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

Larry W. Minor
Federal Motor Carrier Safety Administration
7 April 2020

[Federal Register Volume 85, Number 67 (Tuesday, April 7, 2020)]
[Notices]
[Pages 19567-19568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07283]



[[Page 19567]]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2019-0230]


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 five 
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-2019-0230 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. 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 November 5, 2019, FMCSA published a Federal Register notice (84 
FR 59672) announcing receipt of applications from six individuals 
treated with ICDs and requested comments from the public. These six 
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 December 
5, 2019, and six comments were received.
    FMCSA has evaluated the eligibility of these applicants and 
concluded that granting five of these six 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). One individual's application was withdrawn. A summary of 
each applicant's medical history related to their ICD exemption request 
was discussed in the November 5, 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 six comments in this proceeding. Five of the six 
comments were favorable towards the applicants continuing to drive 
CMV's with ICD's. The sixth comment was submitted by Mr. Corey 
Tugwell's cardiologist. His cardiologist's comments supported the 
withdrawal of Mr. Tugwell's exemption application.
    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 has been implanted as a 
primary or secondary preventive measure. Mr. Tugwell's application was 
withdrawn because an exemption is unnecessary. Mr. Tugwell was notified 
that he must still complete a medical certification examination by a 
certified medical examiner on the National Registry of Certified 
Medical Examiners to determine whether his underlying cardiovascular 
condition is stable, and if he meets the cardiovascular physical 
qualification standards (49 CFR 391.41(b)(4)) to receive a medical 
examiner's certificate.

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 discussed earlier upholds the findings of the April 2007 report 
and

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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 five applicants have 
been denied exemptions from the physical qualification standards in 
Sec.  391.41(b)(4):

Charles Huff (OH)
Brian J. Hullopeter (MN)
John Gittenmeier (MO)
Gaetano Letizia (NJ)
Thomas D. Worsley (VA)

    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. 2020-07283 Filed 4-6-20; 8:45 am]
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