Notice of final disposition entitled, "Qualification of Drivers; Exemption Applications; Diabetes" (68 FR 52441)

[FR Doc. 03–22426 Filed 9–2–03; 8:45 am]
BILLING CODE 3901–01–C

DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety
Administration
[Docket No. FMCSA–2001–9800]

Qualification of Drivers; Exemption
Applications; Diabetes
AGENCY: Federal Motor Carrier Safety
Administration (FMCSA), DOT.
ACTION: Notice of final disposition.
SUMMARY: This notice announces
FMCSA’s decision to issue exemptions
to certain insulin-using diabetic drivers

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of commercial motor vehicles (CMVs)
from the diabetes mellitus prohibitions
contained in the Federal Motor Carrier
Safety Regulations (FMCSRs). The
FMCSA will grant exemptions only to
those applicants who meet the specific
conditions and comply with all the
requirements of the exemption. The
FMCSA will issue exemptions for not
more than a period of two years. Upon
expiration, those holding exemptions
may apply to FMCSA for a renewal
under procedures in effect at that time.
The FMCSA is leaving the docket open
so that interested persons can provide
comments on any changes to the
specific conditions needed to qualify for
the exemption program.
DATES: This notice is effective on
September 3, 2003. FMCSA will begin

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52441

accepting applications for exemptions
on September 22, 2003.
ADDRESSES: Qualified insulin-treated
diabetes mellitus drivers may now
request a diabetes exemption from the
regulations of 49 CFR 391.41(b)(3) by
sending an exemption request to:
Diabetes Exemption Program (MC–PSP),
Office of Bus and Truck Standards and
Operations, Federal Motor Carrier Safety
Administration, 400 Seventh Street,
SW., Washington, DC 20590–0001.
FOR FURTHER INFORMATION CONTACT: Ms.
Sandra Zywokarte, Office of Bus and
Truck Standards and Operations, (202)
366–4001, FMCSA, 400 Seventh Street,
SW., Washington, DC 20590. Office
hours are from 7:45 a.m. to 4:15 p.m.,
e.t., Monday through Friday, except
Federal holidays.

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Federal Register / Vol. 68, No. 170 / Wednesday, September 3, 2003 / Notices

SUPPLEMENTARY INFORMATION:

Docket: For access to the docket to
read background documents or
comments received, go to http://
dms.dot.gov at any time, or to 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 is able to search
the electronic form of all comments
received into any of our dockets by the
name of the individual submitting the
comment (or signing the comment, if
submitted on behalf of an association,
business, labor union, etc.). You may
review the Department of
Transportation’s (DOT) complete
Privacy Act Statement in the Federal
Register published on April 11, 2000
(65 FR 19477), or you may visit http:/
/dms.dot.gov.
Background
The agency established the current
standard for diabetes in 1970 because
several risk studies indicated that
diabetic drivers had a higher rate of
accident involvement than the general
population. The diabetes requirement
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)).
Since 1970, the agency has considered
the diabetes requirement and
undertaken studies to determine if its
diabetes standard for commercial
drivers in interstate commerce should
be amended. It is FMCSA’s view that its
physical qualification standards should
be based on sound medical, scientific
and technological grounds, and that
individual determinations should be
made to the maximum extent possible
consistent with FMCSA’s responsibility
to ensure safety on the nation’s
highways. The FMCSA published a
notice of intent to issue exemptions to
insulin-using diabetic drivers in the
Federal Register on July 31, 2001 (66 FR
39548). This notice of intent discussed
the regulatory history and research
activity addressing the issue of diabetes
and CMV operation.
Feasibility Study To Qualify InsulinTreated Diabetics to Operate CMVs
Section 4018 of the Transportation
Equity Act for the 21st Century (TEA–
21) (Pub. L. 105–178, 112 Stat. 107)
directed the Secretary of Transportation
(the Secretary) to determine if it is
feasible to develop a safe and
practicable program for allowing

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individuals with insulin-treated
diabetes mellitus (ITDM) to operate
CMVs in interstate commerce. In
making the determination, the Secretary
was directed to evaluate research and
other relevant information on the effects
of ITDM on driving performance. TEA–
21 stated that, to accomplish this, the
Secretary shall consult the states with
regard to their programs for CMV
operation by ITDM drivers, evaluate the
DOT policies in other modes of
transportation, analyze pertinent risk
data, consult with interested groups
knowledgeable about diabetes and
related issues, and assess the possible
legal consequences of permitting ITDM
individuals to operate CMVs in
interstate commerce. TEA–21 also
directed the Secretary to report the
findings to Congress and, if a program
is feasible, describe the elements of a
protocol to permit individuals with
ITDM to operate CMVs. The FMCSA
submitted the report to Congress on
August 23, 2000. It is entitled ‘‘A Report
to Congress on the Feasibility of a
Program to Qualify Individuals with
Insulin Treated Diabetes Mellitus to
Operate Commercial Motor Vehicles in
Interstate Commerce as Directed by the
Transportation Equity Act for the 21st
Century,’’ July 2000 (TEA–21 Report to
Congress). It concludes that a safe and
practicable protocol to allow some
ITDM individuals to operate CMVs is
feasible. For a detailed discussion of the
report findings and conclusions, see
July 31, 2001 (66 FR 39548). A copy of
the report is on FMCSA’s Web site at
www.fmcsa.dot.gov/rulesregs/
medreports.htm.
Authority—Exemptions
Under 49 U.S.C. 31315 and 31136(e),
FMCSA may grant an exemption for a
period up to two 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.’’ The statute
also allows the agency to renew
exemptions at the end of the two-year
period, or after the current exemption
expires.
FMCSA must publish a notice in the
Federal Register for each exemption
requested, explaining that the request
has been filed, and providing the public
an opportunity to inspect the safety
analysis and any other relevant
information known to the agency, and
comment on the request. Prior to
granting a request for an exemption, the
agency must publish a notice in the
Federal Register identifying the person
or class of persons who will receive the
exemption, the provisions from which
the person will be exempt, the effective

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period, and all terms and conditions of
the exemption. The terms and
conditions established by FMCSA must
ensure that the exemption will likely
achieve a level of safety that is
equivalent to, or greater than, the level
that would be achieved by complying
with the regulation.
In addition, the agency is required to
monitor the implementation of each
exemption to ensure compliance with
its terms and conditions. If FMCSA
denies a request for an exemption, the
agency must periodically publish a
notice in the Federal Register
identifying the person(s) whom the
agency denied the exemption to and the
reasons for the denial.
Generally, the duration of exemptions
is limited to two years from the date of
approval, but may be renewed. FMCSA
is required to immediately revoke an
exemption 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 the exemption was
granted; or
(3) Continuation of the exemption
would not be consistent with the goals
and objectives of the regulations issued
under the authority of 49 U.S.C. 31315
and 31136(e).
Process for Applying for an Exemption
The procedures for applying for an
exemption may be found at 49 CFR
381.300 through 381.330. The person
applying for an exemption is required to
send a written request to the FMCSA
Administrator. The written request must
include basic information such as the
identity of the person who would be
covered by the exemption, the name of
the motor carrier or other entity that
would be responsible for the use or
operation of CMVs during the
exemption period, and the principal
place of business of the motor carrier or
other entity. Under section 381.310, the
application must include a written
statement that:
(1) Describes the event or CMV
operation for which the exemption
would be used;
(2) Identifies the regulation from
which the applicant is requesting relief;
(3) Estimates the total number of
drivers and CMVs that would be
operating under the terms and
conditions of the exemption; and
(4) Explains how the recipient of the
exemption would ensure that they
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.

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FMCSA Procedures for the Review of
Exemption Applications
Section 381.315 requires FMCSA to
review an application for an exemption
and prepare, for the Administrator’s
signature, a Federal Register notice
requesting public comment. After a
review of the comments received,
FMCSA staff will make a
recommendation to the Administrator.
FMCSA will publish a notice of the
Administrator’s final decision in the
Federal Register. FMCSA will issue a
final decision within 180 days of the
date it receives an individual’s
completed application. However, if the
applicant should omit important details
or other information necessary for the
agency to conduct a comprehensive
evaluation, FMCSA will issue a final
decision within 180 days of the date
that it receives sufficient information
(49 CFR 381.315 and 381.320). FMCSA
recognizes that this potential six-month
waiting period may seem burdensome.
However, the agency must carefully
evaluate each and every application for
regulatory relief from the diabetes
standard, to assess the potential safety
performance of each applicant. In
addition, the agency must prepare and
submit the candidate’s application for
public notice and comment in the
Federal Register and then evaluate
comments received before making a
final decision. FMCSA’s overriding
concern is to ensure the safety of
interstate CMV operations. The agency
will notify all applicants in writing once
it makes a final decision.
Application Information
In considering exemptions, the
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 FMCSA will only
grant exemptions, therefore, to ITDM
individuals who meet certain
conditions. These conditions are set
forth below and the FMCSA based the
conditions on the research literature,
relevant DOT and State exemption
programs, and substantial medical input
from a panel of endocrinologists.
FMCSA will require applicants for an
exemption from the ITDM prohibition to
submit their applications in a letter
(there will be no application form),
include all supporting documentation,
and use the following format:
Vital Statistics
Name (First Name, Middle Initial, Last
Name).
Address (House Number and Street
Name, City, State, and ZIP Code).

