Benzovindiflupyr; Pesticide Tolerances
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 via the Government Publishing Office www.gpo.gov
FR Doc No: 2015-24467
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
EPA-HQ-OPP-2013-0141; FRL-9933-03
Benzovindiflupyr; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of benzovindiflupyr in or on multiple commodities that are identified and discussed later in this document. Syngenta Crop Protection, LLC., requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective October 2, 2015. Objections and requests for hearings must be received on or before December 1, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2013-0141, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room
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is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
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General Information
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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).
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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.
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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.
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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.
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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
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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.
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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.
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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
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RfD, PAD, level of Study and
Exposure/scenario Point of Uncertainty/FQPA concern for risk toxicological
departure safety factors assessment effects
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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.
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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.
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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.
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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.
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Exposure Assessment
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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
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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.
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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 =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.
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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.
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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.
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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.
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Other Considerations
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Analytical Enforcement Methodology
Adequate enforcement methodology (A Quick, Easy, Cheap, Effective, Rugged, and Safe (QuEChERS) multi-residue method (EN15662:2009)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.
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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.
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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.
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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
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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.
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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.
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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).
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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
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The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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Add Sec. 180.686 to subpart C to read as follows:
Page 59634
Sec. emsp14180.686 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.
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Parts per
Commodity million
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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
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\1\ There is no U.S. registration for use of benzovindiflupyr.
(b) Section 18 emergency exemptions. Reserved
(c) Tolerances with regional registrations. Reserved
(d) Indirect or inadvertent residues. Reserved
FR Doc. 2015-24467 Filed 10-1-15; 8:45 am
BILLING CODE 6560-50-P
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