
[Federal Register Volume 76, Number 159 (Wednesday, August 17, 2011)]
[Rules and Regulations]
[Pages 50893-50898]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20835]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0725; FRL-8884-4]


Fluoxastrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
fluoxastrobin in or on squash/cucumber subgroup 9B. Arysta LifeScience 
North America, LLC requested this tolerance under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 17, 2011. Objections and 
requests for hearings must be received on or before October 17, 2011, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2010-0725. 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: Heather Garvie, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-0034; e-mail address: garvie.heather@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2010-0725 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
October 17, 2011. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-0725, 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.

[[Page 50894]]

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 23, 2010 (75 FR 57942) (FRL-
8845-4), 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 
0F7726) by Arysta LifeScience North America, LLC, 15401 Weston Pkwy., 
Suite 150, Cary, NC 27513. The petition requested that 40 CFR 180.609 
be amended by establishing a tolerance for residues of the fungicide, 
fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4- 
pyrimydinyl]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-pyrimydinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O- 
methyloxime, in or on raw agricultural commodities listed under crop 
squash/cucumber subgroup 9B at 0.50 parts per million (ppm). 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 tolerance. A minor 
change has been made to the commodity name to conform to the Agency's 
Food and Feed Commodity Vocabulary.

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 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 phosphatase (ALP). In addition, 
several phase I and phase II liver drug metabolizing enzymes were 
induced.
    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 milligrams/kilogram/day (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 controls and treated animals in spleen cell 
count, macrophage activities after phorbol myristate acetate (PMA) 
stimulation and plaque-forming cell assay after challenge with sheep 
erythrocytes. Slight decreases were noted in immunoglobulin G 
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 immunoglobulin M (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 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 Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin

[[Page 50895]]

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 is shown in Table 1. of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Fluoxastrobin for Use in Human Health Risk Assessment
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                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk         Study and
                                               factors                 assessment         toxicological effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50 years of  None: There was no indication of an adverse effect attributable to a
 age).                                  single dose. An aRfD was not established.
Acute dietary (General population      None: There was no indication of an adverse effect attributable to a
 including infants and children).       single dose. An aRfD was not established.
                                      --------------------------------------------------------------------------
Chronic dietary (All populations)....  NOAEL = 1.5 mg/kg/day..  Chronic RfD = 0.015 mg/  Chronic toxicity in the
                                       UFA = 10x..............   kg/day.                  dog.
                                       UFH = 10x..............  cPAD = 0.015 mg/kg/day.  LOAEL = M/F 8.1/7.7 mg/
                                       FQPA SF = 1x...........                            kg/day based on body
                                                                                          weight reductions and
                                                                                          hepatocytomegaly and
                                                                                          cytoplasmic changes
                                                                                          associated with
                                                                                          increased serum liver
                                                                                          alkaline phosphatase
                                                                                          indicative of
                                                                                          cholestasis.
Incidental oral short-term (1 to 30    NOAEL = 3.0 mg/kg/day..  LOC for MOE = 100......  90-day subchronic dog
 days) and intermediate-term (1 to 6   UFA = 10x..............                            LOAEL = M/F 24.8/24.2
 months).                              UFH = 10x..............                            mg/kg/day (800 ppm)
                                       FQPA SF = 1x...........                            based on dose-related
                                                                                          reductions in net body
                                                                                          weight gain and food
                                                                                          efficiency in addition
                                                                                          to toxicity findings
                                                                                          in the liver
                                                                                          (cholestasis) in both
                                                                                          sexes, and kidneys
                                                                                          (increased relative
                                                                                          weights in females and
                                                                                          degeneration of the
                                                                                          proximal tubular
                                                                                          epithelium in males).
                                      --------------------------------------------------------------------------
Dermal short-term (1 to 30 days).....  None: There were no systemic or dermal toxicity findings in a 28-day
                                        dermal toxicity study in the rat up to the limit dose (1000 mg/kg/day)
                                        and there were no developmental or neurotoxicity concerns raised in
                                        other studies.
                                      --------------------------------------------------------------------------
Dermal intermediate-term (1 to 6       NOAEL = 3.0 mg/kg/day    LOC for MOE = 100......  90-day subchronic dog
 months).                               (dermal absorption                                LOAEL = M/F 24.8/24.2
                                        rate = 2.3%).                                     mg/kg/day (800 ppm)
                                       UFA = 10x..............                            based on dose-related
                                       UFH = 10x..............                            reductions in net body
                                       FQPA SF = 1x...........                            weight gain and food
                                                                                          efficiency in addition
                                                                                          to toxicity findings
                                                                                          in the liver
                                                                                          (cholestasis) in both
                                                                                          sexes, and kidneys
                                                                                          (increased relative
                                                                                          weights in females and
                                                                                          degeneration of the
                                                                                          proximal tubular
                                                                                          epithelium in males).
Inhalation short-term (1 to 30 days)   NOAEL = 3.0 mg/kg/day..  LOC for MOE = 100......  90-day subchronic dog
 and intermediate-term (1 to 6         UFA = 10x..............                            LOAEL = M/F 24.8/24.2
 months).                              UFH = 10x..............                            mg/kg/day (800 ppm)
                                       FQPA SF = 1x...........                            based on dose-related
                                                                                          reductions in net body
                                                                                          weight gain and food
                                                                                          efficiency in addition
                                                                                          to toxicity findings
                                                                                          in the liver
                                                                                          (cholestasis) in both
                                                                                          sexes, and kidneys
                                                                                          (increased relative
                                                                                          weights in females and
                                                                                          degeneration of the
                                                                                          proximal tubular
                                                                                          epithelium in males).
                                      --------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....  Classification: ``Not likely to be carcinogenic to humans.''
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
  reference dose. MOE = margin of exposure. LOC = level of concern.


