[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.
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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
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Guideline No. Study Type Results
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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.
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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).
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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.
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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.
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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]]
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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.
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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.
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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.
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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.
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870. 5550 UDS assay Negative when tested
up to precipitating
concentrations
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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