[Federal Register Volume 82, Number 217 (Monday, November 13, 2017)]
[Rules and Regulations]
[Pages 52229-52248]
[FR Doc No: 2017-24397]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket DOT-OST-2016-0189]
RIN 2105-AE58

Procedures for Transportation Workplace Drug and Alcohol Testing
Programs: Addition of Certain Schedule II Drugs to the Department of
Transportation's Drug-Testing Panel and Certain Minor Amendments

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

ACTION: Final rule.

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

SUMMARY: The Department of Transportation is amending its drug-testing
program regulation to add hydrocodone, hydromorphone, oxymorphone, and
oxycodone to its drug-testing panel; add methylenedioxyamphetamine as
an initial test analyte; and remove methylenedioxyethylamphetamine as a
confirmatory test analyte. The revision of the drug-testing panel
harmonizes DOT regulations with the revised HHS Mandatory Guidelines
established by the U.S. Department of Health and Human Services for
Federal drug-testing programs for urine testing. This final rule
clarifies certain existing drug-testing program provisions and
definitions, makes technical amendments, and removes the requirement
for employers and Consortium/Third Party Administrators to submit blind
specimens.

DATES: This rule is effective on January 1, 2018.

FOR FURTHER INFORMATION CONTACT: Patrice M. Kelly, Acting Director,
Office of Drug and Alcohol Policy and Compliance, 1200 New Jersey
Avenue SE., Washington, DC 20590; telephone number<PHONE_NUMBER>;
[email protected].

SUPPLEMENTARY INFORMATION:

I. Purpose

    The Department of Transportation (DOT or the Department) issued a
notice of proposed rulemaking (NPRM) on January 23, 2017. 82 FR 7771
(Jan. 23, 2017). The NPRM proposed to revise Part 40 of Title 49 of the
Code of Federal Regulations (CFR) to harmonize with certain parts of
the revised the Department of Health and Human Services (HHS) Mandatory
Guidelines for Federal Workplace Drug Testing Programs using Urine (HHS
Mandatory Guidelines), which was published on

the same day. 82 FR 7920 (Jan. 23, 2017). DOT currently requires urine
testing for safety-sensitive transportation industry employees subject
to drug testing under Part 40.
    There are two changes to the HHS Mandatory Guidelines with which
the NPRM proposed to harmonize Part 40. First, the revised HHS
Mandatory Guidelines, in part, allow Federal agencies with drug-testing
responsibilities to test for four additional Controlled Substances Act
(CSA) Schedule II prescription medications: Hydrocodone, hydromorphone,
oxycodone, and oxymorphone. Second, the HHS Mandatory Guidelines remove
methylenedioxyethylamphetamine (MDEA) as a confirmatory test analyte
from the existing drug-testing panel and add methylenedioxyamphetamine
(MDA) as an initial test analyte. In addition to harmonizing with
pertinent sections of the HHS Mandatory Guidelines for urine testing,
the NPRM proposed to clarify certain existing Part 40 provisions; to
remove provisions that no longer are necessary (such as obsolete
compliance dates); to move the content of certain provisions out of
Part 40 and onto the Office of Drug and Alcohol Policy and Compliance's
(ODAPC) Web site; and to update definitions and web links where
necessary. The Department also proposed to remove existing Part 40
requirements related to blind specimen testing.
    The Department received 69 comments on the proposed rulemaking. The
comments were from multiple sources including transportation industry
associations, drug and alcohol testing industry companies and
associations, doctors and medical groups, labor organizations, and
individuals.

II. Authority for This Rulemaking

    This rule is promulgated pursuant to the Omnibus Transportation
Employee Testing Act (OTETA) of 1991 (Pub. L. 102-143, Title V, 105
Stat. 952). OTETA sets forth the requirements for DOT reliance on the
HHS Mandatory Guidelines for scientific testing issues. Section 503 of
the Supplemental Appropriations Act, 1987 (Pub. L. 100-71, 101 Stat
391, 468), 5 U.S.C. 7301, and Executive Order 12564 establish HHS as
the agency that directs 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 the regulations governing testing in the
transportation industries' regulated programs, we must follow the HHS
Mandatory Guidelines for the categories of drugs for which we will
require testing.

III. Background

Relevant History of the DOT Drug-Testing Program Regulation

    The Department first published its drug testing program regulation,
49 CFR part 40 (Part 40) on November 21, 1988 as an interim final rule
(53 FR 47002). We based the rule on the HHS Mandatory Guidelines for
Federal Workplace Drug Testing Programs (See 53 FR 11970, April 11,
1988), which, in part, required cocaine and marijuana to be screened by
Federal agencies. HHS based this requirement on the incidence and
prevalence of the abuse of these two substances in the general
population and on the experiences, at the time, of the Departments of
Defense and Transportation in screening their workforces (53 FR 11973-
11974). The 1988 HHS Mandatory Guidelines also authorized Federal
agencies to test their employees for the use of phencyclidine,
amphetamines, and opiates. The DOT published a final rule on December
1, 1989 (54 FR 49854), which incorporated several provisions from the
1988 HHS Mandatory Guidelines. Among these provisions was a 5-panel
test that included all of the drugs for which HHS authorized testing.
In 1991, Congress passed the Omnibus Transportation Employee Testing
Act (OTETA) which, in part, required the Department and DOT Agencies to
look to the HHS for the scientific and technical guidelines regarding
the drugs for which we test and specimens we collect.
    The Department made comprehensive revisions to Part 40 on August
19, 1994 (59 FR 42996), December 19, 2000 (65 FR 79462), and August 16,
2010 (75 FR 49850). The 2010 revision again harmonized our DOT drug-
testing program, where necessary, with the HHS Mandatory Guidelines
effective October 1, 2010 (73 FR 7185; 75 FR 22809). Specifically, we
required initial and confirmatory testing for
methylenedioxymethamphetamine (MDMA); confirmatory testing for MDA and
MDEA; and initial testing for 6-acetylmorphine (6-AM). We also lowered
the initial and confirmatory test cutoff concentrations for
amphetamines and cocaine.
    Just as we have revised Part 40 in the past, we are revising Part
40 to harmonize, in pertinent part, with the most recently revised HHS
Mandatory Guidelines that have an effective date of October 1, 2017.
See 82 FR 7920.

Changes Relevant to the HHS Mandatory Guidelines

    HHS monitors drug abuse trends and reviews information on new drugs
of abuse from sources such as Federal regulators, researchers, the
drug-testing industry, and public and private sector employers. In its
May 15, 2015 ``Notice of Proposed Revisions'' (See 80 FR 28103), HHS
indicated that, since its original HHS Mandatory Guidelines were
published in 1988, a number of recommendations had been made for
additional drugs to be included in Federal workplace drug-testing
programs. According to HHS, recommendations for adding the four semi-
synthetic drugs were based on a review of scientific information and on
input from the Drug Testing Advisory Board (DTAB) \1\ on the methods
necessary to detect the analytes of drugs and on drug abuse trends.
With the DTAB recommendations, private sector experience findings, and
analysis of current drug abuse trends, HHS concluded that the
additional semi-synthetic opioids, oxycodone, oxymorphone, hydrocodone,
and hydromorphone, should be added in the Federal program.
---------------------------------------------------------------------------

    \1\ The Drug Testing Advisory Board provides advice to HHS (the
Administrator of SAMHSA) based on an ongoing review of the
direction, scope, balance, and emphasis of the Agency's drug-testing
activities and the drug testing laboratory certification program.
See http://www.samhsa.gov/about-us/advisory-councils/drug-testing-advisory-board-dtab/board-charter.
---------------------------------------------------------------------------

    In its Final Rule dated January 23, 2017, HHS acknowledged that,
while it had proposed MDA and MDEA as initial test analytes, three
commenters disagreed with the addition of MDA and MDEA as target
analytes. HHS indicated that the commenters stated that this change
would require modification of current immunoassay reagents, laboratory
processes, or both. The commenters noted that this would impose an
unnecessary burden for compounds with such low incidence in workplace
testing. HHS determined that the number of positive MDEA specimens
reported by HHS-certified laboratories does not support testing all
specimens for MDEA in Federal workplace drug testing programs. Based on
the comments and its own studies, HHS removed MDEA from its Mandatory
Guidelines. HHS indicated that it understands MDA and some other
analytes also have a low incidence of testing positive, but believes
the continued testing for these analytes is warranted in a deterrent
program. In particular, inclusion of MDA as an initial and confirmatory
test analyte is warranted according to HHS because, in

addition to being a drug of abuse, it is a metabolite of MDEA and MDMA.

Harmonizing Changes to the DOT Drug-Testing Program Regulation

    In keeping with our obligations under OTETA to follow the HHS
Mandatory Guidelines for the drugs for which we test, our NPRM proposed
to add and remove the drugs adopted in the revised HHS Mandatory
Guidelines for urine testing. Inclusion of these four semi-synthetic
opioids is intended to help address the nation-wide epidemic of opioid
abuse. Also, adding these four drugs, which are already tested for in
many transportation employers' non-DOT testing programs because of
their widespread use and potentially impairing effect, will allow the
DOT to detect a broader range of drugs being used illegally. This will
enhance the safety of the transportation industries and the public they
serve. The Department's final rule makes these harmonizing amendments
to Part 40.

IV. Main Policy Issues

A. Modification of the Drug Testing Panel

The NPRM
    The Department proposed to add the four semi-synthetic opioids to
the DOT panel (i.e., hydrocodone, hydromorphone, oxycodone, and
oxymorphone) to maintain consistency with the HHS Mandatory Guidelines.
Such consistency is mandated by Federal statute, OTETA, and applies not
only to the drugs tested but also to specimen testing validity values
and initial and confirmatory testing values. To cover these substances,
as well as those previously in the opiate category (i.e., codeine,
morphine, 6-AM), the NPRM proposed to rename the category from
``opiates'' to ``opioids.''
    As we mentioned in the NPRM preamble, opioid abuse and related
problems are a major national concern. Transportation industries are
not immune to this trend and the safety issues it raises. Consequently,
the Department proposed including these substances in its testing panel
not only for consistency with the HHS Mandatory Guidelines but as a
response to a national problem that can affect transportation safety.
    In addition, to be consistent with changes to the HHS Mandatory
Guidelines, the Department proposed to remove MDEA from the testing
panel and add MDA as an initial test analyte.
Comments
    There were 52 comments addressing the addition of the specified
semi-synthetic opioids to the DOT testing panel. Of those comments, 41
supported the NPRM's proposal. Supporters generally recognized the need
for the Department to act consistently with the HHS Mandatory
Guidelines and agreed that addressing opioid abuse issues in the
context of transportation safety is important. Of the other 11
comments, several expressed concerns that adding these substances would
increase circumstances in which drivers innocently using opioids (e.g.,
via a prescription for pain medication) would be unfairly treated as
drug abusers, with consequent positive tests harming their careers. A
few comments suggested adding other substances, such as methadone or
synthetic cannabinoids, to the panel.
    Other commenters, including some labor organizations, were
concerned that employees would have to compromise their medical privacy
in order to avoid results being verified positive by medical review
officers (MROs). One comment suggested raising the cutoff levels to
make it less likely that an employee using a legitimate prescription
medication would receive a positive laboratory result. Other comments
raised concerns about how adding these opioids to the testing panel
would impact other aspects of Part 40, such as MRO determinations about
whether a prescription is legitimate or when it is appropriate for an
MRO to inform an employer of a safety concern after verifying a
negative result based on an employee's legitimate use of prescription
medication. Other comments recommended additional rules or guidance
concerning MRO practice, such as additional opioids training and
directing MROs not to second-guess the prescription judgments of an
employee's physician.
DOT Response
    We acknowledge the 41 comments that supported adding the four semi-
synthetic opiates to the DOT drug testing panel. We agree that this is
an important safety improvement. In addition, we appreciate that so
many commenters recognized that we must follow the HHS Mandatory
Guidelines for the drugs for which we test.
    Although a commenter suggested adding other substances and raising
the HHS established cut-off levels, we are not permitted to make such
changes. As noted above, OTETA requires the Department to conform with
the HHS Mandatory Guidelines with respect to the drugs for which we
test and their cutoff levels. The Department does not have the
discretion to decline to include drugs that are included in the HHS
Mandatory Guidelines or to change the cutoff levels that HHS has
established. Furthermore, HHS conducted a full notice and comment
period regarding these aspects of the HHS Mandatory Guidelines and that
time would have been the appropriate point for commenters to request
HHS to consider their concerns. To further ensure that our regulated
public was kept informed about this opportunity to comment on HHS
rulemakings that could potentially affect them, on May 15 and 19, 2015,
ODAPC sent notices to the ODAPC list-serve informing subscribers about
the HHS proposal so that interested parties could submit comments to
the HHS docket. See http://content.govdelivery.com/accounts/USDOT/bulletins/1047858 and http://content.govdelivery.com/accounts/USDOT/bulletins/1051d3e. Once HHS reaches a final determination on the drugs
and their cutoff levels, the DOT cannot depart from HHS's decisions on
these matters.
    Similarly, DOT does not have the authority to add substances such
as methadone or synthetic cannabinoids to our drug testing panel
without the scientific and technical expertise of the HHS, as expressed
in the HHS Mandatory Guidelines. In addition, HHS is limited to testing
for drugs under Schedules I and II of the CSA. Parties interested in
having additional drugs in those CSA Schedules tested as part of the
Federal or DOT program should discuss the matter with HHS.
    The Department received comments regarding the relationship between
the Department's drug panel and the HHS Mandatory Guidelines during
past rulemaking activities. The Department's position, described above,
affirms its past responses. (See 75 FR 49850, 49850-49853).
    In other sections of this preamble, the Department will discuss
comments related to MRO practice issues that could arise when the four
new semi-synthetic opioids in our testing panel are introduced.
Examples of these issues include an employee's medical privacy,
legitimacy of prescriptions, MROs not questioning the treating
physician's prescription judgment, and safety concerns.

