Methoxyfenozide; Pesticide Tolerances
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Issuing agencies
Abstract
This regulation establishes tolerances for residues of methoxyfenozide, including its metabolites and degradates, (CASRN 161050-58-4) in or on the food and feed commodities listed under Unit II. Petitioned-For Tolerances. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), The Interregional Research Project Number 4 (IR- 4) submitted a petition to EPA requesting that EPA establish a maximum permissible level for residues of this pesticide in or on the identified commodities.
Full Text
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<title>Federal Register, Volume 91 Issue 74 (Friday, April 17, 2026)</title>
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[Federal Register Volume 91, Number 74 (Friday, April 17, 2026)]
[Rules and Regulations]
[Pages 20589-20597]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07560]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2024-0202; FRL-13250-01-OCSPP]
Methoxyfenozide; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
methoxyfenozide, including its metabolites and degradates, (CASRN
161050-58-4) in or on the food and feed commodities listed under Unit
II. Petitioned-For Tolerances. Under the Federal Food, Drug, and
Cosmetic Act (FFDCA), The Interregional Research Project Number 4 (IR-
4) submitted a petition to EPA requesting that EPA establish a maximum
permissible level for residues of this pesticide in or on the
identified commodities.
DATES: This regulation is effective April 17, 2026. Objections and
requests for hearings must be received on or before June 16, 2026 and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of this document).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2024-0202, is available online 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#c99b8d8f9b87a6bda0aaacba89acb9a8e7aea6bf"><span class="__cf_email__" data-cfemail="96c4d2d0c4d8f9e2fff5f3e5d6f3e6f7b8f1f9e0">[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.
Potentially affected entities may include:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
[[Page 20590]]
<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?
EPA is issuing this rulemaking under section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. FFDCA section
408(b)(2)(A)(i) 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.'' FFDCA section
408(b)(2)(A)(ii) 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. FFDCA section 408(b)(2)(C)
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 . . .'' Additionally, FFDCA section 408(b)(2)(D)
requires that the Agency consider, among other things, ``available
information concerning the cumulative effects of a particular
pesticide's residues'' and ``other substances that have a common
mechanism of toxicity.''
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 the docket ID number EPA-HQ-
OPP-2024-0202 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 June 16, 2026.
EPA's Office of Administrative Law Judges (OALJ), in which the
Hearing Clerk is housed, urges parties to file and serve documents by
electronic means only, notwithstanding any other particular
requirements set forth in other procedural rules governing those
proceedings. See ``Order Urging Electronic Filing and Service,'' dated
December 3, 2025, which can be found at <a href="https://www.epa.gov/system/files/documents/2025-12/2025-12-03-order-urging-electronic-filing-and-service.pdf">https://www.epa.gov/system/files/documents/2025-12/2025-12-03-order-urging-electronic-filing-and-service.pdf</a>. Although EPA's regulations require submission via U.S.
Mail or hand delivery, EPA intends to treat submissions filed via
electronic means as properly filed submissions; therefore, EPA believes
the preference for submission via electronic means will not be
prejudicial. When submitting documents to the OALJ electronically, a
person should utilize the OALJ e-filing system at <a href="https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf">https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf</a>.
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 at <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. If you wish to
include CBI in your request, please follow the applicable instructions
at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> and clearly
mark the information that you claim to be CBI. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. 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 <a href="https://www.ecfr.gov//">https://www.ecfr.gov//</a>.
II. Petitioned-For Tolerance
In the Federal Register of July 3, 2025 (90 FR 29516) (FRL-12474-
05- OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of pesticide petition
(PP4E9107) by the Interregional Research Project Number 4 (IR-4), IR-4
Project Headquarters, North Carolina State University, 1730 Varsity
Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requests
that EPA amend 40 CFR 180.544 by establishing tolerances for residues
of methoxyfenozide, including its metabolites and degradates, in or on
the following commodities: Edible podded bean subgroup 6-22A at 2 parts
per million (ppm); Edible podded pea subgroup 6-22B at 2 ppm; Field
corn subgroup 15-22C at 0.05 ppm; Grain sorghum and millet subgroup 15-
22E at 6 ppm; Pulses, dried shelled bean, except soybean, subgroup 6-
22E, except pea, blackeyed, seed and pea, southern, seed at 0.5 ppm;
Pulses, dried shelled pea subgroup 6-22F at 0.5 ppm; Succulent shelled
bean subgroup 6-22C at 0.3 ppm; Succulent shelled pea subgroup 6-22D at
0.3 ppm; Sweet corn subgroup 15-22D at 0.05 ppm; and Tropical and
Subtropical, Medium to Large Fruit, edible peel, subgroup 23B at 6 ppm.
