[Federal Register Volume 83, Number 182 (Wednesday, September 19, 2018)]
[Rules and Regulations]
[Pages 47486-47521]
[FR Doc No: 2018-20161]

Vol. 83

Wednesday,

No. 182

September 19, 2018

Part III

Department of Transportation

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 Federal Motor Carrier Safety Administration

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49 CFR Part 391

Qualifications of Drivers; Diabetes Standard; Final Rule

Federal Register / Vol. 83 , No. 182 / Wednesday, September 19, 2018
/ Rules and Regulations

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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: Final rule.

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SUMMARY: FMCSA revises its regulations to permit individuals with a
stable insulin regimen and properly controlled insulin-treated diabetes
mellitus (ITDM) to be qualified to operate commercial motor vehicles
(CMVs) in interstate commerce. Previously, ITDM individuals were
prohibited from driving CMVs in interstate commerce unless they
obtained an exemption from FMCSA. This rule enables a certified medical
examiner (ME) to grant an ITDM individual a Medical Examiner's
Certificate (MEC), MCSA-5876, for up to a maximum of 12 months. To do
so, the treating clinician (TC), the healthcare professional who
manages, and prescribes insulin for, the treatment of the individual's
diabetes, provides the Insulin-Treated Diabetes Mellitus Assessment
Form (ITDM Assessment Form), MCSA-5870, to the certified ME indicating
that the individual maintains a stable insulin regimen and proper
control of his or her diabetes. The certified ME then determines that
the individual meets FMCSA's physical qualification standards and can
operate CMVs in interstate commerce.

DATES: This final rule is effective November 19, 2018, except for
amendatory instruction 5.b. which is effective November 19, 2019.
Comments sent to the Office of Management and Budget (OMB) on the
collection of information must be received by OMB on or before November
19, 2018.
    Petitions for Reconsideration of this final rule must be submitted
to the FMCSA Administrator no later than October 19, 2018.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division, Federal Motor Carrier Safety Administration,
1200 New Jersey Avenue SE, Washington, DC 20590-0001, by telephone at
(202) 366-4001, or by email at [email protected]. If you have
questions on viewing or submitting material to the docket, contact
Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This final rule is organized as follows:

I. Rulemaking Documents
    A. Availability of Rulemaking Documents
    B. Privacy Act
II. Executive Summary
    A. Purpose of the Amendments
    B. Summary of Major Provisions
    C. Benefits and Costs
III. Abbreviations and Acronyms
IV. Legal Basis for the Rulemaking
V. Background
    A. Brief History of Physical Qualification Standards for CMV
Drivers With ITDM
    B. Exemption Program
    C. May 4, 2015, NPRM
    D. September 9, 2016, Notice of MRB Task Report; Request for
Comments
    E. July 27, 2017, Notice of Proposed ITDM Assessment Form and
Request for Comments
VI. Discussion of Comments and Responses
    A. Comment Overview
    B. Qualifications of a Certified ME To Examine an ITDM
Individual
    C. Definition and Qualifications of a TC
    D. Role and Relationship of the TC and Certified ME
    E. TC Written Notification (ITDM Assessment Form)
    F. Certified ME Certification and TC Evaluation Frequency
    G. Annual Certification of Individuals With Diabetes Mellitus
Not Treated With Insulin
    H. Eye Examinations
    I. Disqualification for Visual Impairment
    J. HbA1C Levels
    K. Specific Blood Glucose Limits
    L. Severe Hypoglycemic Episodes
    M. Hypoglycemia Unawareness
    N. Blood Glucose Self-Monitoring
    O. Requirement To Carry Readily-Absorbable Glucose
    P. Diabetic Complications and Target Organ Damage
    Q. Motor Carrier Responsibility To Enforce the ITDM Standard
    R. ITDM Individuals Operating CMVs Transporting Passengers or
Hazardous Materials
    S. ITDM Individuals With Licenses Issued in Canada or Mexico
    T. The Grandfather Provision for Insulin-Treated Diabetes
    U. Safety of ITDM Individuals
    V. Costs and Benefits of the Proposed Rule
    W. Privacy Issues
    X. Other Comments
    Y. Outside the Scope
VII. Section-by-Section Analysis
VIII. International Impacts
IX. Regulatory Analyses
    A. E.O. 12866 (Regulatory Planning and Review), E.O. 13563
(Improving Regulation and Regulatory Review), and DOT Regulatory
Policies and Procedures
    B. E.O. 13771 (Reducing Regulation and Controlling Regulatory
Costs)
    C. Regulatory Flexibility Act
    D. Assistance for Small Entities
    E. Unfunded Mandates Reform Act of 1995
    F. Paperwork Reduction Act (Collection of Information)
    G. E.O. 13132 (Federalism)
    H. E.O. 12988 (Civil Justice Reform)
    I. E.O. 13045 (Protection of Children)
    J. E.O. 12630 (Taking of Private Property)
    K. Privacy Impact Assessment
    L. E.O. 12372 (Intergovernmental Review)
    M. E.O. 13211 (Energy Supply, Distribution, or Use)
    N. E.O. 13783 (Promoting Energy Independence and Economic
Growth)
    O. E.O. 13175 (Indian Tribal Governments)
    P. National Technology Transfer and Advancement Act (Technical
Standards)
    Q. Environment (National Environmental Policy Act of 1969
(NEPA), Clean Air Act (CAA), Environmental Justice)

I. Rulemaking Documents

A. Availability of Rulemaking Documents

    For access to docket FMCSA-2005-23151 to read background documents
and comments received, go to http://www.regulations.gov at any time, or
to Docket Services at U.S. Department of Transportation, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5
p.m. E.T., Monday through Friday, except Federal holidays.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), the Department of
Transportation (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.transportation.gov/privacy.

II. Executive Summary

A. Purpose of the Amendments

    This final rule amends the Federal Motor Carrier Safety Regulations
(FMCSRs) to allow individuals with stable insulin regimens and properly
controlled ITDM to drive CMVs in interstate commerce if they meet the
physical qualification standards in Sec. Sec.  391.41, 391.45, and
391.46. The final rule eliminates the diabetes grandfather provision
under Sec.  391.64(a) 1 year after the effective date of this rule and
also eliminates the need for the Federal diabetes exemption program.

B. Summary of Major Provisions

    This final rule allows individuals with stable insulin regimens and
properly controlled ITDM to drive CMVs in interstate commerce if they
have an annual or more frequent examination by a certified ME who is
listed on the National Registry of Certified Medical Examiners
(National Registry), are found physically qualified to operate a CMV,
and are issued an

MEC, MCSA-5876, from a certified ME. Prior to the annual or more
frequent examination by the certified ME, the individual must have an
evaluation by his or her TC. The final rule defines a TC as the
healthcare professional who manages, and prescribes insulin for, the
treatment of the individual's diabetes as authorized by the healthcare
professional's State licensing authority.
    The TC provides information to the certified ME via the ITDM
Assessment Form, MCSA-5870, on which the TC attests that the individual
maintains a stable insulin regimen and proper control of his or her
diabetes. The certified ME must receive the ITDM Assessment Form, MCSA-
5870, no later than 45 days after the individual's TC has completed and
signed it for each medical examination. Upon receipt of a valid form,
the certified ME will perform an examination, consider the information
provided by the TC, and determine whether the individual meets FMCSA's
physical qualification standards to operate a CMV safely. If so, the
certified ME may issue an MEC, MCSA-5876, for up to a maximum of 12
months.
    The final rule requires that all ITDM individuals must provide to
the TC at least the preceding 3 months of blood glucose self-monitoring
records while being treated with insulin to be eligible for up to the
maximum 12-month MEC, MCSA-5876. If an individual does not provide the
3 months of records, the certified ME has discretion to grant the
individual up to but not more than a 3-month MEC, MCSA-5876, to allow
time for the individual to collect the necessary records. Once the
individual has 3 months of blood glucose self-monitoring records, the
individual is treated the same as an ITDM individual with 3 months of
records. The individual must first go to the TC for evaluation and then
to the certified ME, who must exercise independent medical judgment, to
determine if the individual is eligible for up to the maximum 12-month
MEC, MCSA-5876.
    If an ITDM individual has had a severe hypoglycemic episode, the
individual is prohibited from operating a CMV and must report the
episode to and be evaluated by a TC as soon as is reasonably
practicable. The prohibition from operating a CMV continues until the
ITDM individual has been evaluated by a TC and the TC determines that
the cause of the severe hypoglycemic episode has been addressed and
that the individual again has a stable insulin regimen and properly
controlled ITDM. Once a TC completes a new ITDM Assessment Form, MCSA-
5870, following the episode, the individual may resume operating a CMV.
This rule defines a severe hypoglycemic episode as one requiring the
assistance of others, or resulting in loss of consciousness, seizure,
or coma.
    ITDM individuals who have been diagnosed with severe non-
proliferative diabetic retinopathy or proliferative diabetic
retinopathy are disqualified permanently from operating a CMV in
interstate commerce. These advanced stages of diabetic retinopathy
present a serious risk to visual function, the safe operation of a CMV,
and public safety.
    The fewer than 100 ITDM individuals currently certified under the
diabetes grandfather provision in Sec.  391.64(a) will have 1 year
after the effective date of this final rule to comply with the
provisions of this rule. During that year, grandfathered individuals
may elect to seek medical certification through the provisions of the
final rule or Sec.  391.64. However, 1 year after the effective date of
this final rule, all grandfathered MECs, MCSA-5876, will become void.
FMCSA anticipates that individuals certified previously under Sec.
391.64(a) will find it advantageous to transition to certification
under this rule as soon as possible because costs potentially may be
reduced and the requirements of this rule are no more stringent than
those of Sec.  391.64(a).
    FMCSA has determined that this rule will ensure that ITDM
individuals can operate a CMV safely. This final rule also creates a
clearer, equally effective, and more consistent framework to certify
ITDM individuals than a program based entirely on granting exemptions
under 49 U.S.C. 31315(b).

C. Benefits and Costs

    This rule revises the FMCSRs to permit individuals with a stable
insulin regimen and properly controlled ITDM to be qualified to operate
CMVs in interstate commerce. Previously, ITDM individuals were
prohibited from driving CMVs in interstate commerce unless they
obtained an exemption from FMCSA. Revising the regulations will reduce
the regulatory burden and result in a $6.21 million cost savings per
year--the aggregate of cost savings to ITDM individuals, motor carriers
that hire ITDM individuals, and FMCSA.
    The notice of proposed rulemaking (NPRM) stage of this rulemaking
action predates the January 30, 2017, Executive Order (E.O.) 13771
titled ``Reducing Regulation and Controlling Regulatory Costs'' (82 FR
9339, Feb. 3, 2017). As such, the analysis of this final rule
introduces several changes necessary to clarify that the final rule
will result in total costs less than zero. The Agency presents the
following comparison of the NRPM and final rule analyses.
    The Preliminary Regulatory Impact Analysis (RIA) published with the
NPRM estimated that existing exemption holders would realize $0.76
million in cost savings attributable to the rule.\1\ It also estimated
there to be 209,664 ITDM individuals operating CMVs in interstate and
intrastate commerce--a group that the NPRM estimated would incur costs
ranging from $7.96 million to $23.90 million depending on the share of
that group that would be medically qualified to receive an MEC, MCSA-
5876.\2\ That range of costs reflected gross compliance costs to those
individuals; however, on a relative basis, the Agency estimated that
compliance costs per individual under the proposed rule would decrease
by $441 versus the cost to comply with the exemption program.
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    \1\ FMCSA Preliminary Regulatory Evaluation of Qualification of
Drivers: Diabetes Standard Notice of Proposed Rulemaking, pp. 11-12,
which is available in the docket for this rulemaking.
    \2\ Id. at 12-13.
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    By reducing compliance costs per ITDM individual, the rule is a
deregulatory action both as proposed in the NPRM and again with this
final rule. The Agency concludes that an ITDM individual not currently
participating in the exemption program will bear the compliance costs
of the final rule only if he or she considers the cost to comply to be
equal to or lesser than his or her perceived cost of non-compliance. As
a result, ITDM individuals not currently participating in the exemption
program will incur no new net costs from this rule, while existing
exemption holders will (in aggregate) receive a savings of $5.09
million in compliance costs per year. On a per-individual basis, the
compliance cost of the final rule is less than the baseline ($332
versus $5,585) during the first year an ITDM individual comes into
compliance and is 75.4 percent less than the baseline ($332 versus
$1,350) in each year thereafter.
    The Final RIA estimates a greater amount of cost savings than in
the Preliminary RIA as a result of several changes and updates. First,
the Final RIA accounts for new ITDM individuals' opportunity costs of
income forgone, as well as corresponding motor carriers' opportunity
costs of labor hours forgone, during the period FMCSA processes an
exemption program application. These costs were not considered in the
Preliminary RIA; the Agency made these changes during the development
of the Final RIA in response to comments received on the NPRM. Second,
the final analysis has

been adjusted to correct the number of endocrinologist visits per year
required by the exemption program, as these visits were not fully
accounted for in the Preliminary RIA. Third, the Final RIA updates
inputs used to estimate the costs of the rule. Medical fees for the
various healthcare professionals' services, driver wage and benefits
values, and the population of drivers were updated using 2016 values.
    Table 1 summarizes the key requirements of the exemption program
and compares them to the final rule. These requirements are reflected
in the cost estimates of the exemption program and the final rule.

