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Indoxacarb (DuPont). September
29, 2000. Pesticide Tolerances.
Final Rule. Federal Register.
Tolerance in or on: apples, pears, Brassica (head and stem subgroup), cotton, leaf lettuce, head lettuce, fruiting vegetable group, sweet corn, milk, and the meat, meat byproducts and fat of cattle, goats, horses, hogs and sheep.
http://www.epa.gov/fedrgstr/EPA-PEST/2000/September/Day-29/p25052.htm
[Federal Register: September 29, 2000 (Volume 65, Number 190)]
[Rules and Regulations]
[Page 58415-58424]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se00-15]
[[Page 58415]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301064; FRL-6747-8]
RIN 2070-AB78]
Indoxacarb; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes permanent tolerances for the
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 a 75:25 mixture (DPX-
MP062), respectively, in or on the raw agricultural commodities as
follows: apples, pears, Brassica (head and stem subgroup), cotton, leaf
lettuce, head lettuce, fruiting vegetable group, sweet corn, milk, and
the meat, meat byproducts and fat of cattle, goats, horses, hogs and
sheep. E. I. du Pont de Nemours and Company requested these tolerances
under the Federal Food, Drug, and Cosmetic Act, as amended by the Food
Quality Protection Act of 1996.
DATES: This regulation is effective September 29, 2000. Objections and
requests for hearings, identified by docket control number OPP-301064,
must be received by EPA on or before November 28, 2000.
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 control number OPP-301064 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT By mail: Jane Smith, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460;
telephone number: 703 305-7378; e-mail address: smith.jane-
scott@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 Potentially
Affected Entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get 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/. 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 control number OPP-301064. 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 April 16, 1998 (63 FR 18912-18919) (FRL-
5782-8), EPA issued a notice pursuant to section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the
Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
announcing the filing of a pesticide petition (PP) 8F4948, for
tolerance by E. I. du Pont de Nemours and Company, P.O. Box 80038,
Wilmington, DE 19880-0038. This notice included a summary of the
petition prepared by DuPont, the registrant. There were three comments
in response to the Notice of Filing from members of the cotton
industry. They expressed concern for the use of terminology associated
with cotton in the Notice of Filing. These cotton terminology comments
were forwarded within the Agency to the evaluators of the cotton
portion of the submission which ultimately did not impact the
interpretation of the submission.
The petition (8F4948) requested that 40 CFR 180.564 be amended by
establishing permanent tolerances for residues of the insecticide DPX-
MP062 (75:25 enantiomeric mixture of indoxacarb and its R-enantiomer),
[R,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] in/on the raw agricultural commodities
as follows: pome fruit at 2.0 parts per million (ppm), apple pomace at
6.0 ppm, Brassicas, head and stem at 10.0 ppm, cottonseed at 3.0 ppm,
cotton gin trash at 15.0 ppm, leaf lettuce at 20.0 ppm, head lettuce at
7.0 ppm, fruiting vegetables at 0.70 ppm, sweet corn kernel at 0.02
ppm, sweet corn forage at 20.0 ppm, and sweet corn stover at 25.0 ppm,
meat 0.02 ppm, milk at 0.10 ppm, cattle kidney at 0.05 ppm; and by
establishing a tolerance for residues of the insecticide DPX-MP062,
(R,S)-
[[Page 58416]]
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 metabolite (IN-JT333),
methyl 7-chloro-2,5-dihydro-2-[[[4-(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2-e][1,3,4]oxadi azine- 4a(3H)-carboxylate, in/
on milk fat at 0.75 ppm and cattle fat at 0.75 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 the combined residues of indoxacarb and
its R-enantiomer in/on the following: 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 ppm;
milk at 0.10 ppm; milk fat at 3.0 ppm; pear at 0.20 ppm; vegetables,
fruiting, group at 0.50 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 and its
R-enantiomer 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. DPX-MP062 is a
75:25 mixture of the two enantiomers: indoxacarb which is
insecticidally active, and its R-enantiomer, which is insecticidally
inactive. DPX-JW062 is a mixture of these same two enantiomers;
however, they are in a 50:50 ratio. Toxicology data submitted on DPX-
JW062 were considered relevant and included in the evaluation.
The technical DPX-MP062 (75:25) is toxicity category I for acute
oral (rat); IV for acute dermal (rat), inhalation (rats) and primary
dermal irritation (rabbit); and III for primary eye irritation
(rabbit). The technical is considered a dermal sensitizer (guinea pig).
