Document ID: EPA-HQ-OPP-2009-0278-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Trifloxystrobin
Posted Date: 2010-06-11T04:00Z

[Federal Register: June 11, 2010 (Volume 75, Number 112)]
[Rules and Regulations]               
[Page 33190-33195]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jn10-11]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0278; FRL-8829-2]

 
Trifloxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation increases existing tolerances for residues of 
trifloxystrobin in or on corn, field, forage; corn, sweet, forage; and 
corn, sweet, stover. Bayer CropScience requested these tolerances under 
the Federal Food, Drug, and Cosmetic Act (FFDCA). Additionally, EPA is 
removing several tolerances which have expired.

DATES: This regulation is effective June 11, 2010. Objections and 
requests for hearings must be received on or before August 10, 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-2009-0278. 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: Tawanda Maignan, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8050; e-mail address: maignan.tawanda@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://www.gpoaccess.gov/ecfr. To 
access the harmonized test guidelines referenced in this document 
electronically, please go http://www.epa.gov/ocspp and select ``Test 
Methods and Guidelines.''

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-2009-0278 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 
August 10, 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. 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-2009-0278, 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

[[Page 33191]]

Friday, excluding legal holidays). Special arrangements should be made 
for deliveries of boxed information. The Docket Facility telephone 
number is (703) 305-5805.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 19, 2009 (74 FR 41898) (FRL-8426-
7), 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 
8F7487) by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
180.555 be amended by increasing existing tolerances for residues of 
the fungicide trifloxystrobin, benzeneacetic acid, (E,E)-[alpha]-
(methoxyimino)-2-[[[[1-[3- (trifluoromethyl) 
phenyl]ethylidene]amino]oxy]methyl]-methyl ester), in or on corn, 
field, forage at 6.0 parts per million (ppm); corn, sweet, forage at 
7.0 ppm; and corn, sweet, stover at 4.0 ppm. That notice referenced a 
summary of the petition prepared by Bayer CropScience, 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 the review of the data supporting the petition, the 
Agency is increasing the existing meat, fat and meat byproduct of 
cattle, goats, horses, and sheep tolerances to 0.1 ppm. The reasons for 
these changes are 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 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 trifloxystrobin 
including exposure resulting from the tolerances established by this 
action. EPA's assessment of exposures and risks associated with 
trifloxystrobin 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.
    Trifloxystrobin exhibits very low toxicity following single oral, 
dermal and inhalation exposures. It is a strong dermal sensitizer. In 
repeated dose tests in rats, the liver is the target organ for 
trifloxystrobin; toxicity is induced following oral and dermal exposure 
for 28 days. In the available toxicity studies on trifloxystrobin, 
there was no estrogen, androgen, and/or thyroid mediated toxicity. The 
toxicological database for trifloxystrobin does not show any evidence 
of treatment-related effects on the immune system. Further, there was 
no evidence of neurotoxicity at the limit dose in an unacceptable acute 
neurotoxicity study or in the other subchronic and chronic studies in 
the database. There is no evidence of increased susceptibility 
following pre-natal exposure to rats and rabbits and post-natal 
exposures to rats. Trifloxystrobin was determined not to be 
carcinogenic in mice or rats following long-term dietary 
administration. Trifloxystrobin is positive for mutagenicity in Chinese 
Hamster V79 cells, albeit at cytotoxic dose levels. However, 
trifloxystrobin is negative in the remaining mutagenicity studies.
    Specific information on the studies received and the nature of the 
adverse effects caused by trifloxystrobin 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 ``Trifloxystrobin. Human Health Risk 
Assessment for a Section 3 Petition Proposing Increased Tolerances for 
Residues in/on Field, Sweet and Pop Corn'' at pages 17 to 21 in docket 
ID number EPA-HQ-OPP-2009-0278.

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 trifloxystrobin used 
for human risk assessment is shown in the following Table.

