81 FR 12642 - Evaluation of Safety Sensitive Personnel for Moderate-to-Severe Obstructive Sleep Apnea
DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
Federal Railroad Administration Federal Register Volume 81, Issue 47 (March 10, 2016)
Federal Motor Carrier Safety Administration
Federal Railroad Administration
Federal Register Volume 81, Issue 47 (March 10, 2016)
| Page Range | 12642-12647 | |
| FR Document | 2016-05396 |
[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)] [Proposed Rules] [Pages 12642-12647] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-05396] [[Page 12642]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Part 391 Federal Railroad Administration 49 CFR Parts 240 and 242 [Docket Numbers FMCSA-2015-0419 and FRA-2015-0111] RIN 2126-AB88 and 2130-AC52 Evaluation of Safety Sensitive Personnel for Moderate-to-Severe Obstructive Sleep Apnea ACTION: Advance notice of proposed rulemaking; request for public comments. ----------------------------------------------------------------------- SUMMARY: The Federal Motor Carrier Safety Administration (FMCSA) and Federal Railroad Administration (FRA) request data and information concerning the prevalence of moderate-to-severe obstructive sleep apnea (OSA) among individuals occupying safety sensitive positions in highway and rail transportation, and on its potential consequences for the safety of rail and highway transportation. FMCSA and FRA (collectively ``the Agencies'') also request information on potential costs and benefits from regulatory actions that address the safety risks associated with motor carrier and rail transportation workers in safety sensitive positions who have OSA. For instance, the agencies request comment on the costs and benefits of requiring motor carrier and rail transportation workers in safety sensitive positions who exhibit multiple risk factors for OSA to undergo evaluation and treatment by a healthcare professional with expertise in sleep disorders. DATES: You must submit comments on or before June 8, 2016. ADDRESSES: You may submit comments identified by either of the docket numbers listed at the beginning of this notice using any one of the following methods: Federal Rulemaking Portal: www.regulations.gov. Fax: 202-493-2251. Mail: Docket Services (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001. Hand delivery: Same as mail address above, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202-366-9329. To avoid duplication, please use only one of these four methods. See the ``Public Participation and Request for Comments'' heading under the SUPPLEMENTARY INFORMATION section below for instructions regarding submitting comments. FOR FURTHER INFORMATION CONTACT: FMCSA: Ms. Christine Hydock, Chief of the Medical Programs Division, FMCSA, 1200 New Jersey Ave. SE., Washington DC 20590-0001, by telephone at 202-366-4001, or by email at [email protected]. FRA: Dr. Bernard Arseneau, Medical Director, Assurance and Compliance, FRA, 1200 New Jersey Avenue SE., Washington, DC 20590, by telephone at 202-493-6232, or by email at [email protected]. If you have questions about viewing or submitting material to the docket, call Ms. Cheryl Collins, Dockets Manager, Docket Services, telephone 202-493-0402. SUPPLEMENTARY INFORMATION: Public Participation and Request for Comments The Department encourages the public to participate in this advance notice of proposed rulemaking (ANPRM), by submitting comments and related materials to the appropriate dockets. Where possible, the Department would like the public to provide scientific peer-reviewed data to support comments. Submitting Comments If you submit a comment, please include the docket number for this ANPRM (FMCSA-2015-0419 and FRA-2015-0111), indicate the heading of the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online, by fax, mail, or hand delivery, but please use only one of these means. The Department recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so an Agency can contact you if it has questions regarding your submission. To submit your comment online, go to www.regulations.gov, type the docket number, ``FMCSA-2015-0419'' or ``FRA-2015-0111 in the ``Keyword'' box, and click ``Search.'' When the new screen appears, click the ``Comment Now!'' button and type your comment into the text box in the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for copying and electronic filing. The Agencies will consider all comments and material received during the comment period and will use them to inform any future rulemaking proposals. Viewing Comments and Documents To view comments and any document mentioned in this preamble, go to www.regulations.gov, insert the docket number, ``FMCSA-2015-0419'' or ``FRA-2015-0111'' in the ``Keyword'' box, and click ``Search.'' Next, click the ``Open Docket Folder'' button and choose the document listed to review. If you do not have access to the Internet, you may view the docket online by visiting the Docket Services in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m. ET, Monday through Friday, except Federal holidays. Privacy Act Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its potential rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy. Legal Basis for the Rulemaking Federal Motor Carrier Safety Administration FMCSA has authority under 49 U.S.C. 31136(a) and 31502(b)-- delegated to the Agency by 49 CFR 1.87(f) and (i), respectively--to establish minimum qualifications, including medical and physical qualifications, for commercial motor vehicle (CMV) drivers operating in interstate commerce. Section 31136(a)(3) requires that FMCSA's safety regulations ensure that the physical conditions of CMV drivers enable them to operate their vehicles safely, and that medical examiners (MEs) trained in physical and medical examination standards perform the physical examinations required of such operators. In 2005, Congress authorized FMCSA to establish a Medical Review Board (MRB) composed of experts ``in a variety of medical specialties relevant to the driver fitness requirements'' to provide advice and recommendations on qualification standards. 49 U.S.C. 31149(a). The position of FMCSA Chief [[Page 12643]] Medical Examiner was authorized at the same time. 49 U.S.C. 31149(b). Under section 31149(c)(1), FMCSA, with the advice of the MRB and Chief Medical Examiner, is directed to ``establish, review and revise . . . medical standards for operators of commercial motor vehicles that will ensure that the physical condition of operators of commercial motor vehicles is adequate to enable them to operate the vehicles safely.'' As discussed below, FMCSA, in conjunction with the Chief Medical Examiner, asked the MRB to review and report specifically on OSA. The MRB's recommendations are described in the MRB and Motor Carrier Safety Advisory Committee (MCSAC) Recommendations section of this ANPRM. Federal Railroad Administration Under 49 U.S.C. 20103, the Secretary of Transportation (Secretary) has broad authority to issue regulations governing every area of railroad safety. The Secretary has delegated rulemaking responsibility under section 20103 to the Administrator of FRA. 49 CFR 1.89(a). The railroad incidents discussed below illustrate the risks to railroad safety posed by railroad employees that have moderate-to-severe OSA. Moreover, FRA has exercised this safety authority to require other medical testing. FRA regulations require locomotive engineers (49 CFR 240.121) and conductors (49 CFR 242.117) to undergo vision and hearing testing as part of their qualification and certification at least every 3 years. There are individual medical circumstances that may lead a railroad to require some engineers or conductors to undergo more frequent testing. In addition, Congress has authorized the Secretary to consider requiring certification of the following other crafts and classes of employees: (1) Car repair and maintenance employees; (2) onboard service workers; (3) rail welders; (4) dispatchers; (5) signal repair and maintenance employees; and (6) any other craft or class of employees that the Secretary determines appropriate. Therefore, the Secretary, and the FRA Administrator by delegation, has statutory authority to issue regulations to address the safety risks posed by employees in safety sensitive positions with OSA. Background What is obstructive sleep apnea? OSA is a respiratory disorder characterized by a reduction or cessation of breathing during sleep. OSA is characterized by repeated