[Federal Register Volume 90, Number 135 (Thursday, July 17, 2025)]
[Rules and Regulations]
[Pages 33277-33283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-13355]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2024-0220; FRL-12817-01-OCSPP]
Cypermethrin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance action for residues of
cypermethrin (CASRN 52315-07-8) in or on the food and feed commodities
of durian. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), the
United States Department of Agriculture (USDA) submitted a petition to
EPA requesting that EPA establish a maximum permissible level for
residues of this pesticide on in or on the identified commodity(ies).
DATES: This rule is effective on July 17, 2025. Objections and requests
for hearings must be received on or before September 15, 2025 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-2024-0220, 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, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. 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:
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 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-
2024-0220 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 September 15, 2025.
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 https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.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 OALJ electronically, a person should
utilize the OALJ 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. 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 August 8, 2024 (89 FR 64842 (FRL-11682-
06-OSCPP)), 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
4E9129) by the United States Department of Agriculture (USDA), 1400
Independence Avenue SW, Washington, DC 20250-1032. The petition
requested that 40 CFR part 180 be amended by
[[Page 33278]]
establishing tolerances for residues of the insecticide cypermethrin in
or on durian at 1.0 parts per million (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.
Based upon review of the data supporting the petition, EPA is
revising the tolerance definition for cypermethrin and setting a
tolerance level for durian.
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 cypermethrin including exposure resulting
from the tolerances established by this action. EPA's assessment of
exposures and risks associated with cypermethrin 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.
Cypermethrin is a mixture of eight different isomers, all of which
are present in equal amounts. Alpha-cypermethrin and zeta-cypermethrin
are separate mixtures of the same isomers; however, they are enriched
in the most insecticidally active isomers. All three have the same
toxicological mode of action and are collectively grouped together as
``the cypermethrins'' for assessment purposes.
The cypermethrins are Type II pyrethroids that contain an alpha-
cyano moiety. The adverse outcome pathway shared by pyrethroids
involves the ability to interact with voltage-gated sodium channels in
the central and peripheral nervous systems leading to changes in neuron
firing and, ultimately, neurotoxicity.
The toxicology database for the cypermethrins is considered
complete with respect to guideline toxicity studies.
The cypermethrins affect the nervous system, and neurotoxicity is
the most sensitive effect observed throughout the toxicology database.
Clinical signs of neurotoxicity were seen for all three compounds
across species, sexes, and routes of administration. The endpoints and
points of departure (PODs) selected for risk assessment are based on
neurotoxicity and are protective of all adverse effects observed in the
database.
The Health Effects Division (HED) determined that the acute
toxicity of alpha-cypermethrin is higher than that of cypermethrin and
zeta-cypermethrin. To account for this toxicity difference, HED applied
a 5X toxicity factor to commodities that have established tolerances
for alpha-cypermethrin. As the current tolerance petitions are for
cypermethrin, the toxicity PODs for cypermethrin were used for risk
assessment.
There was no evidence of increased quantitative or qualitative
susceptibility in the available rat and rabbit developmental toxicity
studies and rat two-generation reproductive studies with the
cypermethrins. A developmental neurotoxicity (DNT) study with zeta-
cypermethrin indicated increased sensitivity in the offspring, based on
body weight changes in pups in the absence of treatment-related effects
in maternal animals at the highest dose tested. However, there is a
clear no observed adverse effect level (NOAEL) for effects seen in
pups, and the doses and endpoints selected for risk assessment are
protective of the susceptibility.
For pyrethroid chemicals, the pharmacokinetics indicate that the
onset of neurotoxicity is rapid, with the time to peak effect for
neurobehavioral effects occurring within hours. This is followed by
rapid metabolism and elimination that does not result in
bioaccumulation. For the cypermethrins, the PODs for clinical signs
after single or repeated exposure are comparable across durations of
exposure; thus, neurotoxicity does not seem to progress with increased
exposure. Therefore, repeated dosing is essentially a series of acute
exposures. As there is no apparent increase in hazard from repeated/
chronic exposures to the cypermethrins, the acute exposure assessment
is protective of chronic exposures. The totality of the information
suggests that only single day risk assessments need to be conducted for
the cypermethrins.
Cypermethrin is classified as a Group C ``Possible Human
Carcinogen'' under the 1986 Agency Cancer Guidelines, based on an
increased incidence of benign lung adenomas and adenomas plus
carcinomas combined in females in a mouse carcinogenicity study (J.
