Methoxyfenozide; Pesticide Tolerance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: September 20, 2002 (Volume 67, Number 183)]
[Rules and Regulations]
[Page 59193-59205]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20se02-14]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0219; FRL-7198-5]

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
methoxyfenozide and the combined residues of methoxyfenozide and its
glucuronide metabolite on various agriculural food commodities. This
regulation also establishes tolerances for indirect or inadvertent
residues for methoxyfenozide and establishes tolerances for indirect or
inadvertent combined residues for methoxyfenozide and its metabolites
on various food commodities, and increases the already established
tolerances for residues of methoxyfenozide and increases the already
established tolerances for the combined residues of methoxyfenozide and
its glucuronide metabolite on various food commodities. Rohm and Haas
Company and the Interregional Research Project Number 4 (IR-4),
Technology Center of New Jersey, the State University of New Jersey
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act, as amended by the Food Quality Protection Act of 1996. The
chemical was subsequently purchased by Dow Agrosciences from Rohm and
Haas Company. The specific food commodities affected by the
establishment or increase of these tolerances are set forth in the
preamble to this document.

DATES: This regulation is effective September 20, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0219,
must be received on or before November 19, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number OPP-2002-0219 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Joseph M. Tavano,
Registration Division 7505C, Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW.,Washington, DC 20460; telephone number: (703) 305-6411; e-mail
address: tavano.joseph@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:

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Examples of Potentially
Categories NAICS Affected Entities
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Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide manufacturing
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This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet home page at http://www.epa.gov/.
To access this document, on the home page select ``Laws and
Regulations'', ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/
nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site
currently under development.
2. In person. The Agency has established an official record for
this action under docket ID number OPP-2002-0219. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

In the Federal Registers of January 10, 2000, 65 FR 1370-1381; FRL-
6394-6; March 19, 2001, 66 FR 15432-15459; FRL-6766-7; May 23, 2001, 66
FR 28482-28487; FRL-6782-5 and August 24, 2001, 66 FR 44629-44634; FRL-
6796-2; and August 14, 2002, 67 FR 52996-53001; FRL-7191-9. EPA issued
notices pursuant to section 408 of the Federal Food, Drug, and Cosmetic
Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection
Act of 1996 (FQPA) (Public Law 104-170), announcing the filing of a
pesticide petitions (PP 9F6033; 9F6062; 0F6201; 0F6213; 1F 6259;
1F6287; 2E6382 and

[[Page 59194]]

2E6408) by Rohm and Haas Company,100 Independence Mall West,
Philadelphia, PA 19106-2399 and the Interregional Research Project
Number 4 (IR-4), Technology Centre of New Jersey, the State University
of New Jersey, 681 U.S. Highway #1 South, North Brunswick, NJ
08902-3390. These notices included a summary of the petitions prepared
by Rohm and Haas Company, the registrant or the Interregional Research
Project Number 4 (IR-4). There were no comments received in response to
these notices of filing.
The petitions requested that 40 CFR 180.544 be amended by
establishing tolerances for residues of the insecticide methoxyfenozide
in or on almond, hulls; artichoke, globe; field corn grain; field corn
forage; field corn stover (fodder); corn, oil; aspirated grain
fractions; sweet corn (K + CWHR); sweet corn forage; sweet corn stover
(fodder); corn silage; stone fruits crop group; prunes; grapes; Spanish
lime; longan; lychee; tree nut crop group; pulasan; raisins; rambutan;
fruiting vegetables (except cucurbits); crop subgroup 4A leafy green
vegetables; 4B leaf petioles; head and stem Brassica; crop subgroup 5B
leafy Brassica greens; at 45.0, 3.0, 0.05, 15.0, 105, 0.2, 1.0, 0.05,
30, 60, 5.0, 5.0, 7.0, 1.0, 2.0, 2.0, 2.0, 0.1, 2.0, 1.5, 2.0, 2.0,
25.0, 10.0, 6.5, 20 parts per million (ppm) respectively and an
increase in the established tolerance for residues of methoxyfenozide
to 0.1 ppm in milk and an increase in the established tolerances for
residues of methoxyfenozide and its glucuronide metabolite in the fat
of cattle, goats, horses, hogs and sheep; liver of cattle, goats,
horses, hogs and sheep; and meat byproducts (except liver) of cattle,
goats, horses hogs and sheep to 0.5, 0.4 and 0.1 ppm respectively.
These petitions also requested that 40 CFR 180.544 be amended by
establishing time limited tolerances for the indirect or inadvertent
residues of methoxyfenozide and its metabolites RH-117,236 free phenol
of methoxyfenozide; 3,5-dimethylbenzoic acid N-tert-butyl-N'-(3-
hydroxy-2-methylbenzoyl) hydrazide, RH-151,055 glucose conjugateof RH-
117,236; 3,5-dimethylbenzoicacid N-tert-butyl-N-
[3(b-D-glucopyranosyloxy)-2-
methylbenzoyl]-hydrazide and RH-152,072 the malonylglycosyl conjugate
of RH 117,236 in or on root and tuber vegetables; leaves of root and
tuber vegetables; bulb vegetables; leafy vegetables (except Brassica);
Brassica vegetables; legume vegetables; foliage of legume vegetables;
forage, fodder, hay, and straw of cereal grains; grass forage, fodder
and hay; forage, fodder, straw and hay of non-grass animal feeds; and
herbs and spices when present therein as a result of application of
methoxyfenozide to growing crops at 0.05, 0.1, 0.1, 0.2, 0.2, 0.05,
8.0, 7.0, 7.0, 8.0 and 8.0 ppm respectively.
Based on the residue data submitted, EPA has determined that the
following changes to the requested tolerances listed above are
necessary. A higher tolerance of 125 ppm is required for field corn
stover. A higher tolerance of 30.0 ppm is required for vegetable, leafy
(except Brassica), leafy greens subgroup. A higher tolerance of 25 ppm
is required for vegetable, leafy (except Brassica), leaf petioles
subgroup. A higher tolerance of 7.0 ppm is required for vegetables,
leafy, Brassica (cole), head and stem subgroup. A higher tolerance of
30.0 ppm is required for vegetables, leafy, Brassica (cole), greens
subgroup. A separate tolerance of 0.30 is needed for plums (fresh
prune). A lower tolerance of 25.0 ppm is required for almond hulls. A
higher tolerance of 2.0 ppm is required for aspirated grain fractions.
No tolerance is required for corn silage since residues in silage are
covered by the proposed tolerance for field corn forage. A tolerance
for processed prunes is not needed. A lower tolerance of 3.0 ppm is
required for stone fruit (except plum, fresh prune). The proposed
higher tolerances for hog commodities are not needed. A tolerance of
0.02 ppm is required for poultry, fat and 0.02 for poultry, meat. A
tolerance of 0.02 ppm is required for eggs. A tolerance of 0.10 ppm is
required for poultry, liver and 0.02 ppm for poultry meat byproducts
(mbyp) (except liver). Higher tolerances for the indirect or
inadvertent residues of methoxyfenozide in or on vegetable, bulb,
group; vegetable, root and tuber, group and vegetable, root and tuber,
leaves, group at 0.20, 0.10, and 0.20 ppm respectively are required.
Tolerances for the indirect or inadvertent residues of methoxyfenozide
in or on leafy and Brassica vegetables are not needed since direct
tolerances are being established for them. Higher tolerances for the
indirect or inadvertent combined residues of methoxyfenozide benzoic
acid, 3-methoxy-2-methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-
dimethylethyl) hydrazide and its metabolites RH-117,236 free phenol of
methoxyfenozide; 3,5-dimethylbenzoic acid N-tert-butyl-N'-(3-hydroxy-2-
methylbenzoyl) hydrazide], RH-151,055 [glucose conjugate of RH-117,236;
3,5-dimethyl benzoic acid N-tert-butyl-N-[3
(b-D-glucopyranosyloxy)-2-
methylbenzoyl]-hydrazide and RH-152,072 the malonylglycosyl conjugate
of RH 117,236 in or on animal feed, non-grass (forage, fodder, straw,
hay), group; grain, cereal, forage, fodder, and straw, group; grass,
forage, fodder, and hay, group; herbs and spices, group; vegetable,
legume, group; and vegetable, legume, foliage, group at 10.0 ppm, 10.0
ppm, 10.0 ppm, 10.0 ppm, 0.10 ppm and 10.0 ppm respectively are needed.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for tolerances for residues of the insecticide
methoxyfenozide in or on almond, hulls; artichoke, globe; cattle, fat;
corn, field, grain; corn, field, forage; corn, field, stover; corn,
oil; corn, aspirated grain fractions; corn, sweet (K + CWHR); corn,
sweet, forage; corn, sweet, stover; fruit, stone, group (except plum,
fresh prune); goat, fat; grape; horse, fat; lime, Spanish; longan;
lychee; milk; nut, tree, group; pistachio; plum (fresh prune); poultry,
fat; poultry, meat; pulasan; raisin; rambutan; sheep, fat; vegetable,

