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[Federal Register Volume 81, Number 45 (Tuesday, March 8, 2016)]
[Rules and Regulations]
[Pages 12015-12024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05025]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0443; FRL-9943-21]

Fluopyram; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes, amends, and deletes tolerances 
for residues of fluopyram in or on multiple commodities which are 
identified and discussed later in this document. Bayer CropScience 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective March 8, 2016. Objections and 
requests for hearings must be received on or before May 9, 2016, 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)

[[Page 12016]]

number EPA-HQ-OPP-2015-0443, 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 is open from 
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2015-0443 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 
May 9, 2016. 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-2015-0443, 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.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 26, 2015 (80 FR 51759) (FRL-9931-
74), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
4F8284) by Bayer CropScience, 2 T. W. Alexander Drive, Research 
Triangle Park, North Carolina 27709. The petition requested that 40 CFR 
180.661 be amended by establishing tolerances for residues of the 
fungicide fluopyram in or on the raw agricultural commodities 
artichoke, globe at 4.0 parts per million; aspirated grain fractions at 
50.0 ppm; peanut hay at 40.0 ppm; hops at 60.0 ppm; root vegetables, 
except beet, sugar, root, crop subgroup 1B at 0.30 ppm; tuberous and 
corm vegetables, crop subgroup 1C at 0.10 ppm; potato wet peel at 0.30 
ppm; vegetables, leaves of root and tuber, crop group 2 at 30.0 ppm; 
bulb vegetables, bulb onion (crop subgroup 3-07A) at 0.30 ppm; bulb 
vegetables, green onions (crop subgroup 3-07B) at 15.0 ppm; leafy 
greens (crop subgroup 4A), without spinach at 20.0 ppm; leafy greens 
(crop subgroup 4A) spinach at 40.0 ppm; leafy petioles subgroup, celery 
(crop subgroup 4B) at 20.0 ppm; brassica leafy vegetables: Head and 
stem (crop subgroup 5A) at 4.0 ppm; brassica leafy vegetables: Leafy 
greens (crop subgroup 5B) at 50.0 ppm; soybean forage at 9.0 ppm; 
soybean hay at 30.0 ppm; legume vegetables: Edible podded (crop 
subgroup 6A) at 4.0 ppm; legume vegetables: Succulent shelled peas and 
beans (crop subgroup 6B) at 0.20 ppm; legume vegetables: Dried shelled 
peas and beans (crop subgroup 6C) at 0.70 ppm; vegetable, foliage of 
legume vegetables, forage, hay and vines, forage (crop group 7) at 90.0 
ppm; fruiting vegetables, tomato subgroup (crop subgroup 8-10A) at 1.00 
ppm; fruiting vegetables, pepper/eggplant subgroup (crop subgroup 8-
10B) at 3.00 ppm; cucurbit vegetables (crop group 9A), melon subgroup 
at 0.90 ppm; cucurbit vegetables (crop group 9B), cucumber/squash 
subgroup at 0.30 ppm; citrus fruits (crop group 10-10) at 0.90 ppm; 
citrus oil at 8.0 ppm; pome fruit (crop group 11-10) at 2.0 ppm; stone 
fruit (crop group 12-12A), cherry subgroup at 2.00 ppm; stone fruit 
(crop group 12-12B), peach subgroup at 1.00 ppm; stone fruit (crop 
group 12-12C), plum subgroup at 0.50 ppm; berries and small fruit: 
Caneberry (crop subgroup 13-07A) at 5.0 ppm; berries and small fruit: 
Bushberry (crop subgroup 13-07B) at 7.0 ppm; raisins at 4.0 ppm; 
berries and small fruit, small fruit vine climbing, except fuzzy kiwi 
(crop subgroup 13-07F) at 1.5 ppm; berries and small fruit: Low growing 
berry (crop subgroup 13-07G) at 2.0 ppm; sorghum, grain at 1.5 ppm; 
wheat milled by-products at 2.0 ppm; grass forage, fodder and hay: 
Forage (crop group 17) at 80.0 ppm; herb crop (crop subgroup 19A) at 
70.0 ppm; dill seed at 70.00 ppm; herbs, dried at 400 ppm; oilseeds, 
rapeseed, canola (crop subgroup 20A) at 0.70 ppm; oilseeds, sunflower, 
seed (crop subgroup 20B) at 0.70 ppm; and oilseeds: Cottonseed (crop 
subgroup 20C) at 0.80 ppm and in or on the animal commodities chicken, 
meat byproducts at 0.40 ppm; chicken, fat at 0.15 ppm; chicken, meat at 
0.10 ppm; goat, fat at 4.00 ppm; and goat, meat at 4.00 ppm. Bayer 
CropScience also requests to establish a tolerance in 40 CFR 180.661 
for indirect or inadvertent

