[Federal Register Volume 85, Number 196 (Thursday, October 8, 2020)]
[Rules and Regulations]
[Pages 63453-63460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21119]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0416 and EPA-HQ-OPP-2019-0101; FRL-10003-93]


Afidopyropen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the 
insecticide afidopyropen, including its metabolites and degradates, in 
or on multiple food and animal commodities identified and discussed 
later in this document. BASF Corporation and the Interregional Research 
Project #4 requested these tolerances under section 346a of the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 8, 2020. Objections and 
requests for hearings must be received on or before December 7, 2020, 
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 dockets for this action, identified by docket 
identification (ID) numbers EPA-HQ-OPP-2016-0416 and EPA-HQ-OPP-2019-
0101, are available at http://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 Building, Room 3334, 1301 Constitution Avenue NW, 
Washington, DC 20460-0001. 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 Public Reading Room is (202) 566-1744, and the 
telephone number for the OPP Docket is (703) 305-5805.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director, 
Registration Division (7505P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Avenue NW, 
Washington, DC 20460-0001; main telephone number: (703) 305-7090; 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).
     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 EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

[[Page 63454]]

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 
numbers EPA-HQ-OPP-2016-0416 and EPA-HQ-OPP-2019-0101 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 December 7, 2020. 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 numbers EPA-HQ-OPP-2016-0416 and EPA-
HQ-OPP-2019-0101, by one of the following methods:
     Federal eRulemaking Portal: http://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 Avenue NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerances

    In the Federal Register of May 9, 2019 (84 FR 20320) (FRL-9992-36), 
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 8E8732) 
by the Interregional Research Project #4 (IR-4), Rutgers, The State 
University of New Jersey, 500 College Road East, Suite 201 W, 
Princeton, NJ 08540-6635. This petition requested that 40 CFR 180.700 
be amended by establishing permanent tolerances 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 Strawberry at 0.15 parts per 
million (ppm) and Vegetable, fruiting, group 8-10 at 0.30 ppm. This 
petition also requested the removal of the existing tolerance for 
Vegetable, fruiting, group 8-10 upon establishment of the new group 8-
10 tolerance. This document referenced a summary of the petition 
prepared by the IR-4, which is available in docket ID EPA-HQ-OPP-2019-
0101, which can be found at http://www.regulations.gov. Comments were 
received on this notice of filing related to the IR-4 petition 
(8E8732). EPA's response to these comments is discussed in Unit IV.C.
    In addition, in the Federal Register of February 11, 2020 (85 FR 
7708) (FRL-10005-02), EPA issued another document pursuant to FFDCA 
section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a 
pesticide petition (PP 9F8734) by BASF Corporation (BASF), 26 Davis 
Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528. This 
petition requested that 40 CFR 180.700 be amended by establishing 
permanent tolerances 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 Alfalfa, seed at 0.30 ppm; Almond, hulls at 0.30 
ppm; Animal feed, nongrass, group 18, forage at 4.0 ppm; Animal feed, 
nongrass, group 18, hay at 9.0 ppm; Animal feed, nongrass, group 18, 
straw at 5.0 ppm; Cattle, meat at 0.25 ppm; Cattle, meat byproducts at 
0.15 ppm; Egg at 0.02 ppm; Goat, meat at 0.25 ppm; Goat, meat 
byproducts at 0.15 ppm; Grain, aspirated fractions at 20 ppm; Grass, 
forage, fodder and hay, group 17 at 10.0 ppm; Hog, meat at 0.02 ppm; 
Hog, meat byproducts at 0.06 ppm; Horse, meat at 0.25 ppm; Horse, meat 
byproducts at 0.15 ppm; Milk at 0.04 ppm; Poultry, meat byproducts at 
0.02 ppm; Sheep, meat at 0.25 ppm; Sheep, meat byproducts at 0.15 ppm; 
Sorghum, grain, forage at 0.30 ppm; Sorghum, grain, grain at 0.20 ppm; 
Sorghum, grain, stover at 0.30 ppm; Sorghum, sweet, grain at 0.20 ppm; 
Sorghum, sweet, forage at 0.30 ppm; Sorghum, sweet, stalk at 0.30 ppm; 
Sorghum, sweet, stover at 0.30 ppm; Soybean, forage at 0.15 ppm; and 
Soybean, hay at 0.40 ppm. This document referenced a summary of the 
petition prepared by BASF, which is available in docket ID EPA-HQ-OPP-
2016-0416 at http://www.regulations.gov. There were no substantive 
comments received in response to the notice of filing related to the 
BASF petition (PP 9F8734).
    Based upon review of the data supporting these petitions and in 
accordance with its authority under FFDCA section 408(d)(1)(A)(i), EPA 
is establishing tolerances that vary from what the petitioners sought. 
The reasons for these changes are explained in detail in Unit IV.D.

