Qualifications of Drivers; Diabetes Standard
Federal Register, Volume 80 Issue 85 (Monday, May 4, 2015)
Federal Register Volume 80, Number 85 (Monday, May 4, 2015)
Proposed Rules
Pages 25260-25272
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2015-09993
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DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
Docket No. FMCSA-2005-23151
RIN 2126-AA95
Qualifications of Drivers; Diabetes Standard
AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.
ACTION: Notice of proposed rulemaking (NPRM).
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SUMMARY: FMCSA proposes to permit drivers with stable, well-controlled insulin-treated diabetes mellitus (ITDM) to be qualified to operate commercial motor vehicles (CMVs) in interstate commerce. Currently, drivers with ITDM are prohibited from driving CMVs in interstate commerce unless they obtain an exemption from FMCSA. This NPRM would enable individuals with ITDM to obtain a Medical Examiner's Certificate (MEC), from a medical examiner (ME) at least annually in order to operate in interstate commerce if the treating clinician (TC) who is the healthcare professional responsible for prescribing insulin for the driver's diabetes, provides documentation to the ME that the condition is stable and well-controlled.
DATES: You must submit comments on or before July 6, 2015.
ADDRESSES: You may submit comments identified by docket number FMCSA-
2005-23151 using any one of the following methods:
Federal eRulemaking Portal: www.regulations.gov.
Fax: 202-493-2251.
Mail: Docket Services (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
Hand delivery: Same as mail address above, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202-366-9329.
To avoid duplication, please use only one of these four methods. See the ``Public Participation and Request for Comments'' heading under the SUPPLEMENTARY INFORMATION section below for instructions regarding submitting comments.
FOR FURTHER INFORMATION CONTACT: If you have questions about this proposed rule, contact Ms. Linda Phillips, Medical Programs Division, FMCSA, 1200 New Jersey Ave SE., Washington DC 20590-0001, by telephone at 202-366-4001, or by email at fmcsamedical@dot.gov. If you have questions about viewing or submitting material to the docket, call Ms. Barbara Hairston, Program Manager, Docket Services, telephone 202-366-
9826.
SUPPLEMENTARY INFORMATION:
Table of Contents for Preamble
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Executive Summary
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Purpose and Summary of the Major Provisions
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Benefits and Costs
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Public Participation and Request for Comments
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Submitting Comments
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Viewing Comments and Documents
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Privacy Act
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Abbreviations and Acronyms
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Legal Basis for the Rulemaking
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Background
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Diabetes
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Brief History of Physical Qualification Standards for CMV Drivers With ITDM
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Current Exemption Program
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Reasons for the Proposed Changes
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Expert Guidance and Studies Concerning Risks for Drivers With Diabetes
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What FMCSA Is Proposing and Why
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Section-By-Section Analysis
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Section 391.41 Physical Qualifications for Drivers
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Section 391.45 Persons Who Must Be Medically Examined and Certified
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Section 391.46 Physical Qualification Standards for a Person With Insulin-Treated Diabetes Mellitus
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Rulemaking Analyses and Notices
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Executive Summary
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Purpose and Summary of Major Provisions
Under the current regulations, a driver with ITDM may not operate a CMV in interstate commerce unless the driver obtains an exemption from FMCSA, which must be renewed at least every 2 years. FMCSA proposes to allow individuals with well-controlled ITDM to drive CMVs in interstate commerce if they are examined at least annually by an ME who is listed in the National Registry of Certified Medical Examiners (National Registry), have received the MEC from the ME, and are otherwise physically qualified. FMCSA believes that this procedure will adequately
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ensure that drivers with ITDM manage the condition so that it is stable and well-controlled, and that such a regulatory provision creates a clearer, equally effective and more consistent framework than a program based entirely on exemptions under 49 U.S.C. 31315(b).
FMCSA evidence reports, ADA studies, and MRB conclusions and recommendations indicate that drivers with ITDM are as safe as other drivers when their condition is well-controlled. In order to determine if a driver with ITDM meets FMCSA's physical qualification standards and is able to obtain a MEC, the driver must be evaluated at least annually by his or her TC. The evaluation by the TC would ensure that the driver is complying with an appropriate standard of care for individuals with ITDM and would allow the TC to monitor for any of the progressive conditions associated with diabetes (e.g., nerve damage to the extremities, diabetic retinopathy, cataracts and hypoglycemia unawareness). The ME must obtain information from the TC to demonstrate the driver's condition is stable and well-controlled.
