[Federal Register Volume 77, Number 37 (Friday, February 24, 2012)]
[Rules and Regulations]
[Pages 10968-10976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4321]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0364; FRL-9336-9]


Fluopyram; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective February 24, 2012. Objections and 
requests for hearings must be received on or before April 24, 2012, 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0364. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Lisa Jones, Registration Division, 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(703) 308-9424; email address: <a href="/cdn-cgi/l/email-protection#dfb5b0b1baacf1b3b6acbe9fbaafbef1b8b0a9"><span class="__cf_email__" data-cfemail="3a5055545f49145653495b7a5f4a5b145d554c">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the 
harmonized test guidelines referenced in this document electronically, 
please go to http://www.epa.gov/ocspp and select ``Test Methods and 
Guidelines.''

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-2009-0364 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 
April 24, 2012. 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2009-0364, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200

[[Page 10969]]

Pennsylvania Ave. NW., Washington, DC 20460-0001.
    <bullet> Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of January 6, 2010 (75 FR 864) (FRL-8801-
5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of two pesticide petitions (PP 
8F7358 and 8F7463) by Bayer Crop Science, 2.T.W. Alexander Drive, 
Research Triangle Park, NC 27709.
    Petition 8F7358 requested that 40 CFR part 180 be amended by 
establishing tolerances on 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 following commodities: Grape at 2.0 parts per million (ppm); 
strawberry at 2.0 ppm; and tomato at 1.0 ppm. A subsequent petition 
8F7463 requested that 40 CFR part 180 be amended by establishing 
additional tolerances on 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 following commodities: Alfalfa, forage at 0.25 ppm; alfalfa, 
hay at 0.80 ppm; almond, hulls at 8.0 ppm; apple, wet pomace at 2.5 
ppm; artichoke at 2.0 ppm; banana at 1.0 ppm; beet, sugar, roots at 
0.10 ppm; berry, low growing, subgroup 13-07G at 2.0 ppm; Brassica, 
head and stem, subgroup 5A at 3.0 ppm; Brassica, leafy greens, subgroup 
5B at 35 ppm; bushberries, subgroup 13-07B at 10 ppm; caneberries, 
subgroup 13-07A at 5.0 ppm; citrus, oil at 10 ppm; corn, sweet, kernel 
plus cob with husk removed at 0.10 ppm; cotton, gin byproducts at 0.05 
ppm; cotton, undelinted seed at 0.10 ppm; fruit, citrus, group 10 at 
1.0 ppm; fruit, pome, group 11 at 1.0 ppm; fruit, small, vine, 
climbing, except fuzzy kiwifruit, subgroup 13-07F at 2.0 ppm; fruit, 
stone, group 12 at 2.0 ppm; grain, cereal, forage, fodder and straw, 
group 16, except rice, forage at 8.0 ppm; grain, cereal, forage, fodder 
and straw, group 16, except rice, hay, straw and stover at 14 ppm; 
grain, cereal, forage, fodder and straw, group 16, except rice, 
aspirated fractions at 50 ppm; grain, cereal, group 15, except rice and 
sweet corn at 3.0 ppm; grape, raisin at 3.5 ppm; grass, forage, fodder 
and hay, group 17, forage at 80 ppm; grass, forage, fodder and hay, 
group 17, hay at 30 ppm; herbs, subgroup 19A, fresh at 50 ppm; herbs, 
