Document ID: EPA-HQ-OPP-2012-0576-0008
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fluoxastrobin
Posted Date: 2014-04-11T04:00Z

[Federal Register Volume 79, Number 70 (Friday, April 11, 2014)]
[Rules and Regulations]
[Pages 20100-20105]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07820]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0576; FRL-9907-46]

Fluoxastrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
fluoxastrobin in or on wheat, grain; and revises tolerances for milk; 
and milk, fat. Arysta LifeScience, North America, LLC, requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 11, 2014. Objections and 
requests for hearings must be received on or before June 10, 2014, 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0576, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: RDFRNotices@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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-2012-0576 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 
June 10, 2014. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2012-0576, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of February 27, 2013 (78 FR 13296) (FRL-
9380-2), EPA issued a document pursuant to

[[Page 20101]]

FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of 
a pesticide petition (PP 2F8130) 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 tolerances 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 wheat, grain at 0.15 
parts per million (ppm). The petition also requested that 40 CFR 
180.609 be amended by revising tolerances for milk from 0.02 ppm to 
0.03 ppm; and milk, fat from 0.50 ppm to 0.75 ppm. That document 
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. Comments were received on the notice of 
filing. EPA's response to these comments is discussed in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA 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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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.
    Following repeated exposure, fluoxastrobin has mild or low toxicity 
in all tested species except for the dog. Repeated oral administration 
to dogs resulted in adverse liver toxicity at considerably lower doses 
than those noted in other species. Based on species sensitivity, the 
effects observed in the dog were used as endpoints for risk assessment. 
In both the 90-day and one-year oral feeding studies in dogs, the liver 
appeared to be the target organ. In dogs, mice, and rats, the kidney 
was another target organ. There was no indication of an adverse effect 
attributable to a single dose. Based on developmental toxicity studies 
(rat and rabbit) and a two-generation reproduction study (rat), there 
was neither increased susceptibility of pre-/postnatal exposure to 
fluoxastrobin, nor adverse effects on reproduction. Furthermore, acute 
neurotoxic effects were not seen in an acute neurotoxicity study in 
rats up to the limit dose of 2,000 milligrams/kilogram/day (mg/kg/day). 
In a subchronic neurotoxicity study in rats, fluoxastrobin did not 
elicit any neurotoxic effects. Repeated dose studies of fluoxastrobin 
in the database did not show immunotoxic effects in rats. Results of 
genotoxicity testing were negative and there were no treatment-related 
carcinogenicity findings in adequately performed carcinogenicity 
studies in rats and mice. Therefore, fluoxastrobin is classified as 
``not likely to be carcinogenic to humans.'' 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 can be found at http://www.regulations.gov in document, 
``Fluoxastrobin. Aggregate Human Health Risk Assessment for the 
Proposed New Uses on Melon Subgroup 9A and Sorghum, Along with 
Establishment of Permanent Tolerances on Wheat, and Amendments to 
Established Tolerances on Milk and Milk Fat'' on pages 26-31 in docket 
ID number EPA-HQ-OPP-2012-0576.

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 the NOAEL and the LOAEL are identified. 
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 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.

[[Page 20102]]

