Qualifications of Drivers; Diabetes Standard, 13801-13805 [06-2417]
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Federal Register / Vol. 71, No. 52 / Friday, March 17, 2006 / Proposed Rules
Authority: 16 U.S.C. 1, 3, 9a, 460(q),
462(k); Sec. 7.96 also issued under D.C. Code
8–137 (1981) and D.C. Code 40–721 (1981).
2. Amend § 7.51 by adding paragraph
(d) to read as follows:
§ 7.51
Curecanti Recreation Area.
*
*
*
*
(d) Personal Watercraft (PWC). PWC
may operate within Curecanti National
Recreation Area in the following
designated areas and under the
following conditions:
(1) PWC may operate and land on
Blue Mesa Reservoir between Beaver
Creek and Blue Mesa dam.
(2) PWC must operate at ‘‘flat wake’’
speeds within Blue Mesa Reservoir in
the following areas upstream of
designated buoys:
(i) Soap Creek arm at approximate
longitude 107°8′9″ N latitude 38°30′16″
W.
(ii) West Elk arm at approximate
longitude 107°16′45″ N latitude
38°29′43″ W.
(iii) Cebolla arm at approximate
longitude 107°12′16″ N latitude
38°27′37″ W.
(iv) Lake Fork arm at approximate
longitude 107°18′19″ N latitude 38°27′2″
W.
(3) PWC must operate at ‘‘flat wake’’
speeds in the following areas:
(i) Within 100′ of shoreline inside Dry
Creek cove.
(ii) Within 500′ of shoreline along old
highway 50 and Bay of Chickens.
(iii) At Elk Creek and Lake Fork
marinas.
(iv) At Iola, Steven’s Creek, and
Ponderosa boat launch areas.
(v) From Lake city bridge east to
Beaver’s Creek.
(vi) Within 100′ of shoreline adjacent
to Steven’s Creek campground.
(4) PWC may be launched from the
following launch ramps:
(i) Elk Creek Marina.
(ii) Lake Fork Marina.
(iii) Iola.
(iv) Steven’s Creek.
(v) Ponderosa.
(5) The Superintendent may
temporarily limit, restrict or terminate
access to the areas designated for PWC
use after taking into consideration
public health and safety, natural and
cultural resource protection, and other
management activities and objectives.
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Dated: March 8, 2006.
Paul Hoffman,
Deputy Assistant Secretary for Fish and
Wildlife and Parks.
[FR Doc. E6–3938 Filed 3–16–06; 8:45 am]
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DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety
Administration
49 CFR Part 391
[Docket No. FMCSA–2005–23151]
RIN 2126–AA95
Qualifications of Drivers; Diabetes
Standard
Federal Motor Carrier Safety
Administration (FMCSA), DOT.
ACTION: Advance notice of proposed
rulemaking (ANPRM); request for
comments.
AGENCY:
SUMMARY: FMCSA announces that it is
considering whether to amend its
medical qualifications standards to
allow the operation of commercial
motor vehicles (CMVs) in interstate
commerce by drivers with insulintreated diabetes mellitus (ITDM) whose
physical conditions are adequate to
allow them to operate safely and
without deleterious effects on their
health. At present, drivers with ITDM
are required to obtain exemptions before
operating CMVs. Upon completion of
this rulemaking, drivers with ITDM
might not be required to apply for
exemptions from the current rule
prohibiting such drivers from operating
in interstate commerce. However, unless
and until the agency changes the current
standard in this rulemaking, drivers
with ITDM are prohibited from
operating CMVs in interstate commerce,
unless such individuals have
exemptions from FMCSA. Any action to
revise the current standard would be
made in conformity with the changes in
FMCSA’s existing authority to establish,
review and revise physical and medical
qualification standards for drivers made
by the Safe, Accountable, Flexible and
Efficient Transportation Equity Act: A
Legacy for Users (SAFETEA–LU), which
added, among other changes, a
requirement that the standards be
developed with the assistance of expert
medical advice.
DATES: You must submit comments
concerning this ANPRM on or before
June 15, 2006.
ADDRESSES: You may submit comments
to the DOT Docket Management System
Number in the heading of this document
by any of the following methods. Do not
submit the same comments by more
than one method. However, in order to
allow effective public participation in
this rulemaking before the comment
period deadline, the Agency encourages
use of the Web site that is listed first.
It will provide the most efficient and
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timely method of receiving and
processing your comments.
• The Web site: https://dms.dot.gov.
Follow the instructions for submitting
comments on the DOT electronic docket
site.
• Fax: 1–202–493–2251.
• Mail: Docket Management Facility;
U.S. Department of Transportation, 400
Seventh Street, SW., Nassif Building,
Room PL–401, Washington, DC 20590–
0001.
• Hand Delivery: Room PL–401 on
the plaza level of the Nassif Building,
400 Seventh Street, SW., Washington,
DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal
Holidays.
• Federal eRulemaking Portal: Go to
https://www.regulations.gov. Follow the
online instructions for submitting
comments.
Instructions: All submissions must
include the organization name and
docket number or Regulatory
Identification Number for this
regulatory action. Note that all
comments received will be posted
without change to https://dms.dot.gov,
including any personal information
provided. Refer to the Privacy Act
heading for further information. If
addressing a specific request for
comments in this ANPRM, please
clearly identify the related section
heading or question number for each
topic addressed in your comments.
Docket: For access to the docket to
read background documents or
comments received, go to https://
dms.dot.gov at any time or to Room PL–
401 on the plaza level of the Nassif
Building, 400 Seventh Street, SW.,
Washington, DC, between 9 a.m. and 5
p.m., Monday through Friday, except
Federal holidays.
Private Act: Anyone is able to search
the electronic form of all comments
received into any of our dockets by the
name of the individual submitting the
comment (or signing the comment, if
submitted on behalf of an association,
business, labor union, etc.). You may
review DOT’s complete Privacy Act
Statement in the Federal Register
published on April 11, 2000 (65 FR
19477) or you may visit https://
dms.dot.gov.
Comments received after the comment
closing date will be included in the
docket and the agency will consider late
comments to the extent practicable.
FMCSA may, however, issue a notice of
proposed rulemaking at any time after
the close of the comment period.
FOR FURTHER INFORMATION CONTACT: Dr.
Mary D. Gunnels, Chief, Physical
Qualifications Division, FMCSA, 400
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Federal Register / Vol. 71, No. 52 / Friday, March 17, 2006 / Proposed Rules
Seventh Street, SW., Room 8301,
Washington, DC 20590; (202) 366–4001.
SUPPLEMENTARY INFORMATION: Copies or
abstracts of all documents referenced in
this notice are in the docket for this
rulemaking: FMCSA–2005–23151.
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Legal Basis for the Rulemaking
FMCSA has authority (delegated from
the Secretary of Transportation
(Secretary) by 49 CFR 1.73) to establish
the minimum qualifications, including
medical and physical qualifications, for
drivers of CMVs operated in interstate
commerce. 49 U.S.C. 31136(a)(3) and
31502(b). As amended by section
4116(b) of SAFETEA–LU, (Pub. L. 109–
59, 119 Stat. 1728, Aug. 10, 2005),
section 31136(a)(3) requires that, at a
minimum, safety regulations shall
ensure that the physical conditions of
operators of CMVs adequately enable
them to operate the vehicles safely and
that the periodic physical examinations
required of such operators are
performed by medical examiners who
have received training in physical and
medical examination standards.
