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Indoxacarb and its R-enantimomer
(DuPont). July 18, 2002.
Pesticide Tolerances. Final Rule. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2002/July/Day-18/p18173.htm
[Federal Register: July 18, 2002 (Volume 67, Number 138)]
[Rules and Regulations]
[Page 47299-47310]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jy02-12]
=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0105; FRL-7186-2]
Indoxacarb; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for combined residues
of indoxacarb in or on alfalfa forage, alfalfa hay, peanut, peanut hay,
potato, soybean seed, soybean aspirated grain fractions, and soybean
hulls. Additionally, this regulation is increasing the tolerance levels
for head lettuce, milk, milk fat, meat, fat, and meat by-products of
cattle, goat, hog, horse, and sheep. E. I. Du Pont de Nemours and
Company requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act
(FQPA) of 1996.
DATES: This regulation is effective July 18, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0105,
must be received on or before September 16, 2002.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number OPP-2002-0105 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Geri McCann, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 605-0716; e-mail address: mccann.geri@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
[[Page 47300]]
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet home page at http://www.epa.gov/.
To access this document, on the home page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/
nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, 
a beta site currently
under development. To access the OPPTS Harmonized Guidelines referenced
in this document, go directly to the guidelines at http://www.epa.gov/
opptsfrs/home/guidelin.htm.
2. In person. The Agency has established an official record for
this action under docket ID number OPP-2002-0105. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of (67 FR 3700, January 25 2002) (FRL-6819-
2), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C.
346a, as amended by the FQPA of 1996 (Public Law 104-170), announcing
the filing of a pesticide petition (PP 1F6301) by E. I. Du Pont de
Nemours and Company. This notice included a summary of the petition
prepared by E. I. Du Pont de Nemours and Company, the registrant. The
Agency received one e-mail letter from consumers/growers that believe
there should be zero pesticide levels on human and animal foods.
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-enantimomer [(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 alfalfa, forage at 10
parts per million (ppm), alfalfa, hay at 50 ppm, peanut at 0.01 ppm,
peanut, hay at 40 ppm, potato at 0.01 ppm, soybean, seed at 0.80 ppm,
aspirated grain fractions at 45 ppm, and soybean, hulls at 4.0 ppm.
Additionally, the petition requested an increase in tolerance levels
for head lettuce, milk, milk fat, meat, fat, and meat by-products of
cattle, goat, hog, horse, and sheep based on a proposed increase in the
labeled use rate for head lettuce and on potential changes in residue
levels in livestock diets. The proposed increases are for head lettuce
at 5.0 ppm, meat of cattle, goat, hog, horse, and sheep at 0.05 ppm,
fat of cattle, goat, hog, horse, and sheep at 1.5 ppm, meat by-products
of cattle, goat, hog, horse, and sheep at 0.03 ppm, milk at 0.15 ppm,
and milk, fat at 4.0 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) 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)
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 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), 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), for a tolerance for combined residues of indoxacarb on
alfalfa, forage at 10 ppm, alfalfa, hay at 50 ppm, peanut at 0.01 ppm,
peanut, hay at 40 ppm, potato at 0.01 ppm, soybean, seed at 0.80 ppm,
aspirated grain fractions at 45 ppm, soybean, hulls at 4.0 ppm,
lettuce, head at 5.0 ppm, meat of cattle, goat, hog, horse, and sheep
at 0.05 ppm, fat of cattle, goat, hog, horse, and sheep at 1.5 ppm,
meat by-products of cattle, goat, hog, horse, and sheep at 0.03 ppm,
milk at 0.15 ppm, and milk, fat at 4.0 ppm. EPA's assessment of
exposures and risks associated with establishing the tolerance(s)
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
[[Page 47301]]
toxic effects caused by indoxacarb are discussed in the following Table
1 as well as the no observed adverse effect level (NOAEL) and the
lowest observed adverse effect level (LOAEL) from the toxicity studies
reviewed.
Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
Guideline No. Study Type Results
------------------------------------------------------------------------
870.3100 90-Day oral DPX-MP062
toxicity rodents NOAEL = M 3.1
milligrams/
kilogram/day (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
------------------------------------------------------------------------
870.3150 90-Day oral DPX-JW062
toxicity in NOAEL = 5.0 mg/kg/
nonrodents 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 DPX-MP062
toxicity 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 DPX-MP062
developmental in Maternal
rodents 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
------------------------------------------------------------------------
[[Page 47302]]
870.3700 Prenatal DPX-JW062 - rabbits
developmental in Maternal
nonrodents 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 DPX-JW062
fertility 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
------------------------------------------------------------------------
870.4100 Chronic toxicity DPX-JW062
rodents 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 DPX-JW062
dogs NOAEL = M 2.3, F
2.4 mg/kg/day
LOAEL = M 18, F 19
mg/kg/day based on
decreased HCT, HGB
nd 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
------------------------------------------------------------------------
870.4200 Carcinogenicity DPX-JW062 (see
rats 870.4100--Chronic
toxicity rodents
above)
No evidence of
carcinogenicity
------------------------------------------------------------------------
870.4300 Carcinogenicity DPX-JW062
mice NOAEL = M 2.6, F
4.0 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
------------------------------------------------------------------------
[[Page 47303]]
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
------------------------------------------------------------------------
870.6200 Acute DPX-MP062
neurotoxicity NOAEL = M 100, F
screening battery 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 DPX-MP062
neurotoxicity NOAEL = M 0.57, F
screening battery 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
pharmacokinetics DPX-JW062 were
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
trifluoromethoxyph
enyl 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 the NOAEL from the toxicology study identified as
appropriate for use in risk assessment is used to estimate the
toxicological level of concern (LOC). However, the lowest dose at which
adverse effects of concern are identified (the LOAEL) is sometimes used
for risk assessment if no NOAEL was achieved in the toxicology study
selected. An uncertainty factor (UF) is applied to reflect
uncertainties inherent in the extrapolation from laboratory animal data
to humans and in the variations in sensitivity among members of the
human population as well as other unknowns. An UF of 100 is routinely
used, 10X to account for interspecies differences and 10X for
intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
[[Page 47304]]
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.
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 indoxacarb used for human
risk assessment is shown in the following Table 2:
Table 2.--Summary of Toxicological Dose and Endpoints for indoxacarb for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary NOAEL = 2.0 mg/kg/day FQPA SF = 1 Developmental rat
Females 13-50 years of age........... UF = 100............... aPAD = acute RfD....... toxicity study
Acute RfD = 0.02 mg/kg. FQPA SF = 0.02 mg/kg/ Developmental LOAEL =
day. 4.0 mg/kg/day based on
decreased fetal body
weight
----------------------------------------------------------------------------------------------------------------
Acute dietary general population NOAEL = 12.5 mg/kg FQPA SF = 1 Acute oral rat
including infants and children UF = 100............... aPAD = acute RfD....... neurotoxicity study
Acute RfD = 0.12 mg/kg. FQPA SF = 0.12 mg/kg/ LOAEL = 50 mg/kg based
day. on decreased body
weight and body weight
gain in females
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations NOAEL = 2.0 mg/kg/day FQPA SF = 1 90-Day rat subchronic
UF = 100............... cPAD = chr RfD......... toxicity study
Chronic RfD = 0.02 mg/ FQPA SF = 0.02 mg/kg/ 90-Day rat
kg/day. day. neurotoxicity study,
chronic/
carcinogenicity rat
study
LOAEL = 3.3 mg/kg/day
based on decreased
body weight, alopecia,
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 oral (1-7 days) Oral study LOC for MOE = 100 Developmental rat
(Residential)........................ NOAEL= 2.0 mg/kg/day.. (Residential, includes toxicity study
the FQPA SF) Maternal
LOAEL = 4.0 mg/kg/day
based on decreased
mean maternal body
weights, body weight
gains, and food
consumption
----------------------------------------------------------------------------------------------------------------
Intermediate-term Oral study LOC for MOE = 100 90-Day rat subchronic
Oral (1 week--several months)........ NOAEL= 2.0 mg/kg/day... (Residential, includes toxicity study
(Occupational/....................... the FQPA SF) LOAEL = 3.8 mg/kg/day
Residential)......................... based on decreased
body weight, body
weight gain, food
consumption and food
efficiency
----------------------------------------------------------------------------------------------------------------
Short-(1-7 days), intermediate (1 Dermal study LOC for MOE = 100 28-Day rat dermal
week--several months), and long NOAEL= 50 mg/kg/day.... (Occupational) toxicity study
(several months--lifetime) LOC for MOE = 100 LOAEL = 500 mg/kg/day
Term dermal.......................... (Residential, includes based on decreased
(Occupational/....................... the FQPA SF). body weights, body
Residential)......................... 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 LOC for MOE = 100 Rat developmental
(Occupational/....................... NOAEL= 2.0 mg/kg/day (Occupational) toxicity study.
