[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
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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.
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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).
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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.
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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).
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Cancer (Oral, dermal, inhalation).... Classification: ``Not likely to be carcinogenic to humans.''
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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