  Table 1--Summary of Toxicological Doses and Endpoints for Fluoxastrobin for Use in Dietary, Non-Occupational,
                                  and Occupational Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population    None: There is no indication of an adverse effect attributable to a single
 including infants and children)                         dose. An aRfD was not established.
 and Females 13-49 years of age.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 1.5 mg/kg/    Chronic RfD = 0.015  Chronic toxicity dog LOAEL = M/F
                                    day.                  mg/kg/day.           8.1/7.7 mg/kg/day based on body
                                   UFA = 10x...........  cPAD = 0.015 mg/kg/   weight reductions and
                                   UFH = 10x...........   day..                hepatocytomegaly and cytoplasmic
                                   FQPA SF = 1x........                        changes associated with increased
                                                                               serum liver alkaline phosphatase
                                                                               indicative of cholestasis.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to   NOAEL = 3.0 mg/kg/    LOC for MOE = 100..  90-day subchronic dog LOAEL = M/F
 30 days) and Intermediate-term     day.                                       24.8/24.2 mg/kg/day based on dose-
 (1-6 months).                     UFA = 10x...........                        related reductions in net body
                                   UFH = 10x...........                        weight gain and food efficiency
                                   FQPA SF = 1x........                        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 (1,000 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/    Residential LOC for  90-day subchronic dog LOAEL = M/F
 months).                           day.                  MOE = 100.           24.8/24.2 mg/kg/day based on dose-
                                   dermal absorption     Occupational LOC      related reductions in net body
                                    factor = 2.3%..       for MOE = 100..      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 \b\ Short-Term (1-30    NOAEL = 3.0 mg/kg/    Residential LOC for  90-day subchronic dog LOAEL = M/F
 days) and Intermediate-Term (1-6   day.                  MOE = 100.           24.8/24.2 mg/kg/day based on dose-
 months).                                                Occupational LOC      related reductions in net body
                                                          for MOE = 100..      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.''
----------------------------------------------------------------------------------------------------------------
\a\ ``Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response
  data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures.'' NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.
  PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC =
  level of concern.
\b\ Toxicity by the oral route is assumed to be equivalent to the inhalation route. A subchronic inhalation
  toxicity study is not required for fluoxastrobin at this time. Although no subchronic inhalation data is
  available EPA has waived the data requirement. In determining the need for a subchronic inhalation study,
  EPA's weight of evidence decision process included both hazard and exposure considerations as well as
  incorporation of a presumed 10X Database Uncertainty Factor (UFdb) for the lack of this study. Specifically,
  with regard to exposure considerations, the Agency's Level of Concern in the evaluating the need for the
  subchronic inhalation study is a Margin of Exposure (MOE) of 1,000 for inhalation exposure, which includes the
  10X inter-species extrapolation factor, 10X intra-species variation factor, and the 10X UFdb. For
  fluoxystrobin, residential inhalation exposures resulted in MOEs higher than the LOC of 1,000 when using an
  oral Point of Departure (POD). This indicates that the lack of an inhalation study does not reduce the overall
  confidence in the risk assessment or result in an uncertainty (i.e., the study will not provide a POD
  sufficiently low to result in a risk of concern). Because EPA's decision to waive the subchronic inhalation
  study essentially incorporates an additional 10X UFdb (i.e. the study was only waived because risks were at
  least 10X lower than required by use of the inter- and intraspecies safety factors), a second additional 10X
  FQPA safety factor is not being retained for the protection of infants and children due to the absence of this
  study.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fluoxastrobin, EPA considered exposure under the 
petitioned-for tolerances as well as all existing fluoxastrobin 
tolerances in 40 CFR 180.609. EPA assessed dietary exposures from 
fluoxastrobin in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. No such effects were 
identified in the toxicological studies for fluoxastrobin; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. A slightly refined chronic dietary exposure 
assessment was performed for fluoxastrobin using tolerance-level 
residues, average field trial residues, and 100 percent crop treated 
(PCT). This risk assessment was conducted using

[[Page 20103]]

the DEEM-FCID Version 3.16. This model uses 2003-2008 food consumption 
data from the U.S. Department of Agriculture's (USDA's) National Health 
and Nutrition Examination Survey, What We Eat in America, (NHANES/
WWEIA).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fluoxastrobin does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for fluoxastrobin. Tolerance level residues and/or 
100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for fluoxastrobin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fluoxastrobin. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm. In 
addition to evaluating the EDWCs from the proposed uses, EDWCs were 
reevaluated for all existing uses with Pesticide Root Zone Model Ground 
Water (PRZM-GW), which models continued use of fluoxastrobin over many 
years. For the chronic dietary assessment, the most conservative EDWC 
(137 [mu]g/L) was based on an existing turf use modeled with a 100 year 
simulation of 100 years of repeated applications, using the highest 
single maximum application rate and the highest yearly application 
rate.
    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: Residential 
handler exposure for adults is expected to be short-term only. 
Intermediate-term and chronic exposures are not likely because of the 
intermittent nature of applications by homeowners. Since there are no 
toxicity findings for the short-term dermal route of exposure up to the 
limit dose, the residential handler assessment only includes the 
inhalation route of exposure. There is also 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. Further information regarding EPA standard assumptions and 
generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    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 available studies used 
to evaluate pre- and postnatal exposure susceptibility do not indicate 
increased susceptibility of rats or rabbits to fluoxastrobin. These 
studies include the following:
    i. Developmental toxicity studies in rats.
    ii. Developmental toxicity studies in rabbits.
    iii. A 2-generation reproduction study in rats.
    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. EPA waived 
the requirement for a subchronic inhalation data based on, among other 
things, its conclusion that even if an additional 10X safety factor was 
applied, inhalation exposure would not raise a risk of concern.
    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. The rat developmental study was tested up to the limit dose 
(1,000 mg/kg/day), and the rabbit developmental study was tested up to 
400 mg/kg/day (highest dose tested). At the highest dose tested, there 
were decreases in food consumption and body weight in the maternal 
animals, but there were no developmental effects. Furthermore, in the 
rat reproduction study, there was no sensitivity in the offspring of 
the pups relative to the parental animals.
    iv. The exposure databases are estimated based on data that 
reasonably account for potential exposures. The chronic dietary food 
exposure assessment was conservatively based on 100 PCT assumptions, 
tolerance-level residues, and conservative ground and surface drinking 
water modeling estimates. New 2012 Residential Standard Operating 
Procedures (SOPs) were used to assess post-application exposure to 
children including incidental oral exposure. The residential post-
application assessment assumes maximum application rates and 
conservative day zero hand-to-mouth

