
[Federal Register Volume 82, Number 13 (Monday, January 23, 2017)]
[Proposed Rules]
[Pages 7771-7782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01131]


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

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: Notice of proposed rulemaking.

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

SUMMARY: The Department of Transportation is proposing to amend its 
drug-testing program regulation to add four opioids (hydrocodone, 
hydromorphone, oxymorphone, and oxycodone) to its drug-testing panel; 
add methylenedioxyamphetamine (MDA) as an initial test analyte; and 
remove methylenedioxyethylamphetamine, (MDEA) as a confirmatory test 
analyte. The proposed revision of the drug-testing panel is intended to 
harmonize with the revised Mandatory Guidelines established by the U.S. 
Department of Health and Human Services for Federal drug-testing 
programs for urine testing. This proposal also adds clarification to 
certain drug-testing program provisions where necessary, removes 
outdated information in the regulations that is no longer needed, and 
proposes to remove the requirement for employers and Consortium/Third 
Party Administrators to submit blind specimens.

DATES: Comments to the notice of proposed rulemaking should be 
submitted by March 24, 2017. Late-filed comments will be considered to 
the extent practicable.

ADDRESSES: To ensure that you do not duplicate your docket submissions, 
please submit them by only one of the following means:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for submitting 
comments.
     Mail: Docket Management Facility, U.S. Department of 
Transportation, 1200 New Jersey Ave. SE., West Building Ground Floor 
Room W12-140, Washington, DC 20590-0001.
     Hand delivery: West Building Ground Floor, Room W-12-140, 
1200 New Jersey Ave. SE., between 9 a.m. and 5 p.m., Monday through 
Friday, except Federal holidays. The telephone number is 202-366-9329.
    Instructions: To ensure proper docketing of your comment, please 
include the agency name and docket number DOT-OST-2016-0189 or the 
Regulatory Identification Number (RIN), 2105-AE58, for the rulemaking 
at the beginning of your comments. All comments received will be posted 
without change to http://www.regulations.gov, including any personal 
information provided.

FOR FURTHER INFORMATION CONTACT: Patrice M. Kelly, Acting Director, 
Office of Drug and Alcohol Policy and Compliance, 1200 New Jersey 
Avenue SE., Washington, DC 20590; telephone number 202-366-3784; 
ODAPCWebMail@dot.gov.

SUPPLEMENTARY INFORMATION: 

I. Purpose

    The Department of Transportation (DOT or the Department) is issuing 
this notice of proposed rulemaking (NPRM) to revise Part 40 of Title 49 
of the Code of Federal Regulations to harmonize with the revised 
Department of Health and Human Services (HHS) Mandatory Guidelines for 
Federal Workplace Drug Testing Programs using Urine (HHS Mandatory 
Guidelines) published on January 23, 2017, effective October 1, 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 to which this 
notice proposes to harmonize Part 40. First, the revised HHS Mandatory 
Guidelines, in part, allow Federal agencies with drug-testing 
responsibilities to test for four additional Schedule II (of the 
Controlled Substances Act) 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, we also propose in this NPRM to 
modify (for clarification) certain existing Part 40 provisions that 
cover the handling of urine specimens; to remove provisions that no 
longer are necessary (such as obsolete compliance dates); and to add 
clarifying language to other provisions (such as updated definitions 
and web links where necessary.) The Department also proposes to remove 
existing Part 40 requirements related to blind specimen testing.

II. Authority for This Rulemaking

    This rulemaking is promulgated pursuant to the Omnibus 
Transportation Employee Testing Act (OTETA) of 1991 (Pub. L. 102-143, 
tit. V, 105 Stat. 952). OTETA sets forth 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.

[[Page 7772]]

III. Background

Relevant History of the DOT Drug-Testing Program Regulation

    The Department first published its drug-testing program regulation 
(49 CFR part 40) on November 21, 1988 as an interim final rule (53 FR 
47002). We based the rule on HHS Mandatory Guidelines for Federal 
Workplace Drug Testing Programs (See 53 FR 11970), 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). Agencies also were 
authorized under the 1988 HHS Mandatory Guidelines to test for 
phencyclidine, amphetamines, and opiates. Among other provisions from 
those guidelines, DOT incorporated a 5-panel test to include all of the 
drugs HHS authorized and published a final rule on December 1, 1989 (54 
FR 49854).
    We made the last comprehensive revisions to Part 40, on August 16, 
2010 (See 75 FR 49850). This 2010 revision once again harmonized our 
DOT drug-testing program, where necessary, with the HHS Mandatory 
Guidelines effective October 1, 2010 (See 73 FR 7185; 75 FR 22809). 
Specifically, to harmonize 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 propose to revise 
Part 40 now to harmonize, in pertinent part, with the most recently 
revised HHS Mandatory Guidelines issued on January 23, 2017. HHS has 
set an effective date of October 1, 2017, for compliance with its final 
revision.

Relevant Changes 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 Guidelines were published in 1988, a 
number of recommendations have been made for additional drugs to be 
included in Federal workplace drug-testing programs. According to HHS, 
recommendations for the four added 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 opioids, 
oxycodone, oxymorphone, hydrocodone, and hydromorphone, should be added 
in the Federal program.
---------------------------------------------------------------------------

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

    In its ``Final Notice of Revisions'' 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 imposes an unnecessary burden for 
compounds with such low incidence in workplace testing. HHS agreed and, 
based on comment, removed MDEA from its Mandatory Guidelines. 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. HHS indicated that it 
understands that MDA and some other analytes also have a low incidence, 
but believes that continued testing for these analytes is warranted in 
a deterrent program. In particular, inclusion of MDA as an initial and 
confirmatory test analyte is warranted according to HHS because, in 
addition to being a drug of abuse, it is a metabolite of MDEA and MDMA.

