

[Federal Register: September 22, 2006 (Volume 71, Number 184)]
[Rules and Regulations]               
[Page 55313-55319]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22se06-9]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0299; FRL-8093-8]

 
Trifloxystrobin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of Trifoxystrobin (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-trifluoromethylphenyl) ethylideneaminooxymethyl] 
phenyl)acetic acid)) in or on soybean, forage at 10.0 parts per million 
(ppm), soybean, hay at 25.0 ppm, and soybean, seed at 0.08 ppm. Bayer 
CropScience requested this tolerance under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 
1996 (FQPA).

DATES: This regulation is effective September 22, 2006. Objections and 
requests for hearings must be received on or before November 21, 2006, 
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-2005-0299. All documents in the 
docket are listed in the index for the docket. Although listed in the 
index, some information is not publicly

[[Page 55314]]

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 
Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is 
open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The Docket telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Janet Whitehurst, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6129; e-mail address: 
janet.whitehurst@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:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
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 Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
 To access the OPPTS Harmonized Guidelines 

referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm



C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. 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-2005-0299 in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be mailed or delivered to the Hearing Clerk on or 
before November 21, 2006.
    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 your copies, identified by docket ID 
number EPA-HQ-OPP-2005-0299, 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 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket'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 telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of January 4, 2006 (71 FR 340) (FRL-7750-
6), 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 
5F6956) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Drive, 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
180.555 be amended by establishing tolerances for combined 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-
trifluoromethylphenyl) ethylideneaminooxymethyl)phenyl)acetic acid)) in 
or on soybean, forage at 8.0 ppm, soybean, hay at 20.0 ppm, and 
soybean, seed at 0.08 ppm. That notice included a summary of the 
petition prepared by BayerCropScience, the registrant. The petition 
also proposed a 4.2 ppm tolerance for aspirated grain fractions (AGF) 
derived from soybean seed. However, this tolerance is not necessary as 
residues in/on soybean AGF are covered by the existing 5.0 ppm 
tolerance or AGF, which was established in conjunction with the use of 
trifloxystrobin on wheat. There were no comments received in response 
to the notice of filing.
    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

[[Page 55315]]

aggregate exposure to the pesticide chemical residue. . . .''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see:
    http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
    http://www.epa.gov/oppfead1/trac/science

    http://www.epa.gov/pesticides/factsheets/ riskassess.htm    http://www.epa.gov/pesticides/trac/science/ aggregate.pdf.
egate.pdf.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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, consistent with section 
408(b)(2) of FFDCA, for a tolerance for combined residues of 
trifloxystrobin and CGA 321113 on soybean, forage at 10.0 ppm, soybean, 
hay at 25.0 ppm, and soybean, seed at 0.08 ppm. EPA's assessment of 
exposures and risks associated with establishing the tolerance 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 toxic 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 in the 
Federal Register of March 29, 2006 (71 FR 15597) (FRL-7759-9).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which the NOAEL from the toxicology study 
identified as appropriate for use in risk assessment is used to 
estimate the toxicological level of concern (LOC). However, the LOAEL 
of concern identified is sometimes used for risk assessment if no NOAEL 
was achieved in the toxicology study selected. An uncertainty factor 
(UF) is applied to reflect uncertainties inherent in the extrapolation 
from laboratory animal data to humans and in the variations in 
sensitivity among members of the human population as well as other 
unknowns.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at either of the following websites:
    http://www.epa.gov/pesticides/factsheets/riskassess htm;    http://www.epa.gov/oppfead1/trac/science.



risk assessment is shown in the following Table 1:

           Table 1.--Summary of Toxicological Dose and Endpoints for for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                  FQPA SF and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (female 13-49 only)      NOAEL = 250 mg/kg/day    FQPA SF = 1X             Developmental toxicity
                                       UF = 100...............  aPAD = aRfD............    rat
                                       Acute RfD = 2.5 mg/kg/   FQPA SF= 2.5 mg/kg/day.  LOAEL = 500 mg/kg/day,
                                        day.                                              based upon increased
                                                                                          fetal skeletal
                                                                                          anomalies.
----------------------------------------------------------------------------------------------------------------
Acute dietary                               General Population including infants and children. There were no
                                           appropriate toxicological effects attributable to a single exposure
                                         (dose) observed in oral toxicity studies including maternal effects in
                                            developmental studies in rats and rabbits. Therefore, a dose and
                                                 endpoint were not identified for this risk assessment.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      Parental NOAEL= 3.8 mg/  FQPA SF = 1X             Two-generation
                                        kg/day                  cPAD = cRfD............   reproduction study -
                                       UF = 100...............  FQPA SF= 0.038 mg/kg/     rat
                                       Chronic RfD = 0.038 mg/   day.                    LOAEL = 55.3 mg/kg/day,
                                        kg/day.                                           based upon decreases
                                                                                          in body weight, body
                                                                                          weight gains, reduced
                                                                                          food consumption and
                                                                                          histopathological
                                                                                          lesions in the liver,
                                                                                          kidneys and spleen.
----------------------------------------------------------------------------------------------------------------
Short-term (1-30 days) and intermed-   Offspring NOAEL= 3.8 mg/ LOC for MOE = 100        Two-Generation
 term (1-6 months) oral                 kg/day                   (residential, includes   reproduction study -
                                                                 the FQPA SF)             rat
                                                                                         LOAEL = 55.3 mg/kg/day,
                                                                                          based upon reduced pup
                                                                                          body weights during
                                                                                          lactation
----------------------------------------------------------------------------------------------------------------
Short-term (1-30 days) and intermed-   Dermal study NOAEL =     LOC for MOE = 100        28-Day dermal toxicity
 term (1-6 months) dermal               100 mg/kg/day            (occupational)           study - rat
                                                                LOC for MOE = 100        LOAEL = 1,000 mg/kg/
                                                                 (residential, includes   day, based upon
                                                                 the FQPA SF).            increases in mean
                                                                                          absolute and relative
                                                                                          liver and kidney
                                                                                          weights
----------------------------------------------------------------------------------------------------------------
Long-term dermal (>6 months)           Oral study NOAEL= 3.8    LOC for MOE = 100        Two-generation
                                        mg/kg/day (dermal        (occupational)           reproduction study -
                                        absorption rate = 33%)  LOC for MOE = 100         rat
                                                                 (residential, includes  LOAEL = 55.3 mg/kg/day,
                                                                 the FQPA SF).            based upon decreases
                                                                                          in body weight, body
                                                                                          weight gains, reduced
                                                                                          food consumption and
                                                                                          histopathological
                                                                                          lesions in the liver,
                                                                                          kidneys and spleen
----------------------------------------------------------------------------------------------------------------

[[Page 55316]]


Short-term (1-30 days), intermed-term  Oral study NOAEL= 3.8    LOC for MOE = 100        Two-generation
 (1-6 months) and long-term >6          mg/kg/day                (occupational)           reproduction study -
 months) inhalation                    (Inhalation absorption   LOC for MOE = 100         rat
                                        rate = 100%).            (residential, includes  LOAEL = 55.3 mg/kg/day,
                                                                 the FQPA SF).            based upon decreases
                                                                                          in body weight, body
                                                                                          weight 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
----------------------------------------------------------------------------------------------------------------
1 UF = uncertainty factor, FQPA SF = Special FQPA SF, NOAEL = no observed adverse effect level, LOAEL = lowest
  observed adverse effect level, 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. Tolerances have been 
established (40 CFR 180.555) for the combined residues of 
trifloxystrobin and CGA 321113 in or on a variety of raw agricultural 
commodities. Risk assessments were conducted by EPA to assess 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 conducting the acute dietary exposure assessment EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCID\TM\), which incorporates food consumption 
data as reported by respondents in the USDA 1994-1996 and 1998 
Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), 
and accumulated exposure to the chemical for each commodity. The 
following assumptions were made for the acute exposure assessments: The 
acute dietary exposure analysis for trifloxystrobin is a Tier 1 
assessment (assuming 100 percent crop treated (%CT) and tolerance level 
residues). The acute dietary endpoint was found to be applicable only 
to the population subgroup females 13-49 years old. An acute dietary 
endpoint for the general population including infants and children was 
not identified.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM-FCID\TM\, which incorporates food 
consumption data as reported by respondents in the USDA 1994-1996 and 
1998 Nationwide CSFII, and accumulated exposure to the chemical for 
each commodity. The following assumptions were made for the chronic 
exposure assessments: A conservative chronic dietary analysis for 
trifloxystrobin was conducted using tolerance-level residues for all 
commodities with existing and proposed tolerances except for meat 
byproducts of cattle, goats, horses, and sheep because the metabolite 
L7a (the taurine conjugate of trifloxystrobin) is included in the risk 
assessment for liver. For all commodities, 100% CT was used.
    iii. Cancer. Trifloxystrobin is classified as a ``Not Likely Human 
Carcinogen.'' Due to the classification, no cancer risk assessment was 
performed.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for trifloxystrobin in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
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. EPA 

