[Federal Register: September 26, 2003 (Volume 68, Number 187)]
[Rules and Regulations]
[Page 55503-55513]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se03-17]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0304]; FRL-7325-8]
Thiacloprid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for combined residues
of thiacloprid ([3-[(6-chloro-3-pridinyl)methyl]-2-
thiazolidinylidene]cyanamide) and metabolites retaining the
thiazolidine ring intact, measured and expressed in terms of
thiacloprid, per se, in or on apple, wet pomace; cotton, undelinted
seed; cotton, gin by-products; fruit, pome group 11; fat, meat, liver,
kidney and meat by-products of cattle, sheep, goat and horse; and milk.
Bayer CropScience 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 September 26, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0304],
must be received on or before November 25, 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: Marilyn Mautz, Registration Division,
7505C, Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone number: 703 305-6785; e-mail address: mautz.marilyn@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-2003-0304. 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/http://.
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
[[Page 55504]]
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 May 7, 2003 (68 FR 24458) (FRL-7303-7),
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 9F6060) by Bayer CropScience, P.O. Box 12014, 2
T.W. Alexander Dr., Research Triangle Park, NC 27709. That notice
included a summary of the petition prepared by Bayer CropScience, 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, thiacloprid,
in or on apple, wet pomace; cattle, meat and meat byproducts; cotton,
gin byproducts; cotton, undelinted seed; fruit, pome, group 11; and
milk at 0.6; 0.2; 11.0; 1.0; 0.3; and 0.1 parts per million (ppm),
respectively. Upon review and evaluation of the data submitted in
support of the petition, the Agency determined that the residues of
concern are thiacloprid plus metabolites retaining the thiazolidine
ring intact. Excluded from the residues of concern are metabolites such
as 6-nicotinic acid (6-CNA) for which the thiazolidine ring is broken.
These metabolites are excluded based on the finding that the toxic
effects of thiacloprid are considered to be associated with the entire
thiacloprid molecule (with both the thiazolidine ring and the
chloropyridine ring intact). Because metabolism and degradation studies
have shown that the thiazolidine ring is less stable than the
chloropyridine ring, it is understood that metabolites retaining the
thiazolidine ring also retain the chloropyridine ring intact.
Metabolites retaining the thiazolidine ring generally constitute most
of the residue in foods and feeds. The petition was subsequently
revised to:
1. Request that 40 CFR part 180 be amended by establishing
tolerances for the insecticide thiacloprid in or on the commodities:
Meat, meat byproducts, liver, fat, and kidney of sheep, goat and horse;
liver; fat and kidney of cattle; and
2. Lowering the previously proposed tolerance levels for the food
commodities, cattle, meat from 0.2 ppm to 0.03 ppm; cattle, meat
byproducts from 0.2 ppm to 0.05 ppm; cotton, undelinted seed from 1.0
ppm to 0.02 ppm and milk from 0.1 ppm to 0.03 ppm based on measurement
of thiacloprid per se rather than measurement of the common moiety, 6-
nicotinic acid (6-CNA) upon which the original proposed tolerances were
based; as summarized in Table 1 of this unit.
Table 1--Proposed Tolerance Levels for Food Commodities.