Harmonizing Changes to the DOT Drug-Testing Program Regulation

    In keeping with our obligations under OTETA to follow the HHS 
Mandatory Guidelines for the drugs for which we test, we propose to add 
and remove the drugs adopted in the revised HHS Mandatory Guidelines 
for urine. Adding the four semi-synthetic opioids, which are already 
tested for in many transportation employers' non-DOT testing programs, 
would allow the DOT to detect a broader range of potentially impairing 
drugs and thereby enhance the safety of the transportation industry and 
the public they serve.

IV. Discussion of the Proposal

    In this NPRM, in addition to proposing to add and remove drugs on 
the DOT drug-testing panel, we are using this opportunity to make some 
necessary modifications to Part 40. Specifically, we are proposing to 
amend certain provisions related to the testing of urine specimens. For 
example, we would add a new section to Part 40 to emphasize that only 
urine specimens screened and confirmed at HHS certified laboratories 
are currently authorized to be used for drug testing. We also have 
determined, based on a focused analysis of historical drug-testing 
program data, that the burdens associated with blind specimen testing 
may not be cost-beneficial. Therefore, in the interest of reducing 
burden on program participants who are affected by blind specimen 
testing requirements, we propose to remove this requirement from our 
program. We propose other, mainly editorial, revisions to improve the 
efficiency of our program, such as removing compliance dates that are 
no longer needed and updating program web links to reflect those 
currently being used on the DOT Web site.
    Here is a more detailed summary of our specific proposals. We 
propose to:
    1. Amend our drug-testing panel and Medical Review Officer (MRO) 
test result verification procedures to add hydrocodone, hydromorphone, 
oxycodone, and oxymorphone (and their corresponding test cutoff 
concentrations), add MDA as an initial test analyte, and remove MDEA.
    2. Remove, modify, and add some definitions to further clarify our 
program and also to make certain definitions consistent with the 
revised HHS Mandatory Guidelines.
    3. Modify three provisions related to urine specimens. We propose 
to: Add a new provision to indicate that only urine specimens are 
authorized to be used for drug testing under Part 40; revise an 
existing provision to describe the procedure for discarding an original 
urine specimen under certain circumstances; and align our regulations 
with the revised National Laboratory Certification Program (NLCP) 
manual by adding three new ``fatal flaws'' to the existing list of four 
``fatal flaws'' currently found in Part 40.
    4. Remove Part 40 provisions that reference blind specimen testing.
    5. Add emphasis to an existing Part 40 provision that prohibits DNA 
testing of urine specimens.
    6. Amend Sec.  40.141, which refers to how an MRO obtains 
information for the

[[Page 7773]]

verification decision. We would amend this section to add a 
clarification that a ``prescription'' means a ``valid prescription 
under the Controlled Substances Act,'' which is language that already 
exists in Part 40 and add a new paragraph that would harmonize this 
section with Section 3.5 of the HHS Mandatory Guidelines, which allows 
MROs to request additional testing of a specimen in certain 
circumstances.
    7. Modify Sec. Sec.  40.137 and 40.139, the sections that address 
how the MRO must verify test results, by proposing to make minor 
modifications to the section headings and regulatory text to 
incorporate the addition of the four new semi-synthetic opioids.
    8. Include a provision that would require collectors, Substance 
Abuse Professionals (SAPs), MROs, Screening Test Technicians (STTs), 
and Breath Alcohol Technicians (BATs) to subscribe to the DOT Office of 
Drug and Alcohol Policy and Compliance (ODAPC) list-serve.
    9. Remove the list of SAP certification organizations from the list 
of qualifying SAP credentials in Part 40. Instead, we would maintain 
the list of certifying organizations on our Web site.
    10. Provide a provision to prohibit program participants from using 
DOT- (or other Federal agency) branded items (such as logos, titles, 
emblems, etc.) on their Web sites, publications, etc.
    11. Remove certain compliance dates that are now obsolete because 
they are more than 5 years old.
    12. Correct two typos, in Sec. Sec.  40.233(c)(4) and 40.162(c), 
that reference incorrect paragraph sections and make an editorial 
correction in Sec.  40.67(n) that would delete erroneous wording.
    13. Update the following appendices to Part 40: Appendices B and C, 
to add the four new drugs 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.
    14. Update web links referenced in the current rule that have 
changed on our DOT Web site.

Detailed Discussion of the Proposals

    1. Modification of the Drug-Testing Panel--We propose to modify the 
existing drug-testing panel in Sec.  40.87(a) and the MRO test result 
verification procedures in Sec. Sec.  40.137 and 40.139, to include 
hydrocodone, hydromorphone, oxycodone, and oxymorphone. We also propose 
to remove MDEA from Sec.  40.87(a) and add MDA as an initial test 
analyte as discussed previously in this document. As indicated above in 
the section of this preamble entitled ``II. Authority for this 
Rulemaking,'' OTETA mandates that the DOT drug-testing panel must 
correspond to HHS Mandatory Guidelines for Federal Workplace Drug 
Testing Programs. As such, since the inception of our drug-testing 
program, the DOT has never deviated from HHS on the drugs for which we 
test, the type of specimens which we test, specimen testing validity 
values, or initial and confirmatory cutoff values. This proposal is no 
different. We propose to fully adhere to the revised HHS guidelines 
regarding the drugs for which we propose to require testing.
    Currently, DOT regulations mandate urine testing under a five-panel 
test. We propose to maintain the current five-panel test, but would 
rename the existing opiates category in Sec.  40.85 from ``opiates'' to 
``opioids'' to include the new HHS-mandated drugs.
    Opiates are derived from opium poppy plant alkaloid compounds, and 
include codeine and morphine. Heroin is produced by acetylation of 
morphine. Opioids is a broader term but, for purposes of Part 40, 
includes only opiate and semi-synthetic compounds (i.e., hydrocodone, 
hydromorphone, oxycodone, and oxymorphone). Semi-synthetic opioids 
interact with the body's chemical system in the same way as natural 
opiates (e.g. codeine, morphine, and heroin) and produce similar 
effects. Misuse, abuse, opioid use disorder (addiction), and overdose 
are potential dangers related to prescription opioids.
    The following is a representative sampling of information provided 
by various organizations who have reported on prescription opioid use 
trends over the past few years:
     CDC data from 2012 indicates that 259 million 
prescriptions were written for prescription opioids, which is more than 
enough to give every American adult their own bottle of pills.\2\
---------------------------------------------------------------------------

