
[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]


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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.

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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
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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
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[FR Doc. 2023-25768 Filed 11-22-23; 8:45 am]
BILLING CODE 6560-50-P