Table 1. -- Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
Guideline No. Study Type Results
------------------------------------------------------------------------
870.3100 90-Day oral DPX--MP062 (75%
toxicity rodents indoxacarb / 25%
-- rats enantiomer) NOAEL
= Male (M) 3.1 mg/
kg/day, Female (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.
------------------------------------------------------------------------
870.3100 90-Day oral DPX--JW062 (50%
toxicity rodents-- indoxacarb / 50%
rats enantiomer) /
NOAEL = M 8.0, F
4.6 mg/kg/day
LOAEL = M 16, F
9.5 mg/kg/day
based on mortality
(F only),
decreased. body
weight, body
weight gain, food
consumption and
food efficiency in
rats.
------------------------------------------------------------------------
870.3100 90-Day oral DPX--JW062 / NOAEL
toxicity rodents-- = M 3.7, F 4.9 mg/
rats kg/day LOAEL = M
7.5, F 12 mg/kg/
day based on
decreased in
absolute body
weight, body
weight gain and
food efficiency in
rats.
------------------------------------------------------------------------
870.3100 90-Day oral DPX--JW062 / NOAEL
toxicity rodents-- = M23, F 16 mg/kg/
mice day LOAEL = M 44,
F 30 mg/kg/day
based on mortality
(M only);
increased
reticulocytes and
Heinz bodies and
decreased body
weight, weight
gain, food
consumption, food
efficiency; and
increased clinical
signs (leaning to
one side and/or
with abnormal gait
or mobility) (F
only) in mice.
------------------------------------------------------------------------
870.3150 90-Day oral DPX--JW062 / NOAEL
toxicity in = 5.0 mg/kg/day
nonrodents--dogs LOAEL = 19 mg/kg/
day based on
hemolytic anemia,
as indicated by
decreased 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);
increased in
splenic EMH; and
RBC hyperplasia in
bone marrow in
dogs.
------------------------------------------------------------------------
[[Page 58417]]
870.3200 28-Day dermal DPX--MP062 / NOAEL
toxicity -- rats = 2,000 mg/kg/day
LOAEL = >2,000 mg/
kg/day in rats.
------------------------------------------------------------------------
870.3200 28-Day dermal DPX--MP062 / NOAEL
toxicity -- rats = 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.
------------------------------------------------------------------------
870.3700a Prenatal DPX--MP062 /
developmental in Maternal NOAEL =
rodents--rats 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.
------------------------------------------------------------------------
870.3700a Prenatal DPX--JW062 /
developmental in Maternal NOAEL =
rodents--rats 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.
------------------------------------------------------------------------
870.3700a Prenatal DPX--JW062 /
developmental in Maternal NOAEL =
rodents--rats 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.
------------------------------------------------------------------------
870.3700b Prenatal DPX--JW062 /
developmental in Maternal NOAEL =
nonrodents--rabbi 500 mg/kg/day
ts 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
decr. fetal body
weights and
reduced
ossification of
the sternebrae.
------------------------------------------------------------------------
870.3800 Reproduction and DPX--JW062 /
fertility Parental/Systemic
effects--rats 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
decreased in the
body weights of
the F1 pups during
lactation.
------------------------------------------------------------------------
870.4100a Chronic toxicity DPX--JW062 / NOAEL
rodents--rats = 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
------------------------------------------------------------------------
870.4100b Chronic toxicity-- DPX--JW062 / NOAEL
dogs = 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.
------------------------------------------------------------------------
870.4200 Carcinogenicity--r DPX--JW062 / see
ats 870.4100a no
evidence of
carcinogenicity
------------------------------------------------------------------------
870.4300 Carcinogenicity--m DPX--JW062 / NOAEL
ice = 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 10-5000
g/plate
------------------------------------------------------------------------
870.5100 Gene mutation 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 10-5000
g/plate.
