Document ID: EPA-HQ-OPP-2010-0876-0003
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Flutriafol
Posted Date: 2011-11-09T05:00Z

[Federal Register Volume 76, Number 217 (Wednesday, November 9, 2011)]
[Rules and Regulations]
[Pages 69642-69648]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28947]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0876; FRL-9325-6]

Flutriafol; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
flutriafol, (()-[alpha]-(2-fluorophenyl)-[alpha]-(4-
fluorophenyl)-1H-1,2,4-triazole-1-ethanol, 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 November 9, 2011. Objections and 
requests for hearings must be received on or before January 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2010-0876. 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: 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: gibson.tamue@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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]-0876 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 
January 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-2010-0876, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     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 December 15, 2010 (75 FR 78241) (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

[[Page 69643]]

pesticide petitions (PP 0E7772, 0F7770, 0F7771) by Cheminova A/S, c/o 
Cheminova, Inc. 1600 Wilson Blvd., Arlington, VA 22209. The petitions 
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 banana, whole (import tolerance) at 0.50 parts per 
million (ppm) (PP 0E7772). 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 (PP 0F7771). The petition also 
requested that the 40 CFR part 180 be amended by establishing 
tolerances for the indirect or inadvertent residues of the fungicide 
flutriafol, including its metabolites and degradates, in or on sweet 
corn, field corn and cotton raw agricultural commodities (corn, sweet, 
forage at 0.05 ppm; corn, sweet, stover at 0.09 ppm; corn, sweet, 
kernels plus cob with husks removed at 0.01 ppm; corn, field, forage at 
0.10 ppm; corn, field, stover at 0.07 ppm; corn, field, grain at 0.01 
ppm; cotton, undelinted seed at 0.01 ppm; and cotton, gin byproducts at 
0.05 ppm) grown in fields previously planted with soybeans that were 
treated with flutriafol (PP 0F7770). That notice referenced a summary 
of the petitions 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, EPA raised 
the requested tolerance levels for direct application to grape; peanut; 
fruit, stone, group 12-10; and rotational crop tolerances for corn, 
sweet, forage. EPA lowered tolerance levels for direct application to 
banana (import); grape, raisin; fruit, pome, group 11-09; beet, sugar; 
and rotational crop tolerances for corn, sweet, stover; corn, field, 
forage; and cotton, gin byproducts. EPA is not granting, at this time, 
tolerances for direct application to beet, sugar, top; peanut, hay; 
beet, sugar, refined; beet, sugar, molasses; beet, sugar, dried pulp; 
milk; corn, field, forage; corn, field, stover; corn, field, grain; 
corn, field, flour; corn, field, refined oil; corn, field, meal; corn, 
pop; corn, pop, stover; wheat, forage; wheat, hay; wheat, straw; wheat, 
grain; wheat, bran; wheat, germ; triticale, grain; 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. 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 section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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:
    1. Minimal to severe fatty changes;
    2. Bile duct proliferation/cholangiolarfibrosis;
    3. Hemosiderin accumulation in Kupffer cells;
    4. Centrilobular hypertrophy, and
    5. 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.
    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),

[[Page 69644]]

Sugar Beets, Wheat, Barley, Triticale, Buckwheat, Oats, Rye, Teosinte 
and Imported Bananas'' at page 40 in docket ID number EPA-HQ-OPP-2010-
0876.

