71036 Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 

Kinetic approach data from studies on 

Cry34Ab1 and studies with known 

allergens and non-allergens, as well as 

the Agency’s allergenicity assessment of 

Cry34Ab1 will be presented to the 

FIFRA SAP. The Panel will be asked to 

consider the appropriateness of the 

kinetic approach, how digestion assays 

should be used in allergenicity 

assessments, and what assay conditions 

should be used for comparing the 

digestion of different proteins.

C. FIFRA SAP Meeting Minutes

The FIFRA SAP will prepare meeting 

minutes summarizing its 

recommendations to the Agency in 

approximately 60 days after the 

meeting. The meeting minutes will be 

posted on the FIFRA SAP web site or 

may be obtained by contacting the PIRIB 

at the address or telephone number 

listed in Unit I.

List of Subjects

Environmental protection, Pesticides 

and pests.

Dated: November 30, 2004.

Joseph Merenda, Jr,

Director, Office of Science Coordination and 

Policy.

[FR Doc. 04–26946 Filed 12–7–04; 8:45 am]

BILLING CODE 6560–50–S

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.

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: 

Kenny.Dan@epa.gov.

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:

• 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–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 

#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 

Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 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 email 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 opp-docket@epa.gov, 

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 #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.

71038 Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 

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)50 was >5,000 milligram/

kilogram (mg/kg) for both male and 

Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 71039

female rats and the acute dermal LD50

was >2,000 mg/kg in rats. The four-hour 

inhalation LC 50 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 nonneoplastic 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 LD50

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 (DEEMTM) 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 DEEMTM 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 longterm (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 

71040 Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 

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

ENVIRONMENTAL PROTECTION 

AGENCY 

[OPP–2004–0236; FRL–7689–3] 

Ethoxyquin; Reregistration Eligibility 

Decision for Low Risk Pesticide; 

Notice of Availability

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the 

availability of EPA’s Reregistration 

Eligibility Decision (RED) for the 

pesticide ethoxyquin, and opens a 

public comment period on this 

document, related risk assessments, and 

other support documents. EPA has 

reviewed the low risk pesticide 

ethoxyquin through a modified, 

streamlined version of the public 

participation process that the Agency 

uses to involve the public in developing 

pesticide reregistration and tolerance 

reassessment decisions. Through these 

programs, EPA is ensuring that all 

pesticides meet current health and 

safety standards.

DATES: Comments, identified by docket 

identification (ID) number OPP–2004–

0236, must be received on or before 

February 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: Tom 

Brennan, Special Review and 

Reregistration Division (7508C), Office 

of Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–

0001; telephone number: (703) 306–

0540; fax number: (703) 308–7042; email address:brennan.thomas@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

This action is directed to the public 

in general, and may be of interest to a 

wide range of stakeholders including 

environmental, human health, and 

agricultural advocates; the chemical 

industry; pesticide users; and members 

of the public interested in the sale, 

distribution, or use of pesticides. Since 

others also may be interested, the 

Agency has not attempted to describe all 

the specific entities that may be affected 

by this action. 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–

0236. 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, 1801 S. 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. 

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