FR Doc 03-23852

[Federal Register: September 17, 2003 (Volume 68, Number 180)]
[Rules and Regulations]
[Page 54386-54394]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se03-12]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0306; FRL-7327-5]

Thiamethoxam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of thiamethoxam and its metabolite in or on imported coffee, pecan,
stone fruit, succulent bean, and sunflower. Syngenta Crop Protection,
Inc. and the Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act (FQPA) of 1996.

DATES: This regulation is effective September 17, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0306,
must be received on or before November 17, 2003.

ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Dani Daniel, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5409; e-mail address: daniel.dani@epa.gov.
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an
agricultural

[[Page 54387]]

producer, food manufacturer, or pesticide manufacturer. Potentially
affected entities may include, but are not limited to:
[sbull] Crop production (NAICS 111)
[sbull] Animal production (NAICS 112)
[sbull] Food manufacturing (NAICS 311)
[sbull] Pesticide manufacturing (NAICS 32532)
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 Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0306. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. 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 at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html/
, a
beta site currently under development.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.

II. Background and Statutory Findings

In the Federal Register of April 2, 2003 (68 FR 16040) (FRL-7298-
7), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, as amended by FQPA (Pub. L. 104-170), announcing the filing of
pesticide petitions (3E06524, 2E06505, 2E06508, 1E06349, and 0F6142) by
IR-4, 681 U.S. Highway 1 South, North Bunswick, NJ 08902-3390
and Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC
27419-8300. That notice included a summary on the petitions prepared by
Syngenta Crop Protection, Inc., the registrant. There were no comments
received in response to the notices of filing.
The petitions requested that 40 CFR 180.565 be amended by
establishing tolerances for the combined residues of the insecticide
thiamethoxam, 3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-
nitro-4H-1,3,5-oxadiazin-4-imine and its metabolite (N-(2-chloro-
thiazol-5-ylmethyl)-N'-methyl-N'-nitro-guanidine), in or on imported
coffee at 0.05 parts per million (ppm) (1E6349), pecan at 0.02 ppm
(0F6142), stone fruit group 12 at 0.5 ppm (2E6505), succulent bean at
0.02 ppm (2E6508), and sunflower at 0.02 ppm (3E6524).
Section 408(b)(2)(A)(i) of the 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 the 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 the 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 the FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances November 26, 1997 (62 FR 62961) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D) of the 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 the FFDCA, for tolerances for the combined residues of
thiamethoxam and its metabolite on imported coffee at 0.05 ppm, pecan
at 0.02 ppm, stone fruit group 12 at 0.5 ppm, succulent bean at 0.02
ppm, and sunflower at 0.02 ppm. EPA's assessment of exposures and risks
associated with establishing the 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 thiamethoxam as
well as the no observed adverse effect level (NOAEL) and the lowest
observed adverse effect level (LOAEL) from the toxicity studies
reviewed are discussed in Unit III.A. of the Federal Register of
November 1, 2002 (67 FR 66561) (FRL-7279-6).

B. Toxicological Endpoints

The dose at which the NOAEL from the toxicology study identified as
appropriate for use in risk assessment is used to estimate the
toxicological level of concern (LOC). However, the 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 intraspecies differences.

[[Page 54388]]

For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where
the RfD is equal to the NOAEL divided by the appropriate UF (RfD =
NOAEL/UF). Where an additional safety factor 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 safty factor.
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 thiamethoxam used for human risk assessment is shown in
the following Table 1:

Table 1.--Summary of Toxicological Dose and Endpoints for Thiamethoxam for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (general population NOAEL = 100 mg/kg/day FQPA SF = 10 Acute mammalian
including infants and children) UF = 100............... aPAD = acute RfD....... neurotoxicity study in
Acute RfD = 1 mg/kg/day FQPA SF = 0.1 mg/kg/day the rat
LOAEL = 500 mg/kg/day
based on treatment-
related neurobehavioral
effects observed in the
FOB and LMA testing
(drooped palpebral
closure, decreased
rectal temperature and
locomotor activity,
increased forelimb grip
strength)
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations) NOAEL = 0.6 mg/kg/day FQPA SF = 10 2-Generation
UF = 100............... cPAD = chronic RfD..... reproduction study
Chronic RfD = 0.006 mg/ FQPA SF = 0.0006 mg/kg/ LOAEL = 1.8 mg/kg/day
kg/day. day. based on increased
incidence and severity
of tubular atrophy in
testes of F1 generation
males
----------------------------------------------------------------------------------------------------------------
Oral non-dietary (all durations) NOAEL = 0.6 mg/kg/day LOC for MOE = 1,000 2-Generation
(Residential).......... reproduction study
LOAEL = 1.8 mg/kg/day
based on increased
incidence and severity
of tubular atrophy in
testes of F1 generation
males
----------------------------------------------------------------------------------------------------------------
Dermal (all durations) Oral study LOC for MOE = 1,000 2-Generation
(Residential)....................... NOAEL = 0.6 mg/kg/day.. (Residential).......... reproduction study
(dermal absorption rate LOC for MOE = 100...... LOAEL = 1.8 mg/kg/day
= 27%). (Occupational)......... based on increased
incidence and severity
of tubular atrophy in
testes of F1 generation
males
----------------------------------------------------------------------------------------------------------------
Inhalation (all durations) Oral study LOC for MOE = 1,000 2-Generation
(Residential)....................... NOAEL = 0.6 mg/kg/day.. (Residential).......... reproduction study
(inhalation absorption LOC for MOE = 100...... LOAEL = 1.8 mg/kg/day
rate = 100%). (Occupational)......... based on increased
incidence and severity
of tubular atrophy in
testes of F1 generation
males
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Likely carcinogen for humans based on increased incidence of
hepatocellular adenomas and carcinomas in male and female mice.
Quantification of risk based on most potent unit risk: Male mouse liver
adenoma and/or carcinoma combined tumor rate. The upper bound estimate of
unit risk, Q1* (mg/kg/day)^-\1\ is 3.77 x 10^-\2\ in human equivalents
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA safty factor refers to any additional safty factor 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 180.565) for the combined residues of thiamethoxam
and its metabolite, in or on a variety of raw agricultural commodities.
Tolerances for thiamethoxam are established on barley, canola, cotton,
sorghum, wheat, tuberous and corm vegetables crop subgroup, fruiting
vegetables crop group, tomato paste, cucurbit vegetables crop group,
pome fruits crop group, field corn forage, field corn stover, sweet
corn stover, field corn grain, popcorn grain, and sweet corn (kernal
and cob with husk removed) milk and the meat and meat by products of
cattle, goats, horses, and sheep. Risk assessments were conducted by
EPA to assess dietary exposures from thiamethoxam in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-

[[Page 54389]]

