[Federal Register Volume 65, Number 130 (Thursday, July 6, 2000)]
[Rules and Regulations]
[Pages 41594-41601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17043]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301008; FRL-6590-1]
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 a time-limited tolerance for 
residues of tebufenozide (benzoic acid, 3,5-dimethyl-1-(1,1-
dimethylethyl)-2-(4-ethylbenzoyl)hydrazide) in or on grapes. This 
action is in response to EPA's granting of an emergency exemption under 
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act 
authorizing use of the pesticide on grapes. This regulation establishes 
a maximum permissible level for residues of tebufenozide in this food 
commodity. The tolerance will expire and is revoked on December 31, 
2001.

DATES: This regulation is effective July 6, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301008, 
must be received by EPA on or before September 5, 2000.

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-301008 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Barbara Madden, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number, 703-305-6463; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected categories and entities may include, but are not 
limited to:

[[Page 41595]]



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

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

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

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' 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/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301008. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408 (l)(6) 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is 
establishing a tolerance for residues of the insecticide tebufenozide, 
in or on grapes at 3 parts per million (ppm). This tolerance will 
expire and is revoked on December 31, 2001. 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(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 Federal Insecticide, Fungicide, and Rodenticide 
Act (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 Grapes and FFDCA 
Tolerances

    Grapes are California's number one ranked crop in dollar value, 
accounting for over 90% of the grapes grown in the United States. The 
European export market for California wines accounts for well over $250 
million. The Grape Leaf folder causes injury in the larval stages by 
rolling and feeding on the leaves, reducing photosynthetic function. 
The Omnivorous leaf roller directly reduces grape yields by injuring 
the flowers and developing berries it feeds on. The Omnivorous leaf 
roller also allows entry of bunch rot organisms that damage entire 
clusters which may result in rejection at the winery.
    Cryolite is the registered alternative most often used to control 
both Grape Leaf folders and Omnivorous leaf rollers. However, for the 
2000 crop year, nearly all major California wineries with export 
markets have advised their growers that they will not accept grapes 
which have been treated with cryolite or any other product which would 
affect the level of fluorides in wine. The European Community recently 
established strict tolerance levels of 1 ppm with respect to fluoride 
residues. There is a direct correlation between even limited use of 
cryolite on wine grapes which can result in fluoride levels in wine 
above 3 ppm. Therefore, the State claims that there is no feasible 
registered alternative available to wine growers to control these 
pests. EPA has authorized under FIFRA section 18 the use of 
tebufenozide on grapes for control of Omnivorous leaf roller and Grape 
leaf folder in California. After having reviewed the submission, EPA 
concurs that emergency conditions exist for wine grapes for the State. 
However, the Agency does not believe that an urgent and non-routine 
finding can be made for table grapes since growers can still use 
cryolite.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of tebufenozide in or on 
grapes. In doing so, EPA considered the safety standard in FFDCA 
section 408(b)(2), and EPA decided that the necessary tolerance under 
FFDCA section 408(l)(6) would be consistent with the safety standard 
and with FIFRA section 18. Consistent with the need to move quickly on 
the emergency exemption in order to address an urgent non-routine 
situation and to ensure that the resulting food is safe and lawful, EPA 
is issuing this tolerance without notice and opportunity for public 
comment as provided in section 408(l)(6). Although

[[Page 41596]]

this tolerance will expire and is revoked on December 31, 2001, under 
FFDCA section 408(l)(5), residues of the pesticide not in excess of the 
amounts specified in the tolerance remaining in or on grapes 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 this tolerance at the time of that 
application. EPA will take action to revoke this tolerance earlier if 
any experience with, scientific data on, or other relevant information 
on this pesticide indicate that the residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether tebufenozide 
meets EPA's registration requirements for use on grapes or whether a 
permanent tolerance for this use would be appropriate. Under these 
circumstances, EPA does not believe that this tolerance serves as a 
basis for registration of tebufenozide by a State for special local 
needs under FIFRA section 24(c). Nor does this tolerance serve as the 
basis for any State other than California to use this pesticide on this 
crop 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 (62 FR 62961, November 26, 1997) (FRL-5754-7).
    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of 
tebufenozide and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a time-limited tolerance for 
residues of tebufenozide in or on grapes at 3 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 effect level (NOAEL) from the 
toxicology study identified as appropriate for use in risk assessment 
is used to estimate the toxicological endpoint. However, the dose at 
which the lowest observed adverse effect level (LOAEL) of concern are 
identified is sometimes used for risk assessment if no NOAEL was 
achieved in the toxicology study selected. An uncertainty factor (UF) 
is applied to reflect uncertainties inherent in the extrapolation from 
laboratory animal data to humans and in the variations in sensitivity 
among members of the human population as well as other unknowns. An UF 
of 100 is routinely used, 10X to account for interspecies differences 
and 10X for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA safety factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the level of concern (LOC). For example, when 100 is the 
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.

