The former chief of the Medical Programs Division for the Federal Motor Carrier Safety Administration separates fact from fiction regarding the Advanced Notice of Proposed Rulemaking published in March 2016.
For years, the Federal Motor Carrier Safety Administration (FMCSA) has been researching obstructive sleep apnea (OSA) and its impact on driving a commercial motor vehicle (CMV). The agency searched the scientific literature for evidence, conducted expert panel meetings of sleep specialists, and developed and published reports. FMCSA’s two advisory committees—Medical Review Board (MRB) and the Motor Carrier Safety Advisory Committee (MCSAC)—reviewed the reports, listened to sleep specialists, industry representatives, and drivers, and developed recommendations for FMCSA’s rulemaking and guidance development.1
All of this has been very controversial. The agency’s actions and its positions have been widely misunderstood. Rumors abound.
At last, on March 10, 2016, FMCSA took action. FMCSA and the Federal Rail Administration (FRA) jointly published an Advanced Notice of Proposed Rulemaking (ANPRM) on OSA. Entitled “Evaluation of Safety Sensitive Personnel for Moderate-to-Severe Obstructive Sleep Apnea,” the ANPRM presents information about OSA and the steps each agency has taken to research the condition. The ANPRM asks the public to respond to 20 questions covering the prevalence of OSA, the cost of diagnostics and treatment, safety benefits, screening procedures and diagnostics, medical qualifications of providers, and how to measure treatment effectiveness. Once FMCSA/FRA gather and review the information, they will decide whether to develop a regulation on OSA.2
This ANPRM is spurring the spread of more misinformation. To quash the rumors, people need accurate information and clear explanations of FMCSA’s regulations and guidance on OSA. As the chief of the FMCSA’s Medical Programs Division during the 8 years when FMCSA was researching OSA and the MRB and MCSAC were making their recommendations to the agency, I am intimately familiar with the MRB/MCSAC recommendations on OSA, the Physical Qualifications regulations, and agency policies and procedures. FMCSA’s Medical Programs Division is responsible for all Physical Qualification regulations. As its chief, I oversaw the division’s research, guided the development of regulations and guidance documents, and oversaw its compliance assistance to the public. The Medical Programs Division staff answer over 2,000 phone calls and 2,000 e-mails each month. With many of the questions related to OSA, we developed a clear understanding of the myths and developed factual responses to debunk them. In addition, the Medical Programs staff was the liaison to the MRB. As Division Chief, I also oversaw the OSA research, the development of the National Registry of Certified Medical Examiners (MEs), the development of the ME certification test, and the development of many other programs. My 18 years’ experience in the federal government—15 of which was with OSHA and FMCSA—gave me in-depth knowledge of the Administrative Procedures Act and the operations of regulatory agencies. I bring this knowledge and experience to you to debunk the 8 most widely held misconceptions and give information on how to effectively participate in the rulemaking process.
Myth 1: The MRB recommendations are FMCSA requirements.
Fact: The MRB and the MCSAC are advisory committees with no power to write regulations or guidance. They make recommendations to the agency. They have made several recommendations, but FMCSA has not adopted them.
Myth 2: Currently, FMCSA requires CMV drivers with a neck circumference of 17 or above and/or a BMI of 35 or above to have a sleep study.
Fact: The neck circumference and BMI numbers are recommendations from MCSAC/MRB, but FMCSA has not taken action on their recommendations. The confusion on this point likely stems in part because the MRB/MCSAC recommendations are published on the FMCSA’s webpage to ensure transparency. But until and unless the FMCSA formally adopts the recommendations, which would be indicated by their publication in the Federal Register, they are NOT requirements or even “FMCSA guidance.”
Myth 3: Drivers diagnosed with OSA and using a CPAP must have a follow-up sleep study.
Fact: Follow-up sleep studies are included in the MRB/MCSAC recommendations but not in the FMCSA regulations or Advisory Criteria. As such, follow-up studies are not required by FMCSA.
Myth 4: Drivers must have a CPAP that provides usage recording.
Fact: FMCSA does not require any specific treatment or equipment in its regulations and Advisory Criteria. This may be a standard of practice in the medical community, but it isn’t an FMCSA requirement.
Myth 5: The agency’s ANPRM on OSA immediately requires CMV drivers to have sleep studies, if they exhibit risk factors for OSA.
Fact: An ANPRM is a very early exploration of rulemaking, not a final rule. The purpose of an ANPRM is to notify the public that the agency(ies) are considering a rulemaking and are requesting information to utilize in their deliberations. ANPRMs ask the public for more data and usually request responses to specific questions.
Myth 6: FMCSA arbitrarily establishes rules on OSA without listening to the public.
Fact: As all federal regulatory agencies, FMCSA is required to follow the Administrative Procedures Act. This act mandates that the agency publish its intentions in the Federal Register and give ample time for the public to comment on the proposed regulation. The agency must follow specific steps before issuing a regulation: 1) the ANPRM (optional); 2) a Notice of Proposed Rulemaking (NPRM) based on the information gathered from the optional ANPRM and other documents; and 3) the final rule based on the NPRM and its public comments.3 The whole process, from ANPRM to final rule, usually takes 4 to 6 years.
Through June 8, 2016, FMCSA is asking the public to participate to help write an evidence-based regulation (www.federalregister.gov/articles/2016/03/10/2016-05396/evaluation-of-safety-sensitive-personnel-for-moderate-to-severe-obstructive-sleep-apnea). Responding with statements of fact and research data is the most helpful to the agency’s deliberations. Merely professing like or dislike does not add value.
