Document ID: FMCSA-2021-0085-0011
Agency: fmcsa
Document Type: Notice
Title: Qualification of Drivers; Exemption Applications: Implantable Cardioverter Defibrillator
Posted Date: 2022-04-01T04:00Z

[Federal Register Volume 87, Number 63 (Friday, April 1, 2022)]
[Notices]
[Pages 19174-19176]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06863]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2021-0085]

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

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

ACTION: Notice of denials.

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SUMMARY: FMCSA announces its decision to deny the applications from 
three individuals treated with an 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, [email protected], FMCSA, 
DOT, 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 Comments

    To view comments go to www.regulations.gov. Insert the docket 
number, FMCSA-2021-0085, in the keyword box, and click ``Search.'' 
Next, sort the results by ``Posted (Newer-Older),'' choose the first 
notice listed, and click ``Browse Comments.'' If you do not have access 
to the internet, you may view the docket online by visiting Dockets 
Operations in Room W12-140 on the ground floor of the DOT West 
Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, 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.

[[Page 19175]]

B. Privacy Act

    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments 
from the public on the exemption request. 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 July 28, 2021, FMCSA published a Federal Register notice (86 FR 
40677) announcing receipt of applications from three individuals 
treated with ICDs and requested comments from the public. The 
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 August 
27, 2021, and eight comments were received.
    FMCSA has evaluated the eligibility of the applicants and concluded 
that granting an exemption 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 July 28, 2021, 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.
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    \1\ The report is available on the internet at https://rosap.ntl.bts.gov/view/dot/16462.
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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. ICDs 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 eight comments in this proceeding. Each of the eight 
comments supported Mr. Willard Drysdale's request for an ICD exemption. 
Mr. Drysdale's cardiologist stated that the chance of Mr. Drysdale 
experiencing an appropriate ICD discharge in the next 5 years is 
approximately 2 to 3 percent. Mr. Drysdale's cardiac rehabilitation 
program attested to his excellent progress with his rehabilitation and 
maintenance program and noted that he was asymptomatic during his 
rehabilitation. The Minnesota Department of Public Safety commented 
that it has no objection to Mr. Drysdale's exemption request. Four 
private citizens familiar with Mr. Drysdale, attested to his years of 
successful CMV driving experience, his good physical condition, and 
that his ICD has not discharged since it was implanted. One of the four 
private citizens also commented on each key question in the April 2007 
and December 2014 ICD Evidence Reports regarding how they relate to Mr. 
Drysdale's circumstances and his ICD exemption request. Regarding the 
April 2007 report, the commenter's opinion was that for two of the most 
relevant studies, one was done in Canada where ICDs are not addressed, 
and that the other study did not find evidence supporting the 
contention that CMV drivers are at an increased risk for a crash in a 
motor vehicle. The commenter further opined that the study was very 
limited and therefore the commenter believed a more comprehensive and 
current study should be implemented. The commenter noted with respect 
to the key questions in the December 2014 report, that Mr. Drysdale's 
ICD had never discharged and offered that Mr. Drysdale would be willing 
to participate in a group study involving ICDs if granted an exemption. 
The applicant, Mr. Drysdale also commented and questioned why he is not 
permitted to cross state lines and go more than 150 miles with a CMV 
yet is permitted to drive across the State of Minnesota to deliver 
exempt agricultural commodities.
    FMCSA evaluates each ICD exemption application received to 
determine whether an equivalent or greater level of safety can be 
achieved by the applicant. FMCSA acknowledges that the existing 
evidence is not conclusive concerning the impact of ICD treatment on 
the safe operation of CMVs and that more studies are needed prior to 
permitting individuals with ICDs to operate CMVs in interstate 
commerce. Regarding Mr. Drysdale's comments, the provisions referenced 
are handled under two separate sections in the FMCSRs. Specifically, 
transportation of agricultural commodities is handled under Sec.  
390.39 and does not require the driver to have a physical qualification 
examination, meet the physical qualification standards in Sec.  
391.41(b)(1) through (13), and receive a Medical Examiner's 
Certificate, Form MCSA-5876.

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 the applicants' 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 an exemption from the physical qualification standards in 
Sec.  391.41(b)(4):

[[Page 19176]]

Willard Drysdale (MN)
William Edwards (NY)
Francisco Garcia (NJ)

    The applicants have, prior to this notice, received a letter of 
final disposition regarding their exemption request. The decision 
letter fully outlined the basis for the denial and constitute final 
action by the Agency. The names of these individuals published in this 
notice 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. 2022-06863 Filed 3-31-22; 8:45 am]
BILLING CODE 4910-EX-P