[Federal Register Volume 87, Number 144 (Thursday, July 28, 2022)]
[Rules and Regulations]
[Pages 45251-45257]
[FR Doc No: 2022-16017]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 147

[EPA-HQ-OW-2020-0595; FRL 8378-04-OW]

State of Michigan Underground Injection Control (UIC) Class II
Program; Primacy Approval

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is issuing a
final rule approving Michigan's Class II Underground Injection Control
(UIC) Program for primacy. EPA has determined that the State's program
is consistent with the provisions of the Safe Drinking Water Act (SDWA)
to prevent underground injection activities that endanger underground
sources of drinking water (USDWs). EPA's approval allows Michigan to
implement and enforce the State's regulations for Class II UIC wells,
which cover oil and gas related injection well activities. EPA will
remain the permitting authority for all other UIC well classes in
Michigan and the sole permitting authority for all UIC well classes in
Indian country within the State. EPA will also oversee Michigan's
administration of the State's UIC Class II program as authorized under
SDWA.

DATES: This final rule is effective on August 29, 2022. The Director of
the Federal Register approved this incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 on August 29, 2022.
For judicial purposes, this final rule is promulgated as of August 29,
2022.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-OW-2020-0595. All documents in the docket are listed on the
www.regulations.gov website. Although listed in the index, some
information is not publicly available, e.g., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the internet and will be publicly available only in hard
copy form. Publicly available docket materials are available
electronically through www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Kyle Carey, Drinking Water Protection
Division, Office of Ground Water and Drinking Water (4606M), U.S.
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address: [email protected], or Anna Miller, UIC Section, U.S.
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604; telephone number:<PHONE_NUMBER>; email
address: [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
    A. UIC Program Primacy
    B. Class II Wells Under the UIC Program
    C. Final Rule
II. Entities Affected by This Action
III. Legal Authorities
IV. EPA's Review of State UIC Program Requirements
V. Michigan's Application for Class II UIC Primacy
    A. Background
    B. Public Participation Activities Conducted by the State of
Michigan
    C. Notice of Completion and Public Participation Activities
Conducted by EPA
VI. Proposed Rule and Public Comments
    A. Background
    B. Public Comments
    C. EPA's Response
VII. Incorporation by Reference
VIII. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act (PRA)
    C. Regulatory Flexibility Act (RFA)
    D. Unfunded Mandates Reform Act (UMRA)
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations
    K. Congressional Review Act (CRA)

I. Introduction

A. UIC Program Primacy

    EPA may grant primary authority and enforcement responsibility or
``primacy'' for implementing the UIC program to states, territories,
and federally recognized tribes--hereafter referred to as applicants
that apply under SDWA. Primacy programs are established under SDWA
Sections 1422 and 1425. To obtain primacy under

SDWA Section 1422, Applicants must meet EPA's regulatory requirements
for UIC programs. SDWA Section 1425 provides an alternative option for
obtaining primacy for the Class II UIC program, which covers oil and
gas related injection well activities. SDWA Section 1425 requires the
applicant to demonstrate that its Class II UIC program is effective in
preventing underground injection that endangers USDWs.
    An applicant seeking UIC program primacy under SDWA Section 1425
must demonstrate to EPA that it has an ``effective'' Class II program
to prevent the endangerment of USDWs, including jurisdiction over
underground injection and provisions for the necessary administrative,
civil, and criminal enforcement penalty remedies under SDWA. EPA
conducts a thorough technical and legal review of the primacy
application. The application and EPA's review include these elements:
The applicant's UIC statutes and regulations; documents describing the
public participation process; a request from the applicant's governor
or authorized representative for primacy under SDWA; the program
description; an attorney general's or authorized representative's
statement of enforcement authority; and a memorandum of agreement (MOA)
between EPA and the applicant, describing the administration,
implementation, and enforcement of the applicant's UIC program.

B. Class II Wells Under the UIC Program

    Class II wells are used only to inject fluids associated with oil
and natural gas production. Class II fluids are typically injected
thousands of feet below the surface into rock formations isolated from
USDWs. Class II wells fall into one of three categories: disposal
wells, which inject fluids brought to the surface during oil and gas
extraction; enhanced recovery wells, which inject fluids into oil-
bearing formations to recover residual oil and, in limited
applications, natural gas; \1\ and hydrocarbon storage wells, which
inject liquid hydrocarbons into underground formations (such as salt
caverns) where they are stored, generally, as part of the U.S.
Strategic Petroleum Reserve.
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    \1\ Class II wells include hydraulic fracturing operations
related to oil and gas production only where diesel fuels are used
in the injection fluid. See SDWA Section 1421(d)(1)(B)(ii).
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C. Final Rule

    In this final rule, EPA is approving Michigan's application because
it meets or exceeds all applicable requirements for approval under SDWA
Section 1425 and the agency has determined that the State can
administer a Class II UIC program in a manner consistent with the terms
and purposes of SDWA and all applicable regulations to protect USDWs.
With EPA's approval, Michigan will implement and enforce a State Class
II UIC regulatory program that is effective in preventing the
endangerment of USDWs. EPA will remain the permitting authority for all
other UIC well classes in Michigan and the sole permitting authority
for all UIC well classes in Indian country within the State. EPA will
also oversee Michigan's administration of the State's UIC Class II
program as authorized under SDWA.

II. Entities Affected by This Action

                           Regulated Entities
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                                                         North American
                                      Examples of           industry
           Category              potentially regulated   classification
                                       entities              system
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Industry......................  Private owners and      211111 & 213111.
                                 operators of Class II
                                 injection wells
                                 located within the
                                 State (Enhanced
                                 Recovery, Produced
                                 Fluid Disposal, and
                                 Hydrocarbon Storage).
------------------------------------------------------------------------

    This table is intended to be a guide for readers regarding entities
likely to be regulated by this action. This table lists the types of
entities that EPA is now aware could potentially be regulated by this
action. If you have questions regarding the applicability of this
action to a particular entity, consult the persons listed in the
preceding FOR FURTHER INFORMATION CONTACT section of this preamble.

III. Legal Authorities

    Michigan applied to EPA under SDWA Section 1425 for primacy for all
Class II injection wells within the State, except those in Indian
country. EPA is approving Michigan's UIC program primacy application
for such Class II injection wells located within the State by rule, as
required under SDWA, to prevent injection activities that endanger
USDWs. Accordingly, EPA codifies Michigan's Class II UIC program in the
Code of Federal Regulations (CFR) at 40 CFR part 147, under the
authority of SDWA Section 1425, 42 U.S.C. 300h-4.

IV. EPA's Review of State UIC Program Requirements

    EPA thoroughly reviewed Michigan's Class II primacy application to
determine whether the State's program constitutes an ``effective''
program to prevent the endangerment of USDWs, in accordance with SDWA
Section 1425. EPA has provided guidance with respect to factors that
EPA may consider in reviewing a Class II UIC program for effectiveness.
Guidance for State Submissions Under Section 1425 of the Safe Drinking
Water Act (SDWA)--Ground Water Program Guidance #19--provides
instructions on how states may apply for primacy approval under SDWA
Section 1425, the process for approval or disapproval, and criteria
that EPA may consider in approving or disapproving an application.
    EPA has determined that Michigan's Class II UIC program is
effective at preventing the endangerment of USDWs, and is accordingly,
approving the State's program. EPA will oversee Michigan's
administration of the Class II UIC program. As part of EPA's oversight
responsibility, EPA will require Michigan to submit semi-annual reports
of non-compliance and annual UIC performance reports. The MOA between
EPA and Michigan, signed by the Regional Administrator on October 13,
2020, makes available to EPA any information obtained or used by
Michigan's Class II UIC program, without restriction. EPA continues to
administer the UIC program for all other injection well classes in the
State and for all wells in Indian country.

