Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders, 70917-70920 [2014-28071]

Download as PDF Federal Register / Vol. 79, No. 229 / Friday, November 28, 2014 / Notices tkelley on DSK3SPTVN1PROD with NOTICES time to route the new driver to his or her State of domicile to obtain a CDL and place the new driver into an on-thejob training position with a drivertrainer. The driver-trainer supervised and observed the new driver, but was not required to be on-duty and in the front seat at all times. Thus, the new driver became productive immediately, allowing more freight movement for C.R. England and compensation for the new driver. C.R. England contends that compliance with the CDL rule prevents it from implementing more efficient and effective operations. The rule places C.R. England in an untenable position of either sending the CLP holder home without having hired him or her (because the person does not yet have a CDL) with no assurance that the driver will remain with C.R. England after obtaining the CDL; or, hiring the CLP holder and sending him or her home in an unproductive non-driving capacity. Granting the exemption would allow the CLP holder to drive as part of a team on that trip, resulting in reduced costs and increased productivity. C.R. England asserts that the exemption would be consistent with FMCSA’s comments in the preamble to the rule that state that ‘‘FMCSA does not believe that it is safe to permit inexperienced drivers who have not passed the CDL skills test to drive unaccompanied.’’ (76 FR 26861) The exemption sought would apply only to those C.R. England drivers who have passed the CDL skills test and hold a CLP. C.R. England believes that the exemption would result in a level of safety that is equivalent to or greater than the level of safety provided under the rule. The only difference between a CLP holder who has passed the CDL skills test and a CDL holder is that the latter has waited in line at the DMV and has received the hard copy CDL. A copy of C.R. England’s application for exemption is available for review in the docket for this notice. Request for Comments In accordance with 49 U.S.C. 31315(b)(4) and 31136(e), FMCSA requests public comment on C.R. England’s application for an exemption from the CDL requirements of 49 CFR part 383. The Agency will consider all comments received by close of business on December 29, 2014. Comments will be available for examination in the docket at the location listed under the ADDRESSES section of this notice. The Agency will consider to the extent practicable comments received in the public docket after the closing date of the comment period. VerDate Sep<11>2014 16:58 Nov 26, 2014 Jkt 235001 Issued on: November 17, 2014. Larry W. Minor, Associate Administrator for Policy. [FR Doc. 2014–28072 Filed 11–26–14; 8:45 am] BILLING CODE 4910–EX–P DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA–2006–25854; FMCSA– 2011–0389; FMCSA–2012–0294; FMCSA– 2013–0109] Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of final disposition. AGENCY: FMCSA announces its decision to grant requests from five individuals for exemptions from the regulatory requirement that interstate commercial motor vehicle (CMV) drivers have ‘‘no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.’’ The regulation and the associated advisory criteria published in the Code of Federal Regulations as the ‘‘Instructions for Performing and Recording Physical Examinations’’ have resulted in numerous drivers being prohibited from operating CMVs in interstate commerce based on the fact that they have had one or more seizures and are taking antiseizure medication, rather than an individual analysis of their circumstances by a qualified medical examiner. The Agency concluded that granting exemptions for these CMV drivers will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions. FMCSA grants exemptions that will allow these five individuals to operate CMVs in interstate commerce for a 2-year period. The exemptions preempt State laws and regulations and may be renewed. DATES: The exemptions are effective November 28, 2014. The exemptions expire on November 28, 2016. FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Division Chief, Physical Qualifications, Office of Medical Programs, (202) 366–4001, fmcsamedical@dot.gov, FMCSA, Department of Transportation, 1200 New Jersey Avenue SE., Room W64– 224, Washington, DC 20590–0001. Office hours are 8:30 a.m. to 5 p.m., e.t., SUMMARY: PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 70917 Monday through Friday, except Federal holidays. SUPPLEMENTARY INFORMATION: A. Electronic Access You may see all the comments online through the Federal Document Management System (FDMS) at: https:// www.regulations.gov. Docket: For access to the docket to read background documents or comments, go to https:// www.regulations.gov and/or Room W12–140 on the ground level of the West Building, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday, except Federal holidays. Privacy Act: Anyone may search the electronic form of all comments received into any of DOT’s dockets by the name of the individual submitting the comment (or of the person signing the comment, if submitted on behalf of an association, business, labor union, or other entity). You may review DOT’s complete Privacy Act Statement in the Federal Register (73 FR 3316, January 17, 2008). This statement is also available at https://Docketinfo.dot.gov. B. Background Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the safety regulations for a 2-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 statute also allows the Agency to renew exemptions at the end of the 2-year period. FMCSA grants five individuals an exemption from the regulatory requirement in § 391.41(b)(8), to allow these individuals who take anti-seizure medication to operate CMVs in interstate commerce for a 2-year period. The Agency’s decision on these exemption applications is based on an individualized assessment of each applicant’s medical information, including the root cause of the respective seizure(s), the length of time elapsed since the individual’s last seizure, and each individual’s treatment regimen. In addition, the Agency reviewed each applicant’s driving record found in the Commercial Driver’s License Information System (CDLIS) 1 1 Commercial Driver License Information System (CDLIS) is an information system that allows the exchange of commercial driver licensing information among all the States. CDLIS