[Federal Register Volume 68, Number 104 (Friday, May 30, 2003)]
[Rules and Regulations]
[Pages 32390-32400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13564]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0133; FRL-7306-8]


Clothianidin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
clothianidin in or on canola, corn, and milk. In addition, tolerances 
are established for indirect or inadvertent residues of clothianidin in 
or on nongrass animal feed; cereal grain forage, fodder and straw; 
grass forage, fodder and hay; and soybean forage and hay. Bayer 
Corporation requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act 
of 1996 (FQPA).

DATES: This regulation is effective May 30, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0133, 
must be received on or before July 29, 2003.

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

FOR FURTHER INFORMATION CONTACT: Daniel Kenny, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone 
number: (703) 305-7546; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Crop Production (NAICS 111)
    [sbull] Animal Production (NAICS 112)
    [sbull] Food Manufacturing (NAICS 311)
    [sbull] Pesticide Manufacturing (NAICS 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0133. 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 November 14, 2001 (66 FR 57079) (FRL-
6809-7), 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 1F6315) by Bayer Corporation, 8400 
Hawthorn Road, Kansas City, MO 64120. That notice included a summary of 
the petition prepared by Bayer Corporation, the registrant. There were 
no comments received in response to the notice of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the insecticide clothianidin, 
(E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in 
or on canola, seed at 0.01 parts per million (ppm); corn, field, grain 
at 0.01 ppm; corn, pop, grain at 0.01 ppm; corn, sweet, kernel plus cob 
with husk removed at 0.01 ppm; corn, field, forage at 0.10 ppm; corn, 
sweet, forage at 0.10 ppm; corn, field, stover at 0.10 ppm; corn, 
sweet, stover at 0.10 ppm; corn, pop, stover at 0.10 ppm; and milk at 
0.01 ppm. Following the review of all the data, tolerances are also 
required on the following rotational crops, which are used only for 
livestock feeds. These tolerances do not impact the dietary risk

[[Page 32391]]

assessment since these residues are significantly lower than those in 
feed items from the crops which are treated directly with clothianidin 
and/or thiamethoxam. Tolerances are established on animal feed, 
nongrass at 0.02 ppm; grain, cereal, forage, fodder and straw at 0.02 
ppm; grass, forage, fodder and hay at 0.02 ppm; soybean, forage at 0.02 
ppm; and soybean, hay 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 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 tolerances for residues of clothianidin on 
canola, seed at 0.01 ppm; corn, field, grain at 0.01 ppm; corn, pop, 
grain at 0.01 ppm; corn, sweet, kernel plus cob with husk removed at 
0.01 ppm; corn, field, forage at 0.10 ppm; corn, sweet, forage at 0.10 
ppm; corn, field, stover at 0.10 ppm; corn, sweet, stover at 0.10 ppm; 
corn, pop, stover at 0.10 ppm; and milk at 0.01 ppm, animal feed, 
nongrass at 0.02 ppm; grain, cereal, forage, fodder and straw at 0.02 
ppm; grass, forage, fodder and hay at 0.02 ppm; soybean, forage at 0.02 
ppm; and soybean, hay at 0.02 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 clothianidin 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: 27.9/34.0
                                  toxicity rodents    milligrams/
                                  (rats)              kilogram/day (mg/
                                                      kg/day) (male/
                                                      female)
                                                     LOAEL: 202.0/254.2
                                                      mg/kg/day (male/
                                                      female: decreased
                                                      body weight (bwt)
                                                      and bwt gain)
------------------------------------------------------------------------
870.3150                         90-Day oral         NOAEL: 19.3/42.1 mg/
                                  toxicity in         kg/day (male/
                                  nonrodents (dogs)   female)
                                                     LOAEL: 40.9/61.8 mg/
                                                      kg/day (thinness,
                                                      decreased bwt, bwt
                                                      gain and anemia
                                                      (one male);
                                                      decreased white
                                                      blood cells,
                                                      albumin, and total
                                                      protein (female)
------------------------------------------------------------------------
870.3200                         21/28-Day dermal    NOAEL: 1,000 mg/kg/
                                  toxicity (rats)     day (highest dose
                                                      tested)
                                                     LOAEL: > 1,000 mg/
                                                      kg/day
------------------------------------------------------------------------
870.3700                         Prenatal            Maternal NOAEL: 10
                                  developmental in    mg/kg/day
                                  rodents (rats)     Maternal LOAEL: 40
                                                      mg/kg/day
                                                      (decreased bwt
                                                      gain and food
                                                      consumption)
                                                     Developmental
                                                      NOAEL: 125 mg/kg/
                                                      day
                                                     Developmental
                                                      LOAEL: cannot be
                                                      established
------------------------------------------------------------------------
870.3700                         Prenatal            Maternal NOAEL: 25
                                  developmental in    mg/kg/day
                                  nonrodents         Maternal LOAEL: 75
                                  (rabbit)            mg/kg/day
                                                      (increased
                                                      incidences of
                                                      clinical signs
                                                      (scant feces and
                                                      orange urine),
                                                      mortalities,
                                                      decreased food
                                                      consumption, early
                                                      delivery,
                                                      abortion, and
                                                      decreased bwt
                                                      gain)
                                                     Developmental
                                                      NOAEL: 25 mg/kg/
                                                      day
                                                     Developmental
                                                      LOAEL: 75 mg/kg/
                                                      day (premature
                                                      deliveries,
                                                      decreased gravid
                                                      uterine weights,
                                                      an increased
                                                      litter incidence
                                                      of a missing lobe
                                                      of the lung and
                                                      decreased litter
                                                      average for
                                                      ossified sternal
                                                      centra per fetus)
------------------------------------------------------------------------