use pesticide if a toxicological study has indicated the possibility of
an effect of concern occurring as a result of a 1 day or single
exposure. The Dietary Exposure Evaluation Model (DEEM^TM)
with the Food Commodity Intake Database (FCID) analysis evaluated the
individual food consumption as reported by respondents in the U.S.
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII) and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the acute exposure assessments: The residues
of concern for the acute analysis are thiamethoxam and its metabolite.
The assessment assumed that 100% of the registered and proposed crops
were treated and that all treated crops and livestock had residues of
concern at the tolerance level. The general U.S. population and all
population subgroups have exposure and risk estimates which are below
EPA's LOC (i.e., the aPADs are all below 100%). The most highly exposed
subgroup is children 1 to 2 years of age, which utilizes 3% of the
aPAD.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEM^TM with the FCID analysis evaluated the
individual food consumption as reported by respondents in the USDA
1994-1996 and 1998 nationwide CSFII and accumulated exposure to the
chemical for each commodity. The following assumptions were made for
the chronic exposure assessments: The residues of concern for the
chronic analysis are thiamethoxam and its metabolite. The chronic
analysis was based on average field trial residue values as well as
percent crop estimates. The general U.S. population and all population
subgroups have exposure and risk estimates which are below EPA's LOC
(i.e., the cPADs are all below 100%). The most highly exposed subgroup
is children 1 to 2 years of age, which utilizes 17% of the cPAD.
iii. Cancer. The residue of concern for the cancer analysis is
thiamethoxam, per se. The residues of its metabolite were removed from
the cancer analysis because the metabolite was found to be ``not likely
to be carcinogenic to humans'' when it was evaluated as an active
ingredient. The cancer analysis was based on average field trial
residue values as well as percent crop treated (PCT) estimates. The
estimated cancer risk from dietary exposure to thiamethoxam is 9.04 x
10^-7.
iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of the FFDCA authorizes EPA to use available data and information on
the anticipated residue levels of pesticide residues in food and the
actual levels of pesticide chemicals that have been measured in food.
If EPA relies on such information, EPA must require that data be
provided 5 years after the tolerance is established, modified, or left
in effect, demonstrating that the levels in food are not above the
levels anticipated. Following the initial data submission, EPA is
authorized to require similar data on a time frame it deems
appropriate. As required by section 408(b)(2)(E) of the FFDCA, EPA will
issue a Data Call-In for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of this
tolerance.
Section 408(b)(2)(F) of the FFDCA states that the Agency may use
data on the actual percent of food treated for assessing chronic
dietary risk only if the Agency can make the following findings:
Condition 1, that the data used are reliable and provide a valid basis
to show what percentage of the food derived from such crop is likely to
contain such pesticide residue; condition 2, that the exposure estimate
does not underestimate exposure for any significant subpopulation
group; and condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to
submit data on PCT. The Agency used PCT information in the following
Table 2:

Table 2.--Thiamethoxam Uses and Estimates of Crop Treated
----------------------------------------------------------------------------------------------------------------
Commodity Percent Crop Treated¹
----------------------------------------------------------------------------------------------------------------
Apples 5
----------------------------------------------------------------------------------------------------------------
Casabas 44
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Cherries (sweet) 37
----------------------------------------------------------------------------------------------------------------
Cherries (tart) 88
----------------------------------------------------------------------------------------------------------------
Coffee 100
----------------------------------------------------------------------------------------------------------------
Crabapples 53
----------------------------------------------------------------------------------------------------------------
Crenshaws 44
----------------------------------------------------------------------------------------------------------------
Cucumbers 5
----------------------------------------------------------------------------------------------------------------
Field corn 6
----------------------------------------------------------------------------------------------------------------
Fruiting vegetables (except cucurbits - crop group 8) 15
----------------------------------------------------------------------------------------------------------------
Lima beans (fresh) 37
----------------------------------------------------------------------------------------------------------------
Lima beans (processed) 52
----------------------------------------------------------------------------------------------------------------
Loquats 53
----------------------------------------------------------------------------------------------------------------
Melons 13
----------------------------------------------------------------------------------------------------------------
Peaches 45
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[[Page 54390]]

Pears 9
----------------------------------------------------------------------------------------------------------------
Pecans 38
----------------------------------------------------------------------------------------------------------------
Plums 60
----------------------------------------------------------------------------------------------------------------
Prunes 43
----------------------------------------------------------------------------------------------------------------
Pumpkins 44
----------------------------------------------------------------------------------------------------------------
Quinces 53
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Snap beans (fresh) 26
----------------------------------------------------------------------------------------------------------------
Snap beans (processed) 38
----------------------------------------------------------------------------------------------------------------
Squash 44
----------------------------------------------------------------------------------------------------------------
Sunflower 25
----------------------------------------------------------------------------------------------------------------
Tuberous and corm vegetables - crop subgroup 1C 9
----------------------------------------------------------------------------------------------------------------