[[Page 59195]]

fruiting (except cucurbits), group; vegetable, leafy (except Brassica),
leafy greens subgroup; vegetable, leafy (except Brassica), leaf
petioles subgroup; vegetable, leafy, Brassica (cole), head and stem
subgroup; vegetable, leafy, Brassica (cole), greens subgroup at 25.0,
3.0, 0.50, 0.05, 15.0, 125.0, 0.20, 2.0, 0.05, 30.0, 60.0, 3.0, 0.50,
1.0, 0.50, 2.0, 2.0, 2.0, 0.10, 0.10, 0.10, 0.30, 0.02, 0.02, 2.0, 1.5,
2.0, 0.5, 2.0, 30.0, 25.0, 7.0 and 30.0 ppm respectively, and for the
combined residues of methoxyfenozide and its glucuronide metabolite in
or on cattle, liver; cattle, meat byproducts (except liver); eggs;
goat, liver; goat meat byproducts (except liver); horse, liver; horse,
meat byproducts (except liver); poultry, liver; poultry, meat
byproducts (except liver); sheep, liver; and sheep, meat byproducts
(except liver) at 0.40, 0.10, 0.02, 0.40, 0.10, 0.40, 0.10, 0.10, 0.02,
0.40 and 0.10 ppm, respectively. EPA also has sufficient data to assess
the hazards of and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for time-limited tolerances for the
indirect or inadvertent residues for methoxyfenozide in or on
vegetable, bulb, group; vegetable, root and tuber, group; and
vegetable, root and tuber, leaves, group when present therein as a
result of the application of methoxyfenozide to growing crops at 0.20,
0.10 and 0.20 ppm, respectively and time-limited indirect or
inadvertent combined residues for methoxyfenozide and its metabolites
RH-117,236 free phenol of methoxyfenozide; 3,5-dimethylbenzoic acid N-
tert-butyl-N'-(3-hydroxy-2-methylbenzoyl) hydrazide], RH-151,055
glucose conjugate of RH-117,236; 3,5-dimethylbenzoicacid N-tert-butyl-
N-[3(b-D-glucopyranosyloxy)-2-
methylbenzoyl]-hydrazide and RH-152,072 the malonylglycosyl conjugate
of RH-117,236 in or on animal feed, non-grass (forage, fodder, straw,
hay), group; grain, cereal, forage, fodder, and straw, group; grass,
forage, fodder, and hay, group; herbs and spices, group; vegetable,
legume, group; and vegetable, legume, foliage, group when present
therein as a result of the application of methoxyfenozide to growing
crops at 10.0, 10.0, 10.0, 10.0, 0.10 and 10.0 ppm, respectively. EPA's
assessment of exposures and risks associated with establishing the
tolerance follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by methoxyfenozide are
discussed below as well as the no observed adverse effect level (NOAEL)
and the lowest observed adverse effect level (LOAEL) from the toxicity
studies reviewed.
In an acute neurotoxicity study in rats (MRID 44617802),
statistically significant decreased hindlimb grip strength was observed
in male rats at 3 hours (approximate time of peak effect) following a
single oral dose of 2,000 milligrams/kilogram (mg/kg) (limit dose) of
methoxyfenozide. Decreased hindlimb grip strength was also observed in
the male rats at 7 and 14 days, but was not statistically significant.
No other systemic or neurotoxic effects were observed in the male rats
or in the female rats at any time in this study. Since this marginal
effect occurred only in one sex, was statistically significant at only
one time, was observed only at the high dose (limit dose) and no other
signs of toxicity were observed in the rats in this study, this
possible effect is not considered to be biologically significant. In
addition, neither decreased hindlimb grip strength nor any other signs
of neurotoxicity were observed in any of the animals at any time in a
90-day subchronic neurotoxicity study in rats (MRID 44617803).
In a 2-week range-finding dietary study in rats (MRID 44617722),
treatment-related effects were observed at >=5,000 ppm in the liver
(increased liver weights and hepatocellular hypertrophy in males and
females), in the thyroid gland (hypertrophy/hyperplasia of follicular
cells in males and females), and in the adrenal gland (increased
adrenal weights and/or hypertrophy of the zona fasciculata in females).
Hypertrophy/hyperplasia of thyroid follicular cells was also observed
in males and females at 1,000 ppm, the LOAEL in this study. The NOAEL
was 250 ppm. Treatment-related hematological changes were not observed
in the rats in this study.
In a 3-month feeding study in rats (MRID 44617722), the predominant
treatment-related effects were increased liver weights in males and
females and periportal hepatocellular hypertrophy in all males and
females at 20,000 ppm (highest dose tested) and at 5,000 ppm. In
addition, at 20,000 ppm, a slightly decreased (7-8%) red blood cell
(RBC) count and slightly decreased (7-8%) hemoglobin concentration,
compared to control rats, were observed in the females. The LOAEL in
this study was 5,000 ppm (353 mg/kg/day in males and 379 mg/kg/day in
females). The NOAEL was 1,000 ppm (69 mg/kg/day in males and 72 mg/kg/
day in females). Although observed in the 2-week dietary study and in
the 2-year chronic feeding/carcinogenicity study in rats, treatment-
related effects in the thyroid and adrenal glands were not observed in
the rats in this 3-month study. There is no available biological
explanation for this difference in findings in the studies.
In a 2-year combined chronic feeding/carcinogenicity study in rats
(MRID 44617731), the following treatment-related effects were observed
at 20,000 ppm (highest dose tested): decreased survival in males,
decreased body weight and food efficiency in females during the last
year of the study, hematological changes (decreased RBC counts,
hemoglobin concentrations, and/or hematocrits; methemoglobinemia; and
increased platelet counts) in males and females, increased liver
weights and periportal hepatocellular hypertrophy in males and females,
thyroid follicular cell hypertrophy in males, altered thyroid colloid
in males and females, and increased adrenal weights in males and
females. At 8,000 ppm, the following treatment-related effects were
observed: hematological changes (decreased RBC counts, hemoglobin
concentrations, and/or hematocrits in males and females), liver
toxicity (increased liver weights in males and periportal
hepatocellular hypertrophy in males and females), histopathological
changes in the thyroid (increased follicular cell hypertrophy in males
and altered colloid in males) and possible adrenal toxicity (increased
adrenal weights in males and females). The LOAEL in this study was
8,000 ppm (411 mg/kg/day in males and 491 mg/kg/day in females), based
on the effects described above. The NOAEL was 200 ppm (10.2 mg/kg/day
in males and 11.9 mg/kg/day in females). This NOAEL was used to
establish the RfD for methoxyfenozide. Utilizing an uncertainty factor
(UF) of 100 to account for both interspecies extrapolation (10X) and
intraspecies variability (10X), the chronic RfD for methoxyfenozide was
calculated to be 0.10 mg/kg/day. No evidence of carcinogenicity was
observed in this study. Dosing was considered adequate because of the
decreased survival in males and the decreased body weights and food
efficiency in females at 20,000 ppm. In addition, the highest dose
tested for both males and females, 20,000 ppm (1,045 mg/kg/day males
and 1,248 mg/kg/day in females), is higher than the limit dose of 1,000
mg/kg/day.
In a 2-week range-finding study in dogs (MRID 44617724), treatment-

[[Page 59196]]

