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Safety Recommendation Details

Safety Recommendation R-00-004
Details
Synopsis: The National Transportation Safety Board has investigated many incidents in all passenger transportation modes in which the use of a licit medication by a vehicle operator has been causal or contributory. As a result, the safety board has previously recommended that various agencies take certain actions to address issues pertaining to the use of medications.
Recommendation: TO THE FEDERAL RAILROAD ADMINISTRATION: Establish, in coordination with the U.S. Dept. of Transportation, the Federal Motor Carrier Safety Administration, the Federal Transit Administration, and the U.S. Coast Guard, comprehensive toxicological testing requirements for an appropriate sample of fatal highway, railroad, transit, and marine accidents to ensure the identification of the role played by common prescription and over-the-counter medications. Review and analyze the results of such testing at intervals not to exceed every 5 years.
Original recommendation transmittal letter: PDF
Overall Status: Open - Unacceptable Response
Mode: Railroad
Location: Burnt Cabins, PA, United States
Is Reiterated: No
Is Hazmat: No
Is NPRM: No
Accident #: HWY98MH033
Accident Reports: Greyhound Motorcoach Run-Off-The-Road Accident
Report #: None
Accident Date: 6/20/1998
Issue Date: 1/13/2000
Date Closed:
Addressee(s) and Addressee Status: FRA (Open - Unacceptable Response)
Keyword(s):

Safety Recommendation History
From: FRA
To: NTSB
Date: 2/25/2019
Response: -From Ronald L. Batory, Administrator: As part of FRA's accident investigation process, our Drug and Alcohol Program Manager regularly receives, studies, and reports on FRA' s post-accident toxicological testing (PATT) program results to help FRA understand the role of common prescription and OTC medications in significant accidents. For example, FRA recently reanalyzed approximately 30 PATT samples that initially screened positive for marijuana but did not confirm as positive, to determine if synthetic marijuana could have caused the initial positive results. Based on similar research, FRA decided to add muscle relaxers and sleep aids to its PATT panel this year. Safety Recommendation R-00-04 also, however, recommends that FRA, in coordination with the Federal Motor Carrier Safety Administration (FMCSA), the Federal Transit Administration (FTA), and the United States Coast Guard (USCG), establish comprehensive toxicological testing requirements for a sample of fatal accidents, and regularly review and analyze the test results to understand the role of medications. FRA is unable to coordinate its PATT program analysis with FMCSA or FTA, since neither agency has a PATT program. FRA, however, exchanges PATT information with the USCG at monthly intermodal drug and alcohol program meetings. While FRA has taken every other available action to meet or exceed the requirements of this recommendation, FRA does not have the authority to compel other DOT modes to collect PATT data. FRA therefore respectfully requests that the NTSB classify Safety Recommendation R-00-04 as "Closed-Acceptable Action." On October 11, 2018, FRA staff met with NTSB staff to share information and answer questions, so we hope that these closures can be expedited. I appreciate your interest in these important safety issues. If FRA can provide additional information or assistance, please contact Mr. Robert C. Lauby, Associate Administrator for Railroad Safety and Chief Safety Officer.

