[Federal Register: September 29, 2004 (Volume 69, Number 188)]
[Rules and Regulations]
[Page 58091-58097]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se04-17]
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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:tavano.joseph@epa.gov.
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)
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U.S. population 0.102 22.9 30 3.5 2800
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All Infants (less than 1 year old) 0.102 37.3 30 3.5 290
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[[Page 58095]]
Children (1-2 years old) 0.102 71.3 30 3.5 2900
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Children (3-5 years old) 0.102 50.1 30 3.5 2900
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Children (6-12 years old) 0.102 27.1 30 3.5 2900
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Youth (13-19 years old) 0.102 18.1 30 3.5 2900
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Adults (20-49 years old) 0.102 18.6 30 3.5 2900
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Females (13-49 years old) 0.102 19.1 30 3.5 2500
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Adults (50+ years old) 0.102 18.8 30 3.5 2900
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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: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. 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