[Federal Register Volume 79, Number 190 (Wednesday, October 1, 2014)]
[Rules and Regulations]
[Pages 59115-59119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-23398]



40 CFR Part 180

[EPA-HQ-OPP-2012-0576; FRL-9916-28]

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 melon subgroup 9A; sorghum, 
grain, grain; sorghum, grain, forage; and sorghum, grain, stover. 
Arysta LifeScience, North America, LLC, requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 1, 2014. Objections and 
requests for hearings must be received on or before December 1, 2014, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

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

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.


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 an 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://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2012-0576 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
December 1, 2014. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2012-0576, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 22, 2012 (77 FR 50661) (FRL-9358-
9), 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 
2F8047) 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 melon, subgroup 9A, at 1.5 parts per million 
(ppm); sorghum grain at 1.5 ppm; sorghum forage at 4 ppm; and sorghum 
stover at 4 ppm. That document referenced a summary of the petition 
prepared by Arysta LifeScience, North America LLC, the registrant, 
which is available in the docket, http://www.regulations.gov.

[[Page 59116]]

Comments were not received on the notice of filing.

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 
    Following repeated exposure, fluoxastrobin has mild or low toxicity 
in all tested species except for the dog. Repeated oral administration 
to dogs resulted in adverse liver toxicity at considerably lower doses 
than those noted in other species. Based on species sensitivity, the 
effects observed in the dog were used as endpoints for risk assessment. 
In both the 90-day and 1-year oral feeding studies in dogs, the liver 
appeared to be the target organ. In dogs, mice, and rats, the kidney 
was another target organ. There was no indication of an adverse effect 
attributable to a single dose. Based on developmental toxicity studies 
(rat and rabbit) and a 2-generation reproduction study (rat), there was 
neither increased susceptibility of pre-/postnatal exposure to 
fluoxastrobin, nor adverse effects on reproduction. Furthermore, 
neurotoxic effects were not seen in an acute neurotoxicity study in 
rats up to the limit dose of 2,000 mg/kg/day. In a subchronic 
neurotoxicity study in rats, fluoxastrobin did not elicit any 
neurotoxic effects. Repeated dose studies of fluoxastrobin in the 
database did not show immunotoxic effects in rats. Results of 
genotoxicity testing were negative and there were no treatment-related 
carcinogenicity findings in adequately performed carcinogenicity 
studies in rats and mice. Therefore, fluoxastrobin is classified as 
``not likely to be carcinogenic to humans.'' Specific information on 
the studies received and the nature of the adverse effects caused by 
fluoxastrobin as well as the no-observed-adverse-effect-level (NOAEL) 
and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity 
studies can be found at http://www.regulations.gov in document 
Fluoxastrobin. Aggregate Human Health Risk Assessment for the Proposed 
New Uses on Melon Subgroup 9A and Sorghum, Along with Establishment of 
Permanent Tolerances on Wheat, and Amendments to Established Tolerances 
on Milk and Milk Fat on page 26 in docket ID number EPA-HQ-OPP-2012-

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 discussed in Unit III.B. of the final rule 
published in the Federal Register of April 11, 2014 (79 FR 20100, 
20101-02) (FRL-9907-46), docket number EPA-HQ-OPP-2012-0576.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fluoxastrobin, EPA considered exposure under the 
petitioned-for tolerances as well as all existing fluoxastrobin 
tolerances in 40 CFR 180.609. EPA assessed dietary exposures from 
fluoxastrobin in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. No such effects were 
identified in the toxicological studies for fluoxastrobin; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. A slightly refined chronic dietary exposure 
assessment was performed for fluoxastrobin using tolerance-level 
residues, average field trial residues, and 100% crop treated (CT). 
This risk assessment was conducted using the DEEM-FCID Version 3.16. 
This model uses 2003-2008 food consumption data from the U.S. 
Department of Agriculture's (USDA's) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fluoxastrobin does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for fluoxastrobin. Tolerance-level residues, average 
field-trial residues, and/or 100% CT were assumed for all food 

[[Page 59117]]

