[Federal Register Volume 83, Number 182 (Wednesday, September 19, 2018)]
[Rules and Regulations]
[Pages 47486-47521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20161]
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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 (202) 366-9826.
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
[[Page 47487]]
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
[[Page 47488]]
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
[[Page 47489]]
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
[[Page 47490]]
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;
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\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.
[[Page 47491]]
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
[[Page 47492]]
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\
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\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.
[[Page 47493]]
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
[[Page 47494]]
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
[[Page 47495]]
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.
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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
[[Page 47496]]
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
[[Page 47497]]
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.
[[Page 47498]]
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.
[[Page 47499]]
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
[[Page 47500]]
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
[[Page 47501]]
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
[[Page 47502]]
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
proper control of his or her ITDM, it is the certified ME's
responsibility to consider safety and make a physical qualification
determination.
L. Severe Hypoglycemic Episodes
NPRM: FMCSA proposed to allow ITDM individuals to drive CMVs if
they were free of severe hypoglycemic reactions in the 12 months prior
to the TC evaluation. A severe hypoglycemic reaction was described as
one that results in loss of consciousness or seizure, requires the
assistance of another person, or results in impaired cognitive
function.
Comments on Severe Hypoglycemic Episodes: The former MRB members,
Concentra, the NTSB, and the ACOEM recommended that FMCSA establish
specific, measurable standards to define a severe hypoglycemic episode.
[[Page 47503]]
Comments included concerns regarding ways of reporting severe
hypoglycemic episodes and the length of time between episodes.
Advocates supported the proposed rulemaking, but was concerned that the
reporting requirement may be too lax and open to potential abuse. SOCO
recommended a note from the TC stating that the ITDM individual is
stable on current therapy and is not experiencing hypoglycemic
episodes. This commenter would require immediate reporting to the
certified ME and the TC of new or recurring hypoglycemia. Instead of
the proposed 12 months, a diabetes educator stated that ITDM
individuals should have to follow-up at least every 6 months with an
endocrinologist and diabetes educator to make sure that the individuals
are not having multiple episodes of hypoglycemia or hyperglycemia.
The former MRB members, Advocates, the ATA, and AAPA-OM agreed that
FMCSA should remove any ITDM individual who has a severe hypoglycemic
episode within a year from work for at least 1 year. AAPA-OM stated
that there should not be recurrent (two or more) severe hypoglycemic
episodes in the last 5 years. The former MRB members recommended
periods of longer than 12 months for not allowing ITDM individuals to
operate CMVs if they had more than two episodes in the last 5 years.
Concentra commented that the safety risks from acute hypoglycemia are
too great not to be defined and that FMCSA should review the criteria
with leading endocrinologists who specialize in diabetes. The NTSB was
concerned that the NPRM required only that the TC determine that an
individual has had no severe hypoglycemic episodes and that the
diabetes is properly managed, rather than providing clinical
information to demonstrate that the individual meets specified
criteria.
2015 MRB Report: The 2015 MRB report defined a severe hypoglycemic
episode as loss of consciousness, seizures or coma, requiring the
assistance of others, or needing urgent treatment (glucagon injection
or intravenous glucose). If an ITDM individual had an episode of severe
hypoglycemia within the previous 6 months, the MRB recommended that the
individual be disqualified from operating a CMV for at least 6 months.
Comments on the MRB's Report on Severe Hypoglycemic Episodes: The
ADA, the ACOEM, and the University of Utah stated that the recommended
definition needs to be clarified. For example, the ADA stated that
urgent treatment is too broad a term and could include self-treatment
by an individual who recognizes dropping blood glucose. The University
of Utah commented that a glucose level below 60 mg/dL is the same as
severe hypoglycemia. This commenter also suggested that there should be
a requirement for the ITDM individual who experienced an episode to
make some adjustment to prevent another episode from occurring. H&SW
recommended that moderate hypoglycemia should be addressed in the
rulemaking because it can pose a serious concern.
Some commenters supported the recommendation that an ITDM
individual who experienced a hypoglycemic episode be disqualified for 6
months, while others who disagreed with it, including an
endocrinologist, stated the disqualification was unreasonable and
discriminatory to ITDM individuals. Commenters who opposed this
recommendation, again including the endocrinologist, stated that
episodes that occurred off duty should not count against the ITDM
individual, as they have no safety implications. They noted that there
are many reasons for low blood glucose, such as acute illness,
infections, or medication. Commenters, including OOIDA, stated that
disqualifying ITDM individuals for 6 months would be financially
burdensome on these individuals and may even lead to job losses. Rather
than having FMCSA set a specific timeframe for disqualification,
commenters, such as the ADA, stated that the TC should determine the
length of the disqualification period, or determine that the
disqualification has been lifted as a result of corrective measures or
lapse in time since the disqualifying event(s). Concentra noted
generally that the 6-month disqualification period may be difficult for
the certified ME to track and that it is conceivable the individual
could be seen by another certified ME who would be unaware of the
disqualification.
Some commenters stated that a single episode of severe hypoglycemia
should not be disqualifying and that the issue needs to be recurring.
For example, the ADA stated that ``any policy that disqualifies a
driver on the basis of a single episode of severe hypoglycemia is
misguided.'' Instead, the ADA maintained, the TC should determine the
cause of the low blood glucose, whether it was an isolated incident,
and the likelihood of such an episode recurring. In contrast, the
University of Utah and the ACOEM stated that the Agency should consider
progressively longer periods of disqualification based on the frequency
of these episodes. The University of Utah indicated that there must be
a limit to the number of severe hypoglycemia episodes.
FMCSA Response: In the final rule, FMCSA has revised the NPRM and
2015 MRB definitions of a severe hypoglycemic episode to eliminate
ambiguity and potential redundancy. FMCSA also has clarified that the
scope of the definition is severe episodes by eliminating from the
definitions that the episode results in impaired cognitive function or
requires urgent treatment. The revised definition provides a more
objective standard that allows for more consistent determinations
regarding what constitutes a severe hypoglycemic episode. A severe
hypoglycemic episode is defined as an episode requiring the assistance
of others, or resulting in a seizure, coma, or the loss of
consciousness.
In view of the potential impact on safety, FMCSA is clarifying in
the final rule that an ITDM individual certified as physically
qualified to operate a CMV who experiences a severe hypoglycemic
episode is prohibited from operating a CMV. The Agency is adding a
requirement in the rule that such an individual must report the episode
to and be evaluated by a treating clinician as soon as is reasonably
practicable.
The driving prohibition continues until the ITDM individual has
been evaluated by a TC (who meets the specifications in the rule), and
a 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. The rule requires the ITDM individual to retain
the form and to provide it to the certified ME at the individual's next
medical certification examination so the certified ME will be aware of
the prior episode.
The Agency agrees with commenters that after an ITDM individual
experiences a severe hypoglycemic episode the individual must
demonstrate that the cause of the episode has been addressed and that a
future episode is not likely to recur. However, the Agency also agrees
with some commenters that prohibiting an individual from driving for 6
to 12 months after a severe hypoglycemic episode is onerous for both
ITDM individuals and employers. In addition, a period of 6 to 12 months
is not necessary medically to determine stability in most instances
because severe hypoglycemic episodes are often the result of short-term
causes. For
[[Page 47504]]
example, in certain circumstances, the cause of an episode might be
able to be addressed while an individual is in an emergency room or
other medical facility, and a TC could complete a new ITDM Assessment
Form, MCSA-5870, at that time. Moreover, the Agency lacks data that
suggest an ITDM individual who has experienced a severe hypoglycemic
episode is likely to experience another episode within any specific
timeframe, and commenters, as well as the MRB, have not provided any
relevant data.
Accordingly, the final rule does not establish a specific timeframe
that an ITDM individual is prohibited from operating a CMV following a
severe hypoglycemic episode. Rather, the rule defers to a TC to make an
individualized assessment as to when the cause of the episode has been
addressed and the individual again has a stable insulin regimen and
properly controlled ITDM. A TC is in a good position to obtain and take
in to account an ITDM individual's medical history. Therefore, a TC is
also in a good position to determine and treat the cause of a severe
hypoglycemic episode, assess the response to treatment, determine when
the cause has been addressed, and, then, complete an ITDM Assessment
Form, MCSA-5870.
FMCSA finds that any regulatory requirement that specifies a
timeframe that an ITDM individual is prohibited from operating a CMV is
not consistent with the intent of this rule to provide for
individualized assessment. The individualized approach the Agency has
adopted appropriately balances the safety of the motoring public with
encouraging ITDM individuals to seek proper treatment and to comply
with the rule's requirements.
The Agency emphasizes that a TC is not determining whether the ITDM
individual is qualified to operate a CMV following a severe
hypoglycemic episode. Rather, a TC's role continues to be limited to
determining whether the ITDM individual has a stable insulin regimen
and properly controlled ITDM.
FMCSA has considered the comments to the effect that severe
hypoglycemic episodes that occur when an ITDM individual is off duty
have no effect on safety. The Agency has revised the definition to
clarify that the episodes of hypoglycemia that trigger the prohibition
from operating a CMV and the reporting requirement are only those that
are severe. FMCSA has concluded that it is in the interest of safety to
require that ITDM individuals seek treatment after having experienced
any severe hypoglycemic episode to ensure that the cause of the episode
has been addressed.
FMCSA also declines to establish by regulation that any particular
number of severe hypoglycemic episodes automatically disqualifies an
ITDM individual from operating a CMV. Such a requirement would be
contrary to the individualized assessment approach adopted in this
rule. Instead, TCs will consider prior episodes of severe hypoglycemic
episodes in determining whether an individual has a stable insulin
regimen and properly controlled ITDM. Additionally, certified MEs will
be aware of prior episodes via the ITDM Assessment Form, MCSA-5870,
provided at any subsequent medical qualification examination.
FMCSA notes that the existing requirement that a new medical
examination and certification must be obtained when an individual has a
physical or mental injury or disease that impairs the individual's
ability to perform his or her normal duties \17\ could, depending on
the circumstances, be applicable to the ITDM individual who experiences
a severe hypoglycemic episode. Such ITDM individuals would be subject
to a new evaluation by the TC, including completion of a new ITDM
Assessment Form, MCSA-5870, and subsequent medical examination by the
certified ME.
---------------------------------------------------------------------------
\17\ Now recodified without change in 49 CFR 391.45(f) by this
final rule.
---------------------------------------------------------------------------
FMCSA declines to define or establish by regulation a moderate
hypoglycemic episode as a disqualifying event. FMCSA expects the TC to
evaluate a moderate hypoglycemic episode and any other diabetic
complications in determining whether the individual maintains a stable
insulin regimen and proper control of his or her ITDM.
The Agency developed the ITDM Assessment Form, MCSA-5870, that
gathers information about an individual's diabetes and addresses many
of the commenters' concerns. The Agency has concluded, through the
completion of the form and evaluation of available subjective and
objective clinical data, such as interviewing the individual and
reviewing blood glucose records for fluctuations over time, that the TC
is equipped to provide an appropriate assessment for the certified ME
to review.
M. Hypoglycemia Unawareness
NPRM: The proposed rule did not address hypoglycemic events
occurring without prior warning, also known as hypoglycemia
unawareness.
Comments on Hypoglycemia Unawareness and Hypoglycemia Unawareness
Training: The former MRB members commented that, to be qualified to
drive, the ITDM individual should not experience hypoglycemia
unawareness. The ATA added that the certified ME or TC should evaluate
whether the individual has experienced any episodes of hypoglycemia
unawareness. In terms of hypoglycemia awareness training, several
commenters recommended that FMCSA require this training as a part of
the diabetes qualification process to prevent an ITDM individual from
experiencing a hypoglycemic episode while operating a CMV. Commenters
who supported this requirement include Advocates, H&SW, the ACOEM, and
TFAC. Comments on this topic included how often ITDM individuals should
attend training sessions and how they should provide documentation to
prove their attendance.
2015 MRB Report: The MRB recommended in its report that an ITDM
individual who had hypoglycemia unawareness within the previous 6
months be disqualified from operating a CMV for at least 6 months.
Comments on the MRB's Report on Hypoglycemia Unawareness:
Commenters generally agreed that impaired awareness of hypoglycemia is
incompatible with driving and asked FMCSA to clarify the definition of
hypoglycemia unawareness. For example, an MD suggested defining
hypoglycemia unawareness as hypoglycemia under 50 ml/dL appearing in
the absence of warning symptoms. The MD noted that symptoms of
hypoglycemia in many well-controlled ITDM individuals without
hypoglycemia unawareness do not arise until the glucose level is under
50, so clinicians may mistakenly label individuals as having
hypoglycemia unawareness. The MD agreed, however, that an episode of
hypoglycemia unawareness, as he defined it, should result in
disqualification for 6 months.
On the other hand, most commenters indicated that a 6-month
disqualification period is too long. An endocrinologist stated that the
period of 6 months is arbitrary, and, in her opinion, unreasonable and
discriminatory. Comments included the view that a single episode of
hypoglycemia unawareness should not be disqualifying, and that such
episodes need to be recurring or ongoing. The ADA and an
endocrinologist indicated that ITDM individuals should be allowed to
return to driving once the appropriate measures to avoid hypoglycemia
and create awareness have been established.
[[Page 47505]]
While some commenters indicated that an ITDM individual should be
reinstated once the hypoglycemic unawareness issue is resolved, the
University of Utah stated that there should be a minimum, perhaps 6
months, of blood glucose logs and symptom reviews to ascertain that the
individual had regained awareness of hypoglycemia. The ACOEM stated
that if an ITDM individual with hypoglycemia unawareness is later able
to demonstrate hypoglycemia awareness and is certified, but
hypoglycemia unawareness recurs, that individual should be permanently
disqualified. The ACOEM commented further that, if an ITDM individual
is not experiencing awareness of a blood glucose level below 60 mg/dL,
the individual should be permanently barred from operating a CMV.
FMCSA Response: FMCSA has determined that hypoglycemia unawareness
on its own should not be considered for medical qualification.