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Revised, Measured
Commodity Original, Measured as Thiacloprid
as 6-CNA (ppm) (ppm)
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Apple, wet pomace 0.6 0.6
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Cattle, meat 0.2 0.03
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Cattle, meat byproducts 0.2 0.05
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Cotton, gin byproducts 11.0 11.0
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Cotton, undelinted seed 1.0 0.02
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Cattle, sheep, goat and horse 0.02
fat
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Cattle, sheep, goat and horse 0.05
kidney
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Cattle, sheep, goat and horse 0.15
liver
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Fruit, pome, group 11 0.3 0.3
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Milk 0.1 0.03
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Sheep, goat and horse meat 0.03
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Sheep, goat and horse meat 0.05
byproducts
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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 combined residues of
thiacloprid and metabolites
[[Page 55505]]
retaining the thiazolidine ring intact, measured and expressed in terms
of thiacloprid, per se on apple, wet pomace; cattle, sheep, goat and
horse meat; meat byproducts; liver; kidney; and fat; cotton, undelinted
seed; cotton, gin byproducts; fruit, pome, group 11; and milk at 0.6;
0.03; 0.05; 0.15; 0.05; 0.02; 0.02; 11.0; 0.3; and 0.03 ppm,
respectively. 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 thiacloprid are
discussed in Table 2 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 2.--Subchronic, Chronic, and Other Toxicity
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Guideline No. Study Type Results
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870.3100 90-Day oral toxicity NOAEL = rats: males, 7.3 mg/kg/day ;
rodents females, 7.6 mg/kg/day; mice, females,
27.3 mg/kg/day ; males 102.6 milligram/
kilogram/day (mg/kg/day)
LOAEL = rats: males,28.6 mg/kg/day;
females, 35.6 mg/kg/day; mice: females,
27.2 mg/kg/day; males, 542.4 mg/kg/day
based on rats: decreased body weight
throughout treatment: mice: females based
on adrenal X-zone changes. males based on
liver effects (weight and hypertrophy).
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870.3150 90-Day oral toxicity in NOAEL = males. 8.5, females, 8.9 mg/kg/day
nonrodents LOAEL = [sim]34.9 mg/kg/day based on mainly
liver enzyme changes, thyroid hormone
level (T4) and binding capacity changes
and prostatic weight change and prostatic
hypertrophy.
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870.3200 21/28-Day dermal toxicity NOAEL = females, 300 mg/kg/day
LOAEL = 1,000 mg/kg/day based on liver and
thyroid effects and clinical signs.
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870.3465 28 Day inhalation toxicity NOAEL = 0.542 mg/kg/day
LOAEL = 4.93 mg/kg/day based on [liver
effects (hypertrophy and increased N-DEM).
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870.3700 Prenatal developmental in Maternal NOAEL = 10 mg/kg/day
rodents LOAEL = 50 mg/kg/day based on decreased
body weights, body weight gains, food
consumption, increased urination, and
changes in water consumption.
Developmental NOAEL = 10 mg/kg/day
LOAEL = 50 mg/kg/day based on increased
resorptions (complete and late), skeletal
retardations, variations (wavy ribs and
asymmetrical sternebrae), and
malformations (dysplastic humerus, radius,
and scapulae) and on decreased fetal
weights
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870.3700 Prenatal developmental in Maternal NOAEL = 2 mg/kg/day
nonrodents LOAEL = 10 mg/kg/day based on decreased
body weight gains, food consumption, and
fecal output.
Developmental NOAEL = 2 mg/kg/day
LOAEL = 10 mg/kg/day based on decreased
fetal weights
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870.3800 Reproduction and fertility Parental/Systemic NOAEL = males, 3.5 mg/kg/
effects day
LOAEL = 21 mg/kg/day based on increased
liver and thyroid weights and on
hepatocytomegaly, liver necrosis, and
thyroid follicular cell hypertrophy.
Reproductive NOAEL = females, 4 .2 mg/kg/
day
LOAEL = 26 mg/kg/day based on dystocia
Offspring NOAEL = females, 4.2 mg/kg/day
LOAEL = females, 21 mg/kg/day based on
decreased pup weight during lactation.
