[Federal Register Volume 77, Number 153 (Wednesday, August 8, 2012)]
[Rules and Regulations]
[Pages 47296-47302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19317]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0875; FRL-9348-8]


Flutriafol; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes and amends tolerances for residues 
of Flutriafol [(()-[alpha]-(2-fluorophenyl)-[alpha]-(4-
fluorophenyl)-1H-1,2,4-triazole-1-ethanol], including its metabolites 
and degradates in or on multiple commodities which are identified and 
discussed later in this document. Cheminova A/S, c/o Cheminova, Inc. 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective August 8, 2012. Objections and 
requests for hearings must be received on or before October 9, 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2010-0875, is available either 
electronically through http://www.regulations.gov or in hard copy at 
the OPP Docket in the Environmental Protection Agency Docket Center 
(EPA/DC), located in EPA West, 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: Tamue L. Gibson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-9096; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     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.

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-2010-0875 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 
October 9, 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-2010-0875, 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 Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

[[Page 47297]]

II. Summary of Petitioned-for Tolerance

    In the Federal Register of December 15, 2010 (75 FR 78240) (FRL-
8853-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
0F7771) by Cheminova A/S, c/o Cheminova, Inc. 1600 Wilson Blvd., 
Arlington, VA 22209. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of the fungicide 
flutriafol, including its metabolites and degradates, in or on corn, 
field, forage at 4.0 ppm; corn, field, stover at 6.0 ppm; corn, field, 
grain at 0.01 ppm; corn, field, flour at 0.03 ppm; corn, field, oil at 
0.07 ppm; corn, field, meal at 0.03 ppm; corn, pop, stover at 6.0 ppm; 
corn, pop, grain at 0.01 ppm; grape at 1.1 ppm; grape, raisin at 2.5 
ppm; peanut at 0.08 ppm; peanut, hay at 18 ppm; fruit, pome (Crop Group 
11) at 0.60 ppm; fruit, stone (Crop Group 12) at 0.80 ppm; beet, sugar, 
root at 1.5 ppm; beet, sugar, tops at 2.5 ppm; beet, sugar, refined at 
0.70 ppm; beet, sugar, molasses at 1.0 ppm; beet, sugar, dried pulp at 
1.0 ppm; wheat, forage at 25 ppm; wheat, hay at 9.0 ppm; wheat, straw 
at 6.0 ppm; wheat, grain at 0.15 ppm; wheat, grain, bran at 0.20 ppm; 
wheat, grain, germ at 0.20 ppm; barley, hay at 9.0 ppm; barley, straw 
at 6.0 ppm; barley, grain at 0.15 ppm; barley, grain, bran at 0.20 ppm; 
buckwheat, grain at 0.15 ppm; oats, forage at 25 ppm; oats, hay at 9.0 
ppm; oats, straw at 6.0 ppm; oats, grain at 0.15 ppm; oats, grain, bran 
at 0.20 ppm; rye, forage at 25 ppm; rye, straw at 6.0 ppm; rye, grain 
at 0.15 ppm; cattle, liver at 0.12 ppm; goat, liver at 0.12 ppm; horse, 
liver at 0.12 ppm; sheep, liver at 0.12 ppm; and milk at 0.02 ppm. The 
proposed tolerance for fruit, pome which is based on new field trial 
data for pears and previously submitted data for apples, will replace 
the current tolerance for apples at 0.20 ppm. That notice referenced a 
summary of the petition prepared by Cheminova A/S, c/o Cheminova, Inc, 
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, tolerances 
for corn, field, forage; corn, field, stover; corn, field, refined oil; 