Hypoglycemia unawareness would be considered by the TC in determining
whether the individual has a stable insulin regimen and proper control
of his or her ITDM. Due to the individualized effect of occurrences of
hypoglycemia unawareness, the assessment, evaluation, and treatment for
this condition should be a component of the TC's individualized
management for a stable insulin regimen and proper control of the ITDM
individual's diabetes. To assist the TC in educating ITDM individuals
regarding hypoglycemic unawareness, FMCSA is planning to develop
education and outreach information to promote recognition of
hypoglycemia unawareness.
N. Blood Glucose Self-Monitoring
NPRM: During the period of medical certification, the NPRM required
the ITDM individual to monitor and maintain blood glucose records as
determined by the TC. The ITDM individual would submit those records to
the TC at the time of evaluation. The NPRM did not propose a minimum
insulin use period for new or established ITDM individuals to be
eligible for medical certification.
Comments on Blood Glucose Self-Monitoring: Some commenters,
including a retired FAA safety inspector, the former MRB members, an
RN, the ACOEM, and H&SW, recommended a specific schedule for blood
glucose monitoring. Commenters generally suggested testing prior to
driving and then every 4 to 6 hours while driving. The retired FAA
safety inspector recommended the most frequent monitoring, with testing
1 hour before driving and at least every 2 hours while driving.
The ACOEM recommended that a log be required consisting of at least
2 weeks of testing four times per day (before meals and at bedtime). It
would require the blood glucose log to be downloaded and printed
directly from the glucometer--no typed or handwritten logs--and to have
a time stamp for each blood glucose value.
Concentra stated that FMCSA should discuss the criteria for self-
monitoring blood glucose while driving. A diabetes educator stated that
ITDM individuals should follow up at least every 6 months with an
endocrinologist who would download their blood glucose readings. SOCO
also recommended that a glucose log be maintained for review by the
treating doctor.
Advocates was concerned about the lack of definitions for
``appropriate ranges'' and ``management.'' To support and document the
conclusions of the TC, Advocates recommended that the Agency require
ITDM individuals to submit blood glucose records for a specified time
prior to the medical evaluation. Advocates indicated that leaving the
definition of the appropriate level of reporting to the TC could
encourage TC shopping.
The IBT and Concentra asked for clarification on how long insulin
must be used before an ITDM individual can be certified to drive. The
AAPA-OM commented that an ITDM individual must be on insulin for at
least 2 years prior to certification. The ACOEM wrote that FMCSA should
require a new insulin user to demonstrate stability, control, and lack
of hypoglycemia over a period of time before being medically cleared
for driving; this monitoring cycle could be more frequent at the
discretion of the TC and the certified ME. The ACOEM commented that the
Law Enforcement Officer Medical Guideline requires 3 months of stable
insulin regimen for individuals on insulin for treatment of type 2
diabetes mellitus, and 6 months for individuals on insulin for
treatment of type 1 diabetes mellitus. If the individual is on an
insulin pump, the ACOEM would require the TC to send the certified ME a
summary report on the use of the pump.
2015 MRB Report: The MRB report recommended that the suggested ITDM
form request information on how many times per day the individual is
testing blood glucose. It also suggested that ITDM individuals test
blood glucose before driving and every 4 hours while driving.
The MRB recommended that the form request information about whether
an individual on insulin with type 2 diabetes has been on a stable
medication regimen for 3 months prior to evaluation by the TC. For
individuals who have been newly diagnosed with type 1 diabetes, the
minimum period of insulin use to establish medication regimen stability
would be not less than 2 months. For individuals who have type 2
diabetes and are converting to insulin use, the minimum period of
insulin use to establish medication regimen stability would be not less
than 1 month.
The MRB specified that all ITDM individuals must have documentation
of ongoing self-monitoring of blood glucose; however, established
insulin users must have records covering a minimum of the most recent 3
months. This monitoring must be done using a finger stick glucose meter
that stores every reading and records date and time of the readings,
which the user can download. Handwritten blood glucose records would
not be acceptable. The MRB recommended that an ITDM individual be
disqualified for an inadequate record of self-monitoring blood glucose,
``i.e., unreliable or absent capillary blood glucose measurements.''
This disqualification would last until the individual could demonstrate
adequate evidence of glucose records, and a minimum of 1 month.
Comments on the MRB's Report on Blood Glucose Self-Monitoring: The
University of Utah commented that the wording ``[i]nadequate record of
self-monitoring of blood glucose'' was ``insufficiently clear.'' It
recommended that it be specified how many readings can be missing over
what period. It suggested considering blood glucose self-monitoring
five times per day on days spent driving and four times per day on
other days. The ACOEM asked what would be defined as adequate self-
monitoring, which may differ based on the treatment. If left to the
examiner to determine, the ACOEM commented that the examiner must be
someone who can evaluate and treat individuals who use insulin. The
ACOEM asked if the monitoring criteria would mirror the exemption
program--prior to driving and every 4 hours while driving.
The ADA agreed with the importance of reviewing blood glucose
records as part of an individualized assessment of an ITDM individual.
It was concerned that the adequacy of records was referenced, but left
undefined. The ADA stated that the adequacy of the records should be
determined only by the TC. The ADA stated that it is inappropriate for
the certified ME or anyone else to determine how often an ITDM
[[Page 47506]]
individual should be testing blood glucose.
The ADA was the only commenter that discussed the length of time an
ITDM individual should be on insulin before being eligible to be
medically certified. It noted the discrepancy between requiring an
individual with type 2 diabetes treated with insulin to be on a stable
medication regimen for 3 months, and the recommendation that an
individual with type 2 diabetes converting to insulin use be using
insulin for not less than 1 month. The ADA commented that these two
standards should be the same and follow the criteria of the existing
exemption program, which requires that an individual with type 2
diabetes use insulin for 1 month prior to eligibility for medical
certification.
In terms of disqualification for inadequate records, the ADA stated
that an ITDM individual should never be disqualified on the assumption
that the individual's records of blood glucose monitoring are
inadequate. An individual stated that the rule should allow for
extenuating circumstances beyond the ITDM individual's control, such as
difficulties with the blood glucose monitor. In such circumstances, the
commenter felt it would be unfair to penalize the individual.
Some commenters wanted the rule to do more to increase the
likelihood that an ITDM individual would keep blood glucose records.
The University of Utah wanted a mechanism in the rule to assure ongoing
compliance with blood glucose monitoring requirements. Concentra was
concerned that an ITDM individual who was certified and became non-
compliant would be able to continue to drive without FMCSA's knowledge.
It stated that there should be a mechanism in place to require the TC
to notify FMCSA if the individual becomes non-compliant or discharges
the TC. H&SW wrote that the ITDM individual has ``additional impetus to
keep blood glucose logs when a regulation requires it.'' A physician
recommended that patients who have type 1 diabetes mellitus for over 5
years use continuous glucose sensors to minimize their risk of driving
while hypoglycemic to ensure safety for the others on the road.
FMCSA Response: FMCSA agrees with the 2015 MRB recommendations and
other commenters that a requirement for a period of blood glucose self-
monitoring records should be included in the final rule. The final rule
requires that all ITDM individuals must provide at least the preceding
3 months of blood glucose self-monitoring records while being treated
with insulin to the TC 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.
FMCSA has included the 3-month requirement for blood glucose self-
monitoring records while being treated with insulin for all ITDM
individuals. FMCSA has determined that there is no basis to
differentiate blood glucose self-monitoring record requirements based
on whether individuals have been newly diagnosed with type 1 diabetes
or have type 2 diabetes and are converting to insulin use because both
categories are beginning the use of insulin.
The Agency is requiring 3 months of records because this timeframe
provides current blood glucose self-monitoring records to the TC, and
is generally consistent with medical practice standards for follow-up
visits for ITDM individuals. 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.
The final rule does not establish the specific frequency of blood
glucose monitoring. FMCSA finds that any regulatory requirement that
specifies monitoring frequency does not support the intent of the rule
for individualized assessment. Rather, the rule provides that ITDM
individuals must self-monitor blood glucose in accordance with the
specific treatment plan prescribed by the TC.
The TC is most familiar with the ITDM individual's medical history.
As such, the TC is in the best position to determine the specific blood
glucose monitoring plan, including monitoring requirements while
driving a CMV, and whether the submitted blood glucose self-monitoring
records are consistent with the plan. The Agency finds that this rule
encourages the maintenance of blood glucose records in a manner that is
focused on good monitoring practices, as well as maintaining proper
control of the individual's diabetes and the overall health of the
individual. Because daily testing and recording of results are routine
aspects of managing ITDM, the rule's requirements do not impose any
additional burden on ITDM individuals.
ITDM individuals must self-monitor blood glucose in accordance with
the specific treatment plan prescribed by the TC. They must maintain
blood glucose records measured with an electronic glucometer that
stores all readings, that records the date and time of readings, and
from which data can be electronically downloaded. A printout of the
electronic blood glucose records or the glucometer must be provided to
the TC at the time of any evaluation. Handwritten blood glucose records
are not acceptable. As long as the ITDM individual can satisfy the
foregoing requirements, the self-monitoring may be performed by finger
stick or continuous glucose sensor.
O. Requirement To Carry Readily-Absorbable Glucose
NPRM: In the NPRM, FMCSA did not propose that ITDM individuals must
carry readily-absorbable glucose, which is required under the existing
exemption program.
Comments on the Requirement to Carry Readily-Absorbable Glucose:
H&SW, Concentra, and a certified ME/physician commented that ITDM
individuals should have readily-absorbable glucose within reach while
driving to mitigate the risk of severe symptoms developing from a
hypoglycemic episode. TFAC, on the other hand, stated that the
requirement to carry readily-absorbable glucose is overly burdensome
and would not improve safety.
2015 MRB Report: The 2015 MRB report did not address carrying
readily-absorbable glucose. No comments were received concerning the
MRB report in this regard.
FMCSA Response: The final rule does not require that ITDM
individuals carry a readily-absorbable form of glucose. FMCSA finds
that treatment for potential hypoglycemia is more appropriately a
component of diabetes management as instructed by the TC rather than a
mandate by a regulatory agency.
P. Diabetic Complications and Target Organ Damage
NPRM: The NPRM proposed that ITDM individuals must meet the
physical qualification standards in Sec. 391.41 and be free of
complications that might impair their ability to operate a CMV.
[[Page 47507]]
Comments on Diabetic Complications and Target Organ Damage: Several
commenters, including SOCO, the ATA, the NTSB, and the ACOEM, indicated
that FMCSA should require evaluation of ITDM individuals to make sure
that they do not show signs of diabetic complications or target organ
damage. Commenters wanted ITDM individuals to be evaluated for
complications such as diabetic neuropathy, paresthesia, and
proprioception. Commenters also stated that ITDM individuals' kidney
function should be evaluated by measuring creatinine. The ACOEM
provided that an ITDM individual with kidney function worse that stage
3 should not be qualified. If the ITDM individual had stage 2 kidney
function, the individual should be more closely monitored.
The ACOEM added that ITDM individuals have the same cardiovascular
risk as someone with established coronary artery disease; thus,
cardiovascular risk factors should be evaluated. The ACOEM recommended
that ITDM individuals who meet certain Cardiovascular Advisory Panel
Guidelines should be subject to the same medical qualifying criteria as
those individuals with known coronary heart disease, including an
exercise stress test. If there is evidence of ischemia, or the left
ventricular ejection fraction is less than 40 percent, then the
individual would be deemed ineligible for certification. SOCO also
commented that FMCSA should require evaluation and documentation of the
presence of coronary atherosclerosis and peripheral or cerebral
vascular disease. Concentra commented that the safety risks from long-
term co-morbidities are too great not to be defined and that FMCSA
should review the criteria with leading endocrinologists who specialize
in diabetes. The NTSB wrote that many ITDM complications cannot be
identified by a routine physical examination.
2015 MRB Report: The MRB report recommended that, if there were
signs of target organ damage, as evidenced by peripheral neuropathy,
diabetic nephropathy, or cardiovascular disease, with the risk of
impairing the ability to operate a CMV safely, an ITDM individual would
be disqualified until the problem was resolved by treatment, if
possible.
Comments on the MRB's Report for Diabetic Complications and Target
Organ Damage: The ACOEM and the ADA supported the MRB recommendation,
but the ACOEM added that there should not be a risk of the target organ
damage recurring. An individual commented that the only factor should
be whether the complication impairs the individual's ability to safely
operate a CMV. An MD commented that the language ``signs of target
organ damage'' is not specific and may not be an appropriate
disqualifier. The MD recommended that the query should be whether
symptomatic target organ damage is present that could render an ITDM
individual unsafe to operate a CMV. If so, the ITDM individual should
be disqualified until the matter is resolved by treatment.
The University of Utah stated that the phrase ``[d]isqualification
until resolved by treatment, if possible'' is unclear. It noted that
one could not resolve a heart attack by treatment and generally it is
impossible to completely resolve neuropathy. This commenter recommended
that those with four or more multiple conditions should be precluded
from driving. For nephropathy, the prior Renal Medical Expert Panel and
MRB recommendations should be applied, including staging of the
nephropathy.
Concentra asked for specific direction regarding the diagnostic
tests, including their frequency, that should be used to evaluate
cardiovascular disease and diabetic nephropathy in ITDM individuals. It
also asked that FMCSA clearly define the severity of diabetic
nephropathy that would warrant disqualification.
FMCSA Response: In the final rule, the Agency continues to require
that an ITDM individual must meet the physical qualification standards
in Sec. 391.41, have an exemption unrelated to diabetes, or have a
Skill Performance Evaluation Certificate, if required. With the
exception of diabetic retinopathy, the Agency declines to establish
specific regulatory requirements pertaining to complications that may
arise from diabetes.
The TC for the ITDM individual is best suited to provide
information regarding diabetes complications. Moreover, the ITDM
Assessment Form, MCSA-5870, adopted in this rule includes specific
questions for the TC to identify diabetes complications and possible
target organ damage. In making the final medical certification
decision, the certified ME will consider the TC's information provided
on the form in determining whether the individual meets the physical
qualification standards to safely operate a CMV. FMCSA notes that the
target organ complications associated with diabetes can result from any
number of other medical conditions that certified MEs evaluate.