------------------------------------------------------------------------
[[Page 58418]]
870.5300 Gene mutation DPX--MP062 /
negative for
mutagenic activity
for the following
concentration
ranges: 3.1-250
g/mL (-
S9); 3.1-250
g/mL
(+S9)
------------------------------------------------------------------------
870.5300 Gene mutation DPX--JW062 /
negative for
mutagenic activity
for the following
concentration
ranges:
Negative;100-1,000
g/mL (-
S9); 100-1,000
g/mL
(+S9), precipitate
1,000
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
g/mL
(+S9)
------------------------------------------------------------------------
870.5375 Cytogenetics DPX--JW062 / no
evidence of
chromosomal
aberrations
induced by the
test article over
background for the
following
concentration
ranges: 19-300
g/mL (-
S9), 19-150 g/mL (+S9);
partial insoluble
and cytotoxicity
150
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
------------------------------------------------------------------------
870.5395 Cytogenetics 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
g/mL;
cytotoxicity was
seen at
concentrations of
100
g/mL
------------------------------------------------------------------------
870.5550 Other effects DPX--JW062 / No
evidence of
mutagenic activity
at the following
concentration
range: 0.1-50
g/mL,
cytotoxicity
observed at 50 g/mL
------------------------------------------------------------------------
870.6200a Acute DPX--MP062 / NOAEL
neurotoxicity = M 100, F 12.5 mg/
screening battery kg LOAEL = M 200
-- rat 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
------------------------------------------------------------------------
870.6200a Acute DPX--JW062 / NOAEL
neurotoxicity >= M 2,000 mg/kg,
screening battery F < 500 mg/kg
--rats LOAEL > M 2,000 mg/
kg, F < 500 mg/kg
based on clinical
signs, decreased
body weight gains
and food
consumption, and
FOB effects
------------------------------------------------------------------------
870.6200b Subchronic DPX--MP062 / NOAEL
neurotoxicity = M 0.57, F 0.68
screening battery mg/kg/day LOAEL =
-- rats M 5.6, F 3.3 mg/kg/
day based on
decreased body
weight and
alopecia.
------------------------------------------------------------------------
870.7485 Metabolism and Both DPX--MP062 and
pharmacokinetic -- DPX--JW062 were
rats 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.
------------------------------------------------------------------------
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety 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
[[Page 58419]]
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 and its R-enantiomer used for human risk
assessment is shown in the following Table 2:
Table 2. -- Summary of Toxicological Dose and Endpoints for Indoxacarb and its R-enantiomer for Use in Human
Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk FQPA Safety Factor
Exposure Scenario Assessment, Uncertainty (SF)* and Endpoint for Study and Toxicological
Factor (UF) Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary females 13-50 years of NOAEL = 2.0 mg/kg/day FQPA SF = 1 aPAD = Developmental rat
age UF = 100 Acute RfD = acute RfD toxicity study.
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 UF = FQPA SF = 1 aPAD = Acute oral rat
including infants and children 100 Acute RfD = 0.12 acute RfD neurotoxicity study.
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 UF FQPA SF = 1 cPAD = chr 90-Day rat subchronic
= 100 Chronic RfD = RfD FQPA SF = toxicity study, 90-day
0.02 mg/kg/day 0.02 mg/kg/day rat 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 NOAEL/
LOAEL of the 3
studies.
----------------------------------------------------------------------------------------------------------------
Short-term oral (1-7 days) Oral study NOAEL= 2.0 LOC for MOE = 100 Developmental rat
(Residential) 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 (1 week - Oral study NOAEL= 2.0 LOC for MOE = 100 90-day rat subchronic
several months) (Residential) mg/kg/day (Residential, includes toxicity study. LOAEL
the FQPA SF) = 3.8 mg/kg/day based
on decreased body
weight, body weight
gain, food consumption
and food efficiency.
----------------------------------------------------------------------------------------------------------------
Short- (1-7 days), intermediate- (1 Dermal study NOAEL= 50 LOC for MOE = 100 28-day rat dermal
week--several months), and long- mg/kg/day (Occupational) LOC for toxicity study. LOAEL
(several months--lifetime) term MOE = 100 = 500 mg/kg/day based
dermal (Occupational/ Residential) (Residential, includes on decreased body
the FQPA SF) 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/ Residential) mg/kg/day (inhalation (Occupational) LOC for toxicity study.
absorption rate = MOE = 100 maternal LOAEL = 4.0
100%) (Residential, includes mg/kg/day based on
the FQPA SF) decreased mean
maternal body weights,
body weight gains, and
food consumption.