    Table 1--Requirements of the Exemption Program vs. the Final Rule
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      Exemption program (baseline)                  Final rule
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 The average processing time      No exemption needed,
 for a new exemption application is 77    therefore no processing wait
 days, during which applicants cannot     time.
 drive CMVs in interstate commerce \3\.
 Annual examination by a          Annual examination by
 certified ME.                            a certified ME.
 Annual vision examination        No annual vision
 performed by an optometrist or           examination is required.
 ophthalmologist for evidence of          No annual examination
 diabetic retinopathy (if retinopathy     or quarterly evaluations by an
 is present, an ophthalmologist report    endocrinologist are required.
 on stability of disease).
 Annual examination by an         Annual evaluation by
 endocrinologist and three quarterly      the TC who completes an ITDM
 visits.                                  Assessment Form, MCSA-5870,
                                          that is provided to the
                                          certified ME.
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    As shown in Table 2, the annualized cost of the baseline (the
exemption program) is estimated at $8.02 million, while the annualized
cost of the final rule is estimated at $1.67 million. The annualized
cost savings of the rule are therefore $6.35 million, a 79 percent
decrease. These cost savings are distributed among certain groups of
ITDM individuals, motor carriers, and FMCSA.
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    \3\ The 77 days represents the average processing time for 3,674
exemption applications accepted between 2012 and 2016 in the
exemption program database maintained by the contractor that assists
FMCSA with the administration of the diabetes exemption program.

                                     Table 2--Total Costs of the Final Rule
                                        [Annualized in millions of 2016$]
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                                                                                Final Rule
                  Entities potentially impacted                    Baseline cost       cost         Total cost
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Currently Compliant ITDM Individuals............................           $6.75           $1.66         ($5.09)
Future Compliant ITDM Individuals...............................            0.17            0.01          (0.16)
Non-Participating ITDM Individuals..............................            0.00            0.00            0.00
Motor Carriers..................................................            0.07            0.00          (0.07)
FMCSA...........................................................            1.03            0.00          (1.03)
    Total.......................................................            8.02            1.67          (6.35)
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    FMCSA estimates that currently compliant ITDM individuals (that is,
individuals that currently have exemptions) will realize $5.09 million
of annualized costs savings because of the rule. These ITDM
individuals' costs to comply with the exemption program are estimated
at $6.75 million, versus $1.66 million to comply with the final rule.
This group of ITDM individuals consists of 3,945 FMCSA exemption
holders and an estimated 930 ITDM individuals with intrastate
commercial driver's licenses (CDLs) issued exemptions in accordance
with State exemption programs.
    The Agency estimates that the number of future compliant ITDM
individuals that would obtain exemptions in the absence of the rule
would increase annually by 27. Under the rule, the annualized cost
savings realized by these 27 individuals are estimated at $0.16 million
($0.17 million to comply with the exemption program versus $0.01
million to comply with the final rule). The difference between the two
cost estimates is due primarily to the elimination of the opportunity
costs associated with the wait for FMCSA to process exemption program
applications. Motor carriers are estimated to realize $0.07 million in
cost savings due to the elimination of the application processing wait
time.
    As discussed earlier, ITDM individuals not currently participating
in the exemption program (referred to as ``Non-Participating ITDM
Individuals'' in Table 2) incur no new net costs from this rule.
    Lastly, the rule will eliminate contractor costs that FMCSA incurs
for the administration of the exemption program. The average cost of
the remaining 3 option years of the contract is $1.03 million, which
the Agency relies on to estimate FMCSA's annual cost savings resulting
from the rule.

III. Abbreviations and Acronyms

AAFP American Academy of Family Physicians
AAPA American Academy of Physician Assistants
AAPA-OM American Academy of Physician Assistants in Occupational
Medicine
ABA American Bus Association
ACOEM American College of Occupational and Environmental Medicine
ADA American Diabetes Association
Advocates Advocates for Highway and Auto Safety
ANPRM Advance Notice of Proposed Rulemaking
AOA American Optometric Association
APN Advanced Practice Nurse
ATA American Trucking Associations, Inc.
BLS Bureau of Labor Statistics
CAA Clean Air Act
CDC Centers for Disease Control and Prevention
CDL Commercial Driver's License
CE Categorical Exclusion
CFR Code of Federal Regulations
CMV Commercial Motor Vehicle
DC Doctor of Chiropractic
DO Doctor of Osteopathy
DOT Department of Transportation
E.O. Executive Order
FAA Federal Aviation Administration
FHWA Federal Highway Administration

FMCSA Federal Motor Carrier Safety Administration
FMCSRs Federal Motor Carrier Safety Regulations
FR Federal Register
HIPAA Health Insurance Portability and Accountability Act
H&SW Health and Safety Works, LLC
IBT International Brotherhood of Teamsters
ICR Information Collection Request
ITDM Insulin-Treated Diabetes Mellitus
LFC Licencia Federal de Conductor
MD Doctor of Medicine
ME Medical Examiner
MEC Medical Examiner's Certificate, MCSA-5876
MRB Medical Review Board
National Registry National Registry of Certified Medical Examiners
NEPA National Environmental Policy Act
NP Nurse Practitioner
NPRM Notice of Proposed Rulemaking
NTSB National Transportation Safety Board
OMB Office of Management and Budget
OOIDA Owner-Operator Independent Driver Association
PA Physician Assistant
PIA Privacy Impact Assessment
RIA Regulatory Impact Analysis
RN Registered Nurse
SAFETEA-LU Safe, Accountable, Flexible, Efficient Transportation
Equity Act: A Legacy for Users
Sec.  Section symbol
SOCO Southern Company Entities
SORN System of Records Notice
TC Treating Clinician
TEA-21 Transportation Equity Act for the 21st Century
TFAC Truckers for a Cause
TTD Transportation Trades Department, AFL-CIO
U.S.C. United States Code
University of Utah University of Utah School of Medicine
UMA United Motorcoach Association

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 individuals operating CMVs in interstate commerce.
Section 31136(a)(3) requires specifically that the Agency's safety
regulations ensure that the physical conditions of CMV drivers enable
them to operate their vehicles safely and that certified MEs trained in
physical and medical examination standards perform the physical
examinations required of such operators.
    Additionally, 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 medical advice and recommendations on qualification standards
(49 U.S.C. 31149(a)). The position of Chief Medical Examiner 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
Examiner, 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 in the NPRM (80 FR 25260, May 4, 2015), the Agency asked the
MRB to review and report on the current diabetes standard. More
recently, the Agency directed the MRB to review and analyze all
comments to the NPRM submitted from medical professionals and
associations, and identify factors the Agency should consider in this
rulemaking. The MRB's recommendations and the Agency's responses are
described elsewhere in this final rule.
    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 (which is the authority for the
CDL regulations and the related drug and alcohol testing requirements)
(49 U.S.C. 31136(a)(5)).
    This rule is based primarily on 49 U.S.C. 31136(a)(3) and 31149(c)
and does not concern the requirements in 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 been reluctant generally to
employ such drivers at all. The original exemption program developed in
the 1990s by the Federal Highway Administration (FHWA) and FMCSA's
subsequent program under 49 U.S.C. 31315(b) allowed selected ITDM
individuals to drive legally for the first time, while also generating
data showing that their safety records were at least as good as those
of all other 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 ITDM individuals. Paragraph (d) of section 4129 provides
that ITDM individuals may not be held by the Secretary of
Transportation to a higher standard of physical qualification to
operate a CMV in interstate commerce than other individuals applying to
operate, or operating, a CMV in interstate commerce; except to the
extent that limited operating, monitoring, and medical requirements are
deemed medically necessary under regulations issued by the Secretary.
FMCSA has determined that this final rule satisfies the purposes of
section 4129(d) by imposing appropriate requirements on such
individuals 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 Regulatory Analyses section of this
final rule.

V. Background

A. Brief History of Physical Qualification Standards for CMV Drivers
With ITDM

    In 1939, one of FMCSA's predecessors recommended that CMV drivers
have urine glucose tests as part of medical examinations for
determining whether they were physically qualified to drive CMVs in
interstate or foreign commerce (4 FR 2296, June 7, 1939). That
recommendation remained in effect from January 1, 1940, until a
replacement standard established by FHWA went into effect on January 1,
1971. In 1970, FHWA established the current standard for ITDM
individuals (35 FR 6463, 6464, April 22, 1970), which also includes
testing urine for glucose. That standard states that a ``person is
physically qualified to drive a commercial motor vehicle if that person
. . . [h]as no established medical history or clinical diagnosis of
diabetes mellitus currently requiring insulin for control'' (49 CFR
391.41(b)(3)). Beginning in 1993, however, CMV drivers with ITDM had
the opportunity to apply to FHWA for a waiver (57 FR 40690, July 29,
1993), until a 1994 Federal court decision invalidated the

waiver program. See Advocates for Highway and Auto Safety v. FHWA, 28
F.3d 1288 (D.C. Cir. 1994).
    In 1998, section 4018 of the Transportation Equity Act for the 21st
Century (TEA-21) (Pub. L. 105-178, 112 Stat. 107, 413, June 9, 1998
(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
ITDM individuals 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'' (section 4018(a)).
    As also 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 on
issues concerned with the treatment, medical screening, and monitoring
of ITDM individuals in the context of operating CMVs. In July 2000,
FMCSA 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). This report concluded
that it was feasible to establish a safe and practicable protocol
containing three components allowing some ITDM individuals to operate
CMVs. The three components were as follows: (1) Screening of qualified
commercial drivers with ITDM; (2) establishing operational requirements
to ensure proper disease management by such drivers; and (3) monitoring
safe driving behavior and proper disease management.
    On July 31, 2001, as a result of the conclusions found in the TEA-
21 Report to Congress, FMCSA published a notice proposing to issue
exemptions from the FMCSRs allowing ITDM individuals 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 ITDM individuals (68 FR 52441, Sept. 3, 2003). 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. Beginning in 2003, ITDM
individuals could apply to FMCSA for an exemption from the prohibition
of operating CMVs in interstate commerce.