These new provisions added by
SAFETEA–LU are clearly intended to
ensure that the Federal Motor Carrier
Safety Regulations (‘‘FMCSRs’’) contain
physical qualification standards that
reflect the advice of the agency’s newly
authorized Medical Review Board and
Chief Medical Examiner. 49 U.S.C.
31149(a) and (b).1 Under new section
31149(c), the Agency, with the advice of
the board and the chief medical
examiner, is directed to ‘‘establish,
review and revise * * * medical
standards for operators of commercial
motor vehicles that will ensure that the
physical condition of operators of
commercial motor vehicles is adequate
to enable them to operate the vehicles
safely.’’ The purpose of these provisions
in section 31149 is to ensure that the
physical and medical qualifications
standards for CMV drivers reflect up-to
date, expert medical advice drawn from
‘‘expertise in a variety of medical
specialties relevant to the driver fitness
requirements.’’ 49 U.S.C. 31149(a)(2)
and House Conf. Report No. 109–203
(July 28, 2005) at 990.
In addition to the statutory factors
that are specific to the physical
qualifications of CMV drivers, FMCSA
must also consider another factor. Any
physical and medical qualifications it
1 New section 31149, added by section 4116(a) of
SAFETEA–LU, becomes effective on August 10,
2006, in accordance with section 4116(f), 119 Stat.
1728, (Aug. 10, 2005) (set out as a note to 49 U.S.C.
31149). However, FMCSA has already announced
the establishment of the Medical Review Board
under the Federal Advisory Committee Act. 70 FR
57642 (Oct. 3, 2005).
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establishes or revises must ensure, at a
minimum, that ‘‘the operation of
commercial motor vehicles does not
have a deleterious effect on the physical
condition of operators’’ as required by
49 U.S.C. 31136(a)(4) and Public Citizen
et al. v. Federal Motor Carrier Safety
Administration, 374 F.3d 1209, 1216
(D.C. Cir. 2004). The D.C. Circuit noted,
in that case however, that it was not
‘‘suggest[ing] that the statute requires
the agency to protect driver health to the
exclusion of those other factors [i.e., the
costs and benefits of the rule], only that
the agency must consider it.’’ Id. at 1217
(emphasis in original). In order to
properly consider this factor in
developing physical qualifications
standards the agency must consider
both (1) the effect of driver health on the
safety of commercial motor vehicle
operations; and (2) the effect of such
operations on driver health.
Finally, before prescribing any
regulations, FMCSA must also consider
their ‘‘costs and benefits’’ 49 U.S.C.
31136(c)(2)(A) and 31502(d). Those
factors are also discussed in the
Rulemaking Analysis section.
History of Federal Regulation of Drivers
With Insulin-Treated Diabetes Mellitus
Beginning in 1940, under the
Interstate Commerce Commission’s
Motor Carrier Safety Regulations (4 FR
2294, June 7, 1939, effective date
January 1, 1940), CMV drivers have
been subject to urine glucose tests as
part of medical examinations for
determining whether a person is
physically qualified to drive in
interstate or foreign commerce. Starting
in 1971 (35 FR 6458, April 22, 1970,
effective date January 1, 1971), the
Federal Highway Administration
(FHWA) (the predecessor to FMCSA)
established the current standard for
drivers with ITDM. This standard states
that a ‘‘person is physically qualified to
drive a commercial motor vehicle if that
person has no established medical
history or clinical diagnosis of diabetes
mellitus currently requiring insulin for
control.’’ 49 CFR 391.41(b)(3). FHWA
established the standard, in consultation
with medical advisers, mainly because
several crash studies indicated that
drivers with ITDM had higher rates of
crashes compared to the general driving
population.
FHWA then became engaged in
several activities to address the issue of
drivers with ITDM and CMV operation.
On March 28, 1977, FHWA published
an ANPRM to solicit comments on the
standard for drivers with ITDM (42 FR
16452). It terminated the rulemaking in
November 1977 without amending the
standard, after determining that the
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more substantive comments and the
literature cited in the ANPRM
supported the prohibition against the
operation of CMVs by drivers with
ITDM because of highway safety
concerns (42 FR 57488). On November
25, 1987, the agency published a new
ANPRM (52 FR 45204) requesting
comments on petitions from two
individuals and the American Diabetes
Association to eliminate the blanket
prohibition against drivers with ITDM
and to grant waivers on a case-by-case
basis.
In September 1987, the Conference on
Diabetic Disorders and Commercial
Drivers was held to review the drivers
with ITDM standard in light of advances
in the care of individuals with ITDM.
Conference participants (physicians,
scientists, Federal officials and
representatives from the motor carrier
industry) recommended that some
drivers with ITDM could be qualified to
drive depending upon insulin use and
under certain conditions (e.g., absence
of recurrent hypoglycemia, safe driving
record) (FHWA, Conference on Diabetic
Disorders and Commercial Drivers;
Final Report, 1988). Following the
conference, FHWA published a Notice
of Proposed Rulemaking (55 FR 41028,
Oct. 5, 1990) requesting comments on a
proposal to revise the drivers with
ITDM standard to allow individuals
with ITDM to operate CMVs and
sponsored a 1990 risk assessment that
estimated various levels of crashes
among drivers with ITDM depending
upon the severity of hypoglycemia
(Federal Highway Administration,
Insulin-using Commercial Motor
Vehicle Drivers, 1992). The level of
crashes of drivers with ITDM was
similar to that of drivers without
diabetes mellitus. FHWA published a
Notice of Intent to Issue Waivers on
October 21, 1992 (57 FR 48011). This
led to the July 29, 1993 waiver program
(58 FR 40690), including the waiver
requirements that a driver with ITDM
have a three-year safe driving record
while using insulin and regular medical
examinations by a board-certified or
board-eligible endocrinologist.
The diabetes waiver program was
terminated in 1996 in response to a
ruling from the U.S. Court of Appeals
for the District of Columbia Circuit. In
Advocates for Highway and Auto Safety
v. FHWA, 28 F.3d 1288 (D.C. Cir. 1994),
the court held that the vision waiver
program was not consistent with the
statutory standard that required that a
waiver be ‘‘consistent with the safe
operation of commercial motor
vehicles.’’ 28 F.3d at 1293 (quoting
former 49 U.S.C. App. 2505(f)).
Although the decision initially affected
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only the vision waiver program, it had
an impact on the diabetes program
because of the similar approach used to
determine driver eligibility. Those
drivers holding waivers at the program’s
termination were allowed to continue to
operate CMVs in interstate commerce
under the grandfather provisions of 49
CFR 391.64.
In 1998, section 4018 of the
Transportation Equity Act for the 21st
Century, Public Law 105–178, 112 Stat.
413–4 (TEA–21) (set out as a note to 49
U.S.C. 31305) directed the Secretary to
determine the feasibility to develop ‘‘a
practicable and cost-effective screening,
operating and monitoring protocol’’ for
allowing drivers with ITDM to operate
CMVs in interstate commerce ‘‘that
would ensure a level of safety equal to
or greater than that achieved with the
current prohibition on individuals with
insulin treated diabetes mellitus driving
such vehicles.’’ As directed by section
4018, FHWA compiled and evaluated
the available research and information.