Quest, TXR# 0055252, Peer Review of Cypermethrin. February 17, 1988;
Guidelines for Carcinogen Risk Assessment, 51 FR 33992, September 24,
1986). No tumors were seen in cypermethrin cancer studies in rats or in
a cancer study in mice with alpha-cypermethrin. The Agency has
determined that quantification of cancer risk using a non-linear
approach (i.e., reference dose (RfD)) will adequately account for all
chronic toxicity, including carcinogenicity, that could result from
exposure to the cypermethrins.
Specific information on the studies received and the nature of the
adverse effects caused by cypermethrin as well as the NOAEL and the
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies
can be found at https://www.regulations.gov in document ``Cypermethrin,
Human Health Risk Assessment for a Proposed Tolerance Without a U.S.
Registration on Durian,'' hereinafter ``Cypermethrin Human Health Risk
Assessment'' at pages 32-39 in docket ID number EPA-HQ-OPP-2024-0220.
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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for cypermethrin used for
human risk assessment can be found in
[[Page 33279]]
the Cypermethrin Human Health Risk Assessment on pages 18-21.
D. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cypermethrin, EPA considered exposure under the petitioned-
for tolerances as well as all existing tolerances for the cypermethrins
in 40 CFR 180.418. EPA assessed dietary exposures from the
cypermethrins in food as follows:
a. 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. Such effects were identified
for cypermethrin. In conducting the acute dietary exposure assessment,
EPA used the 2005-2010 food consumption data from the U.S. Department
of Agriculture's National Health and Nutrition Examination Survey, What
We Eat in America (NHANES/WWEIA), https://www.ars.usda.gov/northeast-area/beltsville-md-bhnrc/beltsville-human-nutrition-research-center/food-surveys-research-group/docs/wweianhanes-overview/. The acute
dietary exposure assessment is a conservative assessment that assumes
tolerance level residues for most commodities and 100 percent crop
treated (PCT) for all commodities. The highest field trial values
obtained in residue studies were used for the commodities that make the
most significant contribution to dietary risk, specifically apples,
peaches, pears, and grapes. Empirical and conservative default
processing factors were used in the assessment. EPA determined that the
toxicity of alpha-cypermethrin is higher than that of cypermethrin and
zeta-cypermethrin. To account for this toxicity difference, HED
multiplied average monitoring data values by a factor of 5.
b. Chronic exposure. A chronic dietary risk assessment is not
required for the cypermethrins because repeated exposure does not
result in a point of departure lower than that resulting from acute
exposure. Therefore, the acute dietary risk assessment is protective of
chronic dietary risk. However, HED performed a chronic dietary exposure
assessment in support of the current aggregate human health risk
assessment. There are residential exposures for the cypermethrins that
were aggregated with background exposure from dietary sources. In the
aggregate human health risk assessment, the chronic exposure estimates
are combined with the appropriate residential exposure estimates and
compared to the POD for cypermethrin.
The chronic dietary exposure assessment is a highly refined
assessment based on Pesticide Data Program monitoring data for most
commodities. To account for the 5x toxicity difference for alpha-
cypermethrin, HED multiplied average monitoring data values by a factor
of 5. Tolerance level residues were used for a small number of
commodities. As with the acute assessment, empirical and conservative
default processing factors were used for the processed commodities for
which they were available. HED made the conservative assumption that
100% of all commodities would be treated. As a result, when monitoring
data were used, average residues were calculated by incorporating \1/2\
limit of detection values for all non-detects. No zeros were used to
calculate the average residues.
The cypermethrins have food handling establishment (FHE) uses that
need to be accounted for in the chronic dietary exposure assessment.
For these uses, HED used a residue value of one-half the FHE tolerance
multiplied by a factor of 5. OPP's Biological and Economic Analysis
Division (BEAD) provided an estimate of the probability that a food
item a person consumes contains residues as a result of treatment in an
FHE at some point with any pesticide (J. Becker, Upper Bound Estimate
of the Likelihood of Pesticide Residues on Food Resulting from
Treatment in Food Handling Establishments, BEAD, 10/7/2014). It is not
specific to the cypermethrins. This estimate is 4.65%. In the chronic
assessment, this value was used for the same commodities as the ones
with the FHE residue value (0.125 ppm).
c. Cancer. EPA determines whether quantitative cancer exposure and
risk assessments are appropriate for a food-use pesticide based on the
weight of the evidence from cancer studies and other relevant data.
