[Federal Register Volume 69, Number 185 (Friday, September 24, 2004)]
[Rules and Regulations]
[Pages 57216-57223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21499]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0209; FRL-7680-9]


Tebufenozide; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
tebufenozide in or on tuberous and corm vegetables (except potato) 
subgroup 1D, grape, citrus (crop group 10), and citrus oil and indirect 
or inadvertent combined residues of tebufenozide, benzoic acid, 3,5-
dimethyl-1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide and its 
metabolite benzoic acid, 3,5-dimethyl-1-(1,1dimethylethyl)-2-[4-(1-
hydroxyethyl)benzoyl]hydrazide in or on forage, fodder, hay and straw 
of cereal grain; forage, fodder, straw and hay of non-grass animal 
feed; forage, fodder and hay of grass and foliage of legume vegetables. 
Dow AgroSciences and Interregional Research Project Number 4 (IR-4) 
requested these tolerance under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), as amended by the Food Quality Protection Act of 1996 
(FQPA).

DATES: This regulation is effective September 24, 2004. Objections and 
requests for hearings must be received on or before November 23, 2004.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2004-0209. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket/. 
Although listed in the index, some information is not publicly 
available, i.e., CBI or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either electronically in EDOCKET or in hard copy at the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall <greek-i>2, 1801 S. Bell St., Arlington, VA. This docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The docket telephone number is (703) 305-
5805.

FOR FURTHER INFORMATION CONTACT: Joseph M. Tavano, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6411; e-mail address: 
<a href="/cdn-cgi/l/email-protection#186c796e7976773672776b7d6870587d6879367f776e"><span class="__cf_email__" data-cfemail="3d495c4b5c53521357524e584d557d584d5c135a524b">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    <bullet> Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
    <bullet> Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
    <bullet> Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
    <bullet> Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be

[[Page 57217]]

affected by this action. Other types of entities not listed in this 
unit could also be affected. The North American Industrial 
Classification System (NAICS) codes have been provided to assist you 
and others in determining whether this action might apply to certain 
entities. If you have any questions regarding the applicability of this 
action to a particular entity, consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of March 19, 2001 (66 FR 15443-15459) (FRL-
6766-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
0F6176) by Rohm and Haas, 100 Independence Mall West, Philadelphia, PA 
19106, which has been subsequently purchased by Dow AgroSciences LLC, 
9330 Zionsville Rd., Indianapolis, IN 46268. The petition requested 
that 40 CFR 180.482 be amended by establishing a tolerance for residues 
of the insecticide tebufenozide, benzoic acid, 3,5-dimethyl-1-(1,1-
dimethylethyl)-2-(4-ethylbenzoyl)hydrazide, in or on citrus (crop group 
10) and citrus oil at 0.80 and 10 parts per million (ppm), 
respectively. That notice included a summary of the petition prepared 
by Rohm and Haas, the registrant at the time. There were no comments 
received in response to the notice of filing.
    In the Federal Register of March 12, 2003 (68 FR 11846-11850) (FRL-
7295-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
2E6397 and PP 2E 6413), by Interregional Research Project Number 4 (IR-
4), 681 U.S. Highway <greek-i>1, South Brunswick, NJ 08902. The 
petitions requested that 40 CFR 180.482 be amended by establishing 
tolerances for residues of the insecticide, tebufenozide, benzoic acid, 
3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide, in or 
on grape at 3.0 ppm (PP 2E6413) and vegetable, tuberous and corm 
(except potato) subgroup 1D at 0.01 ppm (PP 2E6397). That notice 
included a summary of the petition prepared by IR-4. There were no 
comments received in response to the notice of filing.
    In the Federal Register of January 28, 2004 (69 FR 4147-4151) (FRL-
7335-9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
7F4824), by Dow AgroSciences LLC, 9330 Zionsville Rd., Indianapolis, IN 
46268. The petition requested that 40 CFR 180.482 be amended by 
establishing tolerances for indirect or inadvertent combined residues 
of tebufenozide, benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-
ethylbenzoyl)hydrazide and its metabolite benzoic acid, 3,5-dimethyl-1-
(1,1dimethylethyl)-2-[4-(1-hydroxyethyl)benzoyl]hydrazide in or on 
forage, fodder, hay and straw of cereal grain; forage, fodder, straw 
and hay of non-grass animal feed; forage, fodder and hay of grass and 
foliage of legume vegetables at 0.5, 0.5, 0.5, and 0.1 ppm, 
respectively. That notice included a summary of the petition prepared 
by Dow AgroSciences, the registrant. One comment was received in 
response to this notice. The commentator stated that there should be a 
zero tolerance since the data supporting the tolerance was too old. 
EPA, however, believes that the data submitted in 1999 are still 
relevant and reliable. The submitted studies were conducted pursuant to 
EPA regulations and guidelines and the commentor has offered no reason 
as to why the data from these studies is unreliable.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA 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).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for a tolerance for residues of tebufenozide on 
tuberous and corm vegetables (except potato) subgroup 1D, grape, citrus 
(crop group 10), and citrus oil at 0.015, 3.0, 0.80, and 15.0 ppm and 
indirect or inadvertent combined residues of tebufenozide, benzoic 
acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide 
and its metabolite benzoic acid, 3,5-dimethyl-1-(1,1dimethylethyl)-2-
[4-(1-hydroxyethyl)benzoyl]hydrazide in or on forage, fodder, hay and 
straw of ceral grain; forage, fodder, straw and hay of non-grass animal 
feed; forage, fodder and hay of grass and foliage of legume vegetables 
at 1.0, 1.0, 1.0, and 0.20 ppm. EPA'assessment of exposures and risks 
associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by tebufenozide as 
well as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies 
reviewed are discussed in the Federal Register of October 21, 1999 (64 
FR 56690-56697) (FRL-6382-6).

