[Federal Register Volume 69, Number 32 (Wednesday, February 18, 2004)]
[Notices]
[Pages 7632-7635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E4-270]
[[Page 7632]]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2003-0213; FRL-7343-2]
Spirodiclofen; Notice of Filing a Pesticide Petition to Establish
a Tolerances 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-2003-0213, must be
received on or before March 19, 2004.
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: Rita Kumar, Registration Division
(7505C), Office of Pesticide Programs, Environmental Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 308-8291; 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:
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 ID number OPP-2003-0213. 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 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
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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-2003-0213. 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-2003-0213. 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-2003-0213.
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-2003-0213. 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: January 27, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner's summary of the pesticide petition is printed below
as required by FFDCA section 408(d)(3). The summary of the petition was
prepared by Bayer CropScience 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 2F6469
EPA has received a pesticide petition (PP 2F6469) from Bayer
CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, 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
Spirodiclofen; 3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro [4,5]dec-3-en-4-
yl ester 2,2-dimethyl-butanoic acid, in or on the raw agricultural
commodities citrus fruit group at 0.3 parts per million (ppm), citrus
pulp, dried, at 0.4 ppm, citrus oil at 20 ppm, pome fruit group at 0.8
ppm,
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pome fruit pomace, wet, at 6.0 ppm, stone fruit group at 1.0 ppm, tree
nut group at 0.05 ppm, almond hulls at 20 ppm, pistachios at 0.05 ppm,
grape at 2.0 ppm and grape, raisin at 4.0 ppm. Spirodiclofen, 3-(2,4-
dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl ester 2,2-dimethyl-
butanoic acid, and/or its enol metabolite, 3-(2,4-dichlorophenyl)-4-
hydroxy-1-oxaspiro [4,5]dec-3-en-2-one, in or on the raw agricultural
commodities cattle, fat, at 0.01 ppm and cattle, meat by-products, at
0.05 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 spirodiclofen in plants is
adequately understood. Studies have been conducted to delineate the
metabolism of radiolabeled spirodiclofen in various crops, all showing
similar results. The residue of concern is spirodiclofen.
2. Analytical method. Adequate analytical methodology using LC/MS/
MS detection is available for enforcement purposes.
3. Magnitude of residues. Complete residue data exists for
spirodiclofen on these crops and crop groupings. The data support the
requested tolerances.
B. Toxicological Profile
1. Acute toxicity. Oral and dermal LD50 values were
>2,000 milligrams/kilogram body weight (mg/kg bwt). Inhalation
LC50 values were >5,030 mg/m3 air. Spirodiclofen
was not irritating to rabbit skin or eyes but did cause skin
sensitization in the Magnusson/Kligman maximization test in guinea
pigs. Acute toxicity studies for spirodiclofen 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 and developmental no observed adverse effect
levels (NOAELs) were 1,000 mg/kg bwt/day. An oral developmental
toxicity study in rabbits demonstrated a maternal NOAEL of 100 mg/kg
bwt/day and did not reveal any teratogenic potential. A two-generation
study in rats, with a parental toxicity NOAEL of 5.2 mg/kg bwt/day, did
not reveal evidence of a primary reproductive toxicity potential. The
reproductive NOAEL was 26.2 mg/kg bwt/day based on various clinical and
histopathological findings at higher dose levels.
4. Subchronic toxicity. A subchronic toxicity feeding study with
rats over 90 days demonstrated a NOAEL of 32.1 and 8.1 mg/kg bwt/day
for males and females, respectively, based on effects on the lipid
metabolism (decrease of triglycerides and cholesterol), liver effects
(increase in transaminases) and adrenal effects (vacuolation) at the
higher dose levels. A subchronic feeding study in mice over 13-weeks
revealed no clinical toxicological signs. A NOAEL of 30.1 mg/kg bwt/day
for females was observed (a clear NOAEL was not established for males).
A 14-week feeding study in dogs demonstrated a NOAEL of 7.7 mg/kg bwt/
day.
5. Chronic toxicity. A 24-month combined chronic feeding/
carcinogenicity study in rats demonstrated a NOAEL of 14.7 mg/kg bwt/
day. An oncogenicity study in the mouse revealed a NOAEL of 4.1 mg/kg
bwt/day. Uterine and testicular oncogenicity was noted in the rat and
hepatic neoplasia was observed in the mouse. A 1-year feeding study
with dog demonstrated a NOAEL of 1.38 mg/kg bwt/day based on adrenal
effects (vacuolization) as well as changes in circulating cholesterol
and prostate weight at higher dose levels.
