Rule2025-19910
Chlorantraniliprole; Pesticide Tolerance for Emergency Exemption
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 17, 2025
Effective
November 17, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes a time-limited tolerance for residues of chlorantraniliprole, including its metabolites and degradates, in or on rice, grain. This action is in response to EPA's granting of an emergency exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on rice. This regulation establishes a maximum permissible level for residues of chlorantraniliprole. The time-limited tolerance expires on December 31, 2028.
Full Text
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<title>Federal Register, Volume 90 Issue 219 (Monday, November 17, 2025)</title>
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[Federal Register Volume 90, Number 219 (Monday, November 17, 2025)]
[Rules and Regulations]
[Pages 51118-51123]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19910]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2025-0284; FRL-12973-01]
Chlorantraniliprole; Pesticide Tolerance for Emergency Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
residues of chlorantraniliprole, including its metabolites and
degradates, in or on rice, grain. This action is in response to EPA's
granting of an emergency exemption under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide
on rice. This regulation establishes a maximum permissible level for
residues of chlorantraniliprole. The time-limited tolerance expires on
December 31, 2028.
DATES: This rule is effective November 17, 2025. Objections and
requests for hearings must be received on or before January 16, 2026
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
[[Page 51119]]
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2025-0284, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket in person,
is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#83d1c7c5d1cdecf7eae0e6f0c3e6f3e2ade4ecf5"><span class="__cf_email__" data-cfemail="02504644504c6d766b616771426772632c656d74">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.
B. What is EPA's authority for taking this action?
In accordance with the Federal Food, Drug, and Cosmetic Act (FFDCA)
sections 408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), EPA
is establishing a time-limited tolerance for residues of
chlorantraniliprole, including its metabolites and degradates, in or on
rice, grain at 15 parts per million (ppm). This time-limited tolerance
expires on December 31, 2028.
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. If you fail to file an objection to the
final rule within the time period specified in the final rule, you will
have waived the right to raise any issues resolved in the final rule.
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-
2025-0284 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 16, 2026. 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-2025-0284, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Background and Statutory Findings
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under FIFRA
section 18. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
FIFRA section 18 related time-limited tolerances to set binding
precedents for the application of FFDCA section 408 and the safety
standard to other tolerances and exemptions. Section 408(e) of FFDCA
allows EPA to establish a tolerance or an exemption from the
requirement of a tolerance on its own initiative, i.e., without having
received any petition from an outside party.
FFDCA 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. . .
.''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Chlorantraniliprole on Rice and FFDCA
Tolerance
The Louisiana Department of Agriculture and Forestry (LDAF) has
requested a specific emergency exemption for the use of foliar-applied
chlorantraniliprole to control stem borer in rice. The applicant
asserts that stem borer is a major pest in Louisiana rice, and that
stem borer larvae feed internally in rice stems, causing severe
economic damage. According to LDAF, there is a lack of adequate
alternative controls that can be used in production systems where rice
is rotated with crawfish. Without an effective control, Louisiana rice
growers affected by uncontrolled stem borer face significant economic
yield losses.
After having reviewed the submission, EPA determined that an
emergency condition exists for this State, and that the criteria for
approval of an emergency exemption are met. EPA has authorized a
specific exemption under FIFRA section 18 for
[[Page 51120]]
the use of chlorantraniliprole on rice for control of stem borer in
Louisiana.
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of
chlorantraniliprole in or on rice, grain. In doing so, EPA considered
the safety standard in FFDCA section 408(b)(2), and EPA decided that
the necessary tolerance under FFDCA section 408(l)(6) would be
consistent with the safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemption in
order to address an urgent non-routine situation and to ensure that the
resulting food is safe and lawful, EPA is issuing this tolerance
without notice and opportunity for public comment as provided in FFDCA
section 408(l)(6). Although this time-limited tolerance expires on
December 31, 2028, under FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amount specified in the tolerance
remaining in or on rice, grain after that date will not be unlawful,
provided the pesticide was applied in a manner that was lawful under
FIFRA, and the residues do not exceed a level that was authorized by
this time-limited tolerance at the time of that application. EPA will
take action to revoke the time-limited tolerance earlier if any
experience with, scientific data on, or other relevant information on
this pesticide indicate that the residues are not safe.
