[Federal Register Volume 66, Number 147 (Tuesday, July 31, 2001)]
[Notices]
[Pages 39548-39553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19045]
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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 intent to issue exemptions and request for comments.
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SUMMARY: This notice announces the FMCSA's proposal 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 requests
comments on its proposed exemption program, but we are not accepting
applications for exemptions at this time. If a decision to proceed with
the exemption program is made, the exemptions would be granted only to
those applicants who meet the specific conditions and comply with all
the requirements of the exemption. Exemptions would be issued for a
period of two years. After the two years, those holding exemptions
would need to reapply for another two-year exemption.
DATES: Comments must be received on or before October 1, 2001.
ADDRESSES: You can mail, hand deliver, fax, or electronically submit
written comments to the Docket Management Facility, U.S. Department of
Transportation, Room PL-401, 400 Seventh Street, SW., Washington, DC
20590; FAX (202) 493-2251, online at http://dmses.dot.gov/submit.
Please include the docket number that appears in the heading of this
document in your comment. You can examine and copy all comments from 9
a.m. to 5 p.m., e.t., Monday through Friday, except Federal holidays at
the docket facility. You can also examine the docket on the Internet at
http://dms.dot.gov. If you want us to
[[Page 39549]]
notify you of receipt of your comments, please include a self-
addressed, stamped envelope or postcard, or after submitting comments
electronically, print the acknowledgment page.
FOR FURTHER INFORMATION CONTACT: For further information about the
proposed diabetes exemption program in this notice, Ms. Sandra
Zywokarte, Office of Bus and Truck Standards and Operations, (202) 366-
2987; for information about legal issues related to this notice, Mr.
Joseph Solomey, Office of the Chief Counsel, (202) 366-1374, FMCSA,
Department of Transportation, 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.
SUPPLEMENTARY INFORMATION:
Background
The motor carrier regulatory functions of the Federal Highway
Administration (FHWA) were transferred to the recently created Federal
Motor Carrier Safety Administration (FMCSA). The history and delegation
of authority to the FMCSA was published in the Federal Register on
January 4, 2000 (65 FR 220). 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:
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 engaged in several activities to address the
issue of diabetes and CMV operation. On March 28, 1977, the agency
published an Advance Notice of Proposed Rulemaking (ANPRM) to solicit
comments on the diabetes standard (42 FR 16452). The agency terminated
this rulemaking in November 1977 without amending the standard, after
determining that the more substantive comments and the literature cited
in the ANPRM supported the prohibition against the operation of CMVs by
insulin-using diabetics because of highway safety concerns. On November
25, 1987, the agency published a new ANPRM (52 FR 45204) requesting
comments on petitions from two individuals and the American Diabetes
Association to eliminate the blanket prohibition against insulin-using
diabetics and grant waivers on a case-by-case basis. In September 1987,
a Conference on Diabetic Disorders and Commercial Drivers was held to
review the diabetes standard in light of advances in the care of
diabetics. Conference participants (physicians, scientists, federal
officials and representatives from the motor carrier industry)
recommended that some drivers with diabetes could be certified to drive
depending upon insulin use and under certain conditions (absence of
recurrent hypoglycemia, safe driving record, etc.) (Federal Highway
Administration, Conference on Diabetic Disorders and Commercial
Drivers; Final Report, 1988). Following this, the agency published a
Notice of Proposed Rulemaking (55 FR 41208) requesting comments on a
proposal to revise the diabetes standard to allow insulin-using
diabetics to operate CMVs and sponsored a 1990 risk assessment that
estimated various levels of accidents among diabetic drivers depending
upon the severity of hypoglycemia (Federal Highway Administration,
Insulin-using Commercial Motor Vehicle Drivers, 1992). The estimated
level of accidents was deemed acceptable and a Notice of Intent to
Issue Waivers was published in 1992. This led to a 1993 waiver program,
based on a three-year safe driving record while using insulin and
medical examinations by the required specialists.
