[Federal Register Volume 68, Number 48 (Wednesday, March 12, 2003)]
[Notices]
[Pages 11846-11850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5912]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0052; FRL-7295-4]


Tebufenozide; Notice of Filing a Pesticide Petition to Establish 
a Tolerance for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket ID number OPP-2003-0052, must be 
received on or before April 11, 2003.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

     You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Industry (NAICS 111)
    [sbull] Crop production (NAICS 112)
    [sbull] Animal production (NAICS 311)
    [sbull] Food manufacturing, and Pesticide manufacturing (NAICS 
32532)
     This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

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

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2003-0052. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although, a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity

[[Page 11847]]

Branch (PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis 
Hwy., 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.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
     An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit, or view 
public comments, access the index listing of the contents of the 
official public docket, and to access those documents in the public 
docket that are available electronically. Although, not all docket 
materials may be available electronically, you may still access any of 
the publicly available docket materials through the docket facility 
identified in Unit I.B.1. Once in the system, select ``search,'' then 
key in the appropriate docket ID number.
     Certain types of information will not be placed in the EPA 
dockets. Information claimed as CBI and other information whose 
disclosure is restricted by statute, which is not included in the 
official public docket, will not be available for public viewing in 
EPA's electronic public docket. EPA's policy is that copyrighted 
material will not be placed in EPA's electronic public docket but will 
be available only in printed, paper form in the official public docket. 
To the extent feasible, publicly available docket materials will be 
made available in EPA's electronic public docket. When a document is 
selected from the index list in EPA dockets, the system will identify 
whether the document is available for viewing in EPA's electronic 
public docket. Although, not all docket materials may be available 
electronically, you may still access any of the publicly available 
docket materials through the docket facility identified in Unit I.B. 
EPA intends to work towards providing electronic access to all of the 
publicly available docket materials through EPA's electronic public 
docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or on paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and To Whom Do I Submit Comments?

     You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also, include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties, 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2003-0052 The system is an ``anonymous access'' system, which means 
EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID number OPP-2003-0052. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID number OPP-2003-0052.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket 
ID number OPP-2003-0052. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI To the Agency?

     Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI

[[Page 11848]]

on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and 
then identify electronically within the disk or CD ROM the specific 
information that is CBI). Information so marked will not be disclosed 
except in accordance with procedures set forth in 40 CFR part 2.
     In addition to one complete version of the comment that includes 
any information claimed as CBI, a copy of the comment that does not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

     You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

     EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in FFDCA section 408(d)(2); however, 
EPA has not fully evaluated the sufficiency of the submitted data at 
this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: March 4, 2003.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petitions

     The petitioner's summary of the pesticide petitions are printed 
below as required by FFDCA section 408(d)(3). The summary of the 
petitions was prepared by Interregional Research Project Number 4 (IR-
4), and represents the view of the petitioner. The petition summary 
announces the availability of a description of the analytical methods 
available to EPA for the detection and measurement of the pesticide 
chemical residues or an explanation of why no such method is needed.

Interregional Research Project Number (IR-4)

 PP 2E6397 and 2E6413

    EPA has received pesticide petitions (2E6397 and 2E6413) from the 
Interregional Research Project Number 4 (IR-4), 681 U.S. Highway. 
1 South, North Brunswick, NJ 08902 proposing, pursuant to 
section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 
180 by establishing tolerances for residues of tebufenozide in or on 
the raw agricultural commodities vegetable, tuberous and corn, except 
potato, subgroup at 0.01 parts per million (ppm) (2E6397) and grape at 
3.0 ppm (2E6413). EPA has determined that the petitions contain data or 
information regarding the elements set forth in section 408(d)(2) of 
the FFDCA; however, EPA has not fully evaluated the sufficiency of the 
submitted data at this time or whether the data support granting of the 
petitions. Additional data may be needed before EPA rules on the 
petitions. Rohm and Haas company was acquired by Dow Agro Sciences LLC, 
Indianapolis, IN 46268-1054).