Because this time-limited tolerance is being approved under
emergency conditions, EPA has not made any decisions about whether
chlorantraniliprole meets FIFRA's registration requirements for use on
rice or whether a permanent tolerance for this use would be
appropriate. Under these circumstances, EPA does not believe that this
time-limited tolerance decision serves as a basis for registration of
chlorantraniliprole by a State for special local needs under FIFRA
section 24(c). Nor does this tolerance by itself serve as the authority
for persons in any State other than Louisiana to use this pesticide on
rice FIFRA section 18 absent the issuance of an emergency exemption
applicable within that State. For additional information regarding the
emergency exemption for chlorantraniliprole, contact the Agency's
Registration Division at the address provided under FOR FURTHER
INFORMATION CONTACT.
IV. 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 expected as a result of the use proposed by this
emergency exemption request and the time-limited tolerance for residues
of chlorantraniliprole on rice, grain at 15 ppm. EPA's assessment of
exposures and risks associated with establishing the time-limited
tolerance follows.
A. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides</a>.
A summary of the toxicological endpoints for chlorantraniliprole,
and its metabolite and degradates, used for human risk assessment, is
discussed in Unit III of the final rule published in the Federal
Register of February 7, 2014 (79 FR 7397) (FRL-9905-56).
B. Exposure Assessment
1. Dietary exposure from food and feed uses. An acute dietary
toxicity endpoint could not be identified based on the toxicology data
currently available for chlorantraniliprole; therefore, an acute
assessment was not conducted. To assess dietary exposure resulting from
the proposed Section 18 use, EPA performed a chronic dietary analysis
for chlorantraniliprole. In evaluating dietary exposure to
chlorantraniliprole, EPA considered exposure under the time-limited
tolerance established by this action as well as all existing
chlorantraniliprole tolerances in 40 CFR 180.628. EPA assessed dietary
exposures from chlorantraniliprole in food as follows:
i. Acute exposure. An acute dietary toxicity endpoint was not
identified based on the toxicology data currently available for
chlorantraniliprole; therefore, an acute assessment was not performed.
ii. Chronic exposure. In conducting the chronic (food and drinking
water) dietary risk assessment for chlorantraniliprole, a dietary
analysis was performed using tolerance-level residues and 100% crop
treated (PCT) conservative assumptions. Default processing factors were
also used.
iii. Cancer. EPA has classified chlorantraniliprole as ``Not Likely
to be Carcinogenic to Humans'' based on weight of evidence of data.
Therefore, a cancer assessment was not performed.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residues. However, tolerance level residues
and 100% PCT were assumed for all food commodities in the dietary
assessment for chlorantraniliprole.
v. Dietary exposure from drinking water. The Agency used screening
level water exposure models: the Pesticide Root Zone Model (PRZM)-
Exposure Analysis Modeling system EXAMS) and PRZM-Ground Water (GW) in
the dietary exposure analysis and risk assessment for
chlorantraniliprole. These simulation models take into
[[Page 51121]]
account data on the physical, chemical, and fate/transport
characteristics of chlorantraniliprole. Further information regarding
EPA drinking water models used in pesticide exposure assessment can be
found at <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment#aquatic">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment#aquatic</a>.
The highest modeled ground water EDWCs for chlorantraniliprole used
in the dietary risk assessments were entered directly into the latest
version of the Pesticides in Water Calculator (PWC 1.52). The highest
surface water EDWCs for chlorantraniliprole used in the dietary risk
assessments were generated using the Tier 1 Rice Model. EDWCs were
calculated for groundwater and surface water based on the maximum
annual application rate (0.132 lb ai/A/Yr). The estimated drinking
water contribution to chronic dietary exposure risks from drinking
water were 647 parts per billion (ppb) for groundwater and 97 ppb for
surface water. No acute dietary risk assessment was performed because
an acute hazard was not identified. These modeled estimates of drinking
water concentrations were directly entered into the dietary exposure
model.
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).
Residential exposure to chlorantraniliprole is not expected based
on the proposed use pattern on rice. However, chlorantraniliprole is
currently registered for uses (i.e., residential or golf course turf,
residential ornaments, and pre-and post-construction termiticide use),
where residential handler and post-application exposures are
anticipated. No dermal, inhalation or oral PODs have been identified
for short-term exposures to chlorantraniliprole. Therefore, no short-
term risk assessment has been conducted for the residential uses.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at: <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide</a>.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found chlorantraniliprole to share a common mechanism
of toxicity with any other substances. In addition, chlorantraniliprole
does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has not assumed that chlorantraniliprole has a common mechanism of
toxicity with other substances and concluded that it is not appropriate
to conduct a cumulative exposure assessment. 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 <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides</a>.
C. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional SF when reliable data
available to EPA support the choice of a different factor.
