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[Federal Register: November 8, 2005 (Volume 70, Number 215)]
[Notices]
[Page 67777-67781]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08no05-77] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2001-9800] Qualification of Drivers; Eligibility Criteria and Applications; Diabetes Exemption AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of revised final disposition. ----------------------------------------------------------------------- SUMMARY: This notice announces FMCSA's decision to revise the terms and
conditions of its previous decision to issue exemptions to certain
insulin-treated diabetic drivers of commercial motor vehicles (CMVs)
from the diabetes mellitus prohibitions contained in the Federal Motor
Carrier Safety Regulations (FMCSRs). This action is in response to
section 4129 of the Safe, Accountable, Flexible and Efficient
Transportation Equity Act: A Legacy for Users (SAFETEA-LU) which
requires FMCSA within 90 days of enactment to modify its exemption
program to allow individuals who use insulin to treat diabetes mellitus
to operate CMVs in interstate commerce, without having to demonstrate
safe driving experience operating a CMV while using insulin, while at
the same time implementing certain other requirements contained in
section 4129. These changes will remain in effect until FMCSA completes
a rulemaking to revise the FMCSRs to allow drivers with insulin-treated
diabetes mellitus (ITDM) to operate CMVs in interstate commerce in
accordance with the applicable statutory standards. DATES: This notice is effective on November 8, 2005. FMCSA will begin
accepting applications for exemptions under the new criteria on
November 8, 2005. [[Page 67778]] ADDRESSES: Drivers with insulin-treated diabetes mellitus (ITDM) who
meet the modified criteria contained in this notice may now request an
exemption from 49 CFR 391.41(b)(3) by sending an exemption application
request to: Federal 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,
calling 703-448-3094, or faxing a request to 703-448-3077. You may submit comments on the limited issue of the information
collection burden in this notice. FMCSA must receive your information
collection burden comments by January 9, 2006. You may submit
information collection burden comments identified by any of the
following methods. Please identify your comments by the DOT DMS Docket
Number FMCSA-2001-9800. Please also note the paragraph under the
subheading Privacy Act later in this notice about how your comments
will be available to the public. - Web site: http://dms.dot.gov. Follow the instructions for submitting comments on the DOT electronic docket site.
- Fax: 1-202-493-2251.
- Mail: Docket Management Facility; U.S. Department of
Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401,
Washington, DC 20590-0001.
- Hand Delivery: 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.
- Federal eRulemaking Portal: Go to http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Instructions: All submissions must include the agency name and
docket number for this notice. Note that all comments received will be
posted without change to http://dms.dot.gov, including any personal
information provided. Please see the Privacy Act heading under
Regulatory Notices. 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. FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Office of Bus and
Truck Standards and Operations, (202) 366-4001, FMCSA, Department of
Transportation, 400 Seventh Street, SW., Washington, DC 20590-0001.
Office hours are from 8 a.m. to 5 p.m., e.t., Monday through Friday,
except Federal holidays. SUPPLEMENTARY INFORMATION: Background FMCSA established the current physical qualification standard for
drivers with ITDM in 1970 because several risk studies indicated that
such drivers had a higher rate of accident involvement than the general
population. The standard states 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.
FMCSA discussed the regulatory history and research activity addressing
the issue of diabetes and CMV operation in a prior notice in this
proceeding. 66 FR 39548, 39549 (July 31, 2001) In 1998, section 4018 of the Transportation Equity Act for the 21st
Century, Public Law 105-178, 112 Stat. 413-4 (TEA-21) (set out as a
note to 49 U.S.C. 31305) directed the Secretary of Transportation (the
Secretary) to determine if it is feasible to develop "a practicable
and cost-effective screening, operating and monitoring protocol" for
allowing drivers with ITDM to operate CMVs in interstate commerce
"that would ensure a level of safety equal to or greater than that
achieved with the current prohibition on individuals with insulin
treated diabetes mellitus driving such vehicles." As directed by
section 4018, the agency compiled and evaluated the available research
and information. It assembled a panel of medical experts in the
treatment of diabetes to investigate and report on the issues concerned
with the treatment, medical screening and monitoring of ITDM
individuals in the context of operating CMVs. FMCSA then submitted to
Congress in July 2000 a report 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," (TEA-21 Report to Congress). It concluded that it is
feasible to establish a safe and practicable protocol with three
components that would allow some drivers with ITDM to operate CMVs. The
three components included screening of qualified drivers, operational
requirements to ensure proper disease management by such drivers, and
monitoring of safe driving behavior and proper disease management
(refer to pages 64-65). For a detailed discussion of the report's
findings and conclusions, refer to the prior notice in this proceeding.
