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dichlormid Pesticide Petition Filing 5/02

ENVIRONMENTAL PROTECTION AGENCY
[OPP-2002-0046; FRL-6836-4]
Notice of Filing a Pesticide Petition To Establish a Tolerance
fora Certain Pesticide Chemical in or on Food
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the amendment of the pesticide petition
(PP 6F3344) proposing the establishment of regulations for residues of
a certain pesticide chemical in or on various food commodities.
DATES: Comments, identified by docket control number OPP-2002-0046,
must be received on or before June 21, 2002.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I. C. of the SUPPLEMENTARY INFORMATION. To ensure
proper receipt by EPA, it is imperative that you identify docket
control number OPP-2002-0046 in the subject line on the first page of
your response.
FOR FURTHER INFORMATION CONTACT: By mail: Treva Alston, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 308-8373; e-mail address: alston.treva@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
    You may be affected by this action if you are an agricultural
producer, food manufacturer or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
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                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
    1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' ``Regulation and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-2002-0046. The official
record consists of the documents specifically referenced in this
action, any public comments received during an applicable comment
period, and other information related to this action, including any
information claimed as confidential business information (CBI). This
official record includes the documents that are physically located in
the docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period, is available
for inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis
Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The PIRIB telephone number is (703)
305-5805.
C. How and to Whom Do I Submit Comments?
    You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number OPP-2002-0046 in the subject line on
the first page of your response.
    1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1921
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by
e-mail to: opp-docket@epa.gov, or you can submit a computer disk as
described above. Do not submit any information electronically that you
consider to be CBI. Avoid the use of special characters and any form of
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be
identified by docket control number OPP-2002-0046. Electronic comments
may also be filed online at many Federal Depository Libraries.
D. How Should I Handle CBI That I Want to Submit to the Agency?
    Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI 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. 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 version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the person identified 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
control 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 Comestic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in 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: May 3, 2002.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
    The petitioner summary of the pesticide petition is printed below
as required by section 408(d)(3) of the FFDCA. The summary of the
petition was prepared by the petitioner and represents the view of the
petitioners. The summary may have been edited by EPA if the terminology
used was unclear, the summary contained extraneous material for
clarification, or the summary unintentionally made the reader conclude
that the findings reflected EPA's position and not the position 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.
Dow AgroSciences LLC
PP 6F3344
    EPA has received an amendment of the pesticide petition (PP 6F3344)
from Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268
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
re-establishing the time-limited tolerances for residues of dichlormid
in or on the raw agricultural commodity corn (forage, grain, stover) at
0.05 parts per million (ppm). Zeneca Ag Products requested these
tolerances under the Federal Food, Drug, and Cosmetic Act, as amended
by the Food Quality Protection Act of 1996. A Notice of Filing was
submitted and published in the Federal Register of September 16, 1998
(63 FR 49568) (FRL-6025-8). Based on the data submitted by Zeneca, the
Agency determined that only time-limited tolerances for these residues
could be established. The final rule was published on March 27, 2000
(65 FR 16143) (FRL-6498-7) with the time-limited tolerances expiring on
March 27, 2002. To establish permanent tolerances the following studies
are required: (1) Chronic Feeding Study in Dogs, (2) 2-Generation
Reproductive Study in Rats, (3) General Metabolism Study, and (4)
Subchronic Neurotoxicity Study, (5) various product chemistry data-
color, physical state, water solubility; (6) animal metabolism studies,
(7) crop field trials, and (8) rotational crop study (Confined Study).
Zeneca committed to fulfill these data gaps. These time-limited
tolerances expired on March 27, 2002.
    On November 9, 2000, Zeneca Ag Products sold certain parts of its
business to Dow AgroSciences. In connection with the sale, Zeneca Ag
products tranferred all rights, title, and interest in dichlormid to
Dow AgroSciences.Dow AgroSciences has petitioned the Agency to re-
establish time-limited tolerances to allow for continued data
generation. 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 supports granting of
the petition. Additional data may be needed before EPA rules on the
petition.
