[Federal Register Volume 69, Number 112 (Thursday, June 10, 2004)]
[Rules and Regulations]
[Pages 32457-32465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-13146]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0174; FRL-7362-9]


Fenpyroximate; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of fenpyroximate and its metabolites in or on cotton gin byproducts; 
cotton undelinted seed; fruit pome group 11; grape; liver and kidney of 
cattle, goat, horse, and sheep; meat, fat, and meat byproducts 
(excluding liver and kidney) of cattle, goat, horse, and sheep; and 
milk. The Interregional Research Project Number 4 and Nichino America, 
Incorporated requested these tolerances 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 June 10, 2004. Objections and 
requests for hearings, identified by docket ID number OPP-2004-0174, 
must be received on or before August 9, 2004.

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 
ID number OPP-2004-0174. All documents in the docket are listed in the 
EDOCKET index at http://www.epa.gov/edocket/. Although listed in the 
index, some information is not publicly available, i.e., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either electronically in EDOCKET or in hard copy at the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. 
Attention: Docket ID Number OPP-2004-0174. 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: Melody Banks, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone 
number: (703) 305-5413; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and 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 processing (NAICS 3110), e.g., agricultural workers; 
farmers; greenhouse, nursery, and floriculture workers; ranchers; 
pesticide applicators.
     Pesticide manufacturers (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document 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 at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of July 11, 2003 (68 FR 41345) (FRL-7314-
8), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
pesticide petitions (PP 3E6519) by Interregional Research Project 
Number 4, 681 U.S. Highway No. 1 South, North Brunswick, NJ 08902 and 
(PP 2F6437) by Nichino America, Incorporated, 4550 New Linden Hill Rd., 
Wilmington, DE 19808. That notice included a summary of the petition 
prepared by Nichino America, Inc., the registrant. There were no 
comments received in response to the notice of filing.
    The petitions requested that 40 CFR 180.566 be amended by 
establishing tolerances for combined residues of the insecticide 
fenpyroximate, benzoic acid, 4-[[[(E)-[1,3-dimethyl-5-phenoxy-1H-
pyrazol-4 yl)methylene]amino]oxy]methyl]-, 1,1-dimethylethyl ester, in 
or on fruit pome group 11 at 0.3 parts per million (ppm) (PP 3E6519); 
apple fruit at 0.8 ppm, grape at 0.3 ppm, cotton undelinted seed at 0.1 
ppm, cotton gin byproducts at 9.0 ppm, milk at 0.01 ppm, liver and 
kidney of cattle, goat, hog, horse, and sheep at 0.50 ppm, and meat, 
fat, and meat byproducts (excluding liver and

[[Page 32458]]

kidney) of cattle, goat, hog, horse, and sheep at 0.02, 0.08, and 0.01 
ppm, respectively (PP 2F6437).
    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....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

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 tolerances for combined residues of 
fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-
pyrazol-4-yl)methylene] amino]oxy]methyl]benzoate and its Z-isomer, 
(Z)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene] amino]oxy]methyl]benzoate on fruit pome group 11 at 0.40 
ppm, grape at 1.0 ppm, cotton undelinted seed at 0.10 ppm, cotton gin 
byproducts at 10.0 ppm; for combined residues of fenpyroximate and its 
metabolites ((E)-4-[(1,3-dimethyl-5-phenoxypyrazol-4-yl)-
methyleneaminooxymethyl benzoic acid and (E)-1,1-dimethylethyl-2-
hydroxyethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl) 
methylene]amino]oxy]methyl] benzoate, calculated as the parent compound 
in milk at 0.015 ppm, meat, fat, and meat byproducts (excluding liver 
and kidney) of cattle, goat, horse, and sheep at 0.03 ppm; and for 
combined residues of fenpyroximate and its metabolite ((E)-4-[(1,3-
dimethyl-5-phenoxypyrazol-4-yl)-methyleneaminooxymethyl benzoic acid, 
calculated as the parent compound in kidney and liver of cattle, goat, 
horse and sheep at 0.25 ppm. EPA's assessment of exposures and risks 
associated with establishing these tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by fenpyroximate are 
discussed in Table 1 of this unit as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