It assembled a panel of medical experts
in the treatment of diabetes to
investigate and report on the issues
concerned with the treatment, medical
screening and monitoring of ITDM
individuals in the context of operating
CMVs. FMCSA then submitted to
Congress in July 2000 a report entitled
‘‘A Report to Congress on the Feasibility
of a Program to Qualify Individuals with
Insulin Treated Diabetes Mellitus to
Operate Commercial Motor Vehicles in
Interstate Commerce as Directed by the
Transportation Equity Act for the 21st
Century,’’ (TEA–21 Report to Congress).
The motor carrier regulatory functions
of the FHWA were transferred to the
FMCSA in the Motor Carrier Safety
Improvement Act of 1999, Public Law
106–159, 113 Stat. 1748, Dec. 9, 1999.
The Report to Congress concluded that
it is feasible to establish a safe and
practicable protocol with three
components that would allow some
drivers with ITDM to operate CMVs.
The three components included
screening of qualified drivers,
establishing operational requirements
ensuring proper disease management by
such drivers, and monitoring of safe
driving behavior and proper disease
management. For a detailed discussion
of the report’s findings and conclusions,
refer to the notice published at 66 FR
39548 (July 31, 2001). The TEA–21
Report to Congress can be accessed in
the docket in the heading of this notice
FMCSA–2005–23151, item 1, in the
DOT Docket Management System at:
https://dmses.dot.gov/docimages/p64/
139973.tif; or https://dmses.dot.gov/
docimages/pdf71/139973_web.pdf; or
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on FMCSA’s Web site at: https://
www.fmcsa.dot.gov/facts-research/
research-technology/publications/
medreports.htm.
As a result of the conclusions found
in the TEA–21 Report to Congress, the
July 31, 2001 notice proposed to
implement those conclusions and
recommendations by issuing
exemptions from the FMCSRs to allow
operations of CMVs by drivers with
ITDM. After receiving and considering
comments on the proposed use of
exemptions to implement the TEA–21
Report to Congress, FMCSA issued a
Notice of Final Disposition establishing
the procedures and protocols for
implementing the exemptions for
drivers with ITDM. 68 FR 52441
(September 3, 2003) (‘‘2003 Notice’’). In
order to obtain an exemption, a CMV
driver with ITDM must follow the basic
requirements for obtaining an
exemption set out in 49 CFR part 381,
subpart C. FMCSA may not grant an
exemption unless it would maintain a
level of safety equivalent to, or greater
than, the level achieved without the
exemption. 49 U.S.C. 31315 and 49 CFR
381.305(a).
In conformity with the conclusions of
the TEA–21 Report to Congress, the
2003 Notice implemented, with a few
modifications, the three components of
the protocol recommended in the report,
to allow drivers with ITDM to be
qualified with an exemption from the
FMCSRs to operate CMVs. FMCSA
published the first notice granting
exemptions to four drivers with ITDM
on September 2, 2005 (70 FR 52465),
after notice and opportunity for public
comment on May 5, 2005 (70 FR 23904).
Safe, Accountable, Flexible, Efficient
Transportation Equity Act: A Legacy for
Users (SAFETEA–LU)
Section 4129 of SAFETEA–LU
required FMCSA to begin, within 90
days of enactment, to revise the 2003
Notice to allow drivers who use insulin
to treat diabetes to operate CMVs in
interstate commerce. The revision must
provide for individual assessment of
drivers with ITDM, and be consistent
with the criteria described in section
4018 of TEA–21. Section 4129 required
two substantive changes to be made in
the exemption process set out in the
2003 Notice.2
In order to accomplish these changes
within the 90-day time frame
established by section 4129, FMCSA
made immediate revisions to the
2 Section 4129(a) refers to the 2003 Notice as a
‘‘final rule.’’ However, as indicated above, the 2003
Notice did not issue a ‘‘final rule’’ but did establish
the procedures and standards for issuing
exemptions for drivers with ITDM.
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diabetes exemption program established
by the 2003 Notice. These revisions by
FMCSA were necessary to respond to
the specific changes mandated by
section 4129(b) and (c). The changes are:
(1) Elimination of the requirement for
three years of experience operating
CMVs while being treated with insulin;
and (2) establishment of a specified
minimum period of insulin use to
demonstrate stable control of diabetes
before being allowed to operate a CMV.
Section 4129(d) also directed FMCSA
to ensure that CMV drivers with ITDM
are not held to a higher standard than
other drivers, with the exception of
limited operating, monitoring and
medical requirements that are deemed
medically necessary. FMCSA concluded
that all of the operating, monitoring and
medical requirements set out in the
2003 Notice, except as modified, were
in compliance with section 4129(d). All
of the requirements set out in the 2003
Notice, other than those modified in the
Notice in the Federal Register on
November 8, 2005 (70 FR 67777),
remain in effect.
The changes to the exemption
program (i.e., elimination of the
requirement for three years of
experience and establishment of a
specified minimum period of insulin
use) became effective upon publication
of the November 8, 2005 Notice. As this
ANPRM indicates, FMCSA is
considering whether to revise the
FMCSRs to allow certain drivers with
ITDM to operate CMVs in interstate
commerce. Unless and until the agency
issues a final rule, however, drivers
with ITDM must continue to hold
exemptions from the application of 49
CFR 391.41(b)(3) to operate in interstate
commerce.
Requests for Information and
Comments
FMCSA requests responses to the
following questions, as well as
comments and data on other issues
related to CMV drivers with ITDM who
operate in interstate commerce:
(1) Currently, CMV drivers with ITDM
must hold an exemption from the ITDM
prohibition to operate in interstate
commerce. What modifications to the
ITDM prohibition in 49 CFR 391.41
should FMCSA consider to enable such
drivers to operate safely in interstate
commerce without an exemption?
(2) How should FMCSA ensure that
health care professionals who might be
applying any revised standards do so in
a consistent and appropriate manner
which ensures both that the physical
conditions of such drivers are adequate
to enable them to operate safely and that
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the operation of CMVs is not deleterious
to their health?
(3) FMCSA also requests public
comments on the changes made in the
current exemption program for CMV
drivers with ITDM that were made by
the November 8, 2005 Notice.
(4) Should FMCSA allow medical
examiners to assume responsibility for
making an individual determination of
the ITDM driver’s ability to manage this
health condition, or should the agency
require the physician responsible for
treating the driver’s ITDM to certify the
driver meets the revised diabetes
standard?
(5) Should the agency revise the
medical certificate to be issued by the
medical examiner to a driver with ITDM
to include certification from the
‘‘treating physician’’ in addition to the
medical examiner?
(6) Each medical examiner has
discretion to set the expiration date on
a driver’s medical certificate so that it is
valid for any period up to 24 months,
based on the examiner’s determination
of how often a driver needs to be reexamined, such as for a specific health
condition (e.g., hypertension). What
should the Federal standard maximum
period of medical certification be for
drivers with ITDM?
(7) What changes in health condition
of drivers with ITDM (e.g.,
hypoglycemia-induced incidents)
should be reported? What changes in
crash/incident data (e.g., each crash)
should be reported? Who should be
responsible for such reports? To whom
should these reports be submitted?
(8) A number of States offer
exemption, waiver, or grandfather
programs for drivers with ITDM. Other
States do not allow drivers with ITDM
to operate without an exception/
exemption. Would States that prohibit
drivers with ITDM from operating CMVs
continue to do so or would States adopt
rules comparable with the new Federal
standard? How many drivers with ITDM
are currently operating commercially in
these States? If these States have any
evidence as to whether ITDM drivers
operating CMVs are as safe, safer, or less
safe than non-insulin-treated diabetic
drivers or non-diabetic drivers, FMCSA
would like these States to provide such
evidence or identify any sources where
FMCSA may obtain such evidence. Also
please describe any analysis that has
been done on these ITDM drivers, and
any special oversight that States
conduct.