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Telephone Number (Area Code and
Number).
Sex (Male or Female).
Date of Birth (Month, Day, Year).
Age.
Social Security Number.
State Driver’s License Number (List all
licenses held to operate a
commercial motor vehicle during
the 3-year period immediately
preceding the date of application).
Driver’s License Expiration Date.
Driver’s License Classification Code (If
not a commercial driver’s license
(CDL) classification code, specify
what vehicles may be operated
under such code).
Driver’s License Date of Issuance
(Month, Day, Year).
Experience
Number of years driving straight trucks.
Approximate number of miles per year
driving straight trucks.
Number of years driving tractor-trailer
combinations.
Approximate number of miles per year
driving tractor-trailer combinations.
Number of years driving buses.
Approximate number of miles per year
driving buses.
Present Employment
Employer’s Name (If Applicable).
Employer’s Address.
Employer’s Telephone Number.
Type of Vehicle Operated and GVWR
(Straight Truck, Tractor-Trailer
Combination, Bus).
Commodities Transported (e.g., General
Freight, Liquids in Bulk (in cargo
tanks), Steel, Dry-Bulk, Large Heavy
Machinery, Refrigerated Products).
Estimated number of miles driven per
week.
Estimated number of daylight driving
hours per week.
Estimated number of nighttime driving
hours per week.
States in which you will drive if issued
an exemption.
In addition, the applications must
include supporting documentation
showing that the applicant:
(1) Possesses a valid intrastate CDL or
a license (non-CDL) to operate a CMV;
(2) Has operated a CMV, with a
diabetic condition controlled by the use
of insulin, for the three-year period
immediately preceding application;
(3) Has a driving record for that threeyear period that:
Contains no suspensions or
revocations of the applicant’s driver’s
license for the operation of any motor
vehicle (including their personal
vehicle),
Contains no involvement in an
accident for which the applicant

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received a citation for a moving traffic
violation while operating a CMV,
Contains no involvement in an
accident for which the applicant
contributed to the cause of the accident,
and
Contains no convictions for a
disqualifying offense or more than one
serious traffic violation, as defined in 49
CFR 383.5, while operating a CMV;
(4) Has no other disqualifying
conditions including diabetes-related
complications;
(5) Has had no recurrent (two or more)
hypoglycemic reactions resulting in a
loss of consciousness or seizure within
the past five years. A period of one year
of demonstrated stability is required
following the first episode of
hypoglycemia;
(6) Has had no recurrent
hypoglycemic reactions requiring the
assistance of another person within the
past five years. A period of one year of
demonstrated stability is required
following the first episode of
hypoglycemia;
(7) Has had no recurrent
hypoglycemic reactions resulting in
impaired cognitive function that
occurred without warning symptoms
within the past five years. A period of
one year of demonstrated stability is
required following the first episode of
hypoglycemia,
(8) Has been examined by a boardcertified or board-eligible
endocrinologist (who is knowledgeable
about diabetes) who has conducted a
complete medical examination. The
complete medical examination must
consist of a comprehensive evaluation
of the applicant’s medical history and
current status with a report including
the following information:
(A) The date insulin use began,
(B) Diabetes diagnosis and disease
history,
(C) Hospitalization records,
(D) Consultation notes for diagnostic
examinations,
(E) Special studies pertaining to the
diabetes,
(F) Follow-up reports,
(G) Reports of any hypoglycemic
insulin reactions within the last five
years,
(H) Two measures of glycosylated
hemoglobin, the first 90 days before the
last and current measure,
(I) Insulin dosages and types, diet
utilized for control and any significant
factors such as smoking, alcohol use,
and other medications or drugs taken,
and
(J) Examinations to detect any
peripheral neuropathy or circulatory
insufficiency of the extremities;

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(9) Submits a signed statement from
an examining endocrinologist indicating
the following medical determinations:
The endocrinologist is familiar with
the applicant’s medical history for the
past five years, either through actual
treatment over that time or through
consultation with a physician who has
treated the applicant during that time,
The applicant has been using insulin
to control his/her diabetes from the date
of the application back to the date the
three years of driving experience began,
The applicant has been educated in
diabetes and its management,
thoroughly informed of and understands
the procedures which must be followed
to monitor and manage his/her diabetes
and what procedures should be
followed if complications arise, and
The applicant has the ability and has
demonstrated willingness to properly
monitor and manage his/her diabetes;
and
(10) Submits a separate signed
statement from an ophthalmologist or
optometrist that the applicant has been
examined and that the applicant does
not have diabetic retinopathy and meets
the vision standard at 49 CFR
391.41(b)(10), or has been issued a valid
medical exemption. If the applicant has
any evidence of diabetic retinopathy, he
or she must be examined by an
ophthalmologist and submit a separate
signed statement from the
ophthalmologist that he or she does not
have unstable proliferative diabetic
retinopathy (i.e., unstable advancing
disease of blood vessels in the retina).
Requirements for ITDM Individuals
Who Have Been Issued an Exemption
To Operate CMVs
There are special conditions attached
to the issuance of any exemption for
ITDM. The FMCSA will impose the
following requirements:
(1) Individuals with ITDM shall
maintain appropriate medical supplies
for glucose management while
preparing for the operation of a CMV
and during its operation. The supplies
shall include the following:
(A) An acceptable glucose monitor
with memory,
(B) Supplies needed to obtain
adequate blood samples and to measure
blood glucose,
(C) Insulin to be used as necessary,
and
(D) An amount of rapidly absorbable
glucose to be used as necessary;
(2) Individuals with ITDM shall
maintain a daily record of actual driving
time to correlate with the daily glucose
measurements; and
(3) Prior to and while driving, the
individual with ITDM shall adhere to

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the following protocol for monitoring
and maintaining appropriate blood
glucose levels:
Check glucose before starting to drive
and take corrective action if necessary.
If glucose is less than 100 milligrams
per deciliter (mg/dl), take glucose or
food and recheck in 30 minutes. Do not
drive if glucose is less than 100 mg/dl.
Repeat the process until glucose is
greater than 100 mg/dl;
While driving check glucose every
two to four hours and take appropriate
action to maintain it in the range of 100
to 400 mg/dl;
Have food available at all times when
driving. If glucose is less than 100 mg/
dl, stop driving and eat. Recheck in 30
minutes and repeat procedure until
glucose is greater than 100 mg/dl; and
If glucose is greater than 400 mg/dl,
stop driving until glucose returns to the
100 to 400 mg/dl range. If more than
two hours after last insulin injection
and eating, take additional insulin.
Recheck blood glucose in 30 minutes.
Do not resume driving until glucose is
less than 400 mg/dl.

(3) Provide on an annual basis
confirmation by an ophthalmologist or
optometrist that there is no diabetic
retinopathy and the individual meets
the current vision standards at 49 CFR
391.41(b)(10). If there is any evidence of
diabetic retinopathy, provide annual
documentation by an ophthalmologist
that the individual does not have
unstable proliferative diabetic
retinopathy;
(4) Submit annual documentation by
an endocrinologist of ongoing education
in management of diabetes and
hypoglycemia awareness;
(5) Report all episodes of severe
hypoglycemia, significant
complications, or inability to manage
diabetes; and
(6) Report any involvement in an
accident or any other adverse event
whether or not they are related to an
episode of hypoglycemia.

