Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Rules and Regulations 52229 

■ d. Remove paragraph (c)(3). 

■ e. Redesignate paragraphs (c)(4) and 

(5) as paragraphs (c)(3) and (4), 

respectively. 

■ f. Revise newly redesignated 

paragraphs (c)(3)(iii), (iv), and (v) and 

the first sentence in newly redesignated 

paragraph (c)(4). 

■ g. Add paragraph (d). 

The additions and revisions read as 

follows: 

§ 202.13 Secure tests. 

(a) General. This section prescribes 

rules pertaining to the registration of 

secure tests or a group of test items 

prepared for use in a secure test. 

(b) * * * 

(5) A test item is comprised of a 

question (or ‘‘stem’’), the correct answer 

to that question, any incorrect answer 

choices (or ‘‘distractors’’), and any 

associated material, such as a narrative 

passage or diagram, and each item shall 

be considered one work. A single 

narrative, diagram, or other prefatory 

material, followed by multiple sets of 

related questions and correct or 

incorrect answers shall together be 

considered one item. 

(c) Deposit requirements. Pursuant to 

the authority granted by 17 U.S.C. 

408(c)(1), the Register of Copyrights has 

determined that a secure test or a group 

of test items prepared for use in a secure 

test may be registered with identifying 

material, and the filing and examination 

fees required by § 201.3(c) and (d), if the 

following conditions are met: 

* * * * * 

(2) In the case of a secure test, the 

applicant must submit a redacted copy 

of the entire test. In the case of a group 

of test items prepared for use in a secure 

test, the applicant must submit a 

redacted copy of each test item. In all 

cases the redacted copy must contain a 

sufficient amount of visible content to 

reasonably identify the work(s). In 

addition, the applicant must complete 

and submit the secure test questionnaire 

that is posted on the Copyright Office’s 

Web site. The questionnaire and the 

redacted copy must be contained in 

separate electronic files, and each file 

must be uploaded to the electronic 

registration system in Portable 

Document Format (PDF). The Copyright 

Office will review these materials to 

determine if the work(s) qualify for an 

in-person examination. If they appear to 

be eligible, the Copyright Office will 

contact the applicant to schedule an 

appointment to examine an unredacted 

copy of the work(s) under secure 

conditions. 

(3) * * * 

(iii) A copy of the redacted version of 

the work(s) that was uploaded to the 

electronic registration system. 

(iv) A signed declaration confirming 

that the redacted copy specified in 

paragraph (c)(3)(iii) of this section is 

identical to the redacted copy that was 

uploaded to the electronic registration 

system. 

(v) In the case of a secure test, the 

applicant must bring an unredacted 

copy of the entire test. In the case of a 

group of test items prepared for use in 

a secure test, the applicant must bring 

an unredacted copy of all the test items. 

(4) The Copyright Office will examine 

the copies specified in paragraphs 

(c)(3)(iii) and (v) of this section in the 

applicant’s presence. * * * 

(d) Group registration requirements. 

The Copyright Office may register a 

group of test items if the following 

conditions have been met: 

(1) All the test items must be prepared 

for use in a secure test, and the name 

of the secure test must be identified in 

the title of the group. 

(2) The group may contain an 

unlimited amount of works, but the 

applicant must identify the individual 

works included within the group by 

numbering each test item in the deposit. 

(3) The applicant must provide a title 

for the group as a whole, and must 

append the term ‘‘GRSTQ’’ to the 

beginning of the title. 

(4) The group must contain only 

unpublished works, or works published 

within the same three-calendar-month 

period and the application must identify 

the earliest date that the works were 

published. 

(5) All the works in the group must 

have the same author or authors, and 

the copyright claimant for each work 

must be the same. Claims in the 

selection, coordination, or arrangement 

of the group as a whole will not be 

permitted on the application. Each item 

in the group must be separately 

copyrightable or must be excluded from 

the group. 

Dated: November 6, 2017. 

Karyn Temple Claggett, 

Acting Register of Copyrights and Director 

of the U.S. Copyright Office. 

Approved by: 

Carla D. Hayden, 

Librarian of Congress. 

[FR Doc. 2017–24532 Filed 11–9–17; 8:45 am] 

BILLING CODE 1410–30–P 

DEPARTMENT OF TRANSPORTATION 

Office of the Secretary 

49 CFR Part 40 

[Docket DOT–OST–2016–0189] 

RIN 2105–AE58 

Procedures for Transportation 

Workplace Drug and Alcohol Testing 

Programs: Addition of Certain 

Schedule II Drugs to the Department of 

Transportation’s Drug-Testing Panel 

and Certain Minor Amendments 

AGENCY: Office of the Secretary of 

Transportation (OST), U.S. Department 

of Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: The Department of 

Transportation is amending its drugtesting 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 drugtesting 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; 

ODAPCWebMail@dot.gov. 

