[Federal Register Volume 68, Number 170 (Wednesday, September 3, 2003)]
[Notices]
[Pages 52441-52452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22409]


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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.

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SUMMARY: This notice announces FMCSA's decision to issue exemptions to 
certain insulin-using diabetic drivers 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 
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.

[[Page 52442]]


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 Insulin-Treated 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 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 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.

[[Page 52443]]

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).
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 three-year 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 
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 board-certified 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;

[[Page 52444]]

    (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 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.

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;
    (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.

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

    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,

[[Page 52445]]

    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 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 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

[[Page 52446]]

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 
insulin-treated 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 
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 
``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

[[Page 52447]]

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 safely operate CMVs in 
interstate 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 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

[[Page 52448]]

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 three-
year 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 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 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

[[Page 52449]]

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 long-haul 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 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 insulin-using 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 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; Long-Term 
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.

[[Page 52450]]

    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 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 permit-holders. 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 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

[[Page 52451]]

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 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.
    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

[[Page 52452]]

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 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 x 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 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