V. Michigan's Application for Class II UIC Primacy

A. Background

    The UIC program in Michigan has thus far been directly implemented
by EPA for all well classes since the initiation of the program under
SDWA (in 1984). EPA Region 5 has conducted

all application review, permitting, and oversight of injection well
activities within the State. Region 5 and EPA Headquarters worked
closely with Michigan to develop a Class II UIC regulatory structure
and primacy application package that demonstrates a state program that
is effective in preventing the endangerment of USDWs, as required under
SDWA Section 1425.

B. Public Participation Activities Conducted by the State of Michigan

    On February 15, 2018, the State published a notification in the
Michigan Register announcing its UIC Class II regulations and
requesting comment. Michigan accepted public comment through March 16,
2018, and held a public hearing on the State's regulations and its
intent to apply for primacy on February 28, 2018. Both oral and written
comments received for the hearing were generally supportive of the
State pursuing primacy for the Class II UIC program.

C. Notice of Completion and Public Participation Activities Conducted
by EPA

    On April 15, 2020, EPA published a notice of Michigan's complete
application in the Federal Register (80 FR 69629) and posted a similar
announcement on EPA's Region 5 website. The notice established a 60-day
public comment period and a public hearing on May 27, 2020. The May 27,
2020 public hearing was held virtually due to restrictions on meetings
imposed by Michigan related to COVID-19 and to protect public health.
    On March 9, 2020, EPA sent a written invitation to interested
tribes, requesting a consultation regarding the agency's review of
Michigan's request for program approval, in accordance with EPA Policy
for Consultation and Coordination with Indian Tribes (May 4, 2011). EPA
held a telephone consultation conference call with interested tribes on
April 14, 2020. EPA received a total of 40 public comments in the
electronic docket, by paper mail, and during the virtual hearing, most
of which supported Michigan's application. In particular, two tribes
submitted requests to be consulted when EPA is considering a permit
approval for a well adjacent to Indian country and within ceded
territory. EPA communicated the concerns raised in these comments via
email to the Michigan Department of Environment, Great Lakes, and
Energy (EGLE or the Department) on July 23, 2020. In response, EGLE
sent a letter (dated August 6, 2020), in which the Department committed
to consult and coordinate with tribes regarding permit applications for
wells adjacent to Indian country (defined in accordance with 18 U.S.C.
1151) and within the ceded territory where tribes hold off-reservation
treaty rights.
    Detailed documents covering the comments submitted to EPA through
the public comment process and the tribal consultation, as well as the
agency's responses and steps taken, can be viewed in the docket for
this final rule (Docket ID No. EPA-HQ-OW-2020-0595). See the preceding
ADDRESSES section of this preamble for information on accessing the
docket.

VI. Proposed Rule and Public Comments

A. Background

    On March 19, 2021, EPA published in the Federal Register a direct
final rule approving Michigan's UIC Class II application for primacy
(86 FR 14846) and requesting public comments during a 30-day comment
period. Simultaneously with the direct final rule, EPA published a
proposed rule to approve Michigan's UIC Class II application for
primacy (86 FR 14858). EPA stated in that direct final rule that if the
agency received adverse comments by April 19, 2021, the agency would
publish a timely withdrawal of the direct final rule in the Federal
Register, informing the public that the direct final rule would not
take effect and that the agency would consider and address all public
comments in any subsequent final rule based on the proposed rule. EPA
received adverse comments on that direct final rule and subsequently
issued a withdrawal notification on June 17, 2021 (86 FR 32221), before
the effective date of the direct final rule.

B. Public Comments

    In total, EPA received input from 87 individual commenters. Most
comments were submitted by individual citizens opposed to granting
Michigan primacy for the Class II UIC program. Commenters raised
concerns about underground injection, the State's application for
primacy, EPA's review and rulemaking process, and a need for an
additional public hearing to be held by EPA to gather further input on
the agency action.
    Each of the comments and EPA's responses can be viewed in the
docket (ID No. EPA-HQ-OW-2020-0595) as part of the final rule. See the
preceding ADDRESSES section of this preamble for information on
accessing the docket.

C. EPA's Response

    EPA's response to comments provides details on its regulations,
guidance, processes, and actions relative to the concerns raised during
the 30-day public comment period.\2\ In summary, EPA performed a
thorough review of all application elements and worked closely with
Michigan prior to its application submittal to ensure the State's
program met the standard of effectiveness established under SDWA
Section 1425, including Michigan's rules governing public
participation. Furthermore, EPA provided sufficient advance notice of
its intent to approve Michigan's primacy application, along with the
agency's request for public comment, in the Federal Register (85 FR
14858, March 19, 2021), on the agency's website, and in three State
newspapers. The State also provided such notice on its website. These
notifications meet the requirements of the Federal regulations at 40
CFR part 25. Details of the State-Federal partnership between EPA and
Michigan are explicitly listed in the MOA, which is included in the
rulemaking docket. Among the topics included in the MOA are EPA's
compliance monitoring, information sharing, enforcement, and oversight
of the Michigan Class II UIC program.
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    \2\ Additional information about EPA's primacy process can be
found in Section I.A of this preamble or on EPA's website at:
www.epa.gov/uic/primary-enforcement-authority-underground-injection-control-program.
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    After considering public comments, EPA is issuing this final rule
approving primacy to Michigan for the Class II UIC program. EPA's
detailed response to comments document is included in this action's
docket (ID No. EPA-HQ-OW-2020-0595). See the preceding ADDRESSES
section of this preamble for information on accessing the docket.

VII. Incorporation by Reference

    In this action, EPA is approving Michigan's Class II UIC program,
whereby the State will assume primacy for regulating Class II injection
wells in the State, except within Indian country. Michigan's statutes
and supporting documentation are publicly available in EPA's Docket No.
EPA-HQ-OW-2020-0595. This action amends 40 CFR part 147 and
incorporates by reference the EPA-approved State program. EPA will
continue to administer the UIC program for all other well classes in
Michigan and all well classes within Indian country.
    The provisions of Michigan's statutes and regulations that contain
standards, requirements, and procedures applicable to owners or
operators of UIC

Class II wells are incorporated by reference into 40 CFR 147.1150 by
this rule. Any provisions incorporated by reference, as well as all
permit conditions or permit denials issued pursuant to such provisions,
will be enforceable by EPA pursuant to SDWA Section 1423 and 40 CFR
147.1(e).
    To better serve the public, EPA is reformatting the codification of
``EPA-Approved State of Michigan Safe Drinking Water Act Sec.  1425
Underground Injection Control (UIC) Program Statutes and Regulations
for Class II wells.'' Instead of codifying the Michigan statutes and
regulations as separate paragraphs, EPA is now incorporating by
reference a compilation that contains EPA-approved Michigan statutes
and regulations for Class II wells. This compilation is incorporated by
reference into 40 CFR 147.1150 and is available at www.regulations.gov
in the docket for this rule. EPA has made, and will continue to make,
these documents generally available through www.regulations.gov and in
hard copy at the EPA Headquarters in Washington, DC, and EPA Region 5
office in Chicago, Illinois (see the preceding FOR FURTHER INFORMATION
CONTACT section of this preamble for more information). A complete list
of the Michigan statutes and regulations contained in the compilation,
titled ``EPA-Approved State of Michigan Safe Drinking Water Act Sec.
1425 Underground Injection Control (UIC) Program Statutes and
Regulations for Class II Wells,'' dated November 24, 2020, is codified
as Table 1 to paragraph (a) in that section, 40 CFR 147.1150.

