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)
Federal Motor Carrier Safety Administration
Federal Register Volume 81, Issue 242 (December 16, 2016)
| Page Range | 91238-91239 | |
| FR Document | 2016-30283 |
[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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\ --------------------------------------------------------------------------- \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). --------------------------------------------------------------------------- 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. --------------------------------------------------------------------------- \2\ Now available at http://ntl.bts.gov/lib/30000/30100/30123/Final_CVD_Evidence_Report_v2.pdf. --------------------------------------------------------------------------- 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
![91238 Federal Register / Vol. 81, No. 242 / Friday, December 16, 2016 / Notices
By the Board, Rachel D. Campbell, The following is a brief overview of individuals in the notice did not
Director, Office of Proceedings. the request: demonstrate they could achieve a level
Raina S. Contee, The Reno-Tahoe Airport Authority of safety that is equivalent to, or greater
Clearance Clerk. (RTAA) requested a release from the than, the level of safety that would be
[FR Doc. 2016–30249 Filed 12–15–16; 8:45 am] provisions of the Grant Agreement obtained by complying with the
BILLING CODE 4915–01–P Assurances to permit the disposal of regulation.
approximately 0.58 acres of land near
DATES: Denial letters were sent to each
Reno Stead Airport, Reno, Washoe
of the individuals listed in this notice
DEPARTMENT OF TRANSPORTATION County, Nevada to permit Artisan
on October 11, 2016.
Communities to incorporate the 0.58-
FOR FURTHER INFORMATION CONTACT: Ms.
Federal Aviation Administration acre property into their approximately
47-acre community development. The Christine A. Hydock, Chief Medical
Notice of Release From Quitclaim Deed property is located in an area zoned Programs Division, 202–366–4001, U.S.
and Grant Assurance Obligations at residential and the release will Department of Transportation, FMCSA,
Reno Stead Airport, Reno, Washoe eliminate RTAA’s future liability for the 1200 New Jersey Avenue SE., Room
County, Nevada property since the property cannot be W64–224, Washington, DC 20590–0001.
redeveloped for a commercial or airport Office hours are from 8:30 a.m. to 5 p.m.
AGENCY: Federal Aviation Monday through Friday, except Federal
purpose. The airport will be
Administration, DOT. holidays.
compensated for the fair market value of
ACTION: Notice of a land release. SUPPLEMENTARY INFORMATION:
the released property. The RTAA
SUMMARY: The Federal Aviation supports disposal of the parcel, which Background
Administration (FAA) proposes to rule has no identified airport-related purpose
or future use, especially since it is 0.5 Under 49 U.S.C. 31136(e) and 31315,
and invites public comment on the FMCSA may grant an exemption from
application for a land release of miles from the airport. Reuse of the
property will not interfere with the the Federal Motor Carrier Safety
approximately 0.58 acres of airport
airport or its operation, thereby Regulations for up to five years if it
property and associated 15-foot-wide
protecting the interests of civil aviation. finds ‘‘such exemption would likely
access easement owned by Reno Stead
Based on the benefits of fair achieve a level of safety that is
Airport, Reno, Washoe County, Nevada
compensation in exchange for the land, equivalent to or greater than the level
from the airport use provisions of the
the interests of civil aviation will be that would be achieved absent such
Grant Agreement Assurances since the
properly served. exemption.’’ FMCSA can renew
land is not needed for airport purposes.
exemptions for up to an additional five
The subject property is located Issued in Hawthorne, California, on years at the end of each five-year
approximately 0.5 miles from the Reno December 8, 2016.
period.1
Stead Airport and has no identified Brian Q. Armstrong, On August 8, 2016, FMCSA published
airport-related purpose. The airport will Manager, Safety and Standards Branch, for public notice and comment, FMCSA
be compensated for the fair market Airports Division, Western-Pacific Region. 2016–0175, listing 11 individuals
value of the released property. Reuse of [FR Doc. 2016–30210 Filed 12–15–16; 8:45 am] seeking exemptions for ICDs.
the property will not interfere with the BILLING CODE 4910–13–P Accordingly, the Agency has evaluated
airport or its operation, thereby
each applicant’s request to determine
protecting the interests of civil aviation.
whether granting an exemption will
DATES: Comments must be received on DEPARTMENT OF TRANSPORTATION achieve the required level of safety
or before January 17, 2017. mandated by statute.