A. Residue Chemistry
    1. Plant metabolism. The qualitative nature of the residue in
plants is adequately understood based on a study depicting the
metabolism of dichlormid in corn plants. The metabolism of dichlormid
in corn is extensive and occurs via two metabolic pathways. In one
pathway dichlormid is de-chlorinated and oxidized to generate N,N-
diallyl glycolamide. An alternative pathway is the loss of an allyl
group followed by oxidation to form dichloroacetic acid. There is also
extensive incorporation into natural constituents. EPA has previously
determined that dichlormid is the residue of concern for tolerance
setting purposes.
    2. Analytical method. An adequate enforcement method for residues
of dichlormid in corn has been developed and validated by the
Analytical Chemical Laboratory (ACL) of EPA. Analysis is carried out
using gas chromatography with nitrogen selective thermionic detection.
The limit of determination is 0.01 ppm.
    3. Magnitude of residues. Fifteen field trials in field corn with
dichlormid were submitted and reviewed. The submitted data support the
time-limited tolerance level of 0.05 ppm for all corn commodities.
B. Toxicological Profile
    1. Acute toxicity. Dichlormid has low acute toxicity as indicated
by a range of studies including: A rat acute oral study with an
LD50 of 2,816 milligram/kilogram (mg/kg) for males and 2,146
mg/kg for females, respectively; a rat acute dermal study with an
LD50 of <2,040 mg/kg and a rabbit acute dermal study with an
LD50 of <5,000 mg/kg; a rat inhalation study with an
LD50 of <5.5 mg/L; a primary eye irritation study in the
rabbit showing mild ocular irritation; a primary dermal irritation
study in the rabbit showing severe skin irritation; and, a skin
sensitization study which showed that dichlormid was a mild skin
sensitizer in the guinea pig.
    2. Genotoxicity. Dichlormid was not mutagenic in a range of in
vitro assays including the Salmonella/microsome (Ames) assay, the human
lymphocyte cytogenetic assay (both assays with and without metabolic
activation) and an unscheduled DNA synthesis (DNA repair) assay in
hepatocytes. In the L5178Y mouse lymphoma assay small increases in
mutant frequency were observed only at cytotoxic concentrations and
were not considered to be significant. In vivo, dichlormid was negative
in the mouse micronucleus test and in the rat unscheduled DNA synthesis
assay when tested at the maximum tolerated dose.
    3. Reproductive and developmental toxicity. In a developmental
toxicity study, rats were dosed orally by gavage with 0, 10, 40, or 160
mg/kg/day. The no observed adverse effect level (NOAEL) for maternal
toxicity was 10 mg/kg/day based on a reduction in bodyweight gain and
food consumption at 40 and 160 mg/kg/day. The developmental NOAEL was
determined to be 40 mg/kg/day based on marginal fetotoxic effects, including extra
14th ribs probably due to maternal stress, slight sternebra
misalignment and some centra unossified, at 160 mg/kg/day.
    In a developmental toxicity study, rabbits were dosed orally by
gavage with 0, 5, 30, or 180 mg/kg/day. The lowest observed adverse
effect level (LOAEL) for both maternal and fetotoxicity was 180 mg/kg/
day characterized by reduced body weight gain and food consumption and
a small increase in post-implantation loss, an increased number of
early resorptions, a decreased number of fetuses per litter and
evidence of fetotoxicity (partial ossification and misshapen/fused
sternebrae). The NOAEL for both maternal and developmental toxicity was
30 mg/kg/day.
    In a 2-generation reproduction study in rats fed diets of 0, 15,
75, and 500 ppm of dichlormid, dietary administration of 500 ppm
dichlormid (48.5 mg/kg/day) for two successive generations resulted in
decreased bodyweights and increased liver weights in parents and pups
of both generations. There were no effects on reproductive performance
or reproductive organs at dose levels up to and including 500 ppm
dichlormid. There were no toxicologically significant effects in
parents or offspring at a dose level of 75 ppm dichlormid (<7.4 mg/kg/
day).