The petition also requests EPA to establish a regional tolerance for
residues of methoxyfenozide, including its metabolites and degradates,
in or on Rice subgroup 15-22F at 30 ppm.
The petition requests, upon the approval of the requested
tolerances, the removal of the established tolerances for residues of
methoxyfenozide, including its metabolites and degradates in or on the
raw agricultural commodities: Bean, adzuki, dry seed at 0.5 ppm; Bean,
American potato, dry seed at 0.5 ppm; Bean, asparagus, dry seed at 0.5
ppm; Bean, asparagus, edible podded at 2 ppm; Bean, black, dry seed at
0.5 ppm; Bean, broad, dry seed at 0.5 ppm; Bean, broad, succulent
shelled at 0.3 ppm; Bean, catjang, dry seed at 0.5 ppm; Bean, catjang,
edible podded at 2 ppm; Bean, catjang, succulent shelled at 0.3 ppm;
Bean, cranberry, dry seed at 0.5 ppm; Bean, dry, dry seed at 0.5 ppm;
Bean, field, dry seed at 0.5 ppm; Bean, French, dry seed at 0.5 ppm;
Bean, French, edible podded at 2 ppm; Bean, garden, dry seed at 0.5
ppm; Bean, garden, edible podded at 2 ppm; Bean, goa, dry seed at 0.5
ppm; Bean, goa, edible podded at 2 ppm; Bean, goa, succulent shelled at
0.3 ppm; Bean, great northern, dry seed at 0.5 ppm; Bean, green, dry
seed at 0.5 ppm; Bean, green, edible podded at 2 ppm; Bean, guar, dry
seed at 0.5 ppm; Bean, guar, edible podded at 2 ppm; Bean, kidney, dry
seed 0.5 ppm; Bean, kidney, edible podded at 2 ppm; Bean, lablab, dry
seed at 0.5 ppm; Bean, lablab, edible podded at 2 ppm; Bean, lablab
succulent shelled 0.3 ppm; Bean, lima, dry seed at 0.5 ppm; Bean, lima,
succulent shelled at 0.3 ppm; Bean, morama, dry seed at 0.5 ppm; Bean,
moth, dry seed at 0.5 ppm; Bean, moth edible podded at 2 ppm; Bean,
moth, succulent shelled at 0.3 ppm; Bean, mung, edible podded at 2 ppm;
Bean, navy, dry seed at 0.5 ppm; Bean, navy, edible podded at 2 ppm;
Bean, pink, dry seed at 0.5 ppm; Bean, pinto, dry seed at 0.5 ppm;
Bean, red, dry seed at 0.5 ppm; Bean, rice, dry seed
[[Page 20591]]
at 0.5 ppm; Bean, rice, edible podded at 2 ppm; Bean, scarlet runner,
dry seed at 0.5 ppm; Bean, scarlet runner, edible podded at 2 ppm;
Bean, scarlet runner, succulent shelled at 0.3 ppm; Bean, snap, edible
podded at 2 ppm; Bean, sword, dry seed at 0.5 ppm; Bean, sword, edible
podded at 2 ppm; Bean, tepary, dry seed at 0.5 ppm; Bean, urd, dry seed
at 0.5 ppm; Bean, urd, edible podded at 2 ppm; Bean, wax, edible podded
at 2 ppm; Bean, wax, succulent shelled at 0.3 ppm; Bean, yardlong, dry
seed at 0.5 ppm; Bean, yardlong, edible podded at 2 ppm; Bean, yellow,
dry seed at 0.5 ppm; Chickpea, dry seed at 0.5 ppm; Chickpea, edible
podded at 2 ppm; Chickpea, succulent shelled at 0.3 ppm; Corn, field,
grain at 0.05 ppm; Corn, pop, grain at 0.05 ppm; Corn, sweet, kernel
plus cob with husks removed at 0.05 ppm; Cowpea, dry seed at 0.5 ppm;
Cowpea, edible podded at 2 ppm; Cowpea, succulent shelled at 0.3 ppm;
Feijoa at 0.4 ppm; Gram, horse, dry seed at 0.5 ppm; Grass pea, dry
seed at 0.5 ppm; Grass pea, edible podded at 2 ppm; Guava at 0.4 ppm;
