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Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD) Publication: Federal Register Agency: Federal Motor Carrier Safety Administration Byline: Larry W. Minor Date: 1 April 2022 Subjects: American Government  , Driver Licensing
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[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, fmcsamedical@dot.gov, 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