80_FR_59818 80 FR 59627 - Benzovindiflupyr; Pesticide Tolerances

80 FR 59627 - Benzovindiflupyr; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 191 (October 2, 2015)

Page Range59627-59634
FR Document2015-24467

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).

Federal Register, Volume 80 Issue 191 (Friday, October 2, 2015)
[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Rules and Regulations]
[Pages 59627-59634]
From the Federal Register Online  [www.thefederalregister.org]
[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: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
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 <0.14 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 8.4 parts per billion 
(ppb) for surface water was used to assess the contribution to drinking 
water. For chronic dietary risk assessment, the water concentration of 
value 5.4 ppb for surface water 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).
    Benzovindiflupyr is proposed for registration for the following 
uses that could result in residential exposures: turf (e.g. golf 
courses, recreational parks, home lawns, and sod farms) and ornamentals 
(residential landscape areas). EPA assessed residential exposure using 
the following assumptions. The proposed uses of benzovindiflupyr on 
turf and ornamentals in a residential setting by homeowners may result 
in residential handler (adults who are involved in the pesticide 
application process) exposure.
    Residential handler exposure is expected to be short-term (ST) in 
duration. Intermediate-term (IT) exposures are not likely because of 
the intermittent nature of applications by homeowners. In addition, 
since the toxicity endpoints and PODs are the same for all durations, 
the ST assessment will be protective of any longer term exposures that 
may result from residential uses. Since no dermal hazard was identified 
for benzovindiflupyr in the toxicological database, only inhalation 
exposure assessments were conducted for residential handlers.
    There is the potential for post-application exposure to individuals 
(adults and children) as a result of being in an environment that has 
been previously treated with benzovindiflupyr. Post-application 
inhalation exposures while performing activities in previously treated 
turf or ornamentals are not expected and were not assessed primarily 
due to the very low vapor pressure and the expected dilution in outdoor 
air after an application has occurred. In addition, no dermal hazard 
was identified in the toxicity database for benzovindiflupyr and, 
therefore, a quantitative residential post-application dermal risk 
assessment is not required and was not completed. However, incidental 
oral exposures to children contacting treated turf have been assessed. 
Residential post-application exposures are generally considered to be 
intermittent and short-term in duration. Since the benzovindiflupyr 
toxicity endpoints and PODs are the same regardless of duration, the 
short-term assessment is protective of any longer term exposures that 
may occur from the residential uses of benzovindiflupyr. Further 
information regarding EPA standard assumptions and generic inputs for 
residential exposures may be found at 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: [email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has 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



                                                                          Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Rules and Regulations                                                                59627

                                                                                                     PENNSYLVANIA—1997 ANNUAL PM2.5 NAAQS—Continued
                                                                                                                                      [Primary and secondary]

                                                                                                                                                             Designation a                                   Classification
                                                                           Designated area
                                                                                                                                            Date 1                                Type                   Date 2               Type

                                                      Allegheny County (remainder) .............................                 October 2, 2015 ...............      Attainment.
                                                      Armstrong County (part) ......................................             October 2, 2015 ...............      Attainment.
                                                  Elderton Borough and Plumcreek and Washington
                                                    Townships:
                                                      Beaver County .....................................................        October 2, 2015 ...............      Attainment.
                                                      Butler County .......................................................      October 2, 2015 ...............      Attainment.
                                                      Greene County (part) ...........................................           October 2, 2015 ...............      Attainment.
                                                  Monongahela Township:
                                                      Lawrence County (part) .......................................             October 2, 2015 ...............      Attainment.
                                                  Township of Taylor south of New Castle City:
                                                      Washington County ..............................................           October 2, 2015 ...............      Attainment.
                                                      Westmoreland County ..........................................             October 2, 2015 ...............      Attainment.

                                                               *                            *                            *                            *                       *                      *                    *
                                                      a Includes Indian Country located in each county or area, except as otherwise specified.
                                                      1 This date is 90 days after January 5, 2005, unless otherwise noted.
                                                      2 This date is July 2, 2014, unless otherwise noted.




                                                  *       *        *        *        *

                                                                                                               PENNSYLVANIA—2006 24-HOUR PM2.5 NAAQS
                                                                                                                                      [Primary and secondary]

                                                                                                                                                             Designation a                                   Classification
                                                                           Designated area
                                                                                                                                            Date 1                                Type                   Date 2               Type


                                                            *                          *                                 *                            *                       *                      *                    *
                                                  Pittsburgh-Beaver Valley, PA:
                                                       Allegheny County (remainder) .............................                October 2, 2015 ...............      Attainment.
                                                       Armstrong County (part) ......................................            October 2, 2015 ...............      Attainment.
                                                  Elderton Borough and Plumcreek and Washington
                                                    Townships:
                                                       Beaver County .....................................................       October 2, 2015 ...............      Attainment.
                                                       Butler County .......................................................     October 2, 2015 ...............      Attainment.
                                                       Green County (part) .............................................         October 2, 2015 ...............      Attainment.
                                                  Monongahela Township:
                                                       Lawrence County (part) .......................................            October 2, 2015 ...............      Attainment.
                                                  Township of Taylor south of New Castle City:
                                                       Washington County ..............................................          October 2, 2015 ...............      Attainment.
                                                       Westmoreland County ..........................................            October 2, 2015 ...............      Attainment.

                                                               *                            *                            *                            *                       *                      *                    *
                                                      a Includes   Indian County located in each county or area, except as otherwise specified.
                                                      1 This   date is 30 days after November 13, 2009, unless otherwise noted.
                                                      2 This   date is July 2, 2014, unless otherwise noted.


                                                  *       *        *        *        *                                ACTION:       Final rule.                                     must be filed in accordance with the
                                                  [FR Doc. 2015–24851 Filed 10–1–15; 8:45 am]                                                                                       instructions provided in 40 CFR part
                                                  BILLING CODE 6560–50–P                                              SUMMARY:  This regulation establishes                         178 (see also Unit I.C. of the
                                                                                                                      tolerances for residues of                                    SUPPLEMENTARY INFORMATION).
                                                                                                                      benzovindiflupyr in or on multiple
                                                  ENVIRONMENTAL PROTECTION                                            commodities that are identified and                           ADDRESSES:   The docket for this action,
                                                  AGENCY                                                              discussed later in this document.                             identified by docket identification (ID)
                                                                                                                      Syngenta Crop Protection, LLC.,                               number EPA–HQ–OPP–2013–0141, is
asabaliauskas on DSK5VPTVN1PROD with RULES




                                                  40 CFR Part 180                                                     requested these tolerances under the                          available at http://www.regulations.gov
                                                                                                                      Federal Food, Drug, and Cosmetic Act                          or at the Office of Pesticide Programs
                                                  [EPA–HQ–OPP–2013–0141; FRL–9933–03]                                 (FFDCA).                                                      Regulatory Public Docket (OPP Docket)
                                                                                                                                                                                    in the Environmental Protection Agency
                                                  Benzovindiflupyr; Pesticide Tolerances                              DATES: This regulation is effective                           Docket Center (EPA/DC), West William
                                                                                                                      October 2, 2015. Objections and                               Jefferson Clinton Bldg., Rm. 3334, 1301
                                                  AGENCY: Environmental Protection                                    requests for hearings must be received                        Constitution Ave. NW., Washington, DC
                                                  Agency (EPA).                                                       on or before December 1, 2015, and                            20460–0001. The Public Reading Room


