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

Larry W. Minor
Federal Motor Carrier Safety Administration
10 September 2020

[Federal Register Volume 85, Number 176 (Thursday, September 10, 2020)]
[Notices]
[Pages 55927-55928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19952]


-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2020-0124]


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

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

ACTION: Notice of denial.

-----------------------------------------------------------------------

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, 
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-2020-0124 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 Operations in Room W12-

[[Page 55928]]

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 
Docket 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 May 19, 2020, FMCSA published a Federal Register notice (85 FR 
3006) announcing receipt of an application from one individual treated 
with an ICD and requested comments from the public. This 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 June 18, 
2020, and one comment was received.
    FMCSA has evaluated the eligibility of the applicant and concluded 
that granting the exemption request 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 his ICD exemption request 
was discussed in the May 19, 2020, 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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

III. Discussion of Comments

    FMCSA received one comment which was out of scope for 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 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 tan 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):

Kenneth Randolph (FL)

    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 constitutes final action by the 
Agency. The notice 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. 2020-19952 Filed 9-9-20; 8:45 am]
BILLING CODE 4910-EX-P