Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD), 5275-5276 [2020-01550]

Agencies

• Federal Motor Carrier Safety Administration
• DEPARTMENT OF TRANSPORTATION

[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, [email protected], 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 https://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