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 


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52230 Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Rules and Regulations 

1The 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-advisoryboard-dtab/board-charter. 

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 DrugTesting 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 semisynthetic opioids, oxycodone, 

oxymorphone, hydrocodone, and 

hydromorphone, should be added in the 

Federal program. 

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 


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Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Rules and Regulations 52231 

addition to being a drug of abuse, it is 

a metabolite of MDEA and MDMA. 

Harmonizing Changes to the DOT DrugTesting 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 semisynthetic 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’ nonDOT 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 semisynthetic 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 semisynthetic 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 listserve 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 semisynthetic 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. 


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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 laboratoryrelated 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 semisynthetic 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 


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Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Rules and Regulations 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 listserve 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 listserve 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 timeconsuming 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 § 40.33(a); 

Medical Review Officers (MROs) in 

§ 40.151(b)(3); Substance Abuse 

Professionals (SAPs) in § 40.281(b)(3) 

[SAPs]. Similarly; § 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 listserve 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 § 40.141(b) to say that 

‘‘prescription,’’ for purposes of MRO 


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verification determinations, means ‘‘a 

legally valid prescription under the 

Controlled Substances Act [CSA].’’ This 

same language was used in § 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 overthe-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 § 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 

(§ 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 

§ 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 

§ 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, 


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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 § 40.135(e), so we will make a 

technical amendment to that language 

for consistency. In addition, we have 

added the same language to § 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 

§ 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 

§ 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 safetysensitive 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., §§ 40.137(e)(2), 

40.151(e), and DOT ‘‘Medical 

Marijuana’’ Notice https://www.

transportation.gov/odapc/medicalmarijuana-notice; DOT ‘‘Recreational 

Marijuana’’ Notice https://www.

transportation.gov/odapc/dotrecreational-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 


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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 semisynthetic opioids covered by this rule, 

§ 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 § 40.327, we believe this 

section warrants a discussion and a 

slight amendment to the existing 

language of § 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 § 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 §§ 40.135 and 

40.327 to commonly prescribed 

medications that can cause a laboratoryconfirmed 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 

§ 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 § 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 § 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 § 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 


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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 §§ 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 

§ 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 §§ 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 § 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 § 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 

§ 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 

§§ 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 


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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 §§ 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 

§ 40.193(b)(4). 

Only Urine Specimens Are Authorized 

for Testing 

The NPRM proposed to add a new 

section, § 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 § 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 §§ 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 

(§ 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 

§§ 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 §§ 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 


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preamble, the proposed § 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 semisynthetic 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 §§ 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 § 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 § 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 §§ 40.121 (MROs), 40.213 

(BATs/STTs), and 40.281 (SAPs). In 

addition, §§ 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 § 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 § 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 § 40.162(c) a 

reference to § 40.159(f) was corrected to 

cite paragraph (g) of that section. In 

§ 40.233(b)(4), a reference to 

§ 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 


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current http://www.transaportation.gov/ 

odapc. The affected sections are 

§§ 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/splitspecimen-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 §§ 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 EGovernment 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 drugtesting 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 nonregulated tests for transportation 

employers who already include the four 

semi-synthetic opioids in their nonregulated 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 semisynthetic 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 


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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 DOTregulated 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 DOTregulated testing ($0.60 × 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 HHScertified 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 × 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 × 

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 ‘costsavings’ 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 DOTregulated industries. We have added the 

full cost of the MRO review of the nonnegative results for the four semisynthetic 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 × 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-pricefits-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 semisynthetic 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 × 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 × 6,300,000) would be realized by 

employers subject to DOT-regulated 

testing and not the $3,780,000 we 

originally estimated. 


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52242 Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Rules and Regulations 

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-toduty 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 nonDOT testing that 80% of the semisynthetic 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 × $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 × 

$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 costsavings 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 × 

$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 costsavings 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-forprofit 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) 


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Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Rules and Regulations 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 

■ 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. 

■ 2. Amend § 40.3 as follows: 

■ a. Revise the definition of ‘‘Alcohol 

screening device (ASD)’’; 

■ b. Remove the definition ‘‘Blind 

specimen or blind performance test 

specimen’’; 

■ c. Revise and reorder (in correct 

alphabetical order) the definition ‘‘DOT, 

the Department, DOT Agency’’; 

■ d. Revise the definition ‘‘Drugs’’; and 

■ e. Revise the definition of ‘‘Evidential 

breath testing device (EBT)’’. 