6. Animal metabolism. Metabolism and pharmacokinetic studies in the
rat demonstrate that spirodiclofen residues are rapidly absorbed,
metabolized and eliminated. The primary metabolite is the enol, which
is formed by cleavage of the alkyl ester group, but numerous other
metabolites are also formed.
7. Metabolite toxicology. The residue of concern is spirodiclofen
and its enol metabolite, which is a product of hydrolysis in mammalian
systems, as well as in the environment. Since the enol is inherently
present after administration, toxicology data for this metabolite is
completely supported by data obtained for spirodiclofen.
8. Endocrine disruption. The mammalian mode of action for
spirodiclofen includes that classified as inhibitory to steroid
biosynthesis, resulting in an indirect and endogenously-mediated
toxicological response. Effects do not have an impact on fertility,
reproduction, developmental or neuropathological parameters. Additional
mechanistic studies with the chemical indicated that there is no direct
effect on the endocrine system as there is no interaction with hormone
receptors.
C. Aggregate Exposure
1. Dietary exposure. For the acute dietary analysis, the acute
reference dose (aRfD), of 1.0 mg/kg/day was derived from a NOAEL of 100
mg/kg based on a prenatal developmental toxicity study in rabbits and
the application of an uncertainty factor (UF) of 100 to account for
inter-species extrapolation and intra-species variability. For the
chronic dietary analysis, the cRfD, of 0.0138 mg/kg/day was derived
from a NOAEL of 1.38 mg/kg/day based on a 1-year feeding study in dogs
and the application of an UF of 100. An FQPA safety factor of 3 was
also applied to the acute and chronic toxicology values, resulting in
an acute population adjusted dose (aPAD) of 0.33 mg/kg/day and a
chronic population adjusted dose (cPAD) of 0.0046 mg/kg/day. As a
conservative measure, the aPAD and cPAD values were used for all
population sub-groups when conducting the assessments.
i. Food. Assessments were conducted to evaluate the potential risks
due to acute and chronic dietary exposure of the entire U.S. population
and selected population subgroups to residues of spirodiclofen. These
analyses cover the proposed uses on citrus fruits (grapefruits, lemons,
and oranges), pome fruits (apples and pears), stone fruits (cherries,
peaches, and plums), tree nuts (almonds and pecans) and grapes. For the
acute dietary assessment, 100% crop treated and the highest or highest
average field trial residues were assumed. For the chronic assessment,
anticipated market share and average residue values were assumed. For
the acute analysis, the most highly exposed population subgroup was
non-nursing infants (< 1-year) with an exposure equal to 2.3% of the
aPAD at the 95th percentile. Acute exposure of the overall
U.S. population was equivalent to 0.45% of the aPAD. For the chronic
dietary analysis, the most highly exposed population subgroup was
children 1-6 years, with an exposure equal to 1.9% of the cPAD. Chronic
exposure for the overall U.S. population equated to 0.6% of the cPAD.
These acute and chronic dietary exposure estimates are well below EPA's
level of concern for the overall U.S. population as well as the various
population subgroups.
ii. Drinking water. Spirodiclofen is immobile in soil; and
therefore, will not leach into ground water. Additionally, due to
insolubility in water and a highly lipophilic nature, any residues in
[[Page 7635]]
surfacewater will rapidly bind to soil particles and remain with
sediment where it is quickly degraded; and therefore, not contribute to
potential dietary exposure from drinking water. The estimated
environmental concentration (EEC) values for spirodiclofen and the enol
metabolite were calculated using the tier I screening concentration in
ground water (SCI-GROW), screening model for ground water estimates,
and the tier II PRZM/EXAMS, models with index reservoir (IR) and
percent crop area (PCA) factor for surface water estimates. The
potential EEC levels were determined for the maximum usage intensity
for each crop. The acute and chronic percent of population adjusted
dose (%PAD) values associated with drinking water exposure were
calculated based on a NOAEL of 100 mg/kg/day for acute exposure and
1.38 mg/kg/day for chronic exposure. The uncertainty factor (UF)
considered in the analysis was 100X, and an additional Food Quality
Protection Act (FQPA) safety factor of 3X was used both for acute and
chronic calculations. The SCI-GROW estimated maximum ground water EEC
level for spirodiclofen and enol combined was 0.003 ppb, suggesting
that the compounds have a low potential to leach and contaminate the
ground water under normal use. The highest estimate of the total acute
concentration in surface water for spirodiclofen and enol combined was
6.04 parts per billion (ppb). The highest estimate of the total chronic
concentration in surface water for spirodiclofen and enol combined was
0.67 ppb. The maximum %PAD calculated, 1.46%, was for infant/children
chronic exposure. The low %PAD indicates that the human health risk
associated with the presence of spirodiclofen and/or its enol
metabolite in drinking water is minimal.