and corn, pop, stover were lowered. Tolerances for corn, field, flour 
and corn, field, meal were not required. Established tolerances for 
apple; cattle, liver; goat, liver; hog, liver; horse, liver; and sheep, 
liver and established rotational crop tolerances for corn, field, 
forage; corn, field, stover; corn, field, grain; corn, field, refined 
oil; corn, pop; and corn, pop, stover are removed. The proposed 
tolerances for wheat, forage; wheat, hay; wheat, straw; wheat, grain; 
wheat, grain, bran; wheat, grain, germ; barley, hay; barley, straw; 
barley, grain; barley, grain, bran; buckwheat, grain; oat, forage; oat, 
hay; oat, straw; oat, grain; oat, grain, bran; rye, forage; rye, straw; 
and rye, grain were withdrawn by the petitioner. Tolerances were 
previously established on November 9, 2011 for banana, grape, raisin; 
pome and stone fruit, sugar beets and for the rotational corn crops--
sweet, field, and popcorn, and cotton. 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 flutriafol including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with flutriafol 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. Flutriafol has high oral acute toxicity in the mouse. It has 
low acute toxicity via the oral, dermal and inhalation routes in rats. 
Flutriafol is minimally irritating to the eyes and is not a dermal 
irritant. Flutriafol was not shown to be a skin sensitizer when tested 
in guinea pigs.
    Short-term, subchronic, and chronic toxicity studies in rats, mice, 
and dogs identified the liver as the primary target organ of 
flutriafol. Hepatotoxicity was first evident in the subchronic studies 
(rats and dogs) in the form of increases in liver enzyme release 
(alkaline phosphatase), liver weights, and histopathology findings 
ranging from hepatocyte vacuolization to centrilobular hypertrophy and 
slight increases in hemosiderin-laden Kupffer cells. It is noteworthy 
that with chronic exposures, there are no indications of progression of 
liver toxicity in any of the species tested. After over 1 year of 
exposure, hepatotoxicity in rats, dogs, and mice took the form of 
minimal to severe fatty changes; bile duct proliferation/
cholangiolarfibrosis; hemosiderin accumulation in Kupffer cells; 
centrilobular hypertrophy, and increases in alkaline phosphatase 
release. Slight indications of effects in the hematopoietic system are 
sporadically seen in the database. These effects were manifested in the 
form of slight anemia (rats and dogs) and increased platelet, white 
blood cell, neutrophil, and lymphocyte counts (mice). These effects, 
however, were minimal in severity.
    Flutriafol is considered to be ``Not likely to be Carcinogenic to 
Humans'' based on the results of the carcinogenicity studies in rats 
and mice. The results of the rat chronic toxicity/carcinogenicity study 
and the mouse carcinogenicity study are negative for carcinogenicity. 
All genotoxicity studies on flutriafol showed no evidence of 
clastogenicity or mutagenicity.
    Specific information on the studies received and the nature of the 
adverse effects caused by flutriafol as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Flutriafol: Human Health Risk 
Assessment for Proposed Uses on Corn, Grapes, Peanuts, Pome Fruit (Crop 
Group 11), Stone Fruit (Crop Group 12), Sugar Beets, Wheat, Barley, 
Triticale, Buckwheat, Oats, Rye, Teosinte, and Imported Bananas,'' at 
p. 40 in docket ID number EPA-HQ-OPP-2010-0875.

[[Page 47298]]

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for flutriafol used for 
human risk assessment is shown in the following table.

