Document ID: EPA-HQ-OPP-2005-0299-0005
Agency: epa
Document Type: Rule
Title: Trifloxystrobin; Pesticide Tolerance
Posted Date: 2006-03-29T05:00Z

[Federal Register: March 29, 2006 (Volume 71, Number 60)]
[Rules and Regulations]               
[Page 15597-15604]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr06-12]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0299; FRL-7759-9]

 
Trifloxystrobin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined 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-trifluoromethylphenyl)-ethylideneaminooxymethyl]-
phenyl]acetic acid) pesticide petition (PP 4F6892) in or on corn, 
sweet, kernel plus cob with husks removed at 0.04 parts per million 
(ppm), corn, sweet, forage at 0.6 ppm, corn, sweet, stover at 0.25 ppm, 
and corn, sweet, cannery waste at 0.6 ppm; (PP 3E6769) oat, forage at 
0.3 ppm, oat, grain at 0.05 ppm, oat, hay at 0.3 ppm, oat, straw at 5.0 
ppm, barley, grain at 0.05 ppm, barley, hay at 0.3 ppm, barley, straw 
at 5.0 ppm. Bayer Crop Science 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 March 29, 2006. Objections and 
requests for hearings must be received on or before May 30, 2006.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. 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 on the

[[Page 15598]]

http://www.regulations.gov web site. (EDOCKET, EPA's electronic public docket 

and comment system was replaced on November 25, 2005, by an enhanced 
Federal-wide electronic docket management and comment system located at 
http://www.regulations.gov/. Follow the on-line instructions.) Although 

listed in the index, some information is not publicly available, i.e., 
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 either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. 
Bell St., Arlington, VA. This 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 (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6129; e-mail 
address:whitehurst.janet@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 underFOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 

access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings athttp://www.epa.gov/fedrgstr/.
 A frequently updated electronic version of 40 CFR part 180 

is available on E-CFR Beta Site Two athttp://www.gpoaccess.gov/ecfr/.

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 pesticide petition (PP 
4F6892) by Bayer Crop Science, P.O. Box 12014, 2T.W. Alexander Drive, 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
180.555 be amended by establishing a tolerance for combined residues of 
the fungicide trifloxystrobin (benzeneacetic acid, (E,E)-[alpha]-
(methoxyimino)-2-[[[[1-[3-(trifluoromethyl) 
phenyl]ethylidene]amino]oxy]methyl]-, methylester) and the free form of 
its acid metabolite CGA-321113 ((E,E)-methoxyimino-[2-[1-(3-
trifluoromethylphenyl)- ethylideneaminooxymethyl]-phenyl]acetic acid), 
(PP 4F6892) in or on corn, sweet, kernel plus cob with husks removed at 
0.04 ppm, corn, sweet, forage at 0.6 ppm, corn, sweet, stover at 0.25 
ppm, and corn, sweet, cannery waste at 0.6 ppm. That notice included a 
summary of the petition prepared by Bayer Crop Science, the registrant. 
There were no comments received in response to the notice of filing.
    In the Federal Register of January 18, 2006 (71 FR 2929) (FRL-7756-
9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petition (PP 
3E6769) by the Interregional Research Project Number 4 (IR-4), 681 U. 
S. Highway 1 South, North Brunswick, NJ 08902-3390. The 
petition requested that 40 CFR 180.555 be amended by establishing a 
tolerance for residues of the fungicide trifloxystrobin, in or on the 
following raw agricultural commodities: barley, grain at 0.05 parts per 
million (ppm); barley, hay at 0.3 ppm; barley, straw at 5.0 ppm; oat, 
forage at 0.3 ppm; oat, grain at 0.05 ppm; oat, hay at 0.3 ppm; and 
oat, straw at 5.0 ppm. That notice included a summary of the petition 
prepared by IR-4. There were no comments received on 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 aggregate exposure to the pesticide chemical residue. . . 
.''

