[Federal Register Volume 75, Number 91 (Wednesday, May 12, 2010)]
[Rules and Regulations]
[Pages 26668-26673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-11296]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0184; FRL-8812-6]


Flutriafol; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
flutriafol, [(<plus-minus>)-[alpha]-(2-fluorophenyl)-[alpha]-(4-
fluorophenyl)-1H-1,2,4-triazole-1-ethanol], including its metabolites 
and degradates in or on apple at 0.20 ppm; soybean, seed at 0.35 ppm; 
and grain, aspirated fractions at 2.2 ppm; and cattle, goat, hog, horse 
and sheep liver at 0.02 ppm. Cheminova A/S, c/o Cheminova, Inc. 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective May 12, 2010. Objections and 
requests for hearings must be received on or before July 12, 2010, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0184. 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; e-mail address: <a href="/cdn-cgi/l/email-protection#b1d6d8d3c2dedf9fc5d0dcc4d4f1d4c1d09fd6dec7"><span class="__cf_email__" data-cfemail="e2858b80918d8ccc96838f9787a2879283cc858d94">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR cite 
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized Test 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2009-0184 in the subject line on the first 
page of your submission. All requests must be in writing, and must be 
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 
on or before July 12, 2010.
    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 that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA

[[Page 26669]]

without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2009-0184, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of April 8, 2009 (74 FR 15973) (FRL-8407-
4), 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 
7F7197) by Cheminova A/S, c/o Cheminova, Inc., 1600 Wilson Blvd., 
Arlington, VA 22209. The petition requested that 40 CFR 180 be amended 
by establishing tolerances for residues of the fungicide flutriafol in 
or on the following raw agricultural commodities: Apple at 0.2 parts 
per million (ppm); apple, wet pomace at 0.3 ppm; soybean at 0.3 ppm; 
soybean, aspirated grain fractions at 0.5 ppm; and liver (cattle, goat, 
hog, horse and sheep) at 0.01 ppm. That notice referenced a summary of 
the petition prepared by Cheminova A/S, c/o Cheminova Inc., the 
registrant, which is available to the public 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 has 
determined that tolerances are not needed for apple, juice; wet apple 
pomace; soybean meal; soybean hull; and soybean oil. Additionally, 
tolerances were increased for soybean seed; aspirated grain fractions; 
and cattle, goat, hog, horse and sheep liver. The reason for these 
changes are explained in Unit IV.D.

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 the petitioned-for 
tolerances for residues of flutriafol including its metabolites and 
degradates in or on apple at 0.20 ppm; soybean, seed at 0.35 ppm; 
grain, aspirated fractions at 2.2 ppm; and cattle, goat, hog, horse and 
sheep liver at 0.02 ppm. EPA's assessment of exposures and risks 
associated with establishing tolerances 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. 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 Apple and Soybean at page 20 in docket 
ID number EPA-HQ-OPP-2009-0184.
    Flutriafol has low acute oral and inhalation toxicity. A 28-day 
dermal toxicity study did not reveal any signs of toxicity at the limit 
dose (1,000 mg/kg/day). Thus, flutriafol is not considered to be 
acutely toxic via the dermal route. 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.
    The pattern of toxicity attributed to flutriafol exposure via the 
oral route includes hepatotoxicity, developmental toxicity (manifested 
as increased intrauterine death) at the same dose as parental toxicity, 
and generalized toxicity (body weight/body weight gains and food 
consumption decrements as well as slight anemia).
    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 enzymes (alkaline 
phosphatase), liver weights, and histopathology findings ranging from 
hepatocyte vacuolation to centrilobular hypertrophy and slight 
increases in hemosiderin-laden Kupffer cells. With chronic exposures, 
there were no indications of progression of liver toxicity in either 
species. Neither the chronic/carcinogenicity study in rats nor the 
carcinogenicity study in mice revealed treatment-related increases in 
tumor incidences.
    Slight indications of effects on red blood cells were sporadically 
seen in the database. These effects were manifested in the form of 
slight anemia and increased hemosiderin in the liver or spleen of rats 
and dogs. Increased platelet, white blood cell, neutrophil, and 
lymphocyte counts were also observed in one study in mice. However, 
these effects were minimal in severity, were not considered adverse, 
and were not observed in any other study or species.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in