    \2\ Centers for Disease Control and Prevention (2014). Opioid 
Painkiller and Prescribing, Where You Live Makes a Difference. 
Available at: http://www.cdc.gov/vitalsigns/opioid-prescribing/.
---------------------------------------------------------------------------

     According to the SAMHSA National Survey on Drug Use and 
Health 2014 data, almost 2 million Americans misused or were dependent 
on prescription opioids.\3\
---------------------------------------------------------------------------

    \3\ Substance Abuse and Mental Health Services Administration, 
National Survey on Drug Use and Health, 2014. Available at: http://www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FRR1-2014.pdf.
---------------------------------------------------------------------------

     As posted by the Office of National Drug Control Policy, 
according to the National Center for Health Statistics, the number of 
overdose deaths involving opioids rose from 28,647 in 2014 to 33,091 in 
2015.\4\
---------------------------------------------------------------------------

    \4\ https://www.whitehouse.gov/the-press-office/2016/12/08/continued-rise-opioid-overdose-deaths-2015-shows-urgent-need-treatment.
---------------------------------------------------------------------------

     National Center for Health Statistics \5\ data indicates 
that every year since 2002 more than 40 percent of the total number of 
overdose deaths in the United States have been related to prescription 
opioids.
---------------------------------------------------------------------------

    \5\ https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates.
---------------------------------------------------------------------------

    In light of this compelling information regarding opioid use (and 
the national attention being focused on this issue), we propose to 
modify the DOT drug-testing regimen not only to meet our statutory 
obligation under OTETA to do so, but also to raise the level of safety 
for the transportation industry and the public.
    2. Definitions--We propose to revise Sec.  40.3 to make the 
following modifications:
     Blind specimen or blind performance test specimen would be 
removed. Because we are proposing to remove the requirement for blind 
specimen testing, we no longer would need to define this term in Part 
40. In addition, Part 40 provisions do not refer to ``blind performance 
test specimen,'' so we propose to remove it as well.
     DOT, the Department, DOT agency would be revised to make a 
clarification with respect to the status of the U.S. Coast Guard. The 
Coast Guard transferred to the Department of Homeland Security (DHS) in 
2003, and as such, is not part of the DOT. The Coast Guard, however, 
has continued to use Part 40 for most of its drug and alcohol testing 
procedures. This amendment would clarify that, when Part 40 mentions 
DOT agencies, the Coast Guard is included under that heading even 
though it resides in DHS.
     Drugs would be revised (for reasons discussed in detail 
earlier in this preamble) to reflect the addition of hydrocodone, 
hydromorphone, oxycodone, and oxymorphone to the existing DOT drug-
testing panel. Specifically, we would expand the reference to 
``opiates'' in the existing definition to ``opioids.''
    3. Clarification/modifications related to urine specimens--We 
propose the following three amendments relating to the testing of urine 
specimens:
     We propose to add a new Sec.  40.210 entitled: ``Are drug 
tests other than urine permitted under the regulations?'' to indicate 
that only urine specimens are currently authorized for drug testing. 
Adding new Sec.  40.210 would establish

[[Page 7774]]