----------------------------------------------------------------------------------------------------------------
Intermediate- term inhalation (1 Oral study NOAEL= 2.0 LOC for MOE = 100 90-day rat subchronic
week--several months) (Occupational/ mg/kg/day (inhalation (Occupational) LOC for toxicity study. LOAEL
Residential) absorption rate = MOE = 100 = 3.8 mg/kg/day based
100%) (Residential, includes on decreased body
the FQPA SF) weight, body weight
gain, food consumption
and food efficiency.
----------------------------------------------------------------------------------------------------------------
[[Page 58420]]
Long-term inhalation (several Oral study NOAEL= 2.0 LOC for MOE = 100 90-day rat subchronic
months--lifetime) (Occupational/ mg/kg/day (inhalation (Occupational) LOC for toxicity study, 90-day
Residential) absorption rate =100%) MOE = 100 rat neurotoxicity
(Residential, includes study, chronic/
the FQPA SF) 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 or residues of
indoxacarb and its R-enantiomer, in or on a variety of raw agricultural
commodities including apples, pears, Brassica (head and stem subgroup),
cotton, leaf lettuce, head lettuce, fruiting vegetable group, sweet
corn, milk, and the meat, meat byproducts and fat of cattle, goats,
horses, hogs and sheep. Risk assessments were conducted by EPA to
assess dietary exposures from indoxacarb and its R-enantiomer in food
as follows:
i. Acute exposure. Acute dietary risk assessments are performed
for a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. The Dietary Exposure Evaluation Model (DEEM)
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: acute Tier 1 analysis assuming tolerance level
residues and 100% crop treated (CT) information was performed; however,
dietary risk estimates from residues in food exceeded Agency's level of
concern (> 100% aPAD). 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 100%
CT. Note that the Tier 2 assessment is deterministic in that point
estimates were used for all residues and the conservative assumption of
100% CT was made. Additional refinement using % CT data would result in
even lower exposure estimates from residues in food.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment, the DEEM analysis evaluated the individual food consumption
as reported by respondents in the USDA 1989-1992 nationwide CSFII and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the chronic exposure assessments: tolerance
level residues and 100% CT (Tier 1). Additional refinement using less
than 100% CT data would result in even lower exposure estimates from
residues in food.
iii. 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 and its R-
enantiomer 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 and its R-enantiomer.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
the Screening Concentration in Ground Water Model (SCI-GROW), which
predicts pesticide concentrations in ground water. In general, EPA will
use GENEEC (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model)
for a screening-level assessment for surface water. The GENEEC model is
a subset of the PRZM/EXAMS model that uses a specific high-end runoff
scenario for pesticides. GENEEC incorporates a farm pond scenario,
while PRZM/EXAMS incorporate an index reservoir environment in place of
the previous pond scenario. The PRZM/EXAMS model includes a percent
crop area factor as an adjustment to account for the maximum percent
crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated
[[Page 58421]]
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 and its R-
enantiomer they are further discussed in the aggregate risk sections
below.
Based on the PRZM/EXAMS and SCI-GROW models the estimated
environmental concentrations (EECs) of indoxacarb and its R-enantiomer
for acute exposures are estimated to be 3.81 parts per billion (ppb)
for surface water and 0.02 ppb for ground water. The EECs for chronic
exposures are estimated to be 0.56 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 and its R-
enantiomer 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 and its R-enantiomer 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 and its R-enantiomer 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 and
its R-enantiomer has a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the final rule for Bifenthrin
Pesticide Tolerances (62 FR 62961, November 26, 1997).
D. Safety Factor for Infants and Children
1. Safety factor for infants and children--i. In general. FFDCA
section 408 provides that EPA shall apply an additional tenfold margin
of safety for infants and children in the case of threshold effects to
account for prenatal and postnatal toxicity and the completeness of the
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.
ii. Prenatal and postnatal sensitivity. There is no evidence of
susceptibility from either in utero or neonatal exposure to both rat
and rabbit young with either DPX--MP062 or DPX--JW062.
iii. Conclusion. There is a complete toxicity data base for
indoxacarb and its R-enantiomer and exposure data are complete or are
estimated based on data that reasonably accounts for potential
exposures. The FQPA safety factor is 1X. EPA determined that the 10X
safety factor to protect infants and children should be removed
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 SF; the dietary
(food and drinking water) exposure assessments will not under estimate
the potential exposures for infants and children; and 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 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 U S EPA 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, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food only to
indoxacarb and its R-enantiomer will occupy < or = 10% of the aPAD for
the U.S. population, 33% of the aPAD for females 13 years and older, 6%
of the aPAD for infants < 1 year and 10% of the aPAD for children 1-6
years old. In addition, there is potential for acute dietary exposure
to indoxacarb and its R-enantiomer in drinking water. After calculating
DWLOCs and comparing them to the EECs for surface and ground water, EPA
does not expect the aggregate exposure to exceed 100% of the aPAD as
shown in the following Table 3:
[[Page 58422]]
Table 3. -- Aggregate Risk Assessment for Acute Exposure to Indoxacarb and its R-enantiomer.
