Document ID: EPA-HQ-OPP-2009-0677-0012
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fluoxastrobin
Posted Date: 2012-05-04T04:00Z

[Federal Register Volume 77, Number 87 (Friday, May 4, 2012)]
[Rules and Regulations]
[Pages 26467-26471]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10704]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0677; FRL-9345-3]

Fluoxastrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fluoxastrobin in or on peanut and peanut, refined oil. Arysta 
LifeScience North America, LLC requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 4, 2012. Objections and 
requests for hearings must be received on or before July 3, 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0677. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-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 
July 3, 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 that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2009-0677, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

[[Page 26468]]

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 20, 2011 (76 FR 43236) (FRL-8880-
1), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 
1F7871) by Arysta LifeScience North America, LLC, 15401 Weston 
Parkway, Suite 150, Cary, NC 27513. The petition requested that 40 CFR 
180.609 be amended by revising tolerances for residues of the fungicide 
fluoxastrobin in or on peanut and peanut oil, from 0.01 and 0.03 to 
0.02 and 0.06 parts per million (ppm) respectively. That notice 
referenced a summary of the petition prepared by Arysta LifeScinece 
North America, LLC, the registrant, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
corrected the commodity definition for peanut oil. The reason for this 
change is explained 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. The most recent human health risk assessment for 
fluoxastrobin was conducted for use on the squash/cucumber crop 
subgroup 9B. Since that time, no new toxicology data have been 
submitted to the Agency and the hazard characterization and toxicity 
endpoints for risk assessment remain unchanged. 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. 
This rule was published in the Federal Register 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/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 the final rule published 
in the Federal Register of August 17, 2011.

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. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the United States 
Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Survey 
of Food Intake by Individuals (CSFII). As to residue levels in food, 
EPA conducted a conservative dietary exposure assessment for 
fluoxastrobin. The assumptions of this dietary assessment included 
tolerance level residues and 100 percent crop treated (PCT).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fluoxastrobin does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue 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

[[Page 26469]]

regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
fluoxastrobin for chronic exposures for non-cancer assessments are 
estimated to be 52.9 parts per billion (ppb) for surface water and 0.23 
ppb for ground water. Modeled estimates of drinking water 
concentrations were directly entered into the dietary exposure model. 
For chronic dietary risk assessment, the water concentration of value 
53 ppb was used to assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Fluoxastrobin is 
currently registered for the following uses that could result in 
residential exposures: Spot treatment and/or broadcast control of 
diseases on turf, including lawns and golf courses. EPA assessed 
residential exposure using the following assumptions: Because of the 
potential for application four times per year, exposure duration is 
expected to be short-term and intermediate-term. A short-term dermal 
endpoint was not identified; therefore, only intermediate-term dermal 
risks as well as short- and intermediate-term inhalation risks were 
assessed. Homeowner residential applicators are expected to be adults.
    There is also the potential for homeowners and their families (of 
varying ages) to be exposed as a result of entering areas that have 
previously been treated with fluoxastrobin. Exposure might occur on 
areas such as lawns used by children or recreational areas such as golf 
courses used by adults and youths. Potential routes of exposure include 
dermal (adults and children) and incidental oral ingestion (children). 
Since no acute hazard has been identified, an assessment of episodic 
granular ingestion was not conducted. While it is assumed that most 
residential use will result in short-term (1 to 30 days) post-
application exposures, it is believed that intermediate-term exposures 
(greater than 30 days up to 180 days) are also possible. Further 
information regarding EPA standard assumptions and generic inputs for 
residential exposures may be found at: http://www.epa.gov/pesticides/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 Food Quality 
Protection Act Safety Factor (FQPA 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 database for evaluating 
in utero or postnatal susceptibility includes developmental toxicity 
studies in both rats and rabbits and a 2-generation reproduction study 
in the rat. The data provide no indication of increased susceptibility 
of rats or rabbits to prenatal and postnatal exposure to fluoxastrobin.
    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 with the 
exception of an acceptable functional immunotoxicity study. The Agency 
does have an immunotoxicity study for fluoxastrobin but it has 
deficiencies that make it unacceptable at this time. The study may be 
acceptable if additional information is submitted. Nonetheless, the 
Agency does not believe that conducting a new immunotoxicity study will 
result in a lower NOAEL than the regulatory dose for risk assessment. 
First, the available data do not indicate that fluoxastrobin results in 
primary immune system effects; a NOAEL for decreased spleen weight in 
the absence of histopathological findings (male rats) was 53 
milligrams/kilogram/day (mg/kg/day). In addition, there was no 
indication of a functional effect on the immune system in the 
unacceptable mouse immunotoxicity study at doses as high as 2,383 mg/
kg/day. Finally, the registrant recently submitted a new immunotoxicity 
study. The Agency has not fully reviewed the study at this time, but a 
preliminary screen indicates that fluoxastrobin does not appear to 
significantly affect the immune system and would not provide a Point of 
Departure lower than that currently used for risk assessment. For all 
of these reasons, the Agency therefore believes that no additional 
safety factor is needed to account for the deficiencies in the first 
immunotoxicity study.
    ii. There is no indication that fluoxastrobin is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional uncertainty factors to account for neurotoxicity.
    iii. There is no evidence that fluoxastrobin results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. EPA made conservative (protective) assumptions in the ground 
water and surface water modeling used to assess exposure to 
fluoxastrobin in drinking water. EPA used similarly conservative 
assumptions to assess postapplication exposure of children as well as 
incidental oral exposure of toddlers. These assessments will not 
underestimate the exposure and risks posed by fluoxastrobin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and

