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 

Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 71041

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.1. 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 

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–2004–0236. 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–

2004–0236. 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–2004–0236. 

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 S. Bell St., 

Arlington, VA, Attention: Docket ID 

Number OPP–2004–0236. 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 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 your 

estimate.

5. Provide specific examples to 

illustrate your concerns.

6. Offer alternatives.

71042 Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 

7. Make sure to submit your 

comments by the comment period 

deadline identified.

8. To ensure proper receipt by EPA, 

identify the appropriate docket ID 

number in the subject line on the first 

page of your response. It would also be 

helpful if you provided the name, date, 

and Federal Register citation related to 

your comments. 

II. Background 

A. What Action is the Agency Taking?

Under section 4 of the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA), EPA is reevaluating 

existing pesticides to ensure that they 

meet current scientific and regulatory 

standards. Using a modified, 

streamlined version of its public 

participation process, EPA has 

completed a RED for the low risk 

pesticide ethoxyquin, under section 

4(g)(2)(A) of FIFRA. EPA has 

determined that the data base to support 

reregistration is substantially complete 

and that products containing 

ethoxyquin will be eligible for 

reregistration, provided the risks are 

mitigated either in the manner 

described in the RED or by another 

means that achieves equivalent risk 

reduction. Upon submission of any 

required product-specific data under 

section 4(g)(2)(B), and any necessary 

changes to the registration and labeling 

(either to address any concerns 

identified in the RED or as a result of 

product-specific data), EPA will make a 

final reregistration decision under 

section 4(g)(2)(C) for products 

containing ethoxyquin. 

Ethoxyquin is registered for use as an 

antioxidant to control scald (browning ) 

in pears. It can be applied post-harvest 

by spraying/drenching, paper wrapping, 

or a combination thereof. Currently only 

two formulation types are registered for 

this chemical, which include an 

emulsifiable concentrate (1 product) and 

an impregnated wrap (3 products). 

EPA must review tolerances, and 

tolerance exemptions that were in effect 

when the Food Quality Protection Act 

(FQPA) was enacted in August 1996, to 

ensure that these existing pesticide 

residue limits for food, and feed 

commodities meet the safety standard 

established by the new law. Tolerances 

are considered reassessed once the 

safety finding has been made or a 

revocation occurs. EPA has reviewed 

and made the requisite safety finding for 

the ethoxyquin tolerances included in 

this notice. 

EPA is applying the principles of 

public participation to all pesticides 

under going reregistration and tolerance 

reassessment. The Agency’s Pesticide 

Tolerance Reassessment and 

Reregistration; Public Participation 

Process, published in the Federal 

Register of May 14, 2004 (69 FR 26819) 

(FRL–7357–9), explains that in 

conducting these programs, the Agency 

is tailoring its public participation 

process to be commensurate with the 

level of risk, extent of use, complexity 

of issues, and degree of public concern 

associated with each pesticide. EPA can 

expeditiously reach decisions for 

pesticides like ethoxyquin, which pose 

few risk concerns, have low use, affect 

few if any stakeholders, and require 

little risk mitigation. Once EPA assesses 

uses and risks for such pesticides, the 

Agency may go directly to a decision 

and prepare a document summarizing 

its findings. The Agency, therefore is 

issuing the low-risk ethoxyquin RED, 

risk assessments, and related documents 

simultaneously for public comment. 

The reregistration program is being 

conducted under congressionally 

mandated time frames, and EPA 

recognizes the need to make timely 

decisions, and to involve the public in 

finding ways to effectively mitigate 

pesticide risks. Ethoxyquin, however, 

poses few risks that require mitigation. 

The Agency, therefore is issuing the 

ethoxyquin RED, its risk assessments, 

and related support materials 

simultaneously for public comment. 

The comment period is intended to 

provide an opportunity for public input 

and a mechanism for initiating any 

necessary amendments to the RED. All 

comments should be submitted using 

the methods in Unit I.C. and must be 

received by EPA on or before the closing 

date. These comments will become part 

of the EPA Docket for ethoxyquin. 

Comments received after the close of the 

comment period will be marked ‘‘late.’’

EPA is not required to consider these 

late comments. 

EPA will carefully consider all 

comments received by the closing date 

and will provide a response to 

comments memorandum in the Docket 

and electronic EDocket. If any comment 

significantly affects the document, EPA 

also will publish an amendment to the 

RED in the Federal Register. In the 

absence of substantive comments 

requiring changes, the ethoxyquin RED 

will be implemented as it is now 

presented. 

B. What is the Agency’s Authority for 

Taking this Action? 

Section 4(g)(2) of FIFRA as amended 

directs that, after submission of all data 

concerning a pesticide active ingredient, 

‘‘the Administrator shall determine 

whether pesticides containing such 

active ingredient are eligible for 

reregistration,’’ before calling in 

product-specific data on individual enduse products and either reregistering 

products or taking other ‘‘appropriate 

regulatory action.’’

Section 408(q) of the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 21 

U.S.C. 346a(q), requires EPA to review 

tolerances and exemptions for pesticide 

residues in effect as of August 2, 1996, 

to determine whether the tolerance or 

exemption meets the requirements of 

section 408(b)(2) or (c)(2) of FFDCA. 

This review is to be completed by 

August 3, 2006.

List of Subjects 

Environmental protection, Pesticides 

and pests.

Dated: December 2, 2004. 

Peter Caulkins, 

Acting Director, Special Review and 

Reregistration Division, Office of Pesticide 

Programs.

[FR Doc. 04–27003 Filed 12–7–04; 8:45 am] 

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

[OPP–2004–0365; FRL–7688–3]

Tributyltin Methacrylate; Notice of 

Receipt of Request to Voluntarily 

Cancel a Pesticide Registration

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Notice.

SUMMARY: In accordance with section 

6(f)(1) of the Federal Insecticide, 

Fungicide, and Rodenticide Act 

(FIFRA), as amended, EPA is issuing a 

notice of receipt of a request by New 

Nautical Coatings, Inc. to voluntarily 

cancel its pesticide registration for an 

antifouling product containing 

tributyltin methacrylate. This is the last 

tributyltin methacrylate product 

registered for use in the U.S. EPA 

intends to grant this request at the close 

of the comment period for this 

announcement unless the Agency 

receives substantive comments within 

the comment period that would merit its 

further review of this request. Upon 

acceptance of this request, any sale, 

distribution, or use of product listed in 

this notice will be permitted only if 

such sale, distribution, or use is 

consistent with the terms as described 

in the final order.

DATES: Comments, identified by the 

docket ID number OPP–2004–0365, 

must be received on or before January 7, 

2005.