III. 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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of these 
actions. EPA has enough 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 
follows.

A. Toxicological Profile for Afidopyropen and Its Metabolite, 
Cyclopropane Carboxylic Acid (CPCA)

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as

[[Page 63455]]

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.
    Applications of afidopyropen result in pesticide chemical residues 
of concern in or on food of both the parent compound afidopyropen and 
its metabolite cyclopropane carboxylic acid (CPCA). Because the parent 
and degradate have different toxicities, EPA assessed aggregate 
exposure from afidopyropen and from CPCA separately as part of the 
effort to evaluate the safety of afidopyropen tolerances. Detailed 
information on the studies received and the nature of the adverse 
effects caused by afidopyropen and CPCA can be found in the following 
documents: (1) ``Afidopyropen. Human Health Risk Assessment for Section 
3 Requests for a New Active Ingredient,'' dated April 4, 2018; (2) 
``Afidopyropen. Human Health Risk Assessment for the Section 3 Request 
for New Use on Animal Feed, Nongrass (Crop Group 18); Grass, forage, 
fodder and Hay (Crop Group 17); and Sorghum, and a Request for 
Increased Application to Tree Nuts,'' dated December 9, 2019; and (3) 
``Afidopyropen. Human Health Risk Assessment for Section 3 Request for 
Greenhouse Use on Cucumber, Strawberry and Vegetable, Fruiting (Group 
8-10),'' dated October 30, 2019, by going to http://www.regulations.gov. The first two listed documents are available in 
docket ID EPA-HQ-OPP-2016-0416. The third listed document is available 
in docket ID EPA-HQ-OPP-2019-0101.

B. 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 (LOC) 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 http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological doses and endpoints selected for use 
in the human health risk assessment for afidopyropen and CPCA is shown 
in Tables 1 and 2 of this Unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Afidopyropen for Use in Dietary and Non-Occupational
                                          Human Health Risk Assessments
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute Dietary (General             An endpoint was not identified because effects of concern for this population
 population).                       were not observed in the toxicology database.
                                  ------------------------------------------------------------------------------
Acute Dietary (Females 13-49       NOAEL = 16 mg/kg/day  Acute RfD = 0.16 mg/ Rabbit Prenatal Developmental
 years old).                       UFA = 10x...........   kg/day.              Study:
                                   UFH = 10x...........  aPAD = 0.16 mg/kg/   Maternal and developmental LOAEL =
                                   FQPA SF = 1x........   day.                 32 mg/kg/day, based on increased
                                                                               early resorptions per litter.
Chronic Dietary (All populations   NOAEL = 8 mg/kg/day.  Chronic RfD = 0.08   2 Co-critical Studies:
 including females 13-49 years     UFA = 10x...........   mg/kg/day.          Chronic Dog Study: LOAEL = 20 mg/
 old).                             UFH = 10x...........  cPAD = 0.08 mg/kg/    kg/day, based on hyaline droplet
                                   FQPA SF = 1x........   day.                 deposition in hepatocytes and
                                                                               vacuolation of the white matter
                                                                               and neuropil of the cerebrum of
                                                                               male dogs.
                                                                              2-Generation Rat Reproduction
                                                                               Study: Offspring LOAEL = 41 mg/kg/
                                                                               day, based on decreased absolute
                                                                               body weight, and decreased spleen
                                                                               and thymus weights of male rats.
Dermal, Short-term (1-30 days)...  NOAEL = 8 mg/kg/day.  LOC for MOE = 100..  2-Generation Rat Reproduction
                                   UFA = 10x...........  Dermal absorption =   Study: Offspring LOAEL = 41 mg/kg/
                                   UFH = 10x...........   15%.                 day, based on decreased absolute
                                   FQPA SF = 1x........                        body weight, and decreased spleen
                                                                               and thymus weights of male rats.
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Cancer (Oral, Dermal, Inhalation)  Classification: ``Suggestive Evidence of Carcinogenic Potential.'' The
                                    chronic RfD will be protective of potential carcinogenicity.
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  Table 2--Summary of Toxicological Doses and Endpoints for CPCA for Use in Dietary and Non-Occupational Human
                                             Health Risk Assessments
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                                     Point of departure and
         Exposure/scenario             uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
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Acute Dietary......................  An endpoint was not identified because effects of concern for this
                                      population were not observed in the toxicology database.
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[[Page 63456]]

