[Federal Register: May 19, 2004 (Volume 69, Number 97)]
[Rules and Regulations]
[Page 28832-28842]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19my04-9]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0130; FRL-7359-1]
Indoxacarb; Time-Limited Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
residues/combined residues of indoxacarb, (S)-methyl 7-chloro-2,5-
dihydro-2-[[(methoxycarbonyl) [4-(trifluoromethoxy)
phenyl]amino]carbonyl] indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-
carboxylate, and its R-enantiomer, (R)-methyl 7-chloro-2,5-dihydro-2-
[[(methoxycarbonyl)[4-(trifluoromethoxy)
phenyl]amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-
carboxylate, in or on cherry, sweet and cherry, tart. E.I. DuPont de
Nemours and Company, DuPont Crop Protection requested this tolerance
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996 (FQPA). The tolerance will
expire on May 21, 2007.
DATES: This regulation is effective May 19, 2004. Objections and
requests for hearings must be received on or before July 19, 2004.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
ID number OPP-2004-0130. All documents in the docket are listed in the
EDOCKET index at http://www.epa.gov/edocket. Although listed in the
index, some information is not publicly available, i.e., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either electronically in
EDOCKET or in hard copy at the Public Information and Records Integrity
Branch (PIRIB), Rm.
[[Page 28833]]
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.
FOR FURTHER INFORMATION CONTACT: Rita Kumar, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8291; e-mail address:kumar.rita@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:
Crop production (NAICS code 111)
Animal production (NAICS code 112)
Food manufacturing (NAICS code 311)
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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions. 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 Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), 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 E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/
.
II. Background and Statutory Findings
In the Federal Register of March 17, 2004 (69 FR 12664-12670) (FRL-
7345-2), EPA issued a notice pursuant to section 408(d)(3) of the
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 3G6797) by E.I. DuPont de Nemours and Company, DuPont Crop
Protection, Wilmington, DE. This notice included a summary of the
petition prepared by DuPont, the registrant.
The petition requested that 40 CFR 180.564 be amended by
establishing a tolerance for combined residues of the insecticide
indoxacarb, (S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl) [4-
(trifluoromethoxy) phenyl]amino]carbonyl] indeno[1,2-
e][1,3,4]oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2- [[(methoxycarbonyl)[4-(trifluoromethoxy)
phenyl]amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-
carboxylate, in or on cherry, sweet and cherry, tart at 1.0 part per
million (ppm). The tolerance will expire on May 21, 2007. One comment
was received from a private citizen objecting to this tolerance. This
commenter opposes all residues, tolerances, exemptions from tolerance,
animal testing, or the Agency's risk assessment process, and has
objected to numerous Agency actions over the past several months.
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 a tolerance for combined residues of
indoxacarb, (S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl) [4-
(trifluoromethoxy) phenyl]amino]carbonyl] indeno[1,2-
e][1,3,4]oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2- [[(methoxycarbonyl)[4-(trifluoromethoxy)
phenyl]amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-
carboxylate, on cherry, sweet and cherry, tart at 1.0 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 indoxacarb 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.
[[Page 28834]]
Table 1.--Acute, Subchronic, Chronic, and Other Toxicity
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Guideline No. Study Type Results
----------------------------------------------------------------------------------------------------------------
870.3100 90-Day oral toxicity DPX-MP062
rodents NOAEL = M 3.1 mg/kg/day, F 2.1 mg/kg/day
LOAEL = M 6.0 mg/kg/day, F 3.8 mg/kg/day
based on decreased body weight, body
weight gain, food consumption and food
efficiency
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870.3150 90-Day oral toxicity in DPX-JW062
nonrodents NOAEL = 5.0 mg/kg/day
LOAEL = 19 mg/kg/day based on hemolytic
anemia, as indicated by decrease in HGB,
RBCs; increases in platelets, increased
reticulocytes; and secondary
histopathologic findings indicative of
blood breakdown (pigment in Kupffer cells,
renal tubular epithelium, and spleen and
bone marrow macrophages); increase in
splenic EMH; and RBC hyperplasia in bone
marrow in dogs
----------------------------------------------------------------------------------------------------------------
870.3200 21/28-Day dermal toxicity DPX-MP062
NOAEL = 2,000 mg/kg/day
LOAEL = >2,000 mg/kg/day in rats
DPX-MP062
NOAEL = 50 mg/kg/day
LOAEL = 500 mg/kg/day based on decreased
body weights, body weight gains, food
consumption, and food efficiency in F, and
changes in hematology parameters
(increased reticulocytes), the spleen
(increased absolute and relative weight M
only, gross discoloration), clinical signs
of toxicity in both sexes in rats
----------------------------------------------------------------------------------------------------------------
870.3700 Prenatal developmental in DPX-MP062
rodents Maternal NOAEL = 2.0 mg/kg/day
LOAEL = 4.0 mg/kg/day based on decreased
mean body weights, body weight gains, food
consumption
Developmental NOAEL = 2.0 mg/kg/day
LOAEL = 4.0 mg/kg/day based on decreased
fetal weights
DPX-JW062
Maternal NOAEL = 10 mg/kg/day
LOAEL = 100 mg/kg/day based on mortality,
clinical signs, and decreased mean body
weights, body weight gains, and food
consumption
Developmental NOAEL = 10 mg/kg/day
LOAEL = 100 mg/kg/day based on decreased
numbers of live fetuses/litter.
