[Federal Register Volume 65, Number 129 (Wednesday, July 5, 2000)]
[Rules and Regulations]
[Pages 41355-41365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16801]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300983; FRL-6496-5]
RIN 2070-AB78


Methoxyfenozide; Benzoic Acid, 3-methoxy-2-methyl-2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl)hydrazide; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: . This regulation establishes tolerances for residues of 
methoxyfenozide in or on cotton, undelinted seed; cotton gin 
byproducts; pome fruit; apple pomace, wet; milk, meat of cattle, goats, 
hogs, horses and sheep and fat of cattle, goats, hogs, horses and 
sheep; and tolerances for the combined residues of methoxyfenozide and 
its glucuronide metabolite in meat byproduct (except liver) and liver 
of cattle, goats, hogs, horses and sheep. Rohm and Haas Company 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), as amended by the Food Quality Protection Act (FQPA) of 
1996.

DATES: This regulation is effective July 5, 2000. Objections and 
requests for hearings, identified by docket control number OPP-300983, 
must be received by EPA on or before September 5, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify

[[Page 41356]]

docket control number OPP-300983 in the subject line on the first page 
of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Joseph Tavano, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., 
NW.,Washington, DC 20460; telephone number: (703) 305-6411; and e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

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

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

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' 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/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-300983. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of (October 6, 1998, 63 FR 53656) (FRL-
6033-8), EPA issued a notice pursuant to section 408 of the FFDCA, 21 
U.S.C. 346a as amended by the FQPA of 1996 (Public Law 104-170) 
announcing the filing of a pesticide petition for tolerance by Rohm and 
Haas Company, 100 Independence Mall West, Philadelphia, PA 19106-2399. 
This notice included a summary of the petition prepared by Rohm and 
Haas Company, the registrant. There were no comments received in 
response to the notice of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the insecticide, 
methoxyfenozide, in or on cottonseed; cotton gin trash; pome fruit; 
meat, kidney, meat byproducts and milk of cattle, goats, sheep and hogs 
and fat of cattle, goats, sheep and hogs at 2.0, 25.0, 1.25, 0.02, 0.1 
parts per million (ppm) respectively and tolerances for the combined 
residues of methoxyfenozide and its glucuronide metabolite in or on 
liver of cattle, goats, sheep, and hogs at 0.1 ppm.
    Methoxyfenozide is a reduced risk pesticide which will be sold 
under the trade name of Intrepid 2F. Methoxyfenozide controls codling 
moth, green fruitworm, lesser appleworm, Oriental fruit moth, 
obliquebanded leafroler, eyespotted bud moth, fruittree leafroller, 
pandemis leafroller, redbanded leafroller, variegated leafroller, 
tufted apple bud moth, spotted tentiform leafminer and Western 
tentiform leafminer on pome fruit and cotton bollworm, tobacco budworm, 
beet armyworm, cabbage looper, cotton leafworm, fall armyworm, Southern 
armyworm, soybean looper and true armyworm on cotton.
    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 November 26, 1997 (62 FR 62961) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for a tolerance for residues of methoxyfenozide on cotton, 
undelinted seed; cotton gin byproducts; pome fruit; apple pomace, wet; 
milk; meat of cattle, goats, hogs, horses, and sheep and fat of cattle, 
goats, hogs, horses, and sheep at 2.0, 35.0, 1.5, 7.0, 0.02, 0.02, 0.1 
ppm respectively, and tolerances for the combined residues of 
methoxyfenozide and its glucuronide metabolite in liver of cattle, 
goats, hogs, horses and sheep and meat byproducts (except liver) of 
cattle, goats, hogs, horses and sheep at 0.1 and 0.02 ppm respectively. 
EPA's assessment of the

[[Page 41357]]

dietary 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 in this unit.
    Acute toxicity studies with technical grade: Oral LD50 
in the rat is > 5,000 milligrams/kilograms (mg/kg) for males and 
females-Toxicity Category IV; Oral LD50 in the mouse is > 
5,000 mg/kg for males and females-Toxicity Category IV; Dermal 
LD50 in the rat is > 2,000 mg/kg-Toxicity Category III; 
Inhalation LC50 in the rat is > 4.3 millgram/liter (mg/L)-
Toxicity Category IV; Primary Eye Irritation in the rabbit -very mild 
irritant-Toxicity Category IV; Primary skin irritation in the rabbit-
not a skin irritant-Toxicity Category IV. Methoxyfenozide is not a skin 
sensitizer.
    In an acute neurotoxicity study in rats, 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 
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.
    In a 2-week range-finding dietary study in rats, 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 lowest observed adverse effect level (LOAEL) 
in this study. The no observed adverse effect level (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, 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 (HDT) and at 5,000 ppm. In addition, at 
20,000 ppm, a slightly decreased (7-8%) 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 
(353/379 mg/kg/day in males/females, respectively). The NOAEL was 1,000 
ppm (69/72 mg/kg/day in males/females, respectively). 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, 
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 (411/491 mg/kg/day in 
males/females, respectively), based on the effects described above. The 
NOAEL was 200 ppm (10.2/11.9 mg/kg/day in males/females, respectively). 
This NOAEL was used to establish the reference dose (RfD) for 
methoxyfenozide. Utilizing an uncertainty factor 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 HDT for both males and females, 20,000 ppm 
(1,045/1,248 mg/kg/day in males/females, respectively), is higher than 
the limit dose of 1,000 mg/kg/day.
    In a 2-week range-finding study in dogs, treatment-related 
hematological changes were observed in both males and females at 3,500 
ppm, 7,000 ppm, 15,000 ppm, and 30,000 ppm (HDT). 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, 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 HDT viz. 5,000 
ppm (198/209 mg/kg/day in males/females, respectively). 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 (106/111 mg/kg/day), 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, 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/
460 mg/kg/day in males/females,