[[Page 32392]]

 
870.3800                         Reproduction and    Parental systemic
                                  fertility effects   NOAEL: 31.2/36.8
                                  (rat)               mg/kg/day (male/
                                                      female)
                                                     Parental systemic
                                                      LOAEL: 163.4/188.8
                                                      mg/kg/day (male/
                                                      female) (decreased
                                                      bwt, bwt gain and
                                                      absolute and
                                                      relative thymus
                                                      weights)
                                                     Offspring systemic
                                                      NOAEL: 9.8/11.5 mg/
                                                      kg/day (male/
                                                      female)
                                                     Offspring systemic
                                                      LOAEL: 31.2/36.8
                                                      mg/kg/day (male/
                                                      female: decreased
                                                      bwt gains and
                                                      delayed sexual
                                                      maturation (male);
                                                      decreased absolute
                                                      thymus weights in
                                                      F1 pups of both
                                                      sexes and an
                                                      increase in
                                                      stillbirths in
                                                      both generations)
                                                     Reproductive NOAEL:
                                                      31.2/188.8 mg/kg/
                                                      day (male/female)
                                                     Reproductive LOAEL:
                                                      163.4/not
                                                      established mg/kg/
                                                      day (male/female:
                                                      decreased sperm
                                                      motility, and
                                                      increased number
                                                      of sperm with
                                                      detached heads in
                                                      both generations)
------------------------------------------------------------------------
870.4100                         Chronic toxicity    NOAEL: 46.4/40.1 mg/
                                  dogs                kg/day (male/
                                                      female)
                                                     LOAEL: Not
                                                      established/52.9
                                                      mg/kg/day (male/
                                                      female: clinical
                                                      evidence of anemia
                                                      in females). Note:
                                                      dose-related
                                                      decreases in ALT
                                                      activity observed
                                                      in mid- and high-
                                                      dose males and
                                                      females
------------------------------------------------------------------------
870.4200                         Carcinogenicity     NOAEL: 171.4/65.1
                                  mice                mg/kg/day (male/
                                                      female)
                                                     LOAEL: 254.1/215.9
                                                      mg/kg/day (male/
                                                      female: decreased
                                                      bwt and bwt gain;
                                                      decreased food
                                                      consumption and
                                                      food efficiency in
                                                      males at the
                                                      LOAEL). No
                                                      evidence of
                                                      carcinogenicity
------------------------------------------------------------------------
870.4300                         Chronic feeding/    NOAEL: 82.0/32.5 mg/
                                  Carcinogenicity     kg/day (male/
                                  rat                 female)
                                                     LOAEL: 156.5/97.8
                                                      mg/kg/day (male/
                                                      female, decreased
                                                      bwt and food
                                                      consumption and
                                                      altered
                                                      hepatocellular
                                                      eosinophilic focus
                                                      of the liver in
                                                      both sexes; ovary
                                                      interstitial gland
                                                      hyperplasia and
                                                      increased
                                                      lymphohistiocytic
                                                      infiltrate in
                                                      females; and
                                                      slightly increased
                                                      incidences of
