Recent Developments in FRA s Post-Accident Toxicological Testing Program
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1 Recent Developments in FRA s Post-Accident Toxicological Testing Program Transportation Research Board Legal Workshop July 22, 2012 Elizabeth Gross Patricia Sun Trial Attorney Trial Attorney FRA Office of Chief Counsel FRA Office of Chief Counsel elizabeth.gross@dot.gov patricia.sun@dot.gov
2 History of FRA Post-Accident Toxicological Testing FRA began conducting post-accident toxicological testing ( PAT testing ) for railroad employees involved in serious train accidents. PAT testing predates both the Omnibus Transportation Employee Testing Act of 1991 and the Department of Transportation (DOT) testing procedures, found in 49 CFR Part 40. FRA PAT testing is therefore exempt from the procedural requirements of both Part 40 and guidelines published by the Department of Health and Human Services (DHHS). PAT testing is conducted primarily for accident investigation purposes. 2
3 Skinner v. Railway Labor Executives Association, 489 U.S. 602 (1989) The US Supreme Court found The Fourth Amendment applied to the collection and subsequent analysis of railroad employee specimens for FRA PAT testing. It was reasonable under the Fourth Amendment to conduct such tests in the absence of a warrant or reasonable suspicion that an employee was impaired. A compelling government interest served by the regulation outweighed employees privacy concerns. 3
4 History: What has FRA tested for? FRA PAT testing collects both urine and blood specimens (tissue specimens are required for fatalities). FRA also tests for substances not on the standard DOT testing panel (e.g., barbiturates and benzodiazepines). Historically, FRA has tested for alcohol and the following controlled substances. Marijuana Cocaine Phencyclidine (PCP) Certain opiates, amphetamines, barbiturates, and benzodiazepines. FRA also tests for other impairing substances specified by FRA as necessary to the particular accident investigation. (e.g., carbon monoxide). 49 CFR (a). 4
5 What are controlled substances? Controlled substances are high risk drugs regulated by the Controlled Substances Act of 1971 because they have varying levels of dependence potential. (DEA, FDA, DHHS) Schedule I - Illicit drugs for which there is no legitimate medical use (e.g., marijuana, heroin, PCP, etc.) Schedules II to V - Certain prescription drugs with high to low dependence potential/risk. E.g., Morphine (Schedule II), Vicodin (Schedule III), and Valium (Schedule IV). FRA prohibits covered employees from taking a controlled substance at any time, unless the employee is taking the controlled substance in accordance with a valid prescription. 49 CFR and Prescribing medical practitioner must make a good faith judgment that use of controlled substance is consistent with performance of employee s duties. At least one medical practitioner must be informed of all prescribed/authorized medications and must determine their use is consistent with safe performance of employee s duties. Not all prescription drugs are controlled substances. 5
6 How is FRA PAT testing conducted? Following a PAT testing event, a railroad is responsible for collecting blood and urine specimens from surviving employees (tissue specimens for fatalities). The specimens are shipped to and analyzed by FRA s contract laboratory (FRA bears the costs for the analysis). In 2012, there were 76 PAT testing events, with 184 railroad employees (less than.2% of the railroad employee population). 6
7 Review of Positive PAT Testing Results for Controlled Substances Laboratory results are provided to FRA. FRA provides test results for alcohol and controlled substances to the employee and the railroad s Medical Review Officer (MRO). Railroad and MRO must treat results as confidential. Positive test results for surviving employees must be reviewed by the MRO to see whether employee had a legitimate medical prescription for the controlled substance. If so, the employee has not violated an FRA prohibition. (EXCEPTION: medical marijuana) 7
8 Widespread Use of Prescription and OTC Drugs Studies have shown a significant increase in the daily use of prescription drugs, over-the-counter (OTC) drugs, vitamins, and herbal/dietary supplements. Many non-controlled substances have significant impairment potential (e.g., sedation). FRA does not regulate a railroad employee s use of non-controlled substances, such as OTC medications and many prescription drugs. FRA Survey ( ): Asked railroad employees involved in PAT testing events to complete a survey on their recent prescription and OTC drug use. In 80% of the 294 PAT testing events, one or more railroad employees involved reported using at least one generic or brand name drug, and many employees reported using multiple substances. 8
9 New Post-Accident Tests for Non-Controlled Substances FRA NPRM proposed conducting PAT testing for certain noncontrolled substances: tramadol and sedating antihistamines. Tramadol is a semi-synthetic opioid available by prescription only. Sedating antihistamines can be both prescription and OTC. March 5, FRA final rule announcing the addition of noncontrolled substances (tramadol and sedating antihistamines) to its standard post-accident testing program. First major change to FRA s PAT testing program since Rule went into effect on May 6,
10 Handling of Non-Controlled Substance Test Results FRA keeps PAT testing results for tramadol and synthetic antihistamines CONFIDENTIAL. - Results are maintained for research and accident investigation purposes only. Non-controlled substance results may be reported, however, to NTSB upon request, or if employee consents. - A positive non-controlled substance result does NOT result in an FRA violation. FRA still reports results for controlled substances to the employee and the railroad/mro. 10
11 Other New Controlled Substances on the Current Post-Accident Testing Panel FRA also recently added tests for the following synthetic opioids, all of which are controlled substances: - Hydrocodone (Vicodin, Lortab, Lorcet) - Oxycodone (Oxycontin, Percocet) - Hydromorphone (Dilaudid) - Oxymorphone (Numorphan) - Methadone (Dolophine) - Propoxyphene (Darvon, Darvocet) - Fentanyl (Sublimaze) 11
12 References 49 CFR Part 219, Subpart C: FRA s PAT testing regulation. 49 CFR 40.1: Exempts FRA PAT testing from DOT procedures. 77 FR 29307, May 17, 2012: PAT Testing NPRM. 78 FR 14217, March 5, 2013: PAT Testing final rule. Skinner v. Railway Labor Executives Association, 489 U.S. 602 (1989): SCOTUS case upholding constitutionality of FRA PAT testing. 12
13 Questions? 13
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