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.

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

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.

    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

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.

    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.

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

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.
---------------------------------------------------------------------------

    \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

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

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

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

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.

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

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\
---------------------------------------------------------------------------

    \30\ The opportunity cost of drivers' time is estimated in RIA
Section 2.6.1.
---------------------------------------------------------------------------

     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).
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     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

$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.

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/[email protected]/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.

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.

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