[Federal Register Volume 68, Number 250 (Wednesday, December 31, 2003)]
[Notices]
[Pages 75504-75507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-32205]



[[Page 75504]]

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0366; FRL-7334-2]


Clothianidin; 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-2003-0366, must be 
received on or before January 30, 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: Daniel Kenny, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7546; e-mail address:[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

     You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Crop production (NAICS code 111)
    [sbull] Animal production (NAICS code 112)
    [sbull] Food manufacturing (NAICS code 311)
    [sbull] Pesticide manufacturing (NAICS code 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-2003-0366. 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

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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-2003-0366. 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-2003-0366. 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-2003-0366.
    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-2003-0366. 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: December 5, 2003.
Peter Caulkins,
Acting 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 Arvesta Corporation 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.

Arvesta Corporation

PP 1F6342

     EPA has received a pesticide petition (1F6342) from Arvesta 
Corporation, 100 First Street, Suite 1700, San Francisco, CA 94105 
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 clothianidin in or on the raw 
agricultural commodity apples and pears at 1.0 parts per million (ppm). 
EPA has determined that the petition contains data or information 
regarding the elements set forth in section

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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. In plants, the metabolism of clothianidin is 
adequately understood for the purposes of establishing these proposed 
tolerances. Unchanged, parent clothianidin was the predominant residue 
in all crop matrices (14.4% to 64.5% in corn, 66.1% to 96.6% in 
tomatoes, 4.3% to 24.4% in sugar beets and 24.3% to 63.3% in apples), 
with the exception of sugar beet leaves. In sugar beet leaves, the main 
components were the methylguanidine and thiazolylmethylguanidine 
metabolites, accounting for 28.6% and 27.7% respectively. All 
metabolites found in plants were also found in the animal metabolism 
studies. In animals, parent clothianidin was the major component in 
liver, muscle and fat. Based on the available metabolism data, parent 
clothianidin, TZG, TZU, and ATMG-Pyr are proposed to be considered as 
the residues of concern in livestock matrices.
    2. Analytical method. In plants and plant products, the residue of 
concern, parent clothianidin, can be determined using high performance 
liquid chromotography (HPLC) with electrospray mass spectroscopy (MS/
MS) detection. In an extraction efficiency testing, the plant residues 
method has also demonstrated the ability to extract aged clothianidin 
residue.
     In animal matrices, the residues parent clothianidin, TZG, TZU, 
and ATMG-Pyr can also be determined using HPLC with electrospray MS/MS 
detection. In an extraction efficiency testing, the animal residues 
method has also demonstrated the ability to extract aged clothianidin, 
TZG, TZU, and ATMG-Pyr residues.
     Although, the plant and animal residues LC-MS/MS method is highly 
suitable for enforcement method, an LC-UV method has also been 
developed which is suitable for enforcement (monitoring) purposes in 
all relevant matrices.
    3. Magnitude of residues. For apples, a total of 13 field trials 
were conducted to evaluate the magnitude of the residues of 
clothianidin in apples. Apple trees were treated with clothianidin at a 
rate of 0.2 lb active ingredient (a.i./acre). The highest average field 
trial residue found was 0.174 ppm in apple at 7 days pre-harvest 
interval (PHI). The apple processing study conducted at the exaggerated 
rate of 3X rate indicated no concentration in any processed commodities 
including apple juice and wet pomace. A residue decline study was 
conducted, and an estimated half-life value was obtained at 5.9 days.
     For pears, a total of seven field trials were conducted to 
determine the residue level in pear following one single treatment with 
clothianidin at a rate of 0.2 lb a.i./acre. The highest average field 
trial clothianidin residue was 0.163 ppm in pears. A residue decline 
study was conducted, and an estimated half-life value was obtained at 
11.5 days for pears.