2. Non-dietary exposure. There are no indoor residential, indoor
commercial or outdoor residential uses for spirodiclofen. Exposure and
risk assessments were prepared for both mixer/loader-applicators and
reentry workers during use of spirodiclofen on citrus, tree nuts and
pome/stone fruit. Worker margins of exposure (MOE) estimates were
conservatively based on a NOAEL of 1.38 mg/kg/day, maximum label rates,
and a dermal absorption value of 2.3%. An occupational exposure
uncertainty factor of 100 was used in the assessment. Margins of
exposure total ranged from 360 to 69,000, indicating that the use of
spirodiclofen poses no significant risk to workers who mix, load and
apply this product, or to those who reenter treated areas to perform
post-application activities. These data support the use of a single
layer of clothing for mixer/loaders and applicators, and gloves for
mixer/loaders, and a 12-hour REI for reentry workers.
D. Cumulative Effects
Spirodiclofen represents a new class of chemistry, ketoenoles.
Bayer will submit information, if necessary, for EPA to consider
concerning potential cumulative effects of spirodiclofen consistent
with the schedule established by EPA at 62 Federal Register 42020 (Aug.
4, 1997) and other EPA publications pursuant to the Food Quality
Protection Act.
E. Safety Determination
1. U.S. population. Based on the exposure assessments described
above and on the completeness and reliability of the toxicity data, it
can be concluded that total aggregate exposure to spirodiclofen from
all label uses will utilize less than 5% of the RfD for chronic dietary
exposures and that margins of exposure in excess of 360 exist for
aggregate exposure to spirodiclofen for non-occupational exposure. EPA
generally has no concerns 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.
Margins of exposure of 100 or more (300 for infants and children) also,
indicate an adequate degree of safety. Thus, it can be concluded that
there is a reasonable certainty that no harm will result from aggregate
exposure to spirodiclofen residues.
2. Infants and children. In assessing the potential for increased
sensitivity of infants and children, data from developmental studies in
both rat and rabbit and a 2-generation reproduction study in the rat
can be considered. The developmental toxicity studies evaluate any
potential adverse effects on the developing animal resulting from
pesticide exposure of the mother during prenatal development. The
reproduction study evaluates any effects from exposure to the pesticide
on the reproductive capability of mating animals through two
generations, as well as any observed systemic toxicity. None of these
studies conducted with spirodiclofen indicated developmental or
reproductive effects. The toxicology data which support these uses of
spirodiclofen include the following: An oral developmental toxicity
study in rat that did not reveal any evidence of teratogenic potential.
Maternal and developmental NOAELs were 1,000 mg/kg bwt/day. An oral
developmental toxicity study in rabbits demonstrated a maternal NOAEL
of 100 mg/kg bwt/day and did not reveal any teratogenic potential. A
two-generation study in rats, with a parental toxicity NOAEL of 5.2 mg/
kg bwt/day, did not reveal evidence of a primary reproductive toxicity
potential. The reproductive NOAEL was 26.2 mg/kg bwt/day based on
various clinical and histopathological findings at higher dose levels.
FFDCA section 408 provides that EPA may apply an additional safety
factor for infants and children. The additional safety factor may be
used when prenatal and postnatal threshold effects were observed in
studies or to account for incompleteness of the toxicity database.
Based on the toxicological data requirements, the data relative to
prenatal and postnatal effects in children is complete. No indication
of increased susceptibility of younger animals was observed in any of
the above studies. For the population with the highest exposure, non-
nursing infants <1 year old, the acute dietary exposure at the
95th percentile was 2.3% of the aPAD, equivalent to an MOE
of 13,167. For the population described as children 1-6 years old, the
exposure was 1.2% of the aPAD, equivalent to an MOE of 25,638. Acute
exposure of the overall U.S. population was equivalent to 0.45% of the
aPAD. For the chronic dietary analysis, the most highly exposed
population subgroup was children 1-6 years old, with an exposure equal
to 1.9% of the cPAD. Chronic exposure for the overall U.S. population
equated to 0.6% of the cPAD.
F. International Tolerances
Codex maximum residue levels MRLs are not yet established for
spirodiclofen.
[FR Doc. E4-270 Filed 2-17-04; 8:45 am]
BILLING CODE 6560-50-S