[Federal Register: August 31, 2005 (Volume 70, Number 168)]
[Rules and Regulations]
[Page 51597-51604]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31au05-9]
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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:
milan.stacey@epa.gov.
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
----------------------------------------------------------------------------------------------------------------
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: furlow.calvin@epa.gov.
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: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual 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