Cypermethrin is classified as a ``possible human carcinogen.'' The
Agency has determined that quantification of risk using a non-linear
approach (i.e., aPAD or aRfD) will adequately account for all chronic
toxicity, including carcinogenicity, that could result from exposure to
the cypermethrins.
d. Anticipated residue and percent crop treated (PCT) information.
FFDCA section 408(b)(2)(E) authorizes EPA to use available data and
information on the anticipated levels of pesticide residues in food and
the actual levels of pesticide residues that have been measured in
food. If EPA relies on such information, EPA must require pursuant to
FFDCA section 408(f)(1) that data be provided 5 years after the
tolerance is established, modified, or left in effect, demonstrating
that the levels in food are not above the levels anticipated. For the
present action, EPA will issue such data call-ins as are required by
FFDCA section 408(b)(2)(E) and authorized under FFDCA section
408(f)(1). Data will be required to be submitted no later than 5 years
from the date of issuance of these tolerances.
EPA assumed 100% crop treated for all commodities in the acute and
chronic dietary exposure assessments. However, as discussed in Unit
D.1.i.b., in the chronic assessment, a percent FHE treatment value of
4.65% was incorporated for commodities for which the FHE residue value
was used. EPA estimates the percent of commodities treated in FHEs for
uses of active ingredients based on the best available information.
This includes survey information on pesticide usage related to the
number of facilities being treated, product forms used (e.g., liquids
and aerosols), and treatment schedule by FHE segments (e.g., warehouse,
food processor, distributor, and restaurant). EPA also incorporated the
best available information related to the transfer of commodities
between various segments of FHEs and the percent of food consumed by
location, either in the home or outside the home.
All information currently available has been considered and EPA has
concluded that for any active ingredient, including cypermethrin, there
is at most a 4.65% likelihood that a food commodity could contain
potential residues resulting from one or more treatments while in the
FHE channel of trade. EPA intends to periodically re-evaluate this
conclusion consistent with its obligations in the FFDCA.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for cypermethrin in drinking water. 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.
In both the acute and chronic assessments, EPA used estimated
drinking water concentrations (EDWCs) generated with the Surface Water
Concentration Calculator, and in both assessments, the EDWC was used
for both direct and indirect water. Also, in both assessments, the
EDWCs were adjusted by toxicity and application rate factors. For the
acute dietary risk assessment, EPA used a value of 4.375
[[Page 33280]]
ppb, and for the chronic exposure assessment (used to determine
background exposure from food and drinking water for the purpose of
aggregate risk assessment), EPA used a value of 0.044 ppb. EPA also
determined groundwater EDWCs with a different model; however, the
Agency used the adjusted surface water EDWCs in the assessments because
the surface water EDWCs were higher than the groundwater EDWCs. The use
of the surface water values in the dietary exposure assessment is
protective of potential exposure through groundwater sources of
drinking water.
3. 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). The cypermethrins are
registered for a variety of non-agricultural purposes including
recreational sites (i.e., golf courses, athletic fields); indoor
residential/commercial/industrial sites/structural/perimeter and lawn
uses; gardens and trees; as well as mosquito adulticide, termiticide,
and pet uses. The current action is for tolerances without a
corresponding U.S. registration for use on durian, so no new
residential handler or post-application exposures are anticipated.
For assessing aggregate exposure to adults, the Agency used
exposures from the inhalation handler scenario from applying
cypermethrin with a sprinkler can to home gardens. For assessing
aggregate exposure to children, the Agency used exposures to children 1
to <2 years old (dermal and incidental oral) from post-application
exposure to pets treated with the pet medallion/tag formulated with
zeta-cypermethrin.
The PODs for the oral and dermal routes are based on the same
effects; therefore, for children, the oral and dermal routes can be
combined. Since the levels of concern for incidental oral risk and
inhalation risk are different (100 and 30, respectively), the aggregate
risk index (ARI) approach was used to calculate aggregate exposure and
risk for adults. An ARI >= 1 is not of concern. The aggregate risk
estimates are not of concern, as the ARIs are greater than 1.0. Further
information regarding EPA standard assumptions and generic inputs for
residential exposures may be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
4. Cumulative effects from substances with a common mechanism of
toxicity. FFDCA section 408(b)(2)(D)(v) 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.'' The Agency has determined that the
pyrethrins, which are Type II pyrethroids, thus share a common
mechanism of toxicity with other pyrethroids (https://www.regulations.gov; EPA-HQ-OPP-2008-0489-0006). As explained in that
document, the members of this group share the ability to interact with
voltage-gated sodium channels ultimately leading to neurotoxicity. In
2011, after establishing a common mechanism grouping for the
pyrethroids and pyrethrins, the Agency conducted a cumulative risk
assessment (CRA) (https://www.regulations.gov; EPA-HQ-OPP-2011-0746).