From: NTSB
To: FRA
Date: 5/15/2015
Response: In the FRA’s July 24, 2009, letter, your agency agreed that a periodic review of the postaccident drug panel was appropriate and indicated that, as knowledge was obtained from the impending railroad medical fitness-for-duty program, incremental modifications to the drug panel would be made regularly. However, to date, no such railroad medical fitness-for-duty program has been developed. The letter further stated that you would participate in the intermodal analysis of accident investigation findings, and use these findings, together with the outcome of toxicological analyses, to expand your understanding of how to manage risks related to the use of therapeutic drugs. In response, on June 8, 2010, we classified Safety Recommendation R-00-4 “Open—Acceptable Response.” On January 15, 2014, because we had received no recent update to indicate that progress was being made, Safety Recommendation R 00 4 was classified “Open—Unacceptable Response.” We appreciate that your routine postaccident toxicology testing remains more extensive than that required by the DOT, and we recognize your 2005 and 2009 research into the scope of the problem of potentially impairing medications. However, our recent review of toxicology test results from fatally injured pilots demonstrated evidence of drug or medication use that had increased four-fold over the 23 years from 1990 through 2012. In addition, in the last 5 years of the study (2007-2012), more than 20% of fatally injured pilots’ had blood or tissue tests that indicated use of a potentially impairing medication. We are somewhat encouraged that you are contemplating conducting additional research to investigate further the role of prescription and OTC drugs in fatal accidents. However, given the age of the recommendation and the lack of action thus far, Safety Recommendation R 00-4 remains classified OPEN—UNACCEPTABLE RESPONSE. We encourage you to expedite action on this issue or we will have no alternative but to close it in an unacceptable status.

From: FRA
To: NTSB
Date: 1/27/2015
Response: -From Sarah Feinberg, Acting Administrator: This letter is to update you on the status of the National Transportation Safety Board's (NTSB) Safety Recommendations R-00-01 through R-00-04, R-01-17, and R-08-07, issued to the Federal Railroad Administration (FRA). Safety Recommendation R-00-01 asks FRA to establish procedures and criteria for train operating crewmembers who take medications on a list of drugs approved by the U.S. Department of Transportation (DOT). Safety Recommendations R-00-02 through R-00-03 ask FRA to address the hazards of train operating crewmembers using specific medications while performing their duties. Safety Recommendation R-00-04 asks FRA, in coordination with DOT, the Federal Motor Carrier Safety Administration, the Federal Transit Administration, and the U.S. Coast Guard, to conduct post-mortem toxicological testing on a sample number of accident fatalities to determine if the use of prescription and over-the-counter drugs played a role in these fatal accidents. Safety Recommendation R-01-17 asks FRA to narrow its current highway-rail grade crossing exemption to allow the post-accident toxicological testing of any employee who may have contributed to the occurrence or severity of an accident. Finally, Safety Recommendation R-08-07 asks FRA to expand the scope of its drug and alcohol testing program to cover all employees and agents performing the functions listed in Title 49 Code of Federal Regulations Section 209.303. In Enclosure 1, FRA explains the actions that it has taken in response to Safety Recommendations R-00-01 through R-00-04, R-01-17, and R-08-07. FRA respectfully requests that the NTSB classify Safety Recommendation R-00-01 as "Closed-Unacceptable," Safety Recommendations R-00-02 through R-00-04 and R-08-07 as "Open-Acceptable Response," and Recommendation R-01-17 as "Closed-Acceptable Action." We look forward to continuing to work with you on important safety issues. Because FRA's post-accident toxicological (PAT) testing program predates both DOT testing procedures (49 CFR Part 40) and the Omnibus Transportation Employee Testing Act of 1991, neither Part 40 procedures nor Department of Health and Human Services protocols apply to FRA PAT testing. From its inception, FRA's PAT testing program has conducted more intensive accident research into fatalities than other DOT PAT testing programs, since unlike other DOT modes~ FRA requires the testing of post-mortem tissue samples. In fact, as part of its railroad accident investigations, the NTSB routinely asks for samples of FRA post-mortem specimens in lieu of conducting its own independent post-mortem testing. From 2002 to 2009, FRA conducted two research projects specifically designed to determine the role played by common prescription and OTC medications in rail accidents. In a 2012 Notice of Proposed Rulemaking (NPRM), FRA cited the findings of these projects as a factor in its proposal to add routine PAT tests for certain noncontrolled substances with potentially impairing side effects (77 FR 29307, May 17, 20 12). Although neither project specifically researched the role of medications in fatal accidents, their results confirmed that use of prescription and OTC drugs was common among employees involved in human-factor rail accidents or in accidents that qualified for FRA PAT testing because of the fatalities, injuries, and/or significant damage to railroad equipment involved. FRA conducted the first project from April 2002 to April2009. In that project, FRA asked railroad employees who had been involved in reportable human-factor accidents (see FRA's accident reporting regulations at 49 CFR Part 225) to self-report their recent prescription and OTC drug use through the completion of surveys. Of the 294 human-factor accidents surveyed, only 20 percent had no employee self-reports of any medication use (this 20 percent included those accidents where employees refused to complete surveys or could not be located). In the 80 percent of surveyed accidents where employees self-reported prescription, OTC drug use, or both, employees listed a wide variety of generic and brand name drugs, with many also self reporting the use of multiple medications and the use of dietary supplements and herbal preparations. In 2005, FRA initiated a second project in which it retested a sample of 150 frozen PAT testing urine specimens that had previously been reported as negative for the substances in what was then FRA's standard PAT testing panel After redacting any identifying employee information, FRA used a commercially available medical professional drug testing panel to retest these specimens for commonly used prescription and OTC drugs with known risks of adverse side effects, such as pain relievers, anti-depressants, and sedating antihistamines. Of the 150 retested samples, 14 (9.3 percent) tested positive for at least one potentially impairing prescription or OTC drug. As discussed below, in response to Section 412 of the Rail Safety Improvement Act of 2008 (RSIA) and R-08-17, on July 28, 2014, FRA published an NPRM proposing to expand the scope of its drug and alcohol program to cover employees who perform maintenance-of way (MOW) activities. (79 FR 43830, July 28, 2014). FRA is developing a final rule implementing the proposed expansion. Subsequent to the completion of this rule, FRA will pursue a research project specifically investigating the role of prescription and OTC drugs in fatal accidents.