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 (PP 4F6892) in or on corn, sweet, kernel 
plus cob with husks removed at 0.04 ppm, corn, sweet, forage at 0.6 
ppm, corn, sweet, stover at 0.25 ppm, and corn, sweet, cannery waste at 
0.6 ppm; (PP 3E6769) oat, forage at 0.3 ppm, oat, grain at 0.05 ppm, 
oat, hay at 0.3 ppm, oat, straw at 5.0 ppm, barley, grain at 0.05 ppm, 
barley, hay at 0.3 ppm, barley, straw at 5.0 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

[[Page 15599]]

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 and CGA-
321113 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 May 22, 2002 (67 FR 35915)(FRL-
7178-6).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(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 lowest dose at which adverse effects of 
concern are identified (the LOAEL) 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.
    A summary of the toxicological endpoints for trifloxystrobin and 
CGA-321113 used for human risk assessment is shown in Table 1 of this 
unit:

             Table 1.--Summary of Toxicological Endpoints for Use in Human Health Risk Assessment\1\
----------------------------------------------------------------------------------------------------------------
                                                                  Special FQPA SF and
          Exposure Scenario               Dose Used in Risk       Level of Concern for   Study and Toxicological
                                            Assessment, UF          Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (females 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 uponincreased
                                                                                          fetal skeletal
                                                                                          anomalies
----------------------------------------------------------------------------------------------------------------
Acute Dietary General Population       There were no
 including infants and children         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-Rat
                                       UF = 100...............  FQPA SF = 0.038 mg/kg/   LOAEL = 55.3 mg/kg/day,
                                       Chronic RfD = 0.038 mg/   day.                     based upon decreases
                                        kg/day.                                           in body weight, body
                                                                                          weight gains, reduced
                                                                                          food consumption and
                                                                                          histopathological
                                                                                          lesions in the liver,
                                                                                          kidneys and spleen
----------------------------------------------------------------------------------------------------------------
Short- (1-30 days) and Intermed-       Offspring                LOC for MOE = 100        Two-Generation
 Term(1- 6 months) Oral                NOAEL = 3.8 mg/kg/day..  (Residential, includes    reproduction study-Rat
                                                                 the FQPA SF).           LOAEL = 55.3 mg/kg/day,
                                                                                          based upon reduced pup
                                                                                          body weights during
                                                                                          lactation
----------------------------------------------------------------------------------------------------------------
Short- (1-30 days) and Intermed-       Dermal study             LOC for MOE = 100        28-Day Dermal Toxicity
 Term(1-6 months) Dermal               NOAEL = 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-Rat
                                        absorption rate = 33%)  LOC for MOE = 100......  LOAEL = 55.3 mg/kg/day,
                                                                (Residential, includes    based upon decreases
                                                                 theFQPA SF).             in body weight, body
                                                                                          weight gains, reduced
                                                                                          food consumption and
                                                                                          histopathological
                                                                                          lesions in the liver,
                                                                                          kidneys and spleen
----------------------------------------------------------------------------------------------------------------
Short- (1-30 days),Intermed-(1- 6      Oral study NOAEL = 3.8   LOC for MOE = 100        Two-Generation
 months) and Long-Term (> 6             mg/kg/day               (Occupational).........   reproduction study-Rat
 months)Inhalation                     (inhalation absorption   LOC for MOE = 100......  LOAEL = 55.3 mg/kg/day,
                                        rate = 100%).           (Residential, includes    based upon decreases
                                                                 theFQPA SF).             in body weight,body
                                                                                          weight gains, reduced
                                                                                          food consumption and
                                                                                          histopathological
                                                                                          lesions in the liver,
                                                                                          kidneys and spleen
----------------------------------------------------------------------------------------------------------------

[[Page 15600]]

