[Federal Register Volume 68, Number 180 (Wednesday, September 17, 2003)]
[Rules and Regulations]
[Pages 54386-54394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23852]


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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: [email protected].

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 (DEEMTM) 
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 DEEMTM 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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------

[[Page 54390]]

 
Pears                                                                                                          9
----------------------------------------------------------------------------------------------------------------
Pecans                                                                                                        38
----------------------------------------------------------------------------------------------------------------
Plums                                                                                                         60
----------------------------------------------------------------------------------------------------------------
Prunes                                                                                                        43
----------------------------------------------------------------------------------------------------------------
Pumpkins                                                                                                      44
----------------------------------------------------------------------------------------------------------------
Quinces                                                                                                       53
----------------------------------------------------------------------------------------------------------------
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: [email protected].

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 [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to 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: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve 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