                                                      pelvic
                                                      mineralization and
                                                      transitional cell
                                                      hyperplasia in the
                                                      kidney, mottled
                                                      livers of males.
                                                      No evidence of
                                                      carcinogenicity
------------------------------------------------------------------------
870.5100                         Gene Mutation       Small, but
                                  bacterial reverse   significant
                                  mutation assay      increase in
                                  Parent              frequency of
                                                      histidine
                                                      revertants in
                                                      TA1535 strain
                                                      treated at 1,500
                                                      and 5,000 [mu]g/
                                                      plate +/-S9; still
                                                      present but weaker
                                                      in its absence.
                                                      The positive
                                                      response was only
                                                      reproducible at
                                                      5,000 [mu]g/plate
                                                      +/-S9.
                                                      Clothianidin
                                                      considered
                                                      mutagenic under
                                                      conditions of this
                                                      test
------------------------------------------------------------------------
870.5100                         Gene Mutation       No mutagenic
                                  bacterial reverse   activity in
                                  mutation assay      bacteria
                                  Parent              (Salmonella
                                                      typhimurium and
                                                      Escherichia coli)
                                                      under conditions
                                                      of this assay
------------------------------------------------------------------------
870.5100                         Gene Mutation       No mutagenic
                                  bacterial reverse   activity in
                                  mutation assay      bacteria
                                  Parent              (Salmonella
                                                      typhimurium) under
                                                      conditions of this
                                                      assay
------------------------------------------------------------------------
870.5100                         Gene Mutation       Only TA 1535
                                  bacterial reverse   tested. No
                                  mutation assay      mutagenic activity
                                  Parent              in bacteria
                                                      (Salmonella
                                                      typhimurium) under
                                                      conditions of this
                                                      assay
------------------------------------------------------------------------
870.5100                         Gene Mutation       No mutagenic
                                  bacterial reverse   activity in
                                  mutation assay      bacteria
                                  BN0335E2            (Salmonella
                                  metabolite          typhimurium) under
                                                      conditions of this
                                                      assay
------------------------------------------------------------------------
870.5100                         Gene Mutation       No mutagenic
                                  bacterial reverse   activity in
                                  mutation assay      bacteria
                                  TZMU metabolite     (Salmonella
                                                      typhimurium) under
                                                      conditions of this
                                                      assay
------------------------------------------------------------------------
870.5100                         Gene Mutation       No mutagenic
                                  bacterial reverse   activity in
                                  mutation assay      bacteria
                                  methyl guanidine    (Salmonella
                                  intermediate        typhimurium) under
                                                      conditions of this
                                                      assay
------------------------------------------------------------------------
870.5100                         Gene Mutation       No mutagenic
                                  bacterial reverse   activity in
                                  mutation assay      bacteria
                                  TZNG metabolite     (Salmonella
                                                      typhimurium) under
                                                      conditions of this
                                                      assay
------------------------------------------------------------------------
870.5100                         Gene Mutation       No mutagenic
                                  bacterial reverse   activity in
                                  mutation assay      bacteria
                                  TMG metabolite      (Salmonella
                                                      typhimurium) under
                                                      conditions of this
                                                      assay
------------------------------------------------------------------------

[[Page 32393]]

