Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Addition of Oral Fluid Specimen Testing for Drugs, 11156-11186 [2022-02364]
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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
I. Purpose
Office of the Secretary, U.S.
Department of Transportation (DOT).
ACTION: Notice of proposed rulemaking.
AGENCY:
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
https://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 https://
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SUMMARY:
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www.regulations.gov, including any
personal information provided.
FOR FURTHER INFORMATION CONTACT:
Patrice M. Kelly, JD, Office of Drug and
Alcohol Policy and Compliance, 1200
New Jersey Avenue SE, Washington, DC
20590; telephone number 202–366–
3784; ODAPCwebmail@dot.gov.
SUPPLEMENTARY INFORMATION:
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
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testing. Additional authority at 5 U.S.C.
7301 note and Executive Order 12564,
establish HHS as the agency that
establishes scientific and technical
guidelines for Federal workplace drug
testing programs and standards for
certification of laboratories engaged in
such drug testing.
While DOT has discretion concerning
many aspects of its regulations
governing testing in the transportation
industries’ regulated programs, DOT
follows the HHS Mandatory Guidelines
for the laboratory and specimen testing
procedures. Effective January 1, 2020,
the OFMG allowed the option to use
oral fluid specimens for Federal drug
testing. As described in the OFMG
rulemaking, the advantage of every oral
fluid collection is that it will be directly
observed, as opposed to most urine
collections, which are unobserved.
While directly observed urine specimen
collections have long been the most
effective method for preventing
individuals from cheating on their drug
tests by substituting or adulterating their
specimens, directly observed urine
collection may only be done in certain
circumstances due to employee privacy
concerns (see 49 CFR 40.67). Unlike
directly observed urine collections, an
oral fluid collection is much less
intrusive on the tested employee’s
privacy. By providing the option of
collecting an oral fluid specimen, DOT
is broadening options for the testing of
safety-sensitive employees in the
transportation industries. As discussed
below, oral fluid collection can also
reduce costs of compliance with Part 40.
III. Background
On November 21, 1988, the
Department first published its drug
testing program procedures regulation,
Part 40, as an interim final rule (53 FR
47002). The Department based the
scientific requirements in that rule on
the 1988 HHS Mandatory Guidelines for
Federal Agency Employee Drug Testing
Programs (53 FR 11970, Apr. 11, 1988),
which set forth the scientific procedures
for laboratories to analyze urine
specimens for the presence of specified
drugs at the HHS-required cutoff levels
for the initial and confirmation tests for
each specific drug in urine testing.
These cutoff levels for urine were
established at levels to show prohibited
use of the specified drugs.
When the Department adopted its first
drug testing final rule, we established a
procedure for urine collections
generally to take place with visual and
aural privacy afforded to each
employee, unless suspicious activity
under 49 CFR 40.25(f)(14), (16) and (23)
(53 FR 47002, Nov. 21, 1988) called for
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a direct observed collection (i.e., bodyto-bottle observation). In December of
2000, the Department comprehensively
rewrote Part 40 into plain language. The
direct observation provisions for urine
were placed in 49 CFR 40.67, with the
body-to-bottle observation requirement
remaining unchanged. (65 FR 79462,
Dec. 19, 2000).
Urine collections are potentially
invasive searches and seizures of private
citizens, subject to scrutiny under the
Fourth Amendment of the United States
Constitution. Consequently, the
Department has always approached the
collection of urine from transportation
safety-sensitive employees with a
concern for employee privacy, which
must be balanced carefully against the
Department’s need to protect
transportation safety. The Department
protects individual rights by ensuring
visual and aural privacy for employees
undergoing urine testing. Allowing
directly observed collections only for
‘‘cause’’ (i.e., suspicious activity at the
collection site or as determined by the
laboratory testing of a specimen) is
another protection. Yet, because the vast
majority of DOT-regulated urine drug
collections are unobserved, the program
remains vulnerable to cheating by
employees at the collection site, which
can result in adulteration or
substitution.
In June 2008, the Department added
provisions to strengthen directly
observed collection requirements to
include more effective observation
procedures and expanded the
circumstances that would warrant a
direct observation procedure to address
cheating on drug tests. (73 FR 35961,
June 25, 2008). Although the 2008 final
rule was challenged in court and
initially stayed, the stay was lifted, and
the final rule was reinstated. (74 FR
37949, July 30, 2019). This action was
based on the unanimous decision of the
United States Court of Appeals for the
District of Columbia Circuit. The court’s
decision affirmed the Department’s
enhanced direct observation procedures
to prevent the use of prosthetic devices
used for cheating and to expand direct
observation to tests of people who had
already violated the rules (e.g., returnto-duty and follow-up tests for persons
who had tested positive or refused to
test). See BNSF Railway Company v.
Department of Transportation, 566 F.3d
200 (D.C. Cir. 2009).
Before the Department’s move to
expand the direct observation
procedures, HHS was aware of the
potential for cheating on urine tests and
had begun its own rulemaking to
explore alternative testing methods. In
2004, HHS solicited public comment
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upon the following alternative testing
methods, all of which would be directly
observed: oral fluid, hair, and sweat
testing. (69 FR 19673, Apr. 13, 2004).
HHS stated: ‘‘Addition of these
specimens to the Federal Workplace
Drug Testing Program would
complement urine drug testing and aid
in combating the threat from industries
devoted to subverting drug testing
through adulteration, substitution, and
dilution.’’ (Id. at 19675). HHS noted that
there were problems with all three of
the proposed alternative matrices but
asked for additional scientific
information and sought information on
appropriate levels for proficiency testing
for these alternatives.
While the science supporting oral
fluid testing did not meet the standards
of HHS in 2004, science and research
studies have now reached a point where
HHS is able to determine that oral fluid
testing is an appropriate alternative
testing method for identifying illicit
drug use in the Federal workplace. As
such, HHS proposed adding oral fluid
testing to the Federal employee
workplace testing program (80 FR
28054, May 15, 2015) and finalized this
proposal, which became effective for
Federal employee workplace testing on
January 1, 2020 (84 FR 57554, Oct. 25,
2019).
The Department is proposing to add
oral fluid testing as an alternative
testing method because, as noted above,
it has been determined by HHS to be
scientifically viable for Federal
workplace programs and because it
provides a directly observed collection
for every test. The collection of oral
fluid is less invasive than directly
observed urine collection and, therefore,
is consistent with the careful balancing
of an individual’s right to privacy with
the Department’s strong interest in
preserving transportation safety by
deterring illicit drug use.
The Department’s testing statutes
specifically require that the Department
incorporate the HHS Mandatory
Guidelines, which are scientific and
technical guidelines that ‘‘establish
comprehensive standards for all aspects
of laboratory-controlled substances
testing’’ to ensure full reliability and
accuracy in testing. Because HHS has
published its final OFMG, thereby
approving oral fluid testing as a reliable
means of detecting illicit drug use for
Federal employees, the Department is
proposing to allow, but not require, oral
fluid specimen testing as an alternative
method under Part 40, for use by DOTregulated employers for required
transportation industry workplace
testing. Specifically, we are seeking
comments as to whether there are
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circumstances where either urine or oral
fluid should be mandatory. We are also
proposing to amend some of our
provisions that pertain to both urine and
oral fluid testing to harmonize with
pertinent sections of the urine and oral
fluid HHS Mandatory Guidelines. We
are proposing to clarify certain existing
Part 40 provisions that cover the
handling of urine specimens, remove
provisions that are no longer necessary
(such as erroneous compliance dates),
add clarifying language to other
provisions (such as updated definitions
and web links where necessary), and
modify a few substantive provisions to
address issues that have arisen in
practice (such as whether a test
cancelled by a medical review officer
(MRO) can ever be uncancelled, and
whether a Substance Abuse Professional
(SAP) should be allowed to conduct
evaluations virtually).
IV. Principal Policy Considerations
Oral Fluid as an Alternative Drug
Testing Method for Workplace Testing
Since 2004, when HHS previously
considered oral fluid testing, the
scientific viability of that testing has
advanced. In its 2019 final rule, HHS
stated that ‘‘[t]he scientific basis for the
use of oral fluid as an alternative
specimen for drug testing has now been
broadly established and the advances in
the use of oral fluid in detecting drugs
have made it possible for this alternative
specimen to be used in Federal
programs with the same level of
confidence that has been applied to the
use of urine.’’ (84 FR 57554; Oct. 25,
2019). Importantly, HHS stated that its
‘‘OFMG provide the same scientific and
forensic supportability of drug test
results as the Mandatory Guidelines for
Federal Workplace Drug Testing
Programs using Urine . . . .’’ Id.
In its 2019 OFMG, HHS recognized
that products have emerged that can
help people to adulterate a urine
specimen. HHS emphasized that
establishing oral fluid as a testing
method would allow Federal agencies
greater flexibility to address testing
needs while minimizing the opportunity
for specimen adulteration or
substitution. (84 FR 57554, 57571; Oct.
25, 2019).
Adulterating and substituting
unobserved urine specimens is not a
new issue to drug testing. In upholding
the Office of Drug and Alcohol Policy
and Compliance’s (ODAPC) 2008 final
rule allowing additional direct
observation procedures, the U.S. Court
of Appeals for the District of Columbia
Circuit recognized the ‘‘cheating’’
problem: ‘‘especially in light of
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evidence of a growing proliferation of
products that facilitate cheating on drug
tests, the Department solicited comment
on additional procedures to strengthen
testing integrity.’’ BNSF Railway v. US
Department of Transportation, 566 F.3d
at 202.
In the BNSF court case, the D.C.
Circuit upheld directly observed urine
collections under the specific
circumstances imposed by the
Department because of the imminent
threat of individuals cheating on drug
tests. The court acknowledged that ‘‘the
Department determined that it was ‘not
practicable’ to ignore the cheating
problem.’’ Id. at 204. The court also
accepted that oral fluid testing was not
an acceptable method because HHS had
not yet approved any specimen testing
except urine. Id. at 205. With all of this
considered, the court upheld the
Department’s direct observation
procedures. Id. at 208–209. If the
proposal to allow oral fluid testing is
adopted, we could allow the use of oral
fluid testing in lieu of observed urine
tests to assist in addressing the cheating
problem acknowledged in the BNSF
case.
While the Department does not have
data on how much cheating is
occurring, the problem exists and poses
a direct threat to transportation safety.
The court in BNSF noted:
‘‘Acknowledging that it had no statistics
on the rates of actual use of such
devices, the Department inferred their
use from the anecdotal evidence of their
availability.’’ Because the successful use
of a cheating device would produce a
negative drug test result, this would not
show up in statistical reports as
‘‘cheating.’’ Thus, the court agreed with
DOT that ‘‘it was ‘illogical’ to require
statistical evidence of cheating. Given
that people presumably buy cheating
devices to use them, we think this
approach quite reasonable . . .’’
Consequently, the court recognized that
the DOT could not base the rulemaking
on statistical data on cheating. The court
concluded, ‘‘ ‘It is one thing to set aside
agency action under the Administrative
Procedure Act because of failure to
adduce empirical data that can readily
be obtained. It is something else to insist
upon obtaining the unobtainable. BNSF,
566 F.3d at 204 (internal citations
omitted)).
The Department recognizes that the
court upheld directly observed urine
tests in specific circumstances covered
in the regulation. In this rulemaking, the
Department is proposing, as an option to
employers, a specimen collection
methodology that is inherently a
directly observed collection and a much
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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
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completed. For example, when an
employee is unable to provide a
sufficient quantity of urine, Part 40
provides an alternative process with
multiple steps. The employee receives
up to three hours of time to provide a
sufficient specimen and is urged to
consume up to 40 ounces of fluids. If
after three hours these procedures do
not result in a sufficient urine specimen,
the employee must be medically
evaluated to determine whether there is
an adequate medical explanation why
the employee could not provide
sufficient urine. (49 CFR 40.193 and
40.195). This involves much time on the
part of the collector, employee,
employer, MRO, and physician. In
addition, there are the costs of medical
examinations for individuals who have
short-term and long-term medical
conditions that cause, or are claimed to
cause, an inability to provide a
sufficient urine specimen.
Since the Part 40 comprehensive
rewrite in the late 1990s, groups
representing individuals with
‘‘Paruresis’’ have raised concerns that a
urine collection is problematic for
individuals with this condition. Also,
employees who are undergoing dialysis
treatments or who have significant
prostate issues could have difficulty
providing a urine specimen and may
require referrals to evaluating
physicians to determine the legitimacy
of their medical inability to provide a
urine specimen. With the above in
mind, collecting an oral fluid specimen
may eliminate the need for a medical
evaluation and result in a shorter
employee visit to the collection site.
Allowing Alternative Specimens
Provides Flexibility to Employers
In proposing oral fluid testing, the
Department is not requiring employers
to use oral fluid testing instead of urine
testing, or for every test reason (e.g., preemployment, random, etc.). Instead, we
are proposing to offer employers the
flexibility in the type of specimen they
collect. That flexibility will provide
several benefits. For example, when an
employer determines that a DOT postaccident or a reasonable cause/
suspicion test is needed, oral fluid
collections could be done at the scene
of the accident or the incident. The
collection could be done by any oral
fluid collector qualified under Part 40–
either an external contractor or a DOTregulated company employee. There are
fewer requirements for oral fluid
collection sites, as discussed below. The
ready availability of collectors and the
reduced expectations for collection site
requirements should facilitate prompt,
less expensive collections for post-
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accident and reasonable cause/
suspicion testing. We would appreciate
public comments on these matters.
Understanding Windows of Detection
In proposing oral fluid testing, the
Department is offering an alternative
specimen for drug testing; however, we
are not proposing to eliminate urine
drug testing. Each specimen type offers
different benefits to assist employers in
detecting and deterring illegal drug use,
and no single specimen type is perfect
for every situation. It is important to
understand the benefits and limitations
of each method.
There are different windows of
detection that employers should
consider when deciding whether to use
a urine test or an oral fluid test as the
preferred form of testing for any specific
test reason. We have reviewed various
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scientific sources referenced below to
compile the list of windows of
detection, and we invite public
comment, especially from oral fluid
device manufacturers and laboratories,
as to the accuracy of the information
presented in the chart below. Any
additional public comments pertaining
to the accuracy and completeness of the
table below would also be appreciated.
Category of drug 1
Oral fluid
testing window
of detection
Urine testing
window of
detection
Amphetamines ...............................................................................................................................................
Methamphetamines .......................................................................................................................................
Cocaine ..........................................................................................................................................................
Opioids ...........................................................................................................................................................
Marijuana .......................................................................................................................................................
Phencyclidine (PCP) ......................................................................................................................................
1–3 days 2 ...............
1–4 days 2 ...............
1–4 days 2 3 .............
1–2 days 2 ...............
Up to 24 hours 2 4 ....
1–3 days 6 ...............
1–9 days 2.
2–4 days 2.
1–5 days 2 3.
2–4 days 2.
3–67 days 2 5.
Up to 5 days 6.
1 Detection windows in the sources are dependent on amount of drug ingested, situations such as regular heavy use, and cutoff concentrations
used.
2 Cone E.J., Huestis MA. Ann N.Y. Acad Sci. 2007;1098:51–103, pp. 35–37, 42, 45–51, 54 https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC2700061/pdf/nihms118888.pdf.
3 Jufer R., Walsh S.L., Cone E.J., et al. J Anal Toxicol. 2006;30(7):458–462, 460. https://academic.oup.com/jat/article/30/7/458/711502.
4 Newmeyer M.N., Desrosiers N.A., Lee D., et al. Drug Test Anal. 2014;6(10):1002–1010 https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC4169757/pdf/nihms578748.pdf.
5 Huestis M.A., Mitchell J.M., Cone EJ. J Anal Toxicol. 1996;20(6):441–452 https://academic.oup.com/jat/article/20/6/441/777647.
6 Cook C.E., Brine D.S., Jeffcoat A.R., et al. Clinical Pharmacology and Therapeutics. 1982; 31(5)625–634—While the authors did not report
oral fluid concentrations, they did report correlation between plasma levels and oral fluid levels. As PCP was detectable in plasma for 72 h (last
time point) it is reasonable to assume PCP can also be detected in oral fluid that long.
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If an employer is looking to detect
recent drug use, (i.e., reasonable cause/
suspicion, post-accident), an employer
may find that the more immediate
window of detection associated with
oral fluid is acceptable. However, if an
employer is looking to detect a pattern
of intermittent drug use through preemployment, random, return-to-duty,
follow-up testing, the delayed windows
of detection in urine may be preferable.
We seek comment on whether oral fluid
or urine should be mandated, or
prohibited, for certain test reasons,
based on windows of detection. Should
an employer and its service agent be
allowed to opt for a different
methodology if the first test cannot be
completed because of an insufficient
specimen or other reason? Because there
is no drug testing that determines
impairment, oral fluid is being
introduced to detect use, as urine has
done throughout the history of the DOTregulated drug testing program.
Substance Abuse Professional Remote
Evaluations
During the COVID–19 public health
emergency, the Department recognized
that it might not be possible or advisable
for a SAP to meet face-to-face with a
client. As a result, we issued a guidance
document on April 4, 2020 to allow
remote evaluations for a period of time,
and we extended the guidance several
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times. The Department’s COVID
guidance was issued in 2020–2021 and
can be viewed at:
www.transportation.gov/odapc/
Statement_of_Enforcement_Discretion_
SAPs_and_Service_Agents. We said
that, while a remote evaluation may not
provide as much information as an inperson meeting, it is preferable to not
having a SAP evaluation at all. To make
a remote evaluation as effective as
possible, the guidance document
recommended certain technical
parameters and added that SAPs should
document the format of the assessment
in the final SAP report. We also said
that we would not view a remote
evaluation as being an act of serious
noncompliance meriting resort to the
Public Interest Exclusion (PIE) process.
Based on informal contacts with the
SAP community, we believe this
guidance has been well received, with a
considerable use of remote evaluations
by SAPs since the inception of the
guidance. Moreover, it is plausible that
telehealth will become a regular part of
medical practice in a wide variety of
fields in the future.
To make remote evaluations or
assessments a regular option for the
SAP’s practice under Part 40, we are
proposing amendments to several
sections of the regulation. Consistent
with guidance issued in the context of
the COVID–19 public health emergency,
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this proposal would give SAPs the
option of choosing to conduct
evaluations remotely in lieu of face-toface meetings. Part 40 currently requires
all SAP assessments to be done face-toface. An in-person evaluation provides
SAPs with the opportunity to
objectively evaluate ‘‘non-verbals’’—
physical cues to internal feelings,
thoughts, and behaviors. It allows the
SAP to be aware of the client’s
appearance, posture, carriage, ability to
make eye contact, and ability to relate
in person, as well as other physical
characteristics that might be indicative
of problems associated with alcohol
abuse and/or drug use.
The most important proposed change
regarding SAP evaluations is to
§ 40.291(a)(1). The amendment would
replace the current requirement for a
face-to-face meeting with an option: The
SAP could do the evaluation either faceto-face or remotely. If the evaluation is
to be done remotely, there would be
three criteria that the process would
need to meet, to ensure that the SAP can
still objectively evaluate ‘‘non-verbals’’
and physical characteristics to a
sufficient extent. These criteria are also
based on the provisions of the
Department’s guidance document.
First, the technology used must
permit real-time two-way audio and
visual interaction between the SAP and
the employee. A phone conversation not
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including video would not meet this
criterion.
Second, the quality of the technology
(e.g., speed of the internet connection,
clarity of the display), would have to be
sufficient to allow the SAP to gather all
the visual and audible information the
SAP would normally observe in a faceto-face interaction. In addition, the
technology would have to have
sufficiently robust security to protect
the confidentiality of the conversation.
Third, a SAP could only use the
technology in question if the SAP’s
State-issued license authorizes the SAP
to do so. The SAP’s use of the
technology would have to stay within
the parameters of that authority (e.g., a
State license may permit a practitioner
to work only with clients in the State of
licensure). We are also seeking public
comment, especially from SAPs,
regarding whether their respective State
license would allow them to evaluate
individuals who live in a different State
from where the SAP is licensed. Is this
already allowed? Now that virtual video
evaluations are often done outside of the
DOT-regulated context, would
evaluation of individuals not in one’s
State of licensure be allowed? For a SAP
remotely evaluating an individual
outside of the SAP’s locality, what steps
could ensure a working knowledge of
quality programs and qualified
counselors available to the employee?