B. Blind Specimens

The NPRM
    The NPRM proposed to remove from Part 40 the requirements for blind
specimen testing. The purpose of this proposal was to relieve
unnecessary costs and administrative burdens on employers, C/TPAs, and
other parties.

    The blind specimen requirement has been part of the Department's
drug testing program since its inception. The requirement for employers
and C/TPAs to submit blinds was intended to help ensure the accuracy of
the laboratory testing process. Under the current regulation, an
employer will send a blind specimen to an HHS-certified laboratory,
accompanied by a Federal Drug Testing Custody and Control Form (CCF)
with the name of a fictitious donor, for quality control purposes to
see if the laboratory's results match the known contents of that
particular blind specimen.
    Over the years, as the accuracy of the laboratory testing process
was consistently established, DOT reduced the number of blind specimens
that employers were required to send to laboratories to reduce cost and
administrative burdens associated with the process. As we stated in the
NPRM, not one false positive result was found through the testing of
the blind specimens in more than 25 years of drug testing.
    As the NPRM noted, laboratories are subject to thorough biannual
inspections and quarterly proficiency testing through the HHS National
Laboratory Certification Program (NLCP). In addition, if an employee
has questions about the accuracy of the positive, adulterated, or
substituted test result of his or her own specimen, the employee has
the right to request the test of his or her split specimen. Believing
that the blind specimen testing requirement was no longer necessary to
ensure the accuracy and integrity of the testing process, we proposed
eliminating this requirement and sought public comment on the subject.
Comments
    Twenty-five comments addressed this proposal. Fifteen supported
removing the requirement, while ten asked to retain it. Proponents of
removal, principally some testing industry associations and employer
groups, generally agreed that there were sufficient safeguards on the
accuracy and integrity of the system and that blind specimens were
unnecessary. They commented that it was, consequently, a good idea to
eliminate the costs and burdens associated with the requirement. They
said that the accuracy and integrity of the system will not be
compromised by eliminating blind specimen testing. One employer
association noted that the requirement only affected the largest
companies in its industry, and not small businesses.
    Opponents of removing the requirement, including labor
organizations and some laboratory-related entities, made several
arguments. More than one commenter stated that, while the Department
may not have been aware of any false positives resulting from blind
specimen tests, there was no information presented about the incidence
of false negatives. False negatives, they said, could be as damaging to
the integrity and safety objectives of the drug testing programs as
false positives. Some commenters said the existence of blind specimen
testing could provide an incentive to laboratories to maintain the
accuracy of their procedures, somewhat analogous to the deterrent
effect of random testing on employee behavior. In its absence,
laboratories might relax their standards. Other commenters said that,
even if blind specimen testing did not reveal any false positives, the
existence of the process of blind specimens added to, or at least
increased the appearance of, fairness to employees.
    In addition, some commenters noted that because laboratories will
begin testing for new substances proposed under the NPRM (i.e., the
semi-synthetic opioids), it would be useful to maintain blind specimen
testing to help to ensure that errors did not occur in the testing of
these newly added drugs. Also, some of the commenters believed that it
would be better to keep blind specimen testing in place as a safeguard,
as opposed to relying wholly on split specimens and the NLCP. One
commenter noted that NLCP's oversight of laboratories could be weakened
by future decreases in HHS budgets and this could lead to the reduction
of the effectiveness of that program.
DOT Response
    The history of the blind specimen testing requirement shows
decreasing reliance on this process as a safeguard. Laboratories have
accumulated a record of accuracy spanning more than 25 years. Years
ago, the DOT reduced the amount of blind specimen testing from three
percent to one percent, with no known ill effects on the integrity of
the process.
    We disagree with the commenters who implied that elimination of the
blind specimen testing would cause laboratories to change the way they
do business and, thereby lower their standards. Given the continuing
rigorous HHS oversight and the business necessity of maintaining
accuracy, it is not likely that laboratories would relax their
standards simply because the relatively small number of blind specimen
tests now required has been eliminated.
    While commenters who favor retaining the requirement expressed
concern about the possibility of false negatives, or the potential loss
of a deterrent effect on laboratories by eliminating blind specimen
testing, these concerns are speculative. None of the laboratories or
blind specimen manufacturers who commented provided data to support any
assertions of false negatives. Without data to support these
assertions, the Department has no basis on which to substantiate that
there are false negatives indicative of systemic laboratory problems.
Instead of identifying laboratory problems, false negatives, if they
exist, could be attributed to problems with the manufacture of the
blind specimens or employers and C/TPAs not adhering to the
manufacturer's instructions on the use or expiration date of their
product. The Department retention of the blind specimen testing
requirement would exacerbate, not reduce, those problems.
    The Department and the transportation industries rely upon the NLCP
certification and oversight processes, as well as the split specimen
testing process, to ensure that the accuracy of the laboratory testing
is up to NLCP certification standards. In OTETA, Congress directed the
Department to rely on HHS-certified laboratories, without any reference
to the additional process of blind specimen testing. Moreover, there
have been no false positive results for blind specimens reported to the
Department, as required by the current Part 40, either before or after
the NPRM was issued. The Department will continue to rely on HHS for
laboratory certification because now more than 25 years of blind
specimen testing has shown that there have been no false positive blind
specimen results.
    Given the rigorous HHS oversight of the laboratories, as well as
the business necessity for the laboratories to maintain a reliable
record of accuracy, it is not likely that laboratories would relax
their standards simply because the relatively small number of blind
specimen tests now required was eliminated. Consequently, the
Department is adopting its proposal to remove blind specimen testing
requirements from part 40.

C. The DOT List-Serve

The NPRM
    The NPRM proposed requiring key personnel in the drug and alcohol
testing process--collectors, Breath

Alcohol Technicians (BATs), Screening Test Technicians (STTs), Medical
Review Officers (MROs), Substance Abuse Professionals (SAPs)--to
subscribe to the Office of Drug and Alcohol Policy and Compliance
(ODAPC) list-serve. That list-serve is a very useful source of
information for: The DOT drug and alcohol testing rules and programs;
guidance for handling issues that have arisen in the implementation of
the program; relevant antidrug information from Federal partners; and
updates concerning the program. Subscriptions are free to users.
Currently, there are more than 40,000 ODAPC list-serve subscribers.
Comments
    Everyone who commented thought that the list-serve is a very useful
tool that many of them subscribe to and support. Nine of the 13
comments on this proposal expressed full or qualified support for the
proposal to make the ODAPC list-serve mandatory for key persons who
have currency requirements included in their part 40 qualification
requirements. Opponents of requiring subscription to the list-serve
said that the proposed change was unnecessarily prescriptive and could
impose compliance costs (e.g., time spent signing up and reading the
material) that were not considered in the regulatory evaluation. One
commenter stated that subscribing to the list-serve served no safety
purpose. In addition, they asked how the requirement could be
monitored, documented, or enforced. One commenter offered that the
proposal would work better as a ``best practice'' than a mandate. Some
commenters supported the proposal because of the useful information the
list-serve provides, but had questions and concerns about its
implementation. One commenter suggested that supervisors of BATs, STTs,
and collectors should be required to subscribe instead of the BATs,
STTs, and collectors themselves. This commenter believed that their
supervisors should make sure that they learned relevant information
conveyed by the list-serve. Another supporter of the proposal was
concerned that monitoring staff members' compliance could be burdensome
for parties like C/TPAs. Another expressed concern about how the
mandate would work given, the rapid turnover of collectors and BATs.
DOT Response
    The Department is appreciative that the commenters recognized the
value of the list-serve, and that a number of industry organizations
expressed their commitment to publicizing the service and encouraging
their members to take advantage of it. We want to extend our gratitude
to all who have spread the word about the usefulness of the list-serve
and to the more than 40,000 subscribers.
    As noted in the NPRM, we believe that the cost and burdens of
additional drug and alcohol program workers subscribing to the list-
serve would likely be minimal, and that there would be benefits to
everyone receiving the useful information it contains. While some
commenters expressed concern about potential costs, we note that the
service is free. Reading information on the list-serve is unlikely to
be time-consuming and no different than if the service agent were to
receive the information from a different source. Signing up for the
list-serve merely requires one to enter one's email address on the
Office of Drug and Alcohol Policy and Compliance's Web page at
www.transportation.gov/odapc. No comments attempted to provide data
regarding potential costs.
    Since the plain language rewrite of 49 CFR part 40, 65 FR 79462
(December 19, 2000), collectors, MROs and SAPs have been required to
``keep current on any changes to . . . [the applicable regulations and
guidelines].'' This applies to collectors in Sec.  40.33(a); Medical
Review Officers (MROs) in Sec.  40.151(b)(3); Substance Abuse
Professionals (SAPs) in Sec.  40.281(b)(3) [SAPs]. Similarly; Sec.
40.213(a) requires Breath Alcohol Technicians (BATs) and Screening Test
Technicians (STTs) to ``be knowledgeable about the alcohol testing
procedures in this part and the current DOT guidance.''
    DOT agency auditors, inspectors and investigators who inspect the
service agents listed above currently ask the individual collector/BAT/
STT/MRO or SAP whether that individual is current on 49 CFR part 40 and
the applicable guidelines, to ensure the requirements for currency are
met. The individual service agent would need to produce a 101-page copy
of 49 CFR part 40 and the applicable guidelines in hard copy. After the
list-serve requirement becomes effective, the individual service agent
may demonstrate currency by showing the most recent list-serve--most
likely by displaying it on the service agent's smart phone or other
computer. Proving one's subscription to the list-serve will show the
DOT auditor/inspector/investigator that the individual is subscribed to
a system that provides an opportunity to stay current with the latest
information about the program. Unequivocally, this would be a cost
savings, would help to improve compliance by getting the relevant and
timely information into the hands of the specified service agents, and
would demonstrate the DOT's commitment to making information available
electronically.
    Even when a service agent subscribes to the list-serve, it is a
best business practice for that service agent to keep a paper copy of
Part 40 and applicable guidelines for easy reference and for when
electronic retrieval of these documents is not possible. Certainly,
service agents can view these documents on-line at ODAPC's Web site,
but Internet accessibility is not always possible, especially during
transportation operations in remote areas.
    While we would welcome the subscription to the list-serve by
management personnel, it would not make sense to put the requirement of
a list-serve subscription upon the collection site supervisor or other
management personnel because they are not necessarily the individuals
responsible for complying with the qualification requirement under the
existing Part 40 to remain current in his or her knowledge. A
collector/BAT/STT/MRO or SAP is the individual with the requirement for
training, remaining current and maintaining his or her own
documentation.
    The Department disagrees with the comment that subscribing to the
list-serve serves no safety purpose. Over the years, we have used the
list-serve to inform the DOT-regulated industry about various important
program-related information. For example, list-serves have included:
Public Interest Exclusion decisions against fake MROs; changes to the
Federal Drug Testing Custody and Control Form (CCF) and authorization
for use of the electronic CCF (eCCF); updated guidance documents such
as: The Urine Specimen Collector Guidelines; What Employers Need to
Know About DOT Drug and Alcohol Testing; FAA's Designated Employer
Representative videos; FTA's Annual National Drug and Alcohol
Conference; Official ODAPC Interpretations of Part 40; and the FMCSA's
National Drug and Alcohol Testing Clearinghouse. Each of these notices
touched on topics directly related to the DOT's drug and alcohol
testing program. The list-serves communicate information that is
related to the integrity and safety aspect of the program.

