Tebufenozide; Pesticide Tolerances for Emergency Exemptions

[Federal Register: January 10, 2001 (Volume 66, Number 7)]
[Rules and Regulations]
[Page 1875-1882]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10ja01-17]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301091; FRL-6760-3]
RIN 2070-AB78

Tebufenozide; 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 tebufenozide in or on the legume vegetable group, foliage
of legume vegetable group, sunflowers, garden beet roots and garden
beet tops. This action is in response to EPA's granting of emergency
exemptions under section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act authorizing use of the pesticide on legume vegetables,
sunflowers, and table beets. This regulation establishes maximum
permissible levels for residues of tebufenozide in these food
commodities. The tolerances will expire and are revoked on December 31,
2002.

DATES: This regulation is effective January 10, 2001. Objections and
requests for hearings, identified by docket control number OPP-309091,
must be received by EPA on or before March 12, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-309091 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration
Division, 7505C, Office of Pesticide Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone
number: (703) 308-9367 and e-mail address: ertman.andrew@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 categories and entities may include, but are not
limited to:

------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
------------------------------------------------------------------------
Industry........................ 111............... Crop production
.............................. 112............... Animal production
.............................. 311............... Food manufacturing
.............................. 32532............. Pesticide
manufacturing
------------------------------------------------------------------------

This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Get Additional Information, Including Copies of This
Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of
thisdocument, and certain other related documents that might be
available electronically, from the EPA Internet Home Page at http://
www.epa.gov/. To access this document, on the Home Page select ``Laws
and Regulations,'' ``Regulations and Proposed Rules,'' and then look up
the entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
2. In person. The Agency has established an official record for
this action under docket control number OPP-309091. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documentsthat are referenced in those documents.
The public version of the official record does not include any
information claimed as CBI. The public version of the official record,
which includes printed, paper versions of any electronic comments
submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA,
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The PIRIB telephone number is (703) 305-5805.

[[Page 1876]]

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
tebufenozide benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl-2-(4-
ethylbenzoylhydrazide in or on vegetable, legume, group at 2.0 parts
per million (ppm); vegetable, foliage of legume, group at 7.0 ppm;
sunflower at 1.5 ppm; beet, garden, root at 0.3 ppm; and beet, garden,
tops at 9.0 ppm. These tolerances will expire and are revoked on
December 31, 2002. EPA will publish a document in the Federal Register
to remove the revoked tolerance from the Code of Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
Section 18 of 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 (FQPA).
EPA has established regulations governing such emergency exemptions in
40 CFR part 166.

III. Emergency Exemption for Tebufenozide on Legume Vegetables,
Sunflowers, and Table Beets and FFDCA Tolerances

The state of California requested the use of tebufenozide on table
beets to control beet armyworms and the state of Texas requested the
use of tebufenozide on legume vegetables and sunflowers to control beet
armyworms. EPA has authorized under FIFRA section 18 the use of
tebufenozide on legume vegetables and sunflowers in Texas and table
beets in California for control of the beet armyworm. After having
reviewed the submissions, EPA concurs that emergency conditions exist
for these States.
As part of its assessment of these emergency exemptions, EPA
assessed the potential risks presented by residues of tebufenozide in
or on legume vegetables, sunflowers and table beets. In doing so, EPA
considered the safety standard in FFDCA section 408(b)(2), and EPA
decided that the necessary tolerances under FFDCA section 408(l)(6)
would be consistent with the safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemption in
order to address an urgent non-routine situation and to ensure that the
resulting food is safe and lawful, EPA is issuing these tolerances
without notice and opportunity for public comment as provided in
section 408(l)(6). Although these tolerances will expire and are
revoked on December 31, 2002, under FFDCA section 408(l)(5), residues
of the pesticide not in excess of the amounts specified in the
tolerance remaining in or on the legume vegetable group, foliage of
legume vegetable group, sunflowers, garden beet roots and garden beet
tops 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 tebufenozide
meets EPA's registration requirements for use on legume vegetables,
sunflowers or table beets or whether permanent tolerances for these
uses would be appropriate. Under these circumstances, EPA does not
believe that these tolerances serve as a basis for registration of
tebufenozide 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 California and Texas to use this pesticide on these crops under
section 18 of FIFRA without following all provisions of EPA's
regulations implementing section 18 as identified in 40 CFR part 166.
For additional information regarding the emergency exemption for
tebufenozide, contact the Agency's Registration Division at the address
provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances November 26, 1997 (62 FR 62961) (FRL-5754-7).
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
tebufenozide and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for time-limited tolerances for
residues of tebufenozide in or on vegetable, legume, group at 2.0 ppm;
vegetable, foliage of legume, group at 7.0 ppm; sunflower at 1.5 ppm;
beet, garden, root at 0.3 ppm; and beet, garden, tops at 9.0 ppm. EPA's
assessment of the dietary exposures and risks associated with
establishing the tolerance follows.

