[Federal Register Volume 77, Number 206 (Wednesday, October 24, 2012)]
[Rules and Regulations]
[Pages 64911-64915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-26086]



40 CFR Part 180

[EPA-HQ-OPP-2009-0677; FRL-9365-7]

Fluoxastrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for combined residues 
of fluoxastrobin and its Z-isomer in or on poultry, liver; hog, fat; 
hog, meat byproducts; and rice, grain. Arysta LifeScience, North 
America, LLC, requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 24, 2012. Objections and 
requests for hearings must be received on or before December 24, 2012, 
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-2009-0677, 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: Heather Garvie, Registration Division 
(7504P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-0034; email address: garvie.heather@epa.gov.


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-2009-0677 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
December 24, 2012. 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-2009-0677, 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 

[[Page 64912]]

     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http:[sol][sol]www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at 

II. Summary of Petitioned-For Tolerance

    In the Federal Register issue of October 5, 2011 (76 FR 61647) 
(FRL-8890-5), EPA issued a document pursuant to FFDCA section 
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
petition (PP 1F7897) 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 combined 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 rice, grain at 6.0 parts per million (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:[sol][sol]www.regulations.gov. A comment was received 
on the notice of filing. EPA's response to this comment is discussed in 
Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed tolerance on rice, grain to 4.0 ppm and 
established additional tolerances for hog, fat; hog, meat byproducts; 
and poultry, liver. The reason for these changes are explained in Unit 

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 

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 
    The most recent human health risk assessment for fluoxastrobin was 
conducted for use on the squash/cucumber crop subgroup 9B. Since that 
time, an adequate functional immunotoxicity study has been submitted 
and reviewed. In accordance with 40 CFR part 158--Data Requirements for 
Pesticides, a subchronic inhalation study is also required for 
fluoxastrobin. However, the Agency has waived the inhalation toxicity 
study data requirement at this time. The hazard characterization and 
toxicity endpoints for risk assessment remain unchanged.
    Fluoxastrobin and its major metabolites were evaluated in a battery 
of genotoxicity tests and results were negative. 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 
that established a tolerance for residues of fluoxastrobin in or on 
squash/cucumber subgroup 9B. That rule was published in the Federal 
Register issue of August 17, 2011 (76 FR 50893) (FRL-8884-4).

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 factors (UFs)/safety factors (SFs) 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 the final rule published 
in the Federal Register issue of August 17, 2011, p. 50895.

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

[[Page 64913]]

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 Nationwide 
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). The Dietary Exposure Evaluation Model (DEEM) software 
version 7.81 default processing factors were assumed except for where 
tolerances were established for processed commodities or when 
processing studies showed no concentration. Based on processing 
studies, the processing factors for dried potato (granules/flakes), 
potato chips, potato flour, and tomato puree were reduced to 1. 
Separate tolerances were set for peanut oil, tomato paste, and wheat 
bran; therefore, the processing factors for these commodities were set 
at 1.
    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. 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 Tier 1 Rice Model 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 93 parts per billion (ppb) for 
surface water and 0.038 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 value of 93 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: 
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 (Food 
Quality Protection Act) SF. In applying this provision, EPA either 
retains the default value of 10X, or uses a different additional SF 
when reliable data available to EPA support the choice of a different 
    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 
    i. The toxicity database for fluoxastrobin is complete.
    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 
    iv. The exposure databases are estimated based on data that 
reasonably account for potential exposures. The

[[Page 64914]]

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 activities. 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 36% of the cPAD for the 
general population, and 75% 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 
    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 920 for adults 
and 220 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 
    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 currently no 
established Mexican, Canadian, or Codex MRLs or tolerances for 

C. Response to Comment

    One comment was received to the docket from the City of Sacramento, 
CA. The comment was a request that the EPA thoroughly review the 
request to register fluoxastrobin for use on rice with regard to its 
potential to affect drinking water quality. The Agency has determined 
that dietary risks for fluoxastrobin are below the Agency's concern for 
dietary exposure and risk.

D. Revisions to Petitioned-For Tolerances

    The petitioner requested a tolerance level of 6.0 ppm for rice, 
grain in the notice of filing. The Agency has revised the tolerance 
level from 6.0 ppm to 4.0 ppm for rice, grain based on the data used to 
support the risk assessment. The petitioner has subsequently submitted 
a revised notice of filing to the Agency requesting a tolerance level 
of 4.0 ppm for rice, grain.
    The use of fluoxastrobin on rice, grain will result in a slight 
increase in the dietary burden to ruminants; however secondary residues 
in rumiant commodities are not expected to exceed the established 
tolerances for milk and ruminant tissues. The increased dietary burden 
to swine and poultry results in the need for tolerances for hog, fat at 
0.03 ppm; hog meat, byproducts at 0.06 ppm; and poultry, liver at 0.06 

V. Conclusion

    Therefore, tolerances are established for combined residues of 
fluoxastrobin and its Z-isomer, in or on rice, grain at 4.0 ppm; hog, 
fat at 0.03 ppm; hog, meat

[[Page 64915]]

byproducts at 0.06 ppm; and poultry, liver at 0.06 ppm.

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: October 15, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:


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

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

2. In Sec.  180.609:
i. Add alphabetically the commodity ``Rice, grain'' to the table in 
paragraph (a)(1).
ii. Add alphabetically the following commodities to the table in 
paragraph (a)(2). The additions read as follows:

Sec.  180.609  Fluoxastrobin; tolerances for residues.

    (a) * * *
    (1) * * *

                                                              Parts per
                         Commodity                             million
                                * * * * *
Rice, grain................................................          4.0
                                * * * * *

    (2) * * *

                                                              Parts per
                         Commodity                             million
                                * * * * *
Hog, fat...................................................         0.03
Hog, meat byproducts.......................................         0.06
                                * * * * *
Poultry, liver.............................................         0.06
                                * * * * *

* * * * *
[FR Doc. 2012-26086 Filed 10-23-12; 8:45 am]