Oxathiapiprolin; Pesticide Tolerances, 82272-82274 [2023-25768]
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82272
Federal Register / Vol. 88, No. 225 / Friday, November 24, 2023 / Rules and Regulations
21.3.3 Combining USPS Marketing
Mail, Parcel Select, and Package
Services APPS-Machinable Parcels
21.0 Optional Combined Parcel
Mailings
21.1 Basic Standards for Combining
Parcel Select, Package Services, and
USPS Marketing Mail Parcels
21.1.1
Basic Standards
[Revise the introductory text of 21.1.1
to read as follows:]
Package Services parcels, Parcel
Select parcels, and USPS Marketing
Mail parcels in a combined parcel
mailing must meet the following
standards:
*
*
*
*
*
d. Combined mailings must meet the
following minimum volume
requirements:
[Revise the text of item d1 to read as
follows:]
1. USPS Marketing Mail—Minimum
200 pieces or 50 pounds of parcels per
class.
*
*
*
*
*
21.3
21.3.1
Mail Preparation
Basic Standards
Prepare combined mailings as
follows:
a. Different parcel types must be
prepared separately for combined parcel
mailings as indicated below:
[Revise the text of items a1 through a3
to read as follows:]
1. USPS Marketing Mail, Parcel
Select, and Package Services
machinable parcels. Use ‘‘STD/PSVC
MACH’’ for line 2 content labeling.
2. USPS Marketing Mail, Parcel
Select, and Package Services irregular
parcels at least 2 ounces and up to (but
not including) 6 ounces, except for
tubes, rolls, triangles, and other
similarly irregularly-shaped pieces. Use
‘‘STD/PSVC’’ for line 2 content labeling.
3. USPS Marketing Mail, Parcel
Select, and Package Services tubes,
rolls, triangles, and similarly irregularlyshaped parcels; and all parcels weighing
less than 2 ounces. Use ‘‘STD/PSVC
IRREG’’ for line 2 content labeling.
*
*
*
*
*
ddrumheller on DSK120RN23PROD with RULES1
21.3.2 Combining USPS Marketing
Mail, Parcel Select, and Package
Services Machinable Parcels
16:40 Nov 22, 2023
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21.3.4 Combining USPS Marketing
Mail, Parcel Select, and Package
Services Parcels (Not APPSMachinable)
[Revise the introductory text of 21.3.4
to read as follows:]
Prepare and enter USPS Marketing
Mail, Parcel Select, and Package
Services, and USPS Marketing Mail
Marketing parcels under 2 ounces, as
combined not APPS-machinable parcels
as shown in the table below.
*
*
*
*
*
Index
*
*
*
*
*
*
*
*
*
P
*
Parcel Select
*
*
*
*
*
[Delete the ‘‘Lightweight, 253.4.0’’
entry.]
*
*
*
*
*
Notice 123 (Price List)
[Revise competitive prices as
applicable.]
*
*
*
*
*
Sarah Sullivan,
Attorney, Ethics & Legal Compliance.
[FR Doc. 2023–25648 Filed 11–22–23; 8:45 am]
BILLING CODE 7710–12–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[Revise the introductory text of 21.3.2
to read as follows:]
Prepare and enter USPS Marketing
Mail, Parcel Select, and Package
Services machinable parcels, and USPS
Marketing Mail Marketing parcels 6
ounces or more, as combined
machinable parcels as shown in the
table below.
*
*
*
*
*
VerDate Sep<11>2014
[Revise the introductory text of 21.3.3
to read as follows:]
Prepare and enter USPS Marketing
Mail, Parcel Select, and Package
Services irregular parcels, and USPS
Marketing Mail Marketing parcels
(weighing at least 2 ounces, but less
than 6 ounces, that are not tubes, rolls,
triangles, or similarly irregularly shaped
parcels) as combined APPS-machinable
parcels as shown in the table below.
*
*
*
*
*
[EPA–HQ–OPP–2022–0597; FRL–11426–01–
OCSPP]
Oxathiapiprolin; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
tolerance for residues of oxathiapiprolin
SUMMARY:
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in or on peanut, hay. Syngenta Crop
Protection requested this tolerance
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective
November 24, 2023. Objections and
requests for hearings must be received
on or before January 23, 2024, 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–2022–0597, is
available at https://www.regulations.gov
or 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
and docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Charles Smith, Director, Registration
Division (7505T), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; main
telephone number: (202) 566–1030;
email address: RDFRNotices@epa.gov.
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-
E:\FR\FM\24NOR1.SGM
24NOR1
Federal Register / Vol. 88, No. 225 / Friday, November 24, 2023 / Rules and Regulations
CFR site at https://www.ecfr.gov/
current/title-40.
ddrumheller on DSK120RN23PROD with RULES1
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a(g), 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–2022–0597 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
January 23, 2024. 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–
2022–0597, 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/where-sendcomments-epa-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 August 30,
2022 (87 FR 52868) (FRL–9410–04–
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 2F8997) by
VerDate Sep<11>2014
16:40 Nov 22, 2023
Jkt 262001
Syngenta Crop Protection, LLC, P.O.
