Indoxacarb; Pesticide Tolerance, 37633-37641 [E7-13339]
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that this rule will not have a significant
economic impact on a substantial
number of small entities under the
Regulatory Flexibility Act (5 U.S.C. 601
et seq.). Because this action is only a
notice and does not impose any
additional enforceable duty beyond that
required by state law, it does not
contain any unfunded mandate or
significantly or uniquely affect small
governments, as described in the
Unfunded Mandates Reform Act of 1995
(Pub. L. 104–4). This action also does
not have tribal implications because it
will not have a substantial direct effect
on one or more Indian tribes, 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 by Executive Order 13175 (65
FR 67249, November 9, 2000). This
action also does not have Federalism
implications because it does not 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, as specified in
Executive Order 13132 (64 FR 43255,
August 10, 1999). This action merely
notifies the public of EPA’s receipt of
negative declarations for existing OSWI
units from state agencies and does not
alter the relationship or the distribution
of power and responsibilities
established in the Clean Air Act. This
action also is not subject to Executive
Order 13045 ‘‘Protection of Children
from Environmental Health Risks and
Safety Risks’’ (62 FR 19885, April 23,
1997), because it approves a state rule
implementing a Federal Standard.
With regard to negative declarations
for OSWI units received by EPA for
states, EPA’s role is only to notify the
public of the receipt of such negative
declarations. In this context, in the
absence of a prior existing requirement
for the State to use voluntary consensus
standards (VCS), EPA has no authority
to approve or disapprove a CAA section
111(d)/129 plan negative declaration
submission for failure to use VCS. It
would thus be inconsistent with
applicable law for EPA, when it reviews
a CAA section 111(d)/129 negative
declaration, to use VCS in place of a
section 111(d)/129 negative declaration
that otherwise satisfies the provisions of
the Clean Air Act. Thus, the
requirements of section 12(d) of the
National Technology Transfer and
Advancement Act of 1995 (15 U.S.C.
272 note) do not apply. This action does
not impose an information collection
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burden under the provisions of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
B. 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. This action is not
a rulemaking, however, EPA will submit
a report containing this action 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 the rule in
the Federal Register. This rule is not a
‘‘major rule’’ as defined by 5 U.S.C.
804(2).
C. Petitions for Judicial Review
Under section 307(b)(1) of the Clean
Air Act, petitions for judicial review of
this action must be filed in the United
States Court of Appeals for the
appropriate circuit by September 10,
2007. Filing a petition for
reconsideration by the Administrator of
this action does not affect the finality of
this action for the purposes of judicial
review nor does it extend the time
within which a petition for judicial
review may be filed, and shall not
postpone the effectiveness of such
action.
This action approving the section
111(d)/129 negative declarations
submitted by the States of Delaware,
and West Virginia may not be
challenged later in proceedings to
enforce its requirements. (See section
307(b)(2).)
List of Subjects in 40 CFR Part 62
Environmental protection,
Administrative practice and procedure,
Air pollution control, Aluminum,
Fertilizers, Fluoride, Intergovernmental
relations, Paper and paper products
industry, Phosphate, Reporting and
recordkeeping requirements, Sulfur
oxides, Sulfur acid plants, Waste
treatment and disposal.
Dated: June 28, 2007.
William C. Early,
Acting Regional Administrator, Region III.
I
40 CFR part 62 is amended as follows:
PART 62—[AMENDED]
1. The authority citation for part 62
continues to read as follows:
I
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Authority: 42 U.S.C. 7401 et seq.
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Subpart I—Delaware
2. Subpart I is amended by adding an
undesignated center heading and
§ 62.1990 to read as follows:
I
Emissions From Existing Other Solid
Waste Combustion Units
§ 62.1990 Identification of plan—negative
declaration.
Letter from the Delaware Department
of Natural Resources and Environmental
Control submitted June 26, 2006,
certifying that there are no existing
other solid waste incinerator units
within the State of Delaware that are
subject to 40 CFR part 60, subpart FFFF.
Subpart XX—West Virginia
3. Subpart XX is amended by adding
an undesignated center heading and
§ 62.12165 to read as follows:
I
Emissions From Other Solid Waste
Incinerator Units
§ 62.12165 Identification of plan—negative
declaration.
Letter from the West Virginia
Department of Environmental Protection
submitted June 2, 2006, certifying that
there are no existing other solid waste
incinerator units within the State of
West Virginia that are subject to 40 CFR
part 60, subpart FFFF.
[FR Doc. E7–13426 Filed 7–10–07; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2005–0149; FRL–8137–8]
Indoxacarb; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for combined residues of
indoxacarb and its R-enantiomer in or
on cranberry; fruit, pome, except pear,
group 11; fruit, stone, group 12; grape;
grape, raisin; okra; pea, southern, seed;
pear, oriental; peppermint, tops;
spearmint, tops; turnip greens;
vegetable, Brassica, leafy, group 5;
vegetable, cucurbit, group 9; vegetable,
leafy, except Brassica, group 4; and
vegetable, tuberous and corm, subgroup
1-C. E.I. du Pont de Nemours and
Company and the Interregional Research
Project No. 4 (IR-4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA). This
regulation also removes existing
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Federal Register / Vol. 72, No. 132 / Wednesday, July 11, 2007 / Rules and Regulations
tolerances on apple; Brassica, head and
stem, subgroup 5A; lettuce, head;
lettuce, leaf; and potato, which are
superseded by the new tolerances; and
removes expired time-limited tolerances
on cherry, sweet; cherry, tart; peach;
and collards; and the time-limited
tolerance on cranberry (set to expire
December 31, 2007), which are no
longer needed as a result of this action.
Finally, this regulation corrects a
typographical error in the spelling of the
word ‘‘enantiomer’’ in the tolerance
expression for indoxacarb given in 40
CFR 180.564(a)(1).
DATES: This regulation is effective July
11, 2007. Objections and requests for
hearings must be received on or before
September 10, 2007, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2005–0149. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
web site to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. Although listed in the
index, some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov,or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Barbara Madden, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–6463; e-mail address:
madden.barbara@epa.gov.
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ADDRESSES:
SUPPLEMENTARY INFORMATION:
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I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code
111), e.g., agricultural workers;
greenhouse, nursery, and floriculture
workers; farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s pilot
e-CFR site at https://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of the FFDCA,
any person may file an objection to any
aspect of this regulation and may also
request a hearing on those objections.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
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proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2005–0149 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
as required by 40 CFR part 178 on or
before September 10, 2007.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2005–0149, by one of the
following methods:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
on-line instructions for submitting
comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Petition for Tolerance
In the Federal Register of July 2, 2003
(68 FR 39541) (FRL–7312–9), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 3F6576) by E.I. du
Pont de Nemours and Company,
Newark, DE 19711. 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-2,5dihydro-2-[[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2e][1,3,4][oxadiazine-4a(3H)-carboxylate,
and its R-enantiomer, (R)-methyl 7chloro-2,5-dihydro-2[[(methoxycarbonyl) [4(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2e][1,3,4][oxadiazine-4a(3H)-carboxylate,
in or on grape at 2.0 parts per million
(ppm) and raisin at 6.0 ppm. That notice
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included a summary of the petition
prepared by E.I. du Pont de Nemours
and Company, the registrant, which is
available to the public in the docket
EPA–HQ–OPP–2003–0212, https://
www.regulations.gov. One comment was
received on the notice of filing from a
private citizen expressing support for
the proposed tolerances.
In the Federal Register of May 5, 2004
(69 FR 25104) (FRL–7354–9), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 2E6482) by the
Interregional Research Project No. 4 (IR4). The petition requested that 40 CFR
180.564 be amended by revoking
Brassica, head and stem, subgroup at 5.0
ppm and establishing a tolerance for
combined residues of the insecticide
indoxacarb, (S)-methyl 7-chloro-2,5dihydro-2-[[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2e][1,3,4][oxadiazine-4a(3H)-carboxylate,
and its R-enantiomer, (R)-methyl 7chloro-2,5-dihydro-2[[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2e][1,3,4][oxadiazine-4a(3H)-carboxylate,
in or on vegetable, , leafy, group 5 at 12
ppm and turnip greens at 12 ppm. That
notice included a summary of the
petition prepared by E.I. du Pont de
Nemours and Company, the registrant,
which is available to the public in the
docket EPA–HQ–OPP–2004–0064,
https://www.regulations.gov. There were
no comments received in response to
the notice of filing.
In the Federal Register of June 30,
2005 (70 FR 37852) (FRL–7718–9), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of
pesticide petitions (PP 5E6911 and
5E6926) by the Interregional Research
Project No. 4 (IR-4). The petitions
requested that 40 CFR 180.564 be
amended by establishing a tolerance for
combined residues of the insecticide
indoxacarb, (S)-methyl 7-chloro-2,5dihydro-2-[[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2e][1,3,4][oxadiazine-4a(3H)-carboxylate,
and its R-enantiomer, (R)-methyl 7chloro-2,5-dihydro-2[[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2e][1,3,4][oxadiazine-4a(3H)-carboxylate,
in or on leafy greens, except spinach,
subgroup 4A at 10 ppm; spinach at 3.0
ppm; leaf petioles subgroup 4B at 1.5
ppm; fruit, pome, except pear, group 11
at 1.0 ppm; vegetable, tuberous and
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corm, subgroup 1C at 0.01 ppm; okra at
0.5 ppm (all requested in PP 5E6911);
pea (Southern) at 0.1 ppm; and mint at
10 ppm (both requested in PP 5E6926).
