[Federal Register Volume 74, Number 242 (Friday, December 18, 2009)]
[Rules and Regulations]
[Pages 67108-67114]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-30039]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0704; FRL-8803-4]


Fluoxastrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

[[Page 67109]]


ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of fluoxastrobin and its Z isomer in or on berry, low growing, subgroup 
13-07G; corn, field, grain; corn, field, forage; corn, field, stover; 
soybean, forage; soybean, hay; soybean, hulls; soybean, seed; and 
aspirated grain fractions. Arysta LifeScience North America, LLC 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective December 18, 2009. Objections and 
requests for hearings must be received on or before February 16, 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-2008-0704. 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: John Bazuin, Registration Division, 
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 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 electronically, please go to 
http://www.epa.gov/oppts and select ``Test Methods & Guidelines'' on 
the left-side navigation menu.

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-2008-0704 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 February 16, 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 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2008-0704, 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. Petition for Tolerance

    In the Federal Register of December 3, 2008 (73 FR 73640) (FRL-
8390-4), 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 
8F7437) 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 combined 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 corn, field, grain at 0.02 parts per million 
(ppm); corn, field, aspirated grain fractions at 0.50 ppm; corn, field, 
forage at 3.0 ppm; corn, field, fodder/stover at 4.5 ppm; soybean, seed 
at 0.05 ppm; soybean, aspirated grain fractions at 0.40 ppm; soybean, 
forage at 9.0 ppm; soybean, hay at 1.2 ppm; and soybean, hulls at 0.40 
ppm.
    Also in the Federal Register of December 3, 2008 (73 FR 73644) 
(FRL-8386-9), EPA issued a notice pursuant to section 408(d)(3) of 
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a another 
pesticide petition (PP 8F7406) by Arysta LifeScience North America, 
LLC. The petition requested that 40 CFR 180.609 be amended by 
establishing

[[Page 67110]]

tolerances for the combined 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 low 
growing berries (crop subgroup 13-07G) at 1.9 ppm. Each notice 
referenced a summary of the appropriate petition which had been 
prepared by Arysta LifeScience North America, LLC, the registrant, and 
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 
corrected the commodity and subgroup names, and replaced ``corn, field, 
aspirated grain fractions'' and ``soybeans, aspirated grain fractions'' 
with ``aspirated grain fractions.'' EPA has also substantially 
increased the tolerance for aspirated grain fractions and decreased the 
tolerance for soybean, hulls. 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 upper 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 the combined residues of fluoxastrobin and its Z isomer 
in or on aspirated grain fractions at 20 ppm; berry, low growing, 
subgroup 13-07G at 1.9 ppm; corn, field, forage at 3.0 ppm; corn, field 
grain at 0.02 ppm; corn, field, stover at 4.5 ppm; soybean, forage at 
9.0 ppm; soybean, hay at 1.2 ppm; soybean, hulls at 0.20 ppm; soybean, 
seed at 0.05 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. Fluoxastrobin shows low acute toxicity via the oral, dermal, 
and inhalation routes of exposure; is a moderate eye irritant; and is 
neither a dermal irritant nor a sensitizer. Following repeated 
administration, fluoxastrobin has mild or low toxicity in all tested 
species other than the dog which displayed adverse liver toxicity at 
considerably lower doses than those noted for other testing species. 
The most common finding across all testing species is decreased body 
weight. In the available toxicity studies on fluoxastrobin, there is no 
estrogen, androgen, and/or thyroid mediated toxicity. Fluoxastrobin 
does not produce developmental toxicity in rats or rabbits. In the rat 
and rabbit developmental toxicity studies and the two-generation 
reproduction rat study, there is no increased susceptibility to 
prenatal or postnatal exposure to fluoxastrobin and no effects on 
reproduction. Fluoxastrobin is not neurotoxic following acute or 
repeated dosing in the rat. Fluoxastrobin is not genotoxic, and it is 
also not carcinogenic in rats or mice. Specific information on the 
studies received and the nature of the adverse effects caused by 
fluoxastrobin as well as the no-observed-adverse-effect-level (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 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 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 fluoxastrobin used for 
human risk assessment can be found at http://www.regulations.gov in the 
document ``Fluoxastrobin. Human Health Risk Assessment for Proposed 
Uses on Field Corn, Soybean, and the Low-Growing Berry Subgroup 13-
07G,'' at page 20 in docket ID number EPA-HQ-OPP-2008-0704.