B. Exemption Program

    FMCSA administers an exemption program for ITDM individuals 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 the 2003 Notice and a
notice of revised final disposition published in 2005 (70 FR 67777,
Nov. 8, 2005).
    To apply for an exemption under the program administered by FMCSA,
the individual must submit a letter application with medical
documentation showing the following: \4\
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    \4\ The requirements to apply for and maintain an exemption are
not exhaustive.
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    (1) The ITDM individual has been examined by a board-certified or
board-eligible endocrinologist who has (i) conducted a comprehensive
evaluation including one glycosylated hemoglobin test (HbA1C) with a
result within a range of 7 to 10 percent, inclusive,\5\ and (ii) signed
a statement regarding his or her determinations;
---------------------------------------------------------------------------

    \5\ FMCSA subsequently removed the requirement to include one
HbA1C result on the application itself.
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    (2) The ITDM individual has obtained a signed statement from an
ophthalmologist or optometrist indicating that the individual has been
examined, has no unstable proliferative diabetic retinopathy, and meets
the vision standard in Sec.  391.41(b)(10); and
    (3) The ITDM individual has obtained a signed copy of both a
certified ME's Medical Examination Report Form, MCSA-5875, and an MEC,
MCSA-5876, showing that the individual meets all physical qualification
standards in Sec.  391.41(b) other than the diabetes standard.
    FMCSA does not conduct medical examinations of any individuals in
the exemption program. Instead, it makes its decision whether to grant
the exemption based on individual applications and supporting
documentation from healthcare professionals. FMCSA cannot grant an
exemption unless it is likely that a level of safety would be achieved
that is equivalent to, or greater than, the level that would be
achieved without the exemption (49 U.S.C. 31315(b) and 49 CFR
381.305(a)).
    Before granting a request for an exemption, FMCSA must publish a
notice in the Federal Register. The notice explains a request has been
filed and provides 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 must identify: The individual who
will receive the exemption; the provision(s) from which the individual
will be exempted; the effective period; and all terms and conditions of
the exemption. After the conclusion of the comment period, FMCSA must
publish a notice of its decision to approve or deny the request.
    Once approved, to maintain an exemption, the driver must:
    (1) Have annual medical recertification by a certified ME;
    (2) Have quarterly evaluations by an endocrinologist;
    (3) Have annual comprehensive medical evaluations by an
endocrinologist;
    (4) Have annual vision evaluations that confirm there is no
evidence of unstable proliferative diabetic retinopathy and the driver
meets the vision standard for CMV drivers;
    (5) Maintain 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) Follow a protocol to monitor and maintain blood glucose levels;
and
    (7) Report to the Agency all episodes of severe hypoglycemia, any
significant complications relating to diabetes, the inability to manage
his or her diabetes, and any involvement in a crash or other adverse
event.
    A driver must reapply for an exemption every 2 years. FMCSA may
revoke an exemption immediately under standards established in Sec.
381.330.

C. May 4, 2015, NPRM: Qualifications of Drivers; Diabetes Standard

    In the May 2015 NPRM, FMCSA proposed to amend its physical
qualification standards in Sec.  391.41 to allow ITDM individuals to
operate CMVs (80 FR 25272). Proposed paragraph (b)(3) provided that an
individual was physically qualified to drive a CMV either by having no
established medical history or clinical diagnosis of diabetes mellitus
currently requiring insulin for control, or by meeting the requirements
in new Sec.  391.46.
    The NPRM also proposed to reorganize Sec.  391.45, which provides
when individuals must be medically examined and certified, and to add a
new paragraph (e). That proposed paragraph required any ITDM individual
who had been qualified for an MEC, MCSA-5876, under the standards in
Sec.  391.46 to be medically examined and certified as qualified to
drive at least every 12 months.

    Proposed Sec.  391.46 provided that an ITDM individual was
physically qualified to operate a CMV if the individual otherwise met
the physical qualification standards in Sec.  391.41, or had the
exemption or skill performance evaluation certificate, if required, and
had the medical evaluations required by Sec.  391.46.
    Prior to the annual or more frequent examination by a certified ME,
the ITDM individual would have to be evaluated by the TC. The TC was
defined in the proposed rule as a physician or health care professional
who manages and prescribes insulin for the treatment of individuals
with diabetes mellitus. The TC would have to determine that within the
previous 12 months the individual: 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 had properly managed his or her diabetes. During the
period of medical certification, the individual was required to monitor
and maintain blood glucose records as determined by the TC and submit
those blood glucose records to the TC at the time of the evaluation.
    At least annually, the ITDM individual would have to be medically
examined and certified by a certified ME as physically qualified in
accordance with Sec.  391.43 and as free of complications that might
impair the individual's ability to operate a CMV. The certified ME
would be required to obtain written notification from the individual's
TC that the individual's diabetes was being properly managed. The
certified ME also would have to evaluate whether the individual was
physically qualified to operate a CMV.
    Although not part of the proposed regulation, FMCSA requested
comments on whether it should prohibit drivers with ITDM from being
medically qualified to operate CMVs carrying passengers and hazardous
materials, and whether removing the grandfather provision would affect
any driver adversely who is operating currently under Sec.  391.64.
Finally, the Agency also requested comment on the need for an ITDM
individual to be examined by an optometrist or ophthalmologist as a
condition of passing the medical examination.

D. September 9, 2016, Notice of Availability; Request for Comments:
Medical Review Board Task Report on Insulin-Treated Diabetes Mellitus
and Commercial Motor Vehicle Drivers

    The NPRM's comment period closed on July 6, 2015. In that same
month, FMCSA directed the MRB to review and analyze all comments to the
NPRM from medical professionals and associations, and to identify
factors the Agency should consider when making decisions about the next
steps in the diabetes rulemaking (MRB Task 15-1). In response, the
Agency received MRB Task 15-1 Report (2015 MRB report) dated September
1, 2015. FMCSA published a Federal Register notice on September 9,
2016, announcing the availability of the 2015 MRB report and requesting
comments on the MRB recommendations (81 FR 62448). The MRB's
recommendations are considered in the Discussion of Comments and
Responses section below. The full report is available in the docket for
this rulemaking, in addition to being available on the Agency's website
at https://www.fmcsa.dot.gov/advisory-committees/mrb/mrb-task-15-01-report.

E. July 27, 2017, Notice and Request for Comments: Agency Information
Collection Activities; Information Collection Revision Request--Medical
Qualification Requirements, OMB Control Number 2126-0006 (Proposed ITDM
Assessment Form)

    On July 27, 2017, FMCSA published a 60-day notice announcing that
it was considering submitting an Information Collection Request (ICR)
to OMB for its review and approval (82 FR 35041). In anticipation of
this final rule, the notice invited public comment on a revision to an
information collection titled Medical Qualification Requirements,
covered by OMB Control Number 2126-0006, which is currently due to
expire on August 31, 2018. Based on the MRB's 2015 analysis of the
comments and its recommendations, as well as public comments to the
NPRM, FMCSA announced that it was considering replacing the previously
proposed written notification from the TC with the ITDM Assessment
Form. The form would be completed by the TC and provided to the
certified ME. The 60-day notice, draft supporting statement, and
proposed form are available in the docket for this rulemaking. The
comment period closed on September 25, 2017. The comments are addressed
in the Discussion of Comments and Responses section below.

VI. Discussion of Comments and Responses

A. Comment Overview

    In this rule, FMCSA responds to public comments to the following
Federal Register documents.
    NPRM: In response to the May 2015 NPRM (80 FR 25260), FMCSA
received 1,281 submissions between May 4, 2015, and February 16,
2016.\6\ Based on a review of those submissions, 114 submissions were
identified as non-germane and four submissions were duplicates. Almost
all commenters expressed general support for the proposed rule, though
many asked for more detail about the proposal. These commenters include
CMV drivers, individuals diagnosed with diabetes, relatives of
individuals diagnosed with diabetes, diabetes educators, health care
professionals, and medical associations. General opposition to the
proposed rule cited a risk to public safety as the basis for opposition
contending that insulin-controlled diabetes is not a condition well-
suited to the demands of operating CMVs. These commenters included two
individuals diagnosed with diabetes, a physician, and a diabetes
educator. Of the generally-supportive submissions, 561 were form
letters. The common reasons cited for general support of the proposal
include the following: It would treat ITDM individuals fairly by
assessing how diabetes affects each individual rather than focusing on
the diagnosis of diabetes or use of insulin alone; it would simplify
the qualification procedures for ITDM CMV drivers and focus on their
operational safety by requiring that they be evaluated by healthcare
professionals; it would improve safety by encouraging ITDM CMV drivers
to properly manage their condition rather than to hide it in an effort
to keep their jobs; and this action would enable CMV drivers newly
diagnosed with ITDM to keep their jobs and encourage more individuals
to enter the workforce, thereby reducing the driver shortage.
---------------------------------------------------------------------------

    \6\ FMCSA stated in the NPRM, at 80 FR 25261, that it would not
respond to comments made in response to the March 17, 2006, advance
notice of proposed rulemaking (ANPRM) (71 FR 13801). The Agency
requested that commenters reference any previous relevant comments
in their comments to the NPRM. Therefore, this final rule does not
respond to the comments submitted in response to the ANPRM.
---------------------------------------------------------------------------

    Approximately a dozen commenters expressed general opposition to
the proposed diabetes standard. Most of these commenters cited the risk
to public safety for their opposition to the proposed rule and
contended that insulin-controlled diabetes is not a condition well-
suited to the demands of operating CMVs.
    2015 MRB Report: In response to the September 2016 notice of
availability and request for comments on the 2015 MRB report (81 FR
62448), FMCSA received 41 comments, one of which was a duplicate.
Commenters focused

on specific recommendations within the 2015 MRB report.
    ITDM Assessment Form: In response to the request for comments on
the ICR and the ITDM Assessment Form (82 FR 35041), FMCSA received 44
comments. Rather than providing substantive comments on the content or
structure of the ITDM Assessment Form, 39 commenters discussed the
issue of allowing ITDM individuals to operate CMVs. None of these
commenters presented new issues that were not raised in the comments
submitted in response to the NPRM or the 2015 MRB report. Five
substantive comments related to the ITDM Assessment Form are discussed
in the appropriate section below (TC Written Notification (ITDM
Assessment Form)).

B. Qualifications of a Certified ME To Examine an ITDM Individual

    NPRM: FMCSA proposed that ITDM individuals be medically examined
and certified by a certified ME listed on the National Registry as
provided in Sec.  391.43.\7\
---------------------------------------------------------------------------

    \7\ The Agency notes that the categories of healthcare
professionals eligible to be listed on the National Registry are
advanced practice nurses (APNs), doctors of chiropractic (DCs),
doctors of medicine (MDs), doctors of osteopathy (DOs), physician
assistants (PAs), and other healthcare professionals authorized by
applicable State laws and regulations to perform physical
examinations (49 CFR 390.103). APNs, also referred to as advanced
practice registered nurses (APRNs), are registered nurses (RNs)
educated at the masters or post masters level who have passed a
national certification test in a specific role and patient
population. The types of APNs are certified nurse practitioners
(CNPs or NPs), clinical nurse specialists (CNSs), certified
registered nurse anesthetists (CRNAs), and certified nurse-midwifes
(CNMs). See https://www.ncsbn.org/aprn.htm (Accessed May 25, 2018).
---------------------------------------------------------------------------

    Comments on the Qualifications of a Certified ME to Examine an ITDM
Individual: Both the American Academy of Physician Assistants (AAPA)
and the American Academy of Physician Assistants in Occupational
Medicine (AAPA-OM) supported FMCSA's proposal and noted that PAs are
qualified to examine and certify any individual who operates a CMV.
These commenters stated that the certified ME does not need to be a
specialist to examine an individual.
    The National Transportation Safety Board (NTSB) noted that some
certified MEs have no experience prescribing medications or managing
the effects of insulin; thus, they would have to accept the TC's
assessment without further evaluation. The American College of
Occupational and Environmental Medicine (ACOEM) stated the certified ME
should be an MD or DO experienced with the treatment and evaluation of
diabetes and diabetes treated with insulin to medically qualify
individuals using insulin; therefore, there should be designated
certified MEs who review and medically qualify individuals using
insulin. The ACOEM stated further that some certified MEs are making
certification determinations pertaining to individuals with medical
conditions that they are unable to independently diagnose or treat.
    A number of commenters stated that the certified ME should be a
physician (either an MD or DO) or have other professional
qualifications. For example, individuals who identified themselves as
the first five members appointed to the MRB (herein after ``former MRB
members'') \8\ wrote in their comment that there are now thousands of
certified MEs who have no significant medical training. These former
MRB members also stated that the primary care and tertiary care
providers for individuals with diabetes often do not understand the
specific demands on CMV drivers. Based on these considerations, the
former MRB members wrote that FMCSA cannot meet the statutory
requirement under 49 U.S.C. 31136(a)(3) for periodic physical
examinations of individuals by having the TC work in conjunction with
the certified ME.
---------------------------------------------------------------------------

    \8\ The Agency notes that the comments expressed by the former
MRB members in their letter were received in the docket in response
to the Agency's request for public comments.
---------------------------------------------------------------------------