    4. Subchronic toxicity. In a subchronic toxicity study, groups of
12 male and 12 female Wistar-derived alpk:ApfSD rats were fed diets
containing 0, 20, 200, or 2,000 ppm dichlormid for 90 days. Significant
reductions in bodyweight gain and food consumption were seen in male
and female rats receiving 2,000 ppm dichlormid and, to a lesser degree,
in females at 200 ppm. The liver was identified as the principal target
organ (enlargement, increased APDM activity in females, centrilobular
hypertrophy, increased bile duct pigmentation) in the 2,000 ppm group.
The NOAEL was 20 ppm (equivalent to approximately 1.8 mg/kg/day - see
discussion under Chronic toxicity in Unit 2.B.5 of this document) and
the LOAEL was 200 ppm, based on reduced bodyweight gain and food
consumption and a marginal increase in APDM activity in females and
liver enlargement in males.
    In a 90-day dog feeding study, previously submitted and accepted by
EPA, animals were dosed (4 dogs/sex/dose) at 0, 1, 5, 25, and 50 mg/kg/
day. The NOAEL was 5 mg/kg/day and the LOAEL 25 mg/kg/day based on
reduced bodyweight gain, increased liver weight and degenerative
changes in voluntary muscle with an associated increase in plasma
creatine kinase and alkaline phosphatase activity between 6 and 10
weeks.
    In a 14-week rat inhalation study, groups of 18 male and 18 female
Sprague-Dawley CD rats were subjected to a whole body exposure of 0,
2.0, 19.9, or 192.5 mg/m3 for 6 hours per day, 5 days per
week. The NOAEL was 2.0 mg/m3 based on histopathologic
tissue alterations to the nasal olfactory epithelium at 19.9 and 192.5
mg/m3, suggesting that dichlormid was a mild irritant to the
nasal cavity. An increase in relative liver, kidney, and lung weights
at 19.9 and 192.5 mg/m3 was not supported by gross or
histopathological observations.
    5. Chronic toxicity. Rats (64/sex/group) were fed diets containing
0, 20, 100, or 500 ppm dichlormid (0, 1.3, 6.5, 32.8 mg/kg/day for
males and 0, 1.5, 7.5, 37.1 mg/kg/day for females) for up to 2 years.
At 500 ppm in both males and females, there were treatment-related
effects on growth and food consumption, minor reductions in plasma
triglycerides and in males, increased liver weights, accompanied by
hepatocyte vaculolation and pigmentation effects. In females there was
a slight overall increase in malignant tumors, primarily uterine
adenocarcinomas, at 500 ppm, but this specific increase was within the
spontaneous incidence observed in historical data. It was concluded
that there was no evidence of oncogenicity associated with dichlormid
treatment. The NOAEL for chronic toxicity was 100 ppm (6.5 and 7.5 mg/
kg/day for males and females, respectively).
    In an 18-month oncogenicity study, mice (55/sex/group) were fed
dichlormid at doses of 0, 10, 50, or 500 ppm (0, 1.4, 7.0, 70.7 mg/kg
for males and 0, 1.84, 9.2, 92.4 mg/kg for females). At 500 ppm there
was a slight increase in mortality for females from week 64 onwards,
and bodyweights and food utilization were reduced in males, and, to a
lesser extent in females. Also, mice fed 500 ppm dichlormid showed non-
neoplastic changes which were minor and consisted of changes in
severity or incidence of common spontaneous findings. Based on these
effects, the chronic NOAEL was 50 ppm (7.0 and 9.2 mg/kg/day for males
and females, respectively). There was a marginal increase in Harderian
gland adenomas in males at 500 ppm, but this was considered to reflect
the variable spontaneous tumor rate seen in this strain and sex of
mouse. It was concluded there was no evidence of oncogenicity
associated with dichlormid treatment.
