[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Rules and Regulations]
[Pages 46394-46401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19951]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0416; FRL-9976-65]


Afidopyropen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
afidopyropen, [(3S,4R,4aR,6S,6aS,12R,12aS,12bS)-3-
[(cyclopropylcarbonyl)oxy]-1,3,4,4a,5,6,6a,12,12a,12b-decahydro-

[[Page 46395]]

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 multiple commodities 
which are identified and discussed later in this document. BASF 
Corporation requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 13, 2018. Objections and 
requests for hearings must be received on or before November 13, 2018, 
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-2016-0416, is 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. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, P.E., 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: <a href="/cdn-cgi/l/email-protection#c1938587938faeb5a8a2a4b281a4b1a0efa6aeb7"><span class="__cf_email__" data-cfemail="41130507130f2e3528222432012431206f262e37">[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).
    <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 EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing 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, 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-2016-0416 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 
November 13, 2018. 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-2016-0416, by one of 
the following methods:
    <bullet> 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.
    <bullet> Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Avenue 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 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 Tolerance

    In the Federal Register of August 12, 2016 (81 FR 53380) (FRL-9949-
53), 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 
6F8468) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research 
Triangle Park, NC 27709-3528. The petition requested that 40 CFR part 
180 be amended by establishing permanent tolerances in primary crops 
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, its metabolites, and degradates, in 
or on the following raw agricultural and processed commodities: Almond, 
hulls at 0.15 parts per million (ppm); Apple, wet pomace at 0.05 ppm; 
Citrus, oil at 0.3 ppm; Cotton, gin byproducts at 2 ppm; Cotton, 
undelinted seed at 0.1 ppm; Fruit, citrus, group 10-10 at 0.15 ppm; 
Fruit, pome, group 11-10 at 0.03 ppm; Fruit, stone, group 12-12 at 0.03 
ppm; Nut, tree, group 14-12 at 0.01 ppm; Plum, prune at 0.06 ppm; 
Soybean, aspirated grain fractions at 0.4 ppm; Soybean, seed at 0.01 
ppm; Vegetable, brassica, head and stem, group 5-13 at 0.5 ppm; 
Vegetable, cucurbit, group 9 at 0.7 ppm; Vegetable, fruiting, group 8-
10 at 0.15 ppm; Vegetable, leaf petioles, subgroup 22B at 3 ppm; 
Vegetable, leafy, subgroup 4-13A at 2 ppm; Vegetable, leafy, subgroup 
4-13B at 5 ppm; and Vegetable, tuberous and corm, subgroup 1C at 0.01 
ppm. That document referenced a summary of the petition prepared by 
BASF Corporation, the registrant, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.
    Based upon review of the data supporting the petition and EPA 
policy, the Agency has revised some of the commodity definitions and 
tolerance levels from the petition, and concluded that the following 
tolerances are appropriate for afidopyropen in or on the following 
commodities: Almond, hulls at 0.15 ppm; Apple, wet pomace at 0.05 ppm; 
Brassica, head and stem, group 5-16 at 0.50 ppm; Brassica, leafy 
greens, subgroup 4-16B at 5.0 ppm; Citrus, oil at 0.40 ppm; Cotton, gin

[[Page 46396]]

