Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD)
| Published date | 07 April 2020 |
| Citation | 85 FR 19567 |
| Record Number | 2020-07283 |
| Section | Notices |
| Court | Federal Motor Carrier Safety Administration,Transportation Department |
Federal Register, Volume 85 Issue 67 (Tuesday, April 7, 2020)
[Federal Register Volume 85, Number 67 (Tuesday, April 7, 2020)]
[Notices]
[Pages 19567-19568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07283]
[[Page 19567]]
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DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
[Docket No. FMCSA-2019-0230]
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 five
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 http://www.regulations.gov/docket?D=FMCSA-2019-0230 and choose the document to review. If you do
not have access to the internet, you may view the docket online by
visiting the Docket Management Facility 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.dot.gov/privacy.
II. Background
On November 5, 2019, FMCSA published a Federal Register notice (84
FR 59672) announcing receipt of applications from six individuals
treated with ICDs and requested comments from the public. These six
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
5, 2019, and six comments were received.
FMCSA has evaluated the eligibility of these applicants and
concluded that granting five of these six exemption requests 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). One individual's application was withdrawn. A summary of
each applicant's medical history related to their ICD exemption request
was discussed in the November 5, 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 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 reports are available on the internet at https://rosap.ntl.bts.gov/view/dot/16462; https://rosap.ntl.bts.gov/view/dot/21199.
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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. 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 six comments in this proceeding. Five of the six
comments were favorable towards the applicants continuing to drive
CMV's with ICD's. The sixth comment was submitted by Mr. Corey
Tugwell's cardiologist. His cardiologist's comments supported the
withdrawal of Mr. Tugwell's exemption application.
In response to the comments, FMCSA believes that a driver with an
ICD is at risk for incapacitation if the device discharges. This risk
is combined with the risks associated with the underlying
cardiovascular condition for which the ICD has been implanted as a
primary or secondary preventive measure. Mr. Tugwell's application was
withdrawn because an exemption is unnecessary. Mr. Tugwell was notified
that he must still complete a medical certification examination by a
certified medical examiner on the National Registry of Certified
Medical Examiners to determine whether his underlying cardiovascular
condition is stable, and if he meets the cardiovascular physical
qualification standards (49 CFR 391.41(b)(4)) to receive a medical
examiner's certificate.
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
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 discussed earlier upholds the findings of the April 2007 report
and
[[Page 19568]]
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 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 five applicants have
been denied exemptions from the physical qualification standards in
Sec. 391.41(b)(4):
Charles Huff (OH)
Brian J. Hullopeter (MN)
John Gittenmeier (MO)
Gaetano Letizia (NJ)
Thomas D. Worsley (VA)
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).
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2020-07283 Filed 4-6-20; 8:45 am]
BILLING CODE 4910-EX-P
