[Federal Register Volume 87, Number 127 (Tuesday, July 5, 2022)]
[Notices]
[Pages 39892-39894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14226]


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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2022-0083]


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

[[Page 39893]]

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, [email protected], 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-2022-0083, 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 www.regulations.gov, as described in the system of records 
notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.
Background
    On April 27, 2022, FMCSA published a Federal Register notice (87 FR 
25079) 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 May 27, 
2022, 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 April 27, 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 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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II. Discussion of Comments

    FMCSA received 109 comments in this proceeding. All of the comments 
were from private citizens. The majority of the comments were in 
support of Mr. Abiud Ortuno. The remaining comments were not attributed 
to a specific applicant. All of the comments were supportive of 
granting ICD exemptions to the applicants. No adverse comments were 
received in this proceeding. Several commenters felt that FMCSA should 
rely on the authority of a cardiologist's clearance to receive an ICD 
exemption to drive a CMV. In one commenter's opinion, CMV operators and 
other people in general without ICDs suffer cardiac arrest in greater 
numbers than those with ICDs, and whether younger or older, one cannot 
predict when this could happen. The commenter believes that texting and 
other medical conditions were more of a risk to safety while driving a 
CMV than the possibility of having a cardiac arrest and encouraged 
FMCSA to grant the exemptions due to the shortage of CMV drivers. 
Another commenter stated that FMCSA should revise its regulations in 
accordance with current medical standards and with 49 U.S.C. 31136(e) 
and 31315. One commenter referred to two research studies, one from the 
American College of Cardiology that supported statistically low 
fatality rates from road accidents among individuals with ICDs than 
fatality rates of the general population, and a second study of a 
subgroup analysis of the AVID trial, in which the annual incidence of 
accidents in the ICD population was estimated to be 3.4 percent per 
year, significantly lower than the 7.1 percent per year accident rate 
in the general driving population in the USA.''
    Regarding the comment concerning medical clearance by a 
cardiologist to grant ICD exemptions, while FMCSA does not rely solely 
on a cardiologist's medical clearance or opinion to determine whether 
to grant an ICD exemption, FMCSA does consider the cardiologist's 
medical documentation and opinions received as a part of the 
applicant's exemption request in evaluating whether to grant an 
exemption. In response to the comments that other safety risks are 
greater than the risk of ICD deployment due to a cardiac arrest, and 
that FMCSA should update our standards and revise them in accordance 
with 49 U.S.C. 31136(e) and 31315, FMCSA is concerned about all safety 
risks concerning CMVs. FMCSA engages in research, and partners with the 
Agency's Medical Review Board, medical experts, and our stakeholders to 
provide evidence-based rulemaking and guidance with the ultimate goal 
of keeping our roadways safe. FMCSA's exemption process is consistent 
with the current requirements of 49 U.S.C. 31136(e) and 31315 as 
further discussed in the Basis for Exemption Determination section that 
follows in the next section. In response to the

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comment regarding the two research studies, the studies do not appear 
to have a clear relevance to ICDs and CMV-related crashes. The 
commenter did not include specific citations for the study information 
that was referenced. The Antiarrhythmics Versus Implantable 
Defibrillators study appears to evaluate the efficacy of cardiac 
medication treatment over treatment with an ICD rather than ICD crash 
risk.

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):

Timothy Broome (SC); Bryce A. Norman (CA); Abiud J. Ortuno (FL)

    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. 2022-14226 Filed 7-1-22; 8:45 am]
BILLING CODE 4910-EX-P