That notice included a summary of the
petition prepared by E.I. du Pont de
Nemours and Company, the registrant,
which is available to the public in the
docket EPA–HQ–OPP–2005–0149,
https://www.regulations.gov. There were
no comments received in response to
the notice of filing.
In the Federal Register of April 12,
2006 (71 FR 18738) (FRL–7772–2), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 5E6991) by the
Interregional Research Project No. 4 (IR4). The petition requested that 40 CFR
180.564 be amended by establishing a
tolerance for combined residues of the
insecticide indoxacarb, (S)-methyl 7chloro-2,5-dihydro-2[[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2e][1,3,4][oxadiazine-4a(3H)-carboxylate,
and its R-enantiomer, (R)-methyl 7chloro-2,5-dihydro-2[[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2e][1,3,4][oxadiazine-4a(3H)-carboxylate,
in or on vegetable, cucurbit, group 9 at
0.5 ppm; fruit, stone, group 12 at 1 ppm;
and cranberry at 1 ppm. That notice
referenced a summary of the petition
prepared by E.I. du Pont de Nemours
and Company, the registrant, which is
available to the public in the docket
EPA–HQ–OPP–2005–0149, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
Based upon review of the data
supporting the petitions, EPA has
modified the proposed tolerances. The
reasons for these changes are explained
in Unit V.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of the FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of the FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
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408(b)(2)(C) of the FFDCA requires EPA
to give special consideration to
exposure of infants and children to the
pesticide chemical residue in
establishing a tolerance and to ‘‘ensure
that there is a reasonable certainty that
no harm will result to infants and
children from aggregate exposure to the
pesticide chemical residue....’’ These
provisions were added to the FFDCA by
the Food Quality Protection Act (FQPA)
of 1996.
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
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 for
the petitioned-for tolerances for
combined residues of indoxacarb, (S)methyl 7-chloro-2,5-dihydro-2[[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2e][1,3,4][oxadiazine-4a(3H)-carboxylate,
and its R-enantiomer, (R)-methyl 7chloro-2,5-dihydro-2[[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2e][1,3,4][oxadiazine-4a(3H)-carboxylate,
in or on cranberry at 0.90 ppm; fruit,
pome, except pear, group 11 at 1.0 ppm;
fruit, stone, group 12 at 0.90 ppm; grape
at 2.0 ppm; grape, raisin at 5.0 ppm;
okra at 0.50 ppm; pea, southern, seed at
0.10 ppm; pear, oriental at 0.20 ppm;
peppermint, tops at 11 ppm; spearmint,
tops at 11 ppm; turnip greens at 12 ppm;
vegetable, Brassica, leafy, group 5 at 12
ppm; vegetable, cucurbit, group 9 at
0.60 ppm; vegetable, leafy, except
Brassica, group 4 at 14 ppm; and
vegetable, tuberous and corm, subgroup
1-C at 0.01 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. Specific
information on the studies received and
the nature of the adverse effects caused
by indoxacarb as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found at https://
www.regulations.gov. The referenced
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document is available in the docket
established by this action, which is
described under ADDRESSES, and is
identified as EPA–HQ–OPP–2005–0149
in that docket.
Indoxacarb is an isomeric compound
containing two enantiomers, the Senantiomer (DPX-KN128, the
insecticidally active component) and its
R-enantiomer (DPX-KN127, the
insecticidally inactive component).
DPX-MP062 is an enantiomeric mixture
containing the S-enantiomer and its Renantiomer at approximately a 75:25
ratio. DPX-JW062 is the racemic mixture
of the enantiomers at a 50:50 ratio.
DPX-KN128, DPX-MP062 and DPXJW062 appear to be of similar toxicity
acutely. DPX-KN128 and DPX-MP062
were moderately acutely toxic by the
oral route (toxicity category II) while
DPX-JW062 was practically non-toxic
(toxicity category IV) due to its poor
solubility in the corn oil vehicle.
However, it was equally toxic orally,
when tested using a solvent where it
had a higher solubility, such as
polyethylene glycol (PEG). By the
dermal route, they had low toxicity
(toxicity category III and IV). DPXMP062 and DPX-JW062 had low acute
inhalation toxicity (IV). DPX-MP062 and
DPX-JW062 had moderate to low ocular
irritant properties (III and IV), while
DPX-KN128 was practically nonirritating to the rabbit’s eyes. By the
maximization test, DPX-KN128 and
DPX-MP062 were considered dermal
sensitizers, while DPX-JW062 was not a
sensitizer.
There was possible evidence of lung
damage in the acute inhalation studies
with both DPX-MP062 and DPX-JW062.
‘‘Lung noise,’’ observed with JW062
may indicate the development of acute
lung injury and high permeability
pulmonary edema. This was not
unexpected since an oxidant was
generated during indoxacarb
metabolism. ‘‘Hunched over back and
gasping’’ were also present and
suggested arterial hypoxemia that
accompanies alveolar flooding. The
acute inhalation study report with
indoxacarb 70% manufacturing use
product, noted that a ‘‘red nasal
discharge’’ was detected for 2 days after
exposure. This may be indicative of a
lung exudate, a sign of lung injury.
Subchronic (28 days) inhalation toxicity
on indoxacarb in rats was characterized
by increased spleen weights, increased
pigmentation and hematopoiesis in the
spleen, and hematological changes.
The toxicity profiles for DPX-KN128,
DPX-MP062 and DPX-JW062 in rats,
mice and dogs with both subchronic
and chronic oral exposures were
similar. Dermal subchronic exposure in
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the rat also resulted in a similar profile.
The toxic signs occurred at similar
doses and with a similar magnitude of
response, with females generally being
more sensitive than males. The
endpoints that most frequently defined
the LOAEL were non-specific, and
included decreased body weight, weight
gain, food consumption and food
efficiency. These compounds also
affected the hematopoietic system by
decreasing the red blood cell count,
hemoglobin and hematocrit in rats, dogs
and mice. It was frequently
accompanied by an increase in
reticulocytes in all three species and an
increase in Heinz bodies (dogs and mice
only). None of these signs of toxicity
appeared to get worse over time. In one
subchronic rat study, the parameters
appeared to return to normal levels
following a four-week recovery period.
High doses in the rats and mice also
sometimes caused mortality.
There was no evidence of
susceptibility from either in utero or
neonatal exposure to both rat and rabbit
young with either DPX-MP062 or DPXJW062. There was no evidence of
susceptibility from in utero exposure in
rats with DPX-KN128. There was no
evidence of increased susceptibility in
the developmental neurotoxicity study
in rats with DPX-KN128. No evidence of
teratogenicity was observed in rats and
rabbits with DPX-MP062 or DPX-JW062.
No evidence of teratogenicity was
observed in rats with DPX-KN128.
There was no evidence of reproductive
effects in the 2-generation reproduction
study in rats.
Neurotoxicity was present in both rats
and mice; however, it did not occur in
the absence of other signs of toxicity.
Neurotoxicity was characterized by one
or more of the following symptoms in
both male and female rats and mice:
Weakness, head tilting, and abnormal
gait or mobility with inability to stand,
ataxia. Acute and subchronic
neurotoxicity screening batteries were
performed using DPX-MP062 in rats.
Neurotoxicity was characterized by
clinical signs (depression, abnormal
gait, head shake, salivation) and
functional-observation battery (FOB)
(circling behavior, incoordination, slow
righting reflex, decreased forelimb grip
strength, decreased foot splay,
decreased motor activity). However,
there was no evidence of
neurohistopathology in any study.
Learning and memory parameters were
affected in the pups in the
developmental neurotoxicity study in
rats with DPX-KN128.
There was no evidence of
carcinogenicity in either the rat or
mouse in acceptable studies using DPX-
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JW062. DPX-JW062 was not mutagenic
in a complete battery of mutagenicity
studies. There was also no evidence of
mutagenicity with either DPX-KN128, or
DPX-MP062.
Both DPX-JW062 and DPX-MP062
were rapidly absorbed and eliminated
following oral administration. The
absorption of DPX-JW062 was dose
dependent and appeared to be saturated
at the high dose. Both urine and feces
represented major routes of excretion
(35–45% and 33–47%, respectively).
The distribution pattern did not vary
with dosing regimen and overall tissue
burden was limited to only 3.4–12.9%
of the administered dose. The red blood
cells of rats dosed with the
trifluoromethoxyphenyl label
consistently contained much greater
levels of radioactivity than did plasma.
Fat tissue contained the greatest level of
radioactivity (1.76–8.76% of the
administered dose) and, for both
compounds, was greater in female rats.
The finding also demonstrates a greater
propensity for accumulation by female
rats than by male rats. Both DPX-MP062
and DPX-JW062 were extensively
metabolized and the metabolites were
eliminated in the urine, feces, and bile.