subgroup 19A, dried at 260 ppm; hop, dried cones at 100 ppm; nut, tree, 
group (including pistachio) 14 at 0.05 ppm; okra at 8.0 ppm; oilseed, 
group 20, except cotton at 5.0 ppm; onion, bulb, subgroup 3-07A at 0.30 
ppm; onion, green, subgroup 3-07B at 20 ppm; peanut at 0.05 ppm; 
peanut, hay at 50 ppm, pepper, non-bell at 8.0 ppm; potato, processed 
potato waste at 0.15 ppm; soybean, aspirated fractions at 70 ppm; 
soybean, forage at 8.0 ppm; soybean, hay at 30 ppm; soybean, hulls at 
0.40 ppm; soybean, seed at 0.30 ppm; spices, except black pepper, 
subgroup 19B at 100 ppm; vegetable, cucurbit, group 9 at 1.0 ppm; 
vegetable, foliage of legume, except soybean, subgroup 7A, forage at 30 
ppm; vegetable, foliage of legume, except soybean, subgroup 7A, hay at 
75 ppm; vegetable, foliage of legume, except soybean, subgroup 7A, 
vines at 16 ppm; vegetable, fruiting, except non-bell pepper, group 8 
at 1.0 ppm; vegetable, leafy, except Brassica, group 4 at 35 ppm; 
vegetable, leaves of root and tuber, group 2 at 30 ppm; vegetable, 
legume, edible podded, subgroup 6A at 2.0 ppm; vegetable, legume, 
succulent shelled, subgroup 6B at 0.20 ppm; vegetable, pea and bean, 
dried shelled (except soybean), subgroup 6C at 0.50 ppm; vegetable, 
root and tuber, except sugar beet, subgroup 1B at 0.50 ppm; and 
vegetable, tuberous and corm, subgroup 1C at 0.05 ppm.
    This petition (8F7463) also requested that 40 CFR part 180 be 
amended by establishing tolerances on 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 following commodities: Cattle, fat at 0.10 ppm; cattle, 
meat at 0.10 ppm; cattle, meat byproducts, except liver at 0.10 ppm; 
cattle, liver at 1.2 ppm; eggs at 0.1 ppm; goat, fat at 0.10 ppm; goat, 
meat at 0.10 ppm; goat, meat byproducts, except liver at 0.10 ppm; 
goat, liver at 1.2 ppm; hog, fat at 0.01 ppm; hog, meat at 0.01 ppm; 
hog, meat byproducts, except liver at 0.01 ppm; hog, liver at 0.15 ppm; 
horse, fat at 0.10 ppm; horse, meat at 0.10 ppm; horse, meat 
byproducts, except liver at 0.10 ppm; horse, liver at 1.2 ppm, milk at 
1.2 ppm; poultry, fat at 0.05 ppm; poultry, meat at 0.03 ppm; poultry, 
meat byproducts at 0.20 ppm; sheep, fat at 0.10 ppm; sheep, meat at 
0.10 ppm; sheep, meat byproducts, except liver at 0.10 ppm; and sheep, 
liver at 1.2 ppm.
    That notice referenced a summary of the petitions prepared by Bayer 
Crop Science, the registrant, which is available in the docket, http://www.regulations.gov.
    One comment was received from a private citizen who opposed the 
manufacturing and selling of this product due to the lack of available 
bee information. This comment is considered irrelevant because the 
safety standard for approving tolerances under section 408 of the FFDCA 
is directed solely at the safety of the pesticide residues in food to 
the food consumer and does not permit consideration of environmental 
effects on bees.
    Based upon review of the data supporting the petitions, EPA has 
revised tolerance levels. Subsequently, the petitions have been further 
modified per Bayer Crop Science's request to withdraw a majority of the 
primary crops initially proposed for this action, and expanded the 
original rotatable crops of alfalfa and cotton to include canola, 
soybean, and cereals grains except rice, December 8, 2011 (76 FR 76676) 
(FRL-9328-8). The reason for these changes is explained in Unit 
IV.D.START.