Residential)......................... (inhalation absorption LOC for MOE = 100 Maternal
rate = 100%). (Residential, includes LOAEL = 4.0 mg/kg/day
the FQPA SF). based on decreased
mean maternal body
weights, body weight
gains, and food
consumption
----------------------------------------------------------------------------------------------------------------
[[Page 47305]]
Intermediate-term Inhalation (1 week-- Oral study LOC for MOE = 100 90-Day rat subchronic
several months) NOAEL= 2.0 mg/kg/day (Occupational) toxicity study
(Occupational/....................... (inhalation absorption LOC for MOE = 100 LOAEL = 3.8 mg/kg/day
Residential)......................... rate = 100%). (Residential, includes based on decreased
the FQPA SF). body weight, body
weight gain, food
consumption and food
efficiency
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (several months - Oral study LOC for MOE = 100 90-Day rat subchronic
lifetime) NOAEL= 2.0 mg/kg/day (Occupational) toxicity study,
(Occupational/....................... (inhalation absorption LOC for MOE = 100 90-day rat
Residential)......................... rate =100%). (Residential, includes neurotoxicity study,
the FQPA SF). 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
----------------------------------------------------------------------------------------------------------------
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 Safety Factor 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 by-
products 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 by-products 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, and vegetables,
fruiting, group at 0.50 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 1989-1992 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: An acute Tier 2 (partially refined
analysis) dietary assessment was performed with use of anticipated
residues (ARs) from field trial data, processing factors (where
applicable), and assumed 100% crop treated (CT). 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 Dietary Exposure Evaluation Model (DEEMTM
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1989-1992 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: Chronic exposure estimates are expressed in mg/kg
bwt/day and as a percent of the cPAD. The chronic dietary assessment
assumed tolerance level residues, DEEMTM default processing
factors, and 100% CT (Tier 1).
iii. Cancer. There is no evidence for mutagenicity and there is no
evidence of 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.
iv. Anticipated residue and percent crop treated information.
Section 408(b)(2)(E) 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), 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.
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,
chemical, and environmental fate characteristics of indoxacarb.
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS)
to estimate pesticide concentrations in surface water and SCI-GROW,
which predicts pesticide concentrations in 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 meta-model of the PRZM/EXAMS model that uses a specific
high-end runoff scenario
[[Page 47306]]
for pesticides. PRZM/EXAMS incorporate an index reservoir environment
in place of the pond scenario. The PRZM/EXAMS model includes a percent
crop area factor as an adjustment to account for the maximum percent
crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw 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
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 indoxacarb they are further
discussed in the aggregate risk sections.
Based on the PRZM/EXAMS and SCI-GROW models, the estimated
environmental concentrations (EECs) of indoxacarb for acute exposures
are estimated to be 13.86 parts per billion (ppb) for surface water and
0.02 ppb for ground water. The EECs for chronic exposures are estimated
to be 2.47 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) 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 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).
D. Safety Factor for Infants and Children
1. In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the 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 margin of exposure
(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: 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; range finding studies in the rat
comparing indoxacarb and JW062 indicate that the maternal and external
developmental toxicity are comparable; 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: Systemic toxicity is
at similar doses and of similar magnitude to that observed in
subchronic feeding studies with both indoxacarb and JW062; based on the
data base, the 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), 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.
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; central nervous
system 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; and
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.
[[Page 47307]]
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: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and 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 7% of the aPAD for the U.S. population, 41% of
the aPAD for females 13 years and older, 6% of the aPAD for all infants
less than 1 year old and 12% of the aPAD for children 1 to 6 years old,
the children population at greatest exposure. In addition, there is
potential for acute 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 aPAD, as shown in the following Table 3:
Table 3.--Aggregate Risk Assessment for Acute Exposure to Indoxacarb
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface Water EEC Ground Water EEC
Population Subgroup aPAD (mg/kg) %aPAD (Food) (ppb) (ppb) Acute DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population 0.12 7 13.86 0.02 3,900
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females 13 + 0.12 41 13.86 0.02 350
--------------------------------------------------------------------------------------------------------------------------------------------------------
All infants less than 1 year 0.12 6 13.86 0.02 1,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 1 to 6 0.12 12 13.86 0.02 1,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 33% of the cPAD for the U.S.
population, 48% of the cPAD for infants less than 1 year old and 85% of
the cPAD for children 1 to 6 years old, the subpopulation at greatest
exposure. There are no residential uses for indoxacarb that result in
chronic residential exposure to indoxacarb. Based on the use pattern,
chronic residential exposure to residues of indoxacarb is not expected.
