would be.
    In addition to the above, we request comments on whether there are 
situations in which a test, once cancelled, should be ``uncancelled'' 
if circumstances dictate (e.g., a test is cancelled because paperwork 
is missing or delayed, but the paperwork is later found and provided to 
the MRO). Or, alternatively, should a test, once cancelled, remain 
cancelled to ensure finality? We specifically seek comment from MROs on 
the practicality of administering such a process, and from employers on 
the effect that an ``uncancelled'' test would have when administering 
their drug testing program. To be clear, this would not apply to those 
specimens ``rejected'' by the laboratory because of a fatal flaw and 
ultimately reported by the MRO as cancelled. We have proposed language 
in Sec.  40.207(d) to address this circumstance. We have also included 
a requirement for a party seeking to reverse a cancellation to consult 
ODAPC if the decision is being made more than 60 days after the 
cancellation, which is the same consultation requirement we have in 
Sec.  40.149(a)(4), where we allow an MRO to reopen a verified test 
after 60 days. Providing this information helps ODAPC to provide advice 
to MROs regarding what to consider and potential concerns.

V. Section-by-Section Analysis

    In drafting the proposed oral fluid amendments to Part 40, the 
Department is not creating a separate subpart of Part 40 concerning 
oral fluid testing. Since many of the provisions of Part 40 can be 
applied to specimen types in addition to urine, we have sought to 
integrate provisions concerning oral fluid testing within the current 
Part 40 structure. However, since the provisions applicable to Alcohol 
Testing, SAPs, the PIE process, and some other provisions would not 
change based on which specimen types are authorized, we are not 
proposing changes to those provisions.
    Consistent with changes made in the substantive provisions of the 
rule, we propose to modify some section titles as well as adding new 
sections. In many cases, the modifications revise current titles 
specifying urine testing so that they address oral fluid and potential 
future testing matrices.

40.3 What do the terms used in this part mean?

    In addition to proposing to delete the definition of ``screening 
drug test'' because the term is not used in Part 40, the proposed rule 
would delete the definition of ``Invalid drug test'' because that is a 
term that HHS does not use, as such.
    The term ``invalid result'' is an HHS term with a very specific 
meaning and HHS does not have a defined term of ``Invalid drug test.'' 
The term ``invalid'' is sometimes misunderstood in arbitrations, 
courtrooms, and other settings to incorrectly suggest a lack of 
certainty about the underlying testing event. A laboratory reporting an 
invalid result to the MRO does not mean that the underlying drug 
testing event was not valid. For example, when the laboratory reports 
that there was an ``invalid result,'' it is not a characterization of 
the employer's authority to conduct the testing, the collection 
process, etc. The ``invalid result'' refers only to the fact that the 
laboratory has not been able to complete testing or obtain a valid drug 
test result (e.g., because of an unidentified adulterant, an 
interfering substance, or an abnormal physical characteristic). Also, 
for consistency with HHS terminology, we are removing the defined term 
``invalid drug test'' in the definitions section, Sec.  40.3, and are 
updating Sec. Sec.  40.123(c), 40.129(a) and 40.129(d) to use the term 
``invalid result''.
    The proposal would add definitions of seven terms as part of our 
effort to harmonize Part 40 with the HHS Guidelines and to update Part 
40 as needed. An ``alternative specimen'' is an authorized specimen of 
a type other than the one previously collected. For example, in a case 
where the initial collection was urine, oral fluid would be an 
alternative specimen. The ``cutoff'' is the quantitative point 
distinguishing a need for further testing or whether a laboratory 
result, for example, is

[[Page 11161]]

positive or negative (e.g., 2 ng/ml is the confirmatory test cutoff for 
a positive vs. negative oral fluid result reported by the laboratory 
for THC). We are also proposing to add definitions for ``oral fluid 
specimen'' and ``urine specimen.'' ``Specimen'' is the generic term for 
any fluid, breath or material collected from someone for a drug or 
alcohol test. We are proposing to add ``Undiluted (neat) oral fluid'', 
using the same language HHS uses in Section 1.5 of its Oral Fluid 
Mandatory Guidelines. We have also added a definition for the FMCSA's 
Commercial Driver's License (CDL) Drug and Alcohol Clearinghouse 
(Clearinghouse).
    We are also proposing to add a new definition for ``SSN or Employee 
ID No.'', and some minor changes to rule language in Sec. Sec.  40.14, 
40.45, 40.97, 40.163 and 40.311 for the following reasons. Since its 
inception in 1988, Part 40 has required program participants to use the 
donor's Social Security Number (SSN) or an employee identification (ID) 
number in various sections. For example, the employer must supply the 
collection site with the ``Donor SSN, Employee I.D., or CDL State and 
No.'' as referenced on the Federal Drug Testing Custody and Control 
Form (CCF). For the Alcohol Testing Form (ATF), the employer must 
supply the donor's ``SSN or Employee ID No.'' In addition to the unique 
specimen ID number on the CCF and the specimen seals, having the SSN or 
employee ID number on the form assists the MRO in matching the Copy 1 
of the CCF from the laboratory with their copy, Copy 2 of the CCF. The 
SSN or the employee ID number may be used by the employer to, for 
example, run random selection lists and ensure that test results are 
associated with the correct employee. The SAP is required to utilize 
the SSN on the SAP initial and final reports to the employer.
    In the Federal Motor Carrier Safety Administration's (FMCSA) 
Commercial Driver's License Clearinghouse final rule (81 FR 87686; Dec. 
5, 2016), which required the creation of the Drug and Alcohol 
Clearinghouse database (Clearinghouse), the FMCSA amended 49 CFR 
382.123(a) and (b) to require that, for FMCSA-regulated drivers 
undergoing DOT-regulated testing, the employer use a Commercial 
Driver's License (CDL) number and State of issuance, instead of the SSN 
or other employee ID number, on the CCF and Alcohol Testing Form (ATF) 
for all drug and alcohol tests conducted under part 382. It is 
important to note that the Clearinghouse final rule did not affect or 
otherwise allow use of the CDL number for a CDL driver operating under 
another DOT agency's regulation and subject to a test not under Part 
382 (e.g., employers of CDL drivers under PHMSA or FTA). Under this 
proposal, those employers could also use the CDL numbers, which could 
potentially increase efficiency and reduce confusion.
    We are proposing to create a definition of ``SSN or Employee No.'' 
in Sec.  40.3 that would conform to and explicitly acknowledge this 
existing requirement for CDL holders regulated by the FMCSA and to 
allow the use of the CDL number for the drivers being tested under the 
regulations of the other DOT agencies.
    In addition, we are proposing the changes because some employers 
already consider an employee's ID number to be the individual's 
personal driver's license number, State-issued identification number, 
or other State-issued or federally issued identification number. We 
believe that it would be less confusing to explicitly state that it is 
allowable to use these forms of ID, which can be verified by viewing 
the actual ID.
    With increasing concerns of identity theft, SAPs, employers and 
others have indicated that the use of one's SSN is becoming 
increasingly difficult and risky. Some corporations are only allowing 
the use of 4 or 6 digits of the SSN, and others prohibit the use of the 
SSN entirely. We are proposing the additional options of other official 
identifications issued by State or Federal authorities to also address 
these concerns.
    Consequently, we are proposing to create a new definition ``SSN or 
Employee No.'' that will allow a collector, MRO, SAP, BAT, STT or other 
service agent or employer to utilize only the CDL number and State of 
issuance for FMCSA-regulated drivers tested under Part 382, and to 
allow the CDL number to be used as an option on tests conducted under 
the authority of the other DOT Agencies. The definition would also 
allow any other State-issued or federally- issued identification number 
to fulfill Part 40 requirement for a unique identification number.
    We are proposing to modify seventeen definitions. For the most 
part, the changes are not substantive, and would simply conform Part 
40's wording with that of the HHS guidelines. For example, ``collection 
container'' refers to vessels used in all collections, whether of urine 
or oral fluid. In the definition of ``specimen bottle,'' we propose 
noting that the term could include terms like ``tube'' or ``vial'' used 
in oral fluid testing.

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

    The Department is proposing minor changes to paragraphs (b), (c), 
and (d) of this section to clarify them in the context of oral fluid 
testing. For example, paragraph (d) is made applicable only to urine 
testing since oral fluid testing is not part of the normal medical 
examination procedure to which the paragraph applies.
    We propose to redesignate paragraphs the current paragraphs (e) and 
(f), as new paragraphs (f) and (g), and would add a new paragraph (e) 
emphasizing that a drug or alcohol test administered as directed by a 
medical examiner, exclusively as part of a medical examination required 
for an employee to qualify for a certificate or license, is not a DOT 
drug or alcohol test under Part 40 and related DOT agency drug and 
alcohol testing rules. For example, if a certified medical examiner 
decided to give a motor carrier driver a drug test as part of an 
examination for medical card purposes, that would be a ``non-DOT 
test.'' An employer could request a required DOT pre-employment test be 
conducted when the medical examination is being conducted, as currently 
permitted under 49 U.S.C. 31306(d).
    We added a new paragraph (h) to further emphasize that DOT drug and 
alcohol tests are authorized to be conducted only on safety-sensitive 
employees as designated in the agency drug and alcohol testing 
regulations and must not be conducted on non-regulated persons. (See 
Section II of this proposed rule for a discussion of DOT's testing 
authorities.) DOT testing is a legal warrantless search and seizure 
permitted by the Fourth Amendment of the Constitution. The DOT's strong 
interest in maintaining transportation safety, when weighed against an 
individual's right to privacy, allows DOT's regulated testing to pass 
Constitutional scrutiny. See Bluestein v. Skinner, 908 F.2d 451 (9th 
Cir. 1990); Skinner v. Railway Labor Executives' Assn., 489 U.S. 682 
(1989); Treasury Employees v. Von Raab, 489 U.S. 656 (1989). However, 
there is no Federal transportation safety interest in using this 
testing for individuals other than safety-sensitive employees. 
Consequently, DOT testing cannot be conducted on employees not 
regulated by the DOT agencies. DOT regulations also do not allow 
company-authorized non-DOT testing to satisfy an employer's obligation 
to meet its minimal annual testing rate for DOT testing.

[[Page 11162]]

Sec.  40.14 What information must employers provide to collectors?

    Paragraph (b) in this section would be modified for clarity and to 
recognize that, in the motor carrier industry, FMCSA requires the CDL 
to be used for purposes of the Drug and Alcohol Clearinghouse 
(Clearinghouse) (see 49 CFR 382.705). A new paragraph (k) would be 
inserted for ``the specimen type to be collected'' and a new paragraph 
(l) is proposed to specify if a urine test is to be directly observed.

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

    Where there is a stand down waiver in place, the proposed rule 
would add a new paragraph (c)(2)(vii)(C) of this section to explain 
that an employer, after receiving a verified negative result, must not 
send an employee back in for another test using a different specimen 
type. We have clarified that the employer can send and employee in for 
an alternative specimen collection if the MRO cancelled the tested 
(e.g., per the requirements of Sec.  40.159). The authority to stand 
down an employee is very limited and requires an employer to obtain an 
actual waiver from the DOT agency before implementing a stand down 
policy. The waiver authorizes the employer to `stand down' an employee 
from performing safety-sensitive functions based on a laboratory 
confirmed positive result until the MRO issues the employer a verified 
result, which may be negative. We are proposing that an employer cannot 
conduct another test on the employee after an MRO verifies the test as 
negative. We want to prevent harassment of employees who ultimately 
have an MRO-verified negative result and we do not want employers to 
attempt to conduct a second test to see if the window of detection 
could later impact the result.

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

    The proposed rule would make minor conforming changes in the 
language of this section to account for the proposed use of oral fluid 
testing. In the introductory language of paragraph (f), the 
specification of urine testing would be deleted because the paragraph 
would apply to oral fluid as well as urine testing. In paragraphs 
(f)(1) and(5), language would be added emphasizing that oral fluid 
collection is always directly observed. In the event of an invalid 
specimen, the subsequent direct observation collection could either be 
an oral fluid collection or a urine collection under direct 
observation.

Sec.  40.25 Must an employer check on the drug and alcohol testing 
record of employees it is intending to use to perform safety-sensitive 
duties?

    In January 2020, FMCSA implemented its Clearinghouse regulation 
requiring FMCSA-regulated employers that employ drivers subject to the 
CDL testing requirements of 49 CFR part 382 to query the Clearinghouse 
drug and alcohol database for information about an employee's past 
violations of the drug and alcohol testing rules. Until January 2023, 
FMCSA-regulated employers have dual requirements: Query the 
Clearinghouse and continue to follow the procedure of Sec.  40.25, as 
set forth in Sec.  382.413.
    Beginning January 6, 2023, FMCSA-regulated employers will rely 
solely on querying the Clearinghouse with respect to present or former 
FMCSA-regulated employers of an FMCSA-regulated applicant, in 
accordance with Sec.  382.413(b). For example, after January 6, 2023, a 
motor carrier vetting a prospective employee would check the 
Clearinghouse to determine whether the driver's previous FMCSA-
regulated employer(s) reported drug and alcohol testing program 
violations by that driver. To conform the requirements of Sec.  40.25 
with these existing FMCSA requirements, we are proposing to add a 
paragraph stating if an applicant's past employment was with an 
employer regulated by, for example, the Federal Transit Administration 
or the Federal Aviation Administration (FAA), the gaining motor carrier 
employer would continue to use Sec.  40.25 to check on that 
individual's past compliance with the Department's rules, since drug or 
alcohol violations incurred while the driver was employed by a DOT 
modal administration other than FMCSA will not have been recorded in 
the Clearinghouse. We are proposing to add a new paragraph (a)(3) to 
this section to remind employers that when hiring an employee subject 
to both FMCSA and another DOT agency's drug and alcohol testing 
program, they must query the Clearinghouse and request the information 
about the employee listed in paragraphs (b) through (j) of this section 
from any other DOT agency for whom the employee previously worked.

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

    The proposed rule would make a simple editorial change, 
substituting a reference to appendix J for a reference to appendix H. 
This conforms to a re-designation of the appendix letters but would 
make no substantive changes to the section or form.

Sec.  40.29 and similar sections

    In the current Part 40, there are several sections (Sec. Sec.  
40.29, 40.37, 40.113, 40.169, 40.189, 40.217, and 40.313) that list, 
for readers' information, other sections of the regulation touching a 
given topic (e.g., employer responsibilities in Sec.  40.29). These 
lists of cross-references were intended to assist readers in finding 
other relevant information. However, in the 20 years since these 
sections were placed in Part 40, electronic search tools have become 
much more sophisticated and ubiquitous. Under these circumstances, the 
Department proposes removing them as no longer necessary. The 
Department seeks comment on whether users continue to find the cross-
reference lists helpful enough to retain.

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

    The provisions of this section would be updated to separately 
specify the requirements for collectors of urine and oral fluid 
specimens, respectively. We proposed adding wording to require oral 
fluid collectors to be qualified. In addition, we added wording to make 
it clear that employees, relatives, and close friends of the employees 
cannot conduct collections, consistent with existing guidance in the 
Department's Specimen Collection Guidelines. The Department seeks 
comment on these proposed revisions.

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

    The proposed rule would change the title of Sec.  40.33 to reflect 
its focus on urine collectors. We are also proposing a change to Sec.  
40.33(f) to clarify that damage to a specimen resulting in it being 
cancelled does not require retraining of the collector, unless the 
error actually occurred during the collection process. We understand 
that some MROs are requiring collector retraining when a specimen is 
cancelled because the damage occurred during the transportation 
process. When a specimen is damaged by a delivery truck, sort facility, 
or other part of the transportation process, or is lost in transit, it 
would not be the result of an error by the collector during the 
collection process. Consequently, we are proposing language to clarify 
a collector is not subject to the time and costs of retraining for 
errors outside the collection process.

[[Page 11163]]

Sec.  40.35 What training requirements must a collector meet for oral 
fluid collection?

    The proposed rule would renumber existing Sec.  40.35 to become 
Sec.  40.36, and add a new section Sec.  40.35 concerning training for 
oral fluid collectors. Our intent is to parallel, as closely as 
possible, our existing training requirements for urine specimen 
collectors. We seek comment on any differences that may exist between 
the training for collectors for each specimen type. We anticipate, in 
many cases, that collectors may be cross-trained in the two modes of 
collection.
    In discussing who is authorized to monitor the mock collections 
exercise for oral fluid collectors, the proposed rule retains the 
provision applicable to urine collector training, which states that 
someone who has performed DOT collections for at least a year is 
qualified. However, since the oral fluid collection process is new to 
the DOT testing regime, there initially will not be anyone who has 
collected DOT oral fluid specimens for a year. The Department seeks 
comment on how best to address this transition issue. For example, 
would it be sufficient for a monitor, during the first year or two 
under the DOT oral fluid testing process, to have had experience in 
oral fluid collections in non-DOT oral fluid testing? Should only 
someone who has been through a ``train the trainer'' course be able to 
monitor the mock collections test until there are oral fluid collectors 
with a year of experience in DOT oral fluid collections? What role, if 
any, should oral fluid device manufacturers play in the process?
Redesignation Table
    Beginning with subpart D (see below), the Department is proposing 
to redesignate (i.e., renumber and reorder) numerous sections of Part 
40 to provide a more easily followed flow for users of the regulation 
provisions specific to oral fluid drug testing. For the convenience of 
the reader, we are displaying these proposed redesignations in the 
preamble section of the NPRM.
    The Department recognizes that practitioners have likely become 
accustomed to particular section numbers for drug testing procedures 
under the present regulation. While we believe that the reorganization 
will create a logical structure for the rule, we seek comment on 
whether the reorganization would cause any significant degree of 
confusion for practitioners, and if so, how confusion could be 
mitigated.
    For the convenience of the reader, we are including this 
redesignation table to show what the renumbering would be, if the 
proposed changes are adopted:

  Proposed Redesignations the Following Sections of Part 40 as Follows
------------------------------------------------------------------------
                Old section                          New section
------------------------------------------------------------------------
40.35.....................................  40.36.
40.41.....................................  40.42.
40.45.....................................  40.40.
40.47.....................................  40.41.
40.49.....................................  40.44.
40.51.....................................  40.45.
40.73.....................................  40.79.
40.85.....................................  40.82.
40.87.....................................  40.85.
40.89.....................................  40.86.
40.91.....................................  40.87.
40.93.....................................  40.88.
40.95.....................................  40.89.
40.96.....................................  40.90.
40.99.....................................  40.84.
Appendix B................................  Appendix D.
Appendix C................................  Appendix E.
Appendix D................................  Appendix F.
Appendix E................................  Appendix G.
Appendix F................................  Appendix H.
Appendix G................................  Appendix I.
Appendix H................................  Appendix J.
------------------------------------------------------------------------