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 section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has

[[Page 10970]]

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. In the carcinogenicity 
study, increased liver tumors were also observed in female rats. Liver 
effects in rodents were seen at lower dose levels than those in the 
dogs. 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.
    Fluopyram is classified as ``Likely to be Carcinogenic to Humans'' 
and a unit risk, Q1*, of 1.55 x 10<SUP>-2</SUP> (mg/kg/
day)<SUP>-1</SUP> was used for the linear low dose extrapolation of 
cancer risk based on liver tumors in female rats; thyroid tumors were 
also observed in male mice. 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 ``Fluopyram: Human Health Risk 
Assessment for Proposed Uses on Apples, Bananas (Import only), Cherries 
(Sweet and Tart), Dried Beans, Peanuts, Potatoes, Strawberries, Sugar 
Beets, Tree Nuts, Watermelon, and Wine Grapes'' beginning at Appendix 
A, pages 41-47 in docket ID number EPA-HQ-OPP-2009-0364.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    The details for selecting toxicity endpoints and points of 
departure for various exposure scenarios can be found at http://www.regulations.gov in the document ``Fluopyram: Human Health Risk 
Assessment for Proposed Uses on Apples, Bananas (Import only), Cherries 
(Sweet and Tart), Dried Beans, Peanuts, Potatoes, Strawberries, Sugar 
Beets, Tree Nuts, Watermelon, and Wine Grapes'' in Appendix A on pages 
47-66 in docket ID number EPA-HQ-OPP-2009-0364.
    A summary of the toxicological endpoints for fluopyram used for 
human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Fluopyram for Use in Human Health Risk Assessment
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                                                                          RfD, PAD, Level of       Study and
        Exposure/scenario         Point of departure   Uncertainty/ FQPA   concern for risk      toxicological
                                                        safety factors        assessment            effects
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Acute Dietary (General            NOAEL= 50 mg/kg/    UFA= 10X..........  aRfD = 0.50 mg/kg/  Acute
 Population, including Infants     day.               UFH=10X...........   day.                Neurotoxicity
 and Children).                                       FQPA SF=1X........  aPAD = 0.50 mg/kg/   Study in Rats.
                                                                           day.               The LOAEL of 100
                                                                                               mg/kg in females
                                                                                               is based on
                                                                                               decreased motor
                                                                                               and locomotor
                                                                                               activity in
                                                                                               females.
                                                                                              The LOAEL in males
                                                                                               was 125 mg/kg/
                                                                                               day.
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[[Page 10971]]

 
Acute Dietary (Females 13-49      An endpoint attributable to a single dose exposure has not been identified for
 years of age).                    this subpopulation.
                                 -------------------------------------------------------------------------------
Chronic Dietary (All              NOAEL= 1.2 mg/kg/   UFA= 10X..........  cRfD = 0.012 mg/kg/ Combined Chronic/
 Populations).                     day.               UFH=..............   day.                Carcinogenicity
                                                      10X...............  cPAD = 0.012 mg/kg/  in Rats.
                                                      FQPA SF=1X........   day.               The LOAEL of 6.0
                                                                                               mg/kg/day is
                                                                                               based on
                                                                                               follicular cell
                                                                                               hypertrophy in
                                                                                               the thyroid, and
                                                                                               increased liver
                                                                                               weight with gross
                                                                                               pathological and
                                                                                               histopathological
                                                                                               findings.
                                 -------------------------------------------------------------------------------
Cancer (oral, dermal,             Based on the liver tumor in female rats, EPA classified fluopyram as a
 inhalation).                      ``Likely to be Carcinogenic to Human'' and recommended the use of linear low
                                   dose extrapolation model for risk assessment using a unit risk, Q1* = 1.55 x
                                   10-2 (mg/kg/day)-1.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.
  PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose (a = acute, c = chronic). mg/kg/
  day = milligrams/kilogram/day.