 
Chronic Dietary....................  NOAEL = 10 mg/kg/day..  Chronic RfD = 0.1 mg/   Subchronic Rat Study: LOAEL
                                     UFA = 10x.............   kg/day.                 = 30 mg/kg/day, based on
                                     UFH = 10x.............  cPAD = 0.01 mg/kg/day.   clinical chemistry
                                     FQPA SF = 10x.........                           alterations, as well as
                                                                                      microscopic findings in
                                                                                      the liver, thymus heart,
                                                                                      and pancreas.
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Cancer (Oral, Dermal, Inhalation)..  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.
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Tables 1 and 2 abbreviations: Point of Departure (POD) = A data point or an estimated point that is derived from
  observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with
  lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest
  observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human
  (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
  FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose.
  MOE = margin of exposure. LOC = level of concern.

C. 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) as the 
toxicological endpoints are different for these compounds. In 
evaluating dietary exposure to afidopyropen and the metabolite CPCA, 
EPA considered exposure under the petitioned-for tolerances and 
existing tolerances as described below.
    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 
(food + drinking water) exposure for afidopyropen, EPA used food 
consumption information from the Dietary Exposure Evaluation Model-Food 
Commodity Intake Database (DEEM-FCIDTM, Version 3.16), which 
incorporates 2003-2008 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 recommended 
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 
assessment, EPA used DEEM-FCIDTM, Version 3.16, which 
incorporates 2003-2008 consumption data from the USDA's NHANES/WWEIA. 
The chronic dietary assessments for afidopyropen and CPCA were 
conducted using recommended tolerance-level residues and 100 PCT 
assumptions. Empirical and default processing factors were also used.
    iii. Cancer. 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 and/or CPCA; 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 any anticipated residue or PCT information in the 
dietary assessment for afidopyropen or CPCA. Tolerance-level residues 
and 100 PCT 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/or CPCA.
    Afidopyropen and/or CPCA may be transported to surface water and 
groundwater via runoff, leaching, or spray drift. Because the Agency 
does not have comprehensive monitoring data, drinking water 
concentration estimates are made by reliance on simulation or modeling, 
taking into account data on the physical and fate characteristics of 
afidopyropen. Further information regarding EPA drinking water models 
used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    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. Due to differences in 
both structure and mode of action, CPCA is not included in the TTR 
analysis for afidopyropen, and EDWCs were calculated for CPCA 
separately.
    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) and a Percent Cropped Area (PCA) of 
1.0 that are listed on current afidopyropen labels. For afidopyropen in 
surface water, the highest EDWC for the acute assessment is 7.1 ppb and 
for the chronic assessment is 3.9 ppb; for CPCA, the highest EDWCs are 
3.6 ppb for acute assessment and 2.7 ppb for chronic assessment. For 
afidopyropen in groundwater, the highest EDWCs are negligible for acute 
assessment and not expected for chronic assessment; for CPCA, the 
highest EDWCs are 54 ppb for acute assessment and 35 for chronic 
assessment.
    For acute dietary risk assessment for afidopyropen, the EDWC value 
of 7.1 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. 
An acute dietary risk assessment was not conducted for CPCA since an 
acute dietary endpoint was not identified. Therefore, the only EDWC 
used for assessing the contribution to