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870.4100 Chronic toxicity dogs No firm LOAEL was established for this
chronic feeding study with dogs; 1,000 ppm
highest dose tested (HDT). There were no
effects that were of sufficient magnitude
or consistency to justify that they were
definite responses to treatment. Certain
effects noted in the subchronic dog study
on the prostate and other male organs and
an apparent effect on uterine weight in
the subchronic dog study were not seen in
this chronic study. This may be because
the dogs in this study had reached
maturity
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870.4300 Combined chronic feeding/ NOAEL = males, 1.2 mg/kg/day ; females, 1.6
cacinogenicity rats mg/kg/day
LOAEL = males, 2.5 mg/kg/day; females, 3.3
mg/kg/day based on [liver toxicity
(hepatocellular hypertrophy and
cytoplasmic change and increased enzyme
activity), thyroid follicular epithelial
hypertrophy in males and oculotoxicity
(retinal atrophy) in females
Evidence of carcinogenicity based on
increased incidence of thyroid follicular
cell adenomas in males and possibly also
in females and increased incidence of
uterine tumors (adenocarcinomas)
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[[Page 55506]]
870.4200 Carcinogenicity mice NOAEL = males,5.7 mg/kg/day; females: 10.9
mg/kg/day
LOAEL = males, 234.1mg/kg/day; females,
475.3 mg/kg/day based on liver toxicity
and microscopic lymph node changes in both
sexes and increased X-zone vacuolization
of the adrenal glands in female mice
Evidence of carcinogenicity based on
increased incidence of ovarian luteomas
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870.5100 Gene Mutation Negative in a battery of tests
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870.5300 Gene Mutation Negative in a battery of tests
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870.5375 Cytogenetics Negative in battery of tests
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870.5395 Cytogenetics Negative in battery of tests
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870.5500 Cytogenetics Negative in battery of tests
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870.5550 Other Effects Negative
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870.6200 Acute neurotoxicity NOAEL = males, 11 mg/kg bodyweight (bw);
screening battery females, 3.1 mg/kg/day LOAEL = males, 22
mg/kg bw; females, 11 mg/kg/day
In females, based on reductions in motor
and locomotor activity.; in males, (based
on FOB observations of slight tremors and
ptosis of the eyelids on the day of
treatment)
----------------------------------------------------------------------------------------------------------------
870.6200 Subchronic neurotoxicity NOAEL = males , 24.2 mg/kg/day; females,
screening battery 27.9 mg/kg/day
LOAEL = males, 101 mg/kg/day; females, 115
mg/kg/day based on decreased body weight
gains and food consumption in both sexes
and decreased hindlimb grip strength in
males.
----------------------------------------------------------------------------------------------------------------
870.6300 Developmental Maternal NOAEL = 4.4 mg/kg/day
neurotoxicity LOAEL = 25.6 mg/kg/day based on decreased
body weight gain and food consumption
during early gestation (gestation day (GD)
0-6.
Offspring NOAEL = Tentative Offspring , 4.4
mg/kg/day
LOAEL = Tentative Offspring, 25.6 mg/kg/day
based on decreased pre-weaning and post-
weaning body weights in both sexes and
delayed sexual maturation in the males,
and altered performance in passive
avoidance testing.
----------------------------------------------------------------------------------------------------------------
870.7485 Metabolism and Thiacloprid is rapidly absorbed and is
pharmacokinetics rapidly excreted after the following
metabolic processes, with little remaining
in the tissues. The metabolic processes
were summarized as:
1. Hyroxylation of the thiazolidine ring
and subsequent glucuronidation (as shown
by metabolite PIZ 1270),
2. Hydroxylation of the cyanamide moiety
(metabolite KNO 1891),
3. Opening of the thiazolidine ring (e.g.,
metabolites KNO2672, PIZ1297F/WAK 6935),
4. Formation of an oxazole ring (metabolite
PIZ 1253),
5. Oxidation and subsequent methylation of
the thiazolidine ring (e.g., PIZ 1297E and
PIZ 1269X), and
6. Oxidative cleavage of the methylene
bridge (PIZ 1243). Only minor gender-
related quantitative differences in
metabolite profiles were observed.
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870.7600 Dermal penetration A 5% dermal absorption value is appropriate
for estimating the risk resulting from
dermal exposure to Thiacloprid formulated
as a 40.4% liquid formulation (SC 480).
This 5% value is also appropriate for
other liquid thiacloprid formulations that
are similar to the SC 480 liquid
formulation product tested and for aqueous
dilutions of most thiacloprid
formulations.
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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 intra species differences. As
explained in Unit III.D.3., EPA determined that the FQPA SF be reduced
to 3X.
