[Federal Register: September 2, 2005 (Volume 70, Number 170)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
[FMCSA Docket No. FMCSA-2005-20721]
Qualification of Drivers; Exemption Applications; Diabetes
AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.
ACTION: Notice of final disposition.
SUMMARY: FMCSA announces its decision to exempt four individuals from
its rule prohibiting persons with insulin-treated diabetes mellitus
(ITDM) from operating commercial motor vehicles (CMVs) in interstate
commerce. The exemptions will enable these individuals to qualify as
drivers of CMVs in interstate commerce.
DATES: The exemptions are effective September 2, 2005. The exemptions
expire on September 3, 2007.
FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Office of Bus and
Truck Standards and Operations, (202) 366-4001, FMCSA, Department of
Transportation, 400 Seventh Street, SW., Washington, DC 20590-0001.
Office hours are from 8 a.m. to 5 p.m., e.t., Monday through Friday,
except Federal holidays.
You may see all the comments online through the Document Management
System (DMS) at: http://dmses.dot.gov.
Docket: For access to the docket to read background documents or
comments received, go to http://dms.dot.gov and/or Room PL-401 on the
plaza level of the Nassif Building, 400 Seventh Street, SW.,
Washington, DC, between 9 a.m. and 5 p.m., 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 (65 FR 19477, Apr. 11, 2000). This statement is also
available at http://dms.dot.gov.
Authority To Grant Exemptions
Section 4007 of the Transportation Equity Act for the 21st Century
(Pub. L. 105-178, 112 Stat. 107, June 9, 1998) amended 49 U.S.C. 31315
and 31136(e) to provide FMCSA with authority to grant exemptions from
its safety regulations. On December 8, 1998, the Federal Highway
Administration's Office of Motor Carriers, the predecessor to FMCSA,
published an interim final rule implementing section 4007 (63 FR
67600). On August 20, 2004, FMCSA published a Final Rule (69 FR 51589)
on this subject. By this rule, FMCSA must publish a notice of each
exemption request in the Federal Register (49 CFR part 381).
The agency must provide the public with an opportunity to inspect
the information relevant to the application, including any safety
analyses that have been conducted. The agency must also provide an
opportunity for public comment on the request.
The agency must then examine the safety analyses and the public
comments, and determine whether the exemption would achieve a level of
safety equivalent to, or greater than, the level that would be achieved
by complying with the current regulation (49 CFR 381.305). The Agency's
decision must be published in the Federal Register (49 CFR 381.315(b)).
If the agency denies the request, it must state the reason for doing
so. If the decision is to grant the exemption, the notice must specify
the person or class of persons receiving the exemption, and the
regulatory provision or provisions from which an exemption is being
granted. The notice must also specify the effective period of the
exemption (up to two years), and explain the terms and conditions of
the exemption. The exemption may be renewed (49 CFR 381.300(b)).
Establishment of FMCSA's Diabetes Exemption Program
FMCSA published a notice of intent to issue exemptions to drivers
with ITDM on July 31, 2001 (66 FR 39548). On September 3, 2003, the
agency published a notice of final disposition announcing its decision
to issue exemptions to certain insulin-using diabetic drivers of CMVs
from the diabetes mellitus prohibition under 49 CFR 391.41(b)(3). [68
FR 5241] The notice of final disposition explained that in considering
exemptions, FMCSA must ensure that the issuance of diabetes exemptions
will not be contrary to the public interest and that the exemption
achieves an acceptable level of safety. The agency indicated it will
only grant exemptions to insulin-using diabetic drivers that meet the
eligibility criteria provided in its notice of final disposition.
Because FMCSA established eligibility criteria for use in
determining whether the granting of a diabetes exemption would achieve
the requisite level of safety, the agency only publishes for public
comment, the names of exemption applicants that satisfy the eligibility
requirements, based upon the information provided by the applicant.
Applicants that do not meet the requirements are notified by letter
that their applications are denied and the agency periodically
publishes the names of those individuals to satisfy the statutory
requirement for disclosing such information to the public.
On May 5, 2005, FMCSA published a notice of receipt of diabetes
exemption applications from five individuals, and requested comments
from the public (70 FR 20721). The five individuals are: Gerald E. Huelle, Lee R. Kumm,
Mitchell L. Pullen, Charles E. Wheat, Sr. and Steven R. Zoller. The
public comment period closed on June 6, 2005. Five comments were
received, and fully considered by FMCSA in reaching the final decision
to grant the exemptions.
FMCSA has evaluated the eligibility criteria of the five
applications and made a determination that granting the exemptions to
these individuals would achieve a level of safety equivalent to, or
greater than, the level that would be achieved by complying with the
current regulation 49 CFR 391.41(b)(3). One applicant, Charles E.
Wheat, notified FMCSA that he has discontinued use of insulin and
withdrew his application for an exemption.
Diabetes Mellitus and Driving Experience of the Applicants
The agency established the current standard for diabetes in 1970
because several risk studies indicated that diabetic drivers had a
higher rate of crash involvement than the general population. The
diabetes rule provides that: A person is physically qualified to drive
a commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control (49 CFR 391.41(b)(3)).