DPX-JW062
Maternal NOAEL = 1.1 mg/kg/day
LOAEL = 2.2 mg/kg/day based on decreased
mean body weights, body weight gains, food
consumption, and food efficiency.
Developmental NOAEL = 1.1 mg/kg/day
LOAEL = 2.2 mg/kg/day based on decreased
fetal body weights
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870.3700 Prenatal developmental in DPX-JW062 - rabbits
nonrodents Maternal NOAEL = 500 mg/kg/day
LOAEL = 1,000 mg/kg/day based on slight
decreases in maternal body weight gain and
food consumption.
Developmental NOAEL = 500 mg/kg/day
LOAEL = 1,000 mg/kg/day based on decreased
fetal body weights and reduced
ossification of the sternebrae.
----------------------------------------------------------------------------------------------------------------
870.3800 Reproduction and fertility DPX-JW062
effects Parental/Systemic
NOAEL = 1.5 mg/kg/day
LOAEL = 4.4 mg/kg/day based on decreased
body weights, body weight gains, and food
consumption of F0 females, and increased
spleen weights in the F0 and F1 females
Reproductive
NOAEL = 6.4 mg/kg/day
LOAEL = 6.4 mg/kg/day
Offspring
NOAEL = 1.5 mg/kg/day
LOAEL = 4.4 mg/kg/day based on decrease in
the body weights of the F1 pups during
lactation.
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[[Page 28835]]
870.4100 Chronic toxicity rodents DPX-JW062
NOAEL = M 5, F 2.1 mg/kg/day
LOAEL = M 10, F 3.6 mg/kg/day based on
decreased body weight, body weight gain,
and food consumption and food efficiency;
decreased HCT, HGB and RBC at 6 months in
F only.
No evidence of carcinogenic potential
----------------------------------------------------------------------------------------------------------------
870.4100 Chronic toxicity dogs DPX-JW062
NOAEL = M 2.3, F 2.4 mg/kg/day
LOAEL = M 18, F 19 mg/kg/day based on
decreased HCT, HGB and RBC; increased
Heinz bodies and reticulocytes and
associated secondary microscopic changes
in the liver, kidneys, spleen, and bone
marrow; increased absolute and relative
liver weights.
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870.4200 Carcinogenicity rats DPX-JW062 see 870.4100
No evidence of carcinogenicity
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870.4300 Carcinogenicity mice DPX-JW062
NOAEL = M 2.6, F4.0 mg/kg/day
LOAEL = M 14, F 20 mg/kg/day based on
decreased body weight, body weight gain,
and food efficiency and clinical signs
indicative of neurotoxicity.
No evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.5100 Gene mutation DPX-MP062 strains TA97a, TA98, TA100 and
TA1535 of S. typhimurium and strain
WP2(uvrA) of E. coli were negative for
mutagenic activity both with and without
S9 activation for the concentration range
10-5,000 [mu]g/plate
DPX-JW062 strains TA97a, TA98, TA100 and
TA1535 of S. typhimurium and strain
WP2(uvrA) of E. coli were negative for
mutagenic activity both with and without
S9 activation for the concentration range
10-5,000 [mu]g/plate.