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest

[[Page 57218]]

dose at which adverse effects of concern are identified (the LOAEL) is 
sometimes used for risk assessment if no NOAEL was achieved in the 
toxicology study selected. An uncertainty factor (UF) is applied to 
reflect uncertainties inherent in the extrapolation from laboratory 
animal data to humans and in the variations in sensitivity among 
members of the human population as well as other unknowns. An UF of 100 
is routinely used, 10X to account for interspecies differences and 10X 
for intraspecies differences.
    Three other types of safety or uncertainty factors may be used: 
``Traditional uncertainty factors;'' the ``special FQPA safety 
factor;'' and the ``default FQPA safety factor.'' By the term 
``traditional uncertainty factor,'' EPA is referring to those 
additional uncertainty factors used prior to FQPA passage to account 
for database deficiencies. These traditional uncertainty factors have 
been incorporated by the FQPA into the additional safety factor for the 
protection of infants and children. The term ``special FQPA safety 
factor'' refers to those safety factors that are deemed necessary for 
the protection of infants and children primarily as a result of the 
FQPA. The ``default FQPA safety factor'' is the additional 10X safety 
factor that is mandated by the statute unless it is decided that there 
are reliable data to choose a different additional factor (potentially 
a traditional uncertainty factor or a special FQPA safety factor).
    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 an UF of 
100 to account for interspecies and intraspecies differences and any 
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). 
Where a special FQPA safety factor or the default FQPA safety factor is 
used, 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 safety factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the 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). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 X 
10<SUP>-</SUP>\5\), one in a million (1 X 10<SUP>-</SUP>\6\), or one in 
ten million (1 X 10<SUP>-</SUP>\7\). 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<INF>cancer</INF> = point of departure/exposures) is 
calculated.
    A summary of the toxicological endpoints for tebufenozide used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of October 21, 1999 ( 64 FR 56690-
56697) (FRL-6382-6).