Jaboticaba at 0.4 ppm; Jackbean, dry seed at 0.5 ppm; Jackbean, edible
podded at 2 ppm; Jackbean, succulent shelled at 0.3 ppm; Lentil, dry
seed at 0.5 ppm; Lentil, edible podded at 2 ppm; Lentil, succulent
shelled at 0.3 ppm; Longbean, Chinese, dry seed at 0.5 ppm; Longbean,
Chinese, edible podded at 2 ppm; Lupin, Andean, succulent shelled at
0.3 ppm; Lupin, blue, dry seed at 0.5 ppm; Lupin, blue, succulent
shelled at 0.3 ppm; Lupin, grain, dry seed at 0.5 ppm; Lupin, grain,
succulent shelled at 0.3 ppm; Lupin, sweet, dry seed at 0.5 ppm; Lupin,
sweet, succulent shelled at 0.3 ppm; Lupin, sweet white, dry seed at
0.5 ppm; Lupin, sweet white, succulent shelled at 0.3 ppm; Lupin,
white, dry seed at 0.5 ppm; Lupin, white, succulent shelled at 0.3 ppm;
Lupin, yellow, dry seed at 0.5 ppm; Lupin, yellow, succulent shelled at
0.3 ppm; Pea, blackeyed, succulent shelled at 0.3 ppm; Pea, crowder,
dry seed at 0.5 ppm; Pea, crowder, succulent shelled at 0.3 ppm; Pea,
dry, dry seed at 0.5 ppm; Pea, dwarf, edible podded at 2 ppm; Pea,
English, succulent shelled 0.3 ppm; Pea, field, dry seed at 0.5 ppm;
Pea, garden, dry seed at 0.5 ppm; Pea, garden, succulent shelled at 0.3
ppm; Pea, green, dry seed at 0.5 ppm; Pea, green, edible podded at 2
ppm; Pea, green, succulent shelled at 0.3 ppm; Pea, pigeon, dry seed at
0.5 ppm; Pea, pigeon, edible podded at 2 ppm; Pea, pigeon, succulent
shelled at 0.3 ppm; Pea, snap, edible podded at 2 ppm; Pea, snow edible
podded at 2 ppm; Pea, southern, succulent shelled at 0.3 ppm; Pea,
sugar snap, edible podded at 2 ppm; Pea, winged, dry seed at 0.5 ppm;
Pea, winged, edible podded at 2 ppm; Rice, grain at 30 ppm; Sorghum,
grain at 6 ppm; Sorghum, sweet, grain at 6 ppm; Soybean, vegetable, dry
seed at 0.5 ppm; Soybean, vegetable, edible podded at 2 ppm; Soybean,
vegetable, succulent shelled at 0.3 ppm; Starfruit at 0.4 ppm; Velvet
bean, dry seed at 0.5 ppm; Velvet bean, edible podded at 2 ppm; Velvet
bean, succulent shelled at 0.3 ppm; and Yam bean, African, dry seed at
0.5 ppm.
The notice of filing document referenced a summary of the petition
prepared by IR-4, the petitioner, which is available in docket ID
number EPA-HQ-OPP-2024-0202 at <a href="http://www.regulations.gov">http://www.regulations.gov</a>. There were
no comments received in response to the notice of filing.
EPA is establishing tolerances that vary from what the petitioner
proposed. The reason for this change is explained in Unit IV.C.
III. Final Tolerance Actions
A. 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 methoxyfenozide including exposure resulting
from the tolerances established by this action. EPA's assessment of
exposures and risks associated with methoxyfenozide follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemakings for the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemakings, and EPA considers referral back to those
sections as sufficient to provide an explanation of the information EPA
considered in making its safety determination for the new rulemaking.
