[Federal Register Volume 86, Number 28 (Friday, February 12, 2021)]
[Notices]
[Pages 9336-9337]
[FR Doc No: 2021-02848]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-R10-OAR-2020-0724; FRL-10019-86-Region 10]

Proposed Information Collection Request; Comment Request; Federal
Implementation Plans Under the Clean Air Act for Indian Reservations in
Idaho, Oregon and Washington

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA or the Agency) is
planning to submit an information collection request (ICR), Proposed
Information Collection Request; Comment Request; Federal Implementation
Plans under the Clean Air Act for Indian Reservations in Idaho, Oregon
and Washington to the Office of Management and Budget (OMB) for review
and approval in accordance with the Paperwork Reduction Act. Before
doing so, EPA is soliciting public comments on specific aspects of the
proposed information collection as described in this document. This is
a proposal to extend the current ICR, which expires on August 31, 2021.
An Agency may not conduct or sponsor, and a person is not required to
respond to a collection of information, unless it displays a currently
valid OMB control number.

DATES: Comments must be submitted on or before April 13, 2021.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-R10-OAR-
2020-0724, online using https://www.regulations.gov.
    Out of an abundance of caution for members of the public and our
staff, the EPA Docket Center and Reading Room is closed to the public,
with limited exceptions, to reduce the risk of transmitting COVID-19.
Our Docket Center staff will continue to provide remote customer
service via email, phone, and webform. We encourage the public to
submit comments via https://www.regulations.gov/ or email, as there may
be a delay in processing mail and faxes. Hand deliveries and couriers
may be received by scheduled appointment only. For further information
on EPA Docket Center services and the current status, please visit us
online at https://www.epa.gov/dockets.
    The EPA's policy is that all comments received will be included in
the public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information, or other information
whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Sarah Frederick, Air and Radiation
Division, telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that EPA will be collecting are available in the public
docket for this ICR. The docket can be viewed online at https://www.regulations.gov. For additional information about EPA's public
docket, visit https://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the Paperwork Reduction Act,
EPA is soliciting comments and information to enable it to: (i)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the Agency, including

whether the information will have practical utility; (ii) evaluate the
accuracy of the Agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (iii) enhance the quality, utility, and clarity
of the information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: EPA promulgated Federal Implementation Plans (FIPs) under
the Clean Air Act for Indian reservations located in Idaho, Oregon, and
Washington in 40 CFR part 49 (70 FR 18074, April 8, 2005). The FIPs in
the final rule, also referred to as the Federal Air Rules for Indian
Reservations in Idaho, Oregon, and Washington (FARR), include
information collection requirements associated with the partial
delegation of administrative authority to a Tribe in 40 CFR 49.122; the
rule for limiting visible emissions at 40 CFR 49.124; fugitive
particulate matter rule in 40 CFR 49.126; the wood waste burner rule in
40 CFR 49.127; the rule for limiting sulfur in fuels in 40 CFR 49.130;
the rule for open burning in 40 CFR 49.131; the rules for general open
burning permits, agricultural burning permits, and forestry and
silvicultural burning permits in 40 CFR 49.132, 49.133, and 49.134; the
rule for emissions detrimental to human health and welfare in 40 CFR
49.135; the registration rule in 40 CFR 49.138; and the rule for non-
title V operating permits in 40 CFR 49.139. EPA uses this information
to manage the activities and sources of air pollution on the Indian
reservations in Idaho, Oregon, and Washington. EPA believes these
information collection requirements are appropriate because they will
enable EPA to develop and maintain accurate records of air pollution
sources and their emissions, track emissions trends and changes,
identify potential air quality problems, allow EPA to issue permits or
approvals, and ensure appropriate records are available to verify
compliance with these FIPs. The information collection requirements
listed above are all mandatory. Regulated entities can assert claims of
business confidentiality and EPA will address these claims in
accordance with the provisions of 40 CFR part 2, subpart B.
    Form Numbers:
    The forms associated with this ICR are:

EPA Form 7630-1 Nez Perce Reservation Air Quality Permit:
Agricultural Burn
EPA Form 7630-2 Nez Perce Reservation Air Quality Permit: Forestry
Burn
EPA Form 7630-3 Nez Perce Reservation Air Quality Permit: Large Open
Burn
EPA Form 7630-4 Initial or Annual Source Registration
EPA Form 7630-5 Report of Change of Ownership
EPA Form 7630-6 Report of Closure
EPA Form 7630-7 Report of Relocation
EPA Form 7630-8 Small Burn Air Quality Permit Application
EPA Form 7630-9 Non-Title V Operating Permit Application Form
EPA Form 7630-10 Umatilla Indian Reservation: Agricultural Burn
Permit Application
EPA Form 7630-11 Umatilla Indian Reservation: Forestry Burn Permit
Application
EPA Form 7630-12 Umatilla Indian Reservation: Large Open Burn Permit
Application

The forms listed above are available for review in the EPA docket.
    Respondents/affected entities: Respondents or entities potentially
affected by this action include owners and operators of air emission
sources in all industry groups and tribal governments, located in the
identified Indian reservations.
    Respondent's obligation to respond: Respondents obligation to
respond is mandatory. See 40 CFR 49.122, 49.124, 49.126, 49.130 through
135, 49.138, and 49.139.
    Estimated number of respondents: 1,732 (total).
    Frequency of response: Annual or occasional.
    Total estimated burden: 3,601 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $286,888 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in Estimates: There is a decrease of 614 hours in the total
estimated respondent burden compared with the ICR currently approved by
OMB. This decrease is based on input from source consultations,
supersedence of the provisions of one rule (49.139), and information we
have learned about the source universe through implementing the rules
since the ICR was updated in 2018.

