Document ID: EPA-HQ-OPP-2009-0553-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Flutolanil
Posted Date: 2010-04-07T04:00Z

[Federal Register: April 7, 2010 (Volume 75, Number 66)]
[Rules and Regulations]               
[Page 17566-17571]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ap10-6]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0553; FRL-8817-9]

 
Flutolanil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
flutolanil in or on cotton and soybean. Nichino America, Inc. requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective April 7, 2010. Objections and 
requests for hearings must be received on or before June 7, 2010, 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-2009-0553. 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: Lisa Jones, Registration Division, 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(703) 308-9424; e-mail address: jones.lisa@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 cite at http://www.gpoaccess.gov/ecfr. To 
access the OPPTS harmonized test guidelines referenced in this document 
electronically, please go http://www.epa.gov/oppts and select ``Test 
Methods and Guidelines.''

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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

[[Page 17567]]

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-2009-0553 in the subject line on the first page of 
your submission. All objections and requests for a hearing must be in 
writing, and must be received by the Hearing Clerk on or before June 7, 
2010. 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 that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2009-0553, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line 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.

II. Petition for Tolerance

    In the Federal Register of September 4, 2009 (74 FR 45848) (FRL-
8434-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
9F7542) by Nichino America, Inc., 4550 New Linden Hill Rd., Suite 501, 
Wilmington, DE 19808. The petition requested that 40 CFR 180.484 be 
amended by establishing tolerances for residues of the fungicide 
flutolanil, (N-(3-(1-methylethoxy) phenyl) -2-(trifluoromethyl) 
benzamide) and its metabolite, M-4, desisopropylflutolanil (N-(3-
hydroxyphenyl)-2-(trifluromethyl) benzamide), expressed as 2-
trifluoromethyl benzoic acid and calculated as flutolanil, in or on 
cotton at 0.05 parts per million (ppm) and in or on soybean at 0.05 
ppm. That notice referenced a summary of the petition prepared by 
Nichino America, Inc., the registrant, which is available to the public 
in the docket, http://www.regulations.gov. Comments were received on 
the notice of filing. EPA's response to these comments is discussed in 
Unit IV.C.
    EPA has modified the proposed tolerance expression to: ``residues 
of flutolanil, (N-(3-(1-methylethoxy) phenyl)-2-(trifluoromethyl) 
benzamide), including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only flutolanil and 
its metabolites converted to 2-(trifluoromethyl) benzamide and 
calculated as flutolanil.'' Based on review of the data supporting the 
petition, EPA has also modified the proposed tolerances to be 
established under paragraph (a), General, for flutolanil at 40 CFR 
180.484 as follows: Soybean, seed, 0.20 ppm; soybean, forage, 8.0 ppm; 
soybean, hay, 2.5 ppm; cotton, undelinted seed, 0.20 ppm and cotton, 
gin byproducts, 0.20 ppm. Additionally, the following tolerances will 
be removed from paragraph (d), Indirect or inadvertent residues, for 
flutolanil as redundant: Soybean, seed 0.20 ppm; soybean, forage, 8.0 
ppm and soybean hay, 2.5 ppm. The reasons 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 section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 flutolanil including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with flutolanil 
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.
    Specific information on the studies received and the nature of the 
adverse effects caused by flutolanil 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 
published in the Federal Register of June 11, 2008, (73 FR 33013) (FRL-
8365-6). The complete toxicological profile for flutolanil can be found 
at http://www.regulations.gov on pages 7 through 12 in the document 
``Flutolanil, Human Health Risk Assessment: Requests for Inadvertent or 
Indirect Tolerances for Use on Soybean, Wheat, Corn and Cotton'' in 
docket ID number EPA-HQ-OPP-2007-1021.

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

[[Page 17568]]

