Document ID: FMCSA-2005-23151-0098
Agency: fmcsa
Document Type: Proposed Rule
Title: Qualification of Drivers; Diabetes Standard
Posted Date: 2015-05-04T04:00Z

[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

49 CFR Part 391

[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

I. Executive Summary
    A. Purpose and Summary of the Major Provisions
    B. Benefits and Costs
II. Public Participation and Request for Comments
    A. Submitting Comments
    B. Viewing Comments and Documents
    C. Privacy Act
III. Abbreviations and Acronyms
IV. Legal Basis for the Rulemaking
V. Background
    A. Diabetes
    B. Brief History of Physical Qualification Standards for CMV 
Drivers With ITDM
    C. Current Exemption Program
VI. Reasons for the Proposed Changes
    A. Expert Guidance and Studies Concerning Risks for Drivers With 
Diabetes
    B. What FMCSA Is Proposing and Why
VII. Section-By-Section Analysis
    A. Section 391.41 Physical Qualifications for Drivers
    B. Section 391.45 Persons Who Must Be Medically Examined and 
Certified
    C. Section 391.46 Physical Qualification Standards for a Person 
With Insulin-Treated Diabetes Mellitus
VIII. Rulemaking Analyses and Notices

I. Executive Summary

A. 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

[[Page 25261]]

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.

B. 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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II. 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.

A. 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.

B. 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,

[[Page 25262]]

Monday through Friday, except Federal holidays.

C. 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.

III. 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

IV. 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.

V. Background

A. 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

[[Page 25263]]

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.

B. 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

[[Page 25264]]

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.

C. 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 <=10 percent, and (ii) a signed statement regarding the 
doctor's determinations;
    (2) The driver has obtained a signed statement from an 
ophthalmologist or optometrist that the driver has been examined, has 
no unstable proliferative diabetic retinopathy, and meets the vision 
standard in Sec.  391.41(b)(10); and
    (3) The driver has obtained a signed copy of an ME's Medical 
Evaluation Report and of a Medical Examiner's Certificate issued 
showing that the driver meets all other standards in Sec.  391.41(b).
    FMCSA does not conduct exams of any of the drivers in the exemption 
program. We accept the paperwork from the MEs and the TCs and make our 
decision based on the paperwork. To maintain the exemption, the driver 
must meet certain conditions, which include the following:
    (1) Yearly medical re-certification by an ME;
    (2) Quarterly reports submitted by an endocrinologist to FMCSA 
including blood glucose logs, insulin regimen changes and hypoglycemic 
events, if any, that the driver has experienced;
    (3) Annual comprehensive medical evaluation by an endocrinologist;
    (4) An annual vision evaluation confirming no evidence of unstable 
proliferative diabetic retinopathy and meeting the vision standard for 
CMV drivers;
    (5) Maintaining appropriate medical supplies for glucose 
management, including a monitor, insulin, and an amount of rapidly 
absorbable glucose in the vehicle to be used as necessary;
    (6) Following a protocol to monitor and maintain blood glucose 
levels; and
    (7) Reporting all episodes of severe hypoglycemia, significant 
complications, or inability to manage diabetes, and any involvement in 
a crash or adverse event to the Agency.
    According to the annual report for the diabetes exemption program, 
FMCSA received 858 applications in 2012, continuing the growth trend of 
the preceding six years.\12\ Before granting a request for an 
exemption, FMCSA must publish a notice in the Federal Register for each 
exemption requested, explaining that the request has been filed, and 
providing the public an opportunity to inspect the safety analysis and 
any other relevant information known to the Agency and to comment on 
the request. The notice also must identify the person or class of 
persons who will receive the exemption, the provisions from which the 
person will be exempt, the effective period, and all terms and 
conditions of the exemption. In addition, the Agency must monitor the 
implementation of each exemption to ensure compliance with its terms 
and conditions.
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    \12\ Annual Report for the FMCSA Diabetes Exemption Program, 
December 31, 2012.
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    After the comment period, as part of the approval process, FMCSA 
must publish a notice of its decision to approve or deny the request. A 
driver must reapply for an exemption every 2 years. However, FMCSA may 
revoke an exemption immediately under standards set out in Sec.  
381.330.
    Should this proposal become a final rule, CMV drivers with ITDM 
could meet physical qualification standards under the new rule without 
applying for or receiving exemptions.

VI. Reasons for the Proposed Changes

    This section of the preamble is divided into two major subsections. 
The first section discusses data reflected in evidence reports and 
American Diabetes Association (ADA) studies examining risks associated 
with diabetes and driving in general, and the association between 
hypoglycemia and ITDM in particular. It also discusses MRB findings and 
conclusions based on evidence reports. The second section explains why 
FMCSA is proposing to eliminate the exemption program and establish a 
medical qualification standard for drivers with ITDM, including 
relating the proposed rule elements to the current exemption program, 
MRB recommendations, and findings from the ADA studies.

A. Expert Guidance and Studies

Medical Review Board Guidance
    FMCSA uses an evidence-based systematic review process and 
consultation with the MRB and the Chief Medical Officer to revise or 
develop medical standards and guidelines for commercial drivers. In its 
deliberations concerning commercial drivers with ITDM, the MRB reviewed 
the analysis of a 2006 evidence-based report and a 2010 update of that 
report.\13\ Both reports focused primarily on the risks to driver 
safety from the acute risks associated with diabetes mellitus (e.g., 
hypoglycemia), but did not address driver safety issues related to 
chronic complications of diabetes (e.g., diabetic nephropathy, 
neuropathy, retinopathy, and/or cardiovascular conditions resulting 
from the long-term complications of diabetes). Both the evidence 
reports and ADA studies, discussed in the next section, show that 
hypoglycemia is the chief safety concern for drivers with the disease. 
Further, the 2010 Update studies show use of insulin, a long duration 
on insulin, and impaired hypoglycemic awareness as among the factors 
``repeatedly shown to be associated with an increased incidence of 
severe hypoglycemia.'' \14\
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    \13\ The 2006 ITDM evidence report is Tregear, SJ, Rizzo M, 
Tiller M, et al., ``Evidence Report: Diabetes and Commercial Motor 
Vehicle Driver Safety,'' September 8, 2006. Accessed on May 20, 
2015, at: http://ntl.bts.gov/lib/30000/30100/30117/Final_Diabetes_Evidence_Report.pdf. The 2010 update report is 
Bieber-Tregear, M.; Funmilayo, D; Amana, A.; Connor, D; Tregear, S.; 
and Tiller, M., ``Evidence Report: 2010 Update: Diabetes and 
Commercial Motor Vehicle Driver Safety,'' May 27, 2011. Accessed on 
May 20, 2015, at http://ntl.bts.gov/lib/39000/39400/39416/2010_Diabetes_Update_Final_May_27_2011.pdf, (2010 Update).
    \14\ 2010 Update Page 10.
---------------------------------------------------------------------------

