Document ID: EPA-HQ-OPP-2009-0677-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fluoxastrobin
Posted Date: 2010-09-30T04:00Z

[Federal Register: September 30, 2010 (Volume 75, Number 189)]
[Rules and Regulations]               
[Page 60327-60333]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30se10-11]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0677; FRL-8845-7]

 
Fluoxastrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fluoxastrobin in or on multiple commodities which are identified and 
discussed later in this document. Arysta LifeScience North America, LLC 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective September 30, 2010. Objections and 
requests for hearings must be received on or before November 29, 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-2007-0677. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some

[[Page 60328]]

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: John Bazuin, Registration Division 
(7504P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7381; e-mail address: bazuin.john@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://www.gpoaccess.gov/ecfr.

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-2007-0677 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 
November 29, 2010. 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-2007-0677, 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 Tolerances

    In the Federal Register of October 7, 2009 (74 FR 51597) (FRL-8792-
7), 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 
9F7567) by Arysta LifeScience North America, LLC, 15401 Weston Parkway, 
Suite 150, Cary, NC 27513. The petition requested that 40 CFR 180.609 
be amended by establishing tolerances for residues of the fungicide 
fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime and its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime in or on aspirated grain fractions at 15 parts per million 
(ppm); meat byproducts (cattle, goat, horse, sheep) at 0.2 ppm; sweet 
corn, forage at 13 ppm; sweet corn (kernels plus cob with husks 
removed) at 0.02 ppm; sweet corn, stover at 10 ppm; wheat, bran at 0.2 
ppm; wheat, forage at 7.0 ppm; wheat, grain at 0.09 ppm; wheat, hay at 
17 ppm; and wheat, straw at 11 ppm. The proposed tolerance in or on 
aspirated grain fractions is actually a decrease in the pre-existing 
tolerance for fluoxastrobin and its Z isomer in 40 CFR 180.609 of 20 
ppm. The proposed meat byproduct tolerances are actually changes in the 
tolerance expression from fluoxastrobin, its Z isomer, and its phenoxy-
hydroxypyrimidine metabolite, 6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinol to fluoxastrobin and its Z isomer and an increase in the 
pre-existing tolerance levels in 40 CFR 180.609 of 0.10 ppm for meat 
byproducts of cattle, goat, horse, and sheep. That notice referenced a 
summary of the petition prepared by Arysta LifeScience North America, 
LLC, 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 has made 
the following changes to the proposed fluoxastrobin tolerances. Minor 
changes have been made to several commodity names to conform them to 
the Agency's Food and Feed Commodity Vocabulary. The tolerance 
expression for the meat byproduct commodities has been corrected to add 
the phenoxy-hydroxypyrimidine metabolite. The proposed tolerance of 
0.02 ppm in or on sweet corn, kernels plus cob with husks removed and 
of 0.2 ppm in or on wheat, bran have been reduced and the proposed 
tolerance of 15 ppm in or on aspirated grain fractions has been 
increased. 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

[[Page 60329]]