episodes of upper airway collapse in the region of the upper throat (pharynx) that results in intermittent periods of partial airflow obstruction (hypopneas), complete airflow obstruction (apneas), and respiratory effort-related arousals from sleep (RERAs) in which affected individuals awaken partially and may experience gasping and choking as they struggle to breathe. Risk factors for developing OSA include: Obesity, male gender, advancing age, family history of OSA, large neck size, and an anatomically small oropharynx (throat). Additionally, OSA is associated with increased risk for other adverse health conditions such as: Hypertension (high blood pressure), diabetes, obesity, cardiac dysrhythmias (irregular heartbeat), myocardial infarction (heart attack), stroke, and sudden cardiac death. Individuals who have undiagnosed OSA are often unaware they have experienced periods of sleep interrupted by breathing difficulties (apneas, hypopneas, or RERAs) when they awaken in the morning. As a result, the condition is often unrecognized by affected individuals and underdiagnosed by medical professionals. What are the safety risks in transportation? For individuals with OSA, eight hours of sleep can be less restful or refreshing than four hours of ordinary, uninterrupted sleep.\1\ Undiagnosed or inadequately treated moderate to severe OSA can cause unintended sleep episodes and resulting deficits in attention, concentration, situational awareness, and memory, thus reducing the capacity to safely respond to hazards when performing safety sensitive duties. Thus, OSA is a critical safety issue that can affect operations in all modes of travel in the transportation industry. --------------------------------------------------------------------------- \1\ Gay, P., Weaver, T., Loube, D., Iber, C. (2006). Evaluation of positive airway pressure treatment for sleep related breathing disorders in adults. Positive Airway Pressure Task Force; Standards of Practice Committee; American Academy of Sleep Medicine. Sleep 29:381-401. --------------------------------------------------------------------------- The following paragraphs provide some examples of accidents where the National Transportation Safety Board (NTSB) determined that OSA played a role in causing an accident (or near-accident) involving motor carriers and trains. Work Zone Collision, Jackson, Tennessee On July 26, 2000, the driver of a tractor-trailer traveling on Interstate 40 near Jackson, Tennessee, collided with a Tennessee Highway Patrol vehicle trailing construction vehicles, killing the state trooper inside. The tractor-trailer then traveled across the median and collided with a Chevrolet Blazer heading in the opposite direction, seriously injuring the driver of the Blazer. The tractor- trailer driver was 5 feet, 11 inches tall, weighed 358 pounds, and had been diagnosed with and undergone surgery for OSA, but had not indicated either the diagnosis or the surgery on examinations for medical certification. The NTSB found that the driver's unreported OSA, untreated hypothyroidism, or complications from either or both conditions predisposed him to impairment or incapacitation, including falling asleep at the wheel while driving. The NTSB determined the probable cause of the accident was the driver's incapacitation, which resulted from the failure of the medical certification process to detect and remove a medically unfit driver from service.\2\ --------------------------------------------------------------------------- \2\ Work Zone Collision Between a Tractor-Semitrailer and a Tennessee Highway Patrol Vehicle, Jackson, Tennessee, July 26, 2000, Highway Accident Report NTSB/HAR-02/01 (Washington, DC: National Transportation Safety Board, 2002), available at http://www.ntsb.gov/investigations/AccidentReports/Reports/HAR0201.pdf. --------------------------------------------------------------------------- BNSF Railway Collision, Red Oak, Iowa On April 17, 2011, at approximately 6:55 a.m. CDT, an eastbound BNSF Railway (BNSF) coal train traveling near Red Oak, Iowa collided with the rear end of a standing BNSF maintenance-of-way equipment train. The collision resulted in the derailment of two locomotives and 12 cars, a diesel fuel fire, and the deaths of both crewmembers on the striking train. In its investigative report, the NTSB noted that neither of the fatally injured train crewmembers had undergone a sleep study prior to the incident. However, in each case, medical records indicated that both crewmembers had multiple risk factors for OSA.\3\ NTSB determined that the probable cause of the accident was ``the failure of the crew of the striking train to comply with the signal indication requiring them to operate in accordance with restricted speed requirements and stop short of the standing train because they had fallen asleep due to fatigue resulting from their irregular work schedules and their medical conditions.'' \4\ NTSB recommended that FRA ``require railroads to medically screen employees [[Page 12644]] with safety sensitive duties for sleep apnea and other sleep disorders.'' \5\ --------------------------------------------------------------------------- \3\ NTSB, Railroad Accident Report, RAR-12/02, Collision of BNSF Coal Train with the Rear End of Standing BNSF Maintenance-of-Way Equipment Train, Red Oak, Iowa, April 17, 2011, pp. 43-44. http://www.ntsb.gov/investigations/AccidentReports/Reports/RAR1202.pdf. \4\ Id. at 72. \5\ Id. at 73. --------------------------------------------------------------------------- Metro-North Railroad Derailment, Bronx, NY On December 1, 2013, at approximately 7:20 a.m. EST, southbound Metro-North Railroad (Metro-North) passenger train 8808 derailed as it approached the Spuyten Duyvil Station in New York City. All passenger cars and the locomotive derailed, and, as a result, four passengers died and at least 61 passengers were injured. The train was traveling at 82 mph when it derailed in a section of curved track where the maximum authorized speed was 30 mph. Following the accident, the engineer reported that: (1) He felt dazed just before the derailment; \6\ and (2) his wife had previously complained about his snoring. The engineer then underwent a sleep evaluation, which identified excessive daytime sleepiness, followed by a sleep study, which diagnosed severe OSA. Based on its investigation of the derailment, the NTSB concluded that the engineer had multiple OSA risk factors, such as obesity, male gender, snoring, complaints of fatigue, and excessive daytime sleepiness. Even though the engineer exhibited these OSA risk factors, neither his personal health care provider nor his Metro-North occupational health evaluations had screened the engineer for OSA.\7\ NTSB determined that the probable cause of the accident was the ``engineer's noncompliance with the 30-mph speed restriction because he had fallen asleep due to undiagnosed severe obstructive sleep apnea exacerbated by a recent circadian rhythm shift required by his work schedule.'' \8\ --------------------------------------------------------------------------- \6\ NTSB, Railroad Accident Brief, RAB-14/12, Metro-North Railroad Derailment, October 24, 2014, p. 2. http://www.ntsb.gov/investigations/AccidentReports/Reports/RAB1412.pdf. \7\ Id. at 3. \8\ Id. at 5. --------------------------------------------------------------------------- Union Pacific Railroad and BNSF Railway Chaffee Collision On May 25, 2013, at approximately 2:30 a.m., a Union Pacific Railroad (UP) freight train collided with a BNSF freight train at an interlocking near Chaffee, Missouri. The collision resulted in the derailment of 13 cars from the BNSF train, two locomotives and 11 cars from the UP train, and a diesel fuel fire. The two crew members from the UP train were injured and transported to a local hospital. The derailing train cars struck nearby highway bridge supports, resulting in the collapse of portions of the bridge, two motor vehicle accidents, and injury to five motor vehicle occupants. NTSB estimated the total damages to be more than $11 million.\9\ --------------------------------------------------------------------------- \9\ NTSB, Railroad Accident Report 14/02, Collision of Union Pacific Railroad Freight Train with BNSF Railway Freight Train Near Chaffee, Missouri, May 25, 2013, p. ii. http://www.ntsb.gov/investigations/accidentreports/reports/rar1402.pdf. --------------------------------------------------------------------------- NTSB determined the probable cause of the accident to be ``failure of the Union Pacific Railroad train crewmembers to comply with wayside signals leading into the Rockview Interlocking as a result of their disengagement from their task, likely because of fatigue-induced performance degradation.'' NTSB concluded that a contributing factor to the engineer's fatigue was undiagnosed OSA.