    Unless TCs are required to have appropriate additional training,
experience, and certification, Truckers for a Cause (TFAC) suggested
that FMCSA require that ITDM individuals get their MECs, MCSA-5876,
from a certified ME who is an MD, DO, NP, or PA. TFAC was concerned
that not all certified MEs, e.g., DCs, will have the medical expertise
to evaluate the information from a TC. TFAC wrote that in some States,
for example Illinois, it would be a violation of State law for a DC to
render an expert medical opinion on an individual meeting a diabetes
treatment requirement. An individual commenter wanted to delay a
rulemaking until there is assurance that the certified MEs can safely
screen ITDM individuals.
    2015 MRB Report: The 2015 MRB report did not change the
qualifications of certified MEs for conducting medical certification
examinations on ITDM individuals.
    Comments on the MRB Report Regarding the Qualifications of a
Certified ME: The University of Utah School of Medicine (University of
Utah) stated that, unless the form proposed by the MRB clearly
specifies what the outcome of a particular response is, the only
alternative is to have diabetes examinations done by those with medical
backgrounds, which is ``particularly mandatory because of the large
number of non-medically trained examiners.'' An NP who is a certified
ME hoped that NPs and PAs certified in primary care and experienced in
managing patients with ITDM would not be excluded from certifying ITDM
individuals. The NP stated that numerous studies have demonstrated that
APNs in primary care settings perform as well as physicians in terms of
clinical outcomes and patient satisfaction. The ACOEM stated that the
certified ME must have the training and knowledge to evaluate whether
the documentation provided is sufficient. Concentra commented that
certified MEs who are not licensed to prescribe insulin should not be
allowed to certify an individual with ITDM.
    FMCSA Response: In this final rule, the Agency continues to provide
that ITDM individuals may be examined and medically certified by any
certified ME on the National Registry. As such, the categories of
healthcare professionals eligible to become certified MEs remain
unchanged from when the National Registry was established (77 FR 24104;
April 20, 2012). All certified MEs are required to be licensed,
registered, or certified by their States to perform physical
examinations. FMCSA will continue to rely on State determinations
regarding which categories of healthcare professionals have sufficient
education and training to qualify them to perform physical
examinations.
    To become a certified ME and be listed on the National Registry,
healthcare professionals are required to receive training on the
Agency's physical qualification standards and the demands of driving a
CMV, complete a certification test, and receive a certificate
evidencing that they are qualified to perform medical certification
examinations and determine who is qualified to safely operate a CMV. A
State has found certified MEs to possess sufficient medical training to
perform a physical examination and the Agency has found them to be
proficient in the use of the medical protocols necessary to perform the
medical certification examination in accordance with the FMCSRs. As
such, the Agency's certified MEs have a significant training on
performing medical certification examinations. Moreover, the National
Registry allows FMCSA to monitor and audit certified MEs and to provide
periodic training to its certified MEs.

    The current categories of certified MEs have been evaluating
individuals with diabetes and have been making qualification
determinations based on the existing physical qualification standards
in Sec.  391.41(b) for many years. In addition, conditions that may
result from complications of diabetes may also result from medical
conditions other than diabetes. The Agency has no data that suggests
MEs have had difficulty applying the physical qualification standards
to individuals with diabetes or to any specific conditions. If a
certified ME encounters a condition that is outside his or her scope of
practice or requires evaluation by a specialist, FMCSA expects the
certified ME to make any appropriate referral and to confer with the
specialist as necessary.
    FMCSA emphasizes that the role of the certified ME is to conduct a
medical certification examination to determine if the individual meets
the physical qualification standards and to evaluate the safety impact
of any medical conditions; it is not to diagnose or treat individuals.
As such, FMCSA has concluded that it is not necessary for a certified
ME to be licensed or certified to diagnose and treat every condition
that is addressed by the physical qualifications standards. FMCSA has
no data that suggests that this longstanding conclusion is flawed.
    The Agency has determined that its certified MEs are qualified to
examine and medically certify that ITDM individuals are physically
qualified to drive a CMV in accordance with Sec.  391.43 and new Sec.
391.46, and are free of complications that may impair an individual's
ability to safely operate a CMV. The Agency finds that this medical
certification approach through certified MEs is consistent with
congressional intent to have certified MEs make an individualized
assessment of an individual's health status and ability to safely
operate a CMV.

C. Definition and Qualifications of a TC

    NPRM: The NPRM defined a TC as a physician or healthcare
professional who manages and prescribes insulin for the treatment of
diabetes mellitus.
    Comments on the Definition and Qualifications of a TC: Because of
the TC's personal knowledge of the driver's medical history and
condition, both the Illinois Office of the Secretary of State and the
Owner-Operator Independent Driver Association (OOIDA) stated that the
TC would be able to make an accurate determination of a driver's
condition. The Illinois Office of the Secretary of State agreed with
FMCSA's proposal to use the TC, working with a certified ME to complete
the physical examination of drivers.
    Some commenters, including AAPA, AAPA-OM, and TFAC, stated that a
TC should be a physician, PA, or NP who manages and prescribes insulin
for the treatment of individuals with diabetes mellitus. AAPA and AAPA-
OM noted these represent the three types of healthcare professionals in
the United States who provide primary medical care. In rural and other
medically-underserved communities, a PA may be the only healthcare
professional.
    The AAPA-OM noted further that PAs are trained in primary care and
complete board certification every 10 years in primary care. The AAPA-
OM commented that PAs have been treating patients with complicated
medical conditions for over 40 years and should be allowed to continue
the evaluations of commercial drivers with ITDM.
    The American Trucking Associations, Inc. (ATA) requested that FMCSA
further define the term TC to reduce ambiguity and ensure the person
making the recommendation is properly certified and knowledgeable about
ITDM. Health & Safety Works, LLC (H&SW) was concerned FMCSA did not
address drivers who receive insulin without a prescription and
therefore would not have a TC. This commenter recommended FMCSA should
state that ``anyone without a prescription or a treating clinician may
not be qualified to operate a CMV in interstate commerce.''
    Some commenters agreed with FMCSA that TCs do not need to be
licensed physicians or specialists in diabetes treatment and
management, but could be other types of healthcare professionals.
Commenters, including the ATA, the American Diabetes Association (ADA),
the International Brotherhood of Teamsters (IBT), and TFAC, supported
allowing the certified ME to consult with the TC instead of requiring
approval from an endocrinologist, noting that driver access to board-
certified endocrinologists may be limited. The IBT wrote that the TC,
rather than an endocrinologist, would be a more suitable medical
provider to monitor any of the progressive conditions associated with
diabetes (e.g., nerve damage to the extremities and diabetic
retinopathy).
    The American Academy of Family Physicians (AAFP) urged FMCSA to
allow applicants to be examined by their family physicians, rather than
endocrinologists. This commenter noted that not all applicants have
access to an endocrinologist, and the family physician is more than
capable of managing and treating patients with diabetes, as well as
completing the forms needed by CMV drivers.
    Some commenters, including the American Bus Association (ABA), two
diabetes educators, a physician, an NP, and the Southern Company
Entities (SOCO), disagreed with the proposal and wanted ITDM
individuals to continue to be evaluated by endocrinologists. While ABA
appreciated the interest in simplifying the process or putting fewer
restrictions on the medical professionals available to drivers with
ITDM, it could not support this proposed provision because in its
opinion endocrinologists are the best qualified individuals to be
engaged in the process. SOCO would require a note from the treating
physician with a specialty in diabetes, such as an endocrinologist, who
is also familiar with the essential job functions of a commercial
driver. The note would document that the driver is stable and not
experiencing hypoglycemic episodes.
    The NP objected to removing an endocrinologist from the process of
certifying drivers with ITDM because it significantly limits objective,
specialized medical assessment of the disease. This commenter indicated
that primary care providers are sometimes too lenient.
    While they did not indicate that evaluation by an endocrinologist
is necessary, some commenters stated that the TC should be a licensed
physician or other medical professional with appropriate training. In
order to address sufficient training in diabetes, the complications of
diabetes, and interactions among diabetic medications, the former MRB
members stated that an MD or DO should, at a minimum, oversee a mid-
level provider and this physician should countersign the forms
approving the ITDM driver as safe to drive. An RN stated that drivers
should be followed by a primary care physician. A physician commented
that a diabetologist--not an endocrinologist--should evaluate patients
for safety because they are better equipped to determine whether a
patient with type 1 diabetes might be a low-risk driver. Advocates for
Highway and Auto Safety (Advocates) stated that the Agency should
require the TC to be a physician and establish penalties for both
drivers and TCs who submit falsified reports, specifically concerning
diabetes management and severe hypoglycemic reactions.
    The ADA agreed that requiring a specialist to perform evaluations
of drivers with ITDM is unnecessary. It stated that internists or
primary care

physicians--not endocrinologists--treat many individuals with diabetes
and that there are parts of the country where no endocrinologists are
available. The ADA commented that the important qualification is that
the TC must have knowledge of the disease and treatment regimens in
order to assess an individual's diabetes management and determine
whether CMV operation is safe and practicable in accordance with the
revised standard and accompanying diabetes guidelines.
    TFAC agreed that requiring an evaluation by a board-certified
endocrinologist places an undue burden on a driver, due to the lack of
these specialists nationwide. However, TFAC did not think that FMCSA's
qualifications for a TC specified enough medical training and
certification to evaluate properly a CMV operator with ITDM. TFAC
recommended that the TC have completed appropriate additional training
and have the experience to hold a certification in Advanced Diabetes
Care and Management.
    A physician wrote that FMCSA is putting the TC, whose duty is to
his or her patient, in the position of losing patients who will doctor
shop until they find a TC to sign off on their condition.
    2015 MRB Report: The 2015 MRB report recommended that a TC be
defined as the MD, DO, NP, or PA who prescribes insulin to the driver
and is knowledgeable regarding the treatment of diabetes.
    Comments on the MRB's Report on the Definition and Qualifications
of a TC: The AAPA stated that allowing PAs who have clinical experience
with diabetes to act as TCs will ensure that drivers who are under the
care of a PA can remain in compliance with FMCSA regulations, while
continuing to see their current healthcare provider. It commented that
this is particularly important in medically-underserved areas, where
there may be less access to specialists. The AAPA described the breadth
of PA education, testing, and experience, particularly as it applies to
diabetes.
    OOIDA agreed that letting an MD, DO, NP, or PA who has prescribed
insulin to the driver perform the assessment will provide a better way
to determine if the driver's condition is well-controlled. It would
reduce the costs and treatment delays caused by the requirement for an
evaluation by a board-certified or board-eligible endocrinologist.
    A certified ME, who is an NP, commented that there is a shortage of
MD and DO primary care providers in her region; therefore, the use of
NPs and PAs improves access to needed care. She also stated that access
to endocrinologists is limited in her area, so most ITDM individuals
are managed by their primary care providers.
    The ADA stated that an appropriate TC, including endocrinologists,
physicians, PAs, NPs, and diabetes educators, is one who is
knowledgeable and experienced in the management of diabetes, not
necessarily a specialist.
    A driver, a certified ME, and SOCO stated that a TC, as defined by
the MRB, is not qualified to properly assess drivers with ITDM. These
commenters indicated that only an endocrinologist should assess such
drivers. The certified ME stated that the rulemaking will increase the
burden on the certified ME and affect the certified ME's willingness to
accept a ``clinician'' statement about a driver's control of diabetes
mellitus.
    H&SW, the University of Utah, AAFP, Concentra, and an individual
were not satisfied with the definition and qualifications of a TC in
the 2015 MRB report and indicated that the TC should meet additional
requirements. Some commenters stated that many TCs are not familiar
with the requirements of commercial driving. For example, H&SW noted
that the total reliance on the TC to evaluate a driver's management of
his or her diabetes was a flaw in the proposal. H&SW pointed out that
FMCSA has no authority over the TC. It did not agree that the Agency
should assign responsibility to the TC, who is not certified to perform
CMV physical examinations.
    The University of Utah wanted the TC to have knowledge of at least
3 years of the driver's treatment--either through direct knowledge or
from medical records. The commenter added that there also had to be a
mechanism to stop drivers with ITDM from doctor shopping for a
favorable opinion. Concentra stated that the TC should have treated the
driver for the preceding 12 months, so the TC can attest to the lack of
hypoglycemic reactions and to the driver having properly managed the
diabetes.
    While the AAFP urged FMCSA to allow drivers to be examined by their
primary care physicians, rather than to require examination by an
endocrinologist, it asked FMCSA to allow only a DO or MD to perform
these services. Both Concentra and the individual indicated that the
non-physician healthcare professional should qualify as a TC only if
under the supervision of an endocrinologist or other physician.
    The individual commenter warned that the TC must be held to high
standards, and any TC who submitted a falsified or disingenuous report
should be penalized. This commenter also wrote that FMCSA should
require the TC to notify the Agency if the driver becomes noncompliant
or if the driver discharges the TC.
    FMCSA Response: The final rule does not limit the TC to a specific
discipline or require the TC to be an endocrinologist. The Agency
agrees with commenters who stated that an appropriate TC is one who is
knowledgeable and experienced in the management of diabetes and is not
necessarily a specialist.
    FMCSA defines the TC in the final rule as a healthcare professional
who manages, and prescribes insulin for, the treatment of the
individual's diabetes mellitus as authorized by the healthcare
professional's State licensing authority. The final rule establishes
that the ITDM individual must have a prescription from his or her TC
for treatment with insulin. FMCSA adds this requirement because
prescriptive authority for some healthcare disciplines may be limited
by the State's scope of practice. This requirement ensures that the
healthcare professional who routinely treats the ITDM individual is the
one who prescribes the individual's insulin for treatment.
    The Agency declines to specify disciplines that may serve as the TC
for purposes of this rulemaking due to the differences in scopes of
practice among States. Some areas of the country may be underserved in
some disciplines and have greater access to other disciplines. FMCSA
finds that identifying specific disciplines disadvantages individuals
who may not have access to those healthcare professionals. The Agency's
definition allows for maximum flexibility in addressing issues related
to shortages in various categories of licensed healthcare professionals
in all States.
    FMCSA agrees with the commenters who stated that requiring
evaluation by an endocrinologist is burdensome to ITDM individuals
seeking certification because of the scarcity of endocrinologists in
many regions of our country. A June 2014 Endocrine Society white paper
states that there were approximately 4,841 adult endocrinologists
engaged in clinical practice in 2011, and it projected a shortage of
1,484 adult endocrinologists by 2015.\9\ The paper also shows that 85
percent of office visits for diabetes were with physicians other than

