# Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD)
**AGENCY:**
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
**ACTION:**
Notice of final disposition.
**SUMMARY:**
FMCSA announces its decision to deny the applications of two individuals treated with an Implantable Cardioverter Defibrillator (ICD) who requested an exemption from the Federal Motor Carrier Safety Regulations (FMCSRs) prohibiting operation of a commercial motor vehicle (CMV) in interstate commerce by persons with a current clinical diagnosis of myocardial infarction, angina pectoris, coronary insufficiency, thrombosis, or any other cardiovascular disease of a variety known to be accompanied by syncope (transient loss of consciousness), dyspnea (shortness of breath), collapse, or congestive heart failure.
**FOR FURTHER INFORMATION CONTACT:**
Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-0001, (202) 366-4001, *[email protected].* Office hours are from 8:30 a.m. to 5 p.m. ET Monday through Friday, except Federal holidays. If you have questions regarding viewing materials in the docket, contact Dockets Operations, (202) 366-9826.
**SUPPLEMENTARY INFORMATION:**
**I. Public Participation**
**A. Viewing Comments**
To view comments go to *www.regulations.gov.* Insert the docket number (FMCSA-2024-0004) in the keyword box and click “Search.” Next, sort the results by “Posted (Newer-Older),” choose the first notice listed, and click “Browse Comments.” If you do not have access to the internet, you may view the docket online by visiting Dockets Operations on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m. ET Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366-9317 or (202) 366-9826 before visiting Dockets Operations.
**B. Privacy Act**
In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments from the public on the exemption requests. DOT posts these comments, including any personal information the commenter provides, to *www.regulations.gov,* as described in the system of records notice DOT/ALL-14 FDMS (Federal Docket Management System), which can be reviewed at *https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices.* The comments are posted without edit and are searchable by the name of the submitter.
**II. Legal Basis**
FMCSA has authority under 49 U.S.C. 31136(e) and 31315(b) to grant exemptions from Federal Motor Carrier Safety Regulations (FMCSRs). FMCSA must publish a notice of each exemption request in the *Federal Register* (49 CFR 381.315(a)). The Agency must provide the public an opportunity to inspect the information relevant to the application, including the applicant's safety analysis. The Agency must provide an opportunity for public comment on the request.
The Agency reviews the application, safety analyses, and public comments submitted and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved absent such exemption, pursuant to the standard set forth in 49 U.S.C. 31315(b)(1). The Agency must publish its decision in the *Federal Register* (49 CFR 381.315(b)). If granted, the notice will identify the regulatory provision from which the applicant will be exempt the effective period, and all terms and conditions of the exemption (49 CFR 381.315(c)(1)). If the exemption is denied, the notice will explain the reason for the denial (49 CFR 381.315(c)(2)). The exemption may be renewed (49 CFR 381.300(b)). FMCSA grants medical exemptions from the FMCSRs for a 2-year period to align with the maximum duration of a driver's medical certification.
**III. Background**
The physical qualification standard for drivers regarding cardiovascular diseases and loss of consciousness provides that a person is physically qualified to drive a CMV if that person has “no current clinical diagnosis of myocardial infarction, angina pectoris, coronary insufficiency, thrombosis, or any other cardiovascular disease of a variety known to be accompanied by syncope, dyspnea, collapse, or congestive cardiac failure” (49 CFR 391.41(b)(4)). To assist in applying this standard, FMCSA publishes guidance for medical examiners (ME) in the form of medical advisory criteria in appendix A to 49 CFR part 391. [^1] The advisory criteria for § 391.41(b)(4) indicates that ICDs are installed to address an ongoing underlying cardiovascular condition and that syncope or collapse is likely to occur as a result of both the underlying cardiovascular condition as well as when the ICDs discharge. Therefore, ICDs are medically disqualifying. In April 2007, FMCSA published an evidence report titled, “Cardiovascular Disease and Commercial Motor Vehicle Driver Safety,” presenting findings regarding cardiovascular disease and CMV driver safety. [^2] In December 2014, FMCSA published a research report titled, “Implantable Cardioverter Defibrillators and the Impact of a Shock in a Patient When Deployed,” that provided evidence regarding the potential impact of ICD deployment and how it may interfere with the safe operation of a CMV. [^3]
[^1] 49 CFR part 391, app.A.II.C, available at *https://www.ecfr.gov/current/title-49/subtitle-B/chapter-III/subchapter-B/part-391/appendix-Appendix%20A%20to%20Part%20391.*
[^2] “Evidence Report: Cardiovascular Disease” (Apr. 27, 2007), available at *https://doi.org/10.21949/1502991.*
[^3] “Implantable Cardio Defibrillators and the Impact of a Shock to the Patient when Deployed Research White Paper” (Dec. 17, 2014), available at *https://www.fmcsa.dot.gov/sites/fmcsa.dot.gov/files/2021-06/Cardio%20Defibrillators%20White%20Paper_Final_508C.pdf.*
The Agency considers the medical advisory criteria, the April 2007 evidence report, the December 2014 research report, the application, and each individual's medical information in deciding whether to grant the exemption.
On January 15, 2025, FMCSA published a notice announcing receipt of applications from two individuals requesting an exemption from 49 CFR 391.41(b)(4) and requested comments from the public (90 FR 3997). The public comment period ended on February 14, 2025, and no comments were received.
**IV. Discussion of Comments**
FMCSA received no comments in this proceeding.
**V. Basis for Exemption Determination**
The Agency's decision regarding these exemption applications is based on an individualized assessment of the applicants' medical information, available medical and scientific data concerning ICDs, and any relevant public comments received.
In the case of persons with ICDs, the underlying condition for which the ICD was implanted places the individual at high risk for syncope or other unpredictable events known to result in gradual or sudden incapacitation. ICDs may discharge, which could result in loss of ability to safely control a CMV. The December 2014 focused research report referenced previously upholds the findings of the April 2007 report and indicates that the available scientific data on persons with ICDs and CMV driving does not support the conclusion that persons with ICDs are able to meet an equivalent or greater level of safety in operating a CMV as persons without those devices.
**VI. Conclusion**
The Agency has determined that the available medical and scientific literature and research provides insufficient data to enable the Agency to conclude that granting these exemptions would likely achieve a level of safety equivalent to, or greater than, the level of safety maintained without the exemption. Therefore, the following applicants have been denied an exemption from the physical qualification standards in § 391.41(b)(4):
Micos Mims (AL) and Paul Siefker (OH).
The applicants have, prior to this notice, received a letter of final disposition regarding their exemption request. The decision letter fully outlined the basis for the denial and constitutes final action by the Agency. The names of these individuals published today summarizes the Agency's recent denials as required under 49 U.S.C. 31315(b)(4).
Larry W. Minor,
Associate Administrator for Policy.