(9) Should new and emerging
therapies for treatment of diabetes
mellitus be considered in reviewing and
revising the current standard? If so,
how? If a revised FMCSA standard for
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drivers with ITDM is established, how
would new and emerging therapies,
particularly injectable medications (e.g.,
incretin mimetics) and continuous
subcutaneous insulin infusion therapy,
affect the implementation of a new
standard?
(10) What quantitative data are there
on safety performance of drivers with
ITDM? Do these studies link efficacy of
medication and therapy with risk and
incidence of crashes in commercial and
non-commercial motor vehicles? If so,
how?
(11) How many individuals with
ITDM are likely to enter the motor
carrier occupation if the current medical
standards are changed to allow them to
drive in interstate commerce?
(12) The TEA–21 Report to Congress
discusses occupational and health risks
and challenges for individuals with
ITDM who operate CMVs. Are there
additional occupational and health risks
and challenges the TEA–21 Report to
Congress did not discuss? Are there
additional attributes of this occupation,
which may make it particularly difficult
for such drivers to manage their
condition? Are these attributes
characteristic of certain segments of the
industry? Should individuals with
ITDM be restricted to operating in only
certain segments of the industry (e.g.,
driving locally or short-haul, but not
long-haul)?
(13) What are the potential
operational stressors and physical
impacts associated with CMV driving
that may adversely impact a CMV
operator with ITDM? Please provide
references or available peer-reviewed
research data.
Rulemaking Analyses and Notices
Executive Order 12866 (Regulatory
Planning and Review) and DOT
Regulatory Policies and Procedures
FMCSA has determined this ANPRM
is a significant regulatory action within
the meaning of Executive Order 12866
and the Department of Transportation
regulatory policies and procedures (44
FR 11034, February 26, 1979). The
Office of Management and Budget has
reviewed this ANPRM as required by
Executive Order 12866.
The Agency is not yet in a position to
analyze fully any potential actions it
may initiate in response to this ANPRM.
FMCSA seeks comments on the
following issues to guide our analysis
for a potential notice of proposed
rulemaking:
(1) The costs and benefits of
potentially effective and reasonably
feasible alternatives to the current
regulations, including improving the
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current regulation and reasonably viable
non-regulatory actions; and
(2) Any preliminary impact
assessments of these regulatory and
non-regulatory alternatives on the
health of CMV drivers with ITDM.
Regulatory Flexibility Act
The Regulatory Flexibility Act (5
U.S.C. 601–612), as amended by the
Small Business Regulatory Enforcement
and Fairness Act (Pub. L. 104–121),
(RFA) requires Federal agencies to
analyze the impact of regulatory
alternatives on small entities, unless
FMCSA certifies that a regulatory
alternative will not have a significant
economic impact on a substantial
number of small entities, and to
consider non-regulatory alternatives that
could achieve our goal while
minimizing the burden on small
entities.
The Agency is not yet in a position to
analyze fully any potential actions it
may initiate in response to this ANPRM.
FMCSA requests comments and data
from the public on how potential
alternatives may impact small motor
carriers, including owner-operators,
who may employ or use a driver with
ITDM. This information would
represent a major input to estimating the
costs of any potential alternatives on
small entities. The agency also
specifically requests comments on the
benefits of potential alternatives. In
addition, FMCSA asks entities and
associations of small entities to identify
their gross revenues.
Executive Order 13132 (Federalism)
Although the agency believes there
are no Federalism issues, the agency is
not yet in a position to analyze fully any
potential actions in accordance with the
principles and criteria contained in
Executive Order 13132, (64 FR 43255,
August 10, 1999). As stated earlier in
this ANPRM, FMCSA and its
predecessors have regulated the
physical condition of drivers with ITDM
since 1971. The agency believes
regulating drivers with ITDM in
interstate commerce is an issue that is
national in scope. The agency
specifically requests comment from
State and local officials on any
Federalism issues.
Unfunded Mandates Reform Act of 1995
The Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4; 2 U.S.C. 1532)
requires each agency to assess the
effects of its regulatory actions on State,
local, and tribal governments and the
private sector. Any agency promulgating
a final rule likely to result in a Federal
mandate requiring expenditures by a
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Federal Register / Vol. 71, No. 52 / Friday, March 17, 2006 / Proposed Rules
State, local, or tribal government, or by
the private sector of $120.7 million or
more in 2003 dollars in any one year,
must prepare a written statement
incorporating various assessments,
estimates, and descriptions that are
delineated in the Act. Although FMCSA
believes there would be no unfunded
mandates arising from any change in the
current standard, the Agency is not yet
in a position to analyze fully any
potential actions it may initiate and that
may meet the requirements of the
Unfunded Mandates Reform Act.
FMCSA seeks specific comments
whether such impacts are likely for any
regulatory or non-regulatory alternative
for agency consideration.
Paperwork Reduction Act
Under the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501–3520), a Federal
agency must obtain approval from OMB
for each collection of information it
conducts, sponsors, or requires through
regulations.
Current exemption program
applicants provide personal, employee
health and driving information during
the application process. There may be
additional health information required
as a result of this rulemaking action.
The agency is not yet in a position to
analyze fully any potential action the
agency may initiate that may fall within
the scope of the Paperwork Reduction
Act. If FMCSA initiates a potential
regulatory alternative in the future,
incorporating these or other relevant
provisions, the Agency would seek
approval of any collection of
information requirements to generate,
maintain, retain, disclose, and provide
information to, or for, the agency under
49 CFR part 391.
erjones on PROD1PC68 with PROPOSALS
National Environmental Policy Act
It is not expected that this rulemaking
will have environmental impacts,
although the agency is not yet in a
position to analyze fully any potential
actions under the requirements of the
National Environmental Policy Act of
1969 (42 U.S.C. 4321–4370f) and our
environmental procedures Order 5610.1
(issued on March 1, 2004, 69 FR 9680).
The agency believes potential actions
the agency may initiate in response to
this ANPRM may be categorically
excluded (CE) from further
VerDate Aug<31>2005
15:20 Mar 16, 2006
Jkt 208001
environmental documentation under
Appendix 2.6.d. and 2.6.z. of Order
5610.1, which contain categorical
exclusions for regulations concerning
the training, qualifying, licensing,
certifying, and managing of personnel
and regulations establishing minimum
qualifications for persons who drive
CMVs as, for, or on behalf of motor
carriers. In addition, FMCSA believes
potential actions the agency may initiate
would not involve extraordinary
circumstances that would affect the
quality of the environment.
FMCSA is not yet in a position to
analyze fully any potential actions
under the requirements of the Clean Air
Act, as amended (CAA) section 176(c),
(42 U.S.C. 7401–7671) and
implementing regulations promulgated
by the Environmental Protection
Agency. FMCSA believes potential
actions the agency may initiate would
be exempt from the CAA’s General
conformity requirement since they
would involve policy development and
civil enforcement activities, such as
investigations, inspections,
examinations, and the training of law
enforcement personnel. See 40 CFR
93.153(c)(2). The agency anticipates
potential actions the agency may initiate
in response to this ANPRM would not
result in any emissions increase or
result in emissions that are above the
general conformity rule’s de minimis
emission threshold levels because
potential actions would merely establish
standards for drivers to control their
diabetes mellitus.