With the exception of parent compound
(DPX-JW062, which accounted for
19.2% of a single low dose in the feces
of female rats), none of the metabolites
from any source represented more than
12.3% of the administered dose. 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. All of the
biliary metabolites appear to undergo
further biotransformation in the gut.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the toxicological level of concern
(LOC) is derived from the highest dose
at which the NOAEL in the toxicology
study identified as appropriate for use
in risk assessment. However, if a
NOAEL cannot be determined, the
lowest dose at which adverse effects of
concern are identified (the LOAEL) is
sometimes used for risk assessment.
Uncertainty/safety factors (UF) are used
in conjunction with the LOC to take into
account 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. Safety is assessed for acute
and chronic risks by comparing
aggregate exposure to the pesticide to
the acute population adjusted dose
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(‘‘aPAD’’) and chronic population
adjusted dose (‘‘cPAD’’). The aPAD and
cPAD are calculated by dividing the
LOC by all applicable uncertainty/safety
factors. Short-term, intermediate-term,
and long-term risks are evaluated by
comparing aggregate exposure to the
LOC to ensure that the margin of
exposure (‘‘MOE’’) called for by the
product of all applicable uncertainty/
safety factors is not exceeded.
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk and
estimates risk in terms of the probability
of occurrence of additional adverse
cases. Generally, cancer risks are
considered non-threshold. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
A summary of the toxicological
endpoints for indoxacarb used for
human risk assessment can be found at
www.regulations.gov in document
‘‘PP#s: 2E6482, 3F6576, 5E6911,
5E6926, and 5E6991. Indoxacarb. Health
Effects Division (HED) Risk Assessment
for Grapes; Vegetable, Brassica, Leafy,
Group 5; Turnip Greens; Vegetable,
Leafy, Except Brassica (Group 4); Pome
Fruits (Group 11, except pear); Tuberous
and Corm Vegetables (Subgroup 1C);
Cucurbit Vegetables (Group 9); Stone
Fruits (Group 12); Cranberry; Mint;
Okra; Southern Pea; and Fire Ant Bait.’’
at pages 23–24 in Docket ID EPA–HQ–
OPP–2005–0149.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to indoxacarb, EPA considered
exposure under the petitioned-for
tolerances as well as all existing
indoxacarb tolerances in (40 CFR
180.564). EPA assessed dietary
exposures from indoxacarb in food as
follows:
i. Acute exposure. Quantitative acute
dietary exposure and 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. In estimating acute dietary
exposure, EPA used food consumption
information from the USDA 1994–1996
and 1998 Nationwide Continuing
Surveys of Food Intake by Individuals
(CSFII). As to residue levels in food,
EPA relied upon anticipated residues
for most commodities and percent crop
treated information for most currently
registered commodities. EPA assumed
100 percent crop (PCT) treated for all of
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the new commodities. Anticipated
residues for all registered and new food
commodities were based on field trial
data.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 1994–1996 and 1998
Nationwide CSFII. As to residue levels
in food, EPA relied upon anticipated
residues for most commodities and PCT
information for most currently
registered commodities. EPA assumed
100 PCT for all of the new commodities.
Anticipated residues for all registered
and new food commodities were based
on field trial data.
iii. Cancer. EPA has classified
indoxacarb as ‘‘not likely’’ to be
carcinogenic to humans via relevant
routes of exposure using the Guidelines
for Carcinogen Risk Assessment.
Therefore, a cancer exposure assessment
was not conducted.
iv. Anticipated residue and PCT
information. Section 408(b)(2)(E) of the
FFDCA authorizes EPA to use available
data and information on the anticipated
residue levels of pesticide residues in
food and the actual levels of pesticide
residues that have been measured in
food. If EPA relies on such information,
EPA must pursuant to section 408(f)(1)
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. For the present
action, EPA will issue such data call-ins
as are required by FFDCA section
408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be
required to be submitted no later than
5 years from the date of issuance of
these tolerances.
Section 408(b)(2)(F) of the FFDCA
states that the Agency may use data on
the actual percent of food treated for
assessing chronic dietary risk only if:
a. The data used are reliable and
provide a valid basis to show what
percentage of the food derived from
such crop is likely to contain such
pesticide residue;
b. The exposure estimate does not
underestimate exposure for any
significant subpopulation group; and
c. Data are available on pesticide use
and food consumption in a particular
area, the exposure estimate does not
understate exposure for the population
in such area. In addition, the Agency
must provide for periodic evaluation of
any estimates used. To provide for the
periodic evaluation of the estimate of
PCT as required by section 408(b)(2)(F)
of FFDCA, EPA may require registrants
to submit data on PCT.
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The Agency used PCT information as
follows:
For the acute assessment, maximum
PCT estimates were used for the
following commodities: apple (5%),
broccoli (50%), cabbage (25%),
cauliflower and the remaining Brassica
head and stem vegetables (55%), sweet
corn (2.5%), head lettuce (25%), leaf
lettuce (11%), peanut (2.5%), pear
(2.5%), peppers (15%), potato (2.5%),
soybean (1%), spinach (5%) and tomato
(25%).
For the chronic assessment, average
weighted PCT estimates were used for
the following commodities: apple (1%),
broccoli (40%), cabbage (15%),
cauliflower and the remaining Brassica
head and stem vegetables (35%), sweet
corn (1%), head lettuce (18%), leaf
lettuce (9%), peanut (1%), pear (1%),
peppers (10%), potato (1%), soybean
(1%), spinach (5%) and tomato (15%).
EPA uses an average PCT for chronic
dietary risk analysis. The average PCT
figure for each existing use is derived by
combining available federal, state, and
private market survey data for that use,
averaging by year, averaging across all
years, and rounding up to the nearest
multiple of five percent except for those
situations in which the average PCT is
less than one. In those cases <1% is
used as the average and <2.5% is used
as the maximum. EPA uses a maximum
PCT for acute dietary risk analysis. The
maximum PCT figure is the single
maximum value reported overall from
available federal, state, and private
market survey data on the existing use,
across all years, and rounded up to the
nearest multiple of five percent. In most
cases, EPA uses available data from
United States Department of
Agriculture/National Agricultural
Statistics Service (USDA/NASS),
Proprietary Market Surveys, and the
National Center for Food and
Agriculture Policy (NCFAP) for the most
recent six years.
The Agency believes that the three
conditions listed above have been met.
With respect to Condition 1, PCT
estimates are derived from Federal and
private market survey data, which are
reliable and have a valid basis. The
Agency is reasonably certain that the
percentage of the food treated is not
likely to be an underestimation. As to
Conditions 2 and 3, regional
consumption information and
consumption information for significant
subpopulations is taken into account
through EPA’s computer-based model
for evaluating the exposure of
significant subpopulations including
several regional groups. Use of this
consumption information in EPA’s risk
assessment process ensures that EPA’s
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exposure estimate does not understate
exposure for any significant
subpopulation group and allows the
Agency to be reasonably certain that no
regional population is exposed to
residue levels higher than those
estimated by the Agency. Other than the
data available through national food
consumption surveys, EPA does not
have available information on the
regional consumption of food to which
indoxacarb may be applied in a
particular area.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring 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 environmental fate characteristics of
indoxacarb. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the EPA’s Pesticide Root
Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS) and
Screening Concentration in Ground
Water (SCI-GROW) models, the
estimated environmental concentrations
(EECs) of indoxacarb for acute
exposures are estimated to be 25.1 parts
per billion (ppb) for surface water and
0.21 ppb for ground water. The EECs for
chronic exposures are estimated to be
5.37 ppb for surface water and 0.21 ppb
for ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 25.1 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration of
value 5.37 ppb was used to assess the
contribution to drinking water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Indoxacarb is currently registered for
the following residential non-dietary
sites: as a fire ant bait for turf, which
may be applied as a mound treatment or
as a broadcast application by
‘‘residential’’ (i.e., private persons)
applicators as well as by commercial
handlers.
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EPA assessed residential exposure
using the following assumptions: EPA
has determined that residential handlers
are likely to be exposed to indoxacarb
residues via dermal and inhalation
routes during handling and applying
activities. Based on the current use
pattern, EPA expects duration of
exposure to be short-term (1–30 days).
The broadcast treatment results in a
higher handler exposure than the
mound treatment and is, therefore, the
scenario assessed by EPA. EPA assessed
exposure of residential handlers
applying indoxacarb with a push-type
spreader using SOPs for Residential
Exposure Assessments (DEC-1997) in
conjunction with unit exposures
developed by the Outdoor Residential
Exposure Task Force (ORETF).
There is also the potential for shortterm and intermediate-term postapplication exposure of adults and
children from entering areas previously
treated with indoxacarb (i.e., turf treated
for fire ants). The post-application
scenarios assessed from exposure to
treated turf include: Dermal exposure
from treated lawns due to high contact
lawn activities (adult and toddler);
Dermal exposure from treated turf due
to golfing (adults and youths); Hand-tomouth transfer of pesticide residues on
lawns (toddler); Incidental ingestion of
granules from pesticide-treated
residential areas (toddler); and
Incidental ingestion of soil from
pesticide-treated residential areas
(toddler).
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of the FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
indoxacarb and any other substances
and 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 EPA’s website at https://
www.epa.gov/pesticides/cumulative.
