[Federal Register Volume 91, Number 161 (Friday, August 21, 2026)]
[Rules and Regulations]
[Pages 54228-54234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-17088]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0455; FRL-13520-01-OCSPP]
Carboxin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
carboxin in or on multiple crops that are discussed later in this
document. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), UPL
Delaware Inc. 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 August 21, 2026. Objections and
requests for hearings must be received on or before October 20, 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-2022-0455, is available at
https://www.regulations.gov. Additional information about dockets
generally, along with instructions for visiting the docket in person,
is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Registration Division
(7505T), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number: (202) 566-1030; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. 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.
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
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
[[Page 54229]]
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-
2022-0455 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 October 20, 2026.
EPA's Administrative Law Judges Division (ALJD), 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 https://www.epa.gov/system/files/documents/2025-12/2025-12-03-order-urging-electronic-filing-and-service.pdf. 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 ALJD electronically, a
person should utilize the ALJD e-filing system at https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf.
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 https://www.regulations.gov. Follow
the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute. If you wish to
include CBI in your request, please follow the applicable instructions
at https://www.epa.gov/dockets/commenting-epa-dockets#rules 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 September 29, 2025 (90 FR 46544 (FRL-
12474-07-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 1F8976) by UPL Delaware, Inc. and UPL NA, Inc., 630
Freedom Business Center, Suite 402, King of Prussia, PA 19406. The
petition requested that 40 CFR 180.301 be amended by establishing
tolerances for residues of the fungicide carboxin in or on vegetable,
legume, forage and hay, except soybean, subgroup 7-22A at 2 parts per
million (ppm); vegetable, legume, pulse, bean, dried shelled, except
soybean, subgroup 6-22E at 0.2 ppm; and vegetable, legume, pulse, pea,
dried shelled, subgroup 6-22F at 0.2 ppm. The petition also requested
that 40 CFR 180.301 be amended by removing the tolerance for residues
of carboxin in or on bean, dry, seed. The document referenced a summary
of the petition prepared by UPL Delaware, Inc. and UPL NA Inc., which
is available in the docket at https://www.regulations.gov.
The September 29, 2025 notice of filing supersedes two earlier
notices of filing published in the Federal Register on January 3, 2023
(88 FR 38) (FRL-9410-08-OCSPP), and September 12, 2023 (88 FR 62499)
(FRL-10579-07-OCSPP), which were based on earlier versions of the same
petition (PP 1F8976) requesting tolerances for crop subgroup 6-22E:
dried shelled bean, except soybean at 0.2 ppm; crop subgroup 6-22F:
pulses, dried shelled pea at 0.2 ppm; pea, dry, forage at 0.4 ppm; and
pea, dry, hay at 2 ppm. UPL Delaware, Inc. and UPL NA, Inc.
subsequently amended their petition as noticed in the September 29,
2025, Federal Register.
EPA received one comment in response to the September 29, 2025,
notice of filing expressing concerns that pesticide use is linked to
cancer and other chronic diseases and any ``exemption'' should rarely
be allowed outside of uses tied to national security. EPA also received
one comment in response to the September 12, 2023, notice of filing
expressing concerns about pesticide residues in food and their
connection to resistance and allergic reactions.
The Agency acknowledges the commenters' concerns regarding
potential health effects associated with pesticide use. However, the
existing legal framework provided by section 408 of the FFDCA
authorizes EPA to establish a tolerance when it determines that the
tolerance is safe. Upon consideration of the validity, completeness,
and reliability of the available data, as well as other factors the
FFDCA requires EPA to consider, EPA has determined that the carboxin
tolerances established in this action are safe. The commenters provided
no information supporting the conclusion that these tolerances are not
safe.
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 carboxin, including exposure resulting from the
tolerances established by this action. EPA's assessment of exposures
and risks associated with carboxin 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.