                                             VerDate Sep<11>2014       20:30 Oct 01, 2015       Jkt 238001    PO 00000         Frm 00079   Fmt 4700       Sfmt 4700   E:\FR\FM\02OCR1.SGM   02OCR1


                                                  59628              Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Rules and Regulations

                                                  is open from 8:30 a.m. to 4:30 p.m.,                    mail and hand delivery of objections                  byproducts at 3 ppm; vegetables,
                                                  Monday through Friday, excluding legal                  and hearing requests are provided in 40               cucurbits, crop group 9 at 0.2 ppm;
                                                  holidays. The telephone number for the                  CFR 178.25(b).                                        fruits, pome, crop group 11–10 at 0.2
                                                  Public Reading Room is (202) 566–1744,                    In addition to filing an objection or               ppm; fruits, small vines climbing,
                                                  and the telephone number for the OPP                    hearing request with the Hearing Clerk                except fuzzy kiwi subgroup 13–07F at 1
                                                  Docket is (703) 305–5805. Please review                 as described in 40 CFR part 178, please               ppm; grain, aspirated fractions at 7 ppm;
                                                  the visitor instructions and additional                 submit a copy of the filing (excluding                oat, grain at 1.5 ppm; oat, hay at 15
                                                  information about the docket available                  any Confidential Business Information                 ppm; oat, straw at 15 ppm; peas and
                                                  at http://www.epa.gov/dockets.                          (CBI)) for inclusion in the public docket.            bean, dried shelled, except soybean,
                                                  FOR FURTHER INFORMATION CONTACT:                        Information not marked confidential                   subgroup 6C at 0.2 ppm; peas, hay at 7
                                                  Susan Lewis, Registration Division                      pursuant to 40 CFR part 2 may be                      ppm; peas, vine at 1.5 ppm; peanut,
                                                  (7505P), Office of Pesticide Programs,                  disclosed publicly by EPA without prior               nutmeat at 0.01 ppm; peanut, hay at 15
                                                  Environmental Protection Agency, 1200                   notice. Submit the non-CBI copy of your               ppm; potato, wet peel at 0.1 ppm; raisin
                                                  Pennsylvania Ave. NW., Washington,                      objection or hearing request, identified              at 4 ppm; rapeseed, subgroup 20A at
                                                  DC 20460–0001; main telephone                           by docket ID number EPA–HQ–OPP–                       0.15 ppm; rye, grain at 0.1 ppm; rye, hay
                                                  number: (703) 305–7090; email address:                  2013–0141, by one of the following                    at 15 ppm; rye, straw at 10 ppm;
                                                  RDFRNotices@epa.gov.                                    methods:                                              soybean, seed at 0.07 ppm; soybean,
                                                                                                            • Federal eRulemaking Portal: http://               forage at 15 ppm; soybean, hay at 50
                                                  SUPPLEMENTARY INFORMATION:
                                                                                                          www.regulations.gov. Follow the online                ppm; vegetables, fruiting, crop group 8–
                                                  I. General Information                                  instructions for submitting comments.                 10 at 0.8 ppm; vegetables, tuberous and
                                                                                                          Do not submit electronically any                      corm subgroup 1C at 0.02 ppm; wheat,
                                                  A. Does this action apply to me?                        information you consider to be CBI or                 grain at 0.1 ppm; wheat, forage at 4
                                                     You may be potentially affected by                   other information whose disclosure is                 ppm; wheat, hay at 15 ppm; wheat,
                                                  this action if you are an agricultural                  restricted by statute.                                straw at 10 ppm; and at 0.01 ppm in or
                                                  producer, food manufacturer, or                           • Mail: OPP Docket, Environmental                   on the following animal commodities:
                                                  pesticide manufacturer. The following                   Protection Agency Docket Center (EPA/                 cattle, goat, horse, and sheep fat, kidney,
                                                  list of North American Industrial                       DC), (28221T), 1200 Pennsylvania Ave.                 liver, meat, and meat byproducts; egg;
                                                  Classification System (NAICS) codes is                  NW., Washington, DC 20460–0001.                       hog, fat, liver, meat, and meat
                                                  not intended to be exhaustive, but rather                 • Hand Delivery: To make special                    byproducts; milk; milk, fat; and poultry,
                                                  provides a guide to help readers                        arrangements for hand delivery or                     byproducts, fat, liver, meat, and skin.
                                                  determine whether this document                         delivery of boxed information, please                    That document referenced a summary
                                                  applies to them. Potentially affected                   follow the instructions at http://                    of the petition prepared by Syngenta
                                                  entities may include:                                   www.epa.gov/dockets/contacts.html.                    Crop Protection, the registrant, which is
                                                     • Crop production (NAICS code 111).                    Additional instructions on                          available in the docket, http://
                                                     • Animal production (NAICS code                      commenting or visiting the docket,                    www.regulations.gov. Comments were
                                                  112).                                                   along with more information about                     received on the notice of filing. EPA’s
                                                     • Food manufacturing (NAICS code                     dockets generally, is available at http://            response to these comments is
                                                  311).                                                   www.epa.gov/dockets.                                  discussed in Unit IV.C.
                                                     • Pesticide manufacturing (NAICS                     II. Summary of Petitioned-For                            Based upon review of the data
                                                  code 32532).                                            Tolerance                                             supporting the petition, EPA has
                                                                                                                                                                modified the requested tolerances and
                                                  B. How can I get electronic access to                      In the Federal Register of June 5, 2013            levels for the reasons explained in Unit
                                                  other related information?                              (78 FR 33785) (FRL–9386–2), EPA                       IV.D.
                                                     You may access a frequently updated                  issued a document pursuant to FFDCA
                                                  electronic version of EPA’s tolerance                   section 408(d)(3), 21 U.S.C. 346a(d)(3),              III. Aggregate Risk Assessment and
                                                  regulations at 40 CFR part 180 through                  announcing the filing of two pesticide                Determination of Safety
                                                  the Government Printing Office’s e-CFR                  petitions (PP 2E8123 and 2F8121) by                      Section 408(b)(2)(A)(i) of FFDCA
                                                  site at http://www.ecfr.gov/cgi-bin/text-               Syngenta Crop Protection, LLC., P.O.                  allows EPA to establish a tolerance (the
                                                  idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                    Box 18300, Greensboro, NC 27419.                      legal limit for a pesticide chemical
                                                  40tab_02.tpl.                                           Petition 2E8123 requested that 40 CFR                 residue in or on a food) only if EPA
                                                                                                          part 180 be amended by establishing                   determines that the tolerance is ‘‘safe.’’
                                                  C. How can I file an objection or hearing               tolerances for residues of the fungicide,             Section 408(b)(2)(A)(ii) of FFDCA
                                                  request?                                                benzovindiflupyr in or on coffee, bean,               defines ‘‘safe’’ to mean that ‘‘there is a
                                                    Under FFDCA section 408(g), 21                        green at 0.09 parts per million (ppm)                 reasonable certainty that no harm will
                                                  U.S.C. 346a, any person may file an                     and sugarcane, cane at 0.04 ppm.                      result from aggregate exposure to the
                                                  objection to any aspect of this regulation              Petition 2F8121 requested that 40 CFR                 pesticide chemical residue, including
                                                  and may also request a hearing on those                 part 180 be amended by establishing                   all anticipated dietary exposures and all
                                                  objections. You must file your objection                tolerances for residues of the fungicide,             other exposures for which there is
                                                  or request a hearing on this regulation                 benzovindiflupyr in or on apple, wet                  reliable information.’’ This includes
                                                  in accordance with the instructions                     pomace at 0.6 ppm; barley, grain at 1.5               exposure through drinking water and in
                                                  provided in 40 CFR part 178. To ensure                  ppm; barley, hay at 15 ppm; barley,                   residential settings, but does not include
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                                                  proper receipt by EPA, you must                         straw at 15 ppm; corn, field, grain at                occupational exposure. Section
                                                  identify docket ID number EPA–HQ–                       0.02 ppm; corn, field, forage at 3 ppm;               408(b)(2)(C) of FFDCA requires EPA to
                                                  OPP–2013–0141 in the subject line on                    corn, field, stover at 15 ppm; corn, pop,             give special consideration to exposure
                                                  the first page of your submission. All                  grain at 0.02 ppm; corn, pop, stover at               of infants and children to the pesticide
                                                  objections and requests for a hearing                   15 ppm; corn, sweet, ear at 0.01 ppm;                 chemical residue in establishing a
                                                  must be in writing, and must be                         corn, sweet, forage at 4 ppm; corn,                   tolerance and to ‘‘ensure that there is a
                                                  received by the Hearing Clerk on or                     sweet, stover at 5 ppm; cottonseed,                   reasonable certainty that no harm will
                                                  before December 1, 2015. Addresses for                  subgroup 20C at 0.15 ppm; cotton, gin                 result to infants and children from