includes the databases of fifty-one licensing jurisdictions and the CDLIS Central Site, all connected by a telecommunications network. E:\FR\FM\28NON1.SGM 28NON1 70918 Federal Register / Vol. 79, No. 229 / Friday, November 28, 2014 / Notices for commercial driver’s license (CDL) holders, and interstate and intrastate inspections recorded in Motor Carrier Management Information System (MCMIS).2 For non-CDL holders, the Agency reviewed the driving records from the State licensing agency. The Agency acknowledges the potential consequences of a driver experiencing a seizure while operating a CMV. However, the Agency believes the drivers covered by the exemptions granted here have demonstrated that they are unlikely to have a seizure and their medical condition does not pose a risk to public safety. In reaching the decision to grant these exemption requests, the Agency considered both current medical literature and information and the 2007 recommendations of the Agency’s Medical Expert Panel (MEP). The Agency previously gathered evidence for potential changes to the regulation at 49 CFR 391.41(b)(8) by conducting a comprehensive review of scientific literature that was compiled into the ‘‘Evidence Report on Seizure Disorders and Commercial Vehicle Driving’’ (Evidence Report) [CD–ROM HD TL230.3 .E95 2007]. The Agency then convened a panel of medical experts in the field of neurology (the MEP) on May 14–15, 2007, to review 49 CFR 391.41(b)(8) and the advisory criteria regarding individuals who have experienced a seizure, and the 2007 Evidence Report. The Evidence Report and the MEP recommendations are published on-line at https:// www.fmcsa.dot.gov/rules-regulations/ topics/mep/mep-reports.htm, under Seizure Disorders, and are in the docket for this notice. tkelley on DSK3SPTVN1PROD with NOTICES MEP Criteria for Evaluation On October 15, 2007, the MEP issued the following recommended criteria for evaluating whether an individual with epilepsy or a seizure disorder should be allowed to operate a CMV.3 The MEP recommendations are included in previously published dockets. Epilepsy diagnosis. If there is an epilepsy diagnosis, the applicant should be seizure-free for 8 years, on or off medication. If the individual is taking anti-seizure medication(s), the plan for medication should be stable for 2 years. 2 Motor Carrier Management Information System (MCMIS) is an information system that captures data from field offices through SAFETYNET, CAPRI, and other sources. It is a source for FMCSA inspection, crash, compliance review, safety audit, and registration data. 3 Engel, J., Fisher, R.S., Krauss, G.L., Krumholz, A., and Quigg, M.S., ‘‘Expert Panel Recommendations: Seizure Disorders and Commercial Motor Vehicle Driver Safety,’’ FMCSA, October 15, 2007. VerDate Sep<11>2014 16:58 Nov 26, 2014 Jkt 235001 Stable means no changes in medication, dosage, or frequency of medication administration. Recertification for drivers with an epilepsy diagnosis should be performed every year. Single unprovoked seizure. If there is a single unprovoked seizure (i.e., there is no known trigger for the seizure), the individual should be seizure-free for 4 years, on or off medication. If the individual is taking anti-seizure medication(s), the plan for medication should be stable for 2 years. Stable means no changes in medication, dosage, or frequency of medication administration. Recertification for drivers with a single unprovoked seizure should be performed every 2 years. Single provoked seizure. If there is a single provoked seizure (i.e., there is a known reason for the seizure), the Agency should consider specific criteria that fall into the following two categories: low-risk factors for recurrence and moderate-to-high risk factors for recurrence. • Examples of low-risk factors for recurrence include seizures that were caused by a medication; by nonpenetrating head injury with loss of consciousness less than or equal to 30 minutes; by a brief loss of consciousness not likely to recur while driving; by metabolic derangement not likely to recur; and by alcohol or illicit drug withdrawal. • Examples of moderate-to-high-risk factors for recurrence include seizures caused by non-penetrating head injury with loss of consciousness or amnesia greater than 30 minutes, or penetrating head injury; intracerebral hemorrhage associated with a stroke or trauma; infections; intracranial hemorrhage; post-operative complications from brain surgery with significant brain hemorrhage; brain tumor; or stroke. The MEP report indicates individuals with moderate to high-risk conditions should not be certified. Drivers with a history of a single provoked seizure with low risk factors for recurrence should be recertified every year. Medical Review Board Recommendations and Agency Decision FMCSA presented the MEP’s findings and the Evidence Report to the Medical Review Board (MRB) for consideration. The MRB reviewed and considered the 2007 ‘‘Seizure Disorders and Commercial Driver Safety’’ evidence report and the 2007 MEP recommendations. The MRB recommended maintaining the current advisory criteria, which provide that ‘‘drivers with a history of epilepsy/ seizures off anti-seizure medication and PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 seizure-free for 10 years may be qualified to drive a CMV in interstate commerce. Interstate drivers with a history of a single unprovoked seizure may be qualified to drive a CMV in interstate commerce if seizure-free and off anti-seizure medication for a 5 year period or more’’ [Advisory criteria to 49 CFR 391.43(f)]. The Agency acknowledges the MRB’s position on the issue but believes relevant current medical evidence supports a less conservative approach. The medical advisory criteria for epilepsy and other seizure or loss of consciousness episodes was based on the 1988 ‘‘Conference on Neurological Disorders and Commercial Drivers’’ (NITS Accession No. PB89–158950/AS). A copy of the report can be found in the docket referenced in this notice. The MRB’s recommendation treats all drivers who have experienced a seizure the same, regardless of individual medical conditions and circumstances. In addition, the recommendation to continue prohibiting drivers who are taking anti-seizure medication from operating a CMV in interstate commerce does not consider a driver’s actual seizure history and time since the last seizure. The Agency has decided to use the 2007 MEP recommendations as the basis for evaluating applications for an