[Federal Register Volume 66, Number 213 (Friday, November 2, 2001)]
[Rules and Regulations]
[Pages 55585-55593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27603]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301185; FRL-6806-4]
RIN 2070-AB78


Methoxyfenozide; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of methoxyfenozide in or on field corn grain, stover and oil, 
aspirated grain fractions and soybean forage, hay, oil, and seed. This 
action is in response to EPA's granting of an emergency exemption under 
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) authorizing use of the pesticide on field corn and soybeans. 
This regulation establishes a maximum permissible level for residues of 
methoxyfenozide in these food commodities. The tolerances will expire 
and are revoked on December 31, 2003.

DATES: This regulation is effective November 2, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301185, 
must be received by EPA on or before January 2, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301185 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Barbara Madden, Registration 
Division (7505C), Office of Pesticide

[[Page 55586]]

Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-6463; and e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected 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 homepage at http://www.epa.gov/. 
To access this document, on the homepage select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently 
under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301185. 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, 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

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing tolerances for residues of the insecticide 
methoxyfenozide, benzoic acid, 3-methoxy-2-methyl-2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl)hydrazide, in or on field corn 
grain at 0.02 part per million (ppm), field corn forage at 10 ppm, 
field corn stover at 75 ppm, corn oil at 0.1 ppm, aspirated grain 
fractions at 20 ppm, soybean seed at 0.04 ppm, soybean forage at 10 
ppm, soybean hay at 75 ppm and soybean oil at 1.0 ppm. These tolerances 
will expire and are revoked on December 31, 2003. EPA will publish a 
document in the Federal Register to remove the revoked tolerance from 
the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to 
establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    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. . . .''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' This provision was not 
amended by the Food Quality Protection Act of August 3, 1996 (FQPA). 
EPA has established regulations governing such emergency exemptions in 
40 CFR part 166.

III. Emergency Exemption for Methoxyfenozide on Field Corn and 
Soybeans and FFDCA Tolerances

    Field Corn - The southwestern corn borer (Pyralidae: Diarrhea 
grandiosella) is one of several major corn pests in the southern United 
States. There are usually three generations per year. First generation 
larvae feed in the whorl, where it is susceptible to foliar insecticide 
applications. Second and third generation larvae bore into the stalk, 
where they are protected from insecticide applications. Larvae tunnel 
down the main stem to the base of the plant and overwinter in the crown 
of the corn stalk, just below soil surface, where they are susceptible 
to death by freezing, drowning, or mechanical destruction.
    The Mississippi University Cooperative Extension Service recommends 
the following chemicals for southwestern corn borer control: Carbaryl, 
carbofuran, chlorpyrifos, cyhalothrin, esfenvalerate, and permethrin. 
According to the Mississippi application frequent summer rains have 
affected the effectiveness of the registered pesticides, most of which 
have short residual lives, resulting in poor southwestern corn borer 
control and

[[Page 55587]]