C. 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. 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. An appropriate endpoint attributable to a single dose 
was not identified. This risk is considered to be negligible.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates 
food consumption data as reported by respondents in the U.S. Department 
of Agriculture 1994-1996 and 1998 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 tolerances established in this action it 
was assumed that 100% of the crops would be treated with tebufenozide. 
Percent crop treated (PCT) estimates were used for some already 
existing tolerances. No anticipated residues were used.
    iii. Cancer. Tebufenozide has been classified as a Group E ``No 
evidence of carcinogenicity for humans.'' Thus, tebufenozide is 
considered to pose at most a negligible risk of cancer and a 
quantitative exposure assessment for assessing cancer risk is 
unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(F) of FFDCA 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 underestimate 
exposure for any significant subpopulation group.
    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) of FFDCA, EPA may require 
registrants to submit data on PCT.
    The Agency used PCT information in Table 1 of this unit as follows:
    Estimates of PTC were used for the following crops. In all cases 
the maximum estimate was used.


                     Table 1.--Percent Crop Treated
------------------------------------------------------------------------
            Commodity                   Average             Maximum
------------------------------------------------------------------------
Almonds                           <1%                 <1%
------------------------------------------------------------------------
Apples                            1%                  2%
------------------------------------------------------------------------
Beans/Peas, dry                   0%                  1%
------------------------------------------------------------------------
Cotton                            1%                  4%
------------------------------------------------------------------------
Walnuts                           10%                 16%
------------------------------------------------------------------------
Cabbage, fresh                    2%                  3%
------------------------------------------------------------------------
Cole crops                        1%                  2%
------------------------------------------------------------------------
 Spinach, fresh                    2%                 3%
------------------------------------------------------------------------
 Spinach, processed                20%                29%
------------------------------------------------------------------------

    The Agency believes that the three conditions listed in this unit 
have been met. With respect to Condition 1, PCT estimates are derived 
from Federal and private market survey data, which are

[[Page 57219]]

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 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 Model/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 screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would 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), which are the model estimates of a 
pesticide's concentration in water. EECs derived from these models are 
used 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 in Unit III.E.
    Based on the PRZM/EXAMS and SCI-GROW models, the EECs of 
tebufenozide for acute exposures are estimated to be 15 parts per 
billion (ppb) for surface water and 1.19 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 effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to tebufenozide and any other 
substances and 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 policy statements released by EPA's OPP concerning 
common mechanism determinations and procedures for cumulating effects 
from substances found to have a common mechanism on EPA's web site at 
http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA 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 database on toxicity and exposure 
unless EPA determines based on reliable data 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. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. EPA evaluated the potential 
for increased susceptibility of infants and children from exposure to 
tebufenozide. EPA concluded that there are no

[[Page 57220]]

concerns or residual uncertainties for prenatal and postnatal toxicity.
    3. Conclusion. There is a complete toxicity database for 
tebufenozide and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. Based on these 
data, EPA determined that the 10X SF to protect infants and children 
should be removed. The FQPA factor is removed because:
    i. The toxicology database is complete.
    ii. There is no indication of increased susceptibility of rats or 
rabbit fetuses to in utero and/or postnatal exposure in the 
developmental and reproductive toxicity data.
    iii. Dietary exposure estimates are only partially refined by use 
of PCT information and therefore provide a very conservative (health-
protective) estimate of dietary exposure through food.
    iv. Modeling is used for the ground and surface source drinking 
water exposure assessments, resulting in estimates that are 
conservative upper-bound concentrations.
    v. There are currently no registered residential uses for 
tebufenozide and therefore, non-dietary exposure to infants and 
children is not expected.
    vi. No evidence of neurotoxicity was reported.

