[Federal Register Volume 79, Number 170 (Wednesday, September 3, 2014)]
[Rules and Regulations]
[Pages 52210-52215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-20928]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0504; FRL-9915-46]


Trifloxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
trifloxystrobin in or on pea, dry, seed; pea, field, hay; and pea, 
field, vines. Bayer CropScience requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 3, 2014. Objections and 
requests for hearings must be received on or before November 3, 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-2013-0504, 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; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://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-2013-0504 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 
November 3, 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-2013-0504, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     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 October 25, 2013 (78 FR 63938) (FRL-
9901-96), 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 
3F8180) 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 establishing tolerances for 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, calculated as the 
stoichiometric equivalent of trifloxystrobin, in or on pea, dry, seed 
at 0.06 parts per million (ppm); pea, field, hay at 15 ppm; pea, field, 
vines at 4.0 ppm; chickpea, seed at 0.06 ppm; and lentil, seed at 0.06 
ppm. That document 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 review of the data supporting the petition, EPA has 
corrected proposed commodity definitions and eliminated certain 
proposed crop tolerances. 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

[[Page 52211]]

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 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 their 
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 and a 
mild dermal and eye irritant. 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. Liver effects characterized by an 
increase in liver weights and an increased incidence of hepatocellular 
hypertrophy and/or hepatocellular necrosis were seen in rats, mice, and 
dogs.
    There is no concern for neurotoxicity or immunotoxicity in the 
database. In the rabbit developmental toxicity study, an increase in 
the incidence of fused sternabrae was seen at a dose 10 times higher 
than the maternal lowest observed adverse effect level (LOAEL). In the 
rat reproduction study, both parents and offspring showed decreases in 
body weight during lactation. The rat and rabbit developmental and the 
rat reproduction toxicity data do not demonstrate an increase in 
susceptibility in the fetus or other offspring.
    Trifloxystrobin is classified as: ``Not likely to be Carcinogenic 
to Humans'' based on negative results in:
    1. The battery of mutagenicicty tests (except at a cytoxic dose in 
one in vitro test), and
    2. The long-term carcinogenicity studies in rats and mice.
    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 are discussed in the final rule 
published in the Federal Register of June 11, 2010 (75 FR 33190) (FRL-
8829-2) and in the document ``Trifloxystrobin. Aggregate Human Health 
Risk Assessment for the Proposed New Uses on Chickpea, Dry Peas, and 
Lentils with Updated Residential Risk Estimates of All Existing 
Residential Uses (Lawns/Turf; Gardens and Trees),'' dated June 10, 
2014, Appendix A, pp. 27-31 in docket ID number EPA-HQ-OPP-2013-0504.

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 was discussed in Unit III B. of the final 
rule published in the Federal Register of June 11, 2010. However, 
subsequent to that Federal Register publication, EPA reassessed the 
liver effects seen in the 28-day dermal toxicity study according to 
current policy, and determined that since these effects should not be 
considered adverse, no toxicity endpoint was identified. The NOAEL for 
the 28-day dermal study was set at 1,000 mg/kg/day and the LOAEL was 
not established. Therefore, the endpoints assessed as part of this 
action exclude the endpoint for dermal exposure identified in the table 
published in the above-referenced Federal Register on June 11, 2010.

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. Such effects were identified 
for trifloxystrobin. In estimating acute dietary (food and water) 
exposure for females 13-49 years old, EPA conducted an analysis using 
the Dietary Exposure Evaluation Model (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). An acute dietary 
assessment was conducted assuming tolerance level residues (plus the 
additional metabolite residues as noted in this paragraph) and 100 
percent crop treated (PCT) for all commodities. For the dietary 
assessment, a value of 0.20 ppm for the metabolite L7a was added to the 
tolerance level for meat byproducts of cattle, goats, horses, and sheep 
to account for the higher residues in liver; therefore, these 
commodities were assessed in the dietary assessments at 0.3 ppm. Pork 
was assessed in the DEEM at the established tolerance level of 0.05 
ppm; pork, liver was assessed at 0.16 ppm to account for the residues 
of the metabolite L7a. DEEM version 7.81 default processing factors 
were assumed except for where tolerances were established for processed 
commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure

[[Page 52212]]

Evaluation Model (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). A chronic dietary exposure assessment was 
conducted assuming 100 PCT, anticipated residues (ARs) for grapes, 
apples, oranges, and pears, and tolerance level residues for the rest 
of the commodities, including additional metabolite residues as noted 
in this paragraph. A value of 0.20 ppm for the metabolite L7a was added 
to the tolerance level for meat byproducts of cattle, goats, horses, 
and sheep to account for the higher residues in liver; therefore, these 
commodities were assessed in the dietary assessments at 0.3 ppm. Pork 
was assessed in the DEEM at the established tolerance level of 0.05 
ppm; pork, liver was assessed at 0.16 ppm to account for residues of 
the metabolite L7a. DEEM version 7.81 default processing factors were 
assumed except for where tolerances were established for processed 
commodities.
    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 (AR) and 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.
    EPA used anticipated residue information in the chronic dietary 
assessment for trifloxystrobin for grapes, apples, oranges, and pears.
    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 can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and PRZMGround Water (PRZM-GW) models, the 
estimated drinking water concentrations (EDWCs) of total toxic residues 
of trifloxystrobin and its major degradation product for acute 
exposures are estimated to be 29 parts per billion (ppb) for surface 
water and 427 ppb for ground water. For chronic exposures for non-
cancer assessments are estimated to be 23 ppb for surface water and 365 
ppb for ground water. Modeled estimates of drinking water 
concentrations were directly entered into the dietary exposure model. 
For acute dietary risk assessment, the water concentration value of 427 
ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of 
value 365 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).
    Trifloxystrobin is currently registered for the following uses that 
could result in residential exposures: Ornamentals and turfgrass. EPA 
assessed residential exposure from relevant registered trifloxystrobin 
products using the Agency's 2012 Residential Standard Operating 
Procedures (SOPs) along with updates in dermal risk assessment hazard 
and policy regarding body weight in addition to the following 
assumptions:
    i. Residential handler exposures. Residential handler exposure is 
expected to be short-term only. Intermediate-term exposures are not 
likely because of the intermittent nature of applications by 
homeowners. Dermal handler exposures were not assessed since no adverse 
systemic dermal hazard was identified for trifloxystrobin.
    ii. Residential post-application exposures. Since dermal hazard has 
not been identified for trifloxystrobin, a quantitative post-
application assessment for dermal exposure is not necessary and the 
only exposure scenarios quantitatively assessed are for children 1 to 
<2 years old who may experience short-term incidental oral exposure to 
trifloxystrobin from treated turf. Incidental oral granule ingestion is 
not applicable because there is no endpoint identified for the acute 
dietary duration. Intermediate-term incidental oral post-application 
exposures are not expected because trifloxystrobin is not persistent in 
soil or water; furthermore, the short-term incidental oral risk 
estimates would be protective of the possible intermediate-term 
incidental oral exposures because the POD for both durations is the 
same. Post-application inhalation exposure is expected to be negligible 
for the proposed residential uses.
    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 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 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 
factor.
    2. Prenatal and postnatal sensitivity. There is no indication of 
increased

[[Page 52213]]