The toxicity database for carboxin is adequate, with the exception
of a subchronic inhalation toxicity study. In subchronic and chronic
feeding studies in rats with carboxin, the kidney was the primary
target organ with effects including chronic progressive nephropathy and
histopathological changes showing increased incidence and severity with
time. For dogs and mice, the primary target organ appeared to be the
liver. The developmental toxicity studies in rats and rabbits and the
reproduction study in rats with carboxin indicated no increased
quantitative or qualitative susceptibility of the fetuses or pups, as
compared to adults. In the carcinogenicity study in mice with carboxin,
dose-related increases in the incidence of liver centrilobular
hypertrophy were observed; however, this is considered to be an
adaptive rather than an adverse response. Carboxin is classified as
``Not Likely to Be Carcinogenic to Humans'' based on the lack of
evidence of
[[Page 54230]]
carcinogenicity in male and female rats and mice in acceptable
carcinogenicity studies. Carboxin exhibits low acute toxicity via oral
(Toxicity Category III), inhalation (Toxicity Category IV), and dermal
(Toxicity Category III) routes of exposure. It is a slight eye irritant
(Toxicity Category III). It is not a skin irritant (Toxicity Category
IV) and is negative for dermal sensitization. The developmental
toxicity studies in rats and rabbits and the reproduction study in rats
with carboxin indicated no increased quantitative or qualitative
susceptibility of the fetuses or pups, as compared to adults. In the
developmental toxicity studies in rats for carboxin, no adverse effects
were observed in either the dams or the fetuses. In a developmental
toxicity study in rabbits, abortions were observed at 750 mg/kg/day on
GDs 27-28. The abortions are considered to be both maternal and
developmental adverse effects. In a two-generation reproduction study
with carboxin in rats, the reproductive effects (decreased fertility
indices in F2b parents) and offspring effects (decreased pup weight)
occurred at higher doses than the parental effects (gross and
histopathological changes in the kidneys, e.g., chronic nephritis).
Although no high temperature hydrolysis data is available for
carboxin, the chemical structure of carboxin suggests that the release
of aniline may occur following the processing of carboxin-treated crop
commodities. Aniline may be a potential degradation product of carboxin
in cooked food, but it is toxicologically different from carboxin. EPA
has classified aniline as a B2-probable human carcinogen with an oral
cancer slope factor of 5.7 x 10-3 (mg/kg/day)-1,
which is considered very conservative for cancer assessment of aniline.
The Agency did not identify any other oral endpoint for aniline.
Specific information on the risk assessment conducted in support of
this action, including on the studies received and the nature of the
adverse effects caused by carboxin and aniline, can be found in the
document titled ``Carboxin: Human Health Risk Assessment for the Use of
Liquid Formulations on Dried Shelled Peas; to Establish a Tolerance for
Residues in/on Vegetable, legume, pulse, pea, dried shelled, subgroup
6-22F and Vegetable, Legume, Forage and Hay, Except Soybean, Subgroup
7-22A; to Convert the Existing Tolerance for Residues in/on Bean, Dry,
Seed Tolerance to Vegetable, legume, pulse, bean, dried shelled, except
soybean, subgroup 6-22E; and to Allow a 0-Day Plantback Interval for
Vegetable, Legume, Pulse, Pea, Dried Shelled, Subgroup 6-22F in
Conjunction with a Tolerance on this Crop Subgroup'' (hereinafter
``Carboxin Human Health Risk Assessment'') which is available in the
docket for this action.
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, 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 https://www.epa.gov/science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for carboxin and aniline
used for human health risk assessment can be found in the Carboxin
Human Health Risk Assessment, which is available in the docket for this
action.
D. Exposure Assessment
1. Dietary Exposure From Food and Feed Uses
In evaluating dietary exposure to carboxin and aniline, EPA
considered exposure under the petitioned-for tolerances as well as all
existing carboxin tolerances in 40 CFR 180.301. EPA assessed dietary
exposures from carboxin and aniline in food as follows:
i. Acute exposure. Carboxin. 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 carboxin;
therefore, a quantitative acute dietary exposure and risk assessment is
not necessary.
Aniline. There are no data to determine an acute endpoint for
aniline at this time; therefore, a quantitative acute dietary exposure
and risk assessment for carboxin-derived aniline residues was not
conducted.
ii. Chronic exposure. Carboxin. In conducting the chronic dietary
exposure assessment for carboxin, EPA used the Dietary Exposure
Evaluation Model software with the Food Commodity Intake Database
Version 4.02, which uses 2005-2010 food consumption data from the
United States Department of Agriculture's National Health and Nutrition
Examination Survey, What We Eat in America. As to residue levels in
food, EPA assumed tolerance-level residues, default processing factors,
and 100 percent crop treated (PCT) for all crops.