Monitoring for ITDM Individuals Who
Have Been Issued an Exemption To
Operate CMVs
In addition to the requirements for
controlling ITDM, FMCSA will monitor
exemption recipients during the period
that the exemption is valid. FMCSA will
conduct monitoring by requiring the
exemption recipients to submit the
following information to the Diabetes
Exemption Program, MC–PSP, Office of
Bus and Truck Standards and
Operations, Federal Motor Carrier Safety
Administration, 400 Seventh Street,
SW., Washington, DC 20590–0001:
(1) Provide written confirmation from
the endocrinologist on a quarterly basis:
(A) The make and model of the
glucose monitoring device with
memory;
(B) The individual’s blood glucose
measurements and glycosylated
hemoglobin are generally in an adequate
range based on:
a. All daily glucose measurements
taken with the glucose monitoring
device and correlated with the daily
records of driving time; and
b. A current measurement of
glycosylated hemoglobin.
(2) Submit on an annual basis, a
comprehensive medical evaluation by
an endocrinologist. The evaluation will
include a general physical examination
and a report of glycosylated hemoglobin
concentration. The evaluation will also
involve an assessment of the
individual’s willingness and ability to
monitor and manage the diabetic
condition;

Because diabetes is a chronic disease
requiring constant control and
monitoring, FMCSA will impose
conditions on ITDM individuals, who
have been issued an exemption, similar
to the provisions that apply to drivers
who participated in the agency’s
diabetes waiver program before March
31, 1996 under 49 CFR 391.64. The
required conditions include the
following:
(1) Each individual must have a
physical examination every year:
(a) The physical examination must
first be conducted by an endocrinologist
indicating the driver is:
1. Free of insulin reactions. ‘‘Free of
insulin reactions’’ in this context means
that the individual has had:
(A) No recurrent (two or more)
hypoglycemic reactions resulting in a
loss of consciousness or seizure within
the past five years. A period of one year
of demonstrated stability is required
following the first episode of
hypoglycemia,
(B) No recurrent hypoglycemic
reactions requiring the assistance of
another person within the past five
years. A period of one year of
demonstrated stability is required
following the first episode of
hypoglycemia, and
(C) No recurrent hypoglycemic
reactions resulting in impaired cognitive
function that occurred without warning
symptoms within the past five years. A
period of one year of demonstrated
stability is required following the first
episode of hypoglycemia,

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Medical Examination-Certificate of
Physical Examination for ITDM
Individuals Who Have Been Issued an
Exemption To Operate CMVs

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2. Able to and has demonstrated
willingness to properly monitor and
manage his/her diabetes, and
3. Will not likely suffer any
diminution in driving ability due to his/
her diabetic condition; and
(b) Secondly, the physical
examination must be conducted by a
medical examiner who attests that the
individual is physically qualified under
49 CFR 391.41, or holds a valid
exemption.
(2) Each individual must agree to and
must comply with the following
conditions:
(a) Carry a source of rapidly
absorbable glucose at all times while
driving;
(b) Self-monitor blood glucose levels
prior to driving and every two to four
hours while driving using a portable
glucose monitoring device equipped
with a computerized memory;
(c) Submit blood glucose records to
both the endocrinologist and medical
examiner at the annual examinations or
when otherwise directed by an
authorized agent of FMCSA; and
(d) Provide a copy of the
endocrinologist’s report to the medical
examiner at the time of the annual
medical examination; and
(3) Each individual must provide a
copy of the optometrist’s or
ophthalmologist’s report indicating that
there is no diabetic retinopathy and the
individual meets the current vision
standards at 49 CFR 391.41(b)(10). If
there is any evidence of diabetic
retinopathy, the individual must
provide to the medical examiner at the
time of the annual medical examination
a copy of the ophthalmologist’s report
indicating that the individual does not
have unstable proliferative diabetic
retinopathy; and
(4) Each individual must provide a
copy of the annual medical certification
to the employer for retention in the
driver’s qualification file, or must keep
a copy in his/her driver’s qualification
file if he/she is self-employed. The
driver must also have a copy of the
certification when driving for
presentation to a duly authorized
Federal, State, or local enforcement
official.
Basis for Determination
Under 49 U.S.C. 31315 and 31136 (e),
the FMCSA may grant an exemption for
up to a two-year period if it finds that
the action would likely achieve a level
of safety that is equivalent to, or greater
than, the level of safety that would be
achieved absent such exemption. This
requirement sets the criteria for safety in
developing new programs. In this
context, relative to diabetes, Section

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4018 of TEA–21 directed the Secretary
to determine if it is feasible to develop
a safe and practicable program for
allowing individuals with ITDM to
operate CMVs in interstate commerce.
In making that determination, the
primary focus was on whether such a
program could achieve a level of safety
that is equal to or greater than the level
that exists without the program. To do
this, multiple sources of information
were sought.
The sources of information sought to
reach a determination ranged from
background research and risk
assessment to consultation with experts
and an examination of how other
similar programs were conducted.
Specifically, this involved: (1) Literature
reviews to identify earlier risk studies
and how ITDM is treated and managed,
(2) investigation of the policies and
programs of other DOT modal
administrations, (3) an examination of
how such States treated drivers with
ITDM and their experience in allowing
such drivers to operate CMVs, and (4)
examining the results of recent risk
studies. Further, to obtain expert input
concerning the treatment of ITDM, the
agency assembled a panel of physicians
whose main focus was the treatment of
diabetes. Overall, the conclusions
reached in this determination were,
therefore, based on a broad range of
relevant information.
The approach was guided by the best
principles of risk assessment in
conjunction with program development.
The feasibility focused primarily on the
potential safety of such a program, and
the procedures that can ensure safety,
while providing a benefit to the public.
The results of the determination led to
a conclusion that a safe and practicable
program was feasible. The conclusions
further showed that a viable program
protocol for allowing certain individuals
with ITDM to operate CMVs would
require three components.
The first component is screening
applicants to identify qualified drivers.
This process examines the applicant’s
experience and safety in operating a
CMV. As stated above, the screening
criteria require three years of safe CMV
operation with ITDM. The criteria are
based on the evidence available from
the above referenced waiver program,
previous program reviews by
researchers in the field, and the safety
prediction literature. FMCSA believes
that a safe driving history is a required
basis for screening, because the primary
focus of the determination is to develop
a program with the necessary safety
level. The screening component requires
an acceptable history of hypoglycemia
along with the results of examinations

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52445

by required medical specialists. An
important aspect of screening also
involves education in the management
of the condition and awareness of
hypoglycemia.
The second component provides
guidelines for managing ITDM for the
qualified applicants. This includes
direction in the supplies to be used and
the protocol for monitoring and
maintaining appropriate blood glucose
levels. This is based on the experience
of other successful programs and
detailed input from the above
referenced medical panel.
The last component specifies the
process to be used for monitoring
qualified ITDM operators of CMVs. This
addresses the required medical
examinations and the schedule for their
submission. It also specifies how
glucose measures should be taken and
reviewed and the methods for reporting
episodes of severe hypoglycemia and
accidents. The monitoring component
increases the degree of rigor to meet the
needed level of safety. In the program,
qualified drivers will be required to
reapply and be screened every two years
to renew their exemptions. This means
that the drivers in the program will need
to verify their safe driving behavior,
health status, and education in a
manner that involves ongoing
monitoring. In addition, to monitor
health status, the drivers will be
required to be examined by an
endocrinologist and obtain medical
certification on an annual basis.
The FMCSA believes this is a
comprehensive program. It thoroughly
addresses the wide range of concerns
about this type of program. The
program’s structure reflects the range of
input from numerous sources. It also
reflects how the most feasible and
effective aspects of each input were
combined to develop a program that
provides great benefit with a primary
focus on safety.
Discussion of Comments
There were 396 comments to the
notice of intent to issue exemptions
published in the Federal Register on
July 31, 2001 (66 FR 39548), with 373
commenters generally in favor of the
proposal and 23 in opposition. Among
the comments submitted, some were
sent multiple times by the same
individuals or organizations. Those in
support of the proposed program largely
directed their comments to the removal
of a comprehensive prohibition on the
operation of CMVs by insulin-using
diabetics, which would be replaced by
an individual assessment of their ability
to drive the CMVs. Those in support
often did not agree with all aspects of