A. Residue Chemistry

    1. Plant metabolism. The qualitative nature of the residue in 
plants is adequately understood based upon acceptable apple, sugar 
beet, and rice metabolism studies. The Agency has concluded that the 
residue of regulatory concern is tebufenozide per se.
    2. Analytical method. High performance liquid chromatographic 
(HPLC) analytical methods using ultraviolet (UV) detection have been 
validated for grape and sweet potato. The methods involve extraction by 
blending with solvents, purification of the extracts by liquid-liquid 
partitions, and final purification of the residues using solid phase 
extraction column chromatography.
    3. Magnitude of residues. Complete residue data for tebufenozide on 
grape and sweet potato have been submitted. The requested tolerances 
are adequately supported.

B. Toxicological Profile

    1. Acute toxicity. Acute toxicity studies with technical grade: 
Oral lethal dose LD50 in the rat is >5 grams for males and 
females - Toxicity Category IV; dermal LD50 in the rat is 
equal to 5,000 milligrams/kilogram (mg/kg) for males and females - 
Toxicity Category III; inhalation LD50 in the rat is >4.5 
milligram/liter (mg/l) - Toxicity Category III; primary eye irritation 
study in the rabbit is a non-irritant; primary skin irritation in the 
rabbit >5 mg - Toxicity Category IV. Tebufenozide is not a sensitizer.
    2. Genotoxicty. Several mutagenicity tests were all negative. These 
include an Ames assay with and without metabolic activation, an in vivo 
cytogenetic assay in rat bone marrow cells, and in vitro chromosome 
aberration assay in Chinese hampster ovary (CHO) cells, a CHO/HGPRT 
assay, a reverse mutation assay with E. Coli, and an unscheduled DNA 
synthesis assay (UDS) in rat hepatocytes.
    3. Reproductive and developmental toxicity. In a prenatal 
developmental toxicity study in Sprague-Dawley rats 25/group, 
tebufenozide was administered on gestation days 6-15 by gavage in 
aqueous methyl cellulose at dose levels of 50, 250, or 1,000 mg/kg/day 
and a dose volume of 10 millilter/kilogram (ml/kg). There was no 
evidence of maternal or developmental toxicity; the maternal and 
developmental toxicity no observed adverse effect level (NOAEL) was 
1,000 mg/kg/day.
     In a prenatal developmental toxicity study conducted in New 
Zealand white rabbits 20/group, tebufenozide was administered in 5 ml/
kg of aqueous methyl cellulose at gavage doses of 50, 250, or 1,000 mg/
kg/day on gestation days 7-19. No evidence of maternal or developmental 
toxicity was observed; the maternal and developmental toxicity NOAEL 
was 1,000 mg/kg/day.
    4. Subchronic toxicity. A 1-year dog feeding study with a lowest 
observed adverse effect level (LOAEL) of 250 ppm, 9 mg/kg/day for male 
and female

[[Page 11849]]

