[Federal Register Volume 67, Number 212 (Friday, November 1, 2002)]
[Rules and Regulations]
[Pages 66561-66571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-27830]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0298; FRL-7279-6]


Thiamethoxam; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a tolerance for combined residues 
of thiamethoxam and its metabolite in or on corn forage, corn stover 
and popcorn, corn grain and sweet corn (kernal and cob with husk 
removed). Syngenta Crop Protection, Inc. 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 November 1, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0298, 
must be received on or before December 31, 2002.

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 affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                 Examples of Potentially
             Categories                 NAICS       Affected Entities
------------------------------------------------------------------------
Industry                                    111  Crop production
                                            112  Animal production
                                            311  Food manufacturing
                                          32532  Pesticide manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
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-2002-0298. 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. To access the OPPTS 
Harmonized Guidelines referenced in this document, go directly to the 
guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    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 June 27, 2002 (67 FR 43310-43314) (FRL-
7183-2), EPA issued a notice pursuant to section 408 of FFDCA, 21 
U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the 
filing of a pesticide petition (PP 0F6142) by Syngenta Crop Protection, 
Inc., P.O. Box 18300 Greensboro, NC 27419-8300. That notice included a 
summary of the petition prepared by Syngenta Crop Protection, Inc., the 
registrant. There were no comments received in response to the notice 
of filing.
    The petition 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 (N-(2-chloro-
thiazol-5-ylmethyl)-N'-methyl-N'-nitro-guanidine) in or on the raw 
agricultural commodities: field corn forage at 0.10 parts per million 
(ppm), sweet corn forage at 0.10 ppm, popcorn forage at 0.10 ppm, field 
corn stover at 0.05 ppm, sweet corn stover at 0.05 ppm, field corn 
grain at 0.07 ppm, popcorn grain at 0.02 ppm, and sweet corn (kernal 
and cob with husk removed) at 0.02 ppm.
    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

[[Page 66562]]

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 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 a tolerance for combined residues of 
thiamethoxam and its metabolite on field corn forage at 0.10 parts per 
million (ppm), sweet corn forage at 0.10 ppm, popcorn forage at 0.10 
ppm, field corn stover at 0.05 ppm, sweet corn stover at 0.05 ppm, 
field corn grain at 0.07 ppm popcorn grain at 0.02 ppm, and sweet corn 
(kernal and cob with husk removed) at 0.02 parts per million (ppm). 
EPA's assessment of exposures and risks associated with establishing 
the tolerance 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 are 
discussed in Table 1 of this unit as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies reviewed.