The revisions read as follows: 

§ 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. 

* * * * * 

■ 3. Revise § 40.26 to read as follows: 

§ 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. 


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52244 Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Rules and Regulations 

§ 40.29 [Amended] 

■ 4. Amend § 40.29 by removing the 

entry ‘‘§§ 40.103–40.105—Blind 

specimen requirements.’’ 

■ 5. Amend § 40.33 by revising 

paragraphs (a) and (d) to read as follows: 

§ 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/getodapc-email-updates. 

* * * * * 

(d) You must meet the requirements 

of paragraphs (b) and (c) of this section 

before you begin to perform collector 

functions. 

* * * * * 

§ 40.37 [Amended] 

■ 6. Amend § 40.37 by removing the 

entry ‘‘§ 40.103—Processing blind 

specimens.’’ 

§ 40.45 [Amended] 

■ 7. Amend § 40.45(a) by removing the 

parenthetical ‘‘(http://www.dot.gov/ 

odapc)’’ and adding, in its place 

‘‘(http://www.transportation.gov/ 

odapc)’’ and § 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)’’ 

■ 8. Amend § 40.67 by revising 

paragraph (n) to read as follows: 

§ 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. 

■ 9. Amend § 40.83 by revising 

paragraph (c) to read as follows: 

§ 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). 

* * * * * 

■ 10. Revise § 40.85 to read as follows: 

§ 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). 

■ 11. Amend § 40.87 by revising 

paragraph (a) to read as follows: 

§ 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 analyte Initial test cutoff 1 Confirmatory test analyte 

Confirmatory 

test cutoff concentration 

Marijuana metabolites (THCA) 2 .............. 50 ng/mL3 ............................................... THCA ..................................................... 15 ng/mL. 

Cocaine metabolite (Benzoylecgonine) ... 150 ng/mL 3 ............................................ Benzoylecgonine .................................... 100 ng/mL. 

Codeine/ ..................................................

Morphine 

2000 ng/mL ............................................ Codeine ..................................................

Morphine ................................................

2000 ng/mL. 

2000 ng/mL. 

Hydrocodone/ ..........................................

Hydromorphone 

300 ng/mL .............................................. Hydrocodone ..........................................

Hydromorphone .....................................

100 ng/mL. 

100 ng/mL. 

Oxycodone/ .............................................

Oxymorphone 

100 ng/mL .............................................. Oxycodone .............................................

Oxymorphone .........................................

100 ng/mL. 

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 .........................................

Methamphetamine .................................

250 ng/mL. 

250 ng/mL. 

MDMA4/MDA5 ........................................ 500 ng/mL .............................................. MDMA ....................................................

MDA .......................................................

250 ng/mL. 

250 ng/mL. 

1For 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. 2An immunoassay must be calibrated with the target analyte, D-9-tetrahydrocannabinol-9-carboxylic acid (THCA). 3Alternate 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). 


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* * * * * 

§ 40.103 [Removed] 

■ 12. Remove § 40.103. 

§ 40.105 [Removed] 

■ 13. Remove § 40.105. 

■ 14. Amend § 40.121 by revising 

paragraphs (b)(3) and (c)(3), and the 

paragraph (d) introductory text to read 

as follows: 

§ 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/getodapc-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. 

* * * * * 

■ 15. Amend § 40.123 by revising 

paragraph (e) to read as follows: 

§ 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). 

* * * * * 

■ 16. Amend § 40.135 by revising 

paragraph (e) to read as follows: 

§ 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 

§ 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 

§ 40.327. 

■ 17. Amend § 40.137 by revising the 

section heading and paragraph (a) to 

read as follows: 

§ 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. 

* * * * * 

■ 18. Amend § 40.139 by revising the 

section heading and paragraphs (c) 

introductory text and (c)(3) to read as 

follows: 

§ 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.) 

* * * * * 

■ 19. Amend § 40.141 by revising 

paragraph (b) to read as follows: 

§ 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 HHScertified laboratory with validated 

protocols (see § 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. 

■ 20. Amend § 40.162 by revising 

paragraph (c) to read as follows: 

§ 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 § 40.159(g) 

when any verified non-negative result is 

also invalid. 

