81 FR 91238 - Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillators

DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration

Federal Register Volume 81, Issue 242 (December 16, 2016)

FMCSA announces its decision to deny applications from 11 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 of 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 11 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.

[Federal Register Volume 81, Number 242 (Friday, December 16, 2016)]
[Notices]
[Pages 91238-91239]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-30283]


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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2016-0175]


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 11 
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 of 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 11 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 October 11, 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, Public Law 114-94, div. A, title V, 129 Stat. 1537 (Dec. 
4, 2015).
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    On August 8, 2016, FMCSA published for public notice and comment, 
FMCSA 2016-0175, listing 11 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.


[[Page 91239]]


    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 August 8, 2016, FMCSA published in a Federal Register Notice the 
names of 11 individuals seeking ICD exemption and requested public 
comment. The public comment period closed on September 7, 2016. A total 
of 29 commenters responded to the notice. Each of the comments was 
favorable towards the applicants continuing to drive CMV's with ICD's. 
Many commenters believed that the individuals seeking exemptions were 
safe drivers with safe professional work histories, and that their 
exemption request should be considered on an individual case basis 
based on merit. Several commenters expressed that individual driving 
records and experience should be factors in allowing persons with ICD's 
to operate CMVs.

FMCSA's Response

    FMCSA acknowledges the commenters' concerns. The Agency reviews and 
considers each applicant's request individually. 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.

Conclusion

    FMCSA evaluated the 11 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 11 applicants are denied exemptions from the 
cardiovascular standard.

Charles R. Allen (MI)
William Blake (NH)
Roosevelt Tyrone Brown (SC)
Kevin Coulter (CA)
John Dudar (CT)
Timothy Godwin (NC)
James Goslee (MD)
Richard Hacker (MD)
Kathryn Kosse (AZ)
Joseph Skrzyniarz (MI)
Wylanne Deon Sanders (IL)

    Issued on: December 8, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-30283 Filed 12-15-16; 8:45 am]
 BILLING CODE 4910-EX-P