exemption from the seizure regulation on an individual, case-by-case basis. C. Exemptions Following individualized assessments of the exemption applications, including a review of detailed follow-up information requested from each applicant, FMCSA is granting exemptions from 49 CFR 391.41(b)(8) to five individuals. Under current FMCSA regulations, all of the five drivers receiving exemptions from 49 CFR 391.41(b)(8) would have been considered physically qualified to drive a CMV in interstate commerce except that they presently take or have recently stopped taking anti-seizure medication. For these five drivers, the primary obstacle to medical qualification was the FMCSA Advisory Criteria for Medical Examiners, based on the 1988 ‘‘Conference on Neurological Disorders and Commercial Drivers,’’ stating that a driver should be off anti-seizure medication in order to drive in interstate commerce. In fact, the Advisory Criteria have little if anything to do with the actual risk of a seizure and more to do with assumptions about individuals who are taking anti-seizure medication. In addition to evaluating the medical status of each applicant, FMCSA evaluated the crash and violation data E:\FR\FM\28NON1.SGM 28NON1 Federal Register / Vol. 79, No. 229 / Friday, November 28, 2014 / Notices for the five drivers, some of whom currently drive a CMV in intrastate commerce. The CDLIS and MCMIS were searched for crash and violation data on the five applicants. For non-CDL holders, the Agency reviewed the driving records from the State licensing agency. These exemptions are contingent on the driver maintaining a stable treatment regimen and remaining seizure-free during the 2-year exemption period. The exempted drivers must submit annual reports from their treating physicians attesting to the stability of treatment and that the driver has remained seizure-free. The driver must undergo an annual medical examination by a medical examiner, as defined by 49 CFR 390.5, following the FCMSA’s regulations for the physical qualifications for CMV drivers. FMCSA published a notice of receipt of application and requested public comment during a 30-day public comment period in a Federal Register notice for each of the applicants. A short summary of the applicants’ qualifications and a discussion of the comments received follows this section. For applicants who were denied an exemption, a notice will be published at a later date. D. Comments Docket # FMCSA–2006–25854 On August 9, 2007, FMCSA published a notice of receipt of exemption applications and requested public comment on nine individuals (72 FR 44916; Docket number FMCSA–2006– 25854). The comment period ended on September 10, 2007. Five comments were received. A discussion of the comments were presented in a previous notice. Of the nine applicants, five were previously granted exemptions, one withdrew his request, and two were denied. The Agency has determined that the following applicant should be granted an exemption. tkelley on DSK3SPTVN1PROD with NOTICES Jay Whitehead Mr. Whitehead is a 51 year-old class B CDL holder in New York. He has a history of seizures and has remained seizure free since 1983. He takes antiseizure medication with the dosage and frequency remaining the same for over 2 years. If granted the exemption, he would like to continue to drive a CMV. His physician states he is supportive of Mr. Whitehead receiving an exemption. Docket # FMCSA–2011–0389 On January 5, 2012, FMCSA published a notice of receipt of exemption applications and requested VerDate Sep<11>2014 16:58 Nov 26, 2014 Jkt 235001 public comment on 15 individuals (77 FR 33781; Docket number FMCSA– 2011–0389). The comment period ended on February 5, 2012. Seven comments were received. A discussion of the comments were presented in a previous notice. Of the 15 applicants, three were previously granted exemptions. FMCSA has determined that the following applicant should be granted an exemption. The Agency will issue a decision on the other drivers at a later date. Lonnie Rieker Mr. Rieker is a 55 year-old class A CDL holder in Illinois. He has a history of a single seizure and has remained seizure free for 4 years. He takes antiseizure medication with the dosage and frequency remaining the same for over 2 years. If granted the exemption, he would like to continue to drive a CMV. His physician states he is supportive of Mr. Rieker receiving an exemption. Docket # FMCSA–2012–0294 On January 15, 2013, FMCSA published a notice of receipt of exemption applications and requested public comment on nine individuals (78 FR 00712; Docket number FMCSA– 2012–0294). The comment period ended on February 15, 2013. Eight comments were received, including three duplicate comments. A discussion of the comments were presented in a previous notice. Of the nine applicants, eight were previously granted exemptions. FMCSA has determined that the following applicant should be granted an exemption. Michael Ranalli Mr. Ranalli is a 29 year-old driver in Pennsylvania. He has a history of juvenile epilepsy and has remained seizure free for 8 years. He takes antiseizure medication with the dosage and frequency remaining the same since that time. If granted the exemption, he would like to drive a CMV. His physician states he is supportive of Mr. Ranalli receiving an exemption. Docket # FMCSA–2013–0109 On November 13, 2013, FMCSA published a notice of receipt of exemption applications and requested public comment on 11 individuals (78 FR 68144). The comment period ended on December 13, 2013. No commenters responded to this Federal Register notice. Of the 11 applicants, four were previously granted exemptions. FMCSA has determined that the following two applicants should be granted an exemption. The Agency will issue a PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 70919 decision on the other drivers at a later date. Jeffrey Ballweg Mr. Ballweg is 51 year-old driver in Wisconsin. He has a history of epilepsy and has remained seizure free for 8 years. He takes anti-seizure medication with the dosage and frequency remaining the same for over 2 years. If granted the exemption, he would like to drive a CMV. His physician states he is supportive of Mr. Ballweg receiving an exemption. Bryan Couture Mr. Couture is a 48 year-old class B CDL holder in Rhode Island. He has a history of seizure and has remained seizure free for 10 years. He takes antiseizure medication with the dosage and frequency remaining the same for over 2 years. If granted