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                                                                       Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Rules and Regulations                                           59629

                                                  aggregate exposure to the pesticide                     pups. There are indications of                          10, 9, and 11–10; Crop Subgroups 1C,
                                                  chemical residue . . . .’’                              reproductive toxicity in rats such as                   6C, 13–07F, 20A, and 20C; and
                                                    Consistent with FFDCA section                         decreased follicle counts, but these                    Establishment of Tolerances on
                                                  408(b)(2)(D), and the factors specified in              effects did not result in reduced fertility.            Imported Coffee and Sugarcane in
                                                  FFDCA section 408(b)(2)(D), EPA has                        No evidence of specific neurotoxicity                docket ID number EPA–HQ–OPP–2013–
                                                  reviewed the available scientific data                  was observed in the acute neurotoxicity                 0141.
                                                  and other relevant information in                       (ACN) or subchronic neurotoxicity
                                                                                                                                                                  B. Toxicological Points of Departure/
                                                  support of this action. EPA has                         (SCN) studies. Benzovindiflupyr caused
                                                                                                                                                                  Levels of Concern
                                                  sufficient data to assess the hazards of                decreased activity and decreased grip
                                                  and to make a determination on                          strength in the neurotoxicity studies;                     Once a pesticide’s toxicological
                                                  aggregate exposure for benzovindiflupyr                 however, there were no supportive                       profile is determined, EPA identifies
                                                  including exposure resulting from the                   neurohistopathology in any                              toxicological points of departure (POD)
                                                  tolerances established by this action.                  toxicological study, even at the highest                and levels of concern to use in
                                                  EPA’s assessment of exposures and risks                 doses tested.                                           evaluating the risk posed by human
                                                  associated with benzovindiflupyr                           There was no evidence of immune                      exposure to the pesticide. For hazards
                                                  follows.                                                system toxicity in a study conducted in                 that have a threshold below which there
                                                                                                          the mouse, or in any other toxicity                     is no appreciable risk, the toxicological
                                                  A. Toxicological Profile                                studies in the database.                                POD is used as the basis for derivation
                                                     EPA has evaluated the available                         Benzovindiflupyr caused tumors in                    of reference values for risk assessment.
                                                  toxicity data and considered its validity,              the thyroid in the chronic rat study at                 PODs are developed based on a careful
                                                  completeness, and reliability as well as                the highest dose tested. In mice, no                    analysis of the doses in each
                                                  the relationship of the results of the                  tumor formation was observed.                           toxicological study to determine the
                                                  studies to human risk. EPA has also                     Benzovindiflupyr was negative in all                    dose at which no adverse effects are
                                                  considered available information                        mutagenicity studies. Based on the fact                 observed (the NOAEL) and the lowest
                                                  concerning the variability of the                       that evidence of tumors were found in                   dose at which adverse effects of concern
                                                  sensitivities of major identifiable                     only one species at only the highest                    are identified (the LOAEL). Uncertainty/
                                                  subgroups of consumers, including                       dose tested and lack of mutagenicity,                   safety factors are used in conjunction
                                                  infants and children.                                   the Agency has determined that using a                  with the POD to calculate a safe
                                                     Benzovindiflupyr has low acute                       non-linear approach (i.e., RfD; reference               exposure level—generally referred to as
                                                  toxicity by the dermal and inhalation                   dose) will adequately account for all                   a population-adjusted dose (PAD) or a
                                                  routes, with moderate toxicity via the                  chronic toxicity, including                             reference dose (RfD)—and a safe margin
                                                  oral route. It is not a dermal sensitizer,              carcinogenicity, that could result from                 of exposure (MOE). For non-threshold
                                                  but causes mild skin irritation and                     exposure to benzovindiflupyr.                           risks, the Agency assumes that any
                                                  moderate eye irritation. The target                        Specific information on the studies                  amount of exposure will lead to some
                                                  organs for effects of benzovindifulpyr                  received and the nature of the adverse                  degree of risk. Thus, the Agency
                                                  are the liver, thyroid, and kidneys.                    effects caused by benzovindiflupyr as                   estimates risk in terms of the probability
                                                     Benzovindiflupyr produced effects in                 well as the no-observed-adverse-effect-                 of an occurrence of the adverse effect
                                                  rat fetuses (i.e. decreased fetal weight                level (NOAEL) and the lowest-observed-                  expected in a lifetime. For more
                                                  and ossification) in developmental                      adverse-effect-level (LOAEL) from the                   information on the general principles
                                                  toxicity studies but only at maternally                 toxicity studies can be found at http://                EPA uses in risk characterization and a
                                                  toxic doses. In the rabbit developmental                www.regulations.gov in document                         complete description of the risk
                                                  study, there were no adverse effects in                 Benzovindiflupyr New Active                             assessment process, see http://
                                                  either the does or the fetuses at the                   Ingredient Human Health Risk                            www.epa.gov/pesticides/factsheets/
                                                  highest dose tested. In reproduction                    Assessment to Support the Proposed                      riskassess.htm. A summary of the
                                                  studies, offspring effects occurred at                  Uses on Cereals (wheat, triticale, barley,              toxicological endpoints for
                                                  doses higher than the doses causing                     rye, and oat), Blueberries (non-bearing),               benzovindiflupyr used for human risk
                                                  parental effects; thus, there was no                    Corn (field, pop, and sweet), Peanuts,                  assessment is shown in Table 1 of this
                                                  quantitative increase in sensitivity in rat             Turf, and Ornamentals; Crop Groups 8–                   unit.

