Notice2022-06120
Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD)
Primary source
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Published
March 23, 2022
Issuing agencies
Transportation DepartmentFederal Motor Carrier Safety Administration
Abstract
FMCSA announces its decision to deny the applications from five 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.
Full Text
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<title>Federal Register, Volume 87 Issue 56 (Wednesday, March 23, 2022)</title>
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[Federal Register Volume 87, Number 56 (Wednesday, March 23, 2022)]
[Notices]
[Pages 16546-16547]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-06120]
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DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
[Docket No. FMCSA-2021-0159]
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
five 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, <a href="/cdn-cgi/l/email-protection#deb8b3bdadbfb3bbbab7bdbfb29ebab1aaf0b9b1a8"><span class="__cf_email__" data-cfemail="0462696777656961606d67656844606b702a636b72">[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-2021-0159, 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>.
II. Background
On November 12, 2021, FMCSA published a Federal Register notice (86
FR 62868) announcing receipt of applications from five 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 December
13, 2021, and one comment was 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 November 12, 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 <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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III. Discussion of Comments
FMCSA received one comment in this proceeding. The commenter
supported granting exemptions to the applicants stipulating a 6-month
cardiology review and a 6-month medical certification period as safety
assurances.
FMCSA acknowledges that while a more frequent cardiology review and
physical qualification period may be feasible for some of the
applicants, others may find a more frequent medical review period
burdensome and costly. In addition, there continues to be a risk for
arrhythmias, and inherent complications such as inappropriate
discharges, and ICD malfunction which could pose a risk to the
individual and the public while driving a CMV.
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
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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):
Rosie A. Byrd (TX)
Thomas Jacobs (NY)
Lee Latin (NC)
Wayne Pimpare (ME)
Bradley Plunket (IL)
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. 2022-06120 Filed 3-22-22; 8:45 am]
BILLING CODE 4910-EX-P
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