The agency seeks comment on the
effect on the environment of any
potential action alternatives.
Executive Order 12630 (Taking of
Private Property)
The Agency is not yet in a position to
analyze fully any potential actions that
may constitute a taking of private
property or otherwise have taking
implications under Executive Order
12630, Governmental Actions and
Interference with Constitutionally
Protected Property Rights. FMCSA seeks
comment on whether potential actions it
may initiate in response to this ANPRM
would constitute a taking of private
property or otherwise have implications
under Executive Order 12630.
PO 00000
Frm 00024
Fmt 4702
Sfmt 4702
13805
Executive Order 12372
(Intergovernmental Review)
The agency is not yet in a position to
analyze fully any potential actions that
may require intergovernmental
consultation on Federal programs and
activities under Executive Order 12372,
as amended. FMCSA seeks comment on
whether potential actions the agency
may initiate in response to this ANPRM
would require any intergovernmental
consultation on Federal programs and
activities under Executive Order 12372,
as amended.
Executive Order 13211 (Energy Supply,
Distribution, or Use)
FMCSA is not yet in a position to
analyze fully any potential actions that
may affect energy supply, distribution,
or use under Executive Order 13211,
Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use. The agency seeks
comment on whether potential actions
the agency may initiate in response to
this ANPRM would affect any regulatory
or non-regulatory alternatives that may
significantly affect energy supply,
distribution, or use.
Executive Order 12988 (Civil Justice
Reform)
The agency is not yet in a position to
analyze fully any potential actions that
may meet applicable standards in
sections 3(a) and 3(b)(2) of Executive
Order 12988, Civil Justice Reform, to
minimize litigation, eliminate
ambiguity, and reduce burden. The
agency seeks comment on whether
potential actions FMCSA may initiate in
response to this ANPRM would meet
the standards in Executive Order 12988.
List of Subjects in 49 CFR Part 391
Alcohol abuse, Diabetes, Drug abuse,
Drug testing, Highway safety, Medical,
Motor carriers, Physical qualifications,
Reporting and recordkeeping
requirements, Safety, Transportation.
Issued on: March 6, 2006.
Annette M. Sandberg,
Administrator.
[FR Doc. 06–2417 Filed 3–16–06; 8:45 am]
BILLING CODE 4910–EX–P
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Agencies
[Federal Register Volume 71, Number 52 (Friday, March 17, 2006)]
[Proposed Rules]
[Pages 13801-13805]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-2417]
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DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
49 CFR Part 391
[Docket No. FMCSA-2005-23151]
RIN 2126-AA95
Qualifications of Drivers; Diabetes Standard
AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.
ACTION: Advance notice of proposed rulemaking (ANPRM); request for
comments.
-----------------------------------------------------------------------
SUMMARY: FMCSA announces that it is considering whether to amend its
medical qualifications standards to allow the operation of commercial
motor vehicles (CMVs) in interstate commerce by drivers with insulin-
treated diabetes mellitus (ITDM) whose physical conditions are adequate
to allow them to operate safely and without deleterious effects on
their health. At present, drivers with ITDM are required to obtain
exemptions before operating CMVs. Upon completion of this rulemaking,
drivers with ITDM might not be required to apply for exemptions from
the current rule prohibiting such drivers from operating in interstate
commerce. However, unless and until the agency changes the current
standard in this rulemaking, drivers with ITDM are prohibited from
operating CMVs in interstate commerce, unless such individuals have
exemptions from FMCSA. Any action to revise the current standard would
be made in conformity with the changes in FMCSA's existing authority to
establish, review and revise physical and medical qualification
standards for drivers made by the Safe, Accountable, Flexible and
Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU),
which added, among other changes, a requirement that the standards be
developed with the assistance of expert medical advice.
DATES: You must submit comments concerning this ANPRM on or before June
15, 2006.
ADDRESSES: You may submit comments to the DOT Docket Management System
Number in the heading of this document by any of the following methods.
Do not submit the same comments by more than one method. However, in
order to allow effective public participation in this rulemaking before
the comment period deadline, the Agency encourages use of the Web site
that is listed first. It will provide the most efficient and timely
method of receiving and processing your comments.
The Web site: https://dms.dot.gov. Follow the instructions
for submitting comments on the DOT electronic docket site.
Fax: 1-202-493-2251.
Mail: Docket Management Facility; U.S. Department of
Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401,
Washington, DC 20590-0001.
Hand Delivery: Room PL-401 on the plaza level of the
Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9
a.m. and 5 p.m., Monday through Friday, except Federal Holidays.
Federal eRulemaking Portal: Go to https://
www.regulations.gov. Follow the online instructions for submitting
comments.
Instructions: All submissions must include the organization name
and docket number or Regulatory Identification Number for this
regulatory action. Note that all comments received will be posted
without change to https://dms.dot.gov, including any personal
information provided. Refer to the Privacy Act heading for further
information. If addressing a specific request for comments in this
ANPRM, please clearly identify the related section heading or question
number for each topic addressed in your comments.
Docket: For access to the docket to read background documents or
comments received, go to https://dms.dot.gov at any time or to Room PL-
401 on the plaza level of the Nassif Building, 400 Seventh Street, SW.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
Private Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477) or you may visit https://dms.dot.gov.
Comments received after the comment closing date will be included
in the docket and the agency will consider late comments to the extent
practicable. FMCSA may, however, issue a notice of proposed rulemaking
at any time after the close of the comment period.
FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Chief, Physical
Qualifications Division, FMCSA, 400
[[Page 13802]]
Seventh Street, SW., Room 8301, Washington, DC 20590; (202) 366-4001.
SUPPLEMENTARY INFORMATION: Copies or abstracts of all documents
referenced in this notice are in the docket for this rulemaking: FMCSA-
2005-23151.
Legal Basis for the Rulemaking
FMCSA has authority (delegated from the Secretary of Transportation
(Secretary) by 49 CFR 1.73) to establish the minimum qualifications,
including medical and physical qualifications, for drivers of CMVs
operated in interstate commerce. 49 U.S.C. 31136(a)(3) and 31502(b). As
amended by section 4116(b) of SAFETEA-LU, (Pub. L. 109-59, 119 Stat.
1728, Aug. 10, 2005), section 31136(a)(3) requires that, at a minimum,
safety regulations shall ensure that the physical conditions of
operators of CMVs adequately enable them to operate the vehicles safely
and that the periodic physical examinations required of such operators
are performed by medical examiners who have received training in
physical and medical examination standards.
These new provisions added by SAFETEA-LU are clearly intended to
ensure that the Federal Motor Carrier Safety Regulations (``FMCSRs'')
contain physical qualification standards that reflect the advice of the
agency's newly authorized Medical Review Board and Chief Medical
Examiner. 49 U.S.C. 31149(a) and (b).\1\ Under new section 31149(c),
the Agency, with the advice of the board and the chief medical
examiner, is directed to ``establish, review and revise * * * medical
standards for operators of commercial motor vehicles that will ensure
that the physical condition of operators of commercial motor vehicles
is adequate to enable them to operate the vehicles safely.'' The
purpose of these provisions in section 31149 is to ensure that the
physical and medical qualifications standards for CMV drivers reflect
up-to date, expert medical advice drawn from ``expertise in a variety
of medical specialties relevant to the driver fitness requirements.''