While we continue to believe that
face-to-face interactions are the ‘‘gold
standard’’ for the SAP evaluations, we
also believe that the remote evaluation
option may have considerable merit,
and we seek comment on the proposed
approach, as well as on the specific
technical parameters under which SAPs
would perform remote virtual
evaluations. We welcome comments
regarding the experience of both SAP
and employees under the COVID–19
guidance. We also seek comment on
whether remote virtual evaluations and
assessments should be limited to certain
circumstances, e.g., natural disasters,
pandemic situations, and where there
are few or no SAPs available.
khammond on DSKJM1Z7X2PROD with PROPOSALS2
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
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the use of hair testing are not relevant
at this time.
In addition, we are proposing to
amend § 40.67 to address situations
where a same gender observer is not
available for the collection of urine
specimens. Specifically, we request
public comment on allowing direct
observations by any licensed or certified
medical professional legally authorized
to take part in a medical examination in
the jurisdiction where the collection
takes place.
Currently, per § 40.141(b), MROs must
personally contact pharmacies to verify
a prescription that an employee has
cited as a potential legitimate medical
explanation for a laboratory-confirmed
positive test. We believe it would
increase efficiency and assist MRO
office workflow if MRO staff were able
to make these inquiries. The Department
seeks comment on whether this change
is advisable and what the estimated cost
savings would be.
In addition to the above, we request
comments on whether there are
situations in which a test, once
cancelled, should be ‘‘uncancelled’’ if
circumstances dictate (e.g., a test is
cancelled because paperwork is missing
or delayed, but the paperwork is later
found and provided to the MRO). Or,
alternatively, should a test, once
cancelled, remain cancelled to ensure
finality? We specifically seek comment
from MROs on the practicality of
administering such a process, and from
employers on the effect that an
‘‘uncancelled’’ test would have when
administering their drug testing
program. To be clear, this would not
apply to those specimens ‘‘rejected’’ by
the laboratory because of a fatal flaw
and ultimately reported by the MRO as
cancelled. We have proposed language
in § 40.207(d) to address this
circumstance. We have also included a
requirement for a party seeking to
reverse a cancellation to consult ODAPC
if the decision is being made more than
60 days after the cancellation, which is
the same consultation requirement we
have in § 40.149(a)(4), where we allow
an MRO to reopen a verified test after
60 days. Providing this information
helps ODAPC to provide advice to
MROs regarding what to consider and
potential concerns.
V. Section-by-Section Analysis
In drafting the proposed oral fluid
amendments to Part 40, the Department
is not creating a separate subpart of Part
40 concerning oral fluid testing. Since
many of the provisions of Part 40 can be
applied to specimen types in addition to
urine, we have sought to integrate
provisions concerning oral fluid testing
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within the current Part 40 structure.
However, since the provisions
applicable to Alcohol Testing, SAPs, the
PIE process, and some other provisions
would not change based on which
specimen types are authorized, we are
not proposing changes to those
provisions.
Consistent with changes made in the
substantive provisions of the rule, we
propose to modify some section titles as
well as adding new sections. In many
cases, the modifications revise current
titles specifying urine testing so that
they address oral fluid and potential
future testing matrices.
40.3 What do the terms used in this
part mean?
In addition to proposing to delete the
definition of ‘‘screening drug test’’
because the term is not used in Part 40,
the proposed rule would delete the
definition of ‘‘Invalid drug test’’ because
that is a term that HHS does not use, as
such.
The term ‘‘invalid result’’ is an HHS
term with a very specific meaning and
HHS does not have a defined term of
‘‘Invalid drug test.’’ The term ‘‘invalid’’
is sometimes misunderstood in
arbitrations, courtrooms, and other
settings to incorrectly suggest a lack of
certainty about the underlying testing
event. A laboratory reporting an invalid
result to the MRO does not mean that
the underlying drug testing event was
not valid. For example, when the
laboratory reports that there was an
‘‘invalid result,’’ it is not a
characterization of the employer’s
authority to conduct the testing, the
collection process, etc. The ‘‘invalid
result’’ refers only to the fact that the
laboratory has not been able to complete
testing or obtain a valid drug test result
(e.g., because of an unidentified
adulterant, an interfering substance, or
an abnormal physical characteristic).
Also, for consistency with HHS
terminology, we are removing the
defined term ‘‘invalid drug test’’ in the
definitions section, § 40.3, and are
updating §§ 40.123(c), 40.129(a) and
40.129(d) to use the term ‘‘invalid
result’’.
The proposal would add definitions
of seven terms as part of our effort to
harmonize Part 40 with the HHS
Guidelines and to update Part 40 as
needed. An ‘‘alternative specimen’’ is an
authorized specimen of a type other
than the one previously collected. For
example, in a case where the initial
collection was urine, oral fluid would
be an alternative specimen. The ‘‘cutoff’’
is the quantitative point distinguishing
a need for further testing or whether a
laboratory result, for example, is
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positive or negative (e.g., 2 ng/ml is the
confirmatory test cutoff for a positive vs.
negative oral fluid result reported by the
laboratory for THC). We are also
proposing to add definitions for ‘‘oral
fluid specimen’’ and ‘‘urine specimen.’’
‘‘Specimen’’ is the generic term for any
fluid, breath or material collected from
someone for a drug or alcohol test. We
are proposing to add ‘‘Undiluted (neat)
oral fluid’’, using the same language
HHS uses in Section 1.5 of its Oral Fluid
Mandatory Guidelines. We have also
added a definition for the FMCSA’s
Commercial Driver’s License (CDL) Drug
and Alcohol Clearinghouse
(Clearinghouse).
We are also proposing to add a new
definition for ‘‘SSN or Employee ID
No.’’, and some minor changes to rule
language in §§ 40.14, 40.45, 40.97,
40.163 and 40.311 for the following
reasons. Since its inception in 1988,
Part 40 has required program
participants to use the donor’s Social
Security Number (SSN) or an employee
identification (ID) number in various
sections. For example, the employer
must supply the collection site with the
‘‘Donor SSN, Employee I.D., or CDL
State and No.’’ as referenced on the
Federal Drug Testing Custody and
Control Form (CCF). For the Alcohol
Testing Form (ATF), the employer must
supply the donor’s ‘‘SSN or Employee
ID No.’’ In addition to the unique
specimen ID number on the CCF and the
specimen seals, having the SSN or
employee ID number on the form assists
the MRO in matching the Copy 1 of the
CCF from the laboratory with their copy,
Copy 2 of the CCF. The SSN or the
employee ID number may be used by
the employer to, for example, run
random selection lists and ensure that
test results are associated with the
correct employee. The SAP is required
to utilize the SSN on the SAP initial and
final reports to the employer.
In the Federal Motor Carrier Safety
Administration’s (FMCSA) Commercial
Driver’s License Clearinghouse final
rule (81 FR 87686; Dec. 5, 2016), which
required the creation of the Drug and
Alcohol Clearinghouse database
(Clearinghouse), the FMCSA amended
49 CFR 382.123(a) and (b) to require
that, for FMCSA-regulated drivers
undergoing DOT-regulated testing, the
employer use a Commercial Driver’s
License (CDL) number and State of
issuance, instead of the SSN or other
employee ID number, on the CCF and
Alcohol Testing Form (ATF) for all drug
and alcohol tests conducted under part
382. It is important to note that the
Clearinghouse final rule did not affect or
otherwise allow use of the CDL number
for a CDL driver operating under
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another DOT agency’s regulation and
subject to a test not under Part 382 (e.g.,
employers of CDL drivers under
PHMSA or FTA). Under this proposal,
those employers could also use the CDL
numbers, which could potentially
increase efficiency and reduce
confusion.
We are proposing to create a
definition of ‘‘SSN or Employee No.’’ in
§ 40.3 that would conform to and
explicitly acknowledge this existing
requirement for CDL holders regulated
by the FMCSA and to allow the use of
the CDL number for the drivers being
tested under the regulations of the other
DOT agencies.
In addition, we are proposing the
changes because some employers
already consider an employee’s ID
number to be the individual’s personal
driver’s license number, State-issued
identification number, or other Stateissued or federally issued identification
number. We believe that it would be
less confusing to explicitly state that it
is allowable to use these forms of ID,
which can be verified by viewing the
actual ID.
With increasing concerns of identity
theft, SAPs, employers and others have
indicated that the use of one’s SSN is
becoming increasingly difficult and
risky. Some corporations are only
allowing the use of 4 or 6 digits of the
SSN, and others prohibit the use of the
SSN entirely. We are proposing the
additional options of other official
identifications issued by State or
Federal authorities to also address these
concerns.
Consequently, we are proposing to
create a new definition ‘‘SSN or
Employee No.’’ that will allow a
collector, MRO, SAP, BAT, STT or other
service agent or employer to utilize only
the CDL number and State of issuance
for FMCSA-regulated drivers tested
under Part 382, and to allow the CDL
number to be used as an option on tests
conducted under the authority of the
other DOT Agencies. The definition
would also allow any other State-issued
or federally- issued identification
number to fulfill Part 40 requirement for
a unique identification number.
We are proposing to modify seventeen
definitions. For the most part, the
changes are not substantive, and would
simply conform Part 40’s wording with
that of the HHS guidelines. For
example, ‘‘collection container’’ refers
to vessels used in all collections,
whether of urine or oral fluid. In the
definition of ‘‘specimen bottle,’’ we
propose noting that the term could
include terms like ‘‘tube’’ or ‘‘vial’’ used
in oral fluid testing.
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11161
§ 40.13 How do DOT drug and alcohol
tests relate to non-DOT tests?
The Department is proposing minor
changes to paragraphs (b), (c), and (d) of
this section to clarify them in the
context of oral fluid testing. For
example, paragraph (d) is made
applicable only to urine testing since
oral fluid testing is not part of the
normal medical examination procedure
to which the paragraph applies.
We propose to redesignate paragraphs
the current paragraphs (e) and (f), as
new paragraphs (f) and (g), and would
add a new paragraph (e) emphasizing
that a drug or alcohol test administered
as directed by a medical examiner,
exclusively as part of a medical
examination required for an employee
to qualify for a certificate or license, is
not a DOT drug or alcohol test under
Part 40 and related DOT agency drug
and alcohol testing rules. For example,
if a certified medical examiner decided
to give a motor carrier driver a drug test
as part of an examination for medical
card purposes, that would be a ‘‘nonDOT test.’’ An employer could request
a required DOT pre-employment test be
conducted when the medical
examination is being conducted, as
currently permitted under 49 U.S.C.
31306(d).
We added a new paragraph (h) to
further emphasize that DOT drug and
alcohol tests are authorized to be
conducted only on safety-sensitive
employees as designated in the agency
drug and alcohol testing regulations and
must not be conducted on non-regulated
persons. (See Section II of this proposed
rule for a discussion of DOT’s testing
authorities.) DOT testing is a legal
warrantless search and seizure
permitted by the Fourth Amendment of
the Constitution. The DOT’s strong
interest in maintaining transportation
safety, when weighed against an
individual’s right to privacy, allows
DOT’s regulated testing to pass
Constitutional scrutiny. See Bluestein v.
Skinner, 908 F.2d 451 (9th Cir. 1990);
Skinner v. Railway Labor Executives’
Assn., 489 U.S. 682 (1989); Treasury
Employees v. Von Raab, 489 U.S. 656
(1989). However, there is no Federal
transportation safety interest in using
this testing for individuals other than
safety-sensitive employees.
Consequently, DOT testing cannot be
conducted on employees not regulated
by the DOT agencies. DOT regulations
also do not allow company-authorized
non-DOT testing to satisfy an
employer’s obligation to meet its
minimal annual testing rate for DOT
testing.
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§ 40.14 What information must
employers provide to collectors?
an oral fluid collection or a urine
collection under direct observation.
Paragraph (b) in this section would be
modified for clarity and to recognize
that, in the motor carrier industry,
FMCSA requires the CDL to be used for
purposes of the Drug and Alcohol
Clearinghouse (Clearinghouse) (see 49
CFR 382.705). A new paragraph (k)
would be inserted for ‘‘the specimen
type to be collected’’ and a new
paragraph (l) is proposed to specify if a
urine test is to be directly observed.
§ 40.25 Must an employer check on the
drug and alcohol testing record of
employees it is intending to use to
perform safety-sensitive duties?
In January 2020, FMCSA
implemented its Clearinghouse
regulation requiring FMCSA-regulated
employers that employ drivers subject
to the CDL testing requirements of 49
CFR part 382 to query the Clearinghouse
drug and alcohol database for
information about an employee’s past
violations of the drug and alcohol
testing rules. Until January 2023,
FMCSA-regulated employers have dual
requirements: Query the Clearinghouse
and continue to follow the procedure of
§ 40.25, as set forth in § 382.413.
Beginning January 6, 2023, FMCSAregulated employers will rely solely on
querying the Clearinghouse with respect
to present or former FMCSA-regulated
employers of an FMCSA-regulated
applicant, in accordance with
§ 382.413(b). For example, after January
6, 2023, a motor carrier vetting a
prospective employee would check the
Clearinghouse to determine whether the
driver’s previous FMCSA-regulated
employer(s) reported drug and alcohol
testing program violations by that
driver. To conform the requirements of
§ 40.25 with these existing FMCSA
requirements, we are proposing to add
a paragraph stating if an applicant’s past
employment was with an employer
regulated by, for example, the Federal
Transit Administration or the Federal
Aviation Administration (FAA), the
gaining motor carrier employer would
continue to use § 40.25 to check on that
individual’s past compliance with the
Department’s rules, since drug or
alcohol violations incurred while the
driver was employed by a DOT modal
administration other than FMCSA will
not have been recorded in the
Clearinghouse. We are proposing to add
a new paragraph (a)(3) to this section to
remind employers that when hiring an
employee subject to both FMCSA and
another DOT agency’s drug and alcohol
testing program, they must query the
Clearinghouse and request the
information about the employee listed
in paragraphs (b) through (j) of this
section from any other DOT agency for
whom the employee previously worked.
§ 40.21 May an employer stand down
an employee before the MRO has
completed the verification process?
Where there is a stand down waiver
in place, the proposed rule would add
a new paragraph (c)(2)(vii)(C) of this
section to explain that an employer,
after receiving a verified negative result,
must not send an employee back in for
another test using a different specimen
type. We have clarified that the
employer can send and employee in for
an alternative specimen collection if the
MRO cancelled the tested (e.g., per the
requirements of § 40.159). The authority
to stand down an employee is very
limited and requires an employer to
obtain an actual waiver from the DOT
agency before implementing a stand
down policy. The waiver authorizes the
employer to ‘stand down’ an employee
from performing safety-sensitive
functions based on a laboratory
confirmed positive result until the MRO
issues the employer a verified result,
which may be negative. We are
proposing that an employer cannot
conduct another test on the employee
after an MRO verifies the test as
negative. We want to prevent
harassment of employees who
ultimately have an MRO-verified
negative result and we do not want
employers to attempt to conduct a
second test to see if the window of
detection could later impact the result.
khammond on DSKJM1Z7X2PROD with PROPOSALS2
§ 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
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§ 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-
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Sfmt 4702
designation of the appendix letters but
would make no substantive changes to
the section or form.
§ 40.29
and similar sections
In the current Part 40, there are
several sections (§§ 40.29, 40.37, 40.113,
40.169, 40.189, 40.217, and 40.313) that
list, for readers’ information, other
sections of the regulation touching a
given topic (e.g., employer
responsibilities in § 40.29). These lists
of cross-references were intended to
assist readers in finding other relevant
information. However, in the 20 years
since these sections were placed in Part
40, electronic search tools have become
much more sophisticated and
ubiquitous. Under these circumstances,
the Department proposes removing
them as no longer necessary. The
Department seeks comment on whether
users continue to find the crossreference lists helpful enough to retain.
§ 40.31 Who may collect specimens for
DOT drug testing?
The provisions of this section would
be updated to separately specify the
requirements for collectors of urine and
oral fluid specimens, respectively. We
proposed adding wording to require oral
fluid collectors to be qualified. In
addition, we added wording to make it
clear that employees, relatives, and
close friends of the employees cannot
conduct collections, consistent with
existing guidance in the Department’s
Specimen Collection Guidelines. The
Department seeks comment on these
proposed revisions.
§ 40.33 What training requirements
must a collector meet for urine
collection?
The proposed rule would change the
title of § 40.33 to reflect its focus on
urine collectors. We are also proposing
a change to § 40.33(f) to clarify that
damage to a specimen resulting in it
being cancelled does not require
retraining of the collector, unless the
error actually occurred during the
collection process. We understand that
some MROs are requiring collector
retraining when a specimen is cancelled
because the damage occurred during the
transportation process. When a
specimen is damaged by a delivery
truck, sort facility, or other part of the
transportation process, or is lost in
transit, it would not be the result of an
error by the collector during the
collection process. Consequently, we are
proposing language to clarify a collector
is not subject to the time and costs of
retraining for errors outside the
collection process.
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§ 40.35 What training requirements
must a collector meet for oral fluid
collection?
The proposed rule would renumber
existing § 40.35 to become § 40.36, and
add a new section § 40.35 concerning
training for oral fluid collectors. Our
intent is to parallel, as closely as
possible, our existing training
requirements for urine specimen
collectors. We seek comment on any
differences that may exist between the
training for collectors for each specimen
type. We anticipate, in many cases, that
collectors may be cross-trained in the
two modes of collection.
In discussing who is authorized to
monitor the mock collections exercise
for oral fluid collectors, the proposed
rule retains the provision applicable to
urine collector training, which states
that someone who has performed DOT
collections for at least a year is
qualified. However, since the oral fluid
collection process is new to the DOT
testing regime, there initially will not be
anyone who has collected DOT oral
fluid specimens for a year. The
Department seeks comment on how best
to address this transition issue. For
example, would it be sufficient for a
monitor, during the first year or two
under the DOT oral fluid testing
process, to have had experience in oral
fluid collections in non-DOT oral fluid
testing? Should only someone who has
been through a ‘‘train the trainer’’
course be able to monitor the mock
collections test until there are oral fluid
collectors with a year of experience in
DOT oral fluid collections? What role, if
any, should oral fluid device
manufacturers play in the process?
khammond on DSKJM1Z7X2PROD with PROPOSALS2
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.
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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:
11163
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
PROPOSED REDESIGNATIONS THE FOL- appropriate contact information’’ to
LOWING SECTIONS OF PART 40 AS permit the inclusion of email addresses
or other means of contacting the
FOLLOWS
appropriate parties. The Department is
considering removing requirements
Old section
New section
related to fax numbers on the CCF,
40.35 ......................... 40.36.
allowing the fax number if the parties
40.41 ......................... 40.42.
have one. We seek comment on whether
40.45 ......................... 40.40.
specifying the use of fax numbers
40.47 ......................... 40.41.
remains relevant. We are proposing to
40.49 ......................... 40.44.
add a provision allowing the Designated
40.51 ......................... 40.45.
Employer Representative’s (DER) name
40.73 ......................... 40.79.
and contact information to be
40.85 ......................... 40.82.
40.87 ......................... 40.85.
preprinted on the CCF. We specifically
40.89 ......................... 40.86.
seek comments from the laboratories on
40.91 ......................... 40.87.
the availability of space on the CCF to
40.93 ......................... 40.88.
pre-print the information, as well as the
40.95 ......................... 40.89.
logistics and timeliness of sending out
40.96 ......................... 40.90.
updated CCFs with the new DER
40.99 ......................... 40.84.
information. To recognize the
Appendix B ................ Appendix D.
responsibility of collectors, as well as
Appendix C ............... Appendix E.
Appendix D ............... Appendix F.
collection site operators, for proper
Appendix E ................ Appendix G.
collections, we would add ‘‘collectors’’
Appendix F ................ Appendix H.
to the title of § 40.43.
Appendix G ............... Appendix I.