VIII. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is exempt from review by the Office of Management and
Budget (OMB) because OMB has determined that the approval of primacy
for the UIC program is not a significant regulatory action.

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the PRA. EPA determined that there is no need for an Information
Collection Request under the PRA because this final rule does not
impose any new Federal reporting or recordkeeping requirements.
Reporting or recordkeeping requirements will be based on Michigan's UIC
regulations, and Michigan is not subject to the PRA. However, OMB has
previously approved the information collection activities contained in
the existing UIC regulations and for SDWA Section 1425, under the
provisions of the PRA, 44 U.S.C. 3501 et seq., and has assigned OMB
control number 2040-0042.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. In
making this determination, EPA concludes that the impact of concern for
this rule is any significant adverse economic impact on small entities
and that the agency is certifying that this rule will not have a
significant economic impact on a substantial number of small entities
if the rule has no net burden on the small entities subject to the
rule. This action would not impose any new requirements on small
entities. It simply approves and codifies Michigan's Class II UIC
program, which meets the same standard under SDWA Section 1425 as is
required for EPA's regulations governing its direct implementation of a
Class II UIC well program, both of which must ensure effective programs
to prevent underground injection that endangers USDWs. We have
therefore concluded that this action will have no net regulatory burden
for all directly regulated small entities.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local, or tribal governments or the private sector. EPA's approval of
Michigan's primacy application will not constitute a Federal mandate
because there is no requirement that a state establish a UIC regulatory
program and because the program is a state rather than a Federal
program.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It 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.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175 and as explained in section I.C of this preamble.
Nevertheless, EPA engaged the interested public during a public hearing
and specifically conducted a consultation with federally recognized
tribes to obtain unique perspectives to inform EPA's approval of
Michigan's UIC Class II Program within the State, except on Indian
lands, as described in section V.C of this preamble. Thus, Executive
Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that EPA has reason to believe may disproportionately affect children,
per the definition of ``covered regulatory action'' in section 2-202 of
the Executive order. This action is not subject to Executive Order
13045 because it approves a state action as explained in section I.C of
this preamble.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations

    EPA has determined that this action is not subject to Executive
Order 12898 (59 FR 7629, February 16, 1994) because it does not
establish an environmental health or a safety standard. This action is
providing Michigan with primacy under SDWA Section 1425 for a Class II
UIC program, pursuant to which Michigan will be implementing a program
that is effective in preventing the endangerment of USDWs. As a part of
EPA's primacy review, the agency engaged the interested public during a
public hearing and conducted a consultation with federally recognized
tribes to obtain unique perspectives to

inform the agency's approval of Michigan's UIC Class II Program within
the State, except in Indian country, as described in section V.C of
this preamble.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, and EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 147

    Environmental protection, Incorporation by reference, Indian lands,
Intergovernmental relations, Reporting and recordkeeping requirements,
Water supply.

Michael S. Regan,
Administrator.

    For the reasons set out in the preamble, EPA amends 40 CFR part 147
as follows:

PART 147--STATE, TRIBAL, AND EPA-ADMINISTERED UNDERGROUND INJECTION
CONTROL PROGRAMS

0
1. The authority citation for part 147 continues to read as follows:

    Authority: 42 U.S.C. 300f et seq.; and 42 U.S.C. 6901 et seq.

Subpart X--Michigan

0
2. Add Sec.  147.1150 to read as follows:

Sec.  147.1150  State-administered program--Class II wells.

    The UIC program for Class II injection wells in the State of
Michigan, except for those in Indian country, is the program
administered by the Michigan Department of Environment, Great Lakes,
and Energy, approved by EPA pursuant to the Safe Drinking Water Act
(SDWA) section 1425. The effective date of this program is August 29,
2022. Table 1 to paragraph (a) of this section is the table of contents
of the Michigan State statutes and regulations incorporated as follows
by reference. This program consists of the following elements, as
submitted to the EPA in the State's program application.
    (a) Incorporation by reference. The requirements set forth in the
State's statutes and regulations approved by EPA for inclusion in
``EPA-Approved State of Michigan Safe Drinking Water Act Sec.  1425
Underground Injection Control (UIC) Program Statutes and Regulations
for Class II wells,'' dated November 24, 2020, and listed in Table 1 to
this paragraph (a), are hereby incorporated by reference and made a
part of the applicable UIC program under SDWA for the State of
Michigan. This incorporation by reference was approved by the Director
of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies of the Michigan regulations and statutes that are
incorporated by reference may be inspected at the U.S. Environmental
Protection Agency, Water Docket, EPA Docket Center (EPA/DC), EPA WJC
West, Room 3334, 1301 Constitution Ave. NW, Washington, DC 20004; the
U.S. Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604; or the Michigan Department of
Environment, Great Lakes, and Energy, Oil, Gas, and Minerals Division,
Constitution Hall, 525 West Allegan Street, Lansing, Michigan 48909;
telephone number<PHONE_NUMBER>. If you wish to obtain materials from
the EPA Headquarters in Washington DC, please call the Water Docket at
(202) 566-2426 or from the EPA Regional Office, please call (312) 353-
2147. You may also inspect the materials at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, email [email protected], or go to
www.archives.gov/federal-register/cfr/ibr-locations.html.

Table 1 to Paragraph (a)--EPA-Approved State of Michigan SDWA Section 1425 Underground Injection Control Program
                                   Statutes and Regulations for Well Class II
----------------------------------------------------------------------------------------------------------------
            State citation                  Title/subject         State effective date      EPA approval date
----------------------------------------------------------------------------------------------------------------
Natural Resources and Environmental    Supervisor of Wells....  Effective September 10,  July 28, 2022, [INSERT
 Protection Act, Act 451 of 1994,                                2004.                    Federal Register
 Part 615 (Supervisor of Wells),                                                          CITATION]
 Michigan Compiled Laws (MCL)
 Sections 324.61501--324.61527.
Natural Resources and Environmental    Permits................  Effective March 29,      July 28, 2022, [INSERT
 Protection Act, Act 451 of 1994,                                2019.                    Federal Register
 Part 13 (Permits), MCL Sections                                                          CITATION]
 324.1301-324.1317.
Natural Resources and Environmental    Orphan Well Fund.......  Effective May 24, 1995.  July 28, 2022, [INSERT
 Protection Act, Act 451 of 1994,                                                         Federal Register
 Part 616 (Orphan Well Fund), MCL                                                         CITATION]
 Sections 324.61601-324.61607.
Natural Resources and Environmental    Michigan Environmental   Effective March 30,      July 28, 2022, [INSERT
 Protection Act, Act 451 of 1994,       Protection Act.          1995.                    Federal Register
 Part 17 (Michigan Environmental                                                          CITATION]
 Protection Act), MCL Sections
 324.1701-324.1706.
Administrative Procedures Act, Act     Administrative           Effective June 29, 2018  July 28, 2022, [INSERT
 306 of 1969, MCL Sections 24.201-      Procedures Act.                                   Federal Register
 24.328.                                                                                CITATION]
Revised Judicature Act of 1961, Act    Revised Judicature Act.  Effective April 1, 1974  July 28, 2022, [INSERT
 236 of 1961, MCL Section 600.631.                                                        Federal Register
                                                                                CITATION]
Michigan Department of Environmental   Oil and Gas Operations   Effective 2019.........  July 28, 2022, [INSERT
 Quality Part 615 (Oil and Gas          (administrative rules).                           Federal Register
 Operations) Administrative Rules,                                                        CITATION]
 Michigan Administrative Code (MAC)
 as follows: R 324.101 to 324.199, R
 324.201 to 324.208, R 324.210 to
 324.216, R 324.401 to 324.422, R
 324.501 to 324.504, R 324.507, R
 324.508, R 324.510, R 324.511, R
 324.701 to 324.705, R 324.801 to
 324.808, R 324.810 to 324.816, R
 324.901 to 324.904, R 324.1001 to
 324.1013, R 324.1015, R 324.1101 to
 324.1130, R 324.1201 to 324.1212, R
 324.1301, and R 324.1401 to 324.1406.