49 U.S.C. 31149(a)(2) and House Conf. Report No. 109-203 (July 28,
2005) at 990.
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\1\ New section 31149, added by section 4116(a) of SAFETEA-LU,
becomes effective on August 10, 2006, in accordance with section
4116(f), 119 Stat. 1728, (Aug. 10, 2005) (set out as a note to 49
U.S.C. 31149). However, FMCSA has already announced the
establishment of the Medical Review Board under the Federal Advisory
Committee Act. 70 FR 57642 (Oct. 3, 2005).
---------------------------------------------------------------------------
In addition to the statutory factors that are specific to the
physical qualifications of CMV drivers, FMCSA must also consider
another factor. Any physical and medical qualifications it establishes
or revises must ensure, at a minimum, that ``the operation of
commercial motor vehicles does not have a deleterious effect on the
physical condition of operators'' as required by 49 U.S.C. 31136(a)(4)
and Public Citizen et al. v. Federal Motor Carrier Safety
Administration, 374 F.3d 1209, 1216 (D.C. Cir. 2004). The D.C. Circuit
noted, in that case however, that it was not ``suggest[ing] that the
statute requires the agency to protect driver health to the exclusion
of those other factors [i.e., the costs and benefits of the rule], only
that the agency must consider it.'' Id. at 1217 (emphasis in original).
In order to properly consider this factor in developing physical
qualifications standards the agency must consider both (1) the effect
of driver health on the safety of commercial motor vehicle operations;
and (2) the effect of such operations on driver health.
Finally, before prescribing any regulations, FMCSA must also
consider their ``costs and benefits'' 49 U.S.C. 31136(c)(2)(A) and
31502(d). Those factors are also discussed in the Rulemaking Analysis
section.
History of Federal Regulation of Drivers With Insulin-Treated Diabetes
Mellitus
Beginning in 1940, under the Interstate Commerce Commission's Motor
Carrier Safety Regulations (4 FR 2294, June 7, 1939, effective date
January 1, 1940), CMV drivers have been subject to urine glucose tests
as part of medical examinations for determining whether a person is
physically qualified to drive in interstate or foreign commerce.
Starting in 1971 (35 FR 6458, April 22, 1970, effective date January 1,
1971), the Federal Highway Administration (FHWA) (the predecessor to
FMCSA) established the current standard for drivers with ITDM. This
standard states that a ``person is physically qualified to drive a
commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control.'' 49 CFR 391.41(b)(3). FHWA established the
standard, in consultation with medical advisers, mainly because several
crash studies indicated that drivers with ITDM had higher rates of
crashes compared to the general driving population.
FHWA then became engaged in several activities to address the issue
of drivers with ITDM and CMV operation. On March 28, 1977, FHWA
published an ANPRM to solicit comments on the standard for drivers with
ITDM (42 FR 16452). It terminated the rulemaking in November 1977
without amending the standard, after determining that the more
substantive comments and the literature cited in the ANPRM supported
the prohibition against the operation of CMVs by drivers with ITDM
because of highway safety concerns (42 FR 57488). On November 25, 1987,
the agency published a new ANPRM (52 FR 45204) requesting comments on
petitions from two individuals and the American Diabetes Association to
eliminate the blanket prohibition against drivers with ITDM and to
grant waivers on a case-by-case basis.
In September 1987, the Conference on Diabetic Disorders and
Commercial Drivers was held to review the drivers with ITDM standard in
light of advances in the care of individuals with ITDM. Conference
participants (physicians, scientists, Federal officials and
representatives from the motor carrier industry) recommended that some
drivers with ITDM could be qualified to drive depending upon insulin
use and under certain conditions (e.g., absence of recurrent
hypoglycemia, safe driving record) (FHWA, Conference on Diabetic
Disorders and Commercial Drivers; Final Report, 1988). Following the
conference, FHWA published a Notice of Proposed Rulemaking (55 FR
41028, Oct. 5, 1990) requesting comments on a proposal to revise the
drivers with ITDM standard to allow individuals with ITDM to operate
CMVs and sponsored a 1990 risk assessment that estimated various levels
of crashes among drivers with ITDM depending upon the severity of
hypoglycemia (Federal Highway Administration, Insulin-using Commercial
Motor Vehicle Drivers, 1992). The level of crashes of drivers with ITDM
was similar to that of drivers without diabetes mellitus. FHWA
published a Notice of Intent to Issue Waivers on October 21, 1992 (57
FR 48011). This led to the July 29, 1993 waiver program (58 FR 40690),
including the waiver requirements that a driver with ITDM have a three-
year safe driving record while using insulin and regular medical
examinations by a board-certified or board-eligible endocrinologist.
The diabetes waiver program was terminated in 1996 in response to a
ruling from the U.S. Court of Appeals for the District of Columbia
Circuit. In Advocates for Highway and Auto Safety v. FHWA, 28 F.3d 1288
(D.C. Cir. 1994), the court held that the vision waiver program was not
consistent with the statutory standard that required that a waiver be
``consistent with the safe operation of commercial motor vehicles.'' 28
F.3d at 1293 (quoting former 49 U.S.C. App. 2505(f)). Although the
decision initially affected
[[Page 13803]]
only the vision waiver program, it had an impact on the diabetes
program because of the similar approach used to determine driver
eligibility. Those drivers holding waivers at the program's termination
were allowed to continue to operate CMVs in interstate commerce under
the grandfather provisions of 49 CFR 391.64.
In 1998, section 4018 of the Transportation Equity Act for the 21st
Century, Public Law 105-178, 112 Stat. 413-4 (TEA-21) (set out as a
note to 49 U.S.C. 31305) directed the Secretary to determine the
feasibility to develop ``a practicable and cost-effective screening,
operating and monitoring protocol'' for allowing drivers with ITDM to
operate CMVs in interstate commerce ``that would ensure a level of
safety equal to or greater than that achieved with the current
prohibition on individuals with insulin treated diabetes mellitus
driving such vehicles.'' As directed by section 4018, FHWA compiled and
evaluated the available research and information. It assembled a panel
of medical experts in the treatment of diabetes to investigate and
report on the issues concerned with the treatment, medical screening
and monitoring of ITDM individuals in the context of operating CMVs.
FMCSA then submitted to Congress in July 2000 a report entitled ``A
Report to Congress on the Feasibility of a Program to Qualify
Individuals with Insulin Treated Diabetes Mellitus to Operate
Commercial Motor Vehicles in Interstate Commerce as Directed by the
Transportation Equity Act for the 21st Century,'' (TEA-21 Report to
Congress). The motor carrier regulatory functions of the FHWA were
transferred to the FMCSA in the Motor Carrier Safety Improvement Act of
1999, Public Law 106-159, 113 Stat. 1748, Dec. 9, 1999. The Report to
Congress concluded that it is feasible to establish a safe and
practicable protocol with three components that would allow some
drivers with ITDM to operate CMVs. The three components included
screening of qualified drivers, establishing operational requirements
ensuring proper disease management by such drivers, and monitoring of
safe driving behavior and proper disease management. For a detailed
discussion of the report's findings and conclusions, refer to the
notice published at 66 FR 39548 (July 31, 2001). The TEA-21 Report to
Congress can be accessed in the docket in the heading of this notice
FMCSA-2005-23151, item 1, in the DOT Docket Management System at:
https://dmses.dot.gov/docimages/p64/139973.tif; or https://dmses.dot.gov/
docimages/pdf71/139973_web.pdf; or on FMCSA's Web site at: https://
www.fmcsa.dot.gov/facts-research/research-technology/publications/
medreports.htm.