FMCSA established its diabetes exemption program, based on the
agency's July 2000 study entitled "A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century." The report concluded that a
safe and practicable protocol to allow some insulin-treated diabetic
drivers to operate CMVs is feasible. The September 3, 2003, notice of
final disposition provides the protocol for allowing such drivers to
operate CMVs in interstate commerce.
These four applicants have had ITDM for 4 to 37 years. These
applicants report no more than one hypoglycemic reaction that resulted
in loss of consciousness or seizure, that required the assistance of
another person, or resulted in impaired cognitive function without
warning symptoms in the past 5 years (with one year of stability
following any such episode). In each case, an endocrinologist has
verified the driver's demonstrated willingness to properly monitor and
manage their diabetes. These drivers report no other disqualifying
conditions, including diabetes-related complications. Each meets the
vision standard at 49 CFR 391.41(b)(10).
The four applicants have driven CMVs with their ITDM for careers
ranging from 4 to 37 years. While possessing a valid commercial
driver's license (CDL) or non-CDL to operate a CMV, they have been
authorized to drive in intrastate commerce, even though their ITDM
disqualifies them from driving in interstate commerce. Before issuing
CDLs, States subject drivers to knowledge and performance tests
designed to evaluate their qualifications to operate a CMV. These
applicants satisfied testing standards for their State of residence. In
the past 3 years, one of the drivers has had a conviction for a traffic
violation (speeding), and no crashes were reported.
The qualifications, experience, and medical condition of each
applicant were stated and discussed in detail in the May 5, 2005,
notice (70 FR 23904). Because there were no docket comments on the
specific merits or qualifications of any applicant, we have not
repeated the individual profiles here.
Basis for Exemption Determination
Under 49 U.S.C. 31315 and 31136(e), FMCSA may grant an exemption
from the diabetes standard in 49 CFR 391.41(b)(3) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. The exemption allows the applicants
to operate CMVs in interstate commerce.
To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, as
well as driving records and experience with ITDM. To qualify for an
exemption from the diabetes standard, FMCSA requires verifiable
evidence that he or she has driven a commercial vehicle safely with
ITDM for 3 years.
The applicants' intrastate driving experience and history provide
an adequate basis for validating their ability to drive safely in
interstate commerce. Consequently, FMCSA finds that exempting these
applicants from the diabetes standard in 49 CFR 391.41(b)(3) is likely
to achieve a level of safety equal to that existing without the
exemption. The agency is granting the exemptions for the 2-year period
allowed by 49 U.S.C. 31315 and 31136(e) to Gerald E. Huelle, Lee R.
Kumm, Mitchell L. Pullen and Steven R. Zoller.
Conditions and Requirements
The terms and conditions of the exemption will be provided to the
applicants in the exemption document.
Discussion of Comments
FMCSA received five comments in this proceeding. The comments were
considered and are discussed below.
Medical Requirements and Documentation
Two physicians and one professional medical society commented on
specific issues relative to medical requirements for diabetes exemption
(1) Dr. Brahman Levy, M.D. commented on the importance of
ascertaining the level of glucose control, such as with glycosylated
hemoglobin (HgbA1c) levels, and asked how co-morbid medical conditions,
(e.g., hypertension, obesity) would be considered in the application
FMCSA requires each applicant for a diabetes exemption to submit
two measures of HgbA1c, to confirm the endocrinologist's report of
applicant ability to adequately control blood glucose levels. Each
applicant is required to submit documentation by an endocrinologist who
has conducted a complete medical examination. The applicant must also
submit documentation from an examining physician stating he or she has
no other disqualifying conditions, including diabetes-related
(2) Dr. Daniel E. Jimenez, M.D. asked for detailed medical
information about each of the applicants, and information about the
type of driving performed (e.g., intracity, intrastate, interstate).
Dr. Jimenez opposes granting exemptions to drivers with ITDM in
general, because (1) the demands of commercial driving make it
difficult to maintain vigilance over meal schedules and types of food
to eat; (2) these drivers may have demonstrated non-compliance (with
treatment, health regimen), and (3) drivers with ITDM are likely to
have co-morbid conditions.
FMCSA has examined detailed medical information about each of the
applicants as specified in the notice of final disposition announcing
FMCSA's decision to issue exemptions to certain insulin-using diabetic
drivers published September 3, 2003 (68 FR 52441), but has not included
the details in the notice of applications in accordance with the Health
Insurance Portability and Accountability Act of 1996 (Pub. L. 104-191,
also known as HIPAA) (45 CFR 160.102). This is the citation for the
implementing regulations listed by the United States Department of
Health and Human Services. The issue of comorbidity is addressed in
previous discussion (refer to Levy comments).
(3) The American College of Occupational and Environmental Medicine (ACOEM) states that (1) the medical documentation of each
applicant should be reviewed by a physician who understands the safety
risks inherent in commercial operations or the criteria for the
evaluation should be included in the summary of each driver's
qualifications published in the Federal Register and (2) additional
medical testing and evaluation is merited (e.g., exercise stress test,
cardiac and renal function assessment).
