[Federal Register: May 30, 2003 (Volume 68, Number 104)]
[Rules and Regulations]
[Page 32390-32400]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30my03-20]
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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.
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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: kenny.dan@epa.gov.
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: residuemethods@epa.gov.
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 tompkins.jim@epa.gov,
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: opp-docket@epa.gov. 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