----------------------------------------------------------------------------------------------------------------
Surface Ground
Scenario / Population Subgroup aPAD (mg/kg/ % aPAD Water EEC Water EEC Acute DWLOC
day) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13-50 years old 0.02 33 3.81 0.02 3,400
----------------------------------------------------------------------------------------------------------------
General U.S. Population 0.12 6 3.81 0.02 4,000
----------------------------------------------------------------------------------------------------------------
All Infants < 1 year old 0.12 6 3.81 0.02 1,100
----------------------------------------------------------------------------------------------------------------
Children 1-6 years old 0.12 10 3.81 0.02 1,100
----------------------------------------------------------------------------------------------------------------
Children 7-12 years old 0.12 7 3.81 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 and its R-enantiomer from food will utilize 28% of the cPAD
for the U.S. population, 37% of the cPAD for infants <1 year old, and
73% of the cPAD for children 1-6 years old. There are no residential
uses for indoxacarb and its R-enantiomer that result in chronic
residential exposure to indoxacarb and its R-enantiomer. In addition,
there is potential for chronic dietary exposure to indoxacarb and its
R-enantiomer in drinking water. After calculating the DWLOCs and
comparing them to the EECs for surface and ground water, EPA does not
expect the aggregate exposure to exceed 100% of the cPAD, as shown in
the following Table 4:
Table 4. -- Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to Indoxacarb and its R-enantiomer
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.12 28 0.56 0.02 500
----------------------------------------------------------------------------------------------------------------
All Infants <1 year old 0.12 37 0.56 0.02 130
----------------------------------------------------------------------------------------------------------------
Children 1-6 years old 0.12 73 0.56 0.02 53
----------------------------------------------------------------------------------------------------------------
Children 7-12 years old 0.12 40 0.56 0.02 120
----------------------------------------------------------------------------------------------------------------
Females 13-50 years old 0.12 22 0.56 0.02 540
----------------------------------------------------------------------------------------------------------------
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 and its r-
enantiomer 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 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
and its R-enantiomer 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. 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 and its R-enantiomer 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: 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
No other international residue limits have been established at this
time.
C. Conditions
The following toxicology studies are required as confirmatory: a
developmental neurotoxicity study in the rat (Guideline #870.6300) and
a 90-day inhalation toxicity study in the rat (Guideline #870.3465).
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 the following raw
agricultural commodities: 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;
[[Page 58423]]
lettuce, leaf at 10 ppm; milk at 0.10 ppm; milk fat at 3.0 ppm; pear at
0.20 ppm; and vegetables, fruiting, group at 0.50 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 control number OPP-301064 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before November
28, 2000.
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 control number OPP-301064, 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 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 file format 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). 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 prior consultation as specified by Executive Order
13084, entitled Consultation and Coordination with Indian Tribal
Governments (63 FR 27655, May 19, 1998); special considerations as
required by Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or require 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
[[Page 58424]]
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).
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: September 21, 2000.
Susan B. Hazen,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), (346a) and 371.
2. Section 180.564 is added to read as follows:
Sec. 180.564 Indoxacarb; tolerances for residues.
(a) General. Tolerances are established for the 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
the following raw agricultural commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Apple...................................................... 1.0
Apple, wet pomace.......................................... 3.0
Brassica, head and stem, subgroup.......................... 5.0
Cattle, goat, horse, sheep and hog fat..................... 0.75
Cattle, goat, horse, sheep and hog meat.................... 0.03
Cattle, goat, horse, sheep and hog meat byproducts......... 0.02
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
Lettuce, head.............................................. 4.0
Lettuce, leaf.............................................. 10
Milk....................................................... 0.10
Milk fat................................................... 3.0
Pear....................................................... 0.20
Vegetables, fruiting, group................................ 0.50
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(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 00-25052 Filed 9-28-00; 8:45 am]
BILLING CODE 6560-50-S