    Dated: February 4, 2021.
Krishnaswamy Viswanathan,
Director, Air and Radiation Division, Region 10.
[FR Doc. 2021-02848 Filed 2-11-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 201 (Thursday, October 19, 2023)]
[Notices]
[Pages 72090-72091]
[FR Doc No: 2023-23111]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2023-0002; Internal Agency Docket No. FEMA-B-2379]

Proposed Flood Hazard Determinations

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

ACTION: Notice.

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SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP).

DATES: Comments are to be submitted on or before January 17, 2024.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location https://hazards.fema.gov/femaportal/prelimdownload and the
respective Community Map Repository address listed in the tables below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-2379, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC
20472,<PHONE_NUMBER>, or (email) [email protected].

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location
https://hazards.fema.gov/femaportal/

prelimdownload and the respective Community Map Repository address
listed in the tables. For communities with multiple ongoing Preliminary
studies, the studies can be identified by the unique project number and
Preliminary FIRM date listed in the tables. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Nicholas A. Shufro,
Deputy Assistant Administrator for Risk Management, Federal Emergency
Management Agency, Department of Homeland Security.

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                                             Community map repository
               Community                             address
------------------------------------------------------------------------
             Greene County, Missouri and Incorporated Areas
  Project: 17-07-0862S Preliminary Dates: November 18, 2022 and June 2,
                                  2023
------------------------------------------------------------------------
City of Ash Grove......................  City Hall, 100 West Main
                                          Street, Ash Grove, MO 65604.
City of Fair Grove.....................  City Hall, 81 South Orchard
                                          Boulevard, Fair Grove, MO
                                          65648.
City of Republic.......................  City Hall, 213 North Main
                                          Avenue, Republic, MO 65738.
City of Springfield....................  Busch Municipal Building, 840
                                          North Boonville Avenue,
                                          Springfield, MO 65802.
City of Strafford......................  City Hall, 126 South Washington
                                          Avenue, Strafford, MO 65757.
City of Willard........................  City Hall, 224 West Jackson
                                          Street, Willard, MO 65781.
Unincorporated Areas of Greene County..  Greene County Courthouse, 940
                                          North Boonville Avenue,
                                          Springfield, MO 65802.
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[FR Doc. 2023-23111 Filed 10-18-23; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register: January 29, 2008 (Volume 73, Number 19)]
[Rules and Regulations]
[Page 5101-5104]
[DOCID:fr29ja08-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2007-0024; FRL-8519-4]

Approval and Promulgation of Air Quality Implementation Plans;
Michigan; Oxides of Nitrogen Regulations, Phase II

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The EPA is approving Michigan's oxides of nitrogen
(NOX) rules which satisfy the requirements of EPA's
NOX SIP Call Phase II Rule (the Phase II Rule). We are
approving these regulations based on Michigan's demonstration that they
will result in the achievement of the Phase II budget through source
compliance with rules affecting stationary internal combustion (IC)
engines which are identified in the NOX plan submittal.
Limiting NOX emissions from IC engines will enable the State
to meet the Phase II incremental difference of 1,033 tons during the
ozone season, thereby improving air quality and protecting the health
of Michigan citizens.

DATES: This direct final will be effective March 31, 2008, unless EPA
receives adverse comments by February 28, 2008. If adverse comments are
received, EPA will publish a timely withdrawal of the direct final in
the Federal Register informing the public that the rule will not take
effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2007-0024, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: John M. Mooney, Chief, Criteria Pollutant Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: John M. Mooney, Chief, Criteria Pollutant
Section, Air Programs Branch (AR-18J), U.S. Environmental Protection
Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. Such
deliveries are only accepted during the Regional Office normal hours of
operation, and special arrangements should be made for deliveries of
boxed information. The Regional Office official hours of business are
Monday through Friday, 8:30 a.m. to 4:30 p.m. excluding Federal
holidays.

    Instructions: Direct your comments to Docket ID No. EPA-R05-OAR-
2007-0024. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-mail.

The http://www.regulations.gov Web site is an ``anonymous access'' system,

which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://www.regulations.gov

your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
instructions on submitting comments, go to Section I of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: All documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Environmental Protection

Agency, Region 5, Air and Radiation Division, 77 West Jackson
Boulevard, Chicago, Illinois 60604. This facility is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. We
recommend that you telephone Douglas Aburano, Engineer, at (312) 353-
6960 before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Douglas Aburano, Engineer, Criteria
Pollutant Section, Air Programs Branch (AR-18J), U.S. Environmental
Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago,
Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What should I consider as I prepare my comments for EPA?
II. Background
III. Who is affected by the new rule and the amended rules?
IV. What does approval of this rule accomplish?
V. How are owners and operators expected to comply with the new
requirement?
VI. What action is EPA taking today?
VII. Statutory and Executive Order Reviews

I. What should I consider as I prepare my comments for EPA?

    When submitting comments, remember to:
    1. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date and page number).
    2. Follow directions--The EPA may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    6. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline
identified.