determined estimated drinking water concentrations (EDWCs) of 
trifloxystrobin using the PRZM/EXAMS, FIRST and SCI-GROW models. The 
highest EDWCs for surface water and ground water acute exposure (92 
parts per billion (ppb)) and surface water and ground water chronic 
exposure (140 ppb) were used in the dietary analysis. The chronic 
exposure value is higher than the acute exposure value due to some very 
conservative assumptions in the chronic assessment. These estimates of 
residues in drinking water were incorporated directly into the DEEM-
FCID model of the dietary risk assessment.
    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 use on the following 
residential non-dietary sites: Turfgrass and ornamentals. The risk 
assessment was conducted using the following residential exposure 
assumptions: Trifloxystrobin is currently registered for residential 
uses including disease control in turfgrass and ornamentals. Up to 
three applications may be made in a season, with the shortest interval 
between applications being 5-7 days. Because FQPA requires 
consideration of aggregate exposure to all likely non-occupational 
uses, this assessment uses non-occupational post-application contact 
with trifloxystrobin following use on turfgrass as the most common and 
worst case contributor to such exposures.There is potential for dermal 
(adults and children) and incidental oral exposure (children only) 
during post-application activities. The following post-application 
exposure scenarios resulting from lawn treatment were assessed: i. 
Dermal exposure from pesticide residues on lawns, ii. incidental non-
dietary ingestion of pesticide residues on lawns from hand-to-mouth 
transfer, iii. incidental non-dietary ingestion of residues from 
object-to-mouth activities (pesticide-treated turfgrass), and iv. 
incidental non-dietary ingestion of soil from pesticide-treated 
residential areas. Post-application exposures from various activities 
following lawn treatment are considered to be the most common and 
significant in residential settings. The exposure via incidental non-
dietary ingestion involving other plant material may occur but is 
considered negligible. Intermediate and chronic, or long-term exposures 
are not expected.
    4. Cumulative effects from substances with a common mechanism of 
toxicity.

[[Page 55317]]

Section 408(b)(2)(D)(v) of the 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to trifloxystrobin and 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 not assumed that trifloxystrobin 
has 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 the policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative
.