E. 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 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 + residential 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 EPA's Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide 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 residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. An acute exposure risk assessment was not performed 
since no toxicity endpoint for tebufenozide attributable to a single 
dose was identified. Acute risk from exposure to tebufenozide is 
expected to be negligible.
    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, 27% of the cPAD for all infants (1 year), and 92% of the 
cPAD for children 1-2 years. There are no residential uses for 
tebufenozide that result in chronic residential exposure to 
tebufenozide. In addition, there is potential for chronic dietary 
exposure to tebufenozide in drinking water. After calculating DWLOCs 
and comparing them to the EECs for surface and ground water, EPA does 
not expect the aggregate exposure to exceed 100% of the cPAD, as shown 
in Table 2 of this unit:

                                  Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Tebufenozide
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Surface Water EEC       Ground Water EEC
        Population Subgroup              cPAD mg/kg/day           %cPAD (Food)               (ppb)                  (ppb)           Chronic DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population                      0.02 milligram/         25                      15                     1.19                   530
                                      kilogram/day (mg/kg/
                                      day)
--------------------------------------------------------------------------------------------------------------------------------------------------------
All Infants (<1year)                 0.02 mg/kg/day          27                      15                     1.19                   150
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 1-2 years                   0.02 mg/kg/day           92                     15                     1.19                    16
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 3-5 years                   0.02 mg/kg/day          64                      15                     1.19                   75
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 6-12 years                  0.02 mg/kg/day          32                      15                     1.19                   140
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth 13-19 years                    0.02 mg/kg/day          17                      15                     1.19                   170
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults 20-29 years                   0.02 mg/kg/day          18                      15                     1.19                   580
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults 50+ years                     0.02 mg/kg/day          21                      15                     1.19                   560
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females 13-49 years                  0.02 mg/kg/day           18                     15                     1.19                   490
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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).
    Tebufenozide is not registered for use on any sites that would 
result in residential exposure. Therefore, the

[[Page 57221]]

aggregate risk is the sum of the risk from food and water, which do not 
exceed the Agency's level of concern.
    4. Intermediate-term risk. 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. Therefore, the aggregate risk is the 
sum of the risk from food and water, which do not exceed the Agency's 
level of concern.
    5. Aggregate cancer risk for U.S. population. Tebufenozide is 
classified as ``no evidence of carcinogenic for humans;'' therefore, 
tebufenozide is expected to pose no greater than a negligible cancer 
risk.
    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.

IV. Other Considerations

A. Analytical Enforcement Methodology

Citrus (Crop Group 10)

    The analytical method used for analysis of tebufenozide residues 
in/on oranges, lemons, and grapefruit was Preliminary Residue Method 
for RH-5992 in Citrus (Orange, Grapefruit, Lemon and Mandarin Orange), 
Y.Meng and D.W.Chu, Rohm and Haas Analytical Method TR 34-96-184, 12/4/
96. This (high performance liquid chromatography using ultraviolet 
(HPLC-UV) detection) method is very similar to the proposed food 
tolerance enforcement method for plant commodities (TR 34-94-38) and 
thus is adequate for collection of residue data, ergo, the method is 
suitable for the quantitation of tebufenozide in/on citrus commodities. 
The Agency has previously requested that the petitioner revise the 
analytical method submitted for enforcement purposes on directly 
treated crops (TR 34-94-38) to correct deficiencies noted during Agency 
method validation. Adequate recovery data for citrus samples (fortified 
with tebufenozide) were provided. The limit of detection (LOD) for 
tebufenozide in/on citrus was 0.006 ppm. The limit of quantitation 
(LOQ) for tebufenozide in/on citrus was 0.020 ppm.