The diabetes waiver program, originally part of a research study,
was terminated in 1996. The D.C. Circuit Court of Appeals had found
that the initial determination that the agency's vision waiver program
would not adversely affect the safe operation of CMVs was ``devoid of
empirical support in the record'' and, therefore, contrary to law
(Advocates for Highway and Auto Safety v. Federal Highway
Administration, 28 F. 3d 1288 (D.C. Circuit 1994)). Although the
decision initially affected only the vision waiver program, it had a
direct effect on the diabetes program because of the similar approach
used to prequalify drivers. Those drivers holding waivers at the
program's termination were allowed to continue to operate CMVs in
interstate commerce under grandfather provisions at 49 CFR 391.64.
Feasibility Study To Qualify Insulin-Treated Diabetics To Operate CMVs
On June 9, 1998, the President signed the Transportation Equity Act
for the 21st Century (TEA-21) (Pub. L. 105-178, 112 Stat. 107). Section
4018 of the TEA-21 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 Department of
Transportation's (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 report was submitted to Congress on August 23, 2000, and
concludes that a safe and practicable protocol to allow some ITDM
individuals to operate CMVs is feasible. A copy of the report is
included in the docket. The FMCSA's feasibility assessment included a
review of background research on the risk of driving with diabetes.
Although the relationship between diabetes and automobile crashes had
been assessed since 1965, the epidemiological evidence from 1965 to
1991 produced conflicting results. The lack of consistent results was
in many cases caused by flawed methodology. Further, none of the
studies addressed the operation of CMVs. With the termination of the
waiver program and its research component, the agency lacked clear risk
assessment information.
A literature review was conducted on the treatment and management
of ITDM. The research results showed positive findings. Six studies
have been reported in the literature. The two largest and most reported
studies (The Diabetes Control and Complications Trial and the United
Kingdom Prospective Diabetes Study Group) represented the most
extensive investigations of insulin therapy and had similar findings.
Both showed that patients experienced reductions in blood glucose
levels and significantly fewer microvascular complications with
intensive treatment. However, the studies also showed significant
adverse effects from insulin use, notably, a significantly higher rate
of hypoglycemia.
Investigation of the policies of other DOT modal administrations
regarding ITDM showed that only the Federal Aviation Administration
(FAA) has a well-developed program. In 1994, the
[[Page 39550]]
FAA determined that selected ITDM individuals can be considered for
special issuance of a third-class Airman Medical Certificate under a
screening, glucose management, and monitoring protocol. The program
evolved through a series of steps in which the agency capitalized on
its experience, reviewed relevant research, consulted medical experts,
and considered comments from the public and interested organizations.
As a part of its feasibility determination, the FMCSA examined how
the states treated drivers with ITDM. Although the states have the
option to apply the FMCSRs to the medical qualifications for intrastate
CMV operators, they also have the flexibility to deviate from the
FMCSRs. A few states have chosen to adopt the federal standards and not
allow ITDM individuals to operate CMVs. Some states have granted
grandfather rights to drivers who were already driving intrastate,
while allowing no new drivers after a specific date. Other states have
programs whereby drivers can apply for the opportunity to operate in
intrastate commerce. Based on several surveys of the states and contact
with individual states, the programs of four states (Utah, Michigan,
Kentucky and Delaware) are presented in the report as examples of more
extensive approaches. These states have screening, operating and
monitoring protocols of varying degrees of intensity and coverage, but
do not monitor results.