                                                     TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR BENZOVINDIFLUPYR FOR USE IN HUMAN HEALTH
                                                                                             RISK ASSESSMENT
                                                                                                                                RfD, PAD, level of
                                                                                  Point of            Uncertainty/FQPA
                                                   Exposure/scenario                                                             concern for risk                    Study and toxicological effects
                                                                                 departure              safety factors             assessment

                                                  Acute dietary (All       NOAEL = 10 mg/            UFA = 10x ............    Acute RfD = 0.10         Acute neurotoxicity screening battery (rat).
                                                    populations, in-        kg/day.                  UFH = 10x                   mg/kg/day.             NOAEL = 10 mg/kg/day.
                                                    cluding infants                                  FQPA SF= 1x               aPAD =0.10 mg/           LOAEL = 30 mg/kg/day based on multiple clinical obser-
                                                    and children).                                                               kg/day                   vations, decreases in mean body temperature, de-
                                                                                                                                                          creases in locomotor activity parameters, reduced food
                                                                                                                                                          consumption and/or decreases in mean grip strength.
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                                                  59630              Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Rules and Regulations

                                                     TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR BENZOVINDIFLUPYR FOR USE IN HUMAN HEALTH
                                                                                       RISK ASSESSMENT—Continued
                                                                                                                                RfD, PAD, level of
                                                                                  Point of            Uncertainty/FQPA
                                                   Exposure/scenario                                                             concern for risk                    Study and toxicological effects
                                                                                 departure              safety factors             assessment

                                                  Chronic dietary (All     Parental/Off-spring       UFA = 10x ............    Chronic RfD =      2-generation reproduction study (rat).
                                                    populations).          NOAEL = 8.2 (fe-          UFH = 10x                   0.082 mg/kg/day. Parental/Offspring NOAEL = 8.2 mg/kg/day (F).
                                                                             males) mg/kg/           FQPA SF= 1x               cPAD = 0.082 mg/ LOAEL = 19.4 mg/kg/day (F) based on decreased body
                                                                             day.                                                kg/day.            weight and decreased food consumption in parental
                                                                                                                                                    animals as well as increases in liver weights,
                                                                                                                                                    centrilobular hepatocellular hypertrophy, increased inci-
                                                                                                                                                    dence of cell hypertrophy in the pars distalis of the pi-
                                                                                                                                                    tuitary, reduced body weight, delayed preputial separa-
                                                                                                                                                    tion, and decreased spleen weights in the F1 and/or F2
                                                                                                                                                    offspring.
                                                  Incidental oral Short    Parental/Off-spring       UFA = 10x ............    Residential LOC    2-generation reproduction toxicity study (rat).
                                                    –term (1–30            NOAEL = 8.2 (fe-          UFH = 10x                   for MOE = 100.   Parental/Offspring NOAEL = 8.2 mg/kg/day (F).
                                                    days).                   males) mg/kg/           FQPA SF= 1x                                  LOAEL = 19.4 mg/kg/day (F) based on decreased body
                                                                             day                                                                    weight and decreased food consumption in parental
                                                                                                                                                    animals as well as increases in liver weights,
                                                                                                                                                    centrilobular hepatocellular hypertrophy, increased inci-
                                                                                                                                                    dence of cell hypertrophy in the pars distalis of the pi-
                                                                                                                                                    tuitary, reduced body weight, delayed preputial separa-
                                                                                                                                                    tion, and decreased spleen weights in the F1 and/or F2
                                                                                                                                                    offspring.
                                                  Inhalation Short-        Parental/Off-spring       UF A = 10x ...........    Residential LOC    2-generation reproduction study (rat).
                                                    term (1–30 days)         NOAEL: 8.2 mg/          UF H = 10x                  for MOE = 100.   Parental/Offspring NOAEL = 8.2 mg/kg/day (F).
                                                    and Intermediate-        kg/day (F).             FQPA SF = 1x                                 LOAEL = 19.4 mg/kg/day (F) based on decreased body
                                                    term (1–6                                                                                       weight and decreased food consumption in parental
                                                    months).                                                                                        animals as well as increases in liver weights,
                                                                                                                                                    centrilobular hepatocellular hypertrophy, increased inci-
                                                                                                                                                    dence of cell hypertrophy in the pars distalis of the pi-
                                                                                                                                                    tuitary, reduced body weight, delayed preputial separa-
                                                                                                                                                    tion, and decreased spleen weights in the F1 and/or F2
                                                                                                                                                    offspring.

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


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                                                                     Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Rules and Regulations                                        59631