Aniline. Aniline is a high temperature hydrolysis degradate for
another registered pesticide, buprofezin. The highly refined estimated
dietary exposure of the most highly exposed adult population (adults
50-99 years old) to buprofezin-derived aniline in cooked foods is
0.000052 mg/kg/day. Estimated chronic exposures to buprofezin-derived
aniline residues are orders of magnitude below any potential chronic
non-cancer reference dose for aniline. Any chronic exposures to
carboxin-derived aniline residues are expected to be significantly
lower than to buprofezin-derived aniline residues based on carboxin's
limited use patterns and lower tolerance-level residues in food
commodities. Therefore, a quantitative chronic non-cancer dietary
exposure and risk assessment for carboxin-derived aniline residues is
not necessary.
iii. Cancer. Carboxin. Based on the data discussed in Unit III.A.,
EPA has concluded that carboxin is not likely to be carcinogenic to
humans. Therefore, a dietary exposure assessment for the purpose of
assessing cancer risk is not necessary.
Aniline. Due to the absence of high temperature hydrolysis data for
carboxin, a quantitative cancer dietary exposure and risk assessment
for carboxin-derived aniline residues was not conducted. However,
cancer dietary exposure and risk assessments for buprofezin-derived
aniline residues are currently available. See ``Buprofezin: Acute,
Chronic (Food and Drinking Water) and Cancer (Aniline; Cooked Food
Only) Aggregate Dietary Exposure
[[Page 54231]]
and Risk Assessments for the New Use on Bushberry Crop Subgroup 13-07B
and Proposed Amendment to Expand the Use on Succulent Beans to All
Members of Proposed Edible Podded Bean Legume Vegetable Subgroup 6-
22A'' and ``Buprofezin. Human Health Risk Assessment for Proposed New
Use on Bushberry Crop Subgroup 13-07B and Proposed Amendments to Expand
Use on Succulent Beans to All Members of Proposed Edible Podded Bean
Legume Vegetable Subgroup 6-22A and Use on Greenhouse-Grown Tomatoes
and Peppers to All Members of Fruiting Vegetable Crop Group 8-10'' in
docket ID number EPA-HQ-OPP-2020-0235. EPA conducted a qualitative
assessment of cancer dietary exposure and risk for carboxin-derived
aniline residues based on the assessments for buprofezin-derived
aniline residues.
Buprofezin is applied as a broadcast foliar application on a
variety of food crops with the maximum seasonal application rates
ranging from 0.7 to 4.0 pounds of active ingredient per acre per
growing season. Tolerances established for residues of buprofezin in or
on various food commodities range from 0.02 to 80 ppm, with most
tolerances greater than 0.2 ppm. Buprofezin residue data indicate that
there is a proportion of buprofezin residues in or on food crops that
is available for conversion to aniline during food processing that is
subjected to high temperature cooking conditions. A highly refined
cancer dietary exposure and risk assessment for buprofezin-derived
aniline residues was conducted for cooked food only using an oral
cancer slope factor (Q1* of 5.7 x 10-3 (mg/kg/
day)-1) for aniline. This assessment was conducted using a
maximum conversion factor of buprofezin to aniline of 18.9%, which was
the highest found in a high temperature hydrolysis study of buprofezin-
derived aniline and was applied to estimate residues of buprofezin-
derived aniline which may form in food as a result of cooking. The
highly refined estimated dietary exposure of the most highly exposed
adult population (adults 50-99 years old) to buprofezin-derived aniline
in cooked foods is 0.000052 mg/kg/day.
Any dietary exposure to carboxin-derived aniline residues in cooked
foods are expected to be significantly lower than buprofezin-derived
aniline residues based on carboxin's limited use patterns and lower
tolerance-level residues. Carboxin is used for pre-planting seed
treatment, with low maximum application rates ranging from 0.005 to
0.825 pounds of active ingredient per acre per year. Carboxin residues
in or on certain food crops were non-detectable or below the limit of
quantitation (LOQ) based on field trials conducted at exaggerated use
rates. Residue data for other food crops indicate that there was not
much carboxin residue, at the most less than 0.025 to less than 0.2
ppm, available for conversion to aniline during food processing that is
subjected to high temperature cooking conditions. Tolerances
established for residues of carboxin in or on various food commodities,
including the tolerances established in this action, range from 0.03 to
0.2 ppm, with several tolerances at 0.2 ppm. The LOQ of the residue
data collection method was 0.025 ppm, whereas the LOQ of the
enforcement analytical methods was 0.2 ppm, indicating that many of the
tolerances at 0.2 ppm would be much lower if not for the limitation of
the enforcement analytical methods. These low residue levels can be
attributed to carboxin's limited used patterns.
2. Dietary Exposure From Drinking Water
The Agency used screening level water exposure models in the
dietary exposure analysis and risk assessment for carboxin in drinking
water. These simulation models take into account data on the physical,
chemical, and fate/transport characteristics of carboxin. Further
information regarding EPA drinking water models used in pesticide
exposure assessment can be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment.