[[Page 12017]]

residues of the fungicide fluopyram in or on the raw agricultural 
commodity sugarcane, cane at 0.08 ppm. The petition also requested to 
amend tolerances in 40 CFR 180.661 for residues of the fungicide 
fluopyram in or on the raw agricultural commodities peanut at 0.20 ppm; 
sugar beet, roots at 0.09 ppm; soybean, seed at 0.30 ppm; soybean 
forage at 9.0 ppm; soybean hay at 30.0 ppm; tree nuts (crop group 14) 
at 0.04 ppm; almond hulls at 10.00 ppm; grain, cereal, except rice and 
sorghum (crop group 15) at 0.90 ppm; cereal grain, except rice, forage, 
fodder and straw (crop group 16) at 20.0 ppm; and cotton gin by-product 
at 30.00 ppm and in or on the animal commodities cattle, meat 
byproducts at 40.00 ppm; cattle, fat at 4.00 ppm; cattle, meat at 4.00 
ppm; milk, cattle at 2.00 ppm; eggs, chicken at 0.20 ppm; hog, meat 
byproducts at 0.40 ppm; hog, fat at 0.04 ppm; hog, meat at 0.04 ppm; 
horse, meat byproducts at 40.00 ppm; horse, fat at 4.00 ppm; horse, 
meat at 4.00 ppm; goat, meat byproducts at 40.00 ppm; sheep, meat 
byproducts at 40.00 ppm; sheep, fat at 4.00 ppm; and sheep, meat at 
4.00 ppm. Bayer CropScience also requests to delete tolerances in 40 
CFR 180.661 for residues of the fungicide fluopyram in or on the raw 
agricultural commodities apple at 0.30 ppm; bean, dry at 0.09 ppm; 
beet, sugar, roots at 0.04 ppm; apple wet pomace at 0.60 ppm; cherry at 
0.60 ppm; grape, wine at 2.0 ppm; potato at 0.02 ppm; strawberry at 1.5 
ppm; and watermelon at 1.0 ppm. That document referenced a summary of 
the petition prepared by Bayer CropScience, the registrant, which is 
available in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA is 
issuing some tolerances that vary from the fluopyram tolerances as 
requested. The reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue . . 
. .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for fluopyram including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with fluopyram 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.
    Decreased body weight and liver effects were the common and 
frequent findings in the fluopyram subchronic and chronic oral toxicity 
studies in rats, mice, and dogs, and they appeared to be the most 
sensitive effects. Liver effects were characterized by increased liver 
weight, hepatocellular hypertrophy, hepatocellular vacuolation, 
increased mitosis and hepatocellular necrosis. Thyroid effects were 
found at dose levels similar to those that produced liver effects in 
rats and mice; these effects consisted of follicular cell hypertrophy, 
increased thyroid weight, and hyperplasia at dose levels greater than 
or equal to 100 milligrams/kilogram/day (mg/kg/day). Changes in thyroid 
hormone levels were also seen in a subchronic toxicity study. In male 
mice, there was an increased incidence of thyroid adenomas.
    Although increased liver tumors were observed in female rats in the 
carcinogenicity study, EPA has concluded that fluopyram is ``Not Likely 
to be Carcinogenic to Humans'' at doses that do not induce cellular 
proliferation in the liver or thyroid glands. This classification was 
based on convincing evidence that non-genotoxic modes of action for 
liver tumors in rats and thyroid tumors in mice have been established 
and that the carcinogenic effects have been demonstrated as a result of 
a mode of action dependent on activation of the CAR/PXR receptors. The 
Agency is using a point of departure for regulating fluopyram (NOAEL of 
1.2 mg/kg/day) that is below the doses that cause cell proliferation in 
the liver (11 mg/kg/day) and subsequent liver tumor formation (89 mg/
kg/day); therefore, the Agency concludes that exposure to fluopyram 
will not be carcinogenic. Moreover, fluopyram is not genotoxic or 
mutagenic.
    Fluopyram is not a developmental toxicant, nor did it adversely 
affect reproductive parameters. No evidence of qualitative or 
quantitative susceptibility was observed in developmental studies in 
rats and rabbits or in a multigeneration study in rats.
    In an acute neurotoxicity study, transient decreased motor activity 
was seen only on the day of treatment, but no other findings 
demonstrating neurotoxicity were observed. In addition, no 
neurotoxicity was observed in the subchronic neurotoxicity study in the 
presence of other systemic adverse effects. Fluopyram did not produce 
treatment-related effects on the immune system.
    Fluopyram has low acute toxicity via the oral, dermal, and 
inhalation routes of exposure. Fluopyram is not a skin or eye irritant 
or sensitizer under the conditions of the murine lymph node assay. 
Specific information on the studies received and the nature of the 
adverse effects caused by fluopyram 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 the document entitled: ``Fluopyram: Human Health 
Risk Assessment for Proposed New Uses on Crop Subgroup 1B, Subgroup 1C, 
Crop Group 2, Subgroup 3-07A, Subgroup 3-07B, Subgroup 4A, Subgroup 4B, 
Subgroup 5A, Subgroup 5B, Subgroup 6A, Subgroup 6B, Dried Beans, 
Soybean, Subgroup 8-10A, Subgroup 8-10B, Subgroup 9A, Subgroup 9B, 
Subgroup 10-10, Group 11-10, Subgroup 12-12A, Subgroup 12-12B, Subgroup 
12-12C, Subgroup 13-07A, Subgroup 13-07B, Subgroup 13-07F, Subgroup 13-
07G, Crop Group 15 (except corn and Rice), Crop Group 16, Subgroup 19A, 
Dill Seed, Subgroup 20A, Subgroup 20B, Subgroup 20C, Artichoke (Globe), 
Hops, and Sugarcane (Rotated). Amended Tolerance Requests for the 
Registered Uses due to Crop Group/Subgroup Expansion Requests. Proposed 
New Uses on Turf Grass, Ornamentals, and Christmas trees, and as a seed 
treatment to Peanuts'' in