----------------------------------------------------------------------------------------------------------------
870.5300 Gene mutation DPX-MP062
negative for mutagenic activity for the
following concentration ranges: 3.1-250
[mu]g/mL (-S9); 3.1-250 [mu]g/mL (+S9)
DPX-JW062
negative for mutagenic activity for the
following concentration ranges:
Negative;100-1,000 [mu]g/mL (-S9); 100-
1,000 [mu]g/mL (+S9), precipitate >=1,000
[mu]g/mL
----------------------------------------------------------------------------------------------------------------
870.5375 Cytogenetics DPX-MP062
No evidence of chromosomal aberrations
induced by the test article over
background for the following concentration
ranges: 15.7-1,000 [mu]g/mL (+S9)
DPX-JW062
No evidence of chromosomal aberrations
induced by the test article over
background for the following concentration
ranges: 19-300 [mu]g/mL (-S9), 19-150
[mu]g/mL (+S9); partial insoluble and
cytotoxicity >= 150 [mu]g/mL
----------------------------------------------------------------------------------------------------------------
870.5395 Cytogenetics DPX-MP062
No evidence of mutagenicity for the
following dose ranges: 3,000-4,000 mg/kg -
males; 1,000-2,000 mg/kg - females
DPX-JW062
No evidence of mutagenicity at 2,500 or
5,000 mg/kg
----------------------------------------------------------------------------------------------------------------
870.5550 Other effects DPX-MP062
No evidence of mutagenic activity at the
following concentration range: 1.56-200
[mu]g/mL; cytotoxicity was seen at
concentrations of >=100 [mu]g/mL
DPX-JW062
No evidence of mutagenic activity at the
following concentration range: 0.1-50
[mu]g/mL, cytotoxicity observed at >=50
[mu]g/mL
----------------------------------------------------------------------------------------------------------------
[[Page 28836]]
870.6200 Acute neurotoxicity DPX-MP062
screening battery NOAEL = M 100, F 12.5 mg/kg
LOAEL = M 200 mg/kg based on decreased body
weight gain, decreased food consumption,
decreased forelimb grip strength, and
decreased foot splay. F 50 mg/kg based on
decreased body weight, body weight gain,
and food consumption
DPX-JW062
NOAEL >= M 2,000 mg/kg = F < 500 mg/kg
LOAEL > M 2,000 mg/kg F < 500 mg/kg based
on clinical signs, decreased body weight
gains and food consumption, and FOB
effects
----------------------------------------------------------------------------------------------------------------
870.6200 Subchronic neurotoxicity DPX-MP062
screening battery NOAEL = M 0.57, F 0.68 mg/kg/day
LOAEL = M 5.6, F 3.3 mg/kg/day based on
decreased body weight and alopecia
----------------------------------------------------------------------------------------------------------------
870.7485 Metabolism and Both DPX-MP062 and DPX-JW062 were
pharmacokinetics extensively metabolized and the
metabolites were eliminated in urine,
feces, and bile. The metabolite profile
for DPX-JW062 was dose dependent and
varied quantitatively between males and
females. Differences in metabolite
profiles were also observed for the
different label positions (indanone and
trifluoromethoxyphenyl rings). All biliary
metabolites undergo further
biotransformation in the gut. The proposed
metabolic pathway for both DPX-MP062 and
DPX-JW062 has multiple metabolites bearing
one of the two ring structures (see
870.4100 chronic toxicity rodents above)
----------------------------------------------------------------------------------------------------------------
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. Discuss
any additional UFs (other than the FQPA SF) used in the assessment.
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 factor 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 Safety Factor
(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 106 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 indoxacarb used for human risk assessment is shown in
Table 2 of this unit:
Table 2.--Summary of Toxicological Dose and Endpoints for Indoxacarb for Use in Human Risk Assessment
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FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
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Acute dietary (females 13-50 years of NOAEL = 2.0 mg/kg/day FQPA SF = 1 Developmental rat
age) UF = 100 aPAD = acute RfD/FQPA toxicity study
Acute RfD = 0.02 mg/kg/ SF = 0.02 mg/kg/day. LOAEL = 4.0 mg/kg/day
day. based on decreased
fetal body weight
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[[Page 28837]]
Acute dietary (general population NOAEL = 12 mg/kg/day UF FQPA SF = 1 Acute oral rat
including infants and children) = 100 aPAD = acute RfD/FQPA neurotoxicity study
Acute RfD = 0.12 mg/kg/ SF = 0.12 mg/kg/day. LOAEL = 50 mg/kg/day
day. based on decreased
body weight and body
weight gain in females
-----------------------------------------------------------------------------------------
Chronic dietary (all populations) NOAEL= 2.0 mg/kg/day UF FQPA SF = 1 cPAD = 90-day rat subchronic
= 100 chronic RfD/FQPA SF = toxicity study,
Chronic RfD = 0.02 mg/ 0.02 mg/kg/day 90-day rat
kg/day. neurotoxicity study,
chronic/
carcinogenicity rat
study
LOAEL = 3.3 mg/kg/day
based on decreased
body weight, body
weight gain, food
consumption and food
efficiency; decreased
hematocrit, hemoglobin
and red blood cells
only at 6 months. 3.3
mg/kg/day is the
lowest LOAEL of the
three studies
-----------------------------------------------------------------------------------------
Short-term dermal (1 to 7 days) Dermal (or oral) study LOC for MOE = 100 28-day rat dermal
(Occupational)....................... NOAEL= 50 mg/kg/day (Occupational)......... toxicity study
LOAEL = 500 mg/kg/day
based on based on
decreased body
weights, body weight
gains, food
consumption, and food
efficiency in females,
and changes in
hematology parameters
(increased
reticulocytes), the
spleen (increased
absolute and relative
weight males only,
gross discoloration),
and clinical signs of
toxicity in both sexes
-----------------------------------------------------------------------------------------
Short-term inhalation (1-7 days) oral study NOAEL =2.0 LOC for MOE = 100 Rat developmental
(Occupational)....................... mg/kg/day (inhalation (Occupational)......... toxicity study.
