[Federal Register Volume 78, Number 73 (Tuesday, April 16, 2013)]
[Notices]
[Pages 22599-22602]
[FR Doc No: 2013-08881]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA- 2013-0016]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA).

ACTION: Notice of applications for exemption from the diabetes mellitus
requirement; request for comments.

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SUMMARY: FMCSA announces receipt of applications from 16 individuals
for exemption from the prohibition against persons with insulin-treated
diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) in
interstate commerce. If granted, the exemptions would enable these
individuals with ITDM to operate CMVs in interstate commerce.

DATES: Comments must be received on or before May 16, 2013.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2013-0016 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket numbers for this notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Federal Docket Management System (FDMS) is
available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the Federal Docket
Management System (FDMS) published in the Federal Register on December
29, 2010 (75 FR 82132), or you may visit http://www.gpo.gov/fdsys/pkg/FR-2010-12-29/pdf/2010-32876.pdf.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal Motor Carrier Safety Regulations for a 2-year period
if it finds ``such exemption would likely achieve a

level of safety that is equivalent to or greater than the level that
would be achieved absent such exemption.'' The statute also allows the
Agency to renew exemptions at the end of the 2-year period. The 16
individuals listed in this notice have recently requested such an
exemption from the diabetes prohibition in 49 CFR 391.41(b) (3), which
applies to drivers of CMVs in interstate commerce. Accordingly, the
Agency will evaluate the qualifications of each applicant to determine
whether granting the exemption will achieve the required level of
safety mandated by the statutes.

Qualifications of Applicants

Joseph J. Black

    Mr. Black, 60, has had ITDM since 2012. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Black understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Black meets the vision
requirements of 49 CFR 391.41(b)(10). His ophthalmologist examined him
in 2013 and certified that he has stable nonproliferative diabetic
retinopathy. He holds a Class A CDL from Pennsylvania.

Donald D. Boomgaarn

    Mr. Boomgaarn, 46, has had ITDM since 2012. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Boomgaarn understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely.
    Mr. Boomgaarn meets the requirements of the vision standard at 49
CFR 391.41(b)(10). His optometrist examined him in 2012 and certified
that he does not have diabetic retinopathy. He holds a Class A CDL from
Nebraska.

Hilary C. Clarke

    Mr. Clarke, 43, has had ITDM since 2009. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Clarke understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Clarke meets the vision
requirements of 49 CFR 391.41(b)(10). His optometrist examined him in
2013 and certified that he does not have diabetic retinopathy. He holds
a Class C operator's license from North Carolina.

Roger S. Davis

    Mr. Davis, 55, has had ITDM since 2012. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Davis understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Davis meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Pennsylvania.

Edgar I. Duque

    Mr. Duque, 49, has had ITDM since 2010. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Duque understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Duque meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class C operator's license from New
York.

Kevin D. Gentes

    Mr. Gentes, 24, has had ITDM since 1996. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Gentes understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Gentes meets the vision
requirements of 49 CFR 391.41(b)(10). His optometrist examined him in
2012 and certified that he does not have diabetic retinopathy. He holds
a Class C operator's license from Illinois.

Roger J. Huffsmith

    Mr. Huffsmith, 48, has had ITDM since 2009. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Huffsmith understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Huffsmith meets the
vision requirements of 49 CFR 391.41(b)(10). His optometrist examined
him in 2012 and certified that he does not have diabetic retinopathy.
He holds a Class A CDL from Washington.

Joel M. Jock

    Mr. Jock, 51, has had ITDM since 2003. His endocrinologist examined
him in 2012 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Jock understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Jock meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined

him in 2012 and certified that he does not have diabetic retinopathy.
He holds an operator's license from Virginia.

James S. Marunczak

    Mr. Marunczak, 40, has had ITDM since 2010. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Marunczak understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely.
    Mr. Marunczak meets the vision requirements of 49 CFR
391.41(b)(10). His optometrist examined him in 2012 and certified that
he does not have diabetic retinopathy. He holds a Class A CDL from
Pennsylvania.

William A. Nearhood

    Mr. Nearhood, 52, has had ITDM since 2012. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Nearhood understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Nearhood meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2012 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Pennsylvania.

Charles E. Peck

    Mr. Peck, 66, has had ITDM since 2012. His endocrinologist examined
him in 2012 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Peck understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Peck meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined
him in 2012 and certified that he does not have diabetic retinopathy.
He holds a Class A CDL from Alabama.

Joseph Sawicki, III

    Mr. Sawicki, 25, has had ITDM since 1997. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Sawicki understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Sawicki meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2012 and certified that he does not
have diabetic retinopathy. He holds a Class DL operator's license from
New York.

Michael Steinman

    Mr. Steinman, 59, has had ITDM since 2012. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Steinman understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Steinman meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Pennsylvania.

Christopher T. Thieneman

    Mr. Thieneman, 25, has had ITDM since 2000. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Thieneman understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely.
    Mr. Thieneman meets the vision requirements of 49 CFR
391.41(b)(10). His ophthalmologist examined him in 2012 and certified
that he does not have diabetic retinopathy. He holds a Class D
operator's license from Kentucky.

Matthew A. Waller

    Mr. Waller, 53, has had ITDM since 1988. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Waller understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Waller meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2012 and certified that he has stable
non-proliferative diabetic retinopathy. He holds an operator's license
from Washington.

Lucas P. Walth

    Mr. Walth, 27, has had ITDM since 2003. His endocrinologist
examined him in 2012 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Walth understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Walth meets the vision
requirements of 49 CFR 391.41(b)(10). His optometrist examined him in
2012 and certified that he does not have diabetic retinopathy. He holds
a Class D operator's license from North Dakota.

Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments received before
the close of business on the closing date indicated in the date section
of the notice.

    FMCSA notes that section 4129 of the Safe, Accountable, Flexible
and Efficient Transportation Equity Act: A Legacy for Users requires
the Secretary to revise its diabetes exemption program established on
September 3, 2003 (68 FR 52441).\1\ The revision must provide for
individual assessment of drivers with diabetes mellitus, and be
consistent with the criteria described in section 4018 of the
Transportation Equity Act for the 21st Century (49 U.S.C. 31305).
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    \1\ Section 4129(a) refers to the 2003 notice as a ``final
rule.'' However, 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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    Section 4129 requires: (1) Elimination of the requirement for 3
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.
    In response to section 4129, FMCSA made immediate revisions to the
diabetes exemption program established by the September 3, 2003 notice.
FMCSA discontinued use of the 3-year driving experience and fulfilled
the requirements of section 4129 while continuing to ensure that
operation of CMVs by drivers with ITDM will achieve the requisite level
of safety required of all exemptions granted under 49 USC. 31136 (e).
    Section 4129(d) also directed FMCSA to ensure that drivers of CMVs
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.
    The FMCSA concluded that all of the operating, monitoring and
medical requirements set out in the September 3, 2003 notice, except as
modified, were in compliance with section 4129(d). Therefore, all of
the requirements set out in the September 3, 2003 notice, except as
modified by the notice in the Federal Register on November 8, 2005 (70
FR 67777), remain in effect.