                                Table 1.--Subchronic, Chronic, and Other Toxicity
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             Guideline No.                       Study type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity        NOAEL = 1.5 milligrams/kilogram/day (mg/kg/
                                          (rodent)                    day) (20 ppm)
                                                                     LOAEL = 7.4 mg/kg/day (100 ppm) for rats,
                                                                      based on decreased body weight gains in
                                                                      both sexes.
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870.3150                                 90-Day oral toxicity        NOAEL < 2 mg/kg/day
                                         (non-rodent)..............  LOAEL= 2 mg/kg/day, based on slight
                                                                      bradycardia and an increased incidence of
                                                                      diarrhea in both sexes; and reduced food
                                                                      consumption, body weight, body weight
                                                                      gain, emaciation, and torpor in females.
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870.3200                                 21-Day dermal toxicity      NOAEL < 1,000 mg/kg/day highest dose tested
                                          (rat)                       (HDT)
                                                                     LOAEL = 1,000 mg/kg/day (the limit dose and
                                                                      the only dose tested) based on decreased
                                                                      body weight gains in males and females and
                                                                      increased liver weights in the females.
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870.3200                                 21-Day dermal toxicity      NOAEL = 300 mg/kg/day
                                          (rat)                      LOAEL = 1,000 mg/kg/day (limit dose) based
                                                                      on clinical signs in the females,
                                                                      decreased body weights, body weights
                                                                      gains, and food consumption in both sexes,
                                                                      increased absolute liver weights and a
                                                                      possible increase in hepatocellular
                                                                      necrosis in the females.
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870.3700                                 Prenatal developmental      Maternal NOAEL = 5 mg/kg/day
                                          toxicity (rodent)          LOAEL = 25 mg/kg/day based on marginal
                                                                      decrease in body weight gain and food
                                                                      consumption.
                                                                     Developmental NOAEL = 5 mg/kg/day
                                                                     LOAEL = 25 mg/kg/day based on increased
                                                                      incidence of additional thoracic ribs.
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870.3700                                 Prenatal developmental      Maternal NOAEL = 5 mg/kg/day
                                          (rabbit)                   LOAEL > 5 mg/kg/day
                                                                     Developmental NOAEL = 5 mg/kg/day
                                                                     LOAEL > 5 mg/kg/day
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[[Page 32459]]

