80_FR_38783 80 FR 38654 - Alcohol and Drug Testing: Reporting Positive Results for Tramadol as a Controlled Substance

80 FR 38654 - Alcohol and Drug Testing: Reporting Positive Results for Tramadol as a Controlled Substance

DEPARTMENT OF TRANSPORTATION
Federal Railroad Administration

Federal Register Volume 80, Issue 129 (July 7, 2015)

Page Range38654-38655
FR Document2015-16531

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.

Federal Register, Volume 80 Issue 129 (Tuesday, July 7, 2015) 
[Federal Register Volume 80, Number 129 (Tuesday, July 7, 2015)]
[Rules and Regulations]
[Pages 38654-38655]
From the Federal Register Online  [www.thefederalregister.org]
[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

38654 Federal Register / Vol. 80, No. 129 / Tuesday, July 7, 2015 / Rules and Regulations subject to the Paperwork Reduction Act new requirement is needed in order to substance when FRA began testing for that does not display a current, valid ensure that consumers are properly it, FRA has kept post-accident OMB Control Number. The OMB informed about which devices are toxicological test results for tramadol Control Number is 3060–1189. suitable for their use and how to comply confidential. The foregoing notice is required by with our rules, the Commission required DATES: This document is effective July the Paperwork Reduction Act of 1995, that all Consumer Signal Boosters 7, 2015. Public Law 104–13, October 1, 1995, certified for fixed, in-building operation and 44 U.S.C. 3507. FOR FURTHER INFORMATION CONTACT: Jerry include a label directing consumers that The total annual reporting burdens the device may only be operated in a Powers, FRA Drug and Alcohol Program and costs for the respondents are as fixed, in-building location. The Verizon Manager, W33–310, Federal Railroad follows: Petitioners state that this additional Administration, 1200 New Jersey OMB Control Number: 3060–1189. labeling requirement is necessary to Avenue SE., Washington, DC 20590, OMB Approval Date: June 17, 2015. inform purchasers of fixed Consumer telephone 202–493–6313 or OMB Expiration Date: June 30, 2018. Signal Boosters that they may not gerald.powers@dot.gov; or Sam Noe, Title: Signal Boosters, sections lawfully be installed and operated in a FRA Drug and Alcohol Program 1.1307(b)(1), 20.3, 20.21(a)(2), moving vehicle or outdoor location. We Specialist, telephone 615–719–2951, or 20.21(a)(5), 20.21(e)(2), 20.21(e)(8)(i)(G), recognize that our labeling requirement sam.noe@dot.gov. 20.21(e)(9)(i)(H), 20.21(f), 20.21(h), 22.9, imposes additional costs on entities that SUPPLEMENTARY INFORMATION: 24.9, 27.9. 90.203, 90.219(b)(l)(i), manufacture Consumer Signal Boosters; 90.219(d)(5), and 90.219(e)(5). FRA’s Post-Accident Toxicological however, on balance, we find that such Testing Program Form Number: N/A. costs are outweighed by the benefits of Respondents: Business or other for- ensuring that consumers purchase Since 1985, as part of its accident profit entities, Not for profit institutions appropriate devices. Accordingly, all investigation program, FRA has and Individuals or household. fixed Consumer Signal Boosters, both routinely conducted alcohol and drug Number of Respondents and Provider-Specific and Wideband, tests on railroad employees involved in Responses: 632,595 respondents and manufactured or imported on or after serious train accidents that meet certain 635,215 responses. one year from the effective date of the criteria specified in FRA’s regulations. Estimated Time per Response: .5 See 49 CFR 219.201.1 This post-accident rule change must include the following hours–40 hours. testing is used to determine if alcohol advisory (1) in on-line point-of-sale Frequency of Response: misuse or drug abuse played a role in marketing materials, (2) in any print or Recordkeeping requirement, On the occurrence or severity of an on-line owner’s manual and installation occasion reporting requirement and accident. Since the program’s inception, instructions, (3) on the outside Third party disclosure requirement. FRA has routinely conducted post- Obligation to Respond: Required to packaging of the device, and (4) on a label affixed to the device: ‘‘This device accident tests for alcohol and certain obtain or retain benefits. The statutory drugs the United States Drug authority for this information collection may be operated ONLY in a fixed location for in-building use.’’ Enforcement Administration (DEA) is contained in 47 U.S.C. 154(I), 303(g), classifies as controlled substances. 303(r) and 332. Federal Communications Commission. Controlled substances are drugs or Total Annual Burden: 324,470 hours. Gloria J. Miles, chemicals that are prohibited or strictly Total Annual Cost: No cost. Federal Register Liaison Officer. regulated because of their potential for Privacy Impact Assessment: This [FR Doc. 2015–16536 Filed 7–6–15; 8:45 am] abuse or addiction. See 77 FR 29307, information collection affects BILLING CODE 6712–01–P 29307, May 17, 2002. The DEA oversees individuals or households; thus, there the classification of controlled are impacts under the Privacy Act. substances into five schedules. Section However, the government is not directly I contains illicit drugs such as marijuana DEPARTMENT OF TRANSPORTATION collecting this information and the R&O and heroin, which have no legitimate directs carriers to protect the Federal Railroad Administration medical use under Federal law. information to the extent it is Schedules II–V contain legal drugs that considered Customer Proprietary 49 CFR Part 219 are available only by prescription. See Network Information (CPNI). generally The Controlled Substances Nature and Extent of Confidentiality: [Docket No. FRA–2001–11213, Notice No. 19] Act (CSA), Title II of the Comprehensive There is no need for confidentiality with Drug Abuse Prevention Substances Act this collection of information. Alcohol and Drug Testing: Reporting of 1970 (21 U.S.C. 801 et seq.). Needs and Uses: On September 19, Positive Results for Tramadol as a FRA has historically conducted post- 2014, the Federal Communications Controlled Substance accident tests for the following Commission (Commission or FCC) controlled substances: Marijuana, adopted an Order on Reconsideration in AGENCY: Federal Railroad cocaine, phencyclidine (PCP), and WT Docket No. 10–4, FCC No. 14–138, Administration (FRA), DOT. selected opioids, amphetamines, in which it took the following action, ACTION: Final rule. barbiturates, and benzodiazepines. among others: Required that Consumer Under 49 CFR 219.211(b), FRA reports Signal Boosters certified for fixed SUMMARY: This document announces post-accident test results for these operation only be labeled to notify that FRA will begin reporting post- substances to the employee tested and srobinson on DSK5SPTVN1PROD with RULES consumers that such devices may only accident toxicological test results for the employing railroad’s Medical be used in fixed, in-building locations. tramadol to the employee and the Review Officer (MRO). See 49 CFR Therefore, the new labeling requirement railroad Medical Review Officers. FRA 219.211(b). which requires OMB review and will also begin including post-accident approval is as follows: toxicological test results for tramadol in 1 All references to sections of the Code of Federal The labeling requirement is covered its post-accident toxicology reports. Regulations (CFR) in this document refer to sections under 47 CFR 20.21(f)(1)(iv)(A)(2). The Because tramadol was not a controlled within title 49 of the CFR. VerDate Sep<11>2014 19:51 Jul 06, 2015 Jkt 235001 PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 E:\FR\FM\07JYR1.SGM 07JYR1

