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Fluoxastrobin (Bayer). April 23, 2003. Pesticide petition for tolerances for several raw agricultural commodities. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2003/April/Day-23/p9746.htm
[Federal Register: April 23, 2003 (Volume 68, Number 78)]
[Notices]
[Page 19991-19994]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23ap03-46]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2003-0129; FRL-7303-1]
Fluoxastrobin; 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-2003-0129, must be
received on or before May 23, 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: Dennis McNeilly, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-6742; e-mail address: mcneilly.dennis@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does This Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
¥ Crop production (NAICS 111)
¥ Animal production (NAICS 112)
¥ Food manufacturing (NAICS 311)
¥ 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 identification (ID) number OPP-2003-0129. 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
[[Page 19992]]
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-2003-0129. 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 opp-docket@epa.gov,
Attention: Docket ID Number OPP-2003-0129. 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-2003-0129.
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-2003-0129. 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.
[[Page 19993]]
Dated: April 15, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner summary of the pesticide petition is printed below
as required by FFDCA section 408(d)(3). The summary of the petition was
prepared by the petitioner 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.
Bayer CropScience
PP 3F6556
EPA has received a pesticide petition (3F6556) from Bayer
CropScience, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709
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 part 180 by
establishing a tolerance for residues of fluoxastrobin; 2-[[6-(2-
chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl (5,6-dihydro-1,4,2-
dioxazin-3-yl)methanone-O-methyloxime in or on the raw agricultural
commodities (RACs) alfalfa, forage at 0.05 parts per million (ppm),
alfalfa, hay at 1.0 ppm, cotton, gin byproducts at 0.02 ppm, grain,
cereal, forage at 0.10 ppm, grain, cereal, hay at 0.10 ppm, grain,
cereal, straw at 0.10 ppm, grain, cereal, stover at 0.10 ppm, grass,
forage at 0.10 ppm, grass, hay at 0.50 ppm, legume, seed at 0.01 ppm,
legume, forage at 0.05 ppm, legume, hay at 0.05 ppm, peanut at 0.01
ppm, peanut, hay at 20 ppm, peanut, refined oil at 0.10 ppm, tomato,
paste at 2.0 ppm, vegetable, fruiting, group at 1.0 ppm, vegetable,
leafy, petioles, except brassica, subgroup at 5.0 ppm, and vegetable,
tuberous and corm, subgroup at 0.01 ppm. Fluoxastrobin; 2-[[6-(2-
chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl (5,6-dihydro-1,4,2-
dioxazin-3-yl)methanone-O-methyloxime, and its phenoxy-
hydroxypyrimidine metabolite; 6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinol in or on the RACs cattle, fat at 0.10 ppm, cattle, meat at
0.05 ppm, cattle, meat byproducts at 0.20 ppm, milk at 0.01 ppm, and
milk, fat at 0.10 ppm. EPA has determined that the petition contains
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 petition. Additional data may be needed before
EPA rules on the petition.
A. Residue Chemistry
1. Plant metabolism. The metabolism of fluoxastrobin in plants is
adequately understood. Studies have been conducted to delineate the
metabolism of radiolabeled fluoxastrobin in peanut, tomato, spring
wheat, and various representative rotational crops, all showing similar
results. The residue of concern is parent fluoxastrobin (sum of E and Z
isomers).
2. Analytical method. Adequate analytical methodology using liquid
chromatography/mass spectrometer/mass spectromer (LC/MS/MS) detection
is available for enforcement purposes.
3. Magnitude of residues. Complete residue data exists for
fluoxastrobin on these crops and crop groupings. Magnitude of residue
trials were conducted on peanut, potato, celery, tomato, pepper, and
the rotational crops of alfalfa, cotton, cereal grains (corn, rice,
sorghum and wheat), soybeans, other legume vegetables, and grasses. A
cattle feeding study was performed in order to determine residues in
meat and milk commodities. The data support the proposed tolerances.
B. Toxicological Profile
1. Acute toxicity. Oral and dermal lethal dose (LD)50
values were >2,000 milligrams/kilogram bodyweight (mg/kg) (bwt).
Inhalation lethal concentrations (LC)50 values were >4,998
milligrams/meters (mg/m\3\) air. Fluoxastrobin technical was not
irritating to rabbit skin, was moderately irritating to eyes in
rabbits, and was non-sensitizing dermally in the Magnusson/Kligman
maximization test in guinea pigs. Acute toxicity studies for
fluoxastrobin support an overall Toxicity Category III.
2. Genotoxicity. Several genotoxicity tests were conducted to test
for point-mutagenic activity, chromosome aberration in vitro and in
vivo, and for DNA repair. All tests conducted were negative, indicating
no evidence of mutagenic or genotoxic potential.