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Benefits and Costs
FMCSA believes that this rulemaking would not have a significant economic impact. Compared to other CMV drivers, drivers with ITDM will incur costs for an additional Department of Transportation (DOT) medical examination of $151 annually; however, they will have the ability to earn a living without the inconvenience and added costs of obtaining and maintaining an exemption. The increased monitoring of the driver with ITDM could lead to better driver health while ensuring that the physical condition of CMV drivers enables them to operate CMVs safely. The total annual cost of medically qualifying drivers with ITDM would increase in comparison to the cost of the current exemption program based on a projected increase in the population of drivers who would seek medical certification, as shown in Table 1 below for ITDM drivers:
Table 1--Total Annual Costs
In millions of $
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Proposed rule
(100% ITDM- Proposed rule Proposed rule
Current exemption qualified drivers (66.7% ITDM- (33.3% ITDM-
program (209,664 drivers) qualified drivers qualified drivers
\1\ (139,846 drivers) (69,818 drivers)
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Cost of Visits to Endocrinologist $0.26 $0.00 $0.00 $0.00
($m)...............................
Cost of Annual Exam of Eye 0.40 0.00 0.00 0.00
Specialist ($m)....................
Cost of Issuing Annual Medical 0.13 16.35 10.91 5.45
Certificates ($m)..................
Cost of Applying for Exemption ($m). 0.03 0.00 0.00 0.00
Driver Time Costs of Medical Exams 0.06 7.55 5.03 2.51
($m)...............................
Cost to Government ($m)............. 0.91 0.00 0.00 0.00
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Total Costs ($m)................ 1.79 23.90 15.94 7.96
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As the Agency lacks data to project the affected population changes in subsequent years, the analysis projects this rule's total annual costs to remain constant in real terms during each of the ten years from the initial compliance date. Therefore, for this rule a separate discussion of the annualized costs at the 7% discount rate is unnecessary, as the annualized costs are identical to the corresponding discounted annual costs.
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\1\ ``ITDM-qualified drivers'' are those the Agency believes would qualify under this proposed rule to receive medical examiner's certificates enabling them to operate CMVs in interstate commerce were they to undergo a DOT medical examination. The derivation of the estimated number of ITDM-qualified drivers at the three participation rates evaluated is shown in section 2.4.1 of the regulatory evaluation.
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Public Participation and Request for Comments
FMCSA encourages you to participate in this rulemaking by submitting comments and related materials. Where possible, we would like you to provide scientific, peer-reviewed data to support your comments. On March 17, 2006, the Agency published an Advance Notice of Proposed Rulemaking (ANPRM) on the diabetes standard (71 FR 13810). In this NPRM, the Agency does not respond to comments submitted in response to the ANPRM. If you believe your previous comments are relevant to today's proposed rule, please reference them in your new comments to the docket FMCSA-2005-23151.
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Submitting Comments
If you submit a comment, please include the docket number for this rulemaking (FMCSA-2005-23151), indicate the heading of the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online, by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.
To submit your comment online, go to www.regulations.gov, type the docket number, ``FMCSA-2005-23151'' in the ``Keyword'' box, and click ``Search.'' When the new screen appears, click the ``Comment Now!'' button and type your comment into the text box in the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party, and click ``Submit.'' If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope.
FMCSA will consider all comments and material received during the comment period and may change this proposed rule based on your comments.
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Viewing Comments and Documents
To view comments and any document mentioned in this preamble, go to www.regulations.gov, insert the docket number, ``FMCSA-2005-23151'' in the ``Keyword'' box, and click ``Search.'' Next, click the ``Open Docket Folder'' button and choose the document listed to review. If you do not have access to the Internet, you may view the docket online by visiting the Docket Services in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m. ET,
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Monday through Friday, except Federal holidays.
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Privacy Act
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.
