Rule2025-13813
Afidopyropen; 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
July 23, 2025
Effective
July 23, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes a tolerance for residues of the insecticide afidopyropen in or on lettuce, leaf. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), the Interregional Research Project #4 (IR-4) submitted a petition to EPA requesting that EPA establish a maximum permissible level for residues of this pesticide in or on the identified commodity.
Full Text
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<title>Federal Register, Volume 90 Issue 139 (Wednesday, July 23, 2025)</title>
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[Federal Register Volume 90, Number 139 (Wednesday, July 23, 2025)]
[Rules and Regulations]
[Pages 34602-34608]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-13813]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2024-0200; FRL-12842-01-OCSPP]
Afidopyropen; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of the
insecticide afidopyropen in or on lettuce, leaf. Under the Federal
Food, Drug, and Cosmetic Act (FFDCA), the Interregional Research
Project #4 (IR-4) submitted a petition to EPA requesting that EPA
establish a maximum permissible level for residues of this pesticide in
or on the identified commodity.
DATES: This rule is effective July 23, 2025. Objections and requests
for hearings must be received on or before
[[Page 34603]]
September 22, 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-2024-0200, 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
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(703) 305-7090; email address: <a href="/cdn-cgi/l/email-protection#15475153475b7a617c767066557065743b727a63"><span class="__cf_email__" data-cfemail="fdafb9bbafb39289949e988ebd988d9cd39a928b">[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
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-
2024-0200 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 22, 2025.
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 whose disclosure is restricted by statute. If you wish to
include CBI in your request, please follow the applicable instructions
at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> and clearly
mark the information that you claim to be CBI. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice.
II. Petitioned-For Tolerance
In the Federal Register of August 27, 2024 (89 FR 68571 (FRL-11682-
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
4E9104) by the Interregional Research Project Number 4 (IR-4), IR-4
Project Headquarters, North Carolina State University, 1730 Varsity
Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requested
that 40 CFR 180.700 be amended by establishing tolerances for the
residues of the insecticide afidopyropen, including its metabolites and
degradates, in or on lettuce, leaf at 7 parts per million (ppm) and
leafy greens subgroup 4-16A, except lettuce, leaf at 2 ppm. Compliance
with the tolerance levels specified is to be determined by measuring
only afidopyropen, [(3S,4R,4aR,6S,6aS,12R,12aS,12bS)-3-
[(cyclopropylcarbonyl)oxy]-1,3,4,4a,5,6,6a,12,12a,12b-decahydro-6,12-
dihydroxy-4,6a,12b-trimethyl-11-oxo-9-(3-pyridinyl)-2H,11H-
naphtho[2,1-b]pyrano[3,4-e]pyran-4-yl]methyl cyclopropanecarboxylate.
The petition also requested, upon the approval of the requested
tolerances, the removal of the established tolerance for residues of
afidopyropen, including its metabolites and degradates, in or on leafy
greens subgroup 4-16A at 2.0 ppm.
The notice of filing document referenced a summary of the petition
that was prepared by the petitioner and included in the docket. One
comment was received in response to the notice of filing. EPA's
response to this comment is discussed in Unit IV.C.
III. Final Tolerance Action
Based upon review of the data supporting the petition and in
accordance with its authority under FFDCA section 408(d)(1)(A)(i), EPA
is establishing tolerances that vary from what the petitioner proposed.
The reason for this change is explained in Unit IV.D.
[[Page 34604]]
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 afidopyropen, including exposure resulting from
the tolerances established by this action. EPA's assessment of
exposures and risks associated with afidopyropen is summarized in this
unit.
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 afidopyropen is complete. The liver is a
main target organ in both subchronic and chronic oral toxicity studies
in all three species tested (mouse, rat, and dog). Other target organs
identified following exposure to afidopyropen are the heart, brain,
spleen, and reproductive organs of both sexes. No evidence of
neurotoxicity was seen in the subchronic neurotoxicity (SCN) study in
rats. Afidopyropen caused potential neurotoxic effects in the acute
neurotoxicity (ACN) study; however, effects only occurred at the limit
dose (2000 mg/kg/day), which is not relevant for quantitative risk
assessment. There is evidence of increased susceptibility following
pre- and/or post-natal exposure to afidopyropen. In a prenatal
developmental study in rats, adverse effects in fetuses occurred at a
lower dose than maternal toxicity. In a developmental study in rabbits,
fetal developmental and maternal effects occurred at the same dose
level. Quantitative susceptibility was also observed in two 2-
generation reproduction toxicity rat studies. In the first study, no
reproductive or parental effects were observed up to the highest dose
tested (HDT), while adverse offspring effects occurred at the HDT. In
the second study, the parental and reproductive effects occurred at the
HDT while offspring effects occurred at a lower dose level.
