Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD)

Larry W. Minor
Federal Motor Carrier Safety Administration
23 July 2021

[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39099-39100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15739]


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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2021-0036]


Qualification of Drivers; Exemption Applications; Implantable 
Cardioverter Defibrillator (ICD)

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department 
of Transportation (DOT).

ACTION: Notice of denial.

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SUMMARY: FMCSA announces its decision to deny the application from 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, (202) 366-4001, fmcsamedical@dot.gov, FMCSA, 
DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-
0001. 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-2021-0036, 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 in Room W12-140 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 5 U.S.C. 553(c), DOT solicits comments from the 
public to better inform its rulemaking process. DOT posts these 
comments, without edit, including any personal information the 
commenter provides, to www.regulations.gov, as described in the system 
of records notice (DOT/ALL-14 FDMS), which can be reviewed at 
www.transportation.gov/privacy.

II. Background

    On February 9, 2021, FMCSA published a Federal Register notice (86 
FR 8830) announcing receipt of an application from one individual 
treated with an ICD and requested comments from the public. The 
individual requested an exemption from 49 CFR 391.41(b)(4) which 
prohibits operation of a 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, dyspnea, collapse, or 
congestive heart failure. The public comment period closed on March 11, 
2021, and one comment was received.
    FMCSA has evaluated the eligibility of the applicant and concluded 
that granting an exemption would not provide a level of safety that 
would be equivalent to, or greater than, the level of safety that would 
be obtained by complying with Sec.  391.41(b)(4). A summary of the 
applicant's medical history related to the ICD exemption request was 
discussed in the February 9, 2021, Federal Register notice and will not 
be repeated here.
    The Agency's decision regarding this exemption application is based 
on information from the Cardiovascular Medical Advisory Criteria, an 
April 2007 evidence report titled ``Cardiovascular Disease and 
Commercial Motor Vehicle Driver Safety,'' \1\ and a December 2014 
focused research report titled ``Implantable Cardioverter 
Defibrillators and the Impact of a Shock in a Patient When Deployed.'' 
Copies of these reports are included in the docket.
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    \1\ The report is available on the internet at https://rosap.ntl.bts.gov/view/dot/16462.
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    FMCSA has published advisory criteria to assist medical examiners 
in determining whether drivers with certain medical conditions are 
qualified to operate a CMV in interstate commerce.\2\ The advisory 
criteria for Sec.  391.41(b)(4) indicates that coronary artery bypass 
surgery and pacemaker implantation are remedial procedures and thus, 
not medically disqualifying. ICDs are disqualifying due to risk of 
syncope.
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    \2\ These criteria may be found in 49 CFR part 391, APPENDIX A 
TO PART 391--MEDICAL ADVISORY CRITERIA, section D. Cardiovascular: 
Sec.  391.41(b)(4), paragraph 4, which is available on the internet 
at https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
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III. Discussion of Comments

    FMCSA received one comment in this proceeding. The comment was from 
a private citizen who did not support granting the exemption. The 
individual disagreed that granting an exemption for an ICD would ensure 
the safety of the driver and local pedestrians.
    FMCSA evaluates each ICD application received to determine whether 
an equivalent or greater level of safety can be achieved by the 
applicant. While FMCSA has received and carefully evaluated many ICD 
exemption application requests, thus far the Agency has been unable to 
conclude that granting an exemption to any of the applicants would 
achieve a level of safety equivalent to, or greater than, the level of 
safety maintained without an exemption.

Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption 
from the FMCSRs for no longer than a 5-year period if it finds such 
exemption would likely achieve a level of safety that is equivalent to, 
or greater than, the level that would be achieved absent such 
exemption.
    The Agency's decision regarding this exemption application is based 
on an

[[Page 39100]]

individualized assessment of the applicant's 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 that persons with ICDs who 
operate CMVs are able to meet an equal or greater level of safety.

IV. 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 this exemption would achieve a level of 
safety equivalent to, or greater than, the level of safety maintained 
without the exemption. Therefore, the following applicant has been 
denied an exemption from the physical qualification standards in Sec.  
391.41(b)(4):

Matthew Wackt (WI)

    The applicant has, 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 constitute final action by the 
Agency. The name of the individual 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.
[FR Doc. 2021-15739 Filed 7-22-21; 8:45 am]
BILLING CODE 4910-EX-P