[[Page 26670]]

sensitivity among members of the human population as well as other 
unknowns. Safety is assessed for acute and chronic dietary risks by 
comparing aggregate food and water exposure to the pesticide to the 
acute population adjusted dose (aPAD) and chronic population adjusted 
dose (cPAD). The aPAD and cPAD are calculated by dividing the POD by 
all applicable UFs. Aggregate short-, intermediate-, and chronic-term 
risks are evaluated by comparing food, water, and residential exposure 
to the POD to ensure that the margin of exposure (MOE) called for by 
the product of all applicable UFs is not exceeded. This latter value is 
referred to as the Level of Concern (LOC).
    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 
greater than that 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 can be found at http://www.regulations.gov in 
document Flutriafol. Human-Health Risk Assessment for Proposed Uses on 
Apple and Soybean at page 20 in docket ID number EPA-HQ-OPP-2009-0184.

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 for soybean and apples. Tolerances have been previously 
established in 40 CFR 180.629 in or on soybean treated under section 18 
of FIFRA. 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.
    In conducting the acute dietary exposure assessment, EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCID\TM\, version 2.03) which incorporates food 
consumption data as reported by respondents in the United States 
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). The following 
assumptions were made for the acute exposure assessment: Tolerance-
level residues, 100% crop treated (CT), and DEEM\TM\ version 7.81 
default processing factors were used.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the DEEM\TM\ software with DEEM-FCID\TM\, version 
2.03 which incorporates food consumption data as reported by 
respondents in the USDA 1994-1996 and 1998 Nationwide CSFII. The 
following assumptions were made for the chronic exposure assessment: 
Tolerance-level residues, 100% CT, and DEEM\TM\ version 7.81 default 
processing factors were used.
    iii. Cancer. The Agency classified flutriafol as ``Not Likely to be 
Carcinogenic to Humans'' based on the results of the carcinogenicity 
studies in rats and mice. All genotoxicity studies on flutriafol showed 
no evidence of clastogenicity or mutagenicity. Flutriafol is a member 
of a class of pesticides known as triazoles. Although several triazoles 
are carcinogenic, many are not and flutriafol has been adequately 
tested and found not to be carcinogenic in long-term studies in rats 
and mice. Structure-activity-relationship analysis indicates that 
flutriafol may have the potential to produce thyroid and/or liver 
tumors in rodents. However, in the rat and mouse carcinogenicity 
studies, there were no treatment-related increases in tumor incidence 
when comparing treated animals to controls.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/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 First Index Reservoir Screening Tool (FIRST), and 
Screening Concentration in Ground Water (SCI-GROW) models, 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 4.8 ppb for ground water. For chronic exposures for non-
cancer assessments are estimated to be 5.7 ppb for surface water and 
4.8 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 48.8 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 5.7 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 
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. 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

[[Page 26671]]

common mechanism of toxicity, see EPA's website 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 Identification (ID) Number EPA-HQ-
OPP-2005-0497.
    The Agency completed an updated dietary risk assessment considering 
exposure to T, TA, and TAA based on established and proposed uses of 
triazole fungicides; however, this risk assessment did not include 
flutriafol uses. The resulting acute and chronic exposure to T, TA, and 
TAA were less than the Agency's level of concern (T: <=36% aPAD and 
<=54% cPAD; TA/TAA: 34% aPAD and <=40% cPAD). The Agency concludes that 
revised T and TA/TAA dietary risk assessments are unnecessary for the 
following reasons: (1) Incorporation of the flutriafol uses resulted in 
negligible changes to the T and TA/TAA residue estimates incorporated 
into the previous dietary analyses and (2) the T and TA/TAA drinking 
water estimates incorporated into the previous dietary analyses assumed 
an annual fungicide application rate of 10.38 pound active ingredient/
acre (lb ai/acre) for nonagricultural uses and 2.0 lb ai/acre for 
agricultural uses and the formation of T and/or TA/TAA at 30.7% of the 
applied rate. Since the annual application rate for flutriafol is 
<=0.63 lb ai/acre and since all environmental degradates were 
identified at <10% total radioactive residue (TRR), a revised drinking 
water assessment was unnecessary.