2. Conclusion for chlorantraniliprole. EPA has determined that
reliable data show that the safety of infants and children would be
adequately protected if the FQPA SF were reduced to 1X for all
population subgroups and chlorantraniliprole exposure scenarios. That
decision is based on the following findings:
i. The toxicity database for chlorantraniliprole is (1) considered
complete for evaluating and selecting toxicity endpoints and PODs, (2)
dietary and residential exposure analyses are unlikely to underestimate
exposure, and (3) there is no evidence of susceptibility or
neurotoxicity in the database.
ii. No endpoints have been selected for acute oral, incidental
oral, dermal, or inhalation routes of exposure; therefore, quantitative
acute dietary, residential, and occupational human health assessments
were not performed. However, an endpoint has been selected for chronic
oral exposures and was quantitatively assessed. In general
chlorantraniliprole is non-toxic, as effects are non-adverse up to the
limit dose in most studies (1,000 mg/kg/day for most studies, 2,000 mg/
kg/day for acute neurotoxicity). Chlorantraniliprole is not considered
developmentally toxic, genotoxic, neurotoxic, immunotoxic, or
carcinogenic.
iii. In an 18-month oral (feeding) carcinogenicity study in mice,
there is evidence of chronic dietary adverse effects following
chlorantraniliprole exposure near the LOAEL limit dose of 935 mg/kg/day
based on eosinophilic foci accompanied by hepatocellular hypertrophy
and increased live weight in males only.
iv. There are no residual uncertainties identified in the exposure
databases. Results of the chronic dietary analysis indicate that food
and drinking water exposure are not of concern. This assessment was
performed based on high-end assumptions such as 100% CT and tolerance-
level residues, default processing factors, and modeled high-end
estimates of residues in drinking water, and is not expected to
underestimate the exposure and risks posed by chlorantraniliprole. In
addition, residential exposure to chlorantraniliprole is not expected
based on the proposed use pattern on rice. Based upon the existing
registered uses, residential exposures may occur during and following
the application of products containing chlorantraniliprole. Also, non-
occupational bystander spray drift exposures are possible. In an
occupational setting, applicators may be exposed while handling the
pesticide prior to and during application. There is potential for post-
application exposure for workers re-entering treated areas. In the
absence of any observed hazard from relevant exposures to
chlorantraniliprole, occupational handler and post-application exposure
assessments have not been performed.
D. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. The acute aggregate risk assessment takes into
account acute exposure estimates from dietary
[[Page 51122]]
consumption of food and drinking water. An acute endpoint for
chlorantraniliprole was not identified based on the toxicology data
currently available for chlorantraniliprole; therefore, an acute
assessment was not performed.
2. Chronic risk. Chronic exposures are not expected for adults or
children via residential exposure pathways from either the proposed use
or existing registrations of chlorantraniliprole. Therefore, the
chronic aggregate risk is equivalent to the chronic dietary risk
estimates. The estimated chronic dietary exposure risks from food and
water for chlorantraniliprole are below the LOC (<100% of the cPAD) for
the US general population and all population subgroups. For
chlorantraniliprole, EPA has concluded that chronic exposure from food
and water will utilize 9.3% of the cPAD for Children 1-2 years old, the
population group receiving the greatest exposure. For the overall U.S.
population, chronic exposure from food and water will utilize 3.6% of
the cPAD.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water. Residential exposures are not expected for the proposed use;
however, residential handler and post-application exposures are
anticipated based on the registered use pattern of chlorantraniliprole.
At this time, an endpoint has only been selected for chronic oral
exposures; therefore, short-term aggregate risk is equivalent to the
chronic dietary exposures only and is not of concern.
Chlorantraniliprole is not expected to pose a short-term risk because
no short-term adverse effects were identified.
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). At this time, an endpoint has only been selected for chronic
oral exposures; therefore, intermediate-term aggregate risk is
equivalent to the chronic dietary exposures only and is not of concern.
Chlorantraniliprole is not expected to pose an intermediate-term risk
because no intermediate-term adverse effects were identified.
5. Aggregate cancer risk for U.S. population. Chlorantraniliprole
is classified as ``Not Likely to Be Carcinogenic to Humans,''
therefore, a cancer aggregate assessment was not performed.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children, from aggregate
exposure to chlorantraniliprole residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement methodology is available for plants and
livestock using liquid chromatography/tandem mass spectrometer/mass
spectrometer (LC/MS/MS) for analysis of chlorantraniliprole residues.