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the proposed program, citing
complexities of the application process,
the extent of the medical examination,
and the length of time until FMCSA
grants an exemption. Among the
comments in support, while citing
problems with other elements of the
program, 191 wrote specific comments
about the requirement for three years of
driving experience with the condition.
Nine organizations and individuals
submitted 23 comments in opposition to
the proposal. They argued that available
evidence does not support
implementation of an exemption
program that must meet the safety
requirements for new programs. They
assert that the medical examination
process cannot conclusively identify
safe drivers with ITDM, that interstate
driving is too arduous for such
individuals, and the risk assessment
results are not sufficient to justify a
program that will be as safe or safer than
the existing absence of a program.
The comments on the proposed
program are further discussed below.
Numerous commenters have substantive
concerns about the same issues. The
FMCSA presents its response after the
comments are described.
Comments In Support
The American Diabetes Association
(ADA) generally supports the FMCSA
proposal to end the blanket ban
prohibiting insulin-treated diabetics
from operating CMVs. It believes that
this proposal is long overdue and it
would institute a process for the
individual assessment of applicants.
The ADA said that it does not believe
all individuals with insulin-treated
diabetes should qualify for a CDL. It
strongly supports replacing the blanket
ban with a medically sound protocol
that maximizes safety and employment
opportunities for individuals with
diabetes. Consistent with that support,
the ADA states that it supports most
aspects of the proposed program.
Specifically, the ADA agrees with three
aspects of the proposed protocol; the
careful medical screening, the stringent
guidelines for drivers to use when
driving, and the aggressive monitoring
for safety. It supports the rigorous
approach to assuring the highest levels
of safety and believes that most aspects
of the proposal are excellent.
The ADA, however, disagrees with
the exemption requirement that insulintreated drivers should have three years
of safe driving experience with the
condition. It states that nothing in the
TEA–21 Report to Congress supports
this requirement, and that the proposed
requirement disregards currently
available medical treatment and

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supplies for people with diabetes. The
ADA claims that the agency’s own
medical panel recommended a one or
two month period for a person to adjust
to insulin before applying for a CDL,
and urges the adoption of that standard.
It goes on to state that the three-year
screening criteria should be replaced
with a one-month adjustment period for
those with non-ITDM that are moving to
the use of insulin, and a two month
adjustment period for those newly
diagnosed with the ITDM condition.
Individual circumstances could extend
this latter period. Moreover, the ADA
believes that there should be no
requirement for the CDL applicant to
have any experience driving a CMV.
The ADA also believes that DOT
should change the regulations in
relation to diabetes. It believes that the
proposed exemption program has a
number of difficulties that a regulatory
change would not. The ADA believes
the exemption program could be
terminated at any time in the same
manner the FHWA did when it ended
the diabetes waiver program. It also
believes that an exemption program may
not be able to protect qualified ITDM
drivers from employer discrimination,
citing a supreme court decision,
Albertson’s Inc. v. Kirkingberg, 527 U.S.
555 (1999). The ADA states that an
exemption program could result in more
discrimination and litigation. As a
result, the ADA argues that the general
regulatory standard in 49 CFR
391.41(b)(3) should not continue when
the DOT has determined that individual
assessment is feasible.
The U.S. Equal Employment
Opportunity Commission (EEOC) states
that the proposed exemption program is
intended to increase employment
opportunities for individuals with
disabilities while monitoring for safety.
In this sense, the EEOC claims that the
process is consistent with the
Americans with Disabilities Act.
However, the EEOC is concerned about
the requirement for three years of
driving experience with the condition. It
is concerned that this screening process
may exclude a large number of drivers
from interstate commerce, which may
limit diabetic drivers to a small number
of lower paying jobs. It was also
concerned that some drivers may live in
states that do not allow diabetic drivers
to operate CMVs in intrastate commerce.
The EEOC urges the FMCSA to monitor
the three-year experience requirement if
it is used and reassess it if it becomes
too exclusionary.
The Congressional Diabetic Caucus
(Caucus) generally supports the
program, saying that it is pleased that
the TEA–21 Report to Congress

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‘‘concludes that a safe and practicable
protocol to allow some individuals with
insulin-treated diabetes mellitus to
operate commercial motor vehicles is
feasible.’’ However, it has concerns
about the three-year requirement for
driving experience. It claims that the
proposed three-year requirement ignores
advances in medical treatment. The
Caucus points to the input given by a
DOT medical advisory panel which
recommended a one to two month
adjustment period before driving for
those individuals newly treated with
insulin.
The Caucus also believes that DOT
should not implement the proposed
policy through another exemption or
waiver program. It believes the vast
majority of States and the Federal
Government have successfully
experimented with allowing a limited
number of insulin-treated drivers to
operate CMVs. With the Federal
government’s analysis of the issue,
another exemption (waiver) program
would be inadequate to provide benefits
for all involved. Based on this, it urged
DOT to permanently change the
regulations concerning insulin-treated
diabetes and the operation of CMVs.
The Civil Rights Division of the U.S.
Department of Justice (DOJ) generally
supports the proposed exemption
program as a positive step toward
permitting an individual assessment of
persons with ITDM to operate CMVs in
interstate commerce. The DOJ, however,
has concerns regarding the three-year
driving requirement and urged the
FMCSA to continue to obtain and
analyze data on the safety records of
CMV operators with ITDM from all
available sources. This should permit
the FMCSA to consider if it is
appropriate to modify the three-year
requirement. The DOJ believes that
among those States that allow drivers
with ITDM to operate CMVs, some
monitor the drivers for a variety of
reasons. As a result, those states should
be able to provide the FMCSA with
several years of data to examine the risk
associated with relaxing the three-year
requirement.
The Amalgamated Transit Union
(ATU), which represents over 175,000
members maintaining and operating
bus, light rail, ferry, over-the-road bus,
school bus, and paratransit vehicles in
the U.S. and Canada, strongly supports
the proposed program because advances
in the treatment of diabetes make it
possible for some ITDM individuals to
operate a CMV. However, the ATU
strongly opposes the requirement for
three years of safe CMV operation with
the condition. This aspect of the
proposal, the ATU argues, would place

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a huge obstacle in the path of qualified
individuals with ITDM. This
requirement discriminates against
drivers in non-waiver States. In light of
the medical advances in the treatment of
ITDM, the ATU states there is no
justification for the three-year
requirement. Instead, the ATU claims
that the FMCSA should adopt the
recommendation of the medical panel in
the TEA–21 Report to Congress, wherein
a one or two-month period for
adjustment to insulin would be required
for seeking or maintaining a CDL.
The International Brotherhood of
Teamsters (IBT) applauds the FMCSA’s
efforts to eliminate the blanket ban on
insulin-using diabetic drivers. However,
the IBT agrees with the other
organizations relative to the three-year
driving requirement. In their opposition
to the requirement, the IBT cites the
absence of waivers in some States that
would exclude many drivers. The IBT
also claims that it is not easy for drivers
to obtain the required experience even
in States with waiver programs because
there are significantly fewer jobs in
intrastate operation. They also point to
the unfairness of experienced interstate
drivers losing their CDL when newly
diagnosed with ITDM.
The IBT is also concerned about the
requirement that a CDL applicant have
a safe driving record. It states that the
requirement bears no relation to the
applicant’s medical condition and that
this goes too far even in trying to ensure
safety. It is most concerned about the
requirement that a driving record could
prevent the applicant from obtaining an
exemption based on the applicant’s
accident involvement for which the
driver ‘‘contributed to the cause.’’ The
IBT believes this standard is too broad
and subjective.
The IBT also believes that rulemaking
rather than an exemption program
would better serve the process of
granting CDLs to insulin-using
diabetics. It sees little benefit in the
exemption process of publishing an
application in the Federal Register and
requesting comments on the applicants’
diabetic conditions. The IBT states that
it understands that rulemaking can be a
lengthy process and encourages the
FMCSA to proceed with the exemption
program while continuing to work on
the more permanent solution through a
change in the regulations.
The Owner-Operator Independent
Drivers Association, Inc. (OOIDA)
generally supports and welcomes the
changes proposed by the FMCSA in the
exemption program. Based on reports
from its membership, OOIDA believes
that a number of drivers with ITDM can
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commerce. OOIDA believes that
FMCSA’s proposed program has a
number of steps that will ensure that no
increased safety risks will be present.
However, OOIDA is concerned about
the three-year driving requirement, and
believes that it runs counter to the
proposal to require an activity currently
prohibited in interstate commerce. It
believes that the requirement limits
access to the CDL program because there
are few intrastate driving opportunities.
OOIDA is further concerned about
experienced drivers who would be
using insulin, but choose not to do so
because they will lose their CDLs. While
the proposed exemption program may
help lessen this problem, the three-year
requirement places them in a difficult
economic and health position.
The National Private Truck Council
(NPTC) agrees with the FMCSA that a
blanket prohibition on the operation of
CMVs by individuals with ITDM is
unwarranted and understands the
agency’s concerns relative to the safe
performance of drivers with this
condition. The NPTC, however, believes
that the protocol is so burdensome that
it will discourage participation in the
program. The most onerous provision in
the program, according to the NPTC, is
the requirement for three years of CMV
driving experience with the diabetic
condition. They believe that the
requirement is unnecessary from a
safety standpoint, and presents an
excessive burden on applicants to the
program.
The American Trucking Associations,
Inc. (ATA) supports FMCSA’s proposed
exemption program. ATA recognizes the
advances made in the treatment of
ITDM, the advances in the treatment of
diabetes related heart disease, and the
success of the agency’s earlier diabetes
waiver program. ATA’s support is given
if the proposed exemption program
contains specific components related to
screening, safe driving experience,
medical history and examinations,
guidelines, and monitoring.
The American Optometric
Association (AOA), while supporting
the proposal, takes exception with the
omission of optometrists from the
examination requirements in the
application process. The AOA states
that this omission is inconsistent with
all existing Federal guidelines on the
matter in addition to those put forth by
the AOA, the National Committee on
Quality Assurance, and the
recommendations of the agency’s
medical panel member Edward S.
Horton, M.D. Moreover, the AOA argues
that the omission of optometrists
implies that they are not able to monitor
proliferative diabetic retinopathy. The