The report presents four recent risk assessment studies (1995 to
1997) that specifically address diabetes and the operation of CMVs. Two
of the studies were performed in Canada, while the other two were
conducted by the Office of Motor Carrier Safety (now the FMCSA). The
first study analyzed insurance data for 1,307 truck drivers and found
that diabetics operating smaller trucks had significantly higher
accident rates (diabetics operating large combination trucks did not
have higher rates) (Dionne, G., Desjardin, D., LaBerge-Nadeau, C. and
Moag, U., ``Medical Conditions, Risk Exposure, and Truck Driver's
Accidents: An Analysis with Count Data Regression Models,'' Accident
Analysis and Prevention, 27(3), p. 295-305; 1995). Insulin use was not
considered. The second Canadian study used the same database and
concluded that diabetic drivers did not have accidents that were
significantly more severe than those without the condition (severity
was defined by injuries and fatalities). The third study used data from
the FHWA waiver program (Federal Highway Administration, Final
Descriptive Report: ``Qualifications of Drivers-Vision, Diabetes,
Hearing and Epilepsy,'' 1997). The analysis of these data showed that
the accident rate of the diabetes waiver program drivers was lower than
the national rate. The last study looked at 723 ITDM drivers of large
trucks and a comparison group of 1,297 drivers with commercial driver's
licenses (Federal Highway Administration, ``A Preliminary Study of the
Risk Associated with the Operation of Commercial Motor Vehicles by
Drivers with Insulin-Treated Diabetes Mellitus,'' 1999). After
adjustment for confounding, the results showed no significant
differences between the two groups in accident rate or severity. The
ITDM drivers in this study had at least 3 years experience operating a
commercial vehicle with the condition. All of the recent studies
specifically concerned with diabetes and CMV operation show that
drivers with that condition have a level of safety that is the same or
better than a comparison group or the national accident rate.
The FMCSA also assembled a panel of physicians expert in the
treatment of diabetes. The panel was asked to address the screening and
monitoring issues that would be associated with a process to allow ITDM
individuals to operate CMVs. Responding with written reports and
through discussion at a meeting in Washington, DC, the panel expressed
the opinion that advances in the treatment of diabetes make it possible
both to control the disease and to permit the identification of those
individuals capable of doing so. The panel identified methods to avoid
acute complications, including hypoglycemia, and endorsed a protocol
for monitoring glucose before and during the operation of a CMV. The
panel concluded that from a medical standpoint a process was feasible
for permitting some individuals with ITDM to operate CMVs.
The report concludes that a safe and practicable protocol to allow
some ITDM individuals to operate CMVs is feasible. The research on the
treatment and management of ITDM, combined with the determinations of
the medical panel, indicate that the disease and its adverse effects
can be successfully controlled and monitored. Moreover, recent risk
assessments provide evidence that diabetic CMV operators can perform in
an acceptably safe manner. Finally, the program operated by the FAA and
the analysis of the agency's diabetes waiver study program demonstrate
that it is possible to screen and monitor ITDM individuals so that safe
performance is feasible.
The report further concludes that a viable program protocol for
allowing individuals with ITDM to operate CMVs would require three
components. The first is a screening component to identify qualified
applicants. This process would examine the applicant's experience and
safety in operating CMVs, the applicant's history of hypoglycemia, and
the results of examinations by the required medical specialists
(endocrinologists and ophthalmologists). The second component would
provide guidelines for managing ITDM, including supplies to be used and
the protocol for monitoring and maintaining appropriate blood glucose
levels. The last component would specify the process to be used for
monitoring ITDM commercial drivers. It would address the required
medical examinations and the schedule for their submission. It also
would indicate how glucose measures should be taken and reviewed, and
specify how episodes of severe hypoglycemia and accidents should be
reported. These components are based largely on the structure of the
FAA and FHWA/FMCSA waiver programs. They are presented in detail in the
report.
Finally, the report addresses the legal consequences of permitting
ITDM individuals to drive CMVs in interstate commerce. It was
determined that the legal consequences of a rule (including a
regulation, policy or standard adopted pursuant to the Administrative
Procedure Act (APA)) fall into two categories: (1) An APA challenge to
the validity of the rule and (2) tort liability for damages sustained
in an accident involving an ITDM driver. The assessment concluded that
these consequences are no different from those associated with any
other rule involving driver standards and qualifications. For employers
that hire ITDM drivers, the rule might expose them to new standards of
responsibility for monitoring the health of drivers who meet federal
guidelines.