endocrinologists.\10\ As stated in the NPRM, a requirement to be
evaluated by an endocrinologist seems impracticable for most drivers
with ITDM (80 FR 25266). The frequent monitoring by a specialist as
required by the exemption program was a financial burden for many
individuals, many of whom have primary care providers who are capable
of prescribing and managing insulin treatment for their patients. The
Agency has concluded that the higher cost of an endocrinologist
evaluation is not justified given that a TC can determine that the
individual has a stable insulin regimen and properly controlled ITDM.
---------------------------------------------------------------------------

    \9\ ``Endocrine Clinical Workforce: Supply and Demand
Projections'' prepared for the Endocrine Society by the Lewin Group,
2014, pp. 1-2. Available at https://www.endocrine.org/~/media/
endosociety/files/advocacy-and-outreach/important-documents/white-
paper-endocrinology-workforce-final-white-paper.pdf (May 25, 2018).
    \10\ Id. at 40.
---------------------------------------------------------------------------

    The requirement that the TC must be the healthcare professional who
manages, and prescribes insulin for, the treatment of the individual
who is being evaluated makes it likely that the TC will be the
individual's primary care provider. As the commenters indicate, primary
care providers are well trained and experienced in managing diabetes
and provide most care for diabetes in many areas. As such, FMCSA is not
requiring that a qualified TC hold any specific certification or have
any specialized training with respect to diabetes. The Agency agrees
with commenters that TCs who have personal knowledge of an individual's
medical history and treatment regimens will be able to make an accurate
determination as to whether an individual maintains a stable insulin
regimen and proper control of his or her ITDM. As such TCs managing,
and prescribing insulin for, the treatment of ITDM individuals are
well-suited to monitor for complications related to diabetes. FMCSA is
confident that when necessary, TCs will refer the ITDM individual to
appropriate specialists for any additional medical evaluations for
diabetes-related co-morbid conditions requiring specialized diagnosis
and treatment.
    FMCSA anticipates that the TC would have an ongoing relationship
with the individual being evaluated, but is not requiring that the TC
treat the individual for any specific period. If the TC is newly
establishing a relationship with an individual seeking evaluation, the
TC may exercise his or her independent medical judgment with respect to
the need to obtain and review prior medical records and whether the TC
has sufficient information to complete the ITDM Assessment Form, MCSA-
5870, and to attest the information provided is true and correct to the
best of the TC's knowledge. Similarly, FMCSA declines to require the TC
to notify the Agency if a driver becomes noncompliant or discharges the
TC. The need to obtain the required information from a TC who is
prescribing insulin for the treatment of the individual's ITDM should
discourage noncompliance and doctor shopping for a favorable
attestation.
    FMCSA emphasizes that it is not relying on the TCs to make the
medical qualification determination. FMCSA is implementing the ITDM
Assessment Form, MCSA-5870, as recommended by the 2015 MRB report, that
asks specific questions of the TC and provides information needed for
medical certification determinations by the certified ME. Evaluation by
the TC in this collaborative manner is consistent with current
certified ME practice during the medical certification process.
Certified MEs confer routinely with and obtain the treating providers'
opinions concerning the stability of individuals' underlying medical
conditions and how the medical conditions may impact safety. This
process minimizes the concern that TCs who are primary care providers
may be lenient because certified MEs make the determination regarding
physical qualification.

D. Role and Relationship of the TC and Certified ME

    NPRM: FMCSA proposed that, prior to the annual or more frequent
examination by the certified ME, the ITDM individual would have to be
evaluated by the TC. The TC would determine that within the previous 12
months the individual had no severe hypoglycemic reaction and had
properly managed his or her diabetes. The certified ME had to obtain
written notification from the individual's TC that the individual's
diabetes was being properly managed and had to evaluate whether the
individual was physically qualified to operate a CMV.
    Comments on the Role and Relationship of the TC and Certified ME:
The IBT supported the Agency's proposal. It stated that, although the
TC may not be thoroughly familiar with FMCSA regulations or tasks
performed by a CMV driver, subsequent evaluation by a certified ME
would complement the role of the TC in the certification process. The
ADA noted that the NPRM had not made completely clear the role of the
certified ME in evaluating the applicant's diabetes. However, the ADA
supported a two[hyphen]step certification process where the TC
certifies that the individual with ITDM meets the revised diabetes
standard and the certified ME completes the certification process with
regard to all other aspects not related to diabetes. If the certified
ME had concerns about an individual's diabetes, the ADA recommended
that the certified ME should consult the TC or an independent diabetes
healthcare professional for verification.
    A number of commenters wanted certified MEs and TCs to work
directly together. For example, given that certified MEs are ultimately
responsible for certifying individuals, the Transportation Trades
Department, AFL-CIO (TTD) and the Amalgamated Transit Union wanted
FMCSA to encourage certified MEs and TCs to work closely together so
that fit individuals may work.
    The ACOEM added that allowing the certified ME, who has the
training and understanding of the role of the CMV operator, to obtain
and review additional medical information would increase the margin of
safety in the determination, while lessening the certified ME's
liability in relying on a TC who might not fully understand the safety
concern. The ACOEM commented that FMCSA should require the TC to sign a
statement saying that the ITDM individual can manage his or her health
condition.
    A physician/certified ME, who is also board-certified in
occupational medicine, questioned the value of having certified MEs for
ITDM individuals, if the certified MEs simply defer to the TC. This
commenter wanted FMCSA to clarify that a certified ME can request
whatever medical information is necessary to make a sound
determination. He also stated that the increased cost and
responsibility for the certified ME would be reflected in higher fees.
    The NTSB noted that FMCSA allows healthcare professionals who are
not licensed to prescribe medication to medically-certify individuals
who operate CMVs. Because these certified MEs have no experience
prescribing medications or managing the effects of insulin or other
diabetic medications, the NTSB indicated that these certified MEs must
accept a TC's assurance of ``proper management'' without further
evaluation. The NTSB commented that a TC's interpretation of proper
management, as well as the individual's compliance with
recommendations, might vary considerably.
    TFAC noted that the certified ME is required to certify the ITDM
individual is free of complications, while the written notification
from the TC gives the certified ME no information about how the TC made
that determination. This commenter proposed that ``the statement
required from the TC make[s] it clear in the area of diabetes
management it is the TC who is rendering the expert medical opinion
that the driver is `safe' therefore

relieving the medical examiner from concerns about potential
liability.''
    H&SW disagreed with FMCSA relying solely on the TC for information
about the ITDM individual's management of his or her diabetes. It
recommended that FMCSA require the collection of documentation by the
TC as only one piece of the data gathered by the certified ME. It
further suggested that FMCSA should also require the certified ME to
obtain additional test and laboratory results, review glucose logs, and
ensure the ITDM individual has received hypoglycemic awareness
training. If documentation from a TC is the only tool the certified ME
has, H&SW indicated the Agency is permitting the TC to make the medical
certification decision even though he or she is not listed on the
National Registry. A physician questioned how the certified MEs will
protect themselves from discrimination lawsuits when they do not
approve every individual recommended by the TCs.
    Some commenters were concerned that the NPRM did not provide the
certified ME with sufficient specific criteria to determine if the
individual's diabetes was properly managed or if he or she was
physically qualified to operate a CMV. H&SW indicated that the
certified ME needs to see the blood sugar logs and the results of the
eye examination; ensure the driver has had hypoglycemic awareness
training; and check the blood levels for glucose to make an evidence-
based decision regarding whether the driver is physically qualified to
operate a CMV.
    2015 MRB Report: The 2015 MRB report recommended that a
questionnaire be developed for the TC to complete and send to the
certified ME. Based on the responses to the questionnaire, the TC was
to indicate whether the individual had stable, well-controlled diabetes
and had no severe hypoglycemic episodes over the past year, and to
state that neither the individual's diabetes nor diabetes-related
medical conditions would impair the ability to operate a CMV safely.
The MRB recommended specifically that the final determination as to
whether the ITDM individual was physically qualified to drive a CMV was
to be made by the certified ME.
    Comments on the MRB's Report on the Role and Relationship of the TC
and Certified ME: In response to this recommendation, OOIDA, Concentra,
H&SW, and the ACOEM commented on the appropriate relationship between
certified MEs and TCs. Concentra commented that certified MEs should be
able to review a TC's records of an ITDM individual for at least the
preceding year. OOIDA had concerns that the certified ME could override
the TC's determinations. It suggested that certified MEs should provide
``sound medical evidence'' before challenging the TCs findings or
requiring individuals to undergo more testing. H&SW added that the
certified ME should be given the tools that the TC has and should ask
for detailed tests and laboratory reports from the TC, if needed. H&SW
also wrote that FMCSA should put the TC in a consultation position,
especially because the certified MEs will be held responsible should
the ITDM individual have a crash. The ACOEM stated that certified MEs
must review at least 3-5 years of medical records so the certified ME
can evaluate the individual's condition independently.
    FMCSA Response: This final rule continues the two-step process for
medical certification in which the TC evaluates the individual's
insulin regimen and control of his or her ITDM, then a certified ME
performs an examination and determines whether the individual is
physically qualified under all medical standards to operate a CMV.
FMCSA agrees with commenters that the medical information provided by
the TC to the certified ME should be relevant and useful and allow a
certified ME to make an appropriate medical certification determination
on an ITDM individual. As such, FMCSA is adding a requirement in this
final rule that the TC complete an ITDM Assessment Form, MCSA-5870,
rather than simply provide written notification that the individual's
diabetes was being properly managed.
    As discussed above, the Agency relies on State licensing
authorities to make scope of practice determinations and has found that
the TCs and certified MEs are qualified to perform their respective
roles in this collaborative certification process. The role of the
individual's TC, who is experienced in the management of diabetes, is
to attest on the ITDM Assessment Form, MCSA-5870, that the individual
maintains a stable insulin regimen and proper control of his or her
ITDM. The role and responsibility of the certified ME, who is trained
in FMCSA's physical qualification standards and the demands of
operating a CMV, is to medically certify that the ITDM individual can
safely operate a CMV. In making the qualification determination, the
certified ME is to consider the attestation and information provided by
the TC, but the certified ME does not automatically defer to the TC's
attestation or rely solely on it. Consistent with current practice for
any medical condition, the certified ME may confer with the TC
concerning an individual's medical history and status, make appropriate
referrals, or request medical records, all with appropriate consent.
    The final rule relies on the TC's knowledge of an individual and
understanding of the treatment of ITDM and the certified ME's knowledge
of the requirements to operate a CMV and FMCSA regulations. FMCSA
agrees with commenters and the MRB, as discussed more fully below, that
the certified ME must be provided with more information regarding how
the TC made his or her determinations. This rule adopts the ITDM
Assessment Form, MCSA-5870, as the way to communicate that information.
    The form requests specific information to assist both the TC and
the certified ME in evaluating and assessing whether an ITDM individual
maintains a stable insulin regimen and proper control of his or her
diabetes. The TC will have the relevant and current information on the
individual's medical history needed to complete and sign the ITDM
Assessment Form, MCSA-5870.
    FMCSA notes that, if a certified ME also meets the qualifications
to be an individual's TC, the certified ME may perform the TC
evaluation and medical certification examination contemporaneously. The
certified ME who also acts as the TC must still complete the ITDM
Assessment Form, MCSA-5870.