B. Toxicological Profile

    1. Acute toxicity. The acute oral lethal dose (LD)50 was 
>5,000 milligrams/kilogram body weight (mg/kg bwt) for both male and 
female rats. The acute dermal LD50 was greater than 2,000 
mg/kg bwt in rats. The 4-hour inhalation liquid chromatography 
(LC)50 6.14 milligrams per liter (mg/L) for male and female 
rats. Clothianidin was not irritating to rabbit skin or eyes and did 
not cause skin sensitization in guinea pigs.
    2. Genotoxicty. Extensive mutagenicity studies were conducted with 
clothianidin. Based on the weight of evidence clothianidin was 
considered negative for genotoxicity.
    3. Reproductive and developmental toxicity. In a two-generation 
reproduction study, rats were administered dietary levels of 0, 150, 
500 and 2,500 ppm. The no observed adverse effect level (NOAEL) for 
reproductive parameters was 2,500 ppm. The NOAEL for developmental 
effects was 500 ppm based on decreased pup weights and the parental 
NOAEL and 150 ppm based on the decreased body weights.
     A developmental toxicity study was conducted in rats with 
clothanidin using dose levels of 0, 10, 50 and 125 mg/kg bwt by gavage. 
The NOAEL for maternal toxicity was established at 10 mg/kg bwt and for 
developmental effects it was >125 mg/kg bwt. Additionally, a 
developmental toxicity was conducted with rabbits treated orally by 
gavage at 0, 10, 25, 75 and 100 mg/kg bwt. The NOAEL for maternal 
toxicity was 10 mg/kg bwt and for developmental toxicity it was 75 mg/
kg bwt.
     Developmental toxicity studies showed no primary developmental 
toxicity and no teratogenic potential was evident.
    4. Subchronic toxicity. 90-day feeding studies were conducted in 
rats and dogs. The rat study was conducted at dietary levels of 0, 150, 
500 and 3,000 ppm and the dog study was conducted at 0, 325, 650 and 
1,500 ppm. The NOAELs were established at 500 ppm for rat and 650 ppm 
for the dog.
    5. Chronic toxicity. A two-year combined rat chronic/oncogenicity 
conducted at dietary levels of 0, 150, 500, 1,500 and 3,000 ppm 
demonstrated a NOAEL of 150 ppm based on reduced weight gains and non-
neoplastic histomorphological changes. A 78-week mouse oncogenicity 
study conducted at dose levels of 0, 100, 350, 1,250, and 2,000, and 
1,800 ppm for males and females, respectively, revealed NOAEL of 350 
ppm based on reduced body weight gains and increased incidence of 
hypercellular hypertrophy. No evidence of oncogenicity was seen in the 
rat or the mice. A 52-week chronic toxicity study in dogs conducted at 
dietary levels of 0, 325, 650, 1,500 and 2,000 ppm revealed on overall 
NOAEL of 325 ppm based on slight decrease in ALT.
    6. Animal metabolism. The nature of the clothianidin residue in 
livestock is adequately understood. In animals, parent clothianidin was 
the major component in liver, muscle and fat. Based on the available 
metabolism data, parent clothianidin, TZG, TZU, and ATMG-Pyr are 
proposed to be considered as the residues of concern in livestock 
matrices.
    7. Metabolite toxicology. Eight in vivo metabolites of clothianidin 
identified in the rat were investigated for acute oral endpoint 
mutagenic activity. None of the metabolites were mutagenic either with 
or without activation and the lethal dose (LD)50 values 
range from <500 to >2,000 mg/kg, showing low to moderate toxicity.
    8. Endocrine disruption. All guideline studies conducted to 
characterize toxicological profile showed no endocrine related toxicity 
or tumorgenicity. No effects on T3, T4, TSH were 
observed in the subchronic rat study. In a two-generation reproduction 
study in rat; and rat and rabbit teratology studies, clothianidin did 
not show reproductive or teratogenic effects. The extensive data base 
shows that clothianidin has no endocrine properties.

C. Aggregate Exposure

    1. Dietary exposure. The acute reference dose (aRfD) of 0.6 mg/kg 
bwt/day (acute NOAEL with a 100-fold uncertainty factor) was used to 
assess acute dietary exposure.
     Seed treatment use. Bayer has conducted an acute dietary exposure 
Tier 2 assessment estimating the percent of the aRfD and corresponding 
margins