 
870.3800                                 Reproduction and fertility  Parental/Systemic NOAEL = 1.99 mg/kg/day
                                          effects (rat)               for males 2.44 mg/kg/day for and females
                                                                     LOAEL = 6.59 and 8.60 mg/kg/day for males
                                                                      and females, respectively, based on
                                                                      decreased body weights during the
                                                                      premating period
                                                                     Reproductive NOAEL = 6.59 and 8.60 mg/kg/
                                                                      day for males and females, respectively
                                                                     LOAEL was not established
                                                                     Offspring NOAEL = 2.44 mg/kg/day
                                                                     LOAEL = 8.60 mg/kg/day, based on decreased
                                                                      lactational weight gain in both
                                                                      generations of pups
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity (dog)      NOAEL = 5 mg/kg/day
                                                                     LOAEL = 15 mg/kg/day in both sexes, based
                                                                      on diarrhea, bradycardia, decrease
                                                                      cholesterol, body weight gain, and food
                                                                      consumption (males); vomiting, diarrhea,
                                                                      excess salivation, and decrease
                                                                      cholesterol in females.
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870.4200                                 Carcinogenicity (mice)      NOAEL = Males: 2.4 mg/kg/day; Females: 2.5
                                                                      mg/kg/day
                                                                     LOAEL = Males: 9.5 mg/kg/day; Females: 10
                                                                      mg/kg/day based on decreased body weights
                                                                      and food consumption.
                                                                     No evidence of carcinogenicity.
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870.4300                                 Combined chronic/           NOAEL = Males: 0.97 mg/kg/day; Females:
                                          carcinogenicity (rat)       1.16 mg/kg/day
                                                                     LOAEL = Males: 3.08 mg/kg/day; Females:
                                                                      3.79 mg/kg/day based on decreased mean
                                                                      body weight gain.
                                                                     No evidence of carcinogenicity.
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870.5100                                 Bacterial reverse mutation  At limit concentration(5,000 [mu]g/plate)
                                                                      inhibition of growth was observed in
                                                                      strains TA98, TA1537, TA1538, and WP2uvrA.
                                                                      The positive controls induced the
                                                                      appropriate responses in the corresponding
                                                                      strains. There was no evidence of induced
                                                                      mutant colonies over background.
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870.5300                                 In vitro mammalian cell     Not cytotoxic up to 330 [mu]g/ml, the limit
                                          gene mutation               of solubility. There was no evidence of
                                                                      mutagenic effect at any dose level with or
                                                                      without metabolic activation. The positive
                                                                      controls induced the appropriate response.
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870.5375                                 In vitro mammalian          Tested up to limit of solubility (up to 330
                                          chromosome aberration       [mu]g/ml). For metaphase analysis, the
                                          (helacells)                 highest concentration (20 [mu]g/ml)
                                                                      produced moderate toxicity (mitotic index
                                                                      57% of solvent control). Two lower
                                                                      concentrations produces mitotic indices
                                                                      25% and 12.5% of the high concentration.
                                                                      Positive controls induced the appropriate
                                                                      response. The results of this study
                                                                      provide sufficient evidence to consider
                                                                      NNI-850 negative in this assay.
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870.5395                                 Mammalian micronucleus      There was suggestive evidence that NNI-850
                                          (mouse)                     was cytotoxic to the target cell at the
                                                                      highest dose level. The positive control
                                                                      induced significant increases in
                                                                      micronucleated polychromatic erythrocytes
                                                                      (MPCEs). There was no significant increase
                                                                      in the frequency of MPCEs in bone marrow
                                                                      after any NNI-850 treatment time.
                                                                      Fenpyroximate is considered negative in
                                                                      this micronucleus assay.
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870.5500                                 DNA damage/repair REC       Did not cause any inhibitory zone in either
                                          assay                       strain at any dose level in the presence
                                                                      or absence of metabolic activation. The
                                                                      negative and positive controls induced the
                                                                      appropriate responses.
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870.5550                                 Unscheduled DNA synthesis   Fenpyroximate was negative.
                                          (rat primary hepatocyte)   The positive control induced the
                                                                      appropriate response.
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870.6100                                 Acute delayed               NOAEL >= 5,000 mg/kg/day
                                          neurotoxicity (hen)        LOAEL was not observed
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870.7485                                 Metabolism and              The majority of the radioactivity from the
                                          pharmacokinetics (rat)      single and repeated low doses was excreted
                                                                      in the feces within 24 hours of dosing. In
                                                                      contrast, fecal excretion of the majority
                                                                      of the high dose was delayed until 96-144
                                                                      hours, and at 24 hours the major portion
                                                                      of the single high dose (53.4-63.9%)
                                                                      remained in the stomach contents. The
                                                                      maximum concentration in blood (at the
                                                                      maximum time (tmax)) was reached at 7-11
                                                                      hours following a single low dose compared
                                                                      with 29-101 hours after a single-high
                                                                      dose. The low doses were eliminated from
                                                                      blood within 96 hours, whereas the high
                                                                      dose persisted through 168 hours.
                                                                     A total of 20 metabolites, each accounting
                                                                      for <10% of the dose, were characterized
                                                                      from excreta (urine and feces) of low
                                                                      dosed rats.
                                                                     The preponderance of metabolites and low
                                                                      levels of parent in the feces at the 2 mg/
                                                                      kg dose indicates absorption from the
                                                                      digestive tract, extensive metabolism by
                                                                      the liver, and biliary excretion of the
                                                                      low dose (2 mg/kg).
                                                                     The high dose of 400 mg/kg causes as a
                                                                      toxic effect delayed excretion and
                                                                      decreased absorption and metabolism.
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[[Page 32460]]

 
870.7600                                 Dermal penetration (rat)    Mean absorption based on urinary/fecal
                                                                      excretion, blood, carcass, and cage wash
                                                                      ranged from 0 to 5.3% (0.0 to 5.3% low
                                                                      dose, 0.5 to 2.5% mid dose and 0.52 to
                                                                      1.5% high dose).
                                                                     Dermal absorption factor is 5%
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B. Toxicological Endpoints

    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. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factors 
(SF) is retained due to concerns unique to the FQPA, this additional 
factor is applied to the RfD by dividing the RfD by such additional 
factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is 
a modification of the RfD to accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for fenpyroximate used for human risk assessment is shown in 
Table 2 of this unit:

    Table 2.--Summary of Toxicological Dose and Endpoints for Fenpyroximate for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and level of
           Exposure scenario              Dose used in risk         concern for risk     Study and toxicological
                                            assessment, UF             assessment                effects
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Acute dietary                          NOAEL = 5.0 mg/kg/day    FQPA SF = 1X             Prenatal Developmental-
Females 13-49 years of age...........  UF = 100...............  aPAD = acute RfD/FQPA     Toxicity Study--rat
                                       Acute RfD = 0.05 mg/kg/   SF.                     LOAEL = 25 mg/kg/day
                                        day.                    = 0.05 mg/kg/day.......   based on increase in
                                                                                          the fetal incidence of
                                                                                          additional thoracic
                                                                                          ribs.
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL= 0.97 mg/kg/day    FQPA SF = 1X             Combined Oral Chronic
All populations......................  UF = 100...............  cPAD = chronic RfD/FQPA   Toxicity/
                                       Chronic RfD = 0.01 mg/    SF.                      carcinogenicity Study--
                                        kg/day.                 = 0.01 mg/kg/day.......   rat
                                                                                         LOAEL = 3.1 mg/kg/day
                                                                                          based on decreased
                                                                                          body weights,
                                                                                          accompanied by reduced
                                                                                          food efficiency and a
                                                                                          slight decrease in
                                                                                          mean food consumption.
 
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.566) for the combined residues of fenpyroximate 
and its metabolites, in or on a variety of raw agricultural 
commodities. Time-limited tolerances have been established for imported 
wine grapes and imported hops. Risk assessments were conducted by EPA 
to assess dietary exposures from fenpyroxymate in food as follows:
    i. Acute exposure. Acute dietary 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 one day 
or single exposure. In conducting this acute dietary risk 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: 
Tolerance-level residues and 100% crop treated information for all 
registered and proposed uses of fenpyroximate were used to conduct an 
unrefined acute dietary-exposure assessment for females 13-49 years 
old. The acute dietary-exposure estimate for females 13-49

[[Page 32461]]

years old represents 5% of the aPAD and is below EPA's level of 
concern. Since an effect of concern attributable to a single dose in 
toxicity studies was not identified for the general U.S. population, an 
acute dietary-exposure assessment was not performed for this 
population.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment EPA used DEEM-FCID\TM\ which incorporates food consumption 
data as reported by respondents in CSFII and accumulated exposure to 
the chemical for each commodity. The following assumptions were made 
for the acute exposure assessments: Tolerance-level residues and 100% 
crop treated information for all registered and proposed uses of 
fenpyroximate were used to conduct an unrefined, Tier 1 chronic 
dietary-exposure assessment for the general U.S. population and various 
population subgroups. The chronic dietary-exposure estimates range from 
4% to 29% of the cPAD. These estimates are below EPA's level of concern 
The most highly-exposed population subgroup is children 1-2 years old 
at 29% cPAD.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for fenpyroximate in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of fenpyroximate.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) to estimate pesticide concentrations in surface 
water and Sreening Concentration in Groundwater (SCI-GROW), which 
predicts pesticide concentrations in groundwater. In general, EPA will 
use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) 
for a screening-level assessment for surface water. The GENEEC model is 
a subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. GENEEC incorporates a farm pond scenario, 
while PRZM/EXAMS incorporate an index reservoir environment in place of 
the previous pond scenario. The PRZM/EXAMS model includes a percent 
crop area factor as an adjustment to account for the maximum percent 
crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to fenpyroximate they are 
further discussed in the aggregate risk sections in Unit E.
    Based on the PRZM/EXAMS and SCI-GROW models the EECs of 
fenpyroximate for acute exposures are estimated to be 1.5 parts per 
billion (ppb) for surface water and <0.006 ppb for ground water. The 
EECs for chronic exposures are estimated to be 0.13 ppb for surface 
water and <0.006 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).
    Fenpyroxymate is not registered for use on any sites that would 
result in residential exposure.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether fenpyroximate has a common mechanism of toxicity with other 
substances. 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 fenpyroximate 
and any other substances and fenpyroximate 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 fenpyroximate has 
a common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see the policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1.In general. Section 408 of FFDCA provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines 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.
    2. Prenatal and postnatal sensitivity. EPA evaluated the potential 
for increased susceptibility of infants and children from exposure to 
fenpyroximate according to the February 2002 OPP 10X guidance document. 
EPA concluded that there are no concerns or residual uncertainties for 
prenatal and postnatal toxicity.
    3. Conclusion. Based on these data, EPA determined that the 10X 
safety factor to protect infants and children should be removed. The 
FQPA factor is removed because:
     There are no concerns or residual uncertainties for pre- 
or postnatal toxicity.
     The toxicological database is complete for the assessment 
of toxicity and susceptibility following pre- and/or postnatal 
exposures. No clinical signs of neurotoxicity or neuropathology were 
observed in the database.
     There are no residual concerns regarding completeness of 
the exposure database.
     The dietary food exposure assessment is Tier 1, screening 
level,