related hematological changes were observed in both males and females
at 3,500 ppm, 7,000 ppm, 15,000 ppm and 30,000 ppm (highest dose
tested). These changes included decreased RBC counts, decreased
hemoglobin concentrations, decreased hematocrits, decreased MCHC,
increased MCV, increased MCH, increased Heinz bodies,
methemoglobinemia, changes in RBC morphology such as Howell-Jolly
bodies and polychromasia, increased reticulocyte counts, increased
nucleated RBC and increased platelet counts. At the same dose levels
(>= 3,500 ppm), increased spleen weights and/or enlarged spleens were
also observed. At >= 7,000 ppm, plasma total bilirubin was increased.
The LOAEL in this study was 3,500 ppm (90-184 mg/kg/day in males and
females). The NOAEL was 300 ppm (11-16 mg/kg/day in males and females).
In a 3-month feeding study in dogs (MRID 44617724), no treatment-
related effects other than a suggestion of decreased body weight gains
in males and females were observed in either males or females at the
highest dose tested viz. 5,000 ppm (198 mg/kg/day in males and 209 mg/
kg/day in females). Although hematological effects were noted in dogs
in the 2-week range-finding study at >= 3,500 ppm (90-184 mg/kg/day)
and in the 1-year chronic feeding study at >=3,000 ppm (106 mg/kg/day
in males and 111 mg/kg/day in females), hematological changes were not
observed in this 3-month study at 5,000 ppm (198/209 mg/kg/day). There
is no available biological explanation for this difference in findings
in the studies.
As part of the 3-month study in dogs (MRID 44617724), some male and
female dogs were given 15 ppm (0.6 mg/kg/day) of methoxyfenozide in the
diet for 15 weeks followed by an increase in the dietary dose to 15,000
ppm (422 mg/kg/day in males and 460 mg/kg/day in females) for an
additional 6 weeks. After about 2 weeks and 6 weeks at 15,000 ppm,
hematological examinations were conducted. No hematological changes in
these dogs were observed. Apparently, pretreatment of the dogs at 15
ppm for 15 weeks prevented the occurrence of hematological changes
which would have been expected to occur based on results in the 2-week
and 1-year feeding studies. One possible explanation is that the liver
microsomal enzyme system may have been stimulated so much during
pretreatment at 15 ppm that the metabolic (detoxification ?) rate of
methoxyfenozide was increased to the point where blood levels of
methoxyfenozide may have remained below critical effect levels at
15,000 ppm. Another possible explanation is that compensatory
mechanisms for replacing damaged RBC in pretreated dogs may have been
so efficient that hematological changes were not observed in these dogs
even at 15,000 ppm. Other explanations for this finding are also
possible.
In a 1-year chronic feeding study in dogs (MRID 44617728), the
predominant toxic effects were anemia and signs of an associated
compensatory response. At 30,000 ppm, the highest dose tested, the
following treatment-related effects were observed in both males and
females: decreased RBC counts, decreased hemoglobin concentrations,
decreased hematocrits, methemoglobinemia, nucleated RBC, increased
platelets, increased serum total bilirubin, bilirubinurea, increased
hemosiderin in macrophages in liver and spleen, and increased
hyperplasia in bone marrow of rib and sternum. Increased liver weights
in males and females and increased thyroid weights in males were also
observed at 30,000 ppm. Signs of anemia were also noted at 3,000 ppm
and included decreased RBC counts, decreased hemoglobin concentrations,
decreased hematocrits, methemoglobinemia, increased platelets, and
increased serum total bilirubin and bilirubinurea. The LOAEL in this
study was 3,000 ppm (106 mg/kg/day in males and 111 mg/kg/day in
females). The NOAEL was 300 ppm (9.8 mg/kg/day in males and 12.6 mg/kg/
day in females).
In a 3-month feeding study in mice (MRID 44617723), the only
treatment-related effect was decreased body weight gain in males and
females at 7,000 ppm, the highest dose tested. The LOAEL in this study
was 7,000 ppm (1,149 mg/kg/day in males and 1,742 mg/kg/day in females)
and the NOAEL was 2,500 ppm (428 mg/kg/day in males and 589 mg/kg/day
in females). In an 18-month carcinogenicity study in mice (MRID
44617729), no treatment-related effects were observed at doses up to
and including the limit dose of 7,000 ppm (1,020 mg/kg/day in males and
1,354 mg/kg/day in females). No evidence of carcinogenicity was
observed in this study. Dosing was considered adequate because the
highest dose tested for both males and females, 7,000 ppm (1,020 mg/kg/
day in males and 1,354 mg/kg/day in females, respectively), is higher
than the limit dose of 1,000 mg/kg/day.
In a battery of four mutagenicity studies (with and without
metabolic activation, as appropriate for the specific study), technical
grade methoxyfenozide was negative for genotoxicity in all four
studies. The four studies satisfy the new revised mutagenicity
guideline requirements for a new chemical (published in 1991). An