\10\ --------------------------------------------------------------------------- \10\ Id. at 42. --------------------------------------------------------------------------- NTSB also concluded that absence of positive train control (PTC) \11\ was a contributing factor in each of the above train accidents.\12\ FRA agrees that PTC is an important technology that may prevent certain types of accidents in which OSA is a contributing factor. Nevertheless, PTC is not required on all track segments and any potential OSA regulations could have substantial positive impact at those locations. Potential OSA regulations could also have benefits even where PTC is fully implemented. For instance, compliance with potential OSA regulations could prevent incidents that PTC is not designed to prevent. Even in a situation when an engineer with OSA falls asleep and PTC functions as intended and stops a moving train before certain incidents,\13\ there may be delay costs to passengers and other trains from attending to the engineer that could be avoided by potential OSA regulations. The three examples of train accidents described above are illustrative of the consequences that could result from accidents that occur due to OSA. --------------------------------------------------------------------------- \11\ The NTSB report for the Red Oak accident concluded that a lack of a PTC system ``that identifies the rear of a train and stops a following train if a safe braking profile is exceeded'' contributed to the accident. NTSB Railroad Accident Report, RAR-12/ 02 at 72. NTSB further concluded that the type of PTC system that was in development or being deployed at the time of the report (2011) would not address this type of accident. Id. at 71. \12\ See id. at 72; NTSB Railroad Accident Brief, RAB-14/12 at 5; and NTSB Railroad Accident Report 14/02 at 37-38, and 50. \13\ See 49 CFR 236.1005(a). --------------------------------------------------------------------------- What actions have the Department's operating administrations taken? The Department promotes the safety of America's transportation system through information, Web sites, regulations, guidelines, and policies. The Department's operating administrations regulate transportation safety following authorizations from the Congress. The authorities for determining and ensuring that transportation operators engaged in interstate commerce are physically qualified differ among the Department's operating administrations. Several administrations have been working for many years, in some instances along with advisory groups, to improve policies on medical fitness for duty of personnel in safety-critical functions. The sections below summarize the initiatives that several DOT operating administrations have taken to address OSA under their current authority. Federal Aviation Administration (FAA) Although this ANPRM covers how FMCSA and FRA will potentially treat OSA, FAA's history of its OSA screening of pilots is instructive. The FAA was created to provide the safe and efficient use of the national air space; that mission has evolved to providing the safest, most efficient aerospace system in the world. While the United States has an impressive safety record, the FAA continues to work with the aviation and medical communities to maintain medical certification standards to keep our skies safe. The FAA has always considered OSA a disqualifying condition, but has used its special issuance process \14\ to certificate airman if the hazard of OSA was satisfactorily treated or mitigated. --------------------------------------------------------------------------- \14\ https://www.faa.gov/about/office_org/headquarters_offices/avs/offices/aam/ame/guide/app_process/general/si. --------------------------------------------------------------------------- In November 2013, FAA proposed guidance that would have required pilots with a body mass index (BMI) of 40 or more to be evaluated for OSA. Key aviation industry stakeholders, as well as members of Congress, expressed concerns about this single-factor enhanced screening as lacking a sufficient evidentiary basis, and thus being an example of overregulation by the FAA. In response, FAA worked with stakeholders, to revise the guidance to address those concerns and issued new medical guidance to Aviation Medical Examiners (AMEs) on March 2, 2015, which balanced industry and Congressional concerns with the FAA and NTSB's safety concerns about pilots flying with OSA. Under the new guidance, AMEs screen airman for OSA using an integrated assessment of history, symptoms, and physical/ clinical findings. If screening identifies a need for further evaluation, an OSA risk factor evaluation will be done by the AME at the time of the physical [[Page 12645]] examination using the American Academy of Sleep Medicine (AASM) guidance provided in the Guide for Aviation Medical Examiners.\15\ --------------------------------------------------------------------------- \15\ https://www.faa.gov/about/office_org/headquarters_offices/avs/offices/aam/ame/guide/. --------------------------------------------------------------------------- A pilot identified as being at risk for OSA will be issued a medical certificate, and shortly thereafter receive a letter from FAA's Federal Air Surgeon requesting that an OSA evaluation be completed within 90 days. The evaluation may be done by any physician (including the AME), not just a sleep medicine specialist. If the evaluating physician determines, using the AASM guidelines, that a laboratory sleep study or home study is warranted, it should be ordered at that time. The pilot will have 90 days (or longer under special circumstances) to accomplish this, as outlined in the Federal Air Surgeon's letter. The pilot may continue flying during the evaluation period until they have been diagnosed with OSA. A pilot is not allowed to fly once diagnosed with OSA, but upon submitting documentation of effective treatment to FAA, the FAA will then consider the pilot for a special issuance medical certificate, which allow the pilot to resume flying. More information on FAA guidance can be found at: https://www.faa.gov/news/fact_sheets/news_story.cfm?newsId=18156. Federal Motor Carrier Safety Administration FMCSA's October 5, 2000, Advisory Criteria In 2000, FMCSA issued advisory criteria providing interpretive guidance to MEs concerning its physical qualifications standards. These advisory criteria are recommendations from FMCSA to assist MEs in applying the minimum physical qualification standards. The advisory criteria were published with the Federal Motor Carrier Safety Regulations as part of the medical examination report form in 49 CFR. 391.43 (Physical Qualification of Drivers; Medical Examination; Certificate, 65 FR 59363 (October 5, 2000)). The advisory criterion for section 391.41(b)(5), which has been unchanged since 2000, provides the following guidance for MEs in making the determination whether a driver satisfies the respiratory standard: [Because] a driver must be alert at all times, any change in his or her mental state is in direct conflict with highway safety. Even the slightest impairment in respiratory function under emergency conditions (when greater oxygen supply is necessary for performance) may be detrimental to safe driving. There are many conditions that interfere with oxygen exchange and may result in incapacitation, including emphysema, chronic asthma, carcinoma, tuberculosis, chronic bronchitis and sleep apnea. If the MEs detect a respiratory dysfunction that in any way is likely to interfere with the driver's ability to safely control and drive a commercial motor vehicle, the driver must be referred to a specialist for further evaluation and therapy. . . . Based on the above advisory criterion, it is clear that FMCSA considers OSA to be a respiratory dysfunction that interferes with oxygen exchange. As such, if a ME believes a driver's respiratory condition is, in any way, likely to interfere with the driver's ability to safely control and drive a commercial motor vehicle, the examiner may refer the driver to a specialist for further