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AOA states that this is not true because
studies indicate that optometrists can
detect non-proliferative and
proliferative retinopathy, as well as
general ophthalmologists. The AOA
clinical guidelines for the optometric
care of diabetic patients is identical to
the procedure used by ophthalmologists
to detect proliferative diabetic
retinopathy. Finally, the AOA argues
that it would be inconsistent for the
agency to include optometrists in the
annual medical examination for
diabetics in 49 CFR 391.64, and then
exclude them in the proposed
exemption process.
The Oregon Department of
Transportation and the Illinois State
Police both endorse the proposed
exemption program. Oregon has
extensive experience in issuing
intrastate waivers to insulin-using
diabetic CMV drivers based on stringent
medical requirements. Oregon
maintains crash data for intrastate
commercial operations and had found
no accidents related to complications
from diabetes. Likewise, the State of
Illinois currently allows diabetic drivers
under its grandfather provisions and has
no data to indicate ITDM drivers are a
greater safety risk than other drivers.
The Illinois State Police takes no
exception to the proposed exemption
program if there is strict oversight and
careful scrutiny of each applicant.
The State of Delaware also supports
the proposed exemption program since
it has had a similar program in effect for
15 years. Delaware states that it has no
indication that the program has reduced
highway safety. However, the State
believes that the agency proposal is
overly complex. It points specifically to
the publication of individual
exemptions in the Federal Register for
comment, the decision period of up to
six months, the annual physician report,
and the quarterly specialist review. It
suggests a reduction in these
requirements.
FMCSA’s Response
The comments about the requirement
for three years of driving experience
with the ITDM condition are
understandable. It does place a
constraint on some ITDM drivers who
want to operate a CMV in interstate
commerce. However, under 49 U.S.C.
31315 and 31136(e), FMCSA may grant
an exemption from the diabetes
standard only if the exemption is likely
to achieve an equivalent or greater level
of safety than would be achieved
without the exemption. FMCSA believes
that thorough screening of exemption
applicants, and periodic monitoring of
their safety performance, are the most

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practical and effective ways to ensure
the diabetes exemption program
satisfies the statutory requirement
achieving a level of safety equivalent to,
or greater than, the level of safety
obtained by complying with the safety
regulation. FMCSA believes that the
three-year requirement is crucial to this
screening and monitoring protocol until
data supports a different threshold. The
three-year requirement provides
sufficient time to expose anomalies in
driving records that enhance
predictability of future driving
performance. It also allows the driver to
develop a routine for managing his or
her diabetic condition and establish a
driving record demonstrating those
adaptive skills.
FMCSA based the three-year driving
experience requirement on the best
available scientific evidence. The
previous work the agency performed
under its diabetes waiver program in the
mid-1990s supports the three-year
requirement. Drivers in that program,
who had three years of experience while
using insulin, had accident rates lower
than the national rate. The driving
performance of those who met the threeyear requirement and other program
requirements was analyzed relative to
1993 through 1996 large truck national
accident rates found in the National
Highway Traffic Safety Administration’s
General Estimates System. The accident
rate of the waiver group with over 9
million miles of driving exposure was
1.960 accidents per million miles versus
a national accident rate of 2.272 for the
same period.
On August 24, 1994, the agency
convened a meeting to conduct a review
of the vision waiver program. The
diabetes waiver program used the same
three-year requirement as the vision
program. Agency officials and a variety
of researchers in highway safety and
vision attended the meeting. (See the
Final Descriptive Report ‘‘Qualification
of Drivers—Vision, Diabetes, Hearing
and Epilepsy;’’ FHWA; DTFH61–92–Z–
00158, May 30, 1997). The group
discussed both the formation of the
waiver program and the design of the
associated study. Relative to the design
of the waiver program and the
enrollment of drivers, it was decided
that the program was well conceived
within the context of congressional
mandate expressed in the Motor Carrier
Safety Act of 1984. The group
determined that the conditions
developed for screening and enrolling
drivers into the waiver program were
appropriate. To qualify for a vision
waiver, a driver had to have an
extremely safe driving record for three
full years before applying to the

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program. The group agreed based on the
safety literature that the best predictor
of future driving performance is past
performance. As a result, the group
concluded that the enrolled drivers
would be as safe in the waiver program
as they were before the program.
Because the FMCSA is required to
develop programs that are as safe as or
safer than the prevailing norm, the
agency believes this is compelling
evidence to require the three-year
driving experience requirement in its
diabetes exemption program. However,
the agency will revisit the issue in the
future. FMCSA will examine how
reducing the three-year experience
requirement can be accomplished while
satisfying the statutory requirement
under 49 U.S.C. 31315 and 31136(e).
FMCSA believes that its medical
advisory panel recommendation that
persons could be qualified to drive a
CMV, after a one-or two-month period
of adjustment to insulin use, does not
take into account the complex demands
of operating a large vehicle in interstate
commerce. Diabetes is a chronic disease
requiring constant control and
monitoring. CMV drivers, however, are
frequently required to work long hours
and travel significant distances, often
requiring overnight stays away from
home. Because of economic pressures to
arrive at a delivery site on schedule,
drivers may often have difficulty
maintaining a regular diet, exercise, and
the blood sugar monitoring patterns
necessary to manage their diabetes
properly. Failure to manage diabetes
properly significantly increases the
likelihood of an adverse event, such as
loss of consciousness while driving due
to hypoglycemia (low levels of glucose
in the blood). Advances in the medical
treatment of diabetes do not equal
compliance. There is a strong behavioral
component in managing diabetes.
With respect to comments urging
FMCSA to change the regulations on
ITDM and CMV operation, FMCSA does
not believe there is evidence to support
such a change. In the TEA–21 Report to
Congress conducted for this program,
the FMCSA could find no precedence
for regulatory change for a condition
like ITDM. ITDM is a chronic health
problem.
Diabetes is a condition that is
potentially quite labile, even if an
individual demonstrates good control of
blood glucose levels at a point in time.
The expert medical panel convened for
the TEA–21 Report to Congress agreed
that diabetics have special medical
problems. For this reason, they
concurred that diabetics should be
examined by endocrinologists who are
experienced with the condition. In

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relation to monitoring the ITDM driver’s
management of the condition, the panel
suggested, among other things, that
quarterly reporting of glucose
monitoring data would be a good
method of determining whether the
driver is following the monitoring
guidelines. The panel also agreed that
these drivers should receive ongoing
education in hypoglycemia awareness,
and that this education should be
monitored on an annual basis. For this
reason, FMCSA believes the evidence
supports the requirement that a
responsible, qualified driver should
undergo periodic examinations. The
need for periodic examinations is
underscored by the possible occurrence
of diabetic complications such as retinal
disease and peripheral neuropathy.
FMCSA believes that the periodic
examinations, and the monitoring of the
examinations, both assure the health of
the individual and the safety of the
public at large. Consequently, FMCSA
has determined that the prefered context
in which to guarantee such screening
and monitoring is in an exemption
program.
IBT was concerned about the driver
record requirement that prevents the
applicant from obtaining an exemption
because of involvement in an accident
for which the driver ‘‘contributed to the
cause.’’ IBT believes this type of
assessment is too subjective. However,
FMCSA’s analysis of the driving record
of each individual driver is not
subjective. The analysis of the accident
report seeks to determine whether the
reporting police officer has issued a
citation indicating that the driver is at
fault or has contributed to the cause of
the accident. The analysis also examines
the accident report to determine
whether there is evidence of driving
behavior that could indicate a
hypoglycemic event, such as crossing
the median, swerving, or driving off the
road. In cases where a diabetic driver
receives medical attention, reports on
glucose levels can be obtained.
The AOA took exception to the
exclusion of optometrists from the
proposed exemption process. The
protocols that were in the proposed
program have been revised, today’s final
disposition notice allows applicants to
obtain and submit a signed statement
from an ophthalmologist or optometrist,
indicating that they have been
examined, the applicant does not have
diabetic retinopathy, and meets the
vision standard at 49 CFR 391.41(b)(10).
However, if the driver has any evidence
of diabetic retinopathy, FMCSA requires
an examination by an ophthalmologist
to offer additional expert opinion
regarding stability and risk of