    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for fluoxastrobin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fluoxastrobin. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm. In 
addition to evaluating the EDWCs from the proposed uses, EDWCs were 
reevaluated for all existing uses with Pesticide Root Zone Model Ground 
Water (PRZM-GW), which models continued use of fluoxastrobin over many 
years. For the chronic dietary assessment, the ground water EDWC (137 
[micro]g/L) was more conservative than the surface water EDWC (18.6 
[micro]g/L); the ground water EDWC was based on an existing turf use 
modeled with a 100-year simulation of 100 years of repeated 
applications, using the highest single maximum application rate and the 
highest yearly application rate.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Fluoxastrobin is currently registered for the following uses that 
could result in residential exposures: Broadcast control of diseases on 
turf, including lawns and golf courses. EPA assessed residential 
exposure using the following assumptions:
    i. Residential handler exposure. 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 
    ii. Post-application 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. Residential post-application exposure for adults and 
children is expected to be short-term only because residues are not 
expected to be present for longer periods of time. Exposure might occur 
on areas such as lawns used by children or recreational areas such as 
golf courses used by adults and youths. Potential routes of exposure 
include dermal (adults and children) and incidental oral ingestion 
(children). Since no acute hazard has been identified, an assessment of 
episodic granular ingestion was not conducted. Further information 
regarding EPA standard assumptions and generic inputs for residential 
exposures may be found at: http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found fluoxastrobin to share a common mechanism of 
toxicity with any other substances, and fluoxastrobin does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
fluoxastrobin does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at  http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
    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. EPA waived 
the requirement for a subchronic inhalation data based on, among other 
things, its conclusion that even if an additional 10X safety factor was 
applied, inhalation exposure would not raise a risk of concern.
    ii. There is no indication that fluoxastrobin is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that fluoxastrobin results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study. The rat developmental study was tested up to the limit dose 
(1,000 mg/kg/day), and the rabbit developmental study was tested up to 
400 mg/kg/day (highest dose tested). At the highest dose tested, there 
were decreases in food consumption and body weight in the maternal 
animals, but there were no developmental effects. Furthermore, in the 
rat reproduction study, there was no sensitivity in the offspring of 
the pups relative to the parental animals.
    iv. The exposure databases are estimated based on data that 
reasonably account for potential exposures. The chronic dietary food 
exposure assessment was slightly refined but still based on 100 PCT 
assumptions, tolerance-level residues, some average field-trial 
residues, and conservative ground water modeling estimates. New 2012 
Residential Standard Operating Procedures (SOPs) were used to assess 
post-application exposure to children including incidental oral 
exposure. In addition, the Agency has obtained a Turf Transferable 
Residue (TTR) study, which provides slightly refined chemical-specific 
assumptions to estimate exposure for the hand-to-mouth post-application 
assessment. The assessment is still considered highly conservative 
because it assumes maximum application rates and conservative day zero 
hand-to-mouth activities.

[[Page 59118]]

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
fluoxastrobin is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fluoxastrobin from food and water will utilize 30% of the cPAD for the 
general population, and 66% of the cPAD for all infants <1 year old, 
the population subgroup with the highest estimated chronic dietary 
exposure to fluoxastrobin. Based on the explanation in Unit III.C.3., 
regarding residential use patterns, chronic residential exposure to 
residues of fluoxastrobin is not expected.
    3. Short-term risk. Short-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.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 610 for adults 
and 110 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. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
    An intermediate-term adverse effect was identified; however, 
fluoxastrobin is not registered for any use patterns that would result 
in intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
    5. 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.
    6. 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 livestock commodities. The method may 
be requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; email address: residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    There are no Codex maximum residue limits (MRLs) established for 

C. Revisions to Petitioned-for Tolerances

    The petition requested a tolerance of 4.0 ppm for residues of 
fluoxastrobin and its Z-isomer on sorghum forage and stover. Based on 
the available residue data and using the Organisation for Economic Co-
operation and Development (OECD) tolerance calculation procedure, the 
Agency is establishing a tolerance for these commodities at 5.0 ppm. In 
addition, the Agency is revising the commodity names to ``sorghum, 
grain, grain'', ``sorghum, grain, forage'', and ``sorghum, grain, 
stover'' to be consistent with the commodity vocabulary EPA generally 
uses for tolerances.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
fluoxastrobin and its Z-isomer in or on melon subgroup 9A and sorghum, 
grain, grain at 1.5 ppm; and in or on sorghum, grain, forage and 
sorghum, grain, stover at 5.0 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 

[[Page 59119]]

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: September 24, 2014.
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, add alphabetically ``melon subgroup 9A''; 
``sorghum, grain, forage''; ``sorghum, grain, grain''; and ``sorghum, 
grain, stover'' to the table in paragraph (a)(1) as follows:

Sec.  180.609  Fluoxastrobin; tolerances for residues.

    (a) General. (1) * * *

                                                              Parts per
                         Commodity                             million
                                * * * * *
Melon subgroup 9A..........................................          1.5
                                * * * * *
Sorghum, grain, forage.....................................          5.0
Sorghum, grain, grain......................................          1.5
Sorghum, grain, stover.....................................          5.0
                                * * * * *

* * * * *
[FR Doc. 2014-23398 Filed 9-30-14; 8:45 am]