Therefore, certified MEs should be familiar with the medical
certification process involving such conditions.
FMCSA agrees with the MRB that an individual who has a complication
from diabetes that interferes with safely operating a CMV should not be
medically qualified to operate a CMV. The Agency finds, however, that
diabetes complications should not automatically preclude medical
certification. Such determinations should be based on an individualized
assessment and the severity of symptoms. A complication becomes a
disqualifying factor only if it impairs the ability to operate a CMV
safely. As an alternative to disqualification, a certified ME may
determine that an ITDM individual is unqualified until treatment is
received and appropriate intervention mitigates or addresses the
problem.
Q. Motor Carrier Responsibility To Enforce the ITDM Standard
NPRM: FMCSA did not propose any new requirements for motor carriers
to enforce the ITDM physical qualification standard.
Comments on Motor Carrier Responsibility to Enforce the ITDM
Standard: The ATA stated that no responsibility for monitoring and
submitting compliance information should fall on the motor carrier;
instead, it wrote this responsibility most appropriately resides with
the certified MEs, TCs, and the ITDM individuals. However, the ATA did
want motor carriers to retain access to the health information
available on the ``medical long form'' and other sources to monitor
compliance with Sec. 392.3. ABA stated that passenger carriers should
not be ``placed at the risk of assessing the medical condition of a
driver or whether the driver is vigilant in maintaining [his or her]
condition.''
2015 MRB Report: The MRB did not address the issue of motor
carriers enforcing the ITDM standard. No comments were received
concerning the MRB report in this regard.
FMCSA Response: The final rule revises the physical qualification
standard for ITDM individuals, but does not create any new or
additional monitoring or compliance requirements for motor carriers
beyond those already set out in general terms in the FMCSRs. See 49 CFR
390.11, 391.11(a), and 391.41(a). The provisions of Sec. 392.3 relate
only to determining whether to allow an ill or fatigued individual to
operate a CMV. The rule does not require access to any medical records,
such as an individual's Medical Examination Report Form, MCSA-5875, to
make that determination.
[[Page 47508]]
R. ITDM Individuals Operating CMVs Transporting Passengers or Hazardous
Materials
NPRM: FMCSA did not propose to restrict ITDM individuals from being
medically qualified to operate CMVs carrying passengers or hazardous
materials but indicated that the MRB recommended in 2007 that ITDM
individuals be restricted from passenger and hazardous materials
transportation. The Agency requested public comment on this issue.
Comments on ITDM Individuals Operating CMVs Transporting Passengers
or Hazardous Materials: The ADA, the IBT, OOIDA, and the Illinois
Office of the Secretary of State supported allowing ITDM individuals to
continue to operate CMVs carrying passengers or hazardous materials.
These commenters agreed with FMCSA that the risk posed by an individual
with stable, well-controlled ITDM is very low in general and that there
is no medical evidence to support prohibiting ITDM individuals from
certain operations. The ADA stated that prohibiting individuals from
certain types of operations based on their diagnosis or use of insulin
alone is antithetical to the basic premise of individual assessment
that Congress required in SAFETEA-LU. OOIDA added that individuals who
transport hazardous materials are frequently some of the most
experienced and safest operators on our nation's highways and their
highway safety performance should be the focus, not an arbitrary
condition-based decision.
Commenters that expressed concern about the Agency not restricting
ITDM individuals from transporting passengers or hazardous materials
include the NTSB, United Motorcoach Association (UMA), ABA, Advocates,
and the former MRB members. UMA and ABA, however, supported continuing
the current exemption program for drivers transporting passengers.
The NTSB and ABA questioned relying on the ADA study that FMCSA
cited in the NPRM \18\ to support the Agency's conclusions. For
example, the NTSB stated that the ADA report did not address the risks
to public safety of ITDM individuals who operate CMVs. The NTSB noted
that an individual's risk of becoming impaired from stable, well-
controlled ITDM may not be higher among individuals who operate CMVs,
but the potential consequences of such an event are significantly
greater.
---------------------------------------------------------------------------
\18\ ADA, ``Diabetes and Driving,'' Diabetes Care, vol. 35,
suppl. 1, Jan. 2012, p. S81, which is available in the docket for
this rule.
---------------------------------------------------------------------------
Advocates stated that research has shown individuals with diabetes
in the United States have an increased crash risk, as do individuals
treated with insulin. Advocates recommended that the Agency restrict
ITDM individuals from transporting passengers or hazardous materials
for a specified amount of time until they have driven freight under the
conditions of the proposed regulations and have a safe driving record.
ABA commented that the 2007 MRB recommendation recognized that
drivers of passenger vehicles are not conducting the same operations as
cargo carrying CMV drivers, and required a higher medical standard. ABA
noted that, although the Agency stated it is impermissible under the
law to adopt higher physical standards for ITDM individuals, the law
provides for exceptions, as demonstrated by the current exemption
process.
UMA noted that over-the-road bus operations may not be conducive to
maintaining proper blood glucose levels because schedules often vary
and are not flexible, testing and snacking opportunities are limited,
and passengers may become alarmed when observing a driver injecting
insulin or monitoring blood glucose. UMA recommended that FMCSA study
crash rates for ITDM individuals operating CMVs under the NPRM for at
least 5 years before considering whether to allow ITDM individuals to
obtain a passenger endorsement.
2015 MRB Report: The 2015 MRB report did not mention the 2007 MRB
recommendation proposing to restrict ITDM individuals from operating
CMVs transporting passengers or hazardous materials cited in the NPRM.
Comment on the MRB's Report on ITDM Individuals Operating CMVs
Transporting Passengers or Hazardous Materials: Advocates noted the
omission of the 2007 recommended restriction from the 2015 MRB report.
It stated that the Agency is obliged to provide a full and complete
discussion of the 2007 MRB recommendation, which it characterized as an
important safety precaution. Advocates wrote that the revision of the
medical requirements for ITDM individuals should ensure that they do
not impose any greater risk of crash involvement than non-ITDM
individuals operating CMVs that transport either passengers or
hazardous materials.
FMCSA Response: The Agency continues to conclude that individuals
who maintain a stable insulin regimen and proper control of their ITDM
can operate any category of CMV safely. No new information or data was
provided by commenters that persuades the Agency to depart from its
conclusion. Under section 4129 of SAFETEA-LU, FMCSA may not hold ITDM
individuals to a higher standard of physical qualification than other
individuals, except to the extent that limited operating, monitoring,
and medical requirements are deemed medically necessary under
regulations. The Agency finds that there is no available evidence to
support holding ITDM individuals to a higher standard in connection
with transporting passengers or hazardous materials. FMCSA addresses
the issue of ITDM individuals' ability to safely operate CMVs in a
following section.
S. ITDM Individuals With Licenses Issued in Canada or Mexico
NPRM: The NPRM stated that ITDM individuals with licenses issued in
Canada or Mexico would not be allowed to operate CMVs in the United
States.
Comments on Not Allowing ITDM Individuals with Licenses Issued in
Canada or Mexico to Operate CMVs in the United States: FMCSA received
two comments addressing this issue. The IBT commented that it supports
continuing the current policy applicable to ITDM individuals domiciled
in Canada and Mexico. A Canadian ITDM individual noted that Canada
requires commercial operators to have a medical examination, monitor
HbA1C results, and have a retinopathy examination done annually.
Because the United States recognizes Canadian medical evaluations, this
commenter suggested that FMCSA allow ITDM individuals with licenses
issued by Canada to drive in the United States.
2015 MRB Report: The MRB did not discuss certifying ITDM
individuals from Canada or Mexico and no comments were received
concerning the MRB report in this regard.
FMCSA Response: FMCSA retains its position that ITDM individuals
with licenses issued in Canada or Mexico are prohibited from operating
CMVs in the United States. Individuals from Canada with a license
issued in conformity with the Canadian National Safety Code and from
Mexico with a Licencia Federal de Conductor (LFC) generally may operate
CMVs in the United States (49 CFR 383.23(b) n.1 and 391.41(a)(1)(i)).
Nonetheless, under the terms of the 1998 reciprocity agreement with
Canada, a Canadian ITDM individual is not authorized to operate a CMV
in the United States. Mexico does not issue an LFC to any ITDM
individual. FMCSA cannot change its current position
[[Page 47509]]
unless the underlying reciprocity agreement with Canada is amended or
Mexico changes its policy to allow ITDM individuals to be issued LFCs.
T. The Grandfather Provision for Insulin-Treated Diabetes
NPRM: From 1993 until 1994, ITDM individuals could apply to the
FHWA for a waiver that allowed them to drive a CMV in interstate
commerce. In 1994, a Federal court decision invalidated the waiver
program, but individuals holding waivers were allowed to continue to
drive CMVs under the grandfather provision in Sec. 391.64(a). In the
NPRM, FMCSA stated that the provisions in Sec. 391.64 might be
redundant if the proposed rule was adopted, and asked if removing Sec.
391.64 would affect adversely any individual still operating a CMV
under that rule.
Comments on Removing the Grandfather Provision for Insulin-Treated
Diabetes: A physician/certified ME concurred with FMCSA that Sec.
391.64 would be redundant if the proposed rule was adopted. He stated
that, with the termination of the diabetes exemption program, Sec.
391.64 should be eliminated. This commenter did not see how individuals
certified under Sec. 391.64 would be affected adversely by eliminating
the grandfather provision.
The Illinois Office of the Secretary of State stated that removing
the grandfather provision would not adversely affect individuals
currently operating CMVs under Sec. 391.64. This commenter noted that
there are currently 10 operators in Illinois who are grandfathered
under Sec. 391.64. The commenter wrote that holding these individuals
to the approach proposed in the NPRM would not impact their safety or
the safety of other motorists adversely.
2015 MRB Report: The 2015 MRB report did not discuss the
grandfather provision and no comments were received concerning the MRB
report in this regard.
FMCSA Response: In the final rule, FMCSA eliminates the diabetes
grandfather provision in Sec. 391.64(a). FMCSA agrees with the
commenter that the grandfather provision is redundant of several
requirements in new Sec. 391.46. Individuals currently certified under
Sec. 391.64 are either already able to meet the requirements of this
rule or could meet a less restrictive requirement. FMCSA finds that
discontinuing the grandfather provision has no adverse impact on the
less than 100 currently grandfathered individuals or on motor carriers.
FMCSA provided a year to transition to the new process to avoid any
possible hardships for individuals who would need to be certified just
after the rule becomes effective. FMCSA is directly contacting the
currently grandfathered individuals to further explain the transition
process.
The diabetes grandfather provision in Sec. 391.64(a) will sunset
and will be removed 1 year after the effective date of this final rule.
During that year, individuals certified under the grandfather provision
may choose to be certified under Sec. 391.64(a) or this final rule.
Within 1 year after the effective date, however, all individuals
previously certified under Sec. 391.64(a) must comply with the
provisions outlined in Sec. Sec. 391.41, 391.45, and 391.46 in the
final rule. As such, any individual who chooses to be certified under
Sec. 391.64(a) must be certified again under this final rule within a
year after the effective date, which would mean that the individual
would have to undergo a second evaluation by a TC and a medical
qualification examination. FMCSA anticipates that it will be
advantageous for individuals certified previously under Sec. 391.64(a)
to transition to certification under this rule as soon as possible to
avoid duplicative examination costs and to potentially reduce costs by
being evaluated by a TC, rather than by an endocrinologist. In any
event, any waiver and current MEC, MCSA-5876, issued pursuant to Sec.
391.64(a) will automatically become void 1 year after the effective
date of the final rule.
U. Safety of ITDM Individuals
NPRM: The NPRM proposed to permit individuals with stable, well-
controlled ITDM to be medically qualified to operate CMVs and to
eliminate the diabetes exemption program. The Agency determined that
``[t]he risk posed by a driver with stable, well-controlled ITDM is
very low in general'' (80 FR 25265). In making this determination, the
Agency concurred with a finding of the ADA in its 2012 position
statement titled ``Diabetes and Driving'' that ``[M]ost people with
diabetes safely operate motor vehicles without creating any meaningful
risk of injury to themselves or others.'' \19\ Id.
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\19\ ADA, ``Diabetes and Driving,'' Diabetes Care, vol. 35,
supp1. 1, Jan. 2012 p. S81, which is available in the docket for
this rulemaking.
---------------------------------------------------------------------------
Comments on the Safety of ITDM Individuals: Many commenters agreed
specifically that ITDM individuals whose condition is stable and well
controlled do not pose an unreasonable safety risk. For example, the
National School Transportation Association agreed with this conclusion
and expressed support for the proposed rule as it applies to CMV
operators driving school buses. Additionally, the Transportation
Division of the Sheet Metal, Air, Rail Transportation Union pointed out
data in the Preliminary RIA published with the NPRM showed that the
1,730 drivers in the exemption program performed much better than the
general CMV population in terms of crash rates. Several commenters
noted that the rulemaking alleviates the burden of the exemption
process, while maintaining safety. OOIDA concurred that the proposed
rule would continue to ensure safe operation of CMVs.
Several commenters, including some medical professionals, the
ACOEM, ABA, and the NTSB, stated that changing the exemption program
would decrease safety. TFAC supported removing the exemption program
but stated that the proposed rule went too far in removing requirements
and a compromise group of requirements would be appropriate. H&SW also
concurred with the proposal to eliminate the diabetes exemption
program, but expressed that it is in the best interest of road safety
to maintain some of the important provisions of the exemption program.
Advocates acknowledged recent advances in medical information regarding
ITDM and expressed support for a change to the medical standards to
permit ITDM individuals to operate CMVs. Advocates maintains, however,
that the requirements for ITDM individuals should incorporate the
recommendations of the 2007 MRB that were cited in the NPRM.