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progression of the condition. This
change covers the screening process in
both the initial application and the
annual examination.
Comments In Opposition
The Insurance Institute for Highway
Safety (IIHS) opposes FMCSA’s
proposal to issue exemptions to certain
insulin-using drivers of CMVs. In
voicing its opposition, IIHS resubmitted
the various comments it had submitted
to the agency between 1991 through
1996 concerning the implementation
and disposition of the diabetes waiver
program. In those comments, IIHS
raised concerns that: (1) Diabetes
Mellitus is a risk factor for motor
vehicle crash involvement, (2) severe
hypoglycemia and hypoglycemia
unawareness are a common
consequence of insulin therapy and of
tight control of blood glucose levels in
particular, (3) no studies support the
protocols in a program that would issue
exemptions, (4) compliance by drivers
and employers to program requirements
is unlikely, (5) studies designed to
investigate the safety of issuing waivers
or exemptions would produce no
scientifically valid conclusions, and (6)
the research design used to investigate
safety in an earlier waiver program was
inadequate. The issues raised in these
previous comments have been
addressed at length in 58 FR 40690 (July
29, 1993) (FHWA Docket No. MC–87–
17) and 61 FR 13337 (March 26,1996)
(FHWA Docket No. MC–96–2). FMCSA
will not address these points again here,
but refer interested parties to the earlier
discussions. The IIHS has, however,
raised a new issue and this is discussed
in the following paragraph.
The IIHS stated that the agency has
ignored the concern that the working
conditions of interstate truck drivers are
not compatible with the medical needs
of people with insulin-treated diabetes.
IIHS states that long and irregular work
hours, night responsibilities, variations
in the amount of exercise, and
variations in the amount of food
consumed are integral aspects of longhaul trucking. These factors, IIHS
argues, make it difficult to calibrate
insulin doses to maintain blood glucose
at healthy levels.
FMSCA is aware that operating a
CMV in interstate commerce is an
arduous occupation. The agency
designed the screening criteria in the
exemption program to identify those
insulin-using diabetics, who will have a
high degree of responsibility in
managing the condition while driving in
interstate commerce. The agency bases
this assertion on the experience
obtained in the above referenced

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diabetes waiver program. The evidence
generated by that program, which had
the same screening criteria as that
proposed for the exemption program,
demonstrated that responsible insulinusing diabetics can safely operate a
CMV in interstate commerce. The
evidence obtained in that program
represents over 9 million miles of CMV
operation by individuals who were
successfully screened by the criteria. In
addition, FMCSA will require that an
applicant for the diabetes exemption
program be educated in diabetes and its
management, and have demonstrated a
willingness to properly monitor and
manage his or her diabetes. Finally, not
all operations in interstate commerce
are long-haul.
The Advocates for Highway Safety
(AHAS) stated strong opposition to the
FMCSA proposal to issue exemptions to
selected insulin-using diabetic CMV
operators. In stating its opposition,
AHAS claims that the proposed
exemption program lacks a sufficient
scientific foundation. In particular,
AHAS argues that FMCSA’s assertion
that the ITDM exemption is
scientifically sound and based on good
medical information is conclusionary
and not an accurate representation of
the factual record. AHAS states that
FMCSA is reaching a conclusion that
selectively highlights the most salient
pieces of evidence in the TEA–21
Report to Congress, to support the
implementation of an ITDM exemption
program. In making this claim, AHAS
points to FMCSA’s reference to two
studies in the TEA–21 Report to
Congress (‘‘The Diabetes Control and
Complications Trial’’ (1995) and the
‘‘United Kingdom Prospective Diabetes
Study’’ (1998)), as the most extensive
investigation of insulin therapy to date.
In the presentation of these studies,
AHAS argues that FMCSA claims the
studies show positive results for
reduction in blood glucose levels and
microvascular complications, and that
the agency also reports results that show
significantly higher rates of
hypoglycemia due to the use of insulin.
AHAS states that the agency’s notice of
intent did not explain how these results
support the agency’s determination that
an exemption program for ITDM will
have a safety level that is equal to or
better than the prevailing level.
FMCSA is acutely aware of the threat
presented by tight control of blood
glucose levels and hypoglycemia. It was
not the agency’s intent to use the results
of those studies to support the
determination of safety. Rather, the
intent was to identify a potential threat
that had to be accounted for in the
protocols of the proposed exemption

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program. To this end, the expert
medical panel addressed this issue in
the FMCSA’s TEA–21 Report to
Congress. The panel, while clearly
recognizing hypoglycemia as a threat,
also thought awareness was a bigger
problem. It noted that there was a
correlation between hypoglycemia
awareness and recurrent, severe
hypoglycemic episodes, as shown in the
Diabetes Control and Complications
Trial data. The panel stated that
individuals who are prone to severe
hypoglycemia should not drive. The
panel agreed that severe hypoglycemia
in the past year or several episodes in
the past five years can predict the
future. The panel also agreed that
training in the awareness of
hypoglycemia is necessary for drivers of
CMVs. Because of this, awareness
education is a requirement in the
protocols of the exemption program
announced today.
AHAS points to a 1999 study (Clarke,
W. et al. ‘‘Hypoglycemia and the
Decision to Drive a Motor Vehicle by
Persons with Diabetes.’’ JAMA, August
1999, Vol. 282, No. 8, 750–754) to raise
questions about an exemption program.
According to AHAS, the study found
that even when individuals accurately
estimated low blood sugars levels, a
significant proportion still decided to
drive. However, the researchers in this
study also said that these findings did
not mean ITDM individuals should be
prohibited from driving. They said it
was reasonable for individuals to
measure their blood sugar levels before
driving and take steps to raise
potentially low levels. The researchers
said that drivers with ITDM should
always carry rapid-acting glucose when
they drive. Moreover, these researchers
claim that individuals with ITDM could
benefit from awareness training. In fact,
in a subsequent study by these same
researchers, the results showed that
awareness training improved the
detection of hypoglycemia and
improved judgment for knowing when
to raise low blood glucose, or to lower
elevated blood glucose, and for knowing
when not to drive while hypoglycemia
is a threat (Cox, D. J. et al. ‘‘Blood
Glucose Awareness Training; LongTerm Benefits, Diabetic Care, 2001,
24:637–642). Because of the concerns
about hypoglycemia, FMCSA has
incorporated all of the suggested
interventions in the protocols of today’s
exemption program. The California
Department of Motor Vehicles also
described the same article as AHAS
raising the same concerns. There is an
additional response to their comments
later in this discussion.

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AHAS also took exception to
FMCSA’s interpretation of four recent
risk studies presented in the TEA–21
Report to Congress and the July 2001
notice of intent. It first addressed two
Canadian studies:
1. Dionne, G. et al. ‘‘Medical
Conditions, Risk Exposure, and Truck
Drivers’ Accidents: An Analysis with
Count Data Regression Models,’’
Accident and Prevention, 27(3): 295–
305 (1995); and
2. Dionne G. et al. ‘‘Analysis of the
Economic Impact of Medical and
Optometric Driving Standards on Costs
Incurred By Trucking Firms and on the
Social Costs of Traffic Accidents’’ in
Dionne, G. and Laberge-Nadeau, C.
(Eds.) Automobile Insurance: Road
Safety, New Drivers, Risk Insurance
Fraud and Regulation, Kluwer
Academic Publishers, Boston (1999).
AHAS states that these studies do not
offer any evidence in support of an
exemption program.
The first of these studies (1995)
examined truck drivers in two licensure
classes. One class was for the operation
of large combination trucks, while the
other included truck drivers holding all
other classes of license that were mostly
holders of permits for straight trucks.
The risk analysis in each class
considered diabetic drivers versus all
other drivers. The diabetic drivers of
large combination trucks had an
accident rate that was not significant,
while the diabetic drivers of small
trucks had a significantly higher
accident rate. The analysis did not
consider the use of insulin by the
diabetic drivers. Relative to this, AHAS
alleges that FMCSA’s notice of intent
does not state to the public that
although the researchers were actually
at a loss to explain the results, they
believed that the results could be due to
the use of insulin since the diabetic
drivers of large trucks had fewer
individuals treated in this manner than
those with other classes of license.
For the second study, AHAS states
that the results FMCSA relies on were
not the focus of the study nor its
primary consideration, and that the
primary focus of the study was
estimation of cost per accident. FMCSA
reported a secondary finding, according
to AHAS, in that the data showed that
drivers with diabetes did not have
significantly more severe accidents than
those in the comparison groups.
Severity was measured as the total
number of individuals injured or killed
in an accident. AHAS points out that
the work in the second study was based
on the data used in the first and was a
continuation of that study. It also states