Subpart D--Collection Sites, Forms, Equipment and Supplies Used in DOT 
Collections
    As a starting point, it is important to remember that oral fluid 
drug testing and saliva alcohol testing are completely distinct. The 
devices, procedures and outcomes are never interchangeable. In Part 40, 
we are only proposing the provisions applicable to oral fluid testing 
procedures in subpart D. The saliva alcohol testing provisions in 
subparts K-L remain unchanged.
    To accommodate the addition of provisions pertaining to oral fluid 
drug testing, the Department is proposing to reorganize subpart D. 
Sections applying to the DOT drug testing process generally, regardless 
of specimen type, would come first. Renumbered Sec. Sec.  40.40 and 
40.41 would contain the content of present Sec. Sec.  40.45 and 40.47, 
concerning the use of the Federal Drug Testing Custody and Control Form 
(CCF) in all DOT collections. We note that HHS revised the CCF in 
August 2020. The 2020 CCF and instructions for completing the CCF for 
both urine and oral fluid collections are available on the HHS website, 
https://www.samhsa.gov. The DOT has posted the 2020 CCF on our website, 
https://www.transportation.gov/odapc, and we will post instructions for 
oral fluid collections upon promulgation of any final rule to allow 
oral fluid for DOT-regulated drug testing.
    The above sections would no longer contain the words ``urine'' and 
``urination,'' because these sections now would apply to oral fluid 
collections and would include ``any other appropriate contact 
information'' to permit the inclusion of email addresses or other means 
of contacting the appropriate parties. The Department is considering 
removing requirements related to fax numbers on the CCF, allowing the 
fax number if the parties have one. We seek comment on whether 
specifying the use of fax numbers remains relevant. We are proposing to 
add a provision allowing the Designated Employer Representative's (DER) 
name and contact information to be preprinted on the CCF. We 
specifically seek comments from the laboratories on the availability of 
space on the CCF to pre-print the information, as well as the logistics 
and timeliness of sending out updated CCFs with the new DER 
information. To recognize the responsibility of collectors, as well as 
collection site operators, for proper collections, we would add 
``collectors'' to the title of Sec.  40.43.
    In the proposed reorganization of the subpart, Sec. Sec.  40.42-
40.45 would cover urine testing (renumbered Sec.  40.42 in the proposed 
rule contains the material now found in Sec.  40.41, while renumbered 
Sec. Sec.  40.44 and 40.45 contain the material now found in Sec. Sec.  
40.49 and 40.51). Then we would add new Sec. Sec.  40.47-40.51, 
covering oral fluid testing. These provisions largely parallel their 
urine testing counterparts. We seek comment on the content of the new 
oral fluid provisions, including whether it would be useful to address 
any additional differences between the urine and oral fluid testing 
procedures.
    We are proposing to modify renumbered Sec.  40.40 to clarify what 
address and telephone number a collector must provide on the CCF. In 
January of 2002, ODAPC issued a Question and Answer (Q&A) explaining 
that the collection site address should not be a corporate or ``main 
office'' address. In addition, the Q&A stated that the collector's 
telephone number on the CCF should be the number to directly reach the 
individual collector and/or the collector's supervisor and not a 
corporate ``toll free'' number to a call center. Under the proposal, if 
an MRO, laboratory, employer or any DOT staff need to speak with the 
collector, the telephone number provided on the CCF must give access 
directly to that collector. This proposal would codify requirements for 
the collection site address and collector's telephone number, which 
would render the Q&A unnecessary.

[[Page 11164]]

    In Sec.  40.48(c)(1), we use the term ``dry mouth.'' This is 
shorthand, similar to the term ``shy bladder'' used for urine 
collections, for a situation in which an employee is unable to produce 
a sufficient specimen.

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

    We are proposing to add this section to require that collection 
devices meet the requirements being set forth in a new appendix B. The 
devices meeting the requirements in appendix B would be allowed for 
DOT-regulated collections. It is important to note that not all of the 
devices that HHS would allow for the OFMG will be allowed for DOT-
regulated collections under 49 CFR part 40. Each collection must 
include a split that is subdivided from the original specimen 
collection. See 49 U.S.C. 45104(5) (aviation industry testing), 49 
U.S.C. 20140(c)(5) (rail), 49 U.S.C. 31306(c)(5) (motor carrier), and 
49 U.S.C. 5331(d)(5) (transit). All the devices meeting the 
requirements in appendix B will allow a single specimen to be 
subdivided in the presence of the donor. For example, a device could 
allow two specimens to be collected simultaneously using a single 
collection device that directs the oral fluid into two separate 
collection tubes; or a device could collect a specimen with a single 
pad, which can be subdivided into two separate collection tubes. We are 
seeking public comment as to whether there are other device types we 
should mention that allow one single specimen to be collected and then 
subdivided in the donor's presence.
    We are also seeking public comment as to whether the devices should 
be sufficiently transparent so the collector can observe whether there 
is anything unusual about the specimen collected and take action to 
perform a re-collection, if appropriate.

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

    In paragraphs (b)(1) and (3), the term ``drug testing'' or ``drug 
test'' would be used in place of ``urine,'' since the provision applies 
to the testing of either specimen type. We propose to split the 
existing (b)(3) into (b)(3) and a revised (b)(4). The proposed revision 
to (b)(3) prohibits collection of any kind of specimen from an 
unconscious donor. The proposed revision to (b)(4) includes the 
remaining sentences of the current (b)(3), with a change to the final 
sentence of proposed paragraph (b)(4). The final sentence in (b)(4), if 
adopted, would be changed to emphasize that an employer must decide 
whether a given circumstance constitutes a refusal. In paragraph 
(f)(5)(i), we would note that, when a directly observed test is needed, 
either a directly observed urine collection or oral fluid collection 
would suffice. In (f)(5)(i), we propose to remind the collector to note 
on the CCF whether a directly observed urine or oral fluid test will be 
conducted.
    In addition, we are proposing changes to Sec. Sec.  40.61(e) and 
Sec.  40.73(a)(1) (proposed to be redesignated as Sec.  40.79(a)(1) 
because HHS made changes to the CCF. The DOT requires its regulated 
entities to use HHS's OMB-approved CCF.
    DOT worked closely with HHS on the revised CCF, which incorporates 
changes necessary as a result of HHS's establishment of scientific and 
technical guidelines for the inclusion of oral fluid specimens in the 
Mandatory Guidelines for Federal Workplace Drug Testing Programs. The 
majority of changes to the CCF were made to allow the collection of 
oral fluid specimens, which are not currently authorized in the DOT 
drug testing. The revisions also include other changes to improve the 
clarity and presentation of the form.
    However, because of the revisions to the CCF, it is necessary for 
DOT to amend two sections of Part 40. Specifically, the instructions 
for completing the old CCF were provided on the back of Copy 5 of that 
form. These instructions are not provided on the revised CCF, and 
instead, instructions for completing the form can be found on the HHS 
and DOT (Office of Drug and Alcohol Policy and Compliance) websites. 
Consequently, we are proposing to amend the rule text in 49 CFR 
40.61(e) to reflect the repositioning of the instructions. Also, we are 
proposing to amend Sec.  40.73(a)(1) (proposed to be redesignated as 
Sec.  40.79(a)(1)) to note that the employee needs to provide all 
information required in Step 5 of the revised CCF. This information 
includes the donor's printed name and signature, date of the 
collection, date of birth, daytime and evening phone numbers, and email 
address.

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

    We are proposing to modify Sec.  40.63(a) to remind collectors to 
ensure that all items in Step 1 of the CCF are completed. Specifically, 
we propose to add a parenthetical to remind collectors to check the box 
for the DOT agency in Step 1.D, and to write an address for the actual 
collection site in Step 1.G.

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

    The proposed rule would make two changes to the current regulation 
to ensure that when an immediate re-collection under direct observation 
is needed (e.g., because the temperature of a urine specimen is out of 
range or there were signs of tampering), regardless of whether the 
first specimen was urine or oral fluid, the required directly observed 
collection could be either urine or oral fluid. For example, if a 
directly observed collection is needed after a urine collection, the 
second could be either an oral fluid collection (inherently directly 
observed) or a urine collection carried out under the direct 
observation procedures set forth in 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 are asking for public comment about how communication would take 
place between the employer and the collection site to ensure that an 
alternate methodology is or even should be available. Who should decide 
whether to collect an alternative specimen? Should the collector be the 
one to determine whether to collect an alternate specimen when a 
situation allows for it? Should the employer and the service agents 
communicate in advance to ensure that the alternate specimen type is 
authorized, if the employer wants one--with devices and laboratories 
designated? Could this be accomplished through the contract between the 
employer and the service agent? Are there other means of communication 
to facilitate the collection site process?

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

    In addition to altering the title of the section to refer only to 
urine collections, the proposed rule would make a substantive change to 
paragraph (g), regarding who may act as the observer in a directly 
observed urine collection. The paragraph would retain the general 
requirement that the observer have the same gender as the employee, but 
make an exception for licensed or certified medical professionals or 
those who are legally authorized to take part in a medical examination 
in the jurisdiction where the collection takes place. It is commonplace 
in medical settings for opposite-gender personnel to take part in 
examining a patient (e.g., a female doctor, physician's assistant, 
nurse, Emergency Medical Technician, or an

[[Page 11165]]

individual who holds a ``Persons-In-Charge Medical Care'' U.S. Coast 
Guard designation who might be examining a male patient). To reduce the 
circumstances in which an observed urine collection might be delayed 
for lack of a same-gender observer, we propose that an opposite-gender 
medical professional, if available, could perform this task. The donor 
would not be permitted to decline the direct observed collection by an 
opposite gender medical professional and such a refusal would fall 
under Sec.  40.191(a)(4), if the proposal is adopted. We seek comment 
on whether there should be any limitations on the types of medical 
professionals who could perform this function. In addition, we would 
appreciate comments on whether there are religious or other concerns 
that should be considered in the regulatory language proposed.
    We want to clarify that the collector does not enter the reason for 
the direct observation in the ``Remarks'' section of the CCF if the 
employer is sending the employee in for a required directly observed 
collection (e.g., a return-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 needs to be used 
only when the collector moves to a directly observed collection and the 
employer did not know about it in advance. Thus, we are proposing to 
amend 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)-(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 is being corrected. We are 
proposing to make a technical amendment to Sec.  40.67(c)(1) to strike 
the reference to paragraph (b) because it is an incorrect reference.

Sec.  40.69 How is a monitored urine collection conducted?

    The proposed rule would add new introductory language emphasizing 
that a monitored collection would be conducted if a urine collection 
takes place in a multi-stall restroom and the collector cannot secure 
all sources of water and other substances that could be used for 
adulteration and substitution (49 CFR 40.42(f)(2)(ii)).

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

    The proposed rule would make a minor clarifying change, instructing 
the collector of a urine specimen to check both the boxes for ``urine'' 
and ``split specimen'' on the CCF.

Sec.  40.72-Sec.  40.74

    These three new proposed sections would establish the collection 
procedures for oral fluid testing, consistent with the HHS OFMG and 
parallel, in many respects, to the administrative aspects of urine 
collections. For information on the parallel HHS provisions and the HHS 
rationale for putting them into effect, please see the OFMG, (84 FR 
57554, Oct. 25, 2019).
    At several points in these sections (e.g., Sec.  40.72(a)(2)), the 
proposed rule emphasizes the proper relationship between collection 
sites and employers in cases involving conduct that could be considered 
a refusal. In each case, the collector does not make a unilateral, 
final decision, but rather provides information on the circumstances to 
the employer, who per Sec.  40.355(i), has the non-delegable duty to 
make decisions in these cases.
    The oral fluid specimen collector is expected to follow both the 
Part 40 requirements for collections, as well as the manufacturer's 
instructions on how to collect the specimen. The collector must check 
the expiration date on each device. Each device will have its own 
instructions and, therefore, these are not specifically covered in the 
proposed regulatory text. When we refer to conducting the collection 
``correctly'' in these sections, we mean using the oral fluid device in 
the manner described by its manufacturer.
Subpart F
    The proposed rule would reorganize subpart F (49 CFR 40.81-40.97), 
which addresses drug testing laboratories, to create a logical 
progression of urine drug testing, oral fluid drug testing, and 
provisions common to both. This reorganization involves renumbering 
several provisions and, in some cases, adding language to specify where 
a provision applies only to urine drug testing. For example, the title 
of renumbered Sec.  40.86 (Sec.  40.89 in the current regulation) would 
be changed to read ``Sec.  40.86 What is urine validity testing, and 
are laboratories required to conduct it?''
    In several places in the text of Sec.  40.97, several requirements 
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.
    These editorial changes are not intended to modify the substance of 
the provisions in question. However, we would call readers' attention 
to two proposed substantive changes. First, in renumbered Sec.  40.84 
(Sec.  40.99 in the current regulation), laboratories would be required 
to keep non-negative specimens for only 90 days, rather than the 
present one-year requirement. This change is intended to reduce storage 
burdens on laboratories. We are not aware of any reason a laboratory 
would need to keep the actual specimen beyond 90 days. This change 
would not affect the 2-year record retention requirement that HHS has 
set for documentation supporting the laboratory's analysis of a non-
negative specimen. This would not change a litigation hold placed upon 
the specimen and the paperwork. We seek comment on this change, as well 
as the more general question of whether interested parties find the 
reorganization of the Subpart F useful.
    The most notable new portion of this subpart, consisting of 
Sec. Sec.  40.91-40.93, concerns cutoff concentrations and validity 
testing for oral fluid specimens. These three new sections are drawn 
from the HHS OFMG and are intended to be consistent with the HHS 
provisions. For information on the parallel HHS provisions and the HHS 
rationale for putting them into effect, see the OFMG (84 FR 57554).
    In Sec.  40.111, we propose to add language to paragraphs (a) and 
(d) to clarify that in their statistical reports to employers and DOT, 
laboratories need to submit reports to employers for the specimens for 
which the laboratory tests.
    In addition, we added language in Sec.  40.111 to clarify that a 
laboratory withdrawing from National Laboratory Certification Program 
(NLCP) program certification is required to file with both employers 
and the DOT an aggregate statistical summary for the last period in 
which it conducted DOT-regulated testing. This data is important to the 
Department because it helps DOT identify trends regarding non-negative 
results (e.g., positives, adulterated, substituted and invalid) and 
cancelled tests.
Subpart G--Medical Review Officers
    For the most part, MROs would continue to do their jobs as they 
have under the current regulation. However, the Department is proposing 
a few changes to the MRO provisions. Specifically, in Sec.  40.121, we 
would delete the word ``urine'' from paragraph (c)(1)(i), because 
training for MROs should also include oral fluid testing. We seek 
comment on whether existing and/or new MROs should receive

[[Page 11166]]

additional training specifically with respect to their role in oral 
fluid testing and, if so, what subjects it should cover.
    In Sec.  40.127, concerning MRO reviews of negative results, we 
propose specifying that MROs need not review more than 500 negative 
results ``of all specimen types combined'' in any quarter. This is to 
clarify that, by adding oral fluid testing to the regulation, we do not 
intend to increase MROs' negative test result review requirements.
    In Sec.  40.129(d), we propose deleting ``drug test report'' and 
adding the word ``result'' following ``invalid test.'' In Sec.  
40.135(d), we propose deleting the word ``test'' and adding the word 
``result.'' This would keep the language of that paragraph internally 
consistent and consistent with the definition of the term ``invalid 
result'' in Sec.  40.3.
    In Sec.  40.139(b), we are proposing 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 propose to delete a reference to 
``urine,'' since the provision would apply to all DOT drug tests.
    The proposed rule would make two clarifying changes to Sec.  
40.145. In Sec.  40.145(g)(3), we would delete the word ``urine'' and 
substitute ``drug,'' since in this context we would apply the 
requirement to test in an HHS-certified laboratory to any such test, 
whether urine or oral fluid. In paragraph (h) we would add the word 
``urine'' after ``substituted''.
    In Sec.  40.151, we propose clarifying the language of paragraph 
(a) to direct MROs not to accept the result of any drug test not 
collected and tested under Part 40 procedures. In talking to employees 
who contact ODAPC following a positive drug test, we often hear, ``I 
went to my own doctor the next day and took another test and it was 
negative.'' This paragraph emphasizes that MROs cannot accept such a 
claim, which does not overturn the MRO's decision. We also deleted 
language referring to DNA tests since use of those tests is prohibited 
elsewhere in the regulation (see 49 CFR 40.153(e) and 40.331(f)). In 
paragraph (b), we would change ``urine'' container to ``collection'' 
container in recognition of the advent of oral fluid testing. In 
paragraph (g), we deleted reference to ``MDEA'', since it had been 
removed in a previous rulemaking (82 FR 52229 (Nov. 13, 2017)), in 
response to HHS deleting MDEA from the drug testing panel. MDEA is a 
Schedule I drug in the amphetamines class that was previously a 
required confirmatory test analyte under the HHS Guidelines, but which 
HHS removed.
    In Sec.  40.151, we also propose a technical amendment to paragraph 
(i), replacing the wording ``with no detectable creatinine'' with 
``when the creatinine level is below the laboratory's limit of 
detection.'' This would ensure consistency with the requirement for 
laboratories to provide a numerical value for a substituted result (see 
49 CFR 40.97(e)(2)). Also, it is our understanding that all HHS/NLCP-
certified laboratories must have an established limit of detection for 
creatinine of 1mg/dL or less. Therefore, when a laboratory reports a 
creatinine concentration level at less than its limit of detection, 
MROs can be assured that it falls below the creatinine concentration of 
2mg/dL for a substituted specimen and that an individual cannot 
physiologically produce such a urine specimen.
    In Sec.  40.159, in paragraph (a)(1) we propose to correct the 
reference to Sec.  40.96(c) to become Sec.  40.96(b) and we propose 
adding a new sentence to paragraph (a)(5)(ii), which would require re-
collection when an invalid test is cancelled. The added sentence would 
direct that an alternative specimen be collected if practicable (e.g., 
oral fluid, if the specimen was urine). This could result in a more 
efficient process and reduce the likelihood of multiple invalid 
specimens resulting from use of the same specimen type.
    In Sec.  40.163(c)(2), we propose a small change, substituting 
``employee'' for ``donor.'' In Sec.  40.163(e), we are also making 
minor wording changes to clarify what records the MRO needs to retain 
after having reported a result and to clarify that when completing Copy 
2 of the CCF, either the MRO must sign and date it (for both negatives 
and non-negatives) or MRO staff must stamp and date it (for negatives 
only).

Sec.  40.177 What does the second laboratory do with the split specimen 
when it is tested to reconfirm the presence of a drug or drug 
metabolite?

    In Sec.  40.177, we propose adding a reference to the sections 
pertaining to oral fluid testing.

Sec.  40.179 What does the second laboratory do with the split specimen 
when it is tested to reconfirm an adulterated test result?

    In Sec.  40.179, the proposed rule would change referenced section 
numbers in accordance with renumbering and new oral fluid provisions 
elsewhere in the regulations.

Sec.  40.181 What does the second laboratory do with a urine split 
specimen when it is tested to reconfirm a substituted test result?

    In Sec.  40.181, the proposed rule would change referenced section 
numbers in accordance with renumbering and new oral fluid provisions 
elsewhere in the regulations. In addition, Sec.  40.181 would be 
changed to refer only to urine testing, since the creatinine and 
specific gravity apply only to urine testing.

Sec.  40.187 What does the MRO do with split specimen laboratory 
results?

    In Sec.  40.187, the proposed rule would change references to 
appendix D to appendix F in accordance with the redesignations.