3. Reproductive and developmental toxicity. An oral developmental
toxicity study in rat did not reveal any evidence of teratogenic
potential. The maternal no observed adverse effect level (NOAEL) was
300 mg/kg and the developmental NOAEL was 1,000 mg/kg bwt/day. An oral
developmental toxicity study in rabbits demonstrated a maternal NOAEL
of 25 mg/kg bwt/day, a developmental NOAEL of 100 mg/kg bwt/day and did
not reveal any teratogenic potential. A 2-generation study in rats,
with a parental toxicity NOAEL of 73.7 mg/kg bwt/day for males and 86.7
mg/kg bwt/day for females, did not reveal evidence of a primary
reproductive toxicity potential. The reproductive NOAEL was 763.6 mg/kg
bwt/day for males and 806.5 mg/kg bwt/day in females.
4. Subchronic toxicity. A subchronic toxicity feeding study with
rats over 90 days demonstrated a NOAEL of 7.3 and 18.3 mg/kg bwt/day
for males and females, respectively, based on reduced body weights and
alterations in several urinary tract-related clinical chemistry
parameters, at the higher dose levels. In a subchronic feeding study in
mice over 14 weeks, a NOAEL was not established based on decreased
alanine aminotransferase (ALAT) and increased absolute and relative
liver weights at the low dose level (21.7 and 35.3 mg/kg bwt/day for
males and females respectively). A 14-week feeding study in dogs
demonstrated a NOAEL of 3.0 mg/kg bwt/day based on decreased body
weights and food consumption, and liver effects (enzyme induction,
increased liver weights, cytoplasmic change), and thyroid effects
(decreased T3)
5. Chronic toxicity. A 24-month chronic/oncogenicity feeding study
in rats demonstrated a NOAEL of 53.0 and 35.2 mg/kg bwt/day for males
and females, respectively. An oncogenicity study in the mouse revealed
a NOAEL of 18.5 and 29.5 mg/kg bwt/day for males and females,
respectively based on liver effects. There was no indication in the rat
or mouse for an oncogenic effect of fluoxastrobin. A 1-year feeding
study with dogs demonstrated a NOAEL of 1.7 and 1.5 mg/kg bwt/day for
males and females, respectively based on decreased body weights and
slight liver effects (increased alkaline phosphatase (Aph) and liver
weights).
6. Animal metabolism. Metabolism and pharmacokinetic studies in the
rats, lactating goats, and laying hens demonstrate that fluoxastrobin
residues are rapidly absorbed, metabolized, and eliminated. There was
no evidence of accumulation of residues in any tissues or organs. The
metabolic pattern was always complex and numerous metabolites were
identified. The main metabolic reactions, however, are very comparable
for all tested animal species and most metabolites were present at low
levels. Based on the available metabolism data, fluoxastrobin and
phenoxy-hydroxypyrimidine are the proposed residues of concern in
animals.
7. Metabolite toxicology. The residues of concern are fluoxastrobin
its
[[Page 19994]]
phenoxy-hydroxypyrimidine metabolite. This metabolite was investigated
for acute oral toxicity and point mutagenic activity in a bacterial
reverse mutation assay. The phenoxy-hydroxypyrimidine metabolite did
not show mutagenic activity in the reverse mutation assay and the oral
LD50 was >300 <500 mg/kg body weight.
8. Endocrine disruption. There is no evidence to suggest that
fluoxastrobin has any primary endocrine disruptive potential.
Reproductive and developmental findings provided no evidence of an
enhanced sensitivity of the young.
C. Aggregate Exposure
1. Dietary exposure--i. Food. Acute and chronic dietary analyses
were conducted to estimate exposure to potential fluoxastrobin residues
in/on the following crops and crop groups: celery, fruiting vegetables,
peanuts, and potatoes. Rotational crops included in the analysis are
alfalfa, grasses, legume vegetables, foliage of legume vegetables,
cereal grains, and cotton. Tier I analysis were conducted for both the
acute and chronic scenarios using the Dietary Exposure Evaluation Model
(DEEM) (Exponent, Inc.) software. The acute dietary exposure estimates
at the 95\th\ percentile of exposure for the U.S. population was 1.4%
of the acute reference dose (RfD). The population subgroup with the
highest exposure was children 1 to 6 at 2.7% of the acute RfD. Chronic
dietary exposure estimates from potential residues of fluoxastrobin for
the U.S. population was 6.5% of the chronic RfD. The subpopulation with
the highest exposure was children 1 to 6 with 12.7% of the chronic RfD
used. Tier I assessments use tolerance residue values and 100% crop
treated. These can be considered very conservative values.
ii. Drinking water. EPA's Standard Operating Procedure (SOP) for
Drinking Water Exposure and Risk Assessments was used to perform the
drinking water analysis for fluoxastrobin. This SOP utilizes a variety
of tools to conduct drinking water assessment. These tools include
water models such as Screening Concentration in Groundwater (SCI-GROW),
Generic Estimate Exposure Concentration (GENEEC), Pesticide Root Zone
Model-Exposure Analysis Modeling Systems (PRZM/EXAMS), and monitoring
data. If monitoring data are not available then the models are used to
predict potential residues in surface water and ground water. In the
case of fluoxastrobin, monitoring data do not exist, therefore, PRZMS/
EXAMS and SCI-GROW models were used to estimate a drinking water
residue. The calculated drinking water levels of comparison (DWLOC) for
acute and chronic exposures for all adults and children exceed the
modeled fluoxastrobin drinking water estimated concentrations (DWECs).