 
870.5100                         Gene Mutation       No mutagenic
                                  bacterial reverse   activity in
                                  mutation assay      bacteria
                                  BN0230M             (Salmonella
                                  metabolite          typhimurium) under
                                                      conditions of this
                                                      assay
------------------------------------------------------------------------
870.5100                         Gene Mutation       No mutagenic
                                  bacterial reverse   activity in
                                  mutation assay      bacteria
                                  MAI metabolite      (Salmonella
                                                      typhimurium) under
                                                      conditions of this
                                                      assay
------------------------------------------------------------------------
870.5100                         Gene Mutation       No mutagenic
                                  bacterial reverse   activity in
                                  mutation assay N-   bacteria
                                  Methylnitroguanid   (Salmonella
                                  in intermediate     typhimurium) under
                                                      conditions of this
                                                      assay
------------------------------------------------------------------------
870.5100                         Gene Mutation -     No mutagenic
                                  bacterial reverse   activity in
                                  mutation assay TI   bacteria
                                  435-Triazan         (Salmonella
                                  intermediate        typhimurium) under
                                                      conditions of this
                                                      assay
------------------------------------------------------------------------
870.5100                         Gene Mutation -     No mutagenic
                                  bacterial reverse   activity in
                                  mutation assay TI   bacteria
                                  435-CCMT- Adduct    (Salmonella
                                                      typhimurium) under
                                                      conditions of this
                                                      assay
------------------------------------------------------------------------
870.5300                         Gene Mutation - in  Increases in mutant
                                  vitro mammalian     frequency with and
                                  cell gene           without S9 at dose
                                  mutation test       levels that were
                                  (L5178Y TK +/-      cytotoxic. The
                                  mouse lymphoma      observed response
                                  cells) Parent       was primarily due
                                                      to small colony
                                                      formation,
                                                      indicating
                                                      clastogenic
                                                      activity
------------------------------------------------------------------------
870.5300                         Gene Mutation - in  No increase in
                                  vitro mammalian     mutant frequency
                                  cell gene           under the
                                  mutation test       conditions of the
                                  (V79-HPRT Assay)    study
                                  Parent
------------------------------------------------------------------------
870.5395                         Cytogenetics -      Clothianidin is
                                  mammalian           considered to be
                                  erythrocyte         neither
                                  micronucleus test   clastogenic nor
                                  Parent              aneugenic under
                                                      these test
                                                      conditions
------------------------------------------------------------------------
870.5375                         Cytogenetics - in   Significant
                                  vitro mammalian     increases in
                                  chromosome          frequency of cells
                                  aberration test     with structural
                                  (CHL Cells)         aberrations.
                                  Parent              Predominant types
                                                      were chromatid
                                                      breaks and
                                                      exchanges. There
                                                      was, however, no
                                                      clear indication
                                                      of a dose-related
                                                      response in either
                                                      the presence or
                                                      absence of S9
                                                      activation
------------------------------------------------------------------------
870.5500                         Other Effects -     No potential for
                                  DNA Repair Test     DNA damage under
                                  in Bacillus         these conditions
                                  subtillis Parent
------------------------------------------------------------------------
870.5550                         Other Effects -     No evidence (or a
                                  (UDS) in            dose related
                                  Mammalian Cells     positive response)
                                  in Culture Parent   that UDS was
                                                      induced
------------------------------------------------------------------------
870.6200                         Acute               NOAEL: Not
                                  neurotoxicity       established
                                  screening battery  LOAEL: 100 mg/kg
                                  (rat)               (FOB: decreased
                                                      arousal and
                                                      decreased motor
                                                      and locomotor
                                                      activity)
------------------------------------------------------------------------
870.6200                         Subchronic          NOAEL: 60.0/71.0 mg/
                                  neurotoxicity       kg/day (male/
                                  screening battery   female)
                                  (rat)              LOAEL: 177.0/200.1
                                                      mg/kg/day (male/
                                                      female: Slightly
                                                      decreased food
                                                      consumption, bwt
                                                      and bwt gains)
------------------------------------------------------------------------
870.6300                         Developmental       Maternal NOAEL:
                                  neurotoxicity       42.9 mg/kg/day
                                  (rat)              Maternal LOAEL: 142
                                                      mg/kg/day
                                                      (decreased bwt,
                                                      bwt gains, and
                                                      food consumption)
                                                     Offspring NOAEL:
                                                      12.9 mg/kg/day
                                                     Offspring LOAEL:
                                                      42.9 mg/kg/day
                                                      (decreased bwt and
                                                      bwt gains)
------------------------------------------------------------------------
870.7485                         Metabolism and      Overall recovery:
                                  pharmacokinetics    95-100%. Readily
                                  (rat)               absorbed and
                                                      excreted within 96
                                                      hours following a
                                                      single 2.5 mg/kg
                                                      bwt or repeated
                                                      oral dose of 25 mg/
                                                      kg bwt, but at a
                                                      dose of 250 mg/kg,
                                                      absorption became
                                                      biphasic and was
                                                      saturated
------------------------------------------------------------------------

[[Page 32394]]

