FR Doc 06-2978

[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