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D. Safety Factor for Infants and
Children
1. In general. Section 408 of FFDCA
provides that EPA shall apply an
additional (‘‘10X’’) 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 database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA safety factor. In applying this
provision, EPA either retains the default
value of 10X when reliable data do not
support the choice of a different factor,
or, if reliable data are available, EPA
uses a different additional FQPA safety
factor value based on the use of
traditional uncertainty/safety factors
and/or special FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity.
There was no quantitative or qualitative
evidence of increased prenatal or
postnatal sensitivity in the two
developmental toxicity studies in rats
with DPX-JW062, one developmental
toxicity study in rats with DPX-MP062
and DPX-KN128, one developmental
toxicity study in rabbits with DPXJW062, one 2-generation reproduction
studies in rats with DPX-JW062 and a
developmental neurotoxicity (DNT)
study in rats with DPX-KN128. In these
studies, developmental toxicity was
observed in the presence of maternal
toxicity.
3. Conclusion. EPA has determined
that reliable data show that it would be
safe for infants and children to reduce
the FQPA safety factor to 1X. That
decision is based on the following
findings:
i. The toxicity database for indoxacarb
is complete.
ii. Neurotoxicity was seen in animal
studies in rats and mice but at higher
doses than the hematologic effects on
which EPA’s risk assessments are based.
To evaluate the potential for increased
sensitivity of infants and children to
neurotoxic effects, EPA required a rat
developmental neurotoxicity (DNT)
study. The study has been submitted
and reviewed. There was no evidence of
increased sensitivity of offspring in the
submitted study. Clinical observations,
motor activity, acoustic startle
habituation, and learning and memory
testing were all comparable between the
control and treated groups. Mean brain
weight, gross and microscopic
examinations and morphometric
measurements of the brain were also
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comparable between the controls and
treated groups.
iii. There is no evidence that
indoxacarb results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the two-generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The acute and chronic dietary food
exposure assessments utilize anticipated
residues for most commodities that are
based on reliable field trial data. They
also utilize PCT data that have been
verified by the Agency for most existing
uses. For all new uses, 100 PCT is
assumed. The acute and chronic
assessments are somewhat refined and
based on reliable data and will not
underestimate exposure/risk.
Conservative ground and surface water
modeling estimates were used. Similarly
conservative Residential SOPs were
used to assess post-application exposure
to children as well as incidental oral
exposure of toddlers. These assessments
will not underestimate the exposure and
risks posed by indoxacarb.
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E. Aggregate Risks and Determination of
Safety
Safety is assessed for acute and
chronic risks by comparing aggregate
exposure to the pesticide to the acute
population adjusted dose (‘‘aPAD’’) and
chronic population adjusted dose
(‘‘cPAD’’). The aPAD and cPAD are
calculated by dividing the LOC by all
applicable uncertainty/safety factors.
For linear cancer risks, EPA calculates
the probability of additional cancer
cases given aggregate exposure. Shortterm, intermediate-term, and long-term
risks are evaluated by comparing
aggregate exposure to the LOC to ensure
that the margin of exposure (‘‘MOE’’)
called for by the product of all
applicable uncertainty/safety factors is
not exceeded.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
indoxacarb will occupy 84% of the
aPAD for the population group
(children, 3 to 5 years old) receiving the
greatest exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to indoxacarb from food
and water will utilize 53% of the cPAD
for the population group (children, 1 to
2 years old) with greatest exposure.
Based the use pattern, chronic
residential exposure to residues of
indoxacarb is not expected.
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Indoxacarb is currently registered for
use that could result in short-term
residential exposure and the Agency has
determined that it is appropriate to
aggregate chronic food and water and
short-term exposures for indoxacarb.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded that
food, water, and residential exposures
aggregated result in aggregate MOEs of
620 for the general U.S. population and
190 for children, 1 to 2 years old. The
aggregate MOE for the general U.S.
population is based on the residential
turf (fire ant control) scenario and
includes combined residential
applicator and post-application dermal
exposures. EPA determined that it is not
appropriate to include applicator
inhalation exposure in the aggregate
exposure assessment, since toxicological
endpoints of concern for dermal and
inhalation exposures are different. The
aggregate MOE for children includes
post-application dermal and incidental
oral exposures from entering turf areas
previously treated with indoxacarb for
fire ants.
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 currently registered for
use(s) that could result in intermediateterm residential exposure and the
Agency has determined that it is
appropriate to aggregate chronic food
and water and intermediate-term
exposures for indoxacarb.
Using the exposure assumptions
described in this unit for intermediateterm exposures, EPA has concluded that
food, water, and residential exposures
aggregated result in aggregate MOEs of
620 for the general U.S. population and
190 for children, 1 to 2 years old. The
aggregate MOE for the general U.S.
population is based on the residential
turf (fire ant control) scenario and
includes combined residential
applicator and post-application dermal
exposures. EPA determined that it is not
appropriate to include applicator
inhalation exposure in the aggregate
exposure assessment, since toxicological
endpoints of concern for dermal and
inhalation exposures are different. The
aggregate MOE for children includes
post-application dermal and incidental
oral exposures from entering turf areas
previously treated with indoxacarb for
fire ants.
5. Aggregate cancer risk for U.S.
population. EPA has classified
indoxacarb as ‘‘not likely’’ to be
carcinogenic to humans via relevant
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routes of exposure using the Guidelines
for Carcinogen Risk Assessment.
Therefore, a cancer aggregate exposure
assessment was not conducted.
Indoxacarb is not expected to pose a
cancer risk.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to indoxacarb
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
is available to enforce the tolerance
expression (high-performance liquid
chromatography (HPLC)/column
switching/ultraviolet (UV) methods
AMR 2712-93 and Du Pont 11978 with
confirmation/specificity provided by gas
chromatography (GC)/mass-selective
detector method AMR 3493-95,
Supplement No. 4). These methods may
be requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no established or proposed
Codex maximum residue limits (MRLs)
for indoxacarb.
V. Conclusion
Based upon review of the data
supporting the petitions, EPA has
modified the proposed tolerances as
follows:
(1) PP 3F6576: Revised the
commodity term and tolerance for
‘‘raisin’’ to read ‘‘grape, raisin’’ at 5.0
ppm;
(2) PP 5E6911: Replaced the proposed
tolerances for ‘‘leafy greens, except
spinach, subgroup 4A’’, ‘‘leaf petioles
subgroup 4B’’ and ‘‘spinach’’ with a
single tolerance in or on ‘‘vegetable,
leafy, except Brassica, group 4’’ at 14
ppm; and added a tolerance for ‘‘pear,
oriental’’ at 0.20 ppm;
(3) PP 5E 6926: Revised the
commodity term ‘‘pea (southern’’) to
read ‘‘pea, southern, seed’’; and revised
the commodity term and tolerance level
for ‘‘mint’’ to read ‘‘peppermint, tops’’ at
11 ppm and ‘‘spearmint, tops’’ at 11
ppm; and
(4) PP 5E6991: Revised the tolerances
for ‘‘vegetable, cucurbit, group 9’’,
‘‘fruit, stone, group 12’’ and ‘‘cranberry’’
to 0.60 ppm, 0.90 ppm and 0.90 ppm,
respectively. The reasons for these
changes are discussed below.
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EPA revised the commodity terms
‘‘raisin’’, mint’’ and ‘‘pea (southern)’’ to
agree with recommended commodity
terms in the Office of Pesticide
Program’s Food and Feed Commodity
Vocabulary. Based on data submitted
with PP 5E6911 and data previously
submitted to support the existing
tolerances on leaf and head lettuce, EPA
determined that it was appropriate to
establish a tolerance for the crop group
‘‘vegetable, leafy, except Brassica, group
4’’ instead of the proposed separate
tolerances on ‘‘leafy greens, except
spinach, subgroup 4A’’, ‘‘spinach’’ and
‘‘leaf petioles subgroup 4B’’. The crop
group tolerance of 14 ppm is based on
data for the crop with the highest field
trial residues (spinach). EPA is
establishing a tolerance for ‘‘pear,
oriental’’ at 0.20 ppm. A tolerance for
‘‘pear’’ currently exists at this level.
Although residue field trial data for pear
may be translated to oriental pear, a
separate tolerance must be established
under current regulations. EPA is taking
this action to clarify tolerances for all
members of the pome fruit crop group.
Based on the submitted grape
processing data showing a maximum
concentration in raisins of 2.7x and the
highest average field trial (HAFT)
residue on grapes of 1.52 ppm, EPA has
determined that the proposed raisin
tolerance of 6.0 ppm should be revised
to 5.0 ppm. EPA also determined that
the proposed tolerance levels for
‘‘peppermint, tops’’, ‘‘spearmint, tops’’,
‘‘vegetable, cucurbit, group 9’’, ‘‘fruit,
stone, group 12’’ and ‘‘cranberry’’ were
inappropriate and should be revised as
specified above based on analyses of the
residue field trial data using the
Agency’s Tolerance Spreadsheet in
accordance with the Agency’s Guidance
for Setting Pesticide Tolerances Based
on Field Trial Data Standard Operating
Procedure (SOP).
