[Federal Register Volume 68, Number 63 (Wednesday, April 2, 2003)]
[Notices]
[Pages 16046-16050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7977]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0102; FRL-7299-6]


Fludioxonil; Notice of Filing Pesticide Petitions 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-2003-0102, must be 
received on or before May 2, 2003.

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

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; 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. 
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. Potentially affected entities 
may include, but are not limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] 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

[[Page 16047]]

entities not listed in this unit could also be affected. 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 identification (ID) number OPP-2003-0102. 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 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 in 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-2003-0102. 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-2003-0102. 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

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of Pesticide Programs (OPP), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001, Attention: Docket ID 
number OPP-2003-0102.
    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-2003-0102. 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 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 25, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petitions

    The petitioner's summary of the pesticide petitions is printed 
below as required by FFDCA section 408(d)(3). The summary of the 
petitions was prepared by the petitioner and represents the views 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. The Interregional Research 
Project Number 4 (IR-4) prepared and submitted the pesticide petitions 
to EPA on behalf of Syngenta Crop Protection, Inc., the registrant.

 Interregional Research Project Number 4

PP 2E6486, 2E6462, 3E6526, and 2E6448

    EPA has received pesticide petitions 2E6486, 2E6462, 3E6526, and 
2E6448, from the IR-4 Project, Center for Minor Crop Pest Management, 
Rutgers, The State University of New Jersey, 681 U.S. Highway 
1 South, North Brunswick, NJ 08902-3390 proposing, pursuant to 
section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a(d), to amend 40 CFR 180.516 by establishing tolerances for 
residues of fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-H-
pyrrole-3-carbonitrile, in or on the following raw agricultural 
commodities:
    1. PP 2E6486 proposes tolerances as follows:
    [sbull] Brassica, head and stem subgroup 5a at 1.5 parts per 
million (ppm).
    [sbull] Brassica, leafy greens subgroup 5b at 9.0 ppm.
    [sbull] Turnip, greens at 9.0 ppm.
    2. PP 2E6462 proposes a tolerance for carrot at 0.5 ppm.
    3. PP 3E6526 proposes a tolerance for herb subgroup 19a at 33.0 
ppm.
    4. PP 2E6448 proposes a tolerance for the following:
    [sbull] Longan at 2.0 ppm.
    [sbull] Lychee at 2.0 ppm.
    [sbull] Pulasan at 2.0 ppm.
    [sbull] Rambutan at 2.0 ppm.
    [sbull] Spanish lime at 2.0 ppm.
    Pending PP 3E6526 proposes a tolerance for herb subgroup 19a at 
33.0 ppm. A tolerance currently exist for fludioxonil on herbs and 
spices at 0.02 ppm (40 CFR 180.516). This notice proposes amending 40 
CFR 180.516 as follows:
    1. Delete existing herbs and spices tolerance of 0.02 ppm and 
establish a seperate herb subgroup 19a tolerance at 33.0 ppm.
    2. Establish a seperate spice subgroup 19b tolerance at 0.02 ppm.
    As the result of this proposed amendment, the pending herb subgroup 
19a tolerance at 33.0 ppm precludes the need for the existing herbs 
tolerance of 0.02 ppm. Moreover, the existing spices tolerance of 0.02 
ppm is changed to spice subgroup 19b at 0.02 ppm.
    Additional data may be needed before EPA rules on the petitions. 
Syngenta Crop Protection, Inc., Greensboro, NC 27409 is the 
manufacturer of the chemical pesticide, fludioxinil. Syngenta prepared 
and submitted the following summary of information, data, and arguments 
in support of the pesticide petitions. This summary does not 
necessarily reflect the findings of EPA.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of fludioxonil is adequately 
understood for the purpose of the proposed tolerances.
    2. Analytical method. Syngenta has developed and validated 
analytical methodology for enforcement purposes. This method (Syngenta 
Crop Protection

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Method AG-597B) has passed an Agency petition method validation for 
several commodities and is currently the enforcement method for 
fludioxonil. This method has also been forwarded to the Food and Drug 
Administration for inclusion into PAM II. An extensive data base of 
method validation data using this method on various crop commodities is 
available.
    3. Magnitude of residues. Complete residue data for Brassica, head 
and stem (subgroup 5e.c.), Brassica leafy greens (subgroup 5e.c.), 
turnip, greens, herb (subgroup 19e.c.), and lychee, longan, rambutan, 
pulasan, and Spanish lime have been submitted. The requested tolerances 
are adequately supported by field research data.