A. Toxicological Endpoints

The dose at which no observed adverse effects (NOAEL) are 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 (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

[[Page 1877]]

other unknowns. An UF of 100 is routinely used, 10X to account for
inter-species differences and 10X for intra-species differences.
For dietary risk assessment (other than cancer the Agency uses the
UF to calculate an acute or chronic reference dose (RfD) acute or
chronic RfD where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF, where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
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 x10-6 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 (MOE cancer = point of
departure/exposures is calculated. A summary of the toxicological
endpoints for tebufenozide used for human risk assessment is shown in
the following Table 1:

Table 1.--Summary of Toxicological Dose and Endpoints for Tebufenozide 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 N/A.................... N/A.................... No systemic or
age. neurological effects
in rats at 2,000
milligrams/kilograms/
day (mg/kg/day)
highest dose tested,
(HDT). No maternal or
developmental effects
in rats or rabbits at
1,000 mg/kg/day HDT.
An acute risk
assessment is not
required.
Acute dietary general population N/A.................... N/A.................... No systemic or
including infants and children. neurological effects
in rats at 2,000 mg/kg/
day HDT. No maternal
or developmental
effects in rats or
rabbits at 1,000 mg/kg/
day HDT. An acute risk
assessment is not
required.
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Chronic dietary all populations...... NOAEL= 1.8 mg/kg/day UF FQPA SF = 1X cPAD = NOAEL = 1.8 mg/kg/day
= 100 Chronic RfD = chronic RfD FQPA SF from hematologogical
0.018 mg/kg/day. =0.018 mg/kg/day. effects in a chronic
dog feeding
study.LOAEL = 8.7 mg/
kg/day based on growth
retardation,alteration
s in hematology
parameters, changes in
organ weights, and
histopathological
lesions in the bone,
spleen and liver
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Short-term dermal (1 to 7 days N/A.................... N/A.................... No dermal or systemic
(Residential). toxicity seen in rats
administered 15 dermal
applications at 1,000
mg/kg/day (limit dose
over 21 days) with
either technical
material or 23%
formulation. No
developmental
endpoints of concern.
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Intermediate-term dermal (1 week to N/A.................... N/A.................... No dermal or systemic
several months) (Residential). toxicity seen in rats
administered 15 dermal
applications at 1,000
mg/kg/day (limit dose
over 21 days with
either technical
material or 23%
formulation. No
developmental
endpoints of concern.
----------------------------------------------------------------------------------------------------------------
Long-term dermal (several months to N/A.................... N/A.................... Use pattern indicates
lifetime) (Residential). chronic dermal
exposure not
anticipated. In
addition, no dermal or
systemic toxicity
observed in 21-day
dermal studies with
either technical
material or 23%
formulation.
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1 to 7 days) N/A.................... N/A.................... Toxicity Category IV
(Residential). for this route lethal
concentration (LC)50
4.5 mg/L.
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1 week N/A.................... N/A.................... Toxicity Category IV
to several months) (Residential). for this route LC50
4.5 mg/L.
----------------------------------------------------------------------------------------------------------------

[[Page 1878]]

Long-term inhalation (several months N/A.................... N/A.................... Toxicity Category IV
to lifetime) (Residential). for this route LC50
4.5 mg/L.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation..... N/A.................... N/A.................... Classified Group E -No
evidence of
carcinogenicity in
humans
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
to the FQPA.

B. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established 40 CFR 180.482 for the residues of tebufenozide, in or on a
variety of raw agricultural commodities (RAC). Currently, established
tolerances for residues of tebufenozide are listed under 40 CFR 180.482
and include permanent tolerances for residues in/on pecans 0.01 ppm and
walnuts 0.1 ppm, tolerances for residues in/on imported apples 1.0 ppm
and wine grapes 0.5 ppm, and time-limited tolerances for residues in/on
various plant and animal commodities. Risk assessments were conducted
by EPA to assess dietary exposures from tebufenozide in food as
follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. An acute dietary exposure risk assessment is not
required because the Agency did not identify an acute dietary endpoint
that was applicable to females (13+ years) or to the general
population, including infants and children.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM\tm\) analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1989-1991 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: For the chronic analysis, tolerance level residues and
some percent crop treated (%CT) and some market share assumptions were
used. Where market share information was available, it was used in
preference over %CT data since it is the larger, more conservative
number and therefore, more protective of human health. The highest
chronic dietary exposure was for non-nursing infants 1 year at 0.015071
mg/kg/day, 84% of the cPAD. The chronic dietary assessment should be
viewed as conservative. Further refinement, using anticipated residue
levels and additional CT data, would result in lower exposure rates.
Water modeling data were used to calculate residues (EECs) to compare
to the drinking water levels of comparison (DWLOC) for chronic
exposures.
iii. Cancer. Because tebufenozide has been classified as a ``Group
E'' carcinogen, a cancer risk assessment is not required.
iv. Anticipated residue and %CT information. Section 408(b)(2)(F)
states that the Agency may use data on the actual percent of food
treated for assessing chronic dietary risk only if the Agency can make
the following findings:
Condition a. that the data used are reliable and provide a valid
basis to show what percentage of the food derived from such crop is
likely to contain such pesticide residue. Condition b. that the
exposure estimate does not underestimate exposure for any significant
subpopulation group; and, Condition c, if data are available on
pesticide use and food consumption in a particular area, the exposure
estimate does not understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of percent crop treated (PCT) as required by section 408(b)(2)(F), EPA
may require registrants to submit data on PCT.
The Agency used percent crop treated (PCT information as follows:

----------------------------------------------------------------------------------------------------------------
Crop Average Maximum
----------------------------------------------------------------------------------------------------------------
Almonds........................................... 1% 1%
Apples............................................ 1% 2%
Beans/Peas, dry................................... 0% 1%
Cabbage, fresh.................................... 2% 3%
Cole crops........................................ 1% 2%
Cotton............................................ 1% 4%
Pears............................................. 5% 5%
Spinach, fresh.................................... 2% 3%
Spinach, Processed................................ 20% 29%
Sugarcane......................................... 3% 5%
Walnuts........................................... 10% 16%
----------------------------------------------------------------------------------------------------------------

The Agency believes that the three conditions listed above have
been met. With respect to Condition (1), PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA uses

[[Page 1879]]