Grape

    Grape samples were analyzed for tebufenozide, via HPLC/UV, using 
the Del Monte Research Center Tebufenozide Working Method. This working 
method was based on Tolerance Enforcement Method for RH-5992 in 
Vegetables (Cabbage, Lettuce, Mustard Greens, Spinach, Broccoli and 
Celery), Rohm and Haas Analytical Method TR 34-94-41, 11/3/94. Minor 
modifications were made that would not negatively affect the 
performance of the method. Adequate recovery data for grape samples 
(fortified with tebufenozide) were provided. Method TR 34-94-41 has 
been conditionally approved by the Agency as an analytical enforcement 
method, pending incorporation of the corrections noted during the 
Analytical Chemistry Branch/BEAD's petition method validation (PMV) 
trial. This method is considered adequate for the enforcement of 
tebufenozide residues in/on grapes. The LOD for tebufenozide in/on 
grape was 0.004 ppm. The LOQ for tebufenozide in/on grape was 0.013 
ppm.

Sweet Potato and Yam

    Sweet potato root samples were analyzed for tebufenozide, via HPLC/
UV, using the Del Monte Research Center Tebufenozide Working Method. 
This working method was based on Tolerance Enforcement Method for RH-
5992 in Vegetables (Cabbage, Lettuce, Mustard Greens, Spinach, Broccoli 
and Celery), Rohm and Haas Analytical Method TR 34-94-41, 11/3/94. 
Minor modifications were made that would not negatively affect the 
performance of the method. Adequate recovery data for sweet potato root 
samples (fortified with tebufenozide) were provided. Method TR 34-94-41 
has been conditionally approved by the Agency as an analytical 
enforcement method, pending incorporation of the corrections noted 
during the Analytical Chemistry Branch/BEAD's PMV trial. This method is 
considered adequate for the enforcement of tebufenozide residues in/on 
sweet potato roots. The LOD for tebufenozide in/on sweet potato was 
0.005 ppm. The LOQ for tebufenozide in/on sweet potato was 0.015 ppm.

Field Accumulation in Rotational Crops

    Quantitative analysis of tebufenozide and RH-1788 residues in/on 
foliage of cereal grains and foliage of legumes (as well as cereal 
grain and legume seeds) was performed via the (HPLC/mass spectroscopy 
(MS)/MS) method, Determination of Residues of Tebufenozide and 
Metabolite in Low Moisture Rotational Crops by Liquid Chromatography 
with Tandem Mass Spectrometry, Dow AgroSciences Analytical Method GRM 
02.20, 2002. As stated in the Dow AgroSciences method validation 
report, the LOD was 0.006 ppm (for both tebufenozide and RH-1788) in 
low-moisture foliage samples and the LOQ, as demonstrated by the lowest 
acceptable recovery level, was 0.020 ppm. Fortified samples were 
analyzed over a validation range of 0.020 ppm (LOQ) to 1.00 ppm. The 
recovery results from these samples indicate the method's acceptability 
as a data-gathering method, at minimum. The original proposed 
analytical method for the enforcement of tebufenozide residues in/on 
rotated crops is Rohm and Haas Analytical Method TR 34-99-10. This 
HPLC/MS method has been validated with LOQs for tebufenozide and its 
metabolite in low moisture plant commodities at 0.02 ppm; the reported 
LODs for the analytes were 0.002 ppm. The results of the PMV trial 
demonstrated that, although the third validation attempt was successful 
for the parent compound, the method trial was unsuccessful for the 
metabolite, RH-1788, due to excessive interferences in the 
chromatograms. EPA recommended that the method be returned to the 
petitioner for modifications to improve the cleanup step and recovery 
of the metabolite. As EPA considers DAS Method GRM 02.20 to be the 
superior technique for quantitation of tebufenozide and RH-1788 
residues in low-moisture rotational crops, the registrant has proposed 
it as the tolerance enforcement method, rather than Rohm and Haas 
Method TR 34-99-10. EPA will review the method; an independent method 
validation (ILV) or PMV or possibly both could be required before DAS 
Method GRM 02.20 is deemed acceptable for tolerance enforcement 
purposes.
    These methods may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; e-mail address: 
<a href="/cdn-cgi/l/email-protection#c0b2a5b3a9a4b5a5ada5b4a8afa4b380a5b0a1eea7afb6"><span class="__cf_email__" data-cfemail="beccdbcdd7dacbdbd3dbcad6d1dacdfedbcedf90d9d1c8">[email protected]</span></a>.

