[Federal Register Volume 89, Number 119 (Thursday, June 20, 2024)]
[Rules and Regulations]
[Pages 51843-51849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13447]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2024-0223; FRL-12024-01-OCSPP]


Afidopyropen; Pesticide Tolerance for Emergency Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of afidopyropen, including its metabolites and degradates, in 
or on strawberry. This action is in response to EPA's granting of an 
emergency exemption under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) authorizing use of the pesticide on field-grown 
strawberry. This regulation establishes a maximum permissible level for 
residues of afidopyropen in or on strawberry. The time-limited 
tolerance expires on December 31, 2027.

DATES: This regulation is effective June 20, 2024. Objections and 
requests for hearings must be received on or before August 19, 2024 and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2024-0223, is available at 
https://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20004. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Docket 
Public Reading Room is (202) 566-1744. Please review the visitor 
instructions and additional information about the docket available at 
https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Registration Division 
(7505P), 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. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).

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     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Federal Register Office's e-CFR site at https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect 
of this regulation and may also request a hearing on those objections. 
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-
2024-0223 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 August 19, 2024. Addresses 
for mail and hand delivery of objections and hearing requests are 
provided in 40 CFR 178.25(b).
    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. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2024-0223, by one of 
the following methods:
     Federal eRulemaking Portal: 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.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections 
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is 
establishing a time-limited tolerance for residues of afidopyropen, 
including its metabolites and degradates, in or on strawberry at 0.3 
parts per million (ppm). This time-limited tolerance expires on 
December 31, 2027.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under FIFRA 
section 18. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
FIFRA section 18 related time-limited tolerances to set binding 
precedents for the application of FFDCA section 408 and the safety 
standard to other tolerances and exemptions. Section 408(e) of FFDCA 
allows EPA to establish a tolerance or an exemption from the 
requirement of a tolerance on its own initiative, i.e., without having 
received any petition from an outside party.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue . . 
. .''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Afidopyropen on Strawberry and FFDCA 
Tolerance

    The California Department of Pesticide Regulation (CDPR) has 
requested a specific emergency exemption for use of afidopyropen in 
field-grown strawberry to control lygus bugs (Western Tarnished Plant 
Bugs). The applicant asserts that significant losses have occurred due 
to unprecedented infestations of lygus bugs in California strawberry, 
and an urgent and nonroutine situation is occurring. The applicant 
cites various factors leading to the current situation, including lack 
of commercially and environmentally viable alternative controls due to 
restrictions for using neonicotinoid pesticides, and ongoing resistance 
development to pyrethroid pesticides. Additionally, extreme wet 
conditions over the last several years have contributed to higher 
levels of weeds in nearby areas, hosting high populations of lygus bugs 
which then migrate to the neighboring strawberry fields. Despite the 
use of available controls, the applicant states that lygus bugs have 
not been adequately controlled and strawberry growers are facing 
significant economic losses without an effective control, such as the 
requested afidopyropen.
    After having reviewed the submission, EPA determined that an 
emergency condition exists for this State, and that the criteria for 
approval of an emergency exemption are met. EPA has authorized a 
specific exemption under FIFRA section 18 for the use of afidopyropen 
on field-grown strawberry for control of lygus bug in California.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of afidopyropen 
in or on strawberry. In doing so, EPA considered the safety standard in 
FFDCA section 408(b)(2), and EPA decided that the necessary tolerance 
under FFDCA section 408(l)(6) would be consistent with the safety 
standard and with FIFRA section 18. Consistent with the need to move 
quickly on the emergency exemption in order to address an urgent non-
routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment as provided in FFDCA section 408(l)(6). Although 
this time-limited tolerance expires on December 31, 2027, under FFDCA 
section 408(l)(5), residues of the pesticide not in excess of the 
amount specified in the tolerance remaining in or on strawberry after 
that

