Rule2024-13447
Afidopyropen; Pesticide Tolerance for Emergency Exemption
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
June 20, 2024
Effective
June 20, 2024
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 119 (Thursday, June 20, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
<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; main telephone
number: (202) 566-1030; email address: <a href="/cdn-cgi/l/email-protection#01534547534f6e7568626472416471602f666e77"><span class="__cf_email__" data-cfemail="62302624302c0d160b010711220712034c050d14">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
[[Page 51844]]
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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 <a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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:
<bullet> Federal eRulemaking Portal: <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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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
[[Page 51845]]
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 <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides</a>.
A summary of the toxicological endpoints 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
[[Page 51846]]
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 <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment#aquatic">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment#aquatic</a>.
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: <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide</a>.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency 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 <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides</a>.
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.
[[Page 51847]]
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: <a href="/cdn-cgi/l/email-protection#463423352f2233232b23322e2922350623362768212930"><span class="__cf_email__" data-cfemail="96e4f3e5fff2e3f3fbf3e2fef9f2e5d6f3e6f7b8f1f9e0">[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 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
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