D. MRO Practice Issues

The NPRM
    The NPRM proposed to amend existing Sec.  40.141(b) to say that
``prescription,'' for purposes of MRO

verification determinations, means ``a legally valid prescription under
the Controlled Substances Act [CSA].'' This same language was used in
Sec.  40.135(e), in the context of informing third parties about
potential safety implications of an employee's use of a controlled
substance. The intent of the proposal was to harmonize the language of
these sections for clarity and consistency.
    It has always been the intent of this program to follow the CSA
regarding what constitutes a legally valid prescription. The term
``prescription'' has become more loosely used in recent years. Under
the Internal Revenue Code, individuals can be reimbursed for over-the-
counter medications and some services, if the taxpayer has a
``prescription'' from their doctors for these things that are not
controlled substances under the CSA. In addition, some state laws
allowing marijuana use the term ``prescription,'' even though a
recommendation for someone to use marijuana under state law is not a
prescription consistent with the Controlled Substances Act.
    The NPRM also proposed to allow MROs to conduct additional testing
(i.e., for D,L stereoisomers of amphetamine and methamphetamine isomers
and/or tetrahydrocannabivarin (THC-V)) of a specimen, if doing so is
necessary to verify a test result. The testing for D,L stereoisomers of
amphetamine and methamphetamine can be useful to an MRO in
distinguishing whether a methamphetamine positive resulted from use of
a legitimate over-the counter product. An MRO can order a test for THC-
V to be conducted to determine whether the laboratory reported
marijuana result was due to the smoking of marijuana. The THC-V
differential testing can distinguish whether a THC positive is due to
the smoking of marijuana, a CSA Schedule I illegal drug, or is due to
the use of Marinol, a CSA Schedule III prescribed pharmaceutical.
Because of this regulatory change, MROs do not need to obtain DOT
consent to order such tests. However, MROs can use only laboratories
that meet NLCP criteria for conducting these additional tests.
Comments
    There were only nine comments on these specific proposals. All of
them supported the authorization of MROs to order the laboratory to
test for D,L stereoisomers of amphetamine and methamphetamine or THC-V.
One comment, from a testing industry association, suggested that the
Department issue more detailed guidance to MROs concerning when it is
appropriate to order these tests. Another comment suggested making the
testing for D,L stereoisomers of amphetamine and methamphetamine
mandatory in all methamphetamine positives to avoid delays in reporting
final verification results to employers.
    With respect to the definition of ``prescription,'' eight of the
nine commenters supported the NPRM. The ninth suggested that this was a
matter better left to medical organizations. Another commenter
suggested that the rule specify that there could never be a legally
valid prescription for marijuana, to reinforce that state ``medical
marijuana'' laws do not have validity for the purposes of the DOT
program, which is bound to follow Federal law. One commenter
specifically noted that the word ``prescription'' is not specifically
defined in the CSA.
    As noted earlier in the ``Modification to the Drug Testing Panel''
section, commenters to the proposal to add the four semi-synthetic
opioids raised a number of issues concerning MRO practice. One issue of
concern to several commenters was whether a prescription should still
be considered by the MRO as a legitimate medical explanation if it had
been filled a long time before the positive test result (e.g., six
months, a year, two years before the drug test that an MRO is being
asked to verify). They said this is an important inquiry because the
semi-synthetic opioids proposed to be added to the DOT testing panel
are Schedule II drugs that are frequently prescribed and may be
retained and used by the donor long after the prescription was filled.
Some commenters were concerned that MROs' decisions have been and will
continue to be inconsistent regarding the age of a prescription
considered to be grounds for declaring a legitimate medical explanation
for a positive result.
    A related comment asked that DOT clarify that an MRO could not
question a prescribing physician's decision to issue a prescription.
That is, an MRO should not ``second guess'' the prescribing physician's
determination that it was medically appropriate to prescribe one of the
four semi-synthetic opioids and verify a test as positive
notwithstanding the existence of the prescription.
    Other commenters recommended that MROs should receive more frequent
training than currently required (e.g., requalification training every
three years rather than every five years), with special emphasis on
issues concerning the semi-synthetic opioids added to the DOT panel.
One of these comments suggested that MROs should not be authorized to
make determinations about these drugs until they had received specific
training concerning the semi-synthetic opioids. This commenter also
asked that legal review of MRO decisions be permitted under the
regulations and that MROs and collectors themselves be subject to drug
testing.
    Another area of comment focused upon the provision of Sec.
40.327(a) that directs MROs to report to employers and third parties
when safety concerns remain after a non-negative test laboratory-
confirmed result is downgraded to a negative due to the existence of a
prescription. Some commenters believed that the downgraded non-negative
results are still likely to result in the medical disqualification of
the employee (Sec.  40.327(a)(1)), for those positions that require
medical qualification, such as airline pilots, Coast Guard mariners and
Commercial Driver's License (CDL) drivers. For those without medical
certification requirements, these commenters believed that the MRO
would report a ``safety concern'' under Sec.  40.327(a)(2) when, in the
MRO's medical judgment, the employee's continued performance of his or
her safety-sensitive function is likely to pose a significant safety
risk. These commenters' concern was that, absent further regulatory
language or guidance from DOT, some MROs might report information to
employers (e.g., information about a semi-synthetic opioid that an
employee was legally taking) from which an employer could infer an
employee's medical condition. These commenters believed that release of
information would not only compromise the employee's medical privacy
but could threaten the employee's job. One commenter thought that
paragraph (a)(2) should be deleted altogether. Commenters suggested
that, before reporting a safety concern under Sec.  40.327(a)(1), an
MRO should be required to contact the employee's prescribing physician
to determine whether the physician was aware of the employee's safety-
sensitive duties and, if so, whether the prescribing physician believed
the prescribed drug would not impair the employee's ability to perform
those duties safely.
DOT Response
    The Department is adopting the NPRM's proposal to authorize MROs to
conduct testing for D,L stereoisomers of amphetamine and
methamphetamine and THC-V. Most commenters agreed that these proposals
had merit. We do not believe it necessary to make the testing for D,L
stereoisomers of amphetamine and methamphetamine mandatory in
methamphetamine cases,

believing it better to leave this decision to MROs' discretion. Neither
is it necessary to make THC-V testing mandatory. To make these
requirements would be unnecessary in most cases and would, therefore,
cause needless expense with no additional safety benefit. In response
to those who thought additional guidance is necessary, we will provide
it in the future on the basis of demonstrated need.
    We will also adopt, with a slight change, the NPRM's language
saying that a prescription means a legally valid prescription within
the overall meaning of the CSA. While, as one commenter pointed out,
the CSA does not contain an explicit definition of ``prescription,''
the Drug Enforcement Administration (DEA), which is designated by
statute to carry out the CSA, has regulations and guidance regarding
prescriptions. Therefore, we are changing the proposed language to say
that a prescription must be ``consistent with'' and not simply
``under'' the CSA. The proposed language was already present in Sec.
40.135(e), so we will make a technical amendment to that language for
consistency. In addition, we have added the same language to Sec.
40.137(a) to provide clarity to MROs when verifying laboratory-
confirmed positive test results.
    The key point of the phrase we have added is to make sure that a
prescription is legally valid. For example, regardless of any state
``medical marijuana'' laws, there cannot be a legally valid
prescription for marijuana, since it remains a Schedule I substance
under the CSA.
    The issues concerning restricting an MRO's judgment about how long
a prescription may be considered to be legitimate are complex and not
appropriate for this rulemaking. The Department is concerned that
establishing a ``bright line'' cutoff date for the valid use of a
prescription--i.e., that an otherwise legally valid prescription would
be regarded as no longer providing a legitimate medical explanation for
a laboratory positive after a certain amount of time had passed--would
be a too-facile substitute for the individualized inquiry that we
expect an MRO to make in such cases. It could also result in an
unintended hardship on an employee who is not intentionally abusing a
prescription medication but who unintentionally runs afoul of a
standardized expectation for how quickly he or she will use medication
prescribed.
    The DEA has not set a maximum duration for the length of time a
prescription can be considered to be legally used by the person to whom
it was prescribed. Consequently, it would not be appropriate for the
Department to substitute its judgment for that of the DEA, which is the
Federal agency with the authority for determining what constitutes a
valid prescription under the CSA.
    The MROs are highly qualified individuals who Part 40 requires to
make judgment calls. MROs must take into account differences in
medications, and other case-specific factors. While some commenters
characterize this as ``inconsistent'' across the breadth of a national
program, it carries out the intention that MROs will make
individualized determinations for each donor. Although it might be less
work and superficially ``consistent'' for MROs to make decisions on the
basis of a ``bright line'' standard, doing so would not advance the
objectives of the program. Consequently, the Department will not create
a time limit on the use of a legally valid prescription.
    Some commenters also suggested that the final rule prohibit an MRO
from questioning whether the prescribing physician should have
prescribed the substance. That is, the MRO should not be allowed to
say, in effect, ``yes, the employee has a legally valid prescription
issued by his or her physician, but I think that the physician should
not have issued that prescription in the first place, or the
prescription was for too high a dosage of a drug, so I won't treat the
prescription as a legitimate medical explanation for a laboratory
positive.'' This situation could arise, for example, with respect to
prescriptions for the opioids added to the DOT panel by this rule (or
for any other legally prescribed drug identified in our drug panel), if
an MRO thought an employee's doctor had been too liberal in prescribing
pain medications.
    We agree that it is inappropriate for an MRO to question an
employee's legally valid prescription in this way. Even if the
employee's physician's prescription practices are inconsistent with an
MRO's understanding of good standards of medical practice, employees
are entitled to rely on their physicians' prescriptions as
authorization to use the legally prescribed substance as a legitimate
medical explanation. To say otherwise would place an unfair burden on
the employee to judge the appropriateness of his or her physician's
conduct. As a logical outgrowth of this issue raised by commenters, we
have added language to Sec.  40.137 of the final rule to prohibit MROs
from denying a legitimate medical explanation because the MRO thinks
the prescribing physician should not have prescribed the medication to
the donor. However, it is important to note that a valid concern about
whether the employee can continue performance safely may be present and
the prescribing physician may still be asked to reconsider the
employee's use of the prescription in accordance with Sec.  40.135(e).
    MROs with a concern about a physician's prescribing practices can
address this with the prescribing physician or raise the issue with the
appropriate state licensing agency for the prescribing physician. For
example, an MRO can choose to file a complaint with a local DEA office,
a medical licensing board, or other oversight organization regarding
the practices of a prescribing physician who the MRO believes is
violating standards of care. That approach remains a more direct way to
address the possible malfeasance of the prescribing physician, instead
of denying the legitimacy of the safety-sensitive employee's
prescription.
    The issue of states or nations (i.e., Canada and Mexico) that allow
recommendations or state-recognized ``prescriptions'' for ``medical
marijuana'' presents a completely different consideration. Marijuana is
a Schedule I drug and, therefore, regardless of the prescribing
physician's intent, it cannot be the basis of a legitimate medical
explanation. Consistent with longstanding DOT regulatory language and
guidance (e.g., Sec. Sec.  40.137(e)(2), 40.151(e), and DOT ``Medical
Marijuana'' Notice https://www.transportation.gov/odapc/medical-marijuana-notice; DOT ``Recreational Marijuana'' Notice https://www.transportation.gov/odapc/dot-recreational-marijuana-notice), MROs
must not treat medical marijuana authorizations under state law as
providing a legitimate medical explanation for a DOT drug test that is
positive for marijuana.
    We agree with commenters that MROs should receive appropriate
information concerning issues that may arise with respect to the semi-
synthetic opioids added to the DOT panel in this final rule. The
Department will issue guidance, as needed, highlighting opioid issues
that may arise.
    We believe that shortening the MRO re-training interval to three
years would impose a cost and burden that is unnecessary. Since we
already have opiates in the DOT-regulated drug testing panels, adding
semi-synthetic opioids to the panel is not a radical change for these
highly trained Medical Doctors and Doctors of Osteopathy. Likewise,
requiring special training concerning opioids for MROs, or