As a result of the conclusions found in the TEA-21 Report to
Congress, the July 31, 2001 notice proposed to implement those
conclusions and recommendations by issuing exemptions from the FMCSRs
to allow operations of CMVs by drivers with ITDM. After receiving and
considering comments on the proposed use of exemptions to implement the
TEA-21 Report to Congress, FMCSA issued a Notice of Final Disposition
establishing the procedures and protocols for implementing the
exemptions for drivers with ITDM. 68 FR 52441 (September 3, 2003)
(``2003 Notice''). In order to obtain an exemption, a CMV driver with
ITDM must follow the basic requirements for obtaining an exemption set
out in 49 CFR part 381, subpart C. FMCSA may not grant an exemption
unless it would maintain a level of safety equivalent to, or greater
than, the level achieved without the exemption. 49 U.S.C. 31315 and 49
CFR 381.305(a).
In conformity with the conclusions of the TEA-21 Report to
Congress, the 2003 Notice implemented, with a few modifications, the
three components of the protocol recommended in the report, to allow
drivers with ITDM to be qualified with an exemption from the FMCSRs to
operate CMVs. FMCSA published the first notice granting exemptions to
four drivers with ITDM on September 2, 2005 (70 FR 52465), after notice
and opportunity for public comment on May 5, 2005 (70 FR 23904).
Safe, Accountable, Flexible, Efficient Transportation Equity Act: A
Legacy for Users (SAFETEA-LU)
Section 4129 of SAFETEA-LU required FMCSA to begin, within 90 days
of enactment, to revise the 2003 Notice to allow drivers who use
insulin to treat diabetes to operate CMVs in interstate commerce. The
revision must provide for individual assessment of drivers with ITDM,
and be consistent with the criteria described in section 4018 of TEA-
21. Section 4129 required two substantive changes to be made in the
exemption process set out in the 2003 Notice.\2\
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\2\ Section 4129(a) refers to the 2003 Notice as a ``final
rule.'' However, as indicated above, the 2003 Notice did not issue a
``final rule'' but did establish the procedures and standards for
issuing exemptions for drivers with ITDM.
---------------------------------------------------------------------------
In order to accomplish these changes within the 90-day time frame
established by section 4129, FMCSA made immediate revisions to the
diabetes exemption program established by the 2003 Notice. These
revisions by FMCSA were necessary to respond to the specific changes
mandated by section 4129(b) and (c). The changes are: (1) Elimination
of the requirement for three years of experience operating CMVs while
being treated with insulin; and (2) establishment of a specified
minimum period of insulin use to demonstrate stable control of diabetes
before being allowed to operate a CMV.
Section 4129(d) also directed FMCSA to ensure that CMV drivers with
ITDM are not held to a higher standard than other drivers, with the
exception of limited operating, monitoring and medical requirements
that are deemed medically necessary. FMCSA concluded that all of the
operating, monitoring and medical requirements set out in the 2003
Notice, except as modified, were in compliance with section 4129(d).
All of the requirements set out in the 2003 Notice, other than those
modified in the Notice in the Federal Register on November 8, 2005 (70
FR 67777), remain in effect.
The changes to the exemption program (i.e., elimination of the
requirement for three years of experience and establishment of a
specified minimum period of insulin use) became effective upon
publication of the November 8, 2005 Notice. As this ANPRM indicates,
FMCSA is considering whether to revise the FMCSRs to allow certain
drivers with ITDM to operate CMVs in interstate commerce. Unless and
until the agency issues a final rule, however, drivers with ITDM must
continue to hold exemptions from the application of 49 CFR 391.41(b)(3)
to operate in interstate commerce.
Requests for Information and Comments
FMCSA requests responses to the following questions, as well as
comments and data on other issues related to CMV drivers with ITDM who
operate in interstate commerce:
(1) Currently, CMV drivers with ITDM must hold an exemption from
the ITDM prohibition to operate in interstate commerce. What
modifications to the ITDM prohibition in 49 CFR 391.41 should FMCSA
consider to enable such drivers to operate safely in interstate
commerce without an exemption?
(2) How should FMCSA ensure that health care professionals who
might be applying any revised standards do so in a consistent and
appropriate manner which ensures both that the physical conditions of
such drivers are adequate to enable them to operate safely and that
[[Page 13804]]
the operation of CMVs is not deleterious to their health?
(3) FMCSA also requests public comments on the changes made in the
current exemption program for CMV drivers with ITDM that were made by
the November 8, 2005 Notice.
(4) Should FMCSA allow medical examiners to assume responsibility
for making an individual determination of the ITDM driver's ability to
manage this health condition, or should the agency require the
physician responsible for treating the driver's ITDM to certify the
driver meets the revised diabetes standard?
(5) Should the agency revise the medical certificate to be issued
by the medical examiner to a driver with ITDM to include certification
from the ``treating physician'' in addition to the medical examiner?
(6) Each medical examiner has discretion to set the expiration date
on a driver's medical certificate so that it is valid for any period up
to 24 months, based on the examiner's determination of how often a
driver needs to be re-examined, such as for a specific health condition
(e.g., hypertension). What should the Federal standard maximum period
of medical certification be for drivers with ITDM?
(7) What changes in health condition of drivers with ITDM (e.g.,
hypoglycemia-induced incidents) should be reported? What changes in
crash/incident data (e.g., each crash) should be reported? Who should
be responsible for such reports? To whom should these reports be
submitted?
(8) A number of States offer exemption, waiver, or grandfather
programs for drivers with ITDM. Other States do not allow drivers with
ITDM to operate without an exception/exemption. Would States that
prohibit drivers with ITDM from operating CMVs continue to do so or
would States adopt rules comparable with the new Federal standard? How
many drivers with ITDM are currently operating commercially in these
States? If these States have any evidence as to whether ITDM drivers
operating CMVs are as safe, safer, or less safe than non-insulin-
treated diabetic drivers or non-diabetic drivers, FMCSA would like
these States to provide such evidence or identify any sources where
FMCSA may obtain such evidence. Also please describe any analysis that
has been done on these ITDM drivers, and any special oversight that
States conduct.
(9) Should new and emerging therapies for treatment of diabetes
mellitus be considered in reviewing and revising the current standard?
If so, how? If a revised FMCSA standard for drivers with ITDM is
established, how would new and emerging therapies, particularly
injectable medications (e.g., incretin mimetics) and continuous
subcutaneous insulin infusion therapy, affect the implementation of a
new standard?
(10) What quantitative data are there on safety performance of
drivers with ITDM? Do these studies link efficacy of medication and
therapy with risk and incidence of crashes in commercial and non-
commercial motor vehicles? If so, how?
(11) How many individuals with ITDM are likely to enter the motor
carrier occupation if the current medical standards are changed to
allow them to drive in interstate commerce?
(12) The TEA-21 Report to Congress discusses occupational and
health risks and challenges for individuals with ITDM who operate CMVs.
Are there additional occupational and health risks and challenges the
TEA-21 Report to Congress did not discuss? Are there additional
attributes of this occupation, which may make it particularly difficult
for such drivers to manage their condition? Are these attributes
characteristic of certain segments of the industry? Should individuals
with ITDM be restricted to operating in only certain segments of the
industry (e.g., driving locally or short-haul, but not long-haul)?