    After considering the findings in the evidence-based reports, the 
MRB members agreed unanimously that hypoglycemia among individuals with 
diabetes mellitus is an important risk factor for motor vehicle crashes 
and approved a set of recommendations to FMCSA for CMV drivers with 
diabetes mellitus intended to reduce the likelihood of their operating 
when impaired by hypoglycemic conditions. The MRB recommended that 
FMCSA allow individuals with ITDM to drive CMVs if they are free of 
severe hypoglycemic reactions, have no altered mental status or 
unawareness of hypoglycemia, and manage their diabetes mellitus 
properly to keep blood sugar levels in the appropriate ranges. The MRB 
also recommended that all

[[Page 25265]]

drivers diagnosed with diabetes mellitus be required to obtain at least 
annual recertification by a ME who is a licensed physician, regardless 
of whether they are insulin-treated. However, the MRB recommended 
maintaining a restriction on medical qualification of drivers with ITDM 
from passenger and hazardous materials transportation.
American Diabetes Association Position Paper
    In a 2012 peer-reviewed position paper titled, ``Diabetes and 
Driving,'' the ADA provided ``an overview of existing (drivers) 
licensing rules for people with diabetes, address[ing] the factors that 
impact driving for this population, and identify[ing] general 
guidelines for assessing driver fitness and determining appropriate 
licensing restrictions.'' \15\ At the end of the paper, ADA set out 
recommendations for identifying and evaluating diabetes in drivers.\16\ 
Although the ADA addressed these issues in discussing fitness for non-
CMV drivers with diabetes, the same disease-related conditions that 
present driving concerns in the non-CMV driving population create those 
same concerns in the CMV driving population. ADA begins by stating, 
``[M]ost people with diabetes safely operate motor vehicles without 
creating any meaningful risk of injury to themselves or others.'' \17\ 
Summarizing several studies on understanding diabetes and driving, the 
paper notes inconsistent findings relative to which drivers with 
diabetes are at higher risk of crashes. However, the paper notes that 
according to the studies, ``The single most significant factor 
associated with driving collisions for drivers with diabetes appears to 
be a recent history of severe hypoglycemia,\18\ regardless of the type 
of diabetes or the treatment used.'' \19\ The paper further references 
studies finding that even moderate hypoglycemia ``significantly and 
consistently impairs driving safely and judgment as to whether to 
continue to drive or self-treat under such metabolic conditions.'' \20\
---------------------------------------------------------------------------

    \15\ ADA, ``Diabetes and Driving,'' Diabetes Care, vol. 35, 
supplement 1, January 2012, pp. S81-S85, at S81. Accessed March 20, 
2015, from: http://care.diabetesjournals.org/content/35/Supplement_1/S81.full.pdf+html.
    \16\ Id. at S83-S85.
    \17\ Id. at S81.
    \18\ Id. at S82 (``The American Diabetes Association Workgroup 
on Hypoglycemia defined severe hypoglycemia as low blood glucose 
resulting in neuroglycopenia that disrupts cognitive motor function 
and requires the assistance of another to actively administer 
carbohydrate, glucagon, or other resuscitative actions.'').'' 
Reference omitted.
    \19\ Id. At page 84, the paper states, ``[R]ecurrent episodes of 
severe hypoglycemia, defined as two or more episodes in a year, may 
indicate that a person is not able to safely operate a motor 
vehicle.''
    \20\ Id. References omitted.
---------------------------------------------------------------------------

    In evaluating fitness for drivers with diabetes, the ADA paper 
underscores the importance of individualized assessments ``based not 
solely on diagnosis of diabetes but rather on concrete evidence of 
actual risk.'' \21\ According to the ADA paper, such an assessment 
``must include an assessment by the treating physician or other 
diabetes specialist who can review recent diabetes history'' as these 
health care providers are ``the best source of information concerning 
the driver's diabetes management and history.'' \22\ Among other 
things, the ADA paper recommends physicians provide the following 
information to licensing authorities: (1) The driver's risk of severe 
hypoglycemia; (2) the driver's ability to recognize imminent 
hypoglycemia and take appropriate corrective action; and (3) the 
driver's ability to provide evidence of sufficient self-monitoring of 
blood glucose. Appropriate screening inquiries related to driver 
fitness include ``whether the driver has, within the past 12 months, 
lost consciousness due to hypoglycemia, experienced hypoglycemia that 
required intervention from another person to treat or that interfered 
with driving, or experienced hypoglycemia that developed without 
warning.'' \23\
---------------------------------------------------------------------------

    \21\ Id. at S83.
    \22\ Id.
    \23\ Id.
---------------------------------------------------------------------------

    The ADA's summary of findings concerning the risks of driving and 
diabetes concludes that, ``[M]ost people with diabetes safely operate 
motor vehicles without creating any meaningful risk of injury to 
themselves or others.'' \24\ This statement also reflects FMCSA's 
conclusion based on the available evidence.
---------------------------------------------------------------------------

    \24\ Id. at S81.
---------------------------------------------------------------------------

B. What FMCSA is Proposing and Why

    In accordance with section 4129(d) of SAFETEA-LU referenced earlier 
in the Legal Basis section of the preamble, FMCSA may not adopt higher 
physical qualification standards for drivers with ITDM ``except to the 
extent that limited operating, monitoring, and medical requirements are 
deemed medically necessary.'' As noted above, CMV drivers with diabetes 
whose condition is stable and well-controlled do not pose an 
unreasonable risk to their health or to public safety. Also, as noted, 
studies indicate that hypoglycemia is the chief safety concern for 
drivers with diabetes, and the evidence reports show a connection 
between insulin use and the risk of hypoglycemia. FMCSA has determined 
that the inconvenience and expense for drivers, and the administrative 
burden of an exemption program are no longer necessary to address 
concerns of hypoglycemia and meet the statutory requirement that 
drivers with ITDM maintain a physical condition that ``is adequate to 
enable them to operate (CMVs) safely.'' 49 U.S.C. 31136(a)(3). The 
principal reason for codifying medical qualification standards for ITDM 
drivers is to eliminate the prohibition on physically qualifying these 
drivers, thereby promoting their ability to earn a living without the 
inconvenience and added costs of obtaining and maintaining an 
exemption. As stated above, evidence indicates that these drivers are 
reasonably safe to drive if their diabetes is stable and well-
controlled.
    In this proposed rule, FMCSA would address hypoglycemia as a driver 
health and operational safety risk by establishing a regulatory 
protocol to ensure proper disease monitoring and management for drivers 
using insulin. The Agency is proposing to allow drivers with ITDM to be 
medically qualified. As a result, the exemption program established in 
the 2003 and 2005 notices would be unnecessary, and the notices would 
be withdrawn when this final rule becomes effective. These actions are 
consistent with the MRB recommendations. Further, this rulemaking would 
allow healthcare professionals familiar with a driver's physical 
condition to communicate directly with each other, appropriately 
ensuring that the MEs have the information necessary to complete the 
certificate attesting to the driver's medical qualifications. The 
practice of medical certification through MEs is more efficient and is 
reflective of congressional intent to have MEs on the National Registry 
make an individualized assessment of a particular driver's health 
status and ability to operate a CMV safely.
    Contrary to the MRB recommendations, the Agency is not proposing to 
prohibit drivers with ITDM from being medically qualified to operate 
CMVs carrying passengers and hazardous materials. The risk posed by a 
driver with stable, well-controlled ITDM is very low in general. 
Further, there is no available evidence to support such a prohibition, 
and, as noted, under section 4129 of SAFETEA-LU, FMCSA may not hold 
drivers with ITDM ``to a higher standard of physical qualification . . 
. than other individuals . . . except to the extent that limited 
operating, monitoring, and medical requirements are deemed medically 
necessary under