[[Page 41358]]

respectively) 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, the predominant toxic 
effects were anemia and signs of an associated compensatory response. 
At 30,000 ppm, the HDT, 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 (106/111 mg/kg/day 
in males/females, respectively). The NOAEL was 300 ppm (9.8/12.6 mg/kg/
day in males/females, respectively).
    In a 3-month feeding study in mice, the only treatment-related 
effect was decreased body weight gain in males and females at 7,000 
ppm, the HDT. The LOAEL in this study was 7,000 ppm (1,149/1,742 mg/kg/
day in males/females, respectively) and the NOAEL was 2,500 ppm (428/
589 mg/kg/day in males/females, respectively). 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 (1,020/1,354 mg/kg/day in males/females, respectively). No 
evidence of carcinogenicity was observed in this study. Dosing was 
considered adequate because the HDT for both males and females, 7,000 
ppm (1,020/1,354 mg/kg/day in males/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.
    In a developmental toxicity study in rats, 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, 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, 
treatment-related parental toxicity was observed only at 20,000 ppm, 
the HDT. 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 (1,552/1,821 mg/kg/day for males/females, respectively) and the 
NOAEL was 2,000 ppm (153/181 mg/kg/day for males/females, 
respectively). 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 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, 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 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, 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

[[Page 41359]]

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. Since the definition and regulatory 
significance of the term ``endocrine disruptor chemical'' has not yet 
been established by the Agency, it is not clear whether 
methoxyfenozide, on the basis of these effects on the thyroid gland and 
adrenal gland, should be considered to be an ``endocrine disruptor 
chemical.'' 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