 
870.7485                         Metabolism and      Of the administered
                                  pharmacokinetics    radioactivity,
                                  (mouse)             98.7-99.2% was
                                                      recovered. Readily
                                                      absorbed and
                                                      excreted within
                                                      168 hours
                                                      following a single
                                                      oral dose of 5 mg/
                                                      kg bwt
------------------------------------------------------------------------
870.7600                         Dermal Penetration  Dermal absorption
                                  - monkey            as the sum of
                                                      urinary and fecal
                                                      excretion and Cage/
                                                      Pan/Chair Wash,
                                                      Debris was 0.24 (+
                                                      0.11) as percent
                                                      of dose.
                                                      Adjustment of the
                                                      direct absorption
                                                      determination was
                                                      not necessary
                                                      because recovery
                                                      from the dermal
                                                      dose was 90%.
                                                     A value of 1%
                                                      dermal absorption
                                                      was considered
                                                      appropriate for
                                                      use in risk
                                                      assessment. This
                                                      estimation takes
                                                      into account any
                                                      variability that
                                                      would have likely
                                                      occurred with
                                                      testing several
                                                      dose levels
------------------------------------------------------------------------
                                 Special study:      NOAEL: 25 mg/kg/day
                                  Neurotoxicity and   (male/female)
                                  pharmacology       LOAEL: 50 mg/kg bw
                                  mouse               mg/kg/day
                                                      (transient signs
                                                      of decreased
                                                      spontaneous motor
                                                      activity, tremors,
                                                      and deep
                                                      respirations)
------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which the NOAEL from the toxicology study identified as 
appropriate for use in risk assessment is used to estimate the 
toxicological level of concern (LOC). However, the 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. EPA has concluded that the toxicology 
database for clothianidin is not complete. Due to evidence of effects 
on the immune system and that juvenile rats appear to be more 
susceptible to these effects, EPA has determined that testing should be 
conducted to assess immune system function in adults and in young 
animals following developmental exposures. Therefore, a 10X database UF 
is to be applied to all dietary exposure endpoints for the lack of a 
developmental immunotoxicity study.
    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 clothianidin used for human risk assessment is shown in 
Table 2 of this unit:

     Table 2.--Summary of Toxicological Dose and Endpoints for Clothianidin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk       Special FQPA SF2 and   Study and Toxicological
          Exposure Scenario                Assessment, UF1      LOC for Risk Assessment          Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary                          Developmental NOAEL =    FQPA SF = 1              Developmental rabbit
(Females 13-50 years of age).........   25                      aPAD = acute RfD /FQPA    study
                                       UF = 10001.............   SF= 0.025 mg/kg.        Developmental LOAEL =
                                       Acute RfD = 0.025 mg/kg                            75 mg/kg/day based on
                                                                                          an increased litter
                                                                                          incidence of a missing
                                                                                          lobe of the lung
-----------------------------------------------------------------------------------------
Acute Dietary                          NOAEL = 25               FQPA SF = 1 aPAD =       Special Neurotoxicity/
(General population).................  UF = 10001.............   acute RfD / FQPA SF      Pharmacology Study in
                                       Acute RfD = 0.025 mg/kg  = 0.025 mg/kg..........   Mice and Rats
                                                                                         LOAEL = 50 mg/kg based
                                                                                          on transient signs of
                                                                                          decreased spontaneous
                                                                                          motor activity,
                                                                                          tremors and deep
                                                                                          respirations
-----------------------------------------------------------------------------------------

[[Page 32395]]

