[Federal Register Volume 69, Number 235 (Wednesday, December 8, 2004)]
[Notices]
[Pages 71036-71040]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-27004]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0377; FRL-7687-4]


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 identification (ID) number OPP-
2004-0377 must be received on or before January 7, 2005.

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: Dan 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: <a href="/cdn-cgi/l/email-protection#561d3338382f781237381633263778313920"><span class="__cf_email__" data-cfemail="d09bb5bebea9fe94b1be90b5a0b1feb7bfa6">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    <bullet> Crop production (NAICS 111)
    <bullet> Animal production (NAICS 112)
    <bullet> Food manufacturing (NAICS 311)
    <bullet> 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-2004-0377. 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 <greek-i>2, 1801 South Bell St., Arlington, VA. This 
docket facility is open from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The docket telephone number is (703) 
305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B. EPA intends to work towards 
providing electronic access to all of the publicly available docket 
materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic

[[Page 71037]]

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-2004-0377. 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 <a href="/cdn-cgi/l/email-protection#137c63633e777c70787667537663723d747c65"><span class="__cf_email__" data-cfemail="acc3dcdc81c8c3cfc7c9d8ecc9dccd82cbc3da">[email protected]</span></a>, 
Attention: Docket ID Number OPP-2004-0377. 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-2004-0377.
    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 
<greek-i>2, 1801 South Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2004-0377. 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 record keeping 
requirements.



[[Page 71038]]


    Dated: November 30, 2004.

Lois Rossi,
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.

Arvesta Corporation

PP 4F6869

    EPA has received a pesticide petition (4F6869) 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 commodities grapes at 0.5 parts per million (ppm), raisins 
at 1.0 ppm, and potatoes at 0.1 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 
supports 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 (TMG) 
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 chromatography (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 can also extract aged clothianidin, TZG, TZU, and ATMG-Pyr 
residues.
    Although for the plant and animal residues this HPLC-MS/MS method 
is highly suitable as an enforcement method, an LC-ultraviolet (UV) 
method has also been developed which is suitable for enforcement 
(monitoring) purposes in all relevant matrices.
    3. Magnitude of residues-- i. Potatoes. Fifteen residue trials were 
conducted in key potato producing regions of the United States. At each 
trial, two different application regimes, foliar and in-furrow, were 
studied in separate plots. Samples were analyzed for residues of 
clothianidin.
    Three foliar applications of 0.0661 pounds (lb) per active 
ingredient/acre (ai/A) were made with the 50 WDG formulation at 28, 21 
and 14 days prior to harvest. Clothianidin residues ranged from ND to 
0.0205 ppm for this treatment.
    One in-furrow application of 0.198 lb ai/A was made with the 16 WSG 
formulation. Clothianidin residues ranged from less than the limit of 
detection (LOD) (0.007 ppm) to 0.0332 ppm for this treatment.
    At one of the trial sites, two additional plots were treated at 5X 
the normal application rate for the processing phase of the study. 
Spray volumes range from 13.3 to 31.2 gallons per acre (GPA). The 
processing portions analyzed were whole tubers, granules, chips, and 
wet peel.
    The foliar application of 50WDG was made at the 5X rate of 0.331 lb 
ai/A for the processing phase of the study. All of the clothianidin 
mean residues were less than limit of quantitation (LOQ) except for 
granules, which had mean clothianidin residues of 0.0316 ppm. The 
concentration factor (CF) for granules was calculated as 3.2. It was 
not possible to calculate a reliable CF in commodities other than 
granules. A residue decline study indicated that residues do not 
increase with longer preharvest intervals (PHI).
    The in-furrow application of 16WSG was made at the 5X rate of 0.99 
lb ai/A for the processing phase of the study. Clothianidin mean 
residues in whole tubers, granules, chips, and wet peel were 0.0258, 
0.0546, 0.04 (< LOQ), and 0.007 (<LOQ) ppm, respectively. The CF for 
granules, chips, and wet peel were 2.1, 1.6, and <1, respectively.
    ii. Grapes. Twelve residue trials were conducted in key grape 
producing regions of the United States. At each trial two different 
application regimes, foliar and drip irrigation, were studied in 
separate plots. Samples were analyzed for residues of clothianidin.
    Two foliar applications of 0.0992 lb ai/A/application were made 
with the 50 WDG formulation at 14 and 0 days prior to normal harvest. 
Clothianidin residues ranged from 0.0398 to 0.410 ppm for this 
treatment.
    At all of the trial sites except two in New York, a plot was 
established with one drip application of the 16 WSG formulation at 
0.1984 lb ai/A at 30 days prior to harvest. Clothianidin residues 
ranged from ND to 0.01 ppm (<LOQ) for this treatment.
    At two of the trial sites, plots received two drip applications of 
16 WSG at the 0.5X rate of 0.0992 lb ai/A. Clothianidin residues were 
all less than the LOD, ranging from 0.0005 to 0.006 ppm.
    At one of the trial sites, two additional plots were treated at 5X 
the normal application rate for the processing phase of the study. The 
processing portions analyzed were whole fruit, raisins, and juice.
    Two foliar applications of 50WDG were made at the 5X rate of 0.496 
lb ai/A/application for the processing phase of the study. Clothianidin 
mean residues in whole fruit, raisins, and juice were 0.621, 1.02, and 
0.707 ppm, respectively. The concentration factor (CF) was 1.64 for 
raisins and 1.14 for juice. A residue decline study indicated that 
residues do not increase with longer preharvest intervals (PHI).
    The drip irrigation application of 16WSG was made at the 5X rate of 
0.992 lb ai/A for the processing phase of the study. Clothianidin mean 
residues in whole fruit, raisins, and juice were 0.006, 0.009, and 
0.004 ppm, respectively. Since the mean residues in whole fruit and 
processed commodities were <LOD, it was not possible to calculate a 
reliable CF for either processed commodity.