[[Page 25266]]

regulations.'' In addition, the current exemption program permits these 
drivers to qualify for passenger carrying and hazardous materials 
transportation. The Agency requests public comment specifically on this 
point, however.
    In addition, FMCSA is not proposing to adopt the MRB recommendation 
to require annual or more frequent medical recertification for all 
drivers with diabetes mellitus. The proposed requirements apply only to 
drivers with ITDM. Current regulations do not prohibit any drivers with 
non-insulin treated diabetes mellitus from being qualified medically to 
operate CMVs. Finding no medical necessity for such a prohibition, the 
Agency is not proposing such a change. Furthermore, although the MRB 
recommended evaluation by a licensed physician, the Agency believes the 
TC working in conjunction with the ME, who is certified by the National 
Registry and working within the regulatory framework under part 391, 
meets the statutory requirement under 49 U.S.C. 31136(a)(3) for 
periodic physical examinations of drivers. The Agency seeks comment on 
these issues.
    Today's proposed rule would amend 49 CFR part 391 by revising 
Sec. Sec.  391.41 and 391.45 and by adding new Sec.  391.46 to address 
driver health and public safety concerns associated with hypoglycemia 
related to diabetes and its control through insulin. The elements of 
the proposed rule are limited and medically necessary under section 
4129(d) of SAFETEA-LU, ensure that the physical condition of drivers 
with ITDM is adequate to enable them to operate CMVs safely as required 
by 49 U.S.C. 31136(a)(3), and align with current best medical practice 
standards for monitoring and managing ITDM. In brief, the Agency 
proposes the following elements:
    A driver with ITDM must have an annual or more frequent evaluation 
by a TC prior to a DOT medical examination by a certified ME. This 
proposed requirement is consistent with the MRB recommendations, except 
that the MRB recommended application to all drivers with diabetes 
mellitus. For the reason stated above, FMCSA is proposing this 
requirement only for drivers with ITDM.
    The driver must keep blood glucose records as determined by the TC 
and submit those records to his or her TC at the evaluation. This 
proposed requirement is consistent with the MRB recommendation that 
drivers with ITDM monitor blood glucose levels and submit logs as part 
of their annual evaluation.
    The ME must obtain written notification from the driver's TC, who 
has determined whether, in the preceding 12 months, the driver had a 
severe hypoglycemic reaction or demonstrated hypoglycemic unawareness 
and monitored and managed the condition properly as evidenced by blood 
glucose records. This proposed requirement is consistent with the MRB 
recommendation that drivers with ITDM be free of severe hypoglycemia 
and hypoglycemia unawareness, and that these drivers properly monitor 
and manage the condition.
    At least annually, an ME, listed on the National Registry, must 
examine and certify that the driver is free of complications that would 
impair the driver's ability to operate a CMV safely and only renew the 
medical certificate for up to 1 year. This proposed requirement is 
consistent with the MRB recommendation for annual or more frequent 
recertification. For the reason stated above, FMCSA is proposing this 
requirement only for drivers with ITDM.
    In contrast with the current exemption program, the proposed rule 
would require an annual evaluation by a TC instead of an evaluation by 
an endocrinologist and an annual or more frequent DOT medical 
examination by a certified ME to determine if medical certification is 
warranted. Evaluation by a TC allows for the individualized assessment 
of drivers with ITDM, which is consistent with the recommendations of 
the ADA and other organizations concerned with diagnosis and treatment 
of the disease. Most importantly, under section 4129(a) of SAFETEA-LU, 
Congress expressly directed FMCSA to modify the exemption program to 
``provide for the individual assessment of applicants who use insulin 
to treat their diabetes and who are, except for their use of insulin, 
otherwise qualified under the [FMCSRs].'' FMCSA believes that a similar 
provision for an individual assessment is also appropriate in this 
rule. Further, although the ADA, the U.S. National Institutes of 
Health, and other organizations urge yearly assessments for individuals 
with diabetes by a physician or health care professional knowledgeable 
about the disease, none of these groups calls for yearly evaluations by 
endocrinologists. The National Institute of Diabetes and Digestive and 
Kidney Diseases notes that most people with diabetes receive care from 
a primary care physician--generally an internist or family practice 
doctor. Indeed, a requirement to be evaluated by an endocrinologist now 
seems impracticable for most drivers with ITDM. According to the 
American Board of Internal Medicine, there are only about 5,300 board-
certified endocrinologists in the United States, approximately 1,300 of 
which do not provide clinical care.\25\
---------------------------------------------------------------------------

    \25\ http://thyroid.about.com/od/findlearnfromdoctors/a/endo-shortage.htm. Accessed on March 20, 2015.
---------------------------------------------------------------------------

    Reasonable persons with ITDM have every incentive to manage their 
condition so that the disease is stable and well-controlled, because 
the failure to take care of themselves not only would affect the 
quality of life, but also would significantly increase the risk of a 
hypoglycemic event. For a CMV driver, this situation would result in 
the inability to renew the required medical certificate and to earn an 
income through driving a CMV.
    If a driver who has not used insulin previously begins using 
insulin for control of diabetes mellitus, the driver would be required 
to have an examination by a TC prior to the required DOT medical 
examination by a certified ME . The ME would use medical information 
from the TC in conjunction with the medical certification examination 
to determine whether a driver new to insulin treatment qualifies for 
medical certification. Essentially, in issuing a MEC under FMCSA 
regulations, the ME will reflect his or her evaluation that such 
drivers are free of complications that might impair the ability to 
operate a CMV safely in interstate commerce.
    For all drivers with ITDM, the annual visit with the TC would 
ensure that a driver is complying with an appropriate standard of care 
for individuals with that condition, and it would allow the TC to 
monitor any of the other progressive conditions associated with 
diabetes. Although the proposed rule has no requirement for 
hypoglycemia awareness training, the annual or more frequent ME 
certification exam provides an opportunity for intervention should the 
TC evaluation, and the ME's own examination, provide evidence of 
hypoglycemia unawareness that impairs safe driving. The ME will request 
that the TC provide written notification regarding the ITDM driver's 
disease management prior to the examination of the driver.
    The annual or more frequent requirement for a new MEC aligns with 
the current interval specified under the directives in the notices of 
final disposition and with the interval specified for drivers with ITDM 
by the Canadian Council of Motor Transport Administrators. The 
determination of whether a driver with ITDM is eligible to receive a 
MEC would rest with the ME who, working under part 391 with information 
provided by the TC, is