 
Chronic Dietary                        Offspring NOAEL= 9.8     FQPA SF = 1 cPAD =       2-Generation
(All populations)....................  UF = 10001.............   chronic RfD / FQPA SF    Reproduction Study
                                       Chronic RfD = 0.0098 mg/ = 0.0098 mg/kg/day.....  Offspring LOAEL = 31.2
                                        kg/day.                                           mg/kg/day based on
                                                                                          decreased mean bwt
                                                                                          gain and delayed
                                                                                          sexual maturation,
                                                                                          decreased absolute
                                                                                          thymus weights in F1
                                                                                          pups and an increase
                                                                                          in stillbirths in both
                                                                                          generations
-----------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Classification: Not
                                        likely
----------------------------------------------------------------------------------------------------------------
1 An additional 10X database uncertainty factor for lack of a developmental immunotoxicity study.
2 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. Currently there are no 
tolerances established for clothianidin alone on any commodity. 
However, clothianidin is a major metabolite of thiamethoxam, and 
tolerances for the combined residues of thiamethoxam and its metabolite 
clothianidin have been established under 40 CFR part 180.565 for both 
plant and livestock commodities. Tolerances for thiamethoxam range from 
0.02 ppm to 1.5 ppm. Risk assessments were conducted by EPA to assess 
dietary exposures from clothianidin in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1-day or 
single exposure. The Dietary Exposure Evaluation Model (DEEM[reg]) 
analysis evaluated the individual food consumption as reported by 
respondents in the United States Department of Agriculture (USDA) 1994-
1996 and 1998 nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII) and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the acute exposure 
assessments: The acute analysis was a conservative, Tier I assessment 
which was based on tolerance level residues and the assumption of 100% 
crop treated. Although the only proposed uses for clothianidin are on 
canola and corn, clothianidin is a major metabolite of thiamethoxam 
which has many registered uses and several pending uses. As a result, 
residues of clothianidin which would theoretically result from the 
metabolism of thiamethoxam were included in the analysis. In crop field 
trials and in animal feeding studies, the quantities of both 
clothianidin and thiamethoxam were measured. The ratio of clothianidin 
to thiamethoxam in each commodity was multiplied by the respective 
thiamethoxam tolerance level to arrive at the theoretical maximum 
clothianidin residue level which would be present. These maximum 
clothianidin residues were used in the acute analysis. For the 
commodities which have both thiamethoxam tolerances and proposed 
clothianidin tolerances (i.e., sweet corn, field corn, pop corn, 
canola, and milk), the proposed clothianidin tolerances were added to 
the residues which result from use of thiamethoxam.
    As this is a Tier I assessment, dietary exposure and risk at the 
95th percentile of exposure are reported. The general U.S. population 
and all population subgroups have exposure and risk estimates which are 
below EPA's LOC (i.e., the aPADs are all below 100%). The most highly 
exposed population subgroup is children 1 to 2 years of age, which 
utilizes 16% of the aPAD.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment, the DEEM[reg] analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1994-1996 and 1998 
nationwide CSFII and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the chronic exposure 
assessments: The chronic analysis was a conservative, Tier I assessment 
which was based on tolerance level residues and the assumption of 100% 
crop treated. As stated previously, although the only proposed uses for 
clothianidin are on canola and corn, clothianidin is a major metabolite 
of thiamethoxam which has many registered uses and several pending 
uses. As a result, residues of clothianidin which would theoretically 
result from the metabolism of thiamethoxam were included in the 
analysis. In crop field trials and in animal feeding studies, the 
quantities of both clothianidin and thiamethoxam were measured. The 
ratio of clothianidin to thiamethoxam in each commodity was multiplied 
by the respective thiamethoxam tolerance level to arrive at the 
theoretical maximum clothianidin residue level which would be present. 
These maximum clothianidin residues were used in the chronic analysis. 
For the commodities which have both thiamethoxam tolerances and 
proposed clothianidin tolerances (i.e., sweet corn, field corn, pop 
corn, canola, and milk), the proposed clothianidin tolerances were 
added to the residues which result from use of thiamethoxam.
    The general U.S. population and all population subgroups have 
exposure and risk estimates which are below EPA's LOC (i.e., the 
chronic population adjusted doses (cPADs) are all below 100%). The most 
highly exposed population subgroup is children 1 to 2 years of age, 
which utilizes 18% of the cPAD.
    iii. Cancer. EPA has determined that clothianidin is not likely to 
be a human carcinogen and EPA, therefore, does not expect it to pose a 
cancer risk. As a result, a quantitive cancer dietary exposure analysis 
was not performed.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for clothianidin 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 clothianidin.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), 
to produce estimates of pesticide concentrations in an index reservoir.

[[Page 32396]]