EPA has previously published tolerance rulemakings for
methoxyfenozide in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to methoxyfenozide and established
tolerances for residues of that chemical. EPA is incorporating
previously published sections from these rulemakings as described
further in this rulemaking, as they remain unchanged.
B. Toxicological Profile
For a discussion of the Toxicological Profile of methoxyfenozide,
see Unit III.A. of the methoxyfenozide tolerance rulemaking published
in the Federal Register of March 12, 2019 (84 FR 8820) (FRL-9985-06).
C. 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
[[Page 20592]]
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>.
For a summary of the Toxicological Points of Departure/Levels of
Concern for methoxyfenozide used for human health risk assessment, see
Unit III.B. of the March 12, 2019, rulemaking 2019 (84 FR 8820) (FRL-
9985-06).
D. Exposure Assessment
Much of the exposure assessment for methoxyfenozide remains
unchanged from the discussions in Unit III.C. of the March 12, 2019,
rulemaking, Unit III of the methoxyfenozide tolerance rulemaking
published in the Federal Register of October 11, 2022 (87 FR 61259)
(FRL-9525-01), and Unit III of the streamlined tolerance rulemaking
published in the Federal Register of August 28, 2023 (88 FR 58506)
(FRL-11276-01), except as described in this unit.
EPA's dietary exposure assessments have been updated to include the
additional exposures from the petitioned-for tolerances. An acute
dietary exposure assessment was not performed for methoxyfenozide as
there are no effects in the toxicity database that can be attributed to
a single dose. A chronic aggregate dietary (food and drinking water)
exposure and risk assessment was conducted using the Dietary Exposure
Evaluation Model software using the Food Commodity Intake Database
(DEEM-FCID) Version 4.02. This software uses 2005-2010 food consumption
data from the USDA's National Health and Nutrition Examination Survey,
What We Eat in America (NHANES/WWEIA). The chronic dietary analysis was
conducted using tolerance level residues and 100 percent crop treated
(PCT) assumptions for all existing and proposed uses. EPA's default
processing factors were used for most processed commodities that do not
have individual tolerances. Drinking water was incorporated directly
into the dietary assessment using the maximum estimated drinking water
concentration (EDWC) for groundwater, which is 232 parts per billion.
The chronic food and drinking water exposure and dietary risk estimates
for methoxyfenozide do not exceed EPA's level of concern for the
general U.S. population, or any of the population subgroups (<=100%
PAD).
Non-occupational exposure. There are no proposed or currently
registered residential handler uses of methoxyfenozide. However, there
are registered uses on ornamentals that have previously been assessed
for potential residential dermal and inhalation post-application
exposure. A dermal endpoint was not selected for methoxyfenozide due to
a lack of toxic effects via the dermal route observed in the
toxicological database. Post-application inhalation exposure is
considered negligible, and incidental oral exposure is not expected
from the use on ornamentals; therefore, a quantitative residential
assessment was not conducted. The assessment of residential post-
application exposure is the same as described in Unit III.C.3 of the
March 12, 2019, rulemaking.
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.'' In 2016, EPA's Office of
Pesticide Programs released a guidance document entitled Pesticide
Cumulative Risk Assessment: ``Framework for Screening Analysis''
(<a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework</a>). This document provides
guidance on how to screen groups of pesticides for cumulative
evaluation using a two-step approach beginning with the evaluation of
available toxicological information and, if necessary, followed by a
risk-based screening approach. This framework supplements the existing
guidance documents for establishing common mechanism groups (CMGs) and
conducting cumulative risk assessments (CRA).
The Agency has utilized this framework for methoxyfenozide and
determined that the diacylhydrazine class of insecticides
(methoxyfenozide, halofenozide and tebufenozide) form a candidate CMG.
This group of pesticides is considered a candidate CMG because they
share characteristics to support a testable hypothesis for a common
mechanism of action.
EPA updated the cumulative dietary and residential aggregate
exposure estimates for methoxyfenozide and tebufenozide (there are
currently no registered uses of or tolerances for halofenozide) to take
into account the proposed new use on fig and crop group expansions and
conversions for methoxyfenozide. The updated cumulative dietary and
aggregate risk estimates for methoxyfenozide and tebufenozide are not
of concern. More detailed information on the updated cumulative dietary
and aggregate risk estimates can be found in Appendix D of the document
titled ``Methoxyfenozide. Human Health Risk Assessment for the
Establishment of a Tolerance and Registration for Use on Figs and for
Several Crop Group Expansions and Conversions,'' available at docket ID
number EPA-HQ-OPP-2024-0202.