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
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                                     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.                 LOAEL = 15 mg/kg/day based
                                     UFH = 10x.............  aPAD = 0.075mg/kg/day.   on decreased number of
                                     FQPA SF = 1x..........  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.                    battery-rat LOAEL = 750 mg/
                                     UFH = 10x.............  aPAD = 2.5 mg/kg/day..   kg/day based on decreased
                                     FQPA SF = 1x..........                           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.                 = 20 mg/kg/day based on
                                     UFH = 10x.............  cPAD = 0.05 mg/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.
Dermal short-term (1 to 30 days)--   Dermal (or oral) study  LOC for MOE = 100.....  Developmental toxicity-
 and Intermediate (1-6 months)--      NOAEL = 7.5 mg/kg/day                           rabbit LOAEL = 15 mg/kg/
 Term.                                (dermal absorption                              day based on decreased
                                      rate = 21%).                                    number of live fetuses,
                                     UFA = 10x.............                           complete litter
                                     UFH = 10x.............                           resorptions and increased
                                     FQPA SF = 1x..........                           post-implantation loss
Inhalation short-term (1 to 30       Inhalation (or oral)    LOC for MOE = 100.....  Developmental toxicity-
 days)--and Intermediate (1-6         study NOAEL= 7.5 mg/                            rabbit LOAEL = 15 mg/kg/
 months)--Term.                       kg/day (inhalation                              day based on decreased
                                      absorption rate =                               number of live fetuses,
                                      100%).                                          complete litter
                                                                                      resorptions and increased
                                                                                      post-implantation loss.
                                     UFA = 10x
                                     UFH = 10x
                                     FQPA SF = 1x
                                    ----------------------------------------------------------------------------
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. MOE = margin of exposure. mg/kg/day = milligrams/
  kilogram/day. LOC = level of concern.

[[Page 69645]]

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 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 and 100% crop treated (CT). EPA used 
DEEMTM version 7.81 default processing factors.
    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 and 100% crop treated (CT). EPA used DEEMTM version 
7.81 default processing factors.
    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 percent crop treated (PCT) information. 
EPA did not use anticipated residue or PCT information in the dietary 
assessment for flutriafol. Tolerance level residues and 100% CT were 
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for flutriafol in drinking water. 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 FQPA 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 48.5 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.
    For chronic dietary risk assessment, the water concentration value 
of 202 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 triazole-containing 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 two triazole conjugates triazolylalanine (TA) and 
triazolylacetic acid (TAA). 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, 
TA, and TAA 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 ID Number EPA-HQ-OPP-2005-0497 and 
an update to assess the addition of the commodities included in this 
action 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''.

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

[[Page 69646]]

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 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 two-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 is not needed given these results.
    iii. There are no concerns or residual uncertainties for prenatal 
and/or postnatal toxicity. Though there is evidence for increased 
susceptibility in the prenatal studies in rats and rabbits and the two-
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:
     Clear NOAELs and LOAELs were established in the fetuses/
offspring for each of these studies;
     The dose-response for these effects is well defined and 
characterized;
     Developmental endpoints are used for assessing acute 
dietary risks to the most sensitive population (females 13-49 years 
old) as well as all other short- and intermediate-term exposure 
scenarios; and
     The chronic reference dose is greater than 300-fold lower 
than the dose at which the offspring effects were observed in the two-
generation reproduction studies.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level 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.
    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 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 (NPD) for tolerances and method ICIA AM00306 for 
ruminant liver) is available to enforce the tolerance expression. The 
method may be requested from: Chief, Analytical Chemistry Branch, 
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; 
telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

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

[[Page 69647]]

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. The Codex has not 
established a MRL for flutriafol.

