Rule2025-19794
Cyclobutrifluram; Pesticide Tolerances
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 5, 2025
Effective
November 5, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes a tolerance action for residues of cyclobutrifluram in or on the food and feed commodities of cotton, gin byproducts; cotton, undelinted seed; lettuce, leaf; soybean, seed. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), Syngenta 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 90 Issue 212 (Wednesday, November 5, 2025)</title>
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[Federal Register Volume 90, Number 212 (Wednesday, November 5, 2025)]
[Rules and Regulations]
[Pages 49254-49259]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19794]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0003; FRL-12872-01-OCSPP]
Cyclobutrifluram; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance action for residues of
cyclobutrifluram in or on the food and feed commodities of cotton, gin
byproducts; cotton, undelinted seed; lettuce, leaf; soybean, seed.
Under the Federal Food, Drug, and Cosmetic Act (FFDCA), Syngenta
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 rule is effective on November 5, 2025. Objections and
requests for hearings must be received on or before January 5, 2026 and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.D. of this document).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2022-0003, 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, Registration Division
(7505T), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 566-2427; email address: <a href="/cdn-cgi/l/email-protection#6b392f2d3925041f02080e182b0e1b0a450c041d"><span class="__cf_email__" data-cfemail="a6f4e2e0f4e8c9d2cfc5c3d5e6c3d6c788c1c9d0">[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 might apply 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
proposed 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
[[Page 49255]]
``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 . . .
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-
2022-0003 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 5, 2026.
The 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 ``Revised Order Urging Electronic Filing and
Service,'' dated June 22, 2023, which can be found at <a href="https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf">https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf</a>.
Although the EPA's regulations require submission via U.S. Mail or hand
delivery, the EPA intends to treat submissions filed via electronic
means as properly filed submissions; therefore, the 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 of which the 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.
II. Petitioned For Tolerance
In the Federal Register of May 20, 2022 (87 FR 30855) (FRL-9410-13-
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
1F8954) by Syngenta, P.O. Box 18300, Greensboro, NC 27419. The petition
requested that 40 CFR part 180 be amended by establishing tolerances
for residues of the fungicide/nematicide cyclobutrifluram, in or on
cotton at 0.010 parts per million (ppm); cotton, by-products at 0.010
ppm; lettuce, romaine at 0.015 ppm; and soybean at 0.010 ppm. That
document referenced a summary of the petition that was prepared by the
petitioner and included in the docket. There were no comments received
in response to the notice of filing.
III. Final Tolerance Action
A. Aggregate Risk Assessment and Determination of Safety
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 cyclobutrifluram including exposure resulting
from the tolerances established by this action. EPA's assessment of
exposures and risks associated with cyclobutrifluram follows.
B. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Cyclobutrifluram is a novel pyridine-3-carboxamide
nematicide/fungicide with a pesticidal mode of action that functions
via inhibition of complex II succinate dehydrogenase, but the mammalian
mode of action is not known at this time. Following the administration
of cyclobutrifluram, the target organs include the liver (mouse) and
thyroid (rat). In addition, decreased absolute body weight was observed
in rats and dogs following subchronic administration of the test
compound. No adverse effects were observed in the chronic/
carcinogenicity toxicity study in rats and the carcinogenicity toxicity
study in mice up to the highest doses tested (23/34 mg/kg/day (M/F) and
48/54 mg/kg/day (M/F), respectively).
The thyroid is the most sensitive endpoint in the cyclobutrifluram
toxicity database. Following subchronic exposure of rats to
cyclobutrifluram, follicular cell hypertrophy in males and females was
observed after 28- (331 mg/kg/day) and 90-day (187 mg/kg/day)
exposures. Increased thyroid weights were observed in males of the F1
generation while follicular cell hypertrophy was observed in both sexes
of the P generation and males of the F1 generation of the
multigeneration reproductive toxicity study at 43 mg/kg/day. Maternal
thyroid hormones levels (T3, T4, and TSH) were measured in the
developmental rat toxicity study up to and including the highest dose
tested (250 mg/kg/day) and no adverse changes were observed.
Treatment-related effects to the liver and spleen (increased
reticulocytes along with increased spleen weights and extramedullary
hematopoiesis) were observed in mice following 28-day (338/334 mg/kg/
day (M/F)) and 90-day (249/309 mg/kg/day (M/F)) exposures. Liver
effects included liver hypertrophy, increased liver weights, increased
triglycerides, and increased liver enzymes (alkaline phosphatase (ALP)
and alanine transferase (ALT)) as a suite of effects. Cecum effects
(increased inflammatory cell infiltration of the lamia propria) were
observed in rats at 331/485 mg/kg/day (M/F) following 28-day oral
exposure. Lung effects (alveolar duct wall thickening, increased
alveolar macrophages, and bronchioles/alveolar wall smooth muscle cell
hypertrophy) were observed following inhalation exposure for 28 days at
0.08 mg/L. Following chronic oral exposure of rats and mice to
cyclobutrifluram, no adverse effects were observed up to the
[[Page 49256]]
highest doses tested (23/31 mg/kg/day). Also, no dermal toxicity
following 28-day exposure was identified up to and including the limit
dose in the route specific study.