parity with an existing Part 40 alcohol testing section, Sec.  40.277, 
entitled: ``Are alcohol tests other than saliva or breath permitted 
under these regulations?'' which indicates (for alcohol testing) that 
only saliva and breath are authorized.
     We propose to amend existing Sec.  40.83 and Sec.  40.199 
to include revisions made to the ``fatal flaws'' listing found in the 
latest revision of the NLCP Manual which became effective September 21, 
2016. Existing paragraph (b) of Sec.  40.199 provides for four ``fatal 
flaws'' but would be amended to include three additional fatal flaws 
included in the revised NLCP Manual for a total of seven fatal flaws 
that MROs must consider during the review and verification process.
     We propose to amend paragraph Sec.  40.193(b)(4) to 
address what a collector does when the employee provides a 
``questionable'' specimen (due to signs of tampering or when the 
temperature is out of range), and then the employee does not provide a 
second sufficient specimen under direct observation even after being 
provided with a wait period of up to three hours.
    Currently, Part 40 requires the collector to package and send the 
questionable specimen (i.e., out of temperature range specimen or 
specimen with signs of tampering) to the laboratory along with a second 
sufficient specimen assuming a second specimen was collected 
(Sec. Sec.  40.65(b)(7) & 40.65(c)(2), respectively). Part 40 does not, 
however, instruct the collector on what to do with the questionable 
specimen when the employee does not provide a sufficient specimen after 
a ``shy bladder'' wait period. The instructions in Sec.  40.193(b)(1) 
direct the collector not to discard a questionable specimen; however, 
these instructions are rooted on the assumption that a second specimen 
will be collected. So absent a second sufficient specimen, Sec.  40.193 
does not tell the collector what to do with the questionable specimen.
    Furthermore, we found the following inconsistencies in our guidance 
documents related to questionable specimens. In the July 2008 Q&A on 
Sec.  40.193, the collector is instructed to ``. . . discard any 
specimen the employee previously provided . . .'' However, the Urine 
Specimen Collection Guidelines state that the collector is to send the 
questionable specimen to the laboratory and to immediately initiate 
another collection under direct observation.
    If the employee did not provide a second specimen during the shy 
bladder period, and the collector sends the questionable specimen to 
the laboratory, the MRO must verify the employee's laboratory-reported 
questionable sample. The MRO would also conduct an evaluation to 
determine if a medical condition has, or with a high degree of 
probability could have, precluded the employee from providing a 
sufficient amount of urine.
    The intent of the shy bladder evaluation is to provide the employee 
with an opportunity to provide an explanation for his/her inability to 
provide a sufficient specimen. This rationale becomes clouded when it's 
coupled with a verified drug test result from the same collection 
event. If an employee provides a questionable specimen, the employee 
may have tampered with or substituted his/her specimen. Following this 
logic, the employee should be able to provide a sufficient specimen 
immediately after providing the questionable specimen. If the employee 
cannot provide a sufficient specimen, the employee would have the 
opportunity to provide an explanation for his/her shy bladder via an 
evaluation (Sec.  40.193(c)). Absent a supported medical condition, an 
employee's inability to provide a sufficient specimen indicates that 
the employee chose not to provide a specimen in an effort to avoid a 
positive drug test result. As such, the MRO would report the result as 
a ``refusal to test'' to the employer, further ensuring the safety of 
the traveling public.
    Therefore, we are proposing to require the collector to discard any 
specimen previously collected, thereby leaving the MRO to report only 
the outcome of the required evaluation. The Department seeks comment as 
to whether the proposed amendment to Sec.  40.193 (b)(4) is a 
reasonable approach or whether there may be an alternate solution to 
the proposal.
    4. Removal of blind specimen testing--We are proposing to remove 
existing Part 40 provisions (from Sec. Sec.  40.3, 40.29, 40.103, 
40.105, 40.123, 40.169, and 40.189) that reference blind specimen 
testing. We propose this as a burden-relieving measure for affected 
entities (e.g. employers, C/TPAs, etc.).
    Existing Part 40 defines a blind specimen as ``a specimen submitted 
to a laboratory for quality control testing purposes, with a fictitious 
identifier, so that the laboratory cannot distinguish it from an 
employee specimen.'' Blind specimens are intended to test the accuracy 
and integrity of the laboratory testing system. As part of an overall 
quality control effort, employers have been required, since 1990 (54 FR 
49857), to send blind urine specimens for drug testing to the 
laboratories they use. These samples are made to look like normal 
samples, are packaged in the same manner, and arrive unannounced at the 
laboratory. Only the senders know if the results of the blind specimens 
are negative, positive, adulterated, or substituted.
    Initially, in 1990 (54 FR 49854), the Department required three 
blind test specimens for each 100 employee test specimens. For 
employers with 2000 or more covered employees, approximately 80 percent 
of the samples were required to be negative, with the remaining samples 
positive for one or more of the drugs per sample in a distribution such 
that all the drugs to be tested were included in approximately equal 
frequencies of challenge. The positive samples were required to contain 
only those drugs for which the employer was testing.
    DOT has always been concerned about the burdens associated with 
imposing blind specimen procedures in its drug-testing program and has 
attempted to reduce such burdens incrementally over time. For example, 
in an attempt to simplify the process and reduce burden, in 2001, (65 
FR 79462; December 19, 2000), the Department revised Part 40 blind 
specimen requirements by reducing the number of quarterly blind 
specimens sent to a laboratory from three percent to one percent with a 
maximum number of 50 blinds per quarter.
    In light of this rulemaking and the requirement in Executive Order 
13563 to conduct retrospective analyses, we have once again reviewed 
the impact of blind specimen testing. Upon review, we found that, since 
the 2000 final rule, we did not identify any laboratory problems 
regarding false positives. Any discrepancies that have been brought to 
our attention were problems with the manufacturer of the blinds and not 
the laboratory testing procedures.
    It is also important to remember that the laboratories are 
rigorously inspected through the HHS National Laboratory Certification 
Program (NLCP). After a thorough initial inspection, laboratories are 
inspected semi-annually and receive performance test ``PT'' samples 
every quarter. If there are any discrepancies, NLCP thoroughly 
investigates the matter that requires corrective action as necessary.
    Finally, another important ``check and balance'' already in place 
is the employee's split specimen or the ``B'' bottle. If the employee 
believes that the primary laboratory erred in reporting his/her result 
of the ``A'' bottle, the employee, via the MRO, can request to have 
his/her split (``B'') specimen sent to another laboratory.
    Blind specimen testing requirements have been diligently followed 
over the

[[Page 7775]]