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 fluoxastrobin including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with fluoxastrobin 
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.
    Fluoxastrobin has a low order of acute toxicity via the oral, 
dermal and inhalation routes of exposure. Fluoxastrobin is a moderate 
eye irritant but is neither a dermal irritant nor a skin sensitizer.
    Fluoxastrobin appears to have mild or low toxicity following 
repeated administration in all tested species other than the dog. In 
both the 90-day and 1-year oral feeding dog studies, there was liver 
toxicity in the form of cholestasis as evidenced by hepatocytomegaly 
and cytoplasmic granular changes associated with increased liver weight 
and increased serum liver alkaline phospatase (ALP). In addition, 
several phase I and phase II liver drug metabolizing enzymes were 
induced. Other toxicity in dogs included body weight loss or reduced 
gain, decreased food efficiency, and effects on kidneys including 
increased relative weight in females and degeneration of proximal 
tubular epithelium in males. The no observed adverse effect level 
(NOAEL) of 1.5 milligrams/kilograms/day (mg/kg/day) in the 1-year dog 
study was used for setting the chronic reference dose (RfD).
    The liver appeared to be a target organ in other studies, as well, 
but the toxicological relevance of liver findings in species other than 
the dog is questionable. For example, among the changes noted in the 
treated animals were increased liver weight in the mouse and rat, and 
hypertrophy and cytoplasmic changes in the mouse, but there were no 
increases in any of the serum liver enzymes including ALP.
    In the 90-day oral toxicity study in rats, the urinary system in 
males was a target organ as evidenced by increased kidney weight and 
histopathology findings in kidneys, urinary bladder, and urethra 
including the presence of calculi in the urethra and kidneys. In 
another rat study, there were markedly increased urinary pHs in males 
in addition to increased urinary calcium excretion in the form of 
calcium oxalate crystals. Kidney changes were also seen in a 90-day 
mouse feeding study with increased kidney weights and tubular 
hypertrophy in females. Following 90-day administration in dogs, there 
was degeneration of the proximal tubular epithelium in males.
    The adrenal glands seem to be another target organ in males of the 
90-day rat study where vacuolation was seen in the zona fasciculata of 
the adrenal cortex. In another 30-day rat feeding study, adrenal 
cortical cytomegaly with fine vacuolization was seen in all high dose 
males and the responses were comparable between the groups treated with 
the pure fluoxastrobin E- or 2:1 E/Z-isomers. The adrenal changes are 
not likely to be endocrine related effects.
    In the rat and rabbit developmental toxicity studies and the 2-
generation reproduction rat study, there was no increased 
susceptibility to prenatal or postnatal exposure to fluoxastrobin and 
no effects on reproduction.
    Fluoxastrobin is not acutely neurotoxic in rats up to a single high 
dose of 2,000 mg/kg/day or by repeated dietary feeding in the rat 
subchronic neurotoxicity screening study where the top dose was nearly 
half the limit dose of 1,000 mg/kg/day. Other studies in rats including 
the subchronic, chronic toxicity/carcinogenicity, 2-generation 
reproduction, and developmental toxicity were tested to or above the 
limit dose with no indication of clinical signs, histopathology or 
other signs of toxicity that could be attributed to neurotoxicity. 
Also, in both the 90-day and 1-year dog studies, neurologic 
examinations, including mental status/behavior, gait characteristics, 
postural status and reactions, and spinal/cranial reflexes, were 
carried out and were found to be within normal limits.
    Fluoxastrobin is not immunotoxic based on repeated dosing studies 
in rats and mice. In the 90-day oral toxicity rat study, there was no 
difference between the control and treated animals in spleen cell 
count, macrophage activities after PMA stimulation and plaque-forming 
cell assay after challenge with sheep erythrocytes. Slight decreases 
were noted in IgG concentration in the high dose males but not females. 
An unacceptable subchronic immunotoxicity study in mice found no 
apparent decrease on B-cell activated, T-cell mediated IgM response to 
sheep red blood cell (SRBC) at doses as high as 2,383 mg/kg/day.
    Fluoxastrobin and major metabolites were negative in a battery of 
genotoxicity tests.
    The carcinogenic potential of fluoxastrobin was adequately tested 
in rats and mice of both sexes. The results demonstrated a lack of 
treatment-related increase in tumor incidence in rats or mice. There 
was no mutagenicity concern and no structure activity relationship 
alert. It was concluded that there was no incidence of carcinogenicity 
for fluoxastrobin.
    Specific information on the studies received and the nature of the 
adverse effects caused by fluoxastrobin as well as the NOAEL and the 
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 
are discussed in the final rule published in the Federal Register of 
September 16, 2005 (70 FR 54640) (FRL-7719-9).

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

[[Page 60330]]