[[Page 12018]]

docket ID number EPA-HQ-OPP-2015-0443.

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://iaspub.epa.gov/apex/pesticides/f?p=chemicalsearch:1.
    A summary of the toxicological endpoints for fluopyram used for 
human risk assessment is shown in Table 1.

   Table 1--Summary of Toxicological Doses and Endpoints for Fluopyram for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  NOAEL = 50 mg/kg/day  Acute RfD = 0.50 mg/ Acute Neurotoxicity Study in Rats
 including infants and children).  UFA = 10x...........   kg/day.             LOAEL = 100 mg/kg/day based on
                                   UFH =10x............  aPAD = 0.50 mg/kg/    decreased motor and locomotor
                                   FQPA SF = 1x........   day.                 activity in females. The LOAEL in
                                                                               males was 125 mg/kg/day.
                                  ------------------------------------------------------------------------------
Acute dietary (Females 13-50       An endpoint attributable to a single dose exposure has not been identified
 years of age).                     for this subpopulation.
                                  ------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 1.2 mg/kg/    Chronic RfD = 0.012  Combined Chronic/Carcinogenicity
                                    day.                  mg/kg/day.           in Rats
                                   UFA = 10x...........  cPAD = 0.012 mg/kg/  LOAEL = 6.0 mg/kg/day based on
                                   UFH = 10x...........   day.                 follicular cell hypertrophy in
                                   FQPA SF = 1x........                        the thyroid, and increased liver
                                                                               weight with gross pathological
                                                                               and histopathological findings.
Incidental oral short-term (1 to   NOAEL = 14.5 mg/kg/   LOC for MOE = 100..  Reproduction study in rats
 30 days) and intermediate-term     day.                                      LOAEL = 82.8 mg/kg/day based on
 (1 to 6 months).                  UFA = 10x...........                        clinical pathology changes,
                                   UFH = 10x...........                        decreased spleen and thymus
                                   FQPA SF = 1x........                        weights, increased liver weight
                                                                               and centrilobular hypertrophy in
                                                                               parents, and decreased body
                                                                               weight and body weight gain with
                                                                               decreases in spleen and thymus
                                                                               weights and slight delay in
                                                                               preputial separation in
                                                                               offspring.
Dermal short-term (1 to 30 days)   NOAEL = 300 mg/kg/    Residential LOC for  28-day dermal study in rats
 and intermediate-term (1 to 6      day.                  MOE = 100.          LOAEL = 1000 mg/kg/day based on
 months).                          UFA = 10x...........                        increased cholesterol (F),
                                   UFH = 10x...........                        increased prothrombin time (M).
                                   FQPA SF = 1x........
Inhalation short-term (1 to 30     NOAEL = 14.5 mg/kg/   Residential LOC for  Reproduction study in rats
 days) and intermediate-term (1-6   day.                  MOE = 100.          LOAEL = 82.8 mg/kg/day based on
 months).                          UFA = 10x...........                        clinical chemistry changes and
                                   UFH = 10x...........                        increased kidney weight in
                                   FQPA SF = 1x........                        parents, and decreased body
                                                                               weight and body weight gain with
                                                                               decreases in spleen and thymus
                                                                               weights in offspring.
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  ``Not Likely to be Carcinogenic to Humans'' at doses that do not induce
                                    cellular proliferation in the liver or thyroid glands.
----------------------------------------------------------------------------------------------------------------
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). UF = uncertainty factor. UFA = extrapolation
  from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
  population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fluopyram, EPA considered exposure under the petitioned-for 
tolerances as well as all existing fluopyram tolerances in 40 CFR 
180.661. EPA assessed dietary exposures from fluopyram 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 fluopyram. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination 
Survey/What We Eat in America (NHANES/WWEIA). As to residue levels in 
food, EPA included tolerance residue levels, the assumption

