[Federal Register Volume 70, Number 3 (Wednesday, January 5, 2005)]
[Rules and Regulations]
[Pages 708-720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-89]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0394; FRL-7689-7]


Thiamethoxam; Pesticide Tolerance

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, (CGA-322704) in or on legume 
vegetables, root vegetables (except sugar beet), strawberries, 
bushberries, juneberries, lingonberries, salal, cranberries, spearmint, 
peppermint, rapeseed, mustard, flax, safflower, crambe, borage, and 
potatoes. In addition, the tolerance expression for tuberous and corm 
vegetable crop subgroup (1C) is revised to a tolerance expression for 
tuberous and corm crop subgroup (except potato) (1D). Syngenta Crop 
Protection, Inc. and Interregional Research Project 4 requested this 
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective January 5, 2005. Objections and 
requests for hearings must be received on or before March 7, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2004-0394. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 South 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: 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 producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.

[[Page 709]]

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of This Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of June 2, 2004 (69 FR 31110) (FRL-7361-1), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of pesticide petitions (PP 2E6363, 
3E6781, 3E6800, 3E6805, 3E6806, 3E6807, 4E6819, and 0F6142) by Syngenta 
Crop Protection, Inc., P.O. Box 18300 Greensboro, NC 27419-8300, and 
Interregional Research Project 4 (IR-4), 681 US Highway 1 South, North 
Brunswick, NJ 08902-3390. The petitions requested that 40 CFR 180.565 
be amended by establishing tolerances for 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 CGA-322704 
(N-(2-chloro-thiazol-5-ylmethyl)-N`-methyl-N'`-nitro-guanidine), in or 
on legume vegetables group 6 at 0.02 parts per million (ppm) (3E6805), 
peppermint and spearmint at 4.0 ppm (2E6363); root vegetables (except 
sugar beet) crop subgroup 1B at 0.1 ppm and for radish tops at 0.80 ppm 
(4E6819); strawberry at 0.30 ppm (3E6800); cranberry at 0.01 ppm 
(3E6781); bushberry crop subgroup 13B and juneberry, lingonberry and 
salal at 0.25 ppm (3E6807); rapeseed seed, mustard seed, flax seed, 
safflower seed, crambe seed, and borage seed at 0.02 ppm (3E6806); and 
potato at 0.25 ppm (0F6142). In addition, due to the establishment of 
the individual tolerance for potato, it was requested that the 
tolerance expression for tuberous and corm crop subgroup 1C be revised 
to a tolerance expression for tuberous and corm (except potato) crop 
subgroup 1D. That notice included a summary of these petitions prepared 
by Syngenta Crop Protection, Inc. and IR-4, the registrant. As a result 
of the residue data submitted to support these requests, the proposed 
tolerance level for peppermint and spearmint was subsequently revised 
to 1.5 ppm; the proposed tolerance level for root vegetables (except 
sugar beet) crop subgroup 1B was subsequently revised to 0.02 ppm; the 
proposed tolerance level for bushberry crop subgroup 13B and juneberry, 
lingonberry and salal was subsequently revised to 0.20 ppm; and the 
proposed tolerance for cranberry was revised to 0.02 ppm. There were no 
comments received in response to the notice of filing.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for a tolerance for combined residues of 
thiamethoxam and its metabolite CGA-322704 on legume vegetables group 6 
at 0.02 ppm, peppermint and spearmint at 1.5 ppm; root vegetables 
(except sugar beet) crop subgroup 1B at 0.02 ppm and for radish tops at 
0.80 ppm; strawberry at 0.30 ppm; cranberry at 0.02 ppm; bushberry crop 
subgroup 13B and juneberry, lingonberry and salal at 0.20 ppm; rapeseed 
seed, mustard seed, flax seed, safflower seed, crambe seed, and borage 
seed at 0.02 ppm; and potato at 0.25 ppm. In addition, due to the 
establishment of the individual tolerance for potato, it was requested 
that the tolerance expression for tuberous and corm crop subgroup 1C be 
revised to a tolerance expression for tuberous and corm (except potato) 
crop subgroup 1D. EPA's assessment of exposures and risks associated 
with establishing the tolerance follows.
    In assessing the human health risks associated with the existing 
and proposed uses of thiamethoxam, EPA has included exposure to 
thiamethoxam as well as its metabolite CGA-322704 when evaluating 
exposure from the dietary (food only) pathway. This approach was 
developed when the Agency received the first food-use request for 
registration of thiamethoxam and determined that the CGA-322704 
metabolite/degradate, as well as the parent compound, are residues of 
concern in food; no exposure to CGA-322704 in drinking water was 
considered likely following application of thiamethoxam. At the time, 
toxicological information regarding CGA-322704 was not available, and 
it was assumed that thiamethoxam and this metabolite are 
toxicologically equivalent for estimation of dietary risk. 
Subsequently, the Agency received a petition requesting registration of 
the insecticide clothianidin. Upon review of that petition, the Agency 
discovered that CGA-322704 and clothianidin are identical. With the 
registration of clothianidin uses, the Agency has largely complete 
toxicological databases for both thiamethoxam and CGA-322704 (referred 
to in the remainder of this rule as clothianidin). While some of the 
toxic effects observed following dosing with the two active ingredients 
are similar, it is not clear that they are toxicologically equivalent.
    To date, the Agency has not formally examined the toxicity data to 
determine if it is appropriate to separate exposure to the parent 
compound thiamethoxam