E. TC Written Notification (ITDM Assessment Form)

    NPRM: FMCSA proposed that the certified ME must obtain written
notification from the individual's TC that the individual's diabetes is
being managed properly.
    Comments on TC Written Notification: Some commenters stated that
FMCSA should develop a comprehensive form to organize the certification
criteria, thus ensuring that the information was complete and providing
the certified ME the information necessary to determine that the
individual is physically qualified. The former MRB members suggested a
form that includes sections completed by the driver, the TC, and an
ophthalmologist or optometrist. Some commenters, like the ADA, OOIDA,
the IBT, and the ACOEM, recommended the use of specific forms or
checklists that they suggested be adopted. Several commenters had
extensive lists of documentation they suggested the TC should provide
to the certified ME

including: Properly-maintained glucose logs; proof of proper diabetes
management and compliance; records related to any hypoglycemic
episodes; HbA1C testing results; and proof of yearly preventive care to
screen for the long-term side effects of diabetes, such as retinopathy.
Some commenters, like the ACOEM, requested a full packet of
documentation be submitted to the certified ME.
    Many commenters said the requirements of the proposed rule needed
clarity or more specific guidance for the TC or certified ME to use to
decide whether an ITDM individual may operate a CMV in interstate
commerce. Concentra suggested that the Agency review the criteria with
leading endocrinologists who specialize in diabetes.
    Other commenters suggested adoption of best practices. The NTSB
suggested that FMCSA emulate the Federal Aviation Administration (FAA)
and the United States Coast Guard, which require operators with ITDM to
be evaluated using published or scientifically-based standards. An
individual commenter suggested that FMCSA model the requirements after
FAA requirements, adjusted to allow ITDM individuals to take insulin by
pump or manual injection. H&SW provided specific recommendations, some
based on requirements cited by the ADA and Canada's qualifications for
ITDM individuals.
    TFAC understood FMCSA's reluctance to make very specific medical
requirements, as the science of treatment options changes; yet, it
noted there is a need for specificity in medical requirements to ensure
there is consistency in how certified MEs handle situations. TFAC
stated that without clear criteria, normal practice standards would be
established by individual certified MEs and litigators, rather than by
FMCSA through rulemaking. A physician who had experience with a
discrimination lawsuit stated that, unless FMCSA provides specific
certification guidance, the TC and the certified ME will avoid the risk
of litigation by allowing individuals who should not be driving to get
an MEC, MCSA-5876.
    2015 MRB Report: The 2015 MRB report recommended that FMCSA develop
a questionnaire for the TC to provide to the certified ME and provided
an outline of specific information to obtain. The TC would complete,
sign, and send the form to the certified ME. The form would also be
signed by the ITDM individual. The report also recommended specific
criteria in several areas including severe hypoglycemic episodes,
glucose logs and self-monitoring blood glucose, HbA1C results, eye
examinations, and diabetic complications.
    Comments on the General MRB Recommendation to Develop a Form: The
AAPA supported using the MRB recommended form as proposed. It stated
that the degree of uniformity provided by the form would ensure that
all TCs are assessing commercial drivers in the same way and using the
same metrics when evaluating a driver's health. Additionally, a
certified ME commended inclusion of the TC's signature and stated that
the form would facilitate communication between the certified ME and
TC. The ADA appreciated the efforts of the MRB to provide instruction
to the TC regarding clinical indicators for evaluation but indicated
the criteria were medically inappropriate in several places. An
endocrinologist provided a sample of an assessment form used by the
Pennsylvania DOT in the evaluation of ITDM drivers.
    Concentra stated that the MRB-proposed form was lengthy, complex,
and lacked specific direction, particularly in identifying serious co-
morbid diseases. The University of Utah stated that the form was just
an outline and needed exact requirements and consequences. It wanted a
place for the ITDM individual to sign to attest to its truthfulness and
to include a penalty for that individual not being truthful. It also
stated that the final draft form should be made available to the public
for comment. The ADA stated that having an ITDM individual sign the
form would be inappropriate because FMCSA does not have the legal
authority to require the TC to report any information to a certified ME
unless the patient provides express permission for such reporting.
    Proposed ITDM Assessment Form: FMCSA agreed with commenters that a
form would enhance communication between the TC and certified ME and
provide consistent information to certified MEs. Accordingly, FMCSA
prepared a proposed ITDM Assessment Form and published a 60-day notice
on July 27, 2017, announcing that it was considering replacing the
previously proposed written notification from the TC with the ITDM
Assessment Form (82 FR 35041). The Agency sought comment on the form,
which is available in the docket for this rulemaking.
    Comments on the ITDM Assessment Form: Five commenters provided
substantive comments specific to the ITDM Assessment Form in response
to the 60-day notice. An endocrinologist wholeheartedly agreed with the
proposed approach of the form. A certified ME supported the use of the
form and stated that it should be passed along to the treating primary
care physician for completion and then should be reviewed by a
certified ME who is knowledgeable about the challenges of driving a
CMV. Another certified ME was concerned that the form requests
information on severe hypoglycemic events for only the past 3 months.
This commenter stated that he ``would want to know of any severe
hypoglycemic events over the past 5 years, as previous guidance from
the FMCSA Examiner's Handbook for diabetics not on insulin, was not to
certify if there had been a severe hypoglycemic event within the past
12 months, or 2 within the last 5 years.'' The commenter also wanted to
know the lowest recorded finger-stick blood glucose over the preceding
3 months and all HbA1c results for the preceding year. An MD stated
that the form should include questions about co-morbid conditions such
as peripheral neuropathy, sleep apnea, uncontrolled hyperlipidemia, or
hypertension being treated by the TC.
    The ADA was concerned about the requirement that a driver be on a
stable insulin regimen for the prior 3 months. The ADA also stated that
the Agency requires the driver to have his or her HbA1C measured
intermittently over the last 12 months with the most recent measure
within the preceding 3 months and noted that newly-diagnosed
individuals will not have that data.
    FMCSA Response: The Agency agrees with commenters that more than
written notification from the individual's TC that the individual's
diabetes is being managed properly should be provided by the TC to the
certified ME. The final rule requires that the TC complete the ITDM
Assessment Form, MCSA-5870, to provide additional information for the
certified ME about the ITDM individual's medical history. The Agency
has considered the forms and checklists provided by commenters, and has
determined that the ITDM Assessment Form, MCSA-5870, collects the
appropriate information to enable the certified ME to make his or her
certification determination. Comments on specific criteria are
discussed below by substantive area.
    With respect to the comment that the form should be completed by
the treating primary care physician, FMCSA is not limiting the TC role
to physicians. As discussed above, FMCSA expects that the TC will be
the individual's primary care provider for diabetes treatment.

    A certified ME determines whether an individual meets FMCSA's
physical qualification standards as of the time of the medical
certification examination. Therefore, FMCSA has determined that
providing information to the certified ME regarding whether an ITDM
individual has had a severe hypoglycemic episode in the prior 3 months
is generally sufficient. As discussed elsewhere in this preamble, that
time frame coincides with the Agency's requirement that an ITDM
individual provide the TC with 3 months of blood glucose self-
monitoring records to be eligible for up to the maximum 12-month MEC,
MCSA-5876. The Agency finds that this is a balanced approach for ITDM
individuals that allows time to demonstrate a stable insulin regimen
and proper control of ITDM, while providing enough information for the
certified ME to determine whether the individual can safely operate a
CMV. In any event, an ITDM individual is also required to provide the
certified ME with a completed ITDM Assessment Form, MCSA-5870, for any
severe hypoglycemic episodes that may have occurred since any previous
medical certification examination, so the certified ME will be aware of
such episodes. With respect to comments suggesting that the form be
consistent with guidelines provided in the Medical Examiner Handbook,
FMCSA notes that the Handbook, a tool certified MEs could consider
during the medical certification process, has now been withdrawn.
    The ITDM Assessment Form, MCSA-5870, already includes questions
about co-morbid medical conditions as suggested by a commenter. It also
provides an area for additional comments by the TC where other relevant
conditions may be referenced.
    The final rule requires that, to be eligible for up to the maximum
12-month MEC, MCSA-5876, all ITDM individuals must provide to the TC at
least the preceding 3 months of blood glucose self-monitoring records
while being treated with insulin. If an individual does not provide the
3 months of records, the certified ME has discretion to grant the
individual up to but not more than a 3-month MEC, to allow time for the
individual to collect the necessary records. Once the individual has 3
months of blood glucose self-monitoring records, the individual is
treated the same as an ITDM individual with 3 months of records. The
individual must first go to the TC for evaluation and then to the
certified ME, who must exercise independent medical judgment, to
determine if the individual is eligible for up to the maximum 12-month
MEC.
    The form asks has the individual had HbA1C measured intermittently
over the last 12 months, with the most recent measure within the
preceding 3 months, and, if so, to attach the most recent result. The
Agency notes that the lack of HbA1C data does not automatically
disqualify an individual from being medically certified.
    In the final form, FMCSA made changes to be consistent with the
terminology, definitions, and requirements in the final rule. The
Agency also made minor changes to improve clarity and organization.
More specifically, a sentence was added to specify that the certified
ME must receive the form and begin the medical examination no later
than 45 days after the date on the signed form; however, FMCSA notes
that the medical certification determination does not need to be
completed within 45 days. The Agency also added a provision that an
ITDM individual who is being evaluated after a severe hypoglycemic
episode must retain the form and give it to the certified ME at the
next medical certification examination. FMCSA removed the question that
asked whether the individual experienced any severe hypoglycemic
episodes in the absence of warning symptoms in the preceding 3 months.
The Agency found the question was redundant of the general request for
information about severe hypoglycemic episodes. The Agency added a
request for the individual's driver's license number and issuing State,
but agrees with the ADA that it is not appropriate for the form to
require the individual's signature. The Agency also added a request for
the TC's medical credential, as well as professional license number and
the issuing State, to be able to identify these individuals. Finally,
FMCSA modified the TC's attestation on the form.
    The Agency notes that the ITDM Assessment Form, MCSA-5870, is
available on FMCSA's Medical Programs and National Registry websites.
Additionally, once the TC has signed and dated the form as required,
the form is provided to the certified ME by either the ITDM individual
or the TC.

F. Certified ME Certification and TC Evaluation Frequency

    NPRM: In the NPRM, FMCSA proposed that at least annually, a
certified ME listed on the National Registry must examine and certify
that the ITDM individual is physically qualified and free of
complications that would impair the individual's ability to operate a
CMV. Prior to the annual or more frequent certified ME's examination,
the individual would have to be evaluated by the TC.
    Comments on Certified ME Certification and TC Evaluation Frequency:
While some commenters wanted an interval of 2 years between medical
certification of drivers, others stated the ITDM individual should be
examined more frequently. For example, the ADA, SOCO, Advocates, and
H&SW agreed with the proposed interval of at least annual examination.
The ATA and AAPA-OM suggested a graduated approach whereby certified
MEs would issue shorter-term medical certifications initially and
longer-term certifications after the initial period during which the
ITDM individual demonstrated his or her condition was stable and
properly controlled. The ATA recommended that the longest term of
certification should not exceed a year. A physician/certified ME wrote
that the endocrinologist is responsible for stating that the ITDM
individual is well controlled throughout the year; this commenter
stated that the NPRM took a step back from the effort to improve
medical examinations.
    2015 MRB Report: The 2015 MRB report recommended that a certified
ME could certify an ITDM individual as medically qualified for no more
than 1 year if the individual had no disqualifying factors. The MRB did
not make a specific recommendation regarding the frequency of the TC
evaluation. No comments were received concerning the MRB report in this
regard.
    FMCSA Response: FMCSA agrees with commenters who stated that ITDM
individuals should not be granted medical certification for a period
longer than 12 months. Annual or more frequent recertification by the
certified ME allows for earlier detection and consideration of any
changes or complications that may impact an ITDM individual's ability
to safely operate a CMV. If a certified ME determines an individual
should not be qualified for the maximum 12 months, the certified ME may
certify that individual for a shorter period. FMCSA finds that this
approach allows for the application of individualized medical
certification determinations based on the certified ME's medical
discretion. ITDM individuals must see their TC prior to every medical
certification examination to ensure they maintain a stable insulin
regimen and proper control of their ITDM as the rule requires.

