Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD), 2291-2292 [2018-00560]

Agencies

• Federal Motor Carrier Safety Administration
• DEPARTMENT OF TRANSPORTATION

[Federal Register Volume 83, Number 10 (Tuesday, January 16, 2018)]
[Notices]
[Pages 2291-2292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00560]


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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2017-0116]


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, dyspnea, collapse, or 
congestive heart failure.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief, 
Medical Programs Division, (202) 366-4001, [email protected], 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 or submitting material to the docket, 
contact Docket Services, telephone (202) 366-9826.

SUPPLEMENTARY INFORMATION: 

I. Electronic Access

    You may see all the comments online through the Federal Document 
Management System (FDMS) at: https://www.regulations.gov.
    Docket: For access to the docket to read background documents or 
comments, go to https://www.regulations.gov and/or Room W12-140 on the 
ground level of the West Building, 1200 New Jersey Avenue SE, 
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday, 
except Federal holidays.
    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 https://www.regulations.gov, as described in 
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed 
at https://www.dot.gov/privacy.

II. Background

    On May 4, 2017, FMCSA published a FR notice (82 FR 20961) 
announcing receipt of applications from two individuals treated with 
ICDs and requested comments from the public. These two 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 5, 
2017, and two 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 the regulation 49 CFR 
391.41(b)(4). A summary of each applicant's medical history related to 
their ICD exemption request was discussed in the May 4, 2017, Federal 
Register notice and will not be repeated in this notice.
    In reaching the decision to deny these exemption requests, the 
Agency considered information from the Cardiovascular Medical Advisory 
Criteria, the April 2007 Evidence Report ``Cardiovascular Disease and 
Commercial Motor Vehicle Driver Safety, a December 2014 focused 
research report ``Implantable Cardioverter Defibrillators and the 
Impact of a Shock in a Patient When Deployed.'' Copies of the reports 
are included in the docket.
    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. [Appendix A to Part 
391--Medical Advisory Criteria, section D, paragraph 4.] The advisory 
criteria for 49 CFR 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.

III. Discussion of Comments

    FMCSA received two comments in this proceeding. Each of the 
comments was favorable towards the applicants continuing to drive CMV's 
with ICD's citing their ICDs have not deployed and their medical and 
physical conditions are stable. FMCSA acknowledges the commenters' 
responses concerning stable medical histories with ICDs. Based on the 
available medical literature cited above, however, 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

[[Page 2292]]

ICD has been implanted as a primary or secondary preventive measure.

IV. Basis for Exemption Determination

    Under 49 U.S.C.31136(e) and 31315, FMCSA may grant an exemption if 
it finds such an exemption would likely achieve a level of safety that 
is equivalent to, or greater then, the level that would be achieved 
absent such an exemption.
    The Agency's decision regarding these exemption applications is 
based on an individualized assessment of each applicant's medical 
information provided by the applicant, available medical and scientific 
data concerning ICDs, and 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 (a transient loss of consciousness) 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. See the April 2007 Evidence Report on Cardiovascular Disease and 
Commercial Motor vehicle Driver Safety, April 2007.\1\ A focused 
research report on Implantable Cardioverter Defibrillators and the 
Impact of a Shock on a Patient When Deployed completed for the FMCSA 
December 2014 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 and 
upholds the findings of the April 2007 report.
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    \1\ Now available at https://ntl.bts.gov/lib/30000/30100/30123/Final_CVD_Evidence_Report_v2.pdf.
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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 49 
CFR 391.41(b)(4):

Justin D. Dale (IA)
Raymond M. Loffredo (PA)

    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 constitutes 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: January 5, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-00560 Filed 1-12-18; 8:45 am]
 BILLING CODE 4910-EX-P