[[Page 710]]

from exposure to thiamethoxam's metabolite clothianidin when assessing 
the aggregate risk associated with thiamethoxam tolerances. Therefore, 
EPA has taken the very conservative approach of analzying the non-
cancer risk of thiamethoxam by both (1) aggregating exposure to 
thiamethoxam and its metabolite clothianidin resulting from use of 
thiamethoxam and clothianidin residues resulting from use of 
clothianidin as an active ingredient and comparing this aggregate 
exposure to relevant endpoints for thiamethoxam; and (2) aggregating 
exposure to clothianidin resulting from thiamethoxam use and from use 
of clothianidin as an active ingredient and comparing this aggregate 
exposure to relevant endpoints for clothianidin. EPA has taken the 
further conservative step of assuming that, in instances where both 
thiamethoxam and clothianidin are registered for use on a crop, both 
pesticides will, in fact, be used on that crop. Despite this very 
conservative approach, thiamethoxam non-cancer risks (taking into 
account clothianidin exposure) are well below the Agency's level of 
concern (LOC).
    Pending formal reconsideration of toxicological equivalency for 
thiamethoxam and the clothianidin metabolite, aggregate risks from both 
thiamethoxam and clothianidin are presented below.

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 the Federal Register of September 17, 2003 
(68 FR 54386) (FRL-7327-5). The nature of the toxic effects caused by 
the metabolite clothianidin are discussed in the Federal Register of 
May 30, 2003 (68 FR 32390) (FRL-7306-8).

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 LOC. However, 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.
    Three other types of safety or uncertainty factors may be used: 
``Traditional uncertainty factors;'' the ``special FQPA safety 
factor;'' and the ``default FQPA safety factor.'' By the term 
``traditional uncertainty factor,'' EPA is referring to those 
additional uncertainty factors used prior to FQPA passage to account 
for database deficiencies. These traditional uncertainty factors have 
been incorporated by the FQPA into the additional safety factor for the 
protection of infants and children. The term ``special FQPA safety 
factor'' refers to those safety factors that are deemed necessary for 
the protection of infants and children primarily as a result of the 
FQPA. The ``default FQPA safety factor'' is the additional 10X safety 
factor that is mandated by the statute unless it is decided that there 
are reliable data to choose a different additional factor (potentially 
a traditional uncertainty factor or a special FQPA safety factor).
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 
100 to account for interspecies and intraspecies differences and any 
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). 
Where a special FQPA safety factor or the default FQPA safety factor is 
used, 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 safety 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). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 x 
10-\5\), one in a million (1 x 10-\6\), or one in 
ten million (1 x 10-\7\). 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 Table 1 of this unit:

     Table 1.--Summary of Toxicological Dose and Endpoints for Thiamethoxam for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk       FQPA SF and LOC for    Study and Toxicological
          Exposure Scenario                 Assessment, UF          Risk 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 / FQPA   neurotoxicity study in
                                       Acute RfD = 1 mg/kg/day   SF.                      the rat
                                                                = 0.1 mg/kg/day........  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)
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[[Page 711]]