byproducts at 2.0 ppm; Cotton, undelinted seed at 0.08 ppm; Fruit, 
citrus, group 10-10 at 0.15 ppm; Fruit, pome, group 11-10 at 0.02 ppm; 
Fruit, stone, group 12-12 at 0.03 ppm; Grain, aspirated fractions at 
0.15 ppm; Leafy Greens, subgroup 4-16A at 2.0 ppm; Leaf petiole 
vegetable subgroup 22B at 3.0 ppm; Nut, tree, group 14-12 at 0.01 ppm; 
Soybean, seed at 0.01 ppm; Tomato, dried at 0.50 ppm; Vegetable, 
cucurbit, group 9 at 0.70 ppm; Vegetable, fruiting, group 8-10 at 0.20 
ppm; and Vegetable, tuberous and corm, subgroup 1C at 0.01 ppm. The 
reasons for these changes are explained 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 this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for afidopyropen including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with afidopyropen follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Afidopyropen is classified as category III for acute oral and acute 
dermal, and category IV for acute inhalation, primary eye irritation, 
and dermal irritation. The toxicology database for afidopyropen is 
complete. The target organs identified following exposure to 
afidopyropen are the liver, heart, brain, spleen, and reproductive 
organs of both sexes. The liver is a main target organ in both 
subchronic and chronic oral toxicity studies in all three-species 
tested (i.e., mouse, rat, and dog).
    There was no evidence of neurotoxicity seen in the subchronic 
neurotoxicity study in rats up to the highest dose tested. Afidopyropen 
caused neurotoxic effects in the acute neurotoxicity study; however, 
only at the limit dose of 2,000 milligrams/kilogram/day (mg/kg/day).
    There is evidence of increased susceptibility following pre- and or 
post-natal exposure to afidopyropen. In a prenatal developmental study 
in rats, adverse effects in fetuses included an increased incidence of 
skeletal variations (lumbar ribs), increased ossification of the 
metatarsi, and an altered sex ratio (increased percentage of male 
pups); however, maternal effects were not observed up to the highest 
dose tested. In a second developmental study in rats, adverse fetal 
effects (increased incidence of skeletal variations and supernumerary 
ribs) occurred at a lower dose as compared to maternal effects 
(mortality in one animal). In a developmental study in rabbits, fetal 
developmental and maternal effects occurred at the same dose level. 
Effects included a decreased number of live fetuses, increased early 
resorptions and completely resorbed litters, as well as increased post-
implantation loss. Fetuses also exhibited an altered sex ratio 
(increased percentage of male pups) at this dose level.
    Quantitative susceptibility was also observed in two 2-generation 
rat studies. In the first study, no reproductive or parental effects 
were observed, while offspring effects were decreased absolute body 
weight in both sexes and F1 pup and litter deaths. In the second study, 
offspring effects included decreased absolute body weight and decreased 
spleen and thymus weights in both sexes. Reproductive effects included 
effects on ovary and uterus weight, decreased implantation sites, and 
an altered sex ratio (increased percentage of male pups). In this 
study, the parental and offspring effects occurred at the same dose 
level.
    Afidopyropen did not display systemic effects in the 28-day dermal 
study, even at the limit dose of 1,000 mg/kg/day. There were no adverse 
effects observed in the route-specific dermal toxicity study up to the 
limit dose; however, there is evidence of increased susceptibility 
following pre- and/or post-natal exposure to afidopyropen. As a result, 
an oral point of departure was selected since the dermal toxicity study 
did not evaluate developmental or reproductive endpoints. A point of 
departure (POD) for dermal exposures (all durations) was selected from 
the 2-generation reproduction study in rats, this POD reflects the most 
sensitive endpoint in the database, and is protective of effects 
observed following subchronic exposure, including the fetal effects 
seen in the rat and rabbit developmental studies. This POD is also 
selected for inhalation exposures (all durations), and incidental oral 
and chronic dietary exposures. Chronic dietary was set using 2 co-
critical studies (chronic dog study and 2-generation rat reproduction 
study). For acute dietary exposure, the POD is based on maternal and 
developmental effects (increased early resorptions of litters) observed 
in the rabbit developmental study and is applicable to females of 
childbearing age. An acute dietary POD was not identified for the 
general population because acute effects of concern for this population 
were not observed in the toxicology database.
    In an immunotoxicity study in the rat, there were no adverse 
effects noted up to the highest dose tested.
    Afidopyropen is classified as ``Suggestive Evidence of Carcinogenic 
Potential'' based on benign hepatocellular adenomas in male rats and 
uterine adenocarcinomas and combined adenocarcinomas and adenomas in 
female rats. There is insufficient evidence to support the petition's 
description of a uterine tumor mode-of action (MOA) in female rats. 
There is no concern for mutagenicity. Quantification of human cancer 
risk is not required. The chronic Reference Dose (RfD) will adequately 
account for all chronic toxicity, including carcinogenicity, which 
could result from exposure to afidopyropen.
    More detailed information on the studies received and the nature of 
the adverse effects caused by afidopyropen as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found in the document 
entitled ``Afidopyropen. Human Health Risk Assessment for Section 3 
Requests for a

[[Page 46397]]

New Active Ingredient,'' dated April 4, 2018, by going to http://www.regulations.gov. The referenced document is available in the docket 
established by this action, which is described under ADDRESSES. Locate 
and double-click on the hyperlink for the referenced document to view 
the referenced information on pages 16-23 of 112.