   Table--Summary of Toxicological Doses and Endpoints for Flutriafol for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                     Point of departure and
         Exposure/ Scenario            uncertainty/Safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 years   NOAEL = 7.5 mg/kg/day.  Acute RfD = 0.075 mg/   Developmental study-rabbit
 of age).                            UFA = 10x.............   kg/day aPAD = 0.075     LOAEL = 15 mg/kg/day based
                                     UFH = 10x.............   mg/kg/day.              on decreased number of
                                     FQPA SF = 1x..........                           live fetuses, complete
                                                                                      litter resorptions and
                                                                                      increased post-
                                                                                      implantation loss.
Acute dietary (General population    NOAEL = 250 mg/kg/day.  Acute RfD = 2.5 mg/kg/  Neurotoxicity screening
 including infants and children).    UFA = 10x.............   day aPAD = 2.5 mg/kg/   battery-rat
                                     UFH = 10x.............   day.                   LOAEL = 750 mg/kg/day based
                                     FQPA SF = 1x..........                           on decreased body weight,
                                                                                      body-weight gain, absolute
                                                                                      and relative food
                                                                                      consumption, and clinical
                                                                                      signs of toxicity in both
                                                                                      sexes: Dehydration, urine-
                                                                                      stained abdominal fur,
                                                                                      ungroomed coat, ptosis,
                                                                                      decreased motor activity,
                                                                                      prostration, limp muscle
                                                                                      tone, muscle flaccidity,
                                                                                      hypothermia, hunched
                                                                                      posture, impaired or lost
                                                                                      righting reflex, scant
                                                                                      feces; in males: Red or
                                                                                      tan perioral substance,
                                                                                      chromodacryorrhea,
                                                                                      chromorhinorrhea and
                                                                                      labored breathing, and in
                                                                                      females: piloerection and
                                                                                      bradypnea.
Chronic dietary (All populations)..  NOAEL= 5 mg/kg/day....  Chronic RfD = 0.05 mg/  Chronic toxicity-dog LOAEL
                                     UFA = 10x.............   kg/day cPAD = 0.05 mg/  = 20 mg/kg/day based on
                                     UFH = 10x.............   kg/day.                 adverse liver findings
                                     FQPA SF = 1x..........                           (increased liver weights,
                                                                                      increased centrilobular
                                                                                      hepatocyte lipid in the
                                                                                      liver, and increases in
                                                                                      alkaline phosphatase,
                                                                                      albumin, and
                                                                                      triglycerides), increased
                                                                                      adrenal cortical
                                                                                      vacuolation of the zona
                                                                                      fasciculata, and marked
                                                                                      hemosiderin pigmentation
                                                                                      in the liver and spleen in
                                                                                      both sexes; mild anemia
                                                                                      (characterized by
                                                                                      decreased hemoglobin,
                                                                                      hematocrit, and red blood
                                                                                      cell count) in the males;
                                                                                      and initial body-weight
                                                                                      losses, decreased
                                                                                      cumulative body-weight
                                                                                      gains, and increased
                                                                                      adrenal weights in the
                                                                                      females.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..    Classification: ``Not likely to be Carcinogenic to Humans'' based on the
                                                       carcinogenicity studies in rats and mice.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population-
  adjusted dose (a = acute, c = chronic). RfD = reference dose. mg/kg/day = milligrams/kilogram/day.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to flutriafol, EPA considered exposure under the petitioned-
for tolerances as well as all existing flutriafol tolerances in 40 CFR 
180.629. EPA assessed dietary exposures from flutriafol 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 flutriafol. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide

[[Page 47299]]

Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, EPA made the following assumptions for the acute 
exposure assessment: tolerance-level residues or tolerance-level 
residues adjusted to account for the residues of concern for risk 
assessment, 100 percent crop treated (PCT), and Dietary Exposure 
Evaluation Model (DEEMTM) version 7.81 default processing 
factors were used.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA made the following 
assumptions for the chronic exposure assessment: tolerance-level 
residues or tolerance-level residues adjusted to account for the 
residues of concern for risk assessment, 100 PCT, and DEEMTM 
version 7.81 default processing factors were used.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that flutriafol does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for flutriafol. Tolerance level residues or tolerance-level residues 
adjusted upward to account for the residues of concern for risk 
assessment and 100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the flutriafol dietary exposure analysis 
and risk assessment. These simulation models take into account data on 
the physical, chemical, and fate/transport characteristics of 
flutriafol. 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 Food Quality Protection Act (FQPA) Food Index 
Reservoir Screening Tool (FIRST), and Pesticide Root Zone Model/Ground 
Water (PRZM/GW), the estimated drinking water concentrations (EDWCs) of 
flutriafol for acute exposures are estimated to be 48.8 parts per 
billion (ppb) for surface water and 310 ppb for ground water.
    For chronic exposures for non-cancer assessments the EDWC's are 
estimated to be 5.70 ppb for surface water and 202 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 310 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). Flutriafol 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.''
    Flutriafol is a member of the conazole (triazole) class of 
pesticides. Although conazoles act similarly in plants (fungi) by 
inhibiting ergosterol biosynthesis, there is not necessarily a 
relationship between their pesticidal activity and their mechanism of 
toxicity in mammals. Structural similarities do not constitute a common 
mechanism of toxicity. Evidence is needed to establish that the 
chemicals operate by the same, or essentially the same, sequence of 
major biochemical events (EPA, 2002). In conazoles, however, a variable 
pattern of toxicological responses is found; some are hepatotoxic and 
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some 
induce developmental, reproductive, and neurological effects in 
rodents. Furthermore, the conazoles produce a diverse range of 
biochemical events including altered cholesterol levels, stress 
responses, and altered DNA methylation. It is not clearly understood 
whether these biochemical events are directly connected to their 
toxicological outcomes. Thus, there is currently no evidence to 
indicate that conazoles share common mechanisms of toxicity and EPA is 
not following a cumulative risk approach based on a common mechanism of 
toxicity for the conazoles. For information regarding EPA's procedures 
for cumulating effects from substances found to have a common mechanism 
of toxicity, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
    Triazole-derived pesticides can form the metabolite 1,2,4-triazole 
(T) and several conjugated triazole metabolites. To support existing 
tolerances and to establish new tolerances for triazole-derivative 
pesticides, EPA conducted an initial human-health risk assessment for 
exposure to T and the conjugated triazole metabolites resulting from 
the use of all current and pending uses of any triazole-derived 
fungicide as of September 1, 2005. The risk assessment was a highly 
conservative, screening-level evaluation in terms of hazards associated 
with common metabolites (e.g., use of a maximum combination of 
uncertainty factors) and potential dietary and non-dietary exposures 
(i.e., high-end estimates of both dietary and non-dietary exposures). 
In addition, the Agency retained the additional 10X FQPA SF for the 
protection of infants and children. The assessment included evaluations 
of risks for various subgroups, including those comprised of infants 
and children. The Agency's complete risk assessment can be found in the 
propiconazole reregistration docket at http://www.regulations.gov, 
Docket Identification (ID) Number EPA-HQ-OPP-2005-0497 and an updated 
assessment may be found in docket ID EPA-HQ-OPP-2011-0120 in the 
document entitled ``Common Triazole Metabolites: Updated Dietary (Food 
+ Water) Exposure and Risk Assessment to Address the Amended 
metconazole Section 3 Registration to Add uses on Tuberous and Corm 
Vegetables (Group 1C) and Bushberry Subgroup 13-07B.'' The Agency has 
determined that the proposed application to field and popcorn will not 
result in residues of 1,2,4-triazole (T), triazolylalanine (TA), and 
triazolylacetic acid (TAA) greater than the estimates incorporated in 
the most recent assessment. Therefore, a revised triazole metabolite 
assessment is not needed.

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.

[[Page 47300]]