Afidopyropen did not display adverse effects in the 28-day dermal study
or in the immunotoxicity study.
Afidopyropen is classified as ``Suggestive Evidence of Carcinogenic
Potential'' based on benign hepatocellular adenomas in male rats and
uterine adenocarcinomas and combined adenocarcinomas and/or adenomas in
female rats. There is no mutagenic concern for afidopyropen.
Quantification of risk using a non-linear approach (i.e., a chronic
reference dose) will adequately account for all chronic toxicity,
including carcinogenicity, that could result from exposure to
afidopyropen. Specific information on the studies received and the
nature of the adverse effects caused by afidopyropen 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 in the
document entitled ``Afidopyropen. Human Health Risk Assessment for the
Section 3 Request for New Use on Greenhouse Grown Lettuce'' available
in docket for this rulemaking.
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/pesticides/factsheets/riskassess.html">https://www.epa.gov/pesticides/factsheets/riskassess.html</a>.
An acute dietary endpoint for the general population was not
identified because effects of concern for this population group were
not observed in the database. For females 13-49 years old, an acute
reference dose (aRfD) of 0.16 mg/kg/day was derived from the rabbit
prenatal developmental toxicity based on increased early resorptions
per litter (the statistical unit for early resorptions in developmental
toxicity) at the maternal and developmental LOAEL of 32 mg/kg/day
(maternal and developmental NOAEL = 16 mg/kg/day). Because of the
unknown etiology of this effect, the effect is allocated to both the
maternal and developmental life stages. This study was considered
appropriate for acute dietary endpoint selection for females of
reproductive age. An uncertainty factor of 100X (10X to account for
interspecies extrapolation and 10X for intraspecies variation) was
applied to derive the aRfD. The Food Quality Protection Act Safety
Factor (FQPA SF) was reduced to 1X, therefore the aRfD is equal to the
acute Population Adjusted Dose (aPAD).
For the general population, including females 13-49 years old, a
chronic reference dose (cRfD) of 0.08 mg/kg/day (NOAEL = 8 mg/kg/day)
was selected from two studies considered to be co-critical: (1) the
chronic dog study (LOAEL = 20 mg/kg/day) based on hyaline droplet
deposition in hepatocytes and vacuolation of the white matter and
neuropil of the cerebrum of male dogs; and (2) the 2-generation
reproduction study in rats (offspring LOAEL = 41 mg/kg/day) based on
decreased absolute body weight and decreased spleen and thymus weights
in the offspring. An uncertainty factor of 100X (10X to account for
interspecies extrapolation and 10X for intraspecies variation) was
applied to derive the cRfD. The FQPA SF was reduced to 1X, therefore,
the cRfD is equal to the chronic Population Adjusted Dose (cPAD). This
is the lowest NOAEL in the database and is protective of all other
observed chronic effects in the mouse carcinogenicity, the chronic
carcinogenicity study in rats, and the 1-year rat study.
A chronic dietary endpoint was also established for the
afidopyropen metabolite cyclopropanecarboxylic acid (CPCA), which is a
residue of concern for dietary risk assessment (food and water are the
only pathways of exposure for this metabolite). The POD was selected
from a CPCA-specific subchronic toxicity study in rats in which adverse
effects included clinical chemistry changes and microscopic findings in
the liver, thymus, heart, and pancreas. An uncertainty factor of 1000X
(10X to account for interspecies extrapolation, 10X for intraspecies
variation, and a 10X FQPA SF) is applied to the chronic dietary POD.
The 10X FQPA SF was retained to account
[[Page 34605]]
for a subchronic-to-chronic duration extrapolation and the lack of data
to assess developmental and reproductive CPCA toxicity.
D. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to afidopyropen, EPA considered exposure under the petitioned-
for tolerances as well as all existing afidopyropen tolerances in 40
CFR 180.700. An updated dietary assessment was conducted for
afidopyropen to account for the proposed new use on greenhouse-grown
lettuce. CPCA is only a residue of concern in livestock and drinking
water. Since lettuce is not a contributor to livestock dietary burdens
and a greenhouse use will not change the estimated drinking water
concentrations (EDWCs), the previously conducted dietary assessment of
CPCA, discussed in Unit III of the final rule published in the Federal
Register of October 8, 2020 (85 FR 63453 (FRL-10003-93-OCSPP), remains
current and has not been updated. EPA assessed dietary exposures from
afidopyropen 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. In estimating acute dietary
exposure, EPA used food consumption information from the Dietary
Exposure Evaluation Model software with the Food Commodity Intake
Database (DEEM-FCID\TM\) Version 4.02. This software uses 2005-2010
food consumption data from the U.S. Department of Agriculture's
(USDA's) National Health and Nutrition Examination Survey, What We Eat
in America, (NHANES/WWEIA). The acute dietary assessment for
afidopyropen was conducted using recommended tolerance-level residues
and 100% crop treated (PCT) assumptions. Empirical and default
processing factors were also used.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used DEEM-FCID\TM\, Version 4.02, which incorporates
2005-2010 consumption data from the USDA's NHANES/WWEIA. The chronic
dietary assessment for afidopyropen was conducted using recommended
tolerance-level residues and 100 PCT assumptions. Empirical and default
processing factors were also used.
iii. Cancer. Afidopyropen is classified as ``Suggestive Evidence of
Carcinogenic Potential''. Quantification of risk using a non-linear
approach (i.e., a cPAD) will adequately account for all chronic
toxicity, including carcinogenicity, that could result from exposure to
afidopyropen; the chronic aggregate assessment did not result in
estimates of concern. Therefore, a separate cancer assessment was not
conducted.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for afidopyropen. Tolerance level residues and/or
100% CT 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 afidopyropen in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of afidopyropen. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at <a href="https://www.epa.gov/oppefed1/models/water/index.htm">https://www.epa.gov/oppefed1/models/water/index.htm</a>.
Previous EDWCs were used in the dietary risk assessment as
greenhouse uses are not expected to affect drinking water exposures.
Concentrations for both afidopyropen and its degradate CPCA were
estimated in the 2017 Drinking Water Assessment, which was discussed in
Unit III. of the final rule published in the Federal Register of
October 8, 2020 (85 FR 63453 (FRL-10003-93-OCSPP)).
For acute dietary risk assessment for afidopyropen, the EDWC value
of 7.0 ppb was used to assess the contribution to drinking water. For
chronic and cancer dietary risk assessment for afidopyropen, the EDWC
value of 3.9 ppb was used to assess the contribution to drinking water.
These EDWCs are based on an annual application rate of 0.33 lb a.i./A
and a Percent Cropped Area (PCA) of 100%. An acute dietary risk
assessment was not conducted for CPCA since an acute dietary endpoint
was not identified. For the chronic dietary assessment for CPCA, an
EDWC value of 35 ppb was used to assess the contribution to 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., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Afidopyropen is
registered for use on residential ornamentals. EPA has assumed that
there will not be residential handler exposure based on a presumption
that label language requiring the use of specific clothing or personal
protective equipment indicates that the pesticide will be marketed for
commercial use and not applied by residential handlers. There is a
potential for the registered uses to result in post-application dermal
exposure to afidopyropen, due to activities in treated gardens. EPA
aggregated the worst-case risk estimates from post-application
exposures (i.e., dermal exposures to adults and children (6 to <11
years old) from activities in treated gardens) in its aggregate
assessment. CPCA is not a residue of concern for residential exposures.
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.''
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 afidopyropen and any other
substances. For the purposes of this tolerance action, therefore, EPA
has not assumed that afidopyropen has a common mechanism of toxicity
with other substances.
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 FQPA 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. Conclusion for afidopyropen. 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 for all afidopyropen
exposure scenarios. That decision is based on the following findings:
i. The toxicology database for afidopyropen is considered complete
for evaluating and characterizing toxicity, assessing children's
susceptibility under FQPA, and selecting endpoints for the exposure
pathways of concern.
[[Page 34606]]
ii. Acute oral (gavage) and sub-chronic oral (dietary)
neurotoxicity studies were conducted in rats with effects seen only in
the acute study at the limit dose. In subchronic studies with mice and
dogs, indications of neurotoxicity were limited to vacuolation of white
matter and/or spinal cord, which may have been an artifact of not
preparing the tissues properly. Further, the nervous tissue vacuolation
was observed at doses 7.5x-115x higher than the POD for the chronic
dietary risk assessment. Thus, the potential effects are well-
characterized with clearly established NOAEL/LOAEL values and the
selected PODs are protective for the observed effects.