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 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 endpoints for afidopyropen used for 
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Afidopyropen for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/      RfD, PAD, LOC for    Study and toxicological effects
                                      safety factors        risk assessment
----------------------------------------------------------------------------------------------------------------
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+)......  NOAEL = 16 mg/kg/day  Acute RfD = 0.16 mg/  Rabbit Prenatal Developmental
                                    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+).           UFA = 10X...........   mg/kg/day            Chronic Dog Study:
                                   UFH = 10X...........  cPAD = 0.08 mg/kg/    LOAEL = 20 mg/kg/day, based on
                                   FQPA SF = 1X........   day.                  hyaline droplet 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 to 30 days).  NOAEL = 8 mg/kg/day   LOC for MOE = 100...  2-Generation Rat Reproduction
                                   Dermal absorption =                          Study:
                                    15%.                                       Offspring LOAEL = 41 mg/kg/day,
                                   UFA = 10X...........                         based on decreased absolute body
                                   UFH = 10X...........                         weight, and decreased spleen and
                                   FQPA SF = 1X........                         thymus weights of male rats.
----------------------------------------------------------------------------------------------------------------
Inhalation (All durations).......  A point of departure (POD) used for inhalation exposures (all durations) was
                                    selected from the 2-generation rat reproduction study, is the most sensitive
                                    endpoint in the database, and is protective of effects observed following
                                    subchronic exposure, including the fetal effects seen in the rat and rabbit
                                    developmental studies.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``Suggestive Evidence of Carcinogenic Potential[hairsp]''.
----------------------------------------------------------------------------------------------------------------
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. In evaluating dietary 
exposure to afidopyropen, EPA considered exposure under the petitioned-
for tolerances, and assessed dietary exposures from afidopyropen in 
food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. In estimating acute dietary 
(food and drinking water) exposure, EPA used food consumption 
information from the Dietary Exposure Evaluation Model-Food Commodity 
Intake Database (DEEM-FCID<SUP>TM</SUP>, 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 was conducted using recommended tolerance-level 
residues and 100% crop treated assumptions. Empirical and default 
processing factors were used. Screening-level estimated drinking water 
concentrations (EDWCs)

[[Page 46398]]

were incorporated as point estimates, based on surface water modeling. 
The acute EDWC (7.1 ppb) was modeled using the Florida cabbage 
scenario.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used DEEM-FCID<SUP>TM</SUP>, Version 3.16, which 
incorporates 2003-2008 consumption data from the USDA's NHANES/WWEIA. 
The chronic dietary assessment was conducted using recommended 
tolerance-level residues and 100% crop treated assumptions. Empirical 
and default processing factors were used. Screening-level EDWCs were 
incorporated as point estimates, based on surface water modeling. The 
chronic EDWC (3.9 ppb) was modeled using the California lettuce 
scenario.
    iii. Cancer. As explained in unit III.A., 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.
    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. 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 in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of afidopyropen.
    Afidopyropen may be transported to surface water and groundwater 
via runoff, leaching, or spray drift. Afidopyropen is a new chemical; 
therefore, at this point, no monitoring data are available. 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.
    Based on the latest version of the Pesticides in Water Calculator 
(PWC 1.52) and incorporating the Pesticide Root Zone Model for Ground 
Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of 
afidopyropen for acute exposures are estimated to be 7.1 parts per 
billion (ppb) for surface water, and 3.8 x 10<SUP>-</SUP>4 ppb for 
ground water. For chronic exposures for non-cancer assessments, the 
EDWCs are estimated to be 3.9 ppb for surface water and 1.1 x 
10<SUP>-</SUP>4 ppb for ground water.
    Modeled estimates for drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 7.1 ppb was used to assess 
the contribution to drinking water. For chronic and cancer dietary risk 
assessment, the water concentration value of 3.9 ppb was used to assess 
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). The proposed use of 
afidopyropen on ornamentals can be in residential or recreational 
settings. All afidopyropen product labels require users to wear 
specific clothing and PPE (i.e., gloves), and are assumed to be 
marketed for commercial use; therefore, a quantitative residential 
handler assessment was not conducted.
    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 to share a common mechanism of 
toxicity with any other substances. Afidopyropen and another pesticide, 
aminocyclopyrachlor, both produce the common toxic metabolite CPCA; 
however, co-exposure to CPCA from both pesticides are unlikely to 
occur. Drinking water is the only expected exposure pathway for CPCA 
for either pesticide. The likelihood of having ground water residues of 
both afidopyropen and aminocyclopyrachlor at the EDWC predicted in the 
screening ground water modeling in the same location is miniscule for 
the following reasons: Ground water modeling assumes application of a 
chemical at the maximum rate, and the maximum number of applications, 
every year for up to 100 years, and because lateral flow of chemicals 
away from the application site is relatively slow, both chemicals would 
have to be applied in approximately the same location every year at the 
maximum application rates, at maximum numbers of applications for each, 
for the exposures to be additive, and this is not a feasible scenario. 
For the purposes of this tolerance action; therefore, EPA has assumed 
that afidopyropen does not have a common mechanism of toxicity with 
other substances or cause a cumulative effect as a result of the common 
metabolite with aminocyclopyrachlor. 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 http://www.epa.gov/pesticides/cumulative.