Michigan Department of Licensing and   General Provisions       Effective 2003.........  July 28, 2022, [INSERT
 Regulatory Affairs (Contested Case     (administrative rules).                           Federal Register
 Procedures for Department of                                                             CITATION]
 Environmental Quality)
 Administrative Rules, MAC, R 324.73
 and R 324.74.
Michigan Department of Licensing and   Declaratory Rulings      Effective 2003.........  July 28, 2022, [INSERT
 Regulatory Affairs (Contested Case     (administrative rules).                           Federal Register
 Procedures for Department of                                                             CITATION]
 Environmental Quality)
 Administrative Rules, MAC, R 324.81.
----------------------------------------------------------------------------------------------------------------

    (b) Memorandum of Agreement (MOA). The MOA between EPA Region 5 and
the State of Michigan Department of Environment, Great Lakes, and
Energy signed by the EPA Regional Administrator on October 13, 2020.
    (c) Statements of Legal Authority. ``Underground Injection Control
Program, Attorney General's Statement,'' signed by the Chief of the
Environment, Natural Resources, and Agriculture Division of the
Michigan Department of Attorney General on September 1, 2020.
    (d) Program Description. The Program Description submitted as part
of Michigan's application, and any other materials submitted as part of
this application or as a supplement thereto.

0
3. Amend Sec.  147.1151 by revising the section heading and the first
sentence of paragraph (a) to read as follows:

Sec.  147.1151  EPA-administered program--Class I, III, IV, V, and VI
wells and Indian country.

    (a) * * * The UIC program for Class I, III, IV, V and VI wells and
all wells in Indian country in the State of Michigan is administered by
the EPA. * * *
* * * * *

0
4. Revise Sec. Sec.  147.1153, 147.1154, and 147.1155 to read as
follows:

Sec.  147.1153  Existing Class II disposal wells authorized by rule in
Indian country.

    The owner or operator shall limit injection pressure to the lesser
of:
    (a) A value which will not exceed the operating requirements of
Sec.  144.28(f)(3)(i) or (ii) of this chapter as applicable; or
    (b) A value for well head pressure calculated by using the
following formula:
Pm = (0.800-0.433 Sg)d

Where:

Pm = injection pressure at the well head in pounds per square inch.
Sg = specific gravity of injected fluid (unitless).
d = injection depth in feet.

Sec.  147.1154  Existing Class II enhanced recovery and hydrocarbon
storage wells authorized by rule in Indian country.

    (a) Maximum injection pressure. (1) To meet the operating
requirements of Sec.  144.28(f)(3)(ii)(A) and (B) of this chapter, the
owner or operator:
    (i) Shall use an injection pressure no greater than the pressure
established by the Regional Administrator for the field or formation in
which the well is located. The Regional Administrator shall establish
such a maximum pressure after notice, opportunity for comment, and
opportunity for a public hearing, according to the provisions of part
124, subpart A, of this chapter, and will inform owners and operators
in writing of the applicable maximum pressure; or
    (ii) May inject at pressures greater than those specified in
paragraph (a)(1)(i) of this section for the field or formation in which
he is operating provided he submits a request in writing to the
Regional Administrator and demonstrates to the satisfaction of the
Regional Administrator that such injection pressure will not violate
the requirements of Sec.  144.28(f)(3)(ii)(A) and (B) of this chapter.
The Regional Administrator may grant such a request after notice,
opportunity for comment, and opportunity for a public hearing,
according to the provisions of part 124, subpart A, of this chapter.
    (2) Prior to such time as the Regional Administrator establishes
field rules for maximum injection pressure based on data provided
pursuant to paragraph (a)(2)(ii) of this section the owner or operator
shall:
    (i) Limit injection pressure to a value which will not exceed the
operating requirements of Sec.  144.28(f)(3)(ii) of this chapter; and
    (ii) Submit data acceptable to the Regional Administrator, which
defines the fracture pressure of the formation in which injection is
taking place. A single test may be submitted on behalf of two or more
operators conducting operations in the same formation if the Regional
Administrator approves such submission. The data shall be submitted to
the Regional Administrator within one year following the effective date
of this program.
    (b) Casing and cementing. Where the Regional Administrator
determines that the owner or operator of an existing enhanced recovery
or hydrocarbon storage well may not be in compliance with the
requirements of Sec. Sec.  144.28(e) and 146.22 of this chapter, the
owner or operator shall comply with paragraphs (b)(1) through (4) of
this section, when required by the Regional Administrator:
    (1) Protect underground sources of drinking water (USDWs) by:
    (i) Cementing surface casing by recirculating the cement to the
surface from a point 50 feet below the lowermost USDW; or
    (ii) Isolating all USDWs by placing cement between the outermost
casing and the well bore; and
    (2) Isolate any injection zones by placing sufficient cement to
fill the calculated space between the casing and the well bore to a
point 250 feet above the injection zone; and
    (3) Use cement:
    (i) Of sufficient quantity and quality to withstand the maximum
operating pressure;
    (ii) Which is resistant to deterioration from formation and
injection fluids; and
    (iii) In a quantity no less than 120% of the calculated volume
necessary to cement-off a zone.
    (4) The Regional Administrator may specify other requirements in
addition to or in lieu of the requirements set forth in paragraphs
(b)(1) through (3) of this section, as needed to protect USDWs.

Sec.  147.1155  Requirements for all EPA-administered wells.

    (a) Area of review. Notwithstanding the alternatives presented in
Sec.  146.6 of this chapter, the area of review for Class II wells
shall be a fixed radius as described in Sec.  146.6(b) of this chapter.
    (b) Tubing and packer. The owner or operator of an injection well
injecting salt water for disposal shall inject through tubing and
packer. The owner of an existing well must comply with

this requirement within one year of the effective date of this program.
[FR Doc. 2022-16017 Filed 7-27-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 53 (Thursday, March 19, 2015)]
[Notices]
[Page 14404]
[FR Doc No: 2015-06336]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2014-0033; OMB No. 1660-0132]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

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 will describe the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use.

DATES: Comments must be submitted on or before April 20, 2015.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the Desk
Officer for the Department of Homeland Security, Federal Emergency
Management Agency, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Records Management Division, 500 C Street SW., Washington, DC 20472-
3172, facsimile number<PHONE_NUMBER>, or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Collection of Information

    Title: Level 1 Assessment Form, Level 3 Evaluation Form for
Students, and Level 3 Evaluation Form for Supervisors.
    Type of Information Collection: Revision of currently approved
collection.
    Form Titles and Numbers: FEMA Form 092-0-2, Level 1 Assessment
Form; FEMA Form 092-0-2A, Level 3 Evaluation Form for Students; FEMA
Form 092-0-2B, Level 3 Evaluation Form for Supervisors.
    Abstract: The forms will be used to survey the Center for Domestic
Preparedness (CDP) students enrolled in CDP courses and their
supervisors. The surveys will collect information regarding quality of
instruction, course material, and impact of training on their
professional employment.
    Affected Public: State, Local or Tribal Government.
    Estimated Number of Respondents: 44,600.
    Estimated Total Annual Burden Hours: 11,150.
    Estimated Cost: 403,795.25.

