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[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Rules and Regulations]
[Pages 59627-59634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24467]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0141; FRL-9933-03]

Benzovindiflupyr; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
benzovindiflupyr in or on multiple commodities that are identified and 
discussed later in this document. Syngenta Crop Protection, LLC., 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective October 2, 2015. Objections and 
requests for hearings must be received on or before December 1, 2015, 
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-2013-0141, 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 Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room

[[Page 59628]]

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: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

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 
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-2013-0141 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 1, 2015. 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-2013-0141, 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 Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at 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 June 5, 2013 (78 FR 33785) (FRL-9386-2), 
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of two pesticide petitions (PP 2E8123 
and 2F8121) by Syngenta Crop Protection, LLC., P.O. Box 18300, 
Greensboro, NC 27419. Petition 2E8123 requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of the fungicide, 
benzovindiflupyr in or on coffee, bean, green at 0.09 parts per million 
(ppm) and sugarcane, cane at 0.04 ppm. Petition 2F8121 requested that 
40 CFR part 180 be amended by establishing tolerances for residues of 
the fungicide, benzovindiflupyr in or on apple, wet pomace at 0.6 ppm; 
barley, grain at 1.5 ppm; barley, hay at 15 ppm; barley, straw at 15 
ppm; corn, field, grain at 0.02 ppm; corn, field, forage at 3 ppm; 
corn, field, stover at 15 ppm; corn, pop, grain at 0.02 ppm; corn, pop, 
stover at 15 ppm; corn, sweet, ear at 0.01 ppm; corn, sweet, forage at 
4 ppm; corn, sweet, stover at 5 ppm; cottonseed, subgroup 20C at 0.15 
ppm; cotton, gin byproducts at 3 ppm; vegetables, cucurbits, crop group 
9 at 0.2 ppm; fruits, pome, crop group 11-10 at 0.2 ppm; fruits, small 
vines climbing, except fuzzy kiwi subgroup 13-07F at 1 ppm; grain, 
aspirated fractions at 7 ppm; oat, grain at 1.5 ppm; oat, hay at 15 
ppm; oat, straw at 15 ppm; peas and bean, dried shelled, except 
soybean, subgroup 6C at 0.2 ppm; peas, hay at 7 ppm; peas, vine at 1.5 
ppm; peanut, nutmeat at 0.01 ppm; peanut, hay at 15 ppm; potato, wet 
peel at 0.1 ppm; raisin at 4 ppm; rapeseed, subgroup 20A at 0.15 ppm; 
rye, grain at 0.1 ppm; rye, hay at 15 ppm; rye, straw at 10 ppm; 
soybean, seed at 0.07 ppm; soybean, forage at 15 ppm; soybean, hay at 
50 ppm; vegetables, fruiting, crop group 8-10 at 0.8 ppm; vegetables, 
tuberous and corm subgroup 1C at 0.02 ppm; wheat, grain at 0.1 ppm; 
wheat, forage at 4 ppm; wheat, hay at 15 ppm; wheat, straw at 10 ppm; 
and at 0.01 ppm in or on the following animal commodities: cattle, 
goat, horse, and sheep fat, kidney, liver, meat, and meat byproducts; 
egg; hog, fat, liver, meat, and meat byproducts; milk; milk, fat; and 
poultry, byproducts, fat, liver, meat, and skin.
    That document referenced a summary of the petition prepared by 
Syngenta Crop Protection, the registrant, which is available in the 
docket, http://www.regulations.gov. Comments were received on the 
notice of filing. EPA's response to these comments is discussed in Unit 
IV.C.
    Based upon review of the data supporting the petition, EPA has 
modified the requested tolerances and levels for the reasons 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

[[Page 59629]]