increasing the need for repeated applications. Furthermore, corn 
farmers in Mississippi, mostly small farmers who also grow catfish in 
ponds and handle and apply pesticides themselves, avoid using 
carbofuran, which is perceived as hazardous to themselves and their 
catfish. Methoxyfenozide, an IGR specific to lepidopteran larvae, was 
identified as a suitable alternative because of its moderate residual 
life and low risk to humans and most non-target organisms.
    Transgenic Bt corn is an effective alternative, but is limited to 
50% of the acreage planted due to resistance management compliance. 
Natural enemies destroy a portion of the southwestern corn borer 
population, but not at levels necessary to prevent economic losses. In 
the past, destruction of corn stubble by shredding, disking, or deep 
tillage was an effective cultural control method. However, under the 
present no-till conservation practices, larger numbers of overwintering 
larvae survive and infest the next year's crop.
    The request indicates that yield reductions associated with 
southwestern core borer infestations have been reported in the range of 
10% to 50%.
    Soybean - Saltmarsh caterpillars (often called ``woolly worms'') 
feed in the larval stage in groups on soybean foliage. It feeds on the 
leaves on the upper third of the soybean canopy. The saltmarsh 
caterpillar has historically been only an occasional pest of soybeans 
in Arkansas and Mississippi. Although it is usually present in soybean 
fields, it is rarely at population densities to cause economic damage. 
However, due to favorable conditions, population densities of the 
saltmarsh caterpillar have been increasing over the last few years.
    While environmental conditions played a role in the recent 
saltmarsh caterpillar outbreaks, the inability to control the pest with 
currently registered insecticides was the primary cause for yield loss. 
Control of the pest with currently registered insecticides (thiodicarb, 
esfenvalerate, and spinosad) was seldom greater than 50%. This required 
multiple, short interval, high rate insecticide applications with 
associated increase in cost. Soybeans which suffered the greatest 
impact were the late maturing varieties.
    EPA has authorized under FIFRA section 18 the use of 
methoxyfenozide on field corn for control of Southwestern corn borer in 
Mississippi and for use on soybeans to control Saltmarsh caterpillars 
in Arkansas and Mississippi. After having reviewed the submission, EPA 
concurs that emergency conditions exist for these States.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of methoxyfenozide in or on 
field corn and soybeans. In doing so, EPA considered the safety 
standard in FFDCA section 408(b)(2), and EPA decided that the necessary 
tolerance under FFDCA section 408(l)(6) would be consistent with the 
safety standard and with FIFRA section 18. Consistent with the need to 
move quickly on the emergency exemption in order to address an urgent 
non-routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing these tolerances without notice and opportunity 
for public comment as provided in section 408(l)(6). Although these 
tolerances will expire and are revoked on December 31, 2003, under 
FFDCA section 408(l)(5), residues of the pesticide not in excess of the 
amounts specified in the tolerance remaining in or on field corn and 
soybeans after that date will not be unlawful, provided the pesticide 
is applied in a manner that was lawful under FIFRA, and the residues do 
not exceed a level that was authorized by these tolerances at the time 
of that application. EPA will take action to revoke these tolerances 
earlier if any experience with, scientific data on, or other relevant 
information on this pesticide indicate that the residues are not safe.
    Because these tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether 
methoxyfenozide meets EPA's registration requirements for use on field 
corn and soybeans or whether a permanent tolerance for these uses would 
be appropriate. Under these circumstances, EPA does not believe that 
these tolerances serve as a basis for registration of methoxyfenozide 
by a State for special local needs under FIFRA section 24(c). Nor do 
these tolerances serve as the basis for any State other than Arkansas 
and Mississippi to use this pesticide on these crops under section 18 
of FIFRA without following all provisions of EPA's regulations 
implementing section 18 as identified in 40 CFR part 166. For 
additional information regarding the emergency exemptions for 
methoxyfenozide, contact the Agency's Registration Division at the 
address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
    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 
methoxyfenozide and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for time-limited tolerances for 
residues of methoxyfenozide in or on field corn grain at 0.02 ppm, 
field corn forage at 10 ppm, field corn stover at 75 ppm, corn oil at 
0.1 ppm, aspirated grain fractions at 20 ppm, soybean seed at 0.04 ppm, 
soybean forage at 10 ppm, soybean hay at 75 ppm and soybean oil at 1.0 
ppm. EPA's assessment of the dietary exposures and risks associated 
with establishing these tolerances follows.