FOR FURTHER INFORMATION CONTACT: Federal Motor Carrier Safety
Comments on the request may be mailed Administration Evaluation Criteria—Cardiovascular
or delivered to the FAA at the following [Docket No. FMCSA–2016–0175] Medical Standard and Advisory
address: Mike N. Williams, Manager, Criteria
Airports District Office, Federal Qualification of Drivers; Exemption The individuals included in this
Register Comment, Federal Aviation Applications; Implantable Cardioverter notice have requested an exemption
Administration, Phoenix Airports Defibrillators from the provisions of 49 CFR
District Office, 3800 N. Central Avenue, AGENCY: Federal Motor Carrier Safety 391.41(b)(4), which applies to drivers
Suite 1025, Phoenix, Arizona 85012. In Administration (FMCSA), DOT. who operate CMVs in interstate
addition, one copy of the comment commerce, as defined in 49 CFR 390.5.
ACTION: Notice of denials of exemption
submitted to the FAA must be mailed or Section 391.41(b)(4) states that:
applications.
delivered to Ms. Lissa Butterfield, A person is physically qualified to drive a
Senior Airport Planner, Reno-Tahoe SUMMARY: FMCSA announces its commercial motor vehicle if—
Airport Authority, P.O. Box 12490, decision to deny applications from 11 * * * * *
Reno, NV 89510. individuals seeking exemptions from that person has no current clinical diagnosis
SUPPLEMENTARY INFORMATION: In the Federal cardiovascular standard of myocardial infarction, angina pectoris,
accordance with the Wendell H. Ford applicable to interstate truck and bus coronary insufficiency, thrombosis, or any
Aviation Investment and Reform Act for drivers and discusses the reasons for the other cardiovascular disease of a variety
the 21st Century (AIR 21), Public Law denials. The Agency reviewed the known to be accompanied by syncope [a
mstockstill on DSK3G9T082PROD with NOTICES
106–181 (Apr. 5, 2000; 114 Stat. 61), medical information of each of the temporary loss of consciousness due to a
this notice must be published in the individuals who applied for an sudden decline in blood flow to the brain],
dyspnea [shortness of breath], collapse, or
Federal Register 30 days before the DOT implantable cardioverter defibrillator
congestive cardiac failure.
Secretary may waive any condition (ICD) exemption. Based on a review of
imposed on a federally obligated airport the applications and following an 1 49 U.S.C. 31315(b), as amended by section
by surplus property conveyance deeds opportunity for public comment, 5206(a) of the FAST Act, Public Law 114–94, div.
or grant agreements. FMCSA has concluded that the 11 A, title V, 129 Stat. 1537 (Dec. 4, 2015).
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![Federal Register / Vol. 81, No. 242 / Friday, December 16, 2016 / Notices 91239
The FMCSA provides medical December 2014 report are included in Kevin Coulter (CA)
advisory criteria as recommendations the docket for this notice. John Dudar (CT)
for use by medical examiners in Timothy Godwin (NC)
Discussion of Public Comments
determining whether drivers with James Goslee (MD)
certain medical conditions and drivers On August 8, 2016, FMCSA published Richard Hacker (MD)
who have undergone certain procedures in a Federal Register Notice the names Kathryn Kosse (AZ)
and/or treatments should be certified to of 11 individuals seeking ICD Joseph Skrzyniarz (MI)
operate CMVs in interstate commerce in exemption and requested public Wylanne Deon Sanders (IL)
accordance with the various physical comment. The public comment period Issued on: December 8, 2016.
qualification standards in 49 CFR part closed on September 7, 2016. A total of
Larry W. Minor,
391, subpart E. The advisory criteria are 29 commenters responded to the notice.
Each of the comments was favorable Associate Administrator for Policy.
currently set out in Appendix A to 49
towards the applicants continuing to [FR Doc. 2016–30283 Filed 12–15–16; 8:45 am]
CFR part 391. The advisory criteria for
section 391.41(b)(4) provide, in part, drive CMV’s with ICD’s. Many BILLING CODE 4910–EX–P
that: commenters believed that the
individuals seeking exemptions were
The term ‘‘has no current clinical diagnosis safe drivers with safe professional work DEPARTMENT OF TRANSPORTATION
of’’ is specifically designed to encompass: ‘‘a
histories, and that their exemption
clinical diagnosis of’’ (1) a current Federal Motor Carrier Safety
request should be considered on an
cardiovascular condition, or (2) a Administration
cardiovascular condition which has not fully individual case basis based on merit.