In the proposed reorganization of the
Appendix H ............... Appendix J.
subpart, §§ 40.42–40.45 would cover
urine testing (renumbered § 40.42 in the
Subpart D—Collection Sites, Forms,
proposed rule contains the material now
Equipment and Supplies Used in DOT
found in § 40.41, while renumbered
Collections
§§ 40.44 and 40.45 contain the material
As a starting point, it is important to
now found in §§ 40.49 and 40.51). Then
remember that oral fluid drug testing
we would add new §§ 40.47–40.51,
and saliva alcohol testing are
covering oral fluid testing. These
completely distinct. The devices,
provisions largely parallel their urine
procedures and outcomes are never
testing counterparts. We seek comment
interchangeable. In Part 40, we are only
on the content of the new oral fluid
proposing the provisions applicable to
provisions, including whether it would
oral fluid testing procedures in subpart
be useful to address any additional
D. The saliva alcohol testing provisions
differences between the urine and oral
in subparts K–L remain unchanged.
fluid testing procedures.
To accommodate the addition of
We are proposing to modify
provisions pertaining to oral fluid drug
renumbered § 40.40 to clarify what
testing, the Department is proposing to
address and telephone number a
reorganize subpart D. Sections applying collector must provide on the CCF. In
to the DOT drug testing process
January of 2002, ODAPC issued a
generally, regardless of specimen type,
Question and Answer (Q&A) explaining
would come first. Renumbered §§ 40.40 that the collection site address should
and 40.41 would contain the content of
not be a corporate or ‘‘main office’’
present §§ 40.45 and 40.47, concerning
address. In addition, the Q&A stated
the use of the Federal Drug Testing
that the collector’s telephone number on
Custody and Control Form (CCF) in all
the CCF should be the number to
DOT collections. We note that HHS
directly reach the individual collector
revised the CCF in August 2020. The
and/or the collector’s supervisor and not
2020 CCF and instructions for
a corporate ‘‘toll free’’ number to a call
completing the CCF for both urine and
center. Under the proposal, if an MRO,
oral fluid collections are available on
laboratory, employer or any DOT staff
the HHS website, https://
need to speak with the collector, the
www.samhsa.gov. The DOT has posted
telephone number provided on the CCF
the 2020 CCF on our website, https://
must give access directly to that
www.transportation.gov/odapc, and we
collector. This proposal would codify
will post instructions for oral fluid
requirements for the collection site
collections upon promulgation of any
address and collector’s telephone
final rule to allow oral fluid for DOTnumber, which would render the Q&A
regulated drug testing.
unnecessary.
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In § 40.48(c)(1), we use the term ‘‘dry
mouth.’’ This is shorthand, similar to
the term ‘‘shy bladder’’ used for urine
collections, for a situation in which an
employee is unable to produce a
sufficient specimen.
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§ 40.49 What materials are used to
collect oral fluid?
We are proposing to add this section
to require that collection devices meet
the requirements being set forth in a
new appendix B. The devices meeting
the requirements in appendix B would
be allowed for DOT-regulated
collections. It is important to note that
not all of the devices that HHS would
allow for the OFMG will be allowed for
DOT-regulated collections under 49 CFR
part 40. Each collection must include a
split that is subdivided from the original
specimen collection. See 49 U.S.C.
45104(5) (aviation industry testing), 49
U.S.C. 20140(c)(5) (rail), 49 U.S.C.
31306(c)(5) (motor carrier), and 49
U.S.C. 5331(d)(5) (transit). All the
devices meeting the requirements in
appendix B will allow a single specimen
to be subdivided in the presence of the
donor. For example, a device could
allow two specimens to be collected
simultaneously using a single collection
device that directs the oral fluid into
two separate collection tubes; or a
device could collect a specimen with a
single pad, which can be subdivided
into two separate collection tubes. We
are seeking public comment as to
whether there are other device types we
should mention that allow one single
specimen to be collected and then
subdivided in the donor’s presence.
We are also seeking public comment
as to whether the devices should be
sufficiently transparent so the collector
can observe whether there is anything
unusual about the specimen collected
and take action to perform a recollection, if appropriate.
§ 40.61 What are the preliminary steps
in the drug testing collection process?
In paragraphs (b)(1) and (3), the term
‘‘drug testing’’ or ‘‘drug test’’ would be
used in place of ‘‘urine,’’ since the
provision applies to the testing of either
specimen type. We propose to split the
existing (b)(3) into (b)(3) and a revised
(b)(4). The proposed revision to (b)(3)
prohibits collection of any kind of
specimen from an unconscious donor.
The proposed revision to (b)(4) includes
the remaining sentences of the current
(b)(3), with a change to the final
sentence of proposed paragraph (b)(4).
The final sentence in (b)(4), if adopted,
would be changed to emphasize that an
employer must decide whether a given
circumstance constitutes a refusal. In
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paragraph (f)(5)(i), we would note that,
when a directly observed test is needed,
either a directly observed urine
collection or oral fluid collection would
suffice. In (f)(5)(i), we propose to remind
the collector to note on the CCF whether
a directly observed urine or oral fluid
test will be conducted.
In addition, we are proposing changes
to §§ 40.61(e) and § 40.73(a)(1)
(proposed to be redesignated as
§ 40.79(a)(1) because HHS made changes
to the CCF. The DOT requires its
regulated entities to use HHS’s OMBapproved CCF.
DOT worked closely with HHS on the
revised CCF, which incorporates
changes necessary as a result of HHS’s
establishment of scientific and technical
guidelines for the inclusion of oral fluid
specimens in the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs. The majority of changes to
the CCF were made to allow the
collection of oral fluid specimens,
which are not currently authorized in
the DOT drug testing. The revisions also
include other changes to improve the
clarity and presentation of the form.
However, because of the revisions to
the CCF, it is necessary for DOT to
amend two sections of Part 40.
Specifically, the instructions for
completing the old CCF were provided
on the back of Copy 5 of that form.
These instructions are not provided on
the revised CCF, and instead,
instructions for completing the form can
be found on the HHS and DOT (Office
of Drug and Alcohol Policy and
Compliance) websites. Consequently,
we are proposing to amend the rule text
in 49 CFR 40.61(e) to reflect the
repositioning of the instructions. Also,
we are proposing to amend § 40.73(a)(1)
(proposed to be redesignated as
§ 40.79(a)(1)) to note that the employee
needs to provide all information
required in Step 5 of the revised CCF.
This information includes the donor’s
printed name and signature, date of the
collection, date of birth, daytime and
evening phone numbers, and email
address.
§ 40.63 What steps does the collector
take in the collection process before the
employee provides a urine specimen?
We are proposing to modify § 40.63(a)
to remind collectors to ensure that all
items in Step 1 of the CCF are
completed. Specifically, we propose to
add a parenthetical to remind collectors
to check the box for the DOT agency in
Step 1.D, and to write an address for the
actual collection site in Step 1.G.
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§ 40.65 What does the collector check
for when the employee presents a urine
specimen?
The proposed rule would make two
changes to the current regulation to
ensure that when an immediate recollection under direct observation is
needed (e.g., because the temperature of
a urine specimen is out of range or there
were signs of tampering), regardless of
whether the first specimen was urine or
oral fluid, the required directly observed
collection could be either urine or oral
fluid. For example, if a directly
observed collection is needed after a
urine collection, the second could be
either an oral fluid collection
(inherently directly observed) or a urine
collection carried out under the direct
observation procedures set forth in
§ 40.67. After the second collection is
done, each specimen collected must be
sent to the appropriate laboratory (i.e., a
laboratory certified by HHS for that
specimen type).
We are asking for public comment
about how communication would take
place between the employer and the
collection site to ensure that an alternate
methodology is or even should be
available. Who should decide whether
to collect an alternative specimen?
Should the collector be the one to
determine whether to collect an
alternate specimen when a situation
allows for it? Should the employer and
the service agents communicate in
advance to ensure that the alternate
specimen type is authorized, if the
employer wants one—with devices and
laboratories designated? Could this be
accomplished through the contract
between the employer and the service
agent? Are there other means of
communication to facilitate the
collection site process?
§ 40.67 When and how is a directly
observed urine collection conducted?
In addition to altering the title of the
section to refer only to urine collections,
the proposed rule would make a
substantive change to paragraph (g),
regarding who may act as the observer
in a directly observed urine collection.
The paragraph would retain the general
requirement that the observer have the
same gender as the employee, but make
an exception for licensed or certified
medical professionals or those who are
legally authorized to take part in a
medical examination in the jurisdiction
where the collection takes place. It is
commonplace in medical settings for
opposite-gender personnel to take part
in examining a patient (e.g., a female
doctor, physician’s assistant, nurse,
Emergency Medical Technician, or an
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individual who holds a ‘‘Persons-InCharge Medical Care’’ U.S. Coast Guard
designation who might be examining a
male patient). To reduce the
circumstances in which an observed
urine collection might be delayed for
lack of a same-gender observer, we
propose that an opposite-gender
medical professional, if available, could
perform this task. The donor would not
be permitted to decline the direct
observed collection by an opposite
gender medical professional and such a
refusal would fall under § 40.191(a)(4),
if the proposal is adopted. We seek
comment on whether there should be
any limitations on the types of medical
professionals who could perform this
function. In addition, we would
appreciate comments on whether there
are religious or other concerns that
should be considered in the regulatory
language proposed.
We want to clarify that the collector
does not enter the reason for the direct
observation in the ‘‘Remarks’’ section of
the CCF if the employer is sending the
employee in for a required directly
observed collection (e.g., a return-toduty test, a follow-up test, a test where
the MRO has instructed the employer to
send an employee in for a directly
observed collection). The ‘‘Remarks’’
section needs to be used only when the
collector moves to a directly observed
collection and the employer did not
know about it in advance. Thus, we are
proposing to amend § 40.67(e)(2) to
change a cross-reference to ‘‘§ 40.67(b)’’
to become a cross-reference to
‘‘§ 40.67(c)(2)-(4)’’. This is because
§ 40.67(e)(2) is an instruction to
collectors to follow through with an
entry on the ‘‘Remarks’’ line on a CCF
when an event under § 40.67(c) takes
place. This has nothing to do with
§ 40.67(b), so this cross-reference is
being corrected. We are proposing to
make a technical amendment to
§ 40.67(c)(1) to strike the reference to
paragraph (b) because it is an incorrect
reference.
§ 40.69 How is a monitored urine
collection conducted?
The proposed rule would add new
introductory language emphasizing that
a monitored collection would be
conducted if a urine collection takes
place in a multi-stall restroom and the
collector cannot secure all sources of
water and other substances that could
be used for adulteration and
substitution (49 CFR 40.42(f)(2)(ii)).
§ 40.71 How does the collector prepare
the urine specimens?
The proposed rule would make a
minor clarifying change, instructing the
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collector of a urine specimen to check
both the boxes for ‘‘urine’’ and ‘‘split
specimen’’ on the CCF.
§ 40.72–§ 40.74
These three new proposed sections
would establish the collection
procedures for oral fluid testing,
consistent with the HHS OFMG and
parallel, in many respects, to the
administrative aspects of urine
collections. For information on the
parallel HHS provisions and the HHS
rationale for putting them into effect,
please see the OFMG, (84 FR 57554,
Oct. 25, 2019).
At several points in these sections
(e.g., § 40.72(a)(2)), the proposed rule
emphasizes the proper relationship
between collection sites and employers
in cases involving conduct that could be
considered a refusal. In each case, the
collector does not make a unilateral,
final decision, but rather provides
information on the circumstances to the
employer, who per § 40.355(i), has the
non-delegable duty to make decisions in
these cases.
The oral fluid specimen collector is
expected to follow both the Part 40
requirements for collections, as well as
the manufacturer’s instructions on how
to collect the specimen. The collector
must check the expiration date on each
device. Each device will have its own
instructions and, therefore, these are not
specifically covered in the proposed
regulatory text. When we refer to
conducting the collection ‘‘correctly’’ in
these sections, we mean using the oral
fluid device in the manner described by
its manufacturer.
Subpart F
The proposed rule would reorganize
subpart F (49 CFR 40.81–40.97), which
addresses drug testing laboratories, to
create a logical progression of urine
drug testing, oral fluid drug testing, and
provisions common to both. This
reorganization involves renumbering
several provisions and, in some cases,
adding language to specify where a
provision applies only to urine drug
testing. For example, the title of
renumbered § 40.86 (§ 40.89 in the
current regulation) would be changed to
read ‘‘§ 40.86 What is urine validity
testing, and are laboratories required to
conduct it?’’
In several places in the text of § 40.97,
several requirements are specified to
apply only to urine testing, as they have
no application to oral fluid testing. We
restated § 40.97 in its entirety, given the
number of individual changes made for
this purpose.
These editorial changes are not
intended to modify the substance of the
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provisions in question. However, we
would call readers’ attention to two
proposed substantive changes. First, in
renumbered § 40.84 (§ 40.99 in the
current regulation), laboratories would
be required to keep non-negative
specimens for only 90 days, rather than
the present one-year requirement. This
change is intended to reduce storage
burdens on laboratories. We are not
aware of any reason a laboratory would
need to keep the actual specimen
beyond 90 days. This change would not
affect the 2-year record retention
requirement that HHS has set for
documentation supporting the
laboratory’s analysis of a non-negative
specimen. This would not change a
litigation hold placed upon the
specimen and the paperwork. We seek
comment on this change, as well as the
more general question of whether
interested parties find the
reorganization of the Subpart F useful.
The most notable new portion of this
subpart, consisting of §§ 40.91–40.93,
concerns cutoff concentrations and
validity testing for oral fluid specimens.
These three new sections are drawn
from the HHS OFMG and are intended
to be consistent with the HHS
provisions. For information on the
parallel HHS provisions and the HHS
rationale for putting them into effect,
see the OFMG (84 FR 57554).
In § 40.111, we propose to add
language to paragraphs (a) and (d) to
clarify that in their statistical reports to
employers and DOT, laboratories need
to submit reports to employers for the
specimens for which the laboratory
tests.
In addition, we added language in
§ 40.111 to clarify that a laboratory
withdrawing from National Laboratory
Certification Program (NLCP) program
certification is required to file with both
employers and the DOT an aggregate
statistical summary for the last period in
which it conducted DOT-regulated
testing. This data is important to the
Department because it helps DOT
identify trends regarding non-negative
results (e.g., positives, adulterated,
substituted and invalid) and cancelled
tests.
Subpart G—Medical Review Officers
For the most part, MROs would
continue to do their jobs as they have
under the current regulation. However,
the Department is proposing a few
changes to the MRO provisions.
Specifically, in § 40.121, we would
delete the word ‘‘urine’’ from paragraph
(c)(1)(i), because training for MROs
should also include oral fluid testing.
We seek comment on whether existing
and/or new MROs should receive
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additional training specifically with
respect to their role in oral fluid testing
and, if so, what subjects it should cover.
In § 40.127, concerning MRO reviews
of negative results, we propose
specifying that MROs need not review
more than 500 negative results ‘‘of all
specimen types combined’’ in any
quarter. This is to clarify that, by adding
oral fluid testing to the regulation, we
do not intend to increase MROs’
negative test result review requirements.
In § 40.129(d), we propose deleting
‘‘drug test report’’ and adding the word
‘‘result’’ following ‘‘invalid test.’’ In
§ 40.135(d), we propose deleting the
word ‘‘test’’ and adding the word
‘‘result.’’ This would keep the language
of that paragraph internally consistent
and consistent with the definition of the
term ‘‘invalid result’’ in § 40.3.
In § 40.139(b), we are proposing to
add the cutoffs for oral fluid laboratoryconfirmed results. This is important
because there are different cutoffs for
the MRO to consider when the
specimen is oral fluid versus urine.
These cutoffs trigger a clinical
examination for the use of the naturally
occurring opiates, codeine and
morphine. In addition, in § 40.139(c),
we propose to delete a reference to
‘‘urine,’’ since the provision would
apply to all DOT drug tests.
The proposed rule would make two
clarifying changes to § 40.145. In
§ 40.145(g)(3), we would delete the
word ‘‘urine’’ and substitute ‘‘drug,’’
since in this context we would apply
the requirement to test in an HHScertified laboratory to any such test,
whether urine or oral fluid. In paragraph
(h) we would add the word ‘‘urine’’ after
‘‘substituted’’.
In § 40.151, we propose clarifying the
language of paragraph (a) to direct
MROs not to accept the result of any
drug test not collected and tested under
Part 40 procedures. In talking to
employees who contact ODAPC
following a positive drug test, we often
hear, ‘‘I went to my own doctor the next
day and took another test and it was
negative.’’ This paragraph emphasizes
that MROs cannot accept such a claim,
which does not overturn the MRO’s
decision. We also deleted language
referring to DNA tests since use of those
tests is prohibited elsewhere in the
regulation (see 49 CFR 40.153(e) and
40.331(f)). In paragraph (b), we would
change ‘‘urine’’ container to
‘‘collection’’ container in recognition of
the advent of oral fluid testing. In
paragraph (g), we deleted reference to
‘‘MDEA’’, since it had been removed in
a previous rulemaking (82 FR 52229
(Nov. 13, 2017)), in response to HHS
deleting MDEA from the drug testing
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panel. MDEA is a Schedule I drug in the
amphetamines class that was previously
a required confirmatory test analyte
under the HHS Guidelines, but which
HHS removed.
In § 40.151, we also propose a
technical amendment to paragraph (i),
replacing the wording ‘‘with no
detectable creatinine’’ with ‘‘when the
creatinine level is below the laboratory’s
limit of detection.’’ This would ensure
consistency with the requirement for
laboratories to provide a numerical
value for a substituted result (see 49
CFR 40.97(e)(2)). Also, it is our
understanding that all HHS/NLCPcertified laboratories must have an
established limit of detection for
creatinine of 1mg/dL or less. Therefore,
when a laboratory reports a creatinine
concentration level at less than its limit
of detection, MROs can be assured that
it falls below the creatinine
concentration of 2mg/dL for a
substituted specimen and that an
individual cannot physiologically
produce such a urine specimen.
In § 40.159, in paragraph (a)(1) we
propose to correct the reference to
§ 40.96(c) to become § 40.96(b) and we
propose adding a new sentence to
paragraph (a)(5)(ii), which would
require re-collection when an invalid
test is cancelled. The added sentence
would direct that an alternative
specimen be collected if practicable
(e.g., oral fluid, if the specimen was
urine). This could result in a more
efficient process and reduce the
likelihood of multiple invalid
specimens resulting from use of the
same specimen type.
In § 40.163(c)(2), we propose a small
change, substituting ‘‘employee’’ for
‘‘donor.’’ In § 40.163(e), we are also
making minor wording changes to
clarify what records the MRO needs to
retain after having reported a result and
to clarify that when completing Copy 2
of the CCF, either the MRO must sign
and date it (for both negatives and nonnegatives) or MRO staff must stamp and
date it (for negatives only).
§ 40.177 What does the second
laboratory do with the split specimen
when it is tested to reconfirm the
presence of a drug or drug metabolite?
In § 40.177, we propose adding a
reference to the sections pertaining to
oral fluid testing.
§ 40.179 What does the second
laboratory do with the split specimen
when it is tested to reconfirm an
adulterated test result?
In § 40.179, the proposed rule would
change referenced section numbers in
accordance with renumbering and new
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oral fluid provisions elsewhere in the
regulations.
§ 40.181 What does the second
laboratory do with a urine split
specimen when it is tested to reconfirm
a substituted test result?
In § 40.181, the proposed rule would
change referenced section numbers in
accordance with renumbering and new
oral fluid provisions elsewhere in the
regulations. In addition, § 40.181 would
be changed to refer only to urine testing,
since the creatinine and specific gravity
apply only to urine testing.
§ 40.187 What does the MRO do with
split specimen laboratory results?
In § 40.187, the proposed rule would
change references to appendix D to
appendix F in accordance with the
redesignations.
§ 40.191 What is a refusal to take a
DOT drug test, and what are the
consequences?
This proposed provision carries
through the main points of Part 40’s
existing refusals provision, the main
addition being a provision describing
what can constitute a refusal in an oral
fluid collection. The proposed section
would make a variety of small wording
changes to take oral fluid testing into
account (e.g., in paragraph (a)(8)), ‘‘fail
to permit an inspection of the
employee’s oral cavity or fail to remove
objects from his or her mouth’’), as well
as specifying situations that are
applicable only to urine testing (e.g., in
paragraph (a)(9)), ‘‘fail to comply with
an instruction to permit inspection to
allow the observer to determine whether
there is a prosthetic device in use’’).