Box 18300, Greensboro, NC 27419. The
petition requested that 40 CFR 180.685
be amended by establishing tolerances
for residues of the fungicide
oxathiapiprolin, 1-[4-[4-[5-(2,6difluorophenyl)-4,5-dihydro-3isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2[5-methyl-3-(trifluoromethyl)-1Hpyrazol-1-yl]-ethanone, in or on the
following commodity: peanut hay at
0.15 parts per million (ppm). This
document referenced a summary of the
petition prepared by Syngenta Crop
Protection, LLC, the registrant, which is
available in the docket, https://
www.regulations.gov. No comments
were received on the notice of filing.
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
oxathiapiprolin, including exposure
resulting from the tolerance established
by this action. EPA’s assessment of
exposures and risks associated with
oxathiapiprolin follows.
As indicated in the Federal Register
for previous tolerances established for
residues of oxathiapiprolin (see 81 FR
87463, FRL–9954–69, December 6,
2016), the toxicity database for
oxathiapiprolin supports a decision to
conduct a qualitative risk assessment,
due to the lack of treatment-related
effects and limited toxicity. While
dietary exposure to oxathiapiprolin may
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occur through food and drinking water,
no risks of concern are anticipated due
to the lack of toxicity at anticipated
human exposure levels. While
residential post-application exposures
may occur through the registered uses
on turf and ornamentals, no risks of
concern are anticipated due to the lack
of toxicity at anticipated human
exposure levels. While dietary and
residential exposures may occur
through the registered and proposed
uses for oxathiapiprolin, no aggregate
risks of concern are anticipated due to
the lack of toxicity at anticipated human
exposure levels.
Therefore, based on the lack of
toxicity at anticipated human exposure
levels, EPA concludes there is a
reasonable certainty that no harm will
result to the general population, or to
infants and children, from aggregate
exposure to oxathiapiprolin residues.
More detailed information on the
subject action to establish tolerances for
indirect or inadvertent residues of
oxathiapiprolin in or on peanut, hay can
be found in the document entitled,
‘‘Oxathiapiprolin. Human Health Risk
Assessment to Support a Label
Amendment to Reduce the Plant Back
Interval for Peanut and Sugarcane and
Establish a Tolerance for Peanut, Hay’’
in docket ID number EPA–HQ–OPP–
2022–0597 at https://
www.regulations.gov.
IV. Other Considerations
A. Analytical Enforcement Methodology
Analytical method DuPont-30422,
Supplement 1 is a high performance
liquid chromatography with tandem
mass spectrometry (HPLC–MS/MS)
method available for the quantitation of
oxathiapiprolin residues in plant
matrices. Analytical method DuPont31138 is an HPLC–MS/MS method
available for the analytical enforcement
of oxathiapiprolin residues in livestock
commodities.
The methods may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address: residuemethods@
epa.gov.
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
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Federal Register / Vol. 88, No. 225 / Friday, November 24, 2023 / Rules and Regulations
required by FFDCA section 408(b)(4).
The Codex has not established MRLs for
residues of oxathiapiprolin in peanut
commodities.
V. Conclusion
Therefore, a tolerance is established
for indirect or inadvertent residues of
oxathiapiprolin, 1-[4-[4-[5-(2,6difluorophenyl)-4,5-dihydro-3isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2[5-methyl-3-(trifluoromethyl)-1Hpyrazol-1-yl]-ethanone, in or on peanut,
hay at 0.15 ppm. In addition, EPA
adjusted the existing tolerance for
indirect or inadvertent residues on ‘‘All
other food commodities/feed
commodities’’ to exclude commodities
covered by higher tolerances for indirect
or inadvertent residues, such as the
peanut, hay tolerance established by
this action, or as a result of use on
growing crops.
VI. Statutory and Executive Order
Reviews
This action establishes a tolerance
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 to
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 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 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: November 16, 2023.
Charles Smith,
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
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Amend § 180.685 by revising the
table in paragraph (d) to read as follows:
■
§ 180.685 Oxathiapiprolin; tolerances for
residues.
*
*
*
(d) * * *
*
*
TABLE 2 TO PARAGRAPH (d)
Parts per
million
Commodity
All other food commodities/feed commodities (other than those covered by a higher tolerance as a result of use on growing
crops or indirect or inadvertent residues) ........................................................................................................................................
Peanut, hay ..........................................................................................................................................................................................