 
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.                LOAEL = 1.8 mg/kg/day
                                        kg/day.                  = 0.0006 mg/kg/day....   based on increased
                                                                                          incidence and severity
                                                                                          of tubular atrophy in
                                                                                          testes of F\1\
                                                                                          generation males.
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Oral nondietary (all durations)        NOAEL = 0.6 mg/kg/day    Residential LOC for MOE  2-Generation
                                                                 = 1,000                  reproduction study
                                                                                         LOAEL = 1.8 mg/kg/day
                                                                                          based on increased
                                                                                          incidence and severity
                                                                                          of tubular atrophy in
                                                                                          testes of F\1\
                                                                                          generation males.
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Dermal (all durations)                 Oral study               Resdiential LOC for MOE  2-Generation
                                       NOAEL = 0.6 mg/kg/day     = 1,000                  reproduction study
                                        (dermal absorption                               LOAEL = 1.8 mg/kg/day
                                        rate = 27%).                                      based on increased
                                                                                          incidence and severity
                                                                                          of tubular atrophy in
                                                                                          testes of F\1\
                                                                                          generation males.
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Inhalation (all durations)             Oral study NOAEL = 0.6   Residential LOC for MOE  2-Generation
                                        mg/kg/day(inhalation     = 1,000                  reproduction study
                                        absorption rate =                                LOAEL = 1.8 mg/kg/day
                                        100%)                                             based on increased
                                                                                          incidence and severity
                                                                                          of tubular atrophy in
                                                                                          testes of F\1\
                                                                                          generation males.
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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)\-\2 is 3.77 x 10\-\2 in human equivalents.
----------------------------------------------------------------------------------------------------------------

    A summary of the toxicological endpoints for the metabolite 
clothianidin used for human risk assessment is shown in Table 2 of this 
unit:

     Table 2.--Summary of Toxicological Dose and Endpoints for Clothianidin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,
          Exposure Scenario                Interspecies and     Special FQPA SF and LOC  Study and Toxicological
                                         Intraspecies and any     for Risk Assessment            Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50 years of  Developmental NOAEL =    FQPA SF = 1              Developmental rabbit
 age)                                   25 mg/kg/day            aPAD = acute RfD / FQPA   study
                                       UF = 1,000.............   SF.                     Developmental LOAEL =
                                       Acute RfD = 0.025 mg/kg  = 0.025 mg/kg..........   75 mg/kg/day based on
                                                                                          an increased litter
                                                                                          incidence of a missing
                                                                                          lobe of the lung.
----------------------------------------------------------------
Acute dietary (General population)     NOAEL = 25 mg/kg/day     FQPA SF = 1              Special Neurotoxicity/
                                       UF = 1,000.............  aPAD = acute RfD / FQPA   Pharmacology Study in
                                       Acute RfD = 0.025 mg/kg   SF.                      Mice and Rats
                                                                = 0.025 mg/kg..........  LOAEL = 50 mg/kg based
                                                                                          on transient signs of
                                                                                          decreased spontaneous
                                                                                          motor activity,
                                                                                          tremors and deep
                                                                                          respirations.
----------------------------------------------------------------
Chronic dietary (All populations)      Offspring NOAEL = 9.8    FQPA SF = 1              2-Generation
                                        mg/kg/day               cPAD = chronic RfD /      Reproduction Study
                                       UF = 1,000.............   FQPA SF = 0.0098 mg/kg/ Offspring LOAEL = 31.2
                                       Chronic RfD = 0.0098 mg/  day.                     mg/kg/day based on
                                        kg/day.                                           decreased mean body
                                                                                          weight gain and
                                                                                          delayed sexual
                                                                                          maturation, decreased
                                                                                          absolute thymus
                                                                                          weights in F\1\ pups
                                                                                          and an increase in
                                                                                          stillbirths in both
                                                                                          generations.
----------------------------------------------------------------
Incidental Oral (All durations)        NOAEL = 9.8 mg/kg/day    Residential LOC for MOE  2-Generation
                                                                 = 1,000                  reproduction study
                                                                                         Offspring LOAEL = 31.2
                                                                                          mg/kg/day based on
                                                                                          decreased mean body
                                                                                          weight gain and
                                                                                          delayed sexual
                                                                                          maturation, decreased
                                                                                          absolute thymus
                                                                                          weights in F\1\ pups
                                                                                          and an increase in
                                                                                          stillbirths in both
                                                                                          generations.
----------------------------------------------------------------

[[Page 712]]