additional mutagenicity study, performed on RH-117,236 (Metabolite M-
B), a metabolite of methoxyfenozide, was also negative for
genotoxicity.
Based on the lack of evidence of carcinogenicity in male and female
rats as well as in male and female mice and on the lack of genotoxicity
in an acceptable battery of mutagenicity studies, methoxyfenozide is
classified as a ``not likely'' human carcinogen according to the EPA
Proposed Guidelines for Carcinogen Risk Assessment (April 10, 1996).
In a developmental toxicity study in rats (MRID 44638201), no signs
of maternal toxicity in dams or of developmental toxicity in fetuses
were observed at the limit dose of 1,000 mg/kg/day. The NOAEL in this
study for both maternal toxicity and developmental toxicity was 1,000
mg/kg/day. The LOAEL was >1,000 mg/kg/day. Similarly, in a
developmental toxicity study in rabbits (MRID 44617726), no signs of
maternal toxicity or of developmental toxicity were observed at the
limit dose of 1,000 mg/kg/day. The NOAEL in this study for both
maternal toxicity and developmental toxicity was 1,000 mg/kg/day. The
LOAEL was >1,000 mg/kg/day.
In neither the developmental toxicity study in rats nor in the
developmental toxicity study in rabbits was there any evidence for
increased susceptibility of fetuses to in utero exposure to
methoxyfenozide. In these studies, methoxyfenozide was determined not
to be a developmental toxicant.
In a 2-generation (1 litter/generation) reproduction study in rats
(MRID 44617727), treatment-related parental toxicity was observed only
at 20,000 ppm, the highest dose tested. At this dose, increased liver
weights were observed in males and females of both generations and
midzonal to periportal hepatocellular hypertrophy was observed in the
livers of all males and females of both generations. The LOAEL for
parental toxicity was 20,000 ppm (1,552 mg/kg/day for males and 1,821
mg/kg/day for females) and the NOAEL was 2,000 ppm (153 mg/kg/day for
males and 181 mg/kg/day for females). There were no treatment-related
effects on reproductive parameters for adult (parent) animals. The
NOAEL for reproductive toxicity was 20,000 ppm. Since no treatment-
related effects were observed in the pups, the NOAEL for neonatal
toxicity was also 20,000 ppm. The NOAEL for parental toxicity in this
reproduction study is higher than the NOAEL for the 2-year combined

[[Page 59197]]

chronic feeding/carcinogenicity study in rats because many of the toxic
effects observed in the 2-year study at the LOAEL (hematological
changes, liver toxicity, histopathological changes in the thyroid gland
and increased adrenal weights) were not examined in the reproduction
study.
In a metabolism study in rats (MRID 44617804), 14C-
methoxyfenozide was rapidly absorbed, distributed, metabolized and
almost completely excreted within 48 hours. The major route of
excretion was feces (86-97%) with lesser amounts in the urine (5-13%).
An enterohepatic circulation was observed. The test material was
metabolized principally by O-demethylation of the A-ring methoxy group
and oxidative hydroxylation of the B-ring methyl groups followed by
conjugation with glucuronic acid. No significant sex-related or dose-
dependent differences in metabolic disposition were noted. Seven
metabolites and the parent accounted for 74-90% of the administered
dose in all groups. The glucuronide conjugates are considered to be
less toxic than the parent compound because glucuronide conjugation is
well known to be a commonly occurring ``detoxification'' mechanism in
mammalian species since it results in the formation of more polar, more
water-soluble metabolites which are readily and easily excreted from
the body (in this case, in the bile and urine). Further, based on
similarities of chemical structure, the non-conjugated metabolites
would be expected to be no more toxic than the parent compound.
In a dermal absorption study in rats (MRID 44638201) using an 80%
wettable powder formulation as the test material, the cumulative dermal
absorption of test material after a 10 or 24 hour dermal exposure was
determined to be 2%.
In a 28-day dermal toxicity study in rats (MRID 44617725), no
treatment-related systemic or skin effects were observed at the limit
dose of 1,000 mg/kg/day (HDT).
Regarding effects on endocrine organs, methoxyfenozide affected the
thyroid gland and adrenal gland in the 2-week and 2-year feeding
studies in rats. In the thyroid gland, hypertrophy/hyperplasia of
follicular cells and altered colloid were observed in males and females
at or near the LOAEL in both of these studies. In the adrenal gland,
increased adrenal weights and hypertrophy of the zona fasciculata were
also observed in males and females at or near the LOAEL. In addition,
in the 1-year chronic feeding study in dogs, increased thyroid weight
in males was observed, but only at the very high dose of 30,000 ppm.
Other than the morphological changes described above, there were no
signs of thyroid or adrenal dysfunction in these or in any other
studies on methoxyfenozide.