    Issued on: April 9, 2013.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2013-08881 Filed 4-15-13; 8:45 am]
BILLING CODE P


[Federal Register Volume 86, Number 171 (Wednesday, September 8, 2021)]
[Notices]
[Pages 50347-50348]
[FR Doc No: 2021-19392]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2018-0443; FRL-8850-01-OCSPP]

Octamethylcyclotetra-Siloxane (D4); Draft Scope of the Risk
Evaluation To Be Conducted Under the Toxic Substances Control Act;
Notice of Availability and Request for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In accordance with implementing regulations for the Toxic
Substances Control Act (TSCA), the Environmental Protection Agency
(EPA) is announcing the availability of and soliciting public comment
on the draft scope of the risk evaluation to be conducted for
octamethylcyclotetra-siloxane (D4). D4 (Cyclotetrasiloxane,
2,2,4,4,6,6,8,8-octamethyl-; Chemical Abstracts Service Registry Number
(CASRN) 556-67-2), is a chemical substance for which EPA received a
manufacturer request for risk evaluation. The draft scope for this
chemical substance includes the conditions of use, hazards, exposures,
and the potentially exposed or susceptible subpopulations that EPA
plans to consider in conducting the risk evaluation for this chemical
substance. EPA is also opening a 45-calendar day comment period on the
draft scope to allow for the public to provide additional data or
information that could be useful to the Agency in finalizing the scope
of the risk evaluation; comments may be submitted to this docket.

DATES: Comments must be received on or before October 25, 2021.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2018-0443, online using the Federal eRulemaking
Portal at http://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets/about-epa-dockets.
    Due to the public health emergency the EPA Docket Center (EPA/DC)
and Reading Room were closed to public visitors on March 31, 2020. Our
EPA/DC staff will continue to provide customer service via email,
phone, and webform. For further information on EPA/DC services, docket
contact information and the current status of the EPA/DC and Reading
Room, please visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Bethany Masten, Existing
Chemical Risk Management Division, Office of Pollution Prevention and
Toxics, Environmental Protection Agency (Mailcode 7404T), 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-8803; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general and may be of
interest to entities that manufacture (including import) a chemical
substance regulated under TSCA, 15 U.S.C. 2601 et seq., (e.g., entities
identified under North American Industrial Classification System
(NAICS) codes 325 and 324110). The action may also be of interest to

chemical processors, distributors in commerce, and users; non-
governmental organizations in the environmental and public health
sectors; state and local government agencies; and members of the
public. Since other entities may also be interested, the Agency has not
attempted to describe all the specific entities and corresponding NAICS
codes for entities that may be interested in or affected by this
action.

B. What is the Agency's authority for taking this action?

    The draft scope of the risk evaluation is issued pursuant to TSCA
implementing regulations at 40 CFR 702.41(c)(7).

C. What action is the Agency taking?

    EPA is publishing and requesting public comment on the draft scope
of the risk evaluation for D4 under TSCA. Through the risk evaluation
process, EPA will determine whether the chemical substance presents an
unreasonable risk of injury to health or the environment under the
conditions of use, as determined by the Administrator, in accordance
with TSCA section 6(b)(4).

II. Background

    TSCA allows chemical manufacturers to request an EPA-conducted risk
evaluation of a chemical substance under 40 CFR 702.37. On March 19,
2020, EPA received a manufacturer request for a risk evaluation of D4.
In the Federal Register notice of June 17, 2020 (85 FR 36586; FRL-
10010-49), EPA opened a 45-day public comment period to gather
information relevant to the requested risk evaluation. EPA granted the
request on October 6, 2020, and subsequently initiated the scoping
process for the risk evaluation for this chemical substance on November
5, 2020. The purpose of a risk evaluation is to determine whether a
chemical substance, or group of chemical substances, presents an
unreasonable risk to health or the environment, under the conditions of
use, including an unreasonable risk to a relevant potentially exposed
or susceptible subpopulation (15 U.S.C. 2605(b)(4)(A)). As part of this
process, EPA must evaluate both hazards and exposures for the
conditions of use; describe whether aggregate or sentinel exposures
were considered and the basis for consideration; not consider costs or
other non-risk factors; take into account where relevant, likely
duration, intensity, frequency, and number of exposures; and describe
the weight-of-scientific-evidence for hazards and exposures (15 U.S.C.
2605(b)(4)(F)). This process will culminate in a determination of
whether or not the chemical substance presents an unreasonable risk of
injury to health or the environment under the conditions of use (15
U.S.C. 2605(b)(4)(A); 40 CFR 702.47).

III. Draft Scope of the Risk Evaluation for Octamethylcyclotetra-
Siloxane (D4)

    The chemical substance for which EPA is publishing the draft scope
of the risk evaluation is listed on the TSCA Inventory with CA Index
Name ``Cyclotetrasiloxane, 2,2,4,4,6,6,8,8-octamethyl-'' and the
associated Chemical Abstracts Service Registry Number (CASRN) 556-67-2.
The draft scope of the risk evaluation for this chemical substance
includes the conditions of use, hazards, exposures, and the potentially
exposed or susceptible subpopulations EPA plans to consider in the risk
evaluation (15 U.S.C. 2605(b)(4)(D)). Development of the scope is the
first step of a risk evaluation. The draft scope of the risk evaluation
will include the following components (40 CFR 702.41(c)):
     The conditions of use, as determined by the Administrator,
that EPA plans to consider in the risk evaluation.
     The potentially exposed populations that EPA plans to
evaluate; the ecological receptors that EPA plans to evaluate; and the
hazards to health and the environment that EPA plans to evaluate.
     A description of the reasonably available information and
the science approaches that the Agency plans to use.
     A conceptual model that will describe the actual or
predicted relationships between the chemical substance, the conditions
of use within the scope of the evaluation and the receptors, either
human or environmental, with consideration of the life cycle of the
chemical substance--from manufacturing, processing, distribution in
commerce, storage, use, to release or disposal--and identification of
human and ecological health hazards EPA plans to evaluate for the
exposure scenarios EPA plans to evaluate.
     An analysis plan, which will identify the approaches and
methods EPA plans to use to assess exposure, hazards, and risk,
including associated uncertainty and variability, as well as a strategy
for using reasonably available information and science approaches.
     A plan for peer review.
    EPA encourages commenters to provide information they believe might
be missing or may further inform the risk evaluation. EPA will publish
a notice in the Federal Register announcing the availability of the
final scope of the risk evaluation within three months of publishing
the draft scope.
    Authority: 15 U.S.C. 2601 et seq.

Michael S. Regan,
Administrator.
[FR Doc. 2021-19392 Filed 9-7-21; 8:45 am]
BILLING CODE 6560-50-P


          Approval of Arizona Air Plan Revision; San Manuel, Arizona
                Second 10-Year Maintenance Plan, 1971 SO2 NAAQS
                      Direct Final Rule and Proposed Rule
                      (Docket No. EPA-R09-OAR-2017-0377)

Docket Index Table of Contents

A. U.S. EPA Guidance Documents, Policies, and Rulemakings
B. State Plans, Rules, Support Documents, Reports, and Correspondence
C. Additional Documents for Proposed Rulemaking
D. Notices of Proposed Rulemaking and Technical Support Document
E. Public Comments and Related Documents
F. Additional Documents Considered for Final Plan Action
G. Notices of Final Rulemaking, Plan Action

A. U.S. EPA Guidance Documents, Policies, and Rulemakings

 43 FR 8962, Title 40  -  Protection of the Environment, Chapter I  -  Environmental Protection Agency, Subpart C  -  Air Programs, Part 81  -  Air Quality Control Regions, Criteria, and Control Techniques, Final rule (March 3, 1978).

 44 FR 21261, Air Quality Control Regions, Criteria, and Control Techniques; Attainment Status Designations, Final rule (April 10, 1979).

 Memorandum dated September 4, 1992, from John Calcagni, Director, Air Quality Management Division, Office of Air Quality Planning and Standards, U.S. EPA, to Air Division Directors, Regions I-X, entitled "Procedures for Processing Requests to Redesignate Areas to Attainment."