For surface water, estimated drinking water concentrations (EDWC)
were modeled using Pesticide in Water Calculator (PWC) (version 1.52)
for seed treatment of all labeled crops except rice. EDWCs for rice
seed treatment use were modeled by Pesticide in Flooded Applications
Model Version 2. For groundwater, EDWCs were modeled using PWC and the
six standard groundwater scenarios at the maximum application rate of
0.825 lb a.i./A/yr for registered crops. The highest post breakthrough
average EDWC for carboxin residues of concern (i.e., carboxin and its
sulfoxide metabolite) was 81.7 [micro]g/L or parts per billion (ppb) in
groundwater. The EDWC of carboxin residues of concern in surface water
from chronic exposure was minimal (6.2 [micro]g/L). EDWCs were directly
entered into the dietary exposure model. For the chronic dietary risk
assessment, the ground water concentration value of 81.7 ppb was used
to assess the contribution to drinking water.
For aniline, the Agency has determined that there is no expectation
of carboxin-derived aniline residues in drinking water.
3. From Non-Dietary Exposure
The term ``residential exposure'' is used in this document to refer
to non-occupational, non-dietary exposure (e.g., from lawn and garden
pest control, indoor pest control, termiticides, and flea and tick
control on pets).
Carboxin is not registered for any specific use patterns that would
result in residential exposure to carboxin or carboxin-derived aniline.
4. Cumulative Effects From Substances With a Common Mechanism of
Toxicity
Section 408(b)(2)(D)(v) of the 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.''
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 carboxin and any other
substances. For the purposes of this action, therefore, EPA has not
assumed that carboxin 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/cumulative-assessment-risk-pesticides.
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 Food Quality Protection Act
(FQPA) safety factor. 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.
[[Page 54232]]
2. Prenatal and Postnatal Sensitivity
The developmental toxicity studies in rats and rabbits and the
reproduction study in rats with carboxin indicated no increased
quantitative or qualitative susceptibility of the fetuses or pups, as
compared to adults. In the developmental toxicity studies in rats for
carboxin, no adverse effects were observed in either the dams or the
fetuses. In a developmental toxicity study in rabbits, abortions were
observed at 750 mg/kg/day on GDs 27-28. The abortions are considered to
be both maternal and developmental adverse effects. In a two-generation
reproduction study with carboxin in rats, the reproductive effects
(decreased fertility indices in F2b parents) and offspring
effects (decreased pup weight) occurred at higher doses than the
parental effects (gross and histopathological changes in the kidneys,
e.g., chronic nephritis).
3. Conclusion
EPA has determined that reliable data show the safety of infants
and children would be adequately protected if the FQPA safety factor
were reduced to 1X for dietary exposure scenarios. The current action
does not have residential uses; if any future actions have residential
uses, then the FQPA safety factor would also be 1X for all residential/
non-occupational exposure scenarios, with the exception of inhalation
scenarios due to the lack of a subchronic inhalation toxicity study.
That decision is based on the following findings:
i. With the exception of a subchronic inhalation toxicity study,
the toxicity database for carboxin is adequate for FQPA evaluation.
Developmental toxicity studies in rats and rabbits and a two-generation
reproduction toxicity study in rats with carboxin are available for
FQPA consideration.
ii. There is no evidence of neurotoxicity in the existing toxicity
database. No guideline acute or subchronic neurotoxicity studies were
submitted; however, no indications of neurotoxic effects were observed
in any of the subchronic or chronic studies in dogs, mice, or rats.
Based on a Weight-of-Evidence approach, EPA determined that the acute
and subchronic neurotoxicity studies are not required at this time.
iii. There was no evidence of increased quantitative or qualitative
susceptibility in the developmental toxicity studies in rabbits or rats
with carboxin.
iv. There is no residual uncertainty with respect to the dietary
exposure database. A conservative chronic dietary (food and water) risk
assessment was conducted for carboxin incorporating tolerance-level
residues, EPA's default processing factors, 100 PCT, and the highest
EDWCs. There are no residential uses for carboxin. These assessments
will not underestimate the exposure and risks posed by carboxin.
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. Carboxin: Acute Risk
An acute aggregate risk assessment takes into account acute
exposure estimates from dietary consumption of food and drinking water.
No adverse effect resulting from a single oral exposure was identified
and no acute dietary endpoint was selected. Therefore, carboxin is not
expected to pose an acute risk, and an acute aggregate risk assessment
is not required.