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

    This proposed provision carries through the main points of Part 
40's existing refusals provision, the main addition being a provision 
describing what can constitute a refusal in an oral fluid collection. 
The proposed section would make a variety of small wording changes to 
take oral fluid testing into account (e.g., in paragraph (a)(8)), 
``fail to permit an inspection of the employee's oral cavity or fail to 
remove objects from his or her mouth''), as well as specifying 
situations that are applicable only to urine testing (e.g., in 
paragraph (a)(9)), ``fail to comply with an instruction to permit 
inspection to allow the observer to determine whether there is a 
prosthetic device in use'').
    Like the pre-employment urine collection process, the oral fluid 
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. 
However, as in urine testing, certain blatant conduct by the employee 
at the collection site could constitute a refusal before the collection 
device is unwrapped. For example, if an employee arriving for a pre-
employment test, engages in disruptive or combative conduct at the 
collection site, a collector could report a refusal to the employer for 
determination.
    In addition, it is important to note that when an employee is 
undergoing a pre-employment test and the collector switches to an 
alternate device, it is considered a continuation of the original 
collection and is not subject to

[[Page 11167]]

the pre-employment exception for leaving the collection site before the 
second device is opened. For example, if a collector begins with one 
specimen methodology (e.g., urine) and switches to oral fluid (e.g., 
because the employee was unable to provide a sufficient specimen), the 
employee must not leave the collection site without refusal 
consequences.
    The proposed rule would revise Sec.  40.191(d) and add a new 
paragraph (c)(1) to Sec.  40.261 to clarify an often-misunderstood 
point about who has the authority to declare that conduct at the 
collection site constitutes a refusal to test. The Department has 
received many inquiries in which employers have automatically treated 
as a refusal any situation in which the collection site notes a refusal 
in the remarks section of the CCF. This is not correct.
    Under the long-existing 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 authorized to 
make this decision. Their role is to provide information to the 
employer concerning the circumstances of the event. Then the employer, 
who as a matter of prudence would contact the employee and the 
collector or BAT to gather information, should make the decision, 
taking the entirety of the circumstances into account. The employer 
would have the discretion to consider circumstances that may 
satisfactorily excuse the employee's conduct. For FMCSA-regulated 
owner-operators, C/TPAs stand in the shoes of employers for the 
purposes of determining whether the individual refused a test (49 CFR 
382.705(b)(6)).
    For example, we have heard multiple times about situations in which 
an employee provides an insufficient quantity of urine, begins the 
``shy bladder'' procedure, but the procedure is cut short because the 
collection site closes before the employee has had three hours to 
produce a sufficient urine specimen, as allowed by Sec.  40.193(b)(2). 
If the collection site nevertheless reports the matter to the employer 
as a refusal, the employer has discretion to determine that there was 
no intent on the part of the employee to evade the process. If the 
employer determines that a refusal did not occur, the employer would 
treat the test as an administratively closed non-event. FMCSA-regulated 
employers would have the discretion not report such non-events to the 
Clearinghouse as refusals. The same thinking might apply in a situation 
in which a documented family medical emergency led the employee to 
leave the collection site.
    For random tests administratively closed as a non-event by the 
employer, no further action is required. For those testing events that 
require a ``negative'' test result (e.g., return-to-duty, follow-up), 
the employer would send the employee back for another collection. In 
all cases, the employer should document exactly what happened to 
explain why the employer concluded a refusal did not occur.

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

    The most important change that this section would make is the 
addition of oral fluid testing to paragraph (a), adding insufficient 
specimen provisions for oral fluid testing, parallel to, but briefer 
than, the existing provisions of dealing with insufficient urine 
specimens. Because of the differences between the two types of specimen 
collections, the insufficient specimen collection procedure is shorter 
in duration than the insufficient urine specimen collection procedure 
(e.g., in an oral fluid collection, there would not be a need for a 
three-hour wait period). In paragraph (e), the proposed rule would add 
examples of conditions that might succeed as medical explanations of 
providing an insufficient quantity of oral fluid (e.g., autoimmune 
diseases), as well as examples that would not constitute a valid 
medical explanation (e.g., unsupported assertions of dehydration). We 
seek comment on what sort of evidence is needed to avoid an assertion 
being viewed as ``unsupported'' for this purpose. We note that because 
alternative specimens will be available, using a different type of 
specimen in an insufficient quantity case may be an option. That is, if 
a urine specimen is insufficient, the collector could follow up with an 
oral fluid collection, or vice-versa. In such a case, following the 
insufficient urine specimen procedures would become unnecessary. The 
Department seeks comment on both this concept and whether specific 
language to this effect should be included in the regulatory text.
    We also seek public comment, especially from device manufacturers, 
regarding whether allowing a donor to rinse with up to 8 ounces of 
water is an appropriate amount of fluid for rinsing for the purposes of 
both Sec. Sec.  40.72(b) and 40.193(b)(2). Should we allow more or 
less? Would measuring less than 8 ounces be difficult for collectors?
    We also seek comment on whether a qualified collector should be 
able to make a decision about what methodology to use after an 
insufficient specimen occurs, or whether this should be a decision left 
to the employer, depending, for example on the employer's contract with 
a C/TPA, laboratory, or collection site. In addition, when following an 
insufficient specimen collection, consistent with the HHS OFMG, the 
collector would complete a new CCF for the alternative specimen 
collection. Is this an appropriate way of handling such situations, or 
would it be better to continue the current practice and use the 
original CCF with relevant cross-outs and notations in the remarks 
section?

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 textual change in Sec.  40.195 in the proposed rule is in 
the title, where the more general ``specimen'' is substituted for 
``urine,'' in view of the addition of oral fluid testing to the 
program.

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.

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

    Section 40.199, the ``fatal flaws'' section of the rule, would be 
expanded by adding a new fatal flaw for use of an expired oral fluid 
collection device, in paragraph (b)(8). In paragraph (b)(7) of Sec.  
40.199, the term ``urine'' would be replaced with ``specimen,'' 
reflecting the addition of oral fluid testing to the program.

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

    In paragraph (b)(7) of Sec.  40.199 and paragraph (f) of Sec.  
40.201, the term ``urine'' would be replaced with ``specimen,'' 
reflecting the addition of oral fluid testing to the program.

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

    Throughout the history of Part 40, there has not been a regulatory 
provision that allows an MRO to ``uncancel'' a test that the MRO has 
cancelled. New paragraph (d) is proposed so that an MRO can reverse

[[Page 11168]]

the cancellation of a test. Currently, Sec. Sec.  40.203, 40.205, and 
40.208 address situations that require a test to be cancelled by an 
MRO, if there is not corrective action. For example, if an MRO does not 
receive a timely memorandum for the record from a collector regarding 
required information that was omitted from the CCF, the MRO may cancel 
the test. Once an MRO cancels a test due to an uncorrected correctible 
error, there is currently no authority for the MRO to reverse that 
cancellation decision. So, if the memorandum for the record arrives, 
but the MRO staff misses it, the cancelled test cannot be reversed 
without this proposed rule change. That inability has created 
additional cost for the employer, inconvenience for the employee, and 
also confusion because some MROs think they already have this 
authority. Adding this provision will reduce costs and confusion. In 
addition, for those testing events for which an employer needs a 
negative result (i.e., pre-employment, return-to-duty or follow-up), an 
employee must go in and re-take the test, if the MRO cannot un-cancel 
it after the error is corrected.

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

    This proposed revision notes that oral fluid and/or urine specimens 
can be collected, and must be tested at HHS-certified laboratories. No 
other specimen methodologies are currently permitted.
    We are proposing that an employer can use one or the other, but not 
both urine and oral fluid methodologies at the beginning of the testing 
event. For example, if an employee is sent for a test, either a urine 
or oral fluid specimen can be collected, but not both simultaneously. 
However, if there is a problem in the collection that necessitates a 
second collection (e.g., insufficient quantity of urine, temperature 
out of range, or insufficient oral fluid), we want to propose that a 
second methodology could be used to complete the collection process for 
the testing event. If we adopt this provision, would the employer and/
or its service agent be the correct one(s) to make the decision as to 
which methodology to use in the second collection?

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

    This proposed revision would make a conforming change to Sec.  
40.225 and redesignate appendix G to be appendix I.

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

    We are proposing to add a new paragraph (c)(1) to this section, 
parallel to the proposed Sec.  40.191(b) for drug testing. It spells 
out the respective responsibilities of the service agent(s) and the DER 
in making decisions about whether a situation during an alcohol test 
constitutes a refusal to test. In a situation in which there is not an 
employee signature, at Step 2 of the ATF (see paragraph (a)(6) of this 
section), but a result is nonetheless forwarded to the employer, we 
recommend that the employer take a case-by-case approach, for example 
not treating as a refusal a situation in which there is no signature 
but there is an affidavit from an STT or BAT explaining the situation.

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

    In Sec.  40.283, there is a conforming change redesignating 
aappendix E to aappendix G.

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.

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

    A conforming change, from aappendix F to aappendix H, would be made 
in Sec.  40.345.

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

    In Sec.  40.355(n) (Example 3), the word ``urine'' would be removed 
in light of the addition of oral fluid testing.

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 Considerations section, the 
Department is proposing to permit substance abuse professionals (SAPs) 
to conduct evaluations or assessments remotely. The proposed rule would 
amend Sec. 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. Specifically, the technology must be 
able to allow real-time audio and visual interaction between the SAP 
and the employee. Telephone calls, therefore, would not be acceptable. 
In addition, the proposal would require that the quality of the 
technology be sufficient to allow the SAP to gather all visual and 
audible information that would be apparent in a face-to-face 
interaction.

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

    The proposal would remove the words ``face-to-face'' from paragraph 
(a) this provision. This change, if adopted, would allow remote 
evaluations.

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

    The proposal would remove the words ``face-to-face'' from paragraph 
(b)(2) this provision. It would also add the words ``meeting the 
requirements of Sec.  40.291(a)(1) of this part'', if adopted. This 
proposed change would allow remote evaluations.

Sec.  40.311 What are the requirements concerning SAP reports?

    The proposal would add the words ``and format (i.e., face-to-face 
or remote)'' to Sec.  40.311(c)(4), (d)(4), and (e)(4). In addition, we 
would amend Sec.  40.311 to direct SAPs to note on their SAP reports 
whether a given evaluation occurred face-to-face or remotely.
    We also propose to change ``SSN'' to ``SSN or employee ID number'' 
in paragraphs Sec.  40.311(c)(1), (d)(1) and (e)(1) for consistency of 
terms in Part 40 and to allow the use of additional identification 
numbers in SAP reports, instead of solely the Social Security Number.

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

    We propose to amend Sec.  40.365 to say that a PIE could occur 
because a SAP failed to conduct an evaluation using the means provided 
in Sec.  40.291(a)(1), rather than because there was no face-to-face 
evaluation.

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

    In Sec.  40.327, we would add a clarification that MROs are not to 
use the CCF to transmit information about safety concerns to employers 
or other authorized parties. Rather, a separate communication (e.g., 
secure email, letter) is to be used. The communication should specify 
whether the MRO's safety concern relates to the use of a medication, 
the type of medical condition for which such a medication is typically 
prescribed, or some combination of the two. The purpose of

[[Page 11169]]

providing this information is to allow the employer and/or any third 
parties to focus on the MRO's specific concern, rather than having to 
make an open-ended inquiry. The Department seeks comment on this 
matter. This clarification would echo the Department's 2017 final rule 
preamble discussion that medical information is sent apart from the 
verified result report. (82 FR 52229, 52236; Nov. 13, 2017).
Appendices
    Appendix A, concerning urine collection kits, would remain 
unchanged. The proposed rule would add a new aappendix B, establishing 
standards for oral fluid collection kits, based on material in the HHS 
OFMG and consistent with OTETA requirements for a split specimen. The 
Department seeks comments on the details of the proposed standards.
    The remainder of the appendices would be renumbered and reordered. 
For a summary of these changes, see the redesignation table immediately 
preceding the discussion of subpart D in section V of the preamble. The 
Department seeks comment on the new organization of the appendices.
    Current aappendix B, concerning semi-annual reports by laboratories 
to employers, would become aappendix D. The new version of the appendix 
would break out matters to be reported with respect to urine and oral 
fluid testing respectively. Current aappendix C, regarding semi-annual 
reports by laboratories to the Department, would become aappendix E. 
Meanwhile, the aappendix C slot would be reserved.
    In the redesignated aappendix E (the former aappendix C), the 
Department proposes to amend the data elements that HHS/NLCP certified 
laboratories would submit to DOT semi-annually. Specifically, we 
propose to require laboratories to continue to provide the DOT with the 
drug testing data but to be broken out by specimen type (i.e., urine 
and oral fluid), DOT agency (i.e., FMCSA, FAA, FRA, FTA, PHMSA, U.S. 
Coast Guard) and test reason (i.e., pre-employment, random, reasonable 
suspicion/cause, post-accident, return-to-duty, other, and follow-up). 
The proposal would require each laboratory to submit multiple data 
summaries as opposed to the one data summary they now provide. By 
providing the additional data elements, we hope to evaluate the 
efficacy of testing by oral fluid versus urine. We also hope to get a 
better understanding of any trends in drug testing by specimen type, 
DOT agency and/or test reason(s).
    We do not anticipate that providing the amended data summaries will 
prove to be burdensome to the laboratories. It is our understanding 
that most, if not all of the HHS/NLCP-certified laboratories capture 
these data elements either as a result of implementing the electronic 
Federal Drug Testing Custody and Control Form, or in their Laboratory 
Information Management System, as part of tracking the specimens and 
reporting out test results to the Medical Review Officer. We would 
appreciate information from laboratories as to whether adding the new 
data elements would increase their costs or otherwise impose a 
quantifiable burden of what the costs of adding the new data elements 
would be.
    Current aappendix D, concerning reports on split specimen failures 
to reconfirm, would become aappendix F. We propose to add the 
``specimen type'' as another element to the information the MRO 
currently provides so we can track the two specimen types. Current 
aappendix E, on SAP equivalency requirements for certification 
organizations, would become aappendix G.
    Current aappendix F, concerning drug and alcohol testing 
information can be transmitted by C/TPAs, would become appendix H. 
Current appendix G, the Alcohol Testing Form, would become aappendix I. 
Finally, aappendix H, the MIS data collection form, would be found in 
aappendix J.

VI. Regulatory Analyses and Notices

Executive Order 12866

    The Secretary has examined the impact of the proposed Part 40 
amendments under Executive Order 12866, which directs Federal agencies 
to assess all costs and benefits of available regulatory alternatives 
and, when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety, and other advantages; distributive impacts; 
and equity). This examination draws upon the evaluation performed by 
HHS in its final guidelines concerning oral fluid testing, published 
October 25, 2019 (84 FR 57554), as well as data reflecting the 
Department's experience in implementing its existing drug testing 
program.
    According to Executive Order 12866, a regulatory action is 
``significant'' if it meets any one of a number of specified 
conditions, including having an annual effect on the economy of $100 
million; adversely affecting in a material way a sector of the economy, 
competition, or jobs; or if it raises novel legal or policy issues. The 
proposed amendments do modify existing regulatory requirements and 
allow an activity that was formerly prohibited, but they do not meet 
the Executive Order's criteria for being a significant rule. 
Consequently, OMB has determined that this document proposes a 
nonsignificant rule.
Need for Regulation
    The Department believes that this proposed rule is needed because 
it makes several improvements in the integrity and effectiveness of an 
important safety program, as well as potentially reducing some costs to 
regulated parties. The reasons for this belief include the following:
Enhanced Flexibility
    The proposed rule, consistent with the HHS OFMG, would revise the 
requirement to collect only a urine specimen, which has existed since 
Part 40 was first published in 1988. Urine drug testing is subject to 
issues related to an employee's inability to produce a sufficient urine 
specimen. In such situations, the employee's inability to provide a 
sufficient urine specimen creates delays in getting a result to the 
employer because of the requirement to have the employee evaluated by a 
medical professional to assess the employee's inability to provide a 
sufficient specimen.
    When the proposed amendments to Part 40 permitting oral fluid 
testing are used by a transportation employer, the employer will be 
authorized to collect an oral fluid specimen from an individual who is 
unable to provide a sufficient urine specimen. This added flexibility 
will reduce the need for the Medical Review Officer (MRO) to arrange a 
medical evaluation of an employee's inability to provide a specimen. 
Therefore, the proposed amendments would provide flexibility to address 
workplace drug testing needs of transportation employers by permitting 
the selection of the specimen type best suited for their needs and 
authorizing collection of an alternative specimen type when an employee 
is unable to provide a sufficient urine specimen. The added flexibility 
will also benefit employees, who should be able to provide one of the 
specimen types, thereby facilitating the drug test required for their 
employment.
Enhanced Versatility
    Urine collection requires use of a collection facility, secured 
restrooms, and other special requirements. An oral fluid collection 
does not require an enclosure, the way that a urine collection does. 
With oral fluids, there