E. Safety Factor for Infants and Children
EPA continues to conclude that there are reliable data to support
the reduction of the Food Quality Protection Act (FQPA) safety factor
from 10X to 1X. See Unit III.D. of the March 12, 2019, rulemaking for a
discussion of the Agency's rationale for that determination.
F. Aggregate Risk and Determination of Safety
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). Short-,
intermediate-, and chronic-term risks are evaluated by comparing the
estimated aggregate food, water, and residential exposure to the
appropriate points of departure to ensure that an adequate MOE exists.
For linear cancer risks, EPA calculates the lifetime probability of
acquiring cancer given the estimated aggregate exposure.
An acute dietary risk assessment was not needed for methoxyfenozide
since no toxic effects attributable to a single dose were identified in
the toxicity database. Chronic dietary risks are below the Agency's
level of concern of 100% of the cPAD; they are 91% of the cPAD for
children 1 to 2 years old, the group with the highest exposure. There
are currently no registered residential uses for methoxyfenozide, and
none are pending before the Agency. Therefore short- and intermediate-
term residential exposure to methoxyfenozide is not expected, and the
short- and intermediate-term aggregate risk is equivalent to the
chronic dietary risk, which is not of concern. Methoxyfenozide is
classified as ``Not Likely to Be Carcinogenic to Humans''; therefore,
EPA does not expect methoxyfenozide exposures to pose an aggregate
cancer risk.
Determination of safety. Therefore, based on the risk assessments
and information described above, 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
[[Page 20593]]
methoxyfenozide residues. More detailed information on this action can
be found in the document titled ``Methoxyfenozide. Human Health Risk
Assessment for the Establishment of a Tolerance and Registration for
Use on Figs and for Several Crop Group Expansions and Conversions,''
available at docket ID number EPA-HQ-OPP-2024-0202. Based upon review
of the data supporting the petition and in accordance with its
authority under FFDCA section 408(d)(4)(A)(i), EPA is establishing
tolerances that vary from what the petitioner proposed. The reason for
this change is explained in Unit IV.C.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate methods using high performance liquid chromatography
(HPLC) with ultraviolet (UV) or mass spectrometric (MS) detection are
available for enforcing the current and recommended tolerances for
methoxyfenozide in primary and rotational crops, and in animal
commodities. Depending on the plant commodity, the limits of
quantitation (LOQs) for methoxyfenozide in primary crop commodities are
0.01-0.05 ppm.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has established MRLs for methoxyfenozide in or on
commodities of the following crop groups: Edible podded bean subgroup
6-22A at 2 ppm; Edible podded pea subgroup 6-22B at 2 ppm; Pulses,
dried shelled bean, except soybean, subgroup 6-22E, except pea,
blackeyed, seed and pea, southern, seed at 0.5 ppm; Succulent shelled
bean subgroup 6-22C at 0.3 ppm; and Succulent shelled pea subgroup 6-
22D at 0.3 ppm. These MRLs are the same as the tolerances established
for methoxyfenozide in the United States. The Codex has an established
MRL for Corn, grain at 0.02 ppm and Corn, sweet at 0.02 ppm. EPA is
departing from the Codex MRLs by establishing tolerances for Field corn
subgroup 15-22C at 0.05 ppm and Sweet corn subgroup 15-22D at 0.05 ppm
because the use patterns do not support decreasing the tolerance from
0.05 ppm to 0.02 ppm for the proposed crop group expansions. There is
no established Codex MRL for methoxyfenozide in/on fig.
C. Revisions to Petitioned-For Tolerances
EPA reviewed the available residue data and is establishing a
different tolerance than what was requested for Tropical and
subtropical, medium to large fruit, edible peel, subgroup 23B. A
tolerance on Tropical and subtropical, medium to large fruit, edible
peel, subgroup 23B requires data on both fig and guava. Guava residue
data were previously submitted to the EPA for review, and a tolerance
of 0.4 ppm was established in 2008 (73 FR 11820). The petitioner
requested the removal of the guava tolerance in its petition, upon
establishment of the proposed tolerance on Tropical and subtropical,
medium to large fruit, edible peel, subgroup 23B, which includes guava.