 
Dermal (All durations)                 Oral study               Residential LOC for MOE  2-Generation
                                       NOAEL = 9.8 mg/kg/day     = 1,000                  reproduction study
                                        (dermal absorption                               Offspring LOAEL = 31.2
                                        rate = 1%).                                       mg/kg/day based on
                                                                                          decreased mean body
                                                                                          weight gain and
                                                                                          delayed sexual
                                                                                          maturation, decreased
                                                                                          absolute thymus
                                                                                          weights in F\1\ pups
                                                                                          and an increase in
                                                                                          stillbirths in both
                                                                                          generations.
----------------------------------------------------------------
Inhalation (All durations)             Oral study               Residential LOC for MOE  2-Generation
                                       NOAEL = 9.8 mg/kg/day     = 1,000                  reproduction study
                                        (inhalation absorption                           Offspring LOAEL = 31.2
                                        rate = 100%).                                     mg/kg/day based on
                                                                                          decreased mean body
                                                                                          weight gain and
                                                                                          delayed sexual
                                                                                          maturation, decreased
                                                                                          absolute thymus
                                                                                          weights in F\1\ pups
                                                                                          and an increase in
                                                                                          stillbirths in both
                                                                                          generations.
----------------------------------------------------------------
Cancer (oral, dermal, inhalation)               Classification: Not likely to be carcinogenic to humans.
----------------------------------------------------------------------------------------------------------------

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 clothianidin in or on a variety of raw agricultural 
commodities. Tolerances for thiamethoxam are established on barley, 
canola, cotton, sorghum, wheat, imported coffee, pecan, stone fruit, 
succulent bean, sunflower, 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, sweet corn (kernal 
and cob with husk removed), milk, and the meat and meat by products of 
cattle, goats, horses, and sheep. Since clothianidin is a major 
metabolite of thiamethoxam, residues of clothianidin that would 
theoretically result from registered and pending uses of clothianidin 
and residues that would theoretically result from the metabolism of 
thiamethoxam are included in the analysis. 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-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. In conducting the acute dietary risk assessment EPA 
used the Dietary Exposure Evaluation Model software with the Food 
Commodity Intake Database (DEEM-FCID\TM\), which incorporates food 
consumption data as reported by respondents in the United States 
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: EPA conducted 
the acute dietary exposure analysis based on highly conservative 
assumptions. The residues of concern for the acute analysis are 
thiamethoxam and its metabolite clothianidin. The assessment for 
thiamethoxam 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. The exposure estimate for 
children 1 to 2 years of age is 0.01099 mg/kg/day, which is equivalent 
to 11% of the aPAD.
    For the metabolite clothianidin, the acute analysis is a 
conservative assessment that was based on tolerance level residues and 
the assumption of 100 percent crop treated (PCT) for established and 
proposed clothianidin uses. For the commodities that have both 
thiamethoxam tolerances and established or proposed clothianidin 
tolerances (i.e., sweet corn, field corn, pop corn, canola, milk, and 
pome fruit), the proposed clothianidin tolerances are added to the 
residues that could result from use of thiamethoxam. 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 population subgroup is infants less than 
1 year old, which utilizes 80% of the aPAD.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used the DEEM-FCID\TM\, which incorporates food 
consumption data 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 clothianidin. The chronic analysis 
for thiamethoxam was based on anticipated residues in the form of 
average field trial residue values, and the analysis included 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. The exposure estimate for children 1 
to 2 years of age is 0.000103 mg/kg/day, which is equivalent to 17% of 
the cPAD.
    For clothianidin, the chronic analysis is a relatively conservative 
assessment that was based on tolerance level residues and the 
assumption of 100% crop treated for established and proposed 
clothianidin uses, with the exception of anticipated residues (AR) for 
apples and pears. For the commodities that have both thiamethoxam 
tolerances and established or proposed clothianidin tolerances (i.e., 
sweet corn, field corn, pop corn, canola, and milk), the

[[Page 713]]

proposed clothianidin tolerances are added to the residues that could 
result from use of thiamethoxam. For apples and pears, the highest 
average field trial (HAFT) levels from the residue field trials were 
added to the residues that could result from use of thiamethoxam. 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 population subgroup is children 1 to 2 
years of age, which utilizes 15% of the cPAD.
    iii. Cancer. The residue of concern for the cancer analysis is 
thiamethoxam, per se. The residues of its metabolite clothianidin 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 PCT estimates. The estimated dietary exposure 
to the U.S. population is 0.000263 mg/kg/day.
    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 pursuant to section 
408(f)(1) 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. For the present action, EPA will issue such 
data call-ins for information relating to anticipated residues as are 
required by FFDCA section 408(b)(2)(E) and authorized under FFDCA 
section 408(f)(1). Such data call-ins will be required to be submitted 
no later than 5 years from the date of issuance of this tolerance.
    Section 408(b)(2)(F) of 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 FFDCA, EPA may require registrants to submit 
data on PCT.
    The Agency used PCT information as follows:For existing uses, the 
Agency used estimates of PCT for the chronic exposure assessment which 
was determined using USDA's National Agricultural Statistics Service 
(NASS) Usage Data (1999-2003) and EPA Proprietary Usage Data (2001-
2003). The chronic PCT estimates that were used for existing uses are 
shown in Table 3:

   Table 3.--Thiamethoxam Estimates of Crop Treated for Existing Uses
------------------------------------------------------------------------
                                                          Percent Crop
                      Commodity                             Treated
------------------------------------------------------------------------
Apples...............................................                  5
------------------------------------------------------------------------
Barley...............................................                  1
------------------------------------------------------------------------
Canola...............................................                 55
------------------------------------------------------------------------
Cantaloupes..........................................                 13
------------------------------------------------------------------------
Casabas..............................................                 44
------------------------------------------------------------------------
Cottonseed...........................................                 20
------------------------------------------------------------------------
Crabapples...........................................                 20
------------------------------------------------------------------------
Cucumbers............................................                  5
------------------------------------------------------------------------
Field corn, grain....................................                  6
------------------------------------------------------------------------
Fruiting vegetables (except cucurbits - Crop group 8)                 15
------------------------------------------------------------------------
Honeydew melons......................................                 13
------------------------------------------------------------------------
Loquats..............................................                 53
------------------------------------------------------------------------
Pears................................................                  9
------------------------------------------------------------------------
Popcorn..............................................                  6
------------------------------------------------------------------------
Potatoes.............................................                 41
------------------------------------------------------------------------
Pumpkins.............................................                 44
------------------------------------------------------------------------
Quinces..............................................                 53
------------------------------------------------------------------------
Sorghum (including milo).............................                  9
------------------------------------------------------------------------
Squash...............................................                 44
------------------------------------------------------------------------
Sunflowers...........................................                 25
------------------------------------------------------------------------
Sweet corn...........................................                  6
------------------------------------------------------------------------
Tuberous and Corm Vegetables - Crop subgroup 1C                       33
 (except potatoes)...................................
------------------------------------------------------------------------
Watermelons..........................................                 13
------------------------------------------------------------------------
Wheat................................................                  2
------------------------------------------------------------------------

    For the new uses, the Agency used PCT estimates for the chronic 
exposure assessment based on usage data and market share projections as 
follows. Market share projections for the new uses for thiamethoxam 
were obtained from the registrant and compared to 1999-2003 USDA NASS 
Usage Data and EPA 2001-2003 Proprietary Usage Data for the 
historically, most widely used insecticide for control of insect pests 
for each crop. As a result of this comparison, the highest, most 
conservative PCT estimate for each crop was used for the chronic 
exposure assessment. These highly conservative estimates should not 
underestimate actual usage of thiamethoxam on the new crops/sites. To 
further support the reliability of these PCT estimates, as a condition 
of registration, the registrant will be required to agree to report 
annually on the market share attained for the new uses for which 
thiamethoxam is registered. As a condition of registration, they will 
also be required to agree to mitigate dietary risk as deemed 
appropriate by the Agency should the market share data raise a concern 
for increased dietary risk. The Agency will then compare that market 
share information with the PCT estimates used to evaluate potential 
dietary risk. In those instances where percent market share is 
approaching or exceeding the predicted PCT estimate used in the 
Agency's risk assessment, EPA will conduct a new dietary risk 
assessment to evaluate the new dietary risk. If the market share data 
raise a concern for increased pesticide risk, the Agency will act to 
mitigate that dietary risk and could employ several approaches, 
including but not limited to production caps, geographical limitations, 
removal of uses, or other means deemed appropriate by the Agency. The 
chronic PCT estimates that were used for existing uses are shown in 
Table 4:

[[Page 714]]



      Table 4.--Thiamethoxam Estimates of Crop Treated for New Uses
------------------------------------------------------------------------
                                                          Percent Crop
                      Commodity                             Treated
------------------------------------------------------------------------
Beans, lima..........................................                 38
------------------------------------------------------------------------
Beans, snap..........................................                 37
------------------------------------------------------------------------
Bushberries..........................................                 55
------------------------------------------------------------------------
Carrots..............................................                 20
------------------------------------------------------------------------
Cranberries..........................................                 29
------------------------------------------------------------------------
Mint.................................................                  9
------------------------------------------------------------------------
Peas, green processed................................                 36
------------------------------------------------------------------------
Peas (including dried peas)..........................                 44
------------------------------------------------------------------------
Soybeans.............................................                 11
------------------------------------------------------------------------
Strawberries.........................................                 46
------------------------------------------------------------------------