[[Page 11170]]

is more flexibility regarding the collection site. Specifically, an 
acceptable oral fluid collection site must allow the collector to 
observe the employee, maintain control of the collection device(s) 
during the process, maintain record storage, and protect employee 
privacy. This would provide employers with more flexibility about where 
to conduct a collection. For example, especially in the railroad and 
pipeline industries, where selected employees may be part of 
``travelling gangs'' or in remote locations (e.g., away from locations 
with traditional brick-and-mortar buildings) an enclosure is often 
difficult to find for collecting DOT-regulated specimens.
    Having oral fluid testing as an option available to an employer 
provides flexibility for the employer to choose whether urine or oral 
fluid testing is better due to logistics, costs, and the specific facts 
of a situation. Among other things, when a problematic situation occurs 
at a collection site (e.g., a urine specimen is out of temperature 
range), the ensuing directly observed test could be conducted using 
oral fluid. Choosing the oral fluid testing option in such situations 
can save the employer significant time and money.
Decreased Numbers of Substituted and Adulterated Tests
    All unobserved specimen collections are at risk for substitution 
and adulteration. Per HHS's OFMG preamble, information from the drug 
testing industry indicates that 0.05 to 3% of urine specimens collected 
for drug use detection are determined to be substituted or adulterated. 
(84 FR 57571; Oct. 25, 2019). All oral fluid collections will occur 
under direct observation, which should substantially reduce the risks 
of specimen substitution and adulteration that has been associated with 
urine specimen collections, most of which are unobserved. With the 
above in mind, and to harmonize with HHS, we are proposing changes to 
Sec. Sec.  40.91 and 40.93 to authorize laboratories to conduct 
specimen validity testing (e.g., testing for a biomarker such as 
albumin or immunoglobulin G, IgG or for a specific adulterant).
Time and Cost Savings
    Collecting an oral fluid specimen can require less time than 
collecting a urine specimen, and thereby reduce the employee's time 
away from the workplace and costs to the employer. First, most urine 
collections take place in separate facilities dedicated to collections, 
requiring employees to travel from their workplace to those facilities 
and back. Their time away from their workplace is a cost to their 
employers. On the other hand, most oral fluid collections are likely to 
take place at or near the workplace, making this travel time and cost 
unnecessary.
    The Department does not currently have data on the percentage of 
urine collections that are conducted in dedicated collection 
facilities, or the percentage of oral fluid collections that would 
likely be conducted on-site. We request that commenters submit 
information that would help the Department approximate a calculation of 
the travel time savings that could result from making oral fluid 
testing available as an alternative to urine testing.
    Second, some urine collection events involve the employee's 
inability to provide a sufficient specimen. In these cases, the current 
regulation affords the employee up to three hours to make a second 
attempt at providing a sufficient urine specimen. This wait period can 
be avoided by immediately switching to an oral fluid collection, saving 
up to three hours of time in such cases. From 2018 MIS data, about 334 
insufficient specimen collections resulted in refusals, a number that 
does not include those instances in which the situation is resolved 
without a refusal being declared. The Department seeks comment on the 
incidence of ``shy bladder'' situations, to get a better sense of how 
much time and costs would be saved by eliminating them by the use of 
oral fluid testing.
    In addition, fewer insufficient specimen situations would mean 
fewer medical evaluations, which could also result in time and cost 
savings. The option to collect a urine specimen in the event that the 
employee cannot provide an oral fluid specimen (and vice versa) will 
avoid the need for the MRO to arrange for a medical evaluation of an 
employee's inability to provide a sufficient specimen. We seek comment 
on what degree of time and cost savings might result from this 
proposal.
    We also note that urine testing is subject to other events that may 
involve additional testing. For instance, if an initial urine specimen 
is out of temperature range, or the color or odor of a specimen may 
indicate an attempt to tamper with a specimen, there must be an 
immediate re-collection under direct observation. Many of these 
situations may well evolve into a ``shy bladder'' situation as, having 
just voided, the employee may be unable to produce another specimen 
quickly. These subsequent collections involve time and other costs. We 
seek comment on how frequently such subsequent collections occur, and 
how much time they add to the process.
Reduced Need for Collection Site Security Measures
    Urine testing requires that access to water sources or to any 
potential adulterants or substituting products be secured and 
prohibited. This requires securing of the collection site to ensure the 
integrity of the unobserved testing process and protection against 
cheating. We are proposing substantially fewer steps for oral fluid 
collection site integrity and security because all oral fluid specimen 
collection is directly observed.
    Providing urine is a bodily function that requires more privacy 
than having the employee place a collection device in the employee's 
mouth, in accordance with the collector's instructions. Consequently, 
oral fluid testing is less intrusive and time-consuming than even 
unobserved urine testing.
Versatility in Detection
    Adding oral fluid as an alternate specimen type would allow an 
employer to select the specimen type based on the circumstances of the 
test. For example, in a reasonable suspicion/cause or post-accident 
test, an oral fluid test may show the presence of an active drug, which 
may indicate recent use of the drug, and which might not be detected in 
a urine drug test.
    An oral fluid drug test can detect marijuana use in the past 24 
hours, while a urine drug test detects use ranging from 3-67 days prior 
to collection (see preamble ``Understanding Windows of Detection''). 
Thus, oral fluid testing may give employers more interpretative insight 
into recent drug use.
Lower Likelihood of Adulteration, Substitution or Cheating
    Urine was the original specimen of choice for workplace drug 
testing, and urine testing is expected to remain an established and 
reliable component of DOT's drug testing program. However, a major 
challenge to urine drug testing has been the proliferation and use of 
available commercial products used to adulterate or substitute an 
employee's urine specimen. Due to individual privacy rights, most urine 
collections are unobserved, allowing the opportunity to use such 
products. As under HHS Urine Mandatory Guidelines, laboratories have 
developed procedures to identify adulterated and/or substituted 
specimens, manufacturers have developed new products to avoid 
detection. The use of these products is expected to continue. Like HHS, 
DOT

[[Page 11171]]

believes that oral fluid testing is likely to be less susceptible to 
these problems because the oral fluid collection is a directly observed 
collection.
Costs and Benefits
    Using data obtained from the Federal Workplace Drug Testing 
Programs and HHS-certified laboratories, HHS estimated that 
approximately 7% (or 10,500) of the 150,000 specimens tested in the 
Federal employee program per year would be oral fluid specimens and 93% 
would continue to be urine specimens. HHS further estimated that 
subsequent transition to oral fluid testing would be gradual and steady 
over the course of four years, when it could account for about 30% of 
all tests.
    If, as the Department believes based on industry experience, the 
cost of a urine test is approximately $50, while the cost of an oral 
fluid test is $35, this means that each oral fluid test that is done in 
place of a urine test results in a saving of $15. By this calculation, 
oral fluid testing would cost $14.7 million in the first year and $63 
million after the four-year transition period. This represents a 
potential savings of $6.3 million the first year and $27 million in the 
fourth year, compared to a scenario in which all the tests in question 
were urine tests. The Department seeks comment on whether the 
assumptions behind these calculations make sense and whether and how we 
should modify them.
    It is possible that, over time, the proportion of tests conducted 
using oral fluid could increase beyond this projection, as employers 
take advantage of the lower costs and greater flexibility associated 
with oral fluid testing. If so, then the cost savings of these 
amendments would increase. We do not have data on which to base an 
estimate of how large and how quickly this trend might become. The 
Department seeks comment on this matter.
    Employers and C/TPAs choosing to use oral fluid in their drug 
testing programs may incur collector training costs. Based on an 
average of the limited number of published training costs for oral 
fluid collectors in the non-DOT drug testing industry, oral fluid 
collection training would cost about $348 per collector trained.
    The Department estimates that there are about 25,000 collectors 
currently participating in the DOT-regulated urine drug testing 
program. We assume, per HHS's projection, that after the first year of 
oral fluid testing, 7% of tests would use oral fluid and around 7% of 
collectors would be trained in oral fluid collection by that point. 
Seven percent of 25,000 collectors is 1,750. Their training would cost 
$609,000. By the same logic, by the end of the fourth year, 30% of 
those 25,000 collectors, or 7,500, would have been trained in 
collecting oral fluid. The cost for oral fluid testing training an 
additional 23% of the 25,000 collectors, or 5,750 individuals, in years 
2-4 would be $2,001,000. The Department seeks information and comment 
on this approach and these projections.
    As noted in the time savings discussion above, in a ``shy bladder'' 
situation, a collector can switch from urine to oral fluid collection. 
Likewise, in a ``dry mouth'' situation, a collector can switch from 
oral fluid to urine collection. This flexibility minimizes the required 
waiting period involved in ``shy bladder/dry mouth'' situations at the 
collection site. It also avoids costs and time expenses of subsequent 
medical evaluations to determine whether there is a medical explanation 
of employee's inability to provide a sufficient specimen. As noted 
above, we are seeking information on the number and costs of such 
evaluations. Table 1 summarizes the quantified economic effects of the 
proposed rule. The proposed rule has annual net cost savings (benefits) 
of $5,61,000 in the first year, increasing to $24,999,000 in the fourth 
and subsequent years.

                                   Table 1--Economic Effects of Proposed Rule
----------------------------------------------------------------------------------------------------------------
                           Year                                   Costs         Cost savings    Net cost savings
----------------------------------------------------------------------------------------------------------------
1.........................................................          $609,000        $6,300,000        $5,691,000
2.........................................................          $957,000       $11,475,000       $10,518,000
3.........................................................        $1,305,000       $11,475,000       $10,170,000
4 and beyond..............................................        $2,001,000       $27,000,000       $24,999,000
----------------------------------------------------------------------------------------------------------------

Regulatory Flexibility Act and SBREFA

    This rule does affect small entities, including employees, small 
transportation companies and collection sites. DOT anticipates, 
however, that there will be an overall reduction in costs if drug 
testing is expanded to provide the option of oral fluid testing under 
Part 40. The added flexibility to use either specimen type will permit 
employers to select the specimen type best suited for their needs and 
to authorize collection of an alternative specimen type when an 
employee is unable to provide the specimen type originally authorized. 
This added flexibility will also benefit employees, who should be able 
to provide one of the specimen types, thereby facilitating the 
completion of drug tests required for their employment. For these 
reasons, and as explained in more detail in the preamble to this 
proposed rule, the Secretary has determined that the proposed rule 
would not have a significant economic impact on a substantial number of 
small entities within the meaning of the Regulatory Flexibility Act (5 
U.S.C. 605(b)). Consequently, an initial regulatory flexibility 
analysis is not required for this proposed rule.
    The Secretary has determined that this NPRM is not a ``major rule'' 
for the purpose of congressional review. For the purpose of 
congressional review, a major rule is one which is likely to cause an 
annual effect on the economy of $100 million or more; a major increase 
in costs or prices; significant effects on competition, employment, 
productivity, or innovation; or significant effects on the ability of 
U.S.-based enterprises to compete with foreign-based enterprises in 
domestic or export markets. The proposed rule does none of these 
things, and hence does not constitute a major rule under the Small 
Business Regulatory Enforcement Fairness Act (SBREFA) of 1996.
Unfunded Mandates
    The Secretary has examined the impact of the proposed rule under 
the Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L. 104-4). This 
notice does not trigger the requirement for a written statement under 
sec. 202(a) of the UMRA because this rulemaking does not impose a 
mandate that results in an expenditure of $100 million (adjusted 
annually for inflation) or more by either State, local, and tribal 
governments in the aggregate or by the private sector in any one year. 
In fact, by providing a lower cost alternative to urine drug testing, 
the NPRM would reduce costs to regulated parties, including State and 
local entities (e.g.,

[[Page 11172]]

public transit authorities, public works departments) whose employees 
are subject to testing.
Environmental Impact
    The DOT has analyzed the environmental impacts of this action 
pursuant to the National Environmental Policy Act of 1969 (NEPA) (42 
U.S.C. 4321 et seq.) and has determined that it is categorically 
excluded pursuant to DOT Order 5610.1C, ``Procedures for Considering 
Environmental Impacts'' (44 FR 56420, October 1, 1979). Categorical 
exclusions are actions identified in an agency's NEPA implementing 
procedures that do not normally have a significant impact on the 
environment and therefore do not require either an environmental 
assessment (EA) or environmental impact statement (EIS). The purpose of 
this rulemaking is to amend the transportation industry drug testing 
program procedures regulation to include oral fluid testing. Paragraph 
4(c)(5) of DOT Order 5610.1C incorporates by reference the categorical 
exclusions for all DOT Operating Administrations. This action is 
covered by the categorical exclusion listed in the Federal Transit 
Administration's implementing procedures, ``[p]lanning and 
administrative activities that do not involve or lead directly to 
construction, such as: . . . promulgation of rules, regulations, 
directives. . .'' 23 CFR 771.118(c)(4). The agency does not anticipate 
any environmental impacts, and there are no extraordinary circumstances 
present in connection with this rulemaking.
Executive Order 13132: Federalism
    The Secretary has analyzed the proposed rule in accordance with 
Executive Order 13132: Federalism. Executive Order 13132 requires 
Federal agencies to carefully examine actions to determine if they 
contain policies that have federalism implications or that preempt 
State law. As defined in the Order, ``policies that have federalism 
implications'' refer to regulations, legislative comments or proposed 
legislation, and other policy statements or actions that have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government.
    Most of the regulated parties under the Department's drug testing 
program are private entities. Some regulated entities are public 
entities (e.g., transit authorities, public works departments); 
however, as noted above, this proposal would reduce costs of the 
Department's drug testing program and provide additional flexibility 
for regulated parties. Accordingly, the Secretary has determined that 
the proposed rules do not contain policies that have federalism 
implications.
Executive Order 13175: Consultation and Coordination With Indian Tribal 
Governments
    Executive Order 13175 (65 FR 67249, November 6, 2000) requires 
Federal agencies to develop an accountable process to ensure 
``meaningful and timely input by tribal officials in the development of 
regulatory policies that have tribal implications.'' ``Policies that 
have tribal implications'' as defined in the Executive Order, include 
regulations that have ``substantial direct effects on one or more 
Indian tribes, on the relationship between the Federal Government and 
the Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes.'' This proposed rule 
does not have tribal implications. Nor will they have substantial 
direct effects on tribal governments, on the relationship between the 
Federal Government and Indian tribes, or on the distribution of power 
and responsibilities between the Federal government and Indian tribes, 
as specified in Executive Order 13175.
Information Collection/Record Keeping Requirements
    The proposed rule would not impose additional information 
collection burdens. In August 2020, OMB approved the revised CCF (OMB 
Control No. 0930-0158). It is a single CCF that can be used for either 
urine or oral fluid testing. Collectors, laboratories, MROs and other 
parties in the DOT drug testing program are required to use the 2020 
CCF for urine testing. Upon issuance of any final rule authorizing oral 
fluid testing, the 2020 CCF will be required for oral fluid testing.
    Notwithstanding any other provision of law, no person is required 
to, nor shall any person be subject to a penalty for failure to comply 
with, a collection of information subject to the requirements of the 
PRA unless that collection of information displays a currently valid 
OMB control number.

List of Subjects in 49 CFR Part 40

    Administrative practice and procedures, Alcohol abuse, Alcohol 
testing, Drug abuse, Drug testing, Laboratories, Reporting and 
recordkeeping requirements, Safety, Transportation.
    For the reasons stated in the preamble, the Department proposes to 
amend 49 CFR part 40 as follows:

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

0
1. The authority for part 40 continues to read as follows:

    Authority: 49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and 
54101 et seq.

0
2. In Sec.  40.3:
0
a. Remove the definitions of ``Invalid drug test'' and ``Screening drug 
test'';
0
b. Remove the definition of ``Initial drug test (also known as 
``Screening drug text'') and add a definition for ``Initial drug test'' 
in its place;
0
c. Remove the definition of ``Limit of Quantification'' and add a 
definition for ``Limit of Quantification (LOQ)'' in its place;
0
d. Add in alphabetical order definitions for ``Alternative specimen'', 
``Commercial Driver's License Drug and Alcohol Clearinghouse 
(Clearinghouse)'', ``Cutoff'', ``Oral Fluid Specimen'', ``Specimen'', 
``SSN or Employee ID No.'', ``Undiluted (neat) oral fluid'', and 
``Urine Specimen''; and
0
e. Revise the definitions of ``Collection container'', ``Collection 
site'', ``Confirmatory drug test'', ``Initial drug test'', ``Initial 
specimen validity test'', ``Invalid Result'', ``Laboratory'', ``Limit 
of Detection (LOD)'', ``Limit of Quantitation (LOQ)'', ``Non-negative 
specimen'', ``Primary specimen'', ``Reconfirmed'', ``Shipping 
container'', ``Specimen bottle'', ``Split specimen'', ``Split specimen 
collection'', and ``Substituted specimen''.
    The additions and revisions read as follows:


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

* * * * *
    Alternative specimen. An authorized specimen, other than the type 
of specimen previously collected or attempted to be collected.
* * * * *
    Collection container. A container used to collect a specimen.
    Collection site. A place selected by the employer where employees 
present themselves for the purpose of providing a specimen for a drug 
test.
* * * * *
    Commercial Driver's License Drug and Alcohol Clearinghouse 
(Clearinghouse). A database, administered by the Federal Motor Carrier 
Safety Administration, containing records of commercial motor vehicle 
drivers' violations of controlled

[[Page 11173]]

substances and alcohol testing program requirements, as set forth in 
part 382 of this title, as well as their return-to-duty status.
* * * * *
    Confirmatory drug test. A second analytical procedure performed on 
a different aliquot of the original specimen to identify and quantify a 
specific drug or drug metabolite.
* * * * *
    Cutoff. The analytical value (e.g., drug or drug metabolite 
concentration) used as the decision point to determine a result (e.g., 
negative, positive, adulterated, invalid, or substituted) or the need 
for further testing.
* * * * *
    Initial drug test. The first test used to differentiate a negative 
specimen from one that requires further testing for drugs or drug 
metabolites.
    Initial specimen validity test. The first test used to determine if 
a specimen is adulterated, diluted, substituted, or invalid.
    Invalid result. The result reported by a laboratory for a specimen 
in which the laboratory has not been able to complete testing or obtain 
a valid drug test result (e.g., because of an unidentified adulterant, 
an interfering substance, or an abnormal physical characteristic).
    Laboratory. Any U.S. laboratory certified by HHS under the National 
Laboratory Certification Program as meeting the minimum standards set 
by HHS; or, in the case of foreign laboratories, a laboratory approved 
for participation by DOT under this part.
    Limit of Detection (LOD). The lowest concentration at which the 
analyte (e.g., drug or drug metabolite) can be identified.
    Limit of Quantitation (LOQ). For quantitative assays, the lowest 
concentration at which the identity and concentration of the analyte 
(e.g., drug or drug metabolite) can be accurately established.
* * * * *
    Non-negative specimen. A specimen that is reported as adulterated, 
substituted, positive (for drug(s) or drug metabolite(s)), or invalid.
* * * * *
    Oral Fluid Specimen. A specimen that is collected from an 
employee's oral cavity and is a combination of physiological fluids 
produced primarily by the salivary glands.
* * * * *
    Primary specimen. In drug testing, the specimen bottle that is 
opened and tested by a first laboratory to determine whether the 
employee has a drug or drug metabolite in his or her system; and for 
the purpose of specimen validity testing. The primary specimen is the 
portion of the donor's subdivided specimen designated as the primary 
(``A'') specimen by the collector to distinguish it from the split 
(``B'') specimen, as defined in this section.
* * * * *
    Reconfirmed. The result reported for a split (Bottle B) specimen 
when the second HHS-certified laboratory corroborates the original 
result reported for the primary (Bottle A) specimen.
* * * * *
    Shipping container. A container that is used for transporting and 
protecting specimen bottles and associated documents from the 
collection site to the laboratory.
    Specimen. Fluid, breath, or other material collected from an 
employee at the collection site for the purpose of a drug or alcohol 
test.
    Specimen bottle. The bottle that, after being sealed and labeled 
according to the procedures in this part, is used to hold a primary 
(``A'') or split (``B'') specimen during transportation to the 
laboratory. In the context of oral fluid testing, it may be referred to 
as a ``vial,'' ``tube,'' or ``bottle.''
    Split specimen. In drug testing, the specimen that is sent to a 
first laboratory and stored with its original seal intact, and which is 
transported to a second laboratory for retesting at the employee's 
request following MRO verification of the primary specimen as positive, 
adulterated or substituted.
    Split specimen collection. A collection in which the single 
specimen collected is divided into two separate specimen bottles, the 
primary specimen (Bottle A) and the split specimen (Bottle B).
    SSN or Employee ID No. This number serves as a unique identifier 
that must be used on the Federal Drug Testing Custody and Control Form 
(CCF) or Alcohol Testing Form (ATF) for a donor, on the MRO's reports, 
on SAP reports, or on other documents that are required under this 
part. For all purposes of this part, this term means: Only the 
Commercial Driver's License (CDL) Number and State of issuance for 
drivers tested under the authority of the Federal Motor Carrier Safety 
Administration (FMCSA); and, for all drivers and other safety-sensitive 
employees tested under the authority of the other DOT agencies, this 
can be the individual's actual Social Security Number, a unique 
identifier issued by the employer, a State-issued identification card 
number, a State-issued driver's license number (including a CDL number) 
or any other State-issued or federally-issued identification number.
* * * * *
    Substituted specimen. An employee's specimen not consistent with a 
normal human specimen, as determined by HHS (e.g., a urine specimen, 
with creatinine and specific gravity values that are so diminished, or 
so divergent that they are not consistent with normal human urine).
* * * * *
    Undiluted (neat) oral fluid. An oral fluid specimen to which no 
other solid or liquid has been added. For example: A collection device 
that uses a diluent (or other component, process, or method that 
modifies the volume of the testable specimen) must collect at least 1 
mL of undiluted (neat) oral fluid.
    Urine specimen. Urine collected from an employee at the collection 
site for the purpose of a drug test.
* * * * *
0
3. In Sec.  40.13, revise paragraphs (b), (c), and (d), redesignate 
paragraphs (e) and (f) as paragraphs (f) and (g), respectively, add new 
paragraph (e), and add paragraph (h).
    The revisions and additions to read as follows:


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

* * * * *
    (b) DOT tests must take priority and must be conducted and 
completed before a non-DOT test is begun. When conducting a urine DOT 
drug test, you must discard any excess urine left over from a DOT test 
and collect a separate urine void for the subsequent non-DOT test.
    (c) Except as provided in paragraph (d) of this section, you must 
not perform any tests on DOT specimens other than those tests 
specifically authorized by this part or DOT agency regulations. For 
example, you must not test a DOT specimen for additional drugs. In 
addition, a laboratory is prohibited from making a DOT specimen 
available for a DNA test or other types of specimen identity testing.
    (d) When a DOT urine drug test collection is conducted as part of a 
physical examination required by DOT agency regulations, it is 
permissible to conduct medical tests related to this physical 
examination (e.g., for glucose) on any specimen remaining in the 
collection container after the DOT portion has been sealed into the 
specimen bottles.
    (e) A non-DOT drug or alcohol test administered, as part of a 
physical examination, is not a DOT drug or alcohol test for purposes of 
this part and

[[Page 11174]]

related DOT agency drug and alcohol testing rules, if that test was 
performed to determine if an employee is medically qualified for a 
license or certificate. Consequently, the results of such a test do not 
have consequences under this part.
* * * * *
    (h) No one is permitted to conduct a DOT drug or alcohol test on an 
individual who is not a DOT-regulated employee, as defined by the DOT 
agency regulations.
0
4. In Sec.  40.14, revise paragraph (b) and add paragraphs (k) and (l) 
to read as follows:


Sec.  40.14   What information must employers provide to collectors?

