Proposed Rule2022-02364
Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Addition of Oral Fluid Specimen Testing for Drugs
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Published
February 28, 2022
Issuing agencies
Transportation Department
Abstract
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.
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-02364]
[[Page 11155]]
Vol. 87
Monday,
No. 39
February 28, 2022
Part II
Department of Transportation
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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]]
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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
AGENCY: Office of the Secretary, U.S. Department of Transportation
(DOT).
ACTION: Notice of proposed rulemaking.
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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:
<bullet> Federal eRulemaking Portal: Go to <a href="http://www.regulations.gov">http://www.regulations.gov</a> and follow the online instructions for submitting
comments.
<bullet> 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.
<bullet> 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>, 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;
<a href="/cdn-cgi/l/email-protection#430c070213003426212e222a2f03272c376d242c35"><span class="__cf_email__" data-cfemail="9ad5dedbcad9edfff8f7fbf3f6dafef5eeb4fdf5ec">[email protected]</span></a>.
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 <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2700061/pdf/nihms118888.pdf">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2700061/pdf/nihms118888.pdf</a>.
\3\ Jufer R., Walsh S.L., Cone E.J., et al. J Anal Toxicol. 2006;30(7):458-462, 460. <a href="https://academic.oup.com/jat/article/30/7/458/711502">https://academic.oup.com/jat/article/30/7/458/711502</a> 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 <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4169757/pdf/nihms578748.pdf">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4169757/pdf/nihms578748.pdf</a>.
\5\ Huestis M.A., Mitchell J.M., Cone EJ. J Anal Toxicol. 1996;20(6):441-452 <a href="https://academic.oup.com/jat/article/20/6/441/777647">https://academic.oup.com/jat/article/20/6/441/777647</a> 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: <a href="http://www.transportation.gov/odapc/Statement_of_Enforcement_Discretion_SAPs_and_Service_Agents">www.transportation.gov/odapc/Statement_of_Enforcement_Discretion_SAPs_and_Service_Agents</a>. 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,
<a href="https://www.samhsa.gov">https://www.samhsa.gov</a>. The DOT has posted the 2020 CCF on our website,
<a href="https://www.transportation.gov/odapc">https://www.transportation.gov/odapc</a>, 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 (<a href="https://www.transportation.gov/odapc">https://www.transportation.gov/odapc</a>). You must keep current on any changes to
these materials. You must subscribe to the ODAPC list-serve at: <a href="https://www.transportation.gov/odapc/get-odapc-email-updates">https://www.transportation.gov/odapc/get-odapc-email-updates</a>.
(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 (<a href="http://www.transportation.gov/odapc">http://www.transportation.gov/odapc</a>) or the HHS website (<a href="http://www.workplace.samhsa.gov">http://www.workplace.samhsa.gov</a>).
(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 (<a href="http://www.samhsa.gov/workplace">www.samhsa.gov/workplace</a>) and DOT
(<a href="http://www.transportation.gov/odapc">www.transportation.gov/odapc</a>) 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
[…truncated; see source link]Indexed from Federal Register on February 28, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.