                                                  FFDCA section 408(f)(1). Data will be                   toxicity endpoints and PODs are the                   the cumulative effects of such
                                                  required to be submitted no later than                  same for all durations, the ST                        chemicals, see EPA’s Web site at http://
                                                  5 years from the date of issuance of                    assessment will be protective of any                  www.epa.gov/pesticides/cumulative.
                                                  these tolerances.                                       longer term exposures that may result
                                                     2. Dietary exposure from drinking                                                                          D. Safety Factor for Infants and
                                                                                                          from residential uses. Since no dermal
                                                  water. The Agency used screening-level                                                                        Children
                                                                                                          hazard was identified for
                                                  water exposure models in the dietary                    benzovindiflupyr in the toxicological                    1. In general. Section 408(b)(2)(C) of
                                                  exposure analysis and risk assessment                   database, only inhalation exposure                    FFDCA provides that EPA shall apply
                                                  for benzovindiflupyr in drinking water.                 assessments were conducted for                        an additional tenfold (10X) margin of
                                                  These simulation models take into                       residential handlers.                                 safety for infants and children in the
                                                  account data on the physical, chemical,                    There is the potential for post-                   case of threshold effects to account for
                                                  and fate/transport characteristics of                   application exposure to individuals                   prenatal and postnatal toxicity and the
                                                  benzovindiflupyr. Further information                   (adults and children) as a result of being            completeness of the database on toxicity
                                                  regarding EPA drinking water models                     in an environment that has been                       and exposure unless EPA determines
                                                  used in pesticide exposure assessment                   previously treated with                               based on reliable data that a different
                                                  can be found at http://www.epa.gov/                     benzovindiflupyr. Post-application                    margin of safety will be safe for infants
                                                  oppefed1/models/water/index.htm.                        inhalation exposures while performing                 and children. This additional margin of
                                                     Based on the Pesticide Root Zone                     activities in previously treated turf or              safety is commonly referred to as the
                                                  Model/Exposure Analysis Modeling                        ornamentals are not expected and were                 FQPA Safety Factor (SF). In applying
                                                  System (PRZM/EXAMS) and Pesticide                       not assessed primarily due to the very                this provision, EPA either retains the
                                                  Root Zone Model Ground Water (PRZM                      low vapor pressure and the expected                   default value of 10X, or uses a different
                                                  GW), the estimated drinking water                       dilution in outdoor air after an                      additional safety factor when reliable
                                                  concentrations (EDWCs) of                               application has occurred. In addition,                data available to EPA support the choice
                                                  benzovindiflupyr for acute exposures                    no dermal hazard was identified in the                of a different factor.
                                                  are estimated to be 8.4 parts per billion               toxicity database for benzovindiflupyr                   2. Prenatal and postnatal sensitivity.
                                                  (ppb) for surface water and 0.14 ppb for                and, therefore, a quantitative residential            Benzovindiflupyr produced effects in
                                                  ground water. For chronic exposures for                 post-application dermal risk assessment               rat fetuses (i.e. decreased fetal weight
                                                  non-cancer assessments are estimated to                 is not required and was not completed.                and delayed ossification) in
                                                  be 5.4 ppb for surface water and <0.14                  However, incidental oral exposures to                 developmental toxicity studies at
                                                  ppb for ground water.                                   children contacting treated turf have                 maternally toxic doses (i.e., ataxia,
                                                     Modeled estimates of drinking water                  been assessed. Residential post-                      hunched posture, and decreased
                                                  concentrations were directly entered                    application exposures are generally                   activity); the Agency does not consider
                                                  into the dietary exposure model. For                    considered to be intermittent and short-              the fetal effects to be evidence of
                                                  acute dietary risk assessment, the water                term in duration. Since the                           increased qualitative susceptibility
                                                  concentration value of 8.4 parts per                    benzovindiflupyr toxicity endpoints and               since ossification is not considered to be
                                                  billion (ppb) for surface water was used                PODs are the same regardless of                       a malformation and is reversible (based
                                                  to assess the contribution to drinking                  duration, the short-term assessment is                on the reproduction study), and
                                                  water. For chronic dietary risk                         protective of any longer term exposures               maternal effects are fairly severe at the
                                                  assessment, the water concentration of                  that may occur from the residential uses              same dose levels. In the rabbit
                                                  value 5.4 ppb for surface water was used                of benzovindiflupyr. Further                          developmental study, there were no
                                                  to assess the contribution to drinking                  information regarding EPA standard                    adverse effects in either the dose or the
                                                  water.                                                  assumptions and generic inputs for                    fetuses at the highest dose tested. In rat
                                                     3. From non-dietary exposure. The                    residential exposures may be found at                 reproduction studies, offspring effects
                                                  term ‘‘residential exposure’’ is used in                http://www.epa.gov/pesticides/trac/                   occurred at higher doses higher than
                                                  this document to refer to non-                          science/trac6a05.pdf.                                 those causing parental effects, thus there
                                                  occupational, non-dietary exposure                         4. Cumulative effects from substances              was no quantitative increase in
                                                  (e.g., for lawn and garden pest control,                with a common mechanism of toxicity.                  sensitivity in rat pups. There were no
                                                  indoor pest control, termiticides, and                  Section 408(b)(2)(D)(v) of FFDCA                      single-dose developmental effects
                                                  flea and tick control on pets).                         requires that, when considering whether               identified in the developmental toxicity
                                                     Benzovindiflupyr is proposed for                     to establish, modify, or revoke a                     studies in rats or rabbits. Although
                                                  registration for the following uses that                tolerance, the Agency consider                        decreases in growing follicle counts
                                                  could result in residential exposures:                  ‘‘available information’’ concerning the              were noted in the reproduction toxicity
                                                  turf (e.g. golf courses, recreational parks,            cumulative effects of a particular                    study, this effect did not result in
                                                  home lawns, and sod farms) and                          pesticide’s residues and ‘‘other                      reduced functional fertility in the rat.
                                                  ornamentals (residential landscape                      substances that have a common                         Furthermore, the antral follicle counts at
                                                  areas). EPA assessed residential                        mechanism of toxicity.’’ EPA has not                  a later stage in development were not
                                                  exposure using the following                            found benzovindiflupyr to share a                     decreased, so the decreased growing
                                                  assumptions. The proposed uses of                       common mechanism of toxicity with                     follicle count effect is not considered
                                                  benzovindiflupyr on turf and                            any other substances, and                             adverse.
                                                  ornamentals in a residential setting by                 benzovindiflupyr does not appear to                      3. Conclusion. EPA has determined
                                                  homeowners may result in residential                    produce a toxic metabolite produced by                that reliable data show the safety of
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                                                  handler (adults who are involved in the                 other substances. For the purposes of                 infants and children would be
                                                  pesticide application process) exposure.                this tolerance action, therefore, EPA has             adequately protected if the FQPA SF
                                                     Residential handler exposure is                      assumed that benzovindiflupyr does not                were reduced to 1X. That decision is
                                                  expected to be short-term (ST) in                       have a common mechanism of toxicity                   based on the following findings:
                                                  duration. Intermediate-term (IT)                        with other substances. For information                   i. The toxicity database for
                                                  exposures are not likely because of the                 regarding EPA’s efforts to determine                  benzovindiflupyr is complete.
                                                  intermittent nature of applications by                  which chemicals have a common                            ii. There is no indication that
                                                  homeowners. In addition, since the                      mechanism of toxicity and to evaluate                 benzovindiflupyr is a neurotoxic


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                                                  59632              Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Rules and Regulations