II. Background

    On October 27, 1998 (63 FR 57356), EPA issued the NOX
SIP Call, which required 22 states, including Michigan, to prepare
plans to reduce the transport of ozone throughout the eastern part of
the United States. This was to be accomplished by reducing emissions of
NOX from selected source categories, primarily major fuel
burning sources, using available cost-effective measures. The rule
established a cap on emissions of NOX from each state.
States had flexibility in determining which fuel burning sources were
to be included in their rules. For the most part, states targeted
NOX reductions from electric utilities and other large
industrial boilers, cement kilns, and IC engines as sources which could
be controlled in a cost-effective manner. Background information in
this regard is available from documents prepared by EPA, and can be
found at http://www.epa.gov/ttn/rto/otag/index.html.

    Some states and industry challenged the rule. In Michigan v. EPA,
213 F.3d 663 (DC Cir. 2000), the Court largely upheld EPA's rulemaking.
It did, however, remand a portion of the rule concerning IC engines to
EPA for further notice and public comment.
    Subsequent to the Court's decision, EPA proceeded initially with
rules concerning electric generating units (EGU), industrial boilers
(non-EGU) and cement kilns as Phase I sources. The IC engines fell into
the Phase II group, to be addressed at a later date. Michigan adopted
its Phase I rules and submitted them to EPA. We conditionally approved
them on April 16, 2004 (69 FR 20548) and finally approved them on May
4, 2005 (70 FR 23029).
    On April 21, 2004 (69 FR 21603), EPA issued the Phase II Rule. It
required most states with Phase I budget programs to submit a Phase II
plan to achieve incremental reductions not addressed by Phase I rules.
The Phase II Rule also identified the additional NOX budget
reductions (incremental reductions) that states would have to achieve
by regulating large (greater than one ton per day emissions) IC
engines. EPA calculated the amount of incremental reductions required
by re-calculating the overall budget to reflect a control level of 82
percent from natural gas-fired lean-burn IC engines with greater than
one ton per day NOX emissions. MDEQ drafted the new rule (R
336.1818 Emission limitations for stationary internal combustion
engines, also known as Rule 818) based on guidance from EPA dated
September 19, 2004, which contained an example model rule.
    The public process for Rule 818 started on April 1, 2006 when the
rule was made available for public comment in the Michigan State
Register. On April 3, 2006, notices that the rule was available for
public comment were published in four newspapers throughout Michigan.
Both the notices in the Michigan State Register and the newspapers
indicated that a public hearing would be held on the rule on May 9,
2006.
    On December 22, 2006, the Michigan Department of Environmental
Quality (MDEQ) submitted its Phase II rules to EPA. MDEQ sent
additional follow-up

information addressing the budget demonstration for this source
category in a March 12, 2007 letter requesting EPA approval. Because
Michigan adopted EPA's model rule in which was used to calculate the
state's Phase II budget, it follows that Michigan's Phase II budget
will be met.
    In the Phase II Rule, EPA calculated the 2007 base year emissions
inventory from which Michigan needed additional reductions of 1,033
tons per ozone season. EPA based the calculation upon achieving an 82
percent reduction at all IC engines in Michigan with greater than one
ton per day of NOX emissions.

III. Who is affected by the new rule and the amended rules?

    Rule 818 applies only in the fine grid portion of Michigan, as this
is the only portion of Michigan where the NOX SIP Call (both
Phases I and II) applies (see 69 FR 21627-8). Michigan's fine grid
includes the following counties: Allegan, Barry, Bay, Berrien, Branch,
Calhoun, Cass, Clinton, Eaton, Genesee, Gratiot, Hillsdale, Ingham,
Ionia, Isabella, Jackson, Kalamazoo, Kent, Lapeer, Lenaee, Livingston,
Macomb, Mecosta, Midland, Monroe, Montcalm, Muskegon, Newaygo, Oakland,
Oceana, Ottawa, Saginaw, Saint Clair, Saint Joseph, Sanilac,
Shiawassee, Tuscola, Vanburen, Washtenaw and Wayne. Rule 818 applies to
any person who owns or operates a large stationary reciprocating IC
engine and other smaller stationary internal combustion engines that
are included in a compliance plan. A large IC engine is defined as an
engine that emits more than one ton of NOX per ozone season
day, based on operation during the 1995 ozone season.

IV. What does approval of this rule accomplish?

    EPA published the incremental budget for affected states including
Michigan in the April 21, 2004, Federal Register (69 FR 21604). The
State's budget demonstration shows that the State will be able to
reduce emissions of NOX to meet the Phase II incremental
difference of 1,033 tons of NOX for the ozone season.
    Approval of Rule 818 will provide a means by which the State of
Michigan will meet the required reductions of NOX emissions
from IC engines during the ozone season. The State rule affects
NOX SIP Call IC engines, as well as any other stationary
internal combustion engine subject to NOX control in the
State's rule, within Michigan's fine grid. The emission reductions for
some large engines will be permanent and year-round resulting from low
emission combustion measures retrofitted to existing engines. Low
emission combustion measures cannot be cycled off once the changes are
made to the engine. The combustion control technology is a permanent,
physical change to the design and operation of the engine which, when
implemented, is expected to reduce emissions of NOX year-
round. The State's rules include provisions which the source must
follow to demonstrate compliance with the rules. EPA expects
environmental benefits and health implications to be permanent.