[[Page 33192]]

 Table--Summary of Toxicological Doses and Endpoints for trifloxystrobin for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 years of  NOAEL = 250 milligrams/  Acute RfD = 2.5 mg/kg/   Developmental Toxicity-
 age)                                   kilograms/day (mg/kg/    day                      Rabbit. LOAEL = 500 mg/
                                        day)                    aPAD = 2.5 mg/kg/day...   kg/day based on
                                       UFA = 10x..............                            increased fetal
                                       UFH = 10x..............                            skeletal anomalies.
                                       FQPA SF = 1x...........
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)      NOAEL= 3.8 mg/kg/day     Chronic RfD = 0.038 mg/  Two-Generation
                                       UFA = 10x..............   kg/day                   reproduction study-
                                       UFH = 10x..............  cPAD = 0.038 mg/kg/day.   Rat. LOAEL = 55.3 mg/
                                       FQPA SF = 1x...........                            kg/day based on
                                                                                          decreases in body
                                                                                          weight, body weight
                                                                                          gains, reduced food
                                                                                          consumption and
                                                                                          histopathological
                                                                                          lesions in the liver,
                                                                                          kidneys and spleen.
----------------------------------------------------------------------------------------------------------------
Incidental Oral Short- (1 to 30 days)  Offspring NOAEL= 3.8 mg/ LOC for MOE = 100        Two-Generation
 and Intermediate- (1-6 months) Term    kg/day                                            reproduction study-
                                       UFA = NA...............                            Rat. LOAEL = 55.3 mg/
                                       UFH = NA...............                            kg/day based on
                                       FQPA SF = NA...........                            reduced pup body
                                                                                          weights during
                                                                                          lactation.
----------------------------------------------------------------------------------------------------------------
Dermal Short- (1 to 30 days) and       Dermal study NOAEL =     LOC for MOE = 100        28-Day Dermal Toxicity
 Intermediate- (1 to 6 months) Term     100 mg/kg/day                                     Study-Rat. LOAEL =
                                       UFA = NA...............                            1,000 mg/kg/day based
                                       UFH = NA...............                            on increases in mean
                                       FQPA SF = NA...........                            absolute and relative
                                                                                          liver and kidney
                                                                                          weights.
----------------------------------------------------------------------------------------------------------------
Inhalation Short- (1 to 30 days), and  Oral study NOAEL= 3.8    LOC for MOE = 100        Two-Generation
 Intermediate- (1 to 6 months) Term     mg/kg/day (inhalation                             reproduction study-
                                        absorption rate =                                 Rat. LOAEL = 55.3 mg/
                                        100%)                                             kg/day based on
                                       UFA = NA...............                            decreases in body
                                       UFH = NA...............                            weight, body weight
                                       FQPA SF = NA...........                            gains, reduced food
                                                                                          consumption and
                                                                                          histopathological
                                                                                          lesions in the liver,
                                                                                          kidneys and spleen.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)        Trifloxystrobin is classified as ``Not Likely Human Carcinogen'' based
                                           on the lack of evidence of carcinogenicity in mouse and rat cancer
                                                                        studies.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of
  concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to trifloxystrobin, EPA considered exposure under the 
petitioned-for tolerances as well as all existing trifloxystrobin 
tolerances in 40 CFR 180.555. EPA assessed dietary exposures from 
trifloxystrobin 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.
    In estimating acute dietary exposure for females 13 to 49 years 
old, EPA conducted an analysis using the Dietary Exposure Evaluation 
Model (DEEMTM7.81), which used food consumption information 
from the U.S. Department of Agriculture (USDA) 1994-1996 and 1998, 
Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). 
EPA used tolerance level residues. EPA assumed all commodities with 
established or proposed tolerances were treated with trifloxystrobin.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998, CSFII to be included in DEEM. As to residue levels in food, 
EPA used tolerance level residues for all commodities with the 
exception of apples, oranges and grapes. For these commodities EPA used 
anticipated residues. EPA assumed all commodities with established or 
proposed tolerances were treated with trifloxystrobin.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that trifloxystrobin 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. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for trifloxystrobin in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of trifloxystrobin. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment

[[Page 33193]]

