Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD) |
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Larry W. Minor
Federal Motor Carrier Safety Administration
29 January 2020
[Federal Register Volume 85, Number 19 (Wednesday, January 29, 2020)]
[Notices]
[Pages 5275-5276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01550]
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DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
[Docket No. FMCSA-2019-0167]
Qualification of Drivers; Exemption Applications; Implantable
Cardioverter Defibrillator (ICD)
AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.
ACTION: Notice of denials.
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SUMMARY: FMCSA announces its decision to deny applications from four
individuals treated with Implantable Cardioverter Defibrillators (ICDs)
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-2019-0167 and choose the document to review. If you do
not have access to the internet, you may view the docket online by
visiting Docket Operations in Room W12-140 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.
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.transportation.dot.gov/privacy.
II. Background
On October 1, 2019 FMCSA published a Federal Register notice (84 FR
52163) announcing receipt of applications from four individuals treated
with ICDs and requesting comments from the public. These four
individuals requested an exemption from 49 CFR 391.41(b)(4) that
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 October
31, 2019 and three comments were received.
FMCSA has evaluated the eligibility of these applicants and
concluded that granting these exemptions 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 October 1, 2019, Federal
Register notice and will not be repeated here.
The Agency's decision regarding these exemption applications 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 further supported in
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 April 2007 Evidence 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
[[Page 5276]]
implantation are remedial procedures and thus, not medically
disqualifying. Implantable cardioverter defibrillators 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 three comments in this proceeding. Of the three
comments received, two were duplicate comments from an anonymous
commenter. The anonymous commenter supports all three individuals being
granted an exemption based on the documentation that they have
provided, that they have improved cardiac statuses, and that their ICDs
have never deployed. The commenter states that individuals with
epilepsy and diabetes are able to get approved for exemptions despite
their condition and treatment. This commenter states that the Agency
should do more research and make exemption decisions on a case-by-case
basis. Mr. Christopher Oakland, an applicant, commented in support of
FMCSA granting exemptions for 1 year to individuals who provide medical
documentation from a qualified healthcare provider, that the individual
is stable, the individual has no documented symptoms of syncope,
dyspnea, collapse or congestive heart failure as stated in the
cardiovascular standard, and the ICD has not administered therapy. Mr.
Oakland commented that he submitted a total of three letters and that
two of the three letters are from two different electrocardiologists.
He further commented that the Federal Register notice posted that he
submitted only two letters.
In response to the first commenter, FMCSA reviews and considers
each request received for an ICD exemption individually to determine
whether the applicant is able to meet a level of safety equivalent to,
or greater than, the level achieved without an exemption. While the
individuals' underlying cardiac conditions may demonstrate levels of
improvement, their medical treatment plans also rely on the ICD device.
The device, though it may not have deployed since implantation, may
unpredictably deploy at a future date to deliver therapy. Based on the
available medical and scientific data concerning ICDs, FMCSA finds that
the applicants have an ongoing risk for incapacitation if the device
discharges in response to cardiovascular symptoms. This risk for
incapacitation does not meet an equal or greater level of safety that
would be achieved absent an exemption. Concerning the comments on the
need for additional research, FMCSA has processes and procedures in
place to consider new research and existing research so that the
Agency's determinations are evidence-based.
Mr. Oakland contacted the Agency prior to the close of the comment
period to confirm that he submitted a total of three letters, one from
his cardiologist, and letters from two separate electrophysiologists.
Mr. Oakland was informed that the statement in the Federal Register
regarding the submission of two letters was an oversight, and confirmed
that the content of each of the electrophysiologists' letters was
considered prior to the date that the Federal Register notice was
published.
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 each applicant's medical
information, available medical and scientific data concerning ICDs, and
the public comments received.
ICDs are electronic devices that treat cardiac arrest, ventricular
fibrillation, and ventricular tachycardia, through the delivery of
rapid pacing stimuli or shock therapy. ICDs treat but do not prevent
arrhythmias. Therefore, the individual remains at risk for syncope or
loss of consciousness. The underlying conditions for which the ICD was
implanted therefore places these individuals at high risk for syncope
or other unpredictable events know to result in gradual or sudden
incapacitation. In addition, 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. FMCSA's individual assessment of the exemption applications
and the public comments does not provide any basis for departing from
its general views on the risks posed by individual with an underlying
cardiovascular condition that requires the implantation of an ICD to
control.
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, even when
considered with the individual assessment of each application, 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 four
applicants have been denied exemptions from the physical qualification
standards in Sec. 391.41(b)(4):
Christopher Cloud (GA)
Joby Doucet (LA)
Robert D. Forbes (NY)
Christopher Oakland (RI)
Each applicant has, prior to this notice, received a letter of
final disposition regarding his/her exemption request. Those decision
letters fully outlined the basis for the denial and constitute final
action by the Agency. The list published today summarizes the Agency's
recent denials as required under 49 U.S.C. 31315(b)(4).
Issued on: January 23, 2020.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2020-01550 Filed 1-28-20; 8:45 am]
BILLING CODE 4910-EX-P