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. 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 U.S. Department of Agriculture (USDA) 
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII). The acute dietary analysis included tolerance 
residue levels, 100% crop treated assumption 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 1994-1996 
and 1998 CSFII. The chronic dietary analysis included average residue 
levels from crop field trials, 100% crop treated assumption, and 
processing factors (empirical and default).
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
If quantitative cancer risk assessment is appropriate, cancer risk may 
be quantified using a linear or nonlinear approach. If sufficient 
information on the carcinogenic mode of action is available, a 
threshold or non-linear approach is used and a cancer RfD is calculated 
based on an earlier noncancer key event. If carcinogenic mode of action 
data are not available, or if the mode of action data determines a 
mutagenic mode of action, a default linear cancer slope factor approach 
is utilized. Based on the data summarized in Unit III.A., EPA has 
concluded that fluopyram should be classified as ``Likely to be 
Carcinogenic to Humans'' and a linear approach has been used to 
quantify cancer risk. The cancer dietary analysis included average 
residue levels from crop field trials, processing factors (empirical 
and default, commercial and household), and percent crop treated (PCT) 
estimates.
    iv. Anticipated residue and PCT information. EPA used tolerance 
level residues and assumed 100% crop treated in the acute dietary 
assessment for fluopyram. For the chronic dietary assessment, EPA used 
average residues from field trials and 100% CT information. The cancer 
dietary risk assessment used average residues from field trials and 
projected percent crop treated estimates based on processing factors.
    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:
    <bullet> 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.
    <bullet> Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
    <bullet> 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 new uses as follows:

[[Page 10972]]

    Almonds: 33%; apples: 40%; barley: 22%; dry beans: 7%; cherry: 49%; 
cotton: 7%; grapes: 79%; oats: 23%; peanuts: 67%; potatoes: 64%; 
rapeseed: 73%; rye: 63%; sorghum: 12%; soybeans: 1%; strawberries: 71%; 
sugar beets: 48%; watermelon: 54%; and wheat: 1%.
    EPA's estimate of the percent crop treated for the new uses of 
fluopyram represents the upper bound of use expected during the 
pesticide's initial 5 years of registration; that is, the percent crop 
treated for fluopyram is a threshold of use that EPA is reasonably 
certain will not be exceeded for this registered use site. The percent 
crop treated for use in the chronic dietary assessment is calculated as 
the average percent crop treated of the market leader or leaders (i.e., 
the pesticides with the greatest percent crop treated) on that crop 
over the 3 most recent years of available data. The percent crop 
treated for use in the acute dietary assessment is the maximum observed 
percent crop treated over the same period. Comparisons are only made 
among pesticides of the same pesticide types (e .g., the market leader 
for fungicides on the use crop is selected for comparison with a new 
fungicide). The market leader included in the estimation may not be the 
same for each year since different pesticides may dominate at different 
times.
    To calculate these percent crop treated values, EPA used recent 
data from the National Agricultural Statistics Service (NASS) 2002-
2006, and recent proprietary data (2006-2010). The estimates for the 
primary crops are based on the market leader approach involving several 
registered fungicides, and the estimates for the rotational crops are 
based on acres of wheat, corn, sorghum, barley, oats, rye, millet, 
soybeans, canola, cotton, and alfalfa grown relative to the total 
acreage of dry beans and potatoes treated with fluopyram.
    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.
    Environmental fate studies indicate that the parent fluopyram is 
stable under environmental conditions. Reported half-lives range from 
89 days in field and aqueous photolysis studies to >1,000 days in 
aerobic/anaerobic water/sediment systems. Fluopyram is mobile in soil 
and can therefore, be expected to occur in surface water runoff and/or 
in ground water leachate. Upper-bound ground water estimates were 
derived using the Tier I Screening Concentration in Ground Water (SCI-
GROW) model. Surface water estimates were partially refined by 
incorporating a foliar degradation rate into the Tier II Pesticide Root 
Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) model. The 
foliar decay rate was calculated from field trial studies in which 
residues were determined at various intervals following foliar 
application; no rain or irrigation occurring during the study period. 
All other inputs reflect high-end assumptions regarding application 
rates and percent cropped area (PCA) in the watershed.
    Based on the Tier II PRZM/EXAMS and SCI-GROW models the estimated 
drinking water concentrations (EDWCs) of fluopyram for acute exposures 
are 13 parts per billion (ppb) for surface water and 0.32 ppb for 
ground water. The EDWCs of fluopyram for chronic exposures for non-
cancer assessments are estimated to be 4.9 ppb for surface water and 
0.32 ppb for ground water and the EDWCs of fluopyram chronic exposures 
for cancer assessments are estimated to be 3.5 ppb for surface water 
and 0.32 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 13 ppb (1 in 10 year annual 
peak) based on a maximum application rate of 0.446 lb ai/A/season 
(cucumber) was used to access the contribution to drinking water. For 
chronic dietary risk assessment, the water concentration of value 4.9 
ppb (1 in 10 year annual mean) based on a maximum application rate of 
0.356 lb active ingredient/Acre (a.i./A)/season (potato) was used to 
access the contribution to drinking water. For cancer dietary risk 
assessment, the water concentration of value 3.5 ppb (1 in 30 year 
annual mean) based on a maximum application rate of 0.356 lb a.i./A/
season (potato) was used to access the contribution of 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 not 
registered for any specific use patterns that would result in 
residential exposure.
    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

