Notice2022-14225
Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 5, 2022
Issuing agencies
Transportation DepartmentFederal Motor Carrier Safety Administration
Abstract
FMCSA announces its decision to deny the applications from two individuals 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.
Full Text
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<title>Federal Register, Volume 87 Issue 127 (Tuesday, July 5, 2022)</title>
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[Federal Register Volume 87, Number 127 (Tuesday, July 5, 2022)]
[Notices]
[Pages 39891-39892]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-14225]
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DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
[Docket No. FMCSA-2022-0026]
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 two
individuals 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
[[Page 39892]]
Programs Division, (202) 366-4001, <a href="/cdn-cgi/l/email-protection#6a0c0709190b070f0e03090b062a0e051e440d051c"><span class="__cf_email__" data-cfemail="71171c1202101c14151812101d31151e055f161e07">[email protected]</span></a>, 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 <a href="http://www.regulations.gov">www.regulations.gov</a>. Insert the docket
number, FMCSA-2022-0026, 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.
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 <a href="http://www.regulations.gov">www.regulations.gov</a>, as described in the system of records
notice (DOT/ALL-14 FDMS), which can be reviewed at <a href="http://www.dot.gov/privacy">www.dot.gov/privacy</a>.
Background
On February 17, 2022, FMCSA published a Federal Register notice (87
FR 9101) announcing receipt of applications from two 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 March 21,
2021, and 13 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 February 17, 2022, 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 <a href="https://rosap.ntl.bts.gov/view/dot/16462">https://rosap.ntl.bts.gov/view/dot/16462</a>.
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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 <a href="https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf">https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf</a>.
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II. Discussion of Comments
FMCSA received 13 comments in this proceeding. All comments
received were from private citizens and employers in support of Kelly
Lemus and focused on her experience and skill as a CMV driver, her
stable health, and that her ICD has not deployed. No adverse comments
were received in this proceeding.
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 individuals
with ICDs and CMV driving does not support that individuals with ICDs
who operate CMVs are able to meet an equal or greater level of safety.
III. 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 applicants have been
denied an exemption from the physical qualification standards in Sec.
391.41(b)(4):
Michael Bianculli (MA); Kelly Lemus (WA)
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 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. 2022-14225 Filed 7-1-22; 8:45 am]
BILLING CODE 4910-EX-P
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