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
[[Page 55507]]
(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 thiacloprid used for human risk assessment is shown in
Table 3 of this unit:
Table 3.--Summary of Toxicological Dose and Endpoints for Thiacloprid for Use in Human Risk Assessment
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Special FQPA SF* and
Exposure Scenario Dose Used in Risk Level of Concern for Study and Toxicological
Assessment, UF Risk Assessment Effects
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Acute Dietary (All population groups) NOAEL = 3.1 mg/kg Special FQPA SF = 1 Acute Neurotoxicity -
UF = 300*.............. aPAD = acute RfD/FQPA rats
Acute RfD = 0.01 mg/kg. SF. LOAEL = 11 mg/kg/day
= 0.01 mg/kg........... based on decreased
motor activity in
females.
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Chronic Dietary (All populations) NOAEL= 1.2 mg/kg/day Special FQPA SF = 1 Chronic feeding in
UF = 300*.............. cPAD = chronic RfD/ rats.
Chronic RfD = 0.004 mg/ FQPA SF. LOAEL = 2.5 mg/kg/day
kg/day. = 0.004 mg/kg/day...... based on hepatic
hypertrophy and
cytoplasmic change and
thyroid hypertrophy
and retinal
degeneration.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Q1* (mg/kg/day)-\1\ = Classified as a likely human carcinogen based on
4.06 x 10-\2\ thyroid tumors and uterine tumors in rats and
ovary tumors in mice
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UF = uncertainty factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level,
PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose
* 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. There are no
tolerances established for residues of thiacloprid. Risk assessments
were conducted by EPA to assess dietary exposures from thiacloprid 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\TM\)
analysis evaluated the individual food consumption as reported by
respondents in the 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: A moderately refined, Tier 3 acute
dietary exposure assessment, which incorporated field trial data,
estimates of % market share, and empirical processing factors, was
conducted for the general U.S. population and various population
subgroups. Monitoring data are not available for thiacloprid as it is a
new chemical. EPA estimated exposure at the 99.9th exposure percentile.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis
evaluated the individual food consumption as reported by respondents in
the 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 chronic
exposure assessments: A partially refined, Tier 3 chronic dietary
exposure assessment, which incorporated field trial data, empirical
processing factors, and projected percent crop treated estimates, was
conducted for the general U.S. population and various population
subgroups. Monitoring data are not available for thiacloprid as it is a
new chemical.
iii. Cancer. A cancer assessment was performed using the same
assumptions as the chronic assessment in Unit III.C.1. ii. The cancer
dietary exposure estimate for the general U.S. population is 1.3 x
10-\6\.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must 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
[[Page 55508]]
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 PCT information for both the acute and chronic
dietary risk assessment as follows:
A routine acute and chronic dietary exposure analysis for
thiacloprid was based on 61% of apple crop treated, 51% of pear crop
treated and 1% of cotton crop treated.
The Agency believes that the three conditions previously discussed
have been met. With respect to Condition 1, EPA finds that the PCT
information described in the preceding paragraph for thiacloprid used
on these crops is reliable and has a valid basis. The PCT estimates are
based on use of existing alternate insecticides against insects that
thiacloprid will control. As per Agency practice, the PCT estimates are
what the Agency expects to be likely upper bound market penetrations
for various crop/pest niches. Maximal percent crop treated estimates
were projected for apples, pears, and cotton. The Agency is reasonably
certain that the percentage of the food treated is not likely to be an
underestimation. As to Conditions 2 and 3, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available information on the regional consumption of food to
which thiacloprid may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for thiacloprid 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 thiacloprid.
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.
The SCI-GROW model is used to predict pesticide concentrations in
shallow groundwater. For a screening-level assessment for surface water
EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2
model). The FIRST model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. 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.
The Tier II screening model, PRZM/EXAMS, was used to estimate
residues of thiacloprid and one of its major degradates, YRC 2984 amide
in surface water. The SCI-GROW model was used to estimate the ground
water residues.
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 thiacloprid they are further
discussed in the aggregate risk sections in Unit III.E.