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

[[Page 67111]]

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 was not 
performed.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the United States 
Department of Agriculture 1994-1996 and 1998 CSFII. As to residue 
levels in food, EPA performed an unrefined dietary (food and drinking 
water) exposure assessment. The assumptions of this dietary assessment 
included tolerance level residues and 100% crop treated. Experimentally 
derived processing factors were applied for tomato puree, potato chips, 
dry potato granules/flakes, and potato flour. For all other processed 
commodities, DEEM version 7.81 default processing factors were assumed.
    iii. Cancer. The Agency has concluded that fluoxastrobin is not 
likely to be carcinogenic to humans. Therefore cancer risk is not of 
concern for this chemical.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue or less than 100% crop treated 
information in the dietary assessment for fluoxastrobin. 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 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 FQPA 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 28 
parts per billion (ppb) for surface water and less than 1 ppb for 
ground water. The modeled estimate of surface drinking water 
concentration was directly entered into the dietary exposure model. For 
chronic dietary risk assessment, a water concentration value of 28 ppb 
was used to assess the contribution of drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termite control, and flea and tick control on pets).
    Fluoxastrobin is currently registered for the following uses that 
could result in postapplication residential exposures: Turf, including 
lawns and golf courses. No residential handler exposure uses have been 
registered because all applications to residential turf must be made by 
a certified pest control operator. EPA assessed residential exposure 
using the following assumptions: Maximum application rates, no 
dissipation of residues after the day of application, and no 
dissipation of residues because of periodic growth and recutting of the 
grass. The Agency believes that the calculated risks represent 
screening level estimates. Principal potential routes of exposure 
include dermal and incidental oral ingestion. The Agency has assumed 
that most residential use will result in short-term exposures but that 
intermediate-term exposures are also possible. It should be noted that 
the new fluoxastrobin uses assessed for this final rule do not include 
any residential uses.
    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 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 toxicity database for 
fluoxastrobin, including acceptable developmental toxicity studies in 
rats and rabbits, as well as a two-generation reproduction toxicity 
study, provides no indication of prenatal and/or postnatal sensitivity.
    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 fluoxastrobin is considered adequate 
to support endpoint selection for risk assessment and FQPA evaluation. 
The submitted studies are of good quality and provide sufficient 
information to determine whether fluoxastrobin poses a human health 
hazard. The only data deficiency that exists is the requirement for 
additional information concerning the mouse subchronic immunotoxicity 
study, for potential upgrade of the study. To address the 
immunotoxicity data requirement as presented in 40 CFR part 158 the 
Agency has examined the entire toxicity database for fluoxastrobin and 
drawn the following conclusion: There is no evidence of biologically 
relevant effects on the immune system that are related to fluoxastrobin 
and the overall weight of the evidence indicates that this chemical 
does not directly target the immune system.
    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 indication of increased quantitative or 
qualitative susceptibility in rats or rabbits following in utero and/or 
postnatal exposure to fluoxastrobin.
    iv. There are no residual uncertainties identified in the exposure 
database. The chronic dietary food exposure assessment utilizes 
proposed tolerance-level residues and 100% crop treated 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

[[Page 67112]]

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 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. An acute aggregate risk assessment takes into 
account exposure estimates from acute 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 38% of the cPAD for 
children 1 to 2 years old, the population group 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 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 to be 
a background exposure level). Because all short- and intermediate-term 
quantitative hazard estimates (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). 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 aggregated 
result in aggregate MOEs of 750 for adult males, 840 for adult females, 
and 160 for children 1 to 2 years old. For adult males and adult 
females, residential exposure is via the oral (background) and dermal 
(primary) routes. For children 1 to 2 years old, residential exposure 
is via the oral (background) and incidental oral and dermal (primary) 
routes.
    4. Aggregate cancer risk for the U.S. population. 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 method) is available to enforce the 
tolerance expression. Method No. 00604 is available for plant 
commodities and Method No. 00691, Modification 001, is available for 
animal commodities. 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: residuemethods@epa.gov.

B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican 
Maximum Residue Levels (MRLs) for fluoxastrobin for the low-growing 
berry subgroup 13-07G, soybean, or field corn commodities.