* * * * *
    (b) SSN or Employee ID No.'';
* * * * *
    (k) Specimen type to be collected (i.e., oral fluid or urine).
    (l) If a urine specimen is to be collected under direct 
observation.
0
5. In Sec.  40.21:
0
a. In paragraph (c)(2)(vii)(B), remove the word ``and'' from the end;
0
b. Redesignate paragraph (c)(2)(vii)(C) as paragraph (c)(2)(vii)(D); 
and
0
c. Add a new paragraph (c)(2)(vii)(C).
    The addition reads as follows:


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

* * * * *
    (c) * * *
    (2) * * *
    (vii) * * *
    (C) For a verified negative result, the employee will not be 
required to submit an alternative specimen for the same testing action. 
For a cancelled result, the employee could be required to submit an 
alternative specimen on a re-collection; and
* * * * *
0
6. In Sec.  40.23, revise paragraphs (f) introductory text and (f)(1) 
and (5) to read as follows:


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

* * * * *
    (f) As an employer who receives a drug test result indicating that 
the employee's test was cancelled because it was invalid and that a 
second collection must take place under direct observation--
    (1) You must immediately direct the employee to provide a new 
specimen under direct observation (either an oral fluid specimen or a 
urine specimen under direct observation).
* * * * *
    (5) You must ensure that the collector conducts the collection 
under direct observation (either an oral fluid specimen or a urine 
specimen under direct observation).
* * * * *
0
7. In Sec.  40.25, revise paragraph (a) to read as follows:


Sec.  40.25   Must an employer check on the drug and alcohol testing 
record of employees it is intending to use to perform safety-sensitive 
duties?

    (a)(1) Yes, as an employer, you must, after obtaining an employee's 
written consent, request the information about the employee listed in 
paragraphs (b) through (j) of this section. This requirement applies 
only to employees seeking to begin performing safety-sensitive duties 
for you for the first time (i.e., a new hire, an employee transferring 
into a safety-sensitive position). If the employee refuses to provide 
this written consent, you must not permit the employee to perform 
safety-sensitive functions.
    (2) If you are an employer regulated by FMCSA, beginning January 6, 
2023, you are not required to comply with the requirements of this 
section when checking an employee's testing history with other 
employers regulated by FMCSA. You must continue to comply with the 
requirements of section 40.25 when checking an employee's testing 
history with employers regulated by a DOT operating administration 
other than FMCSA.
    (3) If you are an employer regulated by FMCSA, with a prospective 
employee subject to drug and alcohol testing with a DOT agency other 
than FMCSA, you must continue to request the information about the 
employee listed in in paragraphs (b) through (j) of this section. For 
example, if you are an employer regulated by both FMCSA and PHMSA, and 
you are hiring an employee to perform functions regulated by both DOT 
Agencies, then you must query FMCSA's Clearinghouse to satisfy FMCSA's 
requirements and you must request the information listed in in 
paragraphs (b) through (j) of this section to satisfy PHMSA's 
requirements.
* * * * *


Sec.  40.26  [Amended]

0
8. In Sec.  40.26, remove ``Appendix H'' and add in its place 
``Appendix J''.


Sec.  40.29  [Removed]

0
9. Remove Sec.  40.29.
0
10. In Sec.  40.31,
0
a. Revise the section heading;
0
b. Revise paragraphs (b);
0
c. Redesignate paragraphs (c) and (d) as paragraphs (d) and (e)
0
d. Add new paragraph (c);
0
e. Revise newly redesignated paragraph (d); and
0
f. Add paragraph (f).
    The revisions and additions read as follows:


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

* * * * *
    (b) A urine collector must meet training requirements of Sec.  
40.33.
    (c) An oral fluid collector must meet the training requirements of 
Sec.  40.35.
    (d) To avoid the appearance of a conflict of interest, if you are 
the immediate supervisor of the employee being tested, you must not act 
as the collector when that employee is tested, unless no other 
collector is available and you are permitted to do so under DOT agency 
drug and alcohol regulations.
* * * * *
    (f) Employees are not permitted to be their own collector.
    (1) An employee who is a qualified collector is not permitted to be 
their own collector; another qualified collector must perform the 
collection in accordance with this part.
    (2) To avoid a potential conflict of interest, a collector must not 
be related to the employee being tested (e.g., spouse, ex-spouse, 
relative) or a close personal friend.
0
11. In Sec.  40.33, revise the section heading, introductory text, and 
paragraph (f) to read as follows:


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

    To be permitted to act as a urine collector in the DOT drug testing 
program, you must meet each of the requirements of this section:
* * * * *
    (f) Error correction training. If you make a mistake in the 
collection process that causes a test to be cancelled (i.e., a fatal or 
uncorrected flaw), you must undergo error correction training. This 
training must occur within 30 days of the date you are notified of the 
error that led to the need for retraining. Errors that cause 
cancellation but occur outside the collection process (e.g., when a 
specimen is crushed or otherwise damaged during the transportation 
process, or is lost in transit), the cancellation would not be the 
result of an error by the collector during the collection process and 
does not require the collector to be retrained.
* * * * *


Sec.  40.35  [Redesignated as Sec.  40.36]

0
12. Redesignate Sec.  40.35 as Sec.  40.36.
0
13. Add a new Sec.  40.35 to read as follows:

[[Page 11175]]

Sec.  40.35   What training requirements must a collector meet for oral 
fluid collection?

    To be permitted to act as an oral fluid collector in the DOT drug 
testing program, you must meet each of the requirements of this 
section:
    (a) Basic information. You must be knowledgeable about this part, 
the current applicable guidelines and DOT agency regulations applicable 
to the employers for whom you perform collections. DOT agency 
regulations, guidelines, and other materials are available from ODAPC 
(Department of Transportation, 1200 New Jersey Avenue SE, Washington, 
DC 20590, 202-366-3784, or on the ODAPC website (https://www.transportation.gov/odapc). You must keep current on any changes to 
these materials. You must subscribe to the ODAPC list-serve at: https://www.transportation.gov/odapc/get-odapc-email-updates.
    (b) Qualification training. You must receive qualification training 
meeting the requirements of this paragraph. Qualification training must 
provide instruction on the following subjects:
    (1) The oral fluid collection device manufacturer's training for 
each device the collector will use for DOT-regulated collections;
    (2) All steps necessary to complete a collection correctly and the 
proper completion and transmission of the CCF;
    (3) ``Problem'' collections (e.g., situations like ``dry mouth'' 
and attempts to tamper with a specimen);
    (4) Fatal flaws, correctable flaws, and how to correct problems in 
collections; and
    (5) The collector's responsibility for maintaining the integrity of 
the collection process, ensuring the privacy of employees being tested, 
ensuring the security of the specimen, and avoiding conduct or 
statements that could be viewed as offensive or inappropriate.
    (c) Initial proficiency demonstration. Following your completion of 
qualification training under paragraph (b) of this section, you must 
demonstrate proficiency in collections under this part by completing 
five consecutive error-free mock collections.
    (1) The five mock collections must include one uneventful 
collection scenario, one insufficient specimen quantity scenario; one 
scenario in which the employee has something in their mouth that might 
interfere with the collection; one scenario in which the employee 
attempts to tamper with the specimen; and one scenario in which the 
employee refuses to sign the CCF.
    (2) Another person must monitor and evaluate your performance, in 
person or by a means that provides real-time observation and 
interaction between you and the qualified collector, who must attest in 
writing that the mock collections are ``error-free.'' This person must 
be a qualified collector who has demonstrated necessary knowledge, 
skills, and abilities by--
    (i) Regularly conducting DOT drug test collections for a period of 
at least one year;
    (ii) Conducting collector training under this part for at least one 
year; or
    (iii) Successfully completing a ``train the trainer'' course.
    (d) Schedule for qualification training and initial proficiency 
demonstration. You must meet the requirements of paragraphs (b) and (c) 
of this section before you begin to perform collector functions.
    (e) Refresher training. No less frequently than every five years 
from the date on which you satisfactorily complete the requirements of 
paragraphs (b) and (c) of this section, you must complete refresher 
training that meets all the requirements of paragraphs (b) and (c) of 
this section.
    (f) Error correction training. If you make a mistake in the 
collection process that causes a test to be cancelled (i.e., a fatal or 
uncorrected flaw), you must undergo error correction training. This 
training must occur within 30 days of the date you are notified of the 
error that led to the need for retraining.
    (1) Error correction training must be provided and your proficiency 
documented in writing by a person who meets the requirements of 
paragraph (c)(2) of this section.
    (2) Error correction training is required to cover only the subject 
matter area(s) in which the error that caused the test to be cancelled 
occurred.
    (3) As part of the error correction training, you must demonstrate 
your proficiency in the collection procedures of this part by 
completing three consecutive error-free mock collections. The mock 
collections must include one uneventful scenario and two scenarios 
related to the area(s) in which your error(s) occurred. The person 
providing the training must monitor and evaluate your performance and 
attest in writing that the mock collections were ``error-free.''
    (g) Documentation. You must maintain documentation showing that you 
currently meet all requirements of this section. You must provide this 
documentation on request to DOT agency representatives and to employers 
and C/TPAs who are using or negotiating to use your services.


Sec.  40.37  [Removed]

0
14. Remove Sec.  40.37.

Subpart D [Amended]

0
15. In the heading for subpart D, remove the word ``Urine''.


Sec.  40.41  [Redesignated as Sec.  40.42]

0
16. Redesignate Sec.  40.41 as Sec.  40.42.


Sec.  40.45  [Redesignated as Sec.  40.40]

0
17. Redesignate Sec.  40.45 as Sec.  40.40.
0
18. In newly redesignated Sec.  40.40:
0
a. Revise the section heading and paragraphs (a) and (b), (c) 
introductory text, and (c)(1) through (4); and
0
b. Amend paragraph (d) by removing the words ``social security number 
(SSN) or other employee identification (ID) number'' and adding in 
their place ``SSN or Employee ID No.''.
    The revisions read as follows:


Sec.  40.40   What form is used to document a DOT collection?

    (a) The Federal Drug Testing Custody and Control Form (CCF) must be 
used to document every collection required by the DOT drug testing 
program. You may view this form on the Department's website (http://www.transportation.gov/odapc) or the HHS website (http://www.workplace.samhsa.gov).
    (b) You must not use a non-Federal form or an expired CCF to 
conduct a DOT collection. As a laboratory, C/TPA or other party that 
provides CCFs to employers, collection sites, or other customers, you 
must not provide copies of an expired CCF to these participants. You 
must also affirmatively notify these participants that they must not 
use an expired CCF.
    (c) As a participant in the DOT drug testing program, you are not 
permitted to modify or revise the CCF except as follows:
    (1) You may include, in the area outside the border of the form, 
other information needed for billing or other purposes necessary to the 
collection process.
    (2) The CCF must include the names, addresses, telephone numbers 
and any other appropriate contact information (e.g., an email address 
of the employer and the MRO), including the DER's name and contact 
information. All of this information must be preprinted, typed, or 
handwritten. Fax numbers may be included, but are not required. The MRO 
information must include the physician's name and address, as opposed 
to only a generic clinic, health care organization, or company name. 
This information is required, and an employer, collector, service agent 
or any other party is prohibited from omitting it. In addition, a C/
TPA's name, address,

[[Page 11176]]

telephone and fax numbers, and any other appropriate contact 
information should be included, but is not required. The employer may 
use a C/TPA's address in place of its own, but must continue to include 
its name, telephone and fax numbers, and any other appropriate contact 
information.
    (3) As an employer you may preprint the box in Step 1-D of the CCF 
for the DOT agency under whose authority the test will occur.
    (4) As a collector, you may use a CCF with your name, address, 
telephone number, and fax number preprinted, but under no circumstances 
may you sign the form before the collection event. If a collection 
takes place at a clinic, the actual address of the clinic should be 
used, not a corporate address of the collection company. If the 
collection takes place onsite at the employer, the employer's address 
must be noted as the collection site address. If the collection takes 
place in a ``mobile unit'' or at an accident site, the collector must 
enter the actual location address of the collection or as near an 
approximation as possible. The collector must ensure that the required 
collector telephone number is the number that the laboratory, MRO, or 
employer may use to directly contact the individual collector and/or 
the collector's supervisor.
* * * * *


Sec.  40.47  [Redesignated as Sec.  40.41]

0
19. Redesignate Sec.  40.47 as Sec.  40.41.


Sec.  40.41  [Amended]

0
20. In newly redesignated Sec.  40.41, in paragraph (a), remove the 
word ``urine'' wherever it appears.
0
21. In Sec.  40.43, revise the section heading to read as follows:


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

* * * * *


Sec.  40.49  [Redesignated as Sec.  40.44]

0
22. Redesignate Sec.  40.49 as Sec.  40.44.


Sec.  40.51  [Redesignated as Sec.  40.45]

0
23. Redesignate Sec.  40.51 as Sec.  40.45.
0
24. Add Sec. Sec.  40.47, 40.48, 40.49, and 40.51 to subpart D to read 
as follows:
* * * * *
Sec.
40.47 Where does an oral fluid collection for a DOT drug test take 
place?
40.48 What steps must operators of collection sites and collectors 
take to protect the security and integrity of oral fluid 
collections?
40.49 What materials are used to collect oral fluid specimens?
40.51 What materials are used to send oral fluid specimens to the 
laboratory?
* * * * *


Sec.  40.47   Where does an oral fluid collection for a DOT drug test 
take place?

    (a) An oral fluid collection for a DOT drug test must take place in 
a collection site meeting the requirements of this section.
    (b) If you are operating an oral fluid collection site:
    (1) You must ensure that it meets the security requirements of 
Sec.  40.48;
    (2) The site may be a permanent or temporary facility located 
either at the work site or at a remote site;
    (3) The site may be in a medical facility, a mobile facility (e.g., 
a van), a dedicated collection facility, or any other location meeting 
the requirements of this section; and
    (4) You must have all necessary personnel, materials, equipment, 
and facilities that include privacy and supervision to provide for the 
collection, temporary storage, and shipping of specimens to a 
laboratory, and a suitable clean surface for writing.
    (c) If a collection site is not accessible and there is an 
immediate requirement to collect an oral fluid specimen (e.g., an 
accident investigation), another site may be used for the collection, 
if the collection is performed by a collector who has been trained to 
collect oral fluid specimens in accordance with this part and the 
manufacturer's procedures for the collection device.


Sec.  40.48   What steps must operators of collection sites and 
collectors take to protect the security and integrity of oral fluid 
collections?

    (a) Collectors and operators of collection sites must take the 
steps listed in this section to prevent unauthorized access that could 
compromise the integrity of collections.
    (b) As a collector, you must do the following before each 
collection to deter tampering with specimens:
    (1) Ensure that access to collection materials and specimens is 
effectively restricted;
    (2) Ensure that undetected access (e.g., through a door not in your 
view) is not possible; and
    (3) Secure facility against access during the procedure to ensure 
privacy to the employee and prevent distraction of the collector. 
Limited-access signs must be posted.
    (c) As a collector, you must take the following additional steps to 
ensure security during the collection process:
    (1) To avoid distraction that could compromise security, you are 
limited to conducting a collection for only one employee at a time. 
However, during the time one employee is in the period for drinking 
fluids in a ``dry mouth'' situation (see Sec.  40.72(b)(1)), you may 
conduct a collection for another employee as long as the employee with 
``dry mouth'' remains supervised.
    (2) To the greatest extent practicable, keep an employee's 
collection container within view of both you and the employee between 
the time the employee has provided the oral fluid specimen and the 
specimen is sealed.
    (3) Ensure you are the only person in addition to the employee who 
handles the specimen before it is sealed with tamper-evident seals.
    (4) In the time between when the employee gives you the specimen 
and when you seal the specimen, remain within the collection site.
    (5) Maintain personal control over each specimen and CCF throughout 
the collection process.
    (d) If you are operating a collection site, you must implement a 
policy and procedures to prevent unauthorized personnel from entering 
any part of the site in which oral fluid specimens are collected or 
stored.
    (1) Only employees being tested, collectors and other collection 
site workers, DERs, employee and employer representatives authorized by 
the employer (e.g., employer policy, collective bargaining agreement), 
and DOT agency representatives are authorized persons for purposes of 
paragraph (e) of this section.
    (2) You must ensure that all authorized persons are under the 
supervision of a collector at all times when permitted into the site.
    (3) You or the collector may remove any person who obstructs, 
interferes with, or causes a delay in the collection process.
    (e) If you are operating a collection site, you must minimize the 
number of persons handling specimens.


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

    For each DOT drug test, you must use a collection device meeting 
the requirements of appendix B of this part.


Sec.  40.51  What materials are used to send oral fluid specimens to 
the laboratory?

    (a) Except as provided in paragraph (b) of this section, you must 
use a shipping container that adequately protects the specimen bottles 
from damage in the transport of specimens from the collection site to 
the laboratory.
    (b) You are not required to use a shipping container if a 
laboratory courier hand-delivers the specimens

[[Page 11177]]

from the collection site to the laboratory.