B. Toxicological Endpoints

The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-6 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOE_cancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for methoxyfenozide used for human risk assessment is shown
in the following Table 2:

Table 1.--Summary of Toxicological Dose and Endpoints for Methoxyfenozide for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Exposure Scenario Dose (mg/kg/day) Endpoint Study
----------------------------------------------------------------------------------------------------------------
Acute Dietary None No appropriate endpoint None
was identified in the
oral toxicity studies
including the acute
neurotoxicity study in
rats and the
developmental toxicity
studies in rats and
rabbits.
--------------------------------------------------------------------------
UF = N/A Acute RfD = Not Applicable
----------------------------------------------------------------------------------------------------------------

[[Page 59198]]

Chronic Dietary (Non cancer) All NOAEL = 10.2 mg/kg/day Hematological changes 2-Year combined chronic
Population Subgroups (decreased RBC, feeding/
hemoglobin and/or carcinogenicity, rats
hematocrit), liver
toxicity (increased
weights, hypertrophy),
histopathological
changes in thyroid
(increased follicular
cell hypertrophy,
altered colloid),
possible adrenal
toxicity (increased
weights).
----------------------------------------------------------------------------------------------------------------
UF = 100; FQPA = 1X Chronic RfD = 0.10 mg/kg/day
Chronic Population Adjusted Dose (cPAD) = 0.10
mg/kg/day
This cPAD applies to All population subgroups.
--------------------------------------
Short-Term, Intermediate-Term, and None No systemic toxicity None
Long-Term (Dermal) was seen at the limit
dose following
repeated dermal
application to rats.
----------------------------------------------------------------------------------------------------------------
Short-Term-Intermediate-Term, and None Based on low vapor None
Long-Term (Inhalation) pressure, the low
acute toxicity of both
the technical and
formulated products as
well as the
application rate and
application method,
there is minimal
concern for inhalation
exposure.
----------------------------------------------------------------------------------------------------------------
Cancer None None. None
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
to the FQPA.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.544) for the residues of methoxyfenozide, in or
on a variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from methoxyfenozide in
food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. No appropriate toxicological endpoint attributable
to a single exposure was identified in the available toxicology studies
on methoxyfenozide. Thus, the risk from acute exposure is considered
negligible.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM[reg]) analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by
Individuals (CSFII) and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments:
a. A tier 1( assumptions: tolerance level residues and 100 percent
crop treated ) was conducted.
b. The established tolerances of 40 CFR 180.544 and the new
tolerances established today were included in the analysis.
c. Anticipated residues and percent crop treated were not used in
this analysis.
d. The processing factors applied were the DEEM default values.
As shown in table 2 of this preamble, the resulting dietary food
exposures occupy up to 34.3% of the Chronic PAD for the most highly
exposed population subgroup, children, 1-6 years old. These results
should be viewed as conservative (health protective) risk estimates.
Refinements such as use of percent crop-treated information and/or
anticipated residue values would yield even lower estimates of chronic
dietary exposure.

Table 2.--Summary:Chronic Dietary Exposure Analysis by DEEM (Tier 1)
------------------------------------------------------------------------
Exposure (mg/ % of Chronic
Population Subgroup\1\ kg/day) PAD\2\
------------------------------------------------------------------------
U.S. Population (Total) 0.018704 18.7
-----------------------------------------
All infants (<1 year old) 0.020335 20.3
-----------------------------------------
Nursing infants 0.010197 10.2
-----------------------------------------
Non-nursing infants 0.024603 24.6
-----------------------------------------

[[Page 59199]]

Children (1-6 years old) 0.034286 34.3
-----------------------------------------
Children (7-12 years old) 0.024543 24.5
-----------------------------------------
Females 13+ (nursing) 0.021335 21.3
-----------------------------------------
Non-hispanic/non-white/non-black 0.021910 21.9
------------------------------------------------------------------------
\1\ The subgroups listed are: (1) the U.S. Population (total); (2) those
for infants and children; (3) the most highly exposed of the females
subgroups, in this case Females 13+ (nursing), and (4) the most highly
exposed of the remaining subgroups, in this case Non-hispanic/non-
white/non-black.
\2\ Percent Chronic PAD = (Exposure / Chronic PAD) x 100.

iii. Cancer. Methoxyfenozide is classified as a ``not likely''
human carcinogen. Therefore this risk is considered negligible.
iv. Anticipated residue and percent crop treated information.
Anticipated residue and percent crop treated information was not used
in the Agency's assessment.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for methoxyfenozide in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of methoxyfenozide.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW, which predicts pesticide concentrations in groundwater. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. The PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage
basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead, drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to methoxyfenozide they are
further discussed in the aggregate risk sections.
Based on the PRZM/EXAMS and SCI-GROW models the estimated
environmental concentrations (EECs) of methoxyfenozide for acute
exposures are estimated to be 290 parts per billion (ppb) for surface
water and 12 ppb for ground water. The EECs for chronic exposures are
estimated to be 197 ppb for surface water and 12 ppb for ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Methoxyfenozide is not registered for use on any sites that would
result in residential exposure.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether methoxyfenozide has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
methoxyfenozide 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 methoxyfenozide has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961,
November 26, 1997).