In that document, the Agency concluded that cumulative exposures to
pyrethroids (based on pesticidal uses registered at the time the
assessment was conducted) did not present risks of concern. For
information regarding EPA's efforts to evaluate the risk of exposure to
this class of chemicals, refer to https://www.epa.gov/used-pesticide-products/review-pyrethrins-and-pyrethroids.
Since the 2011 CRA, for each new pyrethroid and pyrethrin use, the
Agency has conducted a screen to evaluate any potential impacts on the
CRA prior to those uses being granted. A new turf use for the
pyrethroid, tau-fluvalinate, was assessed after completion of the 2011
CRA. The new use did impact the worst-case non-dietary risk estimates
identified in the 2011 CRA for the turf scenario. However, the overall
risk finding (i.e., pyrethroid cumulative risk is above the Agency's
level of concern and therefore not of concern) did not change upon
evaluation of this new cypermethrin tolerance for durian.
The recommended tolerance for durian will not significantly impact
the 2011 CRA because durian makes an insignificant contribution to
dietary exposure, and dietary exposures make a minor contribution to
total pyrethroid exposure relative to residential exposures in the 2011
CRA; furthermore, the proposed tolerance is not associated with any
increase in residential or non-occupational exposure. Therefore, the
results of the 2011 CRA are still valid, and there are no cumulative
risks of concern for the pyrethroids/pyrethrins.
E. Safety Factor for Infants and Children
1. In general. FFDCA section 408(b)(2)(C) 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 (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. There was no evidence of
increased quantitative or qualitative susceptibility in the available
rat and rabbit developmental toxicity studies and rat two-generation
reproductive studies with the cypermethrins. A developmental
neurotoxicity (DNT) study with zeta-cypermethrin indicated increased
sensitivity in the offspring, based on body weight changes in pups in
the absence of treatment-related effects in maternal animals at the
highest dose tested. However, there is a clear NOAEL for effects seen
in pups, and the doses and endpoints selected for risk assessment are
protective of the susceptibility.
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 from 10X to 1X. That decision is based on the
following findings:
The toxicity database for the cypermethrins is considered
complete. When evaluated together, the toxicity database for
cypermethrin, zeta-cypermethrin, and alpha-cypermethrin can be used to
characterize the overall suite of effects associated with cypermethrin
exposure, including potential developmental and reproductive toxicity,
immunotoxicity, and neurotoxicity. Acceptable developmental toxicity
studies in rats and rabbits, reproduction studies in rats,
neurotoxicity studies (acute, subchronic, and developmental
neurotoxicity) in rats, and immunotoxicity studies in rats are
available.
Like other pyrethroids, the cypermethrins cause
neurotoxicity by interacting with sodium channels, leading to clinical
signs of
[[Page 33281]]
neurotoxicity. These effects are well characterized and adequately
assessed by the available guideline and non-guideline studies. There
are no residual uncertainties with regard to evidence of neurotoxicity
for the cypermethrins.
No evidence of increased qualitative or quantitative
susceptibility was noted in the developmental toxicity or reproduction
studies for the cypermethrins. However, quantitative susceptibility was
seen in the rat DNT study with zeta-cypermethrin with an increased
sensitivity in the offspring based on body weight changes in pups in
the absence of adverse, treatment-related effects in maternal animals.
The results from the DNT study are very similar to results observed in
the reproduction studies where body weight changes (decreased body
weight gain) were seen in maternal and offspring animals at doses
similar to those in the DNT study, with no indication of increased
susceptibility. Therefore, there is no residual concern for effects
observed in the study since a clear developmental NOAEL and LOAEL were
identified for which the selected PODs for risk assessment are
protective.