The former MRB members disputed FMCSA's conclusions on the safety
of ITDM individuals. They cited five studies \20\ and FMCSA's 2006
Diabetes Evidence Report \21\ that they stated show drivers with
diabetes have about a 20 percent increased risk of crash and drivers
taking insulin have a 40 to 130 percent increased risk of crash. When
parsing the data down to insulin use and studies based in the United
States, the former MRB members stated that FMCSA's 2010 Evidence Report
Update \22\ found that the risk of crash is
[[Page 47510]]
likely doubled, even though the result currently lacks statistical
significance. They stated that a study shows that efforts to keep HbA1C
below 7 percent ``is a substantial concern for further increasing crash
risk.'' \23\
---------------------------------------------------------------------------
\20\ Songer TJ, Lave LB, LaPorte RE. Risk Anal. 1993 Jun; 13(3):
319-26. Songer TJ, Dorsey RR. Annu Proc Assoc Adv Automot Med. 2006;
50: 335-351. Redelmeier DA, Kenshole AB, Ray JG. PLoS Med. 2009 Dec;
6(12): e1000192. Kilpatrick ES, Rigby AS, Warren RE, Atkin SL.
Diabet Med. 2013 May; 30(5): 616-9. Orriols L, et al. Accid Anal
Prev. 2014 Oct; 71: 137-43.
\21\ ``Evidence Report: Diabetes and Commercial Motor Vehicle
Drive Safety,'' Sept. 8, 2006, which is available in the docket for
this rulemaking.
\22\ ``Evidence Report: 2010 Update: Diabetes and Commercial
Motor Vehicle Driver Safety,'' May 27, 2011, which is available in
the docket for this rulemaking.
\23\ Kilpatrick ES, Rigby AS, Warren RE, Atkin SL. Diabet Med.
2013 May; 30(5): 616-9.
---------------------------------------------------------------------------
The former MRB members asserted that an implied purpose of
eliminating the diabetes exemption program is to increase the number of
ITDM individuals operating CMVs. The former MRB members indicated that
it is inappropriate to infer from the diabetes waiver program, the
diabetes exemption program, and The Large Truck Causation Study what
would happen to a larger pool of ITDM individuals.
The NTSB stated that the Agency's justification for the proposed
rule is flawed because the ADA position statement does not address the
risks to public safety of CMV drivers with ITDM. H&SW also stated the
Agency should not apply the ADA information on driving non-CMVs to
driving CMVs. In addition, Advocates disagreed with the Agency's safety
conclusions and cited FMCSA's 2010 Evidence Report Update, which it
quoted as stating that in the United States there is ``approximately a
24 percent increase in crash risk among drivers with diabetes compared
with drivers without diabetes,'' and ``a significant increase [175%] in
crash risk for individuals treated with insulin compared with drivers
treated with oral medication and/or diet alone.'' Based on this
information, Advocates urged the Agency to adopt the 2007 MRB
recommendations.
2015 MRB Report: The 2015 MRB report did not address the safety of
ITDM individuals but stated that the baseline for acceptable risk
should be the current diabetes exemption program.
Comments on the MRB's Report on Safety of ITDM Individuals: Few
commenters specifically referenced data in connection with evaluating
the safety of ITDM individuals. For example, OOIDA commented that,
since the implementation of the exemption program in 2003, individuals
with a stable history of treating their insulin dependent diabetes have
proven to be safe CMV operators. OOIDA was ``unaware of any studies
that have been conducted or any serious concerns that have been raised
concerning those drivers who have completed the current exemption
process.''
In contrast, the University of Utah stated that FMCSA's 2010
Evidence Report Update notes that the risk of crash among ITDM
individuals in the United States is now estimated to be a 2.76-fold
increased risk. The commenter stated that this risk is so high that it
means there may be a very small minority of ITDM individuals who may be
reasonably safe, and that ``[i]t demonstrates that the overwhelming
majority of insulin using drivers are unsafe for driving commercial
vehicles.'' The commenter noted that the United States-based data are
naturally the most important to the question of safety, as European
countries' populations have comparatively minor needs to drive motor
vehicles. Therefore, European populations are arguably not comparable
to the United States.
The University of Utah also stated that DOT's insulin waiver
program, which had stringent criteria and enrolled 139 drivers in the
1990s, had subsequent crash data that suggested there was not an
increased risk of crash for those individuals. The commenter noted that
the comparison group of general CMV drivers likely included drivers who
should not have been driving; thus, it was likely a biased control
group. The University of Utah continued that FMCSA has subsequently had
a fairly-stringent diabetes exemption program and it should be
mandatory to examine the crash risks from that program prior to
consideration of this proposal. While the crash data would still have
the problem of a biased control population, the commenter stated that
it would provide a somewhat reasonable comparison with the prior waiver
program and help to determine whether and the extent to which both
driver safety and public safety can be assured. Finally, the commenter
recommended that there should be a pilot test with monitoring of crash
risks before expanding the medical qualification of ITDM individuals.
FMCSA Response: The Agency continues to conclude that the crash
risk posed by ITDM individuals who maintain a stable insulin regimen
and proper control of their diabetes is very low in general and that
such ITDM individuals do not create any meaningful risk of injury to
themselves or others due to their insulin treatment. Although the
Agency acknowledges that there is conflicting data regarding the crash
risk posed by ITDM individuals, no new data have been presented by
commenters to persuade the Agency to depart from its prior conclusions.
Moreover, the Agency has determined that this final rule includes
sufficient requirements and safeguards to ensure that only individuals
who maintain a stable insulin regimen and proper control of their ITDM
will receive medical qualification. Therefore, this final rule has no
adverse impact on safety.
The Agency acknowledges that the 2012 ADA position statement
focused primarily on non-CMV drivers. FMCSA emphasizes, however, that
it is not the only source the Agency has considered in making its
determination that the risk posed by ITDM individuals who maintain a
stable insulin regimen and proper control of their diabetes is very
low. The Agency has considered its Evidence Reports, information
presented by commenters, and its own experience with CMV drivers.
As a commenter suggested, because there are few studies that
evaluate ITDM individuals who operate CMVs, the Agency's actual
experience with such individuals is highly relevant. Considering the
long period over which the exemption program has operated, the Agency
has determined that there is sufficient data to allow generalized
conclusions to be reached. FMCSA's experience with the exemption
program has demonstrated that the safety performance of ITDM
individuals who hold exemptions is as good as that of the general
population of CMV drivers. As set forth in the NPRM, on a per-driver,
per-year basis, the crash rate for drivers with an exemption was 0.013,
as compared to about 0.038 crashes per year per active CMV driver. As
is discussed more fully in the RIA, a November 2016 analysis of the
safety performance of ITDM individuals who held exemptions for the full
period of 2011 through 2015 shows the 755 diabetes exemption holders
had 58 crashes that resulted in a crash rate of 0.01536 crashes per
driver per year. This compares to a crash rate of 0.03115 crashes per
driver per year for a national population of 4,599,623 drivers and
143,289 crashes. These results were deemed to be demonstrative that
exemption program crash rates were of the same order of magnitude as
the national crash rate derived from the Motor Carrier Management
Information System data. The analysis proceeded to determine if the
0.02986 crash rate for treatment group drivers was significantly
different than the 0.02627 crash rate for the control group drivers, at
a 95 percent confidence level. The analysis indicated that there was no
statistical difference between the treatment group and control group
crash
[[Page 47511]]
rates at the 95 percent confidence level.\24\
---------------------------------------------------------------------------
\24\ ``Safety Performance of Drivers with Medical Exemptions:
How safe are drivers in a medical exemption program compared to
those who are not?'' Nov. 2016, which is available at https://rosap.ntl.bts.gov/view/dot/31521 (June 1, 2018).
---------------------------------------------------------------------------
Although the Agency fully considered FMCSA's 2006 Diabetes Evidence
Report and the 2010 Evidence Report Update at the time of the NPRM, the
Agency will briefly address the 2010 Evidence Report Update due to
comments regarding the crash risks provided in the report. The report
found that the overall quality of the crash risk studies reviewed was
low to moderate. Because only a single study compared crash risk among
CMV drivers with diabetes against comparable CMV drivers without
diabetes, an evidence-based conclusion regarding possible increased
crash risk for CMV drivers with diabetes could not be drawn. The
strength of evidence for the overall finding that drivers with diabetes
are at an increased risk for a crash when compared with comparable
drivers who do not have diabetes was determined to be weak. It could
not be determined whether drivers with type 1 or type 2 diabetes or
ITDM drivers were overrepresented in populations of drivers who have
experienced a motor vehicle crash. As such, the report's findings are
inconclusive at best.
The report noted that studies conducted in the United States showed
approximately a 24 percent increase in crash risk among drivers with
diabetes compared with drivers without diabetes. This finding, however,
was based on six studies that were published in 1965, 1968, 1973, 1988,
1991, and 2003. The Agency agrees with Advocates that knowledge and
treatment of diabetes has increased significantly in recent years.
Because the studies reviewed most likely do not reflect current
treatment practices and protocols, the Agency has determined that they
are of little probative value with respect to the present issue. The
report noted that in the United States there was a significant increase
in crash risk (2.753) for individuals treated with insulin when
compared with drivers treated with oral medication and/or diet alone.
It continued that a firm conclusion could not be made with respect to
this finding because there were only two studies to review. In
addition, those studies, which were published in 1988 and 2003, are too
old to provide probative evidence. FMCSA finds that its more recent
data that relates directly to ITDM individuals who operate CMVs are
more relevant in assessing crash risk in such individuals.
The Agency has reviewed the five journal articles referenced by the
former MRB members. Three of the articles examine the relationship
between diabetes and crash risk for drivers in foreign countries.
Because of potential differences in the experience and training of
drivers, driving regulations, and the treatment of diabetes, drivers in
foreign countries may not be comparable to those in the United States.
The Agency agrees, therefore, with the University of Utah that United
States-based data are the most important to assessing the safety risk
at issue. One of these articles was cited by the former MRB members for
the proposition that increased crash risk is associated with efforts to
maintain tight blood glucose control with HbA1C below 7 percent. In as
much as this rule has not prescribed a specific HbA1C level that must
be achieved to be medically qualified, the rule does not provide an
incentive to maintain HbA1C levels below 7 percent. This was the only
one of the three articles that included CMV operators; however, it also
included non-CMV drivers and did not differentiate between the two
types of drivers in the statistical analysis.
A fourth article examined the extent to which there is an age-
related component to crash risk among individuals with type 1 diabetes.
The article concluded that reported crashes decline with age in all
persons, but the crash risk remained higher for persons with diabetes
throughout the age span. There was no relationship between crashes and
diabetes complications, blood glucose control, and diabetes treatment
patterns. Severe hypoglycemia was consistently and strongly related to
crashes at all ages.\25\ However, the authors found that the link
between reported hypoglycemia history and reported crashes was
indirect, and it was not possible to determine the extent to which
hypoglycemia actually contributed to the reported crashes.
Additionally, the number of crashes identified was low; therefore, the
article concluded further study was necessary to establish the
relationship between hypoglycemia and crashes.\26\ The article does not
identify whether it included CMV operators. It also included drivers
under the age of 21, who generally would not qualify to obtain an
interstate CDL. Finally, the article included individuals with
retinopathy who may not be eligible under this rule to be medically
qualified to operate a CMV.
---------------------------------------------------------------------------
\25\ Songer TJ, Dorsey RR. Annu Proc Assoc Adv Automot Med.
2006; 50: 348.
\26\ Id. at 349.
---------------------------------------------------------------------------
The fifth study presents the results of an analysis in which the
number of crashes are estimated for a hypothetical group of ITDM truck
drivers with an estimated incidence of mild and severe hypoglycemia, an
estimated number of reactions while driving, and an estimated
likelihood of a crash during a mild or severe hypoglycemic reaction, as
compared to a second hypothetical group of truck drivers who are not
insulin dependent. Because the article was not based on actual data and
was published in 1993, FMCSA finds that this article is unreliable and
is no longer relevant.
For the reasons discussed above, the Agency finds that the five
articles cited by the former MRB members are not as persuasive as
FMCSA's actual experience with crash risk for ITDM individuals who
drive CMVs.
The Agency conducted a review of the literature regarding safety of
ITDM individuals to identify studies performed after the 2010 Evidence
Report Update. The Agency did not find any literature pertaining to the
safety risk of ITDM individuals operating CMVs other than its own
studies.
FMCSA declines to pursue a pilot period prior to implementing this
rule, as a commenter has suggested. FMCSA finds that the current
exemption program has demonstrated that ITDM individuals can drive a
CMV in a manner as safe or safer than other CMV drivers.
V. Costs and Benefits of the Proposed Rule
NPRM: The NPRM stated that this rulemaking would not have a
significant economic impact. Compared to other CMV drivers, ITDM
individuals would incur costs for an additional medical examination of
$150 annually; however, they would have the ability to earn a living
without the inconvenience and added costs of obtaining and maintaining
an exemption.
Comments on Costs and Benefits of the Proposed Rule: FMCSA received
comments discussing the costs and benefits associated with the proposed
rule. Two commenters provided information about potential cost savings.
TFAC noted that FMCSA did not account for cost savings to existing
drivers with type 2 diabetes who are trying to avoid insulin treatment.
TFAC indicated that enabling ITDM individuals to be qualified to
operate CMVs would remove the incentive to avoid insulin treatment and
would allow medical professionals to treat their CMV-driver patients
with type 2
[[Page 47512]]
diabetes in the most appropriate, cost-effective manner. An ITDM
individual estimated his costs would decrease by at least $600 annually
from eliminating three of his four annual visits to the
endocrinologist. The IBT, TTD, and OOIDA commented that the exemption
program is a time consuming and financially burdensome process that can
result in lost income and possibly job loss while waiting for FMCSA to
grant an exemption.
Two commenters said FMCSA underestimated the cost of the proposed
rule. A certified ME, who is a physician, stated that because the rule
transfers the ``function and responsibilities'' for medically
qualifying an ITDM individual from the Agency to the certified ME, as a
physician, he would continue to require at least annual assessments
from an ophthalmologist and endocrinologist, and increase his charges
to compensate for the increased time and risk involved in certifying
ITDM individuals. This commenter also indicated that the costs saved by
FMCSA will be transferred as costs to ITDM individuals and certified
MEs.