Based on the PRZM/EXAMS and SCI-GROW models the estimated
environmental concentrations (EECs) of thiacloprid and one of its major
degratates, YRC 2894 amide for acute exposures are estimated to be 10.2
parts per billion (ppb) for surface water and 0.06 ppb for ground
water. The EECs for chronic exposures are estimated to be 2.36 ppb for
surface water and 0.06 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).
Thiacloprid is not registered or proposed for use on any sites that
would result in residential exposure.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Cumulative effects from 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 thiacloprid has a common mechanism of toxicity with other
substances. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to thiacloprid
and any other substances and thiacloprid does not appear to produce a
toxic metabolite produced by other substances. Thiacloprid does produce
6-CNA, a metabolite also produced by another registered
chloronicotinoid pesticide. However, the limiting toxic endpoints used
in this assessment for thiacloprid are not based upon the toxicity of
6-CNA. For the purposes of this tolerance action, therefore, EPA has
not assumed that thiacloprid 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 policy statements
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/
.
[[Page 55509]]
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. Developmental studies did
not show either qualitative or quantitative susceptibility. There is no
increase in quantitative susceptibility demonstrated in the rat
developmental neurotoxicity, rabbit developmental or rat reproduction
studies. There is an apparent qualitative increase in susceptibility in
the rat developmental toxicity study as indicated by increases in
resorptions, increases in skeletal variations and retardations and
malformations, and decreases in fetal body weight that occurred at the
same dose showing a decrease in maternal body weight, but the concern
is low since:
i. There is a well characterized dose response with a clear NOAEL
and LOAEL;
ii. The fetal effects were noted in the presence of maternal
toxicity; and
iii. There are no residual uncertainties.
3. Conclusion. In evaluating whether to retain the 10X SF to
protect infants and children or to select a different safety factor,
EPA considered the following factors:
i. There are no special concerns regarding pre- or post-natal
toxicity exposure;
ii. The exposure databases ( food and drinking water) are complete
and/or employ conservative assumptions;
iii. There is no residential exposure;
iv. The risk assessments cover or approximate all the metabolites
and degradates of concern;
v. The assessments do not underestimate the potential risk for
infants and children; and
vi. The toxicity database is complete except that there is a lack
of morphometric assessments for the low- and mid-dose group animals in
the developmental neurotoxicity study (DNT).
Although the lack of morphometric assessments in the DNT raised
some uncertainty, EPA determined that there were sufficient reliable
data to select an additional safety factor of 3X instead of 10X. The
FQPA safety factor of 3X is in the form of a database uncertainty
factor of 3X. A 3X factor was judged to be adequate because the dose
selected for overall risk assessments is already based on the most
sensitive end points for acute (i.e. clinical signs indicative of
neurotoxicity) and chronic (i.e. liver and thyroid effects) dietary and
non-dietary exposure scenarios, and the available data indicate that
the full characterization of brain morphometrics from the DNT study
would not be expected to lower the dose used for risk assessments by
more than 3-fold.
To elaborate, since the magnitude (4-14%) of the morphometric
histopathology changes seen in the offspring at the highest dose (40.8
mg/kg/day) in the developmental neurotoxicity study were considered to
be at or near the limit of detection for differences in morphometric
measurements, it is unlikely that measurable morphometric changes will
be seen at lower doses. Any possible slight effects at lower doses are
highly unlikely to change the regulatory level. The actual doses used
to establish the acute RfD (3.1 mg/kg/day) and the chronic RfD (1.2 mg/
kg/day) are 13 and 34 fold lower, respectively, than the 40.8 mg/kg/day
dose where the effects of minimal magnitude were seen. Applying the 3 X
factor further renders the adjusted doses 39 and 102-fold lower than
the dose level where the effects of minimal magnitude were seen.
Morever, even if the slight morphometric changes are seen at the mid,
and even the low, dose of the DNT, a RfD calculated on such findings is
highly unlikely to be lower than current acute and chronic RfDs
adjusted by 3X given that the effects seen at the high dose were
marginal. Therefore it is concluded that 3X is adequate to account for
any possible morphometric effects that may be noted in the lower doses
for which the additional readings are being sought.
