Daily Rules, Proposed Rules, and Notices of the Federal Government
Since 1985, as part of its accident investigation program, FRA has conducted post-accident alcohol and drug tests on railroad employees who have been involved in serious train accidents (50 FR 31508, August 2, 1985). If an accident meets FRA's criteria for post-accident testing (
As detailed below, FRA research indicates that prescription and OTC drug use has become prevalent among railroad employees. For this reason FRA is proposing to add certain non-controlled substances to its standard post-accident testing program, which currently routinely tests only for alcohol and controlled substances. At this time, FRA intends to add two types of non-controlled substances, tramadol (a synthetic opioid) and sedating antihistamines. Publication of this NPRM, however, in no way limits FRA's post-accident testing to the identified substances or in any way restricts FRA's ability to make routine amendments to its standard post-accident testing panel without prior notice. Furthermore, in addition to its standard post-accident testing panel, FRA always has the ability to test for “other impairing substances specified by FRA as necessary to the particular accident investigation.”
FRA is proposing to add tests for certain non-controlled substances to respond to the significant rise in prescription and OTC drug use in the more than 25 years since FRA began post-accident testing. In 2006, an ongoing telephone survey about the use of medications by U.S. adults found that 82 percent took at least one prescription or OTC drug, dietary supplement, or herbal remedy, each week.
In 1998, FRA first expressed concerns that § 219.103, which addresses the use of Schedule II-V controlled substances by safety-sensitive employees, may be too narrow to cover the use of prescription and OTC drugs since most of these drugs are not controlled substances. To supplement § 219.103, FRA issued Safety Advisory 98-3 (Advisory),
After issuing this Advisory, FRA initiated two projects to research whether the prevalence of prescription drugs should be more closely evaluated and monitored as a possible safety concern in the rail industry. As detailed below, both projects found that prescription and OTC drug use was prevalent among railroad employees involved in reportable accidents.
In the first project, which lasted from April 2002 to April 2009, FRA asked railroad employees who had been involved in human-factor accidents that were reportable under FRA's accident reporting regulations at 49 CFR part 225 to complete FRA surveys on their recent prescription and OTC drug use. Of the 294 human-factor accidents surveyed, only 20 percent had no employee self-reports of drug use (this 20 percent also included accidents where employees would not complete questionnaires or could not be located). In the 80 percent of surveyed accidents where prescription or OTC drug use, or both, had been self-reported, employees listed a wide variety of generic and brand name drugs, with many employees listing multiple prescription and OTC drugs, as well as dietary supplements and herbal preparations.
In 2005, FRA began a second research project that partially responded to one in a series of recommendations to FRA made by the National Transportation Safety Board (NTSB) concerning the use of prescription and OTC drugs by safety-sensitive employees. (The NTSB made similar recommendations to DOT and other DOT agencies.)
R-00-004: Establish in coordination with the U.S. Department 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 5 years.
Because FRA's post-accident testing program predates both DOT's testing procedures (49 CFR part 40) and the Omnibus Transportation Employee Testing Act of 1991, neither part 40 nor Department of Health and Human Services (HHS) guidelines apply to post-accident testing procedures and protocols.
As explained above, FRA intends to add testing for two types of non-controlled substances (tramadol (a synthetic opioid) and sedating antihistamines) to its standard post-accident testing program to address the widespread use of prescription and OTC drugs by railroad employees. Both tramadol and the drugs in the sedating antihistamine category have potential side effects that could impair an employee's cognitive abilities (such as the ability to stay awake and alert or the ability to recognize and take appropriate emergency action) or cause impairing conditions (such as dizziness, agitation, and loss of coordination). These drugs are discussed below:
Adding testing for these types of non-controlled substances to its post-accident testing program will enable FRA to detect a broader range of potentially impairing drugs that may contribute to the cause or severity of accidents. As FRA has done for the
Although FRA is not proposing any change in its handling of post-accident test results for controlled substances in accordance with 49 CFR 219.211, FRA is proposing to handle the post-accident results for non-controlled substances differently. Specifically, as mentioned earlier, while sedating antihistamines are available at both prescription and OTC dosages, they are usually taken as OTC drugs. Since by definition these drugs can cause sedation, in 2009 FRA began post-accident testing for sedating antihistamines to determine whether their use is becoming a safety issue in the rail industry. This testing has been for research and accident investigation purposes only, and FRA has not reported any sedating antihistamine test results to railroads or employees. FRA intends to continue its research testing related to sedating antihistamines and in this NPRM proposes to continue to keep the testing results confidential and not report to the relevant railroad or employee any sedating antihistamine post-accident test results. FRA seeks comment on this proposal (i.e., whether the agency should continue to keep post-accident test results for sedating antihistamines confidential).