Therefore, tolerances are established
for combined residues of indoxacarb,
(S)-methyl 7-chloro-2,5-dihydro-2[[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2e][1,3,4][oxadiazine-4a(3H)-carboxylate,
and its R-enantiomer, (R)-methyl 7chloro-2,5-dihydro-2[[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2e][1,3,4][oxadiazine-4a(3H)-carboxylate,
in or on cranberry at 0.90 ppm; fruit,
pome, except pear, group 11 at 1.0 ppm;
fruit, stone, group 12 at 0.90 ppm; grape
at 2.0 ppm; grape, raisin at 5.0 ppm;
okra at 0.50 ppm; pea, southern, seed at
0.10 ppm; pear, oriental at 0.20 ppm;
peppermint, tops at 11 ppm; spearmint,
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tops at 11 ppm; turnip greens at 12 ppm;
vegetable, Brassica, leafy, group 5 at 12
ppm; vegetable, cucurbit, group 9 at
0.60 ppm; vegetable, leafy, except
Brassica, group 4 at 14 ppm; and
vegetable, tuberous and corm, subgroup
1-C at 0.01 ppm. Existing tolerances on
apple; Brassica, head and stem,
subgroup 5A; lettuce, head; lettuce, leaf;
and potato, which are superseded by the
new tolerances, are revoked.
Time-limited tolerances were
established for combined residues of
indoxacarb and its R-enantiomer in or
on cherry, sweet; cherry, tart; and peach
in connection with a FIFRA section 5
experimental use permit granted by
EPA. Time-limited tolerances were
established for combined residues of
indoxacarb and its R-enantiomer in or
on collards and cranberry in connection
with FIFRA section 18 emergency
exemptions granted by EPA. All of these
time-limited tolerances have expired,
except the time-limited tolerance on
cranberry, which is set to expire on
December 31, 2007. Because EPA is
establishing tolerances on stone fruit,
Brassica leafy vegetables and cranberry,
these time-limited tolerances, most of
which have already expired, are not
needed. Therefore, the time-limited
tolerances for residues of indoxacarb
and its R-enantiomer under 40 CFR
180.564(a)(2) and 40 CFR 180.564(b) are
revoked.
Finally, the word ‘‘enantiomer’’ is
incorrectly spelled (‘‘enantimomer’’) in
the tolerance expression for indoxacarb
in 40 CFR 180.564(a)(1) and is being
corrected in this regulation.
VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this rule has
been exempted from review under
Executive Order 12866, 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) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
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., nor does it require any special
considerations under Executive Order
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply
to this rule. In addition, This rule does
not 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).
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).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report 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).
E:\FR\FM\11JYR1.SGM
11JYR1
Federal Register / Vol. 72, No. 132 / Wednesday, July 11, 2007 / Rules and Regulations
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 2, 2007.
Donald R. Stubbs,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.564, paragraph (a) is
revised and paragraph (b) is removed
and reserved to read as follows:
I
§ 180.564 Indoxacarb; tolerances for
residues.
(a) General. Tolerances are
established for the combined residues of
the insecticide indoxacarb, (S)-methyl 7chloro-2,5-dihydro-2[[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2e][1,3,4][oxadiazine-4a(3H)-carboxylate,
and its R-enantiomer, (R)-methyl 7chloro-2,5-dihydro-2[[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2e][1,3,4][oxadiazine-4a(3H)-carboxylate,
in or on the following raw agricultural
commodities:
Commodity
Parts per million
Milk, fat ...........................
Okra ................................
Pea, southern, seed .......
Peanut ............................
Peanut, hay ....................
Pear ................................
Pear, oriental ..................
Peppermint, tops ............
Sheep, fat .......................
Sheep, meat ...................
Sheep, meat byproducts
Soybean, aspirated grain
fractions .......................
Soybean, hulls ................
Soybean, seed ................
Spearmint, tops ..............
Turnip, greens ................
Vegetable, Brassica,
leafy, group 5 ..............
Vegetable, cucurbit,
group 9 ........................
Vegetable, fruiting, group
8 ..................................
Vegetable, leafy, except
Brassica, group 4 ........
Vegetable, tuberous and
corm, subgroup 1-C ....
4.0
0.50
0.10
0.01
40
0.20
0.20
11
1.5
0.05
0.03
45
4.0
0.80
11
12
12
0.60
0.50
14
0.01
(b) Section 18 emergency exemptions.
[Reserved]
*
*
*
*
*
[FR Doc. E7–13339 Filed 7–10–07; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0331; FRL–8130–5]
Cymoxanil; Pesticide Tolerance
rfrederick on PROD1PC67 with RULES
Commodity
Parts per million
Apple, wet pomace .........
Alfalfa, forage .................
Alfalfa, hay ......................
Cattle, fat ........................
Cattle, meat ....................
Cattle, meat byproducts
Corn, sweet, forage ........
Corn, sweet, kernel plus
cob with husk removed
Corn, sweet, stover ........
Cotton, gin byproducts ...
Cotton, undelinted seed
Cranberry ........................
Fruit, pome, except pear,
group 11 ......................
Fruit, stone, group 12 .....
Goat, fat ..........................
Goat, meat ......................
Goat, meat byproducts ...
Grape ..............................
Grape, raisin ...................
Hog, fat ...........................
Hog, meat .......................
Hog, meat byproducts ....
Horse, fat ........................
Horse, meat ....................
Horse, meat byproducts
Milk .................................
VerDate Aug<31>2005
14:57 Jul 10, 2007
3.0
10
50
1.5
0.05
0.03
10
0.02
15
15
2.0
0.90
1.0
0.90
1.5
0.05
0.03
2.0
5.0
1.5
0.05
0.03
1.5
0.05
0.03
0.15
Jkt 211001
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of cymoxanil in
or on grape, hop, and caneberry. The
Interregional Research Project (IR-4)
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective July
11, 2007. Objections and requests for
hearings must be received on or before
September 10, 2007, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0331. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
37641
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
web site to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. Although listed in the
index, some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400,
One Potomac Yard (South Building),
2777 S. Crystal Drive, Arlington, VA.
The Docket Facility is open from 8:30
a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Shaja R. Brothers, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–3194; e-mail address:
brothers.shaja@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111),
e.g., agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
E:\FR\FM\11JYR1.SGM
11JYR1
]]>Agencies
[Federal Register Volume 72, Number 132 (Wednesday, July 11, 2007)]
[Rules and Regulations]
[Pages 37633-37641]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-13339]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0149; FRL-8137-8]
Indoxacarb; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for combined residues
of indoxacarb and its R-enantiomer in or on cranberry; fruit, pome,
except pear, group 11; fruit, stone, group 12; grape; grape, raisin;
okra; pea, southern, seed; pear, oriental; peppermint, tops; spearmint,
tops; turnip greens; vegetable, Brassica, leafy, group 5; vegetable,
cucurbit, group 9; vegetable, leafy, except Brassica, group 4; and
vegetable, tuberous and corm, subgroup 1-C. E.I. du Pont de Nemours and
Company and the Interregional Research Project No. 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA). This regulation also removes existing
[[Page 37634]]
tolerances on apple; Brassica, head and stem, subgroup 5A; lettuce,
head; lettuce, leaf; and potato, which are superseded by the new
tolerances; and removes expired time-limited tolerances on cherry,
sweet; cherry, tart; peach; and collards; and the time-limited
tolerance on cranberry (set to expire December 31, 2007), which are no
longer needed as a result of this action. Finally, this regulation
corrects a typographical error in the spelling of the word
``enantiomer'' in the tolerance expression for indoxacarb given in 40
CFR 180.564(a)(1).
DATES: This regulation is effective July 11, 2007. Objections and
requests for hearings must be received on or before September 10, 2007,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0149. To access the
electronic docket, go to https://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov web site to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at https://www.regulations.gov,or, if
only available in hard copy, at the OPP Regulatory Public Docket in Rm.
S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6463; e-mail address: madden.barbara@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, any person may file an objection
to any aspect of this regulation and may also request a hearing on
those objections. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2005-0149 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 as required by 40 CFR part 178 on or
before September 10, 2007.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2005-0149, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of July 2, 2003 (68 FR 39541) (FRL-7312-9),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 3F6576)
by E.I. du Pont de Nemours and Company, Newark, DE 19711. The petition
requested that 40 CFR 180.564 be amended by establishing a tolerance
for combined residues of the insecticide indoxacarb, (S)-methyl 7-
chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl) [4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, in or on grape at 2.0 parts
per million (ppm) and raisin at 6.0 ppm. That notice
[[Page 37635]]
included a summary of the petition prepared by E.I. du Pont de Nemours
and Company, the registrant, which is available to the public in the
docket EPA-HQ-OPP-2003-0212, https://www.regulations.gov. One comment
was received on the notice of filing from a private citizen expressing
support for the proposed tolerances.
In the Federal Register of May 5, 2004 (69 FR 25104) (FRL-7354-9),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 2E6482)
by the Interregional Research Project No. 4 (IR-4). The petition
requested that 40 CFR 180.564 be amended by revoking Brassica, head and
stem, subgroup at 5.0 ppm and establishing a tolerance for combined
residues of the insecticide indoxacarb, (S)-methyl 7-chloro-2,5-
dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, in or on vegetable, , leafy,
group 5 at 12 ppm and turnip greens at 12 ppm. That notice included a
summary of the petition prepared by E.I. du Pont de Nemours and
Company, the registrant, which is available to the public in the docket
EPA-HQ-OPP-2004-0064, https://www.regulations.gov. There were no
comments received in response to the notice of filing.