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. Pre-natal and post-natal sensitivity. There is evidence of 
increased susceptibility following pre- and or post-natal exposure to 
afidopyropen. In a prenatal developmental study in rats, adverse 
effects in fetuses included an increased incidence of lumbar ribs, 
increased ossification of the metatarsi, and an increased percentage of 
male pups; however, maternal effects were not observed up to the 
highest dose tested. In a second developmental study in rats, adverse 
fetal effects (increased incidence of skeletal variations and 
supernumerary ribs) occurred at a lower dose as compared to maternal 
effects (mortality in one animal). In a developmental study in rabbits, 
fetal developmental and maternal effects (increased early resorptions 
and completely resorbed litters) were observed.
    Quantitative susceptibility was also observed in two 2-generation 
rat studies. In the first study, no reproductive or parental effects 
were observed, while offspring effects were decreased absolute body 
weight in both sexes and F1 pup and litter deaths. In the second study, 
offspring effects included decreased absolute body weight and decreased 
spleen and thymus weights in both sexes. Reproductive effects included 
effects on ovary and uterus

[[Page 46399]]

weight, decreased implantation sites, and an altered sex ratio 
(increased percentage of male pups). In this study, the parental and 
offspring effects occurred at the same dose level.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X for all 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. No evidence of specific 
neurotoxicity was seen in the subchronic neurotoxicity study up to the 
highest dose tested (369/438 mg/kg/day). Afidopyropen caused neurotoxic 
effects in the acute study; however, only at the limit dose.
    Indications of neurotoxicity in mice and dogs were limited to 
vacuolation of white matter and/or spinal cord. The Agency has low 
concern because the nervous tissues in the mouse and dog studies were 
not perfused in-situ; therefore, the vacuolation that was observed is 
more likely an artifact of not preparing the tissues properly. The 
nervous tissue vacuolation seen in the subchronic dog and mice 
(subchronic and chronic) studies occurred at doses 7.5X-115X higher 
than the POD for the chronic dietary risk assessment. As a result, the 
effects are well-characterized with clearly established NOAEL/LOAEL 
values and the selected PODs are protective for the observed neurotoxic 
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 lifestages, the selected PODs are protective of all pre- and 
post-natal toxicity observed throughout the database, and no specific 
neuropathological effects were noted. The adverse neuropathological 
effects observed in the subchronic mouse and dog and the chronic mouse 
studies occurred at doses 7.5X-115X higher than the lowest POD, and the 
rat (species typically used in the DNT) is less sensitive than dogs and 
mice to afidopyropen's putative neurotoxic effects.
    iii. There is evidence of increased susceptibility following pre- 
and/or post-natal exposure to afidopyropen. In pre-natal developmental 
studies in rats, adverse fetal effects occurred at lower doses as 
compared to the maternal generation. In the first 2-generation study, 
offspring effects were observed while no adverse reproductive or 
parental effects occurred. In the second 2-generation study, offspring 
effects occurred at a lower dose as compared to the reproductive and 
parental effects. Clear NOAELs have been established for the 
developmental effects in rats and rabbits as well as the offspring 
effects in the two-generation reproduction studies. The NOAEL used for 
the chronic dietary risk assessment (8 mg/kg/day), based on effects 
observed in the 2-generation reproduction study in rats, is 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 in foods, 
100% CT, default processing factors, and modeled, high-end estimates of 
residues in drinking water. All of 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.