In contrast, while tramadol is also a non-controlled substance, it is a prescription-only semi-synthetic opioid that can cause drowsiness and dizziness. FRA is seeking specific comments on how it should handle tramadol post-accident test results. Should FRA release post-accident test results for tramadol as it does for other opioids that are controlled substances? Should FRA keep post-accident results for tramadol confidential as it proposes to continue doing for sedating antihistamines? Is there another approach that would better handle tramadol test results?
The proposed addition of these non-controlled substances to FRA's standard post-accident program would not create new direct costs for employers since FRA would bear the costs of the additional post-accident tests. Any additional costs to employers would be minimal and indirect, such as the cost of responding to an increased number of positive post-accident test results should FRA decide to report tramadol or sedating antihistamine results, or both.
As mentioned above, FRA's post-accident testing program has been in existence since 1985. FRA has received suggestions from railroad representatives, collectors, and others on how to make the program's requirements easier to understand and follow. Although not directly related to the regulatory proposals in this NPRM, FRA is incorporating some of these suggestions into its post-accident testing program. For example, FRA is amending the contents of its standard post-accident testing box, which contains instructions, forms and supplies for the collection of urine and blood samples from three surviving employees. (FRA is not changing the contents of its fatalities post-accident testing box.) FRA is updating Form FRA F 6180.74, Post-Accident Testing Blood/Urine Custody and Control Form (Form 74) by deleting outdated information requests (e.g., removing the space for identification of the employee's home terminal in Step 1), streamlining the chain of custody documentation in Step 5, and making other miscellaneous amendments. (FRA is not changing Form FRA F 6180.73, Accident Information Required for Post-Accident Toxicological Testing.) FRA will also add new guidance documents to the contents of its standard post-accident testing box to familiarize individuals who may become involved in the collection of post-accident samples but who do not regularly work with the rail industry (e.g., employees of independent medical facilities and local law enforcement officers) with the post-accident testing program's basis, purpose, and requirements.
As mentioned above, in FRA's survey of employees involved in reportable human factor accidents, many employees self-reported using multiple substances; most of these, whether prescription drugs, OTC drugs, dietary supplements, or herbal preparations, were non-controlled substances. Part 219 already defines a controlled substance, but FRA believes that a definition of a non-controlled substance is necessary now to help employees better understand the variety of substances available. FRA would define a non-controlled substance as any substance that the DEA has not classified as a controlled substance under the CSA.
FRA is proposing to remove this section from part 219. FRA believes that the preemption language in paragraph (a) of this section is unnecessary because 49 U.S.C. 20106 does not require additional Federal regulatory provisions concerning a regulation's preemptive effect. As stated in the Federalism Implications statement of this NPRM, part 219 could have preemptive effect by operation of law under the Federal Rail Safety Act (FRSA).
As discussed below, however, FRA is proposing to add language similar to that currently found in paragraph (b) of this section to a new paragraph (c) in § 219.17, clarifying the lack of impact that part 219 has on State criminal law. FRA is keeping this language in part 219 because it is instructive and consistent with long-standing FRA guidance.
FRA is proposing to add a new paragraph (c) to this section that would contain language similar to that currently found in § 219.13(b). This language would state that part 219 does not impact State criminal laws imposing sanctions for reckless conduct that leads to actual loss of life, injury, or damage to property, whether such provisions apply specifically to railroad employees or the public at large. As noted above, similar language is currently found in § 219.13(b) and FRA is not proposing any substantive change with this amendment.
In the second sentence of paragraph (a), FRA proposes to replace the phrase “alcohol and controlled substances specified by FRA” with “alcohol, controlled substances, and non-controlled substances specified by FRA” to add routine testing for non-controlled substances to its post-accident testing program. From this same sentence, FRA also proposes to delete the reference to submittal of FRA post-accident testing protocols to HHS. As stated earlier, FRA's post-accident testing program is exempted from HHS guidelines. Finally, FRA would add a sentence stating that substances may be tested for in any form, whether naturally or synthetically derived, since controlled substances can be derived from many sources (e.g., opiates can be natural, synthetic, or semi-synthetic in origin.)