Like the pre-employment urine
collection process, the oral fluid preemployment collection process
generally would not begin until the
device is unwrapped. If an employee
does not appear for a pre-employment
drug test or leaves the collection site
before receiving or unwrapping the
device, this is not a refusal under
§ 40.191. However, as in urine testing,
certain blatant conduct by the employee
at the collection site could constitute a
refusal before the collection device is
unwrapped. For example, if an
employee arriving for a pre-employment
test, engages in disruptive or combative
conduct at the collection site, a collector
could report a refusal to the employer
for determination.
In addition, it is important to note
that when an employee is undergoing a
pre-employment test and the collector
switches to an alternate device, it is
considered a continuation of the
original collection and is not subject to
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the pre-employment exception for
leaving the collection site before the
second device is opened. For example,
if a collector begins with one specimen
methodology (e.g., urine) and switches
to oral fluid (e.g., because the employee
was unable to provide a sufficient
specimen), the employee must not leave
the collection site without refusal
consequences.
The proposed rule would revise
§ 40.191(d) and add a new paragraph
(c)(1) to § 40.261 to clarify an oftenmisunderstood point about who has the
authority to declare that conduct at the
collection site constitutes a refusal to
test. The Department has received many
inquiries in which employers have
automatically treated as a refusal any
situation in which the collection site
notes a refusal in the remarks section of
the CCF. This is not correct.
Under the long-existing § 40.355(i),
making collection site refusal decisions
is a ‘‘non-delegable’’ duty of the actual
employer. Service agents, such as
collectors, BATs or STTs, are not
authorized to make this decision. Their
role is to provide information to the
employer concerning the circumstances
of the event. Then the employer, who as
a matter of prudence would contact the
employee and the collector or BAT to
gather information, should make the
decision, taking the entirety of the
circumstances into account. The
employer would have the discretion to
consider circumstances that may
satisfactorily excuse the employee’s
conduct. For FMCSA-regulated owneroperators, C/TPAs stand in the shoes of
employers for the purposes of
determining whether the individual
refused a test (49 CFR 382.705(b)(6)).
For example, we have heard multiple
times about situations in which an
employee provides an insufficient
quantity of urine, begins the ‘‘shy
bladder’’ procedure, but the procedure
is cut short because the collection site
closes before the employee has had
three hours to produce a sufficient urine
specimen, as allowed by § 40.193(b)(2).
If the collection site nevertheless reports
the matter to the employer as a refusal,
the employer has discretion to
determine that there was no intent on
the part of the employee to evade the
process. If the employer determines that
a refusal did not occur, the employer
would treat the test as an
administratively closed non-event.
FMCSA-regulated employers would
have the discretion not report such nonevents to the Clearinghouse as refusals.
The same thinking might apply in a
situation in which a documented family
medical emergency led the employee to
leave the collection site.
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For random tests administratively
closed as a non-event by the employer,
no further action is required. For those
testing events that require a ‘‘negative’’
test result (e.g., return-to-duty, followup), the employer would send the
employee back for another collection. In
all cases, the employer should
document exactly what happened to
explain why the employer concluded a
refusal did not occur.
§ 40.193 What happens when an
employee does not provide a sufficient
amount of specimen for a drug test?
The most important change that this
section would make is the addition of
oral fluid testing to paragraph (a),
adding insufficient specimen provisions
for oral fluid testing, parallel to, but
briefer than, the existing provisions of
dealing with insufficient urine
specimens. Because of the differences
between the two types of specimen
collections, the insufficient specimen
collection procedure is shorter in
duration than the insufficient urine
specimen collection procedure (e.g., in
an oral fluid collection, there would not
be a need for a three-hour wait period).
In paragraph (e), the proposed rule
would add examples of conditions that
might succeed as medical explanations
of providing an insufficient quantity of
oral fluid (e.g., autoimmune diseases),
as well as examples that would not
constitute a valid medical explanation
(e.g., unsupported assertions of
dehydration). We seek comment on
what sort of evidence is needed to avoid
an assertion being viewed as
‘‘unsupported’’ for this purpose. We
note that because alternative specimens
will be available, using a different type
of specimen in an insufficient quantity
case may be an option. That is, if a urine
specimen is insufficient, the collector
could follow up with an oral fluid
collection, or vice-versa. In such a case,
following the insufficient urine
specimen procedures would become
unnecessary. The Department seeks
comment on both this concept and
whether specific language to this effect
should be included in the regulatory
text.
We also seek public comment,
especially from device manufacturers,
regarding whether allowing a donor to
rinse with up to 8 ounces of water is an
appropriate amount of fluid for rinsing
for the purposes of both §§ 40.72(b) and
40.193(b)(2). Should we allow more or
less? Would measuring less than 8
ounces be difficult for collectors?
We also seek comment on whether a
qualified collector should be able to
make a decision about what
methodology to use after an insufficient
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specimen occurs, or whether this should
be a decision left to the employer,
depending, for example on the
employer’s contract with a C/TPA,
laboratory, or collection site. In
addition, when following an insufficient
specimen collection, consistent with the
HHS OFMG, the collector would
complete a new CCF for the alternative
specimen collection. Is this an
appropriate way of handling such
situations, or would it be better to
continue the current practice and use
the original CCF with relevant crossouts and notations in the remarks
section?
§ 40.195 What happens when an
individual is unable to provide a
sufficient amount of specimen for a preemployment follow-up or return-to-duty
test because of a permanent or longterm medical condition?
The only textual change in § 40.195 in
the proposed rule is in the title, where
the more general ‘‘specimen’’ is
substituted for ‘‘urine,’’ in view of the
addition of oral fluid testing to the
program.
§ 40.197 What happens when an
employer receives a report of a dilute
urine specimen?
The only textual change in § 40.197 in
the proposed rule is in the title, where
the word urine would be inserted
because this section concerns situations
that arise only in urine testing.
§ 40.199 What problems always cause
a drug test to be cancelled?
Section 40.199, the ‘‘fatal flaws’’
section of the rule, would be expanded
by adding a new fatal flaw for use of an
expired oral fluid collection device, in
paragraph (b)(8). In paragraph (b)(7) of
§ 40.199, the term ‘‘urine’’ would be
replaced with ‘‘specimen,’’ reflecting
the addition of oral fluid testing to the
program.
§ 40.201 What problems always cause
a drug test to be cancelled and may
result in a requirement for another
collection?
In paragraph (b)(7) of § 40.199 and
paragraph (f) of § 40.201, the term
‘‘urine’’ would be replaced with
‘‘specimen,’’ reflecting the addition of
oral fluid testing to the program.
§ 40.207 What is the effect of a
cancelled drug test?
Throughout the history of Part 40,
there has not been a regulatory
provision that allows an MRO to
‘‘uncancel’’ a test that the MRO has
cancelled. New paragraph (d) is
proposed so that an MRO can reverse
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the cancellation of a test. Currently,
§§ 40.203, 40.205, and 40.208 address
situations that require a test to be
cancelled by an MRO, if there is not
corrective action. For example, if an
MRO does not receive a timely
memorandum for the record from a
collector regarding required information
that was omitted from the CCF, the
MRO may cancel the test. Once an MRO
cancels a test due to an uncorrected
correctible error, there is currently no
authority for the MRO to reverse that
cancellation decision. So, if the
memorandum for the record arrives, but
the MRO staff misses it, the cancelled
test cannot be reversed without this
proposed rule change. That inability has
created additional cost for the employer,
inconvenience for the employee, and
also confusion because some MROs
think they already have this authority.
Adding this provision will reduce costs
and confusion. In addition, for those
testing events for which an employer
needs a negative result (i.e., preemployment, return-to-duty or followup), an employee must go in and re-take
the test, if the MRO cannot un-cancel it
after the error is corrected.
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§ 40.210 What kinds of drug tests are
permitted under the regulations?
This proposed revision notes that oral
fluid and/or urine specimens can be
collected, and must be tested at HHScertified laboratories. No other
specimen methodologies are currently
permitted.
We are proposing that an employer
can use one or the other, but not both
urine and oral fluid methodologies at
the beginning of the testing event. For
example, if an employee is sent for a
test, either a urine or oral fluid
specimen can be collected, but not both
simultaneously. However, if there is a
problem in the collection that
necessitates a second collection (e.g.,
insufficient quantity of urine,
temperature out of range, or insufficient
oral fluid), we want to propose that a
second methodology could be used to
complete the collection process for the
testing event. If we adopt this provision,
would the employer and/or its service
agent be the correct one(s) to make the
decision as to which methodology to
use in the second collection?
§ 40.225 What form is used for an
alcohol test?
This proposed revision would make a
conforming change to § 40.225 and
redesignate appendix G to be appendix
I.
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§ 40.261 What is a refusal to take an
alcohol test, and what are the
consequences?
We are proposing to add a new
paragraph (c)(1) to this section, parallel
to the proposed § 40.191(b) for drug
testing. It spells out the respective
responsibilities of the service agent(s)
and the DER in making decisions about
whether a situation during an alcohol
test constitutes a refusal to test. In a
situation in which there is not an
employee signature, at Step 2 of the
ATF (see paragraph (a)(6) of this
section), but a result is nonetheless
forwarded to the employer, we
recommend that the employer take a
case-by-case approach, for example not
treating as a refusal a situation in which
there is no signature but there is an
affidavit from an STT or BAT explaining
the situation.
§ 40.283 How does a certification
organization obtain recognition for its
members as SAPs?
In § 40.283, there is a conforming
change redesignating aappendix E to
aappendix G.
§ 40.285 When is a SAP evaluation
required?
In § 40.285, the word ‘‘urine’’ would
be removed if oral fluid testing is added.
§ 40.345 In what circumstances may a
C/TPA act as an intermediary in the
transmission of drug and alcohol testing
information to employers?
A conforming change, from aappendix
F to aappendix H, would be made in
§ 40.345.
§ 40.355 What limitations apply to the
activities of service agents?
In § 40.355(n) (Example 3), the word
‘‘urine’’ would be removed in light of
the addition of oral fluid testing.
§ 40.291 What is the role of the SAP in
the evaluation, referral, and treatment
process of an employee who has
violated DOT agency drug and alcohol
testing regulations?
As discussed in the Principal Policy
Considerations section, the Department
is proposing to permit substance abuse
professionals (SAPs) to conduct
evaluations or assessments remotely.
The proposed rule would amend
§§ 40.291(a)(1) and (3) to remove the
requirement that SAP evaluations be
only ‘‘face-to-face’’ and to explain what
is required for remote evaluations.
Specifically, the technology must be
able to allow real-time audio and visual
interaction between the SAP and the
employee. Telephone calls, therefore,
would not be acceptable. In addition,
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the proposal would require that the
quality of the technology be sufficient to
allow the SAP to gather all visual and
audible information that would be
apparent in a face-to-face interaction.
§ 40.293 What is the SAP’s function in
conducting the initial evaluation of an
employee?
The proposal would remove the
words ‘‘face-to-face’’ from paragraph (a)
this provision. This change, if adopted,
would allow remote evaluations.
§ 40.301 What is the SAP’s function in
the follow-up evaluation of an
employee?
The proposal would remove the
words ‘‘face-to-face’’ from paragraph
(b)(2) this provision. It would also add
the words ‘‘meeting the requirements of
§ 40.291(a)(1) of this part’’, if adopted.
This proposed change would allow
remote evaluations.
§ 40.311 What are the requirements
concerning SAP reports?
The proposal would add the words
‘‘and format (i.e., face-to-face or
remote)’’ to § 40.311(c)(4), (d)(4), and
(e)(4). In addition, we would amend
§ 40.311 to direct SAPs to note on their
SAP reports whether a given evaluation
occurred face-to-face or remotely.
We also propose to change ‘‘SSN’’ to
‘‘SSN or employee ID number’’ in
paragraphs § 40.311(c)(1), (d)(1) and
(e)(1) for consistency of terms in Part 40
and to allow the use of additional
identification numbers in SAP reports,
instead of solely the Social Security
Number.
§ 40.365 What is the Department’s
policy concerning starting a PIE
proceeding?
We propose to amend § 40.365 to say
that a PIE could occur because a SAP
failed to conduct an evaluation using
the means provided in § 40.291(a)(1),
rather than because there was no faceto-face evaluation.
§ 40.327 When must the MRO report
medical information gathered in the
verification process?
In § 40.327, we would add a
clarification that MROs are not to use
the CCF to transmit information about
safety concerns to employers or other
authorized parties. Rather, a separate
communication (e.g., secure email,
letter) is to be used. The communication
should specify whether the MRO’s
safety concern relates to the use of a
medication, the type of medical
condition for which such a medication
is typically prescribed, or some
combination of the two. The purpose of
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providing this information is to allow
the employer and/or any third parties to
focus on the MRO’s specific concern,
rather than having to make an openended inquiry. The Department seeks
comment on this matter. This
clarification would echo the
Department’s 2017 final rule preamble
discussion that medical information is
sent apart from the verified result
report. (82 FR 52229, 52236; Nov. 13,
2017).
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Appendices
Appendix A, concerning urine
collection kits, would remain
unchanged. The proposed rule would
add a new aappendix B, establishing
standards for oral fluid collection kits,
based on material in the HHS OFMG
and consistent with OTETA
requirements for a split specimen. The
Department seeks comments on the
details of the proposed standards.
The remainder of the appendices
would be renumbered and reordered.
For a summary of these changes, see the
redesignation table immediately
preceding the discussion of subpart D in
section V of the preamble. The
Department seeks comment on the new
organization of the appendices.
Current aappendix B, concerning
semi-annual reports by laboratories to
employers, would become aappendix D.
The new version of the appendix would
break out matters to be reported with
respect to urine and oral fluid testing
respectively. Current aappendix C,
regarding semi-annual reports by
laboratories to the Department, would
become aappendix E. Meanwhile, the
aappendix C slot would be reserved.
In the redesignated aappendix E (the
former aappendix C), the Department
proposes to amend the data elements
that HHS/NLCP certified laboratories
would submit to DOT semi-annually.
Specifically, we propose to require
laboratories to continue to provide the
DOT with the drug testing data but to be
broken out by specimen type (i.e., urine
and oral fluid), DOT agency (i.e.,
FMCSA, FAA, FRA, FTA, PHMSA, U.S.
Coast Guard) and test reason (i.e., preemployment, random, reasonable
suspicion/cause, post-accident, returnto-duty, other, and follow-up). The
proposal would require each laboratory
to submit multiple data summaries as
opposed to the one data summary they
now provide. By providing the
additional data elements, we hope to
evaluate the efficacy of testing by oral
fluid versus urine. We also hope to get
a better understanding of any trends in
drug testing by specimen type, DOT
agency and/or test reason(s).
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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
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issues. The proposed amendments do
modify existing regulatory requirements
and allow an activity that was formerly
prohibited, but they do not meet the
Executive Order’s criteria for being a
significant rule. Consequently, OMB has
determined that this document proposes
a nonsignificant rule.
Need for Regulation
The Department believes that this
proposed rule is needed because it
makes several improvements in the
integrity and effectiveness of an
important safety program, as well as
potentially reducing some costs to
regulated parties. The reasons for this
belief include the following:
Enhanced Flexibility
The proposed rule, consistent with
the HHS OFMG, would revise the
requirement to collect only a urine
specimen, which has existed since Part
40 was first published in 1988. Urine
drug testing is subject to issues related
to an employee’s inability to produce a
sufficient urine specimen. In such
situations, the employee’s inability to
provide a sufficient urine specimen
creates delays in getting a result to the
employer because of the requirement to
have the employee evaluated by a
medical professional to assess the
employee’s inability to provide a
sufficient specimen.
When the proposed amendments to
Part 40 permitting oral fluid testing are
used by a transportation employer, the
employer will be authorized to collect
an oral fluid specimen from an
individual who is unable to provide a
sufficient urine specimen. This added
flexibility will reduce the need for the
Medical Review Officer (MRO) to
arrange a medical evaluation of an
employee’s inability to provide a
specimen. Therefore, the proposed
amendments would provide flexibility
to address workplace drug testing needs
of transportation employers by
permitting the selection of the specimen
type best suited for their needs and
authorizing collection of an alternative
specimen type when an employee is
unable to provide a sufficient urine
specimen. The added flexibility will
also benefit employees, who should be
able to provide one of the specimen
types, thereby facilitating the drug test
required for their employment.
Enhanced Versatility
Urine collection requires use of a
collection facility, secured restrooms,
and other special requirements. An oral
fluid collection does not require an
enclosure, the way that a urine
collection does. With oral fluids, there
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is more flexibility regarding the
collection site. Specifically, an
acceptable oral fluid collection site must
allow the collector to observe the
employee, maintain control of the
collection device(s) during the process,
maintain record storage, and protect
employee privacy. This would provide
employers with more flexibility about
where to conduct a collection. For
example, especially in the railroad and
pipeline industries, where selected
employees may be part of ‘‘travelling
gangs’’ or in remote locations (e.g., away
from locations with traditional brickand-mortar buildings) an enclosure is
often difficult to find for collecting
DOT-regulated specimens.
Having oral fluid testing as an option
available to an employer provides
flexibility for the employer to choose
whether urine or oral fluid testing is
better due to logistics, costs, and the
specific facts of a situation. Among
other things, when a problematic
situation occurs at a collection site (e.g.,
a urine specimen is out of temperature
range), the ensuing directly observed
test could be conducted using oral fluid.
Choosing the oral fluid testing option in
such situations can save the employer
significant time and money.
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Decreased Numbers of Substituted and
Adulterated Tests
All unobserved specimen collections
are at risk for substitution and
adulteration. Per HHS’s OFMG
preamble, information from the drug
testing industry indicates that 0.05 to
3% of urine specimens collected for
drug use detection are determined to be
substituted or adulterated. (84 FR
57571; Oct. 25, 2019). All oral fluid
collections will occur under direct
observation, which should substantially
reduce the risks of specimen
substitution and adulteration that has
been associated with urine specimen
collections, most of which are
unobserved. With the above in mind,
and to harmonize with HHS, we are
proposing changes to §§ 40.91 and 40.93
to authorize laboratories to conduct
specimen validity testing (e.g., testing
for a biomarker such as albumin or
immunoglobulin G, IgG or for a specific
adulterant).
Time and Cost Savings
Collecting an oral fluid specimen can
require less time than collecting a urine
specimen, and thereby reduce the
employee’s time away from the
workplace and costs to the employer.
First, most urine collections take place
in separate facilities dedicated to
collections, requiring employees to
travel from their workplace to those
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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
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collections occur, and how much time
they add to the process.
Reduced Need for Collection Site
Security Measures
Urine testing requires that access to
water sources or to any potential
adulterants or substituting products be
secured and prohibited. This requires
securing of the collection site to ensure
the integrity of the unobserved testing
process and protection against cheating.
We are proposing substantially fewer
steps for oral fluid collection site
integrity and security because all oral
fluid specimen collection is directly
observed.
Providing urine is a bodily function
that requires more privacy than having
the employee place a collection device
in the employee’s mouth, in accordance
with the collector’s instructions.
Consequently, oral fluid testing is less
intrusive and time-consuming than even
unobserved urine testing.
Versatility in Detection
Adding oral fluid as an alternate
specimen type would allow an
employer to select the specimen type
based on the circumstances of the test.
For example, in a reasonable suspicion/
cause or post-accident test, an oral fluid
test may show the presence of an active
drug, which may indicate recent use of
the drug, and which might not be
detected in a urine drug test.
An oral fluid drug test can detect
marijuana use in the past 24 hours,
while a urine drug test detects use
ranging from 3–67 days prior to
collection (see preamble
‘‘Understanding Windows of
Detection’’). Thus, oral fluid testing may
give employers more interpretative
insight into recent drug use.