            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
         Guideline No.              Study Type            Results
------------------------------------------------------------------------
870.3100                        90-day oral        NOAEL = 1.74 (males),
                                 toxicity - rat     92.5 (females) mg/kg/
                                                    day
                                                   LOAEL = 17.64
                                                    (males), 182.1
                                                    (females) mg/kg/day
                                                    based on increased
                                                    incidence of hyaline
                                                    change of renal
                                                    tubular epithelium
                                                    (males), fatty
                                                    change in adrenal
                                                    gland of females,
                                                    liver changes in
                                                    females, all at the
                                                    LOAEL.
------------------------------------------------------------------------
870.3100                        90-Day oral        NOAEL = 1.41 (males),
                                 toxicity-mouse     19.2 (females) mg/kg/
                                                    day
                                                   LOAEL = 14.3 (males),
                                                    231 (females) mg/kg/
                                                    day based on
                                                    increased incidence
                                                    of hepatocellular
                                                    hypertrophy. At
                                                    higher dose levels:
                                                    decrease in
                                                    bodyweight and
                                                    bodyweight gain,
                                                    necrosis of
                                                    individual
                                                    hepatocytes,
                                                    pigmentation of
                                                    Kupffer cells, and
                                                    lymphocytic
                                                    infiltration of the
                                                    liver in both sexes;
                                                    slight hematologic
                                                    effects and
                                                    decreased absolute
                                                    and relative kidney
                                                    weights in males;
                                                    and ovarian atrophy,
                                                    decreased ovary and
                                                    spleen weights and
                                                    increased liver
                                                    weights in females.
------------------------------------------------------------------------
870.3150                        90- oral toxicity  NOAEL = 8.23 (males),
                                 - dog              9.27 (females) mg/kg/
                                                    day
                                                   LOAEL = 32.0 (males),
                                                    33.9 (females) mg/kg/
                                                    day based on
                                                    slightly prolonged
                                                    prothrombin times
                                                    and decreased plasma
                                                    albumin and A/G
                                                    ratio (both sexes);
                                                    decreased calcium
                                                    levels and ovary
                                                    weights and delayed
                                                    maturation in the
                                                    ovaries (females);
                                                    decreased
                                                    cholesterol and
                                                    phospholipid levels,
                                                    testis weights,
                                                    spermatogenesis, and
                                                    spermatic giant
                                                    cells in testes
                                                    (males).
------------------------------------------------------------------------
870.3200                        28- dermal         NOAEL = 250 (males),
                                 toxicity - rat     60 (females) mg/kg/
                                                    day
                                                   LOAEL = 1,000
                                                    (males), 250
                                                    (females) mg/kg/day
                                                    based on increased
                                                    plasma glucose,
                                                    triglyceride levels,
                                                    and alkaline
                                                    phosphatase activity
                                                    and inflammatory
                                                    cell infiltration in
                                                    the liver and
                                                    necrosis of single
                                                    hepatocytes in
                                                    females and hyaline
                                                    change in renal
                                                    tubules and a very
                                                    slight reduction in
                                                    body weight in
                                                    males. At higher
                                                    dose levels in
                                                    females, chronic
                                                    tubular lesions in
                                                    the kidneys and
                                                    inflammatory cell
                                                    infiltration in the
                                                    adrenal cortex were
                                                    observed.
------------------------------------------------------------------------
870.3700                        Prenatal           Maternal NOAEL = 30
                                 developmental -    mg/kg/day
                                 rat               LOAEL = 200 mg/kg/day
                                                    based on decreased
                                                    body weight, body
                                                    weight gain, and
                                                    food consumption.
                                                   Developmental NOAEL =
                                                    200 mg/kg/day
                                                   LOAEL = 750 mg/kg/day
                                                    based on decreased
                                                    fetal body weight
                                                    and an increased
                                                    incidence of
                                                    skeletal anomalies.
------------------------------------------------------------------------
870.3700                        Prenatal           Maternal NOAEL = 50
                                 developmental -    mg/kg/day
                                 rabbit            LOAEL = 150 mg/kg/day
                                                    based on maternal
                                                    deaths, hemorrhagic
                                                    uterine contents and
                                                    hemorrhagic
                                                    discharge, decreased
                                                    body weight and food
                                                    intake during the
                                                    dosing period.
                                                   Developmental NOAEL =
                                                    50 mg/kg/day
                                                   LOAEL = 150 mg/kg/day
                                                    based on decreased
                                                    fetal body weights,
                                                    increased incidence
                                                    of post-implantation
                                                    loss and a slight
                                                    increase in the
                                                    incidence of a few
                                                    skeletal anomalies/
                                                    variations.

[[Page 66563]]