Responding with signed template letters written by an organization is not helpful to the agency either. The rulemaking process is not a popularity contest. It is a gathering of scientific and economic data to help the agency ensure it is addressing public safety needs without undue burden on the regulated community.
After the ANPRM, the next step for public participation will be the Notice of Proposed Rulemaking. The NPRM defines the actions the agency intends to take, includes the actual proposed provisions and the agency’s rationale for each, and asks for public comment. However, if the agencies decide not to proceed with the regulation, the next step could be a published notice of the agencies’ decision to withdraw the rulemaking.
It is important for people to participate in the ANPRM public comment. Otherwise, the agency lacks information for decision-making. When the NPRM is published, if no one comments, the agency must publish a final rule based on what the agency wrote in the NPRM. The provisions presented in the NPRM become the final rule unless the public comments on them or unless the agency resubmits a new NPRM that changes the proposed rule’s provisions.
Myth 7: FMCSA does not have any regulations or guidance on OSA.
Fact: FMCSA regulation 49 CFR 391.41(b)(5) states, “(b) A person is physically qualified to drive a commercial motor vehicle if that person . . . (5) Has no established medical history or clinical diagnosis of a respiratory dysfunction likely to interfere with his/her ability to control and drive a commercial motor vehicle safely.”4 As a respiratory dysfunction, OSA is covered by this rule. The rule, written very broadly, does not include criteria, diagnostic testing, or treatment regimen.
FMCSA guidance is its Advisory Criteria, published as part of the Medical Examination Report form in 2000. Remaining unchanged since that time, OSA is specifically mentioned,
“3.There are many conditions that interfere with oxygen exchange and may result in incapacitation, including emphysema, chronic asthma, [. . . ] sleep apnea. If the medical examiner detects 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.”5
The Advisory Criteria do not specify the type of evaluation studies or treatments.
Myth 8: Since FMCSA has no specific rule or guidance on OSA, medical examiners (MEs) may not require a sleep study, CPAP usage, or recording of the CPAP usage.
Fact: The agency does not list specific criteria for diagnosis and treatment of OSA. But FMCSA gives MEs authority to make determinations and decisions based on their medical knowledge, the results of the driver’s physical examination, and the current medical standards of practice. As mentioned above, the FMCSA’s Advisory Criteria direct the ME to refer the CMV driver to a specialist if a respiratory dysfunction is detected. FMCSA expects the ME to gather additional information to ensure that the driver can safely operate a CMV.
The ME must clearly understand and explain to the driver that the tests he/she is requiring are not FMCSA requirements. Since the driver’s livelihood is involved in the ME’s decision, the ME should make practical recommendations considering the driver’s financial situation and lost work time. If the driver can be effectively diagnosed and treated with less expensive modalities, those should be used.
In summary, FMCSA does not require specific diagnostic testing/treatment, but the agency permits the ME to use medical best practices to govern his/her decisions. This nuance is very confusing for drivers, MEs, and carriers.
Lack of specific requirements for OSA results in inconsistent qualification decisions. So, FRA and FMCSA are taking responsible steps to ensure they gather information to determine whether to develop a regulation or guidance. Whatever their decision, it should be based on the most recent data and information.
The best way for the FMCSA to make its decision is to publish an ANPRM (which it published March 10, 2016), ask questions, and obtain recent information from a wide range of people in the regulated community. The best way the public can participate is to obtain accurate information about rulemaking, refrain from spreading rumors, and submit substantive comments to the rulemaking processes.
Prior to founding her occupational and transportation health consulting company, Health and Safety Works, LLC, Elaine Papp, RN, MSN, COHN-S, CM, FAAOHN, worked for 18 years in the federal government for OSHA, SSA, and FMCSA. A board-certified master’s educated occupational health nurse with over 30 years of experience in private companies, international organizations, not-for-profit healthcare institutions, and government entities, Papp is recognized by the American Association of Occupational Health Nurses as a Fellow and has served on the American Board of Occupational Health Nurses, the profession’s credentialing body.
1. Federal Motor Carrier Safety Administration. February 6, 2012 MCSAC and MRB Task 11-05- Final Report on Obstructive Sleep Apnea (OSA). Federal Motor Carrier Safety Administration website. www.fmcsa.dot.gov/february-6-2012-mcsac-and-mrb-task-11-05-final-report-obstructive-sleep-apnea-osa. Published February 2012. Accessed March 8, 2016.
2. Evaluation of Safety Sensitive Personnel for Moderate-to-Severe Obstructive Sleep Apnea (Advanced Notice of Proposed Rulemaking; request for public comment). Federal Register 81:47 (March 10, 2016) 12642 available at: www.gpo.gov/fdsys/pkg/FR-2016-03-10/pdf/2016-05396.pdf. Accessed March 10, 2016.
3. US Department of Justice. Administrative Procedures Act. Public Law 404-79th Congress. US Department of Justice Website. www.justice.gov/sites/default/files/jmd/legacy/2014/05/01/act-pl79-404.pdf. Accessed March 8, 2016.
4. Physical Qualifications of Drivers. Code of Federal Regulation 49 CFR 391.41 Federal Motor Carrier Safety Administration website www.fmcsa.dot.gov/regulations/title49/section/391.41. Accessed March 8, 2016.
5. Physical Qualification of Drivers; Medical Examination; Certificate of Physical Examination. Advisory Criteria. Code of Federal Regulations 49 CFR 391.43 Federal Motor Carrier Safety Administration website. www.fmcsa.dot.gov/regulations/title49/section/391.43. Accessed March 19, 2016.