[[Page 63457]]

drinking water for CPCA is 35 ppb for the chronic dietary risk 
assessment.
    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 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.
    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.''
    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.

D. 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 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.
    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.
    3. Conclusion for CPCA. EPA is 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 CPCA toxicity. No developmental or reproductive toxicity 
studies are available for CPCA to assess pre- and/or post-natal 
toxicity.

E. 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 
CPCA as the toxicological endpoints are different for these compounds.
    1. Acute risk. An acute endpoint for afidopyropen was not 
identified for the U.S. general population because acute effects of 
concern for this population subgroup were not observed in the 
toxicology database; therefore, an acute dietary exposure assessment 
was not conducted for these populations. An acute endpoint for 
afidopyropen was identified for females 13-49 year old, though. Using 
the exposure assumptions discussed in this Unit for acute exposure, the 
estimated acute dietary exposure (food + drinking water) for 
afidopyropen is 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 LOC (<100% of the aPAD). 
An acute dietary endpoint is not identified for CPCA; therefore, the 
Agency does not expect acute risk from exposure to CPCA.
    2. Chronic risk. Using the exposure assumptions discussed in this 
Unit for chronic exposure, the estimated chronic dietary (food + 
drinking water) risk for afidopyropen and for CPCA is below the LOC 
(<100% of the cPAD) for the U.S. general population and all population

[[Page 63458]]

subgroups. The most highly exposed population subgroup is for children 
1-2 years old at 6.5% of the cPAD. The estimated chronic dietary (food 
+ drinking water) risk for CPCA is below the LOC (<100% of the cPAD) 
for the U.S. general population and all subgroups. The most highly 
exposed population subgroup is children 1-2 years old at 30% of the 
cPAD. Residential exposures to afidopyropen or CPCA is 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 considers 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 exposure assessment applies only to 
afidopyropen since residential exposure to CPCA is not expected. The 
short-term aggregate exposure assessment combines residential exposures 
(adults and children (6 to <11 years old contacting previously treated 
ornamentals) and average dietary (food + drinking water) exposures. The 
short-term aggregate MOEs for adults (1,900) and children (1,200) are 
above the LOC (<100) and are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Because no intermediate-term exposure is anticipated, 
afidopyropen and CPCA are not expected to pose an intermediate-term 
aggregate risk.
    5. Aggregate cancer risk for U.S. population. As indicated in Unit 
III.A., afidopyropen and/or CPCA 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/or CPCA; 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, including CPCA 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 new acceptable enforcement method (using LC-MS/MS) has been 
submitted for determining afidopyropen and CPCA 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 in livestock commodities.
    Analytical standards for afidopyropen and CPCA are currently 
unavailable 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, 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). Codex has no established MRLs for afidopyropen.

C. Response to Comments

    Three comments were received in response to the notice of filing 
for the IR-4 petition (PP 8E8732). Two comments opposed the proposed 
tolerances on strawberry and vegetable, fruiting, crop group 8-10 as 
being too high; the other comment was not related to the afidopyropen 
tolerances. The commenters who were concerned that the tolerances were 
too high incorrectly misread the petitioned-for tolerances as 15 ppm 
rather than 0.15 ppm and 20 ppm rather than 0.20 ppm. The Agency is not 
establishing tolerances at those higher levels. Regardless, the 
comments seek even lower tolerances values, essentially no residues of 
the pesticide on strawberries and fruiting vegetables. 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 these afidopyropen tolerances are safe. The commenters have 
provided no information to indicate that afidopyropen is not safe.