Subpart E--[Amended]

0
25. In the heading for subpart E, remove the word ``Urine''.
0
26. In Sec.  40.61, revise the section heading and paragraphs (a), 
(b)(1) introductory text, (b)(3) and (4), (e), and (f)(5)(i) to read as 
follows:


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

* * * * *
    (a) When a specific time for an employee's test has been scheduled, 
or the collection site is at the employee's work site, and the employee 
does not appear at the collection site at the scheduled time, contact 
the DER to determine the appropriate interval within which the DER has 
determined the employee is authorized to arrive. If the employee's 
arrival is delayed beyond that time, you must notify the DER that the 
employee has not reported for testing. In a situation where a C/TPA has 
notified an owner/operator or other individual employee to report for 
testing (other than for a pre-employment test) and the employee does 
not appear, the C/TPA must determine whether the employee has refused 
to test (see Sec.  40.191(a)(1)).
    (b) * * *
    (1) If the employee is also going to take a DOT alcohol test, you 
must ensure, to the greatest extent practicable, that the alcohol test 
is completed before the drug testing collection process begins.
* * * * *
    (3) You must not collect a specimen from an unconscious employee to 
conduct a drug test under this part.
    (4) You must not catheterize a conscious employee for purposes of a 
urine test. However, you must inform an employee who normally voids 
through self-catheterization that the employee is required to provide a 
specimen in that manner. If an employee normally voids through self-
catheterization, but declines to do so for the urine test, the 
collector should notify the DER of the circumstances, so that the 
employer can determine whether the situation constitutes a refusal to 
test by the employee.
* * * * *
    (e) Explain the basic collection procedure to the employee, and 
notify the employee that instructions for completing the CCF can be 
found at the HHS (www.samhsa.gov/workplace) and DOT 
(www.transportation.gov/odapc) websites.
    (f) * * *
    (5) * * *
    (i) Determine if the material appears to be brought to the 
collection site with the intent to alter the specimen, and, if it is, 
either conduct a directly observed urine collection using direct 
observation procedures (see Sec.  40.67) or an oral fluid specimen 
collection, make a note on the CCF and continue with collection 
process; or
* * * * *
0
27. In Sec.  40.63, revise paragraph (a) to read as follows:


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

* * * * *
    (a) Ensure all items under Step 1 of the CCF are complete and 
accurate (e.g., if Step 1.D is not checked, put a check mark for the 
``Specify DOT Agency'' under the authority of which the test will take 
place; if the address where the collection is actually taking place is 
not in Step 1.G, update that.)
* * * * *
0
28. In Sec.  40.65, revise the section heading and paragraphs (b)(5) 
and (6), and (c)(1) to read as follows:


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

* * * * *
    (b) * * *
    (5) If the specimen temperature is outside the acceptable range, 
you must immediately conduct a new urine collection using direct 
observation procedures (see Sec.  40.67) or an oral fluid collection.
    (6) In a case where a specimen is collected under direct 
observation because of the temperature being out of range, you must 
process both the original specimen and the specimen collected using 
direct observation (including oral fluid) and send the two sets of 
specimens to their respective laboratories. This is true even in a case 
in which the original specimen has insufficient volume and the 
temperature is out of range. You must also, as soon as possible, inform 
the DER and collection site supervisor that a collection took place 
under direct observation and the reason for doing so.
* * * * *
    (c) * * *
    (1) If it is apparent from this inspection that the employee has 
tampered with the specimen (e.g., blue dye in the specimen, excessive 
foaming when shaken, or smell of bleach), you must immediately conduct 
a new urine collection using direct observation procedures (see Sec.  
40.67) or an oral fluid collection.
* * * * *
0
29. In Sec.  40.67:
0
a. Revise the section heading;
0
b. In paragraph (c)(1), remove ``paragraphs (a) and (b)'' and add 
``paragraph (a)'' in its place;
0
c. Revise paragraph (d)(2);
0
d. In paragraph (e)(2), remove ``Sec.  40.67(b)'' and add in its place 
``Sec.  40.67(c)(2) through (4)''; and
0
e. Revise paragraph (g).
    The revisions and additions read as follows:


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

* * * * *
    (d) * * *
    (2) As the collector, you must explain to the employee the reason, 
if known, under this part for a directly observed collection.
* * * * *
    (g) As the collector, you must ensure that the observer is the same 
gender as the employee unless the observer is a medical professional 
(e.g., nurse, doctor, physician's assistant, technologist, technician 
licensed or certified to practice in the jurisdiction in which the 
collection takes place). The observer can be a different person from 
the collector and need not be a qualified collector.
0
30. In Sec.  40.69, revise the section heading, redesignate paragraphs 
(a) through (g) as paragraphs (b) through (h); add new paragraph (a), 
and revise newly redesignated paragraph (e) to read as follows:


Sec.  40.69   How is a monitored urine collection conducted?

    (a) As stated in Sec.  40.42(f)(2), if you are conducting a urine 
collection in a multi-stall restroom and you cannot secure all sources 
of water and other substances that could be used for adulteration and 
substitution, you must conduct a monitored collection. This is the only 
circumstance in which you must conduct a monitored collection.
* * * * *
    (e) As the monitor, you must not watch the employee urinate into 
the collection container. If you hear sounds or make other observations 
indicating an attempt to tamper with a specimen, there must be an 
additional collection under direct observation. See Sec. Sec.  
40.63(e), 40.65(c), and 40.67(c)(2)(3)).
* * * * *
0
31. In Sec.  40.71, revise the section heading and paragraph (b)(1) to 
read as follows:


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

* * * * *

[[Page 11178]]

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


Sec.  40.73   [Redesignated as Sec.  40.79]

0
32. Redesignate Sec.  40.73 as Sec.  40.79.
0
33. Add new Sec. Sec.  40.72 through 40.74 to read as follows:
* * * * *
Sec.
40.72 What steps does the collector take in the collection process 
before the employee provides an oral fluid specimen?
40.73 How is an oral fluid specimen collected?
40.74 How does the collector prepare the oral fluid specimens?
* * * * *


Sec.  40.72   What steps does the collector take in the collection 
process before the employee provides an oral fluid specimen?

    (a) The collector requests that the employee open the employee's 
mouth, and the collector inspects the oral cavity to ensure that it is 
free of any items that could impede or interfere with the collection of 
an oral fluid specimen (e.g., candy, gum, food, or tobacco) or could be 
used to adulterate, substitute, or alter the specimen.
    (1) If the employee claims that he or she has a medical condition 
that prevents opening his or her mouth for inspection, the collector 
follows the procedure described in Sec.  40.193(a).
    (2) If the collector observes materials brought to the collection 
site or the employee's conduct clearly indicates an attempt to 
adulterate, substitute, or alter the specimen, the collector must 
terminate the collection, note the circumstances in the Remarks section 
of the CCF, and report the circumstances to the DER, so that the 
employer can decide whether to deem the situation a refusal in 
accordance with Sec.  40.191(a).
    (b) If an item is present that might impede or interfere with the 
collection of an oral fluid specimen, the collector must request the 
employee remove the item.
    (1) If the employee removes any item that could impede or interfere 
with the collection of an oral fluid specimen, the employee has 
abnormally colored saliva, or the employee claims to have ``dry 
mouth,'' then the collector must give the employee water, up to 8 
ounces, to rinse their mouth. The employee may drink the water. The 
collector must then wait 10 minutes before beginning the specimen 
collection.
    (2) If the employee refuses to remove the item or rinse, the 
collector must terminate the collection, note the circumstances in the 
Remarks section of the CCF, and report the information to the DER to 
test as described in Sec.  40.191(a)(8) (failure to cooperate), so that 
the employer can decide whether to deem the situation a refusal.
    (c) If there is nothing of concern in the oral cavity and no ``dry 
mouth'' condition, the collector starts the 10-minute wait period and 
proceeds with the steps below before beginning the specimen collection 
as described in Sec.  40.73.
    (d) During the 10-minute wait:
    (1) Review with the employee the procedures required for a 
successful oral fluid specimen collection as stated in the 
manufacturer's instructions for the specimen collection device.
    (2) Complete all items under Step 1 of the CCF, and for 
clarification:
    (i) In Step 1.D of the CCF, the collector must put a check mark for 
the ``Specify DOT Agency'' under whose authority the test will take 
place.
    (ii) In Step 1.G of the CCF for the ``Collection Site Address'', 
the collector must provide the address where the collection took place.
    (3) The collector will complete Step 2 of the CCF.
    (i) Check ``Oral Fluid'',
    (ii) For ``Oral Fluid: Split Type'' check ``Subdivided,'' and
    (iii) Check ``Each Device Within Expiration Date?'' after ensuring 
that each device is within its expiration date.
    (4) The collector must instruct the employee to use hand sanitizer, 
put on gloves, or wash and dry his or her hands.
    (e) The collector will provide, or the employee may select, a 
specimen collection device that is clean, unused, and wrapped/sealed in 
original packaging. The collector must open the specimen collection 
device in view of the employee.
    (f) To the greatest extent practicable, the collector must keep the 
employee's unwrapped collection device within view of both you and the 
employee, between the time the employee has provided a specimen and the 
specimen is sealed.


Sec.  40.73   How is an oral fluid specimen collected?

    (a) The collector must be present and maintain visual contact with 
the employee during the procedures outlined in this section.
    (b) The collector must note any unusual behavior or appearance of 
the employee on the CCF. If the collector detects any conduct that 
clearly indicates an attempt to tamper with a specimen (e.g., an 
attempt to bring into the collection site an adulterant or oral fluid 
substitute), the collector must terminate the collection and report the 
information to the DER so that the employer can decide whether to deem 
the situation a refusal.
    (c) The employee and collector must complete the specimen 
collection in accordance with the manufacturer instructions for the 
collection device.
    (1) The collector must ensure the collection is performed correctly 
(i.e., using the oral fluid device in the manner described by its 
manufacturer), that the collection device is working properly, and that 
a sufficient specimen volume is collected.
    (i) If there is a failure to collect the specimen, the collector 
must start the process again, beginning with Sec.  40.72(e), using a 
new specimen collection device, and noting the failed collection 
attempt on the CCF.
    (ii) If the employee states that he or she is unable to provide an 
oral fluid specimen during the collection process, or after multiple 
failures to collect the specimen, the collector follows the procedure 
in Sec.  40.193.
    (2) The collector must inspect the specimen for unusual color, 
presence of foreign objects or material, or other signs of tampering. 
If it is apparent from this inspection that the employee has tampered 
with the specimen, you must conduct a new collection.
    (i) Document any unusual characteristics referenced above in the 
Remarks section of the CCF.
    (ii) Proceed with obtaining the new oral fluid specimen from the 
donor. Note on the new CCF that this is another collection for the same 
testing event. (i.e., Document in the remarks section that this is 
Specimen 2 of 2 and include the Specimen ID number of the other 
specimen. Make the same notation on the CCF of the suspect specimen.)


Sec.  40.74  How does the collector prepare the oral fluid specimens?

    (a) The collector follows the manufacturer's instructions to 
package the split specimen collections.
    (b) A volume of at least 1 mL of undiluted (neat) oral fluid is 
collected for the specimen designated as ``Tube A'' and a volume of at 
least 1 mL of undiluted (neat) oral fluid is collected for the specimen 
designated as ``Tube B''.
    (c) In the presence of the employee, the collector places a tamper-
evident seal from the CCF over the cap of each specimen container, 
taking care not to obstruct the expiration date on the collection 
containers. The collector must record the date of the collection on the 
tamper-evident seals, after they are affixed to the specimen 
containers.

[[Page 11179]]

    (d) The collector instructs the employee to initial the tamper-
evident seals on each specimen container. If the employee declines to 
do so, the collector must note this in the ``Remarks'' line of the CCF 
(Step 2) and complete the collection process.


Sec. Sec.  40.75-40.78   [Reserved]

0
34. Add reserved Sec. Sec.  40.75 through 40.78.
0
35. In newly redesignated Sec.  40.79, revise paragraph (a)(1) to read 
as follows:


Sec.  40.79   How is the collection process completed?

* * * * *
    (a) * * *
    (1) Direct the employee to read and sign the certification 
statement on Copy 2 of the CCF and provide all information required in 
Step 5. If the employee declines to sign the CCF or to provide any of 
the required information, you must note this in the ``Remarks'' line 
(Step 2) of the CCF and complete the collection. If the employee 
declines to fill out any information, you must, as a minimum, print the 
employee's name in the appropriate place.
* * * * *


Sec.  40.81  [Amended]

0
36. In Sec.  40.81, in paragraph (a), remove the words ``all testing'' 
and add in their place the words ``each specimen testing methodology 
performed''.


Sec.  40.83  [Amended]

0
37. In Sec.  40.83:
0
a. In paragraph (c)(7), remove the word ``urine'' and add in its place 
the word ``specimen'';
0
b. In paragraph (f) introductory text, add the word ``urine'' before 
the word ``specimen'';
0
c. In paragraph (g) introductory text, remove the cross-reference 
``40.45(a)'' and adding in its place ``40.40(a)'';
0
d. a. In paragraphs (h)(1)(i), (iii), and (iv), remove the word 
``urine'' and add in its place the word ``specimen''; and
0
e. In paragraph (h)(2) removing the cross-reference ``(g)(1)'' and 
adding in its place ``(h)(1)''.


Sec.  40.99  [Redesignated as Sec.  40.84]

0
38. Redesignate Sec.  40.99 as Sec.  40.84.


Sec.  40.84  [Amended]

0
39. In newly redesignated Sec.  40.84:
0
a. In paragraph (a), remove the words ``one year'' and add, in their 
place, the words ``90 days'';
0
b. In the first sentence of paragraph (c) remove the words ``one-year'' 
and add in their the words ``90-day''; and
0
c. In the last sentence of paragraph (c) remove the word ``year'' and 
add in its place the words ``90-day period''.


Sec.  40.85  [Redesignated as Sec.  40.82]

0
40. Redesignate Sec.  40.85 as Sec.  40.82.


Sec.  40.87  [Redesignated as Sec.  40.85]

0
41. Redesignate Sec.  40.87 as Sec.  40.85.


Sec.  40.89  [Redesignated as Sec.  40.86]

0
42. Redesignate Sec.  40.89 as Sec.  40.86.
0
43. In newly redesignated Sec.  40.86, revise the section heading to 
read as follows:


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

* * * * *


Sec.  40.91  [Redesignaed as Sec.  40.87]

0
44. Redesignate Sec.  40.91 as Sec.  40.87.
0
45. In newly redesignated Sec.  40.87, revise the section heading, and 
in the introductory text, remove ``Sec.  40.89'' and add in its place 
``Sec.  40.86''.
    The revision reads as follows:


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

* * * * *


Sec.  40.93  [Redesignated as Sec.  40.88]

0
46. Redesignate Sec.  40.93 as Sec.  40.88.
0
47. In newly redesignated Sec.  40.88, revise the section heading to 
read as follows:


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

* * * * *


Sec.  40.95  [Redesignated Sec.  40.89]

0
48. Redesignate Sec.  40.95 as Sec.  40.89.
0
49. In newly redesignated Sec.  40.89, revise the section heading to 
read as follows:


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

* * * * *


Sec.  40.96  [Redesignated as Sec.  40.90]

0
50. Redesignate existing Sec.  40.96 as Sec.  40.90.
0
51. In newly redesignated Sec.  40.90, revise the section heading to 
read as follows:


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

* * * * *
0
52. Add new Sec. Sec.  40.91 through 40.93 to read as follows:
Sec.
* * * * *
40.91 What are the cutoff concentrations for undiluted (neat) oral 
fluid drug tests?
40.92 What is oral fluid validity testing, and are laboratories 
required to conduct it?
40.93 What validity tests must laboratories conduct on primary oral 
fluid specimens?
* * * * *


Sec.  40.91  What are the cutoff concentrations for undiluted (neat) 
oral fluid drug tests?

    As a laboratory, you must use the cutoff concentrations displayed 
in table 1 to this section for initial and confirmatory drug tests for 
oral fluid specimens. All cutoff concentrations are expressed in 
nanograms per milliliter (ng/mL).

                        Table 1 to Sec.   40.91--Oral Fluid Testing Cutoff Concentrations
----------------------------------------------------------------------------------------------------------------
                                                                   Confirmatory test    Confirmatory test cutoff
        Initial test analyte          Initial test cutoff \1\           analyte               concentration
----------------------------------------------------------------------------------------------------------------
Marijuana (THC) \2\................  4 ng/mL \3\..............  THC...................  2 ng/mL.
Cocaine/Benzoylecgonine............  15 ng/mL.................  Cocaine...............  8 ng/mL.
                                                                Benzoylecgonine.......  8 ng/mL.
Codeine/Morphine...................  30 ng/mL.................  Codeine...............  15 ng/mL.
                                                                Morphine..............  15 ng/mL.
Hydrocodone/Hydromorphone..........  30 ng/mL.................  Hydrocodone...........  15 ng/mL.
                                                                Hydromorphone.........  15 ng/mL.
Oxycodone/Oxymorphone..............  30 ng/mL.................  Oxycodone.............  15 ng/mL.
                                                                Oxymorphone...........  15 ng/mL.
6-Acetylmorphine...................  4 ng/mL \3\..............  6-Acetylmorphine......  2 ng/mL.
Phencyclidine......................  10 ng/mL.................  Phencyclidine.........  10 ng/mL.
Amphetamine/Methamphetamine........  50 ng/mL.................  Amphetamine...........  25 ng/mL.
                                                                Methamphetamine.......  25 ng/mL.

[[Page 11180]]

 
MDMA \4\/MDA \5\...................  50 ng/mL.................  MDMA..................  25 ng/mL.
                                                                MDA...................  25 ng/mL.
----------------------------------------------------------------------------------------------------------------
\1\ For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial
  test cutoff):
Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The
  cross reactivity of the immunoassay to the other analyte(s) within the group must be 80 percent or greater; if
  not, separate immunoassays must be used for the analytes within the group.
Alternate technology: Either one analyte or all analytes from the group must be used for calibration, depending
  on the technology. At least one analyte within the group must have a concentration equal to or greater than
  the initial test cutoff or, alternatively, the sum of the analytes present (i.e., with concentrations equal to
  or greater than the laboratory's validated limit of quantification) must be equal to or greater than the
  initial test cutoff.
\2\ An immunoassay must be calibrated with the target analyte.
\3\ Alternate technology (THC and 6-AM): The confirmatory test cutoff must be used for an alternate technology
  initial test that is specific for the target analyte (i.e., 2 ng/mL for THC, 2 ng/mL for 6-AM).
\4\ Methylenedioxymethamphetamine (MDMA).
\5\ Methylenedioxyamphetamine (MDA).

Sec.  40.92  What is oral fluid validity testing, and are laboratories 
required to conduct it?

    (a) Specimen validity testing is the evaluation of the specimen to 
determine if it is consistent with normal human oral fluid. The purpose 
of validity testing is to determine whether certain adulterants or 
foreign substances were added to the oral fluid, if the oral fluid was 
altered.
    (b) If a specimen exhibits abnormal characteristics (e.g., unusual 
odor or color), causes reactions or responses characteristic of an 
adulterant during initial or confirmatory drug tests (e.g., non-
recovery of internal standard, unusual response), or contains an 
unidentified substance that interferes with the confirmatory analysis, 
then you may conduct validity testing.
    (c) If you determine that the specimen is invalid and HHS 
guidelines direct you to contact the MRO, you must contact the MRO and 
together decide if testing the primary specimen by another HHS-
certified laboratory would be useful in being able to report a positive 
or adulterated test result.