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Abbreviations and Acronyms
ADA American Diabetes Association
ANPRM Advance Notice of Proposed Rulemaking
CAA Clean Air Act
CE Categorical Exclusion
CDL Commercial Driver's License
CMV Commercial Motor Vehicle
DOT U.S. Department of Transportation
E.O. Executive Order
FHWA Federal Highway Administration's
FMCSA Federal Motor Carrier Safety Administration
FR Federal Register
FMCSRs Federal Motor Carrier Safety Regulations
ICR Information Collection Request
ITDM Insulin-Treated Diabetes Mellitus
LFC Licencia Federal de Conductor
ME Certified Medical Examiner
MEC Medical Examiner's Certificate
MRB Medical Review Board
NPRM Notice of Proposed Rulemaking
OMB Office of Management and Budget
PIA Privacy Impact Assessment
PRA Paper Reduction Act
RFA Regulatory Flexibility Act
RIA Regulatory Impact Analysis
SAFETEA-LU Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users
SORN System of Records Notice
TEA-21 Transportation Equity Act for the 21st Century
TC Treating Clinician
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Legal Basis for the Rulemaking
FMCSA has authority under 49 U.S.C. 31136(a) and 31502(b)--
delegated to the Agency by 49 CFR 1.87(f) and (i), respectively--to establish minimum qualifications, including medical and physical qualifications, for CMV drivers operating in interstate commerce. Section 31136(a)(3) requires that the Agency's safety regulations ensure that the physical conditions of CMV drivers enable them to operate their vehicles safely, and that MEs trained in physical and medical examination standards perform the physical examinations required of such operators.
In 2005, Congress authorized the creation of the Medical Review Board (MRB) composed of experts ``in a variety of medical specialties relevant to the driver fitness requirements'' to provide advice and recommendations on qualification standards 49 U.S.C. 31149(a). The position of Chief Medical Officer was authorized at the same time 49 U.S.C. 31149(b). Under section 31149(c)(1), the Agency, with the advice of the MRB and Chief Medical Officer, is directed to ``establish, review and revise . . . medical standards for operators of commercial motor vehicles that will ensure that the physical condition of operators of commercial motor vehicles is adequate to enable them to operate the vehicles safely.'' As discussed below in this proposed rule, the Agency, in conjunction with the Chief Medical Officer, asked the MRB to review and report on the current diabetes standard. The Board's recommendations and the Agency's responses are described elsewhere in this NPRM.
In addition to the statutory requirements specific to the physical qualifications of CMV drivers 49 U.S.C. 31136(a)(3), FMCSA's regulations must also ensure that CMVs are maintained, equipped, loaded and operated safely 49 U.S.C. 31136(a)(1); that the responsibilities imposed on CMV drivers do not impair their ability to operate the vehicles safely 49 U.S.C. 31136(a)(2); that the operation of CMVs does not have a deleterious effect on the physical condition of the drivers 49 U.S.C. 31136(a)(4); and that drivers are not coerced by motor carriers, shippers, receivers, or transportation intermediaries to operate a vehicle in violation of a regulation promulgated under 49 U.S.C. 31136 (which is the basis for much of the FMCSRs), 49 U.S.C. chapter 51 (which authorizes the hazardous materials regulations) or 49 U.S.C. chapter 313 (the authority for the Commercial Driver's License (CDL) regulations and the related drug and alcohol testing requirements) 49 U.S.C. 31136(a)(5).
This proposed rule is based on 49 U.S.C. 31136(a)(3) and 31149(c), but does not deal with 49 U.S.C. 31136(a)(1), (2), or (4). FMCSA believes that coercion of drivers with ITDM to violate the current rule preventing them from operating in interstate commerce--which is prohibited by 49 U.S.C. 31136(a)(5)--does not and will not occur. On the contrary, motor carriers have generally been reluctant to employ such drivers at all. The Federal Highway Administration's (FHWA) original exemption program in the 1990s and FMCSA's subsequent program under 49 U.S.C. 31315(b) allowed selected individuals with ITDM to drive legally for the first time, while also generating data showing that their safety records were at least as good as those of non-ITDM drivers.
Section 4129 of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU) Pub. L. 109-59, 119 Stat. 1144, 1742, Aug. 10, 2005, in paragraphs (a) through (c), directed the Agency to relax certain requirements of its exemption program for drivers with ITDM.\2\ The last paragraph of section 4129 provides that insulin-treated individuals may not be held by the Secretary to a higher standard of physical qualification in order to operate a commercial motor vehicle in interstate commerce than other individuals applying to operate, or operating, a commercial motor vehicle in interstate commerce; except to the extent that limited operating, monitoring, and medical requirements are deemed medically necessary under regulations issued by the Secretary.\3\
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\2\ The exemption requirements were changed in a notice issued November 8, 2005 (70 FR 67777).
