Document ID: FMCSA-2021-0159-0004
Agency: fmcsa
Document Type: Notice
Title: Qualification of Drivers; Exemption Applications: Implantable Cardioverter Defibrillator
Posted Date: 2022-03-23T04:00Z

[Federal Register Volume 87, Number 56 (Wednesday, March 23, 2022)]
[Notices]
[Pages 16546-16547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06120]

[[Page 16546]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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, [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-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 www.regulations.gov, as described in the system of records 
notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

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.
---------------------------------------------------------------------------

    \1\ The report is available on the internet at https://rosap.ntl.bts.gov/view/dot/16462.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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

[[Page 16547]]

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