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

Larry W. Minor
Federal Motor Carrier Safety Administration
1 December 2020

[Federal Register Volume 85, Number 231 (Tuesday, December 1, 2020)]
[Notices]
[Pages 77335-77336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26408]


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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2020-0189]


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 two 
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 Dockets 
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-2020-0087 and choose the document to review. If you do 
not have access to the internet, you may view the docket online by 
visiting the Dockets Operations 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. 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.dot.gov/privacy.

II. Background

    On October 8, 2020, FMCSA published a Federal Register notice (85 
FR 21061) announcing receipt of applications from two individuals 
treated with ICDs and requested comments from the public. These five 
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 November 
9, 2020, and two comments were received.
    FMCSA has evaluated the eligibility of these applicants and 
concluded that granting these two exemption requests 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 October 8, 2020, 
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

[[Page 77336]]

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 Medical 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 Medical 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 two comments in this proceeding. One commenter was 
favorable towards Mr. Ronquillo continuing to drive a CMV with an ICD. 
The second commenter responded that FMCSA should deny granting ICD 
exemptions due to issues associated with public safety.
    In response to the comments, FMCSA believes that a driver with an 
ICD is at risk for incapacitation if the device discharges. This risk 
is combined with the risks associated with the underlying 
cardiovascular condition for which the ICD was implanted either as a 
primary or secondary preventive measure.

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 statute also allows the Agency to renew exemptions at 
the end of the 5-year period. FMCSA grants medical exemptions from the 
FMCSRs for a 2-year period to align with the maximum duration of a 
driver's medical certification.
    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 discussed earlier 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 two applicants have 
been denied exemptions from the physical qualification standards in 
Sec.  391.41(b)(4):

Thomas O. Adams, Jr, (VA); Louis Ronquillo, (CA)

    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).

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2020-26408 Filed 11-30-20; 8:45 am]
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