    1. Acute toxicity. No appropriate toxicological endpoint 
attributable to a single exposure was identified in the available 
toxicology studies on methoxyfenozide including the acute neurotoxicity 
study in rats, the developmental toxicity study in rats and the 
developmental toxicity study in rabbits. In the acute neurotoxicity 
study in rats, 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 mg/kg (limit dose) of 
methoxyfenozide. Decreased hindlimb grip strength was also observed in 
the male rats at 2,000 mg/kg at 7 and 14 days, but was not 
statistically significant. Decreased hindlimb grip strength was not 
observed in the male rats at 1,000 mg/kg. No other systemic or 
neurotoxic effects were observed in the male rats or in the female rats 
at any time in the study. Since this marginal effect occurred only in 
one sex, was statistically significant only one time, was observed only 
at the high dose (limit dose) and no other signs of toxicity were 
observed in the rats in the study, this equivocal effect is not 
considered to be an appropriate toxicological endpoint for acute 
dietary risk assessments. In addition, decreased hindlimb grip strength 
was not observed in a subchronic neurotoxicity study in rats in any of 
the animals at any time. It is also noted that the acute oral 
LD50 for male and female rats for technical grade 
methoxyfenozide (98% active ingredient (a.i.) is > 5,000 mg/kg 
(Toxicity Category IV). No treatment-related effects were observed in 
either dams or pups in the developmental toxicity studies in rats or 
rabbits at doses up to the limit dose of 1,000 mg/kg/day. Thus the risk 
from acute exposure is considered negligible.
    2. Short- and intermediate-term toxicity. In a 28-day repeated dose 
dermal toxicity study in rats, no systemic or dermal toxicity was 
observed at 1,000 mg/kg/day, the HDT (limit dose). By applying the 
dermal absorption factor of 2% (derived from a dermal absorption study 
in rats, to the NOAEL of 10.2 mg/kg/day and the LOAEL of 411 mg/kg/day 
in the 2-year combined chronic feeding/carcinogenicity study in rats, 
the oral NOAEL and LOAEL in this study are equivalent to a dermal NOAEL 
of 510 mg/kg/day and a dermal LOAEL of 20,550 mg/kg/day. By applying 
the dermal absorption factor of 2% to the NOAEL of 9.8 mg/kg/day and 
the LOAEL of 106.1 mg/kg/day in the 1-year chronic feeding study in 
dogs, the oral NOAEL and LOAEL in this study are equivalent to a dermal 
NOAEL of 490 mg/kg/day and a dermal LOAEL of 5,305 mg/kg/day. The 
likelihood of toxic effects resulting from repeated dermal exposure to 
methoxyfenozide is quite low. Further, based on the use pattern, no 
long-term dermal exposure is expected to occur.
    Methoxyfenozide is a non-volatile solid with a very low vapor 
pressure of > 1 x 10-7 torr (or > 1.33 x 10-5 
pascal). In an acute inhalation toxicity study in rats, the acute 
inhalation LC50 for technical grade methoxyfenozide dust 
(98% a.i.) was determined to be > 4.3 mg/L (> 2x limit dose, Toxicity 
Category IV) for both male and female rats. In another acute inhalation 
toxicity study in rats), the acute inhalation LC50 for RH-
112,485 80WP formulation 80% a.i. was determined to be > 4.5 mg/L (> 2x 
limit dose, Toxicity Category IV) for both male and female rats. In 
both of these acute inhalation toxicity studies, there were no 
mortalities, treatment-related clinical signs, changes in body weights 
or necropsy findings. Based on the low vapor pressure, the low acute 
inhalation toxicity (Toxicity Category IV) of the technical grade 
product and the formulated product, the packaging of the formulated 
product (water soluble pouches), the application rate (0.05 to 0.4 lb. 
a.i./acre for a maximum of 2.0 lb. ai/season), and the application 
method, there is minimal concern for potential inhalation risk. 
Further, based on the use pattern, no long-term inhalation exposure is 
expected to occur.
    3. Chronic toxicity. EPA has established the RfD for 
methoxyfenozide at 0.10 mg/kg/day. This RfD is based on a NOAEL of 10.2 
mg/kg/day and an UF of 100 accounting for both interspecies 
extrapolation (10x) and intraspecies variability (10x). This chronic 
RfD is based on the 2-year combined chronic feeding/carcinogenicity 
study in rats, in which the following effects were observed at the 
LOAEL of 411/491 mg/kg/day in males/females: hematological changes 
(decreased RBC counts, hemoglobin concentrations, and/or hematocrit 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 and altered colloid in males) and possible adrenal toxicity 
(increased adrenal weights in males and females). EPA determined that 
the 10x Safety Facter for the protection of infants and children (as 
required by FQPA) should be reduced to 1x. Therefore, the chronic 
Population Adjusted Dose (cPAD) is the same as the RFD. This cPAD is 
used in assessing chronic risk and applies to all population subgroups. 
Reducing the 10x safety factor to 1x is supported by the following 
factors:
    i. The toxicology data base for methoxyfenozide is complete for 
assessment of potential hazard to infants and children.
    ii. Based on weight-of-the-evidence considerations, EPA determined 
that a developmental neurotoxicity study in rats is not required to 
support the registration of methoxyfenozide.
    iii. In developmental toxicity studies in rats and rabbits, no 
increased susceptibility in fetuses as compared to maternal animals was 
observed following in utero exposures.
    iv. In a 2-generation reproduction study in rats, no increased 
susceptibility in pups as compared to adults was observed following in 
utero and postnatal exposures.
    v. 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.
    4. Carcinogenicity. Methoxyfenozide has been classified as a ``not 
likely'' human carcinogen. This classification is 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.

C. Exposures and Risks

    1. From food and feed uses. In today's action tolerances will be 
established (40 CFR part 180) for the residues of methoxyfenozide on 
cotton, undelinted seed; cotton gin byproducts; pome fruit; apple 
pomace, wet; milk; meat of cattle,

[[Page 41360]]

goats, hogs, horses and sheep and fat of cattle, goats, hogs, horses 
and sheep at 2.0, 35.0, 1.5, 7.0, 0.02, 0.02, 0.1 ppm and tolerances 
for the combined residues of methoxyfenozide and its glucuronide 
metabolite in liver of cattle, goats, hogs, horses and sheep and meat 
byproducts (except liver) of cattle, goats, hogs, horses and sheep at 
0.1 and 0.02 ppm respectively. Risk assessments were conducted by EPA 
to assess dietary exposures from methoxyfenozide as follows.
    i. Acute exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a 1-day or single exposure. No appropriate toxicological endpoint 
attributable to a single exposure was identified in the available 
toxicology studies on methoxyfenozide including the acute neurotoxicity 
study in rats, the developmental toxicity study in rats and the 
developmental toxicity study in rabbits. This risk is considered to be 
negligible.
    ii. Chronic exposure and risk. EPA used the Dietary Exposure 
Evaluation Model (DEEM ) software for conducting a chronic dietary 
(food) risk analysis. DEEM is a dietary exposure analysis system that 
is used to estimate exposure to a pesticide chemical in foods 
comprising the diets of the U.S. population, including population 
subgroups. DEEM contains food consumption data as reported by 
respondents in the USDA Continuing Surveys of Food Intake by 
Individuals conducted in 1989-1992. EPA has made the assumptions that 
100% of pome fruit and cotton would be treated and contain 
methoxyfenozide residues at the tolerance level. The following 
tolerance levels were used in the analysis:

 
------------------------------------------------------------------------
                                             Tolerance Level (parts per
                 Commodity                         million) (ppm)
------------------------------------------------------------------------
Cotton, underlinted seed..................  2.0 ppm
Pome fruits...............................  1.5 ppm
Milk......................................  0.02 ppm
Meat*.....................................  0.02 ppm
Meat byproducts* (except liver)...........  0.02 ppm
Fat*......................................  0.1 ppm
Liver.....................................  0.1 ppm
------------------------------------------------------------------------
*of cattle, goats, hogs, horses and sheep.

    Processing factors were also applied to apple juice concentrate 
(3x), dried apples (8x), dried beef (1.92x), dried pears (6.25x), and 
dried veal (1.92x). The processing factors are default values from 
DEEM.
    As shown in the following table, the resulting dietary food 
exposures occupy up to 11% of the Chronic PAD for the most highly 
exposed population subgroup, non-nursing infants. 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.

       Summary: Chronic Dietary Exposure Analysis by DEEM (Tier 1)
------------------------------------------------------------------------
                                   Exposure (mg/kg/
      Population Subgroup1               day)          % of Chronic PAD2
------------------------------------------------------------------------
U.S. population (total).........  0.001839            1.8
All infants (> 1 year)..........  0.009617            9.6
Nursing infants.................  0.005605            5.6
Non-nursing infants.............  0.011306            11
Children (1-6 years)............  0.007350            6.8
Children (7-12 years)...........  0.003103            2.8
U.S. population (autumn season).  0.002285            2.3
U.S. population (winter season).  0.001891            1.9
Northeast region................  0.002014            2.0
Western region..................  0.002004            2.0
Non-hispanic whites.............  0.001917            1.9
Non-hispanic/non-white/non-black  0.002025            2.0
Females (> 13 years, nursing)...  0.002479            2.5
Pacific region..................  0.002023            2.0
------------------------------------------------------------------------
1 The subgroups listed are: (1) The U.S. population (total); (2) those
  for infants and children; (3) the other subgroup(s), if any, for which
  the percentage of the Chronic PAD occupied is greater than that
  occupied by the subgroup U.S. population (total); and, (4) the most
  highly exposed of the females subgroups (in this case, females, > 13
  years, nursing).
2 Percent chronic PAD = (Exposure  Chronic PAD) x 100%.

    2. From drinking water. The Agency currently lacks sufficient 
water-related exposure data from monitoring to complete a quantitative 
drinking water exposure analysis and risk assessment for 
methoxyfenozide. Therefore, the Agency is presently relying on 
computer-generated estimated environmental concentrations (EECs). 
GENEEC and/or PRZM/EXAMS (both produce estimates of pesticide 
concentration in a farm pond) are used to generate EECs for surface 
water and SCI-GROW (an empirical model based upon actual monitoring 
data collected for a number of pesticides that serve as benchmarks) 
predicts EECs in ground water. These models take into account the use 
patterns and the environmental profile of a pesticide, but do not 
include consideration of the impact that processing 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 assessing 
whether a pesticide is likely to be present in drinking water at 
concentrations which would exceed human health levels of concern.
    A drinking water level of comparison (DWLOC) is the concentration 
of a pesticide in drinking water that would be acceptable as a 
theoretical upper limit in light of total aggregate exposure to that 
pesticide from food, water, and residential uses. HED uses DWLOCs 
internally in the risk assessment process as a surrogate measure of 
potential exposure associated with pesticide exposure through drinking 
water. In the absence of monitoring data for a pesticide, the DWLOC is 
used as a point of comparison against the conservative EECs provided by 
computer modeling (SCI-GROW, GENEEC, PRZM/EXAMS).
    i. Acute exposure and risk. Because no acute dietary endpoint was 
determined, the Agency concludes that there is a reasonable certainty 
of no harm from acute exposure from drinking water.
    ii. Chronic exposure and risk. EPA conducted its Tier II screening-
level assessments using the simulation models SCI-GROW and PRZM/EXAMS 
to generate EECs for ground and surface water, respectively. The 
modeling was conducted based on the environmental profile and the 
maximum seasonal application rate proposed for methoxyfenozide (0.4 lb 
ai/acre x 5 applications/acre/year on cotton). PRZM/EXAMS was used to 
generate the surface water EECs, because it can factor the persistent 
nature of the chemical into the estimates.
    The EECs for assessing chronic aggregate dietary risk are 312 parts 
per billion (ppb) (in ground water, based on SCI-GROW) and 3,197 ppb 
(in surface water, based on the PRZM/EXAMS, long-term mean). The back-
calculated DWLOCs for assessing chronic aggregate dietary risk range 
from 890 ppb for the most highly exposed population subgroup (Non-
nursing infants, > 1-year old) to 3,400 ppb for the U.S. population (48 
contiguous States--all seasons) and the U.S. population (autumn 
season).
    The SCI-GROW and PRZM/EXAMS chronic EECs are less than the Agency's