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date will not be unlawful, provided the pesticide was applied in a 
manner that was lawful under FIFRA, and the residues do not exceed a 
level that was authorized by this time-limited tolerance at the time of 
that application. EPA will take action to revoke the time-limited 
tolerance earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe.
    Because this time-limited tolerance is being approved under 
emergency conditions, EPA has not made any decisions about whether 
afidopyropen meets FIFRA's registration requirements for use on field 
grown strawberry or whether a permanent tolerance for this use would be 
appropriate. Under these circumstances, EPA does not believe that this 
time-limited tolerance decision serves as a basis for registration of 
afidopyropen by a State for special local needs under FIFRA section 
24(c). Nor does this tolerance by itself serve as the authority for 
persons in any State other than California to use this pesticide on 
field-grown strawberries under FIFRA section 18 absent the issuance of 
an emergency exemption applicable within that State. For additional 
information regarding the emergency exemption for afidopyropen, contact 
the Agency's Registration Division at the address provided under FOR 
FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with the factors specified in FFDCA section 
408(b)(2)(D), 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 expected as a result of the use proposed by this emergency 
exemption request and the time-limited tolerance for residues of 
afidopyropen on strawberry at 0.3 ppm. EPA's assessment of exposures 
and risks associated with establishing the time-limited tolerance 
follows.

A. 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 afidopyropen, and its 
metabolite of concern, cyclopropane carboxylic acid (CPCA), used for 
human risk assessment is discussed in Unit III of the final rule 
published in the Federal Register of October 8, 2020 (85 FR 63453) 
(FRL-10003-93). The CPCA metabolite is included as a residue of concern 
for ruminant commodities and drinking water.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Separate dietary 
exposure assessments were conducted for afidopyropen (acute and 
chronic) and the afidopyropen metabolite CPCA (chronic only) as the 
toxicological endpoints are different for these compounds. In 
evaluating dietary exposure to afidopyropen, EPA considered exposure 
under the time-limited tolerance established by this action as well as 
all existing afidopyropen tolerances in 40 CFR 180.700. EPA assessed 
dietary exposures from afidopyropen in food as follows:
    i. Acute exposure. In estimating acute dietary exposure (for 
afidopyropen only), EPA used food consumption information from the 
Dietary Exposure Evaluation Model-Food Commodity Intake Database (DEEM-
FCID\TM\, Version 4.02), which incorporates 2005-2010 consumption data 
from the United States 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 tolerance-level residues and 100% crop treated (PCT) 
assumptions. Empirical and default processing factors were also used. 
An acute dietary exposure assessment was not conducted for CPCA since 
an acute dietary endpoint was not identified.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessments for both afidopyropen and CPCA, EPA used DEEM-FCID\TM\, 
Version 4.02, which incorporates 2005-2010 consumption data from the 
USDA's NHANES/WWEIA. The chronic dietary assessments for afidopyropen 
and CPCA were conducted using tolerance-level residues and 100% crop 
treated (PCT) assumptions. Empirical and default processing factors 
were also used.
    iii. Cancer. EPA has classified afidopyropen as ``Suggestive 
Evidence of Carcinogenic Potential.'' A cancer classification for CPCA 
has not been determined; however, a structural-activity relationship 
analysis indicated no structural alerts for genotoxicity or 
carcinogenicity. There were no reports of a tumorigenic response in the 
open literature. 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. 
Cancer risk is quantified using a linear or nonlinear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or nonlinear approach is used and a cancer RfD is 
calculated based on an earlier noncancer key event. If carcinogenic 
mode of action data are not available, or if the mode of action data 
determines a mutagenic mode of action, a default linear cancer slope 
factor approach is utilized. Based on the