From: NTSB
To: FRA
Date: 1/15/2014
Response: Our last letter from the FRA regarding Safety Recommendations R-00-1 through 4 was dated July 24, 2009. Based on information contained in that letter, these recommendations were classified “Open—Acceptable Response” on June 8, 2010, pending the publication of final rules that would satisfy them. We have no evidence that the FRA has made progress on these issues since 2009. Accordingly, pending our receipt of an update from the FRA regarding its actions to address Safety Recommendations R-00-1 through -4, these recommendations are classified OPEN—UNACCEPTABLE RESPONSE.

From: NTSB
To: FRA
Date: 12/1/2011
Response: CC# 201100449 was closed administratively; no response was written or mailed.

From: FRA
To: NTSB
Date: 4/12/2011
Response: -From Ray LaHood, Secretary of the United States Department of Transportation: NTSB Classification and Actions Taken by FRA: Open – Acceptable Response. In 2002, NTSB officials met with members of FRA’s RSAC to discuss concerns with NTSB Rec. Nos. R¬00-01 through R-00-04 and clarify their intent. FRA had already been testing for benzodiazepines and barbiturates, in addition to the “SAMSHA [Substance Abuse and Mental Health Services Administration]-5” drug groups and alcohol, in its post-accident program. FRA had also conducted blind testing of extant archive samples to determine the prevalence of other-drug use in the population of accident-involved employees. FRA presented those results to the NTSB and RSAC’s Medical Standards Working Group in support of the need to include therapeutic drug use management in the forthcoming Medical Standards NPRM. FRA has recently expanded its post-accident testing panel to include additional medications that are of safety concern. Currently, the results for these drugs are being reported only to FRA. FRA is working to publish a proposed rulemaking in early 2011 that would update 49 CFR Part 219 to reflect the expanded panel and to provide a mechanism for reporting non-controlled substance results to railroads. Once the final rule is published, FRA will begin reporting the results for the drugs on the expanded panel. Actions Needed to Be Taken by FRA: Issue regulations.