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that the use of insulin was not
considered in the second study.
FMCSA believes the AHAS claim that
the studies do not contribute to the
finding that ITDM drivers have an
acceptable level of risk is unfounded.
Aside from the finding that diabetic
drivers of small truck CMVs had a
significantly higher accident rate, none
of the other findings refute the position
that diabetics could operate CMVs in
interstate commerce with a level of
safety that is the same or better than the
prevailing standard. While insulin was
not taken into consideration in the
analyses, the studies do nonetheless
offer evidence in support of the
exemption program by virtue of not
contradicting the conceptual design.
Contradiction and refutation are
acceptable approaches in science to
revise a stated theory. None of the work
contradicts the determination that
diabetic drivers have an acceptable level
of risk. In performing risk assessments
through observational studies, it is
necessary to examine all of the evidence
to determine the direction the
preponderance of evidence supports.
After the FMCSA issued the notice of
intent, there has been an additional
contribution to the collection of
evidence on this issue. Some of the
same Canadian researchers who
conducted the previous studies used the
same insurance database to conduct a
third study (Laberge-Nadeau, C. et al.
‘‘Impact of Diabetes on Crash Risks of
Truck-Permit Holders and Commercial
Drivers.’’ Diabetes Care, Vol. 23(5): 612–
617, 2000). These data were augmented
with health status data from a public
health insurer where insulin use was
identified, along with the existence of
complications due to diabetes. Portions
of the database were analyzed with the
new information in a new research
design where diabetic driver permit
holders were group-matched by age to a
random sample of healthy permitholders. Risk was analyzed relative to
type of permit holder (large combination
trucks and straight trucks), use of
insulin, and diabetic complications.
Relative to both classes of trucks,
insulin-using diabetics showed no
significant risk regardless of
complication status. The only group of
diabetics to show significant risk was
the permit holders for straight trucks
who did not use insulin and were
without complications. To explain the
results concerning insulin use and
complications, the researchers stated
that employers hiring drivers for large
combination trucks use higher medical
standards presumably for insulin-using
diabetics and other drivers. This is what

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the protocols in the FMCSA diabetes
exemption program are designed to do.
Many of the points argued by AHAS
in relation to their criticism of the
research design in the waiver program
and their rejection of the legal basis for
the exemption program, have been
previously presented and have been
addressed at length in 58 FR 40690 (July
29, 1993) (FHWA Docket No. MC–87–
17), 61 FR 13337 (March 26, 1996)
(FHWA Docket No. MC–96–2), 63 FR
67601 (December 8, 1998) (DMS Docket
No. FMCSA–1998–4145) and 64 FR
51568 (September 23, 1999) (DMS
Docket No. FMCSA–1999–5578).
FMCSA will not address the points
again here. Interested parties are
referred to the earlier discussions.
In its comments to this notice, AHAS
also raises some new issues. In
particular, it has some concerns relative
to the most recent risk study conducted
by the agency (‘‘A Study of the Risk
Associated with the Operation of
Commercial Motor Vehicles by Drivers
with Insulin-Treated Diabetes Mellitus,’’
FHWA, 1999). AHAS states that the
comparisons made in the study could be
suspect because the comparison group
was composed of interstate drivers,
while the diabetes group contained
mostly intrastate drivers. While it is true
that the diabetes group did primarily
contain intrastate drivers, the
comparison group of CDL holders also
had intrastate drivers, albeit in smaller
proportion. This disparity in
representation by the two groups did
contribute to the range of CMV
operation (intrastate versus interstate)
being identified as a confounding factor
in the study. As a result, FMCSA used
the factor to adjust the initial results.
Observational study research literature
supports this type of adjustment. Had
this factor and others been ignored in
the analyses, the unadjusted results
would have been biased and detracted
from the internal validity of the study.
This aspect of FMCSA’s response also
addresses another AHAS concern
involving the nature of the unadjusted
study results. AHAS correctly pointed
out that the initial (unadjusted) results
show that the diabetes group had a
higher crash rate than the comparison
group. However, since this study was
observational in nature, as are almost all
practical risk investigations, it is
necessary to assess the factors that could
introduce bias into the results and
invalidate the findings. FMCSA did this
and found several factors, including
intrastate versus interstate operation
and marital status. The other source of
potential bias that FMCSA found was
over-dispersion in the distribution of
accidents (a larger than expected

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Federal Register / Vol. 68, No. 170 / Wednesday, September 3, 2003 / Notices
variation in the number of accidents).
Both of these sources of bias tend to
produce false positive (significant)
results if not subjected to adjustment.
FMCSA analyzed the two sources of
potential bias with adjustment
procedures, both separately and jointly,
and found the results were consistent
across all analyses showing no
significant difference in risk between
the two groups. While the AHAS
seemed to characterize this multifaceted
approach to analysis as a contrived
strategy, it is the approach which is
required in an observational study (see
U.S. General Accounting Office, ‘‘Cross
Design Synthesis; A New Strategy for
Medical Effectiveness Research,’’ March
1992 GAO/PEMD–92–18). It is the
consistent results across the varied
adjustment procedures that gives the
FMCSA confidence that bias was
present in the initial (unadjusted)
results and was eliminated in the
ensuing analysis.
AHAS also claims that the Federal
Aviation Administration (FAA)
exemption program for ITDM
individuals is an inappropriate model
for FMCSA’s program for the operation
of CMVs. It stated that the FAA program
issues exemptions only for third-class
airman medical certificates and not for
commercial pilots. The AHAS is correct
in their assessment of the FAA program;
however, the FMCSA had no intention
of using the FAA’s program as a model
for the FMCSA program with respect to
type of target population. FMCSA used
the FAA program as evidence that it
could develop a process of medical
examination and screening to issue
exemptions to individuals with ITDM.
To this end, FMCSA used the FAA
process as part of the template for
development of the proposed medical
examination and screening protocol.
That is why the protocol is analogous to
that of the FAA.
In its opposition, the California
Department of Motor Vehicles
(California) states that the proposed
FMCSA program will unnecessarily
increase the risk to the public and the
drivers receiving the exemptions. While
California regulatory guidelines allow
some experienced ITDM individuals to
operate intrastate, it believes that the
FMCSA exemption program could
greatly expand the number of these
drivers who operate interstate and
thereby increase risk. California limits
the number of exemptions because of
the risk of hypoglycemia. It states blood
sugar is affected by almost everything
including exercise and stress. This in
combination with arduous work
conditions associated with interstate

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operation makes it difficult for drivers
with ITDM to control their blood sugar.
California does not believe that the
proposed FMCSA screening procedures
adequately address the issue of
hypoglycemia. The requirement for a
complete medical examination, by a
board-certified or eligible
endocrinologist with a statement of
familiarity with the applicant’s five-year
medical history, will not preclude an
ITDM driver from experiencing a
hypoglycemia episode.
FMCSA believes it has addressed this
type of circumstance in the exemption
program’s screening protocol.
Specifically, the criteria state that the
applicant must have had no recurrent
(two or more) hypoglycemia reactions
resulting in a loss of consciousness or
seizure within the past five years. A
period of one year of demonstrated
stability is required following the first
episode of hypoglycemia. Moreover, the
criteria require that the applicant does
not have recurrent hypoglycemia
reactions requiring the assistance of
another person and does not have
reactions resulting in impaired cognitive
function that occurred without warning
symptoms within the past five years. In
addition, as a test of these responses
under arduous working conditions, the
screening criteria also require three
years of CMV operation with ITDM. The
same screening criteria were used in the
agency’s previous diabetes waiver
program, and in the three years of that
program, there were no reported cases of
impairment due to episodes of
hypoglycemia. Moreover, screening is
stricter now. In place of a single
screening episode under the previous
program, the driver must reapply for an
exemption every two years, or sooner if
the exemption was issued for a shorter
period. Screening is performed at each
reapplication. In addition, screening is
performed annually by an
endocrinologist, as well as the medical
examiner performing the annual
examination and certification required
under 49 CFR 391.43.
In another issue of concern for
California, it points out that the protocol
proposed in the FMCSA program
requires the exempted drivers to check
their blood sugar levels every two to
four hours. Because of this and other
measures needed to control blood sugar,
California believes that employers
would not let the drivers take the time
necessary to perform all of these
activities. FMCSA, based on its previous
experience, is not aware of any evidence
to suggest that employers would not
allow drivers to take the time needed to
check their blood sugar levels.