[[Page 25267]]

authorized by statute to conduct DOT medical examinations.
    The proposed rule would not change the requirement under 49 CFR 
392.3 for every CMV driver, including those with ITDM, to refrain from 
operating a CMV while the driver's ability or alertness is impaired in 
a way that would compromise safety. The driver's knowledge of the 
issues surrounding ITDM, appropriate monitoring protocols, and 
equipment and supplies are still very important. The proposed rule 
would not allow drivers with ITDM with licenses issued in Canada or 
Mexico to operate a CMV in the United States. Drivers from Mexico with 
a Licencia Federal de Conductor (LFC) generally may operate in the 
United States. 49 CFR 383.23(b), n. 1 and 391.41(a)(1)(i). But Mexico 
does not issue an LFC to any driver with diabetes. Under the terms of 
the 1998 reciprocity agreement with Canada, a Canadian driver with ITDM 
holding a license issued by a Canadian province is not authorized to 
operate a CMV in the United States.
    In 1994, at the termination of the ITDM waiver program described in 
the Background section of this NPRM, FHWA allowed drivers holding 
waivers to continue to operate CMVs in interstate commerce under the 
grandfather provisions of 49 CFR 391.64. The requirements in proposed 
Sec.  391.46 reflect limited and necessary diabetes monitoring and 
management practices based on the results of the ADA studies and the 
evidence reports. On the other hand, under the current requirements in 
Sec.  391.64, a driver with ITDM must continue to receive an annual 
endocrinologist examination, carry an absorbable source of glucose, and 
meet other requirements that FMCSA has determined are impracticable or 
unenforceable. If the requirements proposed today are adopted, the 
Agency believes that grandfathering provisions may be redundant because 
the individuals with waivers would comply already with the necessary 
elements of Sec.  391.64 (e.g., otherwise qualifying under Sec.  391.41 
and annual examination by an ME), or would be able to meet a less 
restrictive requirement (e.g., annual examination by a TC rather than a 
board-certified endocrinologist). However, FMCSA seeks comments 
regarding whether removing these grandfathering provisions would 
adversely affect any driver that is operating currently under Sec.  
391.64.
    The current exemption program requires drivers with ITDM to obtain 
a signed statement from an ophthalmologist or optometrist that the 
applicant has been examined, meets the vision standard in Sec.  
391.41(b) or has an exemption, and does not have diabetic retinopathy. 
If the applicant has diabetic retinopathy, he or she must be tested by 
an ophthalmologist to determine whether the condition is unstable and 
proliferative. Following that exam, the applicant must submit a 
separate signed statement from the ophthalmologist certifying that the 
applicant's diabetic retinopathy is not unstable or proliferative.
    The proposed rule would not require drivers with ITDM to be 
examined or obtain a signed statement from an ophthalmologist or 
optometrist to meet the vision standard or a separate examination for 
diabetic retinopathy. As stated above, FMCSA believes that reasonable 
persons with ITDM have every incentive to manage their condition so 
that the disease is stable and well-controlled, because the failure to 
care for themselves would affect their quality of life. This includes 
examinations by an optometrist or ophthalmologist to assess the 
individual's long term visual health. The regulatory concern for any 
driver is whether he or she can meet the standards in Sec.  
391.41(b)(10). FMCSA believes that meeting the vision acuity standard 
as part of the annual exam by an ME listed in the National Registry of 
Certified Medical Examiners provides reasonable certainty of 
discovering and mitigating risks associated with any safety-related 
condition that would interfere with meeting the standard, including 
diabetic retinopathy. This approach also would be less costly for 
drivers who would incur the cost of seeing a vision specialist only if 
there are signs of a degenerative condition, in contrast to the 
exemption program requirement that these drivers must see an 
optometrist or ophthalmologist to meet visual acuity requirements under 
Sec.  391.41(b). The Agency requests comment on the need for a person 
with ITDM to be examined by an optometrist or ophthalmologist as a 
condition of passing the physical exam.

VII. Section-By-Section Analysis

    This NPRM addresses the physical qualification standards for 
interstate CMV drivers treating their diabetes mellitus with insulin. 
This section-by-section analysis describes the proposed provisions in 
numerical order.

Section 391.41 Physical Qualifications for Drivers

    Section 391.41 would be amended to allow drivers treating diabetes 
mellitus with insulin to operate commercial motor vehicles in 
interstate commerce provided they meet the conditions specified in the 
new Sec.  391.46. Paragraph (b)(3) would be revised to allow a person 
to meet the physical qualification standards to operate a commercial 
motor vehicle either by (1) having no medical history or diagnosis of 
diabetes mellitus requiring insulin for control or (2) meeting the 
requirements in new Sec.  391.46.

Section 391.45 Persons Who Must Be Medically Examined and Certified

    Section 391.45 would be revised to renumber the section for 
clarity. Existing paragraph (b)(1) would become new paragraph (b), 
requiring any driver who has not been medically examined and certified 
as qualified to operate a CMV during the preceding 24 months, unless 
the driver is required to be examined and certified in accordance with 
paragraphs (c), (d), (e) or (f) of this section. Existing paragraph 
(b)(2) would be divided into new paragraphs (c) and (d). Existing 
paragraph (c) would become new paragraph (f). New paragraph (e) would 
require any driver who has diabetes mellitus requiring insulin for 
control and who has been qualified for a MEC under the standards in 
Sec.  391.46 to be medically examined and certified as qualified to 
drive at least every 12 months.

Section 391.46 Physical Qualification Standards for a Person With 
Insulin-Treated Diabetes Mellitus

    A new Sec.  391.46 would be added containing the requirements that 
a person who has diabetes mellitus currently requiring insulin for 
control must meet to be physically qualified to drive a CMV in 
accordance with specific standards for such drivers.
    Proposed paragraph (a) would require that a person with diabetes 
mellitus requiring insulin for control is physically qualified to 
operate a CMV in interstate commerce if he or she otherwise meets the 
standards in Sec.  391.41 and also meets the requirements in paragraphs 
(b) and (c) of proposed Sec.  391.46.
    Paragraph (b) would require the person with diabetes mellitus 
currently requiring insulin for control to have an evaluation by his or 
her TC who would determine that the driver had not experienced a recent 
severe hypoglycemic reaction and was properly managing the disease. A 
definition of TC would be added to the provision. Paragraph (b) also 
would require a person with diabetes mellitus requiring insulin for 
control to be medically examined and certified under Sec.  391.43 by an 
ME. These examinations would occur at least annually. The ME

[[Page 25268]]

must obtain and review written notification from the TC that the person 
is properly managing the diabetes mellitus. Paragraph (c) would require 
that the medically certified driver with ITDM maintain his or her blood 
glucose records per the guidance of the TC for the period of 
certification and submit those records to the TC at the time of the 
evaluation.