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 benzovindiflupyr including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with 
benzovindiflupyr 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.
    Benzovindiflupyr has low acute toxicity by the dermal and 
inhalation routes, with moderate toxicity via the oral route. It is not 
a dermal sensitizer, but causes mild skin irritation and moderate eye 
irritation. The target organs for effects of benzovindifulpyr are the 
liver, thyroid, and kidneys.
    Benzovindiflupyr produced effects in rat fetuses (i.e. decreased 
fetal weight and ossification) in developmental toxicity studies but 
only at maternally toxic doses. In the rabbit developmental study, 
there were no adverse effects in either the does or the fetuses at the 
highest dose tested. In reproduction studies, offspring effects 
occurred at doses higher than the doses causing parental effects; thus, 
there was no quantitative increase in sensitivity in rat pups. There 
are indications of reproductive toxicity in rats such as decreased 
follicle counts, but these effects did not result in reduced fertility.
    No evidence of specific neurotoxicity was observed in the acute 
neurotoxicity (ACN) or subchronic neurotoxicity (SCN) studies. 
Benzovindiflupyr caused decreased activity and decreased grip strength 
in the neurotoxicity studies; however, there were no supportive 
neurohistopathology in any toxicological study, even at the highest 
doses tested.
    There was no evidence of immune system toxicity in a study 
conducted in the mouse, or in any other toxicity studies in the 
database.
    Benzovindiflupyr caused tumors in the thyroid in the chronic rat 
study at the highest dose tested. In mice, no tumor formation was 
observed. Benzovindiflupyr was negative in all mutagenicity studies. 
Based on the fact that evidence of tumors were found in only one 
species at only the highest dose tested and lack of mutagenicity, the 
Agency has determined that using a non-linear approach (i.e., RfD; 
reference dose) will adequately account for all chronic toxicity, 
including carcinogenicity, that could result from exposure to 
benzovindiflupyr.
    Specific information on the studies received and the nature of the 
adverse effects caused by benzovindiflupyr 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 at http://www.regulations.gov in document Benzovindiflupyr New Active Ingredient 
Human Health Risk Assessment to Support the Proposed Uses on Cereals 
(wheat, triticale, barley, rye, and oat), Blueberries (non-bearing), 
Corn (field, pop, and sweet), Peanuts, Turf, and Ornamentals; Crop 
Groups 8-10, 9, and 11-10; Crop Subgroups 1C, 6C, 13-07F, 20A, and 20C; 
and Establishment of Tolerances on Imported Coffee and Sugarcane in 
docket ID number EPA-HQ-OPP-2013-0141.

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

     Table 1--Summary of Toxicological Doses and Endpoints for Benzovindiflupyr for Use in Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                                                          RfD, PAD, level of       Study and
        Exposure/scenario              Point of        Uncertainty/FQPA    concern for risk      toxicological
                                       departure        safety factors        assessment            effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations,   NOAEL = 10 mg/kg/   UFA = 10x.........  Acute RfD = 0.10    Acute
 including infants and children).  day.               UFH = 10x.........   mg/kg/day.          neurotoxicity
                                                      FQPA SF= 1x.......  aPAD =0.10 mg/kg/    screening battery
                                                                           day.                (rat).
                                                                                              NOAEL = 10 mg/kg/
                                                                                               day.
                                                                                              LOAEL = 30 mg/kg/
                                                                                               day based on
                                                                                               multiple clinical
                                                                                               observations,
                                                                                               decreases in mean
                                                                                               body temperature,
                                                                                               decreases in
                                                                                               locomotor
                                                                                               activity
                                                                                               parameters,
                                                                                               reduced food
                                                                                               consumption and/
                                                                                               or decreases in
                                                                                               mean grip
                                                                                               strength.
----------------------------------------------------------------------------------------------------------------

[[Page 59630]]