evaluation and therapy. This advisory criterion is helpful to MEs when the examiner has sufficient experience or information to recognize certain risk factors for OSA and when a driver tells the examiner that he has been diagnosed with OSA. Under these circumstances, MEs may consider referring the driver to a specialist for evaluation before issuing a ME's certificate, or request additional information from the driver and his treating healthcare professional about the management of the driver's OSA, respectively. However, the current guidance is not helpful if the ME does not have sufficient experience or information to suspect the driver may have OSA, or the driver does not share with the examiner any previous diagnosis that he has the condition. MRB and MCSAC Recommendations In consideration of the limitations of the current advisory criterion, FMCSA tasked its MRB and MCSAC in 2011 to provide recommendations that FMCSA should consider to (1) develop new OSA standards for motor carriers, commercial vehicle drivers, and MEs and (2) determine whether drivers with this respiratory condition should receive an unrestricted two-year medical certificate to operate CMVs in interstate commerce. The MCSAC also recommended interim actions that FMCSA could take to help MEs address the issue before completing a rulemaking. A copy of the task statement, all presentations provided to the MCSAC, MRB, and the Committees' December 13, 2011, letter report to the FMCSA Administrator are included in the docket referenced at the beginning of this notice and also at the MCSAC Web page at https://www.fmcsa.dot.gov/advisory-committees/mcsac/2012-past-meetings. During the deliberations of the MCSAC and MRB, experts indicated that studies \16\ show that a using a BMI of 33 as a screening indicator for OSA is the value at which false positives and false negatives are minimized. A false positive would require a driver who does not have moderate-to-severe OSA to undergo a sleep study unnecessarily, while a false negative would fail to require a driver who actually has moderate-to-severe OSA to undergo a sleep study. The medical experts participating in the meeting indicated that approximately 75 percent of moderate-to-severe OSA cases would be correctly identified by requiring a sleep study for drivers with a BMI of 33 or greater; however, approximately 25 percent of drivers with moderate-to-severe OSA would be missed with this cutoff. Because the likelihood of OSA in patients with BMIs of 35 or greater rises to nearly 80 percent, the MCSAC and MRB agreed to use a BMI of 35 (rather than 33) in their interim advice to MEs screening drivers for referral to a specialist. A copy of the MCSAC and MRB discussion notes is included in the docket referenced at the beginning of this notice. --------------------------------------------------------------------------- \16\ Numerous studies were cited in presentations to the groups; links to two relevant presentations are: (1) https://www.fmcsa.dot.gov/advisory-committees/mcsac/addressing-obstructive-sleep-apnea-cmv-drivers, and (2) https://www.fmcsa.dot.gov/advisory-committees/mcsac/screening-osa-commercial-vehicle-operators. --------------------------------------------------------------------------- The chairs of the MRB and MCSAC considered their December 13, 2011, report as a first step towards recommendations for addressing OSA. The two committees completed more detailed recommendations in February 2012 to support a future notice-and-comment rulemaking. A copy of those recommendations is included in the docket referenced at the beginning of this notice. Before FMCSA issued a notice requesting public comment on proposed regulatory guidance, several stakeholder groups expressed concerns about the agency addressing OSA through regulatory guidance, even on an interim basis. These groups requested that FMCSA pursue the matter through a notice-and-comment rulemaking process. In 2013, Congress enacted Public Law 113-45 (127 Stat. 557, October 13, 2013, in a note to 49 U.S.C. 31305) directing FMCSA to issue any new or revised requirements concerning sleep disorders, including OSA, by rulemaking. Such requirements would include those for sleep apnea screening, testing, and treatment of CMV drivers. [[Page 12646]] On January 12, 2015, FMCSA issued a bulletin to healthcare professionals on the National Registry of Certified Medical Examiners regarding OSA. The bulletin reminded healthcare workers of the current physical qualifications standards and advisory criteria concerning the respiratory system, and specifically how those requirements apply to drivers that may have OSA. It encouraged MEs to explain to drivers the distinction between actions based on the current regulations and advisory criteria versus actions based on the MEs' professional judgment. Federal Railroad Administration The FRA has taken various regulatory and non-regulatory actions to address the risk of accidents in which fatigue and/or OSA may be a contributing factor. FRA Hours of Service Laws and Regulations FRA enforces laws and has issued regulations regarding hours of service for certain railroad employees. See 49 U.S.C. chapter 211 and 49 CFR part 228. The hours of service (HOS) laws and regulations establish maximum hours of work and minimum hours of rest for train employees, signal employees, and dispatching service employees, as defined at 49 U.S.C. 21101. HOS laws and regulations are a necessary component of mitigating risk associated with work schedules, including potential fatigue- related risks. However, HOS laws and regulations do not adequately mitigate risks associated with undiagnosed or inadequately treated OSA, even if the work schedules comply with the HOS laws and regulations, as they assume that the sleep that occurs during off-duty time is normal, restful sleep. Fatigue Management Plans RSIA also requires certain railroads to establish a fatigue management plan. See 49 U.S.C. 20156(f). FRA is currently working with the Railroad Safety Advisory Committee (RSAC) to draft a regulation to implement this mandate. The RSIA requires plans to be ``designed to reduce the fatigue experienced by safety-related railroad employees and to reduce the likelihood of accidents, incidents, injuries, and fatalities caused by fatigue.'' Id. at section 20156(f)(1). Further, the RSIA requires a railroad to consider the need to include in its fatigue management plan, as applicable, ``opportunities for identification, diagnosis, and treatment of any medical condition that may affect alertness or fatigue, including sleep disorders.'' Id. at section 20156(f)(3)(B). However, RSIA does not specifically mandate that the regulation require railroads to screen and evaluate safety- related railroad employees for OSA or other sleep disorders. FRA Safety Advisory 2004-04 On September 21, 2004, FRA issued Safety Advisory 2004-04 to alert the railroad community, and especially those employees with safety sensitive duties, to the danger associated with degradation of performance resulting from sleep disorders that are undiagnosed or not successfully treated. 69 FR 58995 (Oct. 1, 2004). FRA recommended that the railroad community take the following actions: 1. Establish training and educational programs to inform employees of the potential for performance impairment as a result of fatigue and sleep related issues; 2. Develop standardized screening tools for diagnosis, referral, and treatment of sleep disorders (especially sleep apnea); 3. Develop rules to encourage voluntary reporting of sleep disorders by employees with safety sensitive duties; 4. Implement policies that would prohibit employees in safety sensitive positions who have incapacitation or performance-impairing medical conditions related to sleep from performing any safety sensitive duties until the medical condition appropriately responds to treatment; and 5. Implement policies to: (a) Promote self-reporting; (b) encourage participation in evaluation and treatment; and (c) establish dispute resolution to resolve any issues regarding fitness of those employees who have reported sleep-related issues. RSAC Medical Standards Working Group In September 2006, the RSAC established the Medical Standards Working Group to develop standards for identifying conditions that could lead to sudden incapacitation or impairment of safety-critical personnel. The Working Group established a Physicians Task Force that developed draft medical standards and protocols. FRA put the Medical Standards Working Group on hiatus due to the requirement to focus on activities mandated in the Rail Safety Improvement Act of 2008. Railroaders' Guide to Healthy Sleep Web Site As part of its non-regulatory efforts to address fatigue, FRA sponsors the Railroaders' Guide to Healthy Sleep Web site.