\3\ See http://www.gpo.gov/fdsys/pkg/STATUTE-119/pdf/STATUTE-119-Pg1144.pdf (pages 599-600 of the 835 page PDF).
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FMCSA believes that this proposed rule would satisfy the purposes of section 4129(d), by imposing appropriate requirements on such drivers as contemplated by that provision and maintaining current levels of highway safety.
Finally, prior to prescribing any regulations, FMCSA must consider their ``costs and benefits'' 49 U.S.C. 31136(c)(2)(A) and 31502(d). Those factors are discussed in the Rulemaking Analyses and Notices section of this NPRM.
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Background
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Diabetes
Diabetes is a disorder of metabolism--the way the body uses digested food for growth and energy.\4\ The body breaks down most food into glucose. After digestion, glucose passes into the bloodstream, where cells use it for growth and energy. For glucose to enter cells, insulin, a hormone produced by the pancreas, must be present. Normally, the pancreas produces the right amount of insulin automatically to move glucose from blood into the cells. In people with diabetes, however, either the pancreas produces little or no insulin or the cells do not respond appropriately to the insulin that is produced. Glucose builds up in the blood, overflows into the urine, and passes out of the body in the urine. Thus, the body loses its main source of fuel although the blood contains large
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amounts of glucose. The excess glucose in the blood (called hyperglycemia) plays an important role in disease-related complications.
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\4\ See the source document for this discussion at http://diabetes.niddk.nih.gov/dm/pubs/overview/DiabetesOverview_508.pdf.
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Type 1 diabetes is an autoimmune disease in which the immune system attacks and destroys the insulin-producing cells in the pancreas. The pancreas then produces little or no insulin. A person who has Type 1 diabetes must take insulin daily to live. Type 1 diabetes accounts for about 5 percent of all diagnosed cases of diabetes in the United States and is usually diagnosed in children and young adults.
In Type 2 diabetes, the pancreas is usually producing enough insulin, but the body cannot use the insulin effectively, a condition called insulin resistance. After several years, insulin production decreases. The result is the same as for Type 1 diabetes--glucose builds up in the blood and the body cannot make efficient use of its main source of fuel. Type 2 diabetes can be treated through diet, with insulin, or with medications other than insulin. The prevalence of Type 2 diabetes increases with age. Type 2 diabetes accounts for about 95 percent of diagnosed diabetes in adults in the United States.
Over time, people with the disease have a heightened potential of developing other problematic medical conditions. These conditions include proliferative diabetic retinopathy,\5\ cataracts and glaucoma, high blood pressure and other cardiovascular problems, kidney disease, and circulation issues for the extremities, which can cause numbness and decreased functionality, particularly with feet and legs.
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\5\ Between 40 and 45 percent of Americans diagnosed with diabetes have some stage of diabetic retinopathy. The four stages of diabetic retinopathy, from mild, non-proliferative to proliferative, are described by the National Eye Institute, National Institutes of Health at: http://www.nei.nih.gov/health/diabetic/retinopathy.asp. Web site accessed on March 20, 2015.
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Of particular concern for drivers, however, are the immediate symptoms of severe hypoglycemia--a condition where insulin treatment may cause blood glucose to drop to a dangerously low concentration.\6\ A person experiencing hypoglycemia may have one or more of the following symptoms: Double vision or blurry vision; shaking or trembling; tiredness or weakness; unclear thinking; fainting; seizures; or coma.\7\ If any of these symptoms of severe hypoglycemia occurs while someone is driving, there is the potential for a crash.
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\6\ According to the ADA Web site, ``Hypoglycemia is a condition characterized by abnormally low blood glucose (blood sugar) levels, usually less than 70 mg/dl.'' http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hypoglycemia-low-blood.html. Web site accessed on March 20, 2015.
\7\ http://www.nlm.nih.gov/medlineplus/ency/article/000386.htm. Web site accessed on March 20, 2015.