 Memorandum dated January 26, 1995, from Sally Shaver, Director, Air Quality Strategies and Standards Division, Office of Air Quality Planning and Standards, U.S. EPA, to Air Division Directors, Regions I-X, entitled "Attainment Demonstration Policy for Sulfur Dioxide Nonattainment Areas."

 64 FR 19916, Approval and Promulgation of Implementation Plans for Arizona and California; General Conformity Rules, Final rule (April 23, 1999).

 73 FR 3396, Approval and Promulgation of Air Quality Implementation Plans; Designation of Areas for Air Quality Planning Purposes; Arizona; San Manuel Sulfur Dioxide State Implementation Plan and Request for Redesignation to Attainment, Direct Final rule (January 18, 2008).

 75 FR 35520, Primary National Ambient Air Quality Standard for Sulfur Dioxide, Final rule (June 22, 2010).

 80 FR 67319, Revisions to Air Plan; Arizona; Stationary Sources; New Source Review, Final rule (November 2, 2015).

B. State Plans, Rules, Support Documents, Reports, and Correspondence

 Arizona State Implementation Plan Revision, San Manuel Sulfur Dioxide Nonattainment Area, Air Quality Division, Arizona Department of Environmental Quality, March 2007.

 San Manuel Sulfur Dioxide Maintenance Plan Renewal, 1971 Sulfur Dioxide National Ambient Air Quality Standards, Air Quality Division, Arizona Department of Environmental Quality, April 20, 2017.

 Email dated July 28, 2017, from Elias Toon, Arizona Department of Environmental Quality, Air Quality Division Planning Unit, to Ashley Graham, U.S. EPA Region 9 Air Planning Office.

C. Additional Documents for Proposed Rulemaking

 Memorandum dated August 8, 2017, from Ashley Graham, U.S. EPA Region 9 Air Planning Office, to docket EPA-R09-OAR-2017-0377, "Technical note regarding emissions inventories in Arizona's San Manuel SO2 2[nd] 10-year maintenance plan."

 Letter dated September 14, 2017, from Elizabeth Adams, U.S. EPA Region 9, Acting Director, Air Division, to Tim S. Franquist, "Completeness Finding for the San Manuel Second 10-Year Maintenance Plan for the 1971 Sulfur Dioxide National Ambient Air Quality Standards."

D. Notices of Proposed Rulemaking and Technical Support Document

[Reserved]

E. Public Comments and Related Documents

[Reserved]

F. Additional Documents Considered for Final Plan Action

[Reserved]

G. Notices of Final Rulemaking, Reclassification

[Reserved]


[Federal Register Volume 82, Number 200 (Wednesday, October 18, 2017)]
[Rules and Regulations]
[Pages 48413-48415]
[FR Doc No: 2017-22590]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. FDA-2017-N-5160]

Medical Devices; Clinical Chemistry and Clinical Toxicology
Devices; Classification of the Organophosphate Test System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the organophosphate test system into class II (special controls). The
special controls that apply to the device type are identified in this
order and will be part of the codified language for the organophosphate
test system's classification. We are taking this action because we have
determined that classifying the device into class II (special controls)
will provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices, in part by reducing regulatory burdens.

DATES: This order is effective October 18, 2017. The classification was
applicable on August 8, 2013.

FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4550, Silver Spring, MD, 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the organophosphate test system as
class II (special controls), which we have determined will provide a
reasonable assurance of safety and effectiveness. In addition, we
believe this action will enhance patients' access to beneficial
innovation, in part by reducing regulatory burdens by placing the
device into a lower device class than the automatic class III
assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to

these devices as ``postamendments devices'' because they were not in
commercial distribution prior to the date of enactment of the Medical
Device Amendments of 1976, which amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act to a predicate device that does not require
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new
device is substantially equivalent to a predicate by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k) and 21 CFR part 807.
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically within
class III, the De Novo classification is considered to be the initial
classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval (PMA) application in order to market a
substantially equivalent device (see 21 U.S.C. 360c(i), defining
``substantial equivalence'').
    Instead, sponsors can use the less burdensome 510(k) process, when
necessary, to market their device.

II. De Novo Classification

    For this device, FDA issued an order on May 2, 2013, finding the
Quantitation of Organophosphate Metabolites in Urine by LC/MS/MS
(liquid chromatography-tandem mass spectrometry (the two ``MS'' next to
each other denote ``tandem'')) not substantially equivalent to a
predicate not subject to PMA. Thus, the device remained in class III in
accordance with section 513(f)(1) of the FD&C Act when we issued the
order.
    On May 31, 2013, Elizabeth Hamelin, on behalf of the Centers for
Disease Control and Prevention, Division of Laboratory Sciences/
National Center for Environmental Health, submitted a request for
classification of the Quantitation of Organophosphate Metabolites in
Urine by LC/MS/MS. FDA reviewed the request in order to classify the
device under the criteria for classification set forth in section
513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to general
controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on August 8, 2013, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 862.3652. We have named
the generic type of device organophosphate test system, and it is
identified as a device intended to measure organophosphate metabolites
quantitatively in human urine from individuals who have signs and
symptoms consistent with cholinesterase poisoning. The data obtained by
this device is intended to aid in the confirmation and investigation of
organophosphate exposure.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

   Table 1--Organophosphate Test System Risks and Mitigation Measures
------------------------------------------------------------------------
         Identified risks                    Mitigation measures
------------------------------------------------------------------------
False Positive....................  (1) The distribution of these
                                     devices is limited to laboratories
                                     with experienced personnel who are
                                     trained to measure and evaluate
                                     organophosphate exposure and guide
                                     public health response.
                                    (2) Analytical testing must
                                     demonstrate the device has
                                     appropriate performance
                                     characteristics, including adequate
                                     precision and accuracy across the
                                     measuring range and near medical
                                     decision points.
False Negative....................  (1) The distribution of these
                                     devices is limited to laboratories
                                     with experienced personnel who are
                                     trained to measure and evaluate
                                     organophosphate exposure and guide
                                     public health response.
                                    (2) Analytical testing must
                                     demonstrate the device has
                                     appropriate performance
                                     characteristics, including adequate
                                     precision and accuracy across the
                                     measuring range and near medical
                                     decision points.
Public Health Risk from Incorrect   (1) The distribution of these
 Test Results.                       devices is limited to laboratories
                                     with experienced personnel who are
                                     trained to measure and evaluate
                                     organophosphate exposure and guide
                                     public health response.
                                    (2) Analytical testing must
                                     demonstrate the device has
                                     appropriate performance
                                     characteristics, including adequate
                                     precision and accuracy across the
                                     measuring range and near medical
                                     decision points.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is subject to premarket
notification requirements under section 510(k).

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
part 807, subpart E, regarding premarket notification submissions have
been approved under OMB control number 0910-0120.

List of Subjects in 21 CFR Part 862

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
862 is amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

0
1. The authority citation for part 862 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  862.3652 to subpart D to read as follows:

Sec.  862.3652  Organophosphate test system.

    (a) Identification. An organophosphate test system is a device
intended to measure organophosphate metabolites quantitatively in human
urine from individuals who have signs and symptoms consistent with
cholinesterase poisoning. The data obtained by this device is intended
to aid in the confirmation and investigation of organophosphate
exposure.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The distribution of these devices is limited to laboratories
with experienced personnel who are trained to measure and evaluate
organophosphate exposure and guide public health response.
    (2) Analytical testing must demonstrate the device has appropriate
performance characteristics, including adequate precision and accuracy
across the measuring range and near medical decision points.

    Dated: October 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-22590 Filed 10-17-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: March 12, 2008 (Volume 73, Number 49)]
[Rules and Regulations]
[Page 13141-13144]
[DOCID:fr12mr08-33]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 271

[EPA-R08-RCRA-2006-0382; FRL-8541-5]

Colorado: Final Authorization of State Hazardous Waste Management
Program Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Immediate final rule.