VIII. Rulemaking Analyses and Notices

A. Regulatory Planning and Review (Executive Order (E.O.) 12866) and 
DOT Regulatory Policies and Procedures

    Under E.O. 12866, ``Regulatory Planning and Review'' (issued 
September 30, 1993, published October 4 at 58 FR 51735, as supplemented 
by E.O. 13563 and DOT policies and procedures, FMCSA must determine 
whether a regulatory action is ``significant'' and therefore subject to 
Office of Management and Budget (OMB) review. E.O. 12866 defines 
``significant regulatory action'' as one likely to result in a rule 
that may:
    (1) Have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or Tribal government or communities.
    (2) Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another Agency.
    (3) Materially alter the budgetary impact of entitlements, grants, 
user fees, or loan programs or the rights and obligations of recipients 
thereof.
    (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the E.O.
    FMCSA determined this proposed rule is not a ``significant 
regulatory action'' under Executive Order 12866, Regulatory Planning 
and Review, and not significant under DOT regulatory policies and 
procedures. The Agency estimates that the economic impact of this 
proposed rule will not exceed the annual $100 million threshold for 
economic significance.
    This Regulatory Impact Analysis (RIA) provides an assessment of the 
costs and benefits of the Qualifications of Drivers: Diabetes NPRM. 
FMCSA proposes to allow the operation of CMVs in interstate commerce by 
drivers with well-controlled ITDM whose physical condition allows them 
to operate safely. Under current medical qualifications requirements an 
insulin-dependent driver does not meet the qualifications of Sec.  
391.41(b)(3) to receive a MEC to operate CMVs in interstate commerce. 
However, FMCSA may grant the driver with stable, well-controlled ITDM 
an exemption to drive in interstate commerce under the procedures in 49 
CFR part 381 and the protocols in the 2003 Notice of Final Disposition 
as updated in 2005.\26\
---------------------------------------------------------------------------

    \26\ 68 FR 52441 and 70 FR 67777.
---------------------------------------------------------------------------

    The proposed rule would change the physical qualification standards 
to allow the ME to qualify drivers with stable, well-controlled ITDM to 
operate CMVs in interstate commerce. FMCSA has evaluated the costs and 
benefits of the proposed rule using the current exemption program as a 
baseline for comparison. The proposed rule and the exemption program 
differ on key provisions that affect costs, which are summarized below.

                       Table 2--Comparison of Current Exemption Program and Proposed Rule
----------------------------------------------------------------------------------------------------------------
    Current exemption program                                      Proposed rule
----------------------------------------------------------------------------------------------------------------
Annual exam by ME................  Annual exam by ME.
Renewable exemption granted by     No exemption needed.
 FMCSA for up to every 2 years.
Annual exam by eye specialist for  No annual exam by eye specialist required in regulations.
 evidence of diabetic retinopathy.
Annual evaluation by board-        Annual evaluation by TC.
 certified endocrinologist.
Submit quarterly reports from      No report required.
 board-certified endocrinologist.
----------------------------------------------------------------------------------------------------------------

    The majority of CMV drivers receive MECs that are valid for two 
years. The proposed rule would require drivers with ITDM to obtain MECs 
at least annually as currently required by the exemption program. 
However these drivers would no longer be required to obtain an 
exemption from FMCSA. A driver with stable, well-controlled ITDM who 
meets the requirements of the proposed rule could obtain a MEC and 
continue to earn income operating CMVs in interstate commerce without 
the additional expense and delay of applying for an exemption.
    Not all drivers who seek to be medically certified under the 
standards described in this proposed rule would be medically qualified 
to operate a CMV, however estimating the number of drivers who would 
join the driver population is difficult. As a result the Agency has 
performed a threshold analysis using various percentages of ITDM-
medically qualified drivers to determine possible costs of the rule 
annually in millions of dollars. Further information on this analysis 
may be found in the RIA in the docket.
    In this analysis, we provide cost estimates if the estimated rates 
of ITDM-qualified driver populations are: 33.3%, 66.7%, and 100%. The 
Agency has no estimate of the actual rate of ITDM-qualified drivers 
certified under the qualifications proposed here and feels that 33.3%, 
66.7%, and 100% acceptance rates allow the reader to understand the 
range of possible impacts of the rule. This has no impact on the rule's 
cost per driver which will be discussed shortly.
    The proposed rule is less onerous for both drivers with ITDM and 
for the Agency. The Agency would change the requirement from an annual 
evaluation by a board-certified endocrinologist to one with a TC 
because the treating licensed healthcare professional is capable of 
determining whether the driver's condition is well-controlled. The 
revised requirement also would eliminate quarterly reports from the 
board-certified endocrinologist, the sharing of information between the 
ME on the National Registry and the TC would ensure that only drivers 
who are controlling their ITDM would receive a 1-year medical 
certificate. The Agency would no longer review applications for 
exemptions, further reducing administrative costs for FMCSA. The rule 
would eliminate an annual eye exam, because a qualified ME on the 
Agency's National Registry could determine whether the driver meets the 
vision standard. For these reasons, the per-driver cost would be 
significantly lower under the proposed rule than under the current 
exemption program.
    The table below compares costs of the current exemption program 
with projected costs of the proposed rule. As the Agency lacks 
sufficient data to project the affected population changes

[[Page 25269]]

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. A separate discussion of the 
annualized costs at the 7% discount rate for this rule is therefore 
unnecessary, as the annualized costs are identical to the corresponding 
discounted annual costs. The Agency seeks comments on the use and 
appropriateness of these ranges in the absence of additional data on 
the prevalence of ITDM-qualified drivers and their likelihood of 
participating in the proposal's certification program.