history of our program resulting in no cause for concern regarding 
laboratory accuracy. After 25 years, blind specimen testing has served 
its purpose and is now redundant in urine testing. Therefore, the 
Department seeks comment on any concerns, or unforeseen or unintended 
consequences, associated with our proposal to remove blind specimen 
requirements.
    5. DNA testing--We propose to amend existing Sec.  40.331 to add 
language that would further clarify that Deoxyribonucleic Acid (DNA) 
testing is not allowed for DOT-regulated urine specimens. To add 
further emphasis to this section, we would amend paragraph (f) to add 
the following sentence: DNA testing or other types of identity testing 
are not authorized. Identity testing, to include (DNA) testing, is 
prohibited in Section 3.3 of the HHS Mandatory Guidelines and in Part 
40. The Department's main reason for imposing this prohibition (See 65 
FR 79484, 79530) was to provide a safeguard against employees who would 
attempt to undermine the collection process by substituting a sample 
and, subsequently, request identity testing so that their sample would 
not be a match. If an employee believes there has been an error with 
his/her sample, the employee can request the Bottle B of the specimen 
to be drug tested (but not DNA tested) at a second HHS certified 
laboratory.
    As the Court of Appeals recently validated in Swaters v. Department 
of Transportation, No. 14-1277 (D.C. Cir. June 24, 2016), the 
procedures described in the HHS Mandatory Guidelines and a properly 
completed Federal Drug Testing Custody and Control Form ensure that the 
specimen provided by the donor is the same specimen tested by a 
laboratory. Permitting DNA testing would undermine the integrity of the 
urine testing program because it would legitimize a donor's 
substitution of urine during an unobserved collection. The Court also 
indicated that ``neither the DOT's general rule against releasing urine 
samples for DNA testing, nor its refusal to release the sample in this 
case, is arbitrary, capricious, or contrary to the Omnibus 
Transportation Employee Testing Act of 1991.''
    6. MRO Verification--We propose to amend existing Sec.  40.141 (b) 
to add a parenthetical ``i.e.'' that would indicate that 
``prescription'' is intended to mean (as currently provided in Sec.  
40.135 (e)), ``a legally valid prescription under the Controlled 
Substances Act (CSA).''
    We understand that there may be various definitions for 
``prescription'' under Federal law (e.g., the Controlled Substances Act 
Pub. L. 91-513, tit. II, 84 Stat. 1242 (1970) and the Patient 
Protection and Affordable Care Act, Pub. L. 111-148, 124 Stat. 119 
(2010)). As such, we propose to amend existing Sec.  40.141 (b) to add 
language to indicate that, in the DOT drug-testing program, 
prescription means ``a legally valid prescription under the Controlled 
Substances Act (CSA).'' Doing so will clarify what prescription an MRO 
can accept when verifying an employee's claim that his/her use of a 
prescribed medication was the reason for the laboratory-confirmed 
positive drug result. This clarification does not create a new standard 
because this language is identical to the language used in Sec.  
40.135(e).
    We also propose to modify Sec.  40.141(b) to harmonize, in part, 
with Section 3.5 of the HHS Mandatory Guidelines. Specifically, we 
propose to allow MROs to conduct additional testing (i.e., D, L 
stereoisomers and tetrahydrocannabivarin (THC-V)) of a DOT urine 
specimen, if the MRO determines such testing is necessary for the 
purpose of verifying the drug test result. For example, the MRO could 
request a D, L stereoisomer test of a laboratory confirmed 
methamphetamine result to help rule out whether the result was possibly 
due to the use of an over-the-counter product. Another example would be 
for the MRO to request a THC-V test when verifying a positive marijuana 
test result after a dronabinol (Marinol) \6\ prescription is provided 
by the donor. THC-V testing provides useful information to the MRO when 
determining whether the laboratory-reported positive result for 
marijuana resulted from the employee's use of marijuana. As proposed, 
the MRO would not need to obtain DOT consent prior to requesting the D, 
L stereoisomer testing and/or the THC-V testing. Furthermore, the HHS-
certified laboratory could only conduct these additional tests if its 
testing meets the appropriate validation and quality control 
requirements through the NLCP.
---------------------------------------------------------------------------

    \6\ Generically known as dronabinol, Marinol is a Schedule III 
drug product formulated in sesame oil in soft gelatin capsules, 
containing synthetic delta-9-THC. FDA has approved Marinol for the 
treatment of nausea and vomiting associated with cancer chemotherapy 
and for anorexia. (For further information see 81 FR 53691.)
---------------------------------------------------------------------------

    7. Revision of certain Part 40 provisions to incorporate references 
to the new drugs--We would revise the existing section headings and 
some regulatory text in Sec. Sec.  40.137 and 40.139 to incorporate the 
proposed addition of the new opioids to the drug-testing panel. We 
would revise the section headings, and corresponding regulatory 
language where appropriate in these sections, to clarify our intent 
regarding how the MRO must verify test results. We would revise the 
Sec.  40.137 section heading to add the text ``semi-synthetic opioids'' 
and the Sec.  40.139 section heading so that it would refer to ``6-
acetylmorphine, codeine, and morphine'' specifically. The Department 
also proposes to clarify the example used in Sec.  40.139(c)(3) 
regarding an employee's admission of an unauthorized use of a substance 
when use of that substance is not confirmed by their drug test.
    8. Subscription to ODAPC list-serve--We would amend Sec. Sec.  
40.33, 40.121, 40.213, and 40.281 to require collectors, MROs, STTs and 
BATs, and SAPs to subscribe to the ODAPC list-serve, found on our Web 
site at https://www.transportation.gov/odapc/get-odapc-email-updates. 
The ODAPC list-serve provides an additional means for these individuals 
to meet existing requirements in the referenced sections to ``be 
knowledgeable about'' and to ``keep current on any changes to'' 
materials used in our program. In addition to all of the information 
(web links) available on the ODAPC Web site, the ODAPC list-serve is 
the vehicle that allows us to communicate all program matters of 
importance to our constituency in the most timely manner possible and, 
by extension, enables us to keep our program responsive. The list-serve 
is free of charge to list-serve subscribers.
    9. Nationally Recognized Training Organizations--We propose to 
remove the list of approved certification organizations and their 
respective certified drug and alcohol counselors found in Sec.  40.281, 
paragraph (a)(6) and to display that list on the ODAPC Web site. 
Currently, when a certification organization requests to be added to 
the list of acceptable credentials for a SAP, that organization needs 
to petition the DOT for inclusion. The DOT reviews the petition. If the 
DOT approves the petition, we must initiate a rulemaking process to add 
the SAP certification organization to Part 40. Each time a new 
certification organization is added, the DOT must initiate a separate 
rulemaking action. Because this is a time-consuming process, we are 
proposing to display the list on the ODAPC Web site and update it when 
necessary instead of including all qualified SAP certification 
organizations in the rule language. Any SAP certification organization 
seeking to be added to the web-based list would still need to petition 
the DOT and meet the criteria set forth in Appendix E of Part 40. 
Although this process would remove the public comment requirement of 
rulemaking, DOT would