the exemption, he would like to continue to drive a CMV. His physician states he is supportive of Mr. Couture receiving an exemption. E. Basis for Exemption Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the epilepsy/seizure standard in 49 CFR 391.41(b)(8) if the exemption is likely to achieve an equivalent or greater level of safety than would be achieved without the exemption. Without the exemption, applicants will continue to be restricted to intrastate driving. With the exemption, applicants can drive in interstate commerce. Thus, the Agency’s analysis focuses on whether an equal or greater level of safety is likely to be achieved by permitting each of these drivers to drive in interstate commerce as opposed to restricting the driver to driving in intrastate commerce. Conclusion The Agency is granting exemptions from the epilepsy standard, 49 CFR 391.41(b)(8), to five individuals based on a thorough evaluation of each driver’s qualifications, safety experience, and medical condition. Safety analysis of information relating to these five applicants meets the burden of showing that granting the exemptions would achieve a level of safety that is equivalent to or greater than the level that would be achieved without the exemption. By granting the exemptions, the interstate CMV industry will gain five highly trained and experienced drivers. In accordance with 49 U.S.C. 31315(b)(1), each exemption will be valid for 2 years, with annual recertification required unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) E:\FR\FM\28NON1.SGM 28NON1 70920 Federal Register / Vol. 79, No. 229 / Friday, November 28, 2014 / Notices The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136 and 31315. FMCSA exempts the following five drivers for a period of 2 years with annual medical certification required: Jeffrey Ballweg (WI); Bryan Couture (RI); Michael Ranalli (PA); Lonnie Rieker (IL); and Jay Whitehead (NY) from the prohibition of CMV operations by persons with a clinical diagnosis of epilepsy or seizures. If the exemption is still in effect at the end of the 2-year period, the person may apply to FMCSA for a renewal under procedures in effect at that time. Issued on: November 21, 2014. Larry W. Minor, Associate Administrator for Policy. [FR Doc. 2014–28071 Filed 11–26–14; 8:45 am] BILLING CODE 4910–EX–P DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA–2014–0309] Qualification of Drivers; Exemption Applications; Diabetes Mellitus Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of applications for exemptions request for comments. AGENCY: FMCSA announces receipt of applications from 63 individuals for exemption from the prohibition against persons with insulin-treated diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) in interstate commerce. If granted, the exemptions would enable these individuals with ITDM to operate CMVs in interstate commerce. DATES: Comments must be received on or before December 29, 2014. ADDRESSES: You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA– 2014–0309 using any of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Docket Management Facility; U.S. Department of Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12–140, Washington, DC 20590–0001. tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:58 Nov 26, 2014 Jkt 235001 • Hand Delivery: West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays. • Fax: 1–202–493–2251. Instructions: Each submission must include the Agency name and the docket numbers for this notice. Note that all comments received will be posted without change to https:// www.regulations.gov, including any personal information provided. Please see the Privacy Act heading below for further information. Docket: For access to the docket to read background documents or comments, go to https:// www.regulations.gov at any time or Room W12–140 on the ground level of the West Building, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Federal Docket Management System (FDMS) is available 24 hours each day, 365 days each year. If you want acknowledgment that we received your comments, please include a selfaddressed, stamped envelope or postcard or print the acknowledgement page that appears after submitting comments on-line. Privacy Act: Anyone may search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or of the person signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT’s Privacy Act Statement for the Federal Docket Management System (FDMS) published in the Federal Register on January 17, 2008 (73 FR 3316). FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, R.N., Chief, Medical Programs Division, (202) 366–4001, fmcsamedical@dot.gov, 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., Monday through Friday, except Federal holidays. SUPPLEMENTARY INFORMATION: I. Background Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption from the Federal Motor Carrier Safety Regulations for a 2-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 statute also allows the Agency to renew PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 exemptions at the end of the 2-year period. The 63 individuals listed in this notice have recently requested such an exemption from the diabetes prohibition in 49 CFR 391.41(b)(3), which applies to drivers of CMVs in interstate commerce. Accordingly, the Agency will evaluate the qualifications of each applicant to determine whether granting the exemption will achieve the required level of safety mandated by statute. II. Qualifications of Applicants Andrew P. Bivens Mr. Bivens, 21, has had ITDM since 1998. His endocrinologist examined him in 2014 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Bivens understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Bivens meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2014 and certified that he does not have diabetic retinopathy. He holds an operator’s license from Tennessee. Everett D. Blevins Mr. Blevins, 50, has had ITDM since 1994. His endocrinologist examined him in 2014 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Blevins understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Blevins meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2014 and certified that he does not have diabetic retinopathy. He holds an operator’s license from Kentucky. Kevin K. Brown Mr. Brown, 36, has had ITDM since 2013. His endocrinologist examined him in 2014 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or E:\FR\FM\28NON1.SGM 28NON1