stabilized regardless of the time limit. The Several commenters expressed that [Docket No. FMCSA–1999–6480; FMCSA–
individual driving records and 2001–11426; FMCSA–2002–11714; FMCSA–
term ‘‘known to be accompanied by’’ is
experience should be factors in allowing 2002–12844; FMCSA–2003–16564; FMCSA–
designed to include a clinical diagnosis of a
persons with ICD’s to operate CMVs. 2004–19477; FMCSA–2005–21711; FMCSA–
cardiovascular disease (1) which is 2005–22727; FMCSA–2005–23099; FMCSA–
accompanied by symptoms of syncope,
FMCSA’s Response 2006–23773; FMCSA–2006–24015; FMCSA–
dyspnea, collapse or congestive cardiac 2008–0021; FMCSA–2009–0011; FMCSA–
failure; and/or (2) which is likely to cause FMCSA acknowledges the 2009–0303; FMCSA–2009–0321; FMCSA–
syncope, dyspnea, collapse, or congestive commenters’ concerns. The Agency 2010–0050; FMCSA–2011–0142; FMCSA–
cardiac failure. reviews and considers each applicant’s 2011–0299; FMCSA–2011–0366; FMCSA–
It is the intent of the Federal Motor Carrier request individually. Based on the 2011–0379; FMCSA–2011–0380; FMCSA–
Safety Regulations to render unqualified, a available medical literature cited above, 2012–0039; FMCSA–2013–0174; FMCSA–
driver who has a current cardiovascular however, FMCSA believes that a driver 2014–0002; FMCSA–2014–0003; FMCSA–
disease which is accompanied by and/or with an ICD is at risk for incapacitation 2014–0004]
likely to cause symptoms of syncope, if the device discharges. This risk is
dyspnea, collapse, or congestive cardiac Qualification of Drivers; Exemption
combined with the risks associated with
failure. However, the subjective decision of Applications; Vision
whether the nature and severity of an
the underlying cardiovascular condition
individual’s condition will likely cause for which the ICD has been implanted AGENCY: Federal Motor Carrier Safety
symptoms of cardiovascular insufficiency is as a primary or secondary preventive Administration (FMCSA), DOT.
on an individual basis and qualification rests measure. ACTION: Notice of renewal of
with the medical examiner and the motor Conclusion exemptions; request for comments.
carrier.
FMCSA evaluated the 11 individual SUMMARY: FMCSA announces its
In the case of persons with ICDs, the exemption requests on their merits, decision to renew the exemptions from
underlying condition for which the ICD available data from Evidence Reports the vision requirement in the Federal
was implanted places the individual at and Medical Expert Panel opinions on Motor Carrier Safety Regulations for 131
high risk for syncope (a transient loss of the impact of ICDs on Commercial individuals. FMCSA has statutory
consciousness) or other unpredictable Motor Vehicle driving, and the public authority to exempt individuals from
events known to result in gradual or comments received. The Agency has the vision requirement if the
sudden incapacitation. ICDs may determined that the available medical exemptions granted will not
discharge, which could result in loss of literature and data does not support a compromise safety. The Agency has
ability to safely control a CMV. See the conclusion that granting these concluded that granting these
Evidence Report on ‘‘Cardiovascular exemptions would achieve a level of exemption renewals will provide a level
Disease and Commercial Motor Vehicle safety equivalent to or greater than the of safety that is equivalent to or greater
Driver Safety,’’ April 2007.2 A focused level of safety maintained without the than the level of safety maintained
research report entitled ‘‘Implantable exemptions. Each applicant has, prior to without the exemptions for these
Cardioverter Defibrillators and the this notice, received a letter of final commercial motor vehicle (CMV)
Impact of a Shock on a Patient When disposition on his/her exemption drivers.
Deployed,’’ completed for the FMCSA request. Those decision letters fully
in December 2014, indicates that the outlined the basis for the denial and DATES: Each group of renewed
available scientific data on persons with constitute final Agency action. The list exemptions was effective from the dates
ICDs and CMV driving does not support published today summarizes the stated in the discussions below.
Comments must be received on or
mstockstill on DSK3G9T082PROD with NOTICES
that persons with ICDs who operate Agency’s recent denials as required
CMVs are able to meet an equal or under 49 U.S.C. 31315(b)(4). before January 17, 2017.
greater level of safety and upholds the The following 11 applicants are ADDRESSES: You may submit comments
findings of the April 2007 report. Copies denied exemptions from the bearing the Federal Docket Management
of the April 2007 report and the cardiovascular standard. System (FDMS) numbers: Docket No.
Charles R. Allen (MI) [Docket No. FMCSA–1999–6480;
2 Now available at http://ntl.bts.gov/lib/30000/ William Blake (NH) FMCSA–2001–11426; FMCSA–2002–
30100/30123/Final_CVD_Evidence_Report_v2.pdf. Roosevelt Tyrone Brown (SC) 11714; FMCSA–2002–12844; FMCSA–
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Document Created: 2018-02-14 09:07:31
Document Modified: 2018-02-14 09:07:31
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of denials of exemption applications. | |
| Dates | Denial letters were sent to each of the individuals listed in this notice on October 11, 2016. | |
| 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. | |
| FR Citation | 81 FR 91238 |
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