V. How are owners and operators expected to comply with the new
requirement?

    The State Rule 818 includes a requirement that an owner or operator
of a large IC engine shall not operate an affected engine during the
ozone period, unless there is a compliance plan which meets the
requirements of the rule. Owners and operators of subject large IC
engines were required to submit compliance plans to the State by
October 1, 2006, and the rules prohibit operation of affected engines
after May 1, 2007, except in compliance with the requirements. Included
in the compliance plan is a requirement that the projected
NOX emissions from the engine, in grams per break
horsepower-hour, be included in a federally enforceable permit. This
information will enable the State to determine if reductions from the
covered sources should meet the Phase II budget increment. The failure
of a source to meet the required NOX reductions is a
violation of the provisions of the permit. The State of Michigan is
expected to enforce non-compliance with its rules by reviewing
monitoring and testing information submitted by the owners and
operators of the affected engines.

VI. What action is EPA taking today?

    EPA is approving Rule 818 submitted by Michigan. We are taking this
action because we have determined that the rule satisfies the
requirements of the Clean Air Act and the NOX SIP Call Phase
II rules. The State has shown, through its budget demonstration, that
it can achieve the Phase II budget increment through source compliance
with the State's rules affecting IC engines and the State's permitting
program. Meeting the Phase II budget increment and the Phase I
increment means the State will meet its total overall ozone season
NOX budget and bring about reductions in ozone
concentrations in the State and downwind from Michigan.

VII. Statutory and Executive Order Reviews

Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, September 30, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget.

Paperwork Reduction Act

    This rule does not impose an information collection burden under
the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501,
et seq.).

Regulatory Flexibility Act

    This action merely proposes to approve state law as meeting Federal
requirements and imposes no additional requirements beyond those
imposed by state law. Accordingly, the Administrator certifies that
this proposed rule will not have a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601, et seq.).

Unfunded Mandates Reform Act

    Because this rule proposes to approve pre-existing requirements
under state law and does not impose any additional enforceable duty
beyond that required by state law, it does not contain any unfunded
mandate or significantly or uniquely affect small governments, as
described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

Executive Order 13132: Federalism

    This action also does not have Federalism implications because it
does not have substantial direct effects on the states, on the
relationship between the national government and the states, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132 (64 FR 43255, August
10, 1999). This action merely proposes to approve a state rule
implementing a federal standard, and does not alter the relationship or
the distribution of power and responsibilities established in the Clean
Air Act.

Executive Order 13175: Consultation and Coordination With Indian Tribal
Governments

    This rule also does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the

Federal Government and Indian tribes, as specified by Executive Order
13175 (65 FR 67249, November 9, 2000).

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

    This rule also is not subject to Executive Order 13045 ``Protection
of Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), because it is not economically significant.

Executive Order 13211: Actions That Significantly Affect Energy Supply,
Distribution, or Use

    Because it is not a ``significant regulatory action'' under
Executive Order 12866 or a ``significant regulatory action,'' this
action is also not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001).

National Technology Transfer Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), 15 U.S.C. 272, requires Federal agencies to use
technical standards that are developed or adopted by voluntary
consensus to carry out policy objectives, so long as such standards are
not inconsistent with applicable law or otherwise impractical. In
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the Clean Air Act. Absent a
prior existing requirement for the state to use voluntary consensus
standards, EPA has no authority to disapprove a SIP submission for
failure to use such standards, and it would thus be inconsistent with
applicable law for EPA to use voluntary consensus standards in place of
a program submission that otherwise satisfies the provisions of the
Clean Air Act. Therefore, the requirements of section 12(d) of the NTTA
do not apply.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements.

    Dated: January 11, 2008.
Gary Gulezian,
Acting Regional Administrator, Region 5.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401, et seq.

Subpart X--Michigan

0
2. In Sec.  52.1170, the table in paragraph (c) entitled ``EPA--
Approved Michigan Regulations'' is amended by adding an entry in Part 8
for ``R 336.1818'' to read as follows:

Sec.  52.1170  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Michigan Regulations
----------------------------------------------------------------------------------------------------------------
                                                          State
     Michigan  citation               Title          effective date     EPA approval date          Comments
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                        Part 8. Emission Limitations and Prohibitions--Oxides of Nitrogen
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
R 336.1818.................  Emission limitations          11/20/06  1/29/08 [Insert page
                              for stationary                          number where the
                              internal combustion                     document begins].
                              engines.
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. E8-1415 Filed 1-28-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 21 (Wednesday, February 1, 2023)]
[Rules and Regulations]
[Pages 6636-6643]
[FR Doc No: 2023-02109]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0449; FRL-10566-01-OCSPP]

Fluopyram; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation revises the tolerance for residues of
fluopyram in or on coffee, green bean and establishes tolerances for
residues of fluopyram in or on multiple commodities which are
identified and discussed later in this document. The Interregional
Project Number 4 (IR-4) requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective on February 1, 2023. Objections and
requests for hearings must be received

on or before April 3, 2023, 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-2021-0449, is available at
https://www.regulations.gov or in-person at the Office of Pesticide
Programs Regulatory Public Docket (OPP Docket) in the Environmental
Protection Agency Docket Center (EPA/DC), West William Jefferson
Clinton 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 and the OPP Docket is (202) 566-
1744. For the latest status information on EPA/DC services, docket
access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

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 Office of the
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