66 FR 39548, 39549-51 (July 31, 2001). The TEA-21 Report to Congress
can be accessed in docket FMCSA-2001-9800, item 87, in the DOT Docket
Management System at: http://dmses.dot.gov/docimages/p64/139973.tif;
http://dmses.dot.gov/docimages/pdf71/139973_web.pdf; or on FMCSA's Web site at: http://www.fmcsa.dot.gov/facts-research/research-technology/ As a result of the conclusions found in the TEA-21 Report to
Congress, in 2001, FMCSA proposed to implement those conclusions and
recommendations by issuing exemptions from the FMCSRs to allow
operations of CMVs by drivers treating their diabetes mellitus with
insulin. After receiving and considering comments on the proposed use
of exemptions to implement the TEA-21 Report to Congress, in 2003,
FMCSA issued a Notice of Final Disposition establishing the procedures
and protocols for implementing the exemptions. 68 FR 52441 (September
3, 2003) ("2003 Notice"). In order to obtain an exemption, a CMV
driver with ITDM must follow the basic requirements for obtaining an
exemption set out in 49 CFR part 381, subpart C. FMCSA may not grant an
exemption unless it would maintain a level of safety equivalent to, or
greater than, the level achieved without the exemption. 49 U.S.C. 31315
and 49 CFR 381.305(a). This is the same basic standard applicable to
the determination under TEA-21 section 4018(a) of a protocol for CMV
drivers with ITDM. Relying on the legislative history of this
section,\1\ FMCSA previously stated that the level of safety would be
equivalent if there is a reasonable expectation that safety will not be
compromised if an exemption is [[Page 67779]] granted. Federal Motor Carrier Safety Regulations; Waivers, Exemptions
and Pilot Programs, 69 FR 51589, 51592 (Aug. 20, 2004). See also House
Conf. Report 105-550 (May 22, 1998) at 489.
--------------------------------------------------------------------------- \1\ Added by section 4007 of Transportation Equity Act for the
21st Century (TEA-21), Public Law 105-178, 112 Stat. 401 (June 9,
1998).
--------------------------------------------------------------------------- In conformity with the conclusions of the TEA-21 Report to
Congress, the 2003 Notice implemented, with a few modifications, the
three components of the protocol recommended in the report, to allow
drivers with ITDM to be qualified with an exemption from the FMCSRs to
operate CMVs (refer to pages 65-69). Notice of the grant of the first
such exemptions to four drivers who use insulin to treat their diabetes
was published on September 2, 2005. 70 FR 52465. Safe, Accountable, Flexible, Efficient Transportation Equity Act Section 4129 of SAFETEA-LU, Public Law 109-59, 119 Stat. 1144,
1742-43 (Aug. 10, 2005) requires the Secretary to begin, within 90 days
of enactment, to revise the 2003 Notice to allow drivers who use
insulin to treat diabetes to operate CMVs in interstate commerce.\2\
The revision must provide for individual assessment of diabetic
mellitus drivers, and be consistent with the criteria described in
section 4018 of TEA-21, discussed above.
--------------------------------------------------------------------------- \2\ Section 4129(a) refers to the 2003 Notice as a "final rule." However, the 2003 Notice did not issue a ``final rule,'' but
did establish the procedures and standards for issuing exemptions
for drivers with ITDM.
--------------------------------------------------------------------------- Section 4129 requires two substantive changes to be made in the
current exemption process set out in the 2003 Notice. As required by
section 4129(b)-(c), the changes are: (1) Elimination of the
requirement for three years of experience operating CMVs while being
treated with insulin; and (2) establishment of a specified minimum
period of insulin use to demonstrate stable control of diabetes before
being allowed to operate a CMV. In order to accomplish these changes within the 90-day time frame
established by section 4129, FMCSA will make immediate revisions to the
current diabetes exemption program established by the 2003 Notice.