2. Carboxin: Chronic Risk
Using the exposure assumptions described in this unit for chronic
exposure, EPA has concluded that chronic exposure to carboxin from food
and drinking water will utilize 87% of the cPAD for all infants less
than 1 year old, the population group receiving the greatest exposure.
There are no residential uses for carboxin. Therefore, chronic
aggregate exposures and risk estimates are equivalent to the chronic
dietary (food and drinking water) exposure and risk estimates. These
risks are not of concern.
3. Carboxin: 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).
Carboxin is not registered for any specific use patterns that would
result in residential exposure. Therefore, short- and intermediate-term
risk is equal to chronic dietary risk, which is not of concern.
4. Carboxin: Aggregate Cancer Risk for U.S. Population
Based on the lack of evidence of carcinogenicity in two adequate
rodent carcinogenicity studies, carboxin is classified as ``Not Likely
to be Carcinogenic to Humans,'' and quantification of cancer risk is
not required.
5. Aniline
There are no data to determine an acute endpoint for aniline at
this time; hence, an acute dietary risk assessment was not conducted
for carboxin-derived aniline residues. The highly refined estimated
chronic exposure of the most highly exposed adult subpopulation (adults
50 to 99 years old) to buprofezin-derived aniline residues is 0.000052
mg/kg/day. Estimated chronic exposures to buprofezin-derived aniline
residues are orders of magnitude below any potential chronic non-cancer
reference dose for aniline. Any chronic exposures to carboxin-derived
aniline residues are expected to be significantly lower than to
buprofezin-derived aniline residues based on carboxin's limited use
patterns and lower tolerance-level residues. Therefore, a quantitative
chronic non-cancer dietary risk assessment for carboxin-derived aniline
residues is not necessary to conclude with reasonable certainty that
chronic exposures from carboxin-derived aniline residues do not pose a
non-cancer dietary risk. The highly refined estimated chronic exposure
of the most highly exposed adult subpopulation to buprofezin-derived
aniline results in an upper bound cancer risk estimate of 3 x
10-7. Based again on carboxin's limited use patterns and
lower tolerance-level residues, the Agency concludes that the cancer
risk estimate for buprofezin-derived aniline residues indicates that
there should not be any cancer risk from carboxin-derived aniline
residues.
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
carboxin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology is available to enforce the
tolerance expression. The Pesticide Analytical Manual, Vol. II lists
three methods for determining the combined residues of carboxin and its
metabolites,
[[Page 54233]]
determined as the common moiety, aniline, and expressed as carboxin.
These methods include a colorimetric method, which in principle is
based on the alkaline hydrolysis of carboxin and its sulfoxide
metabolite to produce aniline; and gas-liquid chromatography (GLC)
methods. A GLC/Mass Selective Detector data-collection method is also
available to enforce tolerances for carboxin.
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 has not established MRLs for carboxin in
or on any commodities.
V. Conclusion
Therefore, tolerances are established for residues of carboxin,
5,6-dihydro-2-methyl- N-phenyl-1,4-oxathiin-3-carboxanilide, including
its metabolites and degradates, in or on Vegetable, legume, forage and
hay, except soybean, subgroup 7-22A at 2 ppm; Vegetable, legume, pulse,
bean, dried shelled, except soybean, subgroup 6-22E at 0.2 ppm; and
Vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F at 0.2
ppm. The existing tolerance for bean, dry, seed at 0.2 ppm is removed
as unnecessary, because this commodity is covered by the new tolerance
for Vegetable, legume, pulse, bean, dried shelled, except soybean,
subgroup 6-22E at the same level.
VI. Statutory and Executive Order Reviews
Additional information about these statutes and executive orders
can be found at https://www.epa.gov/regulations/and-executive-orders.
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 2026 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: August 3, 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:
[[Page 54234]]
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. 180.301, amend table 1 to paragraph (a) by:
0
a. Removing the entry for ``Bean, dry, seed''; and
0
b. Adding alphabetically the entries ``Vegetable, legume, forage and
hay, except soybean, subgroup 7-22A'', ``Vegetable, legume, pulse,
bean, dried shelled, except soybean, subgroup 6-22E'', and ``Vegetable,
legume, pulse, pea, dried shelled, subgroup 6-22F''.
The revisions and additions read as follows:
Sec. 180.301 Carboxin; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Vegetable, legume, forage and hay, except soybean, subgroup 2
7-22A......................................................
Vegetable, legume, pulse, bean, dried shelled, except 0.2
soybean, subgroup 6-22E....................................
Vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F 0.2
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2026-17088 Filed 8-20-26; 8:45 am]
BILLING CODE 6560-50-P