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), GENeric Estimated Exposure Concentration (GENEEC), 
and/or Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of trifloxystrobin for 
the proposed new application are higher than those previously assessed 
for corn; however, the EDWCs for both corn rates are less than those 
previously estimated, via GENEEC, for turf use.
    Based on the PRZM/EXAMS, GENEEC, and/or SCI-GROW models, the EDWCs 
of trifloxystrobin plus its major degradation product, CGA-321113 for 
acute exposures are estimated to be 47.99 parts per billion (ppb) and 
47.31 ppb for chronic exposures. Modeled estimates of drinking water 
concentrations were directly entered into the dietary exposure model.
    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).
    Trifloxystrobin is currently registered for the following uses that 
could result in residential exposures: ornamentals and turfgrass. EPA 
assessed residential exposure using the following assumptions: adult 
post application dermal exposure; child's post application dermal and/
or hand to mouth. 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 trifloxystrobin to share a common mechanism of 
toxicity with any other substances, and trifloxystrobin does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
trifloxystrobin 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 additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There is no indication of 
increased susceptibility of rat or rabbits to trifloxystrobin. In the 
prenatal developmental study in rats, there was no developmental 
toxicity at the limit dose. In the prenatal developmental study in 
rabbits, developmental toxicity was seen at a dose that was higher than 
the dose that caused maternal toxicity. In the two generation 
reproduction study, there was no offspring toxicity at the highest dose 
tested.
    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 trifloxystrobin is complete except for 
neurotoxicity and immunotoxicity testing. Recent changes to 40 CFR part 
158 make neurotoxicity and immunotoxicity testing required for 
pesticide registration; however, the existing data are sufficient for 
endpoint selection for exposure/risk assessment scenarios, and for 
evaluation of the requirements under the FQPA. Although acute and 
subchronic neurotoxicity and immunotoxicity studies are needed to 
complete the database, there are no concerns for immunotoxicity or 
neurotoxicity based on the results of the existing studies. The 
toxicological database for trifloxystrobin does not show any evidence 
of treatment-related effects on the immune system. There was a decrease 
in the incidence of hemosiderosis in the spleen of F0 and F1 parental 
males and females in the 2-generation reproduction study. The effect 
was not seen in any other toxicity studies, and it was not a primary 
effect on the spleen. This decrease may indicate a decrease of red 
blood cell turnover; but it is not an effect on the immune system. 
Further, there was no evidence of neurotoxicity at the limit dose in an 
unacceptable acute neurotoxicity study or in the other subchronic and 
chronic studies in the database. The EPA does not believe that 
conducting neurotoxicity or immunotoxicity studies will result in a 
dose less than the PODs already used in this risk assessment and an 
additional database uncertainty factor for potential neurotoxicity and/
or immunotoxicity does not need to be applied.
    ii. There is no indication that trifloxystrobin is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional uncertainty factors (UFs) to account for neurotoxicity.
    iii. There is no evidence that trifloxystrobin results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the two-generation 
reproduction study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute and chronic dietary food exposure assessments 
utilize existing and proposed tolerance level residues and 100% crop 
treated information for all commodities, except for apples, oranges, 
and grapes which utilized anticipated residue levels for the chronic 
dietary. By using these screening-level assessments with minor 
refinement, actual exposures/risks from residues in food will not be 
underestimated. EPA made conservative (protective) assumptions in the 
ground and surface water modeling used to assess exposure to 
trifloxystrobin 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 trifloxystrobin.

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

[[Page 33194]]

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, 
using the exposure assumptions discussed in this unit for acute 
exposure, the acute dietary exposure from food and water to 
trifloxystrobin will occupy <1% of the aPAD for females 13 to 49 years 
old.
    2. Chronic-term risk. Using the exposure assumptions described in 
this unit for chronic exposure, EPA has concluded that chronic exposure 
to trifloxystrobin from food and water will utilize 15% of the cPAD for 
the general U.S. population and 43% of the cPAD for children 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 trifloxystrobin 
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).
    Trifloxystrobin 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 trifloxystrobin.
    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 1,200 for adults 
(dermal residential + dietary food and drinking water exposures); 680 
for children 1 to 2 years old (dermal residential + dietary food and 
drinking water exposures); and 170 for children 1 to 2 years old 
(incidental oral + dietary food and drinking water exposures). Because 
EPA's level of concern for trifloxystrobin is a MOE of 100 or below, 
these MOEs are not of concern.
    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 
level). Trifloxystrobin is not expected to pose an intermediate-term 
risk based on a short soil half-life (approximately 2 days).
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, trifloxystrobin 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 trifloxystrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with nitrogen 
phosphorus detection (GC/NPD)), Method AG-659A 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

    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.
     The Codex has established a MRL for trifloxystrobin in or on maize 
fodder (dry) at 10 ppm. Canada has a proposed (not yet established) MRL 
of 0.02 for corn grain, sweet corn, popcorn grain for parent and 
metabolite. Since the Codex MRL is for a commodity that is not 
recognized domestically and would normally not be transported across 
international borders, there is no concern for international 
harmonization. Also, since the Canadian MRL has not been established, 
there is no concern for international harmonization.