Agencies

[Federal Register Volume 79, Number 229 (Friday, November 28, 2014)]
[Notices]
[Pages 70917-70920]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28071]


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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2006-25854; FMCSA-2011-0389; FMCSA-2012-0294; FMCSA-
2013-0109]


Qualification of Drivers; Exemption Applications; Epilepsy and 
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

-----------------------------------------------------------------------

SUMMARY: FMCSA announces its decision to grant requests from five 
individuals for exemptions from the regulatory requirement that 
interstate commercial motor vehicle (CMV) drivers have ``no established 
medical history or clinical diagnosis of epilepsy or any other 
condition which is likely to cause loss of consciousness or any loss of 
ability to control a CMV.'' The regulation and the associated advisory 
criteria published in the Code of Federal Regulations as the 
``Instructions for Performing and Recording Physical Examinations'' 
have resulted in numerous drivers being prohibited from operating CMVs 
in interstate commerce based on the fact that they have had one or more 
seizures and are taking anti-seizure medication, rather than an 
individual analysis of their circumstances by a qualified medical 
examiner. The Agency concluded that granting exemptions for these CMV 
drivers will provide a level of safety that is equivalent to or greater 
than the level of safety maintained without the exemptions. FMCSA 
grants exemptions that will allow these five individuals to operate 
CMVs in interstate commerce for a 2-year period. The exemptions preempt 
State laws and regulations and may be renewed.

DATES: The exemptions are effective November 28, 2014. The exemptions 
expire on November 28, 2016.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Division Chief, 
Physical Qualifications, Office of Medical Programs, (202) 366-4001, 
fmcsamedical@dot.gov, FMCSA, Department of Transportation, 1200 New 
Jersey Avenue SE., Room W64-224, Washington, DC 20590-0001. Office 
hours are 8:30 a.m. to 5 p.m., e.t., Monday through Friday, except 
Federal holidays.

SUPPLEMENTARY INFORMATION: 

A. Electronic Access

    You may see all the comments online through the Federal Document 
Management System (FDMS) at: https://www.regulations.gov.
    Docket: For access to the docket to read background documents or 
comments, go to https://www.regulations.gov and/or Room W12-140 on the 
ground level of the West Building, 1200 New Jersey Avenue SE., 
Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday, 
except Federal holidays.
    Privacy Act: Anyone may search the electronic form of all comments 
received into any of DOT's dockets by the name of the individual 
submitting the comment (or of the person signing the comment, if 
submitted on behalf of an association, business, labor union, or other 
entity). You may review DOT's complete Privacy Act Statement in the 
Federal Register (73 FR 3316, January 17, 2008). This statement is also 
available at https://Docketinfo.dot.gov.

B. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption 
from the safety regulations for a 2-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 statute also allows the Agency to renew exemptions at 
the end of the 2-year period.
    FMCSA grants five individuals an exemption from the regulatory 
requirement in Sec.  391.41(b)(8), to allow these individuals who take 
anti-seizure medication to operate CMVs in interstate commerce for a 2-
year period. The Agency's decision on these exemption applications is 
based on an individualized assessment of each applicant's medical 
information, including the root cause of the respective seizure(s), the 
length of time elapsed since the individual's last seizure, and each 
individual's treatment regimen. In addition, the Agency reviewed each 
applicant's driving record found in the Commercial Driver's License 
Information System (CDLIS) \1\

[[Page 70918]]

for commercial driver's license (CDL) holders, and interstate and 
intrastate inspections recorded in Motor Carrier Management Information 
System (MCMIS).\2\ For non-CDL holders, the Agency reviewed the driving 
records from the State licensing agency. The Agency acknowledges the 
potential consequences of a driver experiencing a seizure while 
operating a CMV. However, the Agency believes the drivers covered by 
the exemptions granted here have demonstrated that they are unlikely to 
have a seizure and their medical condition does not pose a risk to 
public safety.
---------------------------------------------------------------------------

    \1\ Commercial Driver License Information System (CDLIS) is an 
information system that allows the exchange of commercial driver 
licensing information among all the States. CDLIS includes the 
databases of fifty-one licensing jurisdictions and the CDLIS Central 
Site, all connected by a telecommunications network.
    \2\ Motor Carrier Management Information System (MCMIS) is an 
information system that captures data from field offices through 
SAFETYNET, CAPRI, and other sources. It is a source for FMCSA 
inspection, crash, compliance review, safety audit, and registration 
data.
---------------------------------------------------------------------------

    In reaching the decision to grant these exemption requests, the 
Agency considered both current medical literature and information and 
the 2007 recommendations of the Agency's Medical Expert Panel (MEP). 
The Agency previously gathered evidence for potential changes to the 
regulation at 49 CFR 391.41(b)(8) by conducting a comprehensive review 
of scientific literature that was compiled into the ``Evidence Report 
on Seizure Disorders and Commercial Vehicle Driving'' (Evidence Report) 
[CD-ROM HD TL230.3 .E95 2007]. The Agency then convened a panel of 
medical experts in the field of neurology (the MEP) on May 14-15, 2007, 
to review 49 CFR 391.41(b)(8) and the advisory criteria regarding 
individuals who have experienced a seizure, and the 2007 Evidence 
Report. The Evidence Report and the MEP recommendations are published 
on-line at https://www.fmcsa.dot.gov/rules-regulations/topics/mep/mep-reports.htm, under Seizure Disorders, and are in the docket for this 
notice.

MEP Criteria for Evaluation

    On October 15, 2007, the MEP issued the following recommended 
criteria for evaluating whether an individual with epilepsy or a 
seizure disorder should be allowed to operate a CMV.\3\ The MEP 
recommendations are included in previously published dockets.
---------------------------------------------------------------------------

    \3\ Engel, J., Fisher, R.S., Krauss, G.L., Krumholz, A., and 
Quigg, M.S., ``Expert Panel Recommendations: Seizure Disorders and 
Commercial Motor Vehicle Driver Safety,'' FMCSA, October 15, 2007.
---------------------------------------------------------------------------

    Epilepsy diagnosis. If there is an epilepsy diagnosis, the 
applicant should be seizure-free for 8 years, on or off medication. If 
the individual is taking anti-seizure medication(s), the plan for 
medication should be stable for 2 years. Stable means no changes in 
medication, dosage, or frequency of medication administration. 
Recertification for drivers with an epilepsy diagnosis should be 
performed every year.
    Single unprovoked seizure. If there is a single unprovoked seizure 
(i.e., there is no known trigger for the seizure), the individual 
should be seizure-free for 4 years, on or off medication. If the 
individual is taking anti-seizure medication(s), the plan for 
medication should be stable for 2 years. Stable means no changes in 
medication, dosage, or frequency of medication administration. 
Recertification for drivers with a single unprovoked seizure should be 
performed every 2 years.
    Single provoked seizure. If there is a single provoked seizure 
(i.e., there is a known reason for the seizure), the Agency should 
consider specific criteria that fall into the following two categories: 
low-risk factors for recurrence and moderate-to-high risk factors for 
recurrence.
     Examples of low-risk factors for recurrence include 
seizures that were caused by a medication; by non-penetrating head 
injury with loss of consciousness less than or equal to 30 minutes; by 
a brief loss of consciousness not likely to recur while driving; by 
metabolic derangement not likely to recur; and by alcohol or illicit 
drug withdrawal.
     Examples of moderate-to-high-risk factors for recurrence 
include seizures caused by non-penetrating head injury with loss of 
consciousness or amnesia greater than 30 minutes, or penetrating head 
injury; intracerebral hemorrhage associated with a stroke or trauma; 
infections; intracranial hemorrhage; post-operative complications from 
brain surgery with significant brain hemorrhage; brain tumor; or 
stroke.