In the Federal Register of June 30, 2005 (70 FR 37852) (FRL-7718-
9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
5E6911 and 5E6926) by the Interregional Research Project No. 4 (IR-4).
The petitions requested that 40 CFR 180.564 be amended by establishing
a tolerance for combined residues of the insecticide indoxacarb, (S)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, in or on leafy greens, except
spinach, subgroup 4A at 10 ppm; spinach at 3.0 ppm; leaf petioles
subgroup 4B at 1.5 ppm; fruit, pome, except pear, group 11 at 1.0 ppm;
vegetable, tuberous and corm, subgroup 1C at 0.01 ppm; okra at 0.5 ppm
(all requested in PP 5E6911); pea (Southern) at 0.1 ppm; and mint at 10
ppm (both requested in PP 5E6926). That notice included a summary of
the petition prepared by E.I. du Pont de Nemours and Company, the
registrant, which is available to the public in the docket EPA-HQ-OPP-
2005-0149, https://www.regulations.gov. There were no comments received
in response to the notice of filing.
In the Federal Register of April 12, 2006 (71 FR 18738) (FRL-7772-
2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
5E6991) by the Interregional Research Project No. 4 (IR-4). The
petition requested that 40 CFR 180.564 be amended by establishing a
tolerance for combined residues of the insecticide indoxacarb, (S)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, in or on vegetable, cucurbit,
group 9 at 0.5 ppm; fruit, stone, group 12 at 1 ppm; and cranberry at 1
ppm. That notice referenced a summary of the petition prepared by E.I.
du Pont de Nemours and Company, the registrant, which is available to
the public in the docket EPA-HQ-OPP-2005-0149, https://
www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petitions, EPA has
modified the proposed tolerances. The reasons for these changes are
explained in Unit V.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....'' These provisions were added to the FFDCA by the Food
Quality Protection Act (FQPA) of 1996.
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in 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 for the petitioned-for tolerances
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 cranberry at 0.90
ppm; fruit, pome, except pear, group 11 at 1.0 ppm; fruit, stone, group
12 at 0.90 ppm; grape at 2.0 ppm; grape, raisin at 5.0 ppm; okra at
0.50 ppm; pea, southern, seed at 0.10 ppm; pear, oriental at 0.20 ppm;
peppermint, tops at 11 ppm; spearmint, tops at 11 ppm; turnip greens at
12 ppm; vegetable, Brassica, leafy, group 5 at 12 ppm; vegetable,
cucurbit, group 9 at 0.60 ppm; vegetable, leafy, except Brassica, group
4 at 14 ppm; and vegetable, tuberous and corm, subgroup 1-C at 0.01
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. Specific information on the studies received and the nature
of the adverse effects caused by indoxacarb as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://
www.regulations.gov. The referenced
[[Page 37636]]
document is available in the docket established by this action, which
is described under ADDRESSES, and is identified as EPA-HQ-OPP-2005-0149
in that docket.
Indoxacarb is an isomeric compound containing two enantiomers, the
S-enantiomer (DPX-KN128, the insecticidally active component) and its
R-enantiomer (DPX-KN127, the insecticidally inactive component). DPX-
MP062 is an enantiomeric mixture containing the S-enantiomer and its R-
enantiomer at approximately a 75:25 ratio. DPX-JW062 is the racemic
mixture of the enantiomers at a 50:50 ratio.
DPX-KN128, DPX-MP062 and DPX-JW062 appear to be of similar toxicity
acutely. DPX-KN128 and DPX-MP062 were moderately acutely toxic by the
oral route (toxicity category II) while DPX-JW062 was practically non-
toxic (toxicity category IV) due to its poor solubility in the corn oil
vehicle. However, it was equally toxic orally, when tested using a
solvent where it had a higher solubility, such as polyethylene glycol
(PEG). By the dermal route, they had low toxicity (toxicity category
III and IV). DPX-MP062 and DPX-JW062 had low acute inhalation toxicity
(IV). DPX-MP062 and DPX-JW062 had moderate to low ocular irritant
properties (III and IV), while DPX-KN128 was practically non-irritating
to the rabbit's eyes. By the maximization test, DPX-KN128 and DPX-MP062
were considered dermal sensitizers, while DPX-JW062 was not a
sensitizer.
There was possible evidence of lung damage in the acute inhalation
studies with both DPX-MP062 and DPX-JW062. ``Lung noise,'' observed
with JW062 may indicate the development of acute lung injury and high
permeability pulmonary edema. This was not unexpected since an oxidant
was generated during indoxacarb metabolism. ``Hunched over back and
gasping'' were also present and suggested arterial hypoxemia that
accompanies alveolar flooding. The acute inhalation study report with
indoxacarb 70% manufacturing use product, noted that a ``red nasal
discharge'' was detected for 2 days after exposure. This may be
indicative of a lung exudate, a sign of lung injury. Subchronic (28
days) inhalation toxicity on indoxacarb in rats was characterized by
increased spleen weights, increased pigmentation and hematopoiesis in
the spleen, and hematological changes.
The toxicity profiles for DPX-KN128, DPX-MP062 and DPX-JW062 in
rats, mice and dogs with both subchronic and chronic oral exposures
were similar. Dermal subchronic exposure in the rat also resulted in a
similar profile. The toxic signs occurred at similar doses and with a
similar magnitude of response, with females generally being more
sensitive than males. The endpoints that most frequently defined the
LOAEL were non-specific, and included decreased body weight, weight
gain, food consumption and food efficiency. These compounds also
affected the hematopoietic system by decreasing the red blood cell
count, hemoglobin and hematocrit in rats, dogs and mice. It was
frequently accompanied by an increase in reticulocytes in all three
species and an increase in Heinz bodies (dogs and mice only). None of
these signs of toxicity appeared to get worse over time. In one
subchronic rat study, the parameters appeared to return to normal
levels following a four-week recovery period. High doses in the rats
and mice also sometimes caused mortality.
There was no evidence of susceptibility from either in utero or
neonatal exposure to both rat and rabbit young with either DPX-MP062 or
DPX-JW062. There was no evidence of susceptibility from in utero
exposure in rats with DPX-KN128. There was no evidence of increased
susceptibility in the developmental neurotoxicity study in rats with
DPX-KN128. No evidence of teratogenicity was observed in rats and
rabbits with DPX-MP062 or DPX-JW062. No evidence of teratogenicity was
observed in rats with DPX-KN128. There was no evidence of reproductive
effects in the 2-generation reproduction study in rats.
Neurotoxicity was present in both rats and mice; however, it did
not occur in the absence of other signs of toxicity. Neurotoxicity was
characterized by one or more of the following symptoms in both male and
female rats and mice: Weakness, head tilting, and abnormal gait or
mobility with inability to stand, ataxia. Acute and subchronic
neurotoxicity screening batteries were performed using DPX-MP062 in
rats. Neurotoxicity was characterized by clinical signs (depression,
abnormal gait, head shake, salivation) and functional-observation
battery (FOB) (circling behavior, incoordination, slow righting reflex,
decreased forelimb grip strength, decreased foot splay, decreased motor
activity). However, there was no evidence of neurohistopathology in any
study. Learning and memory parameters were affected in the pups in the
developmental neurotoxicity study in rats with DPX-KN128.
There was no evidence of carcinogenicity in either the rat or mouse
in acceptable studies using DPX-JW062. DPX-JW062 was not mutagenic in a
complete battery of mutagenicity studies. There was also no evidence of
mutagenicity with either DPX-KN128, or DPX-MP062.
Both DPX-JW062 and DPX-MP062 were rapidly absorbed and eliminated
following oral administration. The absorption of DPX-JW062 was dose
dependent and appeared to be saturated at the high dose. Both urine and
feces represented major routes of excretion (35-45% and 33-47%,
respectively). The distribution pattern did not vary with dosing
regimen and overall tissue burden was limited to only 3.4-12.9% of the
administered dose. The red blood cells of rats dosed with the
trifluoromethoxyphenyl label consistently contained much greater levels
of radioactivity than did plasma. Fat tissue contained the greatest
level of radioactivity (1.76-8.76% of the administered dose) and, for
both compounds, was greater in female rats. The finding also
demonstrates a greater propensity for accumulation by female rats than
by male rats. Both DPX-MP062 and DPX-JW062 were extensively metabolized
and the metabolites were eliminated in the urine, feces, and bile. With
the exception of parent compound (DPX-JW062, which accounted for 19.2%
of a single low dose in the feces of female rats), none of the
metabolites from any source represented more than 12.3% of the
administered dose. 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. All of the biliary metabolites appear to undergo
further biotransformation in the gut.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which the NOAEL in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment. Uncertainty/safety factors (UF) are used in conjunction
with the LOC to take into account 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. Safety is assessed for acute and chronic risks by
comparing aggregate exposure to the pesticide to the acute population
adjusted dose
[[Page 37637]]
(``aPAD'') and chronic population adjusted dose (``cPAD''). The aPAD
and cPAD are calculated by dividing the LOC by all applicable
uncertainty/safety factors. Short-term, intermediate-term, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the margin of exposure (``MOE'') called for by the product
of all applicable uncertainty/safety factors is not exceeded.