quantitative or qualitative susceptibility to trifloxystrobin in rats 
or rabbits. In the prenatal developmental study in rats, there was no 
developmental toxicity at and up to the limit dose. In the prenatal 
developmental study in rabbits, developmental toxicity was seen at a 
dose that was higher than the dose causing maternal toxicity. In the 
multigeneration study, offspring and parental LOAELs are at the same 
dose level.
    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. The 
Agency has waived requirements for a subchronic neurotoxicity study 
because:
    a. Trifloxystrobin was not neurotoxic in the acute neurotoxicity 
study, nor in any of the repeated dose studies in the available data,
    b. There is no evidence of neurotoxicity in the existing 
trifloxystrobin database or that of other strobilurin pesticides, and
    c. Because endpoints and PODs used for risk assessment are likely 
to be protective of neurotoxicity concerns. EPA has also waived 
requirements for subchronic inhalation testing. Trifloxystrobin 
exhibits low toxicity (Category IV) via inhalation route of exposure.
    ii. There is no indication that trifloxystrobin is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity. Adverse effects were 
not seen up to the limit dose in an acute neurotoxicity study. There is 
no evidence of neurotoxicity in subchronic and chronic toxicity studies 
(rats, dogs, mice), in developmental toxicity studies (rats, rabbits), 
or in a reproductive toxicity study (rats). There is no concern for 
neurotoxicity of trifloxystrobin based on the available database.
    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 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The exposure databases are complete or are estimated based 
on data that reasonably account for potential exposures. The exposure 
assessments will not underestimate the potential dietary (food and 
drinking water) or non-dietary exposures for infants and children from 
the use of trifloxystrobin. The acute and chronic dietary food exposure 
assessment was conservatively based on 100 PCT assumptions and 
conservative ground water drinking water modeling estimates. The 
dietary drinking water assessment utilizes water concentration values 
generated by models and associated modeling parameters which are 
designed to provide conservative, health protective, high-end estimates 
of water concentrations, and are not likely to be exceeded. In 
addition, the residential post-application assessment is based upon the 
residential SOPs employing surrogate study data and reasonable ``worst-
case'' assumptions. These data and assessments are reliable and are not 
expected to underestimate exposure and risk posed by trifloxystrobin to 
adults or children as well as incidental oral exposure of young 
children (1-2 years old).

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. With the exception of the subpopulation group, females 
13 to 49 years old, 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 1.3% of the aPAD for females 13-49 years 
old.
    2. Chronic 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 32% of the cPAD for 
the general U.S. population and 78% for all infants <1 year 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 for adults of 300 
(from food, water and residential inhalation exposures) and for 
children 120 (from food, water and residential incidental/hand-to-mouth 
oral exposure). 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).
    Although the Agency identified an intermediate-term endpoint, the 
Agency does not expect trifloxystrobin to result in intermediate-term 
residential exposure, due to the intermittent nature of homeowner 
applications and its short soil half-life (about 2 days). Therefore, 
the Agency relies on the chronic risk assessment to account for 
intermediate-term risk and concludes that trifloxystrobin does not pose 
an intermediate-term aggregate risk.
    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 method with 
nitrogen phosphorus detection (GC/NPD), Method AG-659A) is available to 
enforce the tolerances for the combined residues of trifloxystrobin and 
CGA-321113 in plant and livestock commodities. Subject crops under this

[[Page 52214]]

action were analyzed for residues of trifloxystrobin and CGA-321113 
using a high performance liquid chromatography method with tandem mass 
spectrometry detection (LC/MS/MS). The lowest level of method 
validation (LLMV) is equivalent to the limit of quantitation (LOQ) 
which is 0.010 ppm for each analyte in/on all matrices.
    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: 
[email protected].

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.
    The Codex has not established MRLs for trifloxystrobin on the crops 
subject to this action.

C. Revisions to Petitioned-For Tolerances

    EPA determined that the proposed tolerances for chickpea hay and 
vines are not needed since both commodities are not significant 
livestock feed items. In addition, the proposed tolerances on chickpea 
seed and lentil seed are not needed since pea, dry, seed under the 
definition in 40 CFR 180.1 includes these commodities.
    To reflect the correct commodity definitions, EPA revised the 
proposed commodity listings for ``pea, dry, hay'' and ``pea, dry, 
vines'' to read: ``pea, field, hay'' and ``pea, field, vines'', 
respectively.

V. Conclusion

    Therefore, tolerances are established for residues 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 pea, dry, seed 
at 0.06 ppm; pea, field, hay at 15 ppm; and pea, field, vines at 4 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: August 25, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. In Sec.  180.555, add alphabetically the following entries to the 
table in paragraph (a) to read as follows:


Sec.  180.555  Trifloxystrobin; tolerance for residues.

    (a) * * *

[[Page 52215]]



------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Pea, dry, seed..........................................            0.06
Pea, field, hay.........................................              15
Pea, field, vines.......................................               4
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-20928 Filed 9-2-14; 8:45 am]
BILLING CODE 6560-50-P