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.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
only to afidopyropen will occupy 3.6% of the aPAD for females, 13-49 
years old. Since there was no acute endpoint identified for the general 
population, an acute dietary exposure assessment was not conducted for 
the U.S. general population and other population subgroups.
    2. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). In estimating 
the short-term aggregate risk, EPA has aggregated the total short-term 
residential exposure and average dietary (food and water) exposure. The 
selected residential exposure scenarios for aggregation, adults and 
children (6 to <11 years old) contacting treated ornamentals, represent 
the worst-case risk estimates and are protective of all other 
lifestages and exposure scenarios. The short-term aggregate MOEs for 
adults (2,000) and children (2,500) are above the LOC (100), and are 
not of concern.
    3. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Because no intermediate-term exposure is anticipated, 
afidopyropen is not expected to pose an intermediate-term aggregate 
risk.
    4. Chronic risk. Chronic aggregate risk assessments address 
exposures that are likely to occur continuously for greater than six 
months. Using the exposure assumptions discussed in this unit for 
chronic exposure, EPA has concluded that chronic dietary exposure to 
afidopyropen from food and water only will occupy 2.2% of the cPAD for 
the U.S. general population, and the population subgroup with the 
highest estimated risk was for children, 1-2 years old at 4.4% of the 
cPAD. Residential exposures to afidopyropen 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 EPA's 
LOC.
    5. Aggregate cancer risk for U.S. population. Afidopyropen is 
classified as having ``Suggestive Evidence of Carcinogenic Potential.'' 
The cRfD (cPAD) is considered to be protective of all chronic toxicity, 
including carcinogenicity, that could result from exposure to 
afidopyropen.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the U.S. general population, or to infants and children from 
aggregate exposure to afidopyropen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Suitable tolerance enforcement methods for plants and livestock 
using liquid chromatography- mass spectrometer/mass spectrometer (LC-
MS/MS) analyses were submitted for the analysis of afidopyropen. The 
reported

[[Page 46400]]

limit of quantitation (LOQ) of each method is 0.01 ppm for 
afidopyropen.

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. Maximum residue limits 
(MRLs) for afidopyropen have not been established by Codex.
    For this pesticide, the U.S. EPA and Health Canada's Pest 
Management Regulatory Agency (PMRA) have conducted a joint review of 
the available data. That review used the Organization for Economic Co-
operation and Development (OECD) calculation procedures to determine 
the appropriate MRLs. Therefore, the EPA tolerance levels are 
harmonized with MRLs to be established by Health Canada's PMRA.