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-2021-0449 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
April 3, 2023. 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-2021-0449, by one of
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 22, 2021 (86 FR 52624) (FRL-
8792-03-OCSPP), 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 1E8932) by the Interregional Research Project Number 4
(IR-4), Project Headquarters, North Carolina University, 1730 Varsity
Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requests
to amend 40 CFR 180.661(a)(1) by establishing tolerances for residues
of the fungicide fluopyram, N-[2-[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]ethyl]-2-(trifluoromethyl)benzamide, in or on the following
raw agricultural commodities: Brassica, leafy greens, subgroup 4-16B at
50 parts per million (ppm); celtuce at 20 ppm; coffee, green bean at
0.03 ppm; fennel, Florence, fresh leaves and stalk at 20 ppm; kohlrabi
at 4 ppm; leafy greens subgroup 4-16A at 40 ppm; leaf petiole vegetable
subgroup 22B at 20 ppm; papaya at 1.5 ppm; peppermint, dried leaves at
0.8 ppm; peppermint, fresh leaves at 0.6 ppm; spearmint, dried leaves
at 0.8 ppm; spearmint, fresh leaves at 0.6 ppm; spice group 26 at 70
ppm; vegetable, Brassica, head and stem, group 5-16 at 4 ppm;
individual commodities of proposed crop subgroup 6-XXA; edible podded
bean legume vegetable subgroup at 4 ppm; individual commodities of
proposed crop subgroup 6-XXB edible podded pea legume vegetable
subgroup at 4 ppm; individual commodities of proposed crop subgroup 6-
XXC: succulent shelled bean subgroup at 0.2 ppm; individual commodities
of proposed crop subgroup 6-XXD: succulent shelled pea subgroup at 0.2
ppm; and the individual commodities of proposed crop subgroup 6-XXE:
dried shelled bean, except soybean, subgroup at 0.7 ppm. Due to the
length of the list of commodities, please refer to the document EPA
issued in the Federal Register on September 22, 2021, for a complete
list of the tolerances requested. The petition also requested the
removal of the tolerances for residues of fluopyram in or on bean, dry
at 0.70 ppm; Brassica, head and stem, subgroup 5A at 4.0 ppm; Brassica,
leafy greens, subgroup 5B at 50 ppm; dill, seed at 70 ppm; leafy greens
subgroup 4A at 40 ppm; leafy petioles subgroup 4B at 20 ppm; pea and
bean, succulent shelled, subgroup 6B at 0.20 ppm; and vegetable,
legume, edible podded, subgroup 6A at 4.0 ppm. That document referenced
a summary of the petition prepared by IR-4, the petitioner, which is
available in the docket, https://www.regulations.gov. Three comments
were received on the Notice of Filing; however, the comments were not
relevant to the petition for fluopyram tolerances that are the subject
of this action.

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 therein 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 fluopyram including exposure resulting from the
tolerances established by this action. EPA's assessment of exposures
and risks associated with fluopyram 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. The toxicological database for fluopyram has been re-
evaluated as part of registration review and relevant studies were
updated in accordance with current practices. The fluopyram database is
considered complete.
    Liver effects, thyroid effects, and decreased body weight were the
most common and frequent findings in the subchronic and chronic oral
toxicity studies in rats, mice, and dogs, and appeared to be the most
sensitive effects in the fluopyram toxicological database. Increased
liver tumors were observed in female rats in the carcinogenicity study
at the highest dose tested (89 mg/kg/day). Thyroid effects (increased
thyroid weight along with follicular cell hypertrophy and hyperplasia)
were observed at dose levels similar to those that produced liver
effects in rats and mice. In male mice, there was an increased
incidence of thyroid adenomas at the highest dose tested (105 mg/kg/
day). Fluopyram induces liver enzymes following constitutive androstane
receptor and pregnane X receptor (CAR/PXR) activation, which causes
increased metabolism of thyroid hormones. These changes lead to liver
and thyroid hypertrophy and proliferation, eventually leading to liver
tumors (female rat) and thyroid tumors (male mice). EPA classified
fluopyram as ``Not Likely to be Carcinogenic to Humans'' at doses that
do not induce cellular proliferation in the liver or thyroid glands.
This classification was based on evidence that non-genotoxic modes of
action for liver tumors in rats and thyroid tumors in mice have been
established and that the carcinogenic effects have been demonstrated as
a result of a mode of action dependent on activation of the CAR/PXR
receptors. EPA determined that quantification of risk is not required.
There is sufficient data to ascertain the mode of action of fluopyram.
The chronic Reference Dose (RfD) is derived using the no-observed
adverse-effect level (NOAEL) of 6 mg/kg/day as the POD which is below
the dose of 11 mg/kg/day that caused cell proliferation in the liver (a
key event in tumor formation) and the subsequent liver tumors at a
higher dose (89 mg/kg/day). Additionally, there is no concern for
mutagenicity.
    Fluopyram did not elicit developmental or offspring effects, nor
did it adversely affect reproductive parameters. No evidence of
increased qualitative or quantitative susceptibility was observed in
developmental or reproduction toxicity studies. There is no evidence of
neurotoxicity.
    Specific information on the studies received and the nature of the
adverse effects caused by fluopyram 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 in the document titled
``Fluopyram. Human Health Risk Assessment for Proposed Uses on Coffee,
Green Bean, Papaya, Peppermint, Spearmint and Crop Group Expansions/
Conversions.'' (hereinafter ``Fluopyram Human Health Risk Assessment'')
on pages 43-52 in docket ID number EPA-HQ-OPP-2021-0449.