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 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 a 
multigeneration reproduction toxicity study in rats. Only one of the 
rat developmental toxicity studies was acceptable. Qualitative 
susceptibility was noted in the acceptable rat developmental study and 
in the two-generation reproduction study.
    In the acceptable rat developmental study, developmental toxicity 
(late resorptions, skeletal malformations and variations, decrease in 
fetal weights) occurred at the same dose level that elicited maternal 
toxicity (late resorptions, decreased food consumption, body weight 
gains). In rabbits, a decreased number of live fetuses were observed at 
the same dose that also caused adverse effects in maternal animals 
(complete litter resorptions, increased post-implantation loss, 
decreased body weight gain and food consumption).
    In the two-generation reproduction study, effects in the offspring 
(decreased litter size and percentage of live births and liver 
toxicity) were observed at the same dose as parental toxicity 
(decreased body weight and food consumption and liver toxicity) and may 
be related to the systemic toxicity of the parents. There is no concern 
for the offspring toxicity observed in the developmental and 
reproductive toxicity studies for the following reasons: (1) the 
effects were seen in the presence of maternal/parental/systemic 
toxicity; (2) clear NOAELs and LOAELs were established in the fetuses/
offspring; (3) the dose-response for these effects are well defined and 
characterized; and (4) 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.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings.
    <bullet> Except for an immunotoxicity study, the toxicological 
database is complete. In accordance with the revised part 158 an 
immunotoxicity study is required. In the case of flutriafol, there was 
no evidence of toxicity to the immune organs in any study in the 
database. Increased hemosiderin in the spleen was observed in rats or 
dogs. However, this was considered due to the storage of iron following 
the clearance of damaged erythrocytes from the blood and not to an 
immunotoxic effect. Increased platelet, white blood cell, neutrophil, 
and lymphocyte counts were also observed in one study in mice. However, 
these effects were minimal in severity, were not considered adverse, 
and were not observed in any other study or species. Therefore, they 
are not considered immunotoxic effects.
    In addition, flutriafol does not belong to a class of chemicals 
(e.g., the organotins, heavy metals, or halogenated aromatic 
hydrocarbons) that would be expected to be immunotoxic. Based on the 
above considerations, the Agency does not believe that conducting a 
special series OPPTS Harmonized Guideline 870.7800 immunotoxicity study 
will result in a point of departure lower than that used for overall 
risk assessment. Therefore an additional UFDB does not need to be 
applied.
    <bullet> There are no concerns or residual uncertainties for pre- 
and/or post-natal toxicity. There is no evidence of quantitative 
susceptibility following in utero exposures to rats or rabbits and 
following pre- and post-natal exposures to rats for two generations. 
There is no concern for the offspring toxicity observed in the 
developmental and reproductive toxicity studies for the following 
reasons: (1) The effects were seen in the presence of maternal/parental 
systemic toxicity; (2) clear NOAELs and LOAELs were established in the 
fetuses/offspring; (3) the dose-response for these effects are well 
defined and characterized; and (4) 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.

