FR Doc 04-13146

[Federal Register: June 10, 2004 (Volume 69, Number 112)]
[Rules and Regulations]
[Page 32457-32465]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10jn04-10]

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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: banks.melody@epa.gov.

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
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
870.5550 Unscheduled DNA synthesis Fenpyroximate was negative.
(rat primary hepatocyte) The positive control induced the
appropriate response.
----------------------------------------------------------------------------------------------------------------
870.6100 Acute delayed NOAEL >= 5,000 mg/kg/day
neurotoxicity (hen) LOAEL was not observed
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

[[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%
----------------------------------------------------------------------------------------------------------------

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.

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* 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 tompkins.jim@epa.gov,
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: opp-docket@epa.gov/.
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:

(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