absorption rate = 100% Maternal LOAEL = 4.0
mg/kg/day based on
decreased mean
maternal body weights,
body weight gains, and
food consumption
-----------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) ``Not likely'' to be N/A No evidence of
carcinogenic to humans carcinogenicity in
either the rat or
mouse in acceptable
carcinogenicity
studies and no
evidence of
mutagenicity
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA SF refers to any additional safety factor retained due to concerns unique to the
FQPA.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.564) for the combined residues of indoxacarb,
in or on a variety of raw agricultural commodities. Including
tolerances already established for: Apple at 1.0 ppm, Apple, wet pomace
at 3.0 ppm, Brassica, head and stem, subgroup at 5.0 ppm, Cattle, goat,
horse, sheep, and hog fat at 0.75 ppm, Cattle, goat, horse, sheep, and
hog meat at 0.03 ppm, Cattle, goat, horse, sheep, and hog meat
byproducts at 0.02 ppm, Corn, sweet, forage at 10 ppm, Corn, sweet,
kernel plus cob with husk removed at 0.02 ppm, Corn, sweet stover at 15
ppm, Cotton gin byproducts at 15 ppm, Cotton, undelinted seed at 2.0
ppm, Lettuce, head at 4.0 ppm, Lettuce, leaf at 10.0 ppm, Milk at 0.10
ppm, and Milk, fat at 3.0 ppm, Pear at 0.20 ppm, Vegetables, fruiting,
group at 0.50 ppm, and a time-limited tolerance for peach at 10.0 ppm.
Risk assessments were conducted by EPA to assess dietary exposures from
indoxacarb 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
(DEEMTM) 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 partially
refined, acute dietary exposure assessment was performed with use of
some anticipated residues (ARs) from field trial data, processing
factors (where applicable), and assuming 100% crop treated. ARs for
meat, milk, poultry, and eggs (MMPE) raw agricultural commodities
(RACs) were calculated also.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEMTM 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: Chronic exposure estimates are expressed in mg/kg bw/day
and as a pest percent of the cPAD. The chronic dietary assessment
assumed tolerance level residues, DEEMTM default processing
factors, assumed 100% CT for all crops other than cherries and peaches,
and 1% CT for the peach EUP (300 acres) and cherry EUP (180) acres.
iii. Cancer. There is no evidence for mutagenicity and there is no
evidence of
[[Page 28838]]
carcinogenicity in either the rat or mouse. Indoxacarb has been
classified as ``not likely to be carcinogenic in humans'' by the
Agency; therefore, no carcinogenic dietary risk analysis was performed.
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available
data and information on the anticipated residue levels of pesticide
residues in food and the actual levels of pesticide chemicals that have
been measured in food. If EPA relies on such information, EPA must
require that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. Following the initial
data submission, EPA is authorized to require similar data on a time
frame it deems appropriate. As required by section 408(b)(2)(E) of the
FFDCA, EPA will issue a data call-in for information relating to
anticipated residues to be submitted no later than 5 years from the
date of issuance of this tolerance.
