[Federal Register Volume 81, Number 89 (Monday, May 9, 2016)]
[Notices]
[Pages 28119-28120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10875]
[[Page 28119]]
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DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
[Docket No. FMCSA-2015-0371]
Qualification of Drivers; Exemption Applications; Implantable
Cardioverter Defibrillators
AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.
ACTION: Notice of denials of exemption applications.
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SUMMARY: FMCSA announces its decision to deny applications from 7
individuals seeking exemptions from the Federal cardiovascular standard
applicable to interstate truck and bus drivers and discusses the
reasons for the denials. The Agency reviewed the medical information of
each the individuals who applied for an implantable cardioverter
defibrillator (ICD) exemption. Based on a review of the applications
and following an opportunity for public comment, FMCSA has concluded
that the 7 individuals in the notice did not demonstrate they could
achieve a level of safety that is equivalent to, or greater than, the
level of safety that would be obtained by complying with the
regulation.
DATES: Denial letters were sent to each of the individuals listed in
this notice on March 1, 2016.
FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief Medical
Programs Division, 202-366-4001, U.S. Department of Transportation,
FMCSA, 1200 New Jersey Avenue SE., Room W64-224, Washington, DC 20590-
0001. Office hours are from 8:30 a.m. to 5 p.m. Monday through Friday,
except Federal holidays.
SUPPLEMENTARY INFORMATION:
Background
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal Motor Carrier Safety Regulations for up to five years
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.'' FMCSA can renew exemptions for up to an
additional five years at the end of each five-year period.\1\
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\1\ 49 U.S.C. 31315(b), as amended by section 5206(a) of the
FAST Act, Pub. L. 114-94, div. A, title V, 129 Stat. 1537 (Dec. 4,
2015).
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On November 27, 2015, FMCSA published for public notice and
comment, FMCSA 2015-0371, listing 7 individuals seeking exemptions for
ICDs. Accordingly, the Agency has evaluated each applicant's request to
determine whether granting an exemption will achieve the required level
of safety mandated by statute.
Evaluation Criteria--Cardiovascular Medical Standard and Advisory
Criteria
The individuals included in this notice have requested an exemption
from the provisions of 49 CFR 391.41(b)(4), which applies to drivers
who operate CMVs in interstate commerce, as defined in 49 CFR 390.5.
Section 391.41(b)(4) states that:
A person is physically qualified to drive a commercial motor vehicle
if--
* * * * *
that person has no 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 [a temporary loss of consciousness due to a
sudden decline in blood flow to the brain], dyspnea [shortness of
breath], collapse, or congestive cardiac failure.
The FMCSA provides medical advisory criteria as recommendations for
use by medical examiners in determining whether drivers with certain
medical conditions and drivers who have undergone certain procedures
and/or treatments should be certified to operate CMVs in interstate
commerce in accordance with the various physical qualification
standards in 49 CFR part 391, subpart E. The advisory criteria are
currently set out in Appendix A to 49 CFR part 391. The advisory
criteria for section 391.41(b)(4) provide, in part, that:
The term ``has no current clinical diagnosis of'' is specifically
designed to encompass: ``a clinical diagnosis of'' (1) a current
cardiovascular condition, or (2) a cardiovascular condition which
has not fully stabilized regardless of the time limit. The term
``known to be accompanied by'' is designed to include a clinical
diagnosis of a cardiovascular disease (1) which is accompanied by
symptoms of syncope, dyspnea, collapse or congestive cardiac
failure; and/or (2) which is likely to cause syncope, dyspnea,
collapse, or congestive cardiac failure.
It is the intent of the Federal Motor Carrier Safety Regulations to
render unqualified, a driver who has a current cardiovascular
disease which is accompanied by and/or likely to cause symptoms of
syncope, dyspnea, collapse, or congestive cardiac failure. However,
the subjective decision of whether the nature and severity of an
individual's condition will likely cause symptoms of cardiovascular
insufficiency is on an individual basis and qualification rests with
the medical examiner and the motor carrier.
In the case of persons with ICDs, the underlying condition for
which the ICD was implanted places the individual at high risk for
syncope (a transient loss of consciousness) 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. See the Evidence Report on ``Cardiovascular Disease and Commercial
Motor Vehicle Driver Safety,'' April 2007.\2\ A focused research report
entitled ``Implantable Cardioverter Defibrillators and the Impact of a
Shock on a Patient When Deployed,'' completed for the FMCSA in December
2014, 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 and upholds
the findings of the April 2007 report. Copies of the April 2007 report
and the December 2014 report are included in the docket for this
notice.
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\2\ Now available at http://ntl.bts.gov/lib/30000/30100/30123/Final_CVD_Evidence_Report_v2.pdf.
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Discussion of Public Comments
On November 27, 2015, FMCSA published in a Federal Register Notice
the names of 7 individuals seeking ICD exemption and requested public
comment. The public comment period closed on December 28, 2015. A total
of 13 commenters responded to the notice. Each of the comments was
favorable towards the applicants continuing to drive CMV's with ICD's.
Commenters believed that the individuals seeking exemptions were
responsible drivers who had safe professional driving and work
histories and believed that their medical conditions did not present
safety concerns. One anonymous physician encouraged the FMCSA to
accommodate individuals with ICD's that have never deployed or that
have not deployed in many years by developing an exception to the
general rule that would still protect public safety.
FMCSA's Response
FMCSA acknowledges the commenters' reports of safe driving
histories and concerns for the driving careers of the applicants. Based
on the available medical literature cited above, however, 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.
[[Page 28120]]
Conclusion
FMCSA evaluated the 7 individual exemption requests on their
merits, available data from Evidence Reports and Medical Expert Panel
opinions on the impact of ICDs on Commercial Motor Vehicle driving, and
the public comments received. The Agency has determined that the
available medical literature and data does not support a conclusion
that granting these exemptions would achieve a level of safety
equivalent to or greater than the level of safety maintained without
the exemptions. Each applicant has, prior to this notice, received a
letter of final disposition on his/her exemption request. Those
decision letters fully outlined the basis for the denial and constitute
final Agency action. The list published today summarizes the Agency's
recent denials as required under 49 U.S.C. 31315(b)(4).
The following 7 applicants are denied exemptions from the
cardiovascular standard. Ellis James Benson, Jon Carey, Martin Carter,
Carl Jeglum, William Kastner, Mark Todd Smith, Andre Williams.
Issued on: April 28, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-10875 Filed 5-6-16; 8:45 am]
BILLING CODE 4910-EX-P