limiting their ability to verify opioid positive test results unless
they had received such training, is likely to unnecessarily delay
implementation of the addition of these controlled substances to the
program without a justifiable reason to require the training. There was
no showing by commenters that, absent such specialized training outside
the normal training process, MROs would be incapable of assessing
whether there were legitimate medical explanations for opioid positive
results. Thus, we believe that additional training is not needed to
ensure that MROs are familiar with semi-synthetic opioid issues.
    As noted above, commenters were concerned that, as applied to
commonly prescribed substances like the semi-synthetic opioids covered
by this rule, Sec.  40.327(a)(2) could lead to adverse outcomes for
employees such as compromising the employee's medical privacy or
employment. For example, an MRO might note that an employee had a
legally valid prescription for an opioid, which provided a legitimate
explanation for a laboratory positive result, but then decide that the
employer should be told that the employee's use of that opioid poses a
significant safety risk, endangering the employee's continued
employment. Given the apparent frequency with which opioids are
prescribed, commenters feared that the occurrence of issues of this
kind could increase.
    Although we did not propose any new language to Sec.  40.327, we
believe this section warrants a discussion and a slight amendment to
the existing language of Sec.  40.135 as a logical outgrowth of the
commenter's concerns as to the frequency with which medical information
would be reported because of adding the four semi-synthetic opioids. It
may not be necessary for the MRO to report medical information to third
parties in every case where the MRO receives substantiated evidence
that an employee has a valid prescription that merits downgrading a
result from a positive to a negative.
    Under Sec.  40.327, an MRO must report drug test results and
medical information the MRO learns as part of the verification process
to third parties without the employee's consent if the MRO determines,
in his or her reasonable medical judgement, that either of two concerns
is triggered. First, the MRO is required to disclose to third parties
information when the information obtained during the verification
interview is likely to render the employee medically unqualified under
an applicable DOT agency regulation (e.g., a fitness for duty
requirement). Second, the MRO must report the information to third
parties if the ``information indicates that continued performance by
the employee of his or her safety-sensitive function is likely to pose
a significant safety risk.'' The third parties to whom this information
can be disclosed are: The employer; a DOT agency; a SAP; or an examiner
who determines whether the employee is medically qualified under an
applicable DOT agency safety regulation.
    We understand, and the commenters were concerned, that MROs already
apply the procedures of Sec. Sec.  40.135 and 40.327 to commonly
prescribed medications that can cause a laboratory-confirmed positive
result. Thus, adding the semi-synthetic opioids would pose a similar,
but certainly not a new, scenario of a laboratory-confirmed positive
that would be downgraded to a negative result because of a legally
valid prescription, and this medical information would be reported to a
third party, when appropriate.
    This concern, however, should not be overstated. There is not an
automatic requirement for an MRO to report medical information to third
parties for every downgraded drug test result. There are and will
continue to be cases where the MRO would not need to report medical
information to a third party. We leave the determination of the
significant safety risk to the ``reasonable medical judgment'' of the
MRO, recognizing that every downgraded test result is not the same and
needs the individualized professional judgment of the MRO.
    The MROs have a serious safety duty when verifying the prescription
an employee provides to the MRO. Under Sec.  40.141(b), the MRO (and
not the MRO's staff) must ``review and take all reasonable and
necessary steps to verify the authenticity of all medical records the
employee provides.'' With the advancement of photography manipulation
and enhancement software easily available through the Internet, MROs
should speak with the pharmacy and not simply rely on a photograph of
the prescription label. That contact with the pharmacy can also shed
light on whether there is a significant safety risk posed in the
particular situation the MRO is assessing.
    To ensure that the employee is not caught by surprise by an MRO's
decision to report the medical information regarding a legally valid
prescription to a third party, we have amended Sec.  40.135(e).
Specifically, we will direct the MRO to first provide the employee with
up to five business days after the reporting the verified negative
result to have the prescribing physician contact the MRO to determine
if the medication(s) can be changed to one that does not make the
employee medically unqualified or that does not pose a significant
safety risk before reporting the safety concern. If the MRO does not
receive such information from the prescribing physician, the MRO would
then report to third parties as provided in Sec.  40.327. The provision
of giving the employee five days to have his/her prescribing physician
contact the MRO is not new. In fact, it has been in part 40 since the
year 2000. The only difference is that previously, the MRO would first
report the medical information and then wait for the prescribing
physician to respond. We have no reason to believe this process is not
effective. However, in response to the commenters' concerns, we are
changing this process to provide the employee the opportunity to allay
any MRO safety risk concerns by having his or her prescribing physician
change the medication immediately, discuss other ways to eliminate or
mitigate the MRO's concerns, or both change the medication and discuss
alternatives. This should also reduce the number of reports MROs would
make. We do not anticipate this change will increase costs because
there is no new collection of information, we are simply directing the
MRO to pause for five days before reporting the medical information to
third parties. In fact, this pause may reduce costs because we
anticipate that it should reduce the number of reports to employers
under Sec.  40.135(e).
    Although we are creating a pause before the MRO reports the
information so that the employee can have time to communicate with the
employee's own physician, the part 40 requirement for the MRO to report
the downgraded test result as a verified negative immediately remains
unchanged. With this final rule, the employer will receive a negative
result first and medical information, if necessary, will come later.
    There may be cases where the MRO is contacted by the employee's
physician before the end of the five days, but the communication
between the doctors does not alleviate the significant safety risk that
the MRO has identified. In such cases, the MRO can report the medical
information to third parties after the discussion with the employee's
physician; the MRO is not required to allow five days to elapse.
    Comments that MRO decisions should be legally reviewed and that
MROs and collectors should be subject to drug testing are outside the
scope of this

rulemaking. Thus, they will not be addressed.

E. Fatal Flaws and Questionable Specimens

The NPRM
    The NPRM proposed to add three fatal flaws to the existing list of
four flaws that would cause a test to be cancelled. Each fatal flaw is
an error that cannot be subsequently corrected because of the potential
for each of the flaw to affect the accuracy and integrity of that
specimen. The existing fatal flaws are listed in Sec. Sec.  40.83 and
40.199. The proposed additional flaws were listed in a September 2016
revision of the HHS NLCP Manual. Specifically, the flaws proposed to be
added were: (1) There is no CCF; (2) two separate collections were
performed using one CCF; and (3) there was no specimen submitted to the
laboratory with the CCF.
    The NPRM also addressed a situation when there is an initial
``questionable'' specimen (e.g., one calling for an immediate
recollection under direct observation because the temperature was out
of range or there were signs of tampering), but there was no second
specimen provided (e.g., because the donor was unable to provide the
second specimen under direct observation, even after waiting three
hours and drinking fluids). The current regulation does not provide
clear instructions to the collector regarding what to do with the
initial specimen in this scenario. The NPRM proposed that the collector
discard the initial specimen in this case, leaving the MRO to determine
whether there was a sufficient medical explanation for the ``shy
bladder.''
Comments
    One commenter noted that the changes to fatal flaws by the NLCP,
the source of the Department's proposed changes, had not earlier been
the subject of public comment before HHS changed the HHS Mandatory
Guidelines in this respect. This commenter also noted that there could
be inconsistencies between HHS and DOT criteria for fatal flaws.
    Another commenter raised a technical point with respect to the
proposed Sec.  40.83(c)(2), requesting clarification to say that a CCF
without an accompanying specimen would become a fatal flaw only when an
actual specimen had been collected. The commenter explained that, in a
shy bladder or collection site refusal situation, a collector might
mistakenly send a CCF to the laboratory, even when there was no
specimen to send. If the test were cancelled by the laboratory, then
there would be no shy bladder evaluation and, what may have been a
refusal would result in a cancelled test. Two other commenters, also
referred to this same situation, saying that the solution would be to
clarify that this fatal flaw exists only when a specimen was actually
collected.
    With respect to the ``questionable specimen'' scenario on what to
do with a first specimen that was collected and was out of temperature
range or showed signs of tampering, but then a sufficient second
specimen was not collected under direct observation, we received ten
comments. All of these comments on the proposal supported it.
DOT Response
    Three commenters who were concerned about a fatal flaw cancelling a
test in the ``insufficient specimen'' scenario raised a good point
related not only those scenarios, but also for collection site walk-
away refusals. The Department will adopt these commenters' suggestions
that a fatal flaw will exist in cases where a CCF is sent to the
laboratory without a specimen, as long as there a specimen was actually
collected. This will avoid a situation in which, for example, there was
a CCF filled out for an original specimen, a shy bladder situation
occurred, no second specimen was collected, but the CCF was mistakenly
sent to the laboratory. The ultimate result of this process--a
determination by the MRO about whether there was a sufficient medical
explanation for the employee's failure to provide a full specimen--
could be confused by a laboratory decision that there was a fatal flaw,
even though the fatal flaw has no impact upon the MRO's determination
of a refusal. Accordingly, we have amended Sec. Sec.  40.83 and 40.199,
both of which deal with this particular fatal flaw.
    Otherwise, the Department is adopting its proposal with respect to
fatal flaws without change. Commenters had the opportunity to comment
on these proposed changes in context of the DOT NPRM, whether or not
HHS provided such an opportunity concerning its changes to the HHS
Mandatory Guidelines.
    Regarding the ``questionable specimen'' scenario, the DOT is
adopting the proposed amendment to Part 40 without change. All
commenters agreed that, when a second specimen in a situation calling
for a recollection under direct observation cannot be obtained for
``shy bladder'' reasons, it made sense to discard the first
questionable specimen and rely on the insufficient specimen process for
a result. In the insufficient specimen process, an MRO with advice from
a referral physician determines whether there was a refusal to test or
not. This approach of discarding the insufficient specimen is simple
and direct, and should reduce opportunities for confusion. It is also a
cost-relieving provision.

V. Section-by-Section Analysis

    This portion of the preamble discusses each of the provisions of
Part 40 amended by this final rule, including responses to comments on
matters that have not previously been discussed under ``Main Policy
Issues.''

A. Sections Concerning the Addition of Four Opioids to the DOT Drug
Testing Panel

    In the ``Main Policy Issues'' portion of the preamble, we discussed
the proposal to add four semi-synthetic opioids to the DOT drug testing
panel and responded to comments on that proposal. As noted there, the
Department is adopting this proposal. The primary section in which the
Department's decision to add these substances is carried out is Sec.
40.87, which lists each substance that is part of the DOT panel,
including the additions made by this final rule, together with the
initial test and confirmatory test cutoffs. There are parallel changes
in Sec.  40.85(d) and Appendices B and C, in each case changing the
term ``opiates'' to ``opioids.'' A commenter suggested rewording the
proposed language in Sec.  40.87, footnote 3, to match the language in
the HHS Mandatory Guidelines. After discussing this point with HHS, we
changed the wording from what was proposed to a more accurate and plain
language version, with no intended change in meaning. In Sec. Sec.
40.137 and 40.139, a slightly different term, ``semi-synthetic
opioids,'' is used in the contexts of differing standards for MRO
verification of ``natural'' opioid laboratory positives (e.g., codeine)
and the newly added semi-synthetic opioids to the DOT drug testing
panel (e.g., hydrocodone).

B. Definitions

    The final rule, like the NPRM, clarifies the definition of ``The
Department, DOT Agency'' and ``Drugs.'' The main change in the latter
is to use the broader term ``opioids'' in place of ``opiates,'' to
encompass the substances that the rule adds to the DOT drug panel.
There were few comments on the proposed changes to this section.
    One commenter requested that we clarify that NASA or its
contractors were not DOT agencies. As readers of the existing and new
versions of this

section will note, NASA is not listed as a DOT agency. As a Federal
agency, NASA is subject to the Federal employee program that uses the
HHS Mandatory Guidelines. Contractors to or employees of NASA or other
Federal agencies who are subject to DOT regulations in their own right
(e.g., because they perform safety-sensitive functions as pilots,
drivers or mariners who would be covered by the respective applicable
DOT agency regulations) would be covered by applicable DOT rules.
    We also included a technical amendment to this section based on a
recent official interpretation. Specifically, we are clarifying that
the USCG is only a DOT agency for the drug testing component of Part 40
since its regulation (46 CFR part 16) incorporates Part 40 for drug
testing and not for alcohol testing.

C. Three Provisions Related to Urine Specimens

Fatal Flaws
    The rationale for the Department's decision to add new items to the
list of ``fatal flaws'' and our response to comments on the proposal to
do so, are found in the ``Main Policy Issues'' portion of this
preamble. The affected provisions are Sec. Sec.  40.83(c) (concerning
fatal flaws detected by a laboratory as it processes a specimen) and
40.199 (concerning the MRO's responsibility to cancel tests in which
fatal flaws have been found).
Shy Bladder Process--``Questionable Specimens''
    As discussed under the Fatal Flaws and Questionable Specimens
heading in the Main Policy Issues portion of this preamble, after
considering the comments on the subject, the Department will require
the collector to discard any initial collection that was questionable
(e.g., out of temperature range, showing signs of tampering). The MRO
would then evaluate a ``shy bladder'' situation that developed if the
employee was unable to provide a sufficient specimen for the direct
observation recollection. This provision has been incorporated into
Sec.  40.193(b)(4).
Only Urine Specimens Are Authorized for Testing
    The NPRM proposed to add a new section, Sec.  40.210, clarifying,
that Part 40 authorizes drug testing of only urine specimens screened
and confirmed at HHS-certified laboratories. This means that point-of-
collection instant tests, hair tests, and oral fluid tests are not
presently allowed under Part 40 for DOT drug testing. There were four
comments on this proposal, all of which agreed with it.
    The Department is aware that a rulemaking that would authorize oral
fluid testing under the HHS Mandatory Guidelines is currently in
progress at HHS. If HHS authorizes this method of testing, DOT could
follow on with its own rulemaking to conform Part 40 to the revision of
the HHS Mandatory Guidelines, as long as the HHS final rule is in
accordance with OTETA's other requirements.
    Likewise, it is our understanding that HHS is considering whether
to authorize hair testing as part of the HHS Mandatory Guidelines. As
in the case of oral fluids, and given the Department's statutory
obligation to remain consistent with the HHS Mandatory Guidelines and
with OTETA's other obligations, if HHS authorizes the use of hair
testing in a manner consistent with OTETA requirements, then the
Department would follow suit in its own rulemaking to amend Part 40.
    We are also aware that there are unusual circumstances in which
testing other than urine testing can take place. For example, Federal
Railroad Administration (FRA) post-accident testing, under the
authority of 49 CFR part 219 (not Part 40), can involve blood testing
and the testing of other body fluids and tissues. Likewise, the USCG,
under the authority of 46 CFR part 4, may require other bodily fluids
or tissues be chemically tested to determine the presence or drugs or
alcohol for post-accident events. Part 40 recognizes certain situations
when a clinical evaluation performed under the direction of the MRO is
appropriate, and in those events the MRO may choose to use another
testing methodology (49 CFR 40.195(a)(3)). The MRO may use another
testing methodology in these narrow situations for the purpose of being
able to clarify that a donor is not using drugs, but not to show a
positive test result. However, these situations are not inconsistent
with the new Sec.  40.210, which states that for drug tests required by
Part 40, only urine testing is authorized.