[[Page 10973]]

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 prenatal or postnatal periods. Decreased fetal body weight was 
observed at levels equal to or greater than the maternal LOAEL in both 
rat and rabbit developmental studies. Likewise, body weight effects 
were seen in offspring at levels equal to the parental LOAEL in the rat 
2-generation reproductive toxicity study.
    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 and includes the 
immunotoxicity study and neurotoxicity screening battery.
    ii. The fluopyram toxicology database did not demonstrate evidence 
of neurotoxicity. Although transient decreases in motor and locomotor 
activities in the acute neurotoxicity study on the day of treatment and 
limited use of hind-limbs and reduced motor activity in the rat 
chronic/carcinogenicity study were seen, 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 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. There is no indication that fluopyram is a 
neurotoxic chemical and 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 multi-generation 
reproduction study.
    iv. There are no residual uncertainties in the exposure database. 
Although extended field rotational crop studies are required as a 
condition of registration, the rotational crop tolerances used in the 
dietary risk assessment are not expected to underestimate exposure 
because they are based on crop residue results from direct foliar 
treatment as opposed to residues taken up by plants through roots from 
treated soil. The acute dietary exposure assessment was performed using 
tolerance level residues for all crops whereas the chronic dietary 
assessment included average field trial residue levels for all crops. 
Both acute and chronic assessments assumed 100% crop treated and 
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. Residential exposures are not expected. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to fluopyram in drinking water. These 
assessments will not underestimate the exposure and risks posed by 
fluopyram.

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 8.8% of the aPAD for children 1 to 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 13% of the cPAD for children 
1 to 2 years old, the population group receiving the greatest exposure. 
There are no residential uses for fluopyram.
    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). Because no 
short-term adverse effect was identified; fluopyram is not expected to 
pose a short-term risk.
    A short-term adverse effect was identified; however, fluopyram is 
not registered for any use patterns that would result in short-term 
residential exposure. Short-term risk is assessed based on short-term 
residential exposure plus chronic dietary exposure. Because there is no 
short-term residential exposure and chronic dietary exposure has 
already been assessed under the appropriately protective cPAD (which is 
at least as protective as the POD used to assess short-term risk), no 
further assessment of short-term risk is necessary, and EPA relies on 
the chronic dietary risk assessment for evaluating short-term risk for 
fluopyram.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Because no intermediate-term effect was identified, fluopyram 
is not expected to pose an intermediate-term risk. An intermediate-term 
adverse effect was identified; however, fluopyram is not registered for 
any use patterns that would result in intermediate-term residential 
exposure. Intermediate-term risk is assessed based on intermediate-term 
residential exposure plus chronic dietary exposure. Because there is no 
intermediate-term residential exposure and chronic dietary exposure has 
already been assessed under the appropriately protective cPAD (which is 
at least as protective as the POD used to assess short-term risk), no 
further assessment of intermediate-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for fluopyram.
    5. Aggregate cancer risk for U.S. population. Using the exposure 
assumptions described in this unit for the cancer risk assessment, EPA 
has concluded that exposure to fluopyram from food and water will 
result in a lifetime cancer risk of 2.9 x 10<SUP>-6</SUP> for the 
general U.S. population. EPA generally considers cancer risks in the 
range of 1 in 1 million (1 x 10<SUP>-6</SUP>) or less to be negligible. 
The precision which can be assumed for cancer risk estimates is best 
described by rounding to the nearest integral order of magnitude on the 
log scale; for example, risks falling between