D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold 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 data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
margin of exposure (MOE) analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans. In applying this provision, EPA either retains the default 
value of 10X when reliable data do not support the choice of a 
different factor, or, if reliable data are available, EPA uses a 
different additional safety factor value based on the use of 
traditional UFs and/or special FQPA safety factors, as appropriate.
    2. Conclusion. The Agency found that because the toxicology 
database are complete for FQPA purposes and that there are no residual 
uncertainties for prenatal/postnatal toxicity, the 10X FQPA Safety 
Factor (SF) can be reduced to 1x. The FQPA SF is reduced to 1X because:
     There is no indication of increased susceptibility of rat 
or rabbits to trifloxystrobin. In the developmental and reproduction 
toxicity studies, effects in the fetuses/offspring were observed only 
at or above treatment levels which resulted in evidence of parental 
toxicity;
     The EPA determined that a developmental neurotoxicity 
study in rats is not required;
     The acute and chronic dietary food exposure assessments 
utilize existing and proposed tolerance level residues and 100% CT 
information for all commodities. By using these screening-level 
assessments, actual exposures/risks will not be underestimated;
     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 dietary drinking water assessment utilizes water 
concentration values generated by model and associated modeling 
parameters, which are designed to provide conservative, health 
protective, high-end estimates of water concentrations, which are not 
likely to be exceeded; and
     The residential postapplication assessment is based upon 
using residential standard operating procedures (SOPs). The assessment 
is based upon surrogate study data. These data are reliable and are not 
expected to underestimate risk to adults or children. The residential 
SOPs are based upon reasonable ``worst-case'' assumptions and are not 
expected to underestimate risk.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. The aggregate acute risk estimates include exposure 
to residues of trifloxystrobin in food and drinking water, and does not 
include dermal, inhalation or incidental oral exposure. Since the 
dietary exposure assessment already includes the highest acute exposure 
from the drinking water modeling data, no further calculations are 
necessary. The food and drinking water exposure estimates for females 
13-49 years old is < 1% acute population adjusted dose (aPAD). The acute 
risk estimate for females 13-49 years, resulting from aggregate 
exposure to trifloxystrobin in food and drinking water is below EPA's 
level of concern.
    2. Chronic risk. The aggregate chronic risk assessment takes into 
account average exposure estimates from dietary consumption of 
trifloxystrobin (food and drinking water) and residential uses. Since 
the exposure from turf is considered short-term, the aggregate chronic 
assessment included food and drinking water only. Since the dietary 
exposure assessment already includes the highest chronic exposure from 
the drinking water modeling data, no further calculations are 
necessary. The general U.S. population and all population subgroups 
have exposure and risk estimates which are below EPA's level of concern 
(i.e., the percentages of the (cPADs are all below 100%). The exposure 
to the U.S. population was 21% of the cPAD and the most highly exposed 
subgroup, cildren 1-2 years old, was at 62% of the cPAD. Therefore, 
chronic risk estimates resulting from aggregate exposure to 
trifloxystrobin in food and drinking water are below EPA's level of 
concern from all population subgroups.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). The short-term 
aggregate risk assessment estimates risks likely to result from 1-30 
day exposure to trifloxystrobin residues from food, drinking water, and 
residential pesticide uses. High-end estimates of residential exposure 
are used in the short-term assessment, while average values are used 
for food and drinking water exposure (i.e. chronic exposures).
    Different endpoints were identified by EPA for short-term 
incidental oral and dermal risk assessment (the basis for the oral 
endpoint is reduced pup body weights and the dermal endpoint is based 
on increases in liver and kidney weights). Therefore, it is not 
reasonable, as a toxicological matter, to combine dietary/incidental 
oral exposure with dermal exposure. A short-term aggregate risk 
assessment for dietary plus incidental oral exposure is needed for 
toddlers because there are residential postapplication incidental oral 
exposure scenarios. Toddlers' incidental oral exposure is assumed to 
include hand-to-mouth exposure, object-to-mouth exposure and exposure 
through incidental ingestion of soil. Because toddlers also have post-
application dermal exposure as a result of the residential use and 
because it is not scientifically appropriate to combine oral and dermal 
exposures for trifloxystrobin, a separate short-term aggregate risk 
assessment is needed for toddlers to assess the risk of dermal 
exposure. This separate risk assessment only takes into account dermal 
exposure and compares this exposure to the dermal endpoint. The short-
term aggregate oral exposure to all other

[[Page 55318]]

population groups is from dietary exposure alone (i.e. from food and 
drinking water) because these population groups do not have incidental 
oral exposures. As with toddlers, a separate short-term aggregate risk 
assessment has been conducted for dermal exposure. Table 2 summarizes 
short-term aggregate risks. All short-term aggregate risk estimates 
result is MOEs greater than 100. Therefore, EPA does not consider 
short-term aggregate risk to be a concern.