[[Page 7776]]

fully vet the organization before deciding to add it to the list. 
Therefore, as a burden-relieving measure, the Department proposes to 
remove Sec.  40.281 (a)(6) entirely and henceforth maintain the listing 
of nationally-recognized training or professional organizations in 
guidance material at https://www.transportation.gov/odapc/sap. In this 
manner, we would be able to maintain a more responsive list of 
organizations under which an individual may certify as a SAP and update 
it as needed without undertaking rulemaking action.
    10. Prohibition against use of federal branding--We would amend 
Sec.  40.365 to permit the public interest exclusion of a service agent 
for that agent's use of a DOT, or a DOT Agency's, logo on a Web site, 
in printed materials, or in any other manner that represents that the 
Department has approved, endorsed, or certified the service agent or 
its activities. The use of the DOT or DOT Agency's logo on materials 
generated by the DOT or the DOT Agency are permitted as long as the 
logo was on the original material being reprinted.
    11. Removal of Outdated Compliance Dates--We would remove existing 
compliance dates from several Part 40 sections. Five Part 40 sections 
provide for training with compliance dates dating back to the early 
2000s: Sec.  40.33--A training schedule for collectors for 
qualification training and initial proficiency demonstration; Sec.  
40.121--a training schedule for MROs for qualification training; Sec.  
40.203--a specific timeframe relating to Federal Drug Testing Custody 
and Control Forms that has now expired; Sec.  40.213--a training 
schedule for STTs and BATs for qualification training, initial 
proficiency training, and refresher training; Sec.  40. 281--a training 
schedule for qualification for SAPs. These compliance dates are no 
longer applicable, thus we propose to remove them from these sections 
where they occur.
    12. Editorial corrections--Section 40.162 entitled ``What must MROs 
do with multiple verified results for the same testing event?'' 
contains an incorrect reference to Sec.  40.159(f) in paragraph (c). 
Existing Sec.  40.162(c) refers to how an MRO must handle multiple 
verified non-negative test results and is intended to conform to a 
Sec.  40.159(g) provision that directs the MRO to act on the verified 
non-negative result and not report the invalid result unless the split 
specimen fails to reconfirm the results of the primary specimen. 
Section 40.162(c), however, inadvertently refers to Sec.  40.159(f) 
rather than Sec.  40.159(g) requirements because of a typographical 
error. We would like this 40.162(c) provision to reference Sec.  
40.159(g) which is the correct reference.
    Section 40.233 entitled ``What are the requirements for proper use 
and care of EBTs?'' contains an incorrect reference to Sec.  
40.333(a)(2) in paragraph (c)(4). Existing Sec.  40.233(c)(4) refers to 
maintaining records of the inspection, maintenance, and calibration of 
Evidential Breath Testing devices and is intended to conform to a Sec.  
40.333(a)(3) provision related to the specific timeframe for keeping 
such records. Section 40.233(c)(4), however, inadvertently refers to 
Sec.  40.333(a)(2) rather Sec.  40.333(a)(3) requirements because of a 
typographical error. We would like this Sec.  40.233(c)(4) provision to 
reference Sec.  40.333(a)(3) which is the correct reference.
    Section 40.67 entitled ``When and how is a directly observed 
collection conducted?'' would be revised to remove the words ``As the 
collector'' to clarify that any service agent participating in the 
testing process (not just the collector) who discovers a direct 
observation should have taken place, but did not, would inform the 
employer.
    13. Appendix Items--We propose amendments to four appendices. At 
Appendices B and C, we propose to add to the listing of the new drugs 
to conform with the revised drug testing list in proposed Sec.  40.87 
and also remove references to MDEA in those appendices. These revisions 
are needed to conform with the newly adopted HHS Guidelines that add 
these drugs. At Appendix D, we propose to modify existing web links 
from http://www.dot.gov/ost/odapc to https://www.transportation.gov/odapc. We propose to remove Appendix H in its entirety and relocate it 
to our Web page. This would remove the instruction sheet entitled 
``U.S. Department of Transportation Drug and Alcohol Testing MIS Data 
Collection Form Instruction Sheet'' and the actual MIS Data Collection 
Form. With this change made, we would be able to keep the instruction 
sheet and MIS Data Collection Form updated as necessary without a 
rulemaking action.
    14. Web links/electronic submissions--We would update references to 
web links that have been revised. Periodically our Departmental 
webmaster must update DOT Web sites for any number of reasons. The 
ODAPC Web site ``http://www.dot.gov/ost/odapc'' currently referenced in 
our regulation is now linked at ``https://www.transportation.gov/odapc.'' Therefore, we propose to update the regulation to replace 
http://www.dot.gov/ost/odapc with https://www.transportation.gov/odapc 
where the link occurs in the following sections: Sec. Sec.  40.33, 
40.45, 40.105, 40.121, 40.213, 40.225, and 40.401.

V. Regulatory Analyses and Notices

    Changes to Federal regulations must undergo several analyses. 
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 notice.

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

    This proposal 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. 
Actually, DOT estimates a cost-savings of at least $3.1 million per 
year for the proposed elimination of the requirement for employers to 
submit blind specimen testing to laboratories.

