[Federal Register Volume 80, Number 129 (Tuesday, July 7, 2015)]
[Rules and Regulations]
[Pages 38654-38655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16531]


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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

49 CFR Part 219

[Docket No. FRA-2001-11213, Notice No. 19]


Alcohol and Drug Testing: Reporting Positive Results for Tramadol 
as a Controlled Substance

AGENCY: Federal Railroad Administration (FRA), DOT.

ACTION: Final rule.

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SUMMARY: This document announces that FRA will begin reporting post-
accident toxicological test results for tramadol to the employee and 
the railroad Medical Review Officers. FRA will also begin including 
post-accident toxicological test results for tramadol in its post-
accident toxicology reports. Because tramadol was not a controlled 
substance when FRA began testing for it, FRA has kept post-accident 
toxicological test results for tramadol confidential.

DATES: This document is effective July 7, 2015.

FOR FURTHER INFORMATION CONTACT: Jerry Powers, FRA Drug and Alcohol 
Program Manager, W33-310, Federal Railroad Administration, 1200 New 
Jersey Avenue SE., Washington, DC 20590, telephone 202-493-6313 or 
[email protected]; or Sam Noe, FRA Drug and Alcohol Program 
Specialist, telephone 615-719-2951, or [email protected].

SUPPLEMENTARY INFORMATION: 

FRA's Post-Accident Toxicological Testing Program

    Since 1985, as part of its accident investigation program, FRA has 
routinely conducted alcohol and drug tests on railroad employees 
involved in serious train accidents that meet certain criteria 
specified in FRA's regulations. See 49 CFR 219.201.\1\ This post-
accident testing is used to determine if alcohol misuse or drug abuse 
played a role in the occurrence or severity of an accident. Since the 
program's inception, FRA has routinely conducted post-accident tests 
for alcohol and certain drugs the United States Drug Enforcement 
Administration (DEA) classifies as controlled substances.
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    \1\ All references to sections of the Code of Federal 
Regulations (CFR) in this document refer to sections within title 49 
of the CFR.
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    Controlled substances are drugs or chemicals that are prohibited or 
strictly regulated because of their potential for abuse or addiction. 
See 77 FR 29307, 29307, May 17, 2002. The DEA oversees the 
classification of controlled substances into five schedules. Section I 
contains illicit drugs such as marijuana and heroin, which have no 
legitimate medical use under Federal law. Schedules II-V contain legal 
drugs that are available only by prescription. See generally The 
Controlled Substances Act (CSA), Title II of the Comprehensive Drug 
Abuse Prevention Substances Act of 1970 (21 U.S.C. 801 et seq.).
    FRA has historically conducted post-accident tests for the 
following controlled substances: Marijuana, cocaine, phencyclidine 
(PCP), and selected opioids, amphetamines, barbiturates, and 
benzodiazepines. Under 49 CFR 219.211(b), FRA reports post-accident 
test results for these substances to the employee tested and the 
employing railroad's Medical Review Officer (MRO). See 49 CFR 
219.211(b).

[[Page 38655]]

    In 2013, FRA amended its alcohol and drug testing regulations to 
establish post-accident testing for non-controlled substances.\2\ See 
78 FR 14217, Mar. 5, 2013. In the final rule adopting this revision, 
FRA provided notice of the addition of two non-controlled substances to 
its standard post-accident testing panel: Tramadol and sedating 
antihistamines. FRA also made clear that the agency did not intend to 
report the results of post-accident tests for these non-controlled 
substances to the employee involved or relevant MRO and instead 
intended to use the results for research and data purposes only. See 
id. at 14217 and 14219.
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    \2\ A non-controlled substance is any substance that is not 
currently regulated under 21 U.S.C. 801-971 or 21 CFR part 1308. See 
Sec.  219.5. Non-controlled substances can include prescription 
medications, over-the-counter products, dietary supplements, and 
herbal preparations. See id.
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DEA's Determination To Schedule Tramadol as a Controlled Substance