    Dated: March 13, 2015.
Terry Cochran,
Acting Director, Records Management Division, Mission Support, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2015-06336 Filed 3-18-15; 8:45 am]
 BILLING CODE 9111-53-P


[Federal Register Volume 78, Number 167 (Wednesday, August 28, 2013)]
[Rules and Regulations]
[Pages 53039-53047]
[FR Doc No: 2013-20921]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0549; FRL-9395-5]

Pyraclostrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
pyraclostrobin in or on multiple commodities which are identified and
discussed later in this document. This regulation additionally removes
several permanent and time-limited tolerances that will be superseded
by tolerances established by this action. Interregional Research
Project Number 4 (IR-4) and BASF Corporation requested tolerances
associated with pesticide petition (PP) numbers 2E8069 and 2F8038,
respectively, under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 28, 2013. Objections and
requests for hearings must be received on or before October 28, 2013,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0549, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P),

Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(703) 305-7090; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0549 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 28, 2013. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0549, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerances

    In the Federal Register of January 16, 2013 (78 FR 3377) (FRL-9375-
4), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
2E8069) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ
08540. The petition requested that 40 CFR 180.582 be amended by
establishing tolerances for residues of the fungicide pyraclostrobin,
carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl]methoxy-, methyl ester and its metabolite methyl-
N-[[[1-(4-chlorophenyl) pyrazol-3-yl]oxy]otolyl] carbamate (BF 500-3),
expressed as the parent compound, in or on artichoke, globe at 3.0
parts per million (ppm); endive, belgium at 3.0 ppm; and persimmon at
3.0 ppm. The petition additionally requested that EPA establish
tolerances in or on vegetable, bulb, group 3-07 at 0.9 ppm; vegetable,
fruiting, group 8-10 at 1.4 ppm; fruit, citrus, group 10-10 at 2.0 ppm;
fruit, pome, group 11-10 at 1.5 ppm; oilseed, group 20 at 0.45 ppm;
caneberry subgroup 13-07A at 4.0 ppm; bushberry subgroup 13-07B at 4.0
ppm; small fruit, vine climbing subgroup (except fuzzy kiwi) 13-07F at
2.0 ppm; and low growing berry subgroup 13-07G at 1.2 ppm. Further,
upon approval of these subgroup/crop group tolerances the petition also
requested that the following existing tolerances be removed for berry,
group 13 at 4.0 ppm; fruit, citrus, group 10 at 2.0 ppm; fruit, pome,
group 11 at 1.5 ppm; grape at 2.0 ppm; strawberry at 1.2 ppm;
vegetable, bulb, group 3 at 0.9 ppm; vegetable, fruiting, group 8 at
1.4 ppm; borage, seed at 0.45 ppm; castor oil plant, seed at 0.45 ppm;
chinese tallowtree, seed at 0.45 ppm; crambe, seed at 0.45 ppm; cuphea,
seed at 0.45 ppm; echium, seed at 0.45 ppm; euphorbia, seed at 0.45
ppm; evening primrose, seed at 0.45 ppm; flax seed at 0.45 ppm; gold of
pleasure, seed at 0.45 ppm; hare's ear mustard, seed at 0.45 ppm,
jojoba, seed at 0.45 ppm; lesquerella, seed at 0.45 ppm, lunaria, seed
at 0.45 ppm; meadowfoam, seed at 0.45 ppm; milkweed, seed at 0.45 ppm;
mustard, seed at 0.45 ppm; niger seed, seed at 0.45 ppm; oil radish,
seed at 0.45 ppm; poppy, seed at 0.45 ppm; rapeseed, seed at 0.45 ppm;
rose hip, seed at 0.45 ppm; safflower, seed at 0.45 ppm; sesame, seed
at 0.45 ppm; stokes aster, seed at 0.45 ppm; sunflower, seed at 0.45
ppm; sweet rocket, seed at 0.45 ppm; tallowwood, seed at 0.45 ppm; tea
oil plant, seed at 0.45 ppm; and ternonia, seed at 0.45 ppm. That
document referenced a summary of the petition prepared on behalf of IR-
4 by BASF Corporation, the registrant, which is available in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filing.
    Additionally, in the Federal Register of August 22, 2012 (77 FR
50661) (FRL-9358-9), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 2F8038) by BASF Corporation, 26 Davis Drive, P.O. Box
13528, Research Triangle Park, NC, 27709-3528. The petition requested
that 40 CFR 180.582 be amended by establishing tolerances for residues
of the fungicide pyraclostrobin, carbamic acid, expressed as the parent
compound, in or on sugarcane, cane at 0.2 ppm. No tolerances were
proposed for the processed commodities refined sugar and molasses, as
no concentration of pyraclostrobin residues are expected in these
commodities. That document referenced a summary of the petition
prepared by BASF Corporation, the registrant, which is available in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
revised the proposed tolerance level in or on endive, belgium. Further,
the petitioner later requested to amend low growing berry subgroup 13-
07G to exclude cranberry. The reasons for these changes are explained
in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for pyraclostrobin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with pyraclostrobin
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    There are no concerns for reproductive susceptibility,
neurotoxicity, mutagenicity, genotoxicity, or immunotoxicity. The most
consistently observed effects resulting from pyraclostrobin exposure
across species, genders, and treatment durations were diarrhea and
decreased body weight, body weight gain, and food consumption.
Pyraclostrobin also causes intestinal disturbances, as indicated by
increased incidence of diarrhea or duodenum mucosal thickening. These
intestinal effects appeared to be related to the irritating action on
the mucus membranes as demonstrated by irritation seen in the primary
eye irritation study. In the rat acute and subchronic neurotoxicity
studies, neuropathology and behavior changes were not observed.
    In the rat developmental toxicity study, developmental toxicity
including an increased incidence of dilated renal pelvis and cervical
ribs occurred at a dose greater than the dose causing maternal toxicity
(including decreased body weights and body weight gains and reduced
food consumption and reduced food efficiency). The rabbit developmental
toxicity study indicates qualitative evidence of increased
developmental susceptibility based on increased resorptions per litter,
increased post-implantation loss and dams with total resorptions, in
the presence of maternal toxicity (reduced body weight gain, food
consumption, and food efficiency). In a dose range-finding one-
generation reproduction study, systemic toxicity was manifested as
decreased body weight and body weight gain in both the parents and
offspring. The effects occurred at the same dose levels for both
parental and the offspring, but the decrease in pup weight was more
than that in the parental animals. However, the body weight effect was
not found in the guideline 2-generation reproduction study in either
parental or offspring animals at similar dose level. No reproductive
toxicity was seen.
    Pyraclostrobin has been classified as not likely to be carcinogenic
to humans based on the lack of treated related increase in tumor
incidence in adequately conducted carcinogenicity studies in rats and
mice. Pyraclostrobin did not cause mutagenicity or genotoxicity in the
in vivo and in vitro assays, nor did it cause immunotoxicity in T-cell
dependent antibody response assays in mice with preliminary review.
    Specific information on the studies received and the nature of the
adverse effects caused by pyraclostrobin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document: ``Pyraclostrobin--Human Health Risk
Assessment for a Section 3 Registration of New Uses on Sugarcane, Globe
Artichoke, Belgium Endive, Persimmon, Greenhouse Grown Tomato
Transplants for Home Consumer Market, and Residential Ornamentals,
Landscape Gardens, Fruit Trees, and Nut Trees; Plus Crop Group
Expansions/Revisions for Bulb Vegetable Group 3-07, Fruiting Vegetable
Group 8-10, Citrus Fruit Group 10-10, Pome Fruit Group 11-10, Berry
Subgroups 13-07A, B, F, and G, and Oilseed Group 20'' at pages 43-49 in
docket ID number EPA-HQ-OPP-2012-0549.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for pyraclostrobin used
for human risk assessment is shown in Table 1. of this unit.