No quantitative or qualitative lifestage susceptibility was
observed in either the developmental or reproductive toxicity studies
up to the highest doses tested. Thyroid toxicity to the parental
animals in both the P and F1 generations occurred at the same dose
level (43/55 mg/kg/day (M/F)) as reproductive toxicity (decreased
fertility in both sexes of the F1 generation). In the dose range-
finding and definitive development studies for both the rat and rabbit,
neither maternal toxicity nor developmental toxicity was detected up to
and including the highest doses tested (250 mg/kg/day (rat) and 125 mg/
kg/day (rabbit)).
The Agency concluded that the data for the rat and rabbit
developmental toxicity studies are considered adequate, and there was
no evidence of neurotoxicity.
Cyclobutrifluram is classified as ``Not Likely to Be Carcinogenic
to Humans.'' Cyclobutrifluram exposure did not result in treatment-
related tumors in rats or mice, and there were not biologically or
statistically significant changes in pre-neoplastic lesions. While both
sexes of rats and mice could have tolerated higher doses, the dosing
was considered adequate to assess the carcinogenic potential of
cyclobutrifluram. There is an extensive database that investigated
mutagenicity following exposure to cyclobutrifluram or its metabolites.
Within this battery of genotoxicity testing, cyclobutrifluram and its
metabolites were negative, demonstrating a low concern for mutagenic
potential.
Specific information on the studies received and the nature of the
adverse effects caused by cyclobutrifluram as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at <a href="http://www.regulations.gov">http://www.regulations.gov</a> in document Cyclobutrifluram. Human Health Risk
Assessment to Support the Registration of a New Active Ingredient for
Proposed Uses on Cotton Seed; Soybean Seed; Romaine Lettuce; Turf;
Ornamentals; and Non-bearing (Juvenile) Fruit and Nut Trees, Vines, and
Berries (Cyclobutrifluram Human Health Risk Assessment) in docket ID
number EPA-HQ-OPP-2022-0003.
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 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 and PODs for
Cyclobutrifluram used for human risk assessment can be found in the
Cyclobutrifluram Human Health Risk Assessment in docket ID number EPA-
HQ-OPP-2022-0003.
D. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cyclobutrifluram, EPA considered exposure under the
petitioned-for tolerances. EPA assessed dietary exposures from
cyclobutrifluram in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for cyclobutrifluram;
therefore, a quantitative acute dietary exposure assessment is
unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model--Food
Commodity Intake Database (DEEM-FCID), Version 4.02, which incorporates
2005-2010 consumption data from United States Department of
Agriculture's (USDA's) National Health and Nutrition Examination
Survey/What We Eat in America(NHANES/WWEIA). As to residue levels in
food, EPA used tolerance equivalent-level residues (cyclobutrifluram
and the metabolite SYN510275), 100% crop treated assumptions, and
default processing factors.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that cyclobutrifluram does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for cyclobutrifluram. Tolerance level residues and/
or 100% PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for cyclobutrifluram in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of cyclobutrifluram. 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">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment</a>.
Based on the Pesticide Root Zone Model (PRZM5 version 5.02), the
Variable Volume Water Body Model (VVWM version 1.02), and Pesticide
Root Zone Model Ground Water (PRZM GW version 1.0), the estimated
drinking water concentrations (EDWCs) of cyclobutrifluram for acute
exposures are estimated to be 14.3 parts per billion (ppb) for surface
water and 108.1 ppb for ground water. Chronic exposures for non-cancer
assessments are estimated to be 7.96 ppb for surface water and 94.0 ppb
for ground water. For chronic dietary risk assessment, the water
concentration value of 94.0 ppb was used to assess the contribution to
drinking water. 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). Cyclobutrifluram is
proposed for registration for the following uses that could result in
residential exposures:
[[Page 49257]]
lawns and turf. EPA assessed the following residential exposure
scenarios: Short term residential post-application exposure in children
1 to less than 2 years old (1<2) from incidental oral exposures on
treated turf. 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 considers ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to cyclobutrifluram and any
other substances. For the purposes of this action, therefore, EPA has
not assumed that cyclobutrifluram has a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's website at
https://www.epa.gov/pesticide-science-and- assessing-pesticide-risks/
pesticide- cumulative-risk-assessment-framework.