\17\ This Web site is set up to disseminate educational information to railroad employees and their families about sleep disorders, the relevance of healthy sleep to railroad safety, and information about improving the quality of the railroaders' sleep. The Web site was developed in conjunction with the Division of Sleep Medicine at Harvard Medical School, WGBH Educational Foundation, and Volpe--The National Transportation Systems Center. --------------------------------------------------------------------------- \17\ https://www.railroadersleep.org/. --------------------------------------------------------------------------- Why do the Agencies believe regulatory action may be necessary? Based on the potential severity of OSA-related transportation incidents and accidents, and the varied, non-regulatory, OSA-related actions taken by the Department's Operating Administrations to date, the Agencies are considering taking regulatory action to ensure consistency in addressing the safety issue presented by transportation workers with safety sensitive duties who are at risk for OSA. The Agencies seek information from interested parties regarding OSA, in order to better inform their decision on whether to take regulatory action and, if so, how to craft the most effective and efficient regulation to address the potential safety risks associated with OSA. Request for Comments The Agencies request public comment on the questions below. In your response, please provide supporting materials and identify your interest in this rulemaking, whether in the transportation industry, medical profession, or other. The Problem of OSA 1. What is the prevalence of moderate-to-severe OSA among the general adult U.S. population? How does this prevalence vary by age? 2. What is prevalence of moderate-to-severe OSA among individuals occupying safety sensitive transportation positions? If it differs from that among the general population, why does it appear to do so? If no existing estimates exist, what methods and information sources can the agencies use to reliably estimate this prevalence? 3. Is there information (studies, data, etc.) available for estimating the future consequences resulting from individuals with OSA occupying safety sensitive transportation positions in the absence of new restrictions? For example, does any organization track the number of historical motor carrier or train [[Page 12647]] accidents caused by OSA? With respect to rail, how would any OSA regulations and the current PTC requirements interrelate? 4. Which categories of transportation workers with safety sensitive duties should be required to undergo screening for OSA? On what basis did you identify those workers? Cost & Benefits 5. What alternative forms and degrees of restriction could FMCSA and FRA place on the performance of safety-sensitive duties by transportation workers with moderate-to-severe OSA, and how effective would these restrictions be in improving transportation safety? Should any regulations differentiate requirements for patients with moderate, as opposed to severe, OSA? 6. What are the potential costs of alternative FMCSA/FRA regulatory actions that would restrict the safety sensitive activities of transportation workers diagnosed with moderate-to-severe OSA? Who would incur those costs? What are the benefits of such actions and who would realize them? 7. What are the potential improved health outcomes for individuals occupying safety sensitive transportation positions and would receive OSA treatment due to regulations? 8. What models or empirical evidence is available to use to estimate potential costs and benefits of alternative restrictions? 9. What costs would be imposed on transportation workers with safety sensitive duties by requiring screening, evaluation, and treatment of OSA? 10. Are there any private or governmental sources of financial assistance? Would health insurance cover costs for screening and/or treatment of OSA? Screening Procedures & Diagnostics 11. What medical guidelines other than the AASM FAA currently uses are suitable for screening transportation workers with safety sensitive duties that are regulated by FMCSA/FRA for OSA? What level of effectiveness are you seeing with these guidelines? 12. What were the safety performance histories of transportation workers with safety sensitive duties who were diagnosed with moderate- to-severe OSA, who are now successfully compliant with treatment before and after their diagnosis? 13. When and how frequently should transportation workers with safety sensitive duties be screened for OSA? What methods (laboratory, at-home, split, etc.) of diagnosing OSA are appropriate and why? 14. What, if any, restrictions or prohibitions should there be on a transportation workers' safety sensitive duties while they are being evaluated for moderate-to-severe OSA? 15. What methods are currently employed for providing training or other informational materials about OSA to transportation workers with safety sensitive duties? How effective are these methods at identifying workers with OSA? Medical Personnel Qualifications & Restrictions 16. What qualifications or credentials are necessary for a medical practitioner who performs OSA screening? What qualifications or credentials are necessary for a medical practitioner who performs the diagnosis and treatment of OSA? 17. With respect to FRA should it use Railroad MEs to perform OSA screening, diagnosis, and treatment? 18. Should MEs or other Agencies' designated medical practitioners impose restrictions on a transportation worker with safety sensitive duties who self-reports experiencing excessive sleepiness while performing safety sensitive duties? Treatment Effectiveness 19. What should be the acceptable criteria for evaluating the effectiveness of prescribed treatments for moderate-to-severe OSA? 20. What measures should be used to evaluate whether transportation employees with safety sensitive duties are receiving effective OSA treatment? Rulemaking Analyses and Notices Executive Order (E.O.) 12866 (Regulatory Planning and Review) and DOT Regulatory Policies and Procedures Under E.O. 12866, ``Regulatory Planning and Review'' (issued September 30, 1993, published October 4 at 58 FR 51735, and discussed above in the ``Background'' section), as supplemented by E.O. 13563 and DOT policies and procedures, if a regulatory action is determined to be ``significant,'' it is subject to Office of Management and Budget (OMB) review. E.O. 12866 defines ``significant regulatory action'' as one likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal government or communities. (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency. (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof. (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the E.O. The Department has determined this ANPRM is a ``significant regulatory action'' under E.O. 12866, and significant under DOT regulatory policies and procedures due to significant public interest in the legal and policy issues addressed. Therefore, this notice has been reviewed by OMB. Issued under the authority of delegations in 49 CFR 1.87(f) and (i) and 49 CFR 1.89(a), respectively: T.F. Scott Darling III, Acting Administrator, Federal Motor Carrier Safety Administration. Sarah Feinberg, Administrator, Federal Railroad Administration. [FR Doc. 2016-05396 Filed 3-9-16; 8:45 am] BILLING CODE 4910-EX-P
![12642 Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Proposed Rules
DEPARTMENT OF TRANSPORTATION To avoid duplication, please use only submit your comments by mail or hand
one of these four methods. See the delivery, submit them in an unbound
Federal Motor Carrier Safety ‘‘Public Participation and Request for format, no larger than 81⁄2 by 11 inches,
Administration Comments’’ heading under the suitable for copying and electronic
SUPPLEMENTARY INFORMATION section filing. The Agencies will consider all
49 CFR Part 391 below for instructions regarding comments and material received during
submitting comments. the comment period and will use them
Federal Railroad Administration FOR FURTHER INFORMATION CONTACT: to inform any future rulemaking
FMCSA: Ms. Christine Hydock, Chief proposals.