A different physician asserted that the Agency did not account for
several costs associated with the elimination of the exemption program.
The physician stated that ``to avoid hypoglycemia, the CMV driver will
not be able to maintain tight control which will accelerate the
progression for the [insulin-treated CMV driver] to develop eye, nerve,
and kidney complications.'' The physician suggested that FMCSA did not
address the increased cost on the medical system of ITDM individuals
avoiding hypoglycemia or consider the impact of the proposed rule on
the organ systems and lifespan of ITDM individuals. The commenter noted
that ``[i]n, 2011, about 282,000 emergency room visits for adults aged
18 years or older had hypoglycemia as the first-listed diagnosis and
diabetes as another diagnosis.'' Additionally, in 2011, about 175,000
emergency room visits for people of all ages had hyperglycemic crisis
as the first-listed diagnosis.
2015 MRB Report: The 2015 MRB report did not address the costs and
benefits of the proposed rule.
Comments on the Costs and Benefits of the MRB's Recommendations: A
few commenters discussed the costs and benefits of the 2015 MRB
recommendations. For example, OOIDA supported most of the MRB
recommendations and noted that the recommendations provide a more
efficient and progressive approach than the current exemption process,
which is costly and burdensome. OOIDA stated that the exemption process
can take 180 days or more, plus a 30-day public comment period, and the
costly time off-the-road can put an owner-operator out of business. In
addition, the cost of seeing an endocrinologist can easily reach $200 a
visit. An individual, however, stated that the 2015 MRB recommendations
would increase the burden on the ITDM individual, creating twice the
amount of work and expense for the individual and a high risk of
suspension or loss of license.
FMCSA Response: The RIA published with this final rule does account
for cost savings from replacing four endocrinologist visits with one
visit to a TC. FMCSA estimated the average cost of an office visit with
an endocrinologist at $280, including $60 for the opportunity cost of
an assumed 2 hours for the ITDM individual's time to complete the
appointment, versus $223, inclusive of the ITDM individual's time, for
a TC evaluation. The annual evaluation and quarterly visits under the
exemption program are estimated at $1,120, which compares to the $223
annual cost for the TC evaluation.
The Agency does not have sufficient data, nor did TFAC provide any
substantive data, to confirm TFAC's assertion that the rule will
provide cost savings because type 2 non-ITDM drivers will no longer
have the incentive to continue using oral medication to avoid insulin.
In response to OOIDA, the TTD, and the IBT comments, the Agency
finds that it is appropriate to estimate the income forgone by an
existing CMV operator who begins treatment with insulin. Thus, in the
RIA, the Agency included in the exemption program baseline a
nonrecurring cost of $4,235 per ITDM individual for existing CMV
operators who begin treatment with insulin.
The Agency disagrees with the certified ME's assertion that the
final rule shifts risk to certified MEs and ultimately to individuals
in the form of higher fees. FMCSA does not regulate the fees the
certified ME charges, but continues to believe fees are established by
market forces that will not be altered by this rule. In addition, the
final rule does not prevent a certified ME from mitigating the
perceived risk of performing medical examinations on ITDM individuals
by restricting the certified ME's practice to non-ITDM individuals.
FMCSA disagrees with the commenter who stated that the Agency did
not consider that tight control to avoid hypoglycemia will accelerate
the progression of diabetic complications. The Agency did not specify
ranges for either HbA1C or blood glucose that would apply to all ITDM
individuals. By not specifying such ranges, the Agency provides the TC
with the flexibility to establish and adjust an ITDM individual's
insulin regimen that will minimize the emergence of complications and
the occurrence of hypoglycemic episodes. The commenter did not offer
sufficient data to support the assertions that in 2011 the number of
emergency room visits for hypoglycemia and hyperglycemia demonstrates
that FMCSA failed to recognize such costs. Moreover, the data cited was
for a subset of individuals with coexisting diabetic complications.
Finally, FMCSA does not maintain data on the lifespan of ITDM
individuals. Factors other than the impact of diabetes on target organs
affect an ITDM individual's lifespan. It is beyond the scope of this
rule to determine the cause of death of ITDM individuals that may occur
years after they operate a CMV.
W. Privacy Issues
NPRM: In the NPRM, the Agency determined that the privacy risks and
effects associated with the proposed rule were not unique and had been
addressed in other rules.
Comments Related to Privacy Issues: The IBT expressed its concern
about privacy issues related to releasing medical information.
According to the IBT, in many instances the certified ME is a ``company
doctor'' who requests the entire medical file for individuals as a
prerequisite to performing a certification examination. To obtain that
information, the certified ME requires individuals to sign a ``blanket
authorization,'' which allows the certified ME to release the
individual's medical file to insurance companies, the employer, and
various other entities. The IBT stated that motor carriers should not
be allowed to improperly use the regulations in 49 CFR part 391 as
justification to obtain and release to third parties information that
is not relevant to determining whether an individual is qualified to
operate a CMV.
2015 MRB Report: The 2015 MRB report did not discuss privacy issues
and no comments were received concerning the MRB report in this regard.
FMCSA Response: This final rule does not change the laws and
regulations applicable to the use or disclosure of an individual's
medical information. As such, comments regarding the release of medical
information to employers are outside the scope of this rulemaking.
Nonetheless, FMCSA notes that TCs and certified MEs are bound by the
privacy protections outlined under the Health
[[Page 47513]]
Insurance Portability and Accountability Act (HIPAA), which establishes
national standards to protect individuals' medical records and other
personal health information. HIPAA requires appropriate safeguards to
protect the privacy of personal health information and sets limits and
conditions on the uses and disclosures of such information that may be
made without authorization by an individual. Therefore, an individual
would have to provide his or her consent for a TC or certified ME to
share medical information with other entities, including the motor
carrier. More information on HIPAA and its requirements can be found on
the Department of Health and Human Services' website at https://www.hhs.gov/hipaa/for-professionals/privacy/index.html.
X. Other Comments
Comments on Procedural and Other Issues in the NPRM: Some
commenters expressed concerns about procedural or documentation matters
related to the proposed rule. For example, Advocates stated that the
Expert Panel Opinion resulting from the MRB review of the 2010 Evidence
Update Report had not been published on FMCSA's website or added to the
docket for this rulemaking.
H&SW suggested adding a checkbox to the MEC, MCSA-5876, that states
the individual is physically qualified to operate a CMV when managing
his or her condition so the roadside inspector would know the
individual has ITDM. H&SW noted that roadside inspectors are not
clinicians; therefore, the requirements must set a blood glucose limit
to help them determine whether an ITDM individual should operate a CMV.
In contrast, TFAC strongly opposed any requirements that would make
information on an individual's ITDM status available to roadside
enforcement.
Comments on the Other Issues in the MRB Report: In terms of
procedural issues in response to the 2015 MRB report, Advocates stated
that the MRB report was sent to the Agency on September 1, 2015, but
the Agency took until September 9, 2016, before publishing the report
for comment.
FMCSA Response: As explained elsewhere in this final rule, FMCSA is
not specifying any blood glucose level that would prevent an ITDM
individual from operating a CMV; therefore, there is no need for
involvement of enforcement personnel. The final rule does not provide
any changes to the MEC, MCSA-5876. As with any other medical condition,
if a driver possesses a valid MEC, MCSA-5876, the certified ME has
determined that the ITDM individual has met FMCSA's physical
qualification requirements. Therefore, adding a separate designation on
the MEC, MCSA-5876, would serve no purpose for enforcement personnel.
In response to the two comments from Advocates, the Agency notes
that there is no expert panel commentary in response to the 2010
Evidence Update Report. The Meeting Summary for the June 30, 2011, MRB
meeting shows that FMCSA's contractor presented a summary of the
results of the 2010 Evidence Update Report to the MRB, and the MRB
decided not to request another expert panel following the report.\27\
To clarify, the MRB recommendations referenced in the NPRM were those
provided at the MRB's July 26, 2007, meeting.\28\ The 2015 MRB report
was available for public viewing on FMCSA's website on September 3,
2015, just 2 days after the date of the report. Although the notice of
availability was not published until September 9, 2016, the public was
provided a meaningful opportunity to comment on the report. Comments
received in response to the 2015 MRB report are addressed in this final
rule.
---------------------------------------------------------------------------
\27\ See https://www.fmcsa.dot.gov/summary-june-30-2011-medical-review-board-public-meeting.
\28\ See https://www.fmcsa.dot.gov/summary-july-26-2007-medical-review-board-public-meeting.
---------------------------------------------------------------------------
Y. Outside the Scope
Comments Outside the Scope of the NPRM: Several commenters
suggested adjustments to the proposed rule such as technological
initiatives that are outside the scope of this rule; therefore, a
response is not required. For example, one commenter stressed the
importance of individuals with diabetes controlling their blood sugar
levels, noting both low and high blood glucose index values can impede
thinking, and recommended developing technology that would continually
monitor the blood glucose index to alert the ITDM individual to highs
or lows.
Comments Outside the Scope of the MRB Report: The following
commenters offered some observations that fall outside the scope of the
recommendations of the 2015 MRB report. An individual recommended
Bydureon as an alternative treatment to placing individuals on insulin.
An owner-operator commented on being unable to obtain a CDL since he
was prescribed insulin. He stated that, even though his diabetes is
under control and he does not haul long distance, the current rule
disqualifies him from operating CMVs. He requested that the Agency
provide an exemption for individuals with controlled diabetes who haul
short distances.
VII. Section-by-Section Analysis
This section includes a summary of the regulatory changes in 49 CFR
part 391 organized by section number.
Sec. 391.41 Physical Qualifications for Drivers
In Sec. 391.41, paragraphs (a), (b)(1), and (b)(2) are not
altered.
Paragraph (b)(3) adds an exception at the end of the sentence to
indicate that there are requirements provided in Sec. 391.46 for
individuals who have diabetes mellitus treated with insulin for
control.
Paragraphs (b)(4) through (b)(13) are not modified.
Sec. 391.45 Persons Who Must Be Medically Examined and Certified
Other than deleting ``of this subpart'' from the existing
introductory paragraph, the introductory paragraph and paragraph (a)
are not altered.
The content from paragraph (b)(1) becomes new paragraph (b) and
adds an exception with a reference to the newly created paragraphs (c),
(d), (e), (f), and (g) of this section.
Existing paragraph (b)(2) is separated to form new paragraphs (c)
and (d) of this section. These new paragraphs are slightly modified for
clarity and readability.
New paragraph (e) is inserted to require compliance with new Sec.
391.46.
Content from existing paragraph (c) is moved to new paragraph (f).
Content from existing paragraph (d) is moved to new paragraph (g).
Sec. 391.46 Physical Qualification Standards for an Individual With
Diabetes Mellitus Treated With Insulin for Control
This final rule codifies a new Sec. 391.46.
Paragraph (a), Diabetes mellitus treated with insulin, states that
ITDM individuals may be physically qualified if they meet certain
criteria. Paragraph (a)(1) states that ITDM individuals are required to
meet the physical qualification standards or hold an exemption.
Paragraph (a)(2) explains that ITDM individuals must have the
evaluation and medical examination, as required by paragraphs (b) and
(c).
Paragraph (b), Evaluation by the treating clinician, states that
the ITDM individual must have a TC evaluation completed before any
medical examination by the certified ME and defines a TC. Paragraph
(b)(1) requires the TC to complete the ITDM Assessment Form, MCSA-5870.
[[Page 47514]]
Paragraph (b)(2) requires TCs to sign and date the form, and provide
their business contact information on the form.
Paragraph (c), Medical examiner's examination, sets forth the
requirements for the certified ME's examination, including that the
examination must begin no later than 45 days after the individual's TC
evaluation. Paragraph (c)(1) states that the certified ME must have an
ITDM Assessment Form, MCSA-5870, for each examination. Paragraph (c)(2)
provides that the certified ME is to make a medical qualification
determination by considering the information in the ITDM Assessment
Form, MCSA-5870, and, using independent medical judgement, by applying
the medical qualification standards in the paragraph. The standards
provide that an individual must maintain a stable insulin regimen and
proper control of his or her diabetes, and cannot have severe non-
proliferative diabetic retinopathy or proliferative diabetic
retinopathy. The standards also establish the requirements for blood
glucose self-monitoring for ITDM individuals.
New paragraph (d), Blood glucose self-monitoring records, discusses
the blood glucose record-keeping requirements, including submitting
those records to the TC during the evaluation.
New paragraph (e), Severe hypoglycemic episodes, provides that an
ITDM individual who experiences a severe hypoglycemic episode, which is
defined in the paragraph, 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.
The ITDM individual must retain and provide the form to the certified
ME at the individual's next medical certification examination.
Sec. 391.64 Grandfathering for Certain Drivers Participating in Vision
and Diabetes Waiver Study Programs
FMCSA inserts new language at the beginning of existing paragraph
(a) that provides this rule will not apply to individuals certified
pursuant to Sec. 391.64(a) until 1 year after the effective date of
the rule. During that year, individuals certified under the grandfather
provision may choose to be certified under Sec. 391.64(a) or this
final rule.
FMCSA adds new paragraph (a)(3) to remove and void all of paragraph
(a) 1 year after the effective date of this rule; thus, eliminating
certification under Sec. 391.64(a). FMCSA also adds an amendatory
instruction for the deletion of paragraphs (a) through (a)(3) 1 year
after the effective date of this rule. On this date, this language will
be stricken from the regulation and paragraph (a) will be reserved.
Updates to Appendix A to Part 391--Medical Advisory Criteria
FMCSA removes paragraph II.C., Diabetes Sec. 391.41(b)(3), in its
entirety. That paragraph outlines advisory guidelines for the diabetes
standard. These guidelines are no longer necessary because this final
rule creates a new standard for ITDM individuals.