D. Removing the Blind Specimen Testing Requirement

    The rationale for the Department's decision to remove the blind
specimen testing requirement, and our response to comments on the
proposal to do so, are found in the ``Main Policy Issues'' portion of
this preamble. As a result of this decision, sections, or references in
sections, pertaining to the former blind testing requirement have been
removed. The affected provisions are in Sec. Sec.  40.03, 40.29, 40.37,
40.103, 40.105, 40.123, 40.169, and 40.189.

E. Prohibition on DNA Testing of Urine Specimens

    The NPRM proposed adding a sentence to paragraph (f) of this
section further emphasizing the existing DOT prohibition on the use of
DNA testing on DOT drug testing specimens (Sec.  40.13(e)). The five
commenters who spoke to the proposal supported it. Several comments
supported the Department's long-standing grounds for its position
(e.g., that the CCF process provides sufficient evidence of the
identity of a specimen; that DNA testing would show only that an
original specimen and a reference specimen that the donor provided
behind closed doors were different, not that a donor's specimen was
misidentified). Some commenters added that the prohibition would
preclude further intrusions into an employee's privacy and potential
discrimination by employers against drivers whose DNA test revealed a
potential medical condition. The new language states that DNA testing
is not authorized and ODAPC will not give permission for such testing.
The Department is adopting the proposed language without change.

F. Legal Prescriptions and Additional Testing

    As discussed under the MRO Practice Issues heading in the Main
Policy Issues portion of this preamble, the Department proposed to add
a reference to legal prescriptions under the CSA to this section, as
well as to authorize MROs to obtain THC-V testing and testing for D,L
stereoisomers of amphetamine and methamphetamine at their discretion.
After considering the comments, almost all of which were supportive, as
discussed above, the Department has adopted this proposal with the
slight modification of ``consistent with'' instead of ``under,'' and
incorporated these changes in Sec. Sec.  40.137(b) and 40.135(e) for
consistency.

G. Minor Modification to Certain Section Headings

    The NPRM proposed to modify the section heading of Sec. Sec.
40.137 and 40.139 to incorporate the addition of the four new semi-
synthetic opioids. There were 10 comments on this proposal, all of
which agreed with it. The Department is adopting the proposed language
without change. Also, as commenters correctly pointed out, and as is
discussed under the MRO Practice Issues heading in the ``Main Policy
Issues'' portion of this

preamble, the proposed Sec.  40.139(c)(3) should be rephrased. This
paragraph should provide that, in a situation where there is a
laboratory positive for morphine or codeine (in the absence of a
finding of 6-AM) below 15,000 ng/mL, and the employee admits to
unauthorized use of one of the semi-synthetic opioids, the MRO does not
verify the test as positive. The final rule makes this correction.

H. Subscribing to the ODAPC List-Serve

    The rationale for the Department's decision to require key persons
in the DOT testing process to subscribe to the ODAPC, and our response
to comments on the proposal do so, are found in the ``Main Policy
Issues'' portion of this preamble. The Department is adopting the
proposed language without change. The affected provisions are
Sec. Sec.  40.33 (collectors), 40.121 (MROs), 40.213 (BATs/STTs), and
40.281 (SAPs).

I. Listing SAP Certification Organizations on ODAPC's Web Site

    The NPRM proposed moving organizations who provide SAP
credentialing listed in Sec.  40.281(a)(6) out of Part 40 and onto the
ODAPC Web site. We proposed this change to provide greater flexibility
for changes to the list and quicker updates. There were four comments
to the proposal, all of which supported it. The final rule adopts the
proposal without change.
    One commenter asked for clarification regarding whether there is a
``grace'' period when an organization is removed from the list and what
the timeline would be for a SAP to be `re-qualified' under one of the
approved organizations. When a certifying organization is added or
removed from the list, the Department intends to notify the list-serve
subscribers of the change. Since all SAPs will be required to subscribe
to the list-serve, each SAP would receive this important notification.
However, specific details regarding ``grace periods for
requalification'' would depend upon the facts of each situation and
would, therefore, be guidance that ODAPC would provide at the relevant
times.

J. Prohibition From Using the DOT or DOT Agency Name, Logos, or Other
Official Branding

    The Department is concerned that some service agents misrepresented
themselves as approved, certified, or endorsed by the Department, by
means including, but not limited to, the use of a DOT or DOT agency
logo, title, or emblem. Where we have found these misuses of DOT or DOT
agency names, logos, or other official branding, ODAPC has taken action
under the Public Interest Exclusion provisions to issue Notices of
Corrective Actions.
    The Department does not approve, certify, or endorse service agents
or their activities. We regard the use of such symbols or other means
as implying approval, certification or endorsement. When a service
agent makes such a representation, the Department views it as false and
deceptive holding-out by a party not part of the Federal Government.
For this reason, the NPRM proposed to specifically add such false
representations to the grounds on which the Department could initiate a
PIE proceeding against the offender.
    Five of the six comments on this subject supported this proposal
and its rationale. The sixth disagreed, on the basis that DOT did not
articulate a safety basis for the proposal and that it could impose an
unnecessary burden on companies using agency ``brands'' to distinguish
tests.
    The basis for the proposal is to prevent false and deceptive
representations by organizations marketing to DOT employers. Such
misrepresentations are at least misleading and at worst deliberately
deceptive. When a private party misrepresents that it is part of or
that it is certified, approved or endorsed by the DOT or a DOT agency,
this can have safety implications for an employer that relies on the
holding out of an endorsement if the service agent does not provide
services in accordance with DOT requirements. The Department and the
DOT Agencies are not ``brands,'' and their names should not be used as
if they were.
    One of the commenters who supported the proposal noted that
training materials should be able to include materials that may contain
screen shots or references to DOT Web sites, and publications that
contain DOT logos, titles, etc. We agree. We appreciate that employers
and service agents reproduce our publications and other materials
containing the DOT logos and this regulatory change would not prohibit
members of the public from using and/or reproducing the materials that
are produced by ODAPC and/or the DOT Agencies. The non-deceptive use of
such training materials is not something that we would view as
violating our rules because it does not indicate approval or
certification by the Department or a DOT agency.

K. Removing Obsolete Compliance Dates

    The NPRM proposed removing obsolete compliance dates from several
sections. For example, former Sec.  40.33(d) established compliance
dates for training then-existing collectors in 2001-2003. Similar
training deadlines, all of which were established as part of the
transition to the 1999 revision of Part 40 from previous editions, were
found in Sec. Sec.  40.121 (MROs), 40.213 (BATs/STTs), and 40.281
(SAPs). In addition, Sec. Sec.  40.45 and 40.203 contained a 2011 date
to complete a transition to a revised custody and control form. There
were four comments on these changes, all of which supported them. These
proposed changes are adopted in the final rule. In Sec.  40.121(d), we
also eliminated, as a commenter suggested, a reference to continuing
education units tied to one of the obsolete compliance dates.

L. Editorial Corrections

    In drafting the NPRM, we noted a few sections in which editorial
corrections would be helpful for purposes of clarification. In Sec.
40.67(n), we changed ``collector'' to ``service agent'' to clarify that
all service agents had a responsibility to ensure that a directly
observed collection was conducted when necessary. In Sec.  40.162(c) a
reference to Sec.  40.159(f) was corrected to cite paragraph (g) of
that section. In Sec.  40.233(b)(4), a reference to Sec.  40.333(a)(2)
was corrected to cite paragraph (a)(3) of that section. There were
three comments on these proposals, all of which agreed with the
proposed changes. These changes are adopted in the final rule.

M. Updating Specified Appendices to Part 40

    The NPRM proposed to update the following appendices: Appendices B
and C, to add the four semi-synthetic opioids to the drugs listed and
remove MDEA; Appendix D, to update a web link; and Appendix H, to
remove the instruction sheet for the Management Information System Data
Collection from our regulations and move it to our guidance material
located on our Web site. The reason for proposing to move the MIS
instruction sheet to the ODAPC Web site was to provide greater
flexibility for changes and/or updates to this document. There were
seven comments to the proposal to update the appendices, all of which
supported it. The final rule adopts this proposal without change.

N. Updating Web Links

    The Department proposed to update web links in the rule text that
have changed on our DOT Web site. There were four comments to this
proposal, all of which supported the proposal. In several sections, the
Department updated the ODAPC Web address to the

current http://www.transaportation.gov/odapc. The affected sections are
Sec. Sec.  40.33, 40.45, 40.105, 40.121, 40.205, 40.213, 40.225,
40.281, and 40.401. In addition, in Appendix D, the Department updated
the Web link for reporting split specimens failing to reconfirm to
https://www.transportation.gov/content/split-specimen-cancellation-notification-49-cfr-part-40187-appendix-d. These updates are adopted in
the final rule.

O. Alcohol Testing Device Web Links

    Though not among the originally proposed changes, we are making a
technical amendment to make it easier to permit employers to use
alcohol testing devices approved by the National Highway Traffic Safety
Administration (NHTSA), which are the only devices permitted to be used
for DOT alcohol testing. Since 1994, the regulation has required
employers and service agents to only us a device once the device was
approved by NHTSA and appeared on NHTSA's conforming products lists
(CPLs) for alcohol screening devices (ASDs) and Evidential Breath
Testing Devices (EBTs). NHTSA used the CPLs to add approved devices and
remove devices as appropriate. Because there was no regular schedule
with which the CPLs were published, employers and alcohol technicians
were prohibited by the regulation from using newly approved devices
because a new CPL was not published. To permit employers and alcohol
technician the ability to use a device as soon possible after NHTSA
approves it, we will now list the NHTSA-approved ASDs on a new ODAPC
Web page entitled ``Approved Screening Devices to Measure Alcohol in
Bodily Fluids'' and we will now list the NHTSA approved EBTs on new
ODAPC Web page for ``Approved Evidential Breath Measurement Devices.''
Although, we will no longer require regulated parties to check the
actual CPL, we will continue to rely on NHTSA for approval and removal
of the devices. ODAPC will take responsibility for creating and
continuing to keep the Web pages updated whenever NHTSA notifies us
that a device has been approved and added to the list, or removed from
the list. This is purely an administrative change as to where to find
the list of approved devices. There are no costs associated with this
technical change and it should be burden-reducing because it will avoid
confusion that has been occurring for DOT-regulated parties and for the
product manufacturers. Accordingly, we have made changes to Sec. Sec.
40.3; 40.229; 40.231; 40.233 and 40.235.

VI. Other Comments

    There were two comments concerning the cost-benefit analysis. Those
comments are addressed in the regulatory analysis section titled
Executive Order 12866 and 13563 and DOT's Regulatory Policies and
Procedures.
    There were a number of comments that were outside the scope of the
NPRM, such as including (or not including) hair or oral fluid testing
in the DOT program, reducing the subject matter of refresher training
for BATs/STTs, including additional drugs (e.g., benzodiasepines) in
the drug testing panel, providing more oversight of MRO decisions,
changing some criteria for testing in the Federal Transit
Administration rules (49 CFR part 655), broadening the use of
electronic signatures in the program, allowing laboratories to use
their own protocols for substituted specimen situations, reporting from
laboratories to MROs through a third party, and criteria for
determining when a test is considered to have been refused. While these
and other matters may be worth consideration at a later time, they are
outside the scope of the present rulemaking.