[[Page 50896]]

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fluoxastrobin, EPA considered exposure under the 
petitioned-for tolerance 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 conducted a conservative dietary exposure assessment for 
fluoxastrobin. The assumptions of this dietary assessment included 
tolerance level residues and 100 percent crop treated (PCT).
    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.
    2. Dietary exposure from drinking water. Based on laboratory 
studies, fluoxastrobin persists in soils for several months to several 
years and is slightly to moderately mobile in soil.
    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 Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) 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 52.9 parts per billion (ppb) for surface water and 0.23 
ppb for ground water. Modeled estimates of drinking water 
concentrations were directly entered into the dietary exposure model. 
For chronic dietary risk assessment, the water concentration of value 
53 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 is 
currently registered for the following uses that could result in 
residential exposures: Spot treatment and/or broadcast control of 
diseases on turf, including lawns and golf courses. EPA assessed 
residential 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; therefore, only intermediate-term dermal 
risks as well as short-and intermediate-term inhalation risks were 
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) post-
application exposures, it is believed that intermediate-term exposures 
(greater than 30 days up to 180 days) are also possible. 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 Web site 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 Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. The 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 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 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. First, the available data 
do not indicate that fluoxastrobin results in primary immune system 
effects; a NOAEL for decreased spleen weight in the absence of 
histopathological findings (male rats) was 53 mg/kg/day. Secondly, no 
apparent decrease in B-cell activated, T-cell mediated IgM response to 
SRBC was seen in mice at doses as high as

[[Page 50897]]

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 assessment 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 
aPAD and 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 47% of the cPAD for 
children (1-2 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. Short- and intermediate-term 
aggregate exposure take into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). 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. 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.
    There is potential short- and intermediate-term exposure to 
fluoxastrobin via the dietary (which is considered background exposure) 
and residential (which is considered primary) pathways. For adults, 
these pathways lead to exposure via the oral (background), and dermal 
and inhalation (primary) routes. For children, these pathways lead to 
exposure via the oral (background), and incidental oral and dermal 
(primary) routes.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short- and intermediate-
term food, water, and residential exposures result in aggregate MOEs of 
630 for adults; 170 for children (1-2 years old). Because EPA's level 
of concern for fluoxastrobin is a MOE of 100 or below, these MOEs are 
not of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, fluoxastrobin is not expected to pose a cancer risk to humans.
    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 established Mexican, Canadian, or Codex 
maximum residue limits (MRLs) or tolerances for fluoxastrobin on the 
squash/cucumber subgroup 9B.

C. Revisions to Petitioned-For Tolerances

    EPA converted ``crop subgroup 9B squash/cucumbers'' to ``squash/
cucumber subgroup 9B'' to conform it to the Agency's Food and Feed 
Commodity Vocabulary.

V. Conclusion

    Therefore, a tolerance is established for residues of 
fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4- 
pyrimydinyl]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-pyrimydinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O- 
methyloxime, including its metabolites

[[Page 50898]]

and degradates, in or on squash/cucumber subgroup 9B at 0.50 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) (Pub. L. 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: August 10, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. Section 180.609 is amended by alphabetically adding the following 
commodity to the table in paragraph (a)(1) to read as follows:


Sec.  180.609  Fluoxastrobin; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Squash/cucumber subgroup 9B.................................        0.50
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-20835 Filed 8-16-11; 8:45 am]
BILLING CODE 6560-50-P