A. 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 endpoint. 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.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the level of concern (LOC). For example, when 100 is the

[[Page 55588]]

appropriate UF (10X to account for interspecies differences and 10X for 
intraspecies differences) the LOC is 100. To estimate risk, a ratio of 
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is 
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for methoxyfenozide used for human risk assessment is shown 
in the following Table 1:

   Table 1.--Summary of Toxicological Dose and Endpoints for Methoxyfenozide for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary females 13-50 years of   none                     none                     No appropriate endpoint
 age and the general population                                                           was identified in the
 including infants and children                                                           oral toxicity studies
                                                                                          including the acute
                                                                                          neurotoxicity study in
                                                                                          rats and the
                                                                                          developmental toxicity
                                                                                          studies in rats and
                                                                                          rabbits.
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations        NOAEL= 10.2 mg/kg/day    FQPA SF = 1              2-Year combined chronic
                                       UF = 100...............  cPAD = chronic RfD        feeding/
                                       Chronic RfD = 0.10 mg/     FQPA SF.        carcinogenicity, rats
                                        kg/day.                 = 0.10 mg/kg/day.......  LOAEL = 411 mg/kg/day
                                                                                          based on hematological
                                                                                          changes (decreased
                                                                                          RBC, hemoglobin and
                                                                                          hematocrit), liver
                                                                                          toxicity (increased
                                                                                          weights, hypertrophy),
                                                                                          histopathological
                                                                                          changes in thyroid
                                                                                          (increased follicular
                                                                                          cell hypertrophy,
                                                                                          altered colloid),
                                                                                          possible adrenal
                                                                                          toxicity (increased
                                                                                          weights).
----------------------------------------------------------------------------------------------------------------
Short-term, intermediate-term, and     None                     None                     No systemic toxicity
 long-term dermal and inhalation                                                          was seen at the limit
                                                                                          dose following
                                                                                          repeated dermal
                                                                                          application to rats.
                                                                                         Based on low vapor
                                                                                          pressure, the low
                                                                                          acute toxicity of both
                                                                                          the technical and
                                                                                          formulated products as
                                                                                          well as the
                                                                                          application rate and
                                                                                          application method,
                                                                                          there is minimal
                                                                                          concern for inhalation
                                                                                          exposure.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Methoxyfenozide has                               The classification is
                                        been classified as a                              based on the lack of
                                        ``not likely'' human                              evidence of
                                        carcinogen.                                       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.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

B. 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 including, the pome fruits 
crop group, apple pomace, cotton seed, cotton gin byproducts, milk, and 
meat, fat, liver and meat byproducts of cattle, goats, hogs, horses and 
sheep. Risk assessments were conducted by EPA to assess dietary 
exposures from methoxyfenozide in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one

[[Page 55589]]

day or single exposure. 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. Therefore, 
acute dietary risk assessments were not conducted.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the chronic 
exposure assessments: 100% of all crops were treated and all resulting 
residues were at tolerance level.
    iii. Cancer. Methoxyfenozide has been classified as a ``not 
likely'' human carcinogen. The 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, risk assessments to 
estimate cancer risk were not conducted.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for methoxyfenozide in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of methoxyfenozide.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
SCI-GROW, which predicts pesticide concentrations in ground water. In 
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS 
(a tier 2 model) for a screening-level assessment for surface water. 
The GENEEC model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. GENEEC incorporates a 
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir 
environment in place of the previous pond scenario. The PRZM/EXAMS 
model includes a percent crop area factor as an adjustment to account 
for the maximum percent crop coverage within a watershed or drainage 
basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to methoxyfenozide they are 
further discussed in the aggregate risk sections below.
    Based on the PRZM/EXAMS and SCI-GROW models the estimated 
environmental concentrations (EECs) of methoxyfenozide for chronic 
exposures are estimated to be 30 parts per billion (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 exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether methoxyfenozide has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
methoxyfenozide does not appear to produce a toxic metabolite produced 
by other substances. For the purposes of this tolerance action, 
therefore, EPA has not assumed that methoxyfenozide has a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, 
November 26, 1997).