Updates to Guidance Q&A for Sec. 391.41, Question 3
FMCSA also revises guidance for Sec. 391.41, Question 3. In the
answer to Question 3, FMCSA will remove ``four'' and replace it with
``three'' to update and reflect the correct number of medical
conditions that are not subject to the certified ME's judgement, and
remove ``insulin-using diabetes'' from the list of conditions for which
the certified ME has no discretion.
The answer to Question 3 of the guidance for Sec. 391.41 will now
read as follows: ``The qualification standards cover 13 areas that
directly relate to the driving functions. All but three of the
standards require a judgement by the medical examiner. A person's
qualification to drive is determined by a medical examiner who is
knowledgeable about the driver's functions and whether a particular
condition would interfere with the driver's ability to operate a CMV
safely. In the case of vision, hearing, and epilepsy, the current
standards are absolute, providing no discretion to the medical
examiner.''
VIII. International Impacts
The FMCSRs, and any exceptions to the FMCSRs, apply only within the
United States (and, in some cases, United States territories). Motor
carriers and drivers are subject to the laws and regulations of the
countries in which they operate, unless an international agreement
states otherwise. Drivers and carriers should be aware of the
regulatory differences among nations. As stated previously, ITDM
individuals with licenses issued in Canada or Mexico will not be
allowed to operate CMVs in the United States.
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
FMCSA determined that this final rule is not a significant
regulatory action under section 3(f) of E.O. 12866 (58 FR 51735, Oct.
4, 1993), Regulatory Planning and Review, as supplemented by E.O. 13563
(76 FR 3821, Jan. 21, 2011), Improving Regulation and Regulatory
Review, and does not require an assessment of potential costs and
benefits under section 6(a)(3) of that Order. Accordingly, OMB has not
reviewed it under that Order. It is also not significant within the
meaning of DOT regulatory policies and procedures (DOT Order 2100.5
dated May 22, 1980; 44 FR 11034, Feb. 26, 1979). The Agency, however,
has considered the total costs and benefits of this final rule and
determined they are less than $100 million annually.
The objective of the final rule is to replace the exemption program
with a less time consuming and less costly process that continues to
ensure that ITDM individuals can operate CMVs safely. The final rule
also provides a clearer, equally effective, and more consistent
framework than a program based entirely on exemptions. In the following
sections, the Agency describes the impacts of the rule to the entities
listed in Table 2 (above).
Costs to ITDM Individuals Currently Compliant With the Exemption
Program
The Agency estimates that there are presently 5,000 ITDM
individuals that have exemptions (4,879 = 3,945 FMCSA exemption holders
+ estimated 930 State exemption holders rounded to the nearest
thousand).\29\ As the compliance costs of the exemption program are
greater than those of the final rule, the Agency assumes that these
ITDM individuals will comply with the final rule. Because these ITDM
individuals have already obtained an MEC, MCSA-5876, and an exemption,
the baseline costs for this group consist of annual recurring medical
and associated expenses for examinations necessary to maintain their
exemption.
---------------------------------------------------------------------------
\29\ See RIA Section 2.5.2 for the detailed development of the
estimated number of State exemption holders.
---------------------------------------------------------------------------
To gauge the final rule's cost impact to these ITDM individuals, it
is necessary to compare their compliance costs pre- and post-rule. The
Agency
[[Page 47515]]
estimates the recurring costs in the baseline for an ITDM individual to
maintain an exemption as follows:
The opportunity cost of 1 hour of time to prepare a
renewal application: $30; \30\
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\30\ The opportunity cost of drivers' time is estimated in RIA
Section 2.6.1.
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The cost of four endocrinologist office visits, consisting
of one annual complete medical examination plus three quarterly office
visits. The cost of each endocrinologist office visit is $280
(inclusive of the ITDM individual's time to complete the
examination).\31\ Therefore, these ITDM individuals would each incur
$1,120 ($1,120 = $280 x 4) per year in compliance costs related to this
component of the exemption program;
---------------------------------------------------------------------------
\31\ This cost is estimated in RIA Section 2.6.3.
---------------------------------------------------------------------------
The cost for an annual comprehensive eye examination: $260
(inclusive of the opportunity cost of the ITDM individual's time to
complete the examination).\32\ However, Centers for Disease Control and
Prevention (CDC) data indicate that approximately 65 percent of
individuals with diabetes receive annual dilated vision
examinations.\33\ Therefore, FMCSA assumes that only 35 percent of the
$260 comprehensive eye examination cost is a cost attributable to the
exemption program. Thus, the effective average comprehensive eye
examination cost is reduced to $91 for this analysis ($91 = $260 x (1 -
65 percent)); and
---------------------------------------------------------------------------
\32\ Id.
\33\ CDC, Division of Diabetes Translation, Diabetes Report Card
2014, p. 9. This percentage represents the individuals 18 years and
older that have diabetes and who reported receiving an annual
dilated eye examination. The Diabetes Report Card is published
biennially by the CDC. The report provides current information on
the status of diabetes in the United States. It includes information
and data about diabetes mellitus, gestational diabetes, prediabetes,
preventive care practices, risk factors, quality of care, diabetes
outcomes, and, National and State trends. The data are from the CDC
Behavioral Risk Factor Surveillance System, which is a health-
related telephone (landline and cellphone) survey that collects
State-level data about health-related risk behaviors, chronic health
conditions, and use of preventive services. The survey questions
include 11 questions related to diabetes preventative medicine
covering the frequency of physicals, dilated vision examinations,
blood glucose and HbA1C monitoring, and diabetes education. See
https://www.cdc.gov/diabetes/pdfs/library/diabetesreportcard2014.pdf
(Accessed May 25, 2018).
---------------------------------------------------------------------------
The cost of an out-of-period medical qualification
examination: $218 (inclusive of the opportunity cost of the ITDM
individual's time).\34\ However, the out-of-period examination occurs
only every other year and therefore is halved to $109 for this
analysis.
---------------------------------------------------------------------------
\34\ This cost is estimated in RIA Section 2.6.3.
---------------------------------------------------------------------------
Altogether, the recurring costs for ITDM individuals to renew and
maintain their exemptions total $1,350 each. This is the sum of the
costs noted above, specifically the $30 cost of time to prepare a
renewal application, the $1,120 endocrinologist examination cost, the
$91 vision examination cost, and the $109 out-of-period medical
qualification examination cost.\35\ The continuation of the exemption
program would cost this group of ITDM individuals $6,750,000
($6,750,000 = 5,000 ITDM individuals x $1,350 per ITDM individual) per
year.
---------------------------------------------------------------------------
\35\ The Agency assumes that the cost for an ITDM individual to
obtain a State exemption or an FMCSA exemption is the same.
---------------------------------------------------------------------------
Because of the final rule, the exemption program will be
eliminated. The compliance cost under the final rule for each of these
5,000 ITDM individuals to obtain their MEC, MCSA-5876, is estimated as
follows:
The cost of an annual evaluation by a TC: $223 (inclusive
of the opportunity cost of the ITDM individual's time); \36\ and
---------------------------------------------------------------------------
\36\ This cost is estimated in RIA Section 2.6.3.
---------------------------------------------------------------------------
The cost of an out-of-period medical qualification
examination: $218 (inclusive of the opportunity cost of the ITDM
individual's time). However, the out-of-period examination occurs only
every other year and therefore is halved to $109 for this analysis.
The annual cost each of these 5,000 ITDM individuals will bear per
year to comply with the final rule is therefore $332 ($332 = $223 +
$109), a 75.4 percent decrease relative to the $1,350 compliance cost
of the exemption program. In total, these 5,000 ITDM individuals will
bear a cost of $1,660,000 under the final rule ($1,660,000 = 5,000 ITDM
individuals x $332 per ITDM individual), which is $5.09 million less
than the cost they would bear under the exemption program ($5.09
million = ($6,750,000 - $1,660,000)/$1,000,000), and which constitutes
the largest share of the total cost savings that will result from the
final rule.
Costs to Future Compliant ITDM Individuals
In accordance with 49 CFR 391.41(b)(3), an individual subject to
FMCSA's physical qualification requirements who begins treatment with
insulin for diabetes mellitus cannot be medically qualified to operate
a CMV. Consequently, an ITDM individual in this situation is likely to
lose income until FMCSA issues an exemption. Motor carriers that would
employ these ITDM individuals will also lose income from the
productivity that would have resulted from the labor hours forgone. The
Agency estimates that 27 ITDM individuals and the carriers that would
employ them would continue to bear the burden of obtaining an exemption
in the baseline.\37\
---------------------------------------------------------------------------
\37\ The estimate of 27 new ITDM individuals seeking exemptions
in the baseline is developed in RIA Section 2.5.2.
---------------------------------------------------------------------------
FMCSA does not have data on the average length of time it takes for
an individual beginning treatment with insulin to complete the daily
blood glucose measurements and medical examinations necessary prior to
submitting an initial exemption application.\38\ However, after
receiving an initial exemption application, it takes FMCSA on average
77 days to review a complete application before granting an exemption.
This may be a conservative estimate of the length of time that both
drivers and their potential employers incur opportunity costs, because
the clock for determining the 77-day average waiting period does not
start until the application is deemed complete by FMCSA. For these
reasons, FMCSA finds that the 77-day estimate of the average waiting
period during which drivers beginning treatment with insulin and the
motor carriers that employ them incur opportunity costs may be
conservatively low.
---------------------------------------------------------------------------
\38\ The exemption program requires individuals newly diagnosed
with diabetes mellitus who are beginning treatment with insulin to
provide 60 days of daily blood glucose measurements while being
treated with insulin to the endocrinologist. Drivers transitioning
from oral medication to insulin are required to provide 30 days of
daily blood glucose measurements while being treated with insulin.
FMCSA does not have data to determine how many ITDM individuals
might fall under either of these reporting requirements. Were such
data available, it would likely increase the Agency's estimate of
the length of time an ITDM individual would not be able to operate a
CMV. The daily blood glucose monitoring requirements are specified
in Section 13A of the endocrinologist checklist that is included in
the diabetes exemption program application package. See https://www.fmcsa.dot.gov/medical/driver-medical-requirements/diabetes-exemption-application (Accessed May 25, 2018).
---------------------------------------------------------------------------
The Agency assumes that new ITDM drivers will obtain alternative
employment while waiting for FMCSA to grant an exemption, and that the
alternative employment will produce income (wage and benefits combined)
equal to $25 per hour.\39\ Based on the
[[Page 47516]]
$30 per hour average wage and benefits per driver,\40\ a driver idled
while waiting for an exemption to be granted would forgo $5 of income
per hour he or she is prohibited from driving. Given the 77-day average
wait time for FMCSA to issue an exemption and an 11-hour driving day, a
driver filing an initial exemption application would forgo $4,235
($4,235 = $5 per hour x 11 hours per day x 77 days) of income. The
final rule eliminates this cost, resulting in an annual cost savings of
$114,345 ($114,345 = $4,235 opportunity cost per new exemption program
applicant x 27 new exemption program applicants per year).
---------------------------------------------------------------------------
\39\ The $25 per hour wage is an average of the hourly wage for
several occupations within North American Industrial Classification
System (NAICS) industry 488400 (Support Services Road
Transportation). The 2016 average hourly wage for Laborers and
Freight, Stock and Materials Movers is $13.85 and is $16.73 for Tank
Car, Truck and Shop Loaders. This results in an average wage of
$15.29 ($15.29 = ($13.85 + $16.73) / 2) to which is added $9.54 for
average hourly benefits (discussed in further detail in the RIA).
The Agency used these labor categories because they are
representative of non-driving positions that may be available with
motor carriers for a driver who begins treatment with insulin until
an exemption is granted. The Agency believes that this is a
conservative assumption because a motor carrier could terminate the
employee, which would increase the opportunity cost to the driver.
The Bureau of Labor Statistics (BLS) wage data are available at
https://www.bls.gov/oes/current/naics4_488400.htm#53-0000 (Accessed
May 25, 2018).
\40\ See RIA Section 2.6.1.
---------------------------------------------------------------------------
The Agency also monetizes the opportunity cost to motor carriers
resulting from the loss of available labor inputs during the 77-day
average application waiting period. The Agency estimates motor
carriers' opportunity cost at $3.20 per hour.\41\ At that rate, the
opportunity cost to motor carriers per exemption program applicant is
estimated at $2,710 ($2,710 = $3.20 per hour x 11 hours per day x 77
days). The final rule will eliminate this cost, resulting in an annual
cost savings of $73,170 ($73,170 = $2,710 motor carrier opportunity
cost per new exemption program applicant x 27 new exemption program
applicants per year).
---------------------------------------------------------------------------
\41\ See RIA Section 2.6.2.
---------------------------------------------------------------------------
Together, the driver and motor carrier opportunity costs per new
exemption program applicant sum to $6,945 ($6,945 = $4,235 driver
opportunity cost + $2,710 carrier opportunity cost). Aggregated over
the projected 27 new exemption program applicants per year, this cost
totals $187,515 ($187,515 = 27 applicants x $6,945 per applicant), of
which $114,345 is borne by new ITDM individuals and $73,170 by motor
carriers. In addition to the $114,345 in opportunity costs, ITDM
individuals incur $36,450 of annual medical-related compliance costs
($36,450 = $1,350 medical expenses per individual x 27 individuals). In
total, the baseline annual cost of the exemption program with respect
to new exemption holders and the motor carriers that would employ them
is $223,965 ($223,965 = $187,515 + $36,450).
The final rule eliminates the $187,515 opportunity cost of the
exemption program's 77-day waiting period. The remaining $36,450 of
baseline compliance costs for the 27 new ITDM individuals will be
reduced by the final rule to $8,964 per year (that is, $332 per
individual per year under the final rule versus $1,350 per individual
per year in the baseline). On an annual basis, the cost savings to
these individuals and to motor carriers totals $215,001 ($215,001 =
$187,515 + $36,450-$8,964).
Costs to Non-Participating ITDM Individuals
There is good reason to assume that ITDM individuals compliant with
the requirements of the exemption program will comply with the less
burdensome requirements of the final rule. It is not as simple to
estimate the degree to which the estimated ITDM individuals without
exemptions (among both CDL and non-CDL interstate drivers as well as
intrastate CDL drivers), or intrastate non-CDL holders--also without
exemptions--may alter their behavior in response to the final rule.
