[Federal Register Volume 70, Number 170 (Friday, September 2, 2005)]
[Notices]
[Pages 52465-52467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17466]


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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.

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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.

SUPPLEMENTARY INFORMATION:

Electronic Access

    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.

Background

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

[[Page 52466]]

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 
applicants.
    (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 
evaluation process.
    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 
complications.
    (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

[[Page 52467]]

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.

Conclusion

    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,
Deputy Administrator.
[FR Doc. 05-17466 Filed 9-1-05; 8:45 am]
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