Section 408(b)(2)(F) of the FFDCA states that the Agency may use
data on the actual percent of food treated for assessing chronic
dietary risk only if the Agency can make the following findings:
Condition 1, that the data used are reliable and provide a valid basis
to show what percentage of the food derived from such crop is likely to
contain such pesticide residue; Condition 2, that the exposure estimate
does not underestimate exposure for any significant subpopulation
group; and Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of percent crop
treated (PCT) as required by section 408(b)(2)(F) of the FFDCA , EPA
may require registrants to submit data on PCT.
Dietary exposure estimates were based on 1% CT for peaches and
cherries. This PCT of 1% was based on the fact that the 2-year
experimental use permit s were issued for only 300 acres of peaches,
and 180 acres of cherries to be treated annually, which amounts to 0.2%
of the total peach and cherry acreages in the United States. The reason
for using 1% instead of 0.2% is to allow for any uncertainties in the
residue evaluation. Before making this tolerance permanent,
reevaluation of dietary exposure will be performed using all available
information. Other commodities were assumed to be 100% 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 1% for indoxacarb used on peaches and cherries is
reliable and has a valid basis. A 2-year EUP has been issued for both
of these uses, which will allow for use of indoxacarb on 300 acres of
peaches and 180 acres of cherries in some eastern states. Before these
uses can be expanded for treatment of greater than 300 or 180 acres
respectively per year, permission from the Agency must be obtained. 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 Indoxacarb 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 indoxacarb 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 indoxacarb.
The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS)
to estimate pesticide concentrations in surface water and Screening
Concentrations in Ground Water (SCI-GROW), which predicts pesticide
concentrations in ground water. In general, EPA will use FIRST (a Tier
1 model) before using PRZM/EXAMS (a Tier 2 model) for a screening-level
assessment for surface water. The FIRST model is a subset of the PRZM/
EXAMS model that uses a specific high-end runoff scenario for
pesticides. FIRST and PRZM/EXAMS incorporate an index reservoir
environment. FIRST and PRZM/EXAMS models include 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 screen for sorting out pesticides for which it is
highly unlikely that drinking water concentrations would 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 high-end to bounding estimates 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 indoxacarb they are further
discussed in the aggregate risk sections below.
Based on the PRZM/EXAMS and SCI-GROW models the estimated EECs of
indoxacarb for acute exposures are estimated to be 13.7 parts per
billion (ppb) for surface water and 0.02 ppb for ground water. The EECs
for chronic exposures are estimated to be 3.7 ppb for surface water and
0.02 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).
Indoxacarb is not registered for use on any sites that would result
in residential exposure.
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
[[Page 28839]]
indoxacarb 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, indoxacarb 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
indoxacarb 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) (FRL-5754-7).
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. There is no evidence for
either qualitative or quantitative susceptibility. In all developmental
studies, the developmental endpoint occurs at the maternal LOAEL or
above. Although there is no rabbit developmental toxicity study with
indoxacarb, a study is not required since: (1) studies both using
methyl cellulose comparing JW062 in the rabbit and rat demonstrate that
the toxicity profiles for the rat and rabbit are similar and that the
rat is the more sensitive species; (2) range finding studies in the rat
comparing indoxacarb and JW062 indicate that the maternal and external
developmental toxicity are comparable; (3) a dietary developmental
toxicity study in the rat with JW062 had comparable toxicity to the
gavage indoxacarb rat developmental toxicity study. Developmental
toxicity only occurred at levels at or above maternal toxicity.
The reproduction toxicity study with JW062 can be used to satisfy
the requirement for an indoxacarb study because: (1) systemic toxicity
is at similar doses and of similar magnitude to that observed in
subchronic feeding studies with both indoxacarb and JW062; (2) based on
the data base, EPA determined that there was support for using data
from dietary studies conducted with JW062 to satisfy the data
requirements for indoxacarb.
The Agency has required a developmental neurotoxicity study as
confirmatory data due to:
Clinical signs of neurotoxicity in several studies, males
and females, mice and rats, at some doses that do not cause mortality.
Signs of neurotoxicity in the acute neurotoxicity study
rat with indoxacarb (males and females), no mortality in males at
neurotoxic doses.
Clinical signs of neurotoxicity in the 90-day toxicity
study rat indoxacarb (females), mortality.
Clinical signs of neurotoxicity in the 90-day toxicity
study mouse with the racemic mixture, JW062 (males and females), no
mortality in females at neurotoxic doses, mortality in males.
Clinical signs of neurotoxicity in the 18-month
carcinogenicity study mouse with JW062 (males and females) high and mid
dose, mortality at the high but no mortality at the mid dose.