In response to ACOEM's first comment, the notice of final
disposition published on September 3, 2003 (68 FR 52441), requires each
applicant to be examined by an endocrinologist who performs a complete
medical examination, including a comprehensive evaluation of the
applicant's medical history and current status, and evaluation by an
ophthalmologist or optometrist. As indicated previously, all applicant
health data were not published in accordance with HIPPA. Close
monitoring of these drivers with ITDM by an endocrinologist and other
medical specialists, as well as physical qualification by a medical
examiner, are required.
Americans With Disabilities Act
The American Diabetes Association expressed concerns about the
application process for the exemption program. The American Diabetes
Association also alleged discrimination against drivers with ITDM.
FMCSA has developed a plan and initiated numerous improvements in
the application process for exemption program applicants, including the
initiation of work on web-based solutions to streamline the application
process and work on re-evaluating the eligibility and monitoring
criteria. FMCSA notes that the Safe, Accountable, Flexible, and
Efficient Transportation Equity Act of 2005: A Legacy for Users
(SAFETEA-LU) provides specific changes to the driving requirement for
interstate operators with ITDM. These changes eliminate the three-year
CMV driving requirement and significantly reduce the required time for
management of the diabetic condition with insulin treatment.
FMCSA's exemption process supports drivers with ITDM who seek to
operate in interstate commerce. In addition, the FMCSRs are not
contrary to the Americans with Disabilities Act (ADA) of 1990. The
mandates of the ADA do not require that FMCSA alter the driver
qualification requirements contained in 49 CFR Part 391. The Senate
report on the ADA, submitted by its Committee on Labor and Human
Resources, included the following explanation:
With respect to covered entities subject to rules promulgated by
the Department of Transportation regarding physical qualifications
for drivers of certain classifications of motor vehicles, it is the
Committee's intent that a person with a disability applying for or
currently holding a job subject to these standards must be able to
satisfy these physical qualification standards in order to be
considered a qualified individual with a disability under Title I of
this legislation. S. Rep. 101-116, at 27 (1989).
Ability To Predict Safety Outcomes
The Advocates for Highway and Auto Safety (Advocates) oppose
granting exemptions to drivers with ITDM. Major areas of concern
include: (1) Past driving history is not a predictor for future safe
driving capability, (2) reliance upon previous three-year driving
record is an inaccurate screening criterion, and (3) concern is
significant about individual driver ability to monitor individual blood
sugar while operating commercial (particularly long-haul) vehicles.
In response to the first two comments, the agency considers
previous driving experience to be an appropriate means for predicting
future performance, and monitors the driving record through the
Commercial Driver's License Information System (CDLIS). CDLIS is a
computer system linked to individual databases maintained by the 51
jurisdictions in the United States. In response to the third comment,
the agency relies on the expert medical opinion of the endocrinologist
and the medical examiner, who are required to analyze individual
ability to control and manage the diabetic condition, including the
individual ability and willingness of the driver to monitor blood
glucose level on an ongoing basis.
Advocates also referred to comments filed with docket no. FMCSA-
2001-9800-121 regarding the establishment of the Federal diabetes
exemption program. The agency responded to these comments in its
September 3, 2003, notice of final determination announcing the
establishment of the Federal diabetes exemption program.
After considering the comments to the docket and based upon its
evaluation of the four exemption applications, the FMCSA exempts Gerald
E. Huelle, Lee R. Kumm, Mitchell L. Pullen, and Steven R. Zoller from
the diabetes requirement in 49 CFR 391.41(b)(3), subject to the
conditions listed under "Conditions and Requirements" above.
In accordance with 49 U.S.C. 31315 and 31136(e), each exemption
will be valid for two years unless revoked earlier by the FMCSA. The
exemption will be revoked if: (1) 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 before it was granted;
or (3) continuation of the exemption would not be consistent with the
goals and objectives of 49 U.S.C. 31315 and 31136. If the exemption is
still effective at the end of the 2-year period, the person may apply
to the FMCSA for a renewal under procedures in effect at that time.
FMCSA notes that Section 4129 of SAFETEA-LU requires the agency to
initiate a rulemaking within 90 days of enactment to amend the Federal
physical qualifications rules for truck and bus drivers to allow
individuals who use insulin to treat their diabetes to operate CMVs in
interstate commerce. Therefore, FMCSA will initiate a rulemaking to
revise its safety regulations to allow certain insulin-treated diabetic
drivers to operate CMVs in interstate commerce.
The new rule would allow health care professionals to make
individual determinations about insulin-treated diabetics' ability to
safely operate a CMV in interstate commerce, based on guidelines
established by the agency, through a public notice-and-comment
rulemaking process. Upon completion of the rulemaking required by
section 4129, diabetic drivers would no longer be required to apply
for, or renew exemptions to operate CMVs in interstate commerce. Until
the agency issues a Final Rule, however, insulin-treated diabetic
drivers must continue to apply for exemptions from FMCSA, and request
renewals of such exemptions in a timely manner.
Issued on: August 29, 2005.
Warren E. Hoemann,
[FR Doc. 05-17466 Filed 9-1-05; 8:45 am]
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