 
------------------------------------------------------------------------
870.3800                        Reproduction and   Parental/Systemic
                                 fertility          NOAEL = 1.84
                                 effects - rat      (males), 202.06
                                                    (females) mg/kg/day
                                                   LOAEL = 61.25
                                                    (males), not
                                                    determined (females)
                                                    mg/kg/day based on
                                                    increased incidence
                                                    of hyaline change in
                                                    renal tubules in F0
                                                    and F1 males.
                                                   Reproductive NOAEL =
                                                    0.61 (males), 202.06
                                                    (females) mg/kg/day
                                                   LOAEL = 1.84 (males),
                                                    not determined
                                                    (females) mg/kg/day
                                                    based on increased
                                                    incidence and
                                                    severity of tubular
                                                    atrophy observed in
                                                    testes of the F1
                                                    generation males.
                                                   Offspring NOAEL =
                                                    61.25 (males), 79.20
                                                    (females) mg/kg/day
                                                   LOAEL = 158.32
                                                    (males), 202.06
                                                    (females) mg/kg/day
                                                    based on reduced
                                                    body weight gain
                                                    during the lactation
                                                    period in all
                                                    litters .
------------------------------------------------------------------------
870.4100                        Chronic toxicity - NOAEL = 4.05 (males),
                                  dog               4.49 (females) mg/kg/
                                                    day
                                                   LOAEL = 21.0 (males),
                                                    24.6 (females) mg/kg/
                                                    day based on
                                                    increase in
                                                    creatinine in both
                                                    sexes, transient
                                                    decrease in food
                                                    consumption in
                                                    females, and
                                                    occasional increase
                                                    in urea levels,
                                                    decrease in ALT, and
                                                    atrophy of
                                                    seminiferous tubules
                                                    in males.
------------------------------------------------------------------------
870.4200                        Carcinogenicity -  NOAEL = 2.63 (males),
                                 mouse              3.68 (females) mg/kg/
                                                    day
                                                   LOAEL = 63.8 (males),
                                                    87.6 (females) mg/kg/
                                                    day based on
                                                    hepatocyte
                                                    hypertrophy, single
                                                    cell necrosis,
                                                    inflammatory cell
                                                    infiltration,
                                                    pigment deposition,
                                                    foci of cellular
                                                    alteration,
                                                    hyperplasia of
                                                    Kupffer cells and
                                                    increased mitotic
                                                    activity; also, an
                                                    increase in the
                                                    incidence of
                                                    hepatocellular
                                                    adenoma (both
                                                    sexes). At higher
                                                    doses, there was an
                                                    increase in the
                                                    incidence of
                                                    hepatocellular
                                                    adenocarcinoma (both
                                                    sexes) and the
                                                    number of animals
                                                    with multiple
                                                    tumors.
                                                   evidence of
                                                    carcinogenicity
------------------------------------------------------------------------
870.4300                        Combined chronic   NOAEL = 21.0 (males),
                                 carcinogenicity -  50.3 (females) mg/kg/
                                  rat               day
                                                   LOAEL = 63.0 (males),
                                                    155 (females) mg/kg/
                                                    day based on
                                                    increased incidence
                                                    of lymphocytic
                                                    infiltration of the
                                                    renal pelvis and
                                                    chronic nephropathy
                                                    in males and
                                                    decreased body
                                                    weight gain, slight
                                                    increase in the
                                                    severity of
                                                    hemosiderosis of the
                                                    spleen, foci of
                                                    cellular alteration
                                                    in liver and chronic
                                                    tubular lesions in
                                                    kidney in females.
                                                   no evidence of
                                                    carcinogenicity
------------------------------------------------------------------------
870.5100                        Gene mutation in   No evidence of gene
870.5265......................   S. typhimurium     mutation when tested
                                 and E. coli        up to 5,000 [mu]g/
                                                    plate. There was no
                                                    evidence of
                                                    cytotoxicity.
------------------------------------------------------------------------
870.5265                        Gene mutation in   No evidence of gene
                                 S. typhimurium     mutation when tested
                                                    up to 5,000 [mu]g/
                                                    plate. The S9
                                                    fraction was from
                                                    non-induced mouse
                                                    liver, Aroclor 1254
                                                    induced mouse liver,
                                                    or thiamethoxam
                                                    induced mouse liver,
                                                    following dietary
                                                    administration of
                                                    thiamethoxam for 14
                                                    days at
                                                    concentrations up to
                                                    2,500 ppm.
------------------------------------------------------------------------
870.5300                        Gene mutation in   No evidence of gene
                                 chinese hamster    mutation when tested
                                 V79 cells at       up to solubility
                                 HGPRT locus        limit.
------------------------------------------------------------------------
870.5375                        CHO cell           No evidence of
                                 cytogenetics       chromosomal
                                                    aberrations when
                                                    tested up to
                                                    cytotoxic or
                                                    solubility limit
                                                    concentrations.
------------------------------------------------------------------------
870.5395                        In vivo mouse      Negative when tested
                                 bone marrow        up to levels of
                                 micronucleus       toxicity in whole
                                                    animals; however no
                                                    evidence of target
                                                    cell cytotoxicity.
------------------------------------------------------------------------
870. 5550                       UDS assay          Negative when tested
                                                    up to precipitating
                                                    concentrations
------------------------------------------------------------------------
870.6200                        Acute              NOAEL = 100 mg/kg/day
                                 neurotoxicity     LOAEL = 500 mg/kg/day
                                 screening          based on drooped
                                 battery - rat      palpebral closure,
                                                    decrease in rectal
                                                    temperature and
                                                    locomotor activity
                                                    and increase in
                                                    forelimb grip
                                                    strength (males
                                                    only). At higher
                                                    dose levels,
                                                    mortality, abnormal
                                                    body tone, ptosis,
                                                    impaired
                                                    respiration,
                                                    tremors, longer
                                                    latency to first
                                                    step in the open
                                                    field, crouched-over
                                                    posture, gait
                                                    impairment, hypo-
                                                    arousal, decreased
                                                    number of rears,
                                                    uncoordinated
                                                    landing during the
                                                    righting reflex
                                                    test, slight
                                                    lacrimation (females
                                                    only) and higher
                                                    mean average input
                                                    stimulus value in
                                                    the auditory startle
                                                    response test (males
                                                    only).

[[Page 66564]]