     Table 1.--Summary of Toxicological Dose and Endpoints for Tebufenozide for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                         FQPA SF* and Level       Study and
                Exposure Scenario                   Dose Used in Risk   of Concern for Risk     Toxicological
                                                      Assessment, UF         Assessment            Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary females 13-50 years of age           None                 Not applicable       Not applicable
----------------------------------------------------------------------------------------------------------------
Acute dietary general population including         None                 Not applicable       Not applicable
 infants and children
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations                    NOAEL = 1.8          FQPA SF = 1 cPAD =   Chronic toxicity
                                                    milligram/kilogram/  chronic RfD          study in dogs
                                                    day (mg/kg/day) UF    FQPA SF =   LOAEL = 8.7 mg/kg/
                                                    = 100 Chronic RfD    0.018 mg/kg/day      day based on
                                                    = 0.018 mg/kg/day                         growth
                                                                                              retardation,
                                                                                              alterations in
                                                                                              hematology
                                                                                              parameters,
                                                                                              changes in organ
                                                                                              weights, and
                                                                                              histopathological
                                                                                              lesions in the
                                                                                              bone, spleen and
                                                                                              liver.
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1 to 7 days) (residential)      None                 Not applicable       Not applicable
----------------------------------------------------------------------------------------------------------------

[[Page 41597]]

 
Intermediate-term dermal (1 week to several        None                 Not applicable       Not applicable
 months) (residential)
----------------------------------------------------------------------------------------------------------------
Long-term dermal (several months to lifetime)      None                 Not applicable       Not applicable
 (residential)
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1 to 7 days) (residential)  None                 Not applicable       Not applicable
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1 week to several    None                 Not applicable       Not applicable
 months) (residential)
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (several months to lifetime)  None                 Not applicable       Not applicable
 (residential)
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)                  Tebufenozide is      Not applicable       Not applicable
                                                    classified as
                                                    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. Tolerances, listed under 40 
CFR 180.482, currently exist for residues of tebufenozide on apples, 
berries, brassica crop group, canola, cotton, cranberries, pome fruits, 
pecans, mint, sugarcane, turnips, fruiting vegetables, leafy green 
vegetables, and walnuts. Additionally, time-limited tolerances for 
eggs, milk, pears, peanuts, peppers, rice, sugarcane, sweet potatoes, 
and livestock commodities of cattle, goats, hogs, horses, poultry and 
sheep have been established. 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 1 day or 
single exposure. Toxicity observed in oral toxicity studies were not 
attributable to a single dose or 1 day exposure. Therefore, no 
toxicological endpoint was identified for acute toxicity and no acute 
dietary risk assessment is needed.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM) analysis 
evaluated the individual food consumption as reported by respondents in 
the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII) and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the chronic exposure 
assessments.
    Data included in the application indicate no tebufenozide 
concentration in grape juice or raisins. For the chronic analysis, 
tolerance level residues and some percent crop treated (PCT) and some 
market share assumptions were used. Where market share information was 
available, it was used in preference over PCT data since it is the 
larger, more conservative number and therefore more protective of human 
health.
    iii. Cancer. Tebufenozide is classified as Group E (no evidence of 
carcinogenicity in humans).
    iv. Anticipated residue and PCT 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 1, 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 
2, that the exposure estimate does not under estimate exposure for any 
significant subpopulation group; and Condition 3, 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 PCT as required by section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency used PCT information as follows:  1% almonds, 2% apples, 
1% dry beans/peas, 3% fresh cabbage, 2% cole crops, 4% cotton, 3% fresh 
spinach, 29% processed spinach, 5% sugarcane and 16% walnuts.
    The Agency used Percent Market Share information as follows: 10% 
pome fruit, 19% cotton, 82% sugarcane, 10% fruiting vegetables, 14% 
leafy vegetables, 18% cole crop vegetables, and 25% blueberries.
    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 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 under estimate 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. The Agency is reasonably certain that the percentage of the 
food treated is not likely to be an under estimation. As to Conditions 
2 and 3, regional consumption information and consumption information 
for significant

[[Page 41598]]

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 
screening concentration in ground water (SCI-GROW), which predicts 
pesticide concentrations in ground water. In general, EPA will use 
GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a 
screening-level assessment for surface water. The GENEEC model is a 
subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. GENEEC incorporates a farm pond scenario, 
while PRZM/EXAMS incorporate an index reservoir environment in place of 
the previous pond scenario. The PRZM/EXAMS model includes a percent 
crop area factor as an adjustment to account for the maximum percent 
crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead, drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to tebufenozide they are 
further discussed in the aggregate risk sections below.
    Based on the GENEEC and SCI-GROW models the estimated environmental 
concentrations (EECs) of tebufenozide for chronic exposures are 
estimated to be 17 parts per billion (ppb) for surface water and 1 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). Tebufenozide is not 
registered for use on any sites that would result in residential 
exposure.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether 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 (62 FR 62961, November 26, 1997).