C. Revisions to Petitioned-For Tolerances

    EPA converted ``corn, field, fodder/stover'' to ``corn, field, 
stover'' to conform to the terminology in the current pesticide 
commodity vocabulary. The Agency also replaced ``corn, field, aspirated 
grain fractions'' and ``soybean, aspirated grain fractions'' with 
``aspirated grain fractions'' to conform to the terminology in the 
current pesticide commodity vocabulary. The proposed tolerances of 0.50 
ppm in or on corn, field, aspirated grain fractions and 0.40 ppm in or 
on soybean, aspirated grain fractions were changed to a tolerance of 20 
ppm in or on aspirated grain fractions based on current guidance, which 
recommends that the established tolerance be based on the aspirated 
grain fraction that has the highest residues. In this case it is 
soybean. The soybean highest available field trial (HAFT) residue of 
0.031 ppm multiplied by the expected processing factor for aspirated 
grain fractions of 611x produces calculated expected residues in 
aspirated grain fractions of 18.9 ppm. The fluoxastrobin tolerance in/
on aspirated grain fractions was therefore set at 20 ppm. The proposed 
tolerance of 0.40 ppm in/on soybean hulls was reduced to 0.20 ppm 
because the HAFT residue for soybean of 0.031 ppm is expected to 
concentrate 4x in soybean hulls. This produces a calculated residue of 
0.124 ppm and a decision that a tolerance of 0.20 ppm is appropriate. 
In addition, the establishment of tolerances on field corn commodities 
requires that the tolerance for indirect and inadvertent residues for 
fluoxastrobin and its Z isomer in/on grain, cereal, forage, fodder, and 
straw, group 16, be modified to apply to grain, cereal, forage, fodder, 
and straw, group 16, except corn instead. The tolerance expressions in 
40 CFR 180.609 are also being modified to conform to new Agency 
guidance on the language tolerance expressions should conform to, but 
this change does not have any other effect on the existing 
fluoxastrobin tolerances.

V. Conclusion

    Therefore, tolerances are established for the combined 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 aspirated grain fractions at 20 ppm; berry, low 
growing, subgroup 13-07G at 1.9 ppm; corn, field, forage at 3.0 ppm; 
corn, field, grain at 0.02 ppm; corn, field, stover at 4.5 ppm; 
soybean, forage at 9.0 ppm; soybean,

[[Page 67113]]

hay at 1.2 ppm; soybean, hulls at 0.20 ppm; and soybean, seed at 0.05 
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 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: December 8, 2009.
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.

0
2. Section 180.609 is revised to read as follows:


Sec.  180.609  Fluoxastrobin; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
fluoxastrobin, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only 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, calculated as the 
stoichiometric equivalent of fluoxastrobin.


------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Aspirated grain fractions...............................              20
Berry, low growing, subgroup 13-07G.....................             1.9
Corn, field, forage.....................................             3.0
Corn, field, grain......................................            0.02
Corn, field, stover.....................................             4.5
Leaf petioles subgroup 4B...............................             4.0
Peanut..................................................           0.010
Peanut, hay.............................................            20.0
Peanut, refined oil.....................................           0.030
Soybean, forage.........................................             9.0
Soybean, hay............................................             1.2
Soybean, hulls..........................................            0.20
Soybean, seed...........................................            0.05
Tomato, paste...........................................             1.5
Vegetable, fruiting, group 8............................             1.0
Vegetable, tuberous and corm, subgroup 1C...............           0.010
------------------------------------------------------------------------

    (2) Tolerances are established for residues of fluoxastrobin, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below 
is to be determined by measuring only fluoxastrobin, (1E)-[2-[[6-(2-
chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-
dioxazin-3-yl)methanone O-methyloxime, 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, and its phenoxy-
hydroxypyrimidine, 6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinol, 
calculated as the stoichiometric equivalent of fluoxastrobin.


------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Cattle, fat.............................................            0.10
Cattle, meat............................................            0.05
Cattle, meat byproducts.................................            0.10
Goat, fat...............................................            0.10
Goat, meat..............................................            0.05
Goat, meat byproducts...................................            0.10
Horse, fat..............................................            0.10
Horse, meat.............................................            0.05
Horse, meat, byproducts.................................            0.10
Milk....................................................            0.02
Milk, fat...............................................            0.50
Sheep, fat..............................................            0.10
Sheep, meat.............................................            0.05
Sheep, meat byproducts..................................            0.10
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established 
for the indirect or inadvertent residues of

[[Page 67114]]

fluoxastrobin, including its metabolites and degradates, in or on the 
commodities in the table below, when present therein as a result of the 
application of fluoxastrobin to the growing crops listed in paragraph 
(a)(1) of this section. Compliance with the tolerance levels specified 
below is to be determined by measuring only 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, calculated as the stoichiometric 
equivalent of fluoxastrobin.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.........................................           0.050
Alfalfa, hay............................................            0.10
Cotton, gin byproducts..................................           0.020
Grain, cereal, forage, fodder, and straw, group 16,                 0.10
 except corn............................................
Grass, forage...........................................            0.10
Grass, hay..............................................            0.50
Vegetable, foliage of legume, group 7...................           0.050
------------------------------------------------------------------------


[FR Doc. E9-30039 Filed 12-17-09; 8:45 am]
BILLING CODE 6560-50-S