D. Safety Factor for Infants and Children

1. In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. The toxicology database for
methoxyfenozide included acceptable developmental toxicity studies in
both

[[Page 59200]]

rats and rabbits as well as a 2-generation reproductive toxicity study
in rats. The data provided no indication of increased sensitivity of
rats or rabbits to in utero and/or postnatal exposure to
methoxyfenozide.
3. Conclusion. The 10X safety factor for the protection of infants
and children (as required by FQPA) has been removed (i.e. reduced to
1x) for the following reasons:
? The toxicology data base for methoxyfenozide is complete
for assessment of potential hazard to infants and children.
? Based on weight-of-the-evidence considerations, the HIARC
determined that a developmental neurotoxicity study in rats is not
required to support the registration of methoxyfenozide.
? In developmental toxicity studies in rats and rabbits (MRID
44638201, 44617726), no increased susceptibility in fetuses as compared
to maternal animals was observed following in utero exposures.
? In a 2-generation reproduction study in rats (MRID
44617727), no increased susceptibility in pups as compared to adults
was observed following in utero and post-natal exposures.
? The exposure assessments will not underestimate the
potential dietary (food and drinking water) or non-dietary exposures
for infants and children from the use of methoxyfenozide.

E. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water [e.g., allowable chronic water exposure (mg/kg/day) =
cPAD -(average food + residential exposure)]. This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA are used to calculate DWLOCs: 2L/70 kg (adult
male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body
weights and drinking water consumption values vary on an individual
basis. This variation will be taken into account in more refined
screening-level and quantitative drinking water exposure assessments.
Different populations will have different DWLOCs. Generally, a DWLOC is
calculated for each type of risk assessment used: acute, short-term,
intermediate-term, chronic, and cancer.
When EECs for surface water and groundwater are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, EPA will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. No appropriate toxicological endpoint attributable
to a single (acute) dietary exposure was identified. No acute risk is
expected from exposure to methoxyfenozide.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
methoxyfenozide from food will utilize 18.7% of the cPAD for the U.S.
population, 24.6% of the cPAD for non-nursing infants and 34.3% of the
cPAD for children (1-6 years old). There are no residential uses for
methoxyfenozide that result in chronic residential exposure to
methoxyfenozide. In addition, there is potential for chronic dietary
exposure to methoxyfenozide in drinking water. After calculating DWLOCs
and comparing them to the EECs for surface and ground water, EPA does
not expect the aggregate exposure to exceed 100% of the cPAD, as shown
in the following Table 3:

Table 3.--DWLOCs for Chronic (Non-Cancer) Dietary Exposure
----------------------------------------------------------------------------------------------------------------
Max. Water
Chronic PAD Food Exposure SCI-GROW GENEEC 56- DWLOC ([mu]g/
Population Subgroup (mg/kg/day) Exposure (mg/kg/ ([mu]g/L) day avg L)\2,\\3,\\4\
(mg/kg/day) day)\1\ ([mu]g/L)
----------------------------------------------------------------------------------------------------------------
U.S. Population (total) 0.10 0.019 0.081 12 197 2,800
---------------------------------
Females 13+\5\ 0.10 0.021 0.079 12 2,400
---------------------------------
Infants/Children\5\ 0.10 0.034 0.066 12 197 660
---------------------------------
Other\5\ 0.10 0.022 0.078 12 197 2,700
----------------------------------------------------------------------------------------------------------------
\1\ Maximum Water Exposure (mg/kg/day) = Chronic PAD (mg/kg/day) -[Chronic Food Exposure + Chronic Residential
Exposure (mg/kg/day)]. Methoxyfenozide has no registered residential uses.
\2\ DWLOC ([mu]g/L) = [Maximum water Exposure (mg/kg/day) x body wt (kg)]
/ [(10-3 mg/[mu]g) x water consumed
daily (L/day)]. [mu]g/L = parts per billion.
\3\ EPA default body weights are: General U.S. Population, 70 kg;Males (13+ years old), 70 kg;Females (13+ years
old), 60 kg; Other Adult Populations, 70 kg; and, All Infants/Children, 10 kg.
\4\ EPA default daily drinking rates are 2 L/day for Adults and 1 L/day for Children.
\5\ Within each of these subgroups, the subpopulation with the highest (chronic) food exposure was selected;
namely, Females (13+/nursing); Children 1-6 yrs;and, Non-hispanic/non-white/non-black, respectively.

3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Methoxyfenozide is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.

[[Page 59201]]

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).
Methoxyfenozide is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
5. Aggregate cancer risk for U.S. population. Methoxyfenozide is
classified as a ``not likely'' human carcinogen. Therefore, exposure to
methoxyfenozide is expected to create at most a negligible risk of
cancer.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to methoxyfenozide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

1. Enforcement methods for target crops. Adequate enforcement
methods are available for determination of methoxyfenozide residues in
plant commodities. The similar methods that are used vary depending on
the matrices involved. The enforcement method for cottonseed is TR 34-
96-88 (high production liquid chromatography using ultraviolet
detection (HPLC/UV); MRID 44617821), which has undergone a successful
petition method validation (PMV) trial conducted by EPA (D261663). The
enforcement method for pome fruit (also proposed for globe artichoke
and lychee) is TR 34-98-87 (HPLC/UV; MRID 44626304), which has also
undergone a successful PMV trial conducted by EPA (D261664). The other
proposed enforcement methods are on: corn, TR 34-00-38 (HPLC/UV; MRID
45213504); tree nuts, TR 34-00-107 (HPLC/UV; MRID 45373503); stone
fruit, TR 34-00-109 (HPLC/UV; MRID 45313302); leafy and Brassica (cole)
vegetables, fruiting vegetables, grapes and raisins, TR 34-99-74 (HPLC/
UV or MS; MRID 44873410). Adequate confirmatory method validation,
radiovalidation, and independent laboratory validation (ILV) data for
these methods have been provided.
2. Enforcement method for rotational crops. Method TR 34-00-41(MRID
45194701) is designated as the enforcement method for indirect or
inadvertent residues in rotational crops (D269986). The method
determines residues of methoxyfenozide (HPLC/UV) in high moisture
crops; and residues of methoxyfenozide and its metabolites RH-117,236,
RH-151,055, and RH-152,072 (HPLC/MS) in low moisture crops. Adequate
confirmatory method validation, radiovalidation, and ILV data have been
submitted. EPA concluded (D274209) a PMV trial on this method was not
needed because of its similarity to TR 34-98-87.
3. Enforcement methods for animal commodities. The tolerance
enforcement method for animal commodities (except poultry) is TR 34-98-
106 (MRID 44626305), which has undergone a successful PMV trial
conducted by EPA (D261665). The method determines residues of parent
methoxyfenozide (HPLC/UV) in fat, cream, milk, and muscle;and residues
of methoxyfenozide and its metabolite RH-141,518 (HPLC/MS) in liver and
kidney (D249438). A similar method, TR 34-00-40 (MRID 45213505), will
be the enforcement method for poultry commodities. TR 34-00-40
determines methoxyfenozide in fat (HPLC/UV) and muscle (HPLC/MS);and
methoxyfenozide and RH-141,518 (HPLC/MS) in eggs and liver (D269969).
EPA concluded (D274209) a PMV trial on this method was not needed
because of its similarity to TR 34-98-106. Adequate confirmatory method
validation, radiovalidation, and ILV data have been submitted for both
methods.
4. Multiresidue methods testing. Methoxyfenozide is not recoverable
by the Food and Drug Administration multiresidue method protocols of
the Pesticide Analytical Method, Volume I (D249438). Test data for
metabolites RH-141,518, RH-117,236, RH-151,055, and RH-152,072 are also
required, but have not been submitted. Submission of such test data
will be made a condition of registration.
These methods may be requested from: Calvin Furlow, PIRIB,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW, Washington, DC 20460; telephone number: (703) 305-5229; e-
mail address: furlow.calvin@epa.gov.