Table 1--Summary of Toxicological Doses and Endpoints for Pyraclostrobin for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49       NOAEL = 5.0 mg/kg/    Acute RfD = 0.05 mg/ Developmental toxicity--rabbit.
 years of age).                     day.                  kg/day.              LOAEL = 10.0 mg/kg/day based on
                                   UFA = 10x...........  aPAD = 0.05 mg/kg/    developmental toxicity findings
                                   UFH = 10x...........   day.                 of increased resorptions.
                                   FQPA SF = 1x........
Acute dietary (General population  NOAEL = 300 mg/kg/    Acute RfD = 3.0 mg/  Acute neurotoxicity--rat. LOAEL =
 including infants and children).   day.                  kg/day.              1000 mg/kg/day based on decreased
                                   UFA = 10 x..........  aPAD = 3.0 mg/kg/     body weight gain in males.
                                   UFH = 10 x..........   day.
                                   FQPA SF = 1x........
Chronic dietary (All populations)  NOAEL= 3.4 mg/kg/day  Chronic RfD = 0.034  Carcinogenicity--rat. LOAEL = 9.2
                                   UFA = 10x...........   mg/kg/day.           mg/kg/day based on decreased body
                                   UFH = 10 x..........  cPAD = 0.034 mg/kg/   weight/body weight gain, kidney
                                   FQPA SF = 1x........   day.                 tubular casts and atrophy in both
                                                                               sexes; increased incidence of
                                                                               liver necrosis and erosion/
                                                                               ulceration of the glandular-
                                                                               stomach and fore-stomach in
                                                                               males.
Incidental oral short-term (1 to   NOAEL= 5.8 mg/kg/day  LOC for MOE = 100..  Subchronic toxicity--dog. LOAEL =
 30 days) and intermediate-term    UFA = 10 x..........                        12.9 mg/kg/day based on increased
 (1 to 6 months).                  UFH = 10x...........                        incidence of diarrhea, clinical
                                   FQPA SF = 1x........                        chemistry changes, duodenum
                                                                               mucosal hypertrophy, and
                                                                               decreased body weight and food
                                                                               intake/efficiency.
Dermal short-term (1 to 30 days)   Oral study NOAEL =    LOC for MOE = 100..  Developmental toxicity--rabbit.
 and intermediate-term (1 to 6      5.0 mg/kg/day                              LOAEL = 10.0 mg/kg/day based on
 months).                           (dermal absorption                         developmental toxicity findings
                                    rate = 14%).                               of increased resorptions and
                                   UFA = 10 x..........                        maternal toxicity based on
                                   UFH = 10x...........                        decreased body weight gain and
                                   FQPA SF = 1x........                        decreased food intake/efficiency.
Inhalation short-term............  Inhalation study      LOC for MOE = 100..  Inhalation toxicity--rat. LOAEL =
(1 to 30 days) and intermediate-    NOAEL = 0.23 mg/kg/                        6.9 mg/kg/day (air concentration
 term (1 to 6 months).              day.                                       = 0.03 mg/L) based on duodenum
                                   UFA = 10 x..........                        mucosal hyperplasia and
                                   UFH = 10 x..........                        respiratory system findings
                                   FQPA SF = 1x........                        including alveolar histiocytosis
                                                                               and olfactory atrophy/necrosis in
                                                                               nasal tissue.
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)     Classification: ``not likely to be carcinogenic to humans'' based on the
                                            absence of significant tumor increases in two adequate rodent
                                                              carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pyraclostrobin, EPA considered exposure under the
petitioned-for tolerances as well as all existing pyraclostrobin
tolerances in 40 CFR 180.582. EPA assessed dietary exposures from
pyraclostrobin in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for pyraclostrobin.
    In estimating acute dietary exposure, EPA used Dietary Exposure
Evaluation Model software with the Food Commodity Intake Database
(DEEM-FCID) Version 3.16, which uses food consumption data from the
U.S. Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey, What We Eat in America (NHANES/WWEIA) from 2003
through 2008. As to residue levels in food, EPA used tolerance-level
residues or highest field trial residues and empirical or default
processing factors. Experimentally-derived processing factors were used
for fruit juices, tomato, sugarcane, and wheat commodities. For all
other processed commodities, DEEM default processing factors were
assumed.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's 2003-2008
NHANES/WWEIA. As to residue levels in food, EPA included tolerance-
level or average field trial residues, average percent crop treated
(PCT) estimates when available, and empirical processing factors.
Experimentally-derived processing factors were used for fruit juices,
tomato, sugar cane, and wheat commodities. For all other processed
commodities, DEEM default processing factors were assumed.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that pyraclostrobin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Percent crop treated (PCT) information. Section 408(b)(2)(F) of
FFDCA states that the Agency may use data on the actual percent of food
treated for assessing chronic dietary risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.

     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The following average PCT estimates were used in the chronic
dietary risk assessments for the crops that are currently registered
for pyraclostrobin: almonds 40%; apples 15%; apricots 25%; barley 10%;
green beans 5%; blueberries 45%; broccoli 5%; cabbage 10%; caneberries
50%; cantaloupes 15%; carrots 35%; cauliflower 2.5%; celery 2.5%;
cherries 50%; corn 10%; cotton 2.5%; cucumber 5%; dry beans/peas 10%;
garlic 15%; grapefruit 25%; grapes 30%; hazelnuts (filberts) 15%;
lemons 2.5%; lettuce 5%; nectarines 10%; onions 20%; oranges 5%;
peaches 20%; peanuts 25%; pears 15%; green peas 5%; pecans 2.5%;
peppers 10%; pistachios 30%; plums/prunes 5%; potatoes 15%; pumpkins
20%; soybeans 5%; spinach 5%; squash 15%; strawberries 65%; sugar beets
45%; sweet corn 5%; tangelos 15%; tangerines 10%; tomatoes 25%; walnuts
1%; watermelons 30%; wheat 5%.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which pyraclostrobin may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for pyraclostrobin in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of pyraclostrobin. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
pyraclostrobin for acute exposures are estimated to be 35.6 parts per
billion (ppb) for surface water and 0.06 ppb for ground water. Chronic
exposures for non-cancer assessments are estimated to be 2.3 ppb for
surface water and 0.02 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 35.6 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 2.3 ppb was used to assess
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Pyraclostrobin is
currently registered for the following uses and additional proposed
uses that could result in residential handler and postapplication
exposures: Treated gardens, fruit or nut trees, tomato transplants, and
turf. EPA assessed residential exposure using the following
assumptions: Short-term adult handler exposures via the dermal and
inhalation routes resulting from application of pyraclostrobin to
gardens, trees, and turf. Short-term dermal postapplication exposures
were assessed for adults, youth 11 to 16 years old, and children 6 to
11 years old. Short-term dermal and incidental oral exposures were
assessed for children 1 to < 2 years old. Based on the registered uses
of pyraclostrobin on residential and golf course turf, intermediate-
term postapplication exposures are possible. However, since the short-
and intermediate-term endpoints and PODs for dermal and oral routes are
the same, the short-term exposure and risk estimates are considered to
be protective of potential intermediate-term exposure and risk.
    For the aggregate assessment, inhalation and dermal exposures were
not aggregated together because the toxicity effect from the inhalation
route of exposure was different than the effect from the dermal route
of exposure. The scenarios with the highest residential exposures that
were used in the short-term aggregate assessment for pyraclostrobin are
as follows:
     Adult short-term aggregate assessment--Residential
inhalation exposure from application pyraclostrobin to turf via
manually pressurized hand wand or backpack sprayer; residential dermal
postapplication exposure via activities on treated turf.
     Youth (11-16 years old) short-term aggregate assessment--
Residential dermal exposure from postapplication golfing on treated
turf.
     Children (6-11 years old) short-term aggregate
assessment--Residential dermal exposures from postapplication
activities in treated gardens.
     Children (1 < 2 years old) short-term aggregate
assessment--Residential dermal and hand-to-mouth exposures from
postapplication exposure to treated turf.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA

requires that, when considering whether to establish, modify, or revoke
a tolerance, the Agency consider ``available information'' concerning
the cumulative effects of a particular pesticide's residues and ``other
substances that have a common mechanism of toxicity.''
    EPA has not found pyraclostrobin to share a common mechanism of
toxicity with any other substances, and pyraclostrobin does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
pyraclostrobin does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence that
pyraclostrobin results in increased susceptibility in rats or rabbits
in the prenatal developmental studies or in young rats in the 2-
generation reproduction study. Although there is qualitative evidence
of increased susceptibility in the prenatal development study in
rabbits, the Agency did not identify any residual uncertainties after
establishing toxicity endpoints and traditional UFs to be used in the
risk assessment of pyraclostrobin. The degree of concern for prenatal
and/or postnatal toxicity is low.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for pyraclostrobin is complete.
    ii. There is no indication that pyraclostrobin is a neurotoxic
chemical. Effects seen in the acute and subchronic neurotoxicity
studies in rats are considered to reflect perturbations in
mitochondrial respiration leading to effects on energy production
rather than signs of neurotoxicity; therefore, there is no need for a
developmental neurotoxicity study or additional UFs to account for
neurotoxicity
    iii. There is no evidence that pyraclostrobin results in increased
susceptibility in rats in the prenatal developmental study or in young
rats in the 2-generation reproduction study. The prenatal rabbit
developmental toxicity study showed qualitative evidence of increased
susceptibility to prenatal rabbits; however, this study was chosen for
endpoint selection for the acute dietary (females 13-49) and short-term
dermal exposure scenarios. This study has a clearly defined NOAEL of
5.0 mg/kg/day. EPA did not identify any residual uncertainties after
establishing toxicity endpoints and traditional UFs to be used in the
risk assessment of pyraclostrobin. The degree of concern for prenatal
and/or postnatal toxicity is low.
    iv. There are no residual uncertainties identified in the exposure
databases. The acute dietary exposure assessments were performed
assuming 100 PCT and tolerance-level or highest field trial residues.
The chronic dietary exposure assessments were performed using average
PCT estimates, when available, and tolerance-level or highest field
trial residues. These data are reliable and are not expected to
underestimate risks to adults or children. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to pyraclostrobin in drinking water. EPA used
similarly conservative assumptions to assess postapplication exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
pyraclostrobin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
pyraclostrobin will occupy 87% of the aPAD for females 13-49 years old;
and 2.8% for children 1-2 years old, the population group receiving the
greatest exposure for the general U.S. population, including infants
and children.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
pyraclostrobin from food and water will utilize 27% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
pyraclostrobin is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Pyraclostrobin is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to pyraclostrobin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 120 for children
1-2 years old, 360 for children 6-11 years old, 1,500 for youth 11-16
years old, 760 for adult handlers, and 230 for adults from
postapplication exposures. Because EPA's level of concern for
pyraclostrobin is a MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Pyraclostrobin is currently registered for uses that could
result in intermediate-term residential exposure; however, since the
short- and intermediate-term endpoints and PODs for dermal and oral
routes are the same, the short-term exposure and risk estimates are
considered to be protective of potential

intermediate-term exposure and risk and an intermediate-term aggregate
assessment was not performed.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, pyraclostrobin is not expected to pose a cancer risk to
humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to pyraclostrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Two adequate methods are available to enforce the tolerance
expression for residues of pyraclostrobin and the metabolite BF 500-3
in or on plant commodities: A liquid chromatography with tandem mass
spectrometry (LC/MS/MS) method, BASF Method D9908; and a high-
performance LC with ultraviolet detection (HPLC/UV) method, Method
D9904. The methods may be found in the Pesticide Analytical Manual,
Volume I.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for pyraclostrobin in or on
sugarcane, endive, belgium, and persimmon. A Codex MRL has been
established for pyraclostrobin in or on globe artichoke at 2.0 ppm. EPA
has determined that the U.S. tolerance should be set at 3.0 ppm. The
field trials comprising the data set used by Codex are from Europe, and
these trials were conducted under an application rate and preharvest
interval different from that on the U.S. trials. The U.S. tolerance is
based on application of the Organization for Economic Cooperation and
Development (OECD) tolerance calculation procedures to the validated
field trial data, which shows that the U.S. tolerance for globe
artichoke must be at 3.0 ppm to avoid violations for crops treated in
accordance with the EPA approved label. These different tolerance
levels may be due, in part, to the different residue definitions for
pyraclostrobin for the U.S. tolerances and the Codex MRLs. Codex
established MRLs for residues of pyraclostrobin only, and in the U.S.
tolerances, are currently established for parent and its desmethoxy
metabolite (methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]
phenylcarbamate). Currently, pyraclostrobin has over 100 tolerances for
multiple commodities and crop groups. When this chemical goes through
registration review the U.S. EPA will determine if it is possible to
change the existing residue definition to align with Codex which would
potentially allow for harmonization of MRL and tolerance levels.
However, given the number of existing tolerances it is not appropriate
to consider such a change for this petition only. Therefore, because
the residue definitions are currently different and pyraclostrobin
field trials in the U.S. show higher residue levels than Codex MRL
levels, it is not possible to harmonize the U.S. tolerance for globe
artichoke with the Codex MRL. Additionally, the following U.S. crop
group tolerances established in this action could not be harmonized
because of the difference in residue definitions between U.S.
tolerances for pyraclostrobin and Codex MRLs. The crop group tolerances
which could not be harmonized with Codex MRLs for commodities in these
crop group tolerances include: The bulb vegetable group 3-07; the
fruiting vegetables group 8-10; the pome fruit group 11-10; the
caneberry subgroup 13-07A; the bushberry subgroup 13-07B; the small
fruit vine climbing subgroup 13-07F; and the low growing berry subgroup
13-07G. The Codex has established an MRL for the Codex equivalent of
the U.S. citrus fruit group 10-10 and for the oilseed group 20, but
although the numerical levels for the U.S. and Codex crop groups are
the same, the numerical values refer to different residues.