[[Page 7777]]

Costs

    The HHS Mandatory Guidelines addressed the burdens associated with 
the addition of new drugs to the drug-testing panel. The cost impact of 
drug testing for oxycodone, oxymorphone, hydrocodone, and hydromorphone 
would be minimal because HHS has determined that all HHS 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 proposed drugs 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 drugs would be approximately $0.11-
$0.30 per test. Once the testing has been implemented, the cost per 
specimen for initial testing for the added analytes would range from 
$.06 to $0.20 due to reagent costs. Current costs for each confirmatory 
test range from $5.00 to $10.00 for each specimen reported as positive 
due to costs of sample preparation and analysis. HHS indicated that 
based on information from non-regulated workplace drug testing for 
these analytes in 2012 and testing performed on de-identified federally 
regulated specimens in 2011, approximately 1% of the submitted 
specimens is expected to be confirmed as positive for the added 
analytes. Therefore, HHS indicates that the added cost for confirmatory 
testing will be $0.05 to $0.10 per submitted specimen.
    Approximately 6.3 million DOT-regulated tests occur per year. DOT 
considered the maximum ranges HHS provided in its analysis. Therefore, 
with the projected maximum implementation cost per specimen of $0.30, 
the maximum cost per specimen of initial testing at $0.20, and the 
maximum cost per specimen of confirmation testing at $0.10, the 
additional cost per urine test would be an additional $0.60. Under the 
new HHS Mandatory Guidelines, and based on an estimated 6.3 million DOT 
tests conducted annually, a cost of approximately $3,800,000 would be 
realized by employers subject to DOT-regulated testing ($0.60 x 
6,300,000 DOT tests annually = $3,780,000).
    HHS indicated that there will be minimal costs associated with 
adding MDA as an initial test analyte because the current immunoassays 
can be adapted to test for this analyte. According to HHS, before a lab 
is allowed to test regulated specimens for MDA, HHS must test three 
groups of performance test, or ``PT'' samples. HHS provides the PT 
samples at no cost to its certified laboratories but HHS estimates that 
the laboratory costs to conduct the PT testing would range from $900 to 
$1800 for each certified laboratory. There are approximately 27 HHS-
certified laboratories who process DOT drug tests. With the maximum 
cost estimate of $1800 for each certified laboratory, a cost of 
approximately $48,600 would be realized for DOT ($1800 x 27 
laboratories = $48,600.)
    Testing for additional drugs would result in MRO cost 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 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 would project an additional MRO 
cost of $189,000 (.03 projected increase x 6,300,000 DOT tests 
annually).

Cost-Savings

    DOT estimates a cost-savings of at least $3.1 million per year from 
the proposed 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, 
[see 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).

Net Economic Impact

    The DOT believes the projected cost-savings realized would, for the 
most part, offset the projected cost to the DOT of implementing testing 
for the additional drugs being added to the drug-testing regimen. The 
projected $3,848,600 for the four opioid drugs (and MDA) as well as the 
$189,000 projected MRO costs would result in a total projected cost of 
$4,037,600. The estimated cost impact of this proposal, therefore, 
would be negligible, an estimated $887,600 ($4,037,600-$3,150,000). If 
identifying illicit drug use by safety-sensitive transportation 
employees subjected to drug testing prevents a single serious accident, 
then the benefits of this proposal outweigh its minimal cost. This 
proposal would not have a major impact under Executive Order 12866 
because it would not have an annual effect on the economy of $100 
million or more, nor would it 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 rulemaking proposes to conform the existing DOT drug-testing 
panel to recently issued HHS Mandatory

[[Page 7778]]

Guidelines and, with certain minor amendments (mostly editorial), to 
improve the efficiency of the DOT drug-testing program. As noted above, 
any costs due to this rule are, for the most part, offset by the cost 
savings from the proposed elimination of the requirement for employers 
to submit blind specimen testing to laboratories. The net costs of this 
rule are negligible overall and would not constitute a significant 
burden to any entity, small or otherwise. Consequently, the DOT 
certifies, under the RFA, that this proposal would not have a 
significant economic impact on a substantial number of small entities.

Federalism

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

Paperwork Reduction Act/Privacy Act

    The Paperwork Reduction Act requires that the DOT consider the 
impact of paperwork and other information collection burdens imposed on 
the public. Information collections for Part 40 currently are approved 
under OMB Control No. 2105-0529. The Privacy Act provides safeguards 
against invasion of personal privacy through the misuse of records by 
Federal Agencies. It establishes controls over what personal 
information is collected, maintained, used and disseminated by agencies 
in the executive branch of the Federal government. This proposal would 
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 
proposed 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 
proposal does not meet any of these criteria. Paragraph 3.c.5 of DOT 
Order 5610.1C incorporates by reference the categorical exclusions for 
all DOT Operating Administrations. This action is covered by the 
categorical exclusion listed in the Federal Highway Administration's 
implementing procedures, ``[p]romulgation of rules, regulations, and 
directives.'' 23 CFR 771.117(c)(20). The agency 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.

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 Proposal

    For reasons discussed in the preamble, the Department of 
Transportation proposes to amend 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 continues to read as 
follows:

    Authority:  40 U.S.C. 102, 301, 322, 5331, 20140, 31306, and 
54101 et seq.

0
2. Amend Sec.  40.3 as follows:
0
a. Remove the definition ``Blind specimen or blind performance test 
specimen''; and
0
b. Revise and reorder (in correct alphabetical order) the definitions 
``DOT, the Department, DOT Agency'' and ``Drugs'' to read as follows:


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

* * * * *
    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. 
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.
* * * * *
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 may 
view and download this form and its instructions on the Department's 
Web site (https://www.transportation.gov/odapc). You must submit the 
MIS report in accordance with rule requirements (e.g., dates for 
submission, selection of companies required to submit, and method of 
reporting) established by the DOT agency regulating your operation.