There are no residual uncertainties with regard to
exposure. The dietary exposure assessments account for parent and
metabolites of concern. In addition, they are refined but could be more
highly refined. The assessments include 100 percent crop treated
assumptions, tolerance level residues for most commodities in the acute
dietary exposure assessment, and default processing factors for many of
the processed commodities. Furthermore, conservative, upper-bound
assumptions were used to determine exposure through drinking water and
residential sources, such that these exposures have not been
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 the 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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. Using the exposure assumptions described in this unit
for acute exposure, EPA has concluded that acute exposure to the
cypermethrins from food and water will utilize 71% of the aPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Acute aggregate risk estimates are not of concern for the
general U.S. population or any population subgroup.
2. Chronic risk. A chronic dietary risk assessment is not required
for cypermethrin because repeated exposure does not result in a POD
lower than that resulting from acute exposure. Therefore, the acute
dietary risk assessment is protective of chronic dietary risk.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Cypermethrin
is 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 cypermethrin.
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 an aggregate MOE of 140 for
children and an ARI of 4.6 for adults. Because EPA's level of concern
for cypermethrin is an MOE below 100, or an ARI below 1, these MOEs/
ARIs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). While there is potential intermediate-term residential
exposure, because the single dose and repeat dosing cypermethrin
studies show that repeat exposures do not result in lower points of
departure, and the same endpoint is used regardless of duration.
Therefore, the short-term aggregate assessment is considered protective
of any intermediate-term exposures.
5. Aggregate cancer risk for U.S. population. EPA has classified
cypermethrin as a ``possible human carcinogen'' and determined that a
non-linear approach relying on the acute regulatory endpoints should be
used for cancer assessment. As the acute dietary exposure estimates are
not of concern, cancer risk is not of concern.
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 residues of the cypermethrins.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology as described in the supporting
document is available to enforce the tolerance expression. Adequate
data have been submitted to support the proposed tolerance for residues
in or on durian. There are no outstanding data with respect to
tolerances. The tolerance expression for cypermethrin in 40 CFR
180.418(a)(1) needs to be updated to include the coverage and
compliance statements. The statement should be revised to read as
follows: ``Tolerances are established for residues of cypermethrin,
()alpha cyano-(3-phenoxyphenyl)methyl ()cis,trans-3(2,2-dichloroethenyl-2,2-
dimethylcyclopropanecarboxylate, including its metabolites and
degradates, in or on the commodities in the following table. Compliance
with the tolerance levels specified in the following table is to be
determined by measuring only total cypermethrin, cyano(3-
phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane
carboxylate, in or on the commodity.'' The tolerance expressions for
alpha-cypermethrin and zeta-cypermethrin are currently up to date and
need no revisions.
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.
Codex has established an MRL of 1 ppm for residues of cypermethrin
in or on durian. The U.S. tolerance for residues of cypermethrin in or
on durian is harmonized with the Codex MRL.
[[Page 33282]]
C. Revisions to Petitioned-For Tolerances
USDA requested a tolerance of 1.0 ppm for durian. The United States
conforms to the Organisation for Economic Co-operation and Development
rounding classes when setting tolerances and is establishing the
tolerance level at 1 ppm rather than 1.0 ppm for durian.
V. Conclusion
Therefore, tolerances are established for residues of cypermethrin,
including its metabolites and degradates, in or on durian at 1 ppm. EPA
is also revising the tolerance expression to clarify that (1) as
provided in FFDCA section 408(a)(3), the tolerance covers metabolites
and degradates of cypermethrin not specifically mentioned; and (2)
compliance with the specified tolerance levels is to be determined by
measuring only the specific compounds mentioned in the tolerance
expression. EPA has determined that it is reasonable to make this
change final without prior proposal and opportunity for comment,
because public comment is not necessary, in that the change has no
substantive effect on the tolerance, but rather is merely intended to
clarify the existing tolerance expression.
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 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 documented in the pesticide-specific registration
review documents, located in each chemical docket at https://www.regulations.gov.
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: July 14, 2025.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
For the reasons set forth in the preamble, EPA is amending 40 CFR
chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.418, revise and republish paragraph (a)(1) to read as
follows:
Sec. 180.418 Cypermethrin and isomers alpha-cypermethrin and zeta-
cypermethrin; tolerances for residues.
(a) General. (1) Tolerances are established for residues of
cypermethrin, ()alpha cyano-(3-phenoxyphenyl)methyl ()cis,trans-3(2,2-dichloroethenyl-2,2-
dimethylcyclopropanecarboxylate,
[[Page 33283]]
including its metabolites and degradates, in or on the commodities in
table 1 to paragraph (a). Compliance with the tolerance levels
specified in the following table is to be determined by measuring only
total cypermethrin, cyano(3-phenoxyphenyl)methyl 3-(2,2-
dichloroethenyl)-2,2-dimethylcyclopropane carboxylate, in or on the
commodity.