VII. Regulatory Analyses and Notices

    Changes to Federal regulations are subject to a number of
regulatory requirements, which are identified and discussed below.
First, Executive Orders 12866 and 13563 direct that each Federal agency
shall propose or adopt a regulation only upon a reasoned determination
that the benefits of the intended regulation justify its costs. Second,
the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as codified in
5 U.S.C. 601 et seq., requires agencies to analyze the economic impact
of regulatory changes on small entities. The Paperwork Reduction Act of
1995 (PRA) (44 U.S.C. 3501 et seq.) requires that DOT consider the
impact of paperwork and other information collection burdens imposed on
the public and, under the provisions of PRA section 3507(d), obtain
approval from OMB for each collection of information it conducts,
sponsors, or requires through regulations. Section (a)(5) of division H
of the Fiscal Year 2005 Omnibus Appropriations Act, Public Law 108-447,
118 Stat. 3268 (Dec. 8, 2004) and section 208 of the E-Government Act
of 2002, Public Law 107-347, 116 Stat. 2889 (Dec. 17, 2002) requires
DOT to conduct a Privacy Impact Assessment (PIA) of a regulation that
will affect the privacy of individuals. Finally, the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq.)
requires DOT to analyze this action to determine whether it will have
an effect on the quality of the environment. This portion of the
preamble summarizes the DOT's analyses of these impacts with respect to
this rule.

Executive Order 12866 and 13563 and DOT's Regulatory Policies and
Procedures

    This final rule is not a significant regulatory action under
Executive Order 12866 and 13563, as well as the Department's Regulatory
Policies and Procedures (44 FR 11034). It proposes to harmonize
specific Part 40 procedures with recently mandated HHS Guidelines and,
in the interest of improving efficiency, make certain program
modifications. As such, this proposal would not impose any major policy
changes and would not impose any significant new costs or burdens.

Costs

The NPRM
    As noted in the Department's NPRM, the HHS Mandatory Guidelines
addressed the burdens associated with the addition of new drugs to the
drug-testing panel (82 FR 7920, January 23, 2017). The cost impact of
drug testing for oxycodone, oxymorphone, hydrocodone, and hydromorphone
would be minimal because HHS determined that all HHS-certified
laboratories testing specimens from Federal agencies are currently
conducting tests for one or more of these analytes on non-regulated
urine specimens. HHS further indicated in its analysis that laboratory
personnel currently are trained to test for the additional drugs and
test methods already have been implemented. Many HHS-certified
laboratories conduct non-regulated tests for transportation employers
who already include the four semi-synthetic opioids in their non-
regulated testing programs. For those employers, therefore, shifting
the four drugs from non-regulated tests to regulated tests would not
increase testing costs.
    HHS determined that the costs associated with implementation of
testing for the four additional semi-synthetic opioids would be
approximately $0.11-$0.30 per test. Once the testing has been
implemented, the cost per specimen for initial testing for the added
analytes would range from $.06 to $0.20 due to reagent costs. Current
costs for each confirmatory test range from $5.00 to $10.00 for each
specimen reported as positive due to

costs of sample preparation and analysis. HHS indicated that based on
information from non-regulated workplace drug testing for these
analytes in 2012 and testing performed on de-identified federally
regulated specimens in 2011, approximately 1% of the submitted
specimens is expected to be confirmed as positive for the added
analytes. Therefore, HHS indicates that the added cost for confirmatory
testing will be $0.05 to $0.10 per submitted specimen.
    Approximately 6.3 million DOT-regulated tests occur per year. DOT
considered the maximum ranges HHS provided in its analysis. Therefore,
with the projected maximum implementation cost per specimen of $0.30,
the maximum cost per specimen of initial testing at $0.20, and the
maximum cost per specimen of confirmation testing at $0.10, the
additional cost per urine test would be an additional $0.60. Under the
new HHS Mandatory Guidelines, and based on an estimated 6.3 million DOT
tests conducted annually, a cost of approximately $3,800,000 would be
realized by employers subject to DOT-regulated testing ($0.60 x
6,300,000 DOT tests annually = $3,780,000).
    HHS indicated that there will be minimal costs associated with
adding MDA as an initial test analyte because the current immunoassays
can be adapted to test for this analyte. According to HHS, before a lab
is allowed to test regulated specimens for MDA, HHS must test three
groups of performance test, or ``PT'' samples. HHS provides the PT
samples at no cost to its certified laboratories but HHS estimates that
the laboratory costs to conduct the PT testing would range from $900 to
$1,800 for each certified laboratory. There are approximately 27 HHS-
certified laboratories who process DOT drug tests. With the maximum
cost estimate of $1,800 for each certified laboratory, a cost of
approximately $48,600 would be realized for DOT ($1,800 x 27
laboratories = $48,600.)
    Testing for additional drugs would result in new MRO costs, as MROs
would have additional review and verification to conduct. Based on the
positivity rates from non-regulated workplace drug testing and the
additional review of specimens with a laboratory confirmed positive for
prescription medications, HHS estimates that MRO costs would increase
by approximately 3%. The additional costs for testing and MRO review
would be incorporated into the overall cost for the Federal agency
submitting the specimen to the laboratory. HHS bases the estimation of
costs incurred on overall cost to the Federal agency affected because
cost is usually based on all specimens submitted from an agency, rather
than individual specimen testing costs or MRO review of positive
specimens. Based on this analysis, therefore, DOT projects an
additional MRO cost of $189,000 (.03 projected increase x 6,300,000 DOT
tests annually).
Comments
    There were two comments on our cost estimates. One questioned the
projected cost savings of the proposal to eliminate the blind specimen
testing requirement. Specifically, the commenter said that the cost
savings were inflated because we did not take into consideration the
50-blind specimen limit per quarter and that blinds are not required to
be submitted for employers with fewer than 2,000 employees. The same
commenter also questioned why DOT did not factor in increased potential
costs that were mentioned by commenters in the HHS rulemaking such as,
increased estimated MRO costs of 10% and start-up costs to laboratories
to implement testing for the additional analytes. Another commenter
requested that we further explain the analysis for the costs associated
with confirmation testing. Specifically, the commenter wanted us to
adjust the cost-benefit analysis to address confirmation test costs for
the four prescription drug initial positive tests, not just the
projected 1% of the specimens that are confirmed positive. The
commenter suggested that, when making this calculation, DOT consider
using laboratory data for the percentage of positive test results that
will require a confirmation test.
DOT Response
    Regarding the blind specimen costs, our response is included in the
`cost-savings' paragraph of this section. As for the comment about not
factoring in potential costs that were mentioned by commenters in the
HHS rulemaking, we did not see the need to address them since HHS
already responded to those comments (82 FR 7931). In short, HHS assumed
the start-up costs for testing the four semi-synthetic opioids, and
changes to the amphetamines would be de minimis given that laboratories
could use existing immunoassays.
    To further explain the costs associated with verifying test results
for the additional semi-synthetic opioids, we agree with the commenters
that the 3% estimated by HHS may not be sufficient for calculating the
costs to the DOT-regulated industries. We have added the full cost of
the MRO review of the non-negative results for the four semi-synthetic
opioids instead of just the additional 3% estimated by HHS. As we
understand it, the upper limit cost of a MRO review for non-negatives
is approximately $60. Given the estimated 1% (63,000) of specimens
confirming for the semi-synthetic opioids, the estimated additional
costs for MRO reviews resulting from this final rule would be
$3,780,000 ($60 x 63,000).
    Regarding the specific comment for DOT to consider the confirmation
test costs for the four prescription drug initial positive tests, not
just the projected 1% of the specimens that are confirmed positive, the
Department has no basis to conclude that there will be an additional
cost to DOT-regulated employers for specimens that screen positive but
do not confirm as positive. Furthermore, the commenters did not provide
any data to support their assertion. As we understand it and as
explained in our ``What Employers Need to Know About DOT Drug and
Alcohol Testing'' handbook, employers may choose one of two pricing
structures, bundled and unbundled. Bundled pricing means that one-
price-fits-all. The price of the bundle is dependent on various factors
like volume and positive rate. In unbundled pricing, it is `a la carte'
pricing for each test the laboratory has to run. Our projected costs
assume a bundled pricing structure since it appears to be widely used.
    We also want to address two issues related to information we
provided in our NPRM. First, we incorrectly associated the full cost of
the Proficiency Testing (PT) to only the cost of testing for MDA.
However, based on HHS final rule [82 FR 7931], the cost for PT testing
($48,600) is for all the semi-synthetic opioids and MDA, not just MDA.
Accordingly, our cost analysis now correctly articulates that the cost
of PT is for all the compounds as outlined in HHS' final rule. This
does not change the quantified cost of the rule. Second, we estimated
that the per specimen cost would be an additional $0.60 (implementation
cost of $0.30 and a maximum screening and confirmation testing cost of
$0.30) for a total cost of $3,780,000 ($0.60 x 6,300,000). As we
mentioned earlier, HHS assumed the start-up costs would be de minimis.
DOT agrees that the start-up costs are expected to be de minimis.
Therefore, we have removed the implementation costs (approximately an
additional $0.30 per specimen) that were originally proposed. Thus, a
cost of $1,890,000 ($0.30 x 6,300,000) would be realized by employers
subject to DOT-regulated testing and not the $3,780,000 we originally
estimated.

    On a final note, we acknowledge potential costs that were not
discussed in the NPRM for those employees with positive test results
that would potentially go through the return-to-duty process. As we
mentioned earlier, we estimated that 1% (63,000) of the specimens will
be confirmed for one or more of the semi-synthetic opioids. Based on
MRO's experiences in non-DOT testing that 80% of the semi-synthetic
results will be downgraded to `negative' due to legitimate medical
explanations (e.g., valid prescriptions), we estimate that only 12,600
of the 63,000 laboratory confirmed positives will be reported by the
MRO as verified positive. We further estimate that, of the 12,600
verified positive results, approximately 25% (3,150) will participate
in the return-to-duty process. The other individuals will not return to
positions that require DOT testing or will continue working at their
non-DOT positions. With the mandatory Substance Abuse Professional
(SAP) evaluation costing approximately $400, the return-to-duty test
costing approximately $50, and the minimum of six follow-up tests
costing approximately $300 (6 x $50), the return-to-duty cost would be
approximately $750 per employee. Altogether, the Department estimates
the total return-to-duty costs to be approximately $2,362,500 (3,150 x
$750).
    This estimate does not include costs associated with education or
treatment that the employee completes before taking the required
return-to-duty test. A verified positive result merely identifies that
the individual needs to seek treatment. The positive result does not
create the employee's condition. By seeking treatment sooner than
later, the potential costs associated with education and treatment for
an individual that tests positive could be less than if the employee
did not test positive.

Cost-Savings

The NPRM
    In the NPRM, DOT estimated a cost-savings of at least $3.1 million
per year from the elimination of the requirement for employers to
submit blind specimen testing to laboratories (estimated at
approximately $50 per test). This estimate of cost-savings is based on
the regulatory analysis performed when DOT reduced blind specimen
testing in 2000 (65 FR 79462, 79517, Dec. 19, 2000), adjusted for
inflation. Based on the blind specimen requirements made effective in
2000 for employers to submit 1% of 6,300,000 DOT tests for blind
testing conducted annually at a cost of approximately $50 per test
yields a cost-savings of $3,150,000 (63,000 x $50).
Comments
    One commenter suggested that the savings from the elimination of
blind specimen testing had been overestimated, because the cost-benefit
analysis did not take into account the 50-specimen maximum and the
requirement that only employers with more than 2,000 covered employees
were required to submit blind specimens.
DOT Response
    We revised our calculation to take into consideration the
commenter's concerns. Our revised calculation takes into account: The
estimated number of DOT-regulated employers (728,324) and employees
(5,192,065); the known number of employers (175) with employee counts
from 2,000 to 50,000; an estimated number of C/TPAs (2,158) with an
employee count of 2,000; the 25% random testing rate and estimated
number of other tests; the 1% blind specimen rate; and an estimated
cost of $50 per blind specimen test. The estimated number of C/TPAs is
based on the assumption that the smaller employers (employers with less
than 2,000 employees), would join a C/TPA to administer their random
testing pools and other aspects of the DOT program and include them in
their consortium. Accordingly, we project annual cost-savings from
eliminating the blinds would be $1,298,016. We have placed in the
docket for this rulemaking a document describing the basis for this
estimate and calculation in greater detail.

Net Economic Impact

    The DOT believes the projected cost to the DOT of implementing
testing for the additional drugs being added to the drug-testing
regimen will be minimal. The projected $1,938,600 for the four semi-
synthetic opioid drugs and PT testing ($1,890,000 and $48,600
respectively) and the $3,780,000 projected MRO costs would result in
total projected costs of $5,718,600. The projected cost savings from
eliminating the blind specimen testing requirement would be $1,298,016.
The estimated net cost impact of this proposal, therefore, would be
$4,420,584 ($5,718,600 - $1,298,016) per year. This rule will not have
an economically significant impact under Executive Order 12866 because
it would not have an annual effect on the economy of $100 million or
more, nor do we have any basis to conclude that it would adversely
affect any sector of the economy.

