# Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD)
**AGENCY:**
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
**ACTION:**
Notice of denial.
**SUMMARY:**
FMCSA announces its decision to deny the application of one individual 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, 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 or submitting material to 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-2025-0038) in the keyword box and click “Search.” Next, choose the only 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 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 under the “Department Wide System of Records Notices” link 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 the 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 the 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)).
**III. Background**
The physical qualification standard for drivers regarding cardiovascular diseases and loss of consciousness provides that for a person to be physically qualified to drive a CMV, he or she must have “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 49 CFR 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 Cardio Defibrillators and the Impact of a Shock to the 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 considered the medical advisory criteria, the April 2007 evidence report, the December 2014 research report, the application, and the applicant's medical information in deciding whether to grant the exemption.
On July 24, 2025, FMCSA published a notice announcing receipt of an application from Charles Pereira requesting an exemption from 49 CFR 391.41(b)(4) and requested comments from the public (90 FR 34967). The public comment period ended on August 25, 2025.
**IV. Discussion of Comments**
FMCSA received 43 comments in this proceeding. All commenters were in support of Charles Pereira receiving an exemption from 49 CFR 391.41(b)(4).
**V. Basis for Exemption Determination**
The Agency conducted an individualized assessment of the applicant's medical information, available medical and scientific data concerning ICDs, and all 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. Furthermore, while FMCSA received 43 comments in support of this exemption, none of the comments provided medical evidence to 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**
FMCSA has determined that the available medical and scientific literature and research provides insufficient data to enable the Agency to conclude that granting this exemption would likely achieve a level of safety equivalent to, or greater than, the level of safety maintained without the exemption. Therefore, Charles Pereira (CA) has been denied an exemption from the physical qualification standards in 49 CFR 391.41(b)(4).
Mr. Pereira, prior to this notice, received a letter of final disposition regarding his exemption request. The decision letter fully outlined the basis for the denial and constitutes final action by the Agency. This notice summarizes the Agency's recent denial as required under 49 U.S.C. 31315(b)(6)(C) by publishing the reason for this denial.
Larry W. Minor,
Associate Administrator for Policy.