Based on the research presented in the Report to Congress, the
FMCSA has decided that evidence and precedence indicate the appropriate
form for implementing a process would be an exemption program. Evidence
indicates that diabetes is a chronic disease which requires constant
control, especially ITDM, and needs, therefore, ongoing monitoring to
ensure that the disease is under control. The evidence also strongly
suggests that the process which guarantees an acceptable level of
safety is one that thoroughly screens ITDM drivers who wish to operate
CMVs and periodically monitors the disease-controlling behavior of
those successfully screened. Experience indicates, through the FAA and
FHWA/
[[Page 39551]]
FMCSA programs, such a process is best implemented as an exemption
program, and that type of program is currently defined and authorized
in Section 4007 of TEA-21.
Authority--Waivers and Exemptions
On June 9, 1998, the agency's waiver authority changed with
enactment of the Transportation Equity Act for the 21st Century (TEA-
21), Public Law No. 105-178, 112 Stat. 107. Section 4007 of TEA-21
amended the waiver provisions of 49 U.S.C. 31315 and 31136(e) to change
the standard for evaluating waiver requests, to distinguish between a
waiver and an exemption, and to establish term limits for both. Under
revised sections 31315 and 31136(e), the FMCSA may grant a waiver for a
period of up to 3 months or an exemption for a renewable 2-year period.
The amendments to 49 U.S.C. 31315 and 31136(e) also changed the
criteria for exempting a person from application of a regulation.
Previously an exemption was appropriate if it was consistent with the
public interest and the safe operation of CMVs. Now the FMCSA may grant
an exemption 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 new standard provides the
FMCSA greater flexibility and discretion to deal with exemptions than
the previous standard. (See H.R. Conf. Rep. No. 105-550, at 489
(1998).)
The TEA-21 requires the FMCSA to 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 the 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 the FMCSA denies a request for an exemption, the agency must publish
a notice in the Federal Register identifying the person who was denied
the exemption and the reasons for the denial.
Generally, the duration of exemptions issued under the authority of
section 4007 is limited to two years from the date of approval, but may
be renewed. The 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
that 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 are at 49 CFR 381.300.
The person applying for an exemption is required to send a written
request (which could be a typed or handwritten letter (printed)) to the
Federal Motor Carrier Safety 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.
FMCSA Procedures for the Review of Exemption Applications
Section 381.315 requires the 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, a recommendation will be made to the Administrator.
Notice of the Administrator's final decision will be published in the
Federal Register. The FMCSA would attempt to 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, the FMCSA would attempt to issue a final decision within
180 days of the date the additional information is received (49 CFR
381.315 and 381.320). The 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. The FMCSA's overriding concern is to ensure the safety of
interstate commercial operations. The agency would notify all
applicants in writing once a final decision is made.
Application Information
In considering exemptions, the FMCSA must ensure that the issuance
of diabetes exemptions would not be contrary to the public interest and
that the exemption achieves an acceptable level of safety. Exemptions,
therefore, would only be granted to ITDM individuals who meet certain
conditions. These conditions, which are based on the research
literature, relevant DOT and State exemption programs and with
substantial input from a panel of endocrinologists, are set forth
below. Applicants for an exemption from the ITDM prohibition would be
required to submit their applications in a letter (there would 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 (CMV) 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):
[[Page 39552]]
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 which 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 provided a board-certified or board-eligible
endocrinologist, who is knowledgeable about diabetes, with a complete
medical history including:
The date insulin use began;
Diabetes diagnosis and disease history;
All hospitalization records; Consultation notes for diagnostic
examinations;
Special studies pertaining to the diabetes;
Follow-up reports; and
Reports of any hypoglycemic insulin reactions within the last five
years,
(9) Has been examined by a board-certified or board-eligible
endocrinologist 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:
Two measures of glycosylated hemoglobin, the first 90 days prior
to the last and current measure;
Insulin dosages and types, diet utilized for control and any
significant factors such as smoking, alcohol use, and other
medications or drugs taken; and
Examinations to detect any peripheral neuropathy or circulatory
insufficiency of the extremities,
(10) Submits a signed statement prepared by the 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,
(11) Submits a separate signed statement from an examining
ophthalmologist that the applicant has been examined and that the
applicant does not have clinically significant disease including
unstable proliferative diabetic retinopathy (i.e., unstable advancing
disease of blood vessels in the retina) and meets the vision standard
at 49 CFR 391.41(b)(10).