Regulatory Flexibility Analysis

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354, ``RFA''), 5
U.S.C. 601 et seq., establishes ``as a principle of regulatory issuance
that agencies shall endeavor, consistent with the objectives of the
rule and of applicable statutes, to fit regulatory and informational
requirements to the scale of the businesses, organizations, and
governmental jurisdictions subject to regulation. To achieve this
principle, agencies are required to solicit and consider flexible
regulatory proposals and to explain the rationale for their actions to
assure that such proposals are given serious consideration.'' The RFA
covers a wide-range of small entities, including small businesses, not-
for-profit organizations, and small governmental jurisdictions.
    Agencies must perform a review to determine whether a proposed rule
would have a significant economic impact on a substantial number of
small entities. If the agency determines that it would, the agency must
prepare a regulatory flexibility analysis. However, if an agency
determines that it is not expected to have a significant economic
impact on a substantial number of small entities, section 605(b)
provides that the head of the agency may so certify, and a regulatory
flexibility analysis would not be required. The certification must
include a statement providing the factual basis for this determination,
and the reasoning should be clear.
    This final rule conforms the existing DOT drug-testing panel to
recently issued HHS Mandatory Guidelines and, with certain minor
amendments (mostly editorial), to improve the efficiency of the DOT
drug-testing program. The net costs of this rule do not constitute a
significant burden to any entity, small or otherwise. Consequently, the
DOT certifies, under the RFA, that this rule will not have a
significant economic impact on a substantial number of small entities.

Federalism

    This rule has been analyzed in accordance with the principles and
criteria contained in Executive Order 13132 (``Federalism''). This rule
does not include requirements that (1) have substantial direct effects
on the States, the relationship between the national government and the
States, or the distribution of power and responsibilities among the
various levels of government, (2) impose substantial direct compliance
costs on State and local governments, or (3)

preempt State law. Therefore, the consultation and funding requirements
of Executive Order 13132 do not apply.

Paperwork Reduction Act/Privacy Act

    The Paperwork Reduction Act requires that the DOT consider the
impact of paperwork and other information collection burdens imposed on
the public. Information collections for Part 40 currently are approved
under OMB Control No. 2105-0529. The Privacy Act provides safeguards
against invasion of personal privacy through the misuse of records by
Federal Agencies. It establishes controls over what personal
information is collected, maintained, used and disseminated by agencies
in the executive branch of the Federal government.
    This rule does not create any new paperwork or other information
collection burdens needing approval, nor would it require any further
protections under the Privacy Act.

National Environmental Policy Act

    The Department 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, Oct. 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). See 40 CFR
1508.4. In analyzing the applicability of a categorical exclusion,
Federal agencies also must consider whether extraordinary circumstances
are present that would warrant the preparation of an EA or EIS. This
rule does not meet any of these criteria. The Department does not
anticipate any environmental impacts, and there are no extraordinary
circumstances present in connection with this rulemaking.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) does
not require a written statement for this final rule because the rule
does not include a Federal mandate that may result in the expenditure
in any one year of $155,000,000 or more by State, local, and tribal
governments, or the private sector.
Executive Order 13771: Reducing Regulation and Controlling Regulatory
Costs
    Executive Order 13771 titled ``Reducing Regulation and Controlling
Regulatory Costs,'' directs that, unless prohibited by law, whenever an
executive department or agency publicly proposes for notice and comment
or otherwise promulgates a new regulation, it shall identify at least
two existing regulations to be repealed. In addition, any new
incremental costs associated with new regulations shall, to the extent
permitted by law, be offset by the elimination of existing costs. This
rule is not an Executive Order 13771 regulatory action because this
rule is not significant under Executive Order 12866.

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.

The Final Rule

    For reasons discussed in the preamble, the Department of
Transportation is amending part 40 of Title 49 Code of Federal
Regulations, as follows:

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

0
1. The authority citation for 49 CFR part 40 is revised to read as
follows:

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

0
2. Amend Sec.  40.3 as follows:
0
a. Revise the definition of ``Alcohol screening device (ASD)'';
0
 b. Remove the definition ``Blind specimen or blind performance test
specimen'';
0
c. Revise and reorder (in correct alphabetical order) the definition
``DOT, the Department, DOT Agency'';
0
 d. Revise the definition ``Drugs''; and
0
 e. Revise the definition of ``Evidential breath testing device
(EBT)''.
    The revisions read as follows:

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

* * * * *
    Alcohol screening device (ASD). A breath or saliva device, other
than an EBT, that is approved by the National Highway Traffic Safety
Administration (NHTSA) and appears on ODAPC's Web page for ``Approved
Screening Devices to Measure Alcohol in Bodily Fluids'' because it
conforms to the model specifications from NHTSA.
* * * * *
    DOT, The Department, DOT Agency. These terms encompass all DOT
agencies, including, but not limited to, the Federal Aviation
Administration (FAA), the Federal Railroad Administration (FRA), the
Federal Motor Carrier Safety Administration (FMCSA), the Federal
Transit Administration (FTA), the National Highway Traffic Safety
Administration (NHTSA), the Pipeline and Hazardous Materials Safety
Administration (PHMSA), and the Office of the Secretary (OST). For
purposes of this part, the United States Coast Guard (USCG), in the
Department of Homeland Security, is considered to be a DOT agency for
drug testing purposes only since the USCG regulation does not
incorporate Part 40 for its alcohol testing program. These terms
include any designee of a DOT agency.
* * * * *
    Drugs. The drugs for which tests are required under this part and
DOT agency regulations are marijuana, cocaine, amphetamines,
phencyclidine (PCP), and opioids.
* * * * *
    Evidential Breath Testing Device (EBT). A device that is approved
by the National Highway Traffic Safety Administration (NHTSA) for the
evidential testing of breath at the .02 and .04 alcohol concentrations,
and appears on ODAPC's Web page for ``Approved Evidential Breath
Measurement Devices'' because it conforms with the model specifications
available from NHTSA.
* * * * *

0
3. Revise Sec.  40.26 to read as follows:

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

    As an employer, when you are required to report MIS data to a DOT
agency, you must use the U.S. Department of Transportation Drug and
Alcohol Testing MIS Data Collection Form to report that data. You must
use the form at appendix H to this part. You may view and download the
instructions on the Department's Web site (https://www.transportation.gov/odapc). You must submit the MIS report in
accordance with rule requirements (e.g., dates for submission,
selection of companies required to submit, and method of reporting)
established by the DOT agency regulating your operation.

Sec.  40.29   [Amended]

0
4. Amend Sec.  40.29 by removing the entry ``Sec. Sec.  40.103-40.105--
Blind specimen requirements.''

0
5. Amend Sec.  40.33 by revising paragraphs (a) and (d) to read as
follows:

Sec.  40.33   What training requirements must a collector meet?

* * * * *
    (a) Basic information. You must be knowledgeable about this part,
the current ``DOT Urine Specimen Collection Procedures Guidelines,''
and DOT agency regulations applicable to the employers for whom you
perform collections. DOT agency regulations, the DOT Urine Specimen
Collection Procedures Guidelines, and other materials are available
from ODAPC (Department of Transportation, 1200 New Jersey Avenue SE.,
Washington DC, 20590,<PHONE_NUMBER>, or on the ODAPC Web site (https://www.transportation.gov/odapc). You must keep current on any changes to
these materials. You must subscribe to the ODAPC list-serve at: https://www.transportation.gov/odapc/get-odapc-email-updates.
* * * * *
    (d) You must meet the requirements of paragraphs (b) and (c) of
this section before you begin to perform collector functions.
* * * * *

Sec.  40.37   [Amended]

0
6. Amend Sec.  40.37 by removing the entry ``Sec.  40.103--Processing
blind specimens.''

Sec.  40.45   [Amended]

0
7. Amend Sec.  40.45(a) by removing the parenthetical ``(http://www.dot.gov/odapc)'' and adding, in its place ``(http://www.transportation.gov/odapc)'' and Sec.  40.45(b) by removing the
parenthetical ``(e.g., that after November 30, 2011, they must not use
an expired CCF for DOT urine collections)''

0
8. Amend Sec.  40.67 by revising paragraph (n) to read as follows:

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

* * * * *
    (n) As a service agent, when you learn that a directly observed
collection should have been collected but was not, you must inform the
employer that it must direct the employee to have an immediate
recollection under direct observation.

0
9. Amend Sec.  40.83 by revising paragraph (c) to read as follows:

Sec.  40.83  How do laboratories process incoming specimens?

* * * * *
    (c) You must inspect each specimen and CCF for the following
``fatal flaws:''
    (1) There is no CCF;
    (2) In cases where a specimen has been collected, there is no
specimen submitted with the CCF;
    (3) There is no printed collector's name and no collector's
signature;
    (4) Two separate collections are performed using one CCF;
    (5) The specimen ID numbers on the specimen bottle and the CCF do
not match;
    (6) The specimen bottle seal is broken or shows evidence of
tampering, unless a split specimen can be redesignated (see paragraph
(h) of this section);
    (7) There is an insufficient amount of urine in the primary bottle
for analysis, unless the specimens can be redesignated (see paragraph
(h) of this section).
* * * * *

0
10. Revise Sec.  40.85 to read as follows:

Sec.  40.85   What drugs do laboratories test for?

    As a laboratory, you must test for the following five drugs or
classes of drugs in a DOT drug test. You must not test ``DOT
specimens'' for any other drugs.
    (a) Marijuana metabolites.
    (b) Cocaine metabolites.
    (c) Amphetamines.
    (d) Opioids.
    (e) Phencyclidine (PCP).

0
11. Amend Sec.  40.87 by revising paragraph (a) to read as follows:

Sec.  40.87  What are the cutoff concentrations for drug tests?

    (a) As a laboratory, you must use the cutoff concentrations
displayed in the following table for initial and confirmatory drug
tests. All cutoff concentrations are expressed in nanograms per
milliliter (ng/mL). The table follows:

----------------------------------------------------------------------------------------------------------------
                                       Initial test cutoff      Confirmatory test      Confirmatory test cutoff
        Initial test analyte                   \1\                   analyte                concentration
----------------------------------------------------------------------------------------------------------------
Marijuana metabolites (THCA) \2\...  50 ng/mL\3\...........  THCA..................  15 ng/mL.
Cocaine metabolite                   150 ng/mL \3\.........  Benzoylecgonine.......  100 ng/mL.
 (Benzoylecgonine).
Codeine/...........................  2000 ng/mL............  Codeine...............  2000 ng/mL.
Morphine...........................                          Morphine..............  2000 ng/mL.
Hydrocodone/.......................  300 ng/mL.............  Hydrocodone...........  100 ng/mL.
Hydromorphone......................                          Hydromorphone.........  100 ng/mL.
Oxycodone/.........................  100 ng/mL.............  Oxycodone.............  100 ng/mL.
Oxymorphone........................                          Oxymorphone...........  100 ng/mL.
6-Acetylmorphine...................  10 ng/mL..............  6-Acetylmorphine......  10 ng/mL.
Phencyclidine......................  25 ng/mL..............  Phencyclidine.........  25 ng/mL.
Amphetamine/.......................  500 ng/mL.............  Amphetamine...........  250 ng/mL.
Methamphetamine....................                          Methamphetamine.......  250 ng/mL.
MDMA \4\/MDA \5\...................  500 ng/mL.............  MDMA..................  250 ng/mL.
                                                             MDA...................  250 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., 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, [Delta]-9-tetrahydrocannabinol-9-carboxylic acid
  (THCA).
\3\ Alternate technology (THCA and Benzoylecgonine): When using an alternate technology initial test for the
  specific target analytes of THCA and Benzoylecgonine, the laboratory must use the same cutoff for the initial
  and confirmatory tests (i.e., 15 ng/mL for THCA and 100ng/mL for Benzoylecgonine).
\4\ Methylenedioxymethamphetamine (MDMA).
\5\ Methylenedioxyamphetamine (MDA).

* * * * *

Sec.  40.103   [Removed]

0
12. Remove Sec.  40.103.

Sec.  40.105   [Removed]

0
13. Remove Sec.  40.105.

0
14. Amend Sec.  40.121 by revising paragraphs (b)(3) and (c)(3), and
the paragraph (d) introductory text to read as follows:

Sec.  40.121   Who is qualified to act as an MRO?

* * * * *
    (b) * * *
    (3) You must be knowledgeable about this part, the DOT MRO
Guidelines, and the DOT agency regulations applicable to the employers
for whom you evaluate drug test results, and you must keep current on
any changes to these materials. You must subscribe to the ODAPC list-
serve at https://www.transportation.gov/odapc/get-odapc-email-updates.
DOT agency regulations, DOT MRO Guidelines, and other materials are
available from ODAPC (Department of Transportation, 1200 New Jersey
Avenue SE, Washington, DC 20590,<PHONE_NUMBER>), or on the ODAPC Web
site (http://www.transportation.gov/odapc).
    (c) * * *
    (3) You must meet the requirements of paragraphs (a), (b), and (c)
of this section before you begin to perform MRO functions.
    (d) Requalification training. During each five-year period from the
date on which you satisfactorily completed the examination under
paragraph (c)(2) of this section, you must complete requalification
training.
* * * * *

0
15. Amend Sec.  40.123 by revising paragraph (e) to read as follows:

Sec.  40.123  What are the MRO's responsibilities in the DOT drug
testing program?