                                           Table 3--Total Annual Costs
                                               [In millions of $]
----------------------------------------------------------------------------------------------------------------
                                                           Proposed rule      Proposed rule      Proposed rule
                                                            (100% IDTM-        (66.7% ITDM-       (33.3% ITDM-
                                      Current exemption  qualified drivers      qualified          qualified
                                           program         \27\--209,664     drivers--139,846   drivers--69,818
                                                              drivers)           drivers)           drivers)
----------------------------------------------------------------------------------------------------------------
Cost of Endocrinology Visits ($m)...              $0.26              $0.00              $0.00              $0.00
Cost of Annual Exam of Eye                         0.40               0.00               0.00               0.00
 Specialist ($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                  0.0               7.55               5.03               2.51
 ($m)...............................
Cost to Government ($m).............               0.91               0.00               0.00               0.00
                                     ---------------------------------------------------------------------------
    Total Costs ($m)................               1.79              23.90              15.94               7.96
----------------------------------------------------------------------------------------------------------------

    On a per-driver basis, the annual cost impact of this rule is 
consistent across all ITDM-qualified drivers. These costs include a 
driver's cost of time related to the DOT medical examination ($31 per 
hour) and a driver's expense for the out-of-cycle DOT medical 
examination ($120). Combined, the out-of-pocket cost per ITDM-qualified 
driver resulting from this proposal is $151 (= $31 + $120). If an ITDM-
qualified driver presently participates in the medical exemption 
program, although he or she will still incur the annual $151 cost of 
this proposal, this driver will experience a significant cost reduction 
relative to the cost to participate in the current exemption program, 
discussed further in the RIA.
---------------------------------------------------------------------------

    \27\ ``ITDM-qualified drivers'' are those the Agency believes 
would qualify under this proposed rule to receive medical 
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.
---------------------------------------------------------------------------

    In addition to examining published literature on the safety risk of 
drivers with diabetes, the Agency has also examined the safety 
performance of drivers holding diabetes exemptions.

                                                      Table 4--Diabetes Exemption Analysis Results
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                             Tow away
                                                           Fatal crashes    Fatalities    Injury crashes     Injuries         crashes      Total crashes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pre-Exemption Period....................................              16              24             108             171             193             317
Exemption-Period........................................               0               0              22              31              52              74
Post-Exemption Period...................................               3               4              16              22              22              41
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................              19              28             146             224             267             432
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: December 14, 2012 MCMIS snapshot.

    The table above titled ``Diabetes Exemption Analysis Results'' 
summarizes the crash performance of 1,730 drivers in the Diabetes 
Exemption Program. Crash statistics for the pre-exemption career and 
(if any) post-exemption career \28\ of the drivers are presented, but 
the primary periods of interest are the months and years during which a 
driver was granted an exemption. As can be seen, as a whole, drivers in 
the exemption program were involved in 74 crashes, none of them fatal.
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    \28\ Some drivers continued driving CMVs after their exemption 
was rescinded or terminated. It is unlikely that these drivers 
stopped taking insulin. Instead, it is most likely that these 
drivers ignored the prohibition on driving while being treated with 
insulin unless the driver holds an exemption.
---------------------------------------------------------------------------

    This record of crash history can be compared against the crash 
performance of drivers as a whole. Because one can examine MCMIS 
reported crashes only for drivers in the exemption program, the 
analysis of the safety performance of drivers as a whole is restricted 
to MCMIS reported crashes. The Agency lacks data on vehicle miles 
traveled for drivers in the exemption program, however, and the best 
indication of exposure is therefore years of driving.
    The exemption program provides data on when an exemption was 
granted, renewed, rescinded, or terminated. These data allow one to 
determine, for each exemption holder, approximately how many months and 
years each driver operated a CMV while holding an exemption. FMCSA was 
able to analyze data for 1,730 drivers involved in 74 crashes. Some 
drivers could not be analyzed because of missing data. (They had a 
termination date but no acceptance date, they could not be matched to a 
driver's license record, or some other data problem made it impossible 
to calculate the number of years they had been driving or to match 
their exemption to a crash record.) The 1,730 drivers had an average of 
3.293 years of driving experience in the exemption program. On a per-
driver, per-year basis, the crash rate for drivers with ITDM in the 
exemption program was 0.013 (0.0130 = 74 crashes / 1,730 drivers / 
3.293 years).

[[Page 25270]]

    Data indicate that the safety performance for CMV drivers with ITDM 
who hold exemptions is as good as that of the general population of CMV 
drivers. The table below shows crashes reported to MCMIS for all FMCSA-
regulated CMV drivers from 2005 to 2011. Over this period, there was an 
average of 134,191 crashes reported to MCMIS each year. FMCSA estimates 
that there are currently 3.5 million active CMV drivers in FMCSA-
regulated operations. Consequently, the average number of crashes per 
year per active CMV driver is about 0.038 (134,191 / 3,500,000).

                                         Table 5--MCMIS Crashes (Any Severity) Involving Large Trucks, 2005-2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  Year                        2005          2006          2007          2008          2009          2010          2011         Average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Crashes.................................      149,878       148,221       148,733       134,666       111,502       122,851       123,483       134,191
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: December 2013, MCMIS snapshot.

    The proposed rule would eliminate the blanket prohibition against 
drivers with ITDM so that the exemption program would no longer 
represent the sole means of physically qualifying to operate CMVs. The 
Agency believes that the benefits of the proposed rule to ITDM 
individuals are significant. These individuals may pursue interstate 
driving careers after demonstrating to a ME that their condition is 
well-controlled and that their ability to operate CMVs safely is not 
compromised by their medical condition. Although the annual costs will 
be higher because of the increased number of drivers with stable, well-
controlled ITDM who could be eligible for medical certification under 
the new rule, the Agency expects that drivers with ITDM will benefit 
from greater employment opportunities, and will realize benefits to 
their health through improved monitoring of their ITDM.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.) (RFA) 
requires Federal agencies to consider the effects of the regulatory 
action on small business and other small entities and to minimize any 
significant economic impact. ``Small entities'' consist of small 
businesses and not-for-profit organizations that are independently 
owned and operated and are not dominant in their fields, and 
governmental jurisdictions with a population of less than 50,000.\29\
---------------------------------------------------------------------------

    \29\ Regulatory Flexibility Act (5 U.S.C. 601 et seq.), see 
National Archives at http://www.archives.gov/federal-register/laws/regulaotry-flexibility/601.html.
---------------------------------------------------------------------------

    Accordingly, DOT policy requires an analysis of the impact of all 
regulations on small entities and mandates that agencies strive to 
lessen any adverse effects on these businesses. Under the standards of 
the RFA, as amended by the Small Business Regulatory Enforcement 
Fairness Act of 1996 (Pub. L. 104-121, 110 Stat. 857) (SBREFA), the 
proposed rule does not impose a significant economic impact on a 
substantial number of small entities (SEISNOSE) because the medical 
standards apply to individuals seeking to operate a CMV in interstate 
commerce; they are qualifications for an occupation rather than for 
small entities. Although there are individual drivers who are self-
employed, qualifications for an occupation are not considered a small 
business issue.
    Consequently, I certify that the proposed action will not have a 
significant economic impact on a substantial number of small entities. 
FMCSA invites comment from members of the public who believe there will 
be a significant impact either on small businesses or on governmental 
jurisdictions with a population of less than 50,000.