C. Safety Factor for Infants and Children

    1. In general. FFDCA section 408 provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Developmental toxicity studies. In a developmental toxicity 
study in rats regarding maternal findings, there were no deaths or 
clinical signs, nor where there any effects on body weights or food 
consumption. No changes were noted in any of the reproductive 
parameters. Fetal examinations did not reveal any affects on body 
weight or gross/visceral/skeletal aspects. The maternal NOAEL is 1,000 
mg/kg/day (Highest Dose Tested (HDT), Limit Dose (LD)) and the maternal 
LOAEL is greater than 1,000 mg/kg/day. The developmental NOAEL is 1,000 
mg/kg/day and the developmental LOAEL is greater than 1,000 mg/kg/day.
    In a developmental toxicity study in rabbits regarding maternal 
findings, there were no deaths or clinical signs, nor where there any 
effects on body weights, weight gains or food consumption. No changes 
were noted in any of the reproductive parameters. Fetal examinations 
did not reveal any affects on body weight or gross/visceral/skeletal 
aspects. The maternal NOAEL is 1,000 mg/kg/day (HDT, LD) and the 
maternal LOAEL is greater than 1,000 mg/kg/day. The developmental NOAEL 
is greater than 1,000 mg/kg/day and the

[[Page 55590]]

developmental LOAEL is greater than 1,000 mg/kg/day.
    3. Reproductive toxicity study. In a 2-generation reproduction 
study the LOAEL for systemic toxicity is 20,000 ppm (1,551.9 mg/kg/
day), based on increased absolute and relative liver weights in males 
and females and on hepatocellular hypertrophy in males and females. The 
NOAEL for systemic toxicity is 2,000 ppm (153.4 mg/kg/day). There were 
no treatment-related reproductive effects on the P1 and P2 males and 
females or their F1 and F2 offspring. Therefore, the NOAEL for 
reproductive toxicity is greater 20,000 ppm (1,551.9-2,036.5 mg/kg/day) 
(HDT). The LOAEL for reproductive toxicity was not identified.
    4. Neurotoxicity. In an acute oral neurotoxicity study in rats 
there were no observable signs of a neurotoxic effect even at the 
highest concentration in females. Functional observational battery 
(FOB) assessment on Day 0 revealed a decrease in hindlimb grip strength 
for males in the 2,000 mg/kg group. Motor activity (MA) assessment 
remained comparable to controls throughout the study for males and 
females in all exposure groups. No neuropathological endpoints were 
observed during the histological examinations of the peripheral or 
central nervous systems of these animals at any exposure concentration. 
Based on the absence of any substance-related effects on body weight or 
body weight gain and any clinical signs of toxicity, the NOAEL for 
systemic toxicity is a concentration of 2,000 mg/kg for males and 
females. The NOAEL for neurotoxic effects is 2,000 mg/kg for females. 
Based on a decrease in hindlimb grip strength on day 0 in the 2,000 mg/
kg male group, the NOAEL for males is 1,000 mg/kg and the LOAEL for 
males is 2,000 mg/kg. No LOAEL was established for systemic effects in 
males or females or for neurotoxic effects in females.
    In a subchronic oral neurotoxicity study in rats there were no 
observable signs of a neurotoxic effect even at the highest 
concentration in males or females. FOB and MA remained comparable to 
controls throughout the study and no neuropathological endpoints were 
observed during the histological examinations of these animals at any 
exposure concentration. Based on the absence of any substance-related 
effects on body weight or body weight gain and any clinical signs of 
toxicity, the NOAEL for systemic toxicity is 20,000 ppm for males 
(1,318 mg/kg/day) and females (1,577 mg/kg/day). The NOAEL for 
neurotoxic effects is also 20,000 ppm for males (1,318 mg/kg/day) and 
females (1,577 mg/kg/day). No LOAEL was established for systemic or 
neurotoxic effects.
    In none of the other oral toxicity studies on methoxyfenozide were 
there any signs of neurotoxicity. The studies considered included all 
the available toxicology studies on methoxyfenozide.
    5. Conclusion. The toxicology data base for methoxyfenozide is 
complete and no additional studies are required at this time. The 
scientific and regulatory quality of the toxicology data base for 
methoxyfenozide is high and is considered sufficient to clearly define 
the toxicity of this chemical. There is, therefore, high confidence in 
the hazard and dose-response assessments conducted for this chemical. 
Exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures.
    The toxicology data provided no indication of increased 
susceptibility in rats or rabbits from in utero and/or postnatal 
exposure to methoxyfenozide. In the prenatal developmental toxicity 
studies in rats and rabbits, no developmental toxicity was observed at 
the LD, the HDT. In the 2-generation reproduction study in rats, no 
effects in the offspring were observed at the HDT. In none of the oral 
toxicity studies on methoxyfenozide were there any signs of 
neurotoxicity. The studies considered included all the available 
toxicology studies on methoxyfenozide.
    Therefore, the Agency has determined that the FQPA Safety Factor 
can be reduced to 1X in assessing the risk posed by this chemical.

D. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + chronic non-dietary, non-occupational 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 USEPA Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to methoxyfenozide 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 methoxyfenozide on 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. Therefore, 
acute dietary risk assessments were not conducted.
    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 3% of the cPAD for the U.S. 
population, 13% of the cPAD for all infants (< 1year), the infant 
subpopulation at greatest exposure and 9% of the cPAD for children (1-6 
years old), the children subpopulation at greatest exposure. There are 
no residential uses registered for methoxyfenozide. In addition, 
despite the potential for chronic dietary exposure to methoxyfenozide 
in drinking water, after calculating DWLOCs and comparing them to 
conservative model estimated environmental concentrations of 
methoxyfenozide in surface and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the cPAD, as shown in the 
following Table 2:

[[Page 55591]]



            Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Methoxyfenozide
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                         0.10            3           30          3.5        3,400
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                                0.10            9           30          3.5          900
----------------------------------------------------------------------------------------------------------------
Infants (< 1 year old)                                  0.10           13           30          3.5          870
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk and intermediate-term risk. Short-term and 
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 were 
previously addressed.
    4. Aggregate cancer risk for U.S. population. Methoxyfenozide has 
been classified as a ``not likely'' human carcinogen. The 
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, risk assessments to estimate cancer risk were not conducted.
    5. 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.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expression. The method may be requested from: Calvin Furlow, 
PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; 
telephone number: (703) 305-5229; e-mail address: 
[email protected].

B. International Residue Limits

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

C. Conditions

    A 1-year plant back interval is required for crops not having 
tolerances. Currently, there is a petition under review that may result 
in rotational crop tolerances being established allowing for shorter 
plant back intervals. But, in the absence of such tolerances, a 1-year 
plant back interval is required.
    The existing livestock tolerances are adequate for the uses 
proposed under these emergency exemptions.

VI. Conclusion

    Therefore, tolerances are established for residues of 
methoxyfenozide, benzoic acid, 3-methoxy-2-methyl-2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl)hydrazide, in or on field corn 
grain at 0.02 ppm, field corn forage at 10 ppm, field corn stover at 75 
ppm, corn oil at 0.1 ppm, aspirated grain fractions at 20 ppm, soybean 
seed at 0.04 ppm, soybean forage at 10 ppm, soybean hay at 75 ppm and 
soybean oil at 1.0 ppm.

VII. 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-301185 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 January 
2, 2002.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, 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

[[Page 55592]]

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, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.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 the docket control number OPP-301185, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [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).

VIII. Regulatory Assessment Requirements

    This final rule establishes time limited tolerances under FFDCA 
section 408. 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 FIFRA 
section 18 exemption under FFDCA section 408, such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (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.

IX. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final

[[Page 55593]]

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: October 18, 2001.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.


    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


    2. Section 180.544 is amended by adding text to paragraph (b) to 
read as follows.


Sec. 180.544  Methoxyfenozide; tolerances for residues.

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

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

* * * * *

[FR Doc. 01-27603 Filed 11-1-01; 8:45 am]
BILLING CODE 6560-50-S