Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillators

Larry W. Minor
Federal Motor Carrier Safety Administration
9 May 2016

[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