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SUMMARY: The Solid Waste Disposal Act, as amended, commonly referred to
as the Resource Conservation and Recovery Act (RCRA), allows the
Environmental Protection Agency (EPA) to authorize States to operate
their hazardous waste management programs in lieu of the federal
program. Colorado has applied to EPA for final authorization of the
changes to its hazardous waste program under RCRA. EPA has determined
that these changes satisfy all requirements needed to qualify for final
authorization and is authorizing the State's changes through this
immediate final action.

DATES: This final authorization will become effective on May 12, 2008,
unless the EPA receives adverse written comment by April 11, 2008. If
adverse comment is received, EPA will publish a timely withdrawal of
the immediate final rule in the Federal Register informing the public
that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-
RCRA-2006-0382, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
    Follow the on-line instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Send written comments to Carl Daly, Solid and
Hazardous Waste Program, EPA Region 8, Mailcode 8P-HW, 1595 Wynkoop
Street, Denver, Colorado 80202-1129.
     Hand Delivery or Courier: Deliver your comments to Carl
Daly, Solid and Hazardous Waste Program, EPA Region 8, Mailcode 8P-HW,
1595 Wynkoop Street, Denver, Colorado 80202-1129. Such deliveries are
only accepted during the Regional Office's normal hours of operation.
The public is advised to call in advance to verify the business hours.
Special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket ID No. EPA-R08-RCRA-
2006-0382. EPA's policy is that all comments received will be included
in the public docket without change, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://
www.regulations.gov, or e-mail. The federal web site, http://
www.regulations.gov, is an ``anonymous access'' system, which means EPA
will not know your identity or contact information unless you provide
it in the body of your comment. If you send an e-mail comment directly
to EPA without going through http://www.regulations.gov, your e-mail
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties, and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters or any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information may not be publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available either
electronically through www.regulations.gov or in hard copy at: EPA
Region 8, from 9 a.m. to 4 p.m., 1595 Wynkoop Street, Denver, Colorado;
contact: Carl Daly, phone number<PHONE_NUMBER>, or the Colorado
Department of Public Health and Environment, from 9 a.m. to 4 p.m.,
4300 Cherry Creek Drive South, Denver, Colorado 80222-1530; contact:
Randy Perila, phone number<PHONE_NUMBER>. The public is advised to
call in advance to verify the business hours.

FOR FURTHER INFORMATION CONTACT: Carl Daly, Solid and Hazardous Waste
Program, EPA Region 8, 1595 Wynkoop Street, Denver, Colorado 80202,
(303) 312-6416<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

A. Why Are Revisions to State Programs Necessary?

    States which have received final authorization from EPA under RCRA
section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste
program that is equivalent to, consistent with, and no less stringent
than the federal program. As the federal program changes, States must
change their programs and ask EPA to authorize the changes. Changes to
State programs may be necessary when federal or state statutory or
regulatory authority is modified or when certain other changes occur.
Most commonly, States must change their programs because of changes to
EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124,
260 through 266, 268, 270, 273 and 279.

B. What Decisions Have We Made in This Rule?

    We conclude that Colorado's application to revise its authorized
program meets all of the statutory and regulatory requirements
established by RCRA. Therefore, we grant Colorado final authorization
to operate its hazardous waste program with the changes described in
the authorization applications. Colorado has responsibility for
permitting Treatment, Storage, and Disposal Facilities (TSDFs) within
its borders, except in Indian

Country, and for carrying out the aspects of the RCRA program described
in its revised program application, subject to the limitations of the
Hazardous and Solid Waste Amendments of 1984 (HSWA). New federal
requirements and prohibitions imposed by federal regulations that EPA
promulgates under the authority of HSWA take effect in authorized
States before they are authorized for the requirements. Thus, EPA will
implement those requirements and prohibitions in Colorado, including
issuing permits, until Colorado is authorized to do so.

C. What is the Effect of This Authorization Decision?

    This decision means that a facility in Colorado subject to RCRA
will now have to comply with the authorized State requirements instead
of the equivalent federal requirements in order to comply with RCRA.
Colorado has enforcement responsibilities under its State hazardous
waste program for violations of such program, but EPA retains its
authority under RCRA sections 3007, 3008, 3013, and 7003, which
include, among others, authority to: (1) Conduct inspections; require
monitoring, tests, analyses, or reports; (2) enforce RCRA requirements;
suspend or revoke permits; and, (3) take enforcement actions regardless
of whether Colorado has taken its own actions.
    This action does not impose additional requirements on the
regulated community because the regulations for which Colorado is being
authorized by this action are already effective and are not changed by
this action.

D. Why Wasn't There a Proposed Rule Before This Rule?

    EPA did not publish a proposal before this rule because we view
this as a routine program change. We are providing an opportunity for
the public to comment now. In addition to this rule, in the proposed
rules section of today's Federal Register we are publishing a separate
document that proposes to authorize the State program changes.

E. What Happens if EPA Receives Comments That Oppose This Action?

    If EPA receives comments that oppose this authorization, we will
withdraw this rule by publishing a document in the Federal Register
before the rule becomes effective. EPA will base any further decision
on the authorization of the State program changes on the proposal
mentioned in the previous paragraph. We will then address all public
comments in a later final rule. You may not have another opportunity to
comment, therefore, if you want to comment on this authorization, you
must do so at this time.
    If we receive comments that oppose only the authorization of a
particular change to the Colorado hazardous waste program, we will
withdraw that part of this rule but the authorization of the program
changes that the comments do not oppose will become effective on the
date specified above. The Federal Register withdrawal document will
specify which part of the authorization will become effective and which
part is being withdrawn.

F. For What Has Colorado Previously Been Authorized?

    Colorado initially received final authorization on October 19,
1984, effective November 2, 1984 (49 FR 41036) to implement the RCRA
hazardous waste management program. We granted authorization for
changes to their program on October 24, 1986, effective November 7,
1986 (51 FR 37729); May 15, 1989, effective July 14, 1989 (54 FR
20847); May 10, 1991, effective July 9, 1991 (56 FR 21601); April 7,
1994, effective June 6, 1994 (59 FR 16568); and November 14, 2003,
effective January 13, 2004 (68 FR 64550).

