[Federal Register Volume 82, Number 217 (Monday, November 13, 2017)]
[Rules and Regulations]
[Pages 52229-52248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24397]


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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.

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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 202-366-3784; 
<a href="/cdn-cgi/l/email-protection#3c73787d6c7f6b595e715d55507c585348125b534a"><span class="__cf_email__" data-cfemail="d29d9693829185b7b09fb3bbbe92b6bda6fcb5bda4">[email protected]</span></a>.

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

[[Page 52230]]

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.
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    \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.
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    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

[[Page 52231]]

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.

[[Page 52232]]

    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

[[Page 52233]]

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

[[Page 52234]]

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,

[[Page 52235]]

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

[[Page 52236]]

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

[[Page 52237]]

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

[[Page 52238]]

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

[[Page 52239]]

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

[[Page 52240]]

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

[[Page 52241]]

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.

[[Page 52242]]

    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)

[[Page 52243]]

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.

[[Page 52244]]

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, 202-366-3784, 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).


[[Page 52245]]

* * * * *


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, 202-366-3784), 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) * * *

[[Page 52246]]

    (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, 202-366-3784, 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

[[Page 52247]]

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 (202-366-3784), 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)
    (3) 6-AM (number)
    (4) Hydrocodone (number)
    (5) Hydromorphone (number)
    (6) Oxycodone (number)
    (7) Oxymorphone (number)
    (d) Phencyclidine (number)
    (e) Amphetamines (number)
    (1) Amphetamine (number)
    (2) Methamphetamine (number)
    (3) MDMA (number)
    (4) MDA (number)
5. Adulterated (number)
6. Substituted (number)
7. Invalid Result (number)


0
38. Revise Appendix C to Part 40 to read as follows:

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

    Mail, fax, or email to:
U.S. Department of Transportation, Office of Drug and Alcohol Policy 
and Compliance, W62-300, 1200 New Jersey Avenue SE., Washington, DC 
20590, Fax: (202) 366-3897, Email: <a href="/cdn-cgi/l/email-protection#c8878c89988b9fadaa85a9a1a488aca7bce6afa7be"><span class="__cf_email__" data-cfemail="400f040110031725220d21292c00242f346e272f36">[email protected]</span></a>.

    The following items are required on each report:
Reporting Period: (inclusive dates)
Laboratory Identification: (name and address)
1. DOT Specimen Results Reported (total number)
2. Negative Results Reported (total number)
Negative (number)
Negative-Dilute (number)
3. Rejected for Testing Results Reported (total number)
By Reason
(a) Fatal flaw (number)
(b) Uncorrected Flaw (number)
4. Positive Results Reported (total number)
By Drug
(a) Marijuana Metabolite (number)
(b) Cocaine Metabolite (number)
(c) Opioids (number)
    (1) Codeine (number)
    (2) Morphine (number)
    (3) 6-AM (number)
    (4) Hydrocodone (number)
    (5) Hydromorphone (number)
    (6) Oxycodone (number)
    (7) Oxymorphone (number)
(d) Phencyclidine (number)
(e) Amphetamines (number)
    (1) Amphetamine (number)
    (2) Methamphetamine (number)
    (3) MDMA (number)
    (4) MDA (number)
5. Adulterated Results Reported (total number)
By Reason (number)
6. Substituted Results Reported (total number)
7. Invalid Results Reported (total number)
By Reason (number)


0
39. Revise Appendix D to Part 40 to read as follows:

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

    Mail, fax, or submit electronically to:

U.S. Department of Transportation, Office of Drug and Alcohol Policy 
and Compliance, W62-300, 1200 New Jersey Avenue SE., Washington, DC 
20590, Fax: (202) 366-3897. Submit Electronically: https://www.transportation.gov/content/split-specimen-cancellation-notification-49-cfr-part-40187-appendix-d
    The following items are required on each report:
    1. MRO name, address, phone number, and fax number.
    2. Collection site name, address, and phone number.
    3. Date of collection.
    4. Specimen I.D. number.
    5. Laboratory accession number.
    6. Primary specimen laboratory name, address, and phone number.
    7. Date result reported or certified by primary laboratory.
    8. Split specimen laboratory name, address, and phone number.
    9. Date split specimen result reported or certified by split 
specimen laboratory.
    10. Primary specimen results (e.g., name of drug, adulterant) in 
the primary specimen.
    11. Reason for split specimen failure-to-reconfirm result (e.g., 
drug or adulterant not present, specimen invalid, split not 
collected, insufficient volume).
    12. Actions taken by the MRO (e.g., notified employer of failure 
to reconfirm and requirement for recollection).
    13. Additional information explaining the reason for 
cancellation.
    14. Name of individual submitting the report (if not the MRO)


0
40. Amend Appendix H to Part 40 by:
0
a. Revising the introductory text; and
0
b. Removing the instruction sheet entitled: ``U.S. DEPARTMENT OF

[[Page 52248]]

TRANSPORTATION DRUG AND ALCOHOL TESTING MIS DATA COLLECTION FORM 
INSTRUCTION SHEET''.
    The revision reads as follows:

Appendix H to Part 40--DOT Drug and Alcohol Testing Management 
Information System (MIS) Data Collection Form

    The following form is the MIS Data Collection form required for 
use to report calendar year MIS data.
* * * * *

    Issued in Washington, DC on November 3, 2017.
Elaine L. Chao,
Secretary of Transportation.
[FR Doc. 2017-24397 Filed 11-9-17; 8:45 am]
 BILLING CODE 4910-9X-P


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