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[FR Doc. 2023–25768 Filed 11–22–23; 8:45 am]
BILLING CODE 6560–50–P
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16:40 Nov 22, 2023
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Agencies
[Federal Register Volume 88, Number 225 (Friday, November 24, 2023)]
[Rules and Regulations]
[Pages 82272-82274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25768]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0597; FRL-11426-01-OCSPP]
Oxathiapiprolin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
oxathiapiprolin in or on peanut, hay. Syngenta Crop Protection
requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective November 24, 2023. Objections and
requests for hearings must be received on or before January 23, 2024,
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-2022-0597, is available at
https://www.regulations.gov or 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 and docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; 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-
[[Page 82273]]
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(g), 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-2022-0597 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
January 23, 2024. 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-2022-0597, 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/where-send-comments-epa-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 August 30, 2022 (87 FR 52868) (FRL-9410-
04-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
2F8997) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419. The petition requested that 40 CFR 180.685 be amended by
establishing tolerances for residues of the fungicide oxathiapiprolin,
1-[4-[4-[5-(2,6-difluorophenyl)-4,5-dihydro-3-isoxazolyl]-2-thiazolyl]-
1-piperidinyl]-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]-
ethanone, in or on the following commodity: peanut hay at 0.15 parts
per million (ppm). This document referenced a summary of the petition
prepared by Syngenta Crop Protection, LLC, the registrant, which is
available in the docket, https://www.regulations.gov. No comments were
received on the notice of filing.
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 oxathiapiprolin, including exposure resulting
from the tolerance established by this action. EPA's assessment of
exposures and risks associated with oxathiapiprolin follows.
As indicated in the Federal Register for previous tolerances
established for residues of oxathiapiprolin (see 81 FR 87463, FRL-9954-
69, December 6, 2016), the toxicity database for oxathiapiprolin
supports a decision to conduct a qualitative risk assessment, due to
the lack of treatment-related effects and limited toxicity. While
dietary exposure to oxathiapiprolin may occur through food and drinking
water, no risks of concern are anticipated due to the lack of toxicity
at anticipated human exposure levels. While residential post-
application exposures may occur through the registered uses on turf and
ornamentals, no risks of concern are anticipated due to the lack of
toxicity at anticipated human exposure levels. While dietary and
residential exposures may occur through the registered and proposed
uses for oxathiapiprolin, no aggregate risks of concern are anticipated
due to the lack of toxicity at anticipated human exposure levels.
Therefore, based on the lack of toxicity at anticipated human
exposure levels, EPA concludes there is a reasonable certainty that no
harm will result to the general population, or to infants and children,
from aggregate exposure to oxathiapiprolin residues. More detailed
information on the subject action to establish tolerances for indirect
or inadvertent residues of oxathiapiprolin in or on peanut, hay can be
found in the document entitled, ``Oxathiapiprolin. Human Health Risk
Assessment to Support a Label Amendment to Reduce the Plant Back
Interval for Peanut and Sugarcane and Establish a Tolerance for Peanut,
Hay'' in docket ID number EPA-HQ-OPP-2022-0597 at https://www.regulations.gov.
IV. Other Considerations
A. Analytical Enforcement Methodology
Analytical method DuPont-30422, Supplement 1 is a high performance
liquid chromatography with tandem mass spectrometry (HPLC-MS/MS) method
available for the quantitation of oxathiapiprolin residues in plant
matrices. Analytical method DuPont-31138 is an HPLC-MS/MS method
available for the analytical enforcement of oxathiapiprolin residues in
livestock commodities.
The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; 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
[[Page 82274]]
required by FFDCA section 408(b)(4). The Codex has not established MRLs
for residues of oxathiapiprolin in peanut commodities.
V. Conclusion
Therefore, a tolerance is established for indirect or inadvertent
residues of oxathiapiprolin, 1-[4-[4-[5-(2,6-difluorophenyl)-4,5-
dihydro-3-isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2-[5-methyl-3-
(trifluoromethyl)-1H-pyrazol-1-yl]-ethanone, in or on peanut, hay at
0.15 ppm. In addition, EPA adjusted the existing tolerance for indirect
or inadvertent residues on ``All other food commodities/feed
commodities'' to exclude commodities covered by higher tolerances for
indirect or inadvertent residues, such as the peanut, hay tolerance
established by this action, or as a result of use on growing crops.
VI. Statutory and Executive Order Reviews
This action establishes a tolerance 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 to 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 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 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: November 16, 2023.
Charles Smith,
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. Amend Sec. 180.685 by revising the table in paragraph (d) to read
as follows:
Sec. 180.685 Oxathiapiprolin; tolerances for residues.
* * * * *
(d) * * *
Table 2 to Paragraph (d)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
All other food commodities/feed commodities (other than 0.10
those covered by a higher tolerance as a result of use
on growing crops or indirect or inadvertent residues)..
Peanut, hay............................................. 0.15
------------------------------------------------------------------------
[FR Doc. 2023-25768 Filed 11-22-23; 8:45 am]
BILLING CODE 6560-50-P