Based on the weight of the evidence and taking into consideration
the PODs selected for risk assessment, a developmental neurotoxicity
study is not required at this time. Clear NOAELs have been established
for all life stages, the selected PODs are protective of all pre- and/
or post-natal toxicity observed throughout the toxicology database, and
no specific neuropathological effects were noted. A DNT with rat (the
typical test species) would not be expected to contribute meaningfully
to the database, as the rat is expected to be less sensitive than dogs
and mice.
iii. There is evidence of increased susceptibility following pre-
and/or post-natal exposure to afidopyropen. Clear NOAELs have been
established for the developmental effects in rats and rabbits as well
as the offspring effects in the 2-generation reproduction studies. The
NOAELs chosen for all selected endpoints are protective of all
developmental and offspring effects seen in the database.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary assessment is based on high-end assumptions such
as tolerance-equivalent residue levels of the parent compound and CPCA
in foods, 100 PCT, default processing factors, and modeled, high-end
estimates of residues in drinking water. All the exposure estimates are
based on high-end assumptions and are not likely to underestimate risk.
In addition, the residential exposure assessment was conducted based on
the Residential SOPs such that residential exposure and risk will not
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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. For the acute dietary assessment for afidopyropen, the
estimated risk is 4.2% of the aPAD for females 13-49 years old (the
only population subgroup for which an acute endpoint was identified),
at the 95th percentile of exposure, and is below the level of concern
(<100% of the aPAD). The acute aggregate risk estimates for
afidopyropen include food and drinking water only and are equivalent to
the acute dietary risk estimates, which are below HED's level of
concern.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, the estimated chronic dietary exposure risks
from food and water for afidopyropen are below the LOC (<100% of the
cPAD) for the US general population and all population subgroups. EPA
has concluded that chronic exposure from food and water will utilize
6.3% of the cPAD for children 1-2 years old, the population group
receiving the greatest exposure. The proposed use is for applications
to lettuce grown in greenhouses and is not anticipated to result in
residential exposure on a chronic basis. Therefore, the chronic
aggregate risk estimates are equivalent to the chronic dietary risk
estimates and are below the LOC.
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). In estimating
the short-term aggregate risk, EPA has aggregated the total short-term
residential exposure and average dietary (food + drinking water)
exposure. The short-term aggregate risk assessment applies only to
residues of afidopyropen and combines residential exposures (contacting
previously treated ornamentals) and average dietary (food and drinking
water) exposures. The short-term aggregate assessment results in MOEs
of 1,900 for adults and 2,100 for children (LOC = 100). There are no
short-term aggregate risk estimates 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). Because no intermediate-term exposure is anticipated,
afidopyropen is not expected to pose an intermediate-term aggregate
risk.
5. Aggregate cancer risk for U.S. population. As indicated in Unit
III.A., afidopyropen is classified as having ``suggestive evidence of
carcinogenicity in humans.'' Quantification of risk using a non-linear
approach (e.g., a cPAD) will adequately account for all chronic
toxicity, including carcinogenicity, that could result from exposure to
afidopyropen; the chronic aggregate assessment did not result in risk
estimates 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 U.S. general population, or to infants and children from
aggregate exposure to afidopyropen residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Suitable tolerance enforcement methods for plants and livestock
using liquid chromatography-mass spectrometer/mass spectrometer (LC-MS/
MS) analyses are available for the analysis of afidopyropen. In
addition, a separate acceptable enforcement method (using LC-MS/MS) has
been submitted and reviewed for determining afidopyropen and
cyclopropanecarboxylic acid (CPCA-carnitine) in livestock commodities.
The Quick Easy Cheap Effective Rugged Safe (QuEChERS) multi-residue
method D1514/01 is considered suitable for the analysis of afidopyropen
in plant and livestock commodities. However, this multi-residue method
is not suitable for determination of CPCA-carnitine in livestock
commodities.
Analytical standards for afidopyropen and CPCA-carnitine are
currently available in the EPA National Pesticide Standards Repository.
Supplies of analytical standards will be replenished to the repository
at the following address: USEPA National Pesticide Standards
Repository/Analytical Chemistry Branch, 701 Mapes Road, Fort George G.
Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:
<a href="/cdn-cgi/l/email-protection#b3c1d6c0dad7c6d6ded6c7dbdcd7c0f3d6c3d29dd4dcc5"><span class="__cf_email__" data-cfemail="ed9f889e848998888088998582899ead889d8cc38a829b">[email protected]</span></a>.
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
[[Page 34607]]
safety standards and agricultural practices. EPA considers the
international maximum residue limits (MRLs) established by the Codex
Alimentarius Commission (Codex), as required by FFDCA section
408(b)(4). The Codex Alimentarius is a joint United Nations Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has established a MRL for afidopyropen in or on lettuce,
leaf at 2 ppm.