 
Chronic dietary (All              Parental/Off-       UFA = 10x.........  Chronic RfD =       2-generation
 populations).                     spring.            UFH = 10x.........   0.082 mg/kg/day.    reproduction
                                  NOAEL = 8.2         FQPA SF= 1x.......  cPAD = 0.082 mg/kg/  study (rat).
                                   (females) mg/kg/                        day.               Parental/Offspring
                                   day.                                                        NOAEL = 8.2 mg/kg/
                                                                                               day (F).
                                                                                              LOAEL = 19.4 mg/kg/
                                                                                               day (F) based on
                                                                                               decreased body
                                                                                               weight and
                                                                                               decreased food
                                                                                               consumption in
                                                                                               parental animals
                                                                                               as well as
                                                                                               increases in
                                                                                               liver weights,
                                                                                               centrilobular
                                                                                               hepatocellular
                                                                                               hypertrophy,
                                                                                               increased
                                                                                               incidence of cell
                                                                                               hypertrophy in
                                                                                               the pars distalis
                                                                                               of the pituitary,
                                                                                               reduced body
                                                                                               weight, delayed
                                                                                               preputial
                                                                                               separation, and
                                                                                               decreased spleen
                                                                                               weights in the F1
                                                                                               and/or F2
                                                                                               offspring.
Incidental oral Short -term (1-   Parental/Off-       UFA = 10x.........  Residential LOC     2-generation
 30 days).                         spring.            UFH = 10x.........   for MOE = 100.      reproduction
                                  NOAEL = 8.2         FQPA SF= 1x.......                       toxicity study
                                   (females) mg/kg/                                            (rat).
                                   day.                                                       Parental/Offspring
                                                                                               NOAEL = 8.2 mg/kg/
                                                                                               day (F).
                                                                                              LOAEL = 19.4 mg/kg/
                                                                                               day (F) based on
                                                                                               decreased body
                                                                                               weight and
                                                                                               decreased food
                                                                                               consumption in
                                                                                               parental animals
                                                                                               as well as
                                                                                               increases in
                                                                                               liver weights,
                                                                                               centrilobular
                                                                                               hepatocellular
                                                                                               hypertrophy,
                                                                                               increased
                                                                                               incidence of cell
                                                                                               hypertrophy in
                                                                                               the pars distalis
                                                                                               of the pituitary,
                                                                                               reduced body
                                                                                               weight, delayed
                                                                                               preputial
                                                                                               separation, and
                                                                                               decreased spleen
                                                                                               weights in the F1
                                                                                               and/or F2
                                                                                               offspring.
Inhalation Short-term (1-30       Parental/Off-       UF A = 10x........  Residential LOC     2-generation
 days) and Intermediate-term (1-   spring NOAEL: 8.2  UF H = 10x........   for MOE = 100.      reproduction
 6 months).                        mg/kg/day (F).     FQPA SF = 1x......                       study (rat).
                                                                                              Parental/Offspring
                                                                                               NOAEL = 8.2 mg/kg/
                                                                                               day (F).
                                                                                              LOAEL = 19.4 mg/kg/
                                                                                               day (F) based on
                                                                                               decreased body
                                                                                               weight and
                                                                                               decreased food
                                                                                               consumption in
                                                                                               parental animals
                                                                                               as well as
                                                                                               increases in
                                                                                               liver weights,
                                                                                               centrilobular
                                                                                               hepatocellular
                                                                                               hypertrophy,
                                                                                               increased
                                                                                               incidence of cell
                                                                                               hypertrophy in
                                                                                               the pars distalis
                                                                                               of the pituitary,
                                                                                               reduced body
                                                                                               weight, delayed
                                                                                               preputial
                                                                                               separation, and
                                                                                               decreased spleen
                                                                                               weights in the F1
                                                                                               and/or F2
                                                                                               offspring.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal,             The Agency is using a non-linear (RfD) approach to assess carcinogenic
 inhalation).                      potential; the RfD would be protective of non-carcinogenic and carcinogenic
                                   effects observed in the rat carcinogenicity study or mode of action studies
                                   conducted at higher doses.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population
  (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term
  risk assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to benzovindiflupyr, EPA considered exposure under the 
petitioned-for tolerances. EPA assessed dietary exposures from 
benzovindiflupyr 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.
    Such effects were identified for benzovindiflupyr. In estimating 
acute dietary exposure, EPA used food consumption information from the 
United States Department of Agriculture (USDA), Nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII). As to residue levels in 
food, EPA conducted a highly conservative acute dietary risk assessment 
which used tolerance-level residues for food except for livestock 
commodities, anticipated residues (based on maximum theoretical diets) 
for livestock commodities, and 100% crop treated for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA, CSFII. As 
to residue levels in food, EPA conducted a highly conservative chronic 
dietary risk assessment which used tolerance-level residues for food, 
anticipated residues (based on maximum theoretical diets) for livestock 
commodities, and 100% crop treated for all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that a nonlinear RfD approach was appropriate for assessing 
cancer risk to benzovindiflupyr; therefore, a separate dietary exposure 
assessment for the purpose of assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Tolerance-level residues for food and anticipated residues (based on 
maximum theoretical diets) for livestock commodities were used and 100% 
CT was assumed for all commodities.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under

[[Page 59631]]

FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for benzovindiflupyr in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of benzovindiflupyr. 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 Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM 
GW), the estimated drinking water concentrations (EDWCs) of 
benzovindiflupyr for acute exposures are estimated to be 8.4 parts per 
billion (ppb) for surface water and 0.14 ppb for ground water. For 
chronic exposures for non-cancer assessments are estimated to be 5.4 
ppb for surface water and http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 
benzovindiflupyr to share a common mechanism of toxicity with any other 
substances, and benzovindiflupyr does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that benzovindiflupyr does 
not have a common mechanism of toxicity with other substances. 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 Web site 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. Prenatal and postnatal sensitivity. Benzovindiflupyr produced 
effects in rat fetuses (i.e. decreased fetal weight and delayed 
ossification) in developmental toxicity studies at maternally toxic 
doses (i.e., ataxia, hunched posture, and decreased activity); the 
Agency does not consider the fetal effects to be evidence of increased 
qualitative susceptibility since ossification is not considered to be a 
malformation and is reversible (based on the reproduction study), and 
maternal effects are fairly severe at the same dose levels. In the 
rabbit developmental study, there were no adverse effects in either the 
dose or the fetuses at the highest dose tested. In rat reproduction 
studies, offspring effects occurred at higher doses higher than those 
causing parental effects, thus there was no quantitative increase in 
sensitivity in rat pups. There were no single-dose developmental 
effects identified in the developmental toxicity studies in rats or 
rabbits. Although decreases in growing follicle counts were noted in 
the reproduction toxicity study, this effect did not result in reduced 
functional fertility in the rat. Furthermore, the antral follicle 
counts at a later stage in development were not decreased, so the 
decreased growing follicle count effect is not considered adverse.
    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. That decision is based on the following 
findings:
    i. The toxicity database for benzovindiflupyr is complete.
    ii. There is no indication that benzovindiflupyr is a neurotoxic

[[Page 59632]]

chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that benzovindiflupyr results in 
increased susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to benzovindiflupyr 
in drinking water. EPA also made conservative assumptions for dietary 
food exposures (residues on food and feed crops based on tolerance 
level residues, assuming 100% crop treated) resulting in high-end 
estimates of dietary food. EPA used similarly conservative assumptions 
based on conservative default (non-chemical specific) assumptions to 
assess postapplication exposure of children, including incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by benzovindiflupyr.

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 
to benzovindiflupyr will occupy 30% of the aPAD for children 1-2 years 
old.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
benzovindiflupyr from food and water will utilize 14% of the cPAD for 
children 1-2 years old. Based on the explanation in Unit III.C.3., 
regarding residential use patterns, chronic residential exposure to 
residues of benzovindiflupyr is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). 
Benzovindiflupyr is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to benzovindiflupyr. Using the 
exposure assumptions described in this unit for short-term exposures, 
EPA has concluded the combined short-term food, water, and residential 
exposures result in aggregate MOEs of >=180,000 for all scenarios. 
Because EPA's level of concern for benzovindiflupyr is a MOE of 100 or 
below, these MOEs 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). Intermediate-term exposures are not likely because of the 
intermittent nature of applications by homeowners and the likely short-
term duration of exposures.
    5. Aggregate cancer risk for U.S. population. Based on the results 
of the chronic risk assessment, the Agency does not expect 
benzovindiflupyr to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to benzovindiflupyr residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (A Quick, Easy, Cheap, Effective, 
Rugged, and Safe (QuEChERS) multi-residue method (EN15662:2009)) is 
available to enforce the tolerance expression. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; email address: residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for benzovindiflupyr.

C. Response to Comments

    EPA received a comment to the notice of filing, which requested 
that the Agency reconsider the acceptable residue levels of toxic 
chemicals on food. The Agency understands the commenter's concerns and 
recognizes that some individuals believe that pesticides should be 
banned on agricultural crops. However, the existing legal framework 
provided by section 408 of the Federal Food, Drug and Cosmetic Act 
(FFDCA) states that tolerances may be set when persons seeking such 
tolerances or exemptions have demonstrated that the pesticide meets the 
safety standard imposed by that statute. This citizen's comment appears 
to be directed at the underlying statute and not EPA's implementation 
of it; the citizen has made no contention that EPA has acted in 
violation of the statutory framework.