49 CFR Parts 240 and 242 of the Medical Programs Division, Viewing Comments and Documents
[Docket Numbers FMCSA–2015–0419 and FMCSA, 1200 New Jersey Ave. SE.,
FRA–2015–0111] Washington DC 20590–0001, by To view comments and any document
telephone at 202–366–4001, or by email mentioned in this preamble, go to
RIN 2126–AB88 and 2130–AC52 www.regulations.gov, insert the docket
at fmcsamedical@dot.gov.
FRA: Dr. Bernard Arseneau, Medical number, ‘‘FMCSA–2015–0419’’ or
Evaluation of Safety Sensitive ‘‘FRA–2015–0111’’ in the ‘‘Keyword’’
Personnel for Moderate-to-Severe Director, Assurance and Compliance,
FRA, 1200 New Jersey Avenue SE., box, and click ‘‘Search.’’ Next, click the
Obstructive Sleep Apnea ‘‘Open Docket Folder’’ button and
Washington, DC 20590, by telephone at
ACTION:Advance notice of proposed 202–493–6232, or by email at choose the document listed to review. If
rulemaking; request for public Bernard.arseneau@dot.gov. you do not have access to the Internet,
comments. If you have questions about viewing you may view the docket online by
or submitting material to the docket, call visiting the Docket Services in Room
SUMMARY: The Federal Motor Carrier Ms. Cheryl Collins, Dockets Manager, W12–140 on the ground floor of the
Safety Administration (FMCSA) and Docket Services, telephone 202–493– DOT West Building, 1200 New Jersey
Federal Railroad Administration (FRA) 0402. Avenue SE., Washington, DC 20590,
request data and information concerning between 9 a.m. and 5 p.m. ET, Monday
SUPPLEMENTARY INFORMATION:
the prevalence of moderate-to-severe through Friday, except Federal holidays.
obstructive sleep apnea (OSA) among Public Participation and Request for Privacy Act
individuals occupying safety sensitive Comments
positions in highway and rail Under 5 U.S.C. 553(c), DOT solicits
The Department encourages the
transportation, and on its potential comments from the public to better
public to participate in this advance
consequences for the safety of rail and inform its potential rulemaking process.
notice of proposed rulemaking
highway transportation. FMCSA and DOT posts these comments, without
(ANPRM), by submitting comments and
FRA (collectively ‘‘the Agencies’’) also edit, including any personal information
related materials to the appropriate
request information on potential costs the commenter provides, to
dockets. Where possible, the
and benefits from regulatory actions that www.regulations.gov, as described in
Department would like the public to
address the safety risks associated with the system of records notice (DOT/ALL–
provide scientific peer-reviewed data to
motor carrier and rail transportation 14 FDMS), which can be reviewed at
support comments.
workers in safety sensitive positions www.dot.gov/privacy.
who have OSA. For instance, the Submitting Comments
Legal Basis for the Rulemaking
agencies request comment on the costs If you submit a comment, please
and benefits of requiring motor carrier include the docket number for this Federal Motor Carrier Safety
and rail transportation workers in safety ANPRM (FMCSA–2015–0419 and FRA– Administration
sensitive positions who exhibit multiple 2015–0111), indicate the heading of the FMCSA has authority under 49 U.S.C.
risk factors for OSA to undergo specific section of this document to 31136(a) and 31502(b)—delegated to the
evaluation and treatment by a which each comment applies, and Agency by 49 CFR 1.87(f) and (i),
healthcare professional with expertise provide a reason for each suggestion or respectively—to establish minimum
in sleep disorders. recommendation. You may submit your qualifications, including medical and
DATES: You must submit comments on comments and material online, by fax, physical qualifications, for commercial
or before June 8, 2016. mail, or hand delivery, but please use motor vehicle (CMV) drivers operating
ADDRESSES: You may submit comments only one of these means. The in interstate commerce. Section
identified by either of the docket Department recommends that you 31136(a)(3) requires that FMCSA’s
numbers listed at the beginning of this include your name and a mailing safety regulations ensure that the
notice using any one of the following address, an email address, or a phone physical conditions of CMV drivers
methods: number in the body of your document enable them to operate their vehicles
Federal Rulemaking Portal: so an Agency can contact you if it has safely, and that medical examiners
www.regulations.gov. questions regarding your submission. (MEs) trained in physical and medical
Fax: 202–493–2251. To submit your comment online, go to examination standards perform the
Mail: Docket Services (M–30), U.S. www.regulations.gov, type the docket physical examinations required of such
Department of Transportation, West number, ‘‘FMCSA–2015–0419’’ or operators.
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Building Ground Floor, Room W12–140, ‘‘FRA–2015–0111 in the ‘‘Keyword’’ In 2005, Congress authorized FMCSA
1200 New Jersey Avenue SE., box, and click ‘‘Search.’’ When the new to establish a Medical Review Board
Washington, DC 20590–0001. screen appears, click the ‘‘Comment (MRB) composed of experts ‘‘in a variety
Hand delivery: Same as mail address Now!’’ button and type your comment of medical specialties relevant to the
above, between 9 a.m. and 5 p.m., into the text box in the following screen. driver fitness requirements’’ to provide
Monday through Friday, except Federal Choose whether you are submitting your advice and recommendations on
holidays. The telephone number is 202– comment as an individual or on behalf qualification standards. 49 U.S.C.