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of exposure (MOE) for the overall U.S. population (all seasons) and the 
following subpopulations: all infants (<1 year), non-nursing infants 
(<1 year), children (1-6 years), children (7-12 years), females (13-19 
years), females (13-50 years), males (13-19 years), males (>20 years), 
and seniors (>55 years). In this refined Tier 2 analysis, all evaluated 
population subgroups had an exposure equal to 0% of the aRfD with a 
corresponding MOE of >1 million at the 95th percentile.
     Foliar application use (pome fruit). Tomen has conducted an acute 
dietary exposure Tier 1 analysis with Dietary Exposure Evaluation Model 
(DEEM) using proposed tolerance of 1 ppm, 100% crop treated and no 
adjustment of processing factor for the overall U.S. populations and 
the following subpopulations: all infants, nursing infants (<1 year), 
non-nursing infants (<1 year), children (1-6 years), children (7-12 
years), and females (13-50 years). The results of Tier 1 analysis from 
foliar use of pome fruit indicated that the highest exposure never 
exceeds 5.42% of the aRfD at the 95th percentile.
     The chronic reference dose (cRfD) of 0.097 mg/kg bwt/day (chronic 
NOAEL with a 100-fold uncertainty factor) was used to assess chronic 
dietary exposure.
     Seed treatment use. Bayer's chronic dietary analysis estimated the 
percent of the cRfD and corresponding MOE for the overall U.S. 
population (all seasons) and the following subpopulations: all infants 
(<1 year), non-nursing infants (<1 year), children (1-6 years), 
children (7-12 years), females (13-19 years), females (13-50 years), 
males (13-19 years), males (>20 years), and seniors (>55 years). In 
this analysis, all evaluated population subgroups had an exposure equal 
to 0% of the cRfD. The corresponding MOE was >1 million.
     Foliar application use. Tomen has conducted a chronic Tier 1 
analysis and the results indicated that the highest exposure never 
exceeds 8.7% of the cRfD at the 95th percentile.
    i. Food. See above discussion.
    ii. Drinking water. For drinking water, the models SCI-GROW (ground 
water), and generic expected environmental concentration (GENEEC) 
(surface water), were selected to calculate the potential exposure of 
TM-444 in drinking water. Both short-term (acute) and long-term 
(chronic) exposures were estimated with respect to foliar uses on 
apples and pears. The predicted ground water concentrations for foliar 
application of apples and pears were 1.17 and 1.30 [mu]/L, 
respectively. The highest estimated acute and chronic exposures from 
surface water were 9.10 and 3.07 [mu]/L, respectively. Based on the 
standard exposure scenarios for drinking water (70kg adult- 2L/day; 10 
kg child- 1L/day), the potential human exposure and risk can be 
estimated. Using the acute (0.60 mg/kg/day) and chronic (0.097 mg/kg/
day) reference doses (RfD), the human risk from exposure to TM-444 in 
drinking water is estimated. The risk to adults and children from 
ground water exposure ranged from 0.006 to 0.019% of the acute RfD and 
from 0.038 to 0.134% of the chronic RfD; from surface water, the 
estimated risk ranged from 0.039% to 0.152% of the acute RfD and 0.081 
to 0.316% of the chronic RfD respectively.
    2. Non-dietary exposure. Clothianidin is currently not registered 
for use on any residential non-food site. Therefore, residential 
exposure to clothianidin residues will be through dietary exposure 
only.

D. Cumulative Effects

     There is no information available to indicate that toxic effects 
produced by clothianidin are cumulative with those of any other 
compound.

E. Safety Determination

    1. U.S. population. Using the conservative exposure assumptions 
described above and based on the completeness of the toxicity data, it 
can be concluded that total aggregate exposure to clothianidin from all 
proposed uses will be less than 9% of the RfD for the overall U.S. 
population. All evaluated population subgroups had an exposure less 
than 9% of the RfD. 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. Thus, Arvesta believes that it can be concluded 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to clothianidin residues.
    2. Infants and children. In assessing the potential for additional 
sensitivity of infants and children to residues of clothianidin, the 
data from developmental toxicity studies in both the rat and rabbit, a 
two-generation reproduction study in rats and a developmental 
neurotoxicity study in rats have been considered.
     The developmental toxicity studies evaluate potential adverse 
effects on the developing animal resulting from pesticide exposure of 
the mother during prenatal development. The reproduction study 
evaluates effects from exposure to the pesticide on the reproductive 
capability of mating animals through two generations, as well as any 
observed systemic toxicity.
     The developmental neurotoxicity studies evaluate the 
neurobehavioral and neurotoxic effects on the developing animal 
resulting from the exposure of the mother. FFDCA section 408 provides 
that EPA may apply an additional uncertainty factor for infants and 
children based on the threshold effects to account for prenatal and 
postnatal effects and the completeness of the toxicity data base. Based 
on the current toxicological data requirements the toxicology data base 
for clothianidin relative to prenatal and postnatal development is 
complete, including the developmental neurotoxicity study. None of the 
studies indicated the offsprings to be more sensitive. All effects were 
secondary to severe maternal toxicity. The RfD for clothianidin was 
calculated using the NOAEL of 9.7 mg/kg bw/day from the two-year 
chronic/oncogenicity study. This NOAEL is lower than the NOAEL from the 
two-generation reproduction study, the developmental studies, and the 
developmental neurotoxicity study. Moreover, using a toxicologically 
justified UF of 100, the RfD for a non-oncogenic clothianidin was 
established at a level 0.097 mg/kg/day, a value that offers a measure 
of safety that is the highest among the other alternative compounds for 
control of apple and pear pests.

F. International Tolerances

     No CODEX maximum residue levels (MRL's) have been established for 
residues of clothianidin on any crops at this time.

[FR Doc. 03-32205 Filed 12-30-03; 8:45 am]
BILLING CODE 6560-50-S