    2. Prenatal and postnatal sensitivity. The potential impact of in 
utero and perinatal flutriafol exposure was investigated in three 
developmental toxicity studies (two in rats, one in rabbits) and two 
multigenerational reproduction toxicity studies in rats. In the first 
of two rat developmental toxicity studies, a quantitative 
susceptibility was observed (delayed ossification or non-ossification 
of the skeleton in the fetuses) at a lower dose than maternal effects. 
In the second rat developmental study, a qualitative susceptibility was 
noted. Although developmental toxicity occurred at the same dose level 
that elicited maternal toxicity, the developmental effects (external, 
visceral, and skeletal malformations; embryo lethality; skeletal 
variations; a generalized delay in fetal development; and fewer live 
fetuses) were more severe than the decreased food consumption and body-
weight gains observed in the dams. For rabbits, intrauterine deaths 
occurred at a dose level that also caused adverse effects in maternal 
animals. In the 2-generation reproduction studies, a qualitative 
susceptibility was also seen. Effects in the offspring--decreased 
litter size and percentage of live births (increased pup mortality) and 
liver toxicity--can be attributed to the systemic toxicity of the 
parental animals (decreased body weight and food consumption and liver 
toxicity).
    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 flutriafol is complete.
    ii. There is no concern for neurotoxicity with flutriafol. Signs of 
neurotoxicity were reported in the acute and subchronic neurotoxicity 
studies at the highest dose only; however, these effects were primarily 
seen in animals that were agonal (at the point of death) and thus, are 
not indicative of neurotoxicity. In addition, there was no evidence of 
neurotoxicity in any additional short-term studies in rats, mice, and 
dogs, or in the long-term toxicity studies in rats, mice, and dogs. A 
developmental neurotoxicity study (DNT) is not required given these 
results.
    iii. There are no residual uncertainties for pre- and/or post-natal 
toxicity. Though there is evidence for increased susceptibility in the 
prenatal studies in rats and rabbits and the 2-generation reproduction 
study in rats, there are no concerns for the offspring toxicity 
observed in the developmental and reproductive toxicity studies for the 
following reasons:
    a. Clear NOAELs and LOAELs were established in the fetuses/
offspring;
    b. The dose-response for these effects are well defined and 
characterized;
    c. Developmental endpoints are used for assessing acute dietary 
risks to the most sensitive population (females 13-49) as well as all 
other short- and intermediate-term exposure scenarios; and
    d. The chronic reference dose is greater than 300-fold lower than 
the dose at which the offspring effects were observed in the 2-
generation reproduction studies.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level (or higher) residues. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to flutriafol in drinking water. These 
assessments will not underestimate the exposure and risks posed by 
flutriafol.

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 flutriafol will occupy 24% of the aPAD for females 13-49 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 
flutriafol from food and water will utilize 42% of the cPAD for all 
infants less than 1 year old the population group receiving the 
greatest exposure. There are no residential uses for flutriafol. Based 
on the explanation in Unit III.C.3., regarding residential use 
patterns, chronic residential exposure to residues of flutriafol 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). Flutriafol is 
not registered for any use patterns that would result in short-term 
residential exposure. Therefore, the short-term aggregate risk is the 
sum of the risk from exposure to flutriafol through food and water and 
will not be greater than the chronic aggregate risk.
    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). Flutriafol is not registered for any use patterns that would 
result in intermediate-term residential exposure. Therefore, the 
intermediate-term aggregate risk is the sum of the risk from exposure 
to flutriafol through food and water, which has already been addressed, 
and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, flutriafol 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 flutriafol residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Gas Chromatography/Nitrogen/
Phosphorus detector (GS/NPD) method for proposed tolerances and method 
ICIA AM00306 for ruminant liver) 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: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture

[[Page 47301]]

Organization/World Health Organization food standards program, and it 
is recognized as an international food safety standards-setting 
organization in trade agreements to which the United States is a party. 
EPA may establish a tolerance that is different from a Codex MRL; 
however, FFDCA section 408(b)(4) requires that EPA explain the reasons 
for departing from the Codex level. The Codex has not established a 
MRLs for flutriafol; therefore, harmonization is not an issue.