FRA also proposes to amend the first sentence of paragraph (b) in this section to limit reporting of post-accident test results to results for controlled
This proposed rule has been evaluated in accordance with existing policies and procedures under both Executive Order 12866 and 13563 and DOT policies and procedures.
As part of the regulatory impact analysis, FRA has assessed pertinent costs expected from the implementation of this proposed rule. FRA has not found any costs associated with this NPRM for the regulated industry. Any associated costs for conducting post-accident testing for non-controlled substances would be nominal and assumed by the Federal government in their entirety. Railroads would not be required to change their collection process and would have to follow the same collection, shipping, and handling processes they currently follow. This means that individuals subject to post-accident testing would provide the same specimens currently required, which would then be tested for tramadol and sedating antihistamines at FRA's expense. Since FRA would use these results for research and accident investigation purposes only, tramadol and sedating antihistamines test results would not be reported directly to either the employee or the employing railroad. This reporting process would apply to both surviving and fatally injured employees. No monetary costs would be imposed on the industry as a result of this addition.
As part of the regulatory impact analysis, FRA has explained what the likely benefits for this proposed rule would be, and provided numerical assessments of the potential value of such benefits. The proposed inclusion of tramadol and sedating antihistamines would generate safety benefits. Qualitative benefits would be generated with the inclusion of sedating antihistamines and tramadol in the post-accident testing panel by providing FRA with the data necessary to carry out research to inform future policy on this topic. The NPRM would generate quantifiable benefits upon the addition of sedating antihistamines to the post-accident testing panel by creating a small deterring effect on the use of sedating antihistamines by railroad workers and encouraging the use of alternative medications for allergic relief. Thus, in general, the proposed rule should reduce railroad accidents and their associated casualties and damages. FRA believes the value of the anticipated safety benefits would exceed the cost to the industry of implementing the proposed rule. Over a 10-year period, this analysis finds that $2.3 million in benefits would accrue through accident prevention. The discounted value of this is $1.9 million (PV, 7 percent). The table below presents the estimated benefits associated with the proposed rule.
The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) and Executive Order 13272 require a review of proposed and final rules to assess their impacts on small entities. An agency must prepare an initial regulatory flexibility analysis (IRFA) unless it determines and certifies that a rule, if promulgated, would not have a significant impact on a substantial number of small entities. FRA certifies that this proposed rule would not have a significant impact on a substantial number of small entities.
The revised information collection requirements in this proposed rule are being submitted for approval to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq. The section that contains the revised information collection requirement and the estimated time to fulfill this requirement are as follows:
All estimates include the time for reviewing instructions; searching existing data sources; gathering or maintaining the needed data; and reviewing the information. Pursuant to 44 U.S.C. 3506(c)(2)(B), FRA solicits comments concerning: whether this information collection requirement is necessary for the proper performance of the functions of FRA, including whether the information has practical utility; the accuracy of FRA's estimates of the burden of the information collection requirement; the quality, utility, and clarity of the information to be collected; and whether the burden of collection of information on those who are to respond, including through the
Organizations and individuals desiring to submit comments on the collection of information requirement should direct them to Mr. Robert Brogan or Ms. Kimberly Toone, Federal Railroad Administration, 1200 New Jersey Avenue SE., 3rd Floor, Washington, DC 20590. Comments may also be submitted via email to Mr. Brogan or Ms. Toone at the following address:
OMB is required to make a decision concerning the collection of information requirement contained in this proposed rule between 30 and 60 days after publication of this document in the
FRA is not authorized to impose a penalty on persons for violating information collection requirements which do not display a current OMB control number, if required. FRA intends to obtain current OMB control numbers for any new information collection requirement resulting from this rulemaking action prior to the effective date of the final rule. The OMB control number, when assigned, will be announced by separate notice in the
Executive Order 13132, “Federalism” (64 FR 43255, Aug. 4, 1999), requires FRA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” are defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, the agency may not issue a regulation with federalism implications that imposes substantial direct compliance costs and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or the agency consults with State and local government officials early in the process of developing the regulation. Where a regulation has federalism implications and preempts State law, the agency seeks to consult with State and local officials in the process of developing the regulation. FRA has analyzed this NPRM in accordance with the principles and criteria contained in Executive Order 13132. This NPRM complies with a statutory mandate, and FRA believes it is in compliance with Executive Order 13132.