G. What Changes Are We Authorizing With This Action?

    Colorado submitted complete program revision applications on
December 31, 2002, September 23, 2003, and December 23, 2003 seeking
authorization of their changes in accordance with 40 CFR 271.21. Some
of the revisions that Colorado submitted in these applications are not
granted approval at this time. We now make an immediate final decision,
subject to receipt of written comments that oppose this action that
Colorado's hazardous waste program revisions listed here satisfy all of
the requirements necessary to qualify for final authorization.
Therefore, we grant Colorado final authorization for the following
program changes (the federal citation followed by the analog from the
Code of Colorado Regulations (6 CCR 7007-3), revised through December
30, 2004, unless otherwise noted: Financial Responsibility; Settlement
Agreement (55 FR 25976, 6/26/90)(Checklist 24A)/264.113(a)-(c) and
265.113(a)-(c); Permit Modifications for Hazardous Waste Management
Facilities (53 FR 37912, 9/28/88 & 53 FR 41649, 10/24/88)(Checklists 54
& 54.1)/100.60(c)(1)&(3), 264.54(e), 264.112(c), 264.118(d),
265.112(c)(3)&(4), 265.118(d), 260.10, 100.42(l)(2), 100.62(a)&(b),
100.61, 100.63, and Part 100, Appendix I, 100.22(c)&(d); Delay of
Closure Period for Hazardous Waste Management Facilities (54 FR 33376,
8/14/89)(Checklist 64)/264.13(a)&(b), 264.112(d)(2), 264.113,
266.12(a)(3)&(4), 265.13(a)&(b), 265.112(d), 265.113, and Part 100,
Appendix I; Land Disposal Restrictions for Newly Listed Wastes (57 FR
37194, 08/18/92)(Checklist 109)/100.20(b)(6), 100.40(a)(13),
100.41(a)(2), 100.63(e)(3)(ii)(B), 100.63 Appendix I, I(6), 100.63
Appendix I, 100.63 Appendix I & M, 260.10, 261.3(a)(2)(iii),
261.3(c)(2)(ii)(C)(1)&(2), 261.3(f), 262.34(a)(1)(iii),
262.34(a)(1)(iii)(B), 262.34(a)(1)(iv), 262.34(a)(2), 264.110(b),
264.111(c), 264.112(a)(2), 264.1100-1100(e), 264.1101(a)-(e),
264.1102(a)&(b), 265.110(b)(1)-(b)(4), 265.111(c), 265.112(d)(4),
265.221(h), 265.1100-1100(e), 265.1101(a)-(e), 265.1192(a)&(b),
266.10(b)-(b)(4), 266.12(a), 268.2(g), 268.2(h), 268.5 (reserved),
268.7(a)(1)(iii)-(v), 268.7(a)(2), 268.7(a)(3)(iv)-(vi), 268.7(a)(4),
268.7(b)(4)&(5), 268.7(d), 268.9(d), 268.14(a)-(c), 268.36(a)-(i),
268.40(b)&(d), 268.41(a), 268.41(a)/Table CCWE, 268.41(c), 268.42/Table
2, 268.42(b)&(d), 268.43/Table CCW, 268.45(a)-(d)(5), 268.45/Table 1,
268.46, 268.46/Table 1, 268.50(a)(1)&(2), and 268 Appendix II;
Consolidated Liability Requirements (53 FR 33938, 9/1/88; 56 FR 30200,
7/1/91; and 57 FR 42832, 9/16/92)(Checklists 113, 113.1, & 113.2)/
266.11(h), 266.14(i)(11), 266.16(a),(b),(f),(g),&(i)-(m), and
266.18(f)&(h)-(n); Removal of the Conditional Exemption for Certain
Slag Residues (59 FR 43496, 08/24/94)(Checklist 136)/267.20(c) and
268.41; Universal Waste Rule (60FR 25492, 05/11/95)(Checklist 142E)/
260.20(a), 260.23(a)-(d), 273.80(a)-(c), and 273.81(a)-h); Removal of
Legally Obsolete Rules (60 FR 33912, 06/29/95)(Checklist 144)/
100.11(b)(1), 100.11(c)(2), and 100.11(d); RCRA Expanded Public
Participation (60 FR 63417, 12/11/95)(Checklist 148)/100.11(f)(1)-
(4)(ii)(E), 100.22(a)(5), 100.22(c)(2)(vi)-(x), 100.22(c)(4),
100.41(a)(22), 100.42(n), 100.506(a)(1)(vi) 100.506(a)(1)(vii),
100.506(f)(1)-(5), and 260.10; Imports & Exports of Hazardous Waste:
Implementation of OECD Council Decision (61 FR 16290, 04/12/
96)(Checklist 152)/261.6(a)(5), 261.10(d) thru (h), 262.53(b),
262.56(b), 262.58(a)&(b), 262.80(a)&(b), 262.81 thru (L), 262.82(a)
thru (c)(3), 262.83(a) thru (e)(12), 262.84(a) thru (e), 262.85(a) thru
(g), 262.86(a)&(b), 262.87(a) thru (c)(2),