* * * * *
    (e) You must act to investigate and correct problems where possible
and notify appropriate parties (e.g., HHS, DOT, employers, service
agents) where assistance is needed, (e.g., cancelled or problematic
tests, incorrect results).
* * * * *

0
16. Amend Sec.  40.135 by revising paragraph (e) to read as follows:

Sec.  40.135  What does the MRO tell the employee at the beginning of
the verification interview?

* * * * *
    (e) You must also advise the employee that, before informing any
third party about any medication the employee is using pursuant to a
legally valid prescription consistent with the Controlled Substances
Act, you will allow 5 business days from the date you report the
verified negative result for the employee to have the prescribing
physician contact you to determine if the medication can be changed to
one that does not make the employee medically unqualified or does not
pose a significant safety risk. If, in your reasonable medical
judgment, a medical qualification issue or a significant safety risk
remains after you communicate with the employee's prescribing physician
or after 5 business days, whichever is shorter, you must follow Sec.
40.327. If, as the MRO, you receive information that eliminates the
medical qualification issue or significant safety risk, you must
transmit this information to any third party to whom you previously
provided information under Sec.  40.327.

0
17. Amend Sec.  40.137 by revising the section heading and paragraph
(a) to read as follows:

Sec.  40.137  On what basis does the MRO verify test results involving
marijuana, cocaine, amphetamines, semi-synthetic opioids, or PCP?

    (a) As the MRO, you must verify a confirmed positive test result
for marijuana, cocaine, amphetamines, semi-synthetic opioids (i.e.,
hydrocodone, hydromorphone, oxycodone, and oxymorphone), and/or PCP
unless the employee presents a legitimate medical explanation for the
presence of the drug(s)/metabolite(s) in his or her system. In
determining whether an employee's legally valid prescription consistent
with the Controlled Substances Act for a substance in these categories
constitutes a legitimate medical explanation, you must not question
whether the prescribing physician should have prescribed the substance.
* * * * *

0
18. Amend Sec.  40.139 by revising the section heading and paragraphs
(c) introductory text and (c)(3) to read as follows:

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

* * * * *
    (c) For all other codeine and morphine positive results, you must
verify a confirmed positive test result only if you determine that
there is clinical evidence, in addition to the urine test, of
unauthorized use of any opium, opiate, or opium derivative (i.e.,
morphine, codeine, or heroin).
* * * * *
    (3) To be the basis of a verified positive result for codeine or
morphine, the clinical evidence you find must concern a drug that the
laboratory found in the specimen. (For example, if the test confirmed
the presence of codeine, and the employee admits to unauthorized use of
hydrocodone, you must not verify the test positive for codeine. The
admission must be for the substance that was found through the actual
drug test.)
* * * * *

0
19. Amend Sec.  40.141 by revising paragraph (b) to read as follows:

Sec.  40.141  How does the MRO obtain information for the verification
decision?

* * * * *
    (b) If the employee asserts that the presence of a drug or drug
metabolite in his or her specimen results from taking prescription
medication (i.e., a legally valid prescription consistent with the
Controlled Substances Act), you must review and take all reasonable and
necessary steps to verify the authenticity of all medical records the
employee provides. You may contact the employee's physician or other
relevant medical personnel for further information. You may request an
HHS-certified laboratory with validated protocols (see Sec.  40.81(c))
to conduct testing for D,L stereoisomers of amphetamine and
methamphetamine or testing for tetrahydrocannabivarin (THC- V) when
verifying lab results, as you determine necessary.

0
20. Amend Sec.  40.162 by revising paragraph (c) to read as follows:

Sec.  40.162  What must MROs do with multiple verified results for the
same testing event?

* * * * *
    (c) As an exception to paragraphs (a) and (b) of this section, as
the MRO, you must follow procedures at Sec.  40.159(g) when any
verified non-negative result is also invalid.

Sec.  40.169   [Amended]

0
21. Amend Sec.  40.169 by removing the entry ``Sec.  40.105--
Notification of discrepancies in blind specimen results.''

Sec.  40.189   [Amended]

0
22. Amend Sec.  40.189 by removing the entry ``Sec.  40.103--Blind
split specimens.''

0
23. Amend Sec.  40.193 by revising paragraph (b)(4) to read as follows:

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

* * * * *
    (b) * * *

    (4) 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 to include 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.
* * * * *

0
24. Amend Sec.  40.199 by revising paragraph (b) to read as follows:

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

* * * * *
    (b) The following are ``fatal flaws'':
    (1) There is no CCF;
    (2) In cases where a specimen has been collected, there is no
specimen submitted with the CCF;
    (3) There is no printed collector's name and no collector's
signature;
    (4) Two separate collections are performed using one CCF;
    (5) The specimen ID numbers on the specimen bottle and the CCF do
not match;
    (6) The specimen bottle seal is broken or shows evidence of
tampering (and a split specimen cannot be re-designated, see Sec.
40.83(h)); or
    (7) Because of leakage or other causes, there is an insufficient
amount of urine in the primary specimen bottle for analysis and the
specimens cannot be re-designated (see Sec.  40.83(h)).
* * * * *

0
25. Amend Sec.  40.203 by revising paragraph (d)(3) to read as follows:

Sec.  40.203  What problems cause a drug test to be cancelled unless
they are corrected?

* * * * *
    (d) * * *
    (3) The collector uses a non-Federal form or an expired CCF for the
test. This flaw may be corrected through the procedure set forth in
Sec.  40.205(b)(2), provided that the collection testing process has
been conducted in accordance with the procedures in this part in an
HHS-certified laboratory.

0
26. Add Sec.  40.210 to subpart I to read as follows:

Sec.  40.210  Are drug tests other than urine permitted under the
regulations?

    No. Drug tests other than on urine specimens are not authorized for
testing under this part. Only urine specimens screened and confirmed at
HHS certified laboratories (see Sec.  40.81) are allowed for drug
testing under this part. Point-of-collection urine testing or instant
tests are not authorized.

0
27. Amend Sec.  40.213 by revising paragraphs (a), (d), and (e) to read
as follows:

Sec.  40.213  What training requirements must STTs and BATs meet?

* * * * *
    (a) You must be knowledgeable about the alcohol testing procedures
in this part and the current DOT guidance. Procedures and guidance are
available from ODAPC (Department of Transportation, 1200 New Jersey
Avenue SE., Washington, DC 20590,<PHONE_NUMBER>, or on the ODAPC Web
site, http://www.transportation.gov/odapc). You must keep current on
any changes to these materials. You must subscribe to the ODAPC list-
serve at (https://www.transportation.gov/odapc/get-odapc-email-updates).
* * * * *
    (d) You must meet the requirements of paragraphs (b) and (c) of
this section before you begin to perform STT or BAT 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.
* * * * *

Sec.  40.225   [Amended]

0
28. Amend Sec.  40.225(a) by removing the parenthetical ``(http://www.dot.gov/dapc)'' and adding, in its place ``(http://www.transportation.gov/odapc)''

0
29. Revise Sec.  40.229 to read as follows:

Sec.  40.229   What devices are used to conduct alcohol screening
tests?

    ASDs listed on ODAPC's Web page for ``Approved Screening Devices to
Measure Alcohol in Bodily Fluids'' and EBTs listed on ODAPC's Web page
for ``Approved Evidential Breath Measurement Devices'' are the only
devices you are allowed to use to conduct alcohol screening tests under
this part. You may use an ASD for DOT alcohol tests only if there are
instructions for its use in this part. An ASD can be used only for
screening tests for alcohol, and must not be used for confirmation
tests.

0
30. Amend Sec.  40.231 by revising paragraph (a) to read as follows:

Sec.  40.231   What devices are used to conduct alcohol confirmation
tests?

    (a) EBTs on ODAPC's Web page for ``Approved Evidential Breath
Measurement Devices'' that meet the requirements of paragraph (b) of
this section are the only devices you may use to conduct alcohol
confirmation tests under this part.
* * * * *

0
31. Amend Sec.  40.233 by revising paragraphs (a) introductory text and
(c)(4) to read as follows:

Sec.  40.233   What are the requirements for proper use and care of
EBTs?

    (a) As an EBT manufacturer, you must submit, for NHTSA approval, a
quality assurance plan (QAP) for your EBT before ODAPC places the EBT
on its Web page for ``Approved Evidential Breath Measurement Devices.''
* * * * *
    (c) * * *
    (4) You must maintain records of the inspection, maintenance, and
calibration of EBTs as provided in Sec.  40.333(a)(3).
* * * * *

0
32. Amend Sec.  40.235 by revising paragraph (a) to read as follows:

Sec.  40.235   What are the requirements for proper use and care of
ASDs?

    (a) As an ASD manufacturer, you must submit, for NHTSA approval, a
QAP for your ASD before NHTSA approves it and ODAPC places the device
on its Web page for ``Approved Screening Devices to Measure Alcohol in
Bodily Fluids''. Your QAP must specify the methods used for quality
control checks, temperatures at which the ASD must be stored and used,
the shelf life of the device, and environmental conditions (e.g.,
temperature, altitude, humidity) that may affect the ASD's performance.
* * * * *

0
33. Amend Sec.  40.281 by revising paragraphs (a)(6), (b)(3), and
(c)(3) to read as follows:

Sec.  40.281  Who is qualified to act as a SAP?

* * * * *
    (a) * * *
    (6) You are a drug and alcohol counselor certified by an
organization listed at https://www.transportation.gov/odapc/sap.
    (b) * * *
    (3) You must be knowledgeable about this part, the DOT agency
regulations applicable to the employers for whom you evaluate
employees, and the DOT

SAP Guidelines. You must keep current on any changes to these
materials. You must subscribe to the ODAPC list-serve at https://www.transportation.gov/odapc/get-odapc-email-updates. DOT agency
regulations, DOT SAP Guidelines, and other materials are available from
ODAPC (Department of Transportation, 1200 New Jersey Avenue SE.,
Washington DC, 20590<PHONE_NUMBER>), or on the ODAPC Web site (http://www.transportation.gov/odapc).
    (c) * * *
    (3) You must meet the requirements of paragraphs (a), (b), and (c)
of this section before you begin to perform SAP functions.
* * * * *

0
34. Amend Sec.  40.331 by revising paragraph (f) to read as follows:

Sec.  40.331  To what additional parties must employers and service
agents release information?

* * * * *
    (f) Except as otherwise provided in this part, as a laboratory you
must not release or provide a specimen or a part of a specimen to a
requesting party, without first obtaining written consent from ODAPC.
DNA testing and other types of identity testing are not authorized and
ODAPC will not give permission for such testing. If a party seeks a
court order directing you to release a specimen or part of a specimen
contrary to any provision of this part, you must take necessary legal
steps to contest the issuance of the order (e.g., seek to quash a
subpoena, citing the requirements of Sec.  40.13). This part does not
require you to disobey a court order, however.
* * * * *

0
35. Amend Sec.  40.365 by revising paragraph (b)(10) to read as
follows:

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

* * * * *
    (b) * * *
    (10) For any service agent, falsely representing that the service
agent or its activities is approved or certified by the Department or a
DOT agency (such representation includes, but is not limited to, the
use of a Department or DOT agency logo, title, or emblem).
* * * * *

Sec.  40.401   [Amended]

0
36. Amend Sec.  40.401(a) by removing the parenthetical ``(http://www.dot.gov/ost/dapc)'' and adding, in its place ``(http://www.transportation.gov/odapc)''

0
37. Revise Appendix B to Part 40 to read as follows:

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

    The following items are required on each laboratory report:

Reporting Period: (inclusive dates)
Laboratory Identification: (name and address)
Employer Identification: (name; may include Billing Code or ID code)
C/TPA Identification: (where applicable; name and address)

1. Specimen Results Reported (total number)
By Test Reason
    (a) Pre-employment (number)
    (b) Post-Accident (number)
    (c) Random (number)
    (d) Reasonable Suspicion/Cause (number)
    (e) Return-to-Duty (number)
    (f) Follow-up (number)
    (g) Type of Test Not Noted on CCF (number)
2. Specimens Reported
    (a) Negative (number)
    (b) Negative and Dilute (number)
3. Specimens Reported as Rejected for Testing (total number)
By Reason
    (a) Fatal flaw (number)
    (b) Uncorrected Flaw (number)
4. Specimens Reported as Positive (total number) By Drug
    (a) Marijuana Metabolite (number)
    (b) Cocaine Metabolite (number)
    (c) Opioids (number)
    (1) Codeine (number)
    (2) Morphine (number)