[Federal Register Volume 77, Number 206 (Wednesday, October 24, 2012)]
[Rules and Regulations]
[Pages 64911-64915]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-26086]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0677; FRL-9365-7]
Fluoxastrobin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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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.
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-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
20460-0001.
[[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
http:[sol][sol]www.epa.gov/dockets.
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
IV.D.
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.
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
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.
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. 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
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 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
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 currently no
established Mexican, Canadian, or Codex MRLs or tolerances for
fluoxastrobin.
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
ppm.
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:
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
i. Add alphabetically the commodity ``Rice, grain'' to the table in
paragraph (a)(1).
0
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]
BILLING CODE 6560-50-P