This NPRM will not have a substantial effect on the States, on the relationship between the Federal government and the States, or on the distribution of power and responsibilities among the various levels of government. In addition, this NPRM will not have any federalism implications that impose substantial direct compliance costs on State and local governments.
This NPRM could have preemptive effect by operation of law under certain provisions of the Federal railroad safety statutes, specifically the former FRSA, repealed and recodified at 49 U.S.C 20106. The former FRSA provides that States may not adopt or continue in effect any law, regulation, or order related to railroad safety or security that covers the subject matter of a regulation prescribed or order issued by the Secretary of Transportation (with respect to railroad safety matters) or the Secretary of Homeland Security (with respect to railroad security matters), except when the State law, regulation, or order qualifies under the “local safety or security hazard” exception to section 20106.
FRA has evaluated this proposed rule in accordance with its “Procedures for Considering Environmental Impacts” (“FRA's Procedures”) (64 FR 28545, May 26, 1999) as required by the National Environmental Policy Act (42 U.S.C. 4321 et seq.), other environmental statutes, Executive Orders, and related regulatory requirements. FRA has determined that this proposed rule is not a major FRA action (requiring the preparation of an environmental impact statement or environmental assessment) because it is categorically excluded from detailed environmental review pursuant to section 4(c)(20) of FRA's Procedures. In accordance with section 4(c) and (e) of FRA's Procedures, the agency has further concluded that no extraordinary circumstances exist with respect to this regulation that might trigger the need for a more detailed environmental review. As a result, FRA finds that this proposed rule is not a major Federal action significantly affecting the quality of the human environment.
The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 2 U.S.C. 1531) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditures by State, local or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually (adjusted annually for inflation with base year of 1995). The value equivalent of $100 million in CY 1950, adjusted annually for inflation to CY 2008 levels by the Consumer Price Index for All Urban Consumers (CPI-U) is $141.3 million. This assessment may be included in conjunction with other assessments, as it is here. The proposed rule would not create an unfunded mandate in excess of the threshold amount.
Executive Order 13211 requires Federal agencies to prepare a Statement of Energy Effects for any “significant energy action.” 66 FR 28355 (May 22, 2001). Under the Executive Order, a “significant energy action” is defined as any action by an agency (normally published in the
FRA wishes to inform all interested parties that anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the
Alcohol abuse, Drug abuse, Drug testing, Penalties, Railroad safety, Reporting and recordkeeping requirements, Safety, Transportation.
For the reasons stated above, FRA proposes to amend part 219 of chapter II, subtitle B of title 49, Code of Federal Regulations, as follows:
1. The authority citation for part 219 is revised to read as follows:
49 U.S.C. 20102-20103, 20107, 20140, 21301, 21304, 21311; 28 U.S.C. 2461, note; and 49 CFR 1.49.
2. Amend § 219.5 by adding the following definition for “
3. Remove and reserve § 219.13.
4. Amend § 219.17 by adding paragraph (c) to read as follows:
(c) Impacts provisions of State criminal law that impose sanctions for reckless conduct that leads to actual loss of life, injury or damage to property, whether such provisions apply specifically to railroad employees or generally to the public at large.
5. Amend § 219.211 by revising paragraph (a) and the first sentence of paragraph (b) to read as follows:
(a) The laboratory designated in appendix B to this part undertakes prompt analysis of specimens provided under this subpart, consistent with the need to develop all relevant information and produce a complete report. Specimens are analyzed for alcohol, controlled substances, and non-controlled substances specified by FRA under protocols specified by FRA. These substances may be tested for in any form, whether naturally or synthetically derived. Specimens may be analyzed for other impairing substances specified by FRA as necessary to the particular accident investigation.
(b) Results of post-accident toxicological testing for controlled substances conducted under this subpart are reported to the railroad's Medical Review Officer and the employee. * * *
6. Revise Appendix B to part 219 to read as follows:
The following laboratory is currently designated to conduct post-accident toxicological analysis under subpart C of this part: Quest Diagnostics, 1777 Montreal Circle, Tucker, GA 30084, Telephone: (800) 729-6432.