These revisions are those that are necessary to respond to the specific
changes mandated by section 4129 while continuing to ensure that
operation of CMVs by drivers with ITDM will achieve the necessary level
of safety as also required by section 4129(a). The revisions will
include: (1) Elimination of the requirement for three years of
experience operating CMVs while being treated with insulin; and (2)
definition of stable control, using the TEA-21 Report to Congress. Both
of those changes are discussed in more detail below. Section 4129(d) also directed FMCSA to ensure that drivers of CMVs
with ITDM are not held to a higher standard than other drivers, with
the exception of limited operating, monitoring and medical requirements
that are deemed medically necessary. FMCSA concludes that all of the
operating, monitoring and medical requirements set out in the 2003
Notice, except as modified here, are in compliance with section
4129(d). All of the requirements set out in the 2003 Notice, except as
modified here, will remain in effect. These changes to the exemption program will be effective upon
publication of this Notice in the Federal Register. FMCSA is also
commencing the process for considering revisions to the current
physical qualification standards for drivers with ITDM, and will be
issuing an Advance Notice of Proposed Rulemaking (ANPRM) in the near
future. Interested parties are urged to submit comments on this Notice
and its implementation of the statutory directives in their comments in
response to FMCSA's upcoming ANPRM. Revisions to the Exemption Eligibility Criteria Driving Experience While Using Insulin The TEA-21 Report to Congress states that a necessary component of
the feasible program should be screening of qualified drivers. It is
recommended that criteria for screening a driver with ITDM should
include a review of driving experience and driving record to ensure
that there was a level of safety present that did not compromise public
safety. Section 4129(b) of SAFETEA-LU requires the removal of using driving
experience as screening criteria for approving or disapproving an
exemption from the physical qualifications standards for drivers with
ITDM operating a CMV while using insulin. Therefore, FMCSA will
immediately discontinue use of the 3-year criterion for drivers with
ITDM. Applications from drivers with ITDM will no longer be denied
because the drivers do not have 3 years of experience operating CMVs,
while using insulin. FMCSA will also no longer require submission of a
driving record in order to determine exemption eligibility. The
requirement for drivers with ITDM to provide proof of valid operator's
license will remain in effect. Definition of Stable Control and Minimum Period of Insulin Use Section 4129(c) of SAFETEA-LU requires drivers with ITDM to have a
minimum period of insulin use to demonstrate stable control of diabetes
before operating a CMV in interstate commerce, consistent with the
findings of the expert medical panel reported in the TEA-21 Report to
Congress. For individuals who have been newly diagnosed with Type 1
diabetes, the minimum period of insulin use may not exceed 2 months,
unless directed by the treating physician. For individuals who have
Type 2 diabetes and are converting to insulin use, the minimum period
of insulin use may not exceed 1 month, unless directed by the treating
physician. The TEA-21 Report to Congress states that insulin treatment seems
to pose a dilemma with respect to resolving the issue of allowing
individuals with ITDM to operate CMVs in interstate commerce. From a
positive standpoint, insulin therapy clearly improves the health of
individuals who have diabetes mellitus, which should contribute to the
safe operation of CMVs. Conversely, the use of insulin can cause the
onset of hypoglycemia. Hypoglycemia, as some of the literature tends to
argue, is seen as a serious risk factor in crash causation. If
individuals with ITDM are to be allowed to operate CMVs in interstate
commerce, the risk for hypoglycemia and procedures for controlling that
risk cannot be ignored. Any process focused on allowing ITDM
individuals to operate commercial vehicles must clearly have procedures
for controlling that potential for risk and its influence on the level
of safety (refer to pages 27-28). The TEA-21 Report to Congress found that the primary means for
determining whether a driver of a CMV with ITDM has stable control or
proper disease management is to consider information on any recurrent
hypoglycemic reactions experienced by the driver (refer to page 52). In
addition to the evaluation of hypoglycemic reactions, the TEA-21 Report
to Congress also found that the extreme values of glycosylated
hemoglobin (HgA1C) may be evidence of unstable control and poor disease
management. For drivers who exhibit proper disease management, HgA1C
results can be combined with the results of blood glucose monitoring to
obtain a better insight into individual diabetes management (refer to
pages 52-53). The 2003 Notice recognized the importance of using the HgA1C
measurements as part of the evidence to [[Page 67780]] be submitted to demonstrate stable control of the driver's diabetes. In
accordance with the standard clinical protocol, two measurements taken
90 days apart were required. No particular level for the measurement
was specified. 68 FR 52443. The American Diabetes Association (ADA) recommends the use of < 7%
as a normal HgA1C and recognizes that a more stringent level of < 6% may
be used at the discretion of the physician to reduce microvascular and
neuropathic complications of diabetes. However, as discussed above, the
TEA-21 Report to Congress suggests that this lower level may not be in
the best interest of safety when related to a driver with ITDM
operating a CMV, as it may cause hypoglycemic reactions in some
individuals. Therefore, the Report to Congress suggests that the normal
range as defined by the ADA is not the goal and that there is the