 
------------------------------------------------------------------------
870.6200                        Subchronic         NOAEL = 95.4 (males),
                                 neurotoxicity      216.4 (females) mg/
                                 screening          kg/day, both highest
                                 battery - rat      dose tested.
                                                   LOAEL = not
                                                    determined. No
                                                    treatment-related
                                                    observations at any
                                                    dose level. LOAEL
                                                    was not achieved.
                                                    May not have been
                                                    tested at
                                                    sufficiently high
                                                    dose levels;
                                                    however, new study
                                                    not required because
                                                    the weight of the
                                                    evidence from the
                                                    other toxicity
                                                    studies indicates no
                                                    evidence of concern.
------------------------------------------------------------------------
870.7485                        Metabolism and     Absorbed rapidly and
                                 pharmacokinetics   extensively, widely
                                 - rat              distributed,
                                                    followed by very
                                                    rapid elimination,
                                                    mostly in urine.
                                                    Highest tissue
                                                    concentrations in
                                                    skeletal muscle: 10-
                                                    15% of administered
                                                    dose. Half life
                                                    times from tissues
                                                    ranged from 2-6
                                                    hours. Tissue
                                                    residues after 7
                                                    days extremely low.
                                                    Approximately 84-95%
                                                    of administered dose
                                                    excreted in urine
                                                    and 2.5-6% excreted
                                                    in feces within 24
                                                    hours. Greater than
                                                    0.2% detected in
                                                    expired air. Most
                                                    excreted as
                                                    unchanged parent: 70-
                                                    80% of dose. The
                                                    major
                                                    biotransformation
                                                    reaction is cleavage
                                                    of oxadiazine ring
                                                    to corresponding
                                                    nitroguanidine
                                                    compound. Minor
                                                    pathways: (1)
                                                    cleavage of
                                                    nitroguanidine group
                                                    yielding guanidine
                                                    derivative, (2)
                                                    hydrolysis of
                                                    guanidine group to
                                                    corresponding urea,
                                                    (3) demethylation of
                                                    guanidine group, and
                                                    (4) substitution of
                                                    the chlorine of the
                                                    thiazole ring by
                                                    glutathione.
                                                    Cleavage between
                                                    thiazole- and
                                                    oxadiazine ring
                                                    occurs to a small
                                                    extent. Glutathione
                                                    derivatives prone to
                                                    further degradation
                                                    of the glutathione
                                                    moiety resulting in
                                                    various sulfur-
                                                    containing
                                                    metabolites (e.g.
                                                    mercapturates,
                                                    sulfides, and
                                                    sulfoxides). Both
                                                    the thiazole and
                                                    oxadiazine moiety
                                                    susceptible to
                                                    oxidative attack.
                                                    Small but measurable
                                                    amounts exhaled,
                                                    most probably as
                                                    CO2. Metabolites
                                                    eliminated very
                                                    rapidly.
                                                    Enterohepatic
                                                    circulation
                                                    negligible.
------------------------------------------------------------------------
870.7485                        Metabolism and     Approximately 72% of
                                 pharmacokinetics   administered dose
                                 - mouse            excreted in the
                                                    urine; 19% excreted
                                                    in feces. Small but
                                                    measurable amount
                                                    detected in expired
                                                    air (approximately
                                                    0.2% of dose).
                                                   Predominant
                                                    metabolites:
                                                    unchanged parent (33-
                                                    41% of administered
                                                    dose; 2 other
                                                    metabolites: 8-12%
                                                    and 9-18% of
                                                    administered dose.
                                                    These are the same
                                                    structures that were
                                                    most commonly
                                                    observed in rat
                                                    excreta, however the
                                                    proportions are
                                                    quite different in
                                                    mouse excreta. One
                                                    additional
                                                    significant
                                                    metabolite (mouse
                                                    R6) was isolated
                                                    from feces samples.
                                                    Between 30-60% of
                                                    the administered
                                                    dose was excreted as
                                                    metabolites.
------------------------------------------------------------------------
870.7600                        Dermal             Estimates of dermal
                                 penetration -      absorption were
                                 rat                based on the sum of
                                                    radioactivity in
                                                    skin test site,
                                                    urine, feces, blood,
                                                    and carcass.
                                                    Percentage dermal
                                                    absorption is 27.0,
                                                    highest mean dermal
                                                    absorption value
                                                    across all groups.
                                                    This value is
                                                    considered to
                                                    represent the
                                                    potential cumulative
                                                    dermal absorption of
                                                    test material that
                                                    might occur after a
                                                    10 hour dermal
                                                    exposure. As the
                                                    study design did not
                                                    permit analysis of
                                                    the fate of skin
                                                    bound residues,
                                                    residues at skin
                                                    site were included
                                                    in determination of
                                                    dermal absorption.
------------------------------------------------------------------------
                                Hepatic cell       NOAEL = 16 (males),
                                 proliferation      20 (females) mg/kg/
                                 study - mouse      day
                                                   LOAEL = 72 (males),
                                                    87 (females) mg/kg/
                                                    day based on
                                                    proliferative
                                                    activity of
                                                    hepatocytes. At
                                                    higher dose levels,
                                                    increases in
                                                    absolute and
                                                    relative liver wts,
                                                    speckled liver,
                                                    hepatocellular
                                                    glycogenesis/fatty
                                                    change,
                                                    hepatocellular
                                                    necrosis, apoptosis
                                                    and pigmentation
                                                    were observed.
------------------------------------------------------------------------
                                Replicative DNA    NOAEL = 711 mg/kg/day
                                 synthesis in 28-   (highest dose
                                 day feeding        tested)
                                 study - male rat  LOAEL = not
                                                    established.
                                                    Immunohistochemical
                                                    staining of liver
                                                    sections from
                                                    control and high-
                                                    dose animals for
                                                    proliferating cell
                                                    nuclear antigen gave
                                                    no indication for a
                                                    treatment-related
                                                    increase in the
                                                    fraction of DNA
                                                    synthesizing
                                                    hepatocytes in S-
                                                    phase. CGA 293343
                                                    did not stimulate
                                                    hepatocyte cell
                                                    proliferation in
                                                    male rats.
------------------------------------------------------------------------
                                Special study to   NOAEL = 17 (males),
                                 assess liver       20 (females) mg/kg/
                                 biochemistry in    day
                                 mouse             LOAEL = 74 (males),
                                                    92 (females) mg/kg/
                                                    day based on
                                                    marginal to slight
                                                    increases in
                                                    absolute and
                                                    relative liver
                                                    weights, a slight
                                                    increase in the
                                                    microsomal protein
                                                    content of the
                                                    livers, moderate
                                                    increases in the
                                                    cytochrome P450
                                                    content, slight to
                                                    moderate increases
                                                    in the activity of
                                                    several microsomal
                                                    enzymes, slight to
                                                    moderate induction
                                                    of cytosolic
                                                    glutathione S-
                                                    transferase
                                                    activity. Treatment
                                                    did not affect
                                                    peroxisomal fatty
                                                    acid
                                                    [beta]oxidation.
------------------------------------------------------------------------