Lower Likelihood of Adulteration,
Substitution or Cheating
Urine was the original specimen of
choice for workplace drug testing, and
urine testing is expected to remain an
established and reliable component of
DOT’s drug testing program. However, a
major challenge to urine drug testing
has been the proliferation and use of
available commercial products used to
adulterate or substitute an employee’s
urine specimen. Due to individual
privacy rights, most urine collections
are unobserved, allowing the
opportunity to use such products. As
under HHS Urine Mandatory
Guidelines, laboratories have developed
procedures to identify adulterated and/
or substituted specimens, manufacturers
have developed new products to avoid
detection. The use of these products is
expected to continue. Like HHS, DOT
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believes that oral fluid testing is likely
to be less susceptible to these problems
because the oral fluid collection is a
directly observed collection.
Costs and Benefits
Using data obtained from the Federal
Workplace Drug Testing Programs and
HHS-certified laboratories, HHS
estimated that approximately 7% (or
10,500) of the 150,000 specimens tested
in the Federal employee program per
year would be oral fluid specimens and
93% would continue to be urine
specimens. HHS further estimated that
subsequent transition to oral fluid
testing would be gradual and steady
over the course of four years, when it
could account for about 30% of all tests.
If, as the Department believes based
on industry experience, the cost of a
urine test is approximately $50, while
the cost of an oral fluid test is $35, this
means that each oral fluid test that is
done in place of a urine test results in
a saving of $15. By this calculation, oral
fluid testing would cost $14.7 million in
the first year and $63 million after the
four-year transition period. This
represents a potential savings of $6.3
million the first year and $27 million in
the fourth year, compared to a scenario
in which all the tests in question were
urine tests. The Department seeks
comment on whether the assumptions
behind these calculations make sense
and whether and how we should modify
them.
It is possible that, over time, the
proportion of tests conducted using oral
fluid could increase beyond this
projection, as employers take advantage
of the lower costs and greater flexibility
associated with oral fluid testing. If so,
then the cost savings of these
amendments would increase. We do not
have data on which to base an estimate
of how large and how quickly this trend
might become. The Department seeks
comment on this matter.
Employers and C/TPAs choosing to
use oral fluid in their drug testing
programs may incur collector training
costs. Based on an average of the limited
number of published training costs for
oral fluid collectors in the non-DOT
drug testing industry, oral fluid
collection training would cost about
$348 per collector trained.
The Department estimates that there
are about 25,000 collectors currently
participating in the DOT-regulated urine
drug testing program. We assume, per
HHS’s projection, that after the first year
of oral fluid testing, 7% of tests would
use oral fluid and around 7% of
collectors would be trained in oral fluid
collection by that point. Seven percent
of 25,000 collectors is 1,750. Their
11171
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
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1
2
3
4
Costs
.......................................................................................................................................
.......................................................................................................................................
.......................................................................................................................................
and beyond ...................................................................................................................
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
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$609,000
$957,000
$1,305,000
$2,001,000
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
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Cost savings
$6,300,000
$11,475,000
$11,475,000
$27,000,000
Net cost savings
$5,691,000
$10,518,000
$10,170,000
$24,999,000
none of these things, and hence does not
constitute a major rule under the Small
Business Regulatory Enforcement
Fairness Act (SBREFA) of 1996.
Unfunded Mandates
The Secretary has examined the
impact of the proposed rule under the
Unfunded Mandates Reform Act
(UMRA) of 1995 (Pub. L. 104–4). This
notice does not trigger the requirement
for a written statement under sec. 202(a)
of the UMRA because this rulemaking
does not impose a mandate that results
in an expenditure of $100 million
(adjusted annually for inflation) or more
by either State, local, and tribal
governments in the aggregate or by the
private sector in any one year. In fact,
by providing a lower cost alternative to
urine drug testing, the NPRM would
reduce costs to regulated parties,
including State and local entities (e.g.,
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public transit authorities, public works
departments) whose employees are
subject to testing.
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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
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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.
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For the reasons stated in the
preamble, the Department proposes to
amend 49 CFR part 40 as follows:
PART 40—PROCEDURES FOR
TRANSPORTATION WORKPLACE
DRUG AND ALCOHOL TESTING
PROGRAMS
1. The authority for part 40 continues
to read as follows:
■
Authority: 49 U.S.C. 102, 301, 322, 5331,
20140, 31306, and 54101 et seq.
2. In § 40.3:
a. Remove the definitions of ‘‘Invalid
drug test’’ and ‘‘Screening drug test’’;
■ b. Remove the definition of ‘‘Initial
drug test (also known as ‘‘Screening
drug text’’) and add a definition for
‘‘Initial drug test’’ in its place;
■ c. Remove the definition of ‘‘Limit of
Quantification’’ and add a definition for
‘‘Limit of Quantification (LOQ)’’ in its
place;
■ d. Add in alphabetical order
definitions for ‘‘Alternative specimen’’,
‘‘Commercial Driver’s License Drug and
Alcohol Clearinghouse
(Clearinghouse)’’, ‘‘Cutoff’’, ‘‘Oral Fluid
Specimen’’, ‘‘Specimen’’, ‘‘SSN or
Employee ID No.’’, ‘‘Undiluted (neat)
oral fluid’’, and ‘‘Urine Specimen’’; and
■ e. Revise the definitions of
‘‘Collection container’’, ‘‘Collection
site’’, ‘‘Confirmatory drug test’’, ‘‘Initial
drug test’’, ‘‘Initial specimen validity
test’’, ‘‘Invalid Result’’, ‘‘Laboratory’’,
‘‘Limit of Detection (LOD)’’, ‘‘Limit of
Quantitation (LOQ)’’, ‘‘Non-negative
specimen’’, ‘‘Primary specimen’’,
‘‘Reconfirmed’’, ‘‘Shipping container’’,
‘‘Specimen bottle’’, ‘‘Split specimen’’,
‘‘Split specimen collection’’, and
‘‘Substituted specimen’’.
The additions and revisions read as
follows:
■
■
§ 40.3 What do the terms used in this part
mean?
*
*
*
*
*
Alternative specimen. An authorized
specimen, other than the type of
specimen previously collected or
attempted to be collected.
*
*
*
*
*
Collection container. A container
used to collect a specimen.
Collection site. A place selected by
the employer where employees present
themselves for the purpose of providing
a specimen for a drug test.
*
*
*
*
*
Commercial Driver’s License Drug and
Alcohol Clearinghouse (Clearinghouse).
A database, administered by the Federal
Motor Carrier Safety Administration,
containing records of commercial motor
vehicle drivers’ violations of controlled
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substances and alcohol testing program
requirements, as set forth in part 382 of
this title, as well as their return-to-duty
status.
*
*
*
*
*
Confirmatory drug test. A second
analytical procedure performed on a
different aliquot of the original
specimen to identify and quantify a
specific drug or drug metabolite.
*
*
*
*
*
Cutoff. The analytical value (e.g., drug
or drug metabolite concentration) used
as the decision point to determine a
result (e.g., negative, positive,
adulterated, invalid, or substituted) or
the need for further testing.
*
*
*
*
*
Initial drug test. The first test used to
differentiate a negative specimen from
one that requires further testing for
drugs or drug metabolites.
Initial specimen validity test. The first
test used to determine if a specimen is
adulterated, diluted, substituted, or
invalid.
Invalid result. The result reported by
a laboratory for a specimen in which the
laboratory has not been able to complete
testing or obtain a valid drug test result
(e.g., because of an unidentified
adulterant, an interfering substance, or
an abnormal physical characteristic).
Laboratory. Any U.S. laboratory
certified by HHS under the National
Laboratory Certification Program as
meeting the minimum standards set by
HHS; or, in the case of foreign
laboratories, a laboratory approved for
participation by DOT under this part.
Limit of Detection (LOD). The lowest
concentration at which the analyte (e.g.,
drug or drug metabolite) can be
identified.
Limit of Quantitation (LOQ). For
quantitative assays, the lowest
concentration at which the identity and
concentration of the analyte (e.g., drug
or drug metabolite) can be accurately
established.
*
*
*
*
*
Non-negative specimen. A specimen
that is reported as adulterated,
substituted, positive (for drug(s) or drug
metabolite(s)), or invalid.
*
*
*
*
*
Oral Fluid Specimen. A specimen that
is collected from an employee’s oral
cavity and is a combination of
physiological fluids produced primarily
by the salivary glands.
*
*
*
*
*
Primary specimen. In drug testing, the
specimen bottle that is opened and
tested by a first laboratory to determine
whether the employee has a drug or
drug metabolite in his or her system;
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and for the purpose of specimen validity
testing. The primary specimen is the
portion of the donor’s subdivided
specimen designated as the primary
(‘‘A’’) specimen by the collector to
distinguish it from the split (‘‘B’’)
specimen, as defined in this section.
*
*
*
*
*
Reconfirmed. The result reported for
a split (Bottle B) specimen when the
second HHS-certified laboratory
corroborates the original result reported
for the primary (Bottle A) specimen.
*
*
*
*
*
Shipping container. A container that
is used for transporting and protecting
specimen bottles and associated
documents from the collection site to
the laboratory.
Specimen. Fluid, breath, or other
material collected from an employee at
the collection site for the purpose of a
drug or alcohol test.
Specimen bottle. The bottle that, after
being sealed and labeled according to
the procedures in this part, is used to
hold a primary (‘‘A’’) or split (‘‘B’’)
specimen during transportation to the
laboratory. In the context of oral fluid
testing, it may be referred to as a ‘‘vial,’’
‘‘tube,’’ or ‘‘bottle.’’
Split specimen. In drug testing, the
specimen that is sent to a first laboratory
and stored with its original seal intact,
and which is transported to a second
laboratory for retesting at the
employee’s request following MRO
verification of the primary specimen as
positive, adulterated or substituted.
Split specimen collection. A
collection in which the single specimen
collected is divided into two separate
specimen bottles, the primary specimen
(Bottle A) and the split specimen (Bottle
B).
SSN or Employee ID No. This number
serves as a unique identifier that must
be used on the Federal Drug Testing
Custody and Control Form (CCF) or
Alcohol Testing Form (ATF) for a donor,
on the MRO’s reports, on SAP reports,
or on other documents that are required
under this part. For all purposes of this
part, this term means: Only the
Commercial Driver’s License (CDL)
Number and State of issuance for
drivers tested under the authority of the
Federal Motor Carrier Safety
Administration (FMCSA); and, for all
drivers and other safety-sensitive
employees tested under the authority of
the other DOT agencies, this can be the
individual’s actual Social Security
Number, a unique identifier issued by
the employer, a State-issued
identification card number, a Stateissued driver’s license number
(including a CDL number) or any other
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11173
State-issued or federally-issued
identification number.
*
*
*
*
*
Substituted specimen. An employee’s
specimen not consistent with a normal
human specimen, as determined by
HHS (e.g., a urine specimen, with
creatinine and specific gravity values
that are so diminished, or so divergent
that they are not consistent with normal
human urine).
*
*
*
*
*
Undiluted (neat) oral fluid. An oral
fluid specimen to which no other solid
or liquid has been added. For example:
A collection device that uses a diluent
(or other component, process, or method
that modifies the volume of the testable
specimen) must collect at least 1 mL of
undiluted (neat) oral fluid.
Urine specimen. Urine collected from
an employee at the collection site for the
purpose of a drug test.
*
*
*
*
*
■ 3. In § 40.13, revise paragraphs (b), (c),
and (d), redesignate paragraphs (e) and
(f) as paragraphs (f) and (g), respectively,
add new paragraph (e), and add
paragraph (h).
The revisions and additions to read as
follows:
§ 40.13 How do DOT drug and alcohol
tests relate to non-DOT tests?
*
*
*
*
*
(b) DOT tests must take priority and
must be conducted and completed
before a non-DOT test is begun. When
conducting a urine DOT drug test, you
must discard any excess urine left over
from a DOT test and collect a separate
urine void for the subsequent non-DOT
test.
(c) Except as provided in paragraph
(d) of this section, you must not perform
any tests on DOT specimens other than
those tests specifically authorized by
this part or DOT agency regulations. For
example, you must not test a DOT
specimen for additional drugs. In
addition, a laboratory is prohibited from
making a DOT specimen available for a
DNA test or other types of specimen
identity testing.
(d) When a DOT urine drug test
collection is conducted as part of a
physical examination required by DOT
agency regulations, it is permissible to
conduct medical tests related to this
physical examination (e.g., for glucose)
on any specimen remaining in the
collection container after the DOT
portion has been sealed into the
specimen bottles.
(e) A non-DOT drug or alcohol test
administered, as part of a physical
examination, is not a DOT drug or
alcohol test for purposes of this part and
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related DOT agency drug and alcohol
testing rules, if that test was performed
to determine if an employee is
medically qualified for a license or
certificate. Consequently, the results of
such a test do not have consequences
under this part.
*
*
*
*
*
(h) No one is permitted to conduct a
DOT drug or alcohol test on an
individual who is not a DOT-regulated
employee, as defined by the DOT
agency regulations.
■ 4. In § 40.14, revise paragraph (b) and
add paragraphs (k) and (l) to read as
follows:
§ 40.14 What information must employers
provide to collectors?
*
*
*
*
*
(b) SSN or Employee ID No.’’;
*
*
*
*
*
(k) Specimen type to be collected (i.e.,
oral fluid or urine).
(l) If a urine specimen is to be
collected under direct observation.
■ 5. In § 40.21:
■ a. In paragraph (c)(2)(vii)(B), remove
the word ‘‘and’’ from the end;
■ b. Redesignate paragraph (c)(2)(vii)(C)
as paragraph (c)(2)(vii)(D); and
■ c. Add a new paragraph (c)(2)(vii)(C).
The addition reads as follows:
§ 40.21 May an employer stand down an
employee before the MRO has completed
the verification process?
*
*
*
*
*
(c) * * *
(2) * * *
(vii) * * *
(C) For a verified negative result, the
employee will not be required to submit
an alternative specimen for the same
testing action. For a cancelled result, the
employee could be required to submit
an alternative specimen on a recollection; and
*
*
*
*
*
■ 6. In § 40.23, revise paragraphs (f)
introductory text and (f)(1) and (5) to
read as follows:
§ 40.23 What actions do employers take
after receiving verified test results?
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*
*
*
*
*
(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
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observation (either an oral fluid
specimen or a urine specimen under
direct observation).
*
*
*
*
*
■ 7. In § 40.25, revise paragraph (a) to
read as follows:
§ 40.25 Must an employer check on the
drug and alcohol testing record of
employees it is intending to use to perform
safety-sensitive duties?
(a)(1) Yes, as an employer, you must,
after obtaining an employee’s written
consent, request the information about
the employee listed in paragraphs (b)
through (j) of this section. This
requirement applies only to employees
seeking to begin performing safetysensitive duties for you for the first time
(i.e., a new hire, an employee
transferring into a safety-sensitive
position). If the employee refuses to
provide this written consent, you must
not permit the employee to perform
safety-sensitive functions.
(2) If you are an employer regulated
by FMCSA, beginning January 6, 2023,
you are not required to comply with the
requirements of this section when
checking an employee’s testing history
with other employers regulated by
FMCSA. You must continue to comply
with the requirements of section 40.25
when checking an employee’s testing
history with employers regulated by a
DOT operating administration other
than FMCSA.
(3) If you are an employer regulated
by FMCSA, with a prospective
employee subject to drug and alcohol
testing with a DOT agency other than
FMCSA, you must continue to request
the information about the employee
listed in in paragraphs (b) through (j) of
this section. For example, if you are an
employer regulated by both FMCSA and
PHMSA, and you are hiring an
employee to perform functions
regulated by both DOT Agencies, then
you must query FMCSA’s Clearinghouse
to satisfy FMCSA’s requirements and
you must request the information listed
in in paragraphs (b) through (j) of this
section to satisfy PHMSA’s
requirements.
*
*
*
*
*
§ 40.26
[Amended]
8. In § 40.26, remove ‘‘Appendix H’’
and add in its place ‘‘Appendix J’’.
■
§ 40.29
[Removed]
9. Remove § 40.29.
10. In § 40.31,
a. Revise the section heading;
b. Revise paragraphs (b);
c. Redesignate paragraphs (c) and (d)
as paragraphs (d) and (e)
■ d. Add new paragraph (c);
■
■
■
■
■
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e. Revise newly redesignated
paragraph (d); and
■ f. Add paragraph (f).
The revisions and additions read as
follows:
■
§ 40.31 Who may collect specimens for
DOT drug testing?
*
*
*
*
*
(b) A urine collector must meet
training requirements of § 40.33.
(c) An oral fluid collector must meet
the training requirements of § 40.35.
(d) To avoid the appearance of a
conflict of interest, if you are the
immediate supervisor of the employee
being tested, you must not act as the
collector when that employee is tested,
unless no other collector is available
and you are permitted to do so under
DOT agency drug and alcohol
regulations.
*
*
*
*
*
(f) Employees are not permitted to be
their own collector.
(1) An employee who is a qualified
collector is not permitted to be their
own collector; another qualified
collector must perform the collection in
accordance with this part.
(2) To avoid a potential conflict of
interest, a collector must not be related
to the employee being tested (e.g.,
spouse, ex-spouse, relative) or a close
personal friend.
■ 11. In § 40.33, revise the section
heading, introductory text, and
paragraph (f) to read as follows:
§ 40.33 What training requirements must a
collector meet for urine collection?
To be permitted to act as a urine
collector in the DOT drug testing
program, you must meet each of the
requirements of this section:
*
*
*
*
*
(f) Error correction training. If you
make a mistake in the collection process
that causes a test to be cancelled (i.e., a
fatal or uncorrected flaw), you must
undergo error correction training. This
training must occur within 30 days of
the date you are notified of the error that
led to the need for retraining. Errors that
cause cancellation but occur outside the
collection process (e.g., when a
specimen is crushed or otherwise
damaged during the transportation
process, or is lost in transit), the
cancellation would not be the result of
an error by the collector during the
collection process and does not require
the collector to be retrained.
*
*
*
*
*
§ 40.35
[Redesignated as § 40.36]
12. Redesignate § 40.35 as § 40.36.
13. Add a new § 40.35 to read as
follows:
■
■
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§ 40.35 What training requirements must a
collector meet for oral fluid collection?
To be permitted to act as an oral fluid
collector in the DOT drug testing
program, you must meet each of the
requirements of this section:
(a) Basic information. You must be
knowledgeable about this part, the
current applicable guidelines and DOT
agency regulations applicable to the
employers for whom you perform
collections. DOT agency regulations,
guidelines, and other materials are
available from ODAPC (Department of
Transportation, 1200 New Jersey
Avenue SE, Washington, DC 20590,
202–366–3784, or on the ODAPC
website (https://
www.transportation.gov/odapc). You
must keep current on any changes to
these materials. You must subscribe to
the ODAPC list-serve at: https://
www.transportation.gov/odapc/getodapc-email-updates.
(b) Qualification training. You must
receive qualification training meeting
the requirements of this paragraph.
Qualification training must provide
instruction on the following subjects:
(1) The oral fluid collection device
manufacturer’s training for each device
the collector will use for DOT-regulated
collections;
(2) All steps necessary to complete a
collection correctly and the proper
completion and transmission of the
CCF;
(3) ‘‘Problem’’ collections (e.g.,
situations like ‘‘dry mouth’’ and
attempts to tamper with a specimen);
(4) Fatal flaws, correctable flaws, and
how to correct problems in collections;
and
(5) The collector’s responsibility for
maintaining the integrity of the
collection process, ensuring the privacy
of employees being tested, ensuring the
security of the specimen, and avoiding
conduct or statements that could be
viewed as offensive or inappropriate.
(c) Initial proficiency demonstration.
Following your completion of
qualification training under paragraph
(b) of this section, you must
demonstrate proficiency in collections
under this part by completing five
consecutive error-free mock collections.
(1) The five mock collections must
include one uneventful collection
scenario, one insufficient specimen
quantity scenario; one scenario in which
the employee has something in their
mouth that might interfere with the
collection; one scenario in which the
employee attempts to tamper with the
specimen; and one scenario in which
the employee refuses to sign the CCF.