The submitted fig residue data support a tolerance for residues of
methoxyfenozide in/on fig at 6 ppm. The Agency will not ordinarily
establish a crop group or subgroup tolerance if maximum residues
(tolerances) for the representative crops vary by more than a factor of
5. See 40 CFR 180.40(g). In this case, the fig and guava tolerances
differ by a factor of 15, therefore, EPA maintains the existing
tolerance for residues in/on guava (0.4 ppm) and is establishing an
individual tolerance for residues in/on fig at 6 ppm. EPA is
establishing tolerances for residues in/on the following individual
commodities of Tropical and subtropical, medium to large fruit, edible
peel, subgroup 23B, for which the representative commodity is fig, at 6
ppm: achachairu; ambarella; araza; babaco; bilimbi; borojo; cajou,
fruit; cambuca; carob; cashew apple; ciruela verde; Davidson's plum;
feijoa; gooseberry, Indian; imbe; imbu; jaboticaba; jujube, Indian;
kwai muk; mangaba; Marian plum; mombin, Malayan; mombin, purple;
monkeyfruit; nance; natal plum; noni; papaya, mountain; persimmon,
Japanese; pomerac; rambai; rose apple; sentul; starfruit; Surinam
cherry; tamarind; and uvalha.
During Agency review, the petitioner amended the tolerance
petition, requesting to maintain the established tolerance for residues
of methoxyfenozide in/on Sorghum, sweet, grain at 6.0 ppm. The initial
petition requested the removal of the individual tolerance in/on
Sorghum, sweet, grain upon the establishment of the proposed tolerance
for Grain sorghum and millet subgroup 15-22E. However, sweet sorghum is
not part of crop subgroup 15-22E, and the petitioner rescinded the
request to remove the established tolerance for residues of
methoxyfenozide in/on Sorghum, sweet, grain at 6.0 ppm.
D. 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.
V. Conclusion
Therefore, tolerances are established for residues of
methoxyfenozide (CASRN 161050-58-4), including its metabolites and
degradates, in or on the raw agricultural commodities: Achachairu at 6
ppm; Ambarella at 6 ppm; Araza at 6 ppm; Babaco at 6 ppm; Bilimbi at 6
ppm; Borojo at 6 ppm; Cajou, fruit at 6 ppm; Cambuca at 6 ppm; Carob at
6 ppm; Cashew apple at 6 ppm; Ciruela verde at 6 ppm; Davidson's plum
at 6 ppm; Edible podded bean subgroup 6-22A at 2 ppm; Edible podded pea
subgroup 6-22B at 2 ppm; Feijoa at 6 ppm; Field corn subgroup 15-22C at
0.05 ppm; Fig at 6 ppm; Gooseberry, Indian at 6 ppm; Grain sorghum and
millet subgroup 15-22E at 6 ppm; Imbe at 6 ppm; Imbu at 6 ppm;
Jaboticaba at 6 ppm; Jujube, Indian at 6 ppm; Kwai muk at 6 ppm;
Mangaba at 6 ppm; Marian plum at 6 ppm; Mombin, Malayan at 6 ppm;
Mombin, purple at 6 ppm; Monkeyfruit at 6 ppm; Nance at 6 ppm; Natal
plum at 6 ppm; Noni at 6 ppm; Papaya, mountain at 6 ppm; Persimmon,
Japanese at 6 ppm; Pomerac at 6 ppm; Pulses, dried shelled bean, except
soybean, subgroup 6-22E, except pea, blackeyed, seed and pea, southern,
seed at 0.5 ppm; Pulses, dried shelled pea subgroup 6-22F at 0.5 ppm;
Rambai at 6 ppm; Rose apple at 6 ppm; Sentul at
[[Page 20594]]
6 ppm; Starfruit at 6 ppm; Succulent shelled bean subgroup 6-22C at 0.3
ppm; Succulent shelled pea subgroup 6-22D at 0.3 ppm; Surinam cherry at
6 ppm; Sweet corn subgroup 15-22D 0.05 ppm; Tamarind at 6 ppm; and
Uvalha at 6 ppm. A regional tolerance is established for residues of
methoxyfenozide, including its metabolites and degradates, in or on
Rice subgroup 15-22F at 30 ppm.