[[Page 10974]]

3 x 10<SUP>-7</SUP> and 3 x 10<SUP>-6</SUP> are expressed as risks in 
the range of 10<SUP>-6</SUP>. Considering the precision with which 
cancer hazard can be estimated, the conservativeness of low-dose linear 
extrapolation, and the rounding procedure described above, cancer risk 
should generally not be assumed to exceed the benchmark level of 
concern of the range of 10<SUP>-6</SUP> until the calculated risk 
exceeds approximately 3 x 10<SUP>-6</SUP>. This is particularly the 
case where some conservatism is maintained in the exposure assessment.
    Although the fluopyram exposure risk assessment is refined, it 
retains some conservatism due, among other things, to the use of field 
trial data to estimate residues in food and the use of high-end 
assumptions to estimate residues in water. Accordingly, EPA has 
concluded the cancer risk from aggregate exposure to fluopyram falls 
within the range of 1 x 10<SUP>-6</SUP> and is thus negligible.
    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, has been 
proposed for the enforcement of tolerances for fluopyram residues in or 
on crop commodities, and a high performance liquid chromatography 
method with tandem mass spectrometry detection (HPLC/MS/MS), Method 
01079, has been proposed 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 for 
each analyte in each matrix. The proposed enforcement method for plant 
commodities (DFG Method S19) and livestock commodities (Method 01079) 
are deemed adequate as enforcement methods. Adequate HPLC/MS/MS methods 
were used for data collection for crop and livestock commodities. The 
FDA multiresidue methods of PAM Vol. I are suitable for the 
determination of fluopyram in non-fatty matrices (using Section 302), 
but are not suitable for detection of AE C656948-benzamide residues. 
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: 
<a href="/cdn-cgi/l/email-protection#354750465c5140505850415d5a5146755045541b525a43"><span class="__cf_email__" data-cfemail="1d6f786e747968787078697572796e5d786d7c337a726b">[email protected]</span></a>.

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 U.N. 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.
    Codex Maximum Residue Limits (CXLs) have been established for grape 
at 2 ppm and dried grapes (raisins) at 5 ppm; milk at 0.07 ppm; 
mammalian meat at 0.1 ppm, and edible offal mammalian (meat byproducts) 
at 0.7 ppm. For the purpose of international harmonization, EPA is 
establishing U.S. tolerances for wine grape at 2.0 ppm (raised from 1.4 
ppm); milk at 0.07 ppm (raised from 0.06 ppm); and hog meat byproducts 
at 0.70 ppm (raised from 0.45 ppm).
    The Codex MRL for grapes is based on field trials conducted in 
Europe, and is calculated by rounding up of the statistically 
determined 1.3 ppm to 2 ppm. A U.S. tolerance for dried grapes 
(raisins) is not needed as the tolerance request is for wine-type 
grapes only, which are not converted to raisins.
    Harmonization of recommended U.S. tolerances for meat and meat 
byproducts (other than hog) with Codex MRLs cannot be achieved. The 
Codex MRL for livestock is calculated on the basis of the diets listed 
in Annex 6 of the 2009 JMPR Report (OECD Feedstuffs Derived from Field 
Crops) and the use of a reasonable worst case diet/feed approach 
(RWCF). The dietary burden was calculated using only grape pomace 
residue and 20% contribution to the Australian dairy and beef cattle 
diets. The U.S. tolerance was based on guidance ``Revisions of 
Feedstuffs in (Table 1) OPPTS Test Guideline 860.1000'' and ``Guidance 
on Constructing Maximum Reasonably Balanced Diets (MRBD)''. Based on 
the U.S. livestock diets (which does not include grape pomace) and the 
cattle feeding study, the meat byproduct (cattle, goat horse, sheep) 
tolerances need to be set at 1.1 ppm, a higher level than the 0.7 Codex 
MRL for edible offal. Similarly, the U.S. meat tolerances for these 
animals need to be set higher than the Codex MRL (0.15 versus 0.1 ppm).