dogs based on decreases in red blood cells (RBC), hematocrit (HCT), and 
hemaglobin (HGB), increases in heinz bodies, methemoglobin, mean 
corpuscuslar volume (MCV), mean corpuscular hematocrit (MCH), 
reticulocytes, platelets, plasma total bilirubin, spleen weight, and 
spleen/body weight ratio, and liver/body weight ratio. Hemotopoiesis 
and sinusoidal engorgement occurred in the spleen, and hyperplasis 
occurred in the marrow of the femur and sternum. The liver showed an 
increased pigment in the Kupffer cells. The NOAEL for systemic toxicity 
in both sexes is 50 ppm (1.9 mg/kg/day).
    5. Chronic toxicity. An 18-month mouse carcinogenicity study with 
no carcinogenicity observed at dosage levels up to and including 1,000 
ppm.
     A 2-year rat carcinogenicity with no carcinogenicity observed at 
dosage levels up to and including 2,000 ppm, 97 mg/kg/day and 125 mg/
kg/day for males and females, respectively.
    6. Animal metabolism. The pharmacokinetics and metabolism of 
tebufenozide were studied in female Sprague-Dawley rats (3-6/sex/group) 
receiving a single oral dose of 3 or 250 mg/kg of RH-5992 
14C labeled in one of three positions (A-ring, B-ring or 
buryl carbon). The extent of absorption was not established. The 
majority of the radio labeled material was eliminated or excreted in 
the feces within 48 hours; small amounts (1% to 7% of the administered 
dose) were excreted in the urine and only traces were excreted in 
expired air or remained in the tissues. There was no tendency for 
bioaccumulation. Absorption and excretion were rapid. A total of 11 
metabolites, in addition to the parent compound, were identified in the 
feces; the parent compound accounted for 96% to 99% of the administered 
radioactivity in the high dose group and 35% to 43% in the low dose 
group. No parent compound was found in the urine; urinary metabolites 
were not characterized. The absorption and metabolism of tebufenozide 
were studied in a group of male and female bile-duct cannulated rats. 
Over a 72 hour period, biliary excretion accounted for 30% (males) to 
34% (females) of the administered dose while urinary excretion 
accounted for about 5% of the administered dose and the carcass 
accounted for <0.5% of the administered dose for both males and 
females. Thus systemic absorption (percent of dose recovered in the 
bile, urine and carcass) was 35% male to 39% female. The majority of 
the radioactivity in the bile (20% male to 24% female of the 
administered dose) was excreted within the first 6 hours post-dosing 
indicating rapid absorption. Furthermore, urinary excretion of the 
metabolites was essentially complete within 24 hours post-dosing. A 
large amount (67% female to 70% male) of the administered dose was 
unabsorbed and excreted in the feces by 72 hours. Total recovery of 
radioactivity was 105% of the administered dose.
    7. Metabolite toxicology. A total of 13 metabolites were identified 
in the bile; the parent compound was not identified, i.e. unabsorbed 
compound, nor were the primary oxidation products seen in the feces in 
the pharmacokinetics study. The proposed metabolic pathway proceeded 
primarily by oxidation of the benzylic carbons to alcohols, aldehydes 
or acids. Bile contained most of the other highly oxidized products 
found in the feces. The most significant individual bile metabolites 
accounted for 5% to 18% of the total radioactivity (F and/or M). Bile 
also contained the previously undetected (in the pharmacokinetics 
study) ``A'' Ring ketone and the ``B'' Ring diol. The other major 
components were characterized as high molecular weight conjugates. No 
individual bile metabolite accounted for 5% of the total administered 
dose. Total bile radioactivity accounted for about 17% of the total 
administered dose. No major qualitative differences in biliary 
metabolites were observed between sexes. The metabolic profile in the 
bile was similar to the metabolic profile in the feces and urine.
    8. Endocrine disruption. The toxicology profile of tebufenozide 
shows no evidence of physiological effects characteristic of the 
disruption of the hormone estrogen. Based on structure-activity 
information, tebufenozide is unlikely to exhibit estrogenic activity.