The MEP report indicates individuals with moderate to high-risk 
conditions should not be certified. Drivers with a history of a single 
provoked seizure with low risk factors for recurrence should be 
recertified every year.

Medical Review Board Recommendations and Agency Decision

    FMCSA presented the MEP's findings and the Evidence Report to the 
Medical Review Board (MRB) for consideration. The MRB reviewed and 
considered the 2007 ``Seizure Disorders and Commercial Driver Safety'' 
evidence report and the 2007 MEP recommendations. The MRB recommended 
maintaining the current advisory criteria, which provide that ``drivers 
with a history of epilepsy/seizures off anti-seizure medication and 
seizure-free for 10 years may be qualified to drive a CMV in interstate 
commerce. Interstate drivers with a history of a single unprovoked 
seizure may be qualified to drive a CMV in interstate commerce if 
seizure-free and off anti-seizure medication for a 5 year period or 
more'' [Advisory criteria to 49 CFR 391.43(f)].
    The Agency acknowledges the MRB's position on the issue but 
believes relevant current medical evidence supports a less conservative 
approach. The medical advisory criteria for epilepsy and other seizure 
or loss of consciousness episodes was based on the 1988 ``Conference on 
Neurological Disorders and Commercial Drivers'' (NITS Accession No. 
PB89-158950/AS). A copy of the report can be found in the docket 
referenced in this notice.
    The MRB's recommendation treats all drivers who have experienced a 
seizure the same, regardless of individual medical conditions and 
circumstances. In addition, the recommendation to continue prohibiting 
drivers who are taking anti-seizure medication from operating a CMV in 
interstate commerce does not consider a driver's actual seizure history 
and time since the last seizure. The Agency has decided to use the 2007 
MEP recommendations as the basis for evaluating applications for an 
exemption from the seizure regulation on an individual, case-by-case 
basis.

C. Exemptions

    Following individualized assessments of the exemption applications, 
including a review of detailed follow-up information requested from 
each applicant, FMCSA is granting exemptions from 49 CFR 391.41(b)(8) 
to five individuals. Under current FMCSA regulations, all of the five 
drivers receiving exemptions from 49 CFR 391.41(b)(8) would have been 
considered physically qualified to drive a CMV in interstate commerce 
except that they presently take or have recently stopped taking anti-
seizure medication. For these five drivers, the primary obstacle to 
medical qualification was the FMCSA Advisory Criteria for Medical 
Examiners, based on the 1988 ``Conference on Neurological Disorders and 
Commercial Drivers,'' stating that a driver should be off anti-seizure 
medication in order to drive in interstate commerce. In fact, the 
Advisory Criteria have little if anything to do with the actual risk of 
a seizure and more to do with assumptions about individuals who are 
taking anti-seizure medication.
    In addition to evaluating the medical status of each applicant, 
FMCSA evaluated the crash and violation data

[[Page 70919]]

for the five drivers, some of whom currently drive a CMV in intrastate 
commerce. The CDLIS and MCMIS were searched for crash and violation 
data on the five applicants. For non-CDL holders, the Agency reviewed 
the driving records from the State licensing agency.
    These exemptions are contingent on the driver maintaining a stable 
treatment regimen and remaining seizure-free during the 2-year 
exemption period. The exempted drivers must submit annual reports from 
their treating physicians attesting to the stability of treatment and 
that the driver has remained seizure-free. The driver must undergo an 
annual medical examination by a medical examiner, as defined by 49 CFR 
390.5, following the FCMSA's regulations for the physical 
qualifications for CMV drivers.
    FMCSA published a notice of receipt of application and requested 
public comment during a 30-day public comment period in a Federal 
Register notice for each of the applicants. A short summary of the 
applicants' qualifications and a discussion of the comments received 
follows this section. For applicants who were denied an exemption, a 
notice will be published at a later date.

D. Comments

Docket # FMCSA-2006-25854

    On August 9, 2007, FMCSA published a notice of receipt of exemption 
applications and requested public comment on nine individuals (72 FR 
44916; Docket number FMCSA-2006-25854). The comment period ended on 
September 10, 2007. Five comments were received. A discussion of the 
comments were presented in a previous notice. Of the nine applicants, 
five were previously granted exemptions, one withdrew his request, and 
two were denied. The Agency has determined that the following applicant 
should be granted an exemption.
Jay Whitehead
    Mr. Whitehead is a 51 year-old class B CDL holder in New York. He 
has a history of seizures and has remained seizure free since 1983. He 
takes anti-seizure medication with the dosage and frequency remaining 
the same for over 2 years. If granted the exemption, he would like to 
continue to drive a CMV. His physician states he is supportive of Mr. 
Whitehead receiving an exemption.