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 fluoxastrobin used for 
human risk assessment can be found in ``Fluoxastrobin. Human Health 
Risk Assessment for Proposed Uses on Sweet Corn, Field Corn/Sweet Corn 
Grown for Seed, and Wheat; Revised Tolerances on Peanut and Refined 
Peanut Oil Based on a Peanut Processing Study; and Label Revision 
Allowing Homeowner Residential Application to Turf Grasses,'' p. 23 in 
docket ID number EPA-HQ-OPP-2007-0677.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fluoxastrobin, EPA considered exposure under the 
petitioned-for tolerances as well as all existing fluoxastrobin 
tolerances in 40 CFR 180.609. EPA assessed dietary exposures from 
fluoxastrobin 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.
    No such effects were identified in the toxicological studies for 
fluoxastrobin; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the United States 
Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Surveys 
of Food Intake by Individuals (CSFII). As to residue levels in food, 
EPA performed an unrefined (food and drinking water) exposure 
assessment. The assumptions of this dietary assessment included 
tolerance level residues and 100% crop treated. Based on processing 
studies, the processing factors for tomato puree, potato chips, dry 
potato (granules/flakes), and potato flour were reduced to 1. Separate 
tolerances were set for peanut oil, wheat bran and tomato paste; 
therefore, the processing factors for these commodities were set at 1. 
For all other processed commodities, Dietary Exposure Evaluation Model 
version 7.81 default processing factors were assumed.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fluoxastrobin 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 and/or PCT information in the 
dietary assessment for floxastrobin. Tolerance level residues 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 dietary exposure analysis and risk 
assessment for fluoxastrobin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fluoxastrobin. 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 fluoxastrobin for chronic 
exposures for non-cancer assessments are estimated to be 33 parts per 
billion (ppb) for surface water and less than 1 ppb for ground water. 
The modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 33 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).
    Fluoxastrobin has previously been registered for the following uses 
that could result in post-application residential exposures: Turf, 
including lawns and golf courses. However, applications to residential 
turf have previously been restricted to certified pest control 
operators. Under consideration in the current risk assessment is a 
proposed label that would allow homeowner residential application to 
turf, which would result in residential handler exposure. Residential 
handlers may be exposed via loading and applying granular fluoxastrobin 
for spot treatments and/or broadcast control of turf diseases.
    EPA assessed residential application exposure using the following 
assumptions: Because of the potential for application four times per 
year, exposure duration is expected to be short-term and intermediate-
term. A short-term dermal endpoint was not identified so only 
intermediate-term dermal risks were assessed. Short- and intermediate-
term inhalation risks were also assessed. Homeowner residential 
applicators are expected to be adults.
    There is also the potential for homeowners and their families (of 
varying ages) to be exposed as a result of entering areas that have 
previously been treated with fluoxastrobin. Exposure might occur on 
areas such as lawns used by children or recreational areas such as golf 
courses used by adults and youths. Potential routes of exposure include 
dermal (adults and children) and incidental oral ingestion (children). 
Since no acute hazard has been identified, an assessment of episodic 
granular ingestion was not conducted. While it is assumed that most 
residential use will result in short-term (1 to 30 days) 
postapplication exposures, it is believed that intermediate-term 
exposures (greater than 30 days up to 180 days) are also possible. The 
best data and methodology currently available were used in the 
fluoxastrobin residential assessment. Since chemical-specific data were 
not available, the Agency used the current approaches for residential 
assessment, many of which include recent upgrades to the standard 
operating procedures (SOPs). For example, for the hand-to-mouth 
calculations for children (three to less than six years old), a 5% 
transferability factor was applied to calculate residue levels 
appropriate for this exposure pathway. Overall, the Agency believes 
that the calculated risks represent screening level estimates. 
Estimates are thought to be conservative, even when measures of central 
tendency (e.g., most transfer coefficients) are used, because values 
that would be considered to be in the lower percentile aspect of any 
input parameter have not been used in the calculations. In addition, 
maximum application rates have been used for all scenarios. The risk 
estimates also assume no dissipation of residues after day zero and do 
not take into account the periodic growth and cutting of the grass. 
Actual residues should be considerably lower, which is why 
intermediate-term exposures are unlikely. Further, because a short-term 
dermal toxicity endpoint was not identified, the intermediate-term

[[Page 60331]]