[[Page 12019]]

of 100% crop treated, and processing factors (empirical and default).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA included average 
residue levels, % crop treated, and processing factors (empirical and 
default).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fluopyram does not pose a cancer risk to humans at doses 
that do not induce cellular proliferation in the liver or thyroid 
glands. Therefore, a dietary exposure assessment for the purpose of 
assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
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 
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.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency estimated the PCT for the chronic dietary exposure 
assessment for existing uses as follows:
    Almonds 33%; apples 40%; blackberries 55%; blueberries 54%; 
broccoli 24%; cantaloupes 22%; celery 60%; corn field 9%; corn, sweet 
15%; cucumbers 41%; dry beans/peas 7%; fresh tomatoes 64%; grape wine 
79% (used for grape, wine and sherry); head lettuce 67%; leaf lettuce 
62%; oranges 39%; peaches 56%; pears 43%; peanuts 67%; potatoes 64%; 
processed tomatoes 57%; pumpkins 45%; snap beans 44%; soybeans 17%; 
spinach 43%; squash 47%; strawberries 75%; sugar beets 48%; watermelons 
54%; and wheat 17% (from spring wheat at 17% and winter wheat at 6%).
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6-7 
years. EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available public and private market survey data for that use, averaging 
across all observations, and rounding to the nearest 5%, except for 
those situations in which the average PCT is less than one. In those 
cases, 1% is used as the average PCT and 2.5% is used as the maximum 
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The 
maximum PCT figure is the highest observed maximum value reported 
within the recent 6 years of available public and private market survey 
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which fluopyram may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for fluopyram in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fluopyram. 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 Ground Water (PRZM GW) and 
the surface water concentration calculator (SWCC), the estimated 
drinking water concentrations (EDWCs) of fluopyram for acute exposures 
are estimated to be 50.6 parts per billion (ppb) for surface water and 
97.6 ppb for ground water. The chronic exposures for non-cancer 
assessments are estimated to be 17.3 ppb for surface water and 90.5 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 97.6 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 90.5 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Fluopyram is proposed for use that could result in residential 
exposures: golf course turf, residential lawns, fruit trees, nut trees, 
ornamentals and gardens. EPA assessed residential exposure using the 
following assumptions: short-term dermal, oral (derived from incidental 
oral hand to mouth post-application exposures to treated lawn in 
children), and inhalation exposures derived from treating lawns by 
hose-end sprayers (adults); residential post-application exposures: 
adults and children (1 to 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 fluopyram 
to share a common mechanism of toxicity with any other substances, and 
fluopyram does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has assumed that fluopyram 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. The available developmental 
toxicity studies in rats and rabbits and the multi-generation 
reproduction in rats demonstrate no evidence of increased 
susceptibility in the developing or young animals which were exposed 
during pre- or post-natal periods.
    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 fluopyram is complete.
    ii. There is no indication that fluopyram is a neurotoxic chemical. 
Although transient decreases in motor and locomotor activities in the 
acute neurotoxicity study were seen on the day of treatment and limited 
use of hind-limbs and reduced motor activity was seen in the rat 
chronic/carcinogenicity study, there were no other associated 
neurobehavioral or histopathology changes found in other studies in the 
fluopyram toxicity database. The effects seen in the chronic/
carcinogenicity study were in the presence of increased mortality and 
morbidity such as general pallor and emaciated appearance. Therefore, 
the reduced motor activity and limited use of hind-limbs seen in these 
two studies were judged to be the consequence of the systemic effects 
and not direct neurotoxicity. Additionally there is no need for a 
developmental neurotoxicity study or additional UFs to account for 
neurotoxicity.
    iii. There is no evidence that fluopyram 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. The acute dietary exposure assessment was performed using 
conservative exposure inputs, including tolerance-level residues for 
all crops, whereas the chronic dietary assessment included average 
field-trial residue levels for all crops. The acute dietary assessment 
assumed 100 PCT, whereas the chronic dietary assessment utilized 
average percent crop treated numbers for several crops. Both acute and 
chronic dietary assessments incorporated empirical or default 
processing factors. The dietary exposure assessment also assumed that 
all drinking water will contain fluopyram at the highest EDWC levels 
modeled by the Agency for ground or surface water. Therefore, it can be 
concluded that the dietary exposure analysis does not underestimate 
risk from acute and chronic dietary exposure to fluopyram. While there 
is the potential for handler and post-application residential exposure, 
the best data and approaches currently available were used in the 
fluopyram residential assessment. The Agency used the current 
conservative approaches for residential assessment, many of which 
include recent upgrades to the SOPs. The Agency believes that the 
calculated risks represent conservative estimates of exposure because 
maximum application rates are used to define residue levels upon which 
the calculations are based. Therefore, residential exposures are 
unlikely to be underestimated.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to fluopyram will occupy 35% of the aPAD for children 1-2 years old, 
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fluopyram from food and water will utilize 81% of the cPAD for children 
1-2 years old the population group receiving the greatest exposure. 
Based on the explanation in Unit III.C.3., regarding residential use 
patterns, chronic residential exposure to residues of fluopyram 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). Fluopyram 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 fluopyram.
    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 from handler 
inhalation exposure (the most conservative risk estimate) of 1,500 for 
adults. For children 1-2 years old, post-application incidental oral 
exposures aggregated with food and drinking water resulted in an MOE of 
1,500. Because EPA's level of concern for fluopyram is a MOE of 100 or 
below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure

[[Page 12021]]

takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Intermediate-term residential exposure is not expected given 
the intermittent nature of applications in residential settings.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.A, because the Agency is regulating exposure to fluopyram at doses 
lower than those that may induce cellular proliferation in the liver or 
thyroid glands, fluopyram is not expected to pose a cancer risk to 
humans.
    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 fluopyram residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The German multiresidue method DFG Method S 19, a gas 
chromatography with mass selective detection (GC/MSD) method, is the 
method for the enforcement of tolerances for fluopyram residues in/on 
crop commodities and a high performance liquid chromatography method 
with tandem mass spectrometry detection (HPLC/MS/MS), Method 01079, has 
been accepted for the enforcement of tolerances for residues of 
fluopyram and its metabolite, AE C656948-benzamide, in livestock 
commodities. The validated limit of quantitation (LOQ) is 0.01 ppm and 
the calculated limit of detection (LOD) is 0.003 ppm for each analyte 
in each matrix. The method was adequately validated using cattle milk, 
fat, muscle, liver, and kidney, and hen whole egg fortified with 
fluopyram and AE C656948-benzamide, each at 0.01 and 0.10 ppm. The 
method was subjected to ILV using samples of beef muscle, beef liver, 
eggs, and milk fortified with fluopyram and AE C656948-benzamide, each 
at 0.01 and 0.10 ppm.
    Adequate enforcement methodology DFG Method S 19 and Method 01079 
are available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    There are Codex maximum residue levels MRLs established on berries 
(blackberry and raspberry 3 ppm), broccoli and Brussels sprouts (0.3 
ppm), dry beans (0.07 ppm), head cabbage (0.15 ppm), carrot (0.4 ppm), 
cauliflower (0.09 ppm), cherry (0.7 ppm), cucumber (0.5 ppm), dried 
grapes (currants, raisins and sultanas 5 ppm), grapes (2 ppm), leek 
(0.15 ppm), lettuce (head and leaf 15 ppm), onion bulb (0.07 ppm), 
peach subgroup (1 ppm), peanut (0.03 ppm), plums (0.5 ppm), pome fruits 
(0.5 ppm), potato (0.03 ppm), rapeseed (1 ppm), strawberry (0.4 ppm), 
sugar beet (0.04 ppm), tomato (0.4 ppm), and tree nuts (0.04 ppm).
    The tolerance definitions are harmonized among the US, Canada, and 
Codex for all plant and livestock commodities. In addition, the U.S. 
tolerances for grape (within the fruit, small vine climbing, except 
fuzzy kiwifruit, subgroup 13-07F), peach (within the fruit, stone, 
peach subgroup 12-12B), and plum (within the fruit, stone, plum 
subgroup 12-12C) are harmonized with the Codex MRLs for grape, peach, 
and plum.
    Harmonization with Codex MRLs for berries (blackberry and raspberry 
3 ppm), broccoli and Brussels sprouts (0.3 ppm), dry beans (0.70 ppm), 
head cabbage (0.15 ppm), cauliflower (0.09 ppm), cherry (0.7 ppm), 
cucumber (0.5 ppm), leek (0.15 ppm), lettuce (head and leaf 15 ppm), 
onion bulb (0.07 ppm), peanut (0.03 ppm), pome fruits (0.5 ppm), potato 
(0.03 ppm), rapeseed (1 ppm), strawberry (0.4 ppm), sugar beet (0.04 
ppm), tomato (0.4 ppm), and tree nuts (0.04 ppm) is not possible 
because the Codex MRLs are lower than the recommended U.S. tolerances. 
The U.S. tolerances cannot be harmonized because following the approved 
label directions could result in residues above the recommended 
tolerances. The U.S. tolerances for carrot and raisin are higher than 
the Codex MRLs. EPA is not harmonized with Codex in order to remain 
harmonized with Canada.
    The U.S. and Codex livestock MRLs are not harmonized due to 
different livestock dietary burdens. Fluopyram is approved for use on 
more livestock feed stuffs in the United States and thus contributes to 
a greater portion of the assessment of the livestock dietary burden in 
the United States than in the assessment of livestock dietary burden 
supporting the Codex MRLs. Harmonization could lead to tolerance 
exceedances when the pesticide is used legally in the United States.