Requirements for ITDM Individuals Who Have Been Issued an Exemption
To Operate CMV'S
There are special conditions attached to the issuance of any
exemption for ITDM. The following requirements would be imposed:
(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 should include the
following:
An acceptable glucose monitor with memory;
Supplies needed to obtain adequate blood samples and to measure
blood glucose;
Insulin to be used as necessary; and
An amount of rapidly absorbable glucose to be used as necessary,
(2) 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 100 mg/dl, take glucose or food and recheck
in 30 minutes. Do not drive if glucose is 100 mg/dl. Repeat the process
until glucose is >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 100
mg/dl, stop driving and eat. Recheck in 30 minutes and repeat procedure
until glucose is >100 mg/dl; and
If glucose is >400 mg/dl, stop driving until glucose returns to the
100-400 mg/dl range. If more than two hours after last insulin
injection and eating, take additional insulin. Recheck blood glucose in
30 minutes. Don't resume driving until glucose is 400 mg/dl.
Monitoring for ITDM Individuals Who Have Been Issued an Exemption
to Operate CMV'S
In addition to the requirements for controlling ITDM, exemption
recipients will be monitored during the period that
[[Page 39553]]
the exemption is valid. Monitoring will be conducted by requiring the
exemption recipients to submit the following information to the FMCSA:
(1) Submit to a comprehensive medical evaluation by an
endocrinologist on an annual basis. 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;
(2) Provide records of all daily glucose measurements taken with an
acceptable device (with memory). These measurements will be reviewed by
a specialist on a quarterly basis;
(3) Provide on an annual basis confirmation by an ophthalmologist
that there is no proliferative diabetic retinopathy and no clinically
significant disease that prevents the individual from meeting the
current vision standards at 49 CFR 391.41(b)(10);
(4) Annual documentation by an endocrinologist of ongoing education
in management of diabetes and hypoglycemia awareness;
(5) Report, upon determination of an endocrinologist or other
physician, any episode of severe hypoglycemia, significant
complications or inability to manage diabetes; and
(6) Report any involvement in an accident or any other adverse
event and whether or not they are related to an episode of
hypoglycemia.
Request for Comments
The FMCSA is requesting public comment from all interested persons
on its intent to issue exemptions to certain insulin-using diabetic
drivers of CMVs, from the diabetes requirement in 49 CFR 391.41(b)(3),
and relevant issues discussed in this notice. All comments received
before the close of business on the closing date indicated above will
be considered and will be available for examination in the docket room
at the above address. Comments received after the closing date will be
filed in the docket and will be considered to the extent practicable.
However, the FMCSA may issue a final notice of intent to establish a
process for considering exemptions from the diabetes requirement in
accordance with 49 U.S.C. 311315 and 31136(e), and publish in the
Federal Register that decision at any time after the close of the
comment period. The FMCSA will also continue to file in the docket
relevant information which becomes available. Interested persons should
continue to examine the docket for new material.
Paper 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. The FMCSA has
determined that this notice of intent contains collection of
information requirements for the purposes of the PRA. The proposed
exemption program, when made final, will impact the currently-approved
information collection, ``Medical Qualification Requirements.'' This
approval is covered by OMB Approval No. 2126-0006 and is due to expire
on October 31, 2003. The FMCSA estimates that approximately 200
applications for exemption could be filed annually and that it would
take an average of 90 minutes to complete an application.
Authority: 49 U.S.C. 322, 31136 and 31315; and 49 CFR 1.73.
Issued on: July 25, 2001.
Brian M. McLaughlin,
Acting Deputy Administrator.
[FR Doc. 01-19045 Filed 7-30-01; 8:45 am]
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