    Based on available chronic toxicity data, the Reference Dose (RfD)
for dichlormid is 0.07 mg/kg/day. This RfD is based on the 2-year
feeding study in rats with an NOAEL of 7 mg/kg/day. An uncertainty
factor of 100 was used to account for interspecies extrapolation and
intraspecies variability. The 2-year rat study is consistent with, but
supersedes, the 90-day rat study. The 2-year rat NOAEL of 7 mg/kg/day
lies between 1.8 and 18 mg/kg/day derived from the NOAEL and LOAEL
figures of 20 and 200 ppm, respectively, for the most recent 90-day rat
study. Thus, the overall NOAEL in the rat for both chronic and
subchronic exposure should be regarded as 7 mg/kg/day. Based on the
proposed Guidelines for Carcinogenic Risk Assessment (July 1999),
dichlormid is not likely to be a human carcinogen and a margin of
exposure (MOE) approach should be used for human risk assessment.
    6. Animal metabolism. Dichlormid was well absorbed, extensively
metabolized and eliminated mainly in the urine within 24 hours. A
significant proportion of the dose, up to 11%, was exhaled as
CO2. Two routes of biotransformation have been identified.
One route involved the formation of an alcohol N,N-diallylglycolamide
before subsequent oxidation to N,N-diallyloxamic acid, a major
metabolite present in the urine and feces of both sexes. N,N-
diallylglycolamide also undergoes further biotransformation to minor
dechlorinated metabolites. In the second metabolic pathway
dichloroacetic acid present in the urine of both sexes is formed either
directly from dichlormid or indirectly by transformation of N-allyl-
2,2-dichloro-N-(2,3-dihydroxypropyl)acetamide. Entero-hepatic
recirculation plays a major role in the distribution, metabolism and
excretion of dichlormid. The elimination as CO2, the even
elimination in urine over the first 24 hours, and wide distribution of
retained radioactivity indicates some incorporation into endogenous
metabolic processes.
    7. Metabolite toxicology. No unique plant or soil metabolites have
been identified that warrant a separate toxicological assessment.
    8. Endocrine disruption. There is no overall trend in the
toxicology database that indicates that dichlormid would have endocrine
disrupting activity. The mammalian and ecotoxicology databases do not
indicate significant adverse effects associated with endocrine
disrupter activity.
C. Aggregate Exposure
    1. Food. In conducting a chronic dietary risk assessment, reference
is made to the conservative assumptions made by EPA: Dichlormid time-
limited tolerances (65 FR 16143, March 27, 2000), 100% crop-treated,
and that all commodities contain residues at the tolerance or proposed
tolerance. The analysis was determined using the Novigen Dietary
Exposure Evaluation Model (DEEM Version 6.2) software and the United
States Department of Agriculture (USDA) Nationwide Continuing Surveys
of Food Intake by Individuals (CSFII) survey that was conducted from
1994 through 1996.
    2. Drinking water. Dichlormid is very rapidly degraded in soil
(laboratory measured aerobic half-life of 8 days) and applied at a
maximum rate of 0.5 lb/acre, so despite only exhibiting moderate
adsorption to soil (Koc 36-49), the leaching potential for dichlormid
to reach ground water is expected to be low. The impact of the
interactive processes of adsorption and degradation on leaching have
been assessed using EPA mathematical models of pesticide movement in
soil. Drinking water estimate concentrations (DWEC) were calculated for
ground water using Screening Concentration in Ground Water (SCI-GROW)
modeling, and surface water estimate concentrations were calculated
using Generic Estimated Environmental Concentration (GENEEC) modeling.