C. Revisions to Petitioned-for Tolerances

    Based on the analysis of the residue trial data and Organization 
for Economic Cooperation and Development (OECD) tolerance calculation 
procedures, tolerances for corn, field, forage; corn, pop, stover; and 
corn, field, stover were lowered. Established rotational crop 
tolerances for corn, field forage; corn, field, stover; corn, field, 
grain; corn, field, refined oil; corn, pop; and corn, pop, stover are 
removed as they are superseded by tolerances for direct application to 
the growing crop. The established tolerance for apple is removed and 
superseded by the previously established higher tolerance for fruit, 
pome, group 11-09. The established tolerances for cattle; liver; goat, 
liver; hog, liver; horse, liver; and sheep, liver are replaced by 
tolerances for meat byproducts of cattle, goat, hog, horse, and sheep. 
Based on the results from the field corn processing study, tolerances 
for corn, field, flour and corn, field, meal are not needed. Tolerances 
for wheat, forage; wheat, hay; wheat, straw; wheat, grain; wheat, bran; 
wheat, germ; barley, hay; barley, straw; barley, grain; barley, grain, 
bran; buckwheat, grain; oat, forage; oat, hay; oat, straw; oat, grain; 
oat, grain, bran; rye, forage; rye, straw; rye, grain were withdrawn by 
the petitioner. Tolerances were previously established on November 9, 
2011 for banana; grape; grape, raisin; pome and stone fruit; sugar 
beets and for the rotational crops, field and popcorn, and cotton.

V. Conclusion

    Therefore, tolerances are established for residues of flutriafol, 
[(()-[alpha]-(2-fluorophenyl)-[alpha]-(4-fluorophenyl)-1H-
1,2,4-triazole-1-ethanol], including its metabolites and degradates, in 
or on corn, field, forage at 0.75 ppm; corn, field, stover at 1.5 ppm; 
corn, field, grain at 0.01 ppm; corn, field, refined oil at 0.02 ppm; 
corn, pop at 0.01 ppm; corn, pop, stover at 1.5 ppm; cattle, meat 
byproducts at 0.07 ppm; goat, meat byproducts at 0.07 ppm; hog, meat 
byproducts at 0.02 ppm; horse, meat byproducts at 0.07 ppm and sheep, 
meat byproducts at 0.07 ppm. This final rule deletes established 
tolerances for apple; cattle; liver; goat, liver; hog, liver; horse, 
liver; and sheep, liver. This final rule also deletes established 
rotational crop tolerances for corn, field, forage; corn, field, 
stover; corn, field, grain; corn, field, refined oil; corn, pop; and 
corn, pop, stover.

VI. Statutory and Executive Order Reviews

    This final rule 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 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 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 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 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 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: July 27, 2012.
Lois Rossi,
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 180.629 is amended as follows:
0
i. Remove the entries for ``Apple''; ``Cattle, liver''; ``Goat, 
liver''; ``Hog, liver''; ``Horse, liver''; and ``Sheep, liver'' from 
the table to paragraph (a).
0
ii. Add alphabetically the entries for ``Cattle, meat byproducts''; 
``Corn, field, forage''; ``Corn, field, grain''; ``Corn, field, refined 
oil''; ``Corn, field, stover'';

[[Page 47302]]

``Corn, pop''; ``Corn, pop, stover''; ``Goat meat byproducts''; ``Hog, 
meat byproducts''; ``Horse meat byproducts''; and ``Sheep meat 
byproducts'' to the table in paragraph (a).
0
iii. Remove the entries for ``Corn, field, forage''; ``Corn, field, 
grain''; ``Corn, field, refined oil''; ``Corn, field, stover''; ``Corn, 
pop''; and ``Corn, pop, stover'' from the table in paragraph (d).
    The added entries read as follows:


Sec.  180.629  Flutriafol; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cattle, meat byproducts.................................            0.07
Corn, field, forage.....................................            0.75
Corn, field, grain......................................            0.01
Corn, field, refined oil................................            0.02
Corn, field, stover.....................................            1.5
Corn, pop...............................................            0.01
Corn, pop, stover.......................................            1.5
 
                                * * * * *
Goat, meat byproducts...................................            0.07
 
                                * * * * *
Hog, meat byproducts....................................            0.02
Horse, meat byproducts..................................            0.07
 
                                * * * * *
Sheep, meat byproducts..................................            0.07
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-19317 Filed 8-7-12; 8:45 am]
BILLING CODE 6560-50-P