    In 2014, after FRA issued its final rule establishing post-accident 
testing for non-controlled substances, the DEA placed tramadol \3\ on 
the CSA's Schedule IV. See 79 FR 37623-37630, Jul. 2, 2014. The DEA's 
determination stated that it took into account a scientific and medical 
evaluation the Department of Health and Human Services (HHS) prepared 
which recommended including tramadol in Schedule IV of the CSA. See id. 
at 37623. The HHS evaluation analyzed tramadol taking into 
consideration eight factors listed in 21 U.S.C. 811(c), as well as 
tramadol's abuse potential, legitimate medical use, and dependence 
liability. See id. at 37623-37624. In response to public comment, DEA 
explained that tramadol is considered an opioid because it produces 
pharmacological effects similar to those produced by other opioids. Id. 
at 37626. The DEA also noted ``tramadol is a widely prescribed drug, 
with nearly 40 million prescriptions written in 2012.'' Id. at 37627 
(citations omitted).
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    \3\ The DEA's decision to designate tramadol as a Schedule IV 
controlled substance applied to the substance 2-
[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol (tramadol), 
including its salts, isomers, and salts of isomers. See id. at 
37623.
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Reporting of Tramadol Positives

    Because the DEA now designates tramadol a controlled substance, 
FRA's alcohol and drug regulations apply to tramadol use and possession 
the same as they apply to use and possession of any other controlled 
substance, such as synthetic opioids and valium. For example, FRA's 
regulations place certain limitations on a railroad employee's use and 
possession of controlled substances--those limitations now apply to the 
use and possession of tramadol by railroad employees. The regulations 
prohibit a railroad employee from using or possessing a controlled 
substance while assigned by a railroad to perform covered service,\4\ 
except as provided by Sec.  219.103. See 49 CFR 219.101(a)(1). (Section 
219.103 provides that subject to certain conditions and limitations, a 
covered employee may use and possess Schedule II through IV controlled 
substances if a medical practitioner prescribes or authorizes the use.) 
The regulations also prohibit a railroad employee who performs covered 
service from using a controlled substance at any time, whether on or 
off duty, except as Sec.  219.103 permits. See 49 CFR 219.102. A 
railroad employee who uses or possesses a controlled substance, 
including tramadol, in violation of one of these prohibitions is 
subject to the removal, return-to-service, and follow-up testing 
requirements of Sec.  219.104.
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    \4\ Covered service is service in the United States that is 
subject to the hours of service laws at 49 U.S.C. 21103, 21104, or 
21105. See 49 CFR 219.5. Covered service does not include any period 
the employee is relieved of all responsibilities and is free to come 
and go. See id.
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    FRA is issuing this document to (1) make railroads and railroad 
employees aware of the DEA's classification of tramadol as a controlled 
substance and (2) remind railroads and individuals subject to FRA's 
regulations of the effect of the DEA's designation of tramadol as a 
controlled substance on FRA's post-accident testing program. Issuance 
of this document does not provide precedent that FRA will notify the 
industry whenever DEA designates additional drugs as controlled 
substances or whenever FRA decides to conduct post-accident testing for 
additional controlled substances. This document is also not an 
exhaustive discussion of all FRA requirements governing controlled 
substances.
    Because DEA has designated tramadol as a Schedule IV controlled 
substance, on July 7, 2015 FRA will begin reporting post-accident test 
results for tramadol pursuant to Sec.  219.211(b), which provides that 
post-accident test results for controlled substances will be reported 
to a railroad's MRO and the employee. FRA also intends to include post-
accident test results for tramadol in toxicology reports as Sec.  
219.211(f)(2) requires.
    Railroads and MROs must also treat post-accident test results for 
tramadol consistent with all applicable FRA requirements for controlled 
substances. For example, like post-accident test results for any 
controlled substance, an MRO must review tramadol results with respect 
to any claim of use or administration of tramadol consistent with Sec.  
219.103 that could account for the laboratory findings, and must report 
the results of this review to the employing railroad and FRA. See Sec.  
219.211(c). Railroads and MROs must also treat post-accident test 
results for tramadol as confidential under Sec.  219.211(b). FRA 
encourages any railroad, railroad employee, or MRO that has questions 
about post-accident test results for tramadol to contact FRA's Drug and 
Alcohol Program Manager for guidance.
    Finally, the requirements of Sec. Sec.  219.101, 219.102, 219.103, 
and 219.104 now apply to covered employees' use and possession of 
tramadol.

Robert C. Lauby,
Associate Administrator for Railroad Safety Chief Safety Officer.
[FR Doc. 2015-16531 Filed 7-6-15; 8:45 am]
 BILLING CODE 4910-06-P