C. Safety factor for infants and children

    1. Safety factor for infants and children--i. In general. FFDCA 
section 408 provides that EPA shall apply an additional tenfold margin 
of safety for infants and children in the case of threshold effects to 
account for prenatal and postnatal toxicity and the completeness of the 
data base on toxicity and exposure unless EPA determines that a 
different margin of safety will be safe for infants and children. 
Margins of safety are incorporated into EPA risk assessments either 
directly through use of a MOE analysis or through using uncertainty 
(safety) factors in calculating a dose level that poses no appreciable 
risk to humans.
    ii. 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 mg/kg/day (highest dose tested).
    iii. 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.
    iv. 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.
    v. 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 uncertainty 
factor, 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

[[Page 41599]]

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 to calculate DWLOCs: 2 Liter/70 kilograms (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 groundwater are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to tebufenozide 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 
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 20% of the cPAD for the U.S. 
population, 75% of the cPAD for non-nursing infants and 51% of the cPAD 
for children (1-6 years old). There are no residential uses for 
tebufenozide that result in chronic residential exposure to 
tebufenozide. In addition, despite the potential for chronic dietary 
exposure to tebufenozide in drinking water, after calculating the 
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.

----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     water EEC    water EEC     Chronic
                                                     day         (food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population................................        0.018          20%           17            1          500
Non-nursing infants (1 year old)...............        0.018          75%           17            1           50
Females (13+, nursing).........................        0.018          23%           17            1          400
----------------------------------------------------------------------------------------------------------------

    3. Short-term and intermediate-term risk. Short-term and 
Intermediate-term aggregate exposure takes into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level). Tebufenozide is not registered for use on 
any sites that would result in residential exposure. Additionally, no 
toxicological effects have been identified for short-term and 
intermediate-term toxicity. Therefore, the aggregate risk is the sum of 
the risk from food and water, which were previously addressed.
    5. Aggregate cancer risk for U.S. population. Tebufenozide is 
classified as Group E (no evidence of carcinogenicity in humans).
    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, 
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: 
[email protected].

B. International Residue Limits

    There are no Mexican Maximum Residue Limits (MRL) for tebufenozide 
in or on grapes. Codex has a 1.0 ppm MRL on grapes for fat soluble 
tebufenozide. Canada has a tebufenozide MRL on grapes at 0.5 ppm. 
International harmonization is not feasible for this action.

C. Conditions

    Grapes are not rotated; therefore, a discussion of rotational crop 
requirements is not germane to this action.

VI. Conclusion

    Therefore, the tolerance is established for residues of benzoic 
acid, 3,5-dimethyl-1-(1,1dimethylethyl)-2-(4-ethylbenzoyl)hydrazide, 
tebufenozide, in or on grapes at 3 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,

[[Page 41600]]

you must identify docket control number OPP-301008 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 
September 5, 2000.
    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 [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by the docket control number OPP-301008, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 file format 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 a time limited tolerance under FFDCA 
section 408. The Office of Management and Budget (OMB) has exempted 
these types of actions from review under Executive Order 12866, 
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). 
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 prior consultation 
as specified by Executive Order 13084, entitled Consultation and 
Coordination with Indian Tribal Governments (63 FR 27655, May 19, 
1998); special considerations as required by Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or require 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 petition under FFDCA section 408, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, 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

[[Page 41601]]

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: June 6, 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), (346a) and 371.
    2. In Sec. 180.482, by alphabetically adding ``Grapes'' to the 
table in paragraph (b) to read as follows:


Sec. 180.482  Tebufenozide; tolerances for residues

    *    *    *    *    *
    (b)Section 18 emergency exemptions. *      *      *

 
------------------------------------------------------------------------
                                                     Parts   Expiration/
                     Commodity                        per     Revocation
                                                    million      Date
------------------------------------------------------------------------
 
                  *        *        *        *        *
Grapes............................................     3.0      12/31/01
 
                  *        *        *        *        *
------------------------------------------------------------------------

    *    *    *    *    *
[FR Doc. 00-17043 Filed 6-30-00; 3:20 pm]
BILLING CODE 6560-50-F