    The Agency believes that the three conditions listed in this Unit 
III. 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. 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 FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index 
reservoir. The screening concentration in ground water (SCIGROW) model 
is used to predict pesticide concentrations in shallow ground water. 
For a screening-level assessment for surface water EPA will use FIRST 
(a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model). The FIRST 
model is a subset of the PRZM/EXAMS model that uses a specific high-end 
runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate 
an index reservoir environment, and both models include a percent crop 
area factor as an adjustment to account for the maximum percent crop 
coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
LOC.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs), which are the model estimates of a 
pesticide's concentration in water. EECs derived from these models are 
used 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 E.
    Based on the PRZM/EXAMS and SCIGROW models, the EECs of 
thiamethoxam for acute exposures are estimated to be 11.4 parts per 
billion (ppb) for surface water and 5 ppb for ground water. The EECs 
for chronic non-cancer exposures are estimated to be 0.77 ppb for 
surface water and 1.94 ppb for ground water. The EECs for cancer 
exposures are estimated to be 0.31 ppb for surface water and 1.94 ppb 
for ground water.
    Clothianidin is not a significant degradate of thiamethoxam in 
water. Therefore, residues of clothianidin in water were estimated 
based on applications of clothianidin as an active ingredient. Based on 
the FIRST and SCIGROW models, the EECs of clothianidin for acute 
exposures are estimated to be 7.29 parts per billion (ppb) for surface 
water and 5.84 ppb for ground water. The EECs for chronic exposures are 
estimated to be 1.35 ppb for surface water and 5.84 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.
    Clothianidin is currently registered for use on turfgrasses. 
Exposures and risk resulting from clothianidin residues on turfgrasses 
are included in the aggregate risk assessment for clothianidin.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    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

[[Page 715]]

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 OPP concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's Web site at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    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 special safety factor to protect infants and children 
should be 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 and 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 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 the 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 4% of the aPAD for the U.S. population, 2% of 
the aPAD for females 13 years and older, 10% of the aPAD for infants 
less than one year old, and 11% 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 and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the aPAD, as shown in Table 5 of 
this unit:

                     Table 5.--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            4         11.4            5        3,400
--------------------------------------------------------------
All infants (less than one year old)...........          0.1           10         11.4            5          900
---------------------------------------------------------------------------
Children 1-2 years old.........................          0.1           11         11.4            5          890
---------------------------------------------------------------------------
Females 13-49 years old........................          0.1            2         11.4            5        2,900
----------------------------------------------------------------------------------------------------------------


[[Page 716]]

    Sources of clothianidin residues in food include uses of both 
thiamethoxam and clothianidin. Toxicological doses and endpoints for 
clothianidin were used to calculate risk. The acute dietary exposure 
from food to the metabolite clothianidin will occupy 18% of the aPAD 
for the U.S. population, 12% of the aPAD for females 13 years and 
older, 80% of the aPAD for infants less than one year old, and 60% of 
the aPAD for children 1 to 2 years old. In addition, there is potential 
for acute dietary exposure to clothianidin 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 Table 6 of this unit:

                     Table 6.--Aggregate Risk Assessment for Acute Exposure to Clothianidin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. Population........................        0.025           18         7.29         5.84          710
--------------------------------------------------------------
All infants (less than one year old)...........        0.025           80         7.29         5.84           48
--------------------------------------------------------------
Children 1-2 years old.........................        0.025           60         7.29         5.84           92
--------------------------------------------------------------
Females 13-49 years old........................        0.025           12         7.29         5.84          640
----------------------------------------------------------------------------------------------------------------

    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, 11% of the cPAD for infants less than one 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 and ground water, EPA does 
not expect the aggregate exposure to exceed 100% of the cPAD, as shown 
in Table 7 of this unit:

              Table 7.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Thiamethoxam
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 cPAD (mg/      % cPAD     Water EEC    Water EEC     Chronic
                                                     kg)         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population................................       0.0006            6         0.77         1.94           20
--------------------------------------------------------------
All infants (less than one year old)...........       0.0006           11         0.77         1.94          5.4
--------------------------------------------------------------
Children 1-2 years old.........................       0.0006           17         0.77         1.94            5
--------------------------------------------------------------
Females 13-49 years old........................       0.0006            5         0.77         1.94           17
----------------------------------------------------------------------------------------------------------------