D. Revisions to Petitioned-For Tolerances

    Benzovindiflupyr was evaluated by undergoing a global joint review 
between the EPA, the Pest Management Regulatory Agency (PMRA) of 
Canada, and the Federal Commission for the Protection against Sanitary 
Risk (COFEPRIS) of Mexico. Based upon review of the data supporting the 
petition and calculation procedures for tolerance determination, 
several tolerances modifications were required. Specifically, commodity 
definitions were modified for pea, hay; pea, vine; peanut, nutmeat; 
raisin; and potato, processed waste to reflect the current nomenclature 
used by the Agency. Several tolerance levels were adjusted to account 
for differences in the input data used for the calculation procedures 
for tolerance determination. For example, several trials considered to 
be independent trials by the petitioner were determined by the Agency 
to be replicate (not independent) trials and, as such, these data are 
inputed differently than data from independent trails. Based on this 
discrepancy, the Agency is establishing tolerances for the following 
commodities that are different

[[Page 59633]]

from what the petitioner requested: Cattle, fat; cattle, liver; coffee, 
green bean; fruit, pome, group 11-10; goat, fat; goat, liver; horse, 
fat; horse, liver; milk, fat; pea and bean, dried shelled, except 
soybean, subgroup 6C; potato, processed waste; rye, straw; sheep, fat; 
sheep, liver; vegetable, cucurbit, group 9; vegetable, fruiting, group 
8-10; wheat, grain; and wheat, straw. Also, based on the Agency's 
calculation, the available data supports reducing the raisin tolerance 
(from 4 ppm to 3 ppm) and increasing the aspirated grain fractions 
tolerance (from 7 ppm to 15 ppm).
    A tolerance was recommended for lowbush variety of blueberry in 
non-cropping years following a 365-day PHI. However, no tolerance will 
be established on the basis that it would cover non-bearing blueberries 
which are considered to be a non-food use. Also, the petitioner did not 
include this use in their notice filing. Although the petitioner did 
not request a separate tolerance for tomato, dried, tomato processing 
study data show that residues concentrate in dried tomatoes (7.8X). To 
cover the higher residues and to harmonize with Canada, EPA is 
establishing a tolerance for tomato, dried at 4 ppm. Finally, the 
applicant requested tolerances for apple, wet pomace. As a fruit, pome, 
group 11-10 tolerance of 0.2 ppm will cover any potential residues in 
processed apple, a separate tolerance is not needed.

V. Conclusion

    Therefore, tolerances are established for residues of 
benzovindiflupyr, in or on barley, grain at 1.5 ppm; barley, hay at 15 
ppm; barley, straw at 15 ppm; cattle, fat at 0.02 ppm; cattle, liver at 
0.06 ppm; cattle, meat at 0.01 ppm; cattle, meat byproducts, except 
liver at 0.01 ppm; coffee, green bean at 0.09 ppm; corn, field, forage 
at 3.0 ppm; corn, field, grain at 0.02 ppm; corn, field, stover at 15 
ppm; corn, pop, grain at 0.02 ppm; corn, pop, stover at 15 ppm; corn, 
sweet, forage at 4.0 ppm; corn, sweet, kernel plus cob with husks 
removed at 0.01 ppm; corn, sweet, stover at 5.0 ppm; cottonseed, 
subgroup 20C at 0.15 ppm; cotton, gin byproducts at 3.0 ppm; fruit, 
pome, group 11-10 at 0.20 ppm; fruit, small vine climbing, except fuzzy 
kiwifruit, subgroup 13-07F at 1 ppm; goat, fat at 0.02 ppm; goat, liver 
at 0.06 ppm; goat, meat at 0.01 ppm; goat, meat byproducts, except 
liver at 0.01 ppm; grain, aspirated fractions at 15 ppm; horse, fat at 
0.02 ppm; horse, liver at 0.06 ppm; horse, meat at 0.01 ppm; horse, 
meat byproducts, except liver at 0.01 ppm; milk at 0.01 ppm; milk, fat 
at 0.02 ppm; oat, grain at 1.5 ppm; oat, hay at 15 ppm; oat, straw at 
15 ppm; pea and bean, dried shelled, except soybean, subgroup 6C at 
0.20 ppm; pea, field, hay at 7.0 ppm; pea, field, vine at 1.5 ppm; 
peanut at 0.01 ppm; peanut, hay at 15 ppm; potato, processed potato 
waste at 0.10 ppm; grape, raisin at 3.0 ppm; rapeseed, subgroup 20A at 
0.15 ppm; rye, grain at 0.1 ppm; rye, hay at 15 ppm; rye, straw at 15 
ppm; sheep, fat at 0.02 ppm; sheep, liver at 0.06 ppm; sheep, meat at 
0.01 ppm; sheep meat byproducts, except liver at 0.01 ppm; soybean, 
forage at 15 ppm; soybean, hay at 50 ppm; soybean, hulls at 0.20 ppm; 
soybean, seed at 0.07 ppm; sugarcane, cane at 0.04 ppm; tomato, dried 
at 4.0 ppm; vegetable, cucurbit, group 9 at 0.30 ppm; vegetable, 
fruiting, group 8-10 at 1.5 ppm; vegetable, tuberous and corm, subgroup 
1C at 0.02 ppm; wheat, forage at 4 ppm; wheat, grain at 0.10 ppm; 
wheat, hay at 15 ppm; and wheat, straw at 15 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 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: August 28, 2015.
Jack E. Housenger,
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.  180.686 to subpart C to read as follows:

[[Page 59634]]

Sec.  [emsp14]180.686  Benzovindiflupyr; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide benzovindiflupyr, 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 
benzovindiflupyr (N-[9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-
methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-
carboxamide) in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, grain..............................................         1.5
Barley, hay................................................        15.0
Barley, straw..............................................        15.0
Cattle, fat................................................         0.02
Cattle, liver..............................................         0.06
Cattle, meat...............................................         0.01
Cattle, meat byproducts, except liver......................         0.01
Coffee, green bean\1\......................................         0.09
Corn, field, forage........................................         3.0
Corn, field, grain.........................................         0.02
Corn, field, stover........................................        15.0
Corn, pop, grain...........................................         0.02
Corn, pop, stover..........................................        15.0
Corn, sweet, forage........................................         4.0
Corn, sweet, kernel plus cob with husks removed............         0.01
Corn, sweet, stover........................................         5.0
Cottonseed, subgroup 20C...................................         0.15
Cotton, gin byproducts.....................................         3.0
Fruit, pome, group 11-10...................................         0.20
Fruit, small vine climbing, except fuzzy kiwifruit,                 1.0
 subgroup 13-07F...........................................
Goat, fat..................................................         0.02
Goat, liver................................................         0.06
Goat, meat.................................................         0.01
Goat, meat byproducts, except liver........................         0.01
Grain, aspirated fractions.................................        15.0
Grape, raisin..............................................         3.0
Horse, fat.................................................         0.02
Horse, liver...............................................         0.06
Horse, meat................................................         0.01
Horse, meat byproducts, except liver.......................         0.01
Milk.......................................................         0.01
Milk, fat..................................................         0.02
Oat, grain.................................................         1.5
Oat, hay...................................................        15.0
Oat, straw.................................................        15.0
Pea and bean, dried shelled, except soybean, subgroup 6C...         0.20
Pea, field, hay............................................         7.0
Pea, field, vine...........................................         1.5
Peanut.....................................................         0.01
Peanut, hay................................................        15.0
Potato, processed potato waste.............................         0.10
Rapeseed, subgroup 20A.....................................         0.15
Rye, grain.................................................         0.1
Rye, hay...................................................        15.0
Rye, straw.................................................        15.0
Sheep, fat.................................................         0.02
Sheep, liver...............................................         0.06
Sheep, meat................................................         0.01
Sheep meat byproducts, except liver........................         0.01
Soybean, forage............................................        15.0
Soybean, hay...............................................        50.0
Soybean, hulls.............................................         0.20
Soybean, seed..............................................         0.07
Sugarcane, cane\1\.........................................         0.04
Tomato, dried..............................................         4.0
Vegetable, cucurbit, group 9...............................         0.30
Vegetable, fruiting, group 8-10............................         1.5
Vegetable, tuberous and corm, subgroup 1C..................         0.02
Wheat, forage..............................................         4.0
Wheat, grain...............................................         0.10
Wheat, hay.................................................        15.0
Wheat, straw...............................................        15.0
------------------------------------------------------------------------
\1\ There is no U.S. registration for use of benzovindiflupyr.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2015-24467 Filed 10-1-15; 8:45 am]
 BILLING CODE 6560-50-P
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