The Agency believes that the three conditions listed in this Unit
have been met. With respect to condition 1, PCT estimates are derived
from Federal and private market survey data, which are reliable and
have a valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed, and are unlikely to underestimate an individual's acute
dietary exposure. The Agency is reasonably certain that the percentage
of the food treated is not likely to be an underestimation. As to
conditions 2 and 3, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which thiamethoxam
may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for thiamethoxam 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 thiamethoxam.
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 SCI-GROW, which predicts pesticide concentrations in ground
water. 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 coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever 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 thiamethoxam, they are
further discussed in the aggregate risk sections in Unit III.E.
Based on the PRZM/EXAMS and SCI-GROW models, the estimated
environmental concentrations (EECs) of thiamethoxam for acute exposures
are estimated to be 7.1 parts per billion (ppb) for surface water and
1.94 ppb for

[[Page 54391]]

ground water. The EECs for chronic non-cancer exposures are estimated
to be 0.43 ppb for surface water and 1.94 ppb for ground water. The
EECs for cancer exposures are estimated to be 0.13 ppb for surface
water and 1.94 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).
Thiamethoxam is not registered for use on any sites that would
result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether thiamethoxam 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 thiamethoxam
and any other substances and thiamethoxam 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 thiamethoxam 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 the FFDCA provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines 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. The developmental toxicity
studies indicated no quantitative or qualitative evidence of increased
susceptibility of rat or rabbit fetus to in utero exposure based on the
fact that the developmental NOAELs are either higher than or equal to
the maternal NOAELs. However, the reproductive studies indicate effects
in males rats in the form of increased incidence and severity of
testicular tubular atrophy. These data are considered to be evidence of
increased quantitative susceptibility for male pups when compared to
the parents.
3. Conclusion. There is a complete toxicity data base for
thiamethoxam and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the 10X safety factor to protect infants and children should be
retained. The 10X safety factor is retained based on the following
factors: Effects on endocrine organs observed across species; the
significant decrease in alanine amino transferase levels in the
companion animal studies in the dog studies; the mode of action of this
chemical in insects (interferes with the nicotinic acetyl choline
receptors of the insect's nervous system); the transient clinical signs
of neurotoxicity in several studies across species; and the suggestive
evidence of increased quantitative susceptibility in the rat
reproduction study.

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 ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA 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, EPA 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
thiamethoxam will occupy 3% of the aPAD for the U.S. population, 2% of
the aPAD for females 13 years and older, 9% of the aPAD for all infants
(less than 1 year old), and 10% of the aPAD for children 1 to 2 years
old. In addition, there is potential for acute dietary exposure to
thiamethoxam in drinking water. After calculating DWLOCs and comparing
them to the EECs for surface water and ground water, EPA does not
expect the aggregate exposure to exceed 100% of the aPAD, as shown in
the following Table 3:

[[Page 54392]]

Table 3.--Aggregate Risk Assessment for Acute Exposure to Thiamethoxam
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ %aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. population 0.1 3 7.1 1.94 2,400
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old) 0.1 9 7.1 1.94 910
----------------------------------------------------------------------------------------------------------------
Children (1 - 2 years old) 0.1 10 7.1 1.94 900
----------------------------------------------------------------------------------------------------------------
Females (13 - 49 years old) 0.1 2 7.1 1.94 2,900
----------------------------------------------------------------------------------------------------------------

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
thiamethoxam from food will utilize 6% of the cPAD for the U.S.
population, 14% of the cPAD for all infants (less than 1 year old), and
17% of the cPAD for children 1 to 2 years old. There are no residential
uses for thiamethoxam that result in chronic residential exposure to
thiamethoxam. In addition, there is potential for chronic dietary
exposure to thiamethoxam in drinking water. After calculating DWLOCs
and comparing them to the EECs for surface water and ground water, EPA
does not expect the aggregate exposure to exceed 100% of the cPAD, as
shown in the following Table 4:

Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Thiamethoxam
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ %cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.0006 6 0.43 1.94 20
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old) 0.0006 14 0.43 1.94 5.1
----------------------------------------------------------------------------------------------------------------
Children (1 - 2 years old) 0.0006 17 0.43 1.94 5.0
----------------------------------------------------------------------------------------------------------------

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). Thiamethoxam 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). Thiamethoxam
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. The dietary cancer
risk from residues in food is 9.04 x 10^-7. A cancer DWLOC is
calculated only for the general U.S. population. For risk management
purposes, EPA considers a cancer risk to be greater than negligible
when it exceeds the range of 1 in 1 million. EPA has generally treated
cancer risks up to 3 in 1 million as within the range of 1 in 1
million. The DWLOC for cancer aggregate risk (no residential uses) is
calculated using the following equations:
DWLOC cancer ([mu]g/L) = chronic water exposure milligrams/
kilogram/day (mg/kg/day) x (body weight/kg) /consumption (L) x
10^-3 mg/[mu]g
Chronic water exposure (mg/kg/day) = negligible risk / Q* -
(chronic food exposure)(mg/kg/day)
Assuming that the negligible risk value could be as high as 3 x
10^-6, the chronic water exposure value is estimated to be: 3
x 10^-6 / 3.77 x 10^-2 - 0.000024 = 0.000056 mg/kg/
day
The DWLOC cancer = 0.000056 mg/kg/day x 70 kg / 2L x
10^-3 mg/[mu]g = 1.95 [mu]g/L
The surface water EEC is 0.13 [mu]g/L and the ground water EEC is
1.94 [mu]g/L. Since the ground water value is greater than the surface
water value, it will be used for comparison purposes and will protect
for any concerns for surface water concentrations. Since the cancer
DWLOC is not exceeded by the ground water EEC, the cancer risk is below
EPA's level of concern.
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 thiamethoxam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (solvent extraction, liquid-liquid
partitioning and solid-phase extraction cleanup, and high performance
liquid chromatography using ultra-violet detection (HPLC/UV) analysis)
is available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
B. International Residue Limits

There are no international residue limits for thiamethoxam.

V. Conclusion

Therefore, the tolerances are established for combined residues of
thiamethoxam, 3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-
nitro-4H-1,3,5-oxadiazin-4-imine and its metabolite (N-(2-chloro-
thiazol-5-ylmethyl)-N'-methyl-N'-nitro-guanidine), in or on imported
coffee at 0.05 ppm, pecan at 0.02 ppm, stone fruit

[[Page 54393]]

group 12 at 0.5 ppm, succulent bean at 0.02 ppm, and sunflower at 0.02.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. 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 the 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 the 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 the 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-2003-0306 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before November
17, 2003.
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 issues(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 (1900C),
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 Rm. 104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. 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
(703) 603-0061.
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 the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2003-0306, to: Public
Information and Records Integrity Branch, Information Resources 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 the
PIRIB described in Unit I.B.1. 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 1 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 issues(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 the
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

[[Page 54394]]

(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 the 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 the FFDCA. For these same reasons, the Agency
has determined that this rule does not have any ``tribal implications''
as described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

VIII. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: September 10, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346(a) and 371.

0
2. Section 180.565 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:

Sec. 180.565 Thiamethoxam; tolerances for residues.

(a) * * *

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * * * *
Bean, succulent..................... 0.02
* * * * * * *
Coffee¹............................. 0.05
* * * * * * *
Fruit, stone, group 12.............. 0.5
* * * * * * *
Pecans.............................. 0.02
* * * * * * *
Sunflower........................... 0.02
------------------------------------------------------------------------
¹There are no U.S. registrations as of September 17, 2003.

* * * * *
[FR Doc. 03-23852 Filed 9-15-03; 1:28 pm]

BILLING CODE 6560-50-S