B. Toxicological Profile

    1. Acute toxicity. The acute oral lethal dose (LD)<INF>50</INF> was 
>5,000 milligram/kilogram (mg/kg) for both male and

[[Page 71039]]

female rats and the acute dermal LD<INF>50</INF> was >2,000 mg/kg in 
rats. The four-hour inhalation LC <INF>50</INF> was 6.14 mg/L for male 
and female rats. Clothianidin was not a dermal or eye irritant in 
rabbits and was not a skin sensitizer 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 2-generation 
reproduction study with clothianidin, rats were administered dietary 
levels of 0, 150, 500 and 2,500 ppm. The no observed effect level 
(NOEL) for reproductive parameters was 2,500 ppm. The NOEL for 
developmental effects was 500 ppm based on decreased pup weights and 
the parental NOEL was 150 ppm based on decreased body weights (bw).
    A developmental toxicity study was conducted in rats with 
clothianidin using dose levels of 0, 10, 50 and 125 mg/kg/day by 
gavage. The NOEL for maternal toxicity was established at 10 mg/kg and 
for developmental effects it was >125 mg/kg. Additionally, a 
developmental toxicity study was conducted with rabbits treated orally 
by gavage at 0, 10, 25, 75 and 100 mg/kg/day. The NOEL for maternal 
toxicity was 10 mg/kg and for developmental toxicity, it was 75 mg/kg.
    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 NOELs were established at 500 ppm for rat and 650 ppm 
for the dog.
    5. Chronic toxicity. A 2-year combined rat chronic/oncogenicity 
study conducted at dietary levels of 0, 150, 500, 1,500 and 3,000 ppm 
demonstrated a NOEL 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 2,000/1,800 
ppm for males and females, respectively, revealed a NOEL of 350 ppm 
based on reduced bw gains and increased incidence of hypercellular 
hypertrophy. No evidence of oncogenicity was seen in the rats 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 an overall NOEL of 
325 ppm and no observed adverse effect level (NOAEL) of 650 ppm based 
on a 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 LD<INF>50</INF> values range from <500 to 
>2,000 mg/kg, showing low to moderate toxicity.
    8. Endocrine disruption. All guideline studies conducted to 
characterize the toxicological profile showed no endocrine related 
toxicity or tumorgenicity. No effects on T3, T4, or TSH were observed 
in the subchronic rat study. In a 2-generation reproduction study in 
the rat, and rat and rabbit teratology studies, clothianidin did not 
show reproductive or teratogenic effects. The extensive database shows 
that clothianidin has no endocrine properties.