These models predict a ground water concentration of 0.05 ppb and
surface water concentrations of 27.3 ppb for an instantaneous peak and
26.9 ppb for a 56-day average. However, the interim Agency policy in
March 2000, allowed the average 56-day GENEEC values to be divided by 3
(9.0 ppb) to obtain a value for chronic risk assessments. Drinking
water levels of concern (DWLOC) were then calculated for both chronic
and acute exposure. These DWLOC values are all comfortably below the
water exposure estimates obtained from the screening level model
GENEEC. Dow AgroSciences does not expect exposure to dichlormid
residues in drinking water to be a concern.
    3. Non-dietary exposure. The general population is not expected to
be exposed to dichlormid through non-dietary routes since dichlormid is
used only on agricultural crops and is not used in or around the home.
D. Cumulative Effects
    The potential for cumulative effects of dichlormid and other
substances that have a common mechanism of toxicity have been
considered. There is no reliable information to suggest that dichlormid
has any toxic effects that arise from toxic mechanisms common to other
substances. Therefore, a consideration of common mechanism and
cumulative effects with other substances is not appropriate for
dichlormid.
E. Safety Determination
    1. U.S. population--i. Chronic risk. Using the conservative
exposure assumptions described earlier, and based on the completeness
and reliability of the toxicity data base for dichlormid, the
theoretical maximum residue concentration (TMRC) for the general U.S.
population is calculated to be 0.00009 mg/kg/day, or 4.1% of the cPAD
(0.0022 mg/kg/day). The most highly exposed subgroup are children aged
1-6 years with a TMRC of 0.000211 mg/kg/day, or 9.6% of the cPAD. The
RfD represents the level at or below which daily aggregate dietary
exposure over a lifetime will not pose appreciable risks to human
health. Dow AgroSciences concludes that there is a reasonable certainty
that no harm will result from aggregate exposure to dichlormid
residues.
    ii. Acute risk. The acute toxicity of dichlormid is low and there
are no concerns for acute-dietary, occupational, or non-occupational
exposures to dichlormid.
    2. Infants and children. In assessing the potential for additional
sensitivity of infants and children to residues of dichlormid, data
from developmental toxicity studies in the rat and rabbit have been
considered. The developmental toxicity studies are designed to evaluate
adverse effects on the developing organism resulting from maternal
pesticide exposure during gestation. There was no evidence to suggest
that dichlormid was a developmental toxicant in either the rat or
rabbit. It was also observed that there was no risk below maternally
toxic doses as the NOAEL for developmental effects in the rat was 40
mg/kg/day, compared to the maternal NOAEL of 10 mg/kg/day and, in the
rabbit study, the NOAEL for both maternal and developmental effects was
30 mg/kg/day. EPA previously concluded in the March 27, 2000 Federal
Register that the additional 10x safety factor should be retained due
to the qualitative evidence of increased susceptibility demonstrated
following in utero exposure in the prenatal developmental toxicity in
rabbits and an incomplete toxicity data base. It should be noted that
in the rabbit developmental toxicity study, the LOAEL for both maternal
and developmental toxicity was 180 mg/kg/day. The effects on
resorptions at this dose were observed in dams which showed an average
weight loss (-3.8 gram) during the treatment period compared with an
average weight gain in controls of 272 gram. Also, a multigeneration
study has now been completed and, therefore, an additional safety
factor should no longer be necessary.
    Additional uncertainty factors are not warranted for the safety of
infants and children as reliable data support the appropriate use of a
100-fold uncertainty factor (MOE) to account for interspecies
extrapolation and intraspecies variability. However, using the
conservative exposure assumptions above for the determination in the
general population, it is concluded that the percentage of cPAD that
will be utilized by aggregate exposure to dichlormid is 9.6% for
children aged 1-6 years (the group at highest risk). Therefore, based
on the completeness and reliability of the toxicity database and the
conservative exposure assessment, it is concluded that there is a
reasonable certainty that no harm will result to infants and children
from aggregate exposure to dichlormid residues.
F. International Tolerances
    A Maximum Residue Level has not been established for dichlormid by
the Codex Alimentarius Commission.
[FR Doc. 02-12849 Filed 5-21-02; 8:45 am]
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