a weighted average PCT for chronic dietary exposure estimates. This
weighted average PCT figure is derived by averaging State-level data
for a period of up to 10 years, and weighting for the more robust and
recent data. A weighted average of the PCT reasonably represents a
person's dietary exposure over a lifetime, and is unlikely to
underestimate exposure to an individual because of the fact that
pesticide use patterns (both regionally and nationally) tend to change
continuously over time, such that an individual is unlikely to be
exposed to more than the average PCT over a lifetime. For acute dietary
exposure estimates, EPA uses an estimated maximum PCT. The exposure
estimates resulting from this approach reasonably represent the highest
levels to which an individual could be exposed, and are unlikely to
underestimate an individual's acute dietary exposure. The Agency is
reasonably certain that the percentage of the food treated is not
likely to be an underestimation. As to Conditions (2) and (3), regional
consumption information and consumption information for significant
subpopulations is taken into account through EPA's computer-based model
for evaluating the exposure of significant subpopulations including
several regional groups. Use of this consumption information in EPA's
risk assessment process ensures that EPA's exposure estimate does not
understate exposure for any significant subpopulation group and allows
the Agency to be reasonably certain that no regional population is
exposed to residue levels higher than those estimated by the Agency.
Other than the data available through national food consumption
surveys, EPA does not have available information on the regional
consumption of food to which tebufenozide may be applied in a
particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for tebufenozide 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 tebufenozide.
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/EXAMSincorporate an index reservoir
environment in place of the previous pond scenario. The PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum PC 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 tebufenozide they are
further discussed in the aggregate risk sections below.
Based on the GENEEC and SCI-GROW models the EECs of tebufenozide
for chronic exposures are estimated to be 16.5 parts per billion (ppb)
for surface water and 1.04 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.
The Agency determined that there are potential short-term non-
occupational/residential postapplication exposures (incidental non-
dietary ingestion) to toddlers for the use of tebufenozide on
ornamentals. However, since acute dietary endpoints were not selected,
the short-term postapplication exposure/risk assessment is not
required. Intermediate-term and chronic incidental non-dietary
exposures are not expected for ornamental uses. Risk assessments for
residential applications are not needed due to the absence of dermal
and inhalation endpoints.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether tebufenozide has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
tebufenozide 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 tebufenozide has a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances November 26, 1997 (62 FR 62961).

C. Safety Factor for Infants and Children

1. In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for pre-natal and post-natal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
2. Developmental toxicity studies. In prenatal developmental
toxicity studies in rats and rabbits, there was no evidence of maternal
or developmental toxicity; the maternal and developmental NOAELS were
1,000 milligrams/kilograms/day (mg/kg/day) highest dose tested (HDT).

[[Page 1880]]

3. Reproductive toxicity study. In 2-generation reproduction
studies in rats, toxicity to the fetuses/offspring, when observed,
occurred at equivalent or higher doses than in the maternal/parental
animals.
4. Prenatal and postnatal sensitivity. The data provided no
indication of increased sensitivity of rats or rabbits to; in utero
and/or postnatal exposure to tebufenozide. No maternal or developmental
findings were observed in the prenatal developmental toxicity studies
at doses up to 1,000 mg/kg/day in rats and rabbits. In the 2-generation
reproduction studies in rats, effects occurred at the same or lower
treatment levels in the adults as in the offspring.
5. Conclusion. There is a complete toxicity data base for
tebufenozide and exposure data is complete or is estimated based on
data that reasonably accounts for potential exposures. Data provided no
indication of increased sensitivity of rats or rabbits to in utero and/
or postnatal exposure to tebufenozide. Based on this, EPA concludes
that reliable data support the use of the standard 100-fold UF, and
that the 10X safety factor to protect infants and children should be
removed.

D. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water EECs. DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure mg/kg/day = cPAD
- (average food + chronic non-dietary, non-occupational exposure). This
allowable exposure through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to tebufenozide in drinking water (when considered along with
other sources of exposure for which OPP has reliable data would not
result in unacceptable levels of aggregate human health risk at this
time. Because OPP 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, OPP will reassess the potential impacts of
tebufenozide on drinking water as a part of the aggregate risk
assessment process.
1. Acute risk. No toxicological endpoint was identified for acute
toxicity. Therefore, no acute aggregate risk assessment is needed.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
tebufenozide from food will utilize 25% of the cPAD for the U.S.
population, 83% of the cPAD for non-nursing infants 1 year old and 61%
of the cPAD for children 1-6 years old. Based on the use pattern,
chronic residential exposure to residues of tebufenozide is not
expected. In addition, despite the potential for chronic dietary
exposure to tebufenozide in drinking water, after calculating DWLOCs
and comparing them to conservative model estimated environmental
concentrations of tebufenozide in surface and ground water, EPA does
not expect the aggregate exposure to exceed 100% of the cPAD, as shown
in the following Table 2:

Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Tebufenozide
----------------------------------------------------------------------------------------------------------------
Ground-
Population subgroup cPAD mg/kg/ % cPAD Surface Water EEC Chronic
day (Food) Water (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population................................ 0.018 25 17 1 49
Non-nursing infants 1 year old................ 0.018 83 17 1 30
Females 13+/nursing............................ 0.018 29 17 1 390
----------------------------------------------------------------------------------------------------------------

3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level.
Though residential exposure could occur with the use of
tebufenozide, notoxicological effects have been identified for short-
term toxicity. Therefore, the aggregate risk is the sum of the risk
from food and water, which were previously addressed.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Though residential exposure could occur with the use of
tebufenozide, no toxicological effects have been identified for
intermediate-term toxicity. Therefore, the aggregate risk is the sum of
the risk from food and water, which were previously addressed.0
5. Aggregate cancer risk for U.S. population. Tebufenozide is
classified as Group E (no evidence of carcinogenicity in humans, and
therefore, no cancer risk assessment is required.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to tebufenozide residues.

V. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (example - gas chromotography) is
available to enforce the tolerance expression. The method may be
requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW,

[[Page 1881]]

Washington, DC 20460; telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.

B. International Residue Limits

There are no Codex, Canadian, or Mexican maximum residue limits
(MRLs) for tebufenozide in or on legume vegetables, sunflowers, and
garden beets. International harmonization is not a concern for these
actions.

C. Conditions

Rotational crop restrictions. The following restrictions are
required for these proposed uses. Crops which the label allows to be
treated directly can be planted at anytime. All other crops can be
planted 30- days after application. The previous 12 month plantback
interval for cereal grains, grasses and non-grass animal feeds is no
longer necessary with the establishment of rotational crop tolerances.

VI. Conclusion

Therefore, the tolerances are established for residues of
tebufenozide, in or on the following: vegetable, legume, group at 2.0
ppm; vegetable, foliage of legume, group at 7.0 ppm; sunflower at 1.5
ppm; beet, garden, root at 0.3 ppm;, and beet, garden, tops at 9.0 ppm.

VII. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-309091 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 March 12,
2001.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk 1900,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division, 7505C Office of Pesticide Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division, 7502C Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
3. Copies for the docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by the docket control number OPP-30901, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division, 7502C Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

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

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

VIII. Regulatory Assessment Requirements

This final rule establishes time limited tolerances under FFDCA
section 408. The Office of Management and Budget (OMB) has exempted
these types of actions from review under Executive Order 12866,
entitled Regulatory Planning and Review October 4, 1993 (58 FR 51735).
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

[[Page 1882]]

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
prior consultation as specified by Executive Order 13084, entitled
Consultation and Coordination with Indian Tribal Governments May 19,
1998 (63 FR 27655), special considerations as required by Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations February 16, 1994
(59 FR 7629), or require OMB review or any Agency action under
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks April 23, 1997 (62 FR
19885). This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note). Since tolerances and exemptions that are established on the
basis of a FIFRA section 18 exemption under FFDCA section 408, such as
the tolerances in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism August 10, 1999 (64 FR 43255). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of FFDCA section 408(n)(4).

IX. Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

Dated: December 14, 2000.
James Jones,

Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

2. Section 180.482 is amended by alphabetically adding commodities
to the table in paragraph (b) to read as follows:

Sec. 180.482 Tebufenozide; tolerances for residues.

* * * * *
(b) * * *

----------------------------------------------------------------------------------------------------------------
Commodity Parts per million Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Beet, garden, root 0.3 12/31/02
Beet, garden, top 9.0 12/31/02
* * * * * * *
Sunflower 1.5 12/31/02
* * * * * * *
Vegetable, foliage of legume, group 7.0 12/31/02
Vegetable, legume, group 2.0 12/31/02
----------------------------------------------------------------------------------------------------------------

* * * * *

[FR Doc. 01-574 Filed 1-9-01; 8:45 am]
BILLING CODE 6560-50-S

Tebufenozide; Pesticide Tolerances for Emergency Exemptions

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