endpoint was used for all dermal risk estimates, even though the 
residential exposure duration is believed to be mostly short-term based 
on the use pattern. Finally, based on the Agency's current practices, a 
quantitative post-application inhalation exposure assessment was not 
performed at this time, primarily because fluoxastrobin has a very low 
vapor pressure. Further information regarding EPA standard assumptions 
and generic inputs for residential exposures may be found at http://
www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found fluoxastrobin to share a common mechanism of 
toxicity with any other substances, and fluoxastrobin does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
fluoxastrobin does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act (FQPA) Safety Factor (SF). In applying this provision, 
EPA either retains the default value of 10X, or uses a different 
additional SF when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. The toxicity database for 
fluoxastrobin, including acceptable developmental toxicity studies in 
rats and rabbits, as well as a 2-generation reproductive toxicity 
study, provides no indication of prenatal and/or postnasal sensitivity.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children is adequately protected if the FQPA SF 
is reduced to 1X. That decision is based on the following findings:
    i. The toxicity database for fluoxastrobin is complete except for a 
functional immunotoxicity study as required by the recent changes to 
the pesticide data requirements. The Agency does have an immunotoxicity 
study for fluoxastrobin but it has deficiencies that make it 
unacceptable at this time. Nonetheless, the Agency does not believe 
that conducting a new immunotoxicity study will result in a lower NOAEL 
than the regulatory dose for risk assessment because available data 
showed no apparent decrease in B-cell activated, T-cell mediated 
immunoglobulin M (IgM) response to sheep red blood cells (SRBC) at 
doses as high as 2,383 mg/kg/day. The Agency therefore believes that no 
additional safety factor is needed to account for the lack of this 
study, but the registrant will be required to upgrade it.
    ii. There is no indication that fluoxastrobin is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that fluoxastrobin results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The chronic dietary food exposure assessments utilized 
tolerance-level residues and 100 PCT information for all commodities. 
Use of these screening-level assessment values helps ensure that 
chronic exposures and risks will not be underestimated. EPA 
additionally made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to fluoxastrobin in 
drinking water. EPA used similarly conservative assumptions to assess 
residential post-application exposure of children as well as incidental 
oral exposure of toddlers to fluoxastrobin. These assessments will not 
underestimate the exposure and risks posed by fluoxastrobin.

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. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
fluoxastrobin is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fluoxastrobin from food and water will utilize 42% of the cPAD for 
children (1-2 years old), the population subgroup receiving the 
greatest exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
fluoxastrobin is not expected.
    3. Short- and intermediate-term risk. Fluoxastrobin is currently 
registered for uses that could result in both short- and intermediate-
term residential exposure and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short- and intermediate-term residential exposures of adults and 
children to fluoxastrobin. Short- and intermediate-term aggregate 
exposure assessments take into account short-and intermediate-term 
residential exposure, respectively, plus chronic exposure to food and 
water (considered a background exposure level). Because all short- and 
intermediate-term quantitative hazard assessments (via the dermal and 
incidental oral routes) for fluoxastrobin are based on the same 
endpoint, a screening-level, conservative aggregate risk assessment was 
conducted that combined the short-term incidental oral and 
intermediate-term exposure estimates (i.e., the highest exposure 
estimates) in the risk assessments for adults. The Agency believes that 
most residential exposure will be short-term, based on the use pattern.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that the combined short- and 
intermediate-term food, water, and residential exposures result in 
aggregate MOEs of 470 for adult males; 510 for adult females (13-

[[Page 60332]]

49 years old); 220 for children (1-2 years old), short-term; and 210 
for children (1-2 years old), intermediate-term. Residential exposure 
for adults is intermediate-term dermal exposure from application of the 
product plus post-application dermal exposure plus short- and 
intermediate-term inhalation exposure from application of the product. 
Short-term residential exposure for children is incidental oral 
exposure. Intermediate-term residential exposure for children is post-
application dermal exposure and post-application incidental oral 
exposure. Because EPA's level of concern for fluoxastrobin is a MOE of 
100 or below, these residential MOEs are not of concern.
    4. Aggregate cancer risk for U.S. population. As is explained in 
Unit III.A., the Agency has concluded that fluoxastrobin is not likely 
to be carcinogenic to humans. Therefore cancer risk is not of concern 
for this chemical.
    5. 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 fluoxastrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/mass 
spectrometry/mass spectrometry) is available to enforce the tolerance 
expression. Method No. 00604 is available for plant commodities and 
Method No. 00691 is available for animal commodities. 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; e-mail address: residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint 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. There are currently no 
Codex or Canadian maximum residue limits (MRLs) or tolerances for 
fluoxastrobin in or on sweet corn or wheat.