The limit of quantitation (LOQ) is reported at 0.01 ppm for parent
chlorantraniliprole. The LC/MS/MS method was adequately validated on a
variety of matrices, and an acceptable Independent Laboratory
Validation (ILV) study was submitted. The method for the determination
of chlorantraniliprole in processed commodities is a LC/MS/MS method,
DuPont-14314, which is a slightly modified version of DuPont-11374. The
LOQ is reported at 0.010 ppm for chlorantraniliprole. The requirements
for multiresidue methods data are fulfilled. Chlorantraniliprole is not
recovered by the U.S. Food and Drug Administration's (FDA's)
multiresidue methods.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex and Canada have established maximum residue limits (MRLs)
for residues of chlorantraniliprole in/on rice. The recommended U.S.
tolerance for the time-limited tolerance established by this action of
15 ppm chlorantraniliprole rice, grain is not harmonized with the
Canadian MRL (0.15 ppm) nor the Codex MRL (0.4 ppm) for rice, grain
because of considerable differences in the use pattern, and EPA's
regulations require adequate time-limited tolerances be in place in
order to allow a pesticide use on food under an emergency exemption.
Since EPA has determined that this time-limited tolerance is safe, EPA
is establishing this time-limited tolerance despite the lack of
harmonization with the related Codex MRL.
C. Effective and Expiration Date(s)
In general, a tolerance action is effective on the date of
publication of the final rule in the Federal Register. For actions in
the final rule that lower or revoke existing tolerances, EPA will set
an expiration date for the existing tolerance of six months after the
date of publication of the final rule in the Federal Register, in order
to allow a reasonable interval for producers in exporting members of
the World Trade Organization's (WTO's) Sanitary and Phytosanitary (SPS)
Measures Agreement to adapt to the requirements.
VI. Conclusion
Therefore, a time-limited tolerance is established for residues of
chlorantraniliprole (CAS No. 50000-45-7) in or on food and feed
commodity, rice, grain, at 15 ppm. This tolerance expires on December
31, 2028.
VII. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at <a href="https://www.epa.gov/regulations/laws-and-executive-orders">https://www.epa.gov/regulations/laws-and-executive-orders</a>.
A. Executive Order 12866: Regulatory Planning and Review
This action is exempt from review under Executive Order 12866 (58
FR 51735, October 4, 1993), because it establishes a time-limited
tolerance or an exemption from the requirement of a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under FIFRA
section 18. The Office of Management and Budget has exempted these
types of actions from review under Executive Order 12866.
B. Executive Order 14192: Unleashing Prosperity Through Deregulation
Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply
because actions that establish a tolerance under FFDCA section 408 are
exempted from review under Executive Order 12866.
[[Page 51123]]
C. Paperwork Reduction Act (PRA)
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.
D. Regulatory Flexibility Act (RFA)
Since tolerances and exemptions that are established in accordance
with FFDCA sections 408(e) and 408(1)(6), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the RFA, 5 U.S.C. 601 et seq., do not apply to this
action.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more (in 1995 dollars and adjusted annually for inflation) as described
in UMRA, 2 U.S.C. 1531-1538 and does not significantly or uniquely
affect small governments. The action imposes no enforceable duty on any
State, local, or Tribal governments or on the private sector.
F. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will
not have substantial direct effects on the states, on the relationship
between the National Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000) because it will
not have substantial direct effects on Tribal governments, on the
relationship between the Federal Government and the Indian Tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian Tribes.
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because tolerance actions like this one are exempt from
review under Executive Order 12866.
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not subject to Executive Order 13211 (66 FR 28355)
(May 22, 2001) because it is not a significant regulatory action under
Executive Order 12866.
J. National Technology Transfer Advancement Act (NTTAA)
This action does not involve technical standards that would require
Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
VIII. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to
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 3, 2025.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
For the reasons stated in the preamble, the EPA amends 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. 180.628, add paragraph (b) and Table 2 to read as follows:
Sec. 180.628 Chlorantraniliprole; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. A time-limited tolerance is
established for residues of chlorantraniliprole, including its
metabolites and degradates, in or on the specified agricultural
commodity in the table below. Compliance with the tolerance level
specified in the following table is to be determined by measuring only
chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6[(methylamino)
carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, in
or on the specified agricultural commodity, resulting from use of the
pesticide pursuant to FIFRA section 18 emergency exemption. The
tolerance expires on the date specified in the table.
Table 2 to Paragraph (b)
------------------------------------------------------------------------
Parts per Expiration
Commodity million date
------------------------------------------------------------------------
Rice, grain.................................. 15 12/31/2028
------------------------------------------------------------------------
* * * * *
[FR Doc. 2025-19910 Filed 11-14-25; 8:45 am]
BILLING CODE 6560-50-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.