[[Page 41361]]

level of comparison (the DWLOC value for each population subgroup) for 
methoxyfenozide residues in drinking water as a contribution to chronic 
aggregate exposure. EPA thus concludes with reasonable certainty that 
residues of methoxyfenozide in drinking water will not contribute 
significantly to the aggregate chronic human health risk and that the 
chronic aggregate exposure from methoxyfenozide residues in food and 
drinking water will not exceed the Agency's level of concern (100% of 
the cPAD) for chronic dietary aggregate exposure by any population 
subgroup. EPA generally has no concern for exposures below 100% of the 
cPAD, because it is a level at or below which daily aggregate dietary 
exposure over a lifetime will not pose appreciable risks to the health 
and safety of any population subgroup. This risk assessment is 
considered high confidence, conservative, and very protective of human 
health.
    3. From non-dietary exposure. Methoxyfenozide is not currently 
registered for use on any residential non-food sites. Therefore, there 
is no non-dietary acute, chronic, short- or intermediate-term 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 November 26, 1997 
(62 FR 62961) (5754-7).

D. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. Since no acute toxicological endpoints were 
established, EPA considers acute aggregate risk to be negligible.
    2. Chronic risk. Using the DEEM exposure assumptions described in 
this unit, EPA has concluded that aggregate exposure to methoxyfenozide 
from food will utilize 1.8% of the cPAD for the U.S. population. The 
major identifiable subgroup with the highest aggregate exposure is non-
nursing infants (> 1-year old) at 11% of the cPAD and is discussed 
below. EPA generally has no concern for exposures below 100% of the 
cPAD because the cPAD represents the level at or below which daily 
aggregate dietary exposure over a lifetime will not pose appreciable 
risks to human health. Despite the potential for exposure to 
methoxyfenozide in drinking water, EPA does not expect the aggregate 
exposure to exceed 100% of the cPAD. EPA concludes that there is a 
reasonable certainty that no harm will result from aggregate exposure 
to methoxyfenozide residues.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account chronic dietary food and water 
(considered to be a background exposure level) plus indoor and outdoor 
residential exposure.
    Since there are currently no registered indoor or outdoor 
residential non-dietary uses of methoxyfenozide and no short or 
intermediate term toxic endpoints, EPA considers short or intermediate 
term aggregate risks to be negligible.
    4. Aggregate cancer risk for U.S. population. Methoxyfenozide is 
classified as a ``not likely'' human carcinogen. Therefore this risk 
does is negligible.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to methoxyfenozide residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children--In general. In assessing 
the potential for additional sensitivity of infants and children to 
residues of methoxyfenozide, EPA considered data from developmental 
toxicity studies in the rat and rabbit and a 2-generation reproduction 
study in the rat. The developmental toxicity studies are designed to 
evaluate adverse effects on the developing organism resulting from 
maternal pesticide exposure during gestation. Reproduction studies 
provide information relating to effects from exposure to the pesticide 
on the reproductive capability of mating animals and data on systemic 
toxicity.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for prenatal and postnatal toxicity and 
the completeness of the data base 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. EPA believes that reliable data 
support using the standard uncertainty factor (usually 100 for combined 
interspecies and intraspecies variability) and not the additional 
tenfold MOE/UF when EPA has a complete data base under existing 
guidelines and when the severity of the effect in infants or children 
or the potency or unusual toxic properties of a compound do not raise 
concerns regarding the adequacy of the standard MOE/safety factor.
    2. Prenatal and postnatal sensitivity. The toxicology data base for 
methoxyfenozide included acceptable developmental toxicity studies in 
both 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. There is a complete toxicity data base for 
methoxyfenozide and exposure data are complete or are estimated based 
on data that reasonably accounts for potential exposures. Based on the 
completeness of the data base and the lack of prenatal and postnatal 
toxicity, EPA determined that an additional safety factor was not 
needed for the protection of infants and children.
    4. Acute risk. Since no acute toxicological endpoints were 
established, EPA considers acute aggregate risk to be negligible.
    5. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to methoxyfenozide from 
food will utilize 11% of the cPAD for infants and children. EPA 
generally has no concern for exposures below 100% of the cPAD because 
the cPAD represents the level at or below which daily aggregate dietary 
exposure over a lifetime will not pose appreciable risks to human 
health. Despite the potential for exposure to

[[Page 41362]]

methoxyfenozide in drinking water, EPA does not expect the aggregate 
exposure to exceed 100% of the cPAD.
    6. Short- or intermediate-term risk. Short and intermediate term 
risks are judged to be negligible due to the lack of significant 
toxicological effects observed.
    7. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to infants and children from aggregate exposure to methoxyfenozide 
residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