C. Revisions to Petitioned-for Tolerances

    Based on the data submitted with the petition, EPA is revising the
proposed tolerance in or on endive, belgium from 3.0 ppm to 4.0 ppm.
The Agency revised this tolerance level based on analysis of the
residue field trial data using the OECD tolerance calculation
procedures. EPA is additionally removing the time-limited tolerance in
or on sugarcane, cane at 0.02 ppm as it will be superseded by the
permanent tolerance at 0.2 ppm. Finally, EPA is removing the time-
limited tolerance in or on sugarcane, molasses at 0.4 ppm, as the
Agency has determined that no concentration of pyraclostrobin residues
are expected in these commodities and the tolerance is therefore not
necessary. The information regarding sugarcane, molasses was included
in the August 22, 2012 (77 FR 50661) notice of filing for PP number
2F8038.

V. Conclusion

    Therefore, tolerances are established for residues of
pyraclostrobin, carbamic acid, [2-[[[1-(4-chlorophenyl)-1H- pyrazol-3-
yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy
metabolite (methyl N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl carbamate), calculated as the stoichiometric
equivalent of pyraclostrobin in or on artichoke, globe at 3.0 ppm;
endive, belgium at 4.0 ppm; persimmon at 3.0 ppm; sugarcane, cane at
0.20 ppm; vegetable, bulb, group 3-07 at 0.9 ppm; vegetable, fruiting,
group 8-10 at 1.4 ppm; fruit, citrus, group 10-10 at 2.0 ppm; fruit,
pome, group 11-10 at 1.5 ppm; oilseed group 20 at 0.45 ppm; caneberry
subgroup 13-07A at 4.0 ppm; bushberry subgroup 13-07B at 4.0 ppm;
fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at
2.0 ppm; and berry, low growing, subgroup 13-07G, except cranberry at
1.2 ppm. This regulation additionally removes established tolerances in
or on vegetable, bulb, group 3; vegetable, fruiting, group 8; fruit,
citrus, group 10; fruit, pome, group 11; cotton, undelinted seed;
borage, seed; castor oil plant, seed; Chinese tallowtree, seed; crambe,
seed; cuphea, seed; echium, seed; euphorbia, seed; evening primrose,
seed; flax, seed; gold of pleasure, seed; hare's ear mustard, seed;
jojoba, seed; lesquerella, seed; lunaria, seed; meadowfoam, seed;
milkweed, seed; mustard, seed; niger seed, seed; oil radish, seed;
poppy, seed; rapeseed, seed; rose hip, seed; safflower, seed; sesame,
seed; stokes aster, seed; sunflower, seed; sweet rocket, seed;
tallowwood, seed; tea oil plant, seed; vernonia, seed; berry, group 13;
grape; and strawberry. This regulation finally removes the time-limited
tolerances in or on sugarcane, cane and sugarcane, molasses.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children From Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule 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 of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 14, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.582:
0
a. Revise the table in paragraph (a)(1).
0
b. Remove the commodities ``Sugarcane, cane'' and ``Sugarcane,
molasses'' in the table in paragraph (b).
0
c. Revise the table in paragraph (b).
    The revisions read as follows:

Sec.  180.582  Pyraclostrobin; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.........................................           10
Alfalfa, hay............................................           30
Almond, hulls...........................................            7.0
Apple, wet pomace.......................................            8.0
Artichoke, globe........................................            3.0
Avocado.................................................            0.6
Banana..................................................            0.04
Barley, grain...........................................            1.4
Barley, hay.............................................           25
Barley, straw...........................................            6.0
Bean, succulent shelled.................................            0.5
Beet, sugar, dried pulp.................................            1.0
Beet, sugar, roots......................................            0.2
Beet, sugar, tops.......................................            8.0
Berry, low growing, subgroup 13-07G, except cranberry...            1.2
Brassica, head and stem, subgroup 5A....................            5.0
Brassica, leafy greens, subgroup 5B.....................           16.0
Bushberry subgroup 13-07B...............................            4.0
Caneberry subgroup 13-07A...............................            4.0
Canistel................................................            0.6
Citrus, dried pulp......................................           12.5
Citrus, oil.............................................            9.0
Coffee, green bean......................................        \1\ 0.3
Corn, field, forage.....................................            5.0
Corn, field, grain......................................            0.1
Corn, field, refined oil................................            0.2
Corn, field, stover.....................................           17.0
Corn, pop, grain........................................            0.1
Corn, pop, stover.......................................           17.0
Corn, sweet, forage.....................................            5.0
Corn, sweet, kernel plus cob with husks removed.........            0.04
Corn, sweet, stover.....................................           23.0
Cotton, gin byproducts..................................           30
Endive, belgium.........................................            4.0
Fruit, citrus, group 10-10..............................            2.0
Fruit, pome, group 11-10................................            1.5
Fruit, small vine climbing, except fuzzy kiwifruit,                 2.0
 subgroup 13-07F........................................
Fruit, stone, group 12..................................            2.5
Grain, aspirated fractions..............................            2.5
Grape, raisin...........................................            7.0
Grass, forage...........................................           10
Grass, hay..............................................            4.5
Grass, seed screenings..................................           27
Grass, straw............................................           14
Hop, dried cones........................................           23.0
Mango...................................................            0.6
Nut, tree, group 14.....................................            0.04
Oat, grain..............................................            1.2
Oat, hay................................................           18
Oat, straw..............................................           15
Oilseed group 20........................................            0.45
Papaya..................................................            0.6
Pea, succulent..........................................            0.2
Pea and bean, dried shelled, except soybean, subgroup 6C            0.5
Peanut..................................................            0.05
Peanut, refined oil.....................................            0.1
Peppermint, tops........................................            8.0
Persimmon...............................................            3.0
Pistachio...............................................            0.7
Radish, tops............................................           16
Rye, grain..............................................            0.04
Rye, straw..............................................            0.5
Sapodilla...............................................            0.6
Sapote, black...........................................            0.6
Sapote, mamey...........................................            0.6
Sorghum, grain, forage..................................            5.0
Sorghum, grain, grain...................................            0.60
Sorghum, grain, stover..................................            0.80
Soybean, forage.........................................           11
Soybean, hay............................................           14
Soybean, hulls..........................................            0.06
Soybean, seed...........................................            0.04
Spearmint, tops.........................................            8.0
Star apple..............................................            0.6
Sugarcane, cane.........................................            0.20
Vegetable, bulb, group 3-07.............................            0.9

Vegetable, cucurbit, group 9............................            0.5
Vegetable, foliage of legume, except soybean, subgroup             25.0
 7A.....................................................
Vegetable, fruiting, group 8-10.........................            1.4
Vegetable, leafy, except brassica, group 4..............           29.0
Vegetable, leaves of root and tuber, group 2, except               16.0
 sugar beet.............................................
Vegetable, legume, edible podded, subgroup 6A...........            0.5
Vegetable, root, except sugar beet, subgroup 1B.........            0.4
Vegetable, tuberous and corm, subgroup 1C...............            0.04
Vegetables, foliage of legume, group 7..................           25
Wheat, grain............................................            0.02
Wheat, hay..............................................            6.0
Wheat, straw............................................            8.5
------------------------------------------------------------------------

* * * * *
    (b) Section 18 emergency exemptions. * * *

------------------------------------------------------------------------
                                           Parts per       Expiration/
               Commodity                    million      revocation date
------------------------------------------------------------------------
Endive, belgium.......................            11.0         12/31/13
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-20921 Filed 8-27-13; 8:45 am]
BILLING CODE 6560-50-P