G. Annual Certification of Individuals With Diabetes Mellitus Not
Treated With Insulin

    NPRM: In the NPRM, the Agency did not propose that individuals with
diabetes mellitus not treated with insulin (non-ITDM individuals) be
recertified at least annually. However, FMCSA cited the 2007 MRB
recommendation to require annual or more frequent medical
recertification for all individuals with diabetes mellitus, and
requested comment on the recommendation.
    Comments on Annual Certification of Non-ITDM Individuals: The IBT,
Illinois Office of the Secretary of State, and the ADA said the Agency
should not require that non-ITDM individuals obtain recertification at
least annually because a change to the current procedure for qualifying
these individuals is not warranted. The ADA commented that non-ITDM
individuals should be able to hold a medical certificate for up to 24
months like other individuals, unless their healthcare provider or the
certified ME determines otherwise. In contrast, Advocates recommended
that the Agency should establish more frequent medical certification
for all individuals with diabetes.
    2015 MRB Report: The 2015 MRB report did not address the
requirement that non-ITDM individuals be recertified at least annually;
no comments were received concerning the MRB report in this regard.
    FMCSA Response: FMCSA agrees with commenters that a 2-year
recertification period for non-ITDM individuals is appropriate and will
not adopt the MRB's 2007 recommendation. FMCSA finds that is not
necessary to impose a requirement for annual certification of these
individuals because certified MEs have a long history with
certification of non-ITDM individuals. Certified MEs have been trained
that they may issue short duration MECs, MCSA-5876, for medical
conditions that require frequent monitoring or where additional medical
information is needed. Moreover, the commenters provided no data that
suggests annual medical certification of non-ITDM individuals is
warranted.

H. Eye Examinations

    NPRM: The NPRM did not propose any changes to the existing vision
standards. The Agency requested comments on the need for an ITDM
individual to be examined by an optometrist or ophthalmologist as a
condition of passing the physical examination.
    Comments on Eye Examinations: The ADA commented that it should be
left to the judgment of the TC to refer the individual to an
optometrist or ophthalmologist, as needed, based on clinical indicators
that a screening by an eye specialist is necessary. The ADA's Standards
of Medical Care recommend that individuals with type 1 diabetes be
screened for retinopathy within 5 years of diagnosis because
retinopathy is estimated to take at least 5 years to develop following
hyperglycemia. The Standards of Care recommend that patients with type
2 diabetes be screened shortly after diagnosis. The ADA further
commented that after one or more normal eye examinations, individuals
with well-controlled type 2 diabetes had essentially no risk of
developing significant retinopathy within 3 years of a normal
examination. According to the ADA's comments, ``[n]ot all individuals
with diabetes will develop vision complications, and among those that
do, not all will interfere with safe driving ability. As such, only
those CMV drivers who pose a high risk--because of the presence of
complications that interfere with driving, such as impaired vision--
should be further assessed by a specialist to determine if the risk is
too high.'' OOIDA endorsed the comments submitted by the ADA.
    The Illinois Office of the Secretary of State agreed with the
proposal, provided that the ITDM individual can meet the vision
standards in Sec.  391.41(b)(10). It stated that the process will
provide a reasonable certainty that any ITDM individual who cannot meet
the standards will be discovered by the certified ME during the annual
examination and the process will not present any threat to general
traffic safety. The IBT also agreed with the proposal and FMCSA that
meeting the vision acuity standard provides `` `reasonable certainty of
discovering and mitigating risks associated with any safety-related
condition that would interfere with meeting the standard, including
diabetic retinopathy.' ''
    Some commenters, including H&SW and the ACOEM, stated that FMCSA
should require an annual evaluation from an ophthalmologist or
optometrist. SOCO suggested that FMCSA should require a note from an
ophthalmologist or optometrist stating that the individual is free of
diabetic-related retinal disease and vision impairing cataracts and has
good field of vision in both eyes. The NTSB stated that diabetic
retinopathy can cause loss of areas of vision without affecting acuity;
therefore, a dilated retinal eye examination is an annual standard of
care for most ITDM individuals. It indicated that eliminating the
annual ophthalmological examination will increase the likelihood of
ITDM individuals driving CMVs with significant diabetic retinopathy and
degraded visual performance, which will pose a hazard to public safety.
A physician/certified ME stated that if the exemption program is
eliminated he will continue to expect at least annual assessment from
an ophthalmologist.
    Several commenters that were in favor of requiring annual eye
examinations, including the American Optometric Association (AOA) and
the former MRB members, noted that the certified ME may not have the
experience and training to perform dilated eye examinations or have the
specialized equipment necessary to do so. The former MRB members noted
that by the time an ITDM individual experiences reduced visual acuity
that is captured by the relatively crude examination performed by a
certified ME, it is often too late to avoid complications. Thus, the
former MRB members stated there is further need for mandatory, annual
eye examinations for retinopathy by ophthalmologists or optometrists.
    The AOA noted it is important to understand that the entire range
of diabetic retinopathy complications are predominantly asymptomatic
and can occur without any deterioration in visual acuity. It stated
that a visual acuity test is not a substitute for a dilated eye
examination, which is the only appropriate method for evaluating the
eye health of ITDM individuals and for predicting with high confidence
which individuals will retain adequate visual function in the interim
between eye examinations. It was concerned that the current proposal
could put drivers and the public at serious risk. The AOA suggested,
rather than requiring evaluation by an ophthalmologist, FMCSA could
reduce the cost and burden to ITDM individuals, while maintaining
quality of evaluation, by allowing a doctor of optometry to evaluate
those applicants.
    TFAC suggested FMCSA require a vision examination by a qualified
eye specialist when the individual goes on insulin treatment and every
2 years thereafter. It suggested that the eye specialist complete a
form acknowledging familiarity with the requirements of 49 CFR and the
physical demands of a CMV operator.
    2015 MRB Report: The 2015 MRB report included the recommendation
that ITDM individuals receive a complete eye examination by a qualified
ophthalmologist or optometrist, including a dilated retinal
examination, at least every 2 years. This examination should document
the presence or

absence of retinopathy and macular edema, and, if present, the degree
using the International Classification of Diabetic Retinopathy and
Diabetic Macular Edema. The MRB advised increasing the frequency of
these examinations based on the ophthalmological findings.
    Comments on the MRB's Report on Eye Examinations: HS&W concurred
with the MRB's recommendation. The National Rural Electric Cooperative
Association commented that it was not opposed to a comprehensive eye
examination \11\ every 2 years, but having the TC attest that the TC
reviewed the results of the report was ``duplicative at best and
onerous at worst.''
---------------------------------------------------------------------------

    \11\ The AOA commented that ``comprehensive eye examination'' is
the proper terminology to describe the general evaluation of the
complete visual system, including a dilated retinal examination,
rather than ``an ophthalmology or optometry exam.''
---------------------------------------------------------------------------

    The AOA, the ACOEM, and several individuals suggested a
comprehensive eye examination should be conducted on an annual basis.
The AOA stated that its evidence-based guidelines explain that the
clinical signs of diabetic retinopathy can appear early in the disease
process; however, individuals many not experience symptoms until
relatively late, at which time treatment may be less effective. The AOA
noted that ``[t]he success of appropriate intervention and management
strategies depends upon accurate and timely detection of diabetic eye
disease.'' The University of Utah stated that individuals with non-
proliferative retinopathy should be required to have annual
comprehensive eye examinations.
    The ADA repeated its prior comments to the NPRM that an annual
comprehensive eye examination is not required by its Standards of Care.
It again concluded that it should be left to the judgment of the TC to
refer the ITDM individual to an ophthalmologist or optometrist as
needed.
    FMCSA Response: This rule does not include a mandatory requirement
or specify the frequency for comprehensive eye examinations for ITDM
individuals. FMCSA finds the Standards of Care and comments presented
by the ADA to be persuasive and reasonable. Given that not all
individuals with diabetes will develop vision complications, FMCSA has
determined that it would be inconsistent with the rule's emphasis on
individualized assessment to impose a required frequency for a separate
comprehensive eye examination by an ophthalmologist or optometrist as a
condition of passing the medical certification examination for all ITDM
individuals. FMCSA also finds that to do so is inconsistent with
Congress' instruction that the Agency may not hold ITDM individuals to
a higher standard than other individuals unless it is medically
necessary. The Agency's determination that annual comprehensive eye
examinations should not be required also is supported by the MRB's
recommendation that ITDM individuals undergo such examinations every 2
years, unless clinical indicators suggest otherwise.
    The Agency finds that the TC is in the best position to determine
for each ITDM individual when a comprehensive eye examination is
necessary and, when warranted, to make a referral to an ophthalmologist
or optometrist. If any eye condition that may impact an ITDM
individual's ability to safely operate a CMV is present, it is
reasonable for the Agency to expect that the ITDM individual's TC will
ensure that proper comprehensive eye examinations are obtained to
appropriately monitor any progressive vision impairment. As with all
medical certification examinations, with the ITDM individual's consent,
the certified ME may confer as needed with the TC or an eye specialist
to determine whether additional information or evaluation is necessary
prior to the medical certification decision.
    The final rule does not change the existing requirement that all
individuals must meet the vision standard in Sec.  391.41(b)(10) to
operate a CMV. The Agency continues to find that meeting the vision
standard provides reasonable certainty of discovering and mitigating
risks associated with any safety-related condition that would interfere
with meeting the standard. As such, this rule does not include a
mandatory requirement or specify the frequency for comprehensive eye
examinations for ITDM individuals.

I. Disqualification for Vision Impairment

    NPRM: The NPRM did not propose that any specific visual
complications associated with diabetes would disqualify an ITDM
individual from being medically qualified.
    Comments on Disqualification for Vision Impairment: Commenters
stated that no diabetic retinopathy above stage 1 is acceptable. The
risks of progression, which may occur very suddenly, are too high. No
laser treatments or intraocular injections for retinopathy should be
allowed. Additionally, vision exemptions should not be acceptable in
this context.
    2015 MRB Report: If ITDM individuals had stage 3 or 4 of diabetic
retinopathy, the MRB recommended that such individuals be disqualified
permanently from medical certification.\12\
---------------------------------------------------------------------------

    \12\ The Agency sought clarification from the MRB and was
informed that stage 3 diabetic retinopathy could be termed severe
non-proliferative diabetic retinopathy and stage 4 diabetic
retinopathy could be termed severe proliferative diabetic
retinopathy.
---------------------------------------------------------------------------

    Comments on the MRB's Report on Disqualification for Vision
Impairment: Commenters agreed that stage 3 or 4 retinopathy should be a
permanent disqualification because of the significant risk of sudden
vision compromise from bleeding or retinal detachment. In addition, the
ADA noted that the standard treatment for this stage is pan-retinal
photocoagulation, which cuts down night vision and peripheral vision
that are important to CMV operation.
    The University of Utah stated that anything beyond non-
proliferative retinopathy should be disqualifying because
epidemiological studies suggest sudden onset of vision impairment is
too common. This commenter also stated that it should be made clear
that any laser treatments or intraocular injections for treatment of
retinopathy would preclude driving. Additionally, monocular driving in
combination with any degree of retinopathy, not just stage 3 or 4
retinopathy, should be clearly disqualifying due to the inability to
have a compensatory eye combined with the potential suddenness of onset
of vision impairments.
    In contrast, an endocrinologist stated the 2015 MRB recommendation
is relatively arbitrary. Proliferative retinopathy, even after laser
therapy, affects vision variably. Thus, not all individuals in these
categories will have significant vision impairment. The endocrinologist
commented that the criterion should be based on function, such as
acuity, night vision, and response times to stimuli in the periphery of
visual fields. An individual wrote that, if an ITDM individual receives
treatment for the diabetic retinopathy and an ophthalmologist states
that the individual can operate a CMV safely, the retinopathy should
not be a disqualifying factor.
    FMCSA Response: This final rule requires that the certified ME
disqualify permanently from medical certification any ITDM individual
who is diagnosed with severe non-proliferative diabetic retinopathy or
proliferative diabetic retinopathy.
    The Agency agrees with the 2015 MRB report and commenters that ITDM
individuals with advanced stages of diabetic retinopathy pose a safety
risk while operating a CMV. ITDM individuals whose diabetic retinopathy
has reached the advanced stages of

severe non-proliferative or proliferative diabetic retinopathy are at
risk of sudden incapacitation from a detached retina or bleeding. FMCSA
agrees, therefore, that ITDM individuals with severe non-proliferative
or proliferative diabetic retinopathy should be disqualified
permanently from operating a CMV. Given that treatment for advanced
diabetic retinopathy impacts night and peripheral vision adversely,
which are important for operating a CMV, the Agency has determined that
there is a rational basis to find that ITDM individuals with severe
non-proliferative or proliferative diabetic retinopathy should be
permanently disqualified from being medically certified, despite
treatment.
    The Agency declines to incorporate any specific definition of
severe non-proliferative or proliferative diabetic retinopathy in
either the ITDM Assessment Form, MCSA-5870, or the regulation. Instead,
the Agency refers to classification categories created by eye
specialists, such as the National Eye Institute \13\ and the
International Clinical Diabetic Retinopathy Disease Severity Scale,\14\
with which eye specialists are familiar and well versed for the
definitions. Adding a specific definition would not assist the trained
eyecare specialist in making a clinical determination.
---------------------------------------------------------------------------

