[Federal Register Volume 70, Number 168 (Wednesday, August 31, 2005)]
[Rules and Regulations]
[Pages 51597-51604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17131]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0224; FRL-7732-3]


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 sorghum grain, sorghum grain 
forage, and sorghum grain stover. 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 sorghum grain. This regulation establishes a maximum 
permissible level for residues of methoxyfenozide in these food 
commodities. These tolerances will expire and are revoked on December 
31, 2007.

DATES: This regulation is effective August 31, 2005. Objections and 
requests for hearings must be received on or before October 31, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
identification (ID) number OPP-2005-0224. All documents in the docket 
are listed in the EDOCKET index at http://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 Mall2, 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: Stacey Milan Groce, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-2505; 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 entities may include, but are not limited to:
     Crop production (NAICS code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     Pesticide manufacturing (NAICS code 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 on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

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 sorghum grain 
at 0.05 parts per million (ppm), sorghum grain forage at 15 ppm, and 
sorghum grain stover at 125 ppm. These tolerances will expire and are 
revoked on December 31, 2007. EPA will publish a document in the 
Federal Register to remove the revoked tolerances from the Code of 
Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish time-
limited tolerances or exemptions from the requirement of 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 of the FFDCA 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) of the 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

[[Page 51598]]

exposure through drinking water and in residential settings, but does 
not include occupational exposure. Section 408(b)(2)(C) of the 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. . . .''
    Section 18 of the 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 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

III. Emergency Exemption for Methoxyfenozide on Sorghum Grain, Sorghum 
Grain Forage, Sorghum Grain Stover and FFDCA Tolerances

    The southwestern corn borer is a major pest on corn, but has become 
problematic for Louisiana sorghum producers in recent years. The 
southwestern corn borer is known to infest grain sorghum and had not 
been documented as an important pest of this crop until 2002, when 
heavy moth infestations developed in corn and migrated to late planted 
sorghum fields. Grain sorghum is usually planted in the spring, but 
adverse weather conditions and planting conflicts ensure that a 
significant amount of acreage will be planted late. These conditions 
can provide a susceptible host for heavy southwestern corn borer moth 
flight during late summer. This unexpected heavy migration into grain 
sorghum has left many growers without adequate technology to control 
this pest.
    The sugarcane borer is a major pest of corn grown in the vicinity 
of sugarcane. The sugarcane borer recently became an important pest of 
corn in parts of Louisiana where no sugarcane is produced. This 
northern shift in the infestation range of the sugarcane borer is 
likely the result of mild winters and an increase in reduced tillage 
crop production, which has allowed this pest to become established 
outside of its normal range. Heavy populations of sugarcane borer moth 
infestations have migrated to late planted sorghum fields and growers 
have been ill-prepared in handling this disease.
    The Louisiana State AgCenter recommends the following two 
insecticides: Cypermethrin and lambda-cyhalothrin for control of the 
southwestern corn borer when they are applied before the larvae bore 
into the stalk. However, the short-lived residual effectiveness of both 
pyrethroids requires an effective scouting program to carefully time 
applications. This practice is not available in Louisiana and there are 
currently no insecticides registered for control of the sugarcane borer 
on grain sorghum. Methoxyfenozide is a suitable alternative because of 
its moderate residual life and low risk to humans and most non-target 
organisms.
    Planting grain sorghum early is an important management practice 
against both the southwestern corn borer and the sugarcane borer. Early 
planted sorghum usually matures before southwestern corn borer and 
sugarcane borer populations reach their peak migration from their host 
plants. However, this practice is limited by weather conditions, which 
often delay planting sorghum acreage until late spring and early 
summer. Shredding the crop stubble followed by tillage is no longer 
feasible since most sorghum is now grown under reduced tillage 
conditions. Natural enemies destroy large numbers of the southwestern 
corn borer, but not at levels necessary to prevent significant loss. 
EPA has authorized under FIFRA section 18 the use of methoxyfenozide on 
grain sorghum to control southwestern corn borer and sugarcane borer 
for use on grain sorghum in Louisiana. After having reviewed the 
submission, EPA concurs that emergency conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of methoxyfenozide in or on 
sorghum grain, sorghum grain forage, and sorghum grain stover. In doing 
so, EPA considered the safety standard in section 408(b)(2) of the 
FFDCA, and EPA decided that the necessary tolerances under section 
408(l)(6) of the FFDCA 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) of the FFDCA. Although these 
tolerances will expire and are revoked on December 31, 2007, under 
section 408(l)(5) of the FFDCA, residues of the pesticide not in excess 
of the amounts specified in the tolerance remaining in or on sorghum 
grain, sorghum grain forage, sorghum grain stover 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 
sorghum grain, sorghum grain forage, sorghum grain stover or whether 
permanent tolerances for this use would be appropriate. Under these 
circumstances, EPA does not believe that these tolerances serves 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 Louisiana to use this pesticide on this 
crop under section 18 of FIFRA without following all provisions of 
EPA's regulations implementing FIFRA section 18 as identified in 40 CFR 
part 166. For additional information regarding the emergency exemption 
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 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances of November 26, 1997 (62 FR 62961) 
(FRL-5754-7).
    Consistent with section 408(b)(2)(D) of the 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 
methoxyfenozide and to make a determination on aggregate exposure, 
consistent with section 408(b)(2) of the FFDCA, for time-limited 
tolerances for residues of methoxyfenozide in or on sorghum grain at 
0.05 ppm, sorghum grain forage at 15 ppm, and sorghum grain stover at 
125 ppm. EPA's assessment of the dietary exposures and risks associated 
with establishing these tolerances follows.