262.88, 268.89(a) thru (e), 263.10(c), 263.20(a), 264.12(a)(1)&(2),
264.71(d), 265.12(a)(1)&(2), 265.71(d), 267.70(b)(2)&(3), 273.20,
273.40, 273.56, 273.79 intro, and 273.70(d); Military Munitions Rule
(62 FR 06622, 2/12/97)(Checklist 156)/260.10, 262.20(f),
264.1(g)(8)(iv), 265.1(c)(11)(iv), 267.200-267.202, and 100.10(a)(8);
Organic Air Emission Standards for Tanks, Surface Impoundments, and
Containers; Clarification & Technical Amendment (62 FR 64636, 12/8/
97)(Checklist 163)/100.41(a)(5), 264.15(b)(4), 264.73(b)(6),
264.1030(b)(3), 264.1030(c)&(e), 264.1031, 264.1033(a)(2)(i) thru (iv),
264.1050(b)(3), 264.1050(c)&(f), 264.1060(a) thru (b)(4),
264.1062(b)(2)&(3), 264.1064(g)(6), 264.1064(m), 264.1080(b)(1),
264.1080(c), 264.1082(b), 264.1082(c)(2)(ix)(A)&(B), 264.1082(c)(3),
264.1083(a)(2), 264.1083(b)(1), 264.1083(c)(4)(ii),
264.1084(c)(2)(iii), 264.1084(c)(2)(iii)(B) thru (B)(2),
264.1084(e)(4), 264.1084(f)(3)(i)(D)(4), 264.1084(f)(3)(iii),
264.1084(f)(4), 264.1084(j)(2)(iii), 264.1085(b)(2),
264.1085(d)(1)(iii), 264.1085(d)(2)(i)(B), 264.1085(e)(2)(iii),
264.1086(c)(2), 264.1086(c)(4)(i), 264.1086(d)(2), 264.1086(d)(4)(i),
264.1086(g), 264.1087(c)(3)(ii), 264.1087(c)(7), 264.1089(a),
264.1089(b)(1)(ii)(B), 264.1089(f)(1), 264.1089(j), 265.15(b)(4),
265.73(b)(6), 265.1030(b)(3), 265.1030(d), 265.1033(a)(2)(i) thru (iv),
265.1033(f)(2)(vi)(B), 265.1050(b)(3), 265.1050(e), 265.1060(a)&(b),
265.1062(b)(2)&(3), 265.1064(g)(6), 265.1064(m), 265.1080(b)(1),
265.1080(c), 265.1081, 265.1082(a) thru (d), 265.1083(b),
265.1083(c)(2)(i), 265.1083(c)(2)(ix)(A)&(B), 265.1083(c)(3),
265.1083(c)(4)(ii), 265.1084(a)(2), 265.1084(a)(3)(ii)(B),
265.1084(a)(3)(iii)& (3)(A), 265.1084(a)(3)(iii)(F)&(G),
265.1084(a)(3)(iv)&(v), 265.1084(a)(4)(iv, 265.1084(b)(1),
265.1084(b)(3)(ii)(B), 265.1084(b)(3)(iii), 265.1084(b)(3)(iii)(F)&(G),
265.1084(b)(3)(iv)&(v), 265.1084(b)(8)(iii), 265.1084(b)(9)(iv),
265.1084(d)(5)(ii), 265.1085(c)(2)(iii), 265.1085(c)(2)(iii)(B) thru
(B)(2), 265.1085(e)(4), 265.1085(f)(3)(i)(D)(4), 265.1085(f)(4),
265.1085(j)(2)(iii), 265.1086(b)(2), 265.1086(d)(1)(iii),
265.1086(d)(2)(i)(B), 265.1086(e)(2)(iii), 265.1087(c)(4)(i),
265.1087(d)(4)(i), 265.1087(g), 265.1088(c)(3)(ii), 265.1088(c)(7),
265.1090(a), 265.1090(b)(1)(ii)(B), 265.1090(f)(1), 265.1090(j), and
265 Appendix VI; Land Disposal Restrictions Phase IV--Treatment
Standards for Metal Wastes & Mineral Processing Wastes (63 FR 28556, 5/
26/98)(Checklist 167A)/268.2(i), 268.3(d), 268.34(a) thru (e),
268.40(e)&(h), 268/Table ``Treatment Standards for Hazardous Wastes'',
and 268.48(a)/Table UTS; Land Disposal Restrictions Phase IV--
Corrections (63 FR 28556, 5/26/98 and 63 FR 31266, 6/8/98)(Checklists
167C and 167C.1)/268.4(a)(2)(ii)&(iii), 268.7(a)(7), 268.7(b)(3)(ii)/
Table, 268.7(b)(4)(iv)&(v), 268.7(b)(5)&(6), 268.40(e), 268.40/Table,
268.42(a), 268.45(a) intro, 268.45(d)(3)&(4), 268.48/Table UTS, 268
Appendix VII/Tables 1&2, and 268 Appendix VIII; Organic Air Emission
Standards--Clarification & Technical Amendments (64 FR 03382, 1/21/
99)(Checklist 177)/262.34(a)(1)(i)&(ii), 264.1031, 264.1080(b)(5),
264.1083(a)(1)(i)&(ii), 264.1083(b)(1)(i)&(ii), 264.1084(h)(3),
264.1086(e)(6), 265.1080(b)(5), 265.1084(a)(1)(i)&(ii),
265.1084(a)(3)(ii)(B)&(D), 265.1084(a)(3)(iii), 265.1084(b)(1)(i)&(ii),
265.1084(b)(3)(ii)(B)(&(D), 265.1084(b)(3)(iii), 265.1085(h)(3), and
265.1087(e)(6); Universal Waste Rule: Specific Provisions for Hazardous
Waste Lamps (64 FR 36466, 07/06/99)(Checklist 181)/260.10,
261.9(a)(2),(3)&(5), 264.1(g)(11)(ii),(iii)&(v),
265.1(c)(14)(ii),(iii)&(v), 268.1(f)(2),(3)&(5),
100.10(a)(14)(ii),(iii)&(v), 273.1(a)(2),(3)&(5), 273.2(a)(1)(i),
273.2(a)(2)(ii)&(iii), 273.2(b)(1), 273.2(c)(1), 273.2(e), 273.6&7,
273.8(a)&(b), 273.9 ``lamp'', ``large quantity handler of universal
waste'', ``small quantity handler of universal waste'', & ``universal
waste'', 273.10, 273.13(e), 273.30, 273.32(b)(4), 273.33(b)(5),
273.33(e), 273.34(f), 273.50, 273.60(a), and 273.81(a); Organobromine
Production Wastes Vactur (65 FR 14472, 03/17/00)(Checklist 185)/261.32/
Table, 261.33(f)/Table, 261 Appendix VII & VIII, 268.33, 268.40/Table,
and 268.48/Table; Mixture & Derived-From Rules Revisions (66 FR 27266,
06/16/01)(Checklist 192A)/261.3(a)(2)(iii)&(iv), 261.3(c)(2)(i), and
261.3(g)(1)-(3); Land Disposal Restrictions Correction (66 FR 27266,
05/16/01)(Checklist 192B)/268 Appendix VII/Table 1; Change of Official
EPA Mailing Address (66 FR 34374, 06/28/01)(Checklist 193)/
260.11(a)(11); Mixture & Derived-From Rules Revision II (66 FR 50332,
10/03/01)(Checklist 194)/261.3(a)(2)(iv), and 261.3(g)(4); Inorganic
Chemical Manufacturing Wastes Identification & Listing (66 FR 58258,
11/20/01, and 67 FR 17119, 04/09/02)(Checklists 195 and 195.1)/
261.4(15), 261.32, 261 Appendix VII, 268.36(a)&(b), and 268.40/Table;
Vacatur of Mineral Processing Spent Materials Being Reclaimed as Solid
Wastes & TCLP Use with MGP Waste (67 FR 11251, 03/13/02)(Checklist
199)/261.2(c)(3), 261.4(a)(17), and 261.24(a); Zinc Fertilizer Rule (67
FR 48393, 07/24/02)(Checklist 200)/261.4, 261.4(a)(20)&(21), 267.20,
267.20(d), 267.20(d)(1)&(2), and 268.40; Performance Track (69 FR
21737, 04/22/04 and 69 FR 62217, 10/25/04)(Checklists 204 and 204.1)/
262.34(k)-(m), effective March 2, 2005.

H. Where Are the Revised State Rules Different From the Federal Rules?

    Colorado has requirements that are more stringent than the federal
rules at (references are to the Code of Colorado Regulations, except
where there is no State analog. Then the reference is to the federal
citation): 100.11(f)(2)&(3), 100.11(f)(4)(i)(A)&(C),
100.41(a)(15),(16),&(22), 100 Appendix I, 261.3(a)(2)(iv),
261.3(c)(2)(i), 261.3(h)(1)-(3) no State analogs, 262.34(l)&(m),
264.112(d)(2)(i), 264.113(e)(5), 264.151(i)(2)(d) no State analog,
264.551, 264.552(a)(1), 264.552(a)(1)(ii)(A), 264.552(a)(3)(iii),
264.552(c)(4)&(5), 264.552(c)(7), 264.552(e)(3), 264.552(e)(3)(i) thru
(ii)(A) no State analogs, 264.552(e)(4)(i)(A) thru (B),
264.552(e)(4)(v)(E)(5), 264.552(e)(6)(i)(B), 264.552(e)(6)(v),
264.552(e)(6)(v)(B), 264.552(k), & (l), 264.555(a) thru (g) no State
analogs, 265.112(e), 265.113(e)(5), 266.16(i)(1), 266.16(j)(1),
266.16(k)(1), 266.18(h)(2), 266.18(i) thru (k), 268.40(e), 268.7(a)(7),
268.40/Table ``Treatment Standards for Hazardous Wastes'', 268.48/Table
UTS, 270.14(b)(15)&(16).
    Colorado is broader-in-scope than the federal rules at: 261.32
(K140) and 268.40/table (K140 & U408).
    Colorado is in the process of adopting the federal regulations
regarding Boilers & Industrial Furnaces (BIFs). Until the State is
authorized for BIF regulations, some of the above approved rules do not
include references to these type of facilities at this time.

I. Who Handles Permits After the Authorization Takes Effect?

    Colorado will issue permits for all the provisions for which it is
authorized and will administer the permits it issues. EPA will continue
to administer any RCRA hazardous waste permits or portions of permits
which were issued prior to the effective date of this authorization
until Colorado has equivalent instruments in place. We

will not issue any new permits or new portions of permits for the
provisions listed in Item G after the effective date of this
authorization. EPA previously suspended issuance of permits for other
provisions on the effective date of Colorado's final authorization for
the RCRA base program and each of the revisions listed in Item F. EPA
will continue to implement and issue permits for HSWA requirements for
which Colorado is not yet authorized.

J. How Does This Action Affect Indian Country (18 U.S.C. 1151) in
Colorado?

    Colorado is not authorized to carry out its RCRA program in
``Indian country'', as defined in 18 U.S.C. 1151. This includes: (1)
Lands within the exterior boundaries of the following Indian
reservations located within or abutting the State of Colorado, (a)
Southern Ute Indian Reservation and (b) Ute Mountain Ute Indian
Reservation; (2) any land held in trust by the United States for an
Indian tribe, and (3) any other areas which are ``Indian country''
within the meaning of 18 U.S.C. 1151.
    Therefore, this program revision does not extend to Indian country
where EPA will continue to implement and administer the RCRA program in
these lands.