                                   Table 2.--Short-Term Aggregate Risk (Food, Drinking Water and Residential Exposure)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                              Short-Term Scenario
                                                                -----------------------------------------------------------------------------
                                                                                             Average
                           Population                                                         Food +        Oral        Dermal
                                                                 NOAEL mg/kg/   LOC MOE1      Water     Residential  Residential   Aggregate
                                                                     day                   Exposure mg/  Exposure2   Exposure mg/     MOE3
                                                                                              kg/day     mg/kg/day      kg/day
---------------------------------------------------------------------------------------------------------------------------------------------
U.S. population/adults oral                                              3.8          100     0.008145           NA           NA          470
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population/adults dermal                                            100          100           NA           NA        0.079         1300
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth (13-19 years old)                                                  3.8          100     0.005969           NA           NA          640
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-2 years old) oral                                            3.8          100     0.023704      0.00642           NA          130
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-2 years old) dermal                                          100          100           NA           NA        0.130          770
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-49 years old)                                                3.8          100     0.006396           NA           NA          590
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 The LOC MOE is 100, based on inter-species and intra-species safety factors totaling 100.
2 Oral Residential Exposure = Incidental Oral exposure from all possible sources.
3 Aggregate MOE = NOAEL / (All exposures appropriate to the assessment).

    4. Intermediate-term risk. An intermediate-term aggregate risk 
assessment (1 to 6 months of exposure to trifloxystrobin residues from 
food, drinking water, and residential pesticide uses) is not expected 
to occur based on the short soil half-life (about 2 days). Therefore, 
an intermediate-term aggregate risk assessment was not performed.
    5. Aggregate cancer risk for U.S. population. EPA determined that 
trifloxystrobin should be classified as a ``Not Likely Human 
Carcinogen.'' EPA does not expect trifloxystrobin to pose a cancer 
risk.
    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, and to infants and children from aggregate 
exposure to trifloxystrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate Gas Liquid Chromatography/Nitrogen Phosphorous (GC/NPD) 
method, Method AG-659A, is available for enforcing tolerances for the 
combined residues of trifloxystrobin and the free form of its acid 
metabolite (CGA-321113) in plant and livestock commodities. This method 
was validated by the and forwarded to FDA for inclusion in PAM Vol. II.
    In the current soybean field trials and processing study, residues 
of trifloxystrobin and CGA-321113 were determined using a LC/MS/MS 
method (Bayer Report No. 200177), which was previously developed for 
the analysis of residues in tomatoes and peppers. This method uses the 
same extraction procedures as the current tolerance enforcement method, 
but uses different clean up procedures and detection by LC/MS/MS. This 
method is adequate for collecting residue data on trifloxystrobin and 
CGA-321113 in soybean commodities.

B. International Residue Limits

    There are currently no Codex, Canadian, or Mexican MRL's or 
tolerances for trifloxystrobin on soybeans. Therefore, international 
harmonization is not an issue for this petition.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
trifoxystrobin, (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-trifluoromethylphenyl) 
ethylideneaminooxymethyl)phenyl)acetic acid)) in or on soybean, forage 
at 10.0 ppm, soybean, hay at 25.0 ppm, and soybean, seed at 0.08 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). 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., or 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). 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); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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

[[Page 55319]]

Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, 
section 12(d) (15 U.S.C. 272 note). 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. In addition, 
the Agency has determined that this action will not have a substantial 
direct effect on States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
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: September 14, 2006.
Lois Rossi,
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. Section 180.555 is amended by alphabetically adding commodities to 
the table in paragraph (a) to read as follows:


Sec.  180.555  Trifloxystrobin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Soybean, forage............................................         10.0
Soybean, hay...............................................         25.0
Soybean, seed..............................................         0.08
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 06-8060 Filed 9-21-06; 8:45 am]

BILLING CODE 6560-50-S