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

    As a laboratory, if you conduct validity testing under Sec.  40.92, 
you must conduct it in accordance with the requirements of this 
section.
    (a) You may test for a biomarker such as albumin or immunoglobulin 
G (IgG) or a test for a specific adulterant.
    (b) You must follow the applicable HHS requirements for any 
additional validity testing.
0
53. Revise Sec.  40.97 to read as follows:


Sec.  40.97  What do laboratories report and how do they report it?

    (a) As a laboratory, when reporting a result of any kind, you must 
report the specimen type.
    (b) You must also report the results for each primary specimen, 
which will fall into one of the following three categories. As a 
laboratory, you must report the actual results (and not the 
categories):
    (1) Category 1: Negative Results. As a laboratory, when you find a 
specimen to be negative, you must report the test result as being one 
of the following, as applicable:
    (i) Negative, or
    (ii) For urine only, negative-dilute, with numerical values for 
creatinine and specific gravity.
    (2) Category 2: Non-negative Results. As a laboratory, when you 
find a specimen to be non-negative, you must report the test result as 
being one or more of the following, as applicable:
    (i) Positive, with drug(s)/metabolite(s) noted, with numerical 
values for the drug(s) or drug metabolite(s).
    (ii) Adulterated, with adulterant(s) noted, with confirmatory test 
values (when applicable), and with remarks(s);
    (iii) For urine only, positive-dilute, with drug(s)/metabolite(s) 
noted, with numerical values for the drug(s) or drug metabolite(s) and 
with numerical values for creatinine and specific gravity;
    (iv) For urine only, substituted, with confirmatory test values for 
creatinine and specific gravity; or
    (v) For urine only, invalid result, with remark(s). Laboratories 
will report actual values for pH results.
    (vi) For oral fluid only, invalid result, with remark(s). 
Laboratories must report numerical values of the specimen validity test 
results that support a specimen reported as invalid.
    (3) Category 3: Rejected for Testing. As a laboratory, when you 
reject a specimen for testing, you must report the result as being 
Rejected for Testing, with remark(s).
    (c) As a laboratory, you must report laboratory results directly, 
and only, to the MRO at his or her place of business. You must not 
report results to or through the DER or a service agent (e.g., a C/
TPA).
    (1) Negative results: You must fax, courier, mail, or 
electronically transmit a legible image or copy of the fully completed 
Copy 1 of the CCF which has been signed by the certifying scientist, or 
you may provide the laboratory results report electronically (i.e., 
computer data file).
    (i) If you elect to provide the laboratory results report, you must 
include the following elements, as a minimum, in the report format:
    (A) Laboratory name and address;
    (B) Employer's name (you may include I.D. or account number);
    (C) Medical review officer's name;
    (D) Specimen I.D. number;
    (E) SSN or Employee ID from Step 1C of the CCF, if provided;
    (F) Reason for test, if provided;
    (G) Collector's name and telephone number;
    (H) Date of the collection;
    (I) For oral fluid only, collection device expiration date
    (J) Date received at the laboratory;
    (K) Date certifying scientist released the results;
    (L) Certifying scientist's name;
    (M) Results (e.g., positive, adulterated) as listed in paragraph 
(a) of this section; and
    (N) Remarks section, with an explanation of any situation in which 
a correctable flaw has been corrected.
    (ii) You may release the laboratory results report only after 
review and approval by the certifying scientist. It must reflect the 
same test result information as contained on the CCF signed by the 
certifying scientist. The information contained in the laboratory 
results report must not contain information that does not appear on the 
CCF.

[[Page 11181]]

    (iii) The results report may be transmitted through any means that 
ensures accuracy and confidentiality. You, as the laboratory, together 
with the MRO, must ensure that the information is adequately protected 
from unauthorized access or release, both during transmission and in 
storage (e.g., see Sec.  40.351).
    (2) Non-negative and Rejected for Testing results: You must fax, 
courier, mail, or electronically transmit a legible image or copy of 
the fully completed Copy 1 of the CCF that has been signed by the 
certifying scientist. In addition, you may provide the electronic 
laboratory results report following the format and procedures set forth 
in paragraphs (b)(1)(i) and (ii) of this section.
    (d) In transmitting laboratory results to the MRO, you, as the 
laboratory, together with the MRO, must ensure that the information is 
adequately protected from unauthorized access or release, both during 
transmission and in storage. If the results are provided by fax or 
other electronic means, the electronic communication must be accessible 
only to authorized individuals.
    (e) You must transmit test results to the MRO in a timely manner, 
preferably the same day that review by the certifying scientist is 
completed.
    (f)(1) You must provide quantitative values for confirmed positive 
drug test results to the MRO.
    (2) You must provide numerical values that support the adulterated 
(when applicable) or substituted result, without a request from the 
MRO.
    (3) You must also provide the MRO numerical values for creatinine 
and specific gravity for the negative-dilute urine test result, without 
a request from the MRO.
    (g) You must provide quantitative values for confirmed positive 
morphine and/or codeine urine results at or below 15,000 ng/mL, and for 
confirmed positive morphine or codeine oral fluid results at or below 
150 ng/mL.
0
54. In Sec.  40.111, revise paragraphs (a) and (d) to read as follows:


Sec.  40.111  When and how must a laboratory disclose statistical 
summaries and other information it maintains?

    (a) As a laboratory, you must transmit an aggregate statistical 
summary, by employer, of the data listed in appendix D of this part 
with respect to each specimen type for which you conduct tests to the 
employer on a semi-annual basis.
* * * * *
    (d) As a laboratory, you must transmit an aggregate statistical 
summary listed in appendix E of this part for each specimen type for 
which you conduct testing to DOT on a semi-annual basis. The summary 
must be sent by January 31 of each year for July 1 through December 31 
of the prior year. It must be sent by July 31 of each year for January 
1 through June 30 of the current year. If you withdraw or are removed 
from NLCP's laboratory certification during a reporting period, you 
must provide the aggregate statistical summary to the DOT-regulated 
employers and to ODAPC for the last period in which you conducted DOT-
regulated testing.


Sec.  40.121  [Amended]

0
55. In Sec.  40.121, in paragraph (c)(1)(i), remove the word ``urine''.


Sec.  40.123  [Amended]

0
56. In Sec.  40.123, in paragraph (c), remove the words ``invalid drug 
tests results'' and add in their place ``invalid results''.


Sec.  40.127  [Amended]

0
57. In Sec.  40.127, in paragraph (g)(2), add the words ``of all 
specimen types combined'' before the words ``in any quarter''.


Sec.  40.129  [Amended]

0
58. In Sec.  40.129, in paragraph (a) introductory text, remove the 
words ``invalid drug tests'' and add in their place ``invalid 
results''; in paragraph (d), remove ``drug test report'' and add 
``result'' in its place.


Sec.  40.135  [Amended]

0
59. In Sec.  40.135, in paragraph (d) introductory text, remove the 
word ``test'' and add in its place the word ``result''.
0
60. In Sec.  40.139, revise paragraph (b), and in paragraph (c), remove 
the word ``urine''.
    The revision reads as follows:


Sec.  40.139  On what basis does the MRO verify text results involving 
6-acetylmorphine, codeine, and morphine?

* * * * *
    (b) In the absence of 6-AM, if the laboratory confirms the presence 
of either morphine or codeine equal to or above 15,000 ng/mL (in urine) 
or equal to or above 150 ng/mL (in oral fluid), you must verify the 
test result as positive, unless the employee presents a legitimate 
medical explanation for the presence of the drug or drug metabolite in 
his or her system, as in the case of other drugs (see Sec.  40.139). 
Consumption of food products (e.g., poppy seeds) must not be considered 
a legitimate medical explanation for the employee having morphine or 
codeine at these concentrations.
* * * * *


Sec.  40.145  [Amended]

0
61. In Sec.  40.145, in paragraph (g)(3), remove the word ``urine'' and 
add the word ``drug'' in its place; and in paragraph (h) introductory 
text, add the word ``urine'' before the word ``result''.
0
62. In Sec.  40.151, revise paragraphs (a), (b), (g), and (i) to read 
as follows:


Sec.  40.151  What are MROs prohibited from doing as part of the 
verification process?

* * * * *
    (a) You must not consider any evidence (verbal or written 
information) from any drug tests that are not collected or tested in 
accordance with this part. For example, if an employee tells you he 
went to his own physician, provided a urine specimen, sent it to a 
laboratory, and received a negative test result, you are required to 
ignore this test result.
    (b) It is not your function to make decisions about factual 
disputes between the employee and the collector concerning matters 
occurring at the collection site that are not reflected on the CCF 
(e.g., concerning allegations that the collector left the area or left 
open collection containers where other people could access them.)
* * * * *
    (g) You must not accept an assertion that there is a legitimate 
medical explanation for the presence of PCP, 6-AM, MDMA, or MDA in a 
specimen.
* * * * *
    (i) You must not accept, as a legitimate medical explanation for a 
substituted specimen, an assertion that an employee can produce a urine 
specimen for which the creatinine level is below the laboratory's limit 
of detection. There are no physiological means through which a person 
can produce a urine specimen having this characteristic.
0
63. In Sec.  40.159, revise paragraphs (a)(1) and (a)(5)(ii) to read as 
follows:


Sec.  40.159  What does the MRO do when a drug test result is invalid?

    (a) * * *
    (1) Discuss the laboratory results with a certifying scientist to 
determine if the primary specimen should be tested at another HHS-
certified laboratory. If the laboratory did not contact you as required 
by Sec. Sec.  40.91(e) and 40.96(b), you must contact the laboratory.
* * * * *
    (5) * * *
    (ii) Report to the DER that the test is cancelled, the reason for 
cancellation, and that a second collection must take

[[Page 11182]]

place immediately under direct observation. Recommend to the employer 
that an alternative specimen should be collected if practicable (e.g., 
oral fluid, if the specimen was urine).
* * * * *
0
64. In Sec.  40.163, in paragraph (c)(2), remove the words ``donor SSN 
or employee ID number'' and add in their place the words ``SSN or 
employee ID No.'' and revise paragraph (e).
    The revision reads as follows:


Sec.  40.163  How does the MRO report drug test results?

* * * * *
    (e) If you use a written report as provided in paragraph (c) of 
this section to report results, you must retain a copy of the written 
report. If you use the electronic data file to report negatives, as 
provided in paragraph (d) of this section, you must retain a 
retrievable copy of that report in a format suitable for inspection and 
audit by a DOT representative. In either case, you must keep the 
completed Copy 2 of the CCF. When completing Copy 2, either the MRO 
must sign and date it (for both negatives and non-negatives) or MRO 
staff must stamp and date it (for negatives only).
* * * * *
0
65. In Sec.  40.177, revise paragraphs (a) through (c) to read as 
follows:


Sec.  40.177  What does the second laboratory do with the split 
specimen when it is tested to reconfirm the presence of a drug or drug 
metabolite?

* * * * *
    (a) As the laboratory testing the split specimen, you must test the 
split specimen for the drug(s)/drug metabolite(s) confirmed in the 
primary specimen.
    (b) You must conduct this test without regard to the cutoff 
concentrations of Sec.  40.85 or Sec.  40.91, as applicable.
    (c) If the test fails to reconfirm the presence of the drug(s)/drug 
metabolite(s) that were reported in the primary specimen, you must 
conduct validity tests in an attempt to determine the reason for being 
unable to reconfirm the presence of the drug(s)/metabolite(s). You 
should conduct the same validity tests as you would conduct on a 
primary specimen set forth in Sec.  40.87 or Sec.  40.93, as 
applicable.
* * * * *


Sec.  40.179  [Amended]

0
66. In Sec.  40.179, in paragraph (a), remove ``Sec.  40.95'' and add 
in its place ``Sec.  40.89 or Sec.  40.93, as applicable''.
0
67. Revise Sec.  40.181 to read as follows:


Sec.  40.181  What does the second laboratory do with the split 
specimen when it is tested to reconfirm a substituted test result?

    As the laboratory testing a urine split specimen, you must test the 
split specimen using the confirmatory tests for creatinine and specific 
gravity, using the criteria set forth in Sec.  40.88.


Sec.  40.187  [Amended]

0
68. In Sec.  40.187, in paragraphs (b)(1), (c)(1)(iii), and 
(c)(2)(iii), remove ``Appendix D'' and add in its place ``appendix F'', 
and in paragraph (e)(3), remove ``appendix D'' and add in its place 
``appendix F''.
0
69. In Sec.  40.191, revise paragraphs (a)(2) through (9) and (d)(1) to 
read as follows:


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

    (a) * * *
    (2) Fail to remain at the testing site until the testing process is 
complete. Provided that an employee who leaves the collection site 
before the testing process commences (see Sec.  40.63(c) or Sec.  
40.72(e), as applicable) for a pre-employment test is not deemed to 
have refused to test;
    (3) Fail to provide a specimen for any drug test required by this 
part or DOT agency regulations. Provided that an employee who does not 
provide a specimen because he or she has left the testing site before 
the testing process commences (see Sec.  40.63(c) or Sec.  40.72(e), as 
applicable) for a pre-employment test is not deemed to have refused to 
test;
    (4) In the case of a directly observed or monitored urine 
collection in a drug test, fail to permit the observation or monitoring 
of an employee's provision of a specimen (see Sec. Sec.  40.67(m) and 
40.69(g));
    (5) Fail to provide a sufficient amount of specimen when directed, 
and it has been determined, through a required medical evaluation, that 
there was no adequate medical explanation for the failure (see Sec.  
40.193(d)(2));
    (6) Fail or decline to take an additional drug test the employer or 
collector has directed you to take (see, for instance, Sec.  40.197(b) 
as applicable);
    (7) Fail to undergo a medical examination or evaluation, as 
directed by the MRO as part of the verification process, or as directed 
by the DER under Sec.  40.193(c). In the case of a pre-employment drug 
test, the employee is deemed to have refused to test on this basis only 
if the pre-employment test is conducted following a contingent offer of 
employment. If there was no contingent offer of employment, the MRO 
will cancel the test;
    (8) Fail to cooperate with any part of the testing process (e.g., 
refuse to empty pockets when directed by the collector, behave in a 
confrontational way that disrupts the collection process, fail to wash 
hands after being directed to do so by the collector, fail to remove 
objects from mouth, fail to permit inspection of the oral cavity, or 
fail to complete a rinse when requested);
    (9) For an observed urine collection, fail to follow the observer's 
instructions to raise your clothing above the waist, lower clothing and 
underpants, and to turn around to permit the observer to determine if 
you have any type of prosthetic or other device that could be used to 
interfere with the collection process;
* * * * *
    (d) * * *
    (1) As the collector, you must note the refusal in the ``Remarks'' 
line (Step 2), and sign and date the CCF. The collector does not make 
the final decision about whether the employee's conduct constitutes a 
refusal to test; the employer has the sole responsibility to decide 
whether a refusal occurred, as stated in Sec.  40.355(i), the employer 
has a non-delegable duty to make the decision about whether the 
employee has refused to test.
* * * * *
0
70. Revise Sec.  40.193 to read as follows:


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

    (a) If an employee does not provide a sufficient amount of specimen 
to permit a drug test (i.e., 45 mL of urine in a single void, or 2 mL 
oral fluid in a single sampling, as applicable) you, as the collector, 
must provide another opportunity to the employee to do so. This can be 
done using the same specimen type as the original collection or, if you 
are qualified to collect an alternative specimen, you may use an 
alternative specimen collection for this purpose.
    (b)(1) As the collector, you must do the following when collecting 
a urine specimen:
    (i) Discard the insufficient specimen, except where the 
insufficient specimen was out of temperature range or showed evidence 
of adulteration or tampering (see Sec.  40.65(b) and (c)).
    (ii) Urge the employee to drink up to 40 ounces of fluid, 
distributed reasonably through a period of up to three hours, or until 
the individual has provided a sufficient urine specimen, whichever 
occurs first. It is not a refusal to test if the employee declines to 
drink. Document on the Remarks line of the CCF (Step 2), and inform the 
employee of the time at which the three-hour period begins and ends.