C. Revisions to Petitioned-For Tolerances

    Several of the tolerances requested by the petitioner are different 
from those established in this rule. EPA's tolerance levels are 
expressed to provide sufficient precision for enforcement purposes, and 
this may include the addition of trailing zeros (such as 0.30 ppm 
rather than 0.3 ppm). This is to avoid the situation where rounding of 
an observed violative residue to the level of precision of the 
tolerance expression would result in a residue considered non-violative 
(such as 0.34 ppm being rounded to 0.3 ppm). This revision has been 
made for the following: Brassica, head and stem, group 5-16; Brassica, 
leafy greens, subgroup 4-16B; Cotton, gin byproducts; Leafy Greens, 
subgroup 4-16A; Leaf petiole vegetable subgroup 22B; and Vegetable, 
cucurbit, group 9.
    For citrus oil and cotton, undelinted seed, the levels differ 
because of differences in rounding the values calculated from the 
residue data. The pome fruit tolerance is different because of 
differences in the MRL calculation for pear. Two pear field trials were 
concluded to be replicates for calculation and the petitioner also used 
an additional residue value which is believed to be a transcription 
error. A tolerance for the processed food prunes is not needed because 
residues are not expected to concentrate in prunes. For fruiting 
vegetables, these differences are attributable to the petitioner having 
combined both the bell and non-bell pepper data together for 
calculation. In addition, the petitioner did not request a tolerance 
for the dried tomato processed commodity, but EPA has concluded that 
the tolerance for the crop group will not be adequate to cover that 
commodity. Finally, regarding ``Soybean, aspirated grain fractions,'' 
the tolerance level requested by the petitioner was not consistent with 
data submitted with the petition. EPA reviewed the requested use 
pattern and supporting data, corrected the proposed commodity 
definition, and has decided to establish a tolerance for commodity 
``Grain, aspirated fractions.''

V. Conclusion

    Therefore, tolerances are established for residues of 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 Almond, hulls at 0.15 ppm; Apple, wet pomace at 
0.05 ppm; Brassica, head and stem, group 5-16 at 0.50 ppm; Brassica, 
leafy greens, subgroup 4-16B at 5.0 ppm; Citrus, oil at 0.40 ppm; 
Cotton, gin byproducts at 2.0 ppm; Cotton, undelinted seed at 0.08 ppm; 
Fruit, citrus, group 10-10 at 0.15 ppm; Fruit, pome, group 11-10 at 
0.02 ppm; Fruit, stone, group 12-12 at 0.03 ppm; Grain, aspirated 
fractions at 0.15 ppm; Leafy Greens, subgroup 4-16A at 2.0 ppm; Leaf 
petiole vegetable subgroup 22B at 3.0 ppm; Nut, tree, group 14-12 at 
0.01 ppm; Soybean, seed at 0.01 ppm; Tomato, dried at 0.50 ppm; 
Vegetable, cucurbit, group 9 at 0.70 ppm; Vegetable, fruiting, group 8-
10 at 0.20 ppm; and Vegetable, tuberous and corm, subgroup 1C at 0.01 
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). 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

[[Page 46401]]

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 5, 2018.
Richard P. Keigwin, Jr.,
Director, 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. Add Sec.  180.700 to subpart C to read as follows:


Sec.  [emsp14]180.700  Afidopyropen; Tolerances for residues.

    (a) General. Tolerances are established for residues of 
afidopyropen, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only afidopyropen, 
[(3S,4R,4aR,6S,6aS,12R,12aS,12bS)-3-[(cyclopropylcarbonyl)oxy]-
1,3,4,4a,5,6,6a,12,12a,12b-decahydro-6,12-dihydroxy-4,6a,12b-trimethyl-
11-oxo-9-(3-pyridinyl)-2H,11H-naphtho[2,1-b]pyrano[3,4-e]pyran-4-
yl]methyl cyclopropanecarboxylate, in or on the following food 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        0.15
Apple, wet pomace...........................................        0.05
Brassica, head and stem, group 5-16.........................        0.50
Brassica, leafy greens, subgroup 4-16B......................         5.0
Citrus, oil.................................................        0.40
Cotton, gin byproducts......................................         2.0
Cotton, undelinted seed.....................................        0.08
Fruit, citrus, group 10-10..................................        0.15
Fruit, pome, group 11-10....................................        0.02
Fruit, stone, group 12-12...................................        0.03
Grain, aspirated fractions..................................        0.15
Leafy Greens, subgroup 4-16A................................         2.0
Leaf petiole vegetable subgroup 22B.........................         3.0
Nut, tree, group 14-12......................................        0.01
Soybean, seed...............................................        0.01
Tomato, dried...............................................        0.50
Vegetable, cucurbit, group 9................................        0.70
Vegetable, fruiting, group 8-10.............................        0.20
Vegetable, tuberous and corm, subgroup 1C...................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2018-19951 Filed 9-12-18; 8:45 am]
 BILLING CODE 6560-50-P


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