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 NOAEL and 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints and PODs for fluopyram
used for human risk assessment can be found in the Fluopyram Human
Health Risk Assessment on pages 25-26.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluopyram, EPA considered exposure under the petitioned-for
tolerances as well as all existing fluopyram tolerances in 40 CFR
180.661. EPA assessed dietary exposures from fluopyram in food as
follows:
    i. Acute and 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 fluopyram.
    In estimating acute dietary exposure, EPA used the Dietary Exposure
Evaluation Model software using the Food Commodity Intake Database
(DEEM-FCID) Version 4.02, which uses the 2005-2010 food consumption
data from the United States Department of Agriculture's (USDA's)
National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA). As to residue levels in food, a partially
refined acute dietary exposure assessment was conducted, incorporating
field trial residues for coffee and the commodities of crop group 15
and crop subgroup 20A, and tolerance-level residues for all other crop
commodities. One hundred percent crop treated (PCT) was assumed.
    ii. Chronic exposure. In conducting the chronic dietary exposure

assessment, EPA used the food consumption data from the USDA's 2005-
2010 NHANES/WWEIA and DEEM-FCID; version 4.02. As to residue levels in
food, the chronic dietary exposure assumed tolerance-level residues for
mint and papaya and used mean field trial data and empirical processing
factors for all other commodities. Average PCT estimates were used for
some crops.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fluopyram does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require, pursuant to FFDCA section
408(f)(1), that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
    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 the following conditions are met:
     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, and 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 Agency estimated the PCT for existing uses as follows: almonds,
20%; apples, 25%; apricots, 5%; artichoke, 15%; broccoli, 2.5%;
cabbage, 2.5%; carrots, 1%; cauliflower, 1%; cherries, 25%; cotton, 1%;
dry beans and peas, 1%; grapefruit, 10%; grapes, raisins, 1%; table
grapes, 5%; wine grapes; 20%; lemons, 1%; lettuce, 1%; onions, 1%;
oranges, 15%; peaches, 1%; peanuts, 2.5%; pears, 5%; peppers, 5%;
pistachios, 15%; potatoes, 20%; strawberries, 10%; tomatoes, 1%;
walnuts, 10%; and watermelons, 15%. EPA assumed 100 PCT for all other
commodities included in the chronic assessment.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute 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 1% or less than 2.5%. In those cases, the Agency would use
less than 1% or less than 2.5% as the average PCT value, respectively.
The maximum PCT figure is the highest observed maximum value reported
within the most recent 10 years of available public and private market
survey data for the existing use and rounded up to the nearest multiple
of 5%, except where the maximum PCT is less than 2.5%, in which case,
the Agency uses less than 2.5% as the maximum PCT.
    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 fluopyram 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 fluopyram in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fluopyram. Further information regarding EPA
drinking water models used in pesticide exposure assessments can be
found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-risk-assessment.
    Based on the Surface Water Concentration Calculator (SWCC) and
Pesticide Root Zone Model--Ground Water (PRZM-GW) model, the estimated
drinking water concentrations (EDWCs) of fluopyram for acute exposures
are estimated to be 50.6 parts per billion (ppb) for surface water and
97.6 ppb for ground water. For chronic exposures for non-cancer
assessments, the EDWCs of fluopyram are estimated to be 17.3 ppb for
surface water and 90.5 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 97.6 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of 90.5 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).
    There are no residential exposures associated with the proposed
uses of fluopyram on coffee, mint, and papaya in this action; however,
residential post-application exposures are anticipated from other
registered uses of fluopyram on golf course turf, residential lawns,
fruit trees, nut trees, ornamentals, and gardens. From the reevaluation
of the toxicity database, the endpoints selected for residential
exposures include incidental oral and short- and intermediate-term
inhalation endpoints, but a dermal endpoint is no longer selected. A
dermal endpoint was not selected as there were no adverse effects
observed in the route-specific dermal