From: NTSB
To: FRA
Date: 6/8/2010
Response: The NTSB notes that the FRA already tests for the "SAMSA 5"' drug groups and ethanol (alcohol) in its postaccident testing program, in addition to longer-acting benzodiazepines (minor tranquilizers) and major barbiturates (hypnotics). The FRA is the only DOT modal administration that routinely requires submission of blood specimens and urine from both fatal and nonfatal accidents for testing; blind testing of existing archived specimens of accident-involved employees resulted in the FRA's determining a need to include therapeutic drugs in its upcoming NPRM. The NTSB notes that the FRA has developed a plan, to begin in the next few months, for its postaccident testing toxicology laboratory and its oversight contractor to arrange for the phased-in expansion of the testing protocols to also include therapeutic drugs, additional benzodiazepines, additional amphetamines, synthetic opiates, and sedating antihistamines. The NTSB further notes that the FRA will coordinate with other DOT modal administrations and, as experience is gained, funding is established, and tests are perfected, expects to add other drugs to the existing drug panel. The FRA believes that a periodic review of the postaccident drug panel is appropriate and has indicated that, as knowledge is obtained from the impending railroad's medical fitness-for-duty training program, incremental modifications to the drug panel will be made with some regularity. The FRA intends to contribute in the intermodal analysis of accident investigation findings, together with the outcome of toxicological analyses, to expand its understanding of how to manage risks related to the use of therapeutic drugs. Accordingly, pending completion of a final rule containing comprehensive toxicological testing requirements and periodic review of those requirements for an appropriate sample of fatal railroad accidents to ensure the identification of the role played by common prescription and OTC medications, Safety Recommendation R-00-04 is classified OPEN – ACCEPTABLE RESPONSE.

From: FRA
To: NTSB
Date: 7/24/2009
Response: Letter Mail Controlled 7/28/2009 4:24:35 PM MC# 2090479 - From Joseph C. Szabo, Administrator: In 2002, NTSB officials met with members of FRA's RSAC to discuss concerns with NTSB Recommendations R-00-1 through R-00-4. At that meeting, NTSB clarified the intent of Recommendations R-00-1 through R-00-4. FRA was already testing for longer-acting benzodiazepines and major barbiturates, in addition to the "SAMSA 5" drug groups and alcohol, in its post-accident program. FRA remains the only DOT modal administration that routinely requires submission of blood specimens, as well as urine, from both fatal and nonfatal accidents designated for testing. The FRA also conducted blind testing of extant archive samples to determine the prevalence of other-drug use in the population of accident-involved employees. FRA presented those results to NTSB and RSAC's Medical Standards Working Group in support of the need to include therapeutic drug use management in the forthcoming medical standards NPRM. In light of the Safety Board's recommendation and available information, in 2008, FRA began the development of a plan for phased augmentation of FRA's post-accident testing protocol to include additional drugs used for therapeutic purposes. FRA has in place with its post-accident toxicology laboratory and its oversight contractor arrangements for adding the following drugs within the next few months: Additions to benzodiazepines: lorazepam (Ativan) clonazepam (Klonopin) Additions to amphetamines: MDMA (Ecstasy) MD A MDEA Synthetic opiates: hydrocodone (Vicodin, Lortab, Lorcet) oxycodone (OxyContin, Percocet, Percodan) hydromorphone (Dilaudid) oxymorphone (Numorphan) methadone (Methadone, Dolophine) fentanyl (Fentanyl, Sublimaze) tramadol (Ultram, Ultracet) propoxyphene (Darvocet, Darvon) Sedating antihistamines: diphenhydramine (Benadryl) chlorpheniramine brompheniramine phentermine As further experience is gained, funding is identified, and assays are perfected, FRA expects to add additional drugs to this panel, and in doing so, we will continue to coordinate with other DOT modal administrations. We agree that periodic review of the post-accident drug panel is appropriate, and we believe that as additional knowledge is gained within the forthcoming Medical Fitness-for-Duty Program, incremental adjustments will be made with some frequency. FRA stands ready to participate in intermodal reviews of accident investigation findings, including results of toxicological analyses that can deepen our understanding of how to properly manage the risks associated with therapeutic drug use. In light of these actions, FRA respectfully requests that NTSB classify thi recommendation as "Closed-Acceptable Response."