B. Toxicological Profile

    An assessment of toxic effects caused by fludioxonil is discussed 
in Unit III.A. and Unit III.B. of the Federal Register of August 2, 
2002 (67 FR 50354) (FRL-7188-7).
    1. Animal metabolism. The metabolism of fludioxonil in rats is 
adequately understood.
    2. Metabolite toxicology. The residues of concern for tolerance 
setting purposes is fludioxonil, the parent compound. Consequently, 
there is no additional concern for toxicity of metabolites.
    3. Endocrine disruption. Fludioxonil does not belong to a class of 
chemicals known for having adverse effects on the endocrine system. No 
estrogenic effects have been observed in the various short-term and 
long-term studies conducted with various mammalian species.

C. Aggregate Exposure

    1. Dietary exposure. A Tier III acute and chronic dietary exposure 
evaluation was made using the Dietary Exposure Evaluation Model 
(DEEMTM), version 7.76 from exponent. Empirically derived 
processing studies for apple juice (0.09X), apple pomace (6.77X), and 
grape juice (0.36X) were used in these assessments. The apple juice 
processing factor was used as a surrogate for pear juice and all other 
processing factors used DEEMTM defaults. All consumption 
data for these assessments were taken from the U.S. Department 
Agriculture (USDA) Continuing Survey of Food Intake by Individuals 
(CSFII) with the 1994-96 consumption data base and the Supplemental 
CSFII children's survey (1998) consumption data base. These exposure 
assessments included all registered uses and uses proposed in this 
submission: Brassica, head and stem (subgroup 5e.c.), Brassica, leafy 
greens (subgroup 5e.c.), turnip, greens, carrot, herbs (subgroup 
19e.c.), lychee, longan, and Spanish lime. Secondary residues in animal 
commodities were estimated based on theoretical worst-case, yet 
nutritionally adequate animal diets and transfer information from 
feeding studies.
    i. Food. For the purposes of assessing the potential dietary 
exposure under the proposed tolerances, Syngenta Crop Protection has 
estimated aggregate exposure from all crops for which tolerances are 
established or proposed. These assessments utilized residue data from 
field trials where fludioxonil was applied at the maximum intended use 
rate and samples were harvested at the minimum pre-harvest interval 
(PHI) to obtain maximum residues. Percent of crop treated (PCT) values 
were estimated based upon economic, pest and competitive pressures. The 
values used in these assessments were: All seed treatment uses, 100%; 
apricots and pistachios, 10%; cherries, 16%; nectarines, 49%; onions, 
9%; peaches, 22%; plums, 25%; other stone fruit, 20%; strawberries, 
42%; watercress, 95%; berries, 13%; salal, 13%; herbs, 80%; crop group 
5e.c. and 5e.c., carrots, and lychee, turnips and longan 10%.
    ii. Acute exposure. An acute reference dose (aRfD) of 1.0 
milligram/kilogram body weight (mg/kg/bwt) day for the females 13-50 
years subpopulation only was based on a no observed adverse effect 
level (NOAEL) of 100 mg/kg/bwt day from a rat teratology study and an 
uncertainty factor of 100X. No additional FQPA safety factor was 
applied. For the purpose of aggregate risk assessment, the exposure 
value was expressed in terms of margin of exposure (MOE) which was 
calculated by dividing the NOAEL by the exposure for each population 
subgroup. In addition, exposure was expressed as a percent of the aRfD. 
Acute exposure to the females 13-50 years subpopulation resulted in a 
MOE of 9,933 (1.01%) of the aRfD of the 1.0 mg/kg bwt/day. Since the 
benchmark MOE for the assessment was 100 and since EPA generally has no 
concern for exposures below 100% of the RfD, Syngenta believes that 
there is a reasonable certainty that no harm will result from dietary 
(food) exposure to residues arising from the current and proposed uses 
for fludioxonil.
    iii. Chronic exposure. The chronic reference dose (cRfD) for 
fludioxonil is 0.033 mg/kg bwt/day and is based on a 1-year study in 
dogs with a NOAEL of 3.3 mg/kg bwt/day and an Uncertainty Factor (UF) 
of 100X. No additional Food Quality Protection Act (FQPA) safety factor 
was applied. The fludioxonil Tier III chronic dietary exposure 
assessment was based upon residue field trial results. For the purpose 
of aggregate risk assessment, the exposure values were expressed in 
terms of MOE which was calculated by dividing the NOAEL by the exposure 
for each population subgroup. In addition, exposure was expressed as a 
percent of the RfD. Chronic exposure to the most exposed subpopulation 
(children 1 and 2 years old) resulted in a MOE of 2,668 (3.75%) of the 
cRfD of 0.033 mg/kg bwt/day. Since the benchmark MOE for this 
assessment was 100 and since EPA generally has no concern for exposures 
below 100% of the RfD, Syngenta believes that there is a reasonable 
certainty that no harm will result from dietary (food) exposure to 
residues arising from the current and proposed uses for fludioxonil.
    iv. Drinking water. Another potential source of exposure of the 
general population to residues of fludioxonil are residues in drinking 
water. Fludioxonil rapidly degrades via photolysis on the soil surface 
and in water. The half-lives are 1 day and 10 days, respectively. This 
potential for rapid degradation reduces the potential for ground water 
or surface water exposure. Fludioxonil soil/solution partition 
coefficients vary from 991 to 2,440 indicating a relatively high 
affinity for binding to soil. Estimated Environmental Concentrations 
(EECs) of fludioxonil in drinking water were determined for the highest 
use rate of fludioxonil (turfgrass use). Sceening Concentration in 
Ground Water (SCI-GROW) (Version 2.2) was used to determine acute and 
chronic ECCs in ground water and FQPA Index Reservior Screening Tool 
(FIRST) (Version 1.0) was used to determine acute and chronic estimated 
environmental concentrations in surface water. Based on the model 
outputs, the ECCs of fludioxonil are 0.174 parts per billion (ppb) for 
acute and chronic exposure to ground water and 70 ppb and 33 ppb for 
acute and chronic exposure, respectively, to surface water. Acute 
Drinking Water Levels of Comparison (DWLOC) were calculated based on an 
acute Populated Adjusted Dose (aPAD) of 1 mg/kg/day. For the acute 
assessment, the females (13-50 years) subpopulation generated an acute 
DWLOC of approximately 30,000 ppb. Thus, the acute DWLOC of 30,000 ppb 
is considerably higher than the acute EEC of 70 ppb. Chronic DWLOC were 
calculated based on a cRfD of 0.033 mg/kg/day. For the chronic 
assessment, the children 1 and 2 years old subpopulation generated the 
lowest chronic DWLOC of approximately 320 ppb. Thus, the chronic DWLOC 
of 320 ppb is considerably higher than the chronic EEC of 33 ppb.

