[Federal Register: September 3, 2003 (Volume 68, Number 170)]
[Notices]
[Page 52441-52452]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03se03-91]
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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]