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Federal Diabetes Exemption Program

Federal Motor Carrier Safety Regulation (FMCSR)

49 CFR 381.300 What is an exemption?

"(a) An exemption is temporary regulatory relief from one or more FMCSR given to a person or class of persons subject to the regulations, or who intend to engage in an activity that would make them subject to the regulations.

(b) An exemption provides the person or class of persons with relief from the regulations for up to two years, and may be renewed.

(c) Exemptions may only be granted from one or more of the requirements contained in the following parts and sections of the FMCSRs ...

(c)(3) Part 391 — Qualifications of Drivers."

About the Federal Diabetes Exemption Program

Background

Prior to the implementation of the Federal Diabetes Exemption Program, the Federal Motor Carrier Safety Administration (FMCSA) conducted a waiver study program concerning commercial motor vehicle (CMV) operation by drivers with insulin-controlled diabetes. A small number of the drivers who participated in the study and were participants in good standing on March 31, 1996, were provided a letter from FMCSA that grandfathered them an exemption from standard 49 CFR 391.41(b)(3), by operation of 49 CFR 391.64(a), as long as they were in compliance with the requirements. These drivers are governed by 49 CFR 391.64(a) and must provide the letter from FMCSA as proof of their grandfathered status before you issue a Medical Examiner's Certificate to the driver.

On September 3, 2003, FMCSA published a Notice of Final Disposition announcing the decision to issue exemptions to the diabetes mellitus prohibition under 49 CFR 391.41(b)(3). This program allows some drivers who meet all medical standards and guidelines, other than the use of insulin, to be medically certified and operate a CMV if the driver also meets the parameters for issuance of a Federal diabetes exemption.

The 2003 Notice explained that in considering exemptions, FMCSA must ensure that the issuance of diabetes exemptions will not be contrary to the public interest, and that the exemption achieves an acceptable level of safety.

Responsibilities

As a medical examiner, you are responsible for determining if the driver is otherwise medically fit for duty and issuing a Medical Examiner's Certificate that indicates the driver is certified ONLY IF the driver has a diabetes exemption.

The Federal Diabetes Exemption Program is responsible for determining if the driver meets program requirements and for issuing the diabetes exemption.

The motor carrier is responsible for ensuring that the driver has a current medical examiner's certificate and diabetes exemption before allowing the driver to operate a commercial vehicle.

The driver is responsible for carrying both the Medical Examiner's Certificate and the diabetes exemption while driving and keeping both certificates current. The Federal diabetes exemption must be renewed every 2 years. The driver must also comply with program requirements that include:

  • Annual:
    • CMV driver medical qualification examination.
    • Endocrinologist evaluation.
    • Ophthalmologist/optometrist evaluation.
    • Diabetes mellitus education.
  • Monitoring blood glucose.

NOTE: Although you, as a medical examiner, are not involved in the Diabetes Exemption Program monitoring, it is helpful for you to understand the requirements. The driver must provide a quarterly evaluation checklist from his/her endocrinologist throughout the 2-year period or risk losing the exemption.

The Safe, Accountable, Flexible, Efficient Transportation Equity Act — A Legacy for Users (SAFETEA-LU), August 10, 2005, eliminated the driving experience requirement.

For more information, review the Diabetes Exemption Application (PDF). Please direct questions concerning Driver Exemption Programs to medicalexemptions@dot.gov or call 703-448-3094.

Relevance to Driving

The Center for Disease Control and Prevention (CDC) 2007 National Diabetes Fact Sheet reports that in adults, type 1 diabetes accounts for 5–10% of all diagnosed cases of diabetes. Individuals with type 1 diabetes mellitus:

  • Are distinguished by a virtual lack of insulin production and often severely compromised counter-regulatory mechanisms.
  • Must have insulin replacement therapy.
  • May lack blood glucose control counter-regulatory mechanisms.

Although hypoglycemia can occur in non-insulin-treated diabetes mellitus, it is most often associated with insulin-treated diabetes mellitus. Mild hypoglycemia causes rapid heart rate, sweating, weakness, and hunger, while severe hypoglycemia causes headache and dizziness. FMCSA defines a severe hypoglycemic reaction as one that results in:

  • Seizure.
  • Loss of consciousness.
  • Need of assistance from another person.
  • Period of impaired cognitive function that occurs without warning.

Health History and Physical Examination

General Purpose of Health History and Physical Examination

The general purpose of the history and physical examination is to detect the presence of physical, mental, or organic conditions of such character and extent as to affect the driver ability to operate a CMV safely. This examination is for public safety determination and is considered by FMCSA to be a “medical fitness for duty" examination.