VI. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at <a href="https://www.epa.gov/regulations/and-executive-orders">https://www.epa.gov/regulations/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 or modifies a
pesticide tolerance or a tolerance exemption under FFDCA section 408 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.
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.
C. Paperwork Reduction Act (PRA)
This action does not impose an information collection burden under
the PRA 44 U.S.C. 3501 et seq., because it does not contain any
information collection activities.
D. Regulatory Flexibility Act (RFA)
Since tolerance actions 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 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. However, EPA's 2021 Policy on
Children's Health applies to this action. This rule finalizes tolerance
actions under the FFDCA, which 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 . .
.'' (FFDCA 408(b)(2)(C)). The Agency's consideration is summarized in
Unit III.E.
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).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 15, 2026.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
For the reasons set forth in the preamble, 40 CFR chapter I is
amended 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. 180.544 by:
0
a. Revising and republishing Table 1 to paragraph (a)(1); and
0
b. Revising and republishing Table 3 to Paragraph (c).
The revisions read as follows:
Sec. 180.544 Methoxyfenozide; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Acerola.............................................. 0.4
Achachairu........................................... 6
Almond, hulls........................................ 25
[[Page 20595]]
Ambarella............................................ 6
Animal feed, nongrass, group 18, forage.............. 50.0
Animal feed, nongrass, group 18, hay................. 150.0
Apple, wet pomace.................................... 7.0
Araza................................................ 6
Artichoke, globe..................................... 3.0
Atemoya.............................................. 0.60
Avocado.............................................. 0.6
Babaco............................................... 6
Beet, sugar, roots................................... 0.50
Berry, low growing, subgroup 13-07G, except cranberry 2.0
Bilimbi.............................................. 6
Biriba............................................... 0.60
Borojo............................................... 6
Bushberry subgroup 13-07B............................ 3.0
Cajou, fruit......................................... 6
Cambuca.............................................. 6
Caneberry subgroup 13-07A............................ 6.0
Canistel............................................. 0.6
Carob................................................ 6
ashew apple.......................................... 6
Cattle, fat.......................................... 0.50
Cattle, meat......................................... 0.02
Celtuce.............................................. 25
Cherimoya............................................ 0.60
Chive, fresh leaves.................................. 30
Ciruela verde........................................ 6
Citrus, oil.......................................... 100
Coffee bean \2\...................................... 0.15
Corn, field, forage.................................. 15
Corn, field, refined oil............................. 0.20
Corn, field, stover.................................. 125
Corn, pop, stover.................................... 125
Corn, sweet, forage.................................. 30
Corn, sweet, stover.................................. 60
Cotton, gin byproducts............................... 35
Cottonseed subgroup 20C.............................. 7
Cranberry............................................ 0.5
Custard apple........................................ 0.60
Davidson's plum...................................... 6
Edible podded bean subgroup 6-22A.................... 2
Edible podded pea subgroup 6-22B..................... 2
Feijoa............................................... 6
Fennel, Florence, fresh leaves and stalk............. 25
Field corn subgroup 15-22C........................... 0.05
Fig.................................................. 6
Fruit, citrus, group 10-10........................... 3.0
Fruit, pome, group 11-10............................. 2.0
Fruit, small, vine climbing, except fuzzy kiwifruit, 1.0
subgroup 13-07F.....................................
Fruit, stone, group 12-12, except plum, prune, fresh. 3.0
Goat, fat............................................ 0.50
Goat, meat........................................... 0.02
Gooseberry, Indian................................... 6
Grain, aspirated grain fractions..................... 120
Grain sorghum and millet subgroup 15-22E............. 6
Grape, raisin........................................ 1.5
Grass, forage, fodder and hay, group 17, forage...... 18.0
Grass, forage, fodder and hay, group 17, hay......... 30.0
Guava................................................ 0.4
Herb subgroup 19A, except chive, fresh leaves........ 400
Hog, fat............................................. 0.1
Hog, meat............................................ 0.02
Horse, fat........................................... 0.50
Horse, meat.......................................... 0.02
Ilama................................................ 0.60
Imbe................................................. 6
Imbu................................................. 6
Jaboticaba........................................... 6
Jujube, Indian....................................... 6
Kohlrabi............................................. 7
Kwai muk............................................. 6
Leaf petiole vegetable subgroup 22B.................. 25
[[Page 20596]]
Mangaba.............................................. 6
Mango................................................ 0.6
Marian plum.......................................... 6
Milk................................................. 0.10
Mombin, Malayan...................................... 6
Mombin, purple....................................... 6
Monkeyfruit.......................................... 6
Nance................................................ 6
Natal plum........................................... 6
Noni................................................. 6
Nut, tree, group 14-12............................... 0.10
Onion, green, subgroup 3-07B, except chive, fresh 5.0
leaves..............................................