§ 40.169 [Amended] 

■ 21. Amend § 40.169 by removing the 

entry ‘‘§ 40.105—Notification of 

discrepancies in blind specimen 

results.’’ 

§ 40.189 [Amended] 

■ 22. Amend § 40.189 by removing the 

entry ‘‘§ 40.103—Blind split 

specimens.’’ 

■ 23. Amend § 40.193 by revising 

paragraph (b)(4) to read as follows: 

§ 40.193 What happens when an employee 

does not provide a sufficient amount of 

urine for a drug test? 

* * * * * 

(b) * * * 


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52246 Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Rules and Regulations 

(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. 

* * * * * 

■ 24. Amend § 40.199 by revising 

paragraph (b) to read as follows: 

§ 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 § 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 § 40.83(h)). 

* * * * * 

■ 25. Amend § 40.203 by revising 

paragraph (d)(3) to read as follows: 

§ 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 § 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. 

■ 26. Add § 40.210 to subpart I to read 

as follows: 

§ 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 § 40.81) are 

allowed for drug testing under this part. 

Point-of-collection urine testing or 

instant tests are not authorized. 

■ 27. Amend § 40.213 by revising 

paragraphs (a), (d), and (e) to read as 

follows: 

§ 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. 

* * * * * 

§ 40.225 [Amended] 

■ 28. Amend § 40.225(a) by removing 

the parenthetical ‘‘(http://www.dot.gov/ 

dapc)’’ and adding, in its place ‘‘(http:// 

www.transportation.gov/odapc)’’ 

■ 29. Revise § 40.229 to read as follows: 

§ 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. 

■ 30. Amend § 40.231 by revising 

paragraph (a) to read as follows: 

§ 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. 

* * * * * 

■ 31. Amend § 40.233 by revising 

paragraphs (a) introductory text and 

(c)(4) to read as follows: 

§ 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 

§ 40.333(a)(3). 

* * * * * 

■ 32. Amend § 40.235 by revising 

paragraph (a) to read as follows: 

§ 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. 

* * * * * 

■ 33. Amend § 40.281 by revising 

paragraphs (a)(6), (b)(3), and (c)(3) to 

read as follows: 

§ 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 


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Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Rules and Regulations 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. 

* * * * * 

■ 34. Amend § 40.331 by revising 

paragraph (f) to read as follows: 

§ 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 § 40.13). This part does 

not require you to disobey a court order, 

however. 

* * * * * 

■ 35. Amend § 40.365 by revising 

paragraph (b)(10) to read as follows: 

§ 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). 

* * * * * 

§ 40.401 [Amended] 

■ 36. Amend § 40.401(a) by removing 

the parenthetical ‘‘(http://www.dot.gov/ 

ost/dapc)’’ and adding, in its place 

‘‘(http://www.transportation.gov/ 

odapc)’’ 

■ 37. Revise Appendix B to Part 40 to 

read as follows: 

Appendix B to Part 40—DOT DrugTesting 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) 

■ 38. Revise Appendix C to Part 40 to 

read as follows: 

Appendix C to Part 40—DOT DrugTesting 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) 

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) 

■ 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/splitspecimen-cancellation-notification-49-cfrpart-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-toreconfirm 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) 

■ 40. Amend Appendix H to Part 40 by: 

■ a. Revising the introductory text; and 

■ b. Removing the instruction sheet 

entitled: ‘‘U.S. DEPARTMENT OF 


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52248 Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Rules and Regulations 

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 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 622 

[Docket No. 121004518–3398–01] 

RIN 0648–XF815 

Fisheries of the Caribbean, Gulf of 

Mexico, and South Atlantic; 2017 

Commercial Accountability Measure 

and Closure for Gulf Gray Triggerfish 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; closure. 

SUMMARY: NMFS implements 

accountability measures for commercial 

gray triggerfish in the exclusive 

economic zone (EEZ) of the Gulf of 

Mexico (Gulf) through this temporary 

rule. NMFS projects commercial 

landings for gray triggerfish will reach 

the commercial annual catch target 

(ACT)(commercial quota) by November 

18, 2017. Therefore, NMFS is closing 

the commercial sector for gray 

triggerfish in the Gulf EEZ on November 

18, 2017. This closure is necessary to 

protect the gray triggerfish resource. 

DATES: This rule is effective 12:01 a.m., 

local time, November 18, 2017, until 

January 1, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Kelli O’Donnell, NMFS Southeast 

Regional Office, telephone: 727–824– 

5305, email: kelli.odonell@noaa.gov. 

