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[Federal Register Volume 69, Number 188 (Wednesday, September 29, 2004)]
[Rules and Regulations]
[Pages 58091-58097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21804]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0312; FRL-7681-6]

Methoxyfenozide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
methoxyfenozide (benzoic acid, 3-methyl-2-methyl-,2-(3,5-
methylbenzoyl)-2-(1,1-dimethylethyl) hydrazide) in or onblack sapote; 
canistel; coriander, leaves; mamey sapote; mango; papaya; pea and bean, 
succulent shelled, subgroup 6B; peppermint; sapodilla; spearmint; star 
apple; strawberries; vegetable, foliage of legume (except soybean), 
subgroup 7A; vegetable, leaves of root and tuber, group 2; vegetable, 
legume, edible podded, subgroup 6A; vegetable, root, subgroup 1A. 
Interregional Research Project Number 4 (IR-4) and Dow AgroSciences are 
requesting these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), as amended by the Food Quality Protection Act of 1996 
(FQPA).

DATES: This regulation is effective September 29, 2004. Objections and 
requests for hearings must be received on or before November 29, 2004.

ADDRESSES : To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
identification (ID) number OPP-2004-0312. All documents in the docket 
are listed in the EDOCKET index athttp://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Joseph Tavano, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6411; e-mail address:[email protected].

SUPPLEMENTARY INFORMATION:

[[Page 58092]]

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 32532)
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET(http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of August 18, 2004 (69 FR 51298) (FRL-7361-
1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP PP 
3E6768, PP 3E6784, PP 3E6790, PP 3E6796, and PP 3E6801) by IR-4, 681 
U.S. Highway 1 South, North Brunswick, NJ 08902-3390. The 
petition requested that 40 CFR 180.544 be amended by establishing a 
tolerance 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 raw agricultural commodities: 
Spearmint, tops at 7.0 parts per million (ppm); peppermint, tops at 7.0 
ppm; and dill at 7.0 ppm (PP 3E6768); strawberry at 1.5 ppm (PP 
3E6784); vegetable, root, subgroup 1A at 0.5 ppm, and vegetable, leaves 
of root and tuber, group 2 at 30 ppm (PP 3E6790); papaya; star apple; 
sapote, black; mango; sapodilla; canistel; and sapote, mamey at 0.5 ppm 
(PP 3E6796); coriander, leaves at 30 ppm (PP 3E6796); and vegetable, 
legume, edible podded, subgroup 6A at 1.5 ppm; pea and bean, succulent 
shelled, subgroup 6B at 0.2 ppm; and vegetable, foliage of legume, 
except soybean, subgroup 7A at 35 ppm (PP 3E6801). That notice included 
a summary of the petition prepared by Dow AgroScience, 9330 Zionsville 
Road, Indianapolis, IN 46268, the registrant. There were no comments 
received in response to the notice of filing.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue . . 
. .''
    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 of FFDCA 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) of FFDCA, 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) of FFDCA, for a tolerance for residues of methoxyfenozide, 
benzoic acid,3-methoxy-2-methyl, 2-(3,5-dimethylbenzoyl)-2-(1,1-
dimethylethyl)hydrazide, in or on edible podded legumes (Crop Group 
6A), mint, root vegetables (Crop Group 1A), strawberries, succulent 
shelled pea and bean (Crop Group 6B), and tropical/subtropical fruit 
crop: black sapote, canistel, mamey sapote, mango, papaya, sapodilla, 
and star apple) at 1.5, 7.0, 0.5, 1.5, 0.2, 0.5 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 as 
well as the no observed adverse effect level (NOAEL) and the lowest 
observed adverse effect level (LOAEL) from the toxicity studies 
reviewed are discussed in the Federal Register of September 20, 2002 
(67 FR 59193) (FRL-7198-5).