Papaya............................................... 0.6
Papaya, mountain..................................... 6
Passionfruit......................................... 0.4
Pea, blackeyed, seed................................. 4.0
Pea, southern, seed.................................. 4.0
Peanut............................................... 0.02
Peanut, hay.......................................... 55.0
Peanut, oil.......................................... 0.04
Peppermint, tops..................................... 7.0
Persimmon, Japanese.................................. 6
Pineapple............................................ 0.70
Plum, prune, fresh................................... 0.30
Pomegranate.......................................... 0.6
Pomerac.............................................. 6
Poultry, fat......................................... 0.02
Poultry, meat........................................ 0.02
Pulasan.............................................. 2.0
Pulses, dried shelled bean, except soybean, subgroup 0.5
6-22E, except pea, blackeyed, seed and pea,
southern, seed......................................
Pulses, dried shelled pea subgroup 6-22F............. 0.5
Rambai............................................... 6
Rambutan............................................. 2.0
Rose apple........................................... 6
Sapodilla............................................ 0.6
Sapote, black........................................ 0.6
Sapote, mamey........................................ 0.6
Sentul............................................... 6
Sheep, fat........................................... 0.50
Sheep, meat.......................................... 0.02
Sorghum, grain, forage............................... 15
Sorghum, grain, stover............................... 20
Sorghum, sweet, forage............................... 15
Sorghum, sweet, grain................................ 6
Sorghum, sweet, stalk................................ 15
Sorghum, sweet, stover............................... 20
Soursop.............................................. 0.60
Soybean, aspirated grain fractions................... 160
Soybean, forage...................................... 30
Soybean, hay......................................... 80
Soybean, hulls....................................... 2.0
Soybean, seed........................................ 1.0
Spearmint, tops...................................... 7.0
Star apple........................................... 0.6
Starfruit............................................ 6
Succulent shelled bean subgroup 6-22C................ 0.3
Succulent shelled pea subgroup 6-22D................. 0.3
Sugar apple.......................................... 0.60
Sugar cane \2\....................................... 0.03
Sugar cane, molasses \2\............................. 0.1
Surinam cherry....................................... 6
Sweet corn subgroup 15-22D........................... 0.05
Tamarind............................................. 6
Tea, dried \1\....................................... 20
Tea, instant \1\..................................... 20
Tropical and subtropical, palm fruit, edible peel, 8
subgroup 23C........................................
Tropical and subtropical, small fruit, inedible peel, 2
subgroup 24A........................................
Uvalha............................................... 6
Vegetable, brassica, head and stem, group 5-16....... 7
Vegetable, cucurbit, group 9......................... 0.3
Vegetable, foliage of legume, except soybean, 35
subgroup 7A.........................................
Vegetable, fruiting, group 8-10...................... 2.0
[[Page 20597]]
Vegetable, leafy, group 4-16......................... 30
Vegetable, leaves of root and tuber, group 2......... 30
Vegetable, root, except sugar beet, Subgroup 1B...... 0.90
Vegetable, tuberous and corm, except potato, subgroup 0.02
1D..................................................
Wax jambu............................................ 0.4
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of March 12, 2019 for use on tea.
\2\ There are no U.S. registrations as of August 28, 2023.
* * * * *
(c) * * *
Table 3 to Paragraph (c)
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Rice, hulls.......................................... 55
Rice subgroup 15-22F................................. 30
------------------------------------------------------------------------
* * * * *
[FR Doc. 2026-07560 Filed 4-16-26; 8:45 am]
BILLING CODE 6560-50-P
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</html>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.