[[Page 66565]]

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factors 
(SF) is retained due to concerns unique to the FQPA, this additional 
factor is applied to the RfD by dividing the RfD by such additional 
factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is 
a modification of the RfD to accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-6 or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for thiamethoxam used for human risk assessment is shown in 
Table 2 of this unit:

     Table 2.--Summary of Toxicological Dose and Endpoints for Thiamethoxam for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                              FQPA SF\*\ and Level
         Exposure Scenario              Dose Used in Risk      of Concern for Risk     Study and Toxicological
                                         Assessment, UF            Assessment                  Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietarygeneral population      NOAEL = 100 mg/kg/day   FQPA SF = 10            Acute mammalian
 including infants and children      UF = 100..............  aPAD = acute RfD/FQPA    neurotoxicity study in the
                                     Acute RfD = 1 mg/kg/     SF = 0.1 mg/kg/day.     rat
                                      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)
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations      NOAEL= 0.6 mg/kg/day    FQPA SF = 10            2-Generation reproduction
                                     UF = 100..............  cPAD = chronic RfD/      study
                                     Chronic RfD = 0.006 mg/  FQPA SF = 0.0006 mg/   LOAEL = 1.8 mg/kg/day based
                                      kg/day.                 kg/day.                 on increased incidence and
                                                                                      severity of tubular
                                                                                      atrophy in testes of F1
                                                                                      generation males.
----------------------------------------------------------------------------------------------------------------
Oral Nondietary (all durations)      NOAEL= 0.6 mg/kg/day    LOC for MOE = 1,000     2-Generation reproduction
                                                              (Residential)           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)(Residential)  Oral study NOAEL= 0.6   LOC for MOE = 1,000     2-Generation reproduction
                                      mg/kg/day(dermal        (Residential)           study
                                      absorption rate =      LOC for MOE = 100       LOAEL = 1.8 mg/kg/day based
                                      27%)                    (Occupational).         on increased incidence and
                                                                                      severity of tubular
                                                                                      atrophy in testes of F1
                                                                                      generation males.
----------------------------------------------------------------------------------------------------------------
Inhalation (all                      Oral study NOAEL= 0.6   LOC for MOE = 1,000     2-Generation reproduction
 durations)(Residential)              mg/kg/day (inhalation   (Residential)           study
                                      absorption rate =      LOC for MOE = 100       LOAEL = 1.8 mg/kg/day based
                                      100%)                   (Occupational).         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 SF refers to any additional SF retained due to concerns unique to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.565) for the combined residues of thiamethoxam 
and its metabolite, in or on a variety of raw agricultural commodities. 
The following raw agricultural commodities have established tolerances: 
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,

[[Page 66566]]

 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-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one day 
or single exposure. The Dietary Exposure Evaluation Model (DEEM[reg]) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1994-1996 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: tolerence level residues and 100% crop treated.
    ii. Chronic exposure.In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM[reg]) analysis 
evaluated the individual food consumption as reported by respondents in 
the USDA 1994-1996 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 chronic exposure 
assessments: percent crop treated (based on projected market shares) 
and anticipated residues (tier 3).
    iii. Cancer. The dietary exposure for determining cancer risk is 
based on the chronic exposure explained in the previous paragraph using 
the same assumptions.
    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 percent crop treated (PCT) information as follows 
in Table 3.