(2) Another person must monitor and
evaluate your performance, in person or
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by a means that provides real-time
observation and interaction between
you and the qualified collector, who
must attest in writing that the mock
collections are ‘‘error-free.’’ This person
must be a qualified collector who has
demonstrated necessary knowledge,
skills, and abilities by—
(i) Regularly conducting DOT drug
test collections for a period of at least
one year;
(ii) Conducting collector training
under this part for at least one year; or
(iii) Successfully completing a ‘‘train
the trainer’’ course.
(d) Schedule for qualification training
and initial proficiency demonstration.
You must meet the requirements of
paragraphs (b) and (c) of this section
before you begin to perform collector
functions.
(e) Refresher training. No less
frequently than every five years from the
date on which you satisfactorily
complete the requirements of
paragraphs (b) and (c) of this section,
you must complete refresher training
that meets all the requirements of
paragraphs (b) and (c) of this section.
(f) Error correction training. If you
make a mistake in the collection process
that causes a test to be cancelled (i.e., a
fatal or uncorrected flaw), you must
undergo error correction training. This
training must occur within 30 days of
the date you are notified of the error that
led to the need for retraining.
(1) Error correction training must be
provided and your proficiency
documented in writing by a person who
meets the requirements of paragraph
(c)(2) of this section.
(2) Error correction training is
required to cover only the subject matter
area(s) in which the error that caused
the test to be cancelled occurred.
(3) As part of the error correction
training, you must demonstrate your
proficiency in the collection procedures
of this part by completing three
consecutive error-free mock collections.
The mock collections must include one
uneventful scenario and two scenarios
related to the area(s) in which your
error(s) occurred. The person providing
the training must monitor and evaluate
your performance and attest in writing
that the mock collections were ‘‘errorfree.’’
(g) Documentation. You must
maintain documentation showing that
you currently meet all requirements of
this section. You must provide this
documentation on request to DOT
agency representatives and to employers
and C/TPAs who are using or
negotiating to use your services.
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§ 40.37
■
11175
[Removed]
14. Remove § 40.37.
Subpart D [Amended]
15. In the heading for subpart D,
remove the word ‘‘Urine’’.
■
§ 40.41
■
[Redesignated as § 40.42]
16. Redesignate § 40.41 as § 40.42.
§ 40.45
[Redesignated as § 40.40]
17. Redesignate § 40.45 as § 40.40.
18. In newly redesignated § 40.40:
a. Revise the section heading and
paragraphs (a) and (b), (c) introductory
text, and (c)(1) through (4); and
■ b. Amend paragraph (d) by removing
the words ‘‘social security number
(SSN) or other employee identification
(ID) number’’ and adding in their place
‘‘SSN or Employee ID No.’’.
The revisions read as follows:
■
■
■
§ 40.40 What form is used to document a
DOT collection?
(a) The Federal Drug Testing Custody
and Control Form (CCF) must be used
to document every collection required
by the DOT drug testing program. You
may view this form on the Department’s
website (https://www.transportation.gov/
odapc) or the HHS website (https://
www.workplace.samhsa.gov).
(b) You must not use a non-Federal
form or an expired CCF to conduct a
DOT collection. As a laboratory, C/TPA
or other party that provides CCFs to
employers, collection sites, or other
customers, you must not provide copies
of an expired CCF to these participants.
You must also affirmatively notify these
participants that they must not use an
expired CCF.
(c) As a participant in the DOT drug
testing program, you are not permitted
to modify or revise the CCF except as
follows:
(1) You may include, in the area
outside the border of the form, other
information needed for billing or other
purposes necessary to the collection
process.
(2) The CCF must include the names,
addresses, telephone numbers and any
other appropriate contact information
(e.g., an email address of the employer
and the MRO), including the DER’s
name and contact information. All of
this information must be preprinted,
typed, or handwritten. Fax numbers
may be included, but are not required.
The MRO information must include the
physician’s name and address, as
opposed to only a generic clinic, health
care organization, or company name.
This information is required, and an
employer, collector, service agent or any
other party is prohibited from omitting
it. In addition, a C/TPA’s name, address,
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telephone and fax numbers, and any
other appropriate contact information
should be included, but is not required.
The employer may use a C/TPA’s
address in place of its own, but must
continue to include its name, telephone
and fax numbers, and any other
appropriate contact information.
(3) As an employer you may preprint
the box in Step 1–D of the CCF for the
DOT agency under whose authority the
test will occur.
(4) As a collector, you may use a CCF
with your name, address, telephone
number, and fax number preprinted, but
under no circumstances may you sign
the form before the collection event. If
a collection takes place at a clinic, the
actual address of the clinic should be
used, not a corporate address of the
collection company. If the collection
takes place onsite at the employer, the
employer’s address must be noted as the
collection site address. If the collection
takes place in a ‘‘mobile unit’’ or at an
accident site, the collector must enter
the actual location address of the
collection or as near an approximation
as possible. The collector must ensure
that the required collector telephone
number is the number that the
laboratory, MRO, or employer may use
to directly contact the individual
collector and/or the collector’s
supervisor.
*
*
*
*
*
§ 40.47
■
[Redesignated as § 40.41]
19. Redesignate § 40.47 as § 40.41.
§ 40.41
[Amended]
20. In newly redesignated § 40.41, in
paragraph (a), remove the word ‘‘urine’’
wherever it appears.
■ 21. In § 40.43, revise the section
heading to read as follows:
■
§ 40.43 What steps must operators of
collection sites and collectors take to
protect the security and integrity of urine
collections?
*
*
§ 40.49
■
*
*
*
[Redesignated as § 40.44]
22. Redesignate § 40.49 as § 40.44.
§ 40.51
[Redesignated as § 40.45]
23. Redesignate § 40.51 as § 40.45.
24. Add §§ 40.47, 40.48, 40.49, and
40.51 to subpart D to read as follows:
*
*
*
*
*
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■
■
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?
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40.51 What materials are used to send oral
fluid specimens to the laboratory?
*
*
*
*
*
§ 40.47 Where does an oral fluid collection
for a DOT drug test take place?
(a) An oral fluid collection for a DOT
drug test must take place in a collection
site meeting the requirements of this
section.
(b) If you are operating an oral fluid
collection site:
(1) You must ensure that it meets the
security requirements of § 40.48;
(2) The site may be a permanent or
temporary facility located either at the
work site or at a remote site;
(3) The site may be in a medical
facility, a mobile facility (e.g., a van), a
dedicated collection facility, or any
other location meeting the requirements
of this section; and
(4) You must have all necessary
personnel, materials, equipment, and
facilities that include privacy and
supervision to provide for the
collection, temporary storage, and
shipping of specimens to a laboratory,
and a suitable clean surface for writing.
(c) If a collection site is not accessible
and there is an immediate requirement
to collect an oral fluid specimen (e.g., an
accident investigation), another site may
be used for the collection, if the
collection is performed by a collector
who has been trained to collect oral
fluid specimens in accordance with this
part and the manufacturer’s procedures
for the collection device.
§ 40.48 What steps must operators of
collection sites and collectors take to
protect the security and integrity of oral
fluid collections?
(a) Collectors and operators of
collection sites must take the steps
listed in this section to prevent
unauthorized access that could
compromise the integrity of collections.
(b) As a collector, you must do the
following before each collection to deter
tampering with specimens:
(1) Ensure that access to collection
materials and specimens is effectively
restricted;
(2) Ensure that undetected access
(e.g., through a door not in your view)
is not possible; and
(3) Secure facility against access
during the procedure to ensure privacy
to the employee and prevent distraction
of the collector. Limited-access signs
must be posted.
(c) As a collector, you must take the
following additional steps to ensure
security during the collection process:
(1) To avoid distraction that could
compromise security, you are limited to
conducting a collection for only one
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employee at a time. However, during the
time one employee is in the period for
drinking fluids in a ‘‘dry mouth’’
situation (see § 40.72(b)(1)), you may
conduct a collection for another
employee as long as the employee with
‘‘dry mouth’’ remains supervised.
(2) To the greatest extent practicable,
keep an employee’s collection container
within view of both you and the
employee between the time the
employee has provided the oral fluid
specimen and the specimen is sealed.
(3) Ensure you are the only person in
addition to the employee who handles
the specimen before it is sealed with
tamper-evident seals.
(4) In the time between when the
employee gives you the specimen and
when you seal the specimen, remain
within the collection site.
(5) Maintain personal control over
each specimen and CCF throughout the
collection process.
(d) If you are operating a collection
site, you must implement a policy and
procedures to prevent unauthorized
personnel from entering any part of the
site in which oral fluid specimens are
collected or stored.
(1) Only employees being tested,
collectors and other collection site
workers, DERs, employee and employer
representatives authorized by the
employer (e.g., employer policy,
collective bargaining agreement), and
DOT agency representatives are
authorized persons for purposes of
paragraph (e) of this section.
(2) You must ensure that all
authorized persons are under the
supervision of a collector at all times
when permitted into the site.
(3) You or the collector may remove
any person who obstructs, interferes
with, or causes a delay in the collection
process.
(e) If you are operating a collection
site, you must minimize the number of
persons handling specimens.
§ 40.49 What materials are used to collect
oral fluid specimens?
For each DOT drug test, you must use
a collection device meeting the
requirements of appendix B of this part.
§ 40.51 What materials are used to send
oral fluid specimens to the laboratory?
(a) Except as provided in paragraph
(b) of this section, you must use a
shipping container that adequately
protects the specimen bottles from
damage in the transport of specimens
from the collection site to the
laboratory.
(b) You are not required to use a
shipping container if a laboratory
courier hand-delivers the specimens
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from the collection site to the
laboratory.
Subpart E—[Amended]
25. In the heading for subpart E,
remove the word ‘‘Urine’’.
■ 26. In § 40.61, revise the section
heading and paragraphs (a), (b)(1)
introductory text, (b)(3) and (4), (e), and
(f)(5)(i) to read as follows:
■
§ 40.61 What are the preliminary steps in
the drug testing collection process?
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*
*
*
*
*
(a) When a specific time for an
employee’s test has been scheduled, or
the collection site is at the employee’s
work site, and the employee does not
appear at the collection site at the
scheduled time, contact the DER to
determine the appropriate interval
within which the DER has determined
the employee is authorized to arrive. If
the employee’s arrival is delayed
beyond that time, you must notify the
DER that the employee has not reported
for testing. In a situation where a C/TPA
has notified an owner/operator or other
individual employee to report for testing
(other than for a pre-employment test)
and the employee does not appear, the
C/TPA must determine whether the
employee has refused to test (see
§ 40.191(a)(1)).
(b) * * *
(1) If the employee is also going to
take a DOT alcohol test, you must
ensure, to the greatest extent
practicable, that the alcohol test is
completed before the drug testing
collection process begins.
*
*
*
*
*
(3) You must not collect a specimen
from an unconscious employee to
conduct a drug test under this part.
(4) You must not catheterize a
conscious employee for purposes of a
urine test. However, you must inform an
employee who normally voids through
self-catheterization that the employee is
required to provide a specimen in that
manner. If an employee normally voids
through self-catheterization, but
declines to do so for the urine test, the
collector should notify the DER of the
circumstances, so that the employer can
determine whether the situation
constitutes a refusal to test by the
employee.
*
*
*
*
*
(e) Explain the basic collection
procedure to the employee, and notify
the employee that instructions for
completing the CCF can be found at the
HHS (www.samhsa.gov/workplace) and
DOT (www.transportation.gov/odapc)
websites.
(f) * * *
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(5) * * *
(i) Determine if the material appears
to be brought to the collection site with
the intent to alter the specimen, and, if
it is, either conduct a directly observed
urine collection using direct observation
procedures (see § 40.67) or an oral fluid
specimen collection, make a note on the
CCF and continue with collection
process; or
*
*
*
*
*
■ 27. In § 40.63, revise paragraph (a) to
read as follows:
§ 40.63 What steps does the collector take
in the collection process before the
employee provides a urine specimen?
*
*
*
*
*
(a) Ensure all items under Step 1 of
the CCF are complete and accurate (e.g.,
if Step 1.D is not checked, put a check
mark for the ‘‘Specify DOT Agency’’
under the authority of which the test
will take place; if the address where the
collection is actually taking place is not
in Step 1.G, update that.)
*
*
*
*
*
■ 28. In § 40.65, revise the section
heading and paragraphs (b)(5) and (6),
and (c)(1) to read as follows:
§ 40.65 What does the collector check for
when the employee presents a urine
specimen?
*
*
*
*
*
(b) * * *
(5) If the specimen temperature is
outside the acceptable range, you must
immediately conduct a new urine
collection using direct observation
procedures (see § 40.67) or an oral fluid
collection.
(6) In a case where a specimen is
collected under direct observation
because of the temperature being out of
range, you must process both the
original specimen and the specimen
collected using direct observation
(including oral fluid) and send the two
sets of specimens to their respective
laboratories. This is true even in a case
in which the original specimen has
insufficient volume and the temperature
is out of range. You must also, as soon
as possible, inform the DER and
collection site supervisor that a
collection took place under direct
observation and the reason for doing so.
*
*
*
*
*
(c) * * *
(1) If it is apparent from this
inspection that the employee has
tampered with the specimen (e.g., blue
dye in the specimen, excessive foaming
when shaken, or smell of bleach), you
must immediately conduct a new urine
collection using direct observation
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procedures (see § 40.67) or an oral fluid
collection.
*
*
*
*
*
■ 29. In § 40.67:
■ a. Revise the section heading;
■ b. In paragraph (c)(1), remove
‘‘paragraphs (a) and (b)’’ and add
‘‘paragraph (a)’’ in its place;
■ c. Revise paragraph (d)(2);
■ d. In paragraph (e)(2), remove
‘‘§ 40.67(b)’’ and add in its place
‘‘§ 40.67(c)(2) through (4)’’; and
■ e. Revise paragraph (g).
The revisions and additions read as
follows:
§ 40.67 When and how is a directly
observed urine collection conducted?
*
*
*
*
*
(d) * * *
(2) As the collector, you must explain
to the employee the reason, if known,
under this part for a directly observed
collection.
*
*
*
*
*
(g) As the collector, you must ensure
that the observer is the same gender as
the employee unless the observer is a
medical professional (e.g., nurse, doctor,
physician’s assistant, technologist,
technician licensed or certified to
practice in the jurisdiction in which the
collection takes place). The observer can
be a different person from the collector
and need not be a qualified collector.
■ 30. In § 40.69, revise the section
heading, redesignate paragraphs (a)
through (g) as paragraphs (b) through
(h); add new paragraph (a), and revise
newly redesignated paragraph (e) to
read as follows:
§ 40.69 How is a monitored urine
collection conducted?
(a) As stated in § 40.42(f)(2), if you are
conducting a urine collection in a multistall restroom and you cannot secure all
sources of water and other substances
that could be used for adulteration and
substitution, you must conduct a
monitored collection. This is the only
circumstance in which you must
conduct a monitored collection.
*
*
*
*
*
(e) As the monitor, you must not
watch the employee urinate into the
collection container. If you hear sounds
or make other observations indicating
an attempt to tamper with a specimen,
there must be an additional collection
under direct observation. See
§§ 40.63(e), 40.65(c), and 40.67(c)(2)(3)).
*
*
*
*
*
■ 31. In § 40.71, revise the section
heading and paragraph (b)(1) to read as
follows:
§ 40.71 How does the collector prepare the
urine specimen?
*
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(b) * * *
(1) Check the box on the CCF (Step 2)
indicating that this was a ‘‘Urine’’ and
‘‘Split’’ specimen collection.
*
*
*
*
*
§ 40.73
[Redesignated as § 40.79]
32. Redesignate § 40.73 as § 40.79.
33. Add new §§ 40.72 through 40.74
to read as follows:
*
*
*
*
*
■
■
Sec.
40.72 What steps does the collector take in
the collection process before the
employee provides an oral fluid
specimen?
40.73 How is an oral fluid specimen
collected?
40.74 How does the collector prepare the
oral fluid specimens?
*
*
*
*
*
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§ 40.72 What steps does the collector take
in the collection process before the
employee provides an oral fluid specimen?
(a) The collector requests that the
employee open the employee’s mouth,
and the collector inspects the oral cavity
to ensure that it is free of any items that
could impede or interfere with the
collection of an oral fluid specimen
(e.g., candy, gum, food, or tobacco) or
could be used to adulterate, substitute,
or alter the specimen.
(1) If the employee claims that he or
she has a medical condition that
prevents opening his or her mouth for
inspection, the collector follows the
procedure described in § 40.193(a).
(2) If the collector observes materials
brought to the collection site or the
employee’s conduct clearly indicates an
attempt to adulterate, substitute, or alter
the specimen, the collector must
terminate the collection, note the
circumstances in the Remarks section of
the CCF, and report the circumstances
to the DER, so that the employer can
decide whether to deem the situation a
refusal in accordance with § 40.191(a).
(b) If an item is present that might
impede or interfere with the collection
of an oral fluid specimen, the collector
must request the employee remove the
item.
(1) If the employee removes any item
that could impede or interfere with the
collection of an oral fluid specimen, the
employee has abnormally colored
saliva, or the employee claims to have
‘‘dry mouth,’’ then the collector must
give the employee water, up to 8
ounces, to rinse their mouth. The
employee may drink the water. The
collector must then wait 10 minutes
before beginning the specimen
collection.
(2) If the employee refuses to remove
the item or rinse, the collector must
terminate the collection, note the
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circumstances in the Remarks section of
the CCF, and report the information to
the DER to test as described in
§ 40.191(a)(8) (failure to cooperate), so
that the employer can decide whether to
deem the situation a refusal.
(c) If there is nothing of concern in the
oral cavity and no ‘‘dry mouth’’
condition, the collector starts the 10minute wait period and proceeds with
the steps below before beginning the
specimen collection as described in
§ 40.73.
(d) During the 10-minute wait:
(1) Review with the employee the
procedures required for a successful oral
fluid specimen collection as stated in
the manufacturer’s instructions for the
specimen collection device.
(2) Complete all items under Step 1 of
the CCF, and for clarification:
(i) In Step 1.D of the CCF, the
collector must put a check mark for the
‘‘Specify DOT Agency’’ under whose
authority the test will take place.
(ii) In Step 1.G of the CCF for the
‘‘Collection Site Address’’, the collector
must provide the address where the
collection took place.
(3) The collector will complete Step 2
of the CCF.
(i) Check ‘‘Oral Fluid’’,
(ii) For ‘‘Oral Fluid: Split Type’’ check
‘‘Subdivided,’’ and
(iii) Check ‘‘Each Device Within
Expiration Date?’’ after ensuring that
each device is within its expiration date.
(4) The collector must instruct the
employee to use hand sanitizer, put on
gloves, or wash and dry his or her
hands.
(e) The collector will provide, or the
employee may select, a specimen
collection device that is clean, unused,
and wrapped/sealed in original
packaging. The collector must open the
specimen collection device in view of
the employee.
(f) To the greatest extent practicable,
the collector must keep the employee’s
unwrapped collection device within
view of both you and the employee,
between the time the employee has
provided a specimen and the specimen
is sealed.
§ 40.73 How is an oral fluid specimen
collected?
(a) The collector must be present and
maintain visual contact with the
employee during the procedures
outlined in this section.
(b) The collector must note any
unusual behavior or appearance of the
employee on the CCF. If the collector
detects any conduct that clearly
indicates an attempt to tamper with a
specimen (e.g., an attempt to bring into
the collection site an adulterant or oral
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fluid substitute), the collector must
terminate the collection and report the
information to the DER so that the
employer can decide whether to deem
the situation a refusal.
(c) The employee and collector must
complete the specimen collection in
accordance with the manufacturer
instructions for the collection device.
(1) The collector must ensure the
collection is performed correctly (i.e.,
using the oral fluid device in the
manner described by its manufacturer),
that the collection device is working
properly, and that a sufficient specimen
volume is collected.
(i) If there is a failure to collect the
specimen, the collector must start the
process again, beginning with § 40.72(e),
using a new specimen collection device,
and noting the failed collection attempt
on the CCF.
(ii) If the employee states that he or
she is unable to provide an oral fluid
specimen during the collection process,
or after multiple failures to collect the
specimen, the collector follows the
procedure in § 40.193.
(2) The collector must inspect the
specimen for unusual color, presence of
foreign objects or material, or other
signs of tampering. If it is apparent from
this inspection that the employee has
tampered with the specimen, you must
conduct a new collection.