[[Page 51599]]

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 intra species differences.
    For dietary risk assessments (other than cancer) the Agency uses 
the UF to calculate an acute or chronic reference dose (aRfD or cRfD) 
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 SF.
    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 
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
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                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
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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
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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 = 0.10 mg/kg/     carcinogenicity, rats
                                        kg/day.                  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 hyppertrophy,
                                                                                          altered colloid),
                                                                                          possible adrenal
                                                                                          toxicity (increased
                                                                                          weights)
----------------------------------------------------------------------------------------------------------------
Short-term, intermediate-term, long-   None                     None                     No systemic toxicity
 term dermal and Inhalation                                                               was observed 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 genotoxocity
                                                                                          in an acceptable
                                                                                          battery of
                                                                                          mutagenicity studies
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA SF refers to any additional SF 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, sweet 
corn, field corn, milk, 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-

[[Page 51600]]

use pesticide if a toxicological study has indicated the possibility of 
an effect of concern occurring as a result of a 1-day or single 
exposure. No appropriate 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 (DEEMTM) 
analysis evaluated the individual food consumption as reported by 
respondents in the United States Department of agriculture (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 
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 (PC) area factor as an adjustment to 
account for the maximum percent crop coverage within a watershed or 
drainage basin.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or 
the PRZM/EXAMS to produce estimates of pesticide concentrations in an 
index reservoir. The SCI-GROW model is used to predict pesticide 
concentrations in shallow ground water. For a screening-level 
assessment for surface water EPA will generally 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. While both FIRST and PRZM/EXAMS incorporate an 
index reservoir environment, the PRZM/EXAMS model includes a PC 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 effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the 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 Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

C. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold margin of safety (MOS) 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 MOS will be safe 
for infants and children. MOS 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 
orclinical signs, nor were there any effects on body weights or food 
consumption. No changes were noted in any of the reproductive 
parameters. Fetal examinations did not

[[Page 51601]]

reveal any effects on body weight or gross/visceral/skeletal aspects. 
The maternal NOAEL is 1,000 milligram/ kilogram/day (mg/kg/day) Highest 
dose tested (HDT) 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 were 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 effects on body weight or gross/visceral/skeletal 
aspects. The maternal NOAEL is 1,000 mg/kg/day HDT, 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.
    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 the 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 than 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 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 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 200 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 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 exams 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 also 2,000 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. There is a complete toxicity data base for 
methoxyfenozide 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 post natal 
exposure to methoxyfenozide. In the prenatal developmental toxicity 
studies in rats and rabbits, no developmental toxicity was observed at 
the limit dose, which is 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 
(as required by the FQPA of August 3, 1996) 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 EPA 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 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 23% of the cPAD for the U.S. 
population, 37% of the cPAD

[[Page 51602]]

for all infants < 1-year old, the infant subpopulation at greatest 
exposure and 71% of the cPAD for children 1-2 years old, the children 
subpopulation at greatest exposure. There are no residential uses for 
methoxyfenozide that result in chronic residential exposure to 
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 water and ground water, 
EPA does not expect the aggregate exposure to exceed 100% of the cPAD, 
as shown in the following Table 2:

            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           23           30          3.5        2,700
----------------------------------------------------------------------------------------------------------------
Infants (< 1-year old)                                  0.10           37           30          3.5          630
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                                0.10           71           30          3.5          290
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term and intermediate-term aggregate 
exposures take 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 for use on corn matrices (grain, 
forage, stover) is TR 34-00-38. Information on the analytical 
methodology may be requested from: Calvin Furlow, Public Information 
Resources and Services Branch (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, Ariel Rios Building, 1200 Pennsylvania 
Avenue, N.W., Washington, D.C, 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 regarding the 
proposed U.S. tolerances.

C. Conditions

    Plantback (recropping) restrictions should appear on the registered 
labels. These restrictions should specify that the crops for which 
methoxyfenozide use is registered may be replanted at any time, and all 
other crops grown for food or feed may be replanted after 7 days.
    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 grain sorghum 
at 0.05 ppm, grain sorghum forage at 15 ppm, and grain sorghum stover 
at 125 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, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the 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 the FFDCA, as was provided in the old sections 408 and 409 of the 
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-2005-0224 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 October 
31, 2005.
    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 issue(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

[[Page 51603]]

your request to the Office of the Hearing Clerk in Suite 350, 1099 14th 
St., NW., Washington, DC 2005. 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 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 ADDRESSES. Mail your 
copies, identified by the docket ID number OPP-2005-0224, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VIII. Statutory and Executive Order Reviews

    This final rule establishes time-limited tolerances] under section 
408 of the FFDCA. 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 section 408 of the FFDCA, 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 section 408(n)(4) of the 
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.

IX. 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 Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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


[[Page 51604]]


    Dated: August 19, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. In Sec.  180.554, the table in paragraph (b) is amended by 
alphabetically adding commodities to read as follows:


Sec.  180.544  Methoxyfenozide; tolerance for residues.

* * * * *
    (b) * * *

----------------------------------------------------------------------------------------------------------------
                      Commodity                             Parts per million        Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
sorghum, grain                                                                0.05                    12/31/2007
sorghum, grain, forage                                                          15                    12/31/2007
sorghum, grain, stover                                                         125                    12/31/2007
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 05-17131 Filed 8-30-05; 8:45 am]
BILLING CODE 6560-50-S