    Table 3.--Thiamethoxam Uses and Estimates of Percent Crop Treated
------------------------------------------------------------------------
                                                          Percent Crop
                         Crop                               Treated
------------------------------------------------------------------------
Tuberous and Corm Vegetables - Crop Subgroup 1 C                       9
------------------------------------------------------------------------
Fruiting Vegetables (Except Cucurbits - Crop Group 8                  15
------------------------------------------------------------------------
Cucumbers                                                              5
------------------------------------------------------------------------
Melons                                                                13
------------------------------------------------------------------------
Casabas                                                               44
------------------------------------------------------------------------
Crenshaws                                                             44
------------------------------------------------------------------------
Squash                                                                44
------------------------------------------------------------------------
Pumpkin                                                               44
------------------------------------------------------------------------
Apples                                                                 5
------------------------------------------------------------------------
Crabapples                                                            53
------------------------------------------------------------------------
Pears                                                                  9
------------------------------------------------------------------------
Quinces                                                               53
------------------------------------------------------------------------
Loquats                                                               53
------------------------------------------------------------------------
Field, corn                                                            6
------------------------------------------------------------------------
Pop, sweet corn                                                      100
------------------------------------------------------------------------

    Since the May 23, 2001 Final Rule establishing tolerances for 
thiamethoxam, the Agency has updated the percent crop-treated value for 
apples. The registrant is voluntarily restricting use of thiamethoxam 
on apples to only three states, Michigan, New York and Pennsylvania. 
These three states account for 28% of the U.S. apple production 
(122,000 out of 430,200 bearing acres). After consultation with experts 
in the field, EPA believes that no more than 10% of the apple acreage 
in these states will be treated with thiamethoxam. Thus, using a 
percent crop-treated value of 5% for the U.S. apple acreage is expected 
to be an over-estimate of the acres which will actually be treated with 
thiamethoxam.
    The Agency used 6% CT for field corn since this is the percent 
crop-treated value for the market leader. Sweet corn exposure 
estimates, which currently make up the bulk of the exposure for the 
cereal grains, assume 100% crop treated.
    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 regional populations.
    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/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
SCI-GROW, which predicts pesticide concentrations in groundwater. In 
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS 
(a tier 2 model) for a screening-level assessment for surface water. 
The GENEEC model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. GENEEC incorporates a 
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir 
environment in place of the previous pond scenario. The PRZM/EXAMS 
model includes a percent crop area factor as an adjustment to account 
for the maximum percent crop coverage within a watershed or drainage 
basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw

[[Page 66567]]

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 below.
    Based on the PRZM/EXAMS and SCI-GROW models the estimated 
environmental concentrations (EECs) of thiamethoxam for acute exposures 
are estimated to be 11.4 parts per billion (ppb) for surface water and 
1.94 ppb for ground water. The EECs for chronic exposures are estimated 
to be 0.77 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. Although such uses have been requested, 
they are not being assessed at this time.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) 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 or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
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 final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. Safety factor for infants and children--i. In general. FFDCA 
section 408 provides that EPA shall apply an additional tenfold margin 
of safety for infants and children in the case of threshold effects to 
account for prenatal and postnatal toxicity and the completeness of the 
database on toxicity and exposure unless EPA determines that a 
different margin of safety will be safe for infants and children. 
Margins of safety are incorporated into EPA risk assessments either 
directly through use of a margin of exposure (MOE) analysis or through 
using uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk to humans.
    ii. 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 male 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.
    iii. Conclusion. Based on: a. Effects on endocrine organs observed 
across species.
    b. The significant decrease in alanine amino transferase levels in 
the companion animal studies and in the dog studies.
    c. The mode of action of this chemical in insects (interferes with 
the nicotinic acetyl choline receptors of the insect's nervous system) 
thus a developmental neurotoxicity study is required.
    d. The transient clinical signs of neurotoxicity in several studies 
across species.
    e. The suggestive evidence of increased quantitative susceptibility 
in the rat reproduction study, the Agency is retaining the FQPA factor 
which is l0X.

