Overview of Public Comments on the Diabetes Standard
Overview of Public Comments on the Qualification of Drivers; Diabetes Standard
Notice of Proposed Rulemaking
On May 4, 2015, the Federal Motor Carrier Safety Administration (FMCSA) published the Qualifications of Drivers; Diabetes Standard notice of proposed rulemaking (NPRM) (80 FR 25260). In this notice, FMCSA proposes to permit drivers with stable, well-controlled insulin-treated diabetes mellitus (ITDM) to be qualified to operate commercial motor vehicles (CMVs) in interstate commerce. Currently, drivers with ITDM are prohibited from driving CMVs in interstate commerce unless they obtain an exemption from FMCSA.
Between May 4, 2015 and July 16, 2015, 1,247 submissions were posted to docket number FMCSA-2005-23151. Based on a review of those submissions, 112 submissions were identified as non-germane, and two submissions were duplicates. Of the remaining 1,133 submissions, 1,075 submissions expressed general support for the proposed rule. Of the generally supportive submissions, 551 were identified as form letters. Eleven submissions expressed general opposition to the proposal, 46 submissions addressed substantive issues and 1 submission recommended editorial changes. Of the 46 submissions addressing substantive issues, 34 submissions were identified as containing medically-significant information. The following are examples of some issues raised by public commenters based on a preliminary review of the comments:
- The exemption process is overly burdensome and ought to change, but the proposed requirements in the NPRM do not adequately protect public safety.
- FMCSA should revise the proposal to maintain some of the provisions of the Diabetes Exemption Program (e.g., driver must carry rapidly absorbable glucose, test glucose at certain intervals, undergo hypoglycemic awareness training, etc.)
- The proposal addresses severe hypoglycemic events, and does not address moderate hypoglycemic events, which also pose a serious concern.
- Epidemiological studies show that diabetic drivers have about a 20% increased risk of crash, with some estimates substantially higher. Those taking insulin have an even higher risk of crash. These studies refute the Agency’s statements indicating drivers with ITDM are as safe as other drivers when their condition is well-controlled.
- FMCSA has not provided adequate justification that CMV drivers with ITDM do not pose an unreasonable risk to public safety.
- The proposal relies on the treating clinician (TC) to ensure that the driver with ITDM can safely operate a CMV, but many primary care providers and specialists have no knowledge of the safety sensitive tasks and hazards of commercial driving.
- FMCSA should further define the term Treating Clinician to reduce ambiguity and ensure the person making the recommendation is properly certified and knowledgeable about ITDM.
- FMCSA should require the TC to provide the medical examiner (ME) with specific supporting documentation of properly managed diabetes.
- The proposal does not provide specific criteria for certification of ITDM drivers and would essentially delegate the decision about medical certification of these CMV drivers to their treating clinician, who is likely not well trained regarding the operational environment and additional public safety risks associated with commercial driving.
- The NPRM requires only that the TC determine that a driver has had no “severe hypoglycemic episodes” and that the diabetes is “properly managed,” rather than providing clinical information to demonstrate that the driver meets specified criteria.
- The Medical Examiner Handbook was not available for review during the comment period. It is important that stakeholders have an opportunity to comment on any provisions pertaining to insulin-treated diabetes.
- FMCSA should maintain the restriction on drivers with ITDM from being medically qualified to operate CMVs carrying passengers and hazardous materials. A driver suffering an ITDM-related medical event while operating a motorcoach filled with passengers or a tractor-trailer carrying hazardous materials poses a significant risk to the public.
- The over-the-road bus operations environment may not be conducive to maintaining proper blood-glucose levels sufficient to avoid a crash and may not be in the best interest of the driver’s health.
- Some MEs disagree with the assumption that people with ITDM have every incentive to manage their condition so that the disease is stable and well-controlled.
- FMCSA should require drivers with ITDM to be evaluated by an ophthalmologist or optometrist annually. The proposal to eliminate the requirement for an annual ophthalmological examination will increase the likelihood of ITDM CMV drivers with significant diabetic retinopathy and degraded visual performance that will pose a hazard to public safety.