C. Revisions to Petitioned-For Tolerances

    The petitioned-for tolerances differ from the tolerances that EPA 
is establishing for sugar beet roots, onion bulbs, leafy greens 
subgroup 4A, crop subgroup 6C, fruiting vegetables (8-10B), melon 
subgroup 9A, citrus, subgroup 13-07F, raisin, tree nuts, crop group 15, 
herb subgroup 19A, dill seed, and subgroup 20A.
    For citrus, crop group 15, fruiting vegetables (8-10B), onion 
bulbs, rapeseed subgroup 20A, and tree nuts, the Organization for 
Economic Cooperation and Development (OECD) statistical calculation 
procedures applied to the field trial residue data provided a different 
value than the petitioned-for tolerances. Also, for crop group 15 and 
subgroup 20A, the values petitioner requested were based on a data set 
that excluded a field trial (on sorghum and canola, respectively) as an 
outlier based on statistical tests. However, the trials could not be 
excluded by the Agency since there were no abnormal field conditions.
    While the petitioner requested a tolerance for crop group 15, 
except rice and sorghum, the Agency has determined that a crop group 15 
tolerance, except corn and rice is appropriate. This is due to the wide 
variation in residue levels from the available data. The minimum 
residues on sweet corn at 0.01 ppm and the maximum residues on sorghum 
3.2 ppm differ by more than 5x; therefore, the tolerance level (1.5 
ppm) is not appropriate to establish a crop group tolerance with all 
the representative crops. Rather, based on the available data, EPA is 
establishing tolerances on grain, cereal, except rice and corn, group 
15 at 4.0 ppm; and individual tolerance on corn, field, grain at 0.02 
ppm; corn, pop, grain at 0.02 ppm; and corn, sweet, kernal plus cob 
with husks removed at 0.01 ppm.

[[Page 12022]]

    Although the petitioner requested two separate tolerances for 
commodities of subgroup 4A, the available data support a tolerance of 
40 ppm for residues of fluopyram in/on leafy greens subgroup 4A and at 
20 ppm on leaf petioles subgroup 4B.
    The petitioner requested two separate tolerances for herb subgroup 
19A, fresh and herbs, dried. Because subgroup 19A covers both dried and 
fresh herbs, the Agency is establishing a tolerance on herb subgroup 
19A at 40 ppm, based on available data.
    The petitioner has requested to establish tolerances on vegetables, 
legume; dried beans and peas, except soybeans (subgroup 6C) at 0.70 
ppm. Because only data on dried beans is available, there is not 
sufficient data to support establishing a subgroup tolerance. 
Therefore, based on the available residue data for dried beans, the 
Agency is establishing an individual tolerance of 0.70 ppm on dried 
beans only. EPA is establishing dry bean tolerance at 0.70 ppm to 
harmonize with Canada.
    The petitioner had requested to establish tolerances on vegetables, 
cucurbit, cucumber/squash subgroup at 0.30 ppm and fruit, pome at 1.0 
ppm. Based on available data that reflect the proposed use pattern, EPA 
is establishing a tolerance on squash/cucumber subgroup 9B at 0.60 ppm 
and fruit, pome, group 11-10 at 0.80 ppm.
    For harmonization purposes with Canada, tolerances being 
established for sugar beet, melon subgroup 9A, tree nuts, and subgroup 
13-07F are slightly increased above the tolerance levels requested for 
those commodities.
    The requested grape, raisin tolerance of 4.0 ppm is being reduced 
to 3.0 ppm based on the highest average field trial (HAFT) (0.948 ppm) 
for grape and processing factor of 2.4.
    Because use of fluopyram is limited to Region 3 (Florida), the 
Agency is establishing a tolerance with a regional registration for 
inadvertent or indirect residues of fluopyram on sugarcane, cane (0.08 
ppm) when sugarcane is used as a rotational crop.
    The requested tolerances for livestock commodities were based on 
some livestock feed stuffs that have been withdrawn from the list of 
crops to be treated with fluopyram. Based on a recalculation of the 
livestock dietary burden, the Agency is establishing tolerances for 
livestock commodities that are lower than requested.
    In addition, the Agency has revised several commodity terms to 
reflect the current commodity definitions used by the Agency and 
revised several tolerance level values to be consistent with EPA's 
practice of extending tolerance values out to two significant figures.
    Although the petition requested a tolerance for nut tree group 14, 
the Agency is establishing a tolerance for nut, tree 14-12 consistent 
with its stated policy of not establishing tolerances for pre-existing 
crop groups. See 77 FR 50617, 50619 (Aug. 22, 2012).
    Finally, the requests for tolerances were withdrawn for the 
following commodities: Crop group 7 at 90.0 ppm; crop group 17 at 80.0 
ppm; peanut hay at 40.0 ppm, soybean forage at 9.0 ppm; and soybean hay 
at 30.0 ppm. A separate tolerance for wheat, milled byproducts is not 
needed as it is covered by the crop group 15 tolerance.