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52451

California points to a 1999 study as
another basis for its opposition (Clark,
W. L. et al. ‘‘Hypoglycemia and the
Decision to Drive a Motor Vehicle by
Persons with Diabetes.’’ JAMA, August
1999, Vol. 282, No. 8, 750–754). An
objective of the study was to examine an
ITDM individual’s decision to drive
during the individual’s daily routine,
based on perception of blood sugar
levels compared to actual levels. The
researchers found that significant
numbers of subjects did not correctly
estimate how low their blood sugar was,
and therefore decided to drive. The
findings also showed that even when
individuals accurately estimated low
blood sugar levels, a significant portion
still decided to drive. California,
however, does not indicate the
researchers stated that ITDM
individuals should not be permitted to
drive. California did say the data
suggested that individuals with ITDM
need to be cautious before driving a
motor vehicle. The researchers said that
the suggestion that individuals measure
their blood sugar levels, and raise
potentially low levels before driving,
did not seem unreasonable. They said
that drivers with diabetes should always
carry rapid-acting glucose with them
when they drive. Moreover, the
researchers claim that individuals with
ITDM could benefit from awareness
training to help detect blood sugar
levels. They stated that this type of
training has been shown to improve the
detection abilities of even those with
reduced awareness of hypoglycemia,
and that the improvement has been
sustained for at least a year.
The protocol being adopted in this
final disposition is very consistent with
the conclusions of these researchers. In
the screening component the applicant
must present a signed statement
prepared by the examining
endocrinologist indicating that the
applicant has been educated in diabetes
and its management, thoroughly
informed of and understands the
procedures which must be followed to
monitor and manage his/her diabetes,
and what procedures should be
followed if complications arise. In
addition, the protocol requires, in the
guideline component, that the qualified
applicant have a supply of rapidly
absorbable glucose to be used as
necessary. The protocol also requires, in
the monitoring component, that the
qualified driver provide annual
documentation by a specialist of
ongoing education in diabetes
management and hypoglycemia
awareness. While Clark W. L., et al. was
valuable in identifying the potential

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problems with hypoglycemia awareness,
it also suggested methods for
intervention. The suggestions of the
researchers concerning how they believe
the problem should be addressed are
clearly contained in the protocols of the
exemption program.
Conclusion
After analyzing the comments to the
notice of intent, the FMCSA is
convinced that the proposed program is
responsive to the need and requirements
of the various interested individuals and
organizations. The comments raised a
number of valid issues of concern. The
agency believes that it has successfully
addressed those concerns in the
development of this program. The
public’s concerns must be addressed
because they mainly focus on safety
issues. This is the reason there is a
three-year driving experience
requirement in a part of the exemption
program, in addition to medical
screening, guidance, and monitoring.
The three-year requirement of the
program provides certainty to public
safety, and also protects ITDM drivers.
The ability to operate CMVs safely for
three years clearly helps to indicate that
applicants can perform the arduous
work required in this type of job
category. While we believe this
requirement to be essential, all of the
proposed components are required for a
safe and practicable program.
Nonetheless, FMCSA recognizes that
the three-year requirement will restrict
the number of drivers eligible for an
exemption. The agency has no desire to
make the program more stringent than
necessary and will therefore leave this
docket open indefinitely in order to
provide a means for the submission of
additional views and data on the need
for three years of driving experience.
FMCSA is particularly interested in
obtaining statistical data on the accident
rates of ITDM drivers before and after
they begin a course of insulin treatment.
This analysis depends on knowing,
among other things: (1) The number of
miles driven and accidents experienced
by the driver before beginning insulin
treatment, thus providing a baseline
accident rate; (2) the length of time an
ITDM driver has taken insulin before
resuming a driving career; (3) the date
the ITDM driver resumed driving and
the interval to the first (and any
subsequent) accident; and (4) the
number of miles driven by an ITDM
driver, preferably on a monthly and
annual basis. Although FMCSA will not
ignore any relevant information that
may be submitted, the statutory
standard for an exemption requires the
agency to focus its attention on the

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question whether ITDM drivers with
less experience driving CMVs can
achieve accident rates comparable to
those of ITDM drivers who have at least
three years of experience driving CMVs
prior to applying for an exemption. This
is an issue that can be resolved only by
more and better data. FMCSA is also
interested in learning which segments of
the motor carrier industry have work
conditions most (or least) conducive to
the self-monitoring routines that ITDM
drivers must maintain in order to
control their blood sugar level.
For the reasons above, the FMCSA has
determined that the most desirable
structure to support these components
is an exemption program. Therefore, in
accordance with 49 U.S.C. 31315 and
31136(e), the FMCSA will implement a
program that will issue exemptions to
qualified ITDM drivers. Each exemption
will be valid for up to two years and
require renewal at the end of that
period. Qualified ITDM drivers may
request a diabetes exemption from the
49 CFR 391.41(b)(3) regulation by
sending an exemption request on or
after September 22, 2003, to the
Diabetes Exemption Program at the
address in the ADDRESSES section above.
Paperwork Reduction Act
Under the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3501 et seq.),
Federal agencies must obtain approval
from the Office of Management and
Budget (OMB) for each collection of
information they conduct, sponsor, or
require through regulations. An analysis
of this proposal was made by the
FMCSA, and it has determined that this
Notice of Final Disposition would add
an element, i.e., diabetes exemption
program, to a currently-approved
information collection (OMB Approval
No. 2126–0006), titled Medical
Qualifications Requirements.
The FMCSA estimates that
approximately 700 applications for
exemption could be filed annually, and
that it would take an average of 90
minutes to complete an application. The
addition of the diabetes exemption
program to this existing information
collection would increase the annual
burden by 1,050 hours (700 × 90
minutes / 60 minutes).
Interested parties are invited to send
comments regarding any aspect of this
information collection requirement,
including, but not limited to: (1)
Whether the collection of information is
necessary for the performance of the
functions of the FMCSA, including
whether the information has practical
utility, (2) the accuracy of the estimated
burden, (3) ways to enhance the quality,
utility, and clarity of the collected

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information, and (4) ways to minimize
the collection burden without reducing
the quality of the information collected.
You may submit comments on this
information collection burden directly
to OMB. The OMB must receive your
comments by November 3, 2003. You
must mail or hand deliver your
comments to: Attention: Desk Officer for
the Department of Transportation,
Docket Library, Office of Information
and Regulatory Affairs, Office of
Management and Budget, Room 10102,
725 17th Street, NW., Washington, DC
20503.
Authority: 49 U.S.C. 322, 31136 and 31315;
and 49 CFR 1.73.
Issued on: August 27, 2003.
Annette M. Sandberg,
Administrator.
[FR Doc. 03–22409 Filed 9–2–03; 8:45 am]
BILLING CODE 4910–EX–P

DEPARTMENT OF TRANSPORTATION
Federal Transit Administration
Environmental Impact Statement for
the Bi-County Transitway Project
AGENCY: Federal Transit Administration
(FTA), U.S. Department of
Transportation.
ACTION: Notice of Intent To Prepare an
Environmental Impact Statement (EIS).
SUMMARY: The Federal Transit
Administration (FTA) and the Maryland
Transit Administration (MTA) intend to
prepare an Environmental Impact
Statement (EIS) in accordance to the
National Environmental Policy Act
(NEPA) of 1969, as amended, on the
proposed Bi-County Transitway Project
in Montgomery and Prince George’s
Counties, Maryland, which are in the
metropolitan area of Washington, DC.
The corridor extends 14 miles from the
western branch of the Metrorail Red
Line in Bethesda to the New Carrollton
Metrorail Station. The Bi-County
Transitway will provide high-capacity
transit along the corridor. As a result of
rapid growth in travel and development,
the Bethesda to New Carrollton study
area is facing numerous transportation
challenges. The growing service sector
job base has increased the vitally
important need for efficient transit. The
transit investment will compliment and
support ongoing revitalization efforts
currently underway in the study area.
This project includes the alignment
previously known as the Georgetown
Branch Transitway/Trail (Bethesda to
Silver Spring). A notice of intent to
prepare an EIS for the Georgetown
Branch Transitway and Trail was

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