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 USEPA 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 groundwater are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP 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, OPP 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
thiacloprid will occupy 20% of the aPAD for the U.S. population, 8.5 %
of the aPAD for females 13 years and older, 51 % of the aPAD for all
infants and 47 % of the aPAD for children 1-2 years old. In addition,
there is potential for acute dietary exposure to thiacloprid in
drinking water. After calculating DWLOCs and comparing them to the EECs
for surface and ground water, EPA does not expect the aggregate
exposure to exceed 100% of the aPAD, as shown in Table 4 of this unit:
[[Page 55510]]
Table 4.--Aggregate Risk Assessment for Acute Exposure to Thiacloprid
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. population 0.01 20 10.2 0.06 281
----------------------------------------------------------------------------------------------------------------
All infants < 1 year old 0.01 51 10.2 0.06 49
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old 0.01 47 10.2 0.06 53
----------------------------------------------------------------------------------------------------------------
Children 3-5 years old 0.01 33 10.2 0.06 67
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old 0.01 8.5 10.2 0.06 274
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
thiacloprid from food will utilize <1.0 % of the cPAD for the U.S.
population, 4.4 % of the cPAD for all infants and 4.2% of the cPAD for
children 1-2 years old . There are no residential uses for thiacloprid
that result in chronic residential exposure to thiacloprid. In
addition, there is potential for chronic dietary exposure to
thiacloprid in drinking water. After calculating DWLOCs and comparing
them to the EECs for surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the cPAD, as shown in Table 5 of
this unit:
Table 5.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Thiacloprid
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.004 <1.0 2.36 0.06 139
----------------------------------------------------------------------------------------------------------------
All Infants < 1 year old 0.004 4.4 2.36 0.06 38
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old 0.004 4.2 2.36 0.06 38
----------------------------------------------------------------------------------------------------------------
Children 3-5 years old 0.004 2.9 2.36 0.06 38
----------------------------------------------------------------------------------------------------------------
Children 6-12 years old 0.004 1.3 2.36 0.06 39
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old 0.004 <1.0 2.36 0.06 120
----------------------------------------------------------------------------------------------------------------
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).
Thiacloprid is not registered or proposed 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 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).
Thiacloprid is not registered or proposed 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 level of concern.
5. Aggregate cancer risk for U.S. population. In accordance with
the EPA Draft Guidelines for Carcinogen Risk Assessment: (July 1999),
thiacloprid was classified into the category Likely to be Carcinogenic
to Humans. A linear low-dose extrapolation approach is applied to the
quantifications of risk to be estimated, based upon male rat thyroid,
rat uterine, and mouse ovarian tumors. The data did not support a mode
of action. The Q1* is 4.06 x 10-\2\ in human equivalents
based on the rat uterine adenoma, adenocarcinoma and/or adenosquamous
carcinoma combined tumor rates.
The dietary cancer risk from residues in food is 1.3X
10-\6\. A cancer DWLOC is calculated only for the general
U.S. Population. For this population the calculated DWLOC of 1.5ug/L is
the same as the calculated EEC of 1.5 ug/L.
DWLOC = 3 X 10-\6\/Q1* - average food
exposure (mg/kg/day)]*bwt* 1,000 ug/mg/Water consumption (liter/day)
DWLOC (US Pop.) = 1.5 ug/L. Since the surface water EEC for cancer
is 1.5 ug/L the risk cup is exactly filled to 3 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.
EPA believes that the lifetime exposure will be result in
negligible cancer risk for the following reason:
The cancer risk from the food uses alone is 1.3 x
10-\6\.The dietary risk is based on residue data derived
from the average of field trials. It is not unusual in the Agency's
experience for field trial data to be an order of magnitude above
actual monitoring. Since thiacloprid is a new chemical, actual
monitoring data are 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.