[[Page 26470]]

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 47% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
fluoxastrobin is not expected.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure take into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Fluoxastrobin is 
currently registered for uses that could result in both short- and 
intermediate-term residential exposure, and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with short- and intermediate-term residential exposures of adults 
and children to fluoxastrobin. Because all short- and intermediate-term 
quantitative hazard assessments (via the dermal and incidental oral 
routes) for fluoxastrobin are based on the same endpoint, a screening-
level, conservative aggregate risk assessment was conducted that 
combined the short-term incidental oral and intermediate-term exposure 
estimates (i.e., the highest exposure estimates) in the risk 
assessments for adults. The Agency believes that most residential 
exposure will be short-term, based on the use pattern.
    There is potential short- and intermediate-term exposure to 
fluoxastrobin via the dietary (which is considered background exposure) 
and residential (which is considered primary) pathways. For adults, 
these pathways lead to exposure via the oral (background), and dermal 
and inhalation (primary) routes. For children, these pathways lead to 
exposure via the oral (background), and incidental oral and dermal 
(primary) routes.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short- and intermediate-
term food, water, and residential exposures result in aggregate MOEs of 
630 for adults; 170 for children (1-2 years old). Because EPA's level 
of concern for fluoxastrobin is a MOE of 100 or below, these MOEs are 
not of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, fluoxastrobin is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to fluoxastrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/mass 
spectrometry/mass spectrometry) is available to enforce the tolerance 
expression. Method No. 00604 is available for plant commodities and 
Method No. 00691 is available for animal commodities. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; 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 U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level. There are currently no 
established Mexican, Canadian, or Codex MRLs or tolerances for 
fluoxastrobin in/on peanuts.

C. Revisions to Petitioned-For Tolerances

    The proposed commodity term has been revised to agree with the 
Agency's Food and Feed Commodity Vocabulary. The petitioned for 
commodities were peanut and peanut oil. The correct commodity 
definitions are peanut and peanut, refined oil.

 V. Conclusion

    Therefore, tolerances are established for residues of 
fluoxastrobin, in or on peanut and peanut, refined oil at s 0.02 and 
0.06 ppm respectively.

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

[[Page 26471]]

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

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: April 25, 2012.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

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

Sec.  180.609  Fluoxastrobin; tolerances for residues.

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

------------------------------------------------------------------------
                                                           Parts per
                       Commodity                            million
-----------------------------------------------------------------------
 
                                * * * * *
Peanut................................................            0.02
 
                                * * * * *
Peanut, refined oil...................................            0.06
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-10704 Filed 5-3-12; 8:45 am]
BILLING CODE 6560-50-P