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    Three other types of safety or uncertainty factors may be used: 
``Traditional uncertainty factors;'' the ``special FQPA safety 
factor;'' and the ``default FQPA safety factor.'' By the term 
``traditional uncertainty factor,'' EPA is referring to those 
additional uncertainty factors used prior to FQPA passage to account 
for data base deficiencies. These traditional uncertainty factors have 
been incorporated by the FQPA into the additional safety factor for the 
protection of infants and children. The term ``special FQPA safety 
factor'' refers to those safety factors that are deemed necessary for 
the protection of infants and children primarily as a result of the 
FQPA. The ``default FQPA safety factor''

[[Page 58093]]

is the additional 10X safety factor that is mandated by the statute 
unless it is decided that there are reliable data to choose a different 
additional factor (potentially a traditional uncertainty factor or a 
special FQPA safety factor).
    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 an UF of 
100 to account for interspecies and intraspecies differences and any 
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). 
Where a special FQPA safety factor or the default FQPA safety factor is 
used, 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 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). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 x 
10-\5\), one in a million (1 x 10-\6\), or one in 
ten million (1 x 10-\7\). Under certain specific 
circumstances, MOE calculations will be used for the carcinogenic risk 
assessment. In this non-linear approach, a ``point of departure'' is 
identified below which carcinogenic effects are not expected. The point 
of departure is typically a NOAEL based on an endpoint related to 
cancer effects though it may be a different value derived from the dose 
response curve. To estimate risk, a ratio of the point of departure to 
exposure (MOEcancer = point of departure/exposures) is 
calculated.
    A summary of the toxicological endpoints for methoxyfenozide used 
for human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of September 20, 2002 (67 FR 59193) 
(FRL-7198-5).

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 1-day or 
single 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. A summary of the acute dietary risk assessment for 
methoxyfenozide used for human risk assessment is discussed in Unit 
III.C.1.i. of the final rule published in the Federal Register of 
September 20, 2002 (67 FR 59193).
    ii. Chronic exposure. Conducting the chronic dietary risk 
assessment, EPA used the Dietary Exposure Evaluation Model software 
with the Food Commodity Intake Database (DEEM-FCID\TM\), which 
incorporates food consumption data as reported by respondents in the 
USDA 1994-1996 and 1998 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 Tier 1 (assumptions: tolerance level residues and 100 
percent crop treated) chronic dietary risk assessment was conducted via 
DEEM-FCID. The established tolerances of 40 CFR 180.544 and the 
proposed tolerances were included in the analysis. DEEM default 
processing factors (from DEEM Version 7.76) were used for all processed 
commodities that do not have individual tolerances. Tolerances are not 
being recommended for animal commodities as a result of the proposed 
uses.
    iii. Cancer. Methoxyfenozide is classified as a ``not likely'' 
human carcinogen. Therefore this risk is considered negligible.
    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 FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index 
reservoir. The Screening Concentration in Ground Water (SCI-GROW) model 
is used to predict pesticide concentrations in shallow ground water. 
For a screening-level assessment for surface water EPA will use FIRST 
(a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model). The FIRST 
model is a subset of the PRZM/EXAMS model that uses a specific high-end 
runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate 
an index reservoir environment, and both models include 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 screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs), which are the model estimates of a 
pesticide's concentration in water. EECs derived from these models are 
used 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 section Unit III.E.
    Based on the PRZM/EXAMS and SCI-GROW models, the EECs of

[[Page 58094]]

methoxyfenozide for acute exposures are estimated to be 43 parts per 
billion (ppb) for surface water and 3.5 ppb for ground water. The EECs 
for chronic exposures are estimated to be 30 ppb for surface water and 
3.5 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 effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to methoxyfenozide and any 
other substances and 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 policy statements released by EPA's OPP 
concerning common mechanism determinations and procedures for 
cumulating effects from substances found to have a common mechanism on 
EPA's web site at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines based on reliable data 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 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    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. The 10X FQPA 
factor was removed and reduced to 1X as discussed in the final rule 
published in theFederal Register of September 20, 2002 (67 FR 59193).

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 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's Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. No appropriate endpoint was identified in the oral 
toxicity studies including the acute neurotoxicity study in rats and 
the developmental toxicity studies in rats and rabbits. Accordingly, no 
acute risk is expected from exposure to methoxyfenozide.