    The qualitative nature of methoxyfenozide residues in plants is 
adequately understood based upon acceptable cotton, apple and grape 
metabolism studies. EPA has determined that the residue of concern for 
dietary exposure and tolerance setting purposes in primary crops and 
water is the parent compound, methoxyfenozide.
    The qualitative nature of the residue in animals is adequately 
understood based on acceptable studies conducted on goats and laying 
hens. EPA has determined that the residue of concern in milk and 
ruminant tissues (other than liver and kidney) is the parent compound, 
methoxyfenozide. The residue of concern in ruminant liver and kidney is 
the parent compound, methoxyfenozide, and its glucuronide metabolite 
designated as RH-141,518 (also referred to as RH-1518). The glucuronide 
metabolite was included in the tolerance expression for liver and 
kidney because the conjugation may be reversible and it comprises a 
significant portion of the total radioactive residues (TRR) (up to 42% 
TRR in kidney and up to 29% TRR in liver) in those tissues.

B. Analytical Enforcement Methodology

    The petitioner has proposed HPLC/UV Method TR 34-98-87 for the 
enforcement of tolerances for pome fruits. Adequate confirmatory method 
validation, radiovalidation, and independent method validation data 
have been submitted for this method. This method was sent to the EPA 
laboratory for a petition method validation (PMV). The laboratory has 
reported that the pome fruit method (Method TR 34-98-87) is adequate in 
the interim for enforcement of the proposed tolerances for 
methoxyfenozide in/on pome fruit. Initial recoveries (60%) in the PMV 
were just below the minium acceptable recovery level (70%) as specified 
in OPPTS Harmonized Test Guidelines 860.1340. The laboratory modified 
the method and achieved acceptable recoveries with the modified method. 
EPA will require that Rohm and Haas Company revise and modify the 
method. Additional recovery data will be required for the revised 
method.
    The petitioner has proposed Method TR 43-96-88 for the enforcement 
of tolerances for cotton. This method is a shortened version of the 
pome fruit method. Thus, EPA concludes that Method TR 34-96-87 is 
adequate for enforcement of the proposed tolerances for residues of 
methoxyfenozide in/on cotton commodities. The validation of the cotton 
method is in progress. EPA expects that Method TR 43-96-88 will need to 
be modified or revised and additional recovery data may be required. 
EPA will require Rohm and Haas Company to revise and modify the cotton 
method and submit any additional recovery data if necessary.
    The petitioner has proposed Method TR 34-98-106 for the enforcement 
of tolerances in animal commodities. This method determines residues of 
methoxyfenozide (HPLC/UV) in fat, cream, milk, and muscle and residues 
of methoxyfenozide and its glucuronide metabolite, RH-141,518 (HPLC/MS) 
in liver and kidney. Adequate confirmatory method validation, 
radiovalidation, and independent method validation data, have been 
submitted for this method. This method has been forwarded to the EPA 
laboratory for petition method validation (PMV). The method has passed 
the PMV, however it requires some minor revisions. EPA will require 
that Rohm and Haas Company revise the method and resubmit the final 
revised method.
    The petitioner submitted data concerning the recovery of residues 
of methoxyfenozide using Food and Drug Administration (FDA) 
multiresidue method protocols (PAM Vol. I). Methoxyfenozide was not 
recoverable by these methods. These data will be forwarded to FDA for 
evaluation.
    EPA has determined that the residues of concern in ruminant liver 
and kidney are methoxyfenozide and its metabolite RH-141,518. Data 
concerning the recovery of residues of RH-141,518 using FDA 
multiresidue method protocols (PAM Vol. I) will be required. This will 
be made a condition of the registration for methoxyfenozide.
    Adequate enforcement methodology is available to enforce the 
tolerance expression. The methods may be requested from: Calvin Furlow, 
PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone 
number: (703) 305-5229; e-mail address: [email protected].