Federal Register / Vol. 80, No. 129 / Tuesday, July 7, 2015 / Rules and Regulations 38655 In 2013, FRA amended its alcohol and prescriptions written in 2012.’’ Id. at precedent that FRA will notify the drug testing regulations to establish 37627 (citations omitted). industry whenever DEA designates post-accident testing for non-controlled additional drugs as controlled Reporting of Tramadol Positives substances.2 See 78 FR 14217, Mar. 5, substances or whenever FRA decides to 2013. In the final rule adopting this Because the DEA now designates conduct post-accident testing for revision, FRA provided notice of the tramadol a controlled substance, FRA’s additional controlled substances. This addition of two non-controlled alcohol and drug regulations apply to document is also not an exhaustive substances to its standard post-accident tramadol use and possession the same discussion of all FRA requirements testing panel: Tramadol and sedating as they apply to use and possession of governing controlled substances. antihistamines. FRA also made clear any other controlled substance, such as synthetic opioids and valium. For Because DEA has designated tramadol that the agency did not intend to report example, FRA’s regulations place as a Schedule IV controlled substance, the results of post-accident tests for certain limitations on a railroad on July 7, 2015 FRA will begin reporting these non-controlled substances to the employee involved or relevant MRO and employee’s use and possession of post-accident test results for tramadol instead intended to use the results for controlled substances—those limitations pursuant to § 219.211(b), which research and data purposes only. See id. now apply to the use and possession of provides that post-accident test results at 14217 and 14219. tramadol by railroad employees. The for controlled substances will be regulations prohibit a railroad employee reported to a railroad’s MRO and the DEA’s Determination To Schedule from using or possessing a controlled employee. FRA also intends to include Tramadol as a Controlled Substance substance while assigned by a railroad post-accident test results for tramadol in In 2014, after FRA issued its final rule to perform covered service,4 except as toxicology reports as § 219.211(f)(2) establishing post-accident testing for provided by § 219.103. See 49 CFR requires. non-controlled substances, the DEA 219.101(a)(1). (Section 219.103 provides Railroads and MROs must also treat placed tramadol 3 on the CSA’s that subject to certain conditions and post-accident test results for tramadol Schedule IV. See 79 FR 37623–37630, limitations, a covered employee may consistent with all applicable FRA Jul. 2, 2014. The DEA’s determination use and possess Schedule II through IV requirements for controlled substances. stated that it took into account a controlled substances if a medical For example, like post-accident test scientific and medical evaluation the practitioner prescribes or authorizes the results for any controlled substance, an Department of Health and Human use.) The regulations also prohibit a MRO must review tramadol results with Services (HHS) prepared which railroad employee who performs respect to any claim of use or recommended including tramadol in covered service from using a controlled administration of tramadol consistent Schedule IV of the CSA. See id. at substance at any time, whether on or off with § 219.103 that could account for 37623. The HHS evaluation analyzed duty, except as § 219.103 permits. See the laboratory findings, and must report tramadol taking into consideration eight 49 CFR 219.102. A railroad employee the results of this review to the factors listed in 21 U.S.C. 811(c), as well who uses or possesses a controlled employing railroad and FRA. See as tramadol’s abuse potential, legitimate substance, including tramadol, in § 219.211(c). Railroads and MROs must medical use, and dependence liability. violation of one of these prohibitions is also treat post-accident test results for See id. at 37623–37624. In response to subject to the removal, return-to-service, tramadol as confidential under public comment, DEA explained that and follow-up testing requirements of § 219.211(b). FRA encourages any tramadol is considered an opioid § 219.104. railroad, railroad employee, or MRO because it produces pharmacological FRA is issuing this document to (1) that has questions about post-accident effects similar to those produced by make railroads and railroad employees test results for tramadol to contact other opioids. Id. at 37626. The DEA aware of the DEA’s classification of FRA’s Drug and Alcohol Program also noted ‘‘tramadol is a widely tramadol as a controlled substance and Manager for guidance. prescribed drug, with nearly 40 million (2) remind railroads and individuals subject to FRA’s regulations of the effect Finally, the requirements of 2 A non-controlled substance is any substance of the DEA’s designation of tramadol as §§ 219.101, 219.102, 219.103, and that is not currently regulated under 21 U.S.C. 801– a controlled substance on FRA’s post- 219.104 now apply to covered 971 or 21 CFR part 1308. See § 219.5. Non- employees’ use and possession of controlled substances can include prescription accident testing program. Issuance of medications, over-the-counter products, dietary this document does not provide tramadol. supplements, and herbal preparations. See id. 3 The DEA’s decision to designate tramadol as a 4 Covered Robert C. Lauby, service is service in the United States Schedule IV controlled substance applied to the that is subject to the hours of service laws at 49 Associate Administrator for Railroad Safety substance 2-[(dimethylamino)methyl]-1-(3- U.S.C. 21103, 21104, or 21105. See 49 CFR 219.5. Chief Safety Officer. methoxyphenyl)cyclohexanol (tramadol), including Covered service does not include any period the [FR Doc. 2015–16531 Filed 7–6–15; 8:45 am] its salts, isomers, and salts of isomers. See id. at employee is relieved of all responsibilities and is 37623. free to come and go. See id. BILLING CODE 4910–06–P srobinson on DSK5SPTVN1PROD with RULES VerDate Sep<11>2014 19:51 Jul 06, 2015 Jkt 235001 PO 00000 Frm 00043 Fmt 4700 Sfmt 9990 E:\FR\FM\07JYR1.SGM 07JYR1


Document Created: 2015-12-15 13:27:09
Document Modified: 2015-12-15 13:27:09
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis document is effective July 7, 2015.
ContactJerry 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]
FR Citation80 FR 38654 
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