C. Assistance for Small Entities

    Under section 213(a) of SBREFA, FMCSA wants to assist small 
entities in understanding this proposed rule so that they can better 
evaluate its effects on themselves and participate in the rulemaking 
initiative. If the proposed rule would affect your small business, 
organization, or governmental jurisdiction and you have questions 
concerning its provisions or options for compliance, please consult the 
FMCSA point of contact, Ms. Linda Phillips, using the contact 
information in the FOR FURTHER INFORMATION CONTACT section of this 
proposed rule.

D. Unfunded Mandates Reform Act of 1995

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) 
requires Federal agencies to assess the effects of their discretionary 
regulatory actions. In particular, the Act addresses actions that may 
result in the expenditure by a State, local, or tribal government, 
taken together, or by the private sector of $151 million (which is the 
value in 2012 after adjusting for inflation $100 million from 1995) or 
more in any 1 year. FMCSA's assessment is that this proposed rule would 
not result in such an expenditure.

E. National Environmental Policy Act and Clean Air Act

    FMCSA analyzed this proposed rulemaking for the purpose of the 
National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) and 
determined under our environmental procedures Order 5610.1, published 
March 1, 2004, (69 FR 9680) that this NPRM does not have any 
significant impact on the environment. In addition, the actions in this 
rulemaking are categorically excluded from further analysis and 
documentation per paragraph 6(b) and 6(s)(7) of Appendix 2 of FMCSA's 
Order 5610.1. A Categorical Exclusion determination is available for 
inspection or copying in the www.regulations.gov Web site listed under 
ADDRESSES.
    FMCSA analyzed this proposed rule under the Clean Air Act, as 
amended (CAA), section 176(c) (42 U.S.C. 7401 et seq.), and 
implementing regulations promulgated by the Environmental Protection 
Agency. The Agency has determined that this proposed rule is exempt 
from the CAA's general conformity requirement since the action results 
in no increase in emissions.

F. Environmental Justice (E.O. 12898)

    Under E.O. 12898, each Federal agency must identify and address, as 
appropriate, ``disproportionately high and adverse human health or 
environmental effects of its programs, policies, and activities on 
minority populations and low-income populations'' in the United States, 
its possessions, and territories. FMCSA evaluated the environmental 
justice effects of this proposed rule in accordance with the E.O., and 
has determined that no environmental justice issue is associated with 
this proposed rule, nor is there any collective environmental impact 
that would result from its promulgation.

G. Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995, a Federal agency must 
obtain approval from the OMB for each

[[Page 25271]]

collection of information it conducts, sponsors, or requires through 
regulations. 44 U.S.C. 3501-3520. Current exemption program applicants 
provide personal, employee health, and driving information during the 
application process. In the currently drafted supporting statement for 
the Information Collection Request (ICR), ``Medical Qualifications of 
Drivers'' (OMB control number 2126-0006), FMCSA attributes 2,219 annual 
burden hours to the applications made by CMV drivers to the current 
exemption program, and this proposed rule would eliminate this entire 
burden. However it would add fewer burden hours for the information 
collection of the TC who prepares written notification for the ME on 
the driver health, the completion of the ME report and results, and the 
ME's submission of the exam data and Medical Certificates to FMCSA. The 
supporting statement for this ICR is on display in the docket for your 
review and comment.

H. Governmental Actions and Interference With Constitutionally 
Protected Property Rights (E.O. 12630)

    E.O. 12630 requires Federal agencies to consider the potential 
takings implications of their proposed actions, decisions, or 
regulations on constitutionally protected property rights, and document 
takings implications in all significant rulemaking documents that must 
be submitted to the OMB. FMCSA has determined that this proposed rule 
would not effect a taking of private property or otherwise have taking 
implications under E.O. 12630.

I. Civil Justice Reform (E.O. 12988)

    This proposed rule meets applicable standards in sections 3(a) 
(regarding the general duty to review regulations) and 3(b)(2) 
(addressing important issues affecting clarity and general 
draftsmanship) of E.O. 12988, Civil Justice Reform, to minimize 
litigation, eliminate ambiguity, and reduce burden.

J. Protection of Children (E.O. 13045)

    E.O. 13045, ``Protection of Children from Environmental Health 
Risks and Safety Risks,'' requires that agencies issuing economically 
significant rules, which concern an environmental health or safety risk 
that an Agency has reason to believe may disproportionately affect 
children, must include an evaluation of the environmental health and 
safety effects of the regulation on children. 62 FR 19885 (Apr. 23, 
1997). Section 5 of E.O. 13045 directs an agency to submit for a 
covered regulatory action an evaluation of its environmental health or 
safety effects on children. The FMCSA has determined that this proposed 
rule is not a covered regulatory action as defined under E.O. 13045, 
because this proposal would not constitute an environmental health risk 
or safety risk that would disproportionately affect children.

K. Federalism (E.O. 13132)

    Under E.O. 13132, a rule has implications for federalism if it has 
a substantial direct effect on State or local governments and would 
either preempt State law or impose a substantial direct cost of 
compliance on States or localities. FMCSA has analyzed this proposed 
rule under that E.O. and has determined that it does not have 
implications for federalism. Nothing in this proposed rule would 
preempt State law or regulation or impose substantial direct compliance 
costs on these governmental entities.

L. Intergovernmental Review (E.O. 12372)

    The regulations implementing E.O. 12372 regarding intergovernmental 
consultation on Federal programs and activities do not apply to this 
program.

M. Consultation and Coordination With Indian Tribal Governments (E.O. 
13175)

    FMCSA analyzed this proposed rule in accordance with the principles 
and criteria in E.O. 13175, Consultation and Coordination with Indian 
Tribal Governments. This rulemaking does not significantly or uniquely 
affect Indian tribal governments or impose substantial direct 
compliance costs on tribal governments. Thus, the funding and 
consultation requirements of E.O. 13175 do not apply, and no tribal 
summary impact statement is required.

N. Energy Supply, Distribution, or Use (E.O. 13211)

    FMCSA has analyzed this proposed rule under E.O. 13211, ``Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use.'' This proposal is not a significant energy 
action within the meaning of section 4(b) of the E.O. This proposal is 
not economically significant and would not have a significant adverse 
effect on the supply, distribution, or use of energy.

O. Privacy Impact Analysis

    Section 522 of title I of division H of the Consolidated 
Appropriations Act, 2005, enacted December 8, 2004 (Pub. L. 108-447, 
118 Stat. 2809, 3268, 5 U.S.C. 552a note), requires the Agency to 
conduct a privacy impact assessment (PIA) of a regulation that will 
affect the privacy of individuals. In accordance with this Act, a 
privacy impact analysis is warranted to address any privacy 
implications contemplated in the proposed rulemaking. The Agency 
submitted a Privacy Threshold Assessment analyzing the privacy 
implications to the Department of Transportation, Office of the 
Secretary's Privacy Office to determine whether a PIA is required. The 
DOT Chief Privacy Officer has evaluated the risks and effects that this 
rulemaking might have on collecting, storing, and sharing Personally 
Identifying Information and has examined protections and alternative 
information handling processes in developing the proposal in order to 
mitigate potential privacy risks. The privacy risks and effects 
associated with this proposed rule are not unique and have previously 
been addressed by the medical examination/certification requirements in 
the National Registry of Certified Medical Examiners (National 
Registry) and the Medical Examiner's Certification Integration PIA 
published on the DOT Privacy Web site and the DOT/FMCSA 009--National 
Registry of Certified Medical Examiners System of Records Notice (SORN) 
(77 FR 24247) published on April 23, 2012. An additional PIA and SORN 
for this rulemaking is not required.