V. Conclusion

    Therefore, tolerances are established for residues of fluopyram in 
or on almond, hulls at 10 ppm; artichoke, globe at 4.0 ppm, bean, dry 
at 0.70 ppm; beet, sugar at 0.10 ppm; berry, low growing, except 
cranberry, subgroup 13-07G at 2.0 ppm; brassica, head and stem, 
subgroup 5A at 4.0 ppm; brassica, leafy greens, subgroup 5B at 50 ppm; 
bushberry subgroup 13-07B at 7.0 ppm; grain, aspirated grain fractions 
at 50 ppm; caneberry subgroup 13-07A at 5.0 ppm; cereal, forage, fodder 
and straw, group 16 at 20 ppm; cherry subgroup 12-12A at 2.0 ppm; 
citrus, oil at 8.0 ppm; corn, field, grain at 0.02 ppm; corn, pop, 
grain at 0.02 ppm; corn, sweet, kernel plus cob with husks removed 0.01 
ppm; cotton, gin byproducts at 30 ppm; cottonseed subgroup 20C at 0.80 
ppm; dill, seed at 70 ppm; rapeseed subgroup 20A at 5.0 ppm; fruit, 
citrus, group 10-10 at 1.0 ppm; fruit, pome, group 11-10 at 0.80 ppm; 
fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 
2.0 ppm; grape, raisin at 3.0 ppm; grain, cereal, group 15, except corn 
and rice at 4.0 ppm; grain, herb subgroup 19A at 40 ppm; hop, dried 
cones at 60 ppm; leaf petioles subgroup 4B at 20 ppm; leafy greens 
subgroup 4A at 40 ppm; melon subgroup 9A at 1.0 ppm; nut, tree, group 
14-12 at 0.05 ppm; onion, bulb, subgroup 3-07A at 0.40 ppm; onion, 
green, subgroup 3-07B at 15 ppm; pea and bean, succulent shelled, 
subgroup 6B at 0.20 ppm; peach subgroup 12-12B at 1.0 ppm; peanut at 
0.20 ppm; potato, wet peel at 0.30 ppm; pepper/eggplant subgroup 8-10B 
at 4.0 ppm; plum subgroup 12-12C at 0.50 ppm; soybean, seed at 0.30 
ppm; squash/cucumber subgroup 9B at 0.60 ppm; sunflower subgroup 20B at 
0.70 ppm; tomato subgroup 8-10A at 1.0 ppm; vegetable, leaves of root 
and tuber, group 2 at 30 ppm; vegetable, legume, edible podded, 
subgroup 6A at 4.0 ppm; vegetable, root, except sugar beet, subgroup 1B 
at 0.30 ppm; and vegetable, tuberous and corm, subgroup 1C at 0.10 ppm.
    Tolerances are also established for residues of fluopyram and its 
metabolite 2-(trifluoromethyl)benzamide, expressed in parent 
equivalents for cattle, fat at 0.70 ppm; cattle, meat at 0.80 ppm; 
cattle, meat byproducts at 7.5 ppm; egg at 0.08 ppm; goat, fat at 0.70 
ppm; goat, meat at 0.80 ppm; goat, meat byproducts at 7.5 ppm; hog, 
meat byproducts at 0.20 ppm; horse, fat at 0.70 ppm; horse, meat at 
0.80 ppm; horse, meat byproducts at 7.5 ppm; milk at 0.40 ppm; poultry, 
fat at 0.04 ppm; poultry, meat at 0.04 ppm; poultry, meat byproducts at 
0.16 ppm; sheep, fat at 0.70 ppm; sheep, meat at 0.80 ppm; and sheep, 
meat byproducts at 7.5 ppm.
    In addition, the Agency is removing tolerances for almond, hull; 
apple, wet pomace; bean, dry; beet, sugar, root; canola seed; cotton, 
gin byproducts; cotton, undelinted seed; cherry; grape, wine; grain, 
cereal, except rice, group 15; grain, cereal, forage, fodder, and 
straw, group 16; nut, tree, group 14; peanut; pistachio; potato; 
soybean forage; soybean hay; soybean, seed; strawberry; and watermelon 
because they are superseded by other tolerances being established in 
this action.

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).