C. Revisions to Petitioned-For Tolerances

    Because the Agency's preliminary risk assessment of fluopyram 
determined that aggregate exposure to fluopyram potentially exceeded 
safe levels, the petitioner withdrew tolerance proposals and 
registration requests for the following crops: Crop Group 1B Root 
vegetable; 1C Tuberous and corm vegetable (except potatoes and 
sugarbeet); Crop Group 2 Leaves of root and tuberous vegetables, Crop 
subgroups 3-07A and B Bulb vegetables; Crop Group 4 Leafy vegetables; 
Crop Group 5 Brassica; Crop Group 6A Edible legumes; Crop Group 6B 
Succulent beans and peas; Crop Group 6C (part) Dried peas and some 
dried beans, (except soybeans); Crop Group 7 Foliage of legume 
vegetables; Crop Group 8 Fruiting vegetables; Crop Group 10 Citrus; 
Crop Group 11 Pome fruit (except apple); Crop subgroups 13-07A and B 
Caneberries and Bushberries; Crop subgroup 13-07F Vine fruit (except 
wine grapes); Crop subgroup 13-07G Low growing berries (except 
strawberry); Crop Group 15 Cereal Grains (except for rotational 
purposes); Crop Group16 Forage Cereals (except for rotational 
purposes); Crop Group17 Grasses grown for forage or seed; Crop Group18 
Non grass animal feeds; Crop Group19 Herbs and Spices; Crop Group 20 
Oilseeds (except canola); Hops; Globe artichoke; Christmas Trees; Turf; 
and Ornamentals.
    The petitioner subsequently, submitted a revised registration 
specifying uses only on the following crops: Apple; banana (no U.S. 
registration); bean, dry; beet, sugar, root; cherry (sweet and tart); 
grape, wine; nut tree crop group 14; peanut; pistachio; potatoes; 
strawberry; and watermelon. Based on the available field trial data, 
and NAFTA tolerance calculation procedures, the Agency recommended 
appropriate tolerance levels for individual commodities as opposed to 
levels proposed for crop groups. However, although the petitioner 
proposed a tolerance for ``nut, tree, group 14 (including pistachio)'' 
at 0.05 ppm, EPA determined that separate tolerances must be 
established for the tree nut crop group and pistachio because pistachio 
is not at this time included in crop group 14. The available data 
indicate that 0.05 ppm is an appropriate level for these tolerances.

[[Page 10975]]