[[Page 32462]]

which is based on tolerance level residues and assumes 100% of all 
crops will be treated with fenpyroximate. By using these screening-
level assessments, actual exposures/risks will not be underestimated.
     The dietary drinking water assessment utilizes water 
concentration values generated by models and associated modeling 
parameters which are designed to provide conservative, health-
protective, high-end estimates of water concentrations which will not 
likely be exceeded.
     There are currently no registered or proposed residential 
uses of fenpyroximate.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water [e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)]. This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by EPA's Office of Water are used to calculate DWLOCs: 2 
liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, OPP will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
fenpyroximate will occupy 5% of the aPAD for females 13-49 years old. 
In addition, there is potential for acute dietary exposure to 
fenpyroximate and its M-1 and M-3 metabolites in drinking water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the aPAD, as shown in Table 3 of this unit:

                     Table 3.--Aggregate Risk Assessment for Acute Exposure to Fenpyroximate
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population subgroup                aPAD (mg/kg/    % aPAD     water EEC    water EEC   Acute DWLOC
                                                     day)        (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old                                 0.05            5          1.5      < 0.006        1,400
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
fenpyroximate from food will utilize 8% of the cPAD for the U.S. 
population, 18% of the cPAD for all infants (< 1 year old) and 29% of 
the cPAD for children 1-2 years old. In addition, there is potential 
for chronic dietary exposure to fenpyroximate in drinking water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD, as shown in Table 4 of this unit:

             Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Fenpyroximate
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population subgroup                cPAD mg/kg/     % cPAD     water EEC    water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                         0.01            8         0.13      < 0.006          320
----------------------------------------------------------------------------------------------------------------
All infants (< 1 year old)                              0.01           18         0.13      < 0.006           82
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old                                  0.01           29         0.13      < 0.006           71
----------------------------------------------------------------------------------------------------------------
Children 3-5 years old                                  0.01           21         0.13      < 0.006           79
----------------------------------------------------------------------------------------------------------------
Children 6-12 years old                                 0.01           10         0.13      < 0.006           90
----------------------------------------------------------------------------------------------------------------
Youth 13-19 years old                                   0.01            4         0.13      < 0.006          290
----------------------------------------------------------------------------------------------------------------
Adults 20-49 years old                                  0.01            6         0.13      < 0.006          330
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old                                 0.01            6         0.13      < 0.006          280
----------------------------------------------------------------------------------------------------------------
Adults 50+ years old                                    0.01            5         0.13      < 0.006          330
----------------------------------------------------------------------------------------------------------------


[[Page 32463]]

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Fenpyroximate is not 
registered for use on any sites that would result in residential 
exposure. Therefore, the aggregate risk is the sum of the risk from 
food and water, which do not exceed the Agency's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Fenpyroximate 
is not registered for use on any sites that would result in residential 
exposure. Therefore, the aggregate risk is the sum of the risk from 
food and water, which do not exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. Fenpyroximate is 
classified as not likely to be carcinogenic to humans; therefore, an 
aggregate cancer risk assessment was not performed.
    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 fenpyroximate residues.