toxicity study, which included evaluation of fluopyram target organs,
up to the limit dose of 1,000 mg/kg/day. Additionally, there was no
evidence of increased quantitative susceptibility in the fluopyram
database.
    EPA assessed residential exposure using the following assumptions.
Residential handler exposures and risk are not assessed in this
document because the existing registered uses for residential sites are
from end-use products that require handlers to wear specific clothing
and personal protective equipment (PPE). Thus, EPA has assumed that
those products are not for homeowner use and a quantitative residential
handler assessment is not warranted at this time. There are residential
post-application exposures from existing turf uses that have been
previously assessed. The residential exposure for use in the children 1
to less than 2 years old aggregate assessment reflects incidental oral
hand-to-mouth post-application exposure to treated lawns. The MOE is
5,400, which is greater than the level of concern of 100 and therefore
is not of concern. Further information regarding EPA standard
assumptions and generic inputs for residential exposures may be found
at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/operating-procedures-residential-pesticide.
    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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to fluopyram and any other
substances, and fluopyram does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this action,
therefore, EPA has not assumed that fluopyram has 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 website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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 Food Quality
Protection Act (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 of
increased susceptibility following in utero and/or postnatal exposure
in the developmental toxicity studies in rats or rabbits, or in the 2-
generation rat reproduction study. There is no evidence of
neurotoxicity, and there are no residual uncertainties in the exposure
database. While thyroid effects are observed throughout the database,
EPA determined that the comparative thyroid assay (CTA) be waived based
on a weight-of-evidence approach.
    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 from 10X to 1X. That decision is based on the
following findings:
    i. The toxicology database for fluopyram is complete and adequate
for risk assessment. EPA waived the subchronic inhalation toxicity
study requirement and the previously required CTA for fluopyram for the
following reasons: (1) the margins of exposure are low using the
current endpoints; (2) thyroid effects are well-characterized and
protected for using the current endpoints; and (3) acute inhalation
toxicity is low and the compound is unlikely to volatilize. The
toxicology database includes acceptable developmental toxicity studies
in the rat and rabbit and an acceptable reproductive toxicity study in
the rat, as well as acute and subchronic neurotoxicity studies.
    ii. Potential signs of neurotoxicity were observed in the rat acute
neurotoxicity study (decreased motor activity) and in the rat chronic/
carcinogenicity study (reduced use of hind-limbs and limited motor
activity). However, these effects are not specific to neurotoxicity,
occur in the presence of other effects, and can also be attributed to
systemic toxicity. There is a low degree of concern for potential
neurotoxic effects since (1) clear NOAELs were identified for these
effects, (2) no other neurotoxic effects were identified in the
database, (3) potentially neurotoxic effects are not the most sensitive
effect in the toxicity database, and (4) the endpoints chosen for risk
assessment are protective of these potentially neurotoxic effects.
    iii. The available developmental toxicity studies in rats and
rabbits and the multi-generation reproduction in rats demonstrate no
evidence of increased susceptibility in the developing or young animals
which were exposed during pre- or post-natal periods. No developmental
or offspring effects were noted in these studies.
    iv. There are no residual uncertainties in the exposure database.
The acute dietary exposure assessment was performed using conservative
exposure inputs, including field trial residue levels or tolerance
level residues for all crops; and average field-trial residue levels
were assumed for all crops in the chronic dietary exposure assessment.
The acute dietary assessment assumed 100 PCT, whereas the chronic
dietary assessment utilized average PCT numbers for some crops. Both
acute and chronic dietary assessments incorporated empirical or default
processing factors. EPA made conservative (protective) assumptions in
the ground and surface water modeling used to assess exposure to
fluopyram in drinking water. EPA used similarly conservative
assumptions to assess post application exposure of children as well as
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by fluopyram.

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 population adjusted dose (aPAD) and chronic population adjusted
dose (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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary

exposure from food and water to fluopyram will occupy 25% of the aPAD
for children 1 to 2 years old, the population group receiving the
greatest exposure. The aggregate acute risk estimate includes only
exposure to residues of fluopyram in food and drinking water, which is
below the Agency's level of concern of 100% of the aPAD and is not of
concern.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fluopyram from food and water will utilize 16% of the cPAD for all
infants less than 1 year old, the population group receiving the
greatest exposure. Chronic residential exposure to residues of
fluopyram is not expected. Therefore, the chronic aggregate exposure is
equivalent to the chronic dietary exposure, which is below the Agency's
level of concern of 100% of the cPAD and is not of concern.
    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). Fluopyram is
currently registered for uses that could result in short-term
residential post-application exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with short-term residential exposures to fluopyram. 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 2,100 for children (1 to less
than 2 years old). Because EPA's level of concern for fluopyram is an
MOE of 100 or below, the short-term aggregate risk is 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).
    The short-and intermediate-term PODs are the same and the
intermediate-term exposures are smaller than the short-term exposures,
thus, the short-term aggregate exposure assessment is protective of any
intermediate-term exposures.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, fluopyram is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments and
information described above, 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 fluopyram residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology DFG Method S19 using GC/MSD (gas
chromatography with mass-selective detection) is available to enforce
the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
[email protected].

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.
    There are no established Codex MRLs for Brassica, leafy greens,
subgroup 4-16B; celtuce; coffee, green bean; fennel, Florence, fresh
leaves and stalk; kohlrabi; leaf petiole vegetable subgroup 22B; mint;
papaya; or edible podded peas. The U.S. tolerance for spice group 26 is
harmonized with the Codex MRL of 70 ppm in/on dill seed, which is the
representative crop for spice group 26. The U.S. tolerances for the
succulent shelled bean subgroup 6-22C and succulent shelled pea
subgroup 6-22D are harmonized with the Codex MRL of 0.2 ppm for the
commodities in those subgroups.
    For the remaining commodities (leafy greens subgroup 4-16A;
vegetable, Brassica, head and stem, group 5-16; edible podded bean
subgroup 6-22A; and dried shelled bean, except soybean, subgroup 6-
22E), the established Codex MRLs are lower than the U.S. tolerances.
Harmonization is not possible because decreasing the U.S. tolerances
would put U.S. growers at risk of having violative residues despite
legal use of fluopyram according to the label.

C. Revisions to Petitioned-For Tolerances

    Because the final Phase VI crop group rule has been published, EPA
is establishing tolerances for new subgroups in legume vegetable crop
group 6-22 rather than for each individual commodity in those subgroups
as requested by the petitioner. The Phase VI crop group rule allows the
commodities to be covered as part of the new group or subgroups instead
of needing to be listed separately. The Phase VI crop group was
published on September 21, 2022, and was effective on November 21, 2022
(87 FR 57627) (FRL-5031-13-OCSPP).

