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Withdrawal of Advanced Notice of Proposed Rulemaking (ANPRM) on Obstructive Sleep Apnea (OSA) Does Not Mean Examiners and Employers Should Ignore Safety Risks

Sullivan, Shannon S. MD; Gurubhagavatula, Indira MD, MPH

Journal of Occupational and Environmental Medicine: August 2018 - Volume 60 - Issue 8 - p e431
doi: 10.1097/JOM.0000000000001375
LETTERS TO THE EDITOR
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Department of Psychiatry and Behavioral Sciences, Stanford University, Division of Sleep Medicine, Stanford, California

Division of Sleep Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.

Address correspondence to: Shannon S. Sullivan, MD, Department of Psychiatry and Behavioral Sciences, Stanford University Stanford University, Stanford Sleep Disorders Clinic, 450 Broadway, MC 5704, Stanford, CA 94063 (shannon.s.sullivan@stanford.edu).

The authors report no conflicts of interest.

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To the Editor:

We read with great interest Dr. Hartenbaum's detailed account1 of “the slings and arrows of outrageous fortune”2 in the 25-year regulatory journey of proposed rulemaking regarding evaluation of safety-sensitive transportation personnel for moderate-to-severe obstructive sleep apnea (OSA). The journey has been circuitous indeed.

We concur that the August 2017 decision by the Federal Motor Carrier Safety Administration (FMCSA) and Federal Railroad Administration (FRA) to withdraw their March 2016 Advance Notice of Proposed Rulemaking (ANPRM) on Obstructive Sleep Apnea among Commercial Motor Vehicle Drivers and Rail Workers has led to “confusion for examiners and employers.” Because of the withdrawal, examiners and employers do not have specific rules on which to rely when evaluating commercial vehicle operators, yielding an evaluation process vulnerable to inconsistency. We also agree that this withdrawal in no way invalidates the potentially catastrophic public safety risks and costs of untreated OSA among commercial operators. The agencies openly acknowledged these risk in the notice of withdrawal.3 As a timely reminder of these risks, the National Transportation Safety Board (NTSB) indicated that the probable cause of both the September 29, 2016, New Jersey Transit crash in Hoboken, New Jersey, and the January 4, 2017, Long Island Rail Road crash was engineer fatigue due to undiagnosed, severe OSA, resulting in tragic loss of life as well as extensive property damage.4

As Dr. Hartenbaum points out, the medical examiner evaluating commercial operators is left to rely upon a variety of prior consensus statements and sources, rather than specific rules or guidance. The American Academy of Sleep Medicine (ASSM), as in prior regulatory efforts, has been a vocal participant in this discussion, providing evidence-based, specific responses to each of the 20 queries sought by FMCSA and FRA in the March 2016 ANPRM while also participating in the agencies’ multiple listening sessions in May 2016. The AASM's recommendations for clear, concise, evidence-based risk assessment were subsequently published with the intent of providing a key tool for those evaluating operators.5

In reality, although examiners are expected to “exercise their medical judgment and expertise”6 in determining potential safety risks related to OSA, identification and treatment of affected individuals may be hampered by conflicting guidance which, problematically, may rely upon operators’ self-report of symptoms; general underappreciation of the evidence of risks for OSA; unfamiliarity with up-to-date clinical recommendations for diagnostic testing for OSA7; and a lack of information on costs of testing, evidence supporting improvements in performance, and guidance on restrictions and/or conditional certification. As the recent rail crashes again demonstrate, the risks of untreated sleep disorders are not theoretical,8 but an ongoing threat affecting many lives. Eliminating preventable sleep disorder-related accidents in attainable ways should be a goal that motivates and unites us all.

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REFERENCES

1. Hartenbaum N. Withdrawal of advanced notice of proposed rulemaking (ANPRM) on obstructive sleep apnea (OSA) does not mean examiners and employers should ignore safety risks. J Occup Environ Med 2017; 59:e374–e376.
2. Shakespeare W. The Tragedy of Hamlet Prince of Denmark. Mowat BA, Werstine P, eds. Folger Shakespeare Library. Act III. Scene I. Line 66.
3. Federal Motor Carrier Safety Administration, Federal Railroad Administration. Evaluation of safety sensitive personnel for moderate-to-severe obstructive sleep apnea. Federal Register. August 8, 2017; 82 FR 37038-37039. Available at: https://www.federalregister.gov/documents/2017/08/08/2017-16451/evaluation-of-safety-sensitive-personnel-for-moderate-to-severe-obstructive-sleep-apnea. Accessed March 20, 2018.
4. National Transportation Safety Board. End-of-track collisions at terminal stations, Hoboken, New Jersey, September 29, 2016 and Atlantic Terminal, Brooklyn, New York, January 4, 2017. February 6, 2018. Available at: https://www.ntsb.gov/investigations/AccidentReports/Pages/SIR1801.aspx. Accessed March 20, 2018.
5. Gurubhagavatula I, Sullivan S, Meoli A, et al. Management of obstructive sleep apnea in commercial motor vehicle operators: recommendations of the AASM Sleep and Transportation Safety Awareness Task Force. J Clin Sleep Med 2017; 13:745–758.
6. Federal Motor Carrier Safety Administration. FMCSA bulletin to medical examiners and training organizations regarding obstructive sleep apnea. 2015. Available at: https://nationalregistry.fmcsa.dot.gov/NRPublicUI/documents/OSA; or: http://www.thesleepandrespiratoryscholar.com/fmcsa-issues-advisory-on-sleep-apnea/. Accessed May 31, 2018.
7. Kapur VK, Auckley DH, Chowdhuri S, et al. Clinical practice guideline for diagnostic testing for adult obstructive sleep apnea: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med 2017; 13:479–504.
8. McKay MP. Fatal consequences: obstructive sleep apnea in a train engineer. Ann Fam Med 2015; 13:583–586.
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