C. Aggregate Exposure

    1. Dietary exposure--i. Food. Tolerances have been established (40 
CFR 180.482) for the residues of tebufenozide, in or on a variety of 
raw agricultural commodities. The current petition requests 
establishment of tolerances in or on grape at 3.0 ppm and vegetable, 
tuberous and corn, except potato, subgroup at 0.01 ppm. Risk 
assessments were conducted by Dow AgroSciences to assess dietary 
exposures and risks from tebufenozide, benzoic acid, 3,5-dimethyl-1-
(1,1-dimethylethyl)-2-(4-ethylbenzoyl) hydrazide as follows:
    a. 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. Neither neurotoxicity nor systemic toxicity was 
observed in rats given a single oral administration of tebufenozide at 
0, 500, 1,000 or 2,000 mg/kg. No maternal or developmental toxicity was 
observed following oral administration of tebufenozide at 1,000 mg/kg/
day (limit-dose) during gestation to pregnant rabbits. This risk is 
considered to be negligible.
    b. Chronic exposure. The reference dose (RfD) used for the chronic 
dietary analysis is 0.018 mg/kg/day. In conducting the dietary exposure 
evaluation model (DEEM) analysis for chronic exposure to and risk from 
tebufenozide residues in food, Dow AgroSciences used tolerance level 
residues for all crops and other commodities with established or 
pending tebufenozide tolerances; and percent crop-treated (PCT) 
information for some of these crops.
    ii. Drinking water--a. Acute exposure. Because no acute dietary 
endpoint was determined, Dow AgroSciences concludes that there is a 
reasonable certainty of no harm from acute exposure from drinking 
water.
    b. Chronic exposure. The Agency calculated the Tier I Estimated 
Environmental Concentrations (EECs) for tebufenozide using generic 
expected environmental concentration (GENEEC) (surface water) and 
screening concentration in ground water (SCI-GROW) (ground water) 
models for use in the human health risk assessment. For chronic 
exposure, the worst case EECs for surface water and ground water were 
16.5 parts per billion (ppb) and 1.04 ppb, respectively. These values 
represent upper-bound estimates of the concentrations that might be 
found in surface and ground water.
    2. Non-dietary exposure. There is a potential for occupational 
exposure to tebufenozide during mixing, loading and application 
activities. However the Agency did not identify dermal or inhalation 
endpoints for tebufenozide and determined that risks from these routes 
of exposure are negligible.

D. Cumulative Effects

     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

[[Page 11850]]

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 
petition, Dow AgroSciences has not assumed that tebufenozide has a 
common mechanism of toxicity with other substances.

E. Safety Determination

    1. U.S. population. Using the exposure assumptions previously 
described, and taking into account the completeness and reliability of 
the toxicity data, Dow AgroSciences has concluded that dietary (food 
only) exposure to tebufenozide will utilize 21% of the chronic 
population adjusted dose (cPAD) for the U.S. population. EPA generally 
has no concern for exposures below 100% of the cPAD. Submitted 
environmental fate studies suggest that tebufenozide is moderately 
persistent to persistent and mobile; thus, tebufenozide could 
potentially leach to ground water and runoff to surface water under 
certain environmental conditions. The modeling data for tebufenozide 
indicate levels less than the Agency's DWLOCs. There are no chronic 
non-occupational/residential exposures expected for tebufenozide. 
Therefore, Dow AgroSciences concludes that there is a reasonable 
certainty that no harm will result to adults, infants and children from 
chronic aggregate exposure to tebufenozide residues.
    2. Infants and children. 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 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 margin of exposure (MOE) analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans. EPA believes that reliable 
data support using the standard uncertainty factor (usually 100 for 
combined inter- and intra- species variability) and not the additional 
tenfold MOE/uncertainty factor when EPA has a complete data base under 
existing guidelines and when the severity of the effect in infants or 
children or the potency or unusual toxic properties of a compound do 
not raise concerns regarding the adequacy of the standard MOE/safety 
factor.
     Using the exposure assumptions previously described, and taking 
into account the completeness and reliability of the toxicity data, the 
dietary (food only) exposure to tebufenozide will utilize 51% of the 
cPAD for the most highly exposed population subgroup (children 1-6 
years old). EPA generally has no concern for exposures below 100% of 
the cPAD. Despite the potential for exposure to tebufenozide in 
drinking water and from non-dietary non-occupational exposure, Dow 
AgroSciences does not expect the aggregate exposure to exceed 100% of 
the RfD.

F. International Tolerances

    Codex maximum residue levels have been established for residues of 
tebufenozide in/on pome fruit (1.0 ppm), husked rice (0.1 ppm) and 
walnut (0.05 ppm). Tebufenozide is registered in Canada, and a 
tolerance for residues in/on apples is established at 1.0 ppm. EPA has 
set the pome fruit tolerance at 1.5 ppm based on U.S. field residue 
trials.

[FR Doc. 03-5912 Filed 3-11-03; 8:45 am]
BILLING CODE 6560-50-S