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

Larry W. Minor
Federal Motor Carrier Safety Administration
1 October 2019

[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Notices]
[Pages 52159-52160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21282]


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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2019-0104]


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

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

ACTION: Notice of denials.

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SUMMARY: FMCSA announces its decision to deny applications from three 
individuals treated with Implantable Cardioverter Defibrillators (ICDs) 
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, 
Department of Transportation, 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 Docket 
Operations, (202) 366-9826.

SUPPLEMENTARY INFORMATION: 

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice 
as being available in the docket, go to http://www.regulations.gov/docket?D=FMCSA-2019-0104 and choose the document to review. If you do 
not have access to the internet, you may view the docket online by 
visiting the Docket Management Facility in Room W12-140 on the ground 
floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, 
DC 20590, between 9 a.m. and 5 p.m., ET, Monday through Friday, except 
Federal holidays.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the 
public to better inform its rulemaking process.

[[Page 52160]]

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.dot.gov/privacy.

II. Background

    On May 22, 2019, FMCSA published a FR notice (84 FR 23632) 
announcing receipt of applications from three individuals treated with 
ICDs and requested comments from the public. These three individuals 
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 June 21, 
2019, and no comments were received.
    FMCSA has evaluated the eligibility of these applicants and 
concluded that granting these exemptions 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 each applicant's medical history related to their ICD 
exemption request was discussed in the May 22, 2019, Federal Register 
notice and will not be repeated here.
    The Agency's decision regarding these exemption applications 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 reports are available on the internet at https://rosap.ntl.bts.gov/view/dot/16462; https://rosap.ntl.bts.gov/view/dot/21199.
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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. Implantable cardioverter defibrillators 
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 no comments in this proceeding.

IV. 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 these exemption applications is 
based on an individualized assessment of each 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.

V. 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 achieve a level of 
safety equivalent to, or greater than, the level of safety maintained 
without the exemption. Therefore, the following three applicants have 
been denied exemptions from the physical qualification standards in 
Sec.  391.41(b)(4):

Martin Carter (ME)
Vincent Collelo (WI)
Richard D. Siske (OH)

    Each applicant has, prior to this notice, received a letter of 
final disposition regarding his/her exemption request. Those decision 
letters fully outlined the basis for the denial and constitute final 
action by the Agency. The list published today summarizes the Agency's 
recent denials as required under 49 U.S.C. 31315(b)(4).

    Issued on: September 25, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-21282 Filed 9-30-19; 8:45 am]
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