C. Revisions to Petitioned-For Tolerances

    Trifloxystrobin tolerances for crop commodities listed in 40 CFR 
180.555(a)(1) are expressed in terms of the residues of the fungicide 
trifloxystrobin, benzeneacetic acid, (E,E)-[alpha]-(methoxyimino)-2-
[[[[1-[3-(trifluoromethyl) phenyl]ethylidene] amino]oxy]methyl]-, 
methyl ester, and the free form of its acid metabolite CGA-321113, 
(E,E)-methoxyimino-[2-[1-(3-trifluoromethyl-phenyl)-
ethylideneaminooxymethyl]-phenyl]acetic acid. EPA has revised the 
trifloxystrobin tolerance expression to clarify the chemical moieties 
that are covered by the tolerances and specify how compliance with the 
tolerances is to be measured.
    EPA's analysis of the adequacy of the existing tolerances for meat, 
fat and meat byproduct of cattle, goats, horses, and sheep tolerances 
based on the proposed tolerances as well as existing tolerances 
indicates they need to be increased to 0.1 ppm from 0.05 ppm. Also, EPA 
is removing from paragraph (b), tolerances for soybean, forage; 
soybean, hay; and soybean, seed which expired and were revoked on 
December 31, 2009.

V. Conclusion

    Therefore, existing tolerances in 40 CFR 180.555(a) are increased 
for residues of trifloxystrobin, benzeneacetic acid, (E,E)-[alpha]-
(methoxyimino)-2-[[[[1-[3- (trifluoromethyl) 
phenyl]ethylidene]amino]oxy]methyl]-methyl ester, in or on corn, field, 
forage at 6.0 ppm; corn, sweet, forage at 7.0 ppm; and corn, sweet, 
stover at 4.0 ppm. EPA is also removing paragraph (b) tolerances for 
soybean, forage; soybean, hay; and soybean, seed which expired December 
31, 2009.

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

[[Page 33195]]

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 tolerances 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: May 27, 2010.
Daniel J. Rosenblatt,
Director, Registration Division, Office of Pesticide Programs.

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. Amend Sec.  180.555 as follows:
0
a. Revise the introductory text of paragraph (a).

0
b. Revise the following entries in the table in paragraph (a): cattle, 
fat; cattle, meat; cattle, meat byproducts; corn, field, forage; corn, 
sweet, forage; corn, sweet, stover; goat, fat; goat, meat; goat, meat 
byproducts; horse, fat; horse, meat; horse, meat byproducts; and sheep, 
fat; sheep, meat; and sheep, meat byproducts.

0
c. Revise paragraph (b).
    The revisions read as follows:

Sec.  180.555  Trifloxystrobin; tolerances for residues.

    (a) General. Tolerances are established for residues of 
trifloxystrobin, 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 the sum of 
trifloxystrobin, benzeneacetic acid, (E,E)-[alpha]-(methoxyimino)-2-
[[[[1-[3-(trifluoromethyl) phenyl]ethylidene] amino]oxy]methyl]-, 
methyl ester, and the free form of its acid metabolite CGA-321113, 
(E,E)-methoxyimino-[2-[1-(3-trifluoromethyl-phenyl)-
ethylideneaminooxymethyl]-phenyl]acetic acid, calculated as the 
stoichiometric equivalent of trifloxystrobin, in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Cattle, fat................................................          0.1
Cattle, meat...............................................          0.1
Cattle, meat byproducts....................................          0.1

                                * * * * *
Corn, field, forage........................................          6.0

                                * * * * *
Corn, sweet, forage........................................          7.0

                                * * * * *
Corn, sweet, stover........................................          4.0

                                * * * * *
Goat, fat..................................................          0.1
Goat, meat.................................................          0.1
Goat, meat byproducts......................................          0.1

                                * * * * *
Horse, fat.................................................          0.1
Horse, meat................................................          0.1
Horse, meat byproducts.....................................          0.1

                                * * * * *
Sheep, fat.................................................          0.1
Sheep, meat................................................          0.1
Sheep, meat byproducts.....................................          0.1

                                * * * * *
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. 2010-13938 Filed 6-10-10; 8:45 am]
BILLING CODE 6560-50-S