B. International Residue Limits

    No Canadian or Mexican maximum residue limits (MRL) have been 
established for tebufenozide residues. Codex MRLs have been established 
for grapes at 2.0 ppm. The Codex MRL for grapes was based on data from 
France and Australia. No U.S. data was submitted to Codex.

V. Conclusion

    Therefore, the tolerance is established for residues of 
tebufenozide on tuberous and corm vegetables (except potato) subgroup 
1D, grape, citrus (crop group 10), and citrus oil at 0.015, 3.0, 0.80, 
and 15.0 ppm and indirect or inadvertent combined residues of

[[Page 57222]]

tebufenozide , benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-
ethylbenzoyl)hydrazide and its metabolite benzoic acid, 3,5-dimethyl-1-
(1,1dimethylethyl)-2-[4-(1-hydroxyethyl)benzoyl]hydrazide in or on 
forage, fodder, hay and straw of ceral grain; forage, fodder, straw and 
hay of non-grass animal feed; forage, fodder and hay of grass and 
foliage of legume vegetables at 1.0, 1.0, 1.0, and 0.20 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA provides essentially the same process for persons to 
``object'' to a regulation for an exemption from the requirement of a 
tolerance issued by EPA under new section 408(d) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. However, the period 
for filing objections is now 60 days, rather than 30 days.

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2004-0209 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 November 
23, 2004.
    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 (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2004-0209, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: <a href="/cdn-cgi/l/email-protection#e6899696cb8289858d8392a6839687c8818990"><span class="__cf_email__" data-cfemail="e08f9090cd848f838b8594a0859081ce878f96">[email protected]</span></a>. 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).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
entitled Actions Concerning Regulations That Significantly Affect 
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This 
final rule does not contain any information collections subject to OMB 
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., or impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Public Law 104-4). Nor does it require any special 
considerations under Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or OMB review or any 
Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). This action does not involve any technical standards 
that would require Agency consideration of voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) 
(15 U.S.C. 272 note). Since tolerances and exemptions that are 
established on the basis of a petition under section 408(d) of FFDCA, 
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

[[Page 57223]]

have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: September 16, 2004.
Lois Rossi,
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. Section 180.482 is amended by alphabetically adding commodities 
to the table in paragraph (a)(1) and by revising paragraph (d) to read 
as follows:


Sec.  180.482  Tebufenozide; tolerances for residues.

    (a) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
                                                    * * * * *
Citrus oil............................................                                                      15.0
                                                    * * * * *
Fruit, citrus, group 10...............................                                                      0.80
                                                    * * * * *
Grape.................................................                                                       3.0
                                                    * * * * *
Vegetable, tuberous and corm (except potato), subgroup                                                     0.015
 1D...................................................
                                                    * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established 
for the indirect or inadvertent combined residues of tebufenozide, 
benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-
ethylbenzoyl)hydrazide and its metabolite benzoic acid, 3,5-dimethyl-1-
(1,1dimethylethyl)-2-[4-(1-hydroxyethyl)benzoyl]hydrazide in or on the 
raw agricultural commodities when present therein as a result of the 
application of tebufenozide to growing crops listed in paragraph (a) of 
this section to read as follows:

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Forage, fodder, hay and straw of grain, cereal, group                                                        1.0
 16...................................................
Forage, fodder, straw and hay of non-grass animal                                                            1.0
 feed, group 18.......................................
Grass, forage, fodder and hay, group 17...............                                                       1.0
Vegetable, foliage of legume, group 7.................                                                      0.20
----------------------------------------------------------------------------------------------------------------


[FR Doc. 04-21499 Filed 9-23-04; 8:45 am]
BILLING CODE 6560-50-S


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