                                                  chemical and there is no need for a                     exposure level). Benzovindiflupyr is                  Organization/World Health
                                                  developmental neurotoxicity study or                    currently registered for uses that could              Organization food standards program,
                                                  additional UFs to account for                           result in short-term residential                      and it is recognized as an international
                                                  neurotoxicity.                                          exposure, and the Agency has                          food safety standards-setting
                                                     iii. There is no evidence that                       determined that it is appropriate to                  organization in trade agreements to
                                                  benzovindiflupyr results in increased                   aggregate chronic exposure through food               which the United States is a party. EPA
                                                  susceptibility in in utero rats or rabbits              and water with short-term residential                 may establish a tolerance that is
                                                  in the prenatal developmental studies or                exposures to benzovindiflupyr. Using                  different from a Codex MRL; however,
                                                  in young rats in the 2-generation                       the exposure assumptions described in                 FFDCA section 408(b)(4) requires that
                                                  reproduction study.                                     this unit for short-term exposures, EPA               EPA explain the reasons for departing
                                                     iv. There are no residual uncertainties              has concluded the combined short-term                 from the Codex level.
                                                  identified in the exposure databases.                   food, water, and residential exposures                   The Codex has not established a MRL
                                                  EPA made conservative (protective)                      result in aggregate MOEs of ≥180,000 for              for benzovindiflupyr.
                                                  assumptions in the ground and surface                   all scenarios. Because EPA’s level of
                                                  water modeling used to assess exposure                                                                        C. Response to Comments
                                                                                                          concern for benzovindiflupyr is a MOE
                                                  to benzovindiflupyr in drinking water.                  of 100 or below, these MOEs are not of                   EPA received a comment to the notice
                                                  EPA also made conservative                              concern.                                              of filing, which requested that the
                                                  assumptions for dietary food exposures                     4. Intermediate-term risk.                         Agency reconsider the acceptable
                                                  (residues on food and feed crops based                  Intermediate-term aggregate exposure                  residue levels of toxic chemicals on
                                                  on tolerance level residues, assuming                   takes into account intermediate-term                  food. The Agency understands the
                                                  100% crop treated) resulting in high-                   residential exposure plus chronic                     commenter’s concerns and recognizes
                                                  end estimates of dietary food. EPA used                 exposure to food and water (considered                that some individuals believe that
                                                  similarly conservative assumptions                      to be a background exposure level).                   pesticides should be banned on
                                                  based on conservative default (non-                                                                           agricultural crops. However, the existing
                                                                                                          Intermediate-term exposures are not
                                                  chemical specific) assumptions to assess                                                                      legal framework provided by section
                                                                                                          likely because of the intermittent nature
                                                  postapplication exposure of children,                                                                         408 of the Federal Food, Drug and
                                                                                                          of applications by homeowners and the
                                                  including incidental oral exposure of                                                                         Cosmetic Act (FFDCA) states that
                                                                                                          likely short-term duration of exposures.
                                                  toddlers. These assessments will not                                                                          tolerances may be set when persons
                                                                                                             5. Aggregate cancer risk for U.S.
                                                  underestimate the exposure and risks                                                                          seeking such tolerances or exemptions
                                                                                                          population. Based on the results of the
                                                  posed by benzovindiflupyr.                                                                                    have demonstrated that the pesticide
                                                                                                          chronic risk assessment, the Agency
                                                                                                                                                                meets the safety standard imposed by
                                                  E. Aggregate Risks and Determination of                 does not expect benzovindiflupyr to
                                                                                                                                                                that statute. This citizen’s comment
                                                  Safety                                                  pose a cancer risk.
                                                                                                                                                                appears to be directed at the underlying
                                                                                                             6. Determination of safety. Based on
                                                     EPA determines whether acute and                                                                           statute and not EPA’s implementation of
                                                                                                          these risk assessments, EPA concludes
                                                  chronic dietary pesticide exposures are                                                                       it; the citizen has made no contention
                                                                                                          that there is a reasonable certainty that
                                                  safe by comparing aggregate exposure                                                                          that EPA has acted in violation of the
                                                                                                          no harm will result to the general
                                                  estimates to the acute PAD (aPAD) and                                                                         statutory framework.
                                                                                                          population, or to infants and children
                                                  chronic PAD (cPAD). For linear cancer                                                                         D. Revisions to Petitioned-For
                                                                                                          from aggregate exposure to
                                                  risks, EPA calculates the lifetime                                                                            Tolerances
                                                                                                          benzovindiflupyr residues.
                                                  probability of acquiring cancer given the
                                                  estimated aggregate exposure. Short-,                   IV. Other Considerations                                 Benzovindiflupyr was evaluated by
                                                  intermediate-, and chronic-term risks                                                                         undergoing a global joint review
                                                                                                          A. Analytical Enforcement Methodology                 between the EPA, the Pest Management
                                                  are evaluated by comparing the
                                                  estimated aggregate food, water, and                      Adequate enforcement methodology                    Regulatory Agency (PMRA) of Canada,
                                                  residential exposure to the appropriate                 (A Quick, Easy, Cheap, Effective,                     and the Federal Commission for the
                                                  PODs to ensure that an adequate MOE                     Rugged, and Safe (QuEChERS) multi-                    Protection against Sanitary Risk
                                                  exists.                                                 residue method (EN15662:2009)) is                     (COFEPRIS) of Mexico. Based upon
                                                     1. Acute risk. Using the exposure                    available to enforce the tolerance                    review of the data supporting the
                                                  assumptions discussed in this unit for                  expression. The method may be                         petition and calculation procedures for
                                                  acute exposure, the acute dietary                       requested from: Chief, Analytical                     tolerance determination, several
                                                  exposure from food and water to                         Chemistry Branch, Environmental                       tolerances modifications were required.
                                                  benzovindiflupyr will occupy 30% of                     Science Center, 701 Mapes Rd., Ft.                    Specifically, commodity definitions
                                                  the aPAD for children 1–2 years old.                    Meade, MD 20755–5350; telephone                       were modified for pea, hay; pea, vine;
                                                     2. Chronic risk. Using the exposure                  number: (410) 305–2905; email address:                peanut, nutmeat; raisin; and potato,
                                                  assumptions described in this unit for                  residuemethods@epa.gov.                               processed waste to reflect the current
                                                  chronic exposure, EPA has concluded                                                                           nomenclature used by the Agency.
                                                                                                          B. International Residue Limits                       Several tolerance levels were adjusted to
                                                  that chronic exposure to
                                                  benzovindiflupyr from food and water                      In making its tolerance decisions, EPA              account for differences in the input data
                                                  will utilize 14% of the cPAD for                        seeks to harmonize U.S. tolerances with               used for the calculation procedures for
                                                  children 1–2 years old. Based on the                    international standards whenever                      tolerance determination. For example,
                                                  explanation in Unit III.C.3., regarding                 possible, consistent with U.S. food                   several trials considered to be
asabaliauskas on DSK5VPTVN1PROD with RULES




                                                  residential use patterns, chronic                       safety standards and agricultural                     independent trials by the petitioner
                                                  residential exposure to residues of                     practices. EPA considers the                          were determined by the Agency to be
                                                  benzovindiflupyr is not expected.                       international maximum residue limits                  replicate (not independent) trials and, as
                                                     3. Short-term risk. Short-term                       (MRLs) established by the Codex                       such, these data are inputed differently
                                                  aggregate exposure takes into account                   Alimentarius Commission (Codex), as                   than data from independent trails.
                                                  short-term residential exposure plus                    required by FFDCA section 408(b)(4).                  Based on this discrepancy, the Agency
                                                  chronic exposure to food and water                      The Codex Alimentarius is a joint                     is establishing tolerances for the
                                                  (considered to be a background                          United Nations Food and Agriculture                   following commodities that are different


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                                                                     Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Rules and Regulations                                            59633

