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.

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, 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 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.

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. 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.

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 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.

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 .