            Table 1.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Methoxyfenozide
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                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                        0.102         22.9           30          3.5         2800
-----------------------------------------------------------------------------------------------------
All Infants (less than 1 year old)                     0.102         37.3           30          3.5          290
-----------------------------------------------------------------------------------------------------

[[Page 58095]]

 
Children (1-2 years old)                               0.102         71.3           30          3.5         2900
-----------------------------------------------------------------------------------------------------
Children (3-5 years old)                               0.102         50.1           30          3.5         2900
-----------------------------------------------------------------------------------------------------
Children (6-12 years old)                              0.102         27.1           30          3.5         2900
-----------------------------------------------------------------------------------------------------
Youth (13-19 years old)                                0.102         18.1           30          3.5         2900
-----------------------------------------------------------------------------------------------------
Adults (20-49 years old)                               0.102         18.6           30          3.5         2900
----------------------------------------------------------------------------------------
Females (13-49 years old)                              0.102         19.1           30          3.5         2500
----------------------------------------------------------------------------------------
Adults (50+ years old)                                 0.102         18.8           30          3.5         2900
----------------------------------------------------------------------------------------------------------------

    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 22.9% of the cPAD for the U.S. 
population, 37.3% of the cPAD for all infants (less than 1 year old), 
and 71.3% of the cPAD for children, 1-2 years old. There are no 
residential uses for methoxyfenozide that result in chronic residential 
exposure to methoxyfenozide.
    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.
    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. The Agency has 
classified methoxyfenozide as a ``not likely'' human carcinogen 
according to the ``EPA Proposed Guidelines for Carcinogen Risk 
Assessment (April 10, 1996).'' 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. Therefore, methoxyfenozide is not 
expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to methoxyfenozide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available for determination of 
methoxyfenozide residues in plant commodities. The available Analytical 
Enforcement Methodology was previously reviewed in the Federal Register 
of September 20, 2002 (67 FR 59193)

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 cannot be 
reduced to harmonize with the Mexican MRLs, so incompatibility will 
exist.

V. Conclusion

    Therefore, tolerances are established for residues of 
methoxyfenozide, in or on black sapote; canistel; coriander, leaves; 
mamey sapote; mango; papaya; pea and bean succulent shelled, subgroup 
6B; peppermint; sapodilla; spearmint; star apple; strawberries; 
vegetable, foliage of legume (except soybean), subgroup 7A; vegetable, 
leaves of root and tuber, group 2; vegetable, legume, edible podded, 
subgroup 6A; vegetable, root, subgroup 1A at 0.5, 0.5, 30, 0.5, 0.5, 
0.5, 0.2, 7.0, 0.5, 7.0, 0.5, 1.5, 35, 30, 1.5, 0.5, respectively.
    The original petition submitted by the petitioner requested a 
tolerance for dill, but data was not provided to the Agency to support 
the establishment of a tolerance.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA 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) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. 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-2004-0312 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 
29, 2004.
    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

[[Page 58096]]

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 (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. 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) 564-6255.
    2. 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 ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2004-0312, 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-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. 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 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. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 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 section 408(d) of FFDCA, such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. 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, entitledFederalism 
(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 section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Congressional Review Act

    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

[[Page 58097]]

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 
theFederal 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 22, 2004.
Lois Rossi,
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), 346a and 371.

    2. Section 180.544 is amended by alphabetically adding the 
following commodities to the table in paragraph (a) to read as follows:

Sec.  180.544  Methoxyfenozide; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Black sapote...................................                      0.5
                                * * * * *
Canistel.......................................                      0.5
                                * * * * *
Coriander, leaves..............................                       30
                                * * * * *
Mamey sapote...................................                      0.5
Mango..........................................                      0.5
                                * * * * *
Papaya.........................................                      0.5
Pea and bean, succulent shelled, subgroup 6B...                      0.2
                                * * * * *
Peppermint.....................................                      7.0
                                * * * * *
Sapodilla......................................                      0.5
                                * * * * *
Spearmint......................................                      7.0
Star apple.....................................                      0.5
Strawberries...................................                      1.5
                                * * * * *
Vegetable, foliage of legume, (except                                 35
 soybean)subgroup 7A...........................
Vegetable, leaves of root and tuber, group 2...                       30
Vegetable, legume, edible podded, subgroup 6A..                      1.5
Vegetable, root, subgroup 1A...................                      0.5
------------------------------------------------------------------------

* * * * *

[FR Doc. 04-21804 Filed 9-28-04; 8:45 am]
BILLING CODE 6560-50-S
```