P. National Technology Transfer and Advancement Act (Technical 
Standards)

    The National Technology Transfer and Advancement Act (15 U.S.C. 272 
note) directs agencies to use voluntary consensus standards in their 
regulatory activities unless the agency provides Congress, through OMB, 
with an explanation of why using these standards would be inconsistent 
with applicable law or otherwise impractical. Voluntary consensus 
standards (e.g., specifications of materials, performance, design, or 
operation; test methods; sampling procedures; and related management 
systems practices) are standards that are developed or adopted by 
voluntary consensus standards bodies. This proposed rule does not use 
technical standards. Therefore, we did not consider the use of 
voluntary consensus standards.

Q. E-Government Act of 2002

    The E-Government Act of 2002, Public Law 107-347, sec. 208, 116 
Stat. 2899, 2921 (Dec. 17, 2002), requires Federal agencies to conduct 
a PIA for new or substantially changed technology that collects, 
maintains, or disseminates information in an identifiable form. FMCSA 
has

[[Page 25272]]

determined that this proposed rulemaking does not involve new or 
substantially changed technology.

List of Subjects in 49 CFR Part 391

    Alcohol abuse, Diabetes, Drug abuse, Drug testing, Highway safety, 
Medical, Motor carriers, Physical qualifications, Reporting and 
recordkeeping requirements, Safety, Transportation.

    For the reasons set forth in the preamble, FMCSA proposes to amend 
49 CFR part 391 as follows:

PART 391--QUALIFICATIONS OF DRIVERS AND LONGER COMBINATION VEHICLE 
(LCV) DRIVER INSTRUCTORS

0
1. The authority citation for part 391 continues to read as follows:

    Authority:  49 U.S.C. 504, 508, 31133, 31136, and 31502; sec. 
4007(b) of Pub. L. 102-240, 105 Stat. 1914, 2152; sec. 114 of Pub. 
L. 103-311, 108 Stat. 1673, 1677; sec. 215 of Pub. L. 106-159, 113 
Stat. 1748, 1767; sec. 32934 of Pub. L. 112-141, 126 Stat. 405, 830; 
and 49 CFR 1.87.

0
2. Revise Sec.  391.41(b)(3) to read as follows:

Sec.  391.41  Physical qualifications for drivers.

* * * * *
    (b) * * *
    (3) Has no established medical history or clinical diagnosis of 
diabetes mellitus currently requiring insulin for control, unless the 
person meets the requirements in Sec.  391.46;
* * * * *
0
3. Revise Sec.  391.45 to read as follows:

Sec.  391.45  Persons who must be medically examined and certified.

    Except as provided in Sec.  391.67, the following persons must be 
medically examined and certified in accordance with Sec.  391.43 as 
physically qualified to operate a commercial motor vehicle:
    (a) Any person who has not been medically examined and certified as 
physically qualified to operate a commercial motor vehicle;
    (b) Any driver who has not been medically examined and certified as 
qualified to operate a commercial motor vehicle during the preceding 24 
months, unless the driver is required to be examined and certified in 
accordance with paragraphs (c), (d), (e) or (f) of this section;
    (c) Any driver authorized to operate a commercial motor vehicle 
only within an exempt intra-city zone pursuant to Sec.  391.62, if such 
driver has not been medically examined and certified as qualified to 
drive in such zone during the preceding 12 months;
    (d) Any driver authorized to operate a commercial motor vehicle 
only by operation of the exemption in Sec.  391.64, if such driver has 
not been medically examined and certified as qualified to drive during 
the preceding 12 months;
    (e) Any driver who has diabetes mellitus requiring insulin for 
control and who qualifies for a medical certificate under the standards 
in Sec.  391.46, if such a person has not been medically examined and 
certified as qualified to drive during the preceding 12 months;
    (f) Any driver whose ability to perform his or her normal duties 
has been impaired by a physical or mental injury or disease.
0
4. Add new Sec.  391.46 to read as follows:

Sec.  391.46  Physical qualification standards for a person with 
insulin-treated diabetes mellitus.

    (a) Diabetes mellitus requiring insulin. A person with diabetes 
mellitus requiring insulin for control is physically qualified to 
operate a commercial motor vehicle in interstate commerce provided:
    (1) The person otherwise meets the physical qualification standards 
in Sec.  391.41 or has the exemption or skill performance evaluation 
certificate, if required; and
    (2) The person has the medical evaluations required by paragraph 
(b) of this section and meets the monitoring requirements in paragraph 
(c) of this section.
    (b) Medical evaluations. A person with diabetes mellitus requiring 
insulin for control must have the following medical examinations.
    (1) Evaluation by the treating clinician. Prior to the annual or 
more frequent examination required by Sec.  391.45, the person must be 
evaluated by the treating clinician. For purposes of this paragraph, 
``treating clinician'' means a physician or health care professional 
who manages and prescribes insulin for the treatment of individuals 
with diabetes mellitus. The treating clinician must determine that 
within the previous 12 months the person has--
    (i) Had no severe hypoglycemic reaction resulting in a loss of 
consciousness or seizure, or requiring the assistance of another 
person, or resulting in impaired cognitive function; and
    (ii) Properly managed his or her diabetes.
    (2) Medical examiner's examination. (i) At least annually, the 
person must be medically examined and certified as physically qualified 
in accordance with Sec.  391.43 and free of complications that might 
impair his or her ability to operate a commercial motor vehicle.
    (ii) The medical examiner must obtain written notification from the 
person's treating clinician that the person's diabetes is being 
properly managed and must evaluate whether the person is physically 
qualified to operate a commercial motor vehicle.
    (c) Blood glucose records. During the period of medical 
certification, the driver with insulin-treated diabetes mellitus must 
monitor and maintain blood glucose records as determined by the 
treating clinician and submit those blood glucose records to the 
treating clinician at the time of the evaluation required in paragraph 
(b)(1) of this section.

    Issued under the authority of delegation in 49 CFR 1.87.

    Dated: April 22, 2015.
T.F. Scott Darling, III,
Chief Counsel.
[FR Doc. 2015-09993 Filed 5-1-15; 8:45 am]
 BILLING CODE 4910-EX-P