C. Aggregate Exposure

    1. Dietary exposure. Tolerances are proposed for residues of 
clothianidin on grapes, raisins, and potatoes. For the purposes of 
assessing the potential dietary exposure for these proposed tolerances, 
an exposure assessment was conducted using Dietary Exposure Evaluation 
Model (DEEM\TM\) software, consumption data derived from the 1994-1998 
USDA Continuing Surveys of Food Intake by Individuals (CSFII), and 
residue levels at proposed tolerance levels.
    i. Food -- a. Acute dietary exposure. The acute population adjusted 
dose (aPAD) of 0.25 mg/kg bw/day (acute NOAEL with a 100-fold 
uncertainty factor) was used to assess dietary exposure. Arvesta 
Corporation has conducted an acute dietary exposure Tier 1 analysis 
with DEEM\TM\ using the proposed tolerances for grapes, raisins, and 
potatoes of 0.5, 1.0, and 0.1 ppm, respectively, 100% crop treated and 
default processing factors for the overall US population and the 
following subpopulations: All infants (<1 year), children (1-2 years), 
females (13-49 years), and adults (50+). Arvesta has conducted an acute 
Tier 1 analysis from the uses on grapes and potatoes. This analysis 
also includes the anticipated exposure to clothianidin resulting from 
both Bayer's seed treatment uses and uses of thiamethoxam, of which 
clothianidin is a major metabolite. The results of this Tier 1 analysis 
indicate that the highest exposure never exceeds 18.00% of the aPAD at 
the 95th percentile of exposure.
    b. Chronic dietary exposure. The chronic population adjusted dose 
(cPAD) of 0.098 mg/kg bw/day (chronic NOEL with a 100-fold uncertainty 
factor) was used to assess chronic dietary exposure. Arvesta has 
conducted a chronic Tier 1 analysis, including the anticipated exposure 
to clothianidin resulting from Bayer's seed treatment uses and uses of 
thiamethoxam, and the results indicate that the highest exposure never 
exceeds 13.41% of the cPAD.
    ii. Drinking water. For drinking water, the models screening 
concentration in ground water (SCI-GROW) (ground water) and the Food 
Quality Protection Act (FQPA) index reservoir screening tool (FIRST) 
(surface water), were selected to calculate the potential exposure of 
clothianidin in drinking water. Both short-term (acute) and long-term 
(chronic) exposures were estimated with respect to foliar and drip-
irrigation uses for grapes and foliar and in-furrow uses for potatoes. 
The worst case drinking water estimated concentrations (DWEC) for these 
applications to grapes and potatoes were 15.1 parts per billion (ppb) 
for the acute and 0.5 ppb for the chronic using the FIRST model. The 
acute and chronic drinking water levels of comparison (DWLOC) were 
calculated for each of the population subgroups. The acute DWLOC for 
the most sensitive population subgroup, children 1-2 years, was 
calculated to be 2,050 ppb and the chronic DWLOC for this population 
subgroup is 849 ppb. The acute DWLOC for the U.S. population is 8,417 
ppb and the chronic DWLOC is 3,350 ppb. The calculated acute and 
chronic DWLOCs for the U.S. population and children 1-2 years exceed 
the DWECs from the models.
    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 food-only exposure to clothianidin from all

[[Page 71040]]

proposed crop uses will be less than 3.8% of the aPAD and less than 
2.34% of the cPAD for the overall U.S. population. All evaluated 
population subgroups had an exposure of less than 18.00% of the aPAD 
and less than 13.41% of the cPAD. EPA generally has no concerns for 
exposures below 100% of the PAD, because the PAD represents the level 
at or below which daily aggregate exposure over a lifetime will not 
pose appreciable risks to human health. The DWLOCs exceed the DWECs as 
calculated by conservative models. There are no residential uses of 
clothianidin; therefore, aggregate exposure consists of food and 
drinking water exposures. Thus, 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 
2-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 database. Based 
on the current toxicological data requirements, the toxicology database 
for clothianidin relative to prenatal and postnatal development is 
complete, including the developmental neurotoxicity study. None of the 
studies indicated the offspring to be more sensitive. All effects were 
secondary to severe maternal toxicity. The cPAD for clothianidin was 
calculated using the NOAEL of 9.8 mg/kg bw/day from the 2-generation 
rat reproduction study.

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. 04-27004 Filed 12-7-04; 8:45 am]
BILLING CODE 6560-50-S


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