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data referenced in Unit IV.A., EPA has concluded that a nonlinear RfD 
approach is appropriate for assessing cancer risk from afidopyropen. 
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 
assessments 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 nor PCT information in the dietary 
assessment for afidopyropen and CPCA. Tolerance level residues and 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 and CPCA in drinking water. These 
simulation models take into account data on the physical, chemical, and 
fate/transport characteristics of afidopyropen and CPCA. 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#aquatic.
    Because of the difference in structure and mode of action, EPA 
calculated separate estimated drinking water concentrations (EDWCs) for 
afidopyropen and CPCA. Afidopyropen degrades in soil and water to form 
a wide range of structurally similar transformation products. All 
degradates, except CPCA, are included as residues of concern in the 
afidopyropen total toxic residues (TTR) analysis.
    The highest modeled EDWCs for afidopyropen and for CPCA used in the 
dietary risk assessments were entered directly into the latest version 
of the Pesticides in Water Calculator (PWC 1.52). EDWCs were calculated 
for both surface water and groundwater based on the maximum annual 
application rate (0.33 lb a.i./A). For afidopyropen, the highest EDWCs 
were for surface water. The surface water EDWCs used to assess 
contribution to dietary exposure and risks from drinking water were 7.1 
ppb for the acute assessment and 3.9 ppb for the chronic and cancer 
assessments. For CPCA, an acute dietary risk assessment was not 
conducted since an acute dietary endpoint was not identified. For 
chronic dietary risk assessment, the highest EDWC for CPCA, that for 
groundwater of 35 ppb, was used for assessing the contribution to 
chronic dietary exposure through drinking water. These modeled 
estimates of drinking water concentrations were directly entered into 
the dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Afidopyropen is registered for use on residential ornamentals. 
Residential handler exposure is not expected because the pesticide is 
intended for commercial use and is not labelled for application by 
residential handlers. There is a potential for the registered and 
proposed 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.
    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. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found afidopyropen or CPCA to share a common mechanism 
of toxicity with any other substances. Afidopyropen and another 
pesticide, aminocyclopyrachlor, both produce the toxic metabolite CPCA. 
Drinking water is the only expected exposure pathway for CPCA from both 
pesticides, and co-exposures to CPCA from both pesticides are unlikely 
to occur based on their use patterns. For the purposes of this 
tolerance action, therefore, EPA has concluded that it is not 
appropriate to conduct a cumulative exposure assessment. 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.

C. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional SF when reliable data 
available to EPA support the choice of a different factor.
    2. Conclusion for afidopyropen. EPA has determined that reliable 
data show that 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 toxicity 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.
    ii. Acute oral (gavage) and subchronic 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.

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    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 assessments were performed based on high-end 
assumptions such as 100% CT and tolerance-level residues, 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 assessments for post-application exposures were 
conducted based on the Residential SOPs such that residential exposure 
and risk will not be underestimated. These assessments will not 
underestimate the exposure and risks posed by afidopyropen.
    3. Conclusion for CPCA. No developmental or reproductive toxicity 
studies are available for CPCA to assess pre- and/or post-natal 
toxicity. EPA is therefore retaining the default FQPA safety factor of 
10X to account for a subchronic to chronic duration extrapolation and 
the lack of data to assess developmental and reproductive toxicity of 
CPCA.

D. 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. Separate dietary assessments were conducted for 
afidopyropen and its CPCA metabolite, as the toxicological endpoints 
are different for these compounds.
    1. Acute risk. The acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. An acute endpoint for afidopyropen was identified for 
females 13-49 years old. However, for all other population subgroups, 
including the overall U.S Population, no adverse effects for 
afidopyropen resulting from a single oral exposure was identified, no 
acute dietary endpoints were selected, and acute dietary exposure 
assessments were not conducted for these populations. Using the 
exposure assumptions discussed in this unit for acute exposure, the 
acute dietary exposure from food and water to afidopyropen will occupy 
3.7% 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 (LOC) (<100% 
of the aPAD). An acute dietary endpoint was not identified for CPCA; 
therefore, the Agency does not expect acute risk from exposure to CPCA.
    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 and for CPCA are below the LOC 
(<100% of the cPAD) for the US general population and all population 
subgroups. For afidopyropen, EPA has concluded that chronic exposure 
from food and water will utilize 6.4% of the cPAD for Children 1-2 
years old, the population group receiving the greatest exposure, and 
2.6% of the cPAD for the general U.S. population. For CPCA, EPA has 
concluded that chronic exposure from food and water will utilize 31% of 
the cPAD for Children 1-2 years old, the population group receiving the 
greatest exposure, and 11% of the cPAD for the general U.S population. 
Residential exposures to afidopyropen and CPCA are not expected to 
occur 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). Afidopyropen 
is currently registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to afidopyropen.
    The short-term aggregate exposure assessment applies only to 
afidopyropen since residential exposure to CPCA is not expected. The 
short-term aggregate exposure assessment combines residential exposures 
for adults and children (6 to <11 years old) contacting previously 
treated ornamentals) and average dietary (food + drinking water) 
exposures. EPA has concluded that the combined short-term aggregate 
exposures result in short term aggregate MOEs of 1,900 for adults and 
2,100 for children. Because EPA's LOC for short term aggregate MOEs is 
100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term non-dietary, non-occupational 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level). Because no intermediate-term adverse 
effects were identified, afidopyropen and CPCA are not expected to pose 
an intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. As indicated in unit 
IV, 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, and the chronic aggregate assessment did not result in 
risk estimates of concern. A cancer classification for CPCA has not 
been determined; however, a structural-activity relationship analysis 
indicated no structural alerts for genotoxicity or carcinogenicity. 
There were no reports of a tumorigenic response in the open literature.
    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 afidopyropen and CPCA residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies are available for plants and 
livestock using liquid chromatography/mass spectrometer/mass 
spectrometer (LC-MS/MS) analyses for analysis for afidopyropen. 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 but is not suitable for determination 
of CPCA in livestock commodities. However, an acceptable enforcement 
method (using LC-MS/MS) has been submitted for determining CPCA-
carnetine in livestock commodities.
    The analytical methods and standards for afidopyropen (expiration 
11/1/2024) and CPCA-carnitine (expiration 04/01/2032) are currently 
available in the