D. Revisions to Petitioned-For Tolerances

    Several petitioned-for tolerance levels are different from those 
being established by EPA. Many of these differences are attributable to 
the petitioned-for levels not being consistent with Organization for 
Economic Cooperation and Development (OECD) rounding class practice. 
The Sorghum, grain, grain and Sorghum, sweet, grain tolerance levels 
are lower than the petitioned-for level due to the differences in the 
number of significant figures used in the MRL calculation. EPA is 
establishing a higher tolerance for Grain, aspirated fractions based 
upon calculations using the highest average field trial (HAFT) from 
Sorghum, grain (0.10 ppm) and multiplying that figure by the calculated 
aspirated grains processing factor (PF) of 560x and then rounding up 
using OECD rounding class practice to the tolerance value of 60 ppm.
    Tolerances being established for livestock commodities vary from 
the petitioned-for tolerances due to different models used in 
determining dietary burden and anticipated residues. The petitioner 
proposed tolerances using different models to determine dietary burden 
and scaled anticipated residues from the feeding study at different 
dose levels (transfer factor approach) to calculate a proposed 
tolerance. EPA has determined the appropriate tolerance value using the 
Dietary Burden Calculator PMRA v.2.8 to calculate dietary burden and 
Langmuir Model v.1.5 to determine tolerance level. The difference in 
dietary burden calculations for poultry and swine lead to EPA's 
conclusion that egg, poultry meat byproducts, and hog meat/meat 
byproducts had no reasonable expectation of finite residues, and that 
tolerances are not currently needed for these commodities.
    A tolerance level of 0.30 ppm was proposed for Vegetable, fruiting, 
group 8-10 based on the OECD MRL calculator using the greenhouse pepper 
data,

[[Page 63459]]

although the petitioner pointed out that all residues in the greenhouse 
pepper study were below the current tolerance of 0.20 ppm for 
Vegetable, fruiting, group 8-10. Based on the submitted field trial 
data, residues of afidopyropen in greenhouse-grown commodities in the 
vegetable, fruiting, group 8-10 are not expected to exceed the current 
tolerance of 0.20 ppm. Further, maintaining the current tolerance level 
harmonizes with PMRA's proposed MRL of 0.2 ppm. Therefore, EPA is 
maintaining the tolerance at the current level of 0.20 ppm for 
Vegetable, fruiting, group 8-10 while revising the value to 0.2 ppm to 
be consistent with OECD rounding class practice.

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 Alfalfa, seed at 0.3 ppm; Almond, 
hulls at 0.3 ppm; Animal feed, nongrass, group 18, forage at 4 ppm; 
Animal feed, nongrass, group 18, hay at 9 ppm; Animal feed, nongrass, 
group 18, straw at 5 ppm; Cattle, meat at 0.2 ppm; Cattle, meat 
byproducts at 0.2 ppm; Goat, meat at 0.2 ppm; Goat, meat byproducts at 
0.2 ppm; Grain, aspirated fractions at 60 ppm; Grass, forage, fodder 
and hay, group 17 at 10 ppm; Horse, meat at 0.2 ppm; Horse, meat 
byproducts at 0.2 ppm; Milk at 0.04 ppm; Sheep, meat at 0.2 ppm; Sheep, 
meat byproducts at 0.2 ppm; Sorghum, grain, forage at 0.3 ppm; Sorghum, 
grain, grain at 0.15 ppm; Sorghum, grain, stover at 0.3 ppm; Sorghum, 
sweet, grain at 0.15 ppm; Sorghum, sweet, forage at 0.3 ppm; Sorghum, 
sweet, stalk at 0.3 ppm; Sorghum, sweet, stover at 0.3 ppm; Soybean, 
forage at 0.15 ppm; Soybean, hay at 0.4 ppm; Strawberry at 0.15 ppm, 
and Vegetable, fruiting, group 8-10 at 0.2 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) 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, 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) or Executive Order 13771, 
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 
FR 9339, February 3, 2017). 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 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 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).