C. Magnitude of Residues

    1. Magnitude of the residue in apples and pears. An adequate number 
of geographically representative field trials were submitted to support 
the proposed use on pome fruits. Apples and pears are the 
representative commodities of this crop group. These studies were 
conducted via use patterns approximating those proposed by this 
petition. Residues of methoxyfenozide ranged from 0.16 to 1.2 ppm in/on 
apples and from 0.21 to 0.93 ppm in/on pears treated with the 80% WP 
formulation according to the maximum proposed use patterns. The results 
of the field trials indicate that residues of methoxyfenozide will not 
exceed 1.5 ppm in/on pome fruit when treated as proposed. Rohm and Haas 
Company proposed a tolerance level of 1.25 ppm for residues of 
methoxyfenozide in/on pome fruit. EPA concludes that the proposed 
tolerance must be raised to 1.5 ppm for methoxyfenozide in/on the 
``Crop Group 11; Pome Fruits Group.''
    2. Magnitude of the residue in cotton. An adequate number of 
geographically representative field trials were submitted to support 
the proposed use on cotton. These studies were conducted via use 
patterns approximating those proposed by this petition. The results of 
the cotton field trials indicate that residues of methoxyfenozide will 
not exceed the proposed tolerance level of 2.0 ppm in/on cottonseed 
when treated as proposed. Residues of methoxyfenozide ranged from 0.060 
to 1.8 ppm in/on cottonseed treated with the 80% WP formulation 
according to the maximum proposed use pattern. Residues of 
methoxyfenozide did not vary significantly in cotton treated with ULV 
spray applications (1 GPA) versus standard volume applications (10-30 
GPA). Residues ranged from 0.13 to 0.32 ppm and from 0.12 to 0.66 ppm 
in/on cotton treated in side-by-side plots with ULV and standard volume 
applications, respectively. Rohm and Haas Company requested the 
proposed tolerance on cottonseed at 2.0 ppm. However, EPA has 
determined that it should be ``cotton, undelinted seed'' at 2.0 ppm.
    The results of the cotton field trials indicate that residues of 
methoxyfenozide may exceed the proposed tolerance level of 25 ppm in/on 
cotton gin byproducts when treated as proposed. Residues of 
methoxyfenozide ranged from 3.8 to 31.2 ppm in/on cotton gin byproducts 
treated with the 80% WP formulation

[[Page 41363]]

according to the maximum proposed use pattern. Based on these data, the 
tolerance for residues of methoxyfenozide in/on cotton gin byproducts 
must be raised to 35 ppm.
    3. Magnitude of the residue in apple processed commodities. The 
submitted apple processing data are adequate for the purposes of this 
petition. Residues of methoxyfenozide did not concentrate in juice but 
concentrated 6x in wet pomace processed from whole apples bearing 
detectable residues. Based on the results of the apple processing 
study, a tolerance for residues of methoxyfenozide in apple juice is 
not required. Rohm and Haas proposed a tolerance level of 7.5 ppm for 
residues of methoxyfenozide in/on apple wet pomace. The maximum residue 
level of methoxyfenozide expected in apple wet pomace was 6.06 ppm, 
calculated by multiplying the HAFT residue (1.01 ppm; see apple field 
trial) and the observed concentration factor (6x). Based on this 
calculation, a tolerance of 7.0 ppm for residues of methoxyfenozide in/
on ``apple pomace, wet'' is appropriate.
    4. Magnitude of the residue in cottonseed processed commodities. 
The submitted cotton processing data are adequate for the purposes of 
this petition. No concentration of methoxyfenozide residues was 
observed in hulls, meal, and oil processed from undelinted cottonseed 
bearing detectable residues. Based on the results of the current 
processing study, tolerances for residues of methoxyfenozide in the 
processed commodities of cotton are not required.
    5. Residues in meat, milk, poultry, and eggs. The submitted dairy 
cattle feeding study is adequate for the purpose of establishing 
tolerances for secondary transfer of methoxyfenozide residues in milk 
and ruminant tissues. EPA has determined that the residues of concern 
in milk and ruminant tissues (except kidney and liver) are the parent 
compound, methoxyfenozide. For liver and kidney, the residues of 
concern are the parent compound, methoxyfenozide, and its metabolite 
RH-141,518. EPA concludes that residues of methoxyfenozide are not 
likely to exceed the proposed tolerances of 0.02 ppm in the milk and 
meat of cattle, goats, hogs, horses, and sheep. EPA further concludes 
that residues of methoxyfenozide are not likely to exceed the proposed 
tolerance of 0.1 ppm in the fat of cattle, goats, hogs, horses, and 
sheep as a result of the proposed uses. EPA also concludes that 
residues of methoxyfenozide and its metabolite RH--141,518 are not 
likely to exceed 0.1 ppm in liver and 0.02 ppm in meat byproduct 
(except liver) of cattle, goat, hogs, horses, and sheep. The proposed 
tolerances did not include residues in tissues of horses. However, 
horses must be a part of the tolerance.
    Rohm and Haas Company requested a waiver from the requirements to: 
(i) Conduct a poultry feeding study; (ii) propose tolerances for 
methoxyfenozide residues of concern in eggs and poultry tissues; and 
(iii) provide enforcement method(s) for determination of 
methoxyfenozide residues of concern in eggs and poultry tissues. The 
waiver request is based on the maximum theoretical dietary burden of 
methoxyfenozide for poultry animals as well as the results of the 
poultry metabolism study. The only poultry feed item associated with 
this petition is cotton meal, which would contribute a maximum 
theoretical dietary burden for methoxyfenozide at 0.4 ppm.
    The poultry metabolism study reviewed in this petition was 
conducted at feeding levels of 58 ppm (MOP-label), 60 ppm (DMP-label), 
and 68 ppm (TB-label) which are equivalent to 145x, 150x, and 170x, 
respectively, the maximum theoretical dietary burden for poultry. 
Assuming a linear relationship between dose and residues, the expected 
residues in eggs and poultry tissues would be below the LOD for methods 
used to measure residues in poultry products. EPA concludes that there 
is no reasonable expectation of finite residues in eggs and poultry 
tissues and that a poultry feeding study is not required at this time. 
However, should the dietary burden for poultry increase due to the 
addition of methoxyfenozide-treated poultry feed items through new 
uses, a poultry feeding study may be required. If a poultry feeding 
study is required in the future, then all tissues should be analyzed 
for residues of methoxyfenozide and its metabolite RH-141,518.