[[Page 16050]]

    2. Non-dietary exposure. There is a potential residential post-
application exposure to adults and children entering residential areas 
treated with fludioxonil. Since the Agency did not select a short-term 
endpoint for dermal exposure, only intermediate dermal exposures were 
considered. Based on the residential use pattern, Syngenta believes 
that no long-term post-application residential exposure is expected.
    3. Chronic aggregate exposure. Based on the completeness and 
reliability of the toxicity data supporting these petitions, Syngenta 
believes that there is a reasonable certainty that no harm will result 
from aggregate exposure to residues arising from all current and 
proposed fludioxonil uses, including anticipated dietary exposure from 
food, water, and all other types of non-occupational exposures.

D. Cumulative Effects

    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 fludioxonil has a common mechanism 
of toxicity with other substances or how to include this pesticide in a 
cumulative risk assessment. For the purposes of this tolerance action, 
EPA has not assumed that fludioxonil has a common mechanism of toxicity 
with other substances.

E. Safety Determination

    The chronic dietary exposure analysis (food only) showed that 
exposure from all established and proposed fludioxonil uses would be 
3.75% of the cRfD for the most sensitive subpopulation, children 1 and 
2 years old. Additionally, for females 13-50 years old, the acute 
dietary exposure analysis (food only) showed that exposure from all 
established and proposed fludioxonil uses would be 1.01% of the aPAD. 
EPA has determined that reliable data support using the standard MOE 
and uncertainty factor (100 for combined interspecies and intraspecies 
variability) for fludioxonil and that an additional safety factor of 10 
is not necessary to be protective of infants and children.
    Acute DWLOCs were calculated based on an aPAD of 1 mg/kg/day. For 
the acute assessment, the females (13-50 years) subpopulation generated 
an acute DWLOC of approximately 30,000 ppb. The acute EEC of 70 ppb is 
considerably less than 30,000 ppb. For the chronic assessment, the 
children 1 and 2 years old subpopulation generated the lowest chronic 
DWLOC of approximately 320 ppb. Thus, the chronic DWLOC of 320 ppb is 
considerably higher than the chronic EEC of 33 ppb. Syngenta has 
considered the potential aggregate exposure from food, water and non-
occupational exposure routes and concluded that aggregate exposure is 
not expected to exceed 100% of the cRfD and that there is a reasonable 
certainty that no harm will result to infants and children from the 
aggregate exposure to fludioxonil.

F. International Tolerances

    There are no Codex maximum residue levels established for 
fludioxonil.
[FR Doc. 03-7977 Filed 4-1-03; 8:45 am]
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