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Regulation vs. Guidance

There is a great deal of confusion about what constitutes regulation, or law, and what is guidance. This distinction can be critical: medical examiners are required to follow regulation, while medical examiners are encouraged, but not required, to follow guidance recommendations.

First, the consequences. If a medical examiners fails to follow a regulation, there is inherent liability risk should adverse consequences ensue.  If an insulin dependent driver has an accident due to an episode of hypoglycemia, the medical examiner that certified the driver without requiring a waiver or exemption will be liable. The other risk is regulatory: if an FMCSA audit reveals that a medical examiner failed to follow regulation, it is likely that the medical examiner will be removed from the National Registry.

So what is regulation?  Regulations, or laws, are those requirements that are published in the Federal Register, or the federal code of regulations. These include the examination requirements detailed by the Federal Motor Carrier Safety Administration (FMCSA), including the definition of commercial motor vehicle drivers, the requirements for training and certification of medical examiners, the minimum contents of the driver examination, and specific guidance for certain medical conditions.

The touchstone for regulatory medical conditions has traditionally been the magic triumvirate: insulin-dependent diabetes, monocular vision, and epilepsy. Drivers with these conditions should not be certified except by waiver or exemption. Less clear is whether other conditions referenced in the FMCSA examination description in 49 CFR 391.41 and 391.43 are indeed regulatory, such as minimum hearing requirements, Skill Performance Evaluation (SPE) certificate requirements, and methadone use.

Rather than trying to discern the distinction between regulations and guidance, the medical examiner is probably best served by treating most questions and issues as regulatory – requiring drivers to strictly comply with diagnosis-related requirements.   Erring to the side of strict compliance will likely best serve public  safety – the ultimate reason for these regulations in the first place - and protect the examiner, and motor carrier, from liability risk.

Steven St. Clair, MD, MPH
Dr. St. Clair is a medical consultant to the NRCME Training Institute, LLC. The NRCME Training Institute, LLC provides an affordable 100% online DOT medical examiner training program which meets and exceeds FMCSA requirements.



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