As a medical examiner, your fundamental obligation during the assessment of a driver with diabetes mellitus who uses insulin is to establish whether the driver meets all medical standards and guidelines in accordance with 49 CFR 391.41(b)(1-13), other than the use of insulin to treat diabetes.

The examination is based on information provided by the driver (minimum 5-year history), objective data (physical examination), and additional testing requested by the medical examiner. Your assessment should reflect physical, psychological, and environmental factors.

Medical certification depends on a comprehensive medical assessment of overall health and informed medical judgment about the impact of single or multiple conditions on the whole person.

Key Points for Examination When the Driver Has Diabetes Mellitus and Uses Insulin

This physical examination starts the Federal Diabetes Exemption Program application process. The medical examiner evaluation guidelines stipulate that the medical examiner review the 5-year medical history of the driver. The driver must provide a 5-year medical history for your review before you determine certification status.

The FMCSA Medical Examination Report form includes health history questions and physical examination checklists. Additional questions should be asked to supplement information requested on the form. You should ask about and document diabetes mellitus symptoms, blood glucose monitoring, insulin treatment, and history of hypoglycemic episodes.

It is your responsibility to determine if the driver meets all medical standards and guidelines, other than diabetes, in accordance with 49 CFR 391.41(b)(1-13). Any other medical problems or conditions that prevent a driver being certified by the medical examiner must be corrected BEFORE the driver submits an application to the Federal Diabetes Exemption Program.

  Regulations — You must review and discuss with the driver any "yes" answers

Does the driver have diabetes mellitus or elevated blood glucose controlled by:

  • Diet?
  • Pills?
  • Insulin?
    • Dosage?
    • Route?
    • Frequency?

Recommendations — Questions that you may ask include:

Does the driver:

  • Newly started on insulin have documentation of completion of minimum waiting period?
  • With a valid Federal diabetes exemption have documentation of compliance with program requirements for specialist evaluation?
  • Routinely monitor blood glucose level and have device record for review?
  • Use over-the-counter medications and/or supplements?
  • Use an incretin mimetic?
  • Have a history of fainting, dizziness, or loss of consciousness?
  • Have a history of hypoglycemic reactions that resulted in:
    • Seizure?
    • Loss of consciousness?
    • Need of assistance from another person?
    • Period of impaired cognitive function that occurred without warning?
  • Carry rescue glucose while driving?

NOTE: When the driver has a positive history for severe hypoglycemic reactions, ask about occurrences, including if the driver had:

  • One or more occurrences within last 12 months?
  • Two or more occurrences within last 5 years?

  Regulations — You must evaluate

On examination, does the driver have:

State-issued Medical Waivers and Exemptions

It is important that as a medical examiner you distinguish between intrastate waivers/exemptions and Federal diabetes exemptions for insulin-treated diabetes mellitus.

Record

  Regulations — You must document discussion with the driver about:

  • Any affirmative history, including if available:
    • Onset date, diagnosis.
    • Medication(s), dose, and frequency.
    • Any current limitation(s).
  • Potential negative effects of medication use, including over-the-counter medications, while driving.
  • Any abnormal finding(s), noting:
    • Effect on driver ability to operate a CMV safely.
    • Advice to take the necessary steps to correct the condition as soon as possible particularly if the condition, if neglected, could result in more serious illness that might affect driving.
  • Any additional medical tests and evaluation.

When documenting the certification of the driver with diabetes mellitus who uses insulin, ensure that the Medical Examination Report form periodic monitoring interval and the Medical Examiner's Certificate expiration date agree and do not exceed 1 year. When the driver has or must obtain a Federal diabetes exemption:

  • Mark the "accompanied by a ______________" exemption checkbox.
  • Write "Federal diabetes" on the line.
  • Circle "exemption."

In the case of the driver who has documentation of having been a participant in good standing in the Federal diabetes study on March 31, 1996, mark the "Qualified by operation of 49 CFR 391.64" checkbox.

NOTE: Proof of grandfathered status is the original letter from 1996 granting the right to continue to drive as long as the driver can meet physical qualification requirements. If a letter is not provided, you may verify driver participation in the study program—and the driver can obtain a new copy of the letter—by calling the FMCSA Exemption Program Office at 703-448-3094.

Remember

The diabetes qualification standard parameter is use of insulin, not the diagnosis of diabetes mellitus.

Diabetes Mellitus — Guidance/Advisory Criteria

The following links to insulin therapy guidance/advisory criteria key points:

Federal Diabetes Exemption Program Topic

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