(i) Document any unusual
characteristics referenced above in the
Remarks section of the CCF.
(ii) Proceed with obtaining the new
oral fluid specimen from the donor.
Note on the new CCF that this is another
collection for the same testing event.
(i.e., Document in the remarks section
that this is Specimen 2 of 2 and include
the Specimen ID number of the other
specimen. Make the same notation on
the CCF of the suspect specimen.)
§ 40.74 How does the collector prepare the
oral fluid specimens?
(a) The collector follows the
manufacturer’s instructions to package
the split specimen collections.
(b) A volume of at least 1 mL of
undiluted (neat) oral fluid is collected
for the specimen designated as ‘‘Tube
A’’ and a volume of at least 1 mL of
undiluted (neat) oral fluid is collected
for the specimen designated as ‘‘Tube
B’’.
(c) In the presence of the employee,
the collector places a tamper-evident
seal from the CCF over the cap of each
specimen container, taking care not to
obstruct the expiration date on the
collection containers. The collector
must record the date of the collection on
the tamper-evident seals, after they are
affixed to the specimen containers.
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(d) The collector instructs the
employee to initial the tamper-evident
seals on each specimen container. If the
employee declines to do so, the
collector must note this in the
‘‘Remarks’’ line of the CCF (Step 2) and
complete the collection process.
■
§§ 40.75–40.78
■
[Reserved]
34. Add reserved §§ 40.75 through
40.78.
■ 35. In newly redesignated § 40.79,
revise paragraph (a)(1) to read as
follows:
■
*
*
*
*
(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.
*
*
*
*
*
[Amended]
36. In § 40.81, in paragraph (a),
remove the words ‘‘all testing’’ and add
in their place the words ‘‘each specimen
testing methodology performed’’.
§ 40.83
[Amended]
37. In § 40.83:
■ a. In paragraph (c)(7), remove the
word ‘‘urine’’ and add in its place the
word ‘‘specimen’’;
■ b. In paragraph (f) introductory text,
add the word ‘‘urine’’ before the word
‘‘specimen’’;
■ c. In paragraph (g) introductory text,
remove the cross-reference ‘‘40.45(a)’’
and adding in its place ‘‘40.40(a)’’;
■
§ 40.99
*
[Redesignated as § 40.84]
38. Redesignate § 40.99 as § 40.84.
[Amended]
39. In newly redesignated § 40.84:
a. In paragraph (a), remove the words
‘‘one year’’ and add, in their place, the
words ‘‘90 days’’;
■ b. In the first sentence of paragraph (c)
remove the words ‘‘one-year’’ and add
in their the words ‘‘90-day’’; and
■ c. In the last sentence of paragraph (c)
remove the word ‘‘year’’ and add in its
place the words ‘‘90-day period’’.
■
■
*
■
■
§ 40.84
§ 40.79 How is the collection process
completed?
§ 40.81
d. a. In paragraphs (h)(1)(i), (iii), and
(iv), remove the word ‘‘urine’’ and add
in its place the word ‘‘specimen’’; and
■ e. In paragraph (h)(2) removing the
cross-reference ‘‘(g)(1)’’ and adding in
its place ‘‘(h)(1)’’.
§ 40.85
■
§ 40.87
■
[Redesignated as § 40.82]
40. Redesignate § 40.85 as § 40.82.
[Redesignated as § 40.85]
41. Redesignate § 40.87 as § 40.85.
§ 40.89
47. In newly redesignated § 40.88,
revise the section heading to read as
follows:
§ 40.88 What criteria do laboratories use to
establish that a urine specimen is dilute or
substituted?
§ 40.95
*
*
[Redesignaed as § 40.87]
44. Redesignate § 40.91 as § 40.87.
45. In newly redesignated § 40.87,
revise the section heading, and in the
introductory text, remove ‘‘§ 40.89’’ and
add in its place ‘‘§ 40.86’’.
The revision reads as follows:
■
■
§ 40.87 What validity tests must
laboratories conduct on primary urine
specimens?
*
*
§ 40.93
■
*
*
*
§ 40.96
*
*
*
[Redesignated as § 40.90]
50. Redesignate existing § 40.96 as
§ 40.90.
■ 51. In newly redesignated § 40.90,
revise the section heading to read as
follows:
■
*
§ 40.91
[Redesignated § 40.89]
§ 40.89 What are the adulterant cutoff
concentrations for initial and confirmation
urine tests?
§ 40.86 What is urine validity testing, and
are laboratories required to conduct it?
*
*
48. Redesignate § 40.95 as § 40.89.
49. In newly redesignated § 40.89,
revise the section heading to read as
follows:
*
*
*
■
■
42. Redesignate § 40.89 as § 40.86.
43. In newly redesignated § 40.86,
revise the section heading to read as
follows:
*
*
§ 40.90 What criteria do laboratories use to
establish that a urine specimen is invalid?
[Redesignated as § 40.86]
■
■
*
*
*
[Redesignated as § 40.88]
46. Redesignate § 40.93 as § 40.88.
*
*
*
*
52. Add new §§ 40.91 through 40.93
to read as follows:
■
Sec.
*
*
*
*
40.91 What are the cutoff concentrations for
undiluted (neat) oral fluid drug tests?
40.92 What is oral fluid validity testing, and
are laboratories required to conduct it?
40.93 What validity tests must laboratories
conduct on primary oral fluid
specimens?
*
*
*
*
*
§ 40.91 What are the cutoff concentrations
for undiluted (neat) oral fluid drug tests?
As a laboratory, you must use the
cutoff concentrations displayed in table
1 to this section for initial and
confirmatory drug tests for oral fluid
specimens. All cutoff concentrations are
expressed in nanograms per milliliter
(ng/mL).
khammond on DSKJM1Z7X2PROD with PROPOSALS2
TABLE 1 TO § 40.91—ORAL FLUID TESTING CUTOFF CONCENTRATIONS
Initial test analyte
Initial test
cutoff 1
Confirmatory
test analyte
Marijuana (THC) 2 .............................................................................
Cocaine/Benzoylecgonine ................................................................
4 ng/mL 3 .......
15 ng/mL ........
Codeine/Morphine ............................................................................
30 ng/mL ........
Hydrocodone/Hydromorphone .........................................................
30 ng/mL ........
Oxycodone/Oxymorphone ................................................................
30 ng/mL ........
6-Acetylmorphine ..............................................................................
Phencyclidine ...................................................................................
Amphetamine/Methamphetamine .....................................................
4 ng/mL 3 .......
10 ng/mL ........
50 ng/mL ........
THC ..........................................................
Cocaine ....................................................
Benzoylecgonine ......................................
Codeine ....................................................
Morphine ..................................................
Hydrocodone ............................................
Hydromorphone ........................................
Oxycodone ...............................................
Oxymorphone ...........................................
6-Acetylmorphine .....................................
Phencyclidine ...........................................
Amphetamine ...........................................
Methamphetamine ....................................
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Confirmatory
test cutoff
concentration
2 ng/mL.
8 ng/mL.
8 ng/mL.
15 ng/mL.
15 ng/mL.
15 ng/mL.
15 ng/mL.
15 ng/mL.
15 ng/mL.
2 ng/mL.
10 ng/mL.
25 ng/mL.
25 ng/mL.
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TABLE 1 TO § 40.91—ORAL FLUID TESTING CUTOFF CONCENTRATIONS—Continued
Initial test analyte
Initial test
cutoff 1
Confirmatory
test analyte
MDMA 4/MDA 5 .................................................................................
50 ng/mL ........
MDMA ......................................................
MDA .........................................................
Confirmatory
test cutoff
concentration
25 ng/mL.
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).
§ 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.
khammond on DSKJM1Z7X2PROD with PROPOSALS2
§ 40.93 What validity tests must
laboratories conduct on primary oral fluid
specimens?
As a laboratory, if you conduct
validity testing under § 40.92, you must
conduct it in accordance with the
requirements of this section.
(a) You may test for a biomarker such
as albumin or immunoglobulin G (IgG)
or a test for a specific adulterant.
(b) You must follow the applicable
HHS requirements for any additional
validity testing.
■ 53. Revise § 40.97 to read as follows:
§ 40.97 What do laboratories report and
how do they report it?
(a) As a laboratory, when reporting a
result of any kind, you must report the
specimen type.
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(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
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the MRO at his or her place of business.
You must not report results to or
through the DER or a service agent (e.g.,
a C/TPA).
(1) Negative results: You must fax,
courier, mail, or electronically transmit
a legible image or copy of the fully
completed Copy 1 of the CCF which has
been signed by the certifying scientist,
or you may provide the laboratory
results report electronically (i.e.,
computer data file).
(i) If you elect to provide the
laboratory results report, you must
include the following elements, as a
minimum, in the report format:
(A) Laboratory name and address;
(B) Employer’s name (you may
include I.D. or account number);
(C) Medical review officer’s name;
(D) Specimen I.D. number;
(E) SSN or Employee ID from Step 1C
of the CCF, if provided;
(F) Reason for test, if provided;
(G) Collector’s name and telephone
number;
(H) Date of the collection;
(I) For oral fluid only, collection
device expiration date
(J) Date received at the laboratory;
(K) Date certifying scientist released
the results;
(L) Certifying scientist’s name;
(M) Results (e.g., positive,
adulterated) as listed in paragraph (a) of
this section; and
(N) Remarks section, with an
explanation of any situation in which a
correctable flaw has been corrected.
(ii) You may release the laboratory
results report only after review and
approval by the certifying scientist. It
must reflect the same test result
information as contained on the CCF
signed by the certifying scientist. The
information contained in the laboratory
results report must not contain
information that does not appear on the
CCF.
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(iii) The results report may be
transmitted through any means that
ensures accuracy and confidentiality.
You, as the laboratory, together with the
MRO, must ensure that the information
is adequately protected from
unauthorized access or release, both
during transmission and in storage (e.g.,
see § 40.351).
(2) Non-negative and Rejected for
Testing results: You must fax, courier,
mail, or electronically transmit a legible
image or copy of the fully completed
Copy 1 of the CCF that has been signed
by the certifying scientist. In addition,
you may provide the electronic
laboratory results report following the
format and procedures set forth in
paragraphs (b)(1)(i) and (ii) of this
section.
(d) In transmitting laboratory results
to the MRO, you, as the laboratory,
together with the MRO, must ensure
that the information is adequately
protected from unauthorized access or
release, both during transmission and in
storage. If the results are provided by fax
or other electronic means, the electronic
communication must be accessible only
to authorized individuals.
(e) You must transmit test results to
the MRO in a timely manner, preferably
the same day that review by the
certifying scientist is completed.
(f)(1) You must provide quantitative
values for confirmed positive drug test
results to the MRO.
(2) You must provide numerical
values that support the adulterated
(when applicable) or substituted result,
without a request from the MRO.
(3) You must also provide the MRO
numerical values for creatinine and
specific gravity for the negative-dilute
urine test result, without a request from
the MRO.
(g) You must provide quantitative
values for confirmed positive morphine
and/or codeine urine results at or below
15,000 ng/mL, and for confirmed
positive morphine or codeine oral fluid
results at or below 150 ng/mL.
■ 54. In § 40.111, revise paragraphs (a)
and (d) to read as follows:
khammond on DSKJM1Z7X2PROD with PROPOSALS2
§ 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
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specimen type for which you conduct
testing to DOT on a semi-annual basis.
The summary must be sent by January
31 of each year for July 1 through
December 31 of the prior year. It must
be sent by July 31 of each year for
January 1 through June 30 of the current
year. If you withdraw or are removed
from NLCP’s laboratory certification
during a reporting period, you must
provide the aggregate statistical
summary to the DOT-regulated
employers and to ODAPC for the last
period in which you conducted DOTregulated testing.
§ 40.121
[Amended]
55. In § 40.121, in paragraph (c)(1)(i),
remove the word ‘‘urine’’.
■
§ 40.123
[Amended]
56. In § 40.123, in paragraph (c),
remove the words ‘‘invalid drug tests
results’’ and add in their place ‘‘invalid
results’’.
■
§ 40.127
[Amended]
57. In § 40.127, in paragraph (g)(2),
add the words ‘‘of all specimen types
combined’’ before the words ‘‘in any
quarter’’.
■
§ 40.129
[Amended]
58. In § 40.129, in paragraph (a)
introductory text, remove the words
‘‘invalid drug tests’’ and add in their
place ‘‘invalid results’’; in paragraph (d),
remove ‘‘drug test report’’ and add
‘‘result’’ in its place.
■
§ 40.135
[Amended]
59. In § 40.135, in paragraph (d)
introductory text, remove the word
‘‘test’’ and add in its place the word
‘‘result’’.
■ 60. In § 40.139, revise paragraph (b),
and in paragraph (c), remove the word
‘‘urine’’.
The revision reads as follows:
■
§ 40.139 On what basis does the MRO
verify text results involving 6acetylmorphine, codeine, and morphine?
*
*
*
*
*
(b) In the absence of 6–AM, if the
laboratory confirms the presence of
either morphine or codeine equal to or
above 15,000 ng/mL (in urine) or equal
to or above 150 ng/mL (in oral fluid),
you must verify the test result as
positive, unless the employee presents a
legitimate medical explanation for the
presence of the drug or drug metabolite
in his or her system, as in the case of
other drugs (see § 40.139). Consumption
of food products (e.g., poppy seeds)
must not be considered a legitimate
medical explanation for the employee
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11181
having morphine or codeine at these
concentrations.
*
*
*
*
*
§ 40.145
[Amended]
61. In § 40.145, in paragraph (g)(3),
remove the word ‘‘urine’’ and add the
word ‘‘drug’’ in its place; and in
paragraph (h) introductory text, add the
word ‘‘urine’’ before the word ‘‘result’’.
■ 62. In § 40.151, revise paragraphs (a),
(b), (g), and (i) to read as follows:
■
§ 40.151 What are MROs prohibited from
doing as part of the verification process?
*
*
*
*
*
(a) You must not consider any
evidence (verbal or written information)
from any drug tests that are not
collected or tested in accordance with
this part. For example, if an employee
tells you he went to his own physician,
provided a urine specimen, sent it to a
laboratory, and received a negative test
result, you are required to ignore this
test result.
(b) It is not your function to make
decisions about factual disputes
between the employee and the collector
concerning matters occurring at the
collection site that are not reflected on
the CCF (e.g., concerning allegations
that the collector left the area or left
open collection containers where other
people could access them.)
*
*
*
*
*
(g) You must not accept an assertion
that there is a legitimate medical
explanation for the presence of PCP, 6–
AM, MDMA, or MDA in a specimen.
*
*
*
*
*
(i) You must not accept, as a
legitimate medical explanation for a
substituted specimen, an assertion that
an employee can produce a urine
specimen for which the creatinine level
is below the laboratory’s limit of
detection. There are no physiological
means through which a person can
produce a urine specimen having this
characteristic.
■ 63. In § 40.159, revise paragraphs
(a)(1) and (a)(5)(ii) to read as follows:
§ 40.159 What does the MRO do when a
drug test result is invalid?
(a) * * *
(1) Discuss the laboratory results with
a certifying scientist to determine if the
primary specimen should be tested at
another HHS-certified laboratory. If the
laboratory did not contact you as
required by §§ 40.91(e) and 40.96(b),
you must contact the laboratory.
*
*
*
*
*
(5) * * *
(ii) Report to the DER that the test is
cancelled, the reason for cancellation,
and that a second collection must take
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place immediately under direct
observation. Recommend to the
employer that an alternative specimen
should be collected if practicable (e.g.,
oral fluid, if the specimen was urine).
*
*
*
*
*
■ 64. In § 40.163, in paragraph (c)(2),
remove the words ‘‘donor SSN or
employee ID number’’ and add in their
place the words ‘‘SSN or employee ID
No.’’ and revise paragraph (e).
The revision reads as follows:
§ 40.163 How does the MRO report drug
test results?
*
*
*
*
*
(e) If you use a written report as
provided in paragraph (c) of this section
to report results, you must retain a copy
of the written report. If you use the
electronic data file to report negatives,
as provided in paragraph (d) of this
section, you must retain a retrievable
copy of that report in a format suitable
for inspection and audit by a DOT
representative. In either case, you must
keep the completed Copy 2 of the CCF.
When completing Copy 2, either the
MRO must sign and date it (for both
negatives and non-negatives) or MRO
staff must stamp and date it (for
negatives only).
*
*
*
*
*
■ 65. In § 40.177, revise paragraphs (a)
through (c) to read as follows:
§ 40.177 What does the second laboratory
do with the split specimen when it is tested
to reconfirm the presence of a drug or drug
metabolite?
khammond on DSKJM1Z7X2PROD with PROPOSALS2
*
*
*
*
*
(a) As the laboratory testing the split
specimen, you must test the split
specimen for the drug(s)/drug
metabolite(s) confirmed in the primary
specimen.
(b) You must conduct this test
without regard to the cutoff
concentrations of § 40.85 or § 40.91, as
applicable.
(c) If the test fails to reconfirm the
presence of the drug(s)/drug
metabolite(s) that were reported in the
primary specimen, you must conduct
validity tests in an attempt to determine
the reason for being unable to reconfirm
the presence of the drug(s)/
metabolite(s). You should conduct the
same validity tests as you would
conduct on a primary specimen set forth
in § 40.87 or § 40.93, as applicable.
*
*
*
*
*
§ 40.179
[Amended]
66. In § 40.179, in paragraph (a),
remove ‘‘§ 40.95’’ and add in its place
‘‘§ 40.89 or § 40.93, as applicable’’.
■ 67. Revise § 40.181 to read as follows:
■
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§ 40.181 What does the second laboratory
do with the split specimen when it is tested
to reconfirm a substituted test result?
As the laboratory testing a urine split
specimen, you must test the split
specimen using the confirmatory tests
for creatinine and specific gravity, using
the criteria set forth in § 40.88.
§ 40.187
[Amended]
68. In § 40.187, in paragraphs (b)(1),
(c)(1)(iii), and (c)(2)(iii), remove
‘‘Appendix D’’ and add in its place
‘‘appendix F’’, and in paragraph (e)(3),
remove ‘‘appendix D’’ and add in its
place ‘‘appendix F’’.
■ 69. In § 40.191, revise paragraphs
(a)(2) through (9) and (d)(1) to read as
follows:
■
§ 40.191 What is a refusal to take a DOT
drug test, and what are the consequences?
(a) * * *
(2) Fail to remain at the testing site
until the testing process is complete.
Provided that an employee who leaves
the collection site before the testing
process commences (see § 40.63(c) or
§ 40.72(e), as applicable) for a preemployment test is not deemed to have
refused to test;
(3) Fail to provide a specimen for any
drug test required by this part or DOT
agency regulations. Provided that an
employee who does not provide a
specimen because he or she has left the
testing site before the testing process
commences (see § 40.63(c) or § 40.72(e),
as applicable) for a pre-employment test
is not deemed to have refused to test;
(4) In the case of a directly observed
or monitored urine collection in a drug
test, fail to permit the observation or
monitoring of an employee’s provision
of a specimen (see §§ 40.67(m) and
40.69(g));
(5) Fail to provide a sufficient amount
of specimen when directed, and it has
been determined, through a required
medical evaluation, that there was no
adequate medical explanation for the
failure (see § 40.193(d)(2));
(6) Fail or decline to take an
additional drug test the employer or
collector has directed you to take (see,
for instance, § 40.197(b) as applicable);
(7) Fail to undergo a medical
examination or evaluation, as directed
by the MRO as part of the verification
process, or as directed by the DER under
§ 40.193(c). In the case of a preemployment drug test, the employee is
deemed to have refused to test on this
basis only if the pre-employment test is
conducted following a contingent offer
of employment. If there was no
contingent offer of employment, the
MRO will cancel the test;
(8) Fail to cooperate with any part of
the testing process (e.g., refuse to empty
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pockets when directed by the collector,
behave in a confrontational way that
disrupts the collection process, fail to
wash hands after being directed to do so
by the collector, fail to remove objects
from mouth, fail to permit inspection of
the oral cavity, or fail to complete a
rinse when requested);
(9) For an observed urine collection,
fail to follow the observer’s instructions
to raise your clothing above the waist,
lower clothing and underpants, and to
turn around to permit the observer to
determine if you have any type of
prosthetic or other device that could be
used to interfere with the collection
process;
*
*
*
*
*
(d) * * *
(1) As the collector, you must note the
refusal in the ‘‘Remarks’’ line (Step 2),
and sign and date the CCF. The collector
does not make the final decision about
whether the employee’s conduct
constitutes a refusal to test; the
employer has the sole responsibility to
decide whether a refusal occurred, as
stated in § 40.355(i), the employer has a
non-delegable duty to make the decision
about whether the employee has refused
to test.