assumption that a level exists above this normal range in which the
driver with ITDM would not be at risk for hypoglycemia (refer to page
56). Several members of the expert medical panel involved in the TEA-21
Report to Congress thought that the HgA1C was only relevant at extreme
values at the high end of the range at 10 or 11% (refer to page 57). In
light of all these considerations, FMCSA has determined that the
appropriate measure of HgA1C to demonstrate stable control of diabetes
while using insulin is in the range of 7% and 10%. Acceptable blood glucose ranges were also discussed in the TEA-21
Report to Congress, indicating that the acceptable range for blood
glucose falls between 100 to 400 mg/dl (refer to page 58). The panel
endorsed a protocol for monitoring glucose before and during the
operation of a CMV. This protocol, including those elements relating to
documentation of stable control of diabetes, such as a minimum period
of insulin use, were incorporated into screening and monitoring
components and are currently required by the 2003 Notice as part of the
Federal diabetes exemption process (68 FR 52443-45). The TEA-21 Report to Congress states that defining a period of
insulin use depended on circumstances surrounding the history of
diabetes that a driver include in the application process. It was also
noted that drivers with Type 1 diabetes, with intrastate driving
experience while using insulin, probably have a well established
history of his/her diabetes and its treatment. Setting a period for
insulin use, then, would be necessary mainly for drivers that have Type
2 diabetes or are newly diagnosed with either type. If the driver had
Type 2 diabetes requiring insulin use, the panel thought that a one-
month period would be sufficient to provide adequate individual disease
management skills. If the driver were a newly diagnosed patient with
Type 1 diabetes, the panel was satisfied with a two month period.
However, if the treating physician concluded that the patient needed
adjustment in the insulin dose or had not adequately learned about
diabetes and its management, the period could be extended to a third
month or longer, depending on individual circumstances (refer to page
53). This is the specific criterion referred to in SAFETEA-LU section
4129(c). Based on the TEA-21 Report to Congress under TEA-21 section 4018,
and to ensure that exemptions from the diabetes program continue to
achieve the requisite level of safety, FMCSA therefore continues to
define stable control as specified in the 2003 Notice, with the
exception that, FMCSA will no longer require the submission of two
HgA1C results 90 days apart from driver with ITDM. FMCSA will now
require submission with the application of only one HgA1C result within
the range of >=7% and <=10% to meet the minimum period of insulin use
requirements, as modified by section 4129(c). All other requirements
related to hypoglycemic episodes, blood glucose levels, patient
education, and definition of treating physician currently specified in
the 2003 Notice, 68 FR 52443, will remain in effect. Changes in Application Information Interested applicants with ITDM seeking an exemption are no longer
required to provide documentation to support driving experience, and
will be required to submit only one instead of two HgA1C results as
part of the Federal diabetes application. Conclusion FMCSA reviewed the monitoring protocol specified in the 2003 Notice
and determined it to be adequate under section 4129 of SAFETEA-LU.
Therefore, monitoring requirements will remain in effect as specified. The agency has begun review of all previously denied applications
for Federal diabetes exemptions. The agency has notified these
individuals by letter that the 3-year criterion and driving record
criterion were eliminated, and provided instructions for updating
medical information previously submitted to the agency. In addition to initiating the rulemaking referred to above to
revise the FMCSRs to allow certain insulin-treated diabetic drivers to
operate CMVs in interstate commerce, FMCSA is currently evaluating the
Federal medical exemption and certificate programs to identify areas
for improvement. The agency is currently developing new web-based
public education pages, as well as an on-line application system. Refer
to the new FMCSA medical program page for additional information,
http://www.fmcsa.dot.gov/rules-regulations/topics/medical/medical.htm. 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. In the 2003 Notice, FMCSA estimated that approximately 700
applications for exemption would be filed annually, and that it would
take an average of 90 minutes to complete an application, for a total
burden of 1,050 hours. The number of applications actually filed has
been substantially less. However, with the changes made in the
exemption program by this revised Notice, the number of applications
could increase substantially, and may approximate, at least initially,
the level estimated in 2003. The amount of information to be collected
for this exemption program has decreased because applicants with
insulin treated diabetes mellitus would not have to provide information
regarding their history of operating commercial motor vehicles while
undergoing such treatment and the associated three-year driving record. FMCSA determined there will be no change in the burden in the
currently-approved information collection (OMB Control No. 2126-0006),
titled "Medical Qualifications Requirements," which includes the
diabetes exemption program as a result of the action in this notice.
OMB approved the information collection on December 18, 2003. The
approval will expire on December 31, 2006. 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. [[Page 67781]] 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. Issued on: November 2, 2005.
Annette M. Sandberg,
Administrator.
[FR Doc. 05-22264 Filed 11-7-05; 8:45 am] BILLING CODE 4910-EX-P
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