C. Revisions to Petitioned-For Tolerances

    Based on an analysis of residue levels from crop field trials, EPA 
raised tolerance levels for direct application to grape; peanut; fruit, 
stone, group 12-10; and rotational crop tolerances for corn, sweet, 
forage. For the same reason, EPA lowered tolerance levels for direct 
application to banana (import); grape, raisin; fruit, pome, group 11-
09; beet, sugar; and rotational crop tolerances for corn, sweet, 
stover; corn, field, forage; and cotton, gin byproducts were lowered.
    Additional residue chemistry data are needed to support tolerances 
for direction application to corn, field, forage; corn, field, stover; 
corn, field, grain; corn, field, flour; corn, field, refined oil; corn, 
field, meal; corn, pop; corn, pop, stover; wheat, forage; wheat, hay; 
wheat, straw; wheat, grain; wheat, grain bran; wheat, grain, germ; 
triticale, grain; 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 and 
the proposed milk tolerance. Accordingly, EPA has not made a 
determination with regard to these petitioned-for tolerances at this 
time.
    EPA is not establishing a tolerance for sugar beet tops because the 
Agency no longer considers sugar beet tops to be a feed item. EPA has 
required a label prohibition on feeding of flutriafol-treated peanut 
hay, and thus is not establishing a peanut hay tolerance. Based on 
results of the sugar beet processing study, EPA has determined that 
tolerances are unnecessary for beet, sugar, refined; beet sugar, 
molasses; and beet, sugar dried pulp. These processed commodities are 
adequately covered by the associated raw agricultural tolerances.

V. Conclusion

    Therefore, tolerances are established for residues of flutriafol, 
(()-[alpha]-(2-fluorophenyl)-[alpha]-(4-fluorophenyl)-1H-
1,2,4-triazole-1-ethanol, in or on banana (import) at 0.30 ppm; grape 
at 1.5 ppm; grape, raisin at 2.4 ppm; peanut at 0.09 ppm; fruit, pome 
(crop group 11-09) at 0.40 ppm; fruit, stone (crop group 12-10) at 1.5 
ppm; beet, sugar at 0.08 ppm; and to the rotation to corn, sweet, 
forage at 0.09 ppm; corn, sweet, stover at 0.07 ppm; corn, sweet, 
kernels plus cob with husks removed at 0.01 ppm; corn, field, forage at 
0.09 ppm; corn, field, stover at 0.07 ppm; corn, field, grain at 0.01 
ppm; corn, field, refined oil at 0.02 ppm; corn, pop, stover at 0.07 
ppm; corn, pop at 0.01 ppm; cotton, undelinted seed at 0.01 ppm; and 
cotton, gin byproducts at 0.02 ppm.

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: October 28, 2011.
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 by alphabetically adding the following 
commodities to the table in paragraph

[[Page 69648]]

(a), by adding a new footnote 1, and by revising paragraph (d) to read 
as follows:

Sec.  180.629  Flutriafol; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
 
                              * * * * * * *
Banana\1\......................................                     0.30
Beet, sugar....................................                     0.08
 
                              * * * * * * *
Fruit, pome, group 11-09.......................                     0.40
Fruit, stone, group 12-10......................                      1.5
 
                              * * * * * * *
Grape..........................................                      1.5
Grape, raisin..................................                      2.4
 
                              * * * * * * *
Peanut.........................................                     0.09
 
                              * * * * * * *
------------------------------------------------------------------------
\1\There are no U.S. registrations as of October 26, 2011.

* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established 
for the indirect or inadvertent residues of the fungicide flutriafol, 
including its metabolites and degradates, in or on the commodities in 
the table below when present therein as a result of the application of 
flutriafol to the growing crops listed in the table to paragraph (a) of 
this section. Compliance with the following tolerance levels specified 
below is to be determined by measuring only flutriafol (()-
[alpha]-(2-fluorophenyl)-[alpha]-(4-fluorophenyl)-1H-1,2,4-triazole-1-
ethanol) in or on the following commodities:

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Corn, field, forage............................                     0.09
Corn, field, grain.............................                     0.01
Corn, field, refined oil.......................                     0.02
Corn, field, stover............................                     0.07
Corn, pop......................................                     0.01
Corn, pop, stover..............................                     0.07
Corn, sweet, forage............................                     0.09
Corn, sweet, kernel plus cob with husk removed.                     0.01
Corn, sweet, stover............................                     0.07
Cotton, gin byproducts.........................                     0.02
Cotton, undelinted seed........................                     0.01
------------------------------------------------------------------------

[FR Doc. 2011-28947 Filed 11-8-11; 8:45 am]
BILLING CODE P