[[Page 51848]]

USEPA National Pesticide Standards Repository and may be obtained by 
contacting: Analytical Chemistry Branch/OPP, Environmental Science 
Center, 701 Mapes Road, Ft. Meade, MD 20755-5350; telephone number: 
(410) 305-2905; email address: [email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has established an MRL for residues of afidopyropen in/on 
strawberry that harmonizes with the permanent U.S. tolerance 
established to support use in greenhouse-grown strawberry, both at 0.15 
ppm. However, the time-limited tolerance established by this action of 
0.3 ppm afidopyropen in/on strawberry is not harmonized with the Codex 
MRL. Based on available residue data, use by U.S. growers consistent 
with the approved emergency exemption use directions could result in 
residues that exceed the Codex MRL. Harmonizing with the Codex MRL 
could put U.S. growers at risk of violative residues despite legal use 
of afidopyropen. Moreover, EPA's regulations require adequate time-
limited tolerances be in place in order to allow a pesticide use on 
food under an emergency exemption. A time-limited tolerance harmonized 
with the Codex MRL would not be adequate to cover residues resulting 
from the emergency exemption use in field-grown strawberry. Since EPA 
has determined that this time-limited tolerance is safe, EPA is 
establishing this time-limited tolerance despite the lack of 
harmonization with the related Codex MRL.

VI. Conclusion

    Therefore, a time-limited tolerance is established for residues of 
afidopyropen, in or on strawberry at 0.3 ppm. This tolerance expires on 
December 31, 2027.

VII. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA sections 408(e) and 
408(l)(6). The Office of Management and Budget (OMB) has exempted these 
types of actions from review under Executive Order 12866, entitled 
``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). 
Because this action has been exempted from review under Executive Order 
12866, this action is not subject to Executive Order 13211, entitled 
``Actions Concerning Regulations That Significantly Affect Energy 
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive 
Order 13045, entitled ``Protection of Children from Environmental 
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This 
action does not contain any information collections subject to OMB 
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., nor does it require any special considerations under Executive 
Order 12898, entitled ``Federal Actions to Address Environmental 
Justice in Minority Populations and Low-Income Populations'' (59 FR 
7629, February 16, 1994).
    Since tolerances and exemptions that are established in accordance 
with FFDCA sections 408(e) and 408(l)(6), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal governments, on the relationship between the National Government 
and the States or Tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. 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: June 12, 2024.
Edward Messina,
Director, Office of Pesticide Programs.

    For the reasons stated in the preamble, EPA amends 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.  180.700, add paragraph (b) to read as follows:


Sec.  180.700   Afidopyropen; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of 
afidopyropen, including its metabolites and degradates, in or on the 
commodities in table 3 to this paragraph (b). Compliance with the 
tolerance levels specified in this paragraph (b) is to be determined by 
measuring only afidopyropen, [(3S,4R,4aR,6S,6aS,12R,12aS,12bS)-3-
[(cyclopropylcarbonyl)oxy]-1,3,4,4a,5,6a,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, in or on the

[[Page 51849]]

specified agricultural commodities, resulting from use of the pesticide 
pursuant to FIFRA section 18 emergency exemptions. The tolerances 
expire on the dates specified in table 3 to this paragraph (b).

                        Table 3 to Paragraph (b)
------------------------------------------------------------------------
           Commodity              Parts per million     Expiration date
------------------------------------------------------------------------
Strawberry....................                  0.3          12/31/2027
------------------------------------------------------------------------

* * * * *
[FR Doc. 2024-13447 Filed 6-18-24; 8:45 am]
BILLING CODE 6560-50-P