K. What is Codification and is EPA Codifying Colorado's Hazardous Waste
Program as Authorized in This Rule?

    Codification is the process of placing a State's statutes and
regulations that comprise the State's authorized hazardous waste
program into the CFR. We do this by referencing the authorized State
rules in 40 CFR part 272. We reserve the amendment of 40 CFR part 272,
subpart G for the codification of Colorado's updated program until a
later date.

L. Statutory and Executive Order Reviews

    The Office of Management and Budget has exempted this action from
the requirements of Executive Order 12866 (58 FR 51735, October 4,
1993), and therefore this action is not subject to review by OMB. This
action authorizes State requirements for the purpose of RCRA 3006 and
imposes no additional requirements beyond those imposed by state law.
Accordingly, I certify that this action will not have a significant
economic impact on a substantial number of small entities under the
Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this action
authorizes pre-existing requirements under state law and does not
impose any additional enforceable duty beyond that required by state
law, it does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). For the same reason, this
action also does not significantly or uniquely affect the communities
of Tribal governments, as specified by Executive Order 13175 (65 FR
67249, November 9, 2000). This action will not have 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, as specified
in Executive Order 13132 (64 FR 43255, August 10, 1999), because it
merely authorizes State requirements as part of the State RCRA
hazardous waste program without altering the relationship or the
distribution of power and responsibilities established by RCRA. This
action also is not subject to Executive Order 13045 (62 FR 19885, April
23, 1997), because it is not economically significant and it does not
make decisions based on environmental health or safety risks. This rule
is not subject to Executive Order 13211, ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001), because it is not a significant
regulatory action under Executive Order 12866.
    Under RCRA 3006(b), EPA grants a State's application for
authorization as long as the State meets the criteria required by RCRA.
It would thus be inconsistent with applicable law for EPA, when it
reviews a State authorization application, to require the use of any
particular voluntary consensus standard in place of another standard
that otherwise satisfies the requirements of RCRA. Thus, the
requirements of section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required
by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996),
in issuing this rule, EPA has taken the necessary steps to eliminate
drafting errors and ambiguity, minimize potential litigation, and
provide a clear legal standard for affected conduct. EPA has complied
with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining
the takings implications of the rule in accordance with the ``Attorney
General's Supplemental Guidelines for the Evaluation of Risk and
Avoidance of Unanticipated Takings'' issued under the executive order.
This rule does not impose an information collection burden under the
provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this document and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication in the Federal Register. A major rule cannot take effect
until 60 days after it is published in the Federal Register. This
action is not a ``major rule'' as defined by 5 U.S.C. 804(2). This
action will be effective May 12, 2008.

List of Subjects in 40 CFR Part 271

    Environmental protection, Administrative practice and procedure,
Confidential business information, Hazardous waste, Hazardous waste
transportation, Incorporation-by-reference, Indian lands,
Intergovernmental relations, Penalties, Reporting and recordkeeping
requirements.

    Authority: This action is issued under the authority of sections
2002(a), 3006 and 7004(b) of the Solid Waste Disposal Act as amended
42 U.S.C. 6912(a), 6926, 6974(b).

    Dated: February 28, 2008.
Carol Rushin,
Acting Regional Administrator, Region 8.
 [FR Doc. E8-4978 Filed 3-11-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 203 (Thursday, October 20, 2016)]
[Notices]
[Pages 72640-72641]
[FR Doc No: 2016-25383]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2016-0219]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

-----------------------------------------------------------------------

SUMMARY: FMCSA confirms its decision to exempt 37 individuals from its
rule prohibiting persons with insulin-treated diabetes mellitus (ITDM)
from operating commercial motor vehicles (CMVs) in interstate commerce.
The exemptions enable these individuals to operate CMVs in interstate
commerce.

DATES: The exemptions were effective on September 30, 2016. The
exemptions expire on September 30, 2018.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-113,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.
e.t., Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On August 30, 2016, FMCSA published a notice of receipt of Federal
diabetes exemption applications from 37 individuals and requested
comments from the public (81 FR 59723. The public comment period closed
on September 29, 2016, and 2 comments were received.
    FMCSA has evaluated the eligibility of the 37 applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current requirement for diabetes in 1970
because several risk studies indicated that drivers with diabetes had a
higher rate of crash involvement than the general population. The
diabetes rule provides 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)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The September 3, 2003 (68 FR 52441), Federal
Register notice in conjunction with the November 8, 2005 (70 FR 67777),
Federal Register notice provides the current protocol for allowing such
drivers to operate CMVs in interstate commerce.
    These 37 applicants have had ITDM over a range of 1 to 43 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the past 5 years. In each case,
an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes-related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the August 30, 2016, Federal Register
notice and they will not be repeated in this notice.

III. Discussion of Comments

    FMCSA received 2 comments in this proceeding. John Grubbs stated
that he believes FMCSA should grant exemptions to drivers that use
slow-acting insulin. FMCSA does grant exemptions to drivers who use
slow-acting insulin. Deb Carlson stated that the state of Minnesota has
no concerns with granting exemptions to Craig W. Dennis, Ross L.
Christenson, Troy M. Keller, and Ray E. Vaughn.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes requirement in 49 CFR 391.41(b)(3) if the exemption
is likely to achieve an equivalent or greater level of safety than
would be achieved without the exemption. The exemption allows the
applicants to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, and
reviewed the treating endocrinologists' medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and they include the following:
(1) That each individual submit a quarterly monitoring checklist
completed by the treating endocrinologist as well as an annual
checklist with a comprehensive medical evaluation; (2) that each
individual reports within 2 business days of occurrence, all episodes
of severe hypoglycemia, significant complications, or inability to
manage diabetes; also, any involvement in an accident or any other
adverse event in

a CMV or personal vehicle, whether or not it is related to an episode
of hypoglycemia; (3) that each individual provide a copy of the
ophthalmologist's or optometrist's report to the medical examiner at
the time of the annual medical examination; and (4) that each
individual provide a copy of the annual medical certification to the
employer for retention in the driver's qualification file, or keep a
copy in his/her driver's qualification file if he/she is self-employed.
The driver must also have a copy of the certification when driving, for
presentation to a duly authorized Federal, State, or local enforcement
official.

VI. Conclusion

    Based upon its evaluation of the 37 exemption applications, FMCSA
exempts the following drivers from the diabetes requirement in 49 CFR
391.41(b)(3), subject to the requirements cited above 49 CFR 391.64(b):

Scott G. Barr (FL)
John L. Bauers (NE)
Robert J. Borgese (NJ)
Rodger L. Bratton (LA)
John T. Brecken (MI)
Ross L. Christenson (MN)
Daniel B. Cox (WA)
Raymond Davila, Jr. (NJ)
Craig W. Dennis (MN)
Lawrence M. Duffy, III (NY)
Douglas Endicott (VA)
Carmine Ferraro (CT)
Thomas P. Fogerty (MA)
M.A. Gandolfo, Jr. (NY)
Merlyn C. Gerdes (IA)
Fabian Guerrero-Rodriguez (NV)
Loren T. Hall (NY)
Mark A. Hersh (PA)
James C. Holcomb (LA)
Eric E. Humphrey (MA)
Troy M. Keller (MN)
Ronald C. Kolb (MT)
Robert J. Lockwood (CT)
Kenneth R. Logan, Sr. (IL)
Adam W. Martin (MI)
Michael L. Mitchell (IA)
Clarence H. Mitchell 3rd (CT)
Lucas J. Preston (ND)
William B. L. Robinson (AR)
Michael T. Salsedo (HI)
F. Marino M. Sanchez (NY)
Andrew D. Sanford (TN)
Jeffery J. Stricherz (SD)
Michael A. Taylor (CT)
Jerry W. Thomas (NC)
Ray E. Vaughn (MN)
Ronald L. Yeager (PA)

    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption is
valid for two years unless revoked earlier by FMCSA. The exemption will
be revoked if the following occurs: (1) The person fails to comply with
the terms and conditions of the exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136(e) and 31315. If the
exemption is still effective at the end of the 2-year period, the
person may apply to FMCSA for a renewal under procedures in effect at
that time.

