[Federal Register Volume 70, Number 215 (Tuesday, November 8, 2005)]
[Notices]
[Pages 67777-67781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-22264]


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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.

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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/publications/medreports.htm.
    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.
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    \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).
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    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.
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    \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.
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    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