                                                  from what the petitioner requested:                     ppm; oat, straw at 15 ppm; pea and                    this action alter the relationships or
                                                  Cattle, fat; cattle, liver; coffee, green               bean, dried shelled, except soybean,                  distribution of power and
                                                  bean; fruit, pome, group 11–10; goat, fat;              subgroup 6C at 0.20 ppm; pea, field, hay              responsibilities established by Congress
                                                  goat, liver; horse, fat; horse, liver; milk,            at 7.0 ppm; pea, field, vine at 1.5 ppm;              in the preemption provisions of FFDCA
                                                  fat; pea and bean, dried shelled, except                peanut at 0.01 ppm; peanut, hay at 15                 section 408(n)(4). As such, the Agency
                                                  soybean, subgroup 6C; potato, processed                 ppm; potato, processed potato waste at                has determined that this action will not
                                                  waste; rye, straw; sheep, fat; sheep,                   0.10 ppm; grape, raisin at 3.0 ppm;                   have a substantial direct effect on States
                                                  liver; vegetable, cucurbit, group 9;                    rapeseed, subgroup 20A at 0.15 ppm;                   or tribal governments, on the
                                                  vegetable, fruiting, group 8–10; wheat,                 rye, grain at 0.1 ppm; rye, hay at 15                 relationship between the national
                                                  grain; and wheat, straw. Also, based on                 ppm; rye, straw at 15 ppm; sheep, fat at              government and the States or tribal
                                                  the Agency’s calculation, the available                 0.02 ppm; sheep, liver at 0.06 ppm;                   governments, or on the distribution of
                                                  data supports reducing the raisin                       sheep, meat at 0.01 ppm; sheep meat                   power and responsibilities among the
                                                  tolerance (from 4 ppm to 3 ppm) and                     byproducts, except liver at 0.01 ppm;                 various levels of government or between
                                                  increasing the aspirated grain fractions                soybean, forage at 15 ppm; soybean, hay               the Federal Government and Indian
                                                  tolerance (from 7 ppm to 15 ppm).                       at 50 ppm; soybean, hulls at 0.20 ppm;                tribes. Thus, the Agency has determined
                                                     A tolerance was recommended for                      soybean, seed at 0.07 ppm; sugarcane,                 that Executive Order 13132, entitled
                                                  lowbush variety of blueberry in non-                    cane at 0.04 ppm; tomato, dried at 4.0                ‘‘Federalism’’ (64 FR 43255, August 10,
                                                  cropping years following a 365-day PHI.                 ppm; vegetable, cucurbit, group 9 at                  1999) and Executive Order 13175,
                                                  However, no tolerance will be                           0.30 ppm; vegetable, fruiting, group 8–               entitled ‘‘Consultation and Coordination
                                                  established on the basis that it would                  10 at 1.5 ppm; vegetable, tuberous and                with Indian Tribal Governments’’ (65 FR
                                                  cover non-bearing blueberries which are                 corm, subgroup 1C at 0.02 ppm; wheat,                 67249, November 9, 2000) do not apply
                                                  considered to be a non-food use. Also,                  forage at 4 ppm; wheat, grain at 0.10                 to this action. In addition, this action
                                                  the petitioner did not include this use                 ppm; wheat, hay at 15 ppm; and wheat,                 does not impose any enforceable duty or
                                                  in their notice filing. Although the                    straw at 15 ppm.                                      contain any unfunded mandate as
                                                  petitioner did not request a separate                                                                         described under Title II of the Unfunded
                                                  tolerance for tomato, dried, tomato                     VI. Statutory and Executive Order
                                                                                                          Reviews                                               Mandates Reform Act (UMRA) (2 U.S.C.
                                                  processing study data show that                                                                               1501 et seq.).
                                                  residues concentrate in dried tomatoes                     This action establishes tolerances
                                                                                                          under FFDCA section 408(d) in                            This action does not involve any
                                                  (7.8X). To cover the higher residues and
                                                  to harmonize with Canada, EPA is                        response to a petition submitted to the               technical standards that would require
                                                  establishing a tolerance for tomato,                    Agency. The Office of Management and                  Agency consideration of voluntary
                                                  dried at 4 ppm. Finally, the applicant                  Budget (OMB) has exempted these types                 consensus standards pursuant to section
                                                  requested tolerances for apple, wet                     of actions from review under Executive                12(d) of the National Technology
                                                  pomace. As a fruit, pome, group 11–10                   Order 12866, entitled ‘‘Regulatory                    Transfer and Advancement Act
                                                  tolerance of 0.2 ppm will cover any                     Planning and Review’’ (58 FR 51735,                   (NTTAA) (15 U.S.C. 272 note).
                                                  potential residues in processed apple, a                October 4, 1993). Because this action                 VII. Congressional Review Act
                                                  separate tolerance is not needed.                       has been exempted from review under
                                                                                                          Executive Order 12866, this action is                   Pursuant to the Congressional Review
                                                  V. Conclusion                                           not subject to Executive Order 13211,                 Act (5 U.S.C. 801 et seq.), EPA will
                                                     Therefore, tolerances are established                entitled ‘‘Actions Concerning                         submit a report containing this rule and
                                                  for residues of benzovindiflupyr, in or                 Regulations That Significantly Affect                 other required information to the U.S.
                                                  on barley, grain at 1.5 ppm; barley, hay                Energy Supply, Distribution, or Use’’ (66             Senate, the U.S. House of
                                                  at 15 ppm; barley, straw at 15 ppm;                     FR 28355, May 22, 2001) or Executive                  Representatives, and the Comptroller
                                                  cattle, fat at 0.02 ppm; cattle, liver at               Order 13045, entitled ‘‘Protection of                 General of the United States prior to
                                                  0.06 ppm; cattle, meat at 0.01 ppm;                     Children from Environmental Health                    publication of the rule in the Federal
                                                  cattle, meat byproducts, except liver at                Risks and Safety Risks’’ (62 FR 19885,                Register. This action is not a ‘‘major
                                                  0.01 ppm; coffee, green bean at 0.09                    April 23, 1997). This action does not                 rule’’ as defined by 5 U.S.C. 804(2).
                                                  ppm; corn, field, forage at 3.0 ppm;                    contain any information collections                   List of Subjects in 40 CFR Part 180
                                                  corn, field, grain at 0.02 ppm; corn,                   subject to OMB approval under the
                                                  field, stover at 15 ppm; corn, pop, grain               Paperwork Reduction Act (PRA) (44                       Environmental protection,
                                                  at 0.02 ppm; corn, pop, stover at 15                    U.S.C. 3501 et seq.), nor does it require             Administrative practice and procedure,
                                                  ppm; corn, sweet, forage at 4.0 ppm;                    any special considerations under                      Agricultural commodities, Pesticides
                                                  corn, sweet, kernel plus cob with husks                 Executive Order 12898, entitled                       and pests, Reporting and recordkeeping
                                                  removed at 0.01 ppm; corn, sweet,                       ‘‘Federal Actions to Address                          requirements.
                                                  stover at 5.0 ppm; cottonseed, subgroup                 Environmental Justice in Minority                       Dated: August 28, 2015.
                                                  20C at 0.15 ppm; cotton, gin byproducts                 Populations and Low-Income
                                                  at 3.0 ppm; fruit, pome, group 11–10 at                                                                       Jack E. Housenger,
                                                                                                          Populations’’ (59 FR 7629, February 16,
                                                  0.20 ppm; fruit, small vine climbing,                                                                         Director, Office of Pesticide Programs.
                                                                                                          1994).
                                                  except fuzzy kiwifruit, subgroup 13–07F                    Since tolerances and exemptions that                 Therefore, 40 CFR chapter I is
                                                  at 1 ppm; goat, fat at 0.02 ppm; goat,                  are established on the basis of a petition            amended as follows:
                                                  liver at 0.06 ppm; goat, meat at 0.01                   under FFDCA section 408(d), such as
asabaliauskas on DSK5VPTVN1PROD with RULES




                                                  ppm; goat, meat byproducts, except                      the tolerance in this final rule, do not              PART 180—[AMENDED]
                                                  liver at 0.01 ppm; grain, aspirated                     require the issuance of a proposed rule,
                                                  fractions at 15 ppm; horse, fat at 0.02                 the requirements of the Regulatory                    ■ 1. The authority citation for part 180
                                                  ppm; horse, liver at 0.06 ppm; horse,                   Flexibility Act (RFA) (5 U.S.C. 601 et                continues to read as follows:
                                                  meat at 0.01 ppm; horse, meat                           seq.), do not apply.                                      Authority: 21 U.S.C. 321(q), 346a and 371.
                                                  byproducts, except liver at 0.01 ppm;                      This action directly regulates growers,
                                                  milk at 0.01 ppm; milk, fat at 0.02 ppm;                food processors, food handlers, and food              ■ 2. Add § 180.686 to subpart C to read
                                                  oat, grain at 1.5 ppm; oat, hay at 15                   retailers, not States or tribes, nor does             as follows:


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                                                  59634                     Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Rules and Regulations

                                                  § 180.686         Benzovindiflupyr; tolerances for                                                                         Parts per  Communications, BLM Eastern States
                                                  residues.                                                                             Commodity                             million   Office, 20 M Street SE., Suite 950,
                                                    (a) General. Tolerances are                                                                                                         Washington, DC 20003.
                                                                                                                         Sheep meat byproducts, except                                  FOR FURTHER INFORMATION CONTACT: Bob
                                                  established for residues of the fungicide                                liver ........................................          0.01
                                                  benzovindiflupyr, including its                                        Soybean, forage .......................                  15.0
                                                                                                                                                                                        Gillcash, (202) 912–7712. Persons who
                                                  metabolites and degradates, in or on the                               Soybean, hay ............................                50.0  use a telecommunications device for the
                                                  commodities in the table below.                                        Soybean, hulls ..........................                 0.20 deaf (TDD) may call the Federal
                                                  Compliance with the tolerance levels                                   Soybean, seed ..........................                  0.07 Information Relay Service (FIRS) at 1–
                                                  specified below is to be determined by                                 Sugarcane, cane1 .....................                    0.04 800–877–8339, 24 hours a day, 7 days
                                                  measuring only benzovindiflupyr (N-[9-                                 Tomato, dried ...........................                 4.0  a week.
                                                  (dichloromethylene)-1,2,3,4-tetrahydro-                                Vegetable, cucurbit, group 9 ....                         0.30 SUPPLEMENTARY INFORMATION:
                                                                                                                         Vegetable, fruiting, group 8–10                           1.5
                                                  1,4-methanonaphthalen-5-yl]-3-                                                                                                          I. Background
                                                                                                                         Vegetable, tuberous and corm,
                                                  (difluoromethyl)-1-methyl-1H-pyrazole-                                   subgroup 1C .........................                   0.02   II. Procedural Matters
                                                  4-carboxamide) in or on the commodity.                                 Wheat, forage ...........................                 4.0    I. Background
                                                                                                                         Wheat, grain .............................                0.10
                                                                 Commodity                              Parts per        Wheat, hay ...............................               15.0       This final rule reflects the
                                                                                                         million         Wheat, straw .............................               15.0    administrative action of changing the
                                                                                                                                                                                          street address of the Eastern States office
                                                  Barley, grain .............................                  1.5         1 There is no U.S. registration for use of