Docket # FMCSA-2011-0389

    On January 5, 2012, FMCSA published a notice of receipt of 
exemption applications and requested public comment on 15 individuals 
(77 FR 33781; Docket number FMCSA-2011-0389). The comment period ended 
on February 5, 2012. Seven comments were received. A discussion of the 
comments were presented in a previous notice. Of the 15 applicants, 
three were previously granted exemptions. FMCSA has determined that the 
following applicant should be granted an exemption. The Agency will 
issue a decision on the other drivers at a later date.
Lonnie Rieker
    Mr. Rieker is a 55 year-old class A CDL holder in Illinois. He has 
a history of a single seizure and has remained seizure free for 4 
years. He takes anti-seizure medication with the dosage and frequency 
remaining the same for over 2 years. If granted the exemption, he would 
like to continue to drive a CMV. His physician states he is supportive 
of Mr. Rieker receiving an exemption.

Docket # FMCSA-2012-0294

    On January 15, 2013, FMCSA published a notice of receipt of 
exemption applications and requested public comment on nine individuals 
(78 FR 00712; Docket number FMCSA-2012-0294). The comment period ended 
on February 15, 2013. Eight comments were received, including three 
duplicate comments. A discussion of the comments were presented in a 
previous notice. Of the nine applicants, eight were previously granted 
exemptions. FMCSA has determined that the following applicant should be 
granted an exemption.
Michael Ranalli
    Mr. Ranalli is a 29 year-old driver in Pennsylvania. He has a 
history of juvenile epilepsy and has remained seizure free for 8 years. 
He takes anti-seizure medication with the dosage and frequency 
remaining the same since that time. If granted the exemption, he would 
like to drive a CMV. His physician states he is supportive of Mr. 
Ranalli receiving an exemption.

Docket # FMCSA-2013-0109

    On November 13, 2013, FMCSA published a notice of receipt of 
exemption applications and requested public comment on 11 individuals 
(78 FR 68144). The comment period ended on December 13, 2013. No 
commenters responded to this Federal Register notice. Of the 11 
applicants, four were previously granted exemptions. FMCSA has 
determined that the following two applicants should be granted an 
exemption. The Agency will issue a decision on the other drivers at a 
later date.
Jeffrey Ballweg
    Mr. Ballweg is 51 year-old driver in Wisconsin. He has a history of 
epilepsy and has remained seizure free for 8 years. He takes anti-
seizure medication with the dosage and frequency remaining the same for 
over 2 years. If granted the exemption, he would like to drive a CMV. 
His physician states he is supportive of Mr. Ballweg receiving an 
exemption.
Bryan Couture
    Mr. Couture is a 48 year-old class B CDL holder in Rhode Island. He 
has a history of seizure and has remained seizure free for 10 years. He 
takes anti-seizure medication with the dosage and frequency remaining 
the same for over 2 years. If granted the exemption, he would like to 
continue to drive a CMV. His physician states he is supportive of Mr. 
Couture receiving an exemption.

E. Basis for Exemption

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption 
from the epilepsy/seizure standard in 49 CFR 391.41(b)(8) if the 
exemption is likely to achieve an equivalent or greater level of safety 
than would be achieved without the exemption. Without the exemption, 
applicants will continue to be restricted to intrastate driving. With 
the exemption, applicants can drive in interstate commerce. Thus, the 
Agency's analysis focuses on whether an equal or greater level of 
safety is likely to be achieved by permitting each of these drivers to 
drive in interstate commerce as opposed to restricting the driver to 
driving in intrastate commerce.

Conclusion

    The Agency is granting exemptions from the epilepsy standard, 49 
CFR 391.41(b)(8), to five individuals based on a thorough evaluation of 
each driver's qualifications, safety experience, and medical condition. 
Safety analysis of information relating to these five applicants meets 
the burden of showing that granting the exemptions would achieve a 
level of safety that is equivalent to or greater than the level that 
would be achieved without the exemption. By granting the exemptions, 
the interstate CMV industry will gain five highly trained and 
experienced drivers. In accordance with 49 U.S.C. 31315(b)(1), each 
exemption will be valid for 2 years, with annual recertification 
required unless revoked earlier by FMCSA. The exemption will be revoked 
if the following occurs: (1)

[[Page 70920]]

The person fails to comply with the terms and conditions of the 
exemption; (2) the exemption has resulted in a lower level of safety 
than was maintained prior to being granted; or (3) continuation of the 
exemption would not be consistent with the goals and objectives of 49 
U.S.C. 31136 and 31315.
    FMCSA exempts the following five drivers for a period of 2 years 
with annual medical certification required: Jeffrey Ballweg (WI); Bryan 
Couture (RI); Michael Ranalli (PA); Lonnie Rieker (IL); and Jay 
Whitehead (NY) from the prohibition of CMV operations by persons with a 
clinical diagnosis of epilepsy or seizures. If the exemption is still 
in effect at the end of the 2-year period, the person may apply to 
FMCSA for a renewal under procedures in effect at that time.

    Issued on: November 21, 2014.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2014-28071 Filed 11-26-14; 8:45 am]
BILLING CODE 4910-EX-P
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