[[Page 26672]]

    <bullet> 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.
    <bullet> A developmental neurotoxicity study is not required.
    <bullet> The dietary exposure assessment is conservative in nature 
(utilized tolerance level residues and 100% CT were utilized).
    <bullet> Conservative (protective) assumptions were used in the 
ground water and surface water modeling to assess exposure to 
flutriafol in drinking water.
    <bullet> There are no proposed residential uses.
    <bullet> Based on summaries of confined/field rotational crop 
studies submitted by the petitioner, the Agency determined that 
rotation of only soybean to a treated field was acceptable. The Agency 
is requesting that the petitioner submit a detailed version of these 
studies and views this requirement as confirmatory and, therefore, not 
requiring the application of additional uncertainty factors.
    <bullet> Storage stability data for flutriafol and/or its 
metabolites in/on livestock and soybean commodities have been 
requested. Based on the available storage stability data, which did not 
result in the degradation of flutriafol or its metabolites in a variety 
of matrices, the Agency views these data as confirmatory and, 
therefore, not requiring the application of additional uncertainty 
factors.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    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 3.7% 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 will utilize 4.6% of the cPAD for (children 1 to 2 
years old) the population group receiving the greatest exposure. There 
are no proposed or existing residential uses of flutriafol. Therefore, 
chronic dietary exposure to flutriafol is not a concern to the Agency.
    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. For flutriafol there 
were no treatment-related increases in tumor incidence when comparing 
treated animals to controls in the rat and mouse carcinogenicity 
studies. Therefore, the human cancer risk from flutriafol is 
negligible.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to flutriafol residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies (multiresidue method (MRM) 
Protocol D for apples; GC/Nitrogen/Phosphorus detector (NPD) method for 
soybean seed and method ICIA AM00306 for ruminant liver) are available 
to enforce the tolerance expression. The methods may be requested from: 
Chief, Analytical Chemistry Branch, Environmental Science Center, 701 
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; 
e-mail address: <a href="/cdn-cgi/l/email-protection#473522342e2332222a22332f2823340722372669202831"><span class="__cf_email__" data-cfemail="681a0d1b010c1d0d050d1c00070c1b280d1809460f071e">[email protected]</span></a>.

B. International Residue Limits

    There are no currently established Codex, Canadian, or Mexican 
maximum residue limits for flutriafol on apples and soybeans.

C. Revisions to Petitioned-For Tolerances

    Based on the processing data, the Agency determined that apple 
juice, wet apple pomace, soybean meal, soybean hull, and soybean oil 
tolerances are unnecessary. However, a tolerance for grain, aspirated 
fractions at 2.2 is required. Based on the crop field trial data, 
livestock feeding study, and/or the tolerance calculator, EPA is 
recommending for higher tolerances than that proposed by the petitioner 
for soybean, seed; aspirated grain fractions, and liver (cattle, goat, 
hog, horse, and sheep).

V. Conclusion

    Therefore, tolerances are established for residues of flutriafol 
including its metabolites and degradates in or on apple at 0.20 ppm; 
soybean, seed at 0.35 ppm; grain, aspirated fractions at 2.2 ppm; 
cattle, goat, hog, horse and sheep liver at 0.02 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA 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

[[Page 26673]]

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) (Public Law 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: April 28, 2010.
Steven Bradbury,
Director, Office of Pesticide Programs.

0
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. Revise Sec.  180.629 to read as follows:


180.629  Flutriafol; tolerances for residues.

    (a) General. Tolerances are established for the residues of 
flutriafol, [(<plus-minus>)-[alpha]-(2-fluorophenyl)-[alpha]-(4-
fluorophenyl)-1H-1,2,4-triazole-1-ethanol], including its metabolites 
and degradates in or on the following commodities. Compliance with the 
following tolerances is to be determined by measuring flutriafol only.

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Apple................................................               0.20
Cattle, liver........................................               0.02
Goat, liver..........................................               0.02
Grain, aspirated fractions...........................                2.2
Hog, liver...........................................               0.02
Horse, liver.........................................               0.02
Sheep, liver.........................................               0.02
Soybean, seed........................................               0.35
------------------------------------------------------------------------

    (b) Section 18 tolerance [Reserved].
    (c) Tolerances with regional registrations [Reserved].
    (d) Indirect or inadvertent residues [Reserved].

[FR Doc. 2010-11296 Filed 5-11-10; 8:45 am]
BILLING CODE 6560-50-S


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