(13) What are the potential operational stressors and physical
impacts associated with CMV driving that may adversely impact a CMV
operator with ITDM? Please provide references or available peer-
reviewed research data.
Rulemaking Analyses and Notices
Executive Order 12866 (Regulatory Planning and Review) and DOT
Regulatory Policies and Procedures
FMCSA has determined this ANPRM is a significant regulatory action
within the meaning of Executive Order 12866 and the Department of
Transportation regulatory policies and procedures (44 FR 11034,
February 26, 1979). The Office of Management and Budget has reviewed
this ANPRM as required by Executive Order 12866.
The Agency is not yet in a position to analyze fully any potential
actions it may initiate in response to this ANPRM. FMCSA seeks comments
on the following issues to guide our analysis for a potential notice of
proposed rulemaking:
(1) The costs and benefits of potentially effective and reasonably
feasible alternatives to the current regulations, including improving
the current regulation and reasonably viable non-regulatory actions;
and
(2) Any preliminary impact assessments of these regulatory and non-
regulatory alternatives on the health of CMV drivers with ITDM.
Regulatory Flexibility Act
The Regulatory Flexibility Act (5 U.S.C. 601-612), as amended by
the Small Business Regulatory Enforcement and Fairness Act (Pub. L.
104-121), (RFA) requires Federal agencies to analyze the impact of
regulatory alternatives on small entities, unless FMCSA certifies that
a regulatory alternative will not have a significant economic impact on
a substantial number of small entities, and to consider non-regulatory
alternatives that could achieve our goal while minimizing the burden on
small entities.
The Agency is not yet in a position to analyze fully any potential
actions it may initiate in response to this ANPRM.
FMCSA requests comments and data from the public on how potential
alternatives may impact small motor carriers, including owner-
operators, who may employ or use a driver with ITDM. This information
would represent a major input to estimating the costs of any potential
alternatives on small entities. The agency also specifically requests
comments on the benefits of potential alternatives. In addition, FMCSA
asks entities and associations of small entities to identify their
gross revenues.
Executive Order 13132 (Federalism)
Although the agency believes there are no Federalism issues, the
agency is not yet in a position to analyze fully any potential actions
in accordance with the principles and criteria contained in Executive
Order 13132, (64 FR 43255, August 10, 1999). As stated earlier in this
ANPRM, FMCSA and its predecessors have regulated the physical condition
of drivers with ITDM since 1971. The agency believes regulating drivers
with ITDM in interstate commerce is an issue that is national in scope.
The agency specifically requests comment from State and local officials
on any Federalism issues.
Unfunded Mandates Reform Act of 1995
The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4; 2 U.S.C.
1532) requires each agency to assess the effects of its regulatory
actions on State, local, and tribal governments and the private sector.
Any agency promulgating a final rule likely to result in a Federal
mandate requiring expenditures by a
[[Page 13805]]
State, local, or tribal government, or by the private sector of $120.7
million or more in 2003 dollars in any one year, must prepare a written
statement incorporating various assessments, estimates, and
descriptions that are delineated in the Act. Although FMCSA believes
there would be no unfunded mandates arising from any change in the
current standard, the Agency is not yet in a position to analyze fully
any potential actions it may initiate and that may meet the
requirements of the Unfunded Mandates Reform Act. FMCSA seeks specific
comments whether such impacts are likely for any regulatory or non-
regulatory alternative for agency consideration.
Paperwork Reduction Act
Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), a
Federal agency must obtain approval from OMB for each collection of
information it conducts, sponsors, or requires through regulations.
Current exemption program applicants provide personal, employee
health and driving information during the application process. There
may be additional health information required as a result of this
rulemaking action. The agency is not yet in a position to analyze fully
any potential action the agency may initiate that may fall within the
scope of the Paperwork Reduction Act. If FMCSA initiates a potential
regulatory alternative in the future, incorporating these or other
relevant provisions, the Agency would seek approval of any collection
of information requirements to generate, maintain, retain, disclose,
and provide information to, or for, the agency under 49 CFR part 391.
National Environmental Policy Act
It is not expected that this rulemaking will have environmental
impacts, although the agency is not yet in a position to analyze fully
any potential actions under the requirements of the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f) and our
environmental procedures Order 5610.1 (issued on March 1, 2004, 69 FR
9680). The agency believes potential actions the agency may initiate in
response to this ANPRM may be categorically excluded (CE) from further
environmental documentation under Appendix 2.6.d. and 2.6.z. of Order
5610.1, which contain categorical exclusions for regulations concerning
the training, qualifying, licensing, certifying, and managing of
personnel and regulations establishing minimum qualifications for
persons who drive CMVs as, for, or on behalf of motor carriers. In
addition, FMCSA believes potential actions the agency may initiate
would not involve extraordinary circumstances that would affect the
quality of the environment.
FMCSA is not yet in a position to analyze fully any potential
actions under the requirements of the Clean Air Act, as amended (CAA)
section 176(c), (42 U.S.C. 7401-7671) and implementing regulations
promulgated by the Environmental Protection Agency. FMCSA believes
potential actions the agency may initiate would be exempt from the
CAA's General conformity requirement since they would involve policy
development and civil enforcement activities, such as investigations,
inspections, examinations, and the training of law enforcement
personnel. See 40 CFR 93.153(c)(2). The agency anticipates potential
actions the agency may initiate in response to this ANPRM would not
result in any emissions increase or result in emissions that are above
the general conformity rule's de minimis emission threshold levels
because potential actions would merely establish standards for drivers
to control their diabetes mellitus.
The agency seeks comment on the effect on the environment of any
potential action alternatives.
Executive Order 12630 (Taking of Private Property)
The Agency is not yet in a position to analyze fully any potential
actions that may constitute a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights. FMCSA seeks comment on whether potential actions it may
initiate in response to this ANPRM would constitute a taking of private
property or otherwise have implications under Executive Order 12630.
Executive Order 12372 (Intergovernmental Review)
The agency is not yet in a position to analyze fully any potential
actions that may require intergovernmental consultation on Federal
programs and activities under Executive Order 12372, as amended. FMCSA
seeks comment on whether potential actions the agency may initiate in
response to this ANPRM would require any intergovernmental consultation
on Federal programs and activities under Executive Order 12372, as
amended.
Executive Order 13211 (Energy Supply, Distribution, or Use)
FMCSA is not yet in a position to analyze fully any potential
actions that may affect energy supply, distribution, or use under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use. The agency
seeks comment on whether potential actions the agency may initiate in
response to this ANPRM would affect any regulatory or non-regulatory
alternatives that may significantly affect energy supply, distribution,
or use.
Executive Order 12988 (Civil Justice Reform)
The agency is not yet in a position to analyze fully any potential
actions that may meet applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden. The agency seeks comment on
whether potential actions FMCSA may initiate in response to this ANPRM
would meet the standards in Executive Order 12988.
List of Subjects in 49 CFR Part 391
Alcohol abuse, Diabetes, Drug abuse, Drug testing, Highway safety,
Medical, Motor carriers, Physical qualifications, Reporting and
recordkeeping requirements, Safety, Transportation.
Issued on: March 6, 2006.
Annette M. Sandberg,
Administrator.
[FR Doc. 06-2417 Filed 3-16-06; 8:45 am]
BILLING CODE 4910-EX-P