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 and CGA-321113 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 in the toxicological studies for 
trifloxystrobin and CGA-321113 applicable only to Females 13-49 years 
old. 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: One 
hundred percent of proposed and registered crops are assumed treated 
with trifloxystrobin (100% CT) and tolerance-level residues were used 
in the analysis. The acute dietary endpoint (increased fetal incidence 
of fused sternebrae) is only applicable to the population subgroup 
females 13-49 years old. An acute dietary endpoint for the general 
population including infants and children was not identified. The 
highest estimate for acute drinking water exposure, 92 ppb, was used in 
the analysis.
    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 CSFII, and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the chronic exposure 
assessments: One hundred percent of proposed and registered crops are 
assumed treated with trifloxystrobin (100% CT) and tolerance-level 
residues were used in the analysis. The chronic dietary endpoint 
applies to all population subgroups including infants and children. The 
highest estimate for chronic drinking water exposure, 140 ppb, was used 
in the analysis.
    iii. Cancer. EPA determined that trifloxystrobin should be 
classified as a ``Not Likely Human Carcinogen.'' Due to the 
classification, no cancer exposure assessment was performed.
    2. Dietary exposure from drinking water. Based on the FIRST, and 
Screening Concentrations in Groundwater (SCI-GROW) models, the 
estimated environmental concentrations (EECs) of trifloxystrobin and 
CGA-321113 for acute exposures are estimated to be 92 parts per billion 
(ppb) for surface water and 34 ppb for ground water. The EECs for 
chronic exposures are estimated to be 50 ppb for surface water and 3.4 
ppb for ground 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 use on the following 
residential non-dietary sites: Turfgrass and ornamentals. The risk 
assessment was conducted using the following residential exposure 
assumptions: There is potential for dermal (adults and children) and 
incidental oral exposure (children only) during postapplication 
activities. The following postapplication exposure scenarios resulting 
from lawn treatment were assessed:
    a. Dermal exposure from pesticide residues on lawns,
    b. Incidental non-dietary ingestion of pesticide residues on lawns 
from hand-to-mouth transfer,
    c. Incidental non-dietary ingestion of residues from object-to-
mouth activities (pesticide-treated turfgrass), and
    d. Incidental non-dietary ingestion of soil from pesticide-treated 
residential areas. Postapplication 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.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. 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 athttp://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

[[Page 15601]]

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 
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 (SF) value based on the use of traditional uncertainty factors 
and/or special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. The EPA concluded that the 
toxicology database was complete for Food Quality Protection Act (FQPA) 
purposes and that there are no residual uncertainties for prenatal/
postnatal toxicity.
    3. Conclusion. EPA determined that the 10X SF to protect infants 
and children should be reduced to 1X. The FQPA, SF is reduced because:
    i. There is a complete toxicity data base for trifloxystrobin.
    ii. 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;
    iii. EPA determined that a developmental neurotoxicity study in 
rats is not required;
    iv. Although an acute neurotoxicity study is required (the 
submitted study was unacceptable), the lack of an acute neurotoxicity 
study does not impact EPA's ability to make an FQPA safety factor 
decision because upgrading the study would not result in a lower NOAEL 
than what is present for the acute RfD;
    v. The acute and chronic dietary food exposure assessments utilize 
existing and proposed tolerance level residues and 100% crop treated 
information for all commodities. By using these screening-level 
assessments, actual exposures/risks will not be underestimated;
    vi. 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
    vii. The residential postapplication assessment is based upon the 
residential 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 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 acute risk estimate for females 13-49 years, resulting 
from aggregate exposure to trifloxystrobin in food and drinking water 
is below Health Effects Division (HED)'s level of concern. The food and 
water exposure estimates for females 13-49 yrs old is < 1% aPAD.
    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 chronic population adjusted doses (cPADs) 
are all below 100%). The exposure to the U.S. population was 21% cPAD 
and the most highly exposed subgroup, children 1-2 yrs old, at 62% 
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. The short-term aggregate risk assessment 
estimates risks likely to result from 1- to 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 
possible to combine dietary/incidental oral exposure with dermal 
exposure.
    A short-term risk assessment was not required for adults, because 
no incidental oral exposure is expected for adults. A short-term risk 
assessment is required for infants and children because there are 
residential postapplication 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. Table 2 summarizes short-term aggregate risk from incidental oral 
and dietary food and water sources for children.

                                     Table 2.--Short-Term Aggregate Risk (Food, Water and Incidental Oral Exposure)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                Short-Term Scenario
                                                          ----------------------------------------------------------------------------------------------
                        Population                                                                 Average Food +      Residential       Aggregate MOE
                                                            NOAEL mg/kg/day       LOC MOE\1\     Water Exposure mg/ Exposure\2\ mg/kg/     (food and
                                                                                                       kg/day              day          residential)\3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population                                                          3.8                100           0.008030                N/A                470
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth (13-19 years)                                                      N/A                N/A           0.005867                N/A                650
--------------------------------------------------------------------------------------------------------------------------------------------------------
All Infants (>1 year)                                                    N/A                N/A           0.021883            0.00642                130
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-2 years)                                                     N/A                N/A           0.023429            0.00642                130
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 15602]]

Females (13-49 years old)                                                N/A                N/A           0.006312                N/A                600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The level of concern (LOC) MOE is 100, based on inter- and intra-species safety factors totaling 100.
\2\ Residential Exposure = Incidental Oral exposure from all possible sources. No residential oral exposure is expected for adults.
\3\ Aggregate MOE = NOAEL (3.8 mg/kg/day) / (Avg Food Exposure + Residential Exposure).