VII. 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: September 16, 2020.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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:
0
a. Dedesignate paragraph (a) introductory text as paragraph (a)(1) and 
revise newly designated paragraph (a)(1) introductory text;
0
b. In the table in newly designated paragraph (a)(1):
0
i. Add a heading for the table;
0
ii. Add an entry for ``Alfalfa, seed'' in alphabetical order;
0
iii. Revise the entry for ``Almond, hulls;''
0
iv. Add entries for ``Animal feed, nongrass, group 18, forage,'' 
``Animal feed, nongrass, group 18, hay,'' and ``Animal feed, nongrass, 
group 18, straw'' in alphabetical order;
0
v. Revise the entry for ``Grain, aspirated fractions;''
0
vi. Add entries for ``Grass, forage, fodder and hay, group 17,'' 
``Sorghum, grain, forage,'' ``Sorghum, grain, grain,'' ``Sorghum, 
grain, stover,'' ``Sorghum, sweet, forage,'' ``Sorghum, sweet, grain,'' 
``Sorghum, sweet, stalk,'' ``Sorghum, sweet, stover,'' ``Soybean, 
forage,'' ``Soybean, hay,'' and ``Strawberry'' in alphabetical order; 
and
0
vii. Revise the entry for ``Vegetable, fruiting, group 8-10;'' and
0
c. Add paragraph (a)(2).
    The additions read as follows:

[[Page 63460]]

Sec.  180.700  Afidopyropen; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
afidopyropen, including its metabolites and degradates, in or on the 
commodities in table 1 to this paragraph (a)(1). Compliance with the 
tolerance levels specified in this paragraph (a)(1) 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 
following food commodities:

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Alfalfa, seed...........................................             0.3
Almond, hulls...........................................             0.3
Animal feed, nongrass, group 18, forage.................               4
Animal feed, nongrass, group 18, hay....................               9
Animal feed, nongrass, group 18, straw..................               5
 
                              * * * * * * *
Grain, aspirated fractions..............................              60
Grass, forage, fodder and hay, group 17.................              10
 
                              * * * * * * *
Sorghum, grain, forage..................................             0.3
Sorghum, grain, grain...................................            0.15
Sorghum, grain, stover..................................             0.3
Sorghum, sweet, forage..................................             0.3
Sorghum, sweet, grain...................................            0.15
Sorghum, sweet, stalk...................................             0.3
Sorghum, sweet, stover..................................             0.3
Soybean, forage.........................................            0.15
Soybean, hay............................................             0.4
 
                              * * * * * * *
Strawberry..............................................            0.15
 
                              * * * * * * *
Vegetable, fruiting, group 8-10.........................             0.2
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) Tolerances are established for residues of afidopyropen, 
including its metabolites and degradates, in or on the commodities in 
table 2 to this paragraph (a)(2). Compliance with the tolerance levels 
specified in this paragraph (a)(2) is to be determined by measuring 
only the sum of 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 and its 
metabolite cyclopropanecarboxylic acid carnitine (CPCA-carnitine), 
calculated as the stoichiometric equivalent of afidopyropen in or on 
the following animal commodities:

                       Table 2 to Paragraph (a)(2)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, meat................................................         0.2
Cattle, meat byproducts.....................................         0.2
Goat, meat..................................................         0.2
Goat, meat byproducts.......................................         0.2
Horse, meat.................................................         0.2
Horse, meat byproducts......................................         0.2
Milk........................................................        0.04
Sheep, meat.................................................         0.2
Sheep, meat byproducts......................................         0.2
------------------------------------------------------------------------

* * * * *

[FR Doc. 2020-21119 Filed 10-7-20; 8:45 am]
BILLING CODE 6560-50-P