C. Revisions to Petitioned-For Tolerances

    EPA converted ``aspirated grain fractions'' to ``grain, aspirated 
grain fractions''; ``sweet corn (kernels plus cob with husks removed)'' 
to ``corn, sweet, kernel plus cob with husks removed''; ``sweet corn, 
forage'' to ``corn, sweet, forage''; ``sweet corn, stover'' to ``corn, 
sweet, stover''; ``meat byproducts (cattle, goat, horse, sheep)'' to 
``cattle, meat byproducts'', ``goat, meat byproducts'', ``horse, meat 
byproducts'', and ``sheep, meat byproducts'' to conform them to the 
Agency's Food and Feed Commodity Vocabulary. EPA also corrected the 
tolerance expression for the meat byproduct commodities from 
fluoxastrobin and its Z isomer to fluoxastrobin, its Z isomer, and its 
phenoxy-hydroxypyrimidine metabolite, 6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinol. The proposed tolerance of 0.02 ppm in or on sweet corn, 
kernels plus cob with husks removed has been reduced to 0.01 ppm in or 
on corn, sweet, kernel plus cob with husks removed, based on the 
highest observed residues in the sweet corn crop field trials and the 
limit of quantitation of the residue method of 0.01 ppm for combined 
residues of fluoxastrobin and its Z isomer. The proposed tolerance of 
0.2 ppm in or on wheat, bran has been reduced to 0.15 ppm and the 
proposed tolerance of 15 ppm in or on aspirated grain fractions has 
been increased to 60 ppm in or on grain, aspirated grain fractions 
because the wheat field trials indicate that the highest average field 
trial residue of 0.11 ppm for wheat grain is 0.11 ppm and the wheat 
processing study indicates that residues of fluoxastrobin may 
concentrate in wheat, bran (1.3x) and aspirated grain fractions (518x). 
This is also an increase in the pre-existing tolerance of 20 ppm for 
fluoxastrobin in or on aspirated grain fractions.

V. Conclusion

    Therefore, tolerances are established for residues of 
fluoxastrobin, (1E)-[2[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime and its Z isomer, (1Z)-[2[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime, in or on corn, sweet, forage at 13 ppm; corn, sweet, 
kernel plus cob with husks removed at 0.01 ppm; corn, sweet, stover at 
10 ppm; wheat, bran at 0.15 ppm; wheat, forage at 7.0 ppm; wheat, hay 
at 17 ppm; and wheat, straw at 11 ppm. A pre-existing tolerance for the 
residues of fluoxastrobin and its Z isomer in or on grain, aspirated 
grain fractions is increased from 20 ppm to 60 ppm. Pre-existing 
tolerances are also increased for the residues of fluoxastrobin, its Z 
isomer, and its phenoxy-hydroxypyrimidine metabolite, 6-(2-
chlorophenoxy)-5-fluoro-4-pyrimidinol, in cattle, meat byproducts from 
0.10 ppm to 0.20 ppm; in goat, meat byproducts from 0.10 ppm to 0.20 
ppm; in horse, meat byproducts from 0.10 ppm to 0.20 ppm; and in sheep, 
meat byproducts from 0.10 ppm to 0.20 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 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

[[Page 60333]]

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: September 24, 2010.
Lois Rossi,
Director, Registration Division, 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.

.6090
2. Section 180.609 is amended by:
    i. Removing ``Aspirated grain fractions'' in paragraph (a)(1) in 
the table;
    ii. Adding alphabetically the following commodities to the table in 
paragraph (a)(1); and
    iii. Revising the entries for Cattle, meat byproducts; Goat, meat 
byproducts; Horse, meat byproducts; and Sheep, meat byproducts in the 
table in paragraph (a)(2).
    The amendments read as follows:

Sec.  180.609  Fluoxastrobin; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Corn, sweet, forage..................................                 13
Corn, sweet, kernel plus cob with husks removed......               0.01
Corn, sweet, stover..................................                 10
Grain, aspirated grain fractions.....................                 60
                                * * * * *
Wheat, bran..........................................               0.15
Wheat, forage........................................                7.0
Wheat, hay...........................................                 17
Wheat, straw.........................................                 11
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Cattle, meat byproducts..............................               0.20
                                * * * * *
Goat, meat byproducts................................               0.20
                                * * * * *
Horse, meat byproducts...............................               0.20
                                * * * * *
Sheep, meat byproducts...............................               0.20
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-24575 Filed 9-29-10; 8:45 am]
BILLING CODE 6560-50-S