V. Conclusion

    Therefore, tolerances are established for residues of fluopyram, N-
[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-
(trifluoromethyl)benzamide, in or on Brassica, leafy greens, subgroup
4-16B at 50 ppm; celtuce at 20 ppm; fennel, Florence, fresh leaves and
stalk at 20 ppm; kohlrabi at 4 ppm; leaf petiole vegetable subgroup 22B
at 20 ppm; leafy greens subgroup 4-16A at 40 ppm; papaya at 1.5 ppm;
peppermint, dried leaves at 0.8 ppm; peppermint, fresh leaves at 0.6
ppm; spearmint, dried leaves at 0.8 ppm; spearmint, fresh leaves at 0.6
ppm; spice group 26 at 70 ppm; vegetable, Brassica, head and stem,
group 5-16 at 4 ppm; vegetable, legume, bean, edible podded, subgroup
6-22A at 4 ppm; vegetable, legume, pea, edible podded, subgroup 6-22B
at 4 ppm; vegetable, legume, bean, succulent shelled, subgroup 6-22C at
0.2 ppm; vegetable, legume, pea, succulent shelled, subgroup 6-22D at
0.2 ppm; and vegetable, legume, pulse, bean, dried shelled, except
soybean, subgroup 6-22E at 0.7 ppm. The tolerance for coffee, green
beans at 0.03 ppm is revised to remove the footnote. The following
tolerances are removed: bean, dry at 0.70 ppm; Brassica, head and stem,
subgroup 5A at 4.0 ppm; Brassica, leafy greens, subgroup 5B at 50 ppm;
dill, seed at 70 ppm; leafy greens subgroup 4A at 40 ppm; leafy
petioles subgroup 4B at 20 ppm; pea and bean, succulent shelled,
subgroup 6B; and vegetable, legume, edible podded, subgroup 6A.

VI. Statutory and Executive Order Reviews

    This action 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 action has been
exempted from review under Executive Order 12866, this action 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 action 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 tolerances 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 action 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(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 (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: January 26, 2023.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

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.  180.661, table 1 to paragraph (a)(1) is amended by:
0
a. Removing the entries for ``Bean, dry'' and ``Brassica, head and
stem, subgroup 5A'';
0
b. Adding in alphabetical order the entry ``Brassica, leafy greens,
subgroup 4-16B'';
0
c. Removing the entry for ``Brassica, leafy greens, subgroup 5B'';
0
d. Adding in alphabetical order the entry ``Celtuce'';
0
e. Revising the entry for ``Coffee, green beans'' by removing the
footnote;
0
f. Removing the entry for ``Dill, seed'';
0
g. Adding in alphabetical order the entries ``Fennel, Florence, fresh
leaves and stalk'', ``Kohlrabi'', ``Leaf petiole vegetable subgroup
22B'' and ``Leafy greens subgroup 4-16A'';
0
h. Removing the entries for ``Leafy greens subgroup 4A'' and ``Leafy
petioles subgroup 4B'';
0
i. Adding in alphabetical order the entry ``Papaya'';
0
j. Removing the entry ``Pea and bean, succulent shelled, subgroup 6B'';
0
k. Adding in alphabetical order the entries ``Peppermint, dried
leaves'', ``Peppermint, fresh leaves'', ``Spearmint, dried leaves'',
``Spearmint, fresh leaves'', ``Spice group 26'', ``Vegetable, Brassica,
head and stem, group 5-16'', ``Vegetable, legume, bean, edible podded,
subgroup 6-22A'', and ``Vegetable, legume, bean, succulent shelled,
subgroup 6-22C'';
0
l. Removing the entry ``Vegetable, legume, edible podded, subgroup
6A'';
0
m. Adding in alphabetical order the entries ``Vegetable, legume, pea,
edible podded, subgroup 6-22B'', ``Vegetable, legume, pea, succulent
shelled, subgroup 6-22D''and ``Vegetable, legume, pulse, bean, dried
shelled, except soybean, subgroup 6-22E''; and
0
n. Removing footnote 2.
    The additions and revisions read as follows:

Sec.  180.661  Fluopyram; tolerances for residues.

    (a) * * *
    (1) * * *

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------

                              * * * * * * *
Brassica, leafy greens, subgroup 4-16B...............                 50

                              * * * * * * *
Celtuce..............................................                 20

                              * * * * * * *
Coffee, green beans..................................               0.03

                              * * * * * * *
Fennel, Florence, fresh leaves and stalk.............                 20

                              * * * * * * *
Kohlrabi.............................................                  4
Leaf petiole vegetable subgroup 22B..................                 20
Leafy greens subgroup 4-16A..........................                 40

                              * * * * * * *
Papaya...............................................                1.5

                              * * * * * * *
Peppermint, dried leaves.............................                0.8
Peppermint, fresh leaves.............................                0.6

                              * * * * * * *
Spearmint, dried leaves..............................                0.8
Spearmint, fresh leaves..............................                0.6
Spice group 26.......................................                 70

                              * * * * * * *
Vegetable, Brassica, head and stem, group 5-16.......                  4

                              * * * * * * *
Vegetable, legume, bean, edible podded, subgroup 6-                    4
 22A.................................................
Vegetable, legume, bean, succulent shelled, subgroup                 0.2
 6-22C...............................................
Vegetable, legume, pea, edible podded, subgroup 6-22B                  4
Vegetable, legume, pea, succulent shelled, subgroup 6-               0.2
 22D.................................................
Vegetable, legume, pulse, bean, dried shelled, except                0.7
 soybean, subgroup 6-22E.............................

                              * * * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations.

* * * * *
[FR Doc. 2023-02109 Filed 1-31-23; 8:45 am]
BILLING CODE 6560-50-P