B. International Residue Limits

There are no Codex or Canadian MRLs established for residues of
methoxyfenozide. Mexican MRLs are established for residues of
methoxyfenozide in cottonseed (0.05 ppm) and maize (0.01 ppm). The U.S.
tolerances on these commodities are 2.0 ppm and 0.05 ppm, respectively.
Based on the current use patterns, the U.S. tolerance levels can not be
reduced to harmonize with the Mexican MRLs, so incompatibility will
exist.

C. Conditions

Submission of test data showing the recovery of metabolites RH-
141,518, RH-117,236, RH-151,055, and RH-152,072 through the
multiresidue test protocols of PAM, Vol. 1.
Submission of additional field accumulation trials (the 24
reportedly in progress). In the interim period, only time-limited
tolerances (5 year) should be established.
? Submission of the following additional field trials,
conducted per their respective proposed use pattern:
? Three for spinach (one each from Regions 1, 2, and 10)
? Two for celery (both from Region 3, preferably using
Intrepid 2F)
? Three for mustard greens (one each from Regions 2, 3, and
10)
? Two for plums (one each from Regions 10 and 11)
Submission of the following additional information from the hen
feeding study:
? Results of analysis (to be conducted) of the fat and meat
(muscle) samples for residues of RH-141,518;
? Freezer storage stability data that covers the period of
time these poultry fat and meat (muscle) samples have been maintained
in storage;and,
? Revised tolerances and tolerance expression (to include RH
141,518) for these matrices, if warranted.

V. Conclusion

Therefore, tolerances are established for residues of the
insecticide methoxyfenozide in or on almond, hulls; artichoke, globe;
cattle, fat; corn, field, grain; corn, field, forage; corn, field,
stover; corn, oil; corn, aspirated grain fractions; corn, sweet (K +
CWHR); corn, sweet, forage; corn, sweet, stover; fruit, stone, group
(except plum, fresh prune); goat, fat; grape; horse, fat; lime,
Spanish; longan; lychee; milk; nut, tree, group; pistachio; plum (fresh
prune); poultry, fat; poultry, meat; pulasan; raisin; rambutan; sheep,
fat; vegetable, fruiting (except cucurbits), group; vegetable, leafy
(except Brassica), leafy greens subgroup; vegetable, leafy (except
Brassica), leaf petioles subgroup; vegetable, leafy, Brassica (cole),
head and stem subgroup; vegetable, leafy, Brassica (cole), greens
subgroup at 25.0, 3.0, 0.50,0.05, 15.0, 125.0, 0.20, 2.0, 0.05, 30.0,
60.0, 3.0, 0.50, 1.0,0.50, 2.0,2.0, 2.0 0.10, 0.10,0.10,0.30, 0.02,
0.02, 2.0, 1.5, 2.0, 0.5, 2.0, 30.0, 25.0, 7.0 and 30.0 part per
million (ppm) respectively and for the combined residues of
methoxyfenozide and its glucuronide metabolite in or on cattle,

[[Page 59202]]

liver; cattle, meat byproducts (except liver); eggs; goat, liver; goat
meat byproducts (except liver); horse, liver; horse, meat byproducts
(except liver); poultry, liver; poultry, meat byproducts (except
liver); sheep, liver; and sheep, meat byproducts (except liver) at
0.40, 0.10, 0.02, 0.40, 0.10, 0.40, 0.10, 0.10, 0.02, 0.40 and 0.10
part per million (ppm) respectively. These petitions also requested
that 40 CFR 180.544 be amended by establishing time limited tolerances
for the indirect or inadvertent residues for methoxyfenozide in or on
vegetable, bulb, group; vegetable, root and tuber, group; and
vegetable, root and tuber, leaves, group when present therein as a
result of the application of methoxyfenozide to growing crops at 0.20,
0.10 and 0.20 part per million (ppm) respectively and time limited
indirect or inadvertent combined residues for methoxyfenozide and its
metabolites RH-117,236 free phenol of methoxyfenozide; 3,5-
dimethylbenzoic acid N-tert-butyl-N'-(3-hydroxy-2-methylbenzoyl)
hydrazide, RH-151,055 glucose conjugate of RH-117,236; 3,5-
dimethylbenzoicacid N-tert-butyl-N-
[3(b-D-glucopyranosyloxy)-2-
methylbenzoyl]-hydrazide and RH-152,072 the malonylglycosyl conjugate
of RH 117,236 in or on animal feed, non-grass (forage, fodder, straw,
hay), group; grain, cereal, forage, fodder, and straw, group; grass,
forage, fodder, and hay, group; herbs and spices, group; vegetable,
legume, group; and vegetable, legume, foliage, group when present
therein as a result of the application of methoxyfenozide to growing
crops at 10.0, 10.0, 10.0, 10.0, 0.10 and 10.0 part per million (ppm)
respectively.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2002-0219 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before November
19, 2002.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your written request to the
Office of the Hearing Clerk in Rm. 104, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket ID number OPP-2002-0219, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact;there is a reasonable possibility
that available evidence identified by the requestor would, if
established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary;and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. Regulatory Assessment Requirements

This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the

[[Page 59203]]

Agency. The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because
this rule has been exempted from review under Executive Order 12866 due
to its lack of significance, this rule is not subject to Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This
final rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). Nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or OMB review or any
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks(62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Since tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerance in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of FFDCA section 408(n)(4).
For these same reasons, the Agency has determined that this rule does
not have any ``tribal implications'' as described in Executive Order
13175, entitled Consultation and Coordination with Indian Tribal
Governments (59 FR 22951, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.