In the RIA published at the NPRM stage, FMCSA demonstrated a range
of gross compliance costs that would be incurred by medically qualified
ITDM individuals by considering costs as a function of the share of
medically qualified ITDM individuals. As the Agency does not know what
share of ITDM individuals would be medically qualified, the NPRM
analysis assumed three possible representative values: 100 percent,
66.7 percent, and 33.3 percent. The Agency reconsidered and ultimately
discontinued the use of this approach for the analysis of the final
rule. The Agency concludes that a focus on gross compliance costs fails
to properly characterize the deregulatory nature and cost savings of
the rule. Therefore, it reassessed its analytical approach from a
microeconomic perspective for this analysis of the final rule. Under
the revised approach the Agency first divided the group of ``non-
participating'' ITDM individuals into three subgroups, then considered
each subgroup's pre- and post-rule behavior using rational choice
theory.
The first subgroup consists of an estimated 189,363 ITDM
individuals operating CMVs in interstate commerce either with or
without a CDL, plus those with intrastate CDLs.\42\ By definition,
these individuals should already be in compliance with the exemption
program due to the fact that they either have a CDL, operate a CMV in
interstate commerce, or both. The Agency assumes that these individuals
have chosen not to participate in either FMCSA or State exemption
programs because they perceive the cost of non-compliance to be less
than the cost of compliance--making non-compliance their most rational
choice in the baseline. The final rule may or may not change their
behavior. Each individual will choose between the lesser of the reduced
cost of compliance (that is, a $332 final rule compliance cost, as the
final rule eliminates nearly all of the $5,585 baseline compliance
cost) and his or her perceived cost of non-compliance, which is
unaffected by the final rule. Regardless of the individual's chosen
behavior under the final rule, he or she will not incur any new net
costs, and potentially will incur a cost savings if the $332 compliance
cost of the final rule is less than his or her perceived cost of non-
compliance. Therefore, this rule imposes no costs to this subgroup.
---------------------------------------------------------------------------
\42\ See RIA Section 2.5.2 for the Agency's derivation of the
size of this subgroup's population.
---------------------------------------------------------------------------
The second and third subgroups together are composed of ITDM
individuals operating as intrastate non-CDL drivers.\43\ Subgroup two
consists of individuals operating in States that have medical
requirements applicable to non-CDL individuals. The Agency assumes that
this final rule will indirectly apply to these individuals through
State adoption of compatible regulations in order to maintain
eligibility for Motor Carrier Safety Assistance Program grants.
Therefore, by definition, these individuals should already be in
compliance with State exemption programs, but are not. Following the
same logic as discussed with respect to subgroup one, these individuals
will bear no new net costs under the final rule and could potentially
incur a cost savings.
---------------------------------------------------------------------------
\43\ In Section 2.5.2 of the RIA, the Agency estimates that
subgroups two and three together contain a total of 54,000 ITDM
individuals, but lacks data to estimate the ratio of the size of
subgroup two to subgroup three.
---------------------------------------------------------------------------
The third subgroup is the complement to the second subgroup but is
specific to ITDM individuals operating in States that do not have
medical requirements applicable to non-CDL individuals. The Agency
assumes that these States will not change their regulations as a result
of the final rule; therefore, individuals in this subgroup will be
unaffected and will bear no costs.
Costs to the Agency
FMCSA relies on a contractor to assist it to administer the
diabetes exemption program. The average annual cost for the 3 remaining
option years of the contract is $1,025,474. The final rule eliminates
the need for this service, and will therefore produce an annual cost
savings of $1,025,474.
[[Page 47517]]
Total Annual Costs of the Rule
Table 3 shows the total costs estimated for the final rule. The
Agency based the costs on a representative year approach (using
exemption program participation data from December 31, 2016). The
relative costs between the baseline and the final rule do not change in
future years (save for slight changes due to growth in the baseline of
the exemption holder population that are not accounted for as they are
minimal). Therefore, this analysis does not present a separate
discussion of the annualized costs at either a 3 percent or 7 percent
discount rate, as those costs would be nearly identical to the costs
shown in Table 3, which the Agency characterizes as annualized costs.
The total costs of the final rule are estimated at -$6,347,241,
representing a cost savings of $6.35 million annually.
Table 3--Total Cost of Final Rule
[Annualized in 2016$]
----------------------------------------------------------------------------------------------------------------
Final rule Total cost/
Category Baseline cost cost (savings)
----------------------------------------------------------------------------------------------------------------
Current Compliant ITDM Individuals.............................. $6,750,000 $1,660,000 ($5,090,000)
Future Compliant ITDM Individuals............................... 167,550 8,964 (158,586)
Non-Participating ITDM Individuals.............................. 0 0 0
Motor Carriers.................................................. 73,170 0 (73,170)
FMCSA........................................................... 1,025,474 0 (1,025,474)
-----------------------------------------------
Total....................................................... 8,016,205 1,668,694 (6,347,241)
----------------------------------------------------------------------------------------------------------------
Benefits
The Agency reviewed the literature to identify analyses that
quantified health benefits realized by treating diabetes with insulin.
These studies quantified the benefits of insulin use; however, none of
these analyses were applicable directly to CMV operators. In the
absence of such analyses, the Agency did not quantify health benefits
associated with the final rule, though considers that the final rule
has potential to improve the health of drivers by encouraging that ITDM
individuals manage their health with the help of TCs.
The Agency finds that ITDM individuals do not present a safety risk
greater than CMV drivers that either treat their diabetes with oral
medication or who have not been diagnosed with diabetes. With respect
to ITDM individuals' safety performance, the Agency has released a
study examining the safety performance of CMV operators diagnosed with
diabetes. The study examined whether the crash rate for ITDM
individuals in compliance with the FMCSA exemption program was
significantly different than a control group of non-ITDM individuals.
In November 2016, FMCSA released an Analysis Brief titled ``Safety
Performance of Drivers with Medical Exemptions.'' \44\ This analysis
showed that a 0.02986 crash rate for a treatment group consisting of
diabetes exemption holders was not significantly different than a
0.02627 crash rate for a control group of drivers at a 95 percent
confidence level.
---------------------------------------------------------------------------
\44\ The Analysis Brief is available at https://rosap.ntl.bts.gov/view/dot/31521 (Accessed May 25, 2018).
---------------------------------------------------------------------------
B. E.O. 13771 (Reducing Regulation and Controlling Regulatory Costs)
This final rule is considered to be an E.O. 13771 deregulatory
action.\45\ The present value of the cost savings of this rule,
measured on an infinite time horizon at a 7 percent discount rate, is
$79.2 million. Expressed on an annualized basis, the cost savings are
$5.5 million. These values are expressed in 2016 dollars.
---------------------------------------------------------------------------
\45\ Executive Office of the President. Executive Order 13771 of
January 30, 2017. Reducing Regulation and Controlling Regulatory
Costs. 82 FR 9339-9341. Feb. 3, 2017.
---------------------------------------------------------------------------
C. Regulatory Flexibility Act
The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.)
requires Federal agencies to consider the effects of the regulatory
action on small business and other small entities and to minimize any
significant economic impact. The term ``small entities'' comprises
small businesses and not-for-profit organizations that are
independently owned and operated and are not dominant in their fields
and governmental jurisdictions with populations of less than
50,000.\46\ Accordingly, DOT policy requires an analysis of the impact
of all regulations on small entities, and mandates that agencies shall
strive to lessen any adverse effects on these businesses.
---------------------------------------------------------------------------
\46\ Regulatory Flexibility Act (5 U.S.C. 601). See http://uscode.house.gov/browse/prelim@title5/part1/chapter6&edition=prelim.
---------------------------------------------------------------------------
Under the standards of the Regulatory Flexibility Act, as amended
by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub.
L. 104-121, 110 Stat. 857), this final rule does not impose a
significant economic impact on a substantial number of small entities
because the medical standards apply to individuals seeking to operate a
CMV in interstate commerce. Consequently, I certify that the action
will not have a significant economic impact on a substantial number of
small entities.
D. Assistance for Small Entities
In accordance with section 213(a) of the Small Business Regulatory
Enforcement Fairness Act of 1996, FMCSA wants to assist small entities
in understanding this final rule so that they can better evaluate its
effects on themselves and participate in the rulemaking initiative. If
the final rule will affect your small business, organization, or
governmental jurisdiction and you have questions concerning its
provisions or options for compliance, please consult the FMCSA point of
contact, Ms. Christine Hydock, listed in the For Further Information
Contact section of this final rule.
Small businesses may send comments on the actions of Federal
employees who enforce or otherwise determine compliance with Federal
regulations to the Small Business Administration's Small Business and
Agriculture Regulatory Enforcement Ombudsman and the Regional Small
Business Regulatory Fairness Boards. The Ombudsman evaluates these
actions annually and rates each agency's responsiveness to small
business. If you wish to comment on actions by employees of FMCSA, call
1-888-REG-FAIR (1-888-734-3247). DOT has a policy regarding the rights
of small entities to regulatory enforcement fairness and an explicit
policy against retaliation for exercising these rights.
[[Page 47518]]
E. Unfunded Mandates Reform Act of 1995
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $156 million (which is the
value equivalent of $100,000,000 in 1995, adjusted for inflation to
2015 levels) or more in any one year. This final rule imposes no new
costs on any regulated entities nor upon State, local, or tribal
governments. Therefore, no further examination of unfunded mandates is
required.
F. Paperwork Reduction Act (Collection of Information)
This final rule calls for a collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). As defined in 5
CFR 1320.3(c), ``collection of information'' comprises reporting,
recordkeeping, monitoring, posting, labeling, and other similar
actions. The substantive comments in response to the 60-day notice
addressing the ITDM Assessment Form are discussed in the TC Written
Notification (ITDM Assessment Form) section above. FMCSA did not
receive any comments in response to the burden of this information
collection.
The title and description of the information collection, a
description of those who must collect the information, and an estimate
of the total annual burden follow. The estimate covers the time for
reviewing instructions, searching existing sources of data, gathering
and maintaining the data needed, and completing and reviewing the
collection.
Title: Medical Qualification Requirements.
OMB Control Number: 2126-0006.
Summary of the Collection of Information: The final rule enables an
ITDM individual to obtain an MEC, MCSA-5876, from a certified ME at
least annually if the TC attests to the certified ME on the ITDM
Assessment Form, MCSA-5879, that the individual maintains a stable
insulin regimen and proper control of his or her diabetes, and the
certified ME determines that the individual meets FMCSA's physical
qualification standards. Certified MEs may certify ITDM individuals for
up to 12 months.
Need for Information: This ICR supports the DOT Strategic Goal of
Safety by ensuring that CMV drivers are physically qualified to operate
trucks and buses on our nation's highways.
Use of Information: The TC completes the ITDM Assessment Form,
MCSA-5870, and attests that the ITDM individual maintains a stable
insulin regimen and proper control of his or her diabetes. Within 45
days after the form has been completed, it is provided to the certified
ME, who performs a physical qualification examination, considers the
information provided by the TC, and determines whether the individual
meets FMCSA's physical qualifications standards to safely operate a CMV
in interstate commerce.
Description of the Respondents: TCs.
Number of Respondents: 4,906.
Frequency of Response: Annually.
Burden of Response: 8 minutes.
Estimate of Total Annual Burden: 654 hours.
TC Annual Burden Hours and Salary Costs To Complete a Form Evaluating the Health of a CMV Driver With ITDM
----------------------------------------------------------------------------------------------------------------
Number of Time to Annual salary
Hourly wage of TC 47 forms complete form Annual hours to costs for TC to
completed (minutes) complete forms complete forms
----------------------------------------------------------------------------------------------------------------
$92.38....................................... 4,906 8 minutes 654 $60,417
----------------------------------------------------------------------------------------------------------------
As described in the table above, the final rule results in 654
annual burden hours and $60,417 annual salary costs. However, as
explained in the supporting statement to the ICR, eliminating the
diabetes exemption program results in 2,599 fewer annual burden hours
and a $77,749 reduction in annual salary costs. Therefore, the final
rule results in a net decrease of 1,945 annual burden hours and a net
decrease of $17,332 in salary costs.
---------------------------------------------------------------------------
\47\ Note that the $92.38 TC compensation cost used here differs
from the $163.21 value used to represent the cost of an office visit
to a TC. For PRA purposes, the $92.38 value--an estimate derived
from BLS data to represent the hourly wage and benefits of a TC--is
appropriate for estimating cost as a function of time to complete
the form.
---------------------------------------------------------------------------
As required by the Paperwork Reduction Act, FMCSA will submit a
copy of this final rule to OMB for its review of the collection of
information.
G. E.O. 13132 (Federalism)
A rule has implications for federalism under section 1(a) of E.O.
13132 if it has ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' FMCSA has determined that this rule would not have
substantial direct costs on or for States, nor would it limit the
policymaking discretion of States. Nothing in this document preempts
any State law or regulation. Therefore, this rule does not have
sufficient federalism implications to warrant the preparation of a
Federalism Impact Statement.
H. E.O. 12988 (Civil Justice Reform)
This final rule meets applicable standards in sections 3(a) and
3(b)(2) of E.O. 12988, Civil Justice Reform, to minimize litigation,
eliminates ambiguity, and reduce burden.
I. E.O. 13045 (Protection of Children)
E.O. 13045, Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1997), requires agencies
issuing ``economically significant'' rules, if the regulation also
concerns an environmental health or safety risk that an agency has
reason to believe may disproportionately affect children, to include an
evaluation of the regulation's environmental health and safety effects
on children. The Agency determined this final rule is not economically
significant. Therefore, no analysis of the impacts on children is
required. In any event, the Agency does not anticipate that this
regulatory action could in any respect present an environmental or
safety risk that could disproportionately affect children.
J. E.O. 12630 (Taking of Private Property)
FMCSA reviewed this final rule in accordance with E.O. 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights, and has determined it will not affect a taking of
private property or otherwise have taking implications.