The screening concentration in ground water (SCI-GROW) model is used to 
predict pesticide concentrations in shallow ground water. For a 
screening-level assessment for surface water EPA will use FIRST (a Tier 
I model) before using PRZM/EXAMS (a Tier II model). The FIRST model is 
a subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an 
index reservoir environment, the PRZM/EXAMS model includes a percent 
crop area factor as an adjustment to account for the maximum percent 
crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to clothianidin, they are 
further discussed in the aggregate risk sections.
    Based on the FIRST and SCI-GROW models, the EECs of clothianidin 
for acute exposures are estimated to be 3.97 parts per billion (ppb) 
for surface water and 1.46 ppb for ground water. The EECs for chronic 
exposures are estimated to be 2.14 ppb for surface water and 1.46 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). Clothianidin is not 
registered for use on any sites that would result in residential 
exposure. Clothianidin is a major metabolite of the insecticide 
thiamethoxam in plants and animals. Since there are also no residential 
uses of thiamethoxam, possible residential exposure to clothianidin due 
to thiamethoxam uses is not expected.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether clothianidin 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, 
clothianidin 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 clothianidin 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. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. No quantitative or 
qualitative susceptibility was observed in either of the developmental 
rat or rabbit studies. Quantitative susceptibility was observed in both 
the reproduction and developmental neurotoxicity studies; however, the 
degree of concern for these studies is low because the observed effects 
are well characterized and there are clear NOAELs/LOAELs in each case. 
In addition, the endpoint of concern is the one that is being used for 
short-, intermediate- and long-term dietary and non-dietary exposure 
risk assessments. There are no residual uncertainties. Therefore, there 
are no to low concerns with regard to prenatal and/or postnatal 
toxicity.
    3. Conclusion. The toxicology database for clothianidin is not 
complete for FQPA purposes. A complete complement of acceptable 
developmental, reproduction, developmental neurotoxicity, mammalian 
neurotoxicity and special neurotoxicity studies are available; however, 
due to evidence of decreased absolute and adjusted organ weights of the 
thymus and spleen in multiple studies in the clothianidin data base, 
and since juvenile rats in the 2-generation reproduction study appear 
to be more susceptible to these effects, EPA has determined that 
testing should be conducted to assess immune system function in adults 
and in young animals following developmental exposures. As noted 
previously, a 10X database UF was applied because of the lack of this 
study.
    The FQPA factor is removed because there are no to low concerns and 
no residual uncertainties with regard to prenatal and/or postnatal 
toxicity. As stated above, no quantitative or qualitative 
susceptibility was observed in either of the development rat or rabbit 
studies, and the observed effects are well characterized and there are 
clear NOAELs/LOAELs in the reproduction and developmental neurotoxicity 
studies. In addition, the acute and chronic dietary food exposure 
assessment utilizes existing and proposed tolerance level residues and 
100% crop treated information for all commodities. By using these 
screening-level assessments, acute and chronic exposures/risks will not 
be underestimated. Furthermore, the dietary drinking water assessment 
(Tier I estimates) uses values generated by model and associated 
modeling parameters which are designed to provide conservative, health 
protective, high-end estimates of water concentrations. Finally, there 
are no residential uses for either clothianidin or thiamethoxam.

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

[[Page 32397]]

in water (EECs). DWLOC values are not regulatory standards for drinking 
water. DWLOCs are theoretical upper limits on a pesticide's 
concentration in drinking water in light of total aggregate exposure to 
a pesticide in food and residential uses. In calculating a DWLOC, the 
Agency determines how much of the acceptable exposure (i.e., the PAD) 
is available for exposure through drinking water (e.g., allowable 
chronic water exposure (mg/kg/day) = cPAD - (average food + residential 
exposure)). This allowable exposure through drinking water is used to 
calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by EPA's Office of Water are used to calculate DWLOCs: 2 
liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
clothianidin will occupy 7.3% of the aPAD for the U.S. population, 5.4% 
of the aPAD for females 13 years and older, 11% of the aPAD for all 
infants (less than 1 year old) and 16% of the aPAD for children 1 to 2 
years old. In addition, there is potential for acute dietary exposure 
to clothianidin in drinking water. After calculating DWLOCs and 
comparing them to the EECs for surface water and ground water, EPA does 
not expect the aggregate exposure to exceed 100% of the aPAD, as shown 
in Table 3 of this unit:

                     Table 3.--Aggregate Risk Assessment for Acute Exposure to Clothianidin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. population                                0.025          7.3         3.97         1.46          810
---------------------------------------------------------------------------
All infants (< 1 year old)                             0.025           11         3.97         1.46          220
---------------------------------------------------------------------------
Children (1-2 years old)                               0.025           16         3.97         1.46          210
---------------------------------------------------------------------------
Females (13-49 years old)                              0.025          5.4         3.97         1.46          710
---------------------------------------------------------------------------
Adults (50+ years old)                                 0.025          6.0         3.97         1.46          820
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
clothianidin from food will utilize 5.9% of the cPAD for the U.S. 
population, 9.8% of the cPAD for all infants (less than 1 year old) and 
18% of the cPAD for children 1 to 2 years old. There are no residential 
uses for clothianidin that result in chronic residential exposure to 
clothianidin. In addition, there is potential for chronic dietary 
exposure to clothianidin in drinking water. After calculating DWLOCs 
and comparing them to the EECs for surface water and ground water, EPA 
does not expect the aggregate exposure to exceed 100% of the cPAD, as 
shown in Table 4 of this unit:

              Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Clothianidin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. Population                               0.0098          5.9         2.14         1.46          320
---------------------------------------------------------------------------
All Infants (< 1 year old)                            0.0098          9.8         2.14         1.46           88
---------------------------------------------------------------------------
Children (1-2 years old)                              0.0098           18         2.14         1.46           80
---------------------------------------------------------------------------
Females (13-49 years old)                             0.0098          4.6         2.14         1.46          280
---------------------------------------------------------------------------
Adults (50+ years old)                                0.0098          4.9         2.14         1.46          320
----------------------------------------------------------------------------------------------------------------

    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). Clothianidin and 
thiamethoxam are not registered for use on any sites that would result 
in residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water, which do not exceed the Agency's LOC.
    4. Intermediate-term risk. Intermediate-term aggregate exposure

[[Page 32398]]

takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Clothianidin 
and thiamethoxam are not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which do not exceed the Agency's 
LOC.
    5. Aggregate cancer risk for U.S. population. Clothianidin has been 
classified as a ``not likely human carcinogen.'' Therefore, it is not 
expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to clothianidin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (example - liquid chromotography) 
is available to enforce the tolerance expression. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: [email protected].

B. International Residue Limits

    No Codex, Canadian, or Mexican maximum residue levels (MRLs) have 
been established for residues of clothianidin.

C. Conditions

    A developmental immunotoxicity study with comparative measures 
between the pups and the parents is required.

V. Conclusion

    Therefore, tolerances are established for residues of clothianidin, 
(E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in 
or on canola, seed at 0.01 ppm ; corn, field, grain at 0.01 ppm; corn, 
pop, grain at 0.01 ppm; corn, sweet, kernel plus cob with husk removed 
at 0.01 ppm; corn, field, forage at 0.10 ppm; corn, sweet, forage at 
0.10 ppm; corn, field, stover at 0.10 ppm; corn, sweet, stover at 0.10 
ppm; corn, pop, stover at 0.10 ppm; and milk at 0.01 ppm, animal feed, 
nongrass at 0.02 ppm; grain, cereal, forage, fodder and straw at 0.02 
ppm; grass, forage, fodder and hay at 0.02 ppm; soybean, forage at 0.02 
ppm; and soybean, hay 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 for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. 
However, the period for filing objections is now 60 days, rather than 
30 days.

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0133 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 July 29, 
2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by docket ID number OPP-2003-0133, 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

[[Page 32399]]

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. Statutory and Executive Order Reviews

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

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: May 19, 2003.
James Jones,
Director, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.586 is added to read as follows:


Sec.  180.586  Clothianidin; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-
methyl-2-nitroguanidine, in or on the following raw agricultural 
commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Canola, seed.........................................               0.01
Corn, field, forage..................................               0.10
Corn, field, grain...................................               0.01
Corn, field, stover..................................               0.10
Corn, pop, grain.....................................               0.01
Corn, pop, stover....................................               0.10
Corn, sweet, forage..................................               0.10
Corn, sweet, kernel plus cob with husk removed.......               0.01
Corn, sweet, stover..................................               0.10
Milk.................................................               0.01
------------------------------------------------------------------------


[[Page 32400]]

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect and inadvertant residues. Tolerances are established 
for the indirect or inadvertent residues of the insecticide 
clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-
nitroguanidine, in or on the following raw agricultural commodities 
when present therein as a result of the application of clothianidin to 
crops listed in paragraph (a) of this section:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Animal feed, nongrass................................               0.02
Grain, cereal, forage, fodder and straw..............               0.02
Grass, forage, fodder and hay........................               0.02
Soybean, forage......................................               0.02
Soybean, hay.........................................               0.02
------------------------------------------------------------------------

[FR Doc. 03-13564 Filed 5-29-03; 8:45 am]
BILLING CODE 6560-50-S