VIII. Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: September 16, 2002.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

1. The authority citation for part 180 continues to read as
follows:

Authority: 21 U.S.C. 321(q), 346(a) and 371.

2. Section 180.544 is revised to read as follows:

Sec. 180.544 Methoxyfenozide;tolerances for residues.

(a) General. (1) Tolerances are established for residues of the
insecticide methoxyfenozide per se; benzoic acid, 3-methoxy-2-methyl-,
2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide in or on the
following food commodities:

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almond, hulls.............................................. 25
Apple, wet pomace.......................................... 7.0
Artichoke, globe........................................... 3.0
Brassica, head and stem, subgroup.......................... 7.0
Brassica, leafy greens, subgroup........................... 30
Cattle, fat................................................ 0.50
Cattle, meat............................................... 0.02
Corn, field, forage........................................ 15
Corn, field, grain......................................... 0.05
Corn, field, refined oil................................... 0.20
Corn, field, stover........................................ 125
Corn, sweet, forage........................................ 30
Corn, sweet, kernal plus cob with husks removed............ 0.05
Corn, sweet, stover........................................ 60
Cotton, gin byproducts..................................... 35
Cotton, undelinted seed.................................... 2.0
Fruit, pome, group......................................... 1.5
Fruit, stone, group, except fresh prune plum............... 3.0
Goat, fat.................................................. 0.50
Goat, meat................................................. 0.02
Grain, aspirated fractions................................. 2.0
Grape...................................................... 1.0
Grape, raisin.............................................. 1.5
Hog, fat................................................... 0.1
Hog, meat.................................................. 0.02
Horse, fat................................................. 0.50
Horse, meat................................................ 0.02
Leaf petioles subgroup..................................... 25
Leafy greens subgroup...................................... 30
Longan..................................................... 2.0
Lychee..................................................... 2.0
Milk....................................................... 0.10
Nut, tree, group........................................... 0.10
Pistachio.................................................. 0.10
Plum, prune, fresh......................................... 0.30
Poultry, fat............................................... 0.02
Poultry, meat.............................................. 0.02

[[Page 59204]]

Pulasan.................................................... 2.0
Rambutan................................................... 2.0
Sheep, fat................................................. 0.50
Sheep, meat................................................ 0.02
Spanish lime............................................... 2.0
Vegetable, fruiting, group................................. 2.0
------------------------------------------------------------------------

(2) For combined residues of the insecticide methoxyfenozide;
benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-
dimethylethyl) hydrazide and its glucuronide metabolite RH-141,518;
[beta]-D-Glucopyranuronic acid, 3-[2-(1,1-dimethylethyl)-2-(3,5-
dimethylbenzoyl)-hydrazino]carbonyl-2-methylphenyl-]
in the following
commodities:

(b) Section 18 emergency exemptions. Time-limited tolerances are
established for the residues of the insecticide methoxyfenozide in
connection with the use of the pesticide under section 18 emergency
exemption granted by EPA. The tolerances will expire on the dates
specified in the following tables.

------------------------------------------------------------------------
Parts per Expiration/
Commodity million revocation date
------------------------------------------------------------------------
Corn, field, forage..................... 10 12/31/03
Corn, field, grain...................... 0.02 12/31/03
Corn, field, stover..................... 75 12/31/03
Corn, oil............................... 0.1 12/31/03
Soybean, aspirated grain fractions...... 20 12/31/03
Soybean, forage......................... 10 12/31/03
Soybean, hay............................ 75 12/31/03
Soybean, refined oil.................... 1.0 12/31/03
Soybean, seed........................... 0.04 12/31/03
------------------------------------------------------------------------

(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. (1) Tolerances are
established for the indirect or inadvertent residues of the insecticide
methoxyfenozide per se; benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide in or on the following
raw agricultural commodities, when present therein as a result of the
application of methoxyfenozide to growing crops as listed in paragraph
(a) of this section:

------------------------------------------------------------------------
Parts per Expiration/
Commodity million Revocation Date
------------------------------------------------------------------------
Vegetable, bulb, group.................. 0.20 09/30/07
Vegetable, root and tuber, group........ 0.10 09/30/07
Vegetable, leaves of root and tuber, 0.20 09/30/07
group..................................
------------------------------------------------------------------------

(2)Tolerances are established for the indirect or inadvertent
combined residues of methoxyfenozide; benzoic acid, 3-methoxy-2-methyl-
, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide and its
metabolites RH-117,236 free phenol of methoxyfenozide; 3,5-
dimethylbenzoic acid N-tert-butyl-N'-(3-hydroxy-2-methylbenzoyl)
hydrazide, RH-151,055 glucose conjugate of RH-117,236; 3,5-dimethyl
benzoic acid N-tert-butyl-N-[3 ([beta]-D-glucopyranosyloxy)-2-
methylbenzoyl]-hydrazide and RH-152,072 the malonylglycosyl conjugate
of RH 117,236 in or on the following raw agricultural commodities, when
present therein as a result of the application of methoxyfenozide to
growing crops as listed in paragraph (a) of this section:

------------------------------------------------------------------------
Parts per Expiration/
Commodity million Revocation Date
------------------------------------------------------------------------
Animal feed, non-grass, group........... 10.0 09/30/07
Grain, cereal, forage, fodder and straw, 10.0 09/30/07
group..................................
Grass, forage, fodder, and hay, group... 10.0 09/30/07
Herb and spice, group................... 10.0 09/30/07
Vegetable, legume, group................ 0.10 09/30/07
Vegetable, foliage of legume, group..... 10.0 09/30/07
------------------------------------------------------------------------

[[Page 59205]]

[FR Doc. 02-23996 Filed 9-19-02;8:45 am]
BILLING CODE 6560-50-S

Methoxyfenozide; Pesticide Tolerance

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