Clinical signs of neurotoxicity in the developmental
toxicity study rat with JW062 (using methyl cellulose as the vehicle),
at doses causing mortality.
3. Conclusion. The Agency concluded that the FQPA safety factor
could be reduced to 1X for indoxacarb because:
There is no indication of quantitative or qualitative
increased susceptibility of rats or rabbits to in utero and/or
postnatal exposure.
The requirement of a developmental neurotoxicity study is
not based on the criteria reflecting special concern for the developing
fetuses or young which are generally used for requiring a DNT study -
and a safety factor (e.g., neuropathy in adult animals; CNS
malformations following prenatal exposure; brain weight or sexual
maturation changes in offspring; and/or functional changes in
offspring) - and therefore does not warrant an FQPA safety factor.
The dietary (food and drinking water) exposure assessments
will not underestimate the potential exposures for infants and
children.
There are no registered residential uses at the current
time.
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 high-end to
bounding estimates 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 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
indoxacarb will occupy 12% of the aPAD for the U.S. population, 64% of
the aPAD for females 13 years and older, 67% of the aPAD for infants
less than 1 year old and 36 of the aPAD for children 1 to 2 years old.
In addition, there is potential for acute dietary exposure to
indoxacarb in drinking water. After calculating DWLOCs and comparing
them to the
[[Page 28840]]
EECs for surface 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 Indoxacarb
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.12 12 13.7 0.02 3700
---------------------------------------------------------------------------
Females 13 + 0.12 64 13.7 0.02 220
---------------------------------------------------------------------------
All infants (less than 1 year) 0.12 67 13.7 0.02 400
---------------------------------------------------------------------------
Children (1 to 2 years) 0.12 36 13.7 0.02 760
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
indoxacarb from food will utilize 31% of the cPAD for the U.S.
population, 29% of the cPAD for infants less than 1 year old and 80% of
the cPAD for children 1 to 2 years old. There are no residential uses
for indoxacarb that result in chronic residential exposure to
indoxacarb. In addition, there is potential for chronic dietary
exposure to indoxacarb 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 if this unit:
Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Indoxacarb
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.02 31 3.7 0.02 480
---------------------------------------------------------------------------
All infants (less than 1 year) old 0.02 29 3.7 0.02 140
---------------------------------------------------------------------------
Children (1 to 2 years) 0.02 80 3.7 0.02 40
----------------------------------------------------------------------------------------------------------------
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). Indoxacarb is not
registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which 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). Indoxacarb is
not registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which do not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. There is no evidence
for mutagenicity and there is no evidence of carcinogenicity in either
rat or mouse. Indoxacarb has been classified as ``not likely to be
carcinogenic in humans'' by the Agency; therefore, indoxacarb is not
expected to pose carcinogenic risk when used as directed.
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 indoxacarb residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (example--gas 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
There are no established or proposed Codex, Canadian, or Mexican
maximum residue limits (MRLs) for residues of indoxacarb; therefore,
international harmonization is not an issue at this time.
V. Conclusion
Therefore, the tolerance is established for combined residues of
indoxacarb, (S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl) [4-
(trifluoromethoxy) phenyl]amino]carbonyl] indeno[1,2-
e][1,3,4]oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2- [[(methoxycarbonyl)[4-(trifluoromethoxy)
phenyl]amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-
carboxylate, in or on cherry, sweet and cherry, tart at 1.0 ppm. This
tolerance will expire and is revoked on May 21, 2007.
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
[[Page 28841]]
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), 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-2004-0130 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 19,
2004.
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 (1900L),
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 Suite 350, 1099 14\th\ St., NW.,
Washington, DC 20005. 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 (202) 564-6255.
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 ADDRESSES. Mail your
copies, identified by docket ID number OPP-2004-0130, 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 ADDRESSES. 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
[[Page 28842]]
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. 801et 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 6, 2004.
Lois Rossi,
Director, Registration Division, 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), 346a and 371.
0
2. Section 180.564 is amended by alphabetically adding the following
commodities to the table in paragraph (a)(2) to read as follows:
Sec. 180.564 Indoxacarb; tolerances for residues.
(a) * * * P>(2) * * *
----------------------------------------------------------------------------------------------------------------
Expiration/revocation
Commodity Parts per million date
----------------------------------------------------------------------------------------------------------------
Cherry, sweet......................... 1.0 May 21, 2007
Cherry, tart.......................... 1.0 May 21, 2007
* * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
[FR Doc. 04-11346 Filed 5-18-04; 8:45 am]
BILLING CODE 6560-50-S