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Some people with blood glucose readings at concentrations below optimal levels perceive no symptoms and no early warning signs of low blood glucose--a condition called hypoglycemia unawareness. This condition occurs most often in people with Type 1 diabetes, but it can occur in people with Type 2 diabetes. Note, however, that impairments associated with diabetes mellitus can be abated through proper disease management and monitoring to stabilize and control the condition.
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Brief History of Physical Qualification Standards for CMV Drivers With ITDM \8\
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\8\ A more complete history of the Federal regulation of drivers with ITDM is available in the ANPRM published March 17, 2006 (71 FR 13802), which readers can find in the docket for this rulemaking.
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From 1940 until 1971, one of FMCSA's predecessors recommended that CMV drivers have urine glucose tests as part of medical examinations for determining whether persons are physically qualified to drive CMVs in interstate or foreign commerce (4 FR 2294, June 7, 1939, effective date January 1, 1940). In 1971, FHWA, FMCSA's predecessor agency, established the current standard for drivers with ITDM (35 FR 6458, April 22, 1970, effective date January 1, 1971), which includes testing urine for glucose. That 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). However, beginning in 1993, CMV drivers with ITDM had the opportunity to apply to FHWA for a waiver until a 1994 Federal court decision invalidated the waiver program.
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 to determine the feasibility of developing ``a practicable and cost-effective screening, operating and monitoring protocol'' for allowing drivers with ITDM to operate CMVs in interstate commerce. This protocol ``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, FHWA compiled and evaluated the available research and information. It assembled a panel of medical experts in the treatment of diabetes to investigate and report about the issues concerned with the treatment, medical screening, and monitoring of ITDM individuals in the context of operating CMVs. In July 2000, FMCSA \9\ submitted a report to Congress titled, ``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).\10\ This Report to Congress concluded that it was feasible to establish a safe and practicable protocol containing three components allowing some drivers with ITDM to operate CMVs. The three components were: (1) Screening of qualified ITDM commercial drivers, (2) establishing operational requirements to ensure proper disease management by such drivers, and (3) monitoring safe driving behavior and proper disease management.
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\9\ The motor carrier regulatory functions of the FHWA were transferred to FMCSA in the Motor Carrier Safety Improvement Act of 1999, Public Law 106-159, 113 Stat. 1748, Dec. 9, 1999.
\10\ The TEA-21 Report to Congress can be accessed in the docket for this rulemaking. For a detailed discussion of the report's findings and conclusions, see 66 FR 39548 (July 31, 2001).
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On July 31, 2001, because of the conclusions found in the TEA-21 Report to Congress, FMCSA published a notice proposing to issue exemptions from the FMCSRs allowing drivers with ITDM to operate CMVs in interstate commerce. 66 FR 39548. After receiving and considering comments, FMCSA issued a Notice of Final Disposition (``2003 Notice'') establishing the procedures and protocols for implementing the exemptions for drivers with ITDM. 68 FR 52441 (Sept. 3, 2003). So beginning again in 2003, CMV drivers with ITDM could apply to FMCSA for an exemption from this prohibition.
To obtain an exemption, a CMV driver with ITDM had to meet the specific conditions and comply with the requirements set out in the final disposition. The driver had to follow the application process set out in 49 CFR part 381, subpart C, and FMCSA could not grant an exemption unless a level of safety equivalent to, or greater than, the level achieved without the exemption
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would be maintained. 49 U.S.C. 31315 and 49 CFR 381.305(a).
In conformity with the conclusions of the TEA-21 Report to Congress, the 2003 Notice implemented the three protocol components recommended in the report, with a few modifications.
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Current Exemption Program
FMCSA administers an exemption program for individuals with ITDM who wish to become qualified or maintain their physical qualifications as CMV drivers. The Agency administers this exemption program under 49 CFR part 381 subpart C according to directives in notices of disposition published in 2003 (68 FR 52441, Sept. 3, 2003) and 2005 (70 FR 67777, Nov. 8, 2005).
To apply for an exemption under the current program administered by FMCSA, the driver must submit a letter application with medical documentation showing the following: \11\
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\11\ This list of requirements to apply for and maintain an ITDM exemption is not inclusive.
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(1) The driver has been examined by a board-certified or board-
eligible endocrinologist who has conducted a comprehensive evaluation including (i) one measure of glycosylated hemoglobin within a range of >=7 percent and
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