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 flutolanil used for 
human risk assessment is discussed in Unit III, Aggregate Risk 
Assessment and Determination of Safety, of the final rule published in 
the Federal Register of June 11, 2008 (73 FR 33013) (FRL-8365-6).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to flutolanil, EPA considered exposure under the petitioned-
for tolerances as well as all existing flutolanil tolerances in 40 CFR 
180.484. EPA assessed dietary exposures from flutolanil 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 
flutolanil; 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 U.S. Department 
of Agriculture (USDA) 1994-1996 and 1998 Continuing Survey of Food 
Intake by Individuals (CSFII). As to residue levels in food, the 
chronic dietary analysis included tolerance level residues, 100 percent 
crop treated estimates and processing factors (default).
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight-of-the-evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or nonlinear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or non-linear approach is used and a cancer RfD is 
calculated based on an earlier noncancer key event. If carcinogenic 
mode of action data are not available, or if the mode of action data 
determines a mutagenic mode of action, a default linear cancer slope 
factor approach is utilized. Based on the lack of evidence of 
carcinogenicity in two rodent studies and the lack of evidence of 
mutagenicity, flutolanil is not expected to 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 treaded (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for flutolanil. Tolerance level residues and/or 100% 
CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for flutolanil in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of flutolanil. 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.
    The Agency used the First Approximation Rice Model (FARM) to 
estimate pesticide concentrations in surface water after applying 
flutolanil on rice and Screening Concentrations in Ground Water (SCI-
GROW), which predicts pesticide concentrations in ground water. In 
general, EPA will use Generic Expected Environmental Concentrations 
(GENEEC) (a Tier 1 model) before using Pesticide Root Zone/Exposure 
Analysis Modeling System (PRZM/EXAMS) (a Tier 2 model) for a screening-
level assessment for surface water, but given the unique hydrological 
issues arising from pesticide application to rice paddies, EPA used the 
FARM rather than GENEEC or PRZM/EXAMS for surface water estimates.
    Based on the SCI-GROW model, and the FARM (to estimate pesticide 
concentrations in surface water after applying flutolanil on rice) the 
estimated environmental concentrations (EECs) of flutolanil for acute 
exposures are estimated to be 3.8 parts per billion (ppb) for surface 
water and 0.34 ppb for ground water. The EEC for peak acute exposure is 
estimated to be 11.6 ppb for surface water. The EECs for chronic 
exposures are estimated to be 3.8 ppb for surface water and 0.34 ppb 
for ground water.
    For chronic dietary risk assessment, the water concentration of 
value 3.8 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).
    Flutolanil is currently registered for the following uses that 
could result in residential exposures: Turf grass and ornamental 
plants. EPA assessed residential exposure using the following 
assumptions: Although residential (non-occupational) exposure exists, a 
quantitative exposure assessment was not conducted since no 
toxicological endpoint attributable to acute, short-term or 
intermediate-term exposure have been identified and the current use 
pattern does not indicate chronic or long-term exposure (6 or more 
months of continuous exposure) potential. Further information regarding 
EPA standard assumptions and generic inputs for residential exposures 
may be found at http://www.epa.gov/pesticides/trac/science/
trac6a05.pdf.
    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 flutolanil to share a common mechanism of 
toxicity with any other substances, and flutolanil does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
flutolanil 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 website 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

[[Page 17569]]

additional safety factor when reliable data available to EPA support 
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
increased susceptibility of rat or rabbit fetuses to in utero exposure 
or rat pups to post-natal exposure to flutolanil. Flutolanil is not a 
developmental or reproductive toxicant. No maternal, reproductive, or 
developmental toxicity was observed at the limit dose.
    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 flutolanil is complete except for 
acute and subchronic neurotoxicity and immunotoxicity studies. Recent 
changes to 40 CFR part 158 make acute and subchronic neurotoxicity 
testing (OPPTS Test Guideline 870.6200), and immunotoxicity testing 
(OPPTS Test Guideline 870.7800) required for pesticide registration. 
However, the available data for flutolanil do not suggest that the 
compound produces hematological or thymus/spleen organ effects 
indicative of immunotoxicity. Further, there is no evidence of 
neurotoxicity in any study in the toxicity database for flutolanil. 
Therefore, EPA does not believe that conducting neurotoxicity and 
immunotoxicity studies will result in a NOAEL lower than the NOAEL of 
50 milligrams/kilogram/day (mg/kg/day) already established for 
flutolanil. Consequently, an additional database uncertainty factor 
does not need to be applied.
    ii. There is no indication that flutolanil 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 flutolanil 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. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground water and surface water modeling 
used to assess exposure to flutolanil in drinking water. Residential 
exposure does not pose a concern for flutolanil because (1) chronic 
residential exposure is not expected; and (2) although short-term or 
intermediate-term residential exposure may occur, no relevant adverse 
effects were identified for dermal or incidental oral or inhalation 
exposure related to residential use. These assessments will not 
underestimate the exposure and risks posed by flutolanil.

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 population adjusted dose (aPAD) and chronic population adjusted 
dose (cPAD). For linear cancer risks, EPA calculates the lifetime 
probability of acquiring cancer given the estimated aggregate exposure. 
Short-term, intermediate-term, 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, 
flutolanil 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 
flutolanil from food and water will utilize 2% of the cPAD for children 
between 1 to 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 
flutolanil is not expected.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure take into account short-term and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Because no short- or intermediate-term adverse effect was 
identified, flutolanil is not expected to pose a short-term or 
intermediate-term risk.
    4. Aggregate cancer risk for U.S. population. EPA has classified 
flutolanil as ``not likely'' to be a human carcinogen.
    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 flutolanil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology, (Method AU/95R/04), a common 
moiety Gas Chromatography/Mass Spectrometry (GC/MS) method which 
determines residues of flutolanil and metabolites as 2-trifluoromethyl 
benzoic acid (2-TFBA) is available to enforce the tolerance expression.
    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; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    Codex maximum residue limits (MRLs) are established for residues of 
flutolanil in rice commodities at 1-10 ppm, and in livestock 
commodities at 0.05-0.2 ppm. No Canadian or Mexican MRLs have been 
established. No Codex MRLs are established for soybean, cotton seed, or 
sugar beet commodities.