SUPPLEMENTARY INFORMATION: The reef 

fish fishery of the Gulf includes gray 

triggerfish and is managed under the 

Fishery Management Plan for Reef Fish 

Resources of the Gulf (FMP). The FMP 

was prepared by the Gulf Fishery 

Management Council and is 

implemented under the authority of the 

Magnuson-Stevens Fishery 

Conservation and Management Act 

(Magnuson-Stevens Act) by regulations 

at 50 CFR part 622. All gray triggerfish 

weights discussed in this temporary rule 

are in round weight. 

On August 4, 2008, NMFS established 

gray triggerfish accountability measures 

as well as commercial quotas for gray 

triggerfish through Amendment 30A to 

the FMP (73 FR 38139). On May 9, 2013, 

NMFS issued a final rule to implement 

Amendment 37 to the FMP (78 FR 

27084). In part, Amendment 37 revised 

gray triggerfish commercial annual 

catch limits (ACLs) and ACTS. 

Under 50 CFR 622.41(b)(1), NMFS is 

required to close the commercial sector 

for gray triggerfish when the commercial 

quota is reached, or is projected to be 

reached, by filing a notification to that 

effect with the Office of the Federal 

Register. NMFS has determined that the 

commercial quota for Gulf gray 

triggerfish of 60,900 lb (27,624 kg) will 

be reached by November 18, 2017. 

Accordingly, the commercial sector for 

Gulf gray triggerfish is closed effective 

12:01 a.m., local time, November 18, 

2017, until the start of the next 

commercial fishing season on January 1, 

2018. 

The operator of a vessel with a valid 

commercial vessel permit for Gulf reef 

fish having gray triggerfish onboard 

must have landed and bartered, traded, 

or sold such gray triggerfish prior to 

12:01 a.m., local time, November 18, 

2017. During the closure, the sale or 

purchase of gray triggerfish taken from 

the Gulf EEZ is prohibited. The 

prohibition on the sale or purchase does 

not apply to gray triggerfish that were 

harvested, landed ashore, and sold prior 

to 12:01 a.m., local time, November 18, 

2017, and were held in cold storage by 

a dealer or processor. 

The recreational sector for gray 

triggerfish is also closed through 

December 31, 2017. Therefore all 

harvest or possession of gray triggerfish 

is prohibited until the start of the new 

fishing year (50 CFR 622.39(b)). The 

commercial and recreational sectors for 

gray triggerfish will reopen on January 

1, 2018, the beginning of the 2018 gray 

triggerfish fishing year. 

Classification 

The Regional Administrator, 

Southeast Region, NMFS, has 

determined this temporary rule is 

necessary for the conservation and 

management of gray triggerfish and the 

Gulf reef fish fishery and is consistent 

with the Magnuson-Stevens Act and 

other applicable laws. 

This action is taken under 50 CFR 

622.41(b)(1) and is exempt from review 

under Executive Order 12866. 

These measures are exempt from the 

procedures of the Regulatory Flexibility 

Act because the temporary rule is issued 

without opportunity for prior notice and 

comment. 

This action responds to the best 

scientific information available. The 

NOAA Assistant Administrator for 

Fisheries (AA), finds that the need to 

immediately implement this action to 

close the commercial sector for gray 

triggerfish constitutes good cause to 

waive the requirements to provide prior 

notice and opportunity for public 

comment pursuant to the authority set 

forth in 5 U.S.C. 553(b)(B), as such 

procedures are unnecessary and 

contrary to the public interest. Such 

procedures are unnecessary because the 

final rule implementing Amendment 37 

(78 FR 27084; May 9, 2013), which 

established the closure provision for 

commercial gray triggerfish, have 

already been subject to notice and 

comment, and all that remains is to 

notify the public of the closure. Such 

procedures are contrary to the public 

interest because of the need to 

immediately implement this action to 

protect gray triggerfish since the 

capacity of the fishing fleet allows for 

rapid harvest of the commercial quota. 

Prior notice and opportunity for public 

comment would require time and could 

potentially result in a harvest well in 

excess of the established commercial 

quota. 

For the aforementioned reasons, the 

AA also finds good cause to waive the 

30-day delay in the effectiveness of this 

action under 5 U.S.C. 553(d)(3). 

Authority: 16 U.S.C. 1801 et seq. 

Dated: November 7, 2017. 

Emily H. Menashes, 

Acting Director, Office of Sustainable 

Fisheries, National Marine Fisheries Service. 

[FR Doc. 2017–24519 Filed 11–9–17; 8:45 am] 

BILLING CODE 3510–22–P 


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