Thus, EPA does not expect that the general population would be
exposed to levels that would exceed a neglible cancer risk 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
[[Page 55511]]
population, and to infants and children from aggregate exposure to
thiacloprid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The petitioner proposed a high performance liquid chromatography
mass spectrometry (HPLC/MS/MS) method for determining thiacloprid, YRC-
2894 amide and 4-hydroxy-YRC2894 amide in plants which has been found
to be appropriate for use in the enforcement of the plant tolerances
associated with this petition. The available radiovalidation and
metabolism data supports this method. An adequate Independent Lab
Validation (ILV) has been provided for the method and adequate
confirmatory ions were also identified in the ILV.
The petitioner has proposed a HPLC/MS/MS method for determining
thiacloprid in livestock tissues which has been found to be appropriate
for use in the enforcement of the animal tissue tolerances associated
with this petition. Existing radiovalidation and metabolism data
supports this method as well as does an ILV. Mass spectrometry provides
an adequate confirmatory method. This conclusion is based upon the
successful use of mass spectrometry as a confirmatory method for
thiacloprid in plants, the similarity between the HPLC/MS/MS methods
for thiacloprid in plants and animals, and the Agency's familiarity
with mass spectrometry in general. As a condition of registration, the
registrant will be required to submit a description of the procedures
for the use of mass spectrometry for thiacloprid in animals.
Thiacloprid, parent only, has been tested through the FDA PAM I
multi-residue protocol. Upon request, the methods will be available
prior to the harvest 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
There are no established Codex, Canadian or Mexican maximum residue
limits (MRLs) for thiacloprid.
C. Conditions
The following information must be submitted as a condition for
product registrations related to these tolerances: The registrant will
be required to submit a description of the procedures for the use of
mass spectrometry for thiacloprid in animals.
V. Conclusion
Therefore, tolerances are established for combined residues of
thiacloprid and metabolites retaining the thiazolidine ring intact,
measured and expressed as thiacloprid, per se, in or on apple, wet
pomace at 0.6 ppm; cattle, sheep, goat, and horse meat at 0.03 ppm;
cattle, sheep, goat and horse meat byproducts at 0.05 ppm; cattle,
sheep, goat, and horse liver at 0.15 ppm; cattle, sheep, goat, and
horse kidney at 0.05 ppm; and cattle sheep, goat, and horse fat at 0.02
ppm; cotton, undelinted seed at 0.02 ppm; cotton, gin byproducts at
11.0 ppm; fruit, pome, group 11 at 0.3 ppm; and milk at 0.03 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-2003-0304 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 November
25, 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
[[Page 55512]]
copies, identified by docket ID number OPP-2003-0304, 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 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: September 16, 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 180.594 is added to read as follows:
Sec. 180.594 Thiacloprid; tolerances for residues.
(a) General. Tolerances for combined residues of the insecticide
thiacloprid
[[Page 55513]]
([3-[(6-chloro-3-pyridinyl)methyl]-2-thiazolidinylidene] cyanamide) and
metabolites retaining the thiazolidine ring intact, measured and
expressed in terms of thiacloprid, per se, in or on the following
commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Apple, wet pomace.............................. 0.60
Cattle, fat.................................... 0.020
Cattle, kidney................................. 0.050
Cattle, liver.................................. 0.15
Cattle, meat................................... 0.030
Cattle, meat byproducts........................ 0.050
Cotton, gin byproducts......................... 11.0
Cotton, undelinted seed........................ 0.020
Fruit, pome, group 11.......................... 0.30
Goat, fat...................................... 0.020
Goat, kidney................................... 0.050
Goat, liver.................................... 0.15
Goat, meat..................................... 0.030
Goat, meat byproducts.......................... 0.050
Horse, fat..................................... 0.020
Horse, kidney.................................. 0.050
Horse, liver................................... 0.15
Horse, meat.................................... 0.030
Horse, meat byproducts......................... 0.050
Milk........................................... 0.030
Sheep, fat..................................... 0.020
Sheep, kidney.................................. 0.050
Sheep, liver................................... 0.15
Sheep, meat.................................... 0.030
Sheep, meat byproducts......................... 0.050
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 03-24371 Filed 9-25-03; 8:45 am]
BILLING CODE 6560-50-S