C. Response to Comments

    One comment was received from a private citizen objecting to the 
establishment of tolerances for flutolanil. The commenter criticized 
EPA's reliance on toxicology testing on animals. The Agency has 
received, and responded to, similar comments from this commenter on 
numerous previous occasions. Refer to the Federal Register issues of 
June 30, 2005 (70 FR 37686), January 7, 2005 (70 FR 1354), October 28, 
2004 (FR 69 63096) for the Agency's response to these objections.

D. Revisions to Petitioned-For Tolerances

    The Agency is establishing tolerances that are greater than the 
proposed tolerance for soybean seed and cotton seed because the 
enforcement analytical method has not been validated at a level below 
0.20 ppm, and the greater tolerance value is needed to accommodate 
indirect residues from soybean rotational crops. Additional tolerances 
are established for cotton gin byproducts, as the radiolabeled seed 
treatment study revealed residues on cotton gin trash, and soybean hay 
to accommodate the seed treatment use and the inadvertent residue from 
soybean as a rotational crop.
    EPA is revising the tolerance expression in Sec. 180.484 to clarify 
that, as provided in FFDCA section 408(a)(3), the tolerance covers 
metabolites and degradates of flutolanil not specifically mentioned; 
and that compliance with the specified tolerance levels is to be 
determined by measuring only the

[[Page 17570]]

specific compounds mentioned in the tolerance expression. The tolerance 
definition previously read ``residues of the fungicide flutolanil, N-
(3-(1-methylethoxy)phenyl)-2-(trifluoromethyl)benzamide, and its 
metabolites converted to 2-(trifluoromethyl) benzoic acid and 
calculated as flutolanil.'' It is being changed to ``residues of 
flutolanil, N-(3-(1-methylethoxy)phenyl)-2-(trifluoromethyl)benzamide, 
including its metabolites and degradates, in or on the commodities. 
Compliance with the tolerance levels is to be determined by measuring 
only flutolanil and its metabolites converted to 2-(trifluoromethyl) 
benzoic acid and calculated as flutolanil.''
    Finally, the inadvertent residue, rotational crop tolerances 
previously established for soybean forage and soybean hay encompass the 
use on soybean as a seed treatment. Therefore the tolerances 
established under paragraph (d), Indirect or inadvertent residues, for 
soybean, seed at 0.20 ppm; soybean, forage at 8.0 ppm, and soybean hay 
at 2.5 ppm are being revoked since the same tolerance values are being 
established under paragraph (a), General.

V. Conclusion

    Therefore, tolerances are established for residues of flutolanil, 
N-(3-(1-methylethoxy)phenyl)-2-(trifluoromethyl)benzamide, including 
its metabolites and degradates, in or on cotton, undelinted seed at 
0.20 ppm; soybean, seed at 0.20 ppm; soybean, forage at 8.0 ppm; 
soybean, hay at 2.5 ppm; cotton, gin byproducts at 0.20 ppm. Compliance 
with the tolerance levels is to be determined by measuring only 
flutolanil and its metabolites converted to 2-(trifluoromethyl) benzoic 
acid and calculated as flutolanil.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Public Law 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: March 26, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Prorgams.

0
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 180.484 is amended as follows:
    a. Revise the section heading.
    b. Revise the introductory text of paragraph (a).
    c. Add alphabetically entries to the table in paragraph (a) for 
cotton, gin byproducts; cotton, undelinted seed; soybean forage; 
soybean, hay; and soybean, seed.
    d. Revise paragraph (d).

Sec.  180.484   Flutolanil; tolerances for residues.

    (a) General. Tolerances are established for residues of flutolanil, 
N-(3-(1-methylethoxy) phenyl)-2-(trifluoromethyl)benzamide, including 
its metabolites and degradates, in or on the commodities in the table 
below. Compliance with the tolerance levels specified below is to be 
determined by measuring only flutolanil and its metabolites converted 
to 2-(trifluoromethyl) benzoic acid and calculated as flutolanil, in or 
on the following commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Cotton, gin byproducts...............................               0.20
Cotton, undelinted seed..............................               0.20
                                * * * * *
Soybean, forage......................................                8.0
Soybean, hay.........................................                2.5
Soybean, seed........................................               0.20
------------------------------------------------------------------------

* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established 
for the indirect or inadvertent residues of

[[Page 17571]]

flutolanil, N-(3-(1-methylethoxy)phenyl)-2-(trifluoromethyl)benzamide, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below 
is to be determined by measuring only flutolanil and its metabolites 
converted to 2-(trifluoromethyl) benzoic acid and calculated as 
flutolanil, in or on the following commodities.

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Wheat, bran..........................................               0.20
Wheat, forage........................................                2.5
Wheat, grain.........................................               0.05
Wheat, hay...........................................                1.2
Wheat, straw.........................................               0.20
------------------------------------------------------------------------

* * * * *
[FR Doc. 2010-7624 Filed 4-6-10; 8:45 am]
BILLING CODE 6560-50-S