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Allspice \1\................................................ 0.5
Angelica, seed \1\.......................................... 0.2
Anise pepper \1\............................................ 0.5
Asafoetida \1\.............................................. 0.2
Ashwagandha fruit \1\....................................... 0.5
Batavia-casia, fruit \1\.................................... 0.5
Belleric myrobalan \1\...................................... 0.5
Brassica, head and stem, subgroup 5A........................ 2.0
Brassica, leafy greens, subgroup 5B......................... 14.0
Calamus-root \1\............................................ 0.2
Caper buds \1\.............................................. 0.5
Cardamom, black \1\......................................... 0.5
Cardamom, Ethiopian \1\..................................... 0.5
Cardamom, green \1\......................................... 0.5
Cardamom, Nepal \1\......................................... 0.5
Cardamom-amomum \1\......................................... 0.5
Cassia, fruit \1\........................................... 0.5
Cassia, Chinese, fruit \1\.................................. 0.5
Cattle, fat................................................. 1.0
Cattle, meat................................................ 0.2
Cattle, meat byproducts..................................... 0.05
Chaste tree, Chinese, roots \1\............................. 0.2
Chinese hawthorne \1\....................................... 0.5
Chinese-pepper \1\.......................................... 0.5
Cinnamon, fruit \1\......................................... 0.5
Cinnamon, Saigon, fruit \1\................................. 0.5
Coptis \1\.................................................. 0.2
Coriander, fruit \1\........................................ 0.5
Coriander, seed \1\......................................... 0.2
Cotton, gin byproducts...................................... 11.0
Cotton, undelinted seed..................................... 0.5
Cumin, black \1\............................................ 0.5
Dorrigo pepper, berry \1\................................... 0.5
Dorrigo pepper, leaf \1\.................................... 0.5
Durian\1\................................................... 1
Egg......................................................... 0.05
Eucalyptus \1\.............................................. 0.5
Fingerroot \1\.............................................. 0.2
Gamboge \1\................................................. 0.5
Grains of Selim \1\......................................... 0.5
Goat, fat................................................... 1.0
Goat, meat.................................................. 0.2
Goat, meat byproducts....................................... 0.05
Hog, fat.................................................... 0.1
Hog, meat................................................... 0.05
Horse, fat.................................................. 1.0
Horse, meat................................................. 0.2
Horse, meat byproducts...................................... 0.05
Jalap \1\................................................... 0.2
Juniper, berry \1\.......................................... 0.5
Lettuce, head............................................... 4.0
Lovage, root \1\............................................ 0.2
Lovage, seed \1\............................................ 0.2
Milk, fat (reflecting 0.10 in whole milk)................... 2.5
Miracle fruit \1\........................................... 0.5
Onion, bulb................................................. 0.1
Onion, green................................................ 6.0
Pecan....................................................... 0.05
Pepper, black \1\........................................... 0.5
Pepper, Indian long \1\..................................... 0.5
Pepper, Javanese, long \1\.................................. 0.5
Pepper, pink \1\............................................ 0.5
Pepper, Sichuan \1\......................................... 0.5
Pepper, white \1\........................................... 0.5
Pepperbush berry \1\........................................ 0.5
Pepperbush leaf \1\......................................... 0.5
Peppercorn, green \1\....................................... 0.5
Peppertree \1\.............................................. 0.5
Peppertree, Peruvian \1\.................................... 0.5
Poultry, fat................................................ 0.05
Poultry, meat............................................... 0.05
Saunders, red \1\........................................... 0.5
Sheep, fat.................................................. 1.0
Sheep, meat................................................. 0.2
Sheep, meat byproducts...................................... 0.05
Sumac, fragrant \1\......................................... 0.5
Sumac, smooth, leaf \1\..................................... 0.5
Tamarind, seed \1\.......................................... 0.5
Tasmanian, pepper, berry \1\................................ 0.5
Tea, dried \1\.............................................. 15
Tsaoko \1\.................................................. 0.5
Vanilla \1\................................................. 0.5
Yellow gentian, roots \1\................................... 0.2
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of July 17, 2025.
* * * * *
[FR Doc. 2025-13355 Filed 7-16-25; 8:45 am]
BILLING CODE 6560-50-P