IV. Other Considerations

International Residue Limits

    Codex maximum residue levels (MRLs) are established for residues of 
fenpyroximate per se in/on grapes, apple and cattle commodities. There 
are no established or proposed tolerances for fenpyroximate in or on 
grapes in Canada and Mexico. Harmonization with the Codex MRLs is not 
possible as the U.S. tolerance expressions include additional 
metabolites/isomers.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-
pyrazol-4-yl)methylene] amino]oxy]methyl]benzoate and its Z-isomer, 
(Z)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene] amino]oxy]methyl]benzoate on fruit pome group at 0.40 
ppm, grape at 1.0 ppm, cotton undelinted seed at 0.10 ppm, cotton gin 
byproducts at 10.0 ppm; for combined residues of fenpyroximate and its 
metabolites ((E)-4-[(1,3-dimethyl-5-phenoxypyrazol-4-yl)-
methyleneaminooxymethyl] benzoic acid and (E)-1,1-dimethylethyl-2-
hydroxyethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene]amino]oxy]methyl] benzoate, calculated as the parent 
compound in milk at 0.015 ppm, meat, fat, and meat byproducts 
(excluding liver and kidney) of cattle, goat, horse, and sheep at 0.03 
ppm; and for combined residues of fenpyroximate and its metabolite 
((E)-4-[(1,3-dimethyl-5-phenoxypyrazol-4-yl)-methyleneaminooxymethyl] 
benzoic acid, calculated as the parent compound in kidney and liver of 
cattle, goat, horse, and sheep at 0.25 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by the FQPA, any person 
may file an objection to any aspect of this regulation and may also 
request a hearing on those objections. The EPA procedural regulations 
which govern the submission of objections and requests for hearings 
appear in 40 CFR part 178. Although the procedures in those regulations 
require some modification to reflect the amendments made to FFDCA by 
the 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 OPP-2004-0174 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 August 9, 
2004.
    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.
    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. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. 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 PIRIB for its inclusion in 
the official record that is described in ADDRESSES. Mail your copies, 
identified by docket ID number OPP-2004-0174, to: Public Information 
and Records Integrity Branch, Information Resources

[[Page 32464]]

and Services 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 PIRIB described in ADDRESSES. You may also send an 
electronic copy of your request via e-mail to: [email protected]/. 
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 record 
keeping requirements.

    Dated: May 28, 2004.
James Jones,
Director, 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 180.566 is amended by designating the text of paragraph (a) 
as paragraph (a)(1) and by adding paragraphs (a)(2), (a)(3), and (a)(4) 
to read as follows:


Sec.  180.566  Fenpyroximate; tolerances for residues.

    (a) * * *
    (2) Tolerances are established for residues of the insecticide 
fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl -5-phenoxy-1H-

[[Page 32465]]

pyrazol-4-yl) methylene] amino]oxy]methyl] benzoate and its Z-isomer, 
(Z)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5- phenoxy-1H- pyrazol-4-
yl)methylene] amino]oxy] methyl]benzoate in or on the following 
commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cotton, gin byproducts.....................................           10
Cotton undelinted seed.....................................         0.10
Fruit pome group 11........................................         0.40
Grape......................................................          1.0
Hop\1\.....................................................           10
------------------------------------------------------------------------
 \1\There are no U.S. registrations on hop.

    (3) Tolerances are established for residues of the insecticide 
fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5 -phenoxy-1H-
pyrazol-4-yl) methylene] amino]oxy]methyl] benzoate and its 
metabolites, (E)-4- [(1,3-dimethyl-5- phenoxypyrazol-4-yl)-methylene 
aminooxymethyl]benzoic acid and (E)-1,1-dimethylethyl-2-hydroxyethyl 4- 
[[[[(1,3-dimethyl -5-phenoxy-1H-pyrazol-4-yl) 
methylene]amino]oxy]methyl] benzoate, calculated as the parent compound 
in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................         0.03
Cattle, meat...............................................         0.03
Cattle, meat byproduct (excluding liver and kidney)........         0.03
Goat, fat..................................................         0.03
Goat, meat.................................................         0.03
Goat, meat byproducts (excluding liver and kidney..........         0.03
Horse, fat.................................................         0.03
Horse, meat................................................         0.03
Horse, meat byproducts (excluding liver and kidney)........         0.03
Milk.......................................................        0.015
Sheep, fat.................................................         0.03
Sheep, meat................................................         0.03
Sheep, meat byproducts (excluding liver and kidney.........         0.03
------------------------------------------------------------------------

    (4) Tolerances are established for residues of the insecticide 
fenpyroximate, (E)-1,1-dimethylethyl 4- [[[[(1,3-dimethyl-5-phenoxy-1H-
pyrazol-4-yl) methylene]amino]oxy]methyl] benzoate and its metabolite, 
(E)-4-[(1,3-dimethyl-5-phenoxypyrazol-4-yl)-methylene 
aminooxymethyl]benzoic acid, calculated as the parent compound in the 
following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, kidney.............................................         0.25
Cattle, liver..............................................         0.25
Goat, kidney...............................................         0.25
Goat, liver................................................         0.25
Horse, kidney..............................................         0.25
Horse, liver...............................................         0.25
Sheep, kidney..............................................         0.25
Sheep, liver...............................................         0.25
------------------------------------------------------------------------

* * * * *
[FR Doc. 04-13146 Filed 6-9-04; 8:45 am]
BILLING CODE 6560-50-S