[[Page 20104]]

activities. Although EPA has required additional data on transferable 
residues from treated turf for fluoxastrobin, EPA is confident that it 
has not underestimated turf exposure due to the conservativeness of the 
default turf transfer value and conservative assumptions in the short-
term turf assessment procedures (e.g., assuming residues do not degrade 
over the thirty day assessment period and assuming high-end activities 
on turf for every day of the assessment period). All of the exposure 
estimates for fluoxastrobin are based on conservative high-end 
assumptions and are not likely to result in underestimated risk.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
fluoxastrobin is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fluoxastrobin from food and water will utilize 30% of the cPAD for the 
general population, and 66% of the cPAD for all infants <1 year old, 
the population subgroup with the highest estimated chronic dietary 
exposure to fluoxastrobin. 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 takes into account short-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 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures 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-term food, water, 
and residential exposures result in aggregate MOEs of 610 for adults 
and 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; email 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 United Nations 
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 no Codex MRLs established for fluoxastrobin. However, 
there are Canadian MRLs established on sorghum and milk at 0.02 ppm, 
milk fat at 0.15 ppm, wheat bran at 0.15 ppm, and wheat grain at 0.1 
ppm. Furthermore, the Canadian tolerance expression is not harmonized 
with the US tolerance expression. For plants and livestock, the 
Canadian tolerance expression does not include the Z-isomer.

C. Response to Comments

    Two comments were received to the docket from members of the 
public. Both comments were the same. The commenters objected to the 
proposed tolerance on the ground that it would result in fluoride being 
added to treated crops. The commenters offered no basis for this claim.
    The Agency reviewed all plant, livestock, and environmental 
degradation data and determined that the fluorine will not be released 
into the environment when applied to crops or non-agricultural areas. 
Neither free fluorine nor de-fluorinated fluoxastrobin was observed in 
food or water in any of the metabolism, degradation, and magnitude of 
residue studies.

V. Conclusion

    Therefore, tolerances are established for residues of 
fluoxastrobin, in or on wheat, grain at 0.15 ppm; and tolerances are 
revised for milk and milk, fat at 0.03 ppm and 0.75 ppm respectively. 
Additionally, the established tolerance for wheat bran at 0.15 ppm is 
no longer needed and should be revoked because the recommended 
tolerance of 0.15 ppm for wheat, grain will cover expected residues in 
wheat bran.

[[Page 20105]]

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: March 28, 2014.
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. In Sec.  180.609:
0
a. Remove ``Wheat, bran'' from the table in paragraph (a)(1).
0
b. Add ``Wheat, grain'' in alphabetical order to the table in paragraph 
(a)(1).
0
c. Revise ``Milk'' and ``Milk, fat'' in the table in paragraph (a)(2).
    The amendments read as follows:

Sec.  180.609  Fluoxastrobin; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Wheat, grain............................................            0.15
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Milk....................................................            0.03
Milk, fat...............................................            0.75
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-07820 Filed 4-10-14; 8:45 am]
BILLING CODE 6560-50-P