The greenhouse-grown lettuce data supporting this petition show
that residues from the domestic use of afidopyropen may exceed the
Codex MRL of 2 ppm on lettuce, leaf. Therefore, the Agency is
establishing a tolerance of 7 ppm for greenhouse lettuce, leaf based on
the proposed use pattern and supporting data.
C. Response to Comments
One comment was received in response to the notice of filing for
the IR-4 petition (PP4E9104). The commenter offers that the ``correct
pesticide tolerance is zero.'' Although the Agency recognizes that some
individuals believe that pesticides should be banned on agricultural
crops, the existing legal framework provided by section 408 of the
FFDCA authorizes EPA to establish tolerances 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
this afidopyropen tolerance is safe. The commenter provided no
information to indicate that afidopyropen is not safe.
D. Revisions to Petitioned-For Tolerances
EPA is establishing a tolerance for residues of afidopyropen in or
on lettuce, leaf at 7 ppm as requested by the petitioner. However, the
petitioner initially requested an amendment to the established leafy
greens subgroup 4-16A tolerance at 2.0 ppm, to be revised to ``leafy
greens subgroup 4-16A, except lettuce, leaf at 2 ppm'', upon
establishment of the lettuce, leaf tolerance at 7 ppm. EPA will not
amend the leafy greens subgroup 4-16A to state ``except lettuce,
leaf''. Establishing an individual tolerance for residues of
afidopyropen on lettuce, leaf at 7 ppm, and maintaining the established
leafy greens subgroup 4-16A tolerance at 2.0 ppm covers the permitted
uses and is supported by the submitted and available data.
V. Conclusion
Therefore, tolerances are established for residues of the
insecticide afidopyropen, [(3S,4R,4aR,6S,6aS,12R,12aS,12bS)-3-
[(cyclopropylcarbonyl)oxy]-1,3,4,4a,5,6,6a,12,12a,12b-decahydro-6,12-
dihydroxy-4,6a,12b-trimethyl-11-oxo-9-(3-pyridinyl)-2H,11H -
naphtho[2,1-b]pyrano[3,4-e]pyran-4-yl]methyl cyclopropanecarboxylate,
including its metabolites and degradates, in or on lettuce, leaf at 7
ppm.
VI. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at <a href="https://www.epa.gov/regulations/and-executive-orders">https://www.epa.gov/regulations/and-executive-orders</a>.
A. Executive Order 12866: Regulatory Planning and Review
This action is exempt from review under Executive Order 12866 (58
FR 51735, October 4, 1993), because it establishes or modifies a
pesticide tolerance or a tolerance exemption under FFDCA section 408 in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866.
B. Executive Order 14192: Unleashing Prosperity Through Deregulation
Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply
because actions that establish a tolerance under FFDCA section 408 are
exempted from review under Executive Order 12866.
C. Paperwork Reduction Act (PRA)
This action does not impose an information collection burden under
the PRA 44 U.S.C. 3501 et seq., because it does not contain any
information collection activities.
D. Regulatory Flexibility Act (RFA)
Since tolerance actions that are established on the basis of a
petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the RFA, 5 U.S.C. 601 et seq., do not apply to this
action.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more (in 1995 dollars and adjusted annually for inflation) as described
in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely
affect small governments. The action imposes no enforceable duty on any
State, local, or Tribal governments or on the private sector.
F. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will
not have substantial direct effects on the states, on the relationship
between the National Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will
not have substantial direct effects on Tribal governments, on the
relationship between the Federal Government and the Indian Tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian Tribes.
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because tolerance actions like this one are exempt from
review under Executive Order 12866. However, EPA's 2021 Policy on
Children's Health applies to this action. This rule finalizes tolerance
actions under the FFDCA, which requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
.'' (FFDCA 408(b)(2)(C)). The Agency's consideration is summarized in
Unit III.E.
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not subject to Executive Order 13211 (66 FR 28355)
(May 22,
[[Page 34608]]
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 17, 2025.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
For the reasons set forth in the preamble, 40 CFR chapter I is
amended as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Amend Sec. 180.700 by adding in alphabetical order an entry for
``lettuce, leaf'' to the table in paragraph(a)(1) to read as follows:
Sec. 180.700 Afidopyropen; tolerances for residues.
(a)(1) * * *
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Lettuce, leaf.............................................. 7
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2025-13813 Filed 7-22-25; 8:45 am]
BILLING CODE 6560-50-P
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