366–9329. of a third party and then submit. If you 31149(a). The position of FMCSA Chief
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![Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Proposed Rules 12645
examination using the American performance) may be detrimental to safe During the deliberations of the
Academy of Sleep Medicine (AASM) driving. MCSAC and MRB, experts indicated
guidance provided in the Guide for There are many conditions that interfere that studies 16 show that a using a BMI
with oxygen exchange and may result in
Aviation Medical Examiners.15 incapacitation, including emphysema,
of 33 as a screening indicator for OSA
A pilot identified as being at risk for chronic asthma, carcinoma, tuberculosis, is the value at which false positives and
OSA will be issued a medical certificate, chronic bronchitis and sleep apnea. If the false negatives are minimized. A false
and shortly thereafter receive a letter MEs detect a respiratory dysfunction that in positive would require a driver who
from FAA’s Federal Air Surgeon any way is likely to interfere with the driver’s does not have moderate-to-severe OSA
requesting that an OSA evaluation be ability to safely control and drive a to undergo a sleep study unnecessarily,
completed within 90 days. The commercial motor vehicle, the driver must be while a false negative would fail to
referred to a specialist for further evaluation
evaluation may be done by any require a driver who actually has
and therapy. . . .
physician (including the AME), not just moderate-to-severe OSA to undergo a
a sleep medicine specialist. If the Based on the above advisory criterion, sleep study. The medical experts
evaluating physician determines, using it is clear that FMCSA considers OSA to participating in the meeting indicated
the AASM guidelines, that a laboratory be a respiratory dysfunction that that approximately 75 percent of
sleep study or home study is warranted, interferes with oxygen exchange. As moderate-to-severe OSA cases would be
it should be ordered at that time. The such, if a ME believes a driver’s correctly identified by requiring a sleep
pilot will have 90 days (or longer under respiratory condition is, in any way, study for drivers with a BMI of 33 or
special circumstances) to accomplish likely to interfere with the driver’s greater; however, approximately 25
this, as outlined in the Federal Air ability to safely control and drive a percent of drivers with moderate-to-
Surgeon’s letter. The pilot may continue commercial motor vehicle, the examiner severe OSA would be missed with this
flying during the evaluation period until may refer the driver to a specialist for cutoff. Because the likelihood of OSA in
they have been diagnosed with OSA. A further evaluation and therapy. This patients with BMIs of 35 or greater rises
pilot is not allowed to fly once advisory criterion is helpful to MEs to nearly 80 percent, the MCSAC and
diagnosed with OSA, but upon when the examiner has sufficient MRB agreed to use a BMI of 35 (rather
submitting documentation of effective experience or information to recognize than 33) in their interim advice to MEs
treatment to FAA, the FAA will then certain risk factors for OSA and when a screening drivers for referral to a
consider the pilot for a special issuance driver tells the examiner that he has specialist. A copy of the MCSAC and
medical certificate, which allow the been diagnosed with OSA. Under these MRB discussion notes is included in the
circumstances, MEs may consider docket referenced at the beginning of
pilot to resume flying. More information
referring the driver to a specialist for this notice.
on FAA guidance can be found at:
evaluation before issuing a ME’s
https://www.faa.gov/news/fact_sheets/ The chairs of the MRB and MCSAC
certificate, or request additional
news_story.cfm?newsId=18156. considered their December 13, 2011,
information from the driver and his
report as a first step towards
Federal Motor Carrier Safety treating healthcare professional about
recommendations for addressing OSA.
Administration the management of the driver’s OSA,
respectively. However, the current The two committees completed more
FMCSA’s October 5, 2000, Advisory detailed recommendations in February
Criteria guidance is not helpful if the ME does
not have sufficient experience or 2012 to support a future notice-and-
In 2000, FMCSA issued advisory information to suspect the driver may comment rulemaking. A copy of those
criteria providing interpretive guidance have OSA, or the driver does not share recommendations is included in the
to MEs concerning its physical with the examiner any previous docket referenced at the beginning of
qualifications standards. These advisory diagnosis that he has the condition. this notice.
criteria are recommendations from Before FMCSA issued a notice
MRB and MCSAC Recommendations requesting public comment on proposed
FMCSA to assist MEs in applying the
minimum physical qualification In consideration of the limitations of regulatory guidance, several stakeholder
standards. The advisory criteria were the current advisory criterion, FMCSA groups expressed concerns about the
published with the Federal Motor tasked its MRB and MCSAC in 2011 to agency addressing OSA through
Carrier Safety Regulations as part of the provide recommendations that FMCSA regulatory guidance, even on an interim
medical examination report form in 49 should consider to (1) develop new OSA basis. These groups requested that
CFR. 391.43 (Physical Qualification of standards for motor carriers, commercial FMCSA pursue the matter through a
Drivers; Medical Examination; vehicle drivers, and MEs and (2) notice-and-comment rulemaking
Certificate, 65 FR 59363 (October 5, determine whether drivers with this process.
2000)). respiratory condition should receive an In 2013, Congress enacted Public Law
The advisory criterion for section unrestricted two-year medical certificate 113–45 (127 Stat. 557, October 13, 2013,
391.41(b)(5), which has been unchanged to operate CMVs in interstate commerce. in a note to 49 U.S.C. 31305) directing
since 2000, provides the following The MCSAC also recommended interim FMCSA to issue any new or revised
guidance for MEs in making the actions that FMCSA could take to help requirements concerning sleep
determination whether a driver satisfies MEs address the issue before completing disorders, including OSA, by
the respiratory standard: a rulemaking. A copy of the task rulemaking. Such requirements would
statement, all presentations provided to
mstockstill on DSK4VPTVN1PROD with PROPOSALS
include those for sleep apnea screening,
[Because] a driver must be alert at all the MCSAC, MRB, and the Committees’
times, any change in his or her mental state
testing, and treatment of CMV drivers.
is in direct conflict with highway safety.
December 13, 2011, letter report to the
Even the slightest impairment in respiratory FMCSA Administrator are included in 16 Numerous studies were cited in presentations
function under emergency conditions (when the docket referenced at the beginning to the groups; links to two relevant presentations
greater oxygen supply is necessary for of this notice and also at the MCSAC are: (1) https://www.fmcsa.dot.gov/advisory-
committees/mcsac/addressing-obstructive-sleep-
Web page at https://www.fmcsa.dot.gov/ apnea-cmv-drivers, and (2) https://
15 https://www.faa.gov/about/office_org/ advisory-committees/mcsac/2012-past- www.fmcsa.dot.gov/advisory-committees/mcsac/
headquarters_offices/avs/offices/aam/ame/guide/. meetings. screening-osa-commercial-vehicle-operators.