    As shown above in Table 2, the aggregate short-term MOE for all 
infants less than 1 yr old and children 1-2 years old at 130 does not 
exceed EPA's level of concern, a MOE of 100. It should be noted that 
the maximum surface water concentration, which is included in the 
average food and water exposure, results from the use on rice, is 
considered to be an overestimate of the true value found in the 
environment due to the intricacies of the drinking water model, and 
should be viewed as very conservative. Further, EPA considers the 
turfgrass estimate (50 ppb) to be a more realistic estimate of drinking 
water residues. EPA does not consider short-term aggregate risk for 
children to be a concern.
    4. Intermediate-term risk. An intermediate-term aggregate risk (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).
    5. Aggregate cancer risk for U.S. population. Trifloxystrobin is 
not expected 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

    Adequate enforcement methodology (gas chromatography method using 
nitrogen/phosphorus detector) 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

    The Codex Alimentarius Comission has established maximum residue 
limits (MRLs) for trifloxystrobin in/on corn and barley grain. The U.S. 
tolerances are not compatible with the Codex MRLs because the U.S. and 
Codex tolerance expressions are different. The current U.S. tolerance 
for corn grain (i.e., field corn) is set at 0.05 ppm, while we are 
proposing a tolerance of 0.04 ppm for sweet corn. Both of these U.S. 
tolerances are not compatible with the Codex MRL for maize, because the 
U.S. and Codex tolerance expressions are different. The U.S. and Codex 
residue definitions differ in that the U.S. tolerance includes the acid 
metabolite whereas the Codex does not. Although non-quantifiable 
residues of each compound were observed in both the North American and 
European field trials, the U.S. tolerance on sweet corn (0.04 ppm) is 
being established at twice the level of Codex MRL for maize (0.02 ppm). 
For barley, the European GAP use rate is almost four times the U.S. use 
rate, which partly explains the much higher Codex MRL (0.5 ppm).
    The Canadian MRLs have been established for wheat, oats and barley 
at 0.05 ppm. The U.S. tolerances for barley and oats are being 
established at 0.05 ppm and the wheat tolerance has already been 
established at 0.05 ppm. Harmonization is thus not an issue.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
trifloxystrobin and CGA-321113, (PP 4F6892) in or on corn, sweet, 
kernel plus cob with husks removed at 0.04 ppm, corn, sweet, forage at 
0.6 ppm, corn, sweet, stover at 0.25 ppm, and corn, sweet, cannery 
waste at 0.6 ppm; (PP 3E6769) oat, forage at 0.3 ppm, oat, grain at 
0.05 ppm, oat, hay at 0.3 ppm, oat, straw at 5.0 ppm, barley, grain at 
0.05 ppm, barley, hay at 0.3 ppm, barley, straw at 5.0 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by 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. Although the procedures in those regulations require 
some modification to reflect the amendments made to FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA provides essentially the same process for persons to 
``object'' to a regulation for an exemption from the requirement of a 
tolerance issued by EPA under new section 408(d) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. However, the period 
for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and 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 May 30, 
2006.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issue(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.

[[Page 15603]]

    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number EPA-HQ-OPP-2005-0299, to: Public 
Information and Records Integrity Branch, Information Technology and 
Resources Management Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. In person or by courier, bring a copy to the 
location of the PIRIB described in ADDRESSES. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. 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 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.

VIII. 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.

[[Page 15604]]

    Dated: March 20, 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) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Barley, grain........................................               0.05
Barley, hay..........................................                0.3
Barley, straw........................................                5.0
                                * * * * *
Corn, sweet, cannery waste...........................                0.6
Corn, sweet, forage..................................                0.6
Corn, sweet, kernel plus cob with husks removed......               0.04
Corn, sweet, stover..................................               0.25
                                * * * * *
Oat, forage..........................................                0.3
Oat, grain...........................................               0.05
Oat, hay.............................................                0.3
Oat, straw...........................................                5.0
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 06-2978 Filed 3-28-06; 8:45 am]

BILLING CODE 6560-50-S