From: NTSB
To: FRA
Date: 5/1/2002
Response: Since the November 2001 meeting, the FRA invited Safety Board staff to present the Board’s concerns regarding the potential hazards of medication use by transportation operators to the Railroad Safety Advisory Committee (RSAC). That presentation allowed for the free exchange of ideas and concerns, and was, in our opinion, highly productive. We recognize that the RSAC process is a potentially long one, but believe that the FRA has initiated action consistent with the intent of the Board’s recommendations. We are therefore classifying those recommendations directed at the FRA (Safety Recommendations R-00-1 through -4) as OPEN -- ACCEPTABLE RESPONSE. The RSAC meeting also allowed us to address two apparent potential misunderstandings about the recommendations as they now stand. One, the Board is not recommending that the DOT or any modal administration evaluate each and every drug for its potential to impair vehicle operators. We understand that this is neither feasible nor rightfully within the domain of the DOT. We are recommending that the DOT develop a relatively short list of medications or classes of medications that have been evaluated and found safe for use by vehicle operators, perhaps analogous to similar lists currently provided by the military services for their pilots. Two, the Board is not recommending a new, potentially intrusive, certainly expensive program of testing all vehicle operators for the use of licit medications. The intent of the recommendation was to increase the comprehensive testing rate of fatally injured operators so that, as is done in the FAA, a database can be built to allow determination of the actual extent to which use of potentially impairing medications is a problem in each transportation mode. We believe that it may be productive to invite staff from the DOT and/or each of the modal agencies to discuss with our staff their concerns, priorities, and resource limitations before the Safety Board classifies the open recommendations to the DOT and other modal agencies. Based on our experience with the public meeting and the RSAC, it seems possible that such a meeting could result in some potentially acceptable alternate actions with regard to the current recommendations. We also recognize that each individual modal administration has a unique perspective and approach to the issue of medication use. A meeting between staff could allow a complete discussion of the various distinctive concerns in each transportation mode. If desired, the FDA staff who participated in the public meeting could also be invited for their technical expertise. We are available to meet individually with the modal agencies or as a group.

From: FRA
To: NTSB
Date: 8/17/2000
Response: Letter Mail Controlled 08/22/2000 9:26:00 AM MC# 2001092: - From Jolene M. Molitoris, Administrator: FRA has in place an extensive and effective post-accident toxicological testing program. Following a qualifying accident, FRA conducts drug testing on all fatally injured employees and a large percentage of surviving employees. Tests are conducted for the five illegal drugs, for which the DOT tests, plus two of the more common prescription medications. In addition, FRA's program has the capability of testing for any additional prescribed or OTC medications identified through our investigation which may have contributed to the cause of a fatal accident. FRA believes these procedures address the concerns expressed by the Board's recommendation for testing of prescription and OTC medications in fatal accidents. In the past, FRA has also provided urine, blood, and tissue specimens to the Board for additional testing following certain major train accidents. We are not aware of any instances where the Board has found additional drugs or OTC medications in these specimens under circumstances indicating involvement in the cause of the accident. In addition, the results of FRA's post-accident testing over the years have never indicated a causal relationship between the use of prescription medications and the crash event. FRA will continue to review the mission of this testing program and when the need is established that additional testing is indicated, FRA will plan and program to accomplish the need. In summary, FRA shares the Board's concern about the potential impact of the use of prescription and OTC medications by safety-sensitive transportation personnel. FRA will continue to emphasize with the industry that this is an important matter that requires constant vigilance and is part of the "safety goal" that FRA is striving toward. Emphasizing education and training as a part of FRA and industry endeavors should meet the intent of the Board's recommendations. FRA will keep the Board apprised of the outcome of these efforts. We respectfully request that Safety Recommendations R-00-01 through -04 be classified as "Open-Acceptable Response."