    The petitioner has proposed tolerances for combined residues of 
fluopyram and AE C656948-benzamide in egg; milk; the fat, meat, and 
meat byproducts of poultry; and the fat, liver, meat, and meat 
byproducts (except liver) of cattle, goat, hog, horse, and sheep. The 
estimated livestock dietary burden and available feeding study data 
indicate that most of the proposed tolerances for livestock commodities 
are too low. In addition, EPA no longer establishes separate tolerances 
for liver (it is accounted for in the meat byproducts of livestock 
animals). Based on the NAFTA calculator, the Agency recommended higher 
tolerances.
    The revised registration permits crop rotation to alfalfa, cotton, 
canola, cereal grains (except rice), and soybean with certain 
restrictions. However, extensive field rotational crop data for these 
crops are not available. In the absence of sufficient rotational crop 
data, highly conservative target crop residue data were used for 
setting tolerance for rotational crops. The preference was to select an 
intermediate level between the confined accumulation/limited field 
rotational crop data and primary crop data for the target rotated crops 
so as to discourage potential misuse (i.e., direct foliar application) 
and provide adequate maximum residue levels for legal uses according to 
label instructions. Thus, pending extensive field rotational crop data, 
EPA recommends interim rotational crop tolerances be set at half of the 
calculated primary crop tolerances with a PBI of 30 days.
    In addition, the Agency determined tolerances were not required for 
the following petitioned commodities: Beet, sugar, tops; corn, sweet, 
kernel plus cob with husk removed; grain, cereal, forage, fodder and 
straw, group 16, except rice, aspirated fractions; and soybean hulls, 
thus, these tolerances have been removed. Tolerances were not needed 
for the following reasons: the tolerance for the commodity corn, sweet, 
kernel plus cob with husk removed is covered under grain, cereal, group 
15, except rice; Bayer withdrew their requests for tolerances for 
grain, cereal, forage, fodder and straw, group 16, except rice; 
aspirated fractions and soybean, hulls; and the sugar beet top 
tolerance was withdrawn because sugar beet tops are no longer 
considered a major livestock commodity.
    Moreover, EPA is revising certain crop definitions (as proposed) 
for the following: almond, hulls; beet, sugar, roots; eggs; grain, 
cereal, group 15, except rice and sweet corn. The correct commodity 
terminology are almond, hull; beet, sugar, root; egg; and grain, 
cereal, group 15, except rice, respectively.

V. Conclusion

    Therefore, tolerances are established for residues of fluopyram, in 
or on multiple commodities as shown in the codified text below.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to petitions 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 final rule has been 
exempted from review under Executive Order 12866, this final rule 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 final rule 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 section 408(d) of FFDCA, 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 final rule 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 section 408(n)(4) of FFDCA. 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    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 of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: February 2, 2012.
Steven Bradbury,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. Section 180.661 is added to subpart C 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

[[Page 10976]]

determined by measuring only fluopyram in or on the commodity.

------------------------------------------------------------------------
                                                              Parts  per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hull...............................................         8.0
Apple......................................................         0.30
Apple, wet pomace..........................................         0.60
Banana \1\.................................................         1.0
Bean, dry..................................................         0.09
Beet, sugar, root..........................................         0.04
Cherry.....................................................         0.60
Grape, wine................................................         2.0
Nut, tree, group 14........................................         0.05
Peanut.....................................................         0.02
Pistachio..................................................         0.05
Potato.....................................................         0.02
Potato, processed potato waste.............................         0.08
Strawberry.................................................         1.5
Watermelon.................................................         1.0
------------------------------------------------------------------------
\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................................................         0.11
Cattle, meat...............................................         0.15
Cattle, meat byproducts....................................         1.1
Egg........................................................         0.25
Goat, fat..................................................         0.11
Goat, meat.................................................         0.15
Goat, meat byproducts......................................         1.1
Hog, fat...................................................         0.05
Hog, meat..................................................         0.05
Hog, meat byproducts.......................................         0.70
Horse, fat.................................................         0.11
Horse, meat................................................         0.15
Horse, meat byproducts.....................................         1.1
Milk.......................................................         0.07
Poultry, fat...............................................         0.20
Poultry, meat..............................................         0.15
Poultry, meat byproducts...................................         0.60
Sheep, fat.................................................         0.11
Sheep, meat................................................         0.15
Sheep, meat byproducts.....................................         1.1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (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
Canola, seed...............................................         1.8
Cotton, gin byproducts.....................................         0.05
Cotton, undelinted seed....................................         0.01
Grain, cereal, forage, fodder and straw, group 16, except           4.0
 rice; forage..............................................
Grain, cereal, forage, fodder and straw, group 16, except           7.0
 rice; hay, straw and stover...............................
Grain, cereal, group 15, except rice.......................         1.5
Soybean, forage............................................         4.0
Soybean, hay...............................................        15
Soybean, seed..............................................         0.10
------------------------------------------------------------------------

[FR Doc. 2012-4321 Filed 2-23-12; 8:45 am]
BILLING CODE 6560-50-P


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