E. 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 safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. No evidence of increased
qualitative or quantitative susceptibility was seen in the rat and
rabbit developmental toxicity studies up to the highest doses tested or
in the multigeneration reproduction toxicity study.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for cyclobutrifluram is complete.
ii. There is no indication that cyclobutrifluram is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that cyclobutrifluram results in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The Agency used high-end assumptions in the dietary exposure
assessment, including the use of tolerance-level or average field trial
residues, 100% crop treated assumptions, and upper-bound (protective)
estimates of potential exposure through drinking water. In addition,
the residential post-application exposure assessment was conducted
using chemical-specific turf transferrable residues (TTR) data and the
Agency's 2012 Residential Standard Operating Procedures (SOPs). The
exposure estimates for cyclobutrifluram are unlikely to be
underestimated.
F. 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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to cyclobutrifluram is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
cyclobutrifluram from food and water will utilize 1.9% of the cPAD for
infants less than 1 year old (<1 year old) the population group
receiving the greatest exposure. Based on the explanation in Unit
III.C.3., regarding residential use patterns, chronic residential
exposure to residues of cyclobutrifluram is not expected.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Cyclobutrifluram is currently registered for uses that could result
in short-term residential exposure, and the Agency has determined that
it is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to cyclobutrifluram.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate margins of exposure MOEs
of 1600 for children 1-2 years old. Because EPA's level of concern for
cyclobutrifluram is an MOE below 30, these MOEs are not of concern.
Because no intermediate-term residential exposure is expected, an
intermediate-term aggregate assessment was not conducted.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, cyclobutrifluram is not expected to pose a cancer risk to
humans.
5. 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 cyclobutrifluram residues. More detailed information on
this action can be found in the Cyclobutrifluram Human Health Risk
Assessment in docket ID EPA-HQ-OPP-2022-0003.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology as described in the supporting
documents is available to enforce the tolerance expressions.
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
[[Page 49258]]
(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 not established a MRL for cyclobutrifluram.
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.
D. Revisions to Petitioned-For Tolerances
The petitioner-requested commodity definitions for cotton (cotton,
undelinted seed, and cotton, gin byproducts), lettuce, romaine
(lettuce, leaf), and soybean (soybean, seed) were updated to Agency-
preferred vocabulary (in parentheses, above) for consistency across
chemicals. In addition, the Agency is establishing the tolerances at
higher levels than the petitioner requested for cotton, undelinted seed
(from 0.010 ppm to 0.02 ppm), cotton, gin byproducts (from 0.010 ppm to
0.02 ppm), lettuce, leaf (from 0.015 ppm to 0.06 ppm), and soybean,
seed (from 0.010 ppm to 0.03 ppm) as the recommended residues for
tolerance enforcement were parent cyclobutrifluram and metabolite
SYN510275 calculated as parent equivalent. The applicant calculated the
proposed tolerances using the Organization for Economic Cooperation and
Development (OECD) MRL calculation procedures with parent only as the
residue for tolerance enforcement.
V. Conclusion
Therefore, tolerances are established for residues of
cyclobutrifluram, in or on cotton, gin byproducts at 0.02 ppm, cotton,
undelinted seed at 0.02 ppm, lettuce, leaf at 0.06 ppm, and soybean,
seed at 0.03 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/laws-regulations/laws-and-executive-orders">https://www.epa.gov/laws-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 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.
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: November 3, 2025.
Edward Messina,
Director, Office of Pesticide Programs.
For the reasons set forth in the preamble, 40 CFR chapter I is
amended as follows:
[[Page 49259]]
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. Add Sec. 180.729 to subpart C to read as follows:
Sec. 180.729 Cyclobutrifluram; tolerances for residues.
(a) General. Tolerances are established for residues of the
nematicide/fungicide cyclobutrifluram, including its metabolites and
degradates, in or on the plant commodities in table 1 to this paragraph
(a). Compliance with the tolerance levels specified in table 1 is to be
determined by measuring the sum of cyclobutrifluram (rel-N-[(1R,2R)-2-
(2,4-dichlorophenyl)cyclobutyl]-2-(trifluoromethyl)-3-
pyridinecarboxamide) and its metabolite 2-trifluoromethyl-nicotinamide,
calculated as the stoichiometric equivalent of cyclobutrifluram in or
on plant commodities.
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cotton, gin byproducts.................................. 0.02
Cotton, undelinted seed................................. 0.02
Lettuce, leaf........................................... 0.06
Soybean, seed........................................... 0.03
------------------------------------------------------------------------
(b) [Reserved]
[FR Doc. 2025-19794 Filed 11-4-25; 8:45 am]
BILLING CODE 6560-50-P
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