*
*
*
*
*
■ 70. Revise § 40.193 to read as follows:
§ 40.193 What happens when an employee
does not provide a sufficient amount of
specimen for a drug test?
(a) If an employee does not provide a
sufficient amount of specimen to permit
a drug test (i.e., 45 mL of urine in a
single void, or 2 mL oral fluid in a
single sampling, as applicable) you, as
the collector, must provide another
opportunity to the employee to do so.
This can be done using the same
specimen type as the original collection
or, if you are qualified to collect an
alternative specimen, you may use an
alternative specimen collection for this
purpose.
(b)(1) As the collector, you must do
the following when collecting a urine
specimen:
(i) Discard the insufficient specimen,
except where the insufficient specimen
was out of temperature range or showed
evidence of adulteration or tampering
(see § 40.65(b) and (c)).
(ii) Urge the employee to drink up to
40 ounces of fluid, distributed
reasonably through a period of up to
three hours, or until the individual has
provided a sufficient urine specimen,
whichever occurs first. It is not a refusal
to test if the employee declines to drink.
Document on the Remarks line of the
CCF (Step 2), and inform the employee
of the time at which the three-hour
period begins and ends.
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(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.
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(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
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11183
the basis for them to the MRO. You
must not include in this statement
detailed information on the employee’s
medical condition beyond what is
necessary to explain your conclusion.
(g) If, as the referral physician making
this evaluation in the case of a preemployment, return-to-duty, or followup test, you determine that the
employee’s medical condition is a
serious and permanent or long-term
disability that is highly likely to prevent
the employee from providing a
sufficient amount of specimen for a very
long or indefinite period of time, you
must set forth your determination and
the reasons for it in your written
statement to the MRO. As the MRO,
upon receiving such a report, you must
follow the requirements of § 40.195,
where applicable.
(h) As the MRO, you must seriously
consider and assess the referral
physician’s recommendations in making
your determination about whether the
employee has a medical condition that
has, or with a high degree of probability
could have, precluded the employee
from providing a sufficient amount of
specimen. You must report your
determination to the DER in writing as
soon as you make it.
(i) As the employer, when you receive
a report from the MRO indicating that
a test is cancelled as provided in
paragraph (d)(1) of this section, you take
no further action with respect to the
employee. If the test reason was
‘random’, the employee remains in the
random testing pool.
■ 71. In § 40.195, revise the section
heading to read as follows:
§ 40.195 What happens when an individual
is unable to provide a sufficient amount of
specimen for a pre-employment, follow-up,
or return-to-duty test because of a
permanent or long-term medical condition?
*
*
*
*
*
72. In § 40.197, revise the section
heading to read as follows:
■
§ 40.197 What happens when an employer
receives a report of a dilute urine
specimen?
*
*
*
*
*
73. In § 40.199, revise paragraph (b)(7)
and add paragraph (b)(8) to read as
follows:
■
§ 40.199 What problems always cause a
drug test to be cancelled?
*
*
*
*
*
(b) * * *
(7) Because of leakage or other causes,
there is an insufficient amount of
specimen in the primary specimen
bottle for analysis and the specimens
cannot be re-designated (see § 40.83(h)).
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(8) For an oral fluid collection, the
collector used an expired device at the
time of collection.
*
*
*
*
*
■
§ 40.201
§ 40.261 What is a refusal to take an
alcohol test?
[Amended]
74. In § 40.201, in paragraph (f),
remove the word ‘‘urine’’ and add in its
place the word ‘‘specimen’’.
■ 75. In § 40.207, add paragraph (d) to
read as follows:
■
§ 40.207 What is the effect of a cancelled
drug test?
*
*
*
*
*
(d) If a test is cancelled, only the MRO
who cancelled the test can reverse the
cancellation and must do so within 60
days of the cancellation. After 60 days,
the MRO who cancelled the test cannot
reverse the cancellation without the
permission of ODAPC. For example, if
an MRO cancels a test because the MRO
did not receive a copy of the CCF, but
later receives a copy of the CCF, the
MRO may reverse the decision to cancel
the test within 60 days. After 60 days,
the MRO must contact ODAPC for
permission to reverse the cancellation.
A laboratory is not authorized to reverse
a cancellation due to a fatal flaw, as
described in § 40.199.
§ 40.209
[Amended]
76. In § 40.209, in paragraph (b)(7),
remove ‘‘§ 40.41’’ and add in its place
‘‘§ 40.42’’.
■ 77. Revise § 40.210 to read as follows:
■
khammond on DSKJM1Z7X2PROD with PROPOSALS2
§ 40.210 What kinds of drug tests are
permitted under the regulations?
Both urine and oral fluid specimens
are authorized for collection and testing
under this part. An employer can use
one or the other, but not both at the
beginning of the testing event. For
example, if an employee is sent for a
test, either a urine or oral fluid
specimen can be collected, but not both
simultaneously. However, if there is a
problem in the collection that
necessitates a second collection (e.g.,
insufficient quantity of urine,
temperature out of range, or insufficient
saliva), then a different specimen type
could be chosen by the employer and its
service agent to complete the collection
process for the testing event. Only urine
and oral fluid specimens screened and
confirmed at HHS-certified laboratories
(see § 40.81) are allowed for drug testing
under this part. Point-of-collection
(POC) urine, POC oral fluid drug testing,
hair testing, or instant tests are not
authorized.
§ 40.225
[Amended]
78. In § 40.225, in paragraph (a),
remove ‘‘Appendix G’’ and add in its
place ‘‘appendix I’’.
■
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79. In § 40.261, redesignate paragraph
(c) as paragraph (c)(1) and add
paragraph (c)(2).
The addition reads as follows.
*
*
*
*
*
(c) * * *
(2) As the BAT or STT, you must note
the refusal in the ‘‘Remarks’’ line (Step
3), and sign and date the ATF. The BAT
or STT does not make the final decision
about whether the employee’s conduct
constitutes a refusal to test; the
employer must decide whether a refusal
occurred, as stated in § 40.355(i), the
employer has a non-delegable duty to
make the decision about whether the
employee has refused to test.
§ 40.283
[Amended]
80. In § 40.283, in paragraph (c),
remove ‘‘Appendix E’’ and add in its
place ‘‘appendix G’’.
■
§ 40.285
[Amended]
81. In § 40.285, in paragraph (b),
remove the word ‘‘urine’’.
■ 82. In § 40.291, revise paragraphs
(a)(1) and (3) to read as follows:
■
§ 40.291 What is the role of the SAP in the
evaluation, referral, and treatment process
of an employee who has violated DOT
agency drug and alcohol testing
regulations?
(a) * * *
(1) Making a clinical assessment and
evaluation to determine what assistance
is needed by the employee to resolve
problems associated with alcohol and/or
drug use. This assessment or evaluation
may be performed face-to-face or
remotely. If a SAP is not prohibited
from using technology within the
parameters of the SAP’s State-issued
license, a remote evaluation must be
must be conducted in accordance with
the following criteria:
(i) The technology must permit realtime audio and visual interaction
between the SAP and the employee; and
(ii) The quality of the technology (e.g.,
speed of the internet connection and
clarity of the video display) must be
sufficient to allow the SAP to gather all
the visual and audible information the
SAP would otherwise gather in a faceto-face interaction, while providing
security to protect the confidentiality of
the communication.
*
*
*
*
*
(3) Conducting an evaluation to
determine if the employee has actively
participated in the education and/or
treatment program and has
demonstrated successful compliance
with the initial assessment and
evaluation recommendations. This
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Fmt 4701
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assessment or evaluation may be
performed face-to-face or remotely. A
remote evaluation must be made by
means that meet the criteria in
paragraphs (a)(1)(i) and (ii) of this
section.
*
*
*
*
*
§ 40.293
[Amended]
83. In § 40.293, in paragraph (a),
remove the words ‘‘face-to-face’’ and
after the words ‘‘clinical evaluation,’’
add the words ‘‘meeting the
requirements of § 40.291(a)(1)’’.
■
§ 40.301
[Amended]
84. In § 40.301, in paragraph (b)(2),
remove the words ‘‘face-to-face’’ and
after the words ‘‘clinical interview’’, add
the words ‘‘meeting the requirements of
§ 40.291(a)(1)’’.
■
§ 40.311
[Amended]
85. In § 40.311, in paragraphs (c)(4),
(d)(4), and (e)(4), after the word
‘‘Date(s)’’ add the words ‘‘and format
(i.e., face-to-face or remote)’’; in
paragraphs (c)(1), (d)(1), and (e)(1)
remove ‘‘SSN’’ and add in its place
‘‘SSN or employee ID No.’’.
■ 86. In § 40.327:
■ a. In paragraph (a), remove the
reference ‘‘paragraph (c)’’ and add in its
place ‘‘paragraph (d)’’;
■ b. Redesignate paragraph (c) as
paragraph (d); and
■ c. Add a new paragraph (c).
The addition reads as follows:
■
§ 40.327 When must the MRO report
medical information gathered in the
verification process?
*
*
*
*
*
(c) The MRO must not report such
medical information using the CCF.
Instead, the MRO must provide the
information in a separate written
communication (e.g., letter, secure
email). The information must state the
specific nature of the MRO’s safety
concern (e.g., the effects of a medication
the employee is taking, the employee’s
underlying medical condition which the
employee disclosed to the MRO).
*
*
*
*
*
§ 40.345
[Amended]
87. In § 40.345, in paragraph (b),
remove ‘‘Appendix F’’ and add in its
place ‘‘appendix H’’.
■
§ 40.355
[Amended]
88. In § 40.355, in Example 3 to
paragraph (n), remove the word ‘‘urine’’.
■
§ 40.365
[Amended]
89. In § 40.365, in paragraph (b)(8),
remove the words ‘‘face to face
interviews’’ and add in their place the
■
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words ‘‘without interviews meeting the
requirements of § 40.291(a)(1)’’.
Appendices E Through H to Part 40
[Redesignated as Appendices G
Through J to Part 40]
■ 90. Redesignate appendices E through
H to part 40 as appendices G through J
to part 40.
Appendix C to Part 40 [Redesignated as
Appendix E to Part 40]
■ 91. Redesignate appendix C to part 40
as appendix E to part 40.
Appendix C to Part 40 [Reserved]
92. Add reserved appendix C to part
40.
■
Appendix D to Part 40 [Redesignated as
Appendix F to Part 40]
■ 93. Redesignate appendix D to part 40
as appendix F to part 40.
Appendix B to Part 40 [Redesignated as
Appendix D to Part 40]
■ 94. Redesignate appendix B to Part 40
as appendix D to part 40.
■ 95. Add new appendix B to part 40 to
read as follows:
khammond on DSKJM1Z7X2PROD with PROPOSALS2
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
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the CCF fit with no damage to the seal when
the employee initials it, and the seal overlap
will not conceal printed information.
2. Instructions
a. Must include the manufacturer’s
instructions within the device’s packaging.
The instructions must provide sufficient
detail to allow for an error-free collection
when instructions are followed.
3. Leak-Resistant Plastic Bag
a. Must have two sealable compartments or
pouches that are leak-resistant; one large
enough to hold two specimen bottles and the
other large enough to hold the CCF
paperwork.
b. The sealing methodology must be such
that once the compartments are sealed, any
tampering or attempts to open either
compartment will be evident.
4. Absorbent Material
Each kit must contain enough absorbent
material to absorb the entire contents of both
specimen bottles. Absorbent material must be
designed to fit inside the leak-resistant
plastic bag pouch into which the specimen
bottles are placed.
5. Shipping Container
a. Must be designed to adequately protect
the specimen bottles from damage during
shipment of the specimens from the
collection site to the laboratory (e.g., standard
courier box, small cardboard box, plastic
container).
b. May be made available separately at
collection sites rather than being part of an
actual collection device sent to collection
sites.
c. A shipping container is not necessary if
a laboratory courier hand-delivers the
specimen bottles in the leak-resistant plastic
bags from the collection site to the laboratory.
96. Revise the newly redesignated
appendix D to read as follows:
■
Appendix D to Part 40—DOT Drug
Testing Semi-Annual Laboratory
Report to Employers
The following items are required on each
laboratory report:
Reporting Period: (inclusive dates)
Laboratory Identification: (name and address)
Employer Identification: (name; may include
Billing Code or ID code)
C/TPA Identification: (where applicable;
name and address)
A. Urine Specimens
1. Urine Specimen Results Reported (total
number) By Test Reason
(a) Pre-employment (number)
(b) Post-Accident (number)
(c) Random (number)
(d) Reasonable Suspicion/Cause (number)
(e) Return-to-Duty (number)
(f) Follow-up (number)
(g) Type of Test Not Noted on CCF
(number)
2. Urine Specimens Reported
(a) Negative (number)
(b) Negative and Dilute (number)
3. Urine Specimens Reported as Rejected
for Testing (total number) By Reason
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11185
(a) Fatal flaw (number)
(b) Uncorrected Flaw (number)
4. Urine Specimens Reported as Positive
(total number) By Drug
(a) Marijuana Metabolite (number)
(b) Cocaine Metabolite (number)
(c) Opioids (number)
(1) Codeine (number)
(2) Morphine (number)
(3) 6–AM (number)
(4) Hydrocodone (number)
(5) Hydromorphone (number)
(6) Oxycodone (number)
(7) Oxymorphone (number)
(d) Phencyclidine (number)
(e) Amphetamines (number)
(1) Amphetamine (number)
(2) Methamphetamine (number)
(3) MDMA (number)
(4) MDA (number)
5. Urine Adulterated (number)
6. Urine Substituted (number)
7. Urine Invalid Result (number)
B. Oral Fluid Specimens
1. Oral Fluid Specimen Results Reported
(total number) By Test Reason
(a) Pre-employment (number)
(b) Post-Accident (number)
(c) Random (number)
(d) Reasonable Suspicion/Cause (number)
(e) Return-to-Duty (number)
(f) Follow-up (number)
(g) Type of Test Not Noted on CCF
(number)
2. Oral Fluid Specimens Reported
(a) Negative (number)
(b) Negative and Dilute (number)
3. Oral Fluid Specimens Reported as
Rejected for Testing (total number) By
Reason
(a) Fatal flaw (number)
(b) Uncorrected Flaw (number)
4. Oral Fluid Specimens Reported as
Positive (total number) By Drug
(a) Marijuana (number)
(b) Cocaine and/or Cocaine Metabolite
(number)
(c) Opioids (number)
(1) Codeine (number)
(2) Morphine (number)
(3) 6–AM (number)
(4) Hydrocodone (number)
(5) Hydromorphone (number)
(6) Oxycodone (number)
(7) Oxymorphone (number)
(d) Phencyclidine (number)
(e) Amphetamines (number)
(1) Amphetamine (number)
(2) Methamphetamine (number)
(3) MDMA (number)
(4) MDA (number)
5. Oral Fluid Adulterated (number)
6. Oral Fluid Substituted (number)
7. Oral Fluid Invalid Result (number)
97. Revise newly redesignated
appendix E to part 40 to read as follows:
■
Appendix E to Part 40—Drug Testing
Semi-Annual Laboratory Report to DOT
Mail, fax, or email to: U.S. Department of
Transportation, Office of Drug and Alcohol
Policy and Compliance, 1200 New Jersey
Avenue SE, Washington, DC 20590, Fax:
(202) 366–3897. Email: ODAPCWebMail@
dot.gov.
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khammond on DSKJM1Z7X2PROD with PROPOSALS2
The following items are required on each
report:
Reporting Period: (inclusive dates)
Laboratory Identification: (name and address)
1. Specimen Type:
—oral fluid or urine
2. DOT agency
—FMCSA, FAA, FRA, FTA, PHMSA, or
USCG
3. Test Reason
—Pre-Employment, Random, Reasonable
Suspicion/Cause, Post-Accident, Returnto-Duty, Other, and Follow-up
A. DOT Specimen Results Reported (total
number)
B. Negative Results Reported (total
number)
1. Negative (number)
2. Negative-Dilute (number)
C. Rejected for Testing Results Reported
(total number) By Reason
1. Fatal flaw (number)
2. Uncorrected Flaw (number)
D. Positive Results Reported (total number)
By Drug
1. Marijuana or Marijuana Metabolite
(number)
2. Cocaine and/or Cocaine Metabolite
(number)
3. Opioids (number)
a. Codeine (number)
b. Morphine (number)
c. 6–AM (number)
d. Hydrocodone (number)
e. Hydromorphone (number)
f. Oxycodone (number)
g. Oxymorphone (number)
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4. Phencyclidine (number)
5. Amphetamines (number)
a. Amphetamine (number)
b. Methamphetamine (number)
c. MDMA (number)
d. MDA (number)
E. Adulterated Results Reported (total
number) By Reason (number)
F. Substituted Results Reported (total
number)
G. Invalid Results Reported (total number)
By Reason (number)
98. Revise newly redesignated
appendix F to read as follows:
■
Appendix F to Part 40—Report Format:
Split Specimen Failure To Reconfirm
Mail, fax, or submit electronically to: U.S.
Department of Transportation, Office of Drug
and Alcohol Policy and Compliance, 1200
New Jersey Avenue SE, Washington, DC
20590, Fax: (202) 366–3897.
Submit Electronically: https://
www.transportation.gov/odapc/mro-splitspecimen-cancellation-notification.
The following items are required on each
report:
1. MRO name, address, phone number, and
fax number.
2. Collection site name, address, and phone
number.
3. Date of collection.
4. Specimen I.D. number.
5. Specimen type.
6. Laboratory accession number.
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7. Primary specimen laboratory name,
address, and phone number.
8. Date result reported or certified by
primary laboratory.
9. Split specimen laboratory name,
address, and phone number.
10. Date split specimen result reported or
certified by split specimen laboratory.
11. Primary specimen results (e.g., name of
drug, adulterant) in the primary specimen.
12. Reason for split specimen failure-toreconfirm result (e.g., drug or adulterant not
present, specimen invalid, split not collected,
insufficient volume).
13. Actions taken by the MRO (e.g.,
notified employer of failure to reconfirm and
requirement for re-collection).
14. Additional information explaining the
reason for cancellation.
15. Name of individual submitting the
report (if not the MRO).
Appendix H to Part 40 [Amended]
99. In newly redesignated appendix
H, under ‘‘Drug Testing Information,’’
remove the reference ‘‘§ 40.129(d)’’ and
add in its place the reference
‘‘§ 40.129(e)’’.
■
Signed in Washington, DC, on January 19,
2022.
Peter Paul Montgomery Buttigieg,
Secretary of Transportation.
[FR Doc. 2022–02364 Filed 2–25–22; 8:45 am]
BILLING CODE 4910–9X–P
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Agencies
[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 https://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 https://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 (https://www.transportation.gov/odapc) or the HHS website (https://www.workplace.samhsa.gov).
(b) You must not use a non-Federal form or an expired CCF to
conduct a DOT collection. As a laboratory, C/TPA or other party that
provides CCFs to employers, collection sites, or other customers, you
must not provide copies of an expired CCF to these participants. You
must also affirmatively notify these participants that they must not
use an expired CCF.
(c) As a participant in the DOT drug testing program, you are not
permitted to modify or revise the CCF except as follows:
(1) You may include, in the area outside the border of the form,
other information needed for billing or other purposes necessary to the
collection process.
(2) The CCF must include the names, addresses, telephone numbers
and any other appropriate contact information (e.g., an email address
of the employer and the MRO), including the DER's name and contact
information. All of this information must be preprinted, typed, or
handwritten. Fax numbers may be included, but are not required. The MRO
information must include the physician's name and address, as opposed
to only a generic clinic, health care organization, 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