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![Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Proposed Rules 12647
accidents caused by OSA? With respect split, etc.) of diagnosing OSA are State, local, or Tribal government or
to rail, how would any OSA regulations appropriate and why? communities.
and the current PTC requirements 14. What, if any, restrictions or (2) Create a serious inconsistency or
interrelate? prohibitions should there be on a otherwise interfere with an action taken
4. Which categories of transportation transportation workers’ safety sensitive or planned by another Agency.
workers with safety sensitive duties duties while they are being evaluated (3) Materially alter the budgetary
should be required to undergo screening for moderate-to-severe OSA? impact of entitlements, grants, user fees,
for OSA? On what basis did you identify 15. What methods are currently or loan programs or the rights and
those workers? employed for providing training or other obligations of recipients thereof.
informational materials about OSA to (4) Raise novel legal or policy issues
Cost & Benefits
transportation workers with safety arising out of legal mandates, the
5. What alternative forms and degrees sensitive duties? How effective are these President’s priorities, or the principles
of restriction could FMCSA and FRA methods at identifying workers with set forth in the E.O.
place on the performance of safety- OSA? The Department has determined this
sensitive duties by transportation ANPRM is a ‘‘significant regulatory
workers with moderate-to-severe OSA, Medical Personnel Qualifications & action’’ under E.O. 12866, and
and how effective would these Restrictions significant under DOT regulatory
restrictions be in improving 16. What qualifications or credentials policies and procedures due to
transportation safety? Should any are necessary for a medical practitioner significant public interest in the legal
regulations differentiate requirements who performs OSA screening? What and policy issues addressed. Therefore,
for patients with moderate, as opposed qualifications or credentials are this notice has been reviewed by OMB.
to severe, OSA? necessary for a medical practitioner who Issued under the authority of delegations
6. What are the potential costs of performs the diagnosis and treatment of in 49 CFR 1.87(f) and (i) and 49 CFR 1.89(a),
alternative FMCSA/FRA regulatory OSA? respectively:
actions that would restrict the safety 17. With respect to FRA should it use T.F. Scott Darling III,
sensitive activities of transportation Railroad MEs to perform OSA screening, Acting Administrator, Federal Motor Carrier
workers diagnosed with moderate-to- diagnosis, and treatment? Safety Administration.
severe OSA? Who would incur those 18. Should MEs or other Agencies’ Sarah Feinberg,
costs? What are the benefits of such designated medical practitioners impose
actions and who would realize them? Administrator, Federal Railroad
restrictions on a transportation worker Administration.
7. What are the potential improved with safety sensitive duties who self-
health outcomes for individuals [FR Doc. 2016–05396 Filed 3–9–16; 8:45 am]
reports experiencing excessive
occupying safety sensitive sleepiness while performing safety
BILLING CODE 4910–EX–P
transportation positions and would sensitive duties?
receive OSA treatment due to
regulations? Treatment Effectiveness DEPARTMENT OF TRANSPORTATION
8. What models or empirical evidence 19. What should be the acceptable National Highway Traffic Safety
is available to use to estimate potential criteria for evaluating the effectiveness Administration
costs and benefits of alternative of prescribed treatments for moderate-
restrictions? to-severe OSA? 49 CFR Part 571
9. What costs would be imposed on 20. What measures should be used to
transportation workers with safety evaluate whether transportation [Docket No. NHTSA–2016–0029]
sensitive duties by requiring screening, employees with safety sensitive duties RIN 2127–AL68
evaluation, and treatment of OSA? are receiving effective OSA treatment?
10. Are there any private or Federal Motor Vehicle Safety
governmental sources of financial Rulemaking Analyses and Notices Standards; Electric-Powered Vehicles:
assistance? Would health insurance Executive Order (E.O.) 12866 Electrolyte Spillage and Electrical
cover costs for screening and/or (Regulatory Planning and Review) and Shock Protection
treatment of OSA? DOT Regulatory Policies and
AGENCY: National Highway Traffic
Screening Procedures & Diagnostics Procedures
Safety Administration (NHTSA),
11. What medical guidelines other Under E.O. 12866, ‘‘Regulatory Department of Transportation (DOT).
than the AASM FAA currently uses are Planning and Review’’ (issued ACTION: Notice of proposed rulemaking
suitable for screening transportation September 30, 1993, published October (NPRM).
workers with safety sensitive duties that 4 at 58 FR 51735, and discussed above
are regulated by FMCSA/FRA for OSA? in the ‘‘Background’’ section), as SUMMARY: NHTSA is proposing to
What level of effectiveness are you supplemented by E.O. 13563 and DOT amend Federal Motor Vehicle Safety
seeing with these guidelines? policies and procedures, if a regulatory Standard (FMVSS) No. 305, ‘‘Electric-
12. What were the safety performance action is determined to be ‘‘significant,’’ powered vehicles: Electrolyte spillage
histories of transportation workers with it is subject to Office of Management and electrical shock protection,’’ to
safety sensitive duties who were and Budget (OMB) review. E.O. 12866 adopt various electrical safety
mstockstill on DSK4VPTVN1PROD with PROPOSALS
diagnosed with moderate-to-severe defines ‘‘significant regulatory action’’ requirements in Global Technical
OSA, who are now successfully as one likely to result in a rule that may: Regulation (GTR) No. 13, ‘‘Hydrogen
compliant with treatment before and (1) Have an annual effect on the and fuel cell vehicles.’’ To expand the
after their diagnosis? economy of $100 million or more or standard’s performance requirements
13. When and how frequently should adversely affect in a material way the beyond post-crash conditions, NHTSA
transportation workers with safety economy, a sector of the economy, proposes to adopt electrical safety
sensitive duties be screened for OSA? productivity, competition, jobs, the requirements to protect against direct
What methods (laboratory, at-home, environment, public health or safety, or and indirect contact of high voltage
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Document Created: 2018-02-02 15:11:55
Document Modified: 2018-02-02 15:11:55
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Advance notice of proposed rulemaking; request for public comments. | |
| Dates | You must submit comments on or before June 8, 2016. | |
| Contact | FMCSA: Ms. Christine Hydock, Chief of the Medical Programs Division, FMCSA, 1200 New Jersey Ave. SE., Washington DC 20590-0001, by telephone at 202-366-4001, or by email at [email protected] | |
| FR Citation | 81 FR 12642 | |
| RIN Number | 2126-AB88 and 2130-AC52 | |
| CFR Citation | 49
CFR
240 49 CFR 242 49 CFR 391 |
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