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 the EPA are used to calculate DWLOCs: 2L/70 kg (adult 
male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body 
weights and drinking water consumption values vary on an individual 
basis. This variation will be taken into account in more refined 
screening-level and quantitative drinking water exposure assessments. 
Different populations will have different DWLOCs. Generally, a DWLOC is 
calculated for each type of risk assessment used: acute, short-term, 
intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, 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

[[Page 66568]]

exposure from food to thiamethoxam will occupy 3% of the aPAD for the 
U.S. population, 2% of the aPAD for females 13-49 years old, 7% of the 
aPAD for all infants less than 1 year old and 9% of the aPAD for 
children 1-2 years old. In addition, there is potential for acute 
dietary exposure to thiamethoxam in drinking water. The surface water 
EEC is 11.4 [mu]g/L and the ground water EEC is 1.94 [mu]g/L. Since the 
surface water value is greater than the ground water value, the surface 
water value will be used for comparison purposes and will protect for 
any concerns for ground water concentrations. After calculating DWLOCs 
and comparing them to the EECs for surface water, EPA does not expect 
the aggregate exposure to exceed 100% of the aPAD.

                     Table 4.--Aggregate Risk Assessment for Acute Exposure to Thiamethoxam
----------------------------------------------------------------------------------------------------------------
                                                                              Ground      Surface
               Population Subgroup                 aPAD, mg/     % aPAD     Water EEC,   Water EEC,     DWLOC,
                                                     kg/day      (Food)      [mu]g/L      [mu]g/L      [mu]g/L
----------------------------------------------------------------------------------------------------------------
U.S. Population                                          0.1            3         1.94         11.4        3,400
----------------------------------------------------------------------------------------------------------------
All Infants (0-1 yr)                                     0.1            7         1.94         11.4          930
----------------------------------------------------------------------------------------------------------------
Children (1-2 yr)                                        0.1            9         1.94         11.4          910
----------------------------------------------------------------------------------------------------------------
Children (3-5 yr)                                        0.1            7         1.94         11.4          940
----------------------------------------------------------------------------------------------------------------
Children (6-12 yr)                                       0.1            4         1.94         11.4          960
----------------------------------------------------------------------------------------------------------------
Youth (13-19 yr)                                         0.1            2         1.94         11.4          980
----------------------------------------------------------------------------------------------------------------
Adult (20-49 yr)                                         0.1            2         1.94         11.4        3,400
----------------------------------------------------------------------------------------------------------------
Adult (50+ yr)                                           0.1            2         1.94         11.4        3,400
----------------------------------------------------------------------------------------------------------------
Females (13-49 yr)                                       0.1            2         1.94         11.4        2,900
----------------------------------------------------------------------------------------------------------------
\a\ Population subgroups shown include the U.S. general population and the maximally exposed subpopulation of
  adults, infants and children, and women of child-bearing age for each exposure scenario.
\b\ DWLOC = Maximum Water Exposure (mg/kg/day) H 1,000 [mu]g/mg body weight (70 kg general population/males 13+,
  60 kg females 13+, 10 kg infants and children) Water Consumption (2 L/day adults, 1 L/day infants and
  children). Maximum water exposure = aPAD - dietary exposure (mg/kg/day)

    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 5% of the cPAD for the U.S. 
population, 13% of the cPAD for all infants < 1 year old and 19% of the 
cPAD for children 1-2 years old. Proposed residential uses are not 
being addressed in this risk assessment. In addition to chronic dietary 
exposure, there is potential for chronic dietary exposure to 
thiamethoxam in drinking water. The surface water EEC is 0.6 [mu]g/L 
and the groundwater EEC is 1.94 [mu]g/L. Since the groundwater value is 
greater than the surface water value, the groundwater value will be 
used for comparison purposes and will protect for any concerns for 
surface water concentrations. After calculating the DWLOCs and 
comparing them to the EECs for groundwater, EPA does not expect the 
aggregate exposure to exceed 100% of the cPAD.

                                  Table 5.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Thiamethoxam
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                        % cPAD     Surface Water    Ground Water EEC,
                       Population Subgroup                          cPAD, mg/kg/day     (Food)      EEC, [mu]g/L         [mu]g/L         DWLOC [mu]g/L
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population                                                               0.0006          5               0.77                1.9                 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
All Infants (0-1 yr)                                                          0.0006         13               0.77                1.9                5.3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-2 yr)                                                             0.0006         19               0.77                1.9                4.9
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (3-5 yr)                                                             0.0006         14               0.77                1.9                5.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (6-12 yr)                                                            0.0006          7               0.77                1.9                5.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth (13-19 yr)                                                              0.0006          4               0.77                1.9                5.8
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adult (20-49 yr)                                                              0.0006          4               0.77                1.9                 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adult (50+ yr)                                                                0.0006          4               0.77                1.9                 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-49 yr)                                                            0.0006          4               0.77                1.9                 17
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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

[[Page 66569]]

on any sites that would result in residential exposure. Therefore, the 
aggregate risk is the sum of the risk from food and water, which does 
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 does not exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. The cancer aggregate 
dietary risk estimate was calculated, using the Agency's 6% estimated 
market share for treatment of field corn. The dietary cancer risk from 
residues in food is 0.9 x 10-6. 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:

DWLOCcancer([mu]g/L) = [chronic water exposure(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 - 0.0000245 = 0.0000551 
mg/kg/day