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
the following Table 4:
Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Indoxacarb
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface Water EEC Ground Water EEC
Population Subgroup cPAD mg/kg/day %cPAD (Food) (ppb) (ppb) Chronic DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population 0.02 33 3.65 0.02 470
--------------------------------------------------------------------------------------------------------------------------------------------------------
All infants less than 1 year old 0.02 48 3.65 0.02 100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 1 to 6 0.02 85 3.65 0.02 30
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
[[Page 47308]]
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
the 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 a carcinogenic risk.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to indoxacarb residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (HPLC/UV Method AMR 2712-93) is
available to enforce the tolerance expression. The method may be
requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address:
furlow.calvin@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, tolerances are 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-enantimomer [(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 alfalfa, forage at 10
ppm, alfalfa, hay at 50 ppm, peanut at 0.01 ppm, peanut, hay at 40 ppm,
potato at 0.01 ppm, soybean, seed at 0.80 ppm, aspirated grain
fractions at 45 ppm, soybean, hulls at 4.0 ppm. Additionally, the
petition requested an increase in tolerance levels for head lettuce,
milk, milk fat, meat, fat, and meat by-products of cattle, goat, hog,
horse, and sheep based on a proposed increase in the labeled use rate
for head lettuce and on potential changes in residue levels in
livestock diets. The proposed increases are for head lettuce at 5.0
ppm, meat of cattle, goat, hog, horse, and sheep at 0.05 ppm, fat of
cattle, goat, hog, horse, and sheep at 1.5 ppm, meat by-products of
cattle, goat, hog, horse, and sheep at 0.03 ppm, milk at 0.15 ppm, and
milk, fat at 4.0 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 of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) 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 FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2002-0105 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 September
16, 2002.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. 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) 260-4865.
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.
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.
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.2. Mail your
copies, identified by docket ID number OPP-2002-0105 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.
In person or by courier, bring a copy to the location of
[[Page 47309]]
the PIRIB described in Unit I.B.2. 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. Regulatory Assessment Requirements
This final rule establishes a tolerance under FFDCA section 408(d)
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 3, 2002.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 is revised to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
2. Section 180.564 is amended by revising the table in paragraph
(a) to read as follows:
Sec. 180.564 Indoxacarb, tolerances for residues.
(a) * * *
[[Page 47310]]
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Apple.......................................... 1.0
Apple, wet pomace.............................. 3.0
Brassica, head and stem, subgroup.............. 5.0
Alfalfa, forage................................ 10
Alfalfa, hay................................... 50
Cattle, fat.................................... 1.5
Cattle, meat................................... 0.05
Cattle, meat byproducts........................ 0.03
Corn, sweet, forage............................ 10
Corn, sweet, kernel plus cob with husk removed. 0.02
Corn, sweet, stover............................ 15
Cotton gin byproducts.......................... 15
Cotton, undelinted seed........................ 2.0
Goat, fat...................................... 1.5
Goat, meat..................................... 0.05
Goat, meat byproducts.......................... 0.03
Hog, fat....................................... 1.5
Hog, meat...................................... 0.05
Hog, meat byproducts........................... 0.03
Horse, fat..................................... 1.5
Horse, meat.................................... 0.05
Horse, meat byproducts......................... 0.03
Lettuce, head.................................. 5.0
Lettuce, leaf.................................. 10
Milk........................................... 0.15
Milk, fat...................................... 4.0
Pear........................................... 0.20
Peanut......................................... 0.01
Peanut, hay.................................... 40
Potato......................................... 0.01
Sheep, fat..................................... 1.5
Sheep, meat.................................... 0.05
Sheep, meat byproducts......................... 0.03
Soybean, aspirated grain fractions............. 45
Soybean, hulls................................. 4.0
Soybean, seed.................................. 0.80
Vegetable, fruiting, group..................... 0.50
------------------------------------------------------------------------
* * * * *
[FR Doc. 02-18173 Filed 7-17-02; 8:45 am]
BILLING CODE 6560-50-S