The acute DWLOC values are 8,624 parts per billion (ppb) for adults and
2,433 ppb for children. The worst-case DWEC for acute scenarios is
calculated to be 58 ppb using the PRZMS/EXAMS surface water model. The
chronic DWLOC values are 491 ppb for adults and 131 ppb for children.
The DWEC for the worst-case chronic scenario is 28 ppb PRZM/EXAMS.
2. Non-dietary exposure. Residential (non-dietary) exposure is
limited to post-application exposure of fluoxastrobin from professional
applications to residential turf and golf courses. Using the very
conservative EPA SOPs for residential exposure a margin of exposure
(MOE) of 7,143 was calculated for the youth golfer scenario. Adult and
toddler reentry to treated turf MOEs were 784 and 468 respectively.
Aggregate exposure considers all exposures from food, drinking
water, and residential uses together. Probabilistic models and methods
as well as refined data for these scenarios are under development. In
the interim, as a screening level analysis a worst-case deterministic
calculation can be considered. For fluoxastrobin this would consist of
a child (1 to 6) who has a chronic dietary exposure to potential
residues in food and also plays on a maximally treated lawn (after 4
applications) on a particular day. The childs lawn exposure includes
estimates of dermal exposure and oral exposure from hand to mouth,
object to mouth and soil ingestion SOP scenarios. The childs estimated
dose from the lawn exposure is 0.0194 mg/kg bwt/day. The child 1 to 6
chronic dietary exposure estimate is 0.001907 mg/kg bwt/day. The total
dose for a child 1 to 6 with this worst-case exposure is 0.0213 mg/kg
bwt/day or 8.5% of the acute RfD. The resulting aggregate acute DWLOC
is 2,287 ppb still well above the acute DWEC of 58 ppb. Total adult
exposure (average dietary and dermal lawn) is 0.004804 mg/kg bwt/day or
1.9% of the acute RfD. The resulting aggregate acute DWLOC for adults
is 17,164 ppb.
D. Cumulative Effects
Fluoxastrobin is a novel strobilurin analog. Bayer will submit
information, if necessary, for EPA to consider concerning potential
cumulative effects of fluoxastrobin consistent with the schedule
established by EPA in the Federal Register of August 4, 1997 (62 FR
42020) (FRL-5734-6), and other EPA publications pursuant to the Food
Quality Protection Act (FQPA).
E. Safety Determination
1. U.S. population. Using the conservative assumptions described
above, based on the completeness and reliability of the toxicity data
it is concluded that aggregate exposure to the proposed uses of
fluoxastrobin will utilize at most 1.9% of the RfD for the U.S.
population, and is likely to be much less as more realistic data and
models are developed. EPA generally has no concern for exposures below
100% of the RfD because the RfD represents the level at or below which
daily aggregate exposure over a lifetime will not pose appreciable
risks to human health. DWLOC based on this exposure are much greater
than conservative estimated concentrations, and would be expected to be
well below the 100% level, if they occur at all. Therefore, there is a
reasonable certainty that no harm will occur to the U.S. population
from aggregate exposure to fluoxastrobin.
2. Infants and children. Consideration of the toxicology data base
as described above leads to no additional concerns for infants and
children. Therefore the FQPA safety factor can be established at 1X.
Using the conservative exposure assumptions described in the exposure
section above, the percent of the RfD that will be used for short-term
aggregate exposure to residues of fluoxastrobin will be 8.5% for
children 1 to 6 (the most highly exposed sub-group). This value is
based on a worst-case aggregate exposure calculation of a child 1 to 6
who has a background dietary exposure to potential residues and plays
on a maximally treated lawn. As in the adult situation, DWLOC are much
higher than the worst-case DWECs and would be expected to use well
below 100% of the RfD, if they occur at all. Therefore, there is a
reasonable certainty that no harm will occur to infants and children
from aggregate exposure to residues of fluoxastrobin.
F. International Tolerances
Codex maximum residue levels are not yet established for
fluoxastrobin.
[FR Doc. 03-9746 Filed 4-22-03; 8:45 am]
BILLING CODE 6560-50-S