The DWLOCcancer = 0.0000551 mg/kg/day x 70 kg / 2L x 
10-3 mg/[mu]g = 1.9 [mu]g/L

    The surface water EEC is 0.6 [mu]g/L and the ground water EEC is 
1.9 [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. The estimated 
chronic ground water value for thiamethoxam (1.9 [mu]g/L) is 
essentially at the DWLOCcancer level for the general 
population using the 6% market share for treated field, corn seed.
    The Agency used a screening level model designed to estimate 
pesticide concentrations in shallow ground water. A number of factors 
lead EPA to believe that the actual lifetime exposure through drinking 
water will be less than the DWLOCcancer. These reasons are 
as follows:
    a. Thiamethoxam is systemic. EPA's Tier 1 ground water model 
assumes that all of the product that is applied to the crop is 
available for runoff. The registrant has submitted data to show that a 
percentage (15-25%) of the product is absorbed by the plant, resulting 
in that much less product available to leach into ground water. 
Although the registrant has submitted data on only 2 crops, beans and 
cucumbers, it is likely that the total amount of thiamethoxam that is 
available to leach into ground water is less than the amount EPA uses 
as an input into its model. Due to limited data on the amount absorbed, 
EPA is unable to quantify this.
    b. Although the Agency model is based on aerobic soil half lives, 
EPA's risk assessment for cancer estimate is for lifetime exposure. 
Data indicate the anaerobic aquatic half life for thiamethoxam is 
shorter than the aerobic soil half life and longer than the aerobic 
aquatic half life. Although EPA is unable to predict with a high degree 
of certainty about what happens to thiamethoxam over time in ground 
water, this does provide some support for an expectation that 
concentrations in ground water will decline between annual 
applications.
    c. Shallow ground water modeling is not the perfect model for 
representing all drinking water from ground water sources. It is likely 
to be an overestimate of most drinking water, which tends to originate 
from deeper sources. EPA's experience is that the model is reasonably 
accurate for shallow drinking water, but the Agency believes that it is 
less accurate for drinking water from deeper sources.
    d. The Agency has established conditions of registration for the 
previous uses which include two prospective ground water studies and a 
retrospective monitoring study, so that the reasonable certainty of no 
harm finding will be sustained. Preliminary results have indicated no 
detections of thiamethoxam in ground water.
    e. The cancer risk from the food uses alone is 0.9 x 
10-6. The dietary risk is based on residue data derived from 
the average of field trials, which were performed at a higher applied-
on rate than were accepted by the EPA. It is not unusual in the 
Agency's experience for field trial data to be an order of magnitude 
above actual monitoring. Since thiamethoxam has only recently been 
registered, actual monitoring data is not yet available. It is likely 
that the actual risk contribution from food will be much lower than 
current data indicate, which would result in a larger 
DWLOCcancer. EPA expects that this refined 
DWLOCcancer would be larger than the EECs for the proposed 
uses. It should be noted that there are no detectable residues in the 
subject corn commodities.
    Thus, EPA does not expect that the general population would be 
exposed to levels exceeding the DWLOCcancer over a lifetime.
    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.

A. Analytical Enforcement Methodology

    Adequate enforcement methodology High Performance Liquid 
Chromatography using ultra violet or mass spectrometry (HPLC/UV or MS) 
is available to enforce the tolerance expression. The method may be 
requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, 
Washington, DC 20460; telephone number: (703) 305-5229; 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-nitro-guanidine, in or on field corn 
forage at 0.10 ppm, sweet corn forage at 0.10 ppm, popcorn forage at 
0.10 ppm, field corn stover at 0.05 ppm, sweet corn stover at 0.05 ppm, 
field corn grain at 0.07 ppm, popcorn grain at 0.02 ppm, and sweet corn 
(kernal and cob with husk removed) at 0.02 ppm.

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. 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 
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

[[Page 66570]]

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-2002-0298 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 December 
31, 2002.
    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-2002-0298, 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 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).

VII. Regulatory Assessment Requirements

    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 
(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

[[Page 66571]]

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. Submission to Congress and the Comptroller General

    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, Pesticide and pests, Reporting and 
recordkeeping requirements.

    Dated: October 24, 2002.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

    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) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Corn, field, forage........................................         0.10
Corn, pop, forage..........................................         0.10
Corn, sweet, forage........................................         0.10
Corn, field, grain.........................................        0.020
Corn, pop, grain...........................................         0.02
Corn, field, stover........................................         0.05
Corn pop, stover...........................................         0.05
Corn, sweet, stover........................................         0.05
Corn, sweet, kernal plus cob with husks removed............         0.02
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 02-27830 Filed 10-31-02; 8:45 am]
BILLING CODE 6560-50-S