    \13\ See https://nei.nih.gov/diabetes/content/english/know
(Accessed May 25, 2018).
    \14\ See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3874488/
(Accessed May 25, 2018).
---------------------------------------------------------------------------

    With respect to the disqualification determination process, the
ITDM Assessment Form, MCSA-5870, asks the TC whether the ITDM
individual has been diagnosed with severe non-proliferative diabetic
retinopathy or proliferative diabetic retinopathy. If it is noted on
the form that the ITDM individual has been diagnosed as such, the
certified ME may rely on that representation and disqualify the
individual permanently from medical certification. Alternatively, the
certified ME may exercise his or her independent medical judgment and
refer the individual for further evaluation prior to making a
certification determination.

J. HbA1C Levels

    NPRM: The NPRM did not propose a standard for HbA1C levels for
medical qualification of ITDM individuals.\15\
---------------------------------------------------------------------------

    \15\ The A1C blood test is often referred to as the hemoglobin
A1C, HbA1C, or glycohemoglobin test. See https://www.niddk.nih.gov/health-information/diabetes/overview/tests-diagnosis/a1c-test#1
(Accessed Sept. 13, 2017).
---------------------------------------------------------------------------

    Comments on HbA1C: The former MRB members wanted FMCSA to state its
position on acceptable HbA1C levels, and recommended that driving be
allowed when the HbA1C is below 10 percent. A physician indicated that
FMCSA needs to establish specific guidance regarding what HbA1C level
would enable an individual to operate a CMV safely and asked whether a
level of 12 percent is satisfactory. The commenter stated that FMCSA
will need to provide a table as it does for blood pressure. An RN
stated that ITDM individuals should be required to have an HbA1C test
every 3 months. Another commenter stated that an individual should
check his or her HbA1C every 6 months.
    The ACOEM and TFAC would require the TC to send the certified ME
the current HbA1C results. TFAC stated that this should be done within
30 days of certification. TFAC commented further that the HbA1C test
provides the best information available on long-term control and cannot
be falsified as a daily blood glucose log can. The NTSB suggested that
FMCSA could require clinical information, including HbA1C levels, from
the TC to demonstrate that the individual meets specified criteria.
    The ADA, on the other hand, opposed requiring a specific HbA1C
range when licensing ITDM individuals, and recommended that FMCSA not
use this ``medically unjustified criterion'' in any form. The ADA noted
that, taken alone, an HbA1C above 7 percent in no way indicates the
individual cannot operate a CMV safely. The ADA, along with the ACOEM,
maintained that an HbA1C test is a useful indicator of diabetes
management when used in conjunction with other assessment tools to
assess an individual's ability to drive safely. The ADA wrote that
diabetes management decisions should be made by an individual and his
or her physician based on how diabetes affects that person.
    2015 MRB Report: The 2015 MRB report recommended that an ITDM
individual with uncontrolled diabetes be disqualified from operating
CMVs. The evidence for uncontrolled diabetes would be an HbA1C level
greater than 10 percent. The ITDM individual could be reinstated when
his or her HbA1C level is less than or equal to 10 percent.
    Comments on the MRB's Report on HbA1C: The ACOEM was the sole
commenter who supported this recommendation. It added that the ITDM
individual could be reinstated only when the recommended HbA1C level is
maintained for at least 3 months.
    Some commenters objected to a threshold of 10 percent. An MD
commented that this level does not take into consideration individual
variability in glycation rate and that the criterion could be tighter.
An individual wrote that HbA1C is not clearly defined as a range as it
is in Canadian and European regulations nor is the level in the healthy
or controlled range.
    Other commenters, including H&SW, an MD, the ADA, and the ATA,
objected to the use of HbA1C altogether to determine whether an
individual is safe to drive. H&SW wrote that the HbA1C test measures
average blood sugar over 3 months, and does not give information about
hypoglycemic episodes. An MD commented that he is not aware of any
evidence that a high HbA1C renders an individual unfit to drive. The MD
added that, while a high HbA1C may result in neuropathy, retinopathy,
and other end organ damage that could lead to unsafe driving, these
conditions take many years to develop and an HbA1C greater than 10
percent does not mean that an individual has these conditions. Because
individuals on oral medications would be allowed to drive with HbA1C
levels higher than 10 percent, the MD indicated that this rule would
discriminate against ITDM individuals and create a disincentive for
individuals to seek appropriate treatment with insulin. The MD
recommended either removing this recommendation or increasing the HbA1C
threshold to 12 percent.
    The ADA and the ATA wrote that the HbA1C test is a useful indicator
of poor diabetes management when used with other assessment tools. The
ADA highlighted that the HbA1C measure does not predict hypoglycemia.
Additionally, a high HbA1C does not impair driving, and evaluation of
end organ damage will identify individuals whose diabetes leads to
complications that impact safe driving. The ATA stated that
disqualifying an individual for an HbA1C level greater than 10 percent
may be somewhat arbitrary. This recommendation could create a disparity
between individuals who are managing their diabetes with and without
insulin. The ATA suggested that the certified ME should work with the
TC to determine whether a high HbA1C presents a danger. It recommended
further that FMCSA should consider other factors, in addition to a high
HbA1C level, for determining whether an individual's diabetes is well-
controlled and maintained.
    FMCSA Response: FMCSA agrees with comments that HbA1C values should
not be relied upon as a sole measure of an ITDM individual's ability to
safely operate a CMV. The final rule allows the TC to evaluate all
relevant clinical factors to determine whether an individual maintains
proper control of

his or her ITDM. HbA1C levels are one factor the TC may consider in
making that determination.
    FMCSA agrees further that making a medical qualification
determination based solely on a specific HbA1C level is inconsistent
with the rule's emphasis on individualized assessment. In addition, the
National Institute of Diabetes and Digestive and Kidney Disease states
that HbA1C test results can be up to 0.5 percent higher or lower than
the reported actual percentage; can be unreliable for people of
African, Mediterranean, or Southeast Asian heritage; and can be altered
by diseases that affect blood or hemoglobin.\16\ While a high HbA1C
level may suggest that complications from diabetes might develop in the
future, it does not mean that an individual presently has complications
or is unsafe to drive a CMV.
---------------------------------------------------------------------------

    \16\ See https://www.niddk.nih.gov/health-information/diabetes/overview/tests-diagnosis/a1c-test#1 (Accessed Sept. 13, 2017).
---------------------------------------------------------------------------

    The ITDM Assessment Form, MCSA-5870, asks the TC to report whether
the individual has had HbA1C measured intermittently over the past 12
months, with the most recent measure within the preceding 3 months. If
so, a copy of the most recent laboratory result is to be attached to
the form so that it is available to the certified ME.

K. Specific Blood Glucose Limits

    NPRM: The NPRM did not propose a specific range for blood glucose
readings.
    Comments on Establishing Specific Glucose Limits: The NTSB
suggested FMCSA require ITDM individuals meet specified criteria to
demonstrate that their diabetes is properly managed, including an
acceptable range for blood glucose. Some commenters, including a
retired FAA safety inspector, the former MRB members, an RN, the ACOEM,
and H&SW, recommended specific acceptable blood glucose limits. The
retired FAA safety inspector stated that a reading lower than 80 mg/dL
should be flagged, which would give the individual time to correct
blood glucose. The former MRB members said ITDM individuals should
maintain blood glucose levels of at least 100 mg/dL while driving. If a
blood glucose value is less than 60 mg/dL, the ACOEM would require the
individual to repeat the test at least every 30 minutes until 90 mg/dL
is reached. During this time, the individual would have to document
that he or she was not driving and provide additional documentation on
the low reading. H&SW stated that a blood glucose level within the
normal range of 80 to 140 mg/dL would be appropriate.
    The ADA wrote that it is appropriate to evaluate blood glucose
readings. However, there is no legitimate medical reason to
automatically disqualify individuals whose blood glucose logs show some
readings below 100 mg/dL or above 400 mg/dL, as stipulated in the
current exemption program.
    2015 MRB Report: The MRB recommended that if an ITDM individual had
a blood glucose measure of less than 60 mg/dL, as demonstrated in the
current glucose logs, the individual would be disqualified for at least
6 months.
    Comments on the MRB's Report on Establishing Specific Blood Glucose
Limits: Many commenters objected to the disqualification of an ITDM
individual for having a single reading below 60 mg/dL. Several
commenters stated that it was not appropriate to set a blood glucose
standard for when an individual is not on duty. They, along with the
ATA and ADA, discussed that a single reading of a blood glucose level
below 60 mg/dL should not be sufficient to disqualify an ITDM
individual. They stated that the Agency should consider whether a low
blood glucose recording was an isolated incident or part of an overall
pattern of poorly-controlled diabetes.
    The ADA stated that the recommendation is ``an extreme overreaction
to the potential risk of hypoglycemia, and does not provide for
individualized assessment of a specific driver's diabetes risk.'' It
continued that a blood glucose level less than 60 mg/dL is dangerous
only if it is not treated. The ADA commented that, instead of
disqualifying the individual, it is important to determine the cause of
the low blood glucose level. The ADA strongly urged the Agency to
eliminate all categorical glucose levels from the list of disqualifying
factors.
    An endocrinologist stated that all ITDM individuals will have some
blood glucose readings below 60 mg/dL, perhaps once a week. In the
endocrinologist's opinion, disqualifying individuals for a blood
glucose level any time it was under 60 mg/dL would be ``unreasonable/
discriminatory.'' A different MD stated that disqualification based on
a onetime reading of less than 60 mg/dL ``seems arbitrary.'' The MD
continued that ``[t]his rare low blood glucose reading does not imply
the driver's diabetes is uncontrolled or that the driver has a problem
with hypoglycemic unawareness.''
    The ATA noted that there are several factors that can cause blood
glucose to drop low, including titration following a new treatment. For
this reason, the ATA stated that the TC and certified ME should review
blood glucose logs to determine whether the low blood glucose level was
an isolated incident.
    The ACOEM stated that a blood glucose level of less than 60 mg/dL
is probably too low, as once the blood glucose is at 60 mg/dL the
individual is likely to already be having symptoms. If the blood
glucose is below 70 mg/dL, the ACOEM recommended that the ITDM
individual should not be permitted to drive until all blood glucose
logs show levels above 70 mg/dL for at least 6 months, with recurrent
episodes triggering progressive duration of out of service periods.
    FMCSA Response: The Agency agrees with commenters that an ITDM
individual should not be disqualified for a single blood glucose
reading that falls below or above a specific limit. The intent of the
final rule is for an individualized assessment of the stability of the
individual's insulin regimen and control of his or her ITDM, as
determined by the TC, and of whether the individual satisfies the
physical qualification standards, as determined by the certified ME.
Therefore, FMCSA finds it is appropriate for TCs to set individualized,
clinically-based parameters for blood glucose limits for ITDM
individuals rather than establishing a regulatory requirement. TCs
should look for frequent occurrences of low blood glucose levels and
determine the cause. For example, frequent low blood glucose levels may
indicate potential improper diabetes management or other underlying
medical issues. While the certified ME considers the TC's input on
whether the ITDM individual maintains a stable insulin regimen and