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
A summary of the toxicological endpoints for indoxacarb used for
human risk assessment can be found at www.regulations.gov in document
``PPs: 2E6482, 3F6576, 5E6911, 5E6926, and 5E6991. Indoxacarb.
Health Effects Division (HED) Risk Assessment for Grapes; Vegetable,
Brassica, Leafy, Group 5; Turnip Greens; Vegetable, Leafy, Except
Brassica (Group 4); Pome Fruits (Group 11, except pear); Tuberous and
Corm Vegetables (Subgroup 1C); Cucurbit Vegetables (Group 9); Stone
Fruits (Group 12); Cranberry; Mint; Okra; Southern Pea; and Fire Ant
Bait.'' at pages 23-24 in Docket ID EPA-HQ-OPP-2005-0149.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to indoxacarb, EPA considered exposure under the petitioned-
for tolerances as well as all existing indoxacarb tolerances in (40 CFR
180.564). EPA assessed dietary exposures from indoxacarb in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and 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. In estimating acute dietary
exposure, EPA used food consumption information from the USDA 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII). As to residue levels in food, EPA relied upon anticipated
residues for most commodities and percent crop treated information for
most currently registered commodities. EPA assumed 100 percent crop
(PCT) treated for all of the new commodities. Anticipated residues for
all registered and new food commodities were based on field trial data.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Nationwide CSFII. As to residue levels in food, EPA relied
upon anticipated residues for most commodities and PCT information for
most currently registered commodities. EPA assumed 100 PCT for all of
the new commodities. Anticipated residues for all registered and new
food commodities were based on field trial data.
iii. Cancer. EPA has classified indoxacarb as ``not likely'' to be
carcinogenic to humans via relevant routes of exposure using the
Guidelines for Carcinogen Risk Assessment. Therefore, a cancer exposure
assessment was not conducted.
iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of the FFDCA authorizes EPA to use available data and information on
the anticipated residue levels of pesticide residues in food and the
actual levels of pesticide residues that have been measured in food. If
EPA relies on such information, EPA must pursuant to section 408(f)(1)
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. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
Section 408(b)(2)(F) of the FFDCA states that the Agency may use
data on the actual percent of food treated for assessing chronic
dietary risk only if:
a. The data used are reliable and provide a valid basis to show
what percentage of the food derived from such crop is likely to contain
such pesticide residue;
b. The exposure estimate does not underestimate exposure for any
significant subpopulation group; and
c. Data are available on pesticide use and food consumption in a
particular area, the exposure estimate does not understate exposure for
the population in such area. In addition, the Agency must provide for
periodic evaluation of any estimates used. To provide for the periodic
evaluation of the estimate of PCT as required by section 408(b)(2)(F)
of FFDCA, EPA may require registrants to submit data on PCT.
The Agency used PCT information as follows:
For the acute assessment, maximum PCT estimates were used for the
following commodities: apple (5%), broccoli (50%), cabbage (25%),
cauliflower and the remaining Brassica head and stem vegetables (55%),
sweet corn (2.5%), head lettuce (25%), leaf lettuce (11%), peanut
(2.5%), pear (2.5%), peppers (15%), potato (2.5%), soybean (1%),
spinach (5%) and tomato (25%).
For the chronic assessment, average weighted PCT estimates were
used for the following commodities: apple (1%), broccoli (40%), cabbage
(15%), cauliflower and the remaining Brassica head and stem vegetables
(35%), sweet corn (1%), head lettuce (18%), leaf lettuce (9%), peanut
(1%), pear (1%), peppers (10%), potato (1%), soybean (1%), spinach (5%)
and tomato (15%).
EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available federal, state, and private market survey data for that use,
averaging by year, averaging across all years, and rounding up to the
nearest multiple of five percent except for those situations in which
the average PCT is less than one. In those cases <1% is used as the
average and <2.5% is used as the maximum. EPA uses a maximum PCT for
acute dietary risk analysis. The maximum PCT figure is the single
maximum value reported overall from available federal, state, and
private market survey data on the existing use, across all years, and
rounded up to the nearest multiple of five percent. In most cases, EPA
uses available data from United States Department of Agriculture/
National Agricultural Statistics Service (USDA/NASS), Proprietary
Market Surveys, and the National Center for Food and Agriculture Policy
(NCFAP) for the most recent six years.
The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. The Agency is reasonably certain that the percentage of
the food treated is not likely to be an underestimation. As to
Conditions 2 and 3, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's
[[Page 37638]]
exposure estimate does not understate exposure for any significant
subpopulation group and allows the Agency to be reasonably certain that
no regional population is exposed to residue levels higher than those
estimated by the Agency. Other than the data available through national
food consumption surveys, EPA does not have available information on
the regional consumption of food to which indoxacarb may be applied in
a particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring 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 environmental fate characteristics of
indoxacarb. Further information regarding EPA drinking water models
used in pesticide exposure assessment can be found at https://
www.epa.gov/oppefed1/models/water/index.htm.
Based on the EPA's Pesticide Root Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS) and Screening Concentration in Ground
Water (SCI-GROW) models, the estimated environmental concentrations
(EECs) of indoxacarb for acute exposures are estimated to be 25.1 parts
per billion (ppb) for surface water and 0.21 ppb for ground water. The
EECs for chronic exposures are estimated to be 5.37 ppb for surface
water and 0.21 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 25.1 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 5.37 ppb was used to
assess the contribution to drinking 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 currently registered for the following residential
non-dietary sites: as a fire ant bait for turf, which may be applied as
a mound treatment or as a broadcast application by ``residential''
(i.e., private persons) applicators as well as by commercial handlers.
EPA assessed residential exposure using the following assumptions:
EPA has determined that residential handlers are likely to be exposed
to indoxacarb residues via dermal and inhalation routes during handling
and applying activities. Based on the current use pattern, EPA expects
duration of exposure to be short-term (1-30 days). The broadcast
treatment results in a higher handler exposure than the mound treatment
and is, therefore, the scenario assessed by EPA. EPA assessed exposure
of residential handlers applying indoxacarb with a push-type spreader
using SOPs for Residential Exposure Assessments (DEC-1997) in
conjunction with unit exposures developed by the Outdoor Residential
Exposure Task Force (ORETF).
There is also the potential for short-term and intermediate-term
post-application exposure of adults and children from entering areas
previously treated with indoxacarb (i.e., turf treated for fire ants).
The post-application scenarios assessed from exposure to treated turf
include: Dermal exposure from treated lawns due to high contact lawn
activities (adult and toddler); Dermal exposure from treated turf due
to golfing (adults and youths); Hand-to-mouth transfer of pesticide
residues on lawns (toddler); Incidental ingestion of granules from
pesticide-treated residential areas (toddler); and Incidental ingestion
of soil from pesticide-treated residential areas (toddler).
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to indoxacarb and any other
substances and 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
EPA's website at https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (``10X'') 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 database on toxicity and
exposure unless EPA determines based on reliable data that a different
margin of safety will be safe for infants and children. This additional
margin of safety is commonly referred to as the FQPA safety factor. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional uncertainty/safety
factors and/or special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There was no quantitative or
qualitative evidence of increased prenatal or postnatal sensitivity in
the two developmental toxicity studies in rats with DPX-JW062, one
developmental toxicity study in rats with DPX-MP062 and DPX-KN128, one
developmental toxicity study in rabbits with DPX-JW062, one 2-
generation reproduction studies in rats with DPX-JW062 and a
developmental neurotoxicity (DNT) study in rats with DPX-KN128. In
these studies, developmental toxicity was observed in the presence of
maternal toxicity.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
i. The toxicity database for indoxacarb is complete.
ii. Neurotoxicity was seen in animal studies in rats and mice but
at higher doses than the hematologic effects on which EPA's risk
assessments are based. To evaluate the potential for increased
sensitivity of infants and children to neurotoxic effects, EPA required
a rat developmental neurotoxicity (DNT) study. The study has been
submitted and reviewed. There was no evidence of increased sensitivity
of offspring in the submitted study. Clinical observations, motor
activity, acoustic startle habituation, and learning and memory testing
were all comparable between the control and treated groups. Mean brain
weight, gross and microscopic examinations and morphometric
measurements of the brain were also
[[Page 37639]]
comparable between the controls and treated groups.
iii. There is no evidence that indoxacarb results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the two-generation
reproduction study.
iv. There are no residual uncertainties identified in the exposure
databases. The acute and chronic dietary food exposure assessments
utilize anticipated residues for most commodities that are based on
reliable field trial data. They also utilize PCT data that have been
verified by the Agency for most existing uses. For all new uses, 100
PCT is assumed. The acute and chronic assessments are somewhat refined
and based on reliable data and will not underestimate exposure/risk.
Conservative ground and surface water modeling estimates were used.
Similarly conservative Residential SOPs were used to assess post-
application exposure to children as well as incidental oral exposure of
toddlers. These assessments will not underestimate the exposure and
risks posed by indoxacarb.