Sec.  40.29  [Amended]

0
4. Amend Sec.  40.29 by removing the entry ``Sec. Sec.  40.103-40.105--
Blind specimen requirements.''
0
5. Amend Sec.  40.33 by revising paragraphs (a) and (d) to read as 
follows:


Sec.  40.33  What training requirements must a collector meet?

* * * * *
    (a) Basic information. You must be knowledgeable about this part, 
the current ``DOT Urine Specimen Collection Procedures Guidelines,'' 
and DOT agency regulations applicable to the employers for whom you 
perform

[[Page 7779]]

collections. The DOT Urine Specimen Collection Procedures Guidelines 
document is 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). DOT agency 
regulations are available at each agency's Web site, on the DOT Web 
site (http://www.transportation.dot.gov), or at www.ecfr.gov. You must 
keep current on any changes to these materials. You must subscribe to 
the ODAPC list-serve (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.
* * * * *
0
6. 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 observation.
0
7. 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) 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
8. 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
9. 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:

----------------------------------------------------------------------------------------------------------------
                                                                  Confirmatory test     Confirmatory test cutoff
       Initial test analyte           Initial test cutoff \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/Morphine..................  2000 ng/mL................  Codeine..............  2000 ng/mL.
                                                                Morphine.............  2000 ng/mL.
Hydrocodone/Hydromorphone.........  300 ng/mL.................  Hydrocodone..........  100 ng/mL.
                                                                Hydromorphone........  100 ng/mL.
Oxycodone/Oxymorphone.............  100 ng/mL.................  Oxycodone............  100 ng/mL.
                                                                Oxymorphone..........  100 ng/mL.
6-Acetylmorphine..................  10 ng/mL..................  6-Acetylmorphine.....  10 ng/mL.
Phencyclidine.....................  25 ng/mL..................  Phencyclidine........  25 ng/mL.
Amphetamine/Methamphetamine.......  500 ng/mL.................  Amphetamine..........  250 ng/mL
                                                                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 alternate technology to test for THCA and
  Benzoylecgonine, the screening and confirmatory test cutoff concentrations must be the same respectively
  (i.e., 15 ng/mL for THCA and 100 ng/mL for Benzoylecgnine).''
\4\ Methylenedioxymethamphetamine (MDMA).
\5\ Methylenedioxyamphetamine (MDA).

* * * * *


Sec.  40.103  [Removed]

0
10. Remove Sec.  40.103.
0
11. Remove Sec.  40.105.
0
12. 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.,

[[Page 7780]]

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 or have successfully completed the 
required continuing education requirements, you must complete 
requalification training.
* * * * *
0
13. 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
14. 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.
* * * * *
0
15. 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).
    (1) * * *
    (2) * * *
    (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 verify the test positive for codeine. The 
admission must be for the substance that was found through the actual 
drug test).
* * * * *
0
16. 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 under 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 D, Lstereoisomer testing or tetrahydrocannabivarin (THC-V) 
testing when verifying lab results, as you determine necessary.
0
17. 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
18. Amend Sec.  40.169 by removing the entry ``Sec.  40.105--
Notification of discrepancies in blind specimen results.''


Sec.  40.189  [Amended]

0
19. Amend Sec.  40.189 by removing the entry ``Sec.  40.103--Blind 
split specimens.''
0
20. Amend Sec.  40.193 by revising paragraph (b)(4) to read as follows:


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

* * * * *
    (b) * * *
    (4) If the employee has not provided a sufficient specimen within 
three hours of the first unsuccessful attempt to provide the specimen, 
you must discontinue the collection, note the fact on the ``Remarks'' 
line of the CCF (Step 2), and immediately notify the DER. You must also 
discard any specimen the employee previously provided to include any 
specimen that is `out of temperature range' or shows signs of 
tampering. In the remarks section of the CCF that you will distribute 
to the MRO and DER, you must 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
21. 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?

    (a) * * *
    (b) The following are ``fatal flaws'':
    (1) There is no CCF;
    (2) 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)); and
    (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
22. 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
23. Add Sec.  40.210 in 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

[[Page 7781]]

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
24. 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, 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 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.
* * * * *
0
25. Amend Sec.  40.233 by revising paragraph (c)(4) to read as follows:


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

* * * * *
    (c) * * *
    (4) You must maintain records of the inspection, maintenance, and 
calibration of EBTs as provided in Sec.  40.333(a)(3).
* * * * *
0
26. Amend Sec.  40.281 by revising paragraphs (a)(6), (b)(3), and 
(c)(3) to read as follows:


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

* * * * *
    (a) * * *
    (6) You are a drug and alcohol counselor certified by an 
organization listed at https://www.transportation.gov/odapc/sap.
    (b) * * *
    (3) You must be knowledgeable about this part, the DOT agency 
regulations applicable to the employers for whom you evaluate 
employees, and the DOT SAP Guidelines. You must keep current on any 
changes to these materials. You must subscribe to the ODAPC list-serve 
at https://www.transportation.gov/odapc/get-odapc-email-updates. DOT 
agency regulations, DOT SAP Guidelines, and other materials are 
available from ODAPC (Department of Transportation, 1200 New Jersey 
Avenue SE., Washington DC, 20590 (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
27. 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
28. 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, representing falsely 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).
* * * * *
0
29. 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)

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
30. 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: ODAPCWebMail@dot.gov.

    The following items are required on each report:

Reporting Period: (inclusive dates)
Laboratory Identification: (name and address)
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)

[[Page 7782]]

    (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
31. 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:

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).

Appendix H to Part 40 [Removed]

0
32. Remove appendix H to part 40.

    Dated: January 12, 2017.
Anthony R. Foxx,
Secretary of Transportation.
[FR Doc. 2017-01131 Filed 1-19-17; 8:45 am]
BILLING CODE P