                                                  Barley, hay ................................                15.0       benzovindiflupyr.                                                of the BLM. This rule changes both the
                                                  Barley, straw .............................                 15.0                                                                        postal and street address for the
                                                                                                                         (b) Section 18 emergency exemptions.                             personal filing of documents relating to
                                                  Cattle, fat ..................................               0.02
                                                  Cattle, liver ................................               0.06    [Reserved]                                                         public lands in Arkansas, Iowa,
                                                  Cattle, meat ..............................                  0.01      (c) Tolerances with regional                                     Louisiana, Minnesota, Missouri, and all
                                                  Cattle, meat byproducts, except                                      registrations. [Reserved]                                          States east of the Mississippi River, but
                                                    liver ........................................                0.01   (d) Indirect or inadvertent residues.                            makes no other changes in filing
                                                  Coffee, green bean1 .................                           0.09 [Reserved]                                                         requirements. The BLM has determined
                                                  Corn, field, forage .....................                    3.0       [FR Doc. 2015–24467 Filed 10–1–15; 8:45 am]                      that the rule has no substantive impact
                                                  Corn, field, grain .......................                   0.02
                                                  Corn, field, stover .....................                   15.0       BILLING CODE 6560–50–P                                           on the public, imposes no costs, and
                                                  Corn, pop, grain ........................                    0.02                                                                       merely updates a list of addresses
                                                  Corn, pop, stover ......................                    15.0                                                                        included in the Code of Federal
                                                  Corn, sweet, forage ..................                       4.0       DEPARTMENT OF THE INTERIOR                                       Regulations for the convenience of the
                                                  Corn, sweet, kernel plus cob                                                                                                            public. The Department of the Interior,
                                                    with husks removed ..............                             0.01   Bureau of Land Management                                        therefore, for good cause finds that
                                                  Corn, sweet, stover ..................                          5.0                                                                     under 5 U.S.C. 553(b)(B) and 553(d)(3)
                                                  Cottonseed, subgroup 20C ......                                 0.15   43 CFR Part 1820                                                 notice and public comment procedures
                                                  Cotton, gin byproducts .............                            3.0                                                                     are unnecessary and that the rule may
                                                  Fruit, pome, group 11–10 .........                              0.20   [LLES9120000 L14400000.PN0000]
                                                  Fruit, small vine climbing, ex-
                                                                                                                                                                                          take effect immediately.
                                                    cept fuzzy kiwifruit, subgroup                                       RIN 1004–AE43                                                    II. Procedural Matters
                                                    13–07F ..................................                     1.0
                                                  Goat, fat ....................................                    Application Procedures, Execution and
                                                                                                                  0.02                                                                    Regulatory Planning and Review
                                                  Goat, liver .................................                     Filing of Forms: Correction of State
                                                                                                                  0.06                                                                    (Executive Order 12866)
                                                  Goat, meat ................................                     0.01
                                                                                                                    Office Address for Filings and                                           This final rule is an administrative
                                                  Goat, meat byproducts, except                                     Recordings, Including Proper Offices                                  action to change the address for one
                                                    liver ........................................             0.01 for Recording of Mining Claims;
                                                  Grain, aspirated fractions .........                        15.0                                                                        BLM State Office. This rule was not
                                                  Grape, raisin .............................                  3.0
                                                                                                                    Arkansas, Iowa, Louisiana, Minnesota,                                 subject to review by the Office of
                                                  Horse, fat ..................................                0.02 Missouri, and all States East of the                                  Management and Budget under
                                                  Horse, liver ...............................                 0.06 Mississippi River                                                     Executive Order 12866. The rule
                                                  Horse, meat ..............................                      0.01
                                                                                                                         AGENCY:   Bureau of Land Management,                             imposes no costs, and merely updates a
                                                  Horse, meat byproducts, except                                                                                                          list of addresses included in the Code of
                                                    liver ........................................             0.01      Interior.
                                                                                                                                                                                          Federal Regulations for the convenience
                                                  Milk ...........................................             0.01      ACTION: Final rule.                                              of the public.
                                                  Milk, fat .....................................              0.02
                                                  Oat, grain ..................................                1.5       SUMMARY:    This final rule amends the                           National Environmental Policy Act
                                                  Oat, hay ....................................               15.0       regulations pertaining to execution and                             The BLM has found that this final rule
                                                  Oat, straw .................................                15.0       filing of forms in order to reflect the
                                                  Pea and bean, dried shelled,                                                                                                            is of a procedural nature and thus is
                                                                                                                         new address of the BLM Eastern States                            categorically excluded from
                                                    except soybean, subgroup                                             Office of the Bureau of Land
                                                    6C ..........................................              0.20                                                                       environmental review under Section
                                                                                                                         Management (BLM). All filings and                                102(2)(C) of the National Environmental
                                                  Pea, field, hay ...........................                  7.0
                                                  Pea, field, vine ..........................                  1.5
                                                                                                                         other documents relating to public lands                         Policy Act of 1969 (NEPA), 42 U.S.C.
                                                  Peanut ......................................                0.01      in the States of Arkansas, Iowa,                                 4332(2)(C), pursuant to 43 CFR
                                                                                                                         Louisiana, Minnesota, Missouri and all
asabaliauskas on DSK5VPTVN1PROD with RULES




                                                  Peanut, hay ..............................                  15.0                                                                        46.210(i). In addition, this final rule
                                                  Potato, processed potato waste                               0.10      States east of the Mississippi River must                        does not present any of the 12
                                                  Rapeseed, subgroup 20A .........                             0.15      be filed at the new address of the State                         extraordinary circumstances listed at 43
                                                  Rye, grain .................................                 0.1       Office.
                                                  Rye, hay ...................................                15.0                                                                        CFR 46.215. Pursuant to 43 CFR 46.205
                                                                                                                         DATES: This rule is effective October 2,                         and the Council on Environmental
                                                  Rye, straw .................................                15.0
                                                  Sheep, fat .................................                 0.02
                                                                                                                         2015.                                                            Quality regulations at 40 CFR 1508.4,
                                                  Sheep, liver ...............................                 0.06      ADDRESSES: You may send inquiries or                             the term ‘‘categorical exclusion’’ means
                                                  Sheep, meat .............................                    0.01      suggestions to Deputy State Director for                         a category or kind of action that has no


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Document Created: 2015-12-15 08:44:48
Document Modified: 2015-12-15 08:44:48
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactSusan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation80 FR 59627 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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