E. Aggregate Risks and Determination of Safety
Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the acute population adjusted
dose (``aPAD'') and chronic population adjusted dose (``cPAD''). The
aPAD and cPAD are calculated by dividing the LOC by all applicable
uncertainty/safety factors. For linear cancer risks, EPA calculates the
probability of additional cancer cases given aggregate exposure. Short-
term, intermediate-term, and long-term risks are evaluated by comparing
aggregate exposure to the LOC to ensure that the margin of exposure
(``MOE'') called for by the product of all applicable uncertainty/
safety factors is not exceeded.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to indoxacarb will occupy 84% of the aPAD for the population group
(children, 3 to 5 years old) receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
indoxacarb from food and water will utilize 53% of the cPAD for the
population group (children, 1 to 2 years old) with greatest exposure.
Based the use pattern, chronic residential exposure to residues of
indoxacarb is not expected.
Indoxacarb is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for indoxacarb.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential
exposures aggregated result in aggregate MOEs of 620 for the general
U.S. population and 190 for children, 1 to 2 years old. The aggregate
MOE for the general U.S. population is based on the residential turf
(fire ant control) scenario and includes combined residential
applicator and post-application dermal exposures. EPA determined that
it is not appropriate to include applicator inhalation exposure in the
aggregate exposure assessment, since toxicological endpoints of concern
for dermal and inhalation exposures are different. The aggregate MOE
for children includes post-application dermal and incidental oral
exposures from entering turf areas previously treated with indoxacarb
for fire ants.
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 currently registered for use(s) that could result in
intermediate-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic food and water and
intermediate-term exposures for indoxacarb.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food, water, and
residential exposures aggregated result in aggregate MOEs of 620 for
the general U.S. population and 190 for children, 1 to 2 years old. The
aggregate MOE for the general U.S. population is based on the
residential turf (fire ant control) scenario and includes combined
residential applicator and post-application dermal exposures. EPA
determined that it is not appropriate to include applicator inhalation
exposure in the aggregate exposure assessment, since toxicological
endpoints of concern for dermal and inhalation exposures are different.
The aggregate MOE for children includes post-application dermal and
incidental oral exposures from entering turf areas previously treated
with indoxacarb for fire ants.
5. Aggregate cancer risk for U.S. population. EPA has classified
indoxacarb as ``not likely'' to be carcinogenic to humans via relevant
routes of exposure using the Guidelines for Carcinogen Risk Assessment.
Therefore, a cancer aggregate exposure assessment was not conducted.
Indoxacarb is not expected to pose a cancer risk.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to indoxacarb residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology is available to enforce the
tolerance expression (high-performance liquid chromatography (HPLC)/
column switching/ultraviolet (UV) methods AMR 2712-93 and Du Pont 11978
with confirmation/specificity provided by gas chromatography (GC)/mass-
selective detector method AMR 3493-95, Supplement No. 4). These methods
may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no established or proposed Codex maximum residue limits
(MRLs) for indoxacarb.
V. Conclusion
Based upon review of the data supporting the petitions, EPA has
modified the proposed tolerances as follows:
(1) PP 3F6576: Revised the commodity term and tolerance for
``raisin'' to read ``grape, raisin'' at 5.0 ppm;
(2) PP 5E6911: Replaced the proposed tolerances for ``leafy greens,
except spinach, subgroup 4A'', ``leaf petioles subgroup 4B'' and
``spinach'' with a single tolerance in or on ``vegetable, leafy, except
Brassica, group 4'' at 14 ppm; and added a tolerance for ``pear,
oriental'' at 0.20 ppm;
(3) PP 5E 6926: Revised the commodity term ``pea (southern'') to
read ``pea, southern, seed''; and revised the commodity term and
tolerance level for ``mint'' to read ``peppermint, tops'' at 11 ppm and
``spearmint, tops'' at 11 ppm; and
(4) PP 5E6991: Revised the tolerances for ``vegetable, cucurbit,
group 9'', ``fruit, stone, group 12'' and ``cranberry'' to 0.60 ppm,
0.90 ppm and 0.90 ppm, respectively. The reasons for these changes are
discussed below.
[[Page 37640]]
EPA revised the commodity terms ``raisin'', mint'' and ``pea
(southern)'' to agree with recommended commodity terms in the Office of
Pesticide Program's Food and Feed Commodity Vocabulary. Based on data
submitted with PP 5E6911 and data previously submitted to support the
existing tolerances on leaf and head lettuce, EPA determined that it
was appropriate to establish a tolerance for the crop group
``vegetable, leafy, except Brassica, group 4'' instead of the proposed
separate tolerances on ``leafy greens, except spinach, subgroup 4A'',
``spinach'' and ``leaf petioles subgroup 4B''. The crop group tolerance
of 14 ppm is based on data for the crop with the highest field trial
residues (spinach). EPA is establishing a tolerance for ``pear,
oriental'' at 0.20 ppm. A tolerance for ``pear'' currently exists at
this level. Although residue field trial data for pear may be
translated to oriental pear, a separate tolerance must be established
under current regulations. EPA is taking this action to clarify
tolerances for all members of the pome fruit crop group. Based on the
submitted grape processing data showing a maximum concentration in
raisins of 2.7x and the highest average field trial (HAFT) residue on
grapes of 1.52 ppm, EPA has determined that the proposed raisin
tolerance of 6.0 ppm should be revised to 5.0 ppm. EPA also determined
that the proposed tolerance levels for ``peppermint, tops'',
``spearmint, tops'', ``vegetable, cucurbit, group 9'', ``fruit, stone,
group 12'' and ``cranberry'' were inappropriate and should be revised
as specified above based on analyses of the residue field trial data
using the Agency's Tolerance Spreadsheet in accordance with the
Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial
Data Standard Operating Procedure (SOP).
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-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 cranberry at 0.90
ppm; fruit, pome, except pear, group 11 at 1.0 ppm; fruit, stone, group
12 at 0.90 ppm; grape at 2.0 ppm; grape, raisin at 5.0 ppm; okra at
0.50 ppm; pea, southern, seed at 0.10 ppm; pear, oriental at 0.20 ppm;
peppermint, tops at 11 ppm; spearmint, tops at 11 ppm; turnip greens at
12 ppm; vegetable, Brassica, leafy, group 5 at 12 ppm; vegetable,
cucurbit, group 9 at 0.60 ppm; vegetable, leafy, except Brassica, group
4 at 14 ppm; and vegetable, tuberous and corm, subgroup 1-C at 0.01
ppm. Existing tolerances on apple; Brassica, head and stem, subgroup
5A; lettuce, head; lettuce, leaf; and potato, which are superseded by
the new tolerances, are revoked.
Time-limited tolerances were established for combined residues of
indoxacarb and its R-enantiomer in or on cherry, sweet; cherry, tart;
and peach in connection with a FIFRA section 5 experimental use permit
granted by EPA. Time-limited tolerances were established for combined
residues of indoxacarb and its R-enantiomer in or on collards and
cranberry in connection with FIFRA section 18 emergency exemptions
granted by EPA. All of these time-limited tolerances have expired,
except the time-limited tolerance on cranberry, which is set to expire
on December 31, 2007. Because EPA is establishing tolerances on stone
fruit, Brassica leafy vegetables and cranberry, these time-limited
tolerances, most of which have already expired, are not needed.
Therefore, the time-limited tolerances for residues of indoxacarb and
its R-enantiomer under 40 CFR 180.564(a)(2) and 40 CFR 180.564(b) are
revoked.
Finally, the word ``enantiomer'' is incorrectly spelled
(``enantimomer'') in the tolerance expression for indoxacarb in 40 CFR
180.564(a)(1) and is being corrected in this regulation.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866, 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) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). 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., 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).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers and food retailers, not States or tribes, nor does this action
alter the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of section
408(n)(4) of FFDCA. As such, the Agency has determined that this action
will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and
the States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, the Agency has determined
that Executive Order 13132, entitled Federalism (64 FR 43255, August
10, 1999) and Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000) do not apply to this rule. In addition, This rule does not 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).
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).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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).
[[Page 37641]]
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 2, 2007.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.564, paragraph (a) is revised and paragraph (b) is
removed and reserved 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-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:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Apple, wet pomace.................................... 3.0
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
Cranberry............................................ 0.90
Fruit, pome, except pear, group 11................... 1.0
Fruit, stone, group 12............................... 0.90
Goat, fat............................................ 1.5
Goat, meat........................................... 0.05
Goat, meat byproducts................................ 0.03
Grape................................................ 2.0
Grape, raisin........................................ 5.0
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
Milk................................................. 0.15
Milk, fat............................................ 4.0
Okra................................................. 0.50
Pea, southern, seed.................................. 0.10
Peanut............................................... 0.01
Peanut, hay.......................................... 40
Pear................................................. 0.20
Pear, oriental....................................... 0.20
Peppermint, tops..................................... 11
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
Spearmint, tops...................................... 11
Turnip, greens....................................... 12
Vegetable, Brassica, leafy, group 5.................. 12
Vegetable, cucurbit, group 9......................... 0.60
Vegetable, fruiting, group 8......................... 0.50
Vegetable, leafy, except Brassica, group 4........... 14
Vegetable, tuberous and corm, subgroup 1-C........... 0.01
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. E7-13339 Filed 7-10-07; 8:45 am]
BILLING CODE 6560-50-S