[[Page 11183]]

    (iii) If the employee refuses to make the attempt to provide a new 
urine specimen or leaves the collection site before the collection 
process is complete, you must discontinue the collection, note that 
fact on the ``Remarks'' line of the CCF (Step 2), and immediately 
notify the DER of the conduct as provided in section 40.191(e)(1); the 
employer decides whether the situation is deemed to be a refusal.
    (iv) If the employee has not provided a sufficient specimen within 
three hours of the first unsuccessful attempt to provide the specimen, 
you must discontinue the collection, note the fact on the ``Remarks'' 
line of the CCF (Step 2), and immediately notify the DER. You must also 
discard any specimen the employee previously provided, including any 
specimen that is ``out of temperature range'' or shows signs of 
tampering. In the remarks section of the CCF that you will distribute 
to the MRO and DER, note the fact that the employee provided an ``out 
of temperature range specimen'' or ``specimen that shows signs of 
tampering'' and that it was discarded because the employee did not 
provide a second sufficient specimen.
    (2) As the collector, you must do the following when collecting an 
oral fluid specimen:
    (i) If the employee demonstrates an inability to provide a specimen 
after 15 minutes of using the collection device, and if the donor 
states that he or she could provide a specimen after drinking some 
fluids, urge the employee to drink (up to 8 ounces) and wait an 
additional 10 minutes before beginning the next specimen collection (a 
period of up to one hour must be provided, or until the donor has 
provided a sufficient oral fluid specimen, whichever occurs first). If 
the employee simply needs more time before attempting to provide an 
oral fluid specimen, the employee is not required to drink any fluids 
during the one-hour wait time. It is not a refusal to test if the 
employee declines to drink. The employee must remain at the collection 
site, in a monitored area designated by the collector, during the wait 
period.
    (ii) If the employee has not provided a sufficient specimen within 
one hour of the first unsuccessful attempt to provide the specimen, you 
must discontinue the collection, note the fact on the ``Remarks'' line 
of the CCF (Step 2), and immediately notify the DER.
    (iii) Send Copy 2 of the CCF to the MRO and Copy 4 to the DER. You 
must send or fax these copies to the MRO and DER within 24 hours or the 
next business day.
    (c) As the DER, if the collector informs you that the employee has 
not provided a sufficient amount of specimen (see paragraph (b) of this 
section), you must, after consulting with the MRO, direct the employee 
to obtain, within five days, an evaluation from a licensed physician, 
acceptable to the MRO, who has expertise in the medical issues raised 
by the employee's failure to provide a sufficient specimen. (The MRO 
may perform this evaluation if the MRO has appropriate expertise.)
    (1) As the MRO, if another physician will perform the evaluation, 
you must provide the other physician with the following information and 
instructions:
    (i) That the employee was required to take a DOT drug test, but was 
unable to provide a sufficient amount of specimen to complete the test;
    (ii) The consequences of the appropriate DOT agency regulation for 
refusing to take the required drug test;
    (iii) That the referral physician must agree to follow the 
requirements of paragraphs (d) through (g) of this section.
    (2) [Reserved]
    (d) As the referral physician conducting this evaluation, you must 
recommend that the MRO make one of the following determinations:
    (1) A medical condition has, or with a high degree of probability 
could have, precluded the employee from providing a sufficient amount 
of specimen. As the MRO, if you accept this recommendation, you must:
    (i) Check ``Test Cancelled'' (Step 6) on the CCF; and
    (ii) Sign and date the CCF.
    (2) There is not an adequate basis for determining that a medical 
condition has, or with a high degree of probability could have, 
precluded the employee from providing a sufficient amount of specimen. 
As the MRO, if you accept this recommendation, you must:
    (i) Check the ``Refusal to Test'' box and ``Other'' box in Step 6 
on Copy 2 of the CCF and note the reason next to the ``Other'' box and 
on the ``Remarks'' lines, as needed.
    (ii) Sign and date the CCF.
    (e) For purposes of this paragraph, a medical condition includes an 
ascertainable physiological condition (e.g., a urinary system 
dysfunction in the case of a urine test or autoimmune disorder in the 
case of an oral fluid test), or a medically documented pre-existing 
psychological disorder, but does not include unsupported assertions of 
``situational anxiety'' or dehydration.
    (f) As the referral physician making the evaluation, after 
completing your evaluation, you must provide a written statement of 
your recommendations and the basis for them to the MRO. You must not 
include in this statement detailed information on the employee's 
medical condition beyond what is necessary to explain your conclusion.
    (g) If, as the referral physician making this evaluation in the 
case of a pre-employment, return-to-duty, or follow-up test, you 
determine that the employee's medical condition is a serious and 
permanent or long-term disability that is highly likely to prevent the 
employee from providing a sufficient amount of specimen for a very long 
or indefinite period of time, you must set forth your determination and 
the reasons for it in your written statement to the MRO. As the MRO, 
upon receiving such a report, you must follow the requirements of Sec.  
40.195, where applicable.
    (h) As the MRO, you must seriously consider and assess the referral 
physician's recommendations in making your determination about whether 
the employee has a medical condition that has, or with a high degree of 
probability could have, precluded the employee from providing a 
sufficient amount of specimen. You must report your determination to 
the DER in writing as soon as you make it.
    (i) As the employer, when you receive a report from the MRO 
indicating that a test is cancelled as provided in paragraph (d)(1) of 
this section, you take no further action with respect to the employee. 
If the test reason was `random', the employee remains in the random 
testing pool.
0
71. In Sec.  40.195, revise the section heading to read as follows:


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

* * * * *
0
72. In Sec.  40.197, revise the section heading to read as follows:


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

* * * * *
0
73. In Sec.  40.199, revise paragraph (b)(7) and add paragraph (b)(8) 
to read as follows:


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

* * * * *
    (b) * * *
    (7) Because of leakage or other causes, there is an insufficient 
amount of specimen in the primary specimen bottle for analysis and the 
specimens cannot be re-designated (see Sec.  40.83(h)).

[[Page 11184]]

    (8) For an oral fluid collection, the collector used an expired 
device at the time of collection.
* * * * *


Sec.  40.201  [Amended]

0
74. In Sec.  40.201, in paragraph (f), remove the word ``urine'' and 
add in its place the word ``specimen''.
0
75. In Sec.  40.207, add paragraph (d) to read as follows:


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

* * * * *
    (d) If a test is cancelled, only the MRO who cancelled the test can 
reverse the cancellation and must do so within 60 days of the 
cancellation. After 60 days, the MRO who cancelled the test cannot 
reverse the cancellation without the permission of ODAPC. For example, 
if an MRO cancels a test because the MRO did not receive a copy of the 
CCF, but later receives a copy of the CCF, the MRO may reverse the 
decision to cancel the test within 60 days. After 60 days, the MRO must 
contact ODAPC for permission to reverse the cancellation. A laboratory 
is not authorized to reverse a cancellation due to a fatal flaw, as 
described in Sec.  40.199.


Sec.  40.209  [Amended]

0
76. In Sec.  40.209, in paragraph (b)(7), remove ``Sec.  40.41'' and 
add in its place ``Sec.  40.42''.
0
77. Revise Sec.  40.210 to read as follows:


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

    Both urine and oral fluid specimens are authorized for collection 
and testing under this part. An employer can use one or the other, but 
not both at the beginning of the testing event. For example, if an 
employee is sent for a test, either a urine or oral fluid specimen can 
be collected, but not both simultaneously. However, if there is a 
problem in the collection that necessitates a second collection (e.g., 
insufficient quantity of urine, temperature out of range, or 
insufficient saliva), then a different specimen type could be chosen by 
the employer and its service agent to complete the collection process 
for the testing event. Only urine and oral fluid specimens screened and 
confirmed at HHS-certified laboratories (see Sec.  40.81) are allowed 
for drug testing under this part. Point-of-collection (POC) urine, POC 
oral fluid drug testing, hair testing, or instant tests are not 
authorized.


Sec.  40.225  [Amended]

0
78. In Sec.  40.225, in paragraph (a), remove ``Appendix G'' and add in 
its place ``appendix I''.
0
79. In Sec.  40.261, redesignate paragraph (c) as paragraph (c)(1) and 
add paragraph (c)(2).
    The addition reads as follows.


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

* * * * *
    (c) * * *
    (2) As the BAT or STT, you must note the refusal in the ``Remarks'' 
line (Step 3), and sign and date the ATF. The BAT or STT does not make 
the final decision about whether the employee's conduct constitutes a 
refusal to test; the employer must decide whether a refusal occurred, 
as stated in Sec.  40.355(i), the employer has a non-delegable duty to 
make the decision about whether the employee has refused to test.


Sec.  40.283  [Amended]

0
80. In Sec.  40.283, in paragraph (c), remove ``Appendix E'' and add in 
its place ``appendix G''.


Sec.  40.285  [Amended]

0
81. In Sec.  40.285, in paragraph (b), remove the word ``urine''.
0
82. In Sec.  40.291, revise paragraphs (a)(1) and (3) to read as 
follows:


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

    (a) * * *
    (1) Making a clinical assessment and evaluation to determine what 
assistance is needed by the employee to resolve problems associated 
with alcohol and/or drug use. This assessment or evaluation may be 
performed face-to-face or remotely. If a SAP is not prohibited from 
using technology within the parameters of the SAP's State-issued 
license, a remote evaluation must be must be conducted in accordance 
with the following criteria:
    (i) The technology must permit real-time audio and visual 
interaction between the SAP and the employee; and
    (ii) The quality of the technology (e.g., speed of the internet 
connection and clarity of the video display) must be sufficient to 
allow the SAP to gather all the visual and audible information the SAP 
would otherwise gather in a face-to-face interaction, while providing 
security to protect the confidentiality of the communication.
* * * * *
    (3) Conducting an evaluation to determine if the employee has 
actively participated in the education and/or treatment program and has 
demonstrated successful compliance with the initial assessment and 
evaluation recommendations. This assessment or evaluation may be 
performed face-to-face or remotely. A remote evaluation must be made by 
means that meet the criteria in paragraphs (a)(1)(i) and (ii) of this 
section.
* * * * *


Sec.  40.293  [Amended]

0
83. In Sec.  40.293, in paragraph (a), remove the words ``face-to-
face'' and after the words ``clinical evaluation,'' add the words 
``meeting the requirements of Sec.  40.291(a)(1)''.


Sec.  40.301  [Amended]

0
84. In Sec.  40.301, in paragraph (b)(2), remove the words ``face-to-
face'' and after the words ``clinical interview'', add the words 
``meeting the requirements of Sec.  40.291(a)(1)''.


Sec.  40.311  [Amended]

0
85. In Sec.  40.311, in paragraphs (c)(4), (d)(4), and (e)(4), after 
the word ``Date(s)'' add the words ``and format (i.e., face-to-face or 
remote)''; in paragraphs (c)(1), (d)(1), and (e)(1) remove ``SSN'' and 
add in its place ``SSN or employee ID No.''.
0
86. In Sec.  40.327:
0
a. In paragraph (a), remove the reference ``paragraph (c)'' and add in 
its place ``paragraph (d)'';
0
b. Redesignate paragraph (c) as paragraph (d); and
0
c. Add a new paragraph (c).
    The addition reads as follows:


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

* * * * *
    (c) The MRO must not report such medical information using the CCF. 
Instead, the MRO must provide the information in a separate written 
communication (e.g., letter, secure email). The information must state 
the specific nature of the MRO's safety concern (e.g., the effects of a 
medication the employee is taking, the employee's underlying medical 
condition which the employee disclosed to the MRO).
* * * * *


Sec.  40.345  [Amended]

0
87. In Sec.  40.345, in paragraph (b), remove ``Appendix F'' and add in 
its place ``appendix H''.


Sec.  40.355  [Amended]

0
88. In Sec.  40.355, in Example 3 to paragraph (n), remove the word 
``urine''.


Sec.  40.365  [Amended]

0
89. In Sec.  40.365, in paragraph (b)(8), remove the words ``face to 
face interviews'' and add in their place the

[[Page 11185]]

words ``without interviews meeting the requirements of Sec.  
40.291(a)(1)''.

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

0
90. Redesignate appendices E through H to part 40 as appendices G 
through J to part 40.

Appendix C to Part 40 [Redesignated as Appendix E to Part 40]

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

Appendix C to Part 40 [Reserved]

0
92. Add reserved appendix C to part 40.

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

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

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

0
94. Redesignate appendix B to Part 40 as appendix D to part 40.
0
95. Add new appendix B to part 40 to read as follows:

Appendix B to Part 40--Oral Fluid Collection Kit Contents

1. Oral Fluid Collection Device

    a. A single-use device made to simultaneously collect a total of 
at least 2 mL of undiluted (neat) oral fluid, which can be 
subdivided in the employee's presence, into an ``A'' and a ``B'' 
split sample of at least 1 mL 10 percent undiluted 
(neat) oral fluid per each included specimen bottle; or a single-use 
device made to simultaneously collect a sufficient amount of oral 
fluid, which can be subdivided in the employee's presence, into an 
``A'' and a ``B'' split sample sufficient for laboratory testing. 
For example, when two specimens are collected simultaneously using a 
single collection device that directs the oral fluid into two 
separate collection tubes; or when a device collects a specimen with 
a single pad, which can be subdivided into two separate collection 
tubes.
    b. Must have unit markings or other indicators clearly noting 
that sufficient volume of oral fluid has been achieved.
    c. Must be sufficiently transparent to permit a visual 
assessment of the contents without opening the specimen bottle.
    d. Must be individually packaged in an easily visible tamper-
evident system.
    e. Must have the device's expiration date on the specimen 
bottles or vials sent to the laboratory.
    f. Must not include any substance that would interfere with an 
accurate analysis of analytes per HHS OFMG.
    g. Must include a way to seal specimens to prevent leakage and 
be engineered to withstand storage and shipping while maintaining 
the integrity of the specimen.
    h. Must be designed so that the required tamper-evident bottle 
seals made available on the CCF fit with no damage to the seal when 
the employee initials it, and the seal overlap will not conceal 
printed information.

2. Instructions

    a. Must include the manufacturer's instructions within the 
device's packaging. The instructions must provide sufficient detail 
to allow for an error-free collection when instructions are 
followed.

3. Leak-Resistant Plastic Bag

    a. Must have two sealable compartments or pouches that are leak-
resistant; one large enough to hold two specimen bottles and the 
other large enough to hold the CCF paperwork.
    b. The sealing methodology must be such that once the 
compartments are sealed, any tampering or attempts to open either 
compartment will be evident.

4. Absorbent Material

    Each kit must contain enough absorbent material to absorb the 
entire contents of both specimen bottles. Absorbent material must be 
designed to fit inside the leak-resistant plastic bag pouch into 
which the specimen bottles are placed.

5. Shipping Container

    a. Must be designed to adequately protect the specimen bottles 
from damage during shipment of the specimens from the collection 
site to the laboratory (e.g., standard courier box, small cardboard 
box, plastic container).
    b. May be made available separately at collection sites rather 
than being part of an actual collection device sent to collection 
sites.
    c. A shipping container is not necessary if a laboratory courier 
hand-delivers the specimen bottles in the leak-resistant plastic 
bags from the collection site to the laboratory.

0
96. Revise the newly redesignated appendix D to read as follows:

Appendix D to Part 40--DOT Drug Testing Semi-Annual Laboratory Report 
to Employers

    The following items are required on each laboratory report:

Reporting Period: (inclusive dates)
Laboratory Identification: (name and address)
Employer Identification: (name; may include Billing Code or ID code)
C/TPA Identification: (where applicable; name and address)
A. Urine Specimens
    1. Urine Specimen Results Reported (total number) By Test Reason
    (a) Pre-employment (number)
    (b) Post-Accident (number)
    (c) Random (number)
    (d) Reasonable Suspicion/Cause (number)
    (e) Return-to-Duty (number)
    (f) Follow-up (number)
    (g) Type of Test Not Noted on CCF (number)
2. Urine Specimens Reported
    (a) Negative (number)
    (b) Negative and Dilute (number)
    3. Urine Specimens Reported as Rejected for Testing (total 
number) By Reason
    (a) Fatal flaw (number)
    (b) Uncorrected Flaw (number)
    4. Urine Specimens Reported as Positive (total number) By Drug
    (a) Marijuana Metabolite (number)
    (b) Cocaine Metabolite (number)
    (c) Opioids (number)
    (1) Codeine (number)
    (2) Morphine (number)
    (3) 6-AM (number)
    (4) Hydrocodone (number)
    (5) Hydromorphone (number)
    (6) Oxycodone (number)
    (7) Oxymorphone (number)
    (d) Phencyclidine (number)
    (e) Amphetamines (number)
    (1) Amphetamine (number)
    (2) Methamphetamine (number)
    (3) MDMA (number)
    (4) MDA (number)
    5. Urine Adulterated (number)
    6. Urine Substituted (number)
    7. Urine Invalid Result (number)
B. Oral Fluid Specimens
    1. Oral Fluid Specimen Results Reported (total number) By Test 
Reason
    (a) Pre-employment (number)
    (b) Post-Accident (number)
    (c) Random (number)
    (d) Reasonable Suspicion/Cause (number)
    (e) Return-to-Duty (number)
    (f) Follow-up (number)
    (g) Type of Test Not Noted on CCF (number)
    2. Oral Fluid Specimens Reported
    (a) Negative (number)
    (b) Negative and Dilute (number)
    3. Oral Fluid Specimens Reported as Rejected for Testing (total 
number) By Reason
    (a) Fatal flaw (number)
    (b) Uncorrected Flaw (number)
    4. Oral Fluid Specimens Reported as Positive (total number) By 
Drug
    (a) Marijuana (number)
    (b) Cocaine and/or Cocaine Metabolite (number)
    (c) Opioids (number)
    (1) Codeine (number)
    (2) Morphine (number)
    (3) 6-AM (number)
    (4) Hydrocodone (number)
    (5) Hydromorphone (number)
    (6) Oxycodone (number)
    (7) Oxymorphone (number)
    (d) Phencyclidine (number)
    (e) Amphetamines (number)
    (1) Amphetamine (number)
    (2) Methamphetamine (number)
    (3) MDMA (number)
    (4) MDA (number)
    5. Oral Fluid Adulterated (number)
    6. Oral Fluid Substituted (number)
    7. Oral Fluid Invalid Result (number)

0
97. Revise newly redesignated appendix E to part 40 to read as follows:

Appendix E to Part 40--Drug Testing Semi-Annual Laboratory Report to 
DOT

    Mail, fax, or email to: U.S. Department of Transportation, 
Office of Drug and Alcohol Policy and Compliance, 1200 New Jersey 
Avenue SE, Washington, DC 20590, Fax: (202) 366-3897. Email: 
[email protected]

[[Page 11186]]

    The following items are required on each report:

Reporting Period: (inclusive dates)
Laboratory Identification: (name and address)
1. Specimen Type:
    --oral fluid or urine
2. DOT agency
    --FMCSA, FAA, FRA, FTA, PHMSA, or USCG
3. Test Reason
    --Pre-Employment, Random, Reasonable Suspicion/Cause, Post-
Accident, Return-to-Duty, Other, and Follow-up
    A. DOT Specimen Results Reported (total number)
    B. Negative Results Reported (total number)
    1. Negative (number)
    2. Negative-Dilute (number)
    C. Rejected for Testing Results Reported (total number) By 
Reason
    1. Fatal flaw (number)
    2. Uncorrected Flaw (number)
    D. Positive Results Reported (total number) By Drug
    1. Marijuana or Marijuana Metabolite (number)
    2. Cocaine and/or Cocaine Metabolite (number)
    3. Opioids (number)
    a. Codeine (number)
    b. Morphine (number)
    c. 6-AM (number)
    d. Hydrocodone (number)
    e. Hydromorphone (number)
    f. Oxycodone (number)
    g. Oxymorphone (number)
    4. Phencyclidine (number)
    5. Amphetamines (number)
    a. Amphetamine (number)
    b. Methamphetamine (number)
    c. MDMA (number)
    d. MDA (number)
    E. Adulterated Results Reported (total number) By Reason 
(number)
    F. Substituted Results Reported (total number)
    G. Invalid Results Reported (total number) By Reason (number)

0
98. Revise newly redesignated appendix F to read as follows:

Appendix F to Part 40--Report Format: Split Specimen Failure To 
Reconfirm

    Mail, fax, or submit electronically to: U.S. Department of 
Transportation, Office of Drug and Alcohol Policy and Compliance, 
1200 New Jersey Avenue SE, Washington, DC 20590, Fax: (202) 366-
3897.
    Submit Electronically: https://www.transportation.gov/odapc/mro-split-specimen-cancellation-notification.
    The following items are required on each report:
    1. MRO name, address, phone number, and fax number.
    2. Collection site name, address, and phone number.
    3. Date of collection.
    4. Specimen I.D. number.
    5. Specimen type.
    6. Laboratory accession number.
    7. Primary specimen laboratory name, address, and phone number.
    8. Date result reported or certified by primary laboratory.
    9. Split specimen laboratory name, address, and phone number.
    10. Date split specimen result reported or certified by split 
specimen laboratory.
    11. Primary specimen results (e.g., name of drug, adulterant) in 
the primary specimen.
    12. Reason for split specimen failure-to-reconfirm result (e.g., 
drug or adulterant not present, specimen invalid, split not 
collected, insufficient volume).
    13. Actions taken by the MRO (e.g., notified employer of failure 
to reconfirm and requirement for re-collection).
    14. Additional information explaining the reason for 
cancellation.
    15. Name of individual submitting the report (if not the MRO).

Appendix H to Part 40 [Amended]

0
99. In newly redesignated appendix H, under ``Drug Testing 
Information,'' remove the reference ``Sec.  40.129(d)'' and add in its 
place the reference ``Sec.  40.129(e)''.

    Signed in Washington, DC, on January 19, 2022.
Peter Paul Montgomery Buttigieg,
Secretary of Transportation.
[FR Doc. 2022-02364 Filed 2-25-22; 8:45 am]
BILLING CODE 4910-9X-P