D. International Residue Limits

    There are no established or proposed Codex, Canadian or Mexican 
limits for residues of methoxyfenozide in/on plant or animal 
commodities. Therefore, no compatibility issues exist with regard to 
the proposed U.S. tolerances discussed in this petition review.

E. Rotational Crop Restrictions

    A confined rotational crop study was submitted and reviewed. The 
petitioner has proposed a 30-day plantback interval for all crops not 
listed on the product label. The confined rotational crop study 
demonstrated that methoxyfenozide may accumulate in rotational crop 
commodities at > 0.01 ppm at 30- and 90-day plantback intervals. The 
rotational crop restrictions included on the submitted label are not 
adequate. The label must include the following rotational crop 
restrictions: Cotton may be rotated to treated fields at any time. 
Leafy vegetables (except Brassica vegetables) and root and tuber 
vegetables may be rotated to treated fields 1-year following 
application of methoxyfenozide. Rotation to all other crops is 
prohibited.

V. Conclusion

    Therefore, the tolerances are established for residues of 
methoxyfenozide in or on cotton, undelinted seed; cotton gin 
byproducts; pome fruit; apple pomace, wet; milk; meat of cattle, goats, 
hogs, horses and sheep and fat of cattle, goats, hogs, horses and sheep 
at 2.0, 35.0, 1.5, 7.0, 0.02, 0.02, 0.1 ppm respectively and for the 
combined residues of methoxyfenozide and its glucuronide metabolite in 
liver of cattle, goats, hogs, horses and sheep and meat byproducts 
(except liver) of cattle, goats, hogs, horses and sheep at 0.1 and 0.02 
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 control number OPP-300983 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be

[[Page 41364]]

mailed or delivered to the Hearing Clerk on or before September 5, 
2000.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania 
Ave., NW., Washington, DC 20460. You may also deliver your request to 
the Office of the Hearing Clerk in Rm. M3708, Waterside Mall, 401 M 
St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open 
from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. 
The telephone number for the Office of the Hearing Clerk is (202) 260-
4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, Ariel Rios Bldg., 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, Ariel Rios Bldg., 
1200 Pennsylvania Ave., NW., Washington, DC 20460.
    3. Copies for the docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-300983, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, Ariel Rios Bldg., 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: [email protected]. 
Please use an ASCII file format and avoid the use of special characters 
and any form of encryption. Copies of electronic objections and hearing 
requests will also be accepted on disks in WordPerfect 6.1/8.0 file 
format or ASCII file format. Do not include any CBI in your electronic 
copy. You may also submit an electronic copy of your request at many 
Federal Depository Libraries.

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

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

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (October 4, 1993, 58 FR 51735). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any prior consultation as specified by Executive Order 
13084, entitled Consultation and Coordination with Indian Tribal 
Governments (May 19, 1998, 63 FR 27655); special considerations as 
required by Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (February 16, 1994, 59 FR 7629); or require OMB review or 
any Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (April 23, 
1997, 62 FR 19885). 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 (August 4, 1999, 64 FR 
43255). 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).

[[Page 41365]]

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 United States 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: June 13, 2000.
Suzan B. Hazen,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


    2. Section 180.544 is added to read as follows:


Sec. 180.544  Methoxyfenozide; tolerances for residues.

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

 
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Apple pomace, wet..........................................          7.0
Cotton gin byproducts......................................           35
Cotton, undelinted seed....................................          2.0
Fat of cattle, goats, hogs, horses and sheep...............          0.1
Meat of cattle, goats, hogs, horses and sheep..............         0.02
Milk.......................................................         0.02
Pome fruits crop group.....................................          1.5
------------------------------------------------------------------------

    (2) Tolerances are established for the combined residues of 
methoxyfenozide; benzoic acid, 3-methoxy-2-methyl-2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl)hydrazide and its glucuronide 
metabolite in or on the following agricultural commodities:

 
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Liver of cattle, goats, hogs, horses and sheep.............          0.1
Meat byproducts (except liver) of cattle, goats, hogs,              0.02
 horses and sheep..........................................
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 00-16801 Filed 7-3-00; 8:45 am]
BILLING CODE 6560-50-F