    Sources of clothianidin residues in food include uses of both 
thiamethoxam and clothianidin. Toxicological doses and endpoints for 
clothianidin were used to calculate risk. Exposure to the metabolite 
clothianidin from food will utilize 6% of the cPAD for the U.S. 
population, 13% of the cPAD for infants less than one year old, and 15% 
of the cPAD for children 1 - 2 years old. Combined residential exposure 
estimates range from an MOE of 1,300 for combined oral and dermal 
exposure to toddlers (treated turf + treated soil + dermal) to 8,900 
for dermal exposure to adults (application + post-application) adults. 
In addition, there is potential for chronic dietary exposure to the 
metabolite clothianidin in drinking water. After calculating DWLOCs and 
comparing them to the EECs for surface and ground water, EPA does not 
expect the aggregate exposure to exceed 100% of the cPAD, as shown in 
Table 8 of this unit:

              Table 8.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Clothianidin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 cPAD (mg/      % cPAD     Water EEC    Water EEC     Chronic
                                                     kg)         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population................................       0.0098            6         1.35         5.84          320
--------------------------------------------------------------
All infants (less than one year old)...........       0.0098           13         1.35         5.84           85
--------------------------------------------------------------
Children 1-2 years old.........................       0.0098           15         1.35         5.84           83
--------------------------------------------------------------
Females 13-49 years old........................       0.0098            5         1.35         5.84          280
--------------------------------------------------------------
Adults 50+ years old...........................       0.0098            5         1.35         5.84          330
----------------------------------------------------------------------------------------------------------------


[[Page 717]]

    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 LOC.
    Short-term aggregate exposures from the metabolite clothianidin 
result in aggregate MOEs of 5,900 for the general U.S. population, 
1,100 for children 1 to 2 years old, and 6,200 for females 13 to 49 
years old. These aggregate MOEs do not exceed the Agency's LOC for 
aggregate exposure to food and residential uses. In addition, short-
term DWLOCs were calculated and compared to the EECs for chronic 
exposure of clothianidin in ground and surface water. After calculating 
DWLOCs and comparing them to the EECs for surface water and ground 
water, EPA does not expect short-term aggregate exposure to exceed the 
Agency's LOC, as shown in Table 9 of this unit:

                   Table 9.--Aggregate Risk Assessment for Short-Term Exposure to Clothianidin
----------------------------------------------------------------------------------------------------------------
                                                  Aggregate                  Surface       Ground
              Population Subgroup                MOE (Food +   Aggregate    Water EEC    Water EEC    Short-Term
                                                Residential)      LOC         (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. population.......................         5,900        1,000         1.35         5.84          280
--------------------------------------------------------------
Children 1-2 years old........................         1,100        1,000         1.35         5.84          8.7
--------------------------------------------------------------
Females 13-49 years old.......................         6,200        1,000         1.35         5.84          250
----------------------------------------------------------------------------------------------------------------

    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 LOC.
    Intermediate-term aggregate exposures from the metabolite 
clothianidin result in aggregate MOEs of 5,900 for the general U.S. 
population, 1,100 for children 1 to 2 years old, and 6,200 for females 
13 to 49 years old. These aggregate MOEs do not exceed the Agency's LOC 
for aggregate exposure to food and residential uses. In addition, 
intermediate-term DWLOCs were calculated and compared to the EECs for 
chronic exposure of clothianidin in ground water and surface water. 
After calculating DWLOCs and comparing them to the EECs for surface 
water and ground water, EPA does not expect intermediate-term aggregate 
exposure to exceed the Agency's LOC, as shown in Table 10 of this unit:

               Table 10.--Aggregate Risk Assessment for Intermediate-Term Exposure to Clothianidin
----------------------------------------------------------------------------------------------------------------
                                                Aggregate                  Surface       Ground    Intermediate-
             Population Subgroup               MOE (Food +   Aggregate    Water EEC    Water EEC     Term DWLOC
                                              Residential)      LOC         (ppb)        (ppb)         (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. population.....................         5,900        1,000         1.35         5.84           280
------------------------------------------------------------
Children 1-2 years old......................         1,100        1,000         1.35         5.84           8.7
------------------------------------------------------------
Females 13-49 years old.....................         6,200        1,000         1.35         5.84           250
----------------------------------------------------------------------------------------------------------------

    5. Aggregate cancer risk for U.S. population. In conducting the 
aggregate cancer risk assessment, only dietary and drinking water 
pathways of exposure were considered. At this time, there are no uses 
for thiamethoxam that would result in any non-occupational, non-dietary 
exposure (i.e., there are no dermal or inhalation routes of exposure 
that should be included in an aggregate assessment). A DWLOC was 
derived for the general U.S. population based on EPA's LOC for cancer 
or a risk in the range of 1 in 1 million. The DWLOC is compared to the 
estimated environmental concentrations of thiamethoxam in surface and 
ground water and is used to determine whether or not aggregate cancer 
exposures are likely to result in risk estimates that exceed EPA's LOC. 
Table 11 of this unit summarizes the drinking water estimated 
concentrations of thiamethoxam in surface water and ground water and 
the associated DWLOC for cancer:

                    Table 11.--Aggregate Risk Assessment for Cancer Exposure to Thiamethoxam
----------------------------------------------------------------------------------------------------------------
                                                                Maximum
                                      Maximum        Food        Water        Cancer       Ground      Surface
        Population Subgroup         Exposure mg/ Exposure mg/ Exposure mg/  DWLOC ppb    Water EEC    Water EEC
                                       kg/day       kg/day       kg/day                     ppb          ppb
----------------------------------------------------------------------------------------------------------------
General U.S. population...........  7.96 x 10\-  7.96 x 10\-  7.96 x 10\-         1.87         1.94         0.31
                                             \5           \5           \5
----------------------------------------------------------------------------------------------------------------


[[Page 718]]

    For cancer, the DWLOC is slightly less than the ground water EEC. 
However, the cancer DWLOC is based on a conservative estimate of 
dietary exposure. Available information from actual prospective ground 
water monitoring data demonstrates that actual thiamethoxam residues in 
groundwater occur at or below 0.05 ppb. This interim analysis suggests 
that actual long-term residues of thiamethoxam in ground water will be 
significantly less than the levels predicted by the SCIGROW model. A 
significant decrease in the level of thiamethoxam in drinking water 
results in an aggregate risk estimate that is unlikely to exceed EPA's 
LOC for cancer. Further, the DWLOC numerical computation was done using 
a cancer risk figure of 1 in 1 million although EPA has repeatedly 
found that risk figures marginally higher than 1 in 1 million fall 
within the range of a 1 in 1 million risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to thiamethoxam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (aqueous acetonitrile solvent 
extraction, liquid-liquid partitioning and solid-phase extraction 
cleanup, and high pressure liquid chromatography/ultraviolet (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 tolerance is 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 legume 
vegetables group 6 at 0.02 ppm, peppermint and spearmint at 1.5 ppm; 
root vegetables (except sugar beet) crop subgroup 1B at 0.02 ppm and 
for radish tops at 0.80 ppm; strawberry at 0.30 ppm; cranberry at 0.02 
ppm; bushberry crop subgroup 13B and juneberry, lingonberry and salal 
at 0.20 ppm; rapeseed seed, mustard seed, flax seed, safflower seed, 
crambe seed, and borage seed at 0.02 ppm; and potato at 0.25 ppm. In 
addition, the tolerance expression for tuberous and corm crop subgroup 
1C is revised to a tolerance expression for tuberous and corm (except 
potato) crop subgroup 1D.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by FQPA, any person may 
file an objection to any aspect of this regulation and may also request 
a hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. Although the procedures in those regulations require 
some modification to reflect the amendments made to FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA provides essentially the same process for persons to 
``object'' to a regulation for an exemption from the requirement of a 
tolerance issued by EPA under new section 408(d) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. However, the period 
for filing objections is now 60 days, rather than 30 days.

A. What Do I Need To Do To File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2004-0394 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 March 7, 
2005.
    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 (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2004-0394, 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 ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

[[Page 719]]

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of FFDCA, such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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


    Dated: December 22, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

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


Sec.  180.565  Thiamethoxam; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Borage, seed.........................................               0.02
                                * * * * *
Bushberry, subgroup 13B..............................               0.20
                                * * * * *
Crambe, seed.........................................               0.02
Cranberry............................................               0.02
Flax, seed...........................................               0.02
                                * * * * *
Juneberry............................................               0.20
Lingonberry..........................................               0.20
                                * * * * *
Mustard, seed........................................               0.02
Peppermint...........................................                1.5
Potato...............................................               0.25
Radish, tops.........................................               0.80
Rapeseed, seed.......................................               0.02
Safflower, seed......................................               0.02
Salal................................................               0.20
                                * * * * *
Spearmint............................................                1.5
Strawberry...........................................                0.3
                                * * * * *
Vegetable, legume, group 6...........................               0.02
Vegetable, root, except sugar beet, subgroup 1B......               0.02
------------------------------------------------------------------------

* * * * *
0
3. Section 180.565 is amended by revising the tolerance expression for 
Tuberous and Corm Vegetables Crop Subgroup in the table in paragraph 
(a) to

[[Page 720]]

read Vegetable, tuberous and corm, except potato, subgroup 1D.
* * * * *

[FR Doc. 05-89 Filed 1-4-05; 8:45 am]
BILLING CODE 6560-50-S