[[Page 47519]]
K. Privacy Impact Assessment
Section 522 of title I of division H of the Consolidated
Appropriations Act, 2005, enacted December 8, 2004 (Pub. L. 108-447,
118 Stat. 2809, 3268, 5 U.S.C. 552a note), requires the Agency to
conduct a privacy impact assessment (PIA) of a regulation that will
affect the privacy of individuals. In accordance with this Act, a
privacy impact analysis is warranted to address any privacy
implications contemplated in the rulemaking. The Agency submitted a
Privacy Threshold Assessment analyzing the privacy implications to the
DOT Office of the Secretary's Privacy Office to determine whether a PIA
is required.
The DOT Chief Privacy Officer has evaluated the risks and effects
that this rulemaking might have on collecting, storing, and sharing
Personally Identifying Information and has examined protections and
alternative information handling processes in developing the proposal
in order to mitigate potential privacy risks. The privacy risks and
effects associated with this rule are not unique and have previously
been addressed by the medical examination/certification requirements in
the National Registry of Certified Medical Examiners and the Medical
Examiner's Certification Integration PIA published on the DOT Privacy
website and the DOT/FMCSA 009--National Registry of Certified Medical
Examiners System of Records Notice (SORN) (77 FR 24247), published on
April 23, 2012. An additional PIA and SORN for this rulemaking are not
required.
L. E.O. 12372 (Intergovernmental Review)
The regulations implementing E.O. 12372 regarding intergovernmental
consultation on Federal programs and activities do not apply to this
program.
M. E.O. 13211 (Energy Supply, Distribution, or Use)
FMCSA has analyzed this final rule under E.O. 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. The Agency has determined that it is not a
``significant energy action'' under that order because it is not a
``significant regulatory action'' likely to have a significant adverse
effect on the supply, distribution, or use of energy. Therefore, it
does not require a Statement of Energy Effects under E.O. 13211. The
Administrator of the Office of Information and Regulatory Affairs has
not designated it as a significant energy action. Therefore, it does
not require a Statement of Energy Effects under E.O. 13211.
N. E.O. 13783 (Promoting Energy Independence and Economic Growth)
E.O. 13783 directs executive departments and agencies to review
existing regulations that potentially burden the development or use of
domestically produced energy resources, and to appropriately suspend,
revise, or rescind those that unduly burden the development of domestic
energy resources. In accordance with E.O. 13783, DOT prepared and
submitted a report to the Director of OMB that provides specific
recommendations that, to the extent permitted by law, could alleviate
or eliminate aspects of agency action that burden domestic energy
production. This rule has not been identified by DOT under E.O. 13783
as potentially alleviating unnecessary burdens on domestic energy
production.
O. E.O. 13175 (Indian Tribal Governments)
This rule does not have tribal implications under E.O. 13175,
Consultation and Coordination with Indian Tribal Governments, because
it does not have a substantial direct effect on one or more Indian
tribes, on the relationship between the Federal government and Indian
tribes, or on the distribution of power and responsibilities between
the Federal government and Indian tribes.
P. National Technology Transfer and Advancement Act (Technical
Standards)
The National Technology Transfer and Advancement Act (15 U.S.C. 272
note) directs agencies to use voluntary consensus standards in their
regulatory activities unless the agency provides Congress, through OMB,
with an explanation of why using these standards would be inconsistent
with applicable law or otherwise impractical. Voluntary consensus
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) are standards that are developed or adopted by
voluntary consensus standards bodies. This rule does not use technical
standards. Therefore, FMCSA did not consider the use of voluntary
consensus standards.
Q. Environment (National Environmental Policy Act of 1969 (NEPA), Clean
Air Act (CAA), Environmental Justice)
FMCSA analyzed this rule for the purpose of NEPA (42 U.S.C. 4321 et
seq.) and determined this action is categorically excluded from further
analysis and documentation in an environmental assessment or
environmental impact statement under FMCSA Order 5610.1 (69 FR 9680,
March 1, 2004), Appendix 2, in paragraphs 6(b) and 6(s)(7). The content
in this rule is covered by the Categorical Exclusions (CEs) in
paragraphs 6(b) and 6(s)(7) and the final action does not have any
effect on the quality of the environment. The CE determination is
available for review in the docket.
FMCSA also analyzed this rule under section 176(c) of the CAA, as
amended (42 U.S.C. 7506(c)), and implementing regulations promulgated
by the Environmental Protection Agency. Approval of this action is
exempt from the CAA's general conformity requirement because it does
not affect direct or indirect emissions of criteria pollutants.
Under E.O. 12898, Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations, each Federal agency
must identify and address, as appropriate, ``disproportionately high
and adverse human health or environmental effects of its programs,
policies, and activities on minority populations and low-income
populations'' in the United States, its possessions, and territories.
FMCSA evaluated the environmental justice effects of this rule in
accordance with the E.O., and has determined that no environmental
justice issue is associated with this final rule, nor is there any
collective environmental impact that would result from its
promulgation.
List of Subjects in 49 CFR Part 391
Alcohol abuse, Drug abuse, Drug testing, Highway safety, Motor
carriers, Reporting and recordkeeping requirements, Safety,
Transportation.
PART 391--QUALIFICATIONS OF DRIVERS AND LONGER COMBINATION VEHICLE
(LCV) DRIVER INSTRUCTORS
0
1. The authority citation for part 391 continues to read as follows:
Authority: 49 U.S.C. 504, 508, 31133, 31136, 31149, 31502; sec.
4007(b), Pub. L. 102-240, 105 Stat. 1914, 2152; sec. 114, Pub. L.
103-311, 108 Stat. 1673, 1677; sec. 215, Pub. L. 106-159, 113 Stat.
1748, 1767; sec.
[[Page 47520]]
32934, Pub. L. 112-141, 126 Stat. 405, 830; secs. 5403 and 5524,
Pub. L. 114-94, 129 Stat. 1312, 1548, 1560; sec. 2, Pub. L. 115-105,
131 Stat. 2263; and 49 CFR 1.87.
0
2. Revise Sec. 391.41(b)(3) to read as follows:
Sec. 391.41 Physical qualifications for drivers.
* * * * *
(b) * * *
(3) Has no established medical history or clinical diagnosis of
diabetes mellitus currently treated with insulin for control, unless
the person meets the requirements in Sec. 391.46;
* * * * *
0
3. Revise Sec. 391.45 to read as follows:
Sec. 391.45 Persons who must be medically examined and certified.
The following persons must be medically examined and certified in
accordance with Sec. 391.43 as physically qualified to operate a
commercial motor vehicle:
(a) Any person who has not been medically examined and certified as
physically qualified to operate a commercial motor vehicle;
(b) Any driver who has not been medically examined and certified as
qualified to operate a commercial motor vehicle during the preceding 24
months, unless the driver is required to be examined and certified in
accordance with paragraph (c), (d), (e), (f), or (g) of this section;
(c) Any driver authorized to operate a commercial motor vehicle
only within an exempt intra-city zone pursuant to Sec. 391.62, if such
driver has not been medically examined and certified as qualified to
drive in such zone during the preceding 12 months;
(d) Any driver authorized to operate a commercial motor vehicle
only by operation of the exemption in Sec. 391.64, if such driver has
not been medically examined and certified as qualified to drive during
the preceding 12 months;
(e) Any driver who has diabetes mellitus treated with insulin for
control and who has obtained a medical examiner's certificate under the
standards in Sec. 391.46, if such driver's most recent medical
examination and certification as qualified to drive did not occur
during the preceding 12 months;
(f) Any driver whose ability to perform his or her normal duties
has been impaired by a physical or mental injury or disease; and
(g) Beginning June 22, 2021, any person found by a medical examiner
not to be physically qualified to operate a commercial motor vehicle
under the provisions of paragraph (g)(3) of Sec. 391.43.
0
4. Add Sec. 391.46 to read as follows:
Sec. 391.46 Physical qualification standards for an individual with
diabetes mellitus treated with insulin for control.
(a) Diabetes mellitus treated with insulin. An individual with
diabetes mellitus treated with insulin for control is physically
qualified to operate a commercial motor vehicle provided:
(1) The individual otherwise meets the physical qualification
standards in Sec. 391.41 or has an exemption or skill performance
evaluation certificate, if required; and
(2) The individual has the evaluation required by paragraph (b) and
the medical examination required by paragraph (c) of this section.
(b) Evaluation by the treating clinician. Prior to the examination
required by Sec. 391.45 or the expiration of a medical examiner's
certificate, the individual must be evaluated by his or her ``treating
clinician.'' For purposes of this section, ``treating clinician'' means
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.
(1) During the evaluation of the individual, the treating clinician
must complete the Insulin-Treated Diabetes Mellitus Assessment Form,
MCSA-5870.
(2) Upon completion of the Insulin-Treated Diabetes Mellitus
Assessment Form, MCSA-5870, the treating clinician must sign and date
the Form and provide his or her full name, office address, and
telephone number on the Form.
(c) Medical examiner's examination. At least annually, but no later
than 45 days after the treating clinician signs and dates the Insulin-
Treated Diabetes Mellitus Assessment Form, MCSA-5870, an individual
with diabetes mellitus treated with insulin for control must be
medically examined and certified by a medical examiner as physically
qualified in accordance with Sec. 391.43 and as free of complications
from diabetes mellitus that might impair his or her ability to operate
a commercial motor vehicle safely.
(1) The medical examiner must receive a completed Insulin-Treated
Diabetes Mellitus Assessment Form, MCSA-5870, signed and dated by the
individual's treating clinician for each required examination. This
Form shall be treated and retained as part of the Medical Examination
Report Form, MCSA-5875.
(2) The medical examiner must determine whether the individual
meets the physical qualification standards in Sec. 391.41 to operate a
commercial motor vehicle. In making that determination, the medical
examiner must consider the information in the Insulin-Treated Diabetes
Mellitus Assessment Form, MCSA-5870, signed by the treating clinician
and, utilizing independent medical judgment, apply the following
qualification standards in determining whether the individual with
diabetes mellitus treated with insulin for control may be certified as
physically qualified to operate a commercial motor vehicle.
(i) The individual is not physically qualified to operate a
commercial motor vehicle if he or she is not maintaining a stable
insulin regimen and not properly controlling his or her diabetes
mellitus.
(ii) The individual is not physically qualified on a permanent
basis to operate a commercial motor vehicle if he or she has either
severe non-proliferative diabetic retinopathy or proliferative diabetic
retinopathy.
(iii) The individual is not physically qualified to operate a
commercial motor vehicle up to the maximum 12-month period under Sec.
391.45(e) until he or she provides the treating clinician with at least
the preceding 3 months of electronic blood glucose self-monitoring
records while being treated with insulin that are generated in
accordance with paragraph (d) of this section.
(iv) The individual who does not provide the treating clinician
with at least the preceding 3 months of electronic blood glucose self-
monitoring records while being treated with insulin that are generated
in accordance with paragraph (d) of this section is not physically
qualified to operate a commercial motor vehicle for more than 3 months.
If 3 months of compliant electronic blood glucose self-monitoring
records are then provided by the individual to the treating clinician
and the treating clinician completes a new Insulin-Treated Diabetes
Mellitus Assessment Form, MCSA-5870, the medical examiner may issue a
medical examiner's certificate that is valid for up to the maximum 12-
month period allowed by Sec. 391.45(e) and paragraph (c)(iv) of this
section.
(d) Blood glucose self-monitoring records. Individuals with
diabetes mellitus treated with insulin for control must self-monitor
blood glucose in accordance with the specific treatment plan prescribed
by the treating clinician. Such individuals must maintain blood glucose
records measured with an electronic glucometer that stores all
readings, that records the date and time of readings, and from which
data can be electronically downloaded. A printout of the electronic
blood glucose records
[[Page 47521]]
or the glucometer must be provided to the treating clinician at the
time of any of the evaluations required by this section.
(e) Severe hypoglycemic episodes. (1) An individual with diabetes
mellitus treated with insulin for control who experiences a severe
hypoglycemic episode after being certified as physically qualified to
operate a commercial motor vehicle is prohibited from operating a
commercial motor vehicle, and must report such occurrence to and be
evaluated by a treating clinician as soon as is reasonably practicable.
A severe hypoglycemic episode is one that requires the assistance of
others, or results in loss of consciousness, seizure, or coma. The
prohibition on operating a commercial motor vehicle continues until a
treating clinician:
(i) Has determined that the cause of the severe hypoglycemic
episode has been addressed;
(ii) Has determined that the individual is maintaining a stable
insulin regimen and proper control of his or her diabetes mellitus; and
(iii) Completes a new Insulin-Treated Diabetes Mellitus Assessment
Form, MCSA-5870.
(2) The individual must retain the Form and provide it to the
medical examiner at the individual's next medical examination.
0
5. Amend Sec. 391.64 as follows:
0
a. Revise paragraph (a) introductory text and add paragraph (a)(3); and
0
b. Effective November 19, 2019, remove and reserve paragraph (a).
The revision and addition read as follows:
Sec. 391.64 Grandfathering for certain drivers participating in
vision and diabetes waiver study programs.
(a) Until November 19, 2019, the provisions of Sec. 391.41(b)(3)
do not apply to a driver who was a participant in good standing on
March 31, 1996, in a waiver study program concerning the operation of
commercial motor vehicles by insulin-controlled diabetic drivers;
provided:
* * * * *
(3) On November 19, 2019, the provisions of paragraph (a) of this
section are removed, and any medical examiner's certificate issued
under Sec. 391.43 of this part on the basis that the driver is
qualified by operation of the provisions of 49 CFR 391.64(a), related
to insulin-controlled diabetic drivers, is void.
* * * * *
Appendix A to Part 391 [Amended]
0
6. Remove and reserve paragraph II.C. of appendix A to part 391.
Issued under authority delegated in 49 CFR 1.87 on September 11,
2018.
Raymond P. Martinez,
Administrator, FMCSA.
[FR Doc. 2018-20161 Filed 9-18-18; 8:45 am]
BILLING CODE 4910-EX-P