    Issued on: October 14, 2016.
 Larry W. Minor,
 Associate Administrator for Policy.
[FR Doc. 2016-25383 Filed 10-19-16; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 87, Number 57 (Thursday, March 24, 2022)]
[Notices]
[Page 16724]
[FR Doc No: 2022-06232]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP21-78-000]

ANR Pipeline Company; Notice of Availability of the Final
Environmental Impact Statement for the Proposed Wisconsin Access
Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared a final environmental impact statement (EIS)
for the Wisconsin Access Project, proposed by ANR Pipeline Company
(ANR) in the above-referenced docket. ANR requests authorization to
modify seven existing meter stations in Oneida, Marathon, Oconto, and
Manitowoc Counties, Wisconsin and increase firm transportation capacity
on its pipeline by 50,707 dekatherms per day.
    The final EIS assesses the potential environmental effects of the
construction and operation of the Wisconsin Access Project in
accordance with the requirements of the National Environmental Policy
Act. FERC staff concludes that approval of the Project would not result
in significant environmental impacts, with the exception of climate
change impacts, where staff find the annual operation and downstream
greenhouse gas emissions from the project would exceed the Commission's
presumptive significance threshold based on 100 percent utilization.
    The final EIS addresses the potential environmental effects of the
construction and operation of minor modifications to ANR's existing
Coleman, Lena, Meeme, Mosinee, Rhinelander, Suring, and Two Rivers
Meter Stations. The modifications include the replacement of some
metering and filtering equipment, installation of additional metering
equipment, and replacement of two meter station buildings at the Lena
and Rhinelander Meter Stations.
    The Commission mailed a copy of the Notice of Availability of the
Final Environmental Impact Statement for the Wisconsin Access Project
to federal, state, and local government representatives and agencies;
elected officials; environmental and public interest groups; Native
American tribes; potentially affected landowners and other interested
individuals and groups; and newspapers and libraries in the project
area. The final EIS is only available in electronic format. It may be
viewed and downloaded from the FERC's website (www.ferc.gov), on the
natural gas environmental documents page (https://www.ferc.gov/industries-data/natural-gas/environment/environmental-documents). In
addition, the final EIS may be accessed by using the eLibrary link on
the FERC's website. Click on the eLibrary link (https://elibrary.ferc.gov/eLibrary/search), select ``General Search,'' and
enter the docket number in the ``Docket Number'' field (i.e., CP21-78).
Be sure you have selected an appropriate date range. For assistance,
please contact FERC Online Support at [email protected] or
toll free at<PHONE_NUMBER>, or for TTY, contact<PHONE_NUMBER>.
    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website (www.ferc.gov) using the eLibrary link. The eLibrary link
also provides access to the texts of all formal documents issued by the
Commission, such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription that allows you to keep track of all formal issuances and
submittals in specific dockets. This can reduce the amount of time you
spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to https://www.ferc.gov/ferc-online/overview to
register for eSubscription.

    Dated: March 18, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-06232 Filed 3-23-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 25 (Tuesday, February 7, 2023)]
[Notices]
[Pages 7990-7991]
[FR Doc No: 2023-02573]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2022-0035; OMB No. 1660-0115]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; Environmental and Historic Preservation
Screening Form

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: 30-Day notice of revision and request for comments.

-----------------------------------------------------------------------

SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. The submission seeks comments
concerning the information collection activities required to administer
the Environmental and Historic Preservation Environmental Screening
Form.

DATES: Comments must be submitted on or before March 9, 2023.

ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Information Management Division, 500 C Street SW, Washington, DC 20472,
email address [email protected] or
Beth McWaters-Bjorkman, Environmental Protection Specialist, FEMA,
Grant Programs Directorate,<PHONE_NUMBER> or [email protected].

SUPPLEMENTARY INFORMATION: FEMA's Grant Programs Directorate (GPD)
awards thousands of grants each year through various grant programs.
These programs award funds for projects used to improve homeland
security and emergency preparedness. The National Environmental Policy
Act of 1969 (NEPA) (Pub. L. 91-190, sec. 102 (B) and (C), 42 U.S.C.
4332), the National Historic Preservation Act of 1966 (NHPA) (Pub. L.
89-665, 16 U.S.C. 470f), the Endangered Species Act of 1973 (Pub. L.
93-205, 16 U.S.C. 1531, et seq.), and a variety of other environmental
and historic preservation laws and Executive Orders (E.O.) require the
Federal Government to examine the potential environmental impacts of
its proposed actions on communities, public health and safety, and
cultural, historic, and natural resources including endangered and
threatened species prior to implementing those actions. The GPD process
of considering these potential impacts is called an environmental and
historic preservation (EHP) review which is employed to achieve
compliance with multiple EHP authorities through one consolidated
process.
    With input from recipients, FEMA is proposing to revise the EHP
Screening Form for clarity and ease of use. The 2022 EHP Screening Form
does not require any new information and includes an appendix with
guidance on providing photographs with the EHP submission. Recipients
are no longer required to submit Authorized Equipment List (AEL)
numbers.
    This proposed information collection previously published in the
Federal Register on November 4, 2022, at 87 FR 66718 with a 60 day
public comment period. No comments were received. The purpose of this
notice is to notify the public that FEMA will submit the information
collection abstracted below to the Office of Management and Budget for
review and clearance.

Collection of Information

    Title: Environmental and Historic Preservation Screening Form.
    Type of Information Collection: Extension, with change, of a
currently approved information collection.
    OMB Number: 1660-0115.
    FEMA Forms: FEMA Form FF-119-FY-21-105 (formerly 024-0-1),
Environmental and Historic Preservation Screening Form.

    Abstract: The National Environmental Policy Act of 1969 (NEPA)
requires that each Federal agency examine the impact of a major Federal
action (including the actions of recipients using grant funds)
significantly affecting the quality of the human environment. This
involves considering the environmental impact of the proposed action,
alternatives to the proposed action, informing both decision-makers and
the public of the impacts through a transparent process, and
identifying mitigation measures for any potential adverse impacts (40
CFR 1500.1, 1501.5 and 1501.6). Among other environmental laws, the
review also involves considering the effects of the undertaking on
historic properties under Section 106 of the National Historic
Preservation Act and the effects of the action on any threatened or
endangered species and their habitat under Section 7 of the Endangered
Species Act of 1973. This Screening Form will facilitate the Federal
Emergency Management Agency's (FEMA's) review of recipient Federally-
funded actions in FEMA's effort to comply with the environmental
requirements.
    Affected Public: State, local or Tribal government; Not-for-Profit
Institutions.
    Estimated Number of Respondents: 2,300.
    Estimated Number of Responses: 2,300.
    Estimated Total Annual Burden Hours: 16,752.
    Estimated Total Annual Respondent Cost: $1,039,877.
    Estimated Respondents' Operation and Maintenance Costs: $0.
    Estimated Respondents' Capital and Start-Up Costs: $0.
    Estimated Total Annual Cost to the Federal Government: $6,153,716.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

Millicent Brown Wilson,
Records Management Branch Chief, Office of the Chief Administrative
Officer, Mission Support, Federal Emergency Management Agency,
Department of Homeland Security.
[FR Doc. 2023-02573 Filed 2-6-23; 8:45 am]
BILLING CODE 9111-78-P