[[Page 12023]]

    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: March 1, 2016.
G. Jeffery Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.661 is revised to read as follows:

Sec.  180.661  Fluopyram; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
fungicide Fluopyram, N-[2-[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]ethyl]-2-(trifluoromethyl)benzamide, including its 
metabolites and degradates in or on the commodities in the table below. 
Compliance with the tolerance levels specified in the table is to be 
determined by measuring only fluopyram in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................          10
Artichoke, globe............................................         4.0
Banana \1\..................................................         1.0
Bean, dry...................................................        0.70
Beet, sugar.................................................        0.10
Berry, low growing, except cranberry, subgroup 13-07G.......         2.0
Brassica, head and stem, subgroup 5A........................         4.0
Brassica, leafy greens, subgroup 5B.........................          50
Bushberry subgroup 13-07B...................................         7.0
Caneberry subgroup 13-07A...................................         5.0
Cherry subgroup 12-12A......................................         2.0
Citrus, oil.................................................         8.0
Corn, field, grain..........................................        0.02
Corn, pop, grain............................................        0.02
Corn, sweet, kernel plus cob with husks removed.............        0.01
Cotton, gin byproducts......................................          30
Cottonseed subgroup 20C.....................................        0.80
Dill, seed..................................................          70
Fruit, citrus, group 10-10..................................         1.0
Fruit, pome, group 11-10....................................        0.80
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup         2.0
 13-07F.....................................................
Grain, aspirated grain fractions............................          50
Grain, cereal, forage, fodder and straw, group 16...........          20
Grain, cereal, group 15, except corn and rice...............         4.0
Grape, raisin...............................................         3.0
Herb subgroup 19A...........................................          40
Hop, dried cones............................................          60
Leafy greens subgroup 4A....................................          40
Leafy petioles subgroup 4B..................................          20
Melon subgroup 9A...........................................         1.0
Nut, tree, group 14-12......................................        0.05
Onion, bulb, subgroup 3-07A.................................        0.40
Onion, green, subgroup 3-07B................................          15
Pea and bean, succulent shelled, subgroup 6B................        0.20
Peach subgroup 12-12B.......................................         1.0
Peanut......................................................        0.20
Pepper/eggplant subgroup 8-10B..............................         4.0
Plum subgroup 12-12C........................................        0.50
Potato, wet peel............................................        0.30
Rapeseed subgroup 20A.......................................         5.0
Soybean, seed...............................................        0.30
Squash/cucumber subgroup 9B.................................        0.60
Sunflower subgroup 20B......................................        0.70
Tomato subgroup 8-10A.......................................         1.0
Vegetable, leaves of root and tuber, group 2................          30
Vegetable, legume, edible podded, subgroup 6A...............         4.0
Vegetable, root, except sugar beet, subgroup 1B.............        0.30
Vegetable, tuberous and corm, subgroup 1C...................        0.10
------------------------------------------------------------------------
\1\ There are no U.S. registrations.

    (2) Tolerances are established for residues of the fungicide 
fluopyram, N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-
(trifluoromethyl)benzamide, including its metabolites and degradates. 
Compliance with the tolerance levels specified in the table below is to 
be determined by measuring only the sum of fluopyram and its 
metabolite, 2-(trifluoromethyl)benzamide, calculated as the 
stoichiometric equivalent of fluopyram, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.70
Cattle, meat................................................        0.80
Cattle, meat byproducts.....................................         7.5
Egg.........................................................        0.08
Goat, fat...................................................        0.70
Goat, meat..................................................        0.80
Goat, meat byproducts.......................................         7.5
Hog, fat....................................................        0.20
Hog, meat...................................................        0.02
Hog, meat byproducts........................................        0.20
Horse, fat..................................................        0.70
Horse, meat.................................................        0.80
Horse, meat byproducts......................................         7.5
Milk........................................................        0.40
Poultry, fat................................................        0.04
Poultry, meat...............................................        0.04
Poultry, meat byproducts....................................        0.20
Sheep, fat..................................................        0.70
Sheep, meat.................................................        0.80
Sheep, meat byproducts......................................         7.5
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with 
regional registration, as defined in Sec.  180.1(1), are established 
for indirect or inadvertent residues of fungicide fluopyram, N-[2-[3-
chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-
(trifluoromethyl)benzamide, including

[[Page 12024]]

its metabolites and degradates, in or on the commodities in the table 
below. Compliance with the tolerance levels specified in the table is 
to be determined by measuring only fluopyram in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Sugarcane, cane............................................        0.08
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. It is recommended that 
tolerances be established for indirect or inadvertent residues of 
fungicide fluopyram, N-[2-[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]ethyl]-2-(trifluoromethyl)benzamide, including its 
metabolites and degradates, in or on the commodities in the table 
below. Compliance with the tolerance levels specified in the table is 
to be determined by measuring only fluopyram in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage............................................        0.45
Alfalfa, hay...............................................         1.1
Soybean, seed..............................................        0.10
------------------------------------------------------------------------

[FR Doc. 2016-05025 Filed 3-7-16; 8:45 am]
BILLING CODE 6560-50-P
```