60824 Federal Register / Vol. 70, No. 201 / Wednesday, October 19, 2005 / Notices 

questions, consult the person listed 

under FOR FURTHER INFORMATION

CONTACT. 

II. What Action is EPA Taking? 

This document reopens the public 

comment period established in the 

Federal Register of August 3, 2005 (70 

FR 44632) (FRL–7729–2). In that 

document, EPA made available the 

human health risk assessment for 

ethylene oxide (ETO). ETO is a 

fumigant/sterilant used to sterilize 

medical or laboratory equipment, 

pharmaceuticals, and aseptic packaging, 

or to reduce microbial load on 

cosmetics, whole and ground spices or 

other seasoning materials, and artifacts, 

archival material or library objects. The 

Agency developed this risk assessment 

as part of its public process for making 

pesticide reregistration eligibility and 

tolerance reassessment decisions. 

Through these programs, EPA is 

ensuring that pesticides meet current 

standards under the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) 

and the Federal Food, Drug, and 

Cosmetic Act (FFDCA), as amended by 

the Food Quality Protection Act of 1996 

(FQPA). The Agency received a request 

by a stakeholder to extend the comment 

period. EPA is hereby reopening the 

comment period, which ended on 

October 3, 2005; comments must now be 

received on or before [insert date 30 

days after date of publication in the 

Federal Register]. This extension is 

being given based on the request to have 

additional time to review the extensive 

amount of information provided and the 

nature of the issues involved. 

List of Subjects 

Environmental protection, Pesticides 

and pests. 

Dated: October 5, 2005. 

Peter Caulkins, 

Acting Director, Special Review and 

Reregistration Division, Office of Pesticide 

Programs. 

[FR Doc. 05–20821 Filed 10–18–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[OPP–2005–0229; FRL 7740–4] 

Flumiclorac pentyl; Tolerance 

Reassessment Decision for Low Risk 

Pesticide; Notice of Availability 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: This notice announces the 

availability of EPA’s Tolerance 

Reassessment Decision (TRED) for the 

pesticide flumiclorac pentyl, and opens 

a public comment period on this 

document, related risk assessments, and 

other support documents. EPA has 

reviewed the low risk pesticide 

flumiclorac pentyl through a modified, 

streamlined version of the public 

participation process that the Agency 

uses to involve the public in developing 

pesticide tolerance reassessment and 

reregistration decisions. Through the 

tolerance reassessment program, EPA is 

ensuring that all pesticides meet current 

health and food safety standards. 

DATES: Comments must be received on 

or before November 18, 2005. 

ADDRESSES: Comments, identified by 

docket identification (ID) number OPP–

2005–0229 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: 

Tawanda Spears, Special Review and 

Reregistration Division (7508C), Office 

of Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW, Washington, DC 20460–0001; 

telephone number: (703) 308–8050; fax 

number: (703) 308–8005; e-mail address: 

spears.tawanda@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–2005–

0229. 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 

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 

Federal Register / Vol. 70, No. 201 / Wednesday, October 19, 2005 / Notices 60825 

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–2005–0229. 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 toopp-docket@epa.gov, 

Attention: Docket ID Number OPP–

2005–0229. 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–2005–0229. 

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–2005–0229. 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. 

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? 

EPA completed its evaluation of the 

uses of flumiclorac pentyl, reassessed 

five (5) existing tolerances or legal 

residue limits, and reached a tolerance 

reassessment decision for this low risk 

pesticide on August 23, 2005. 

Flumiclorac pentyl is a post-emergence 

herbicide used on field corn, soybeans 

and non-crop areas, such as: industrial 

sites, airports, military installations, 

roadsides and associated rights-of-way, 

60826 Federal Register / Vol. 70, No. 201 / Wednesday, October 19, 2005 / Notices 

and other similar areas to control a 

selected group of broadleaf weeds, 

specifically morning-glory and velvet 

leaf. Although there are no labeled 

residential homeowner uses, there is 

potential risk for non-occupational 

exposure from other treated areas, such 

as golf courses, athletic fields, 

recreational areas, schools, apartment 

buildings, etc. The Agency is now 

issuing for comment the resulting 

Report on Food Quality Protection Act 

(FQPA) Tolerance Reassessment 

Progress and Risk Management Decision 

for flumiclorac pentyl, known as a 

TRED, as well as related risk 

assessments and technical support 

documents. 

EPA developed the flumiclorac pentyl 

TRED through a modified, streamlined 

version of its public process for making 

tolerance reassessment and 

reregistration eligibility decisions. 

Through these programs, the Agency is 

ensuring that pesticides meet current 

standards under the Federal Food, Drug, 

and Cosmetic Act (FFDCA) and the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA), as amended 

by FQPA. EPA must review tolerances 

and tolerance exemptions that were in 

effect when the FQPA was enacted, 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 flumiclorac pentyl tolerances 

included in this notice. 

The flumiclorac pentyl TRED presents 

the Agency’s tolerance reassessment 

conclusions for flumiclorac pentyl 

alone; however, section 408(b)(2)(D)(v) 

of the FFDCA directs the Agency also to 

consider available information on the 

cumulative risk from substances sharing 

a common mechanism of toxicity. 

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

flumiclorac pentyl and any other 

substances, and flumiclorac pentyl does 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has not assumed that 

flumiclorac pentyl has a common 

mechanism of toxicity with other 

substances. For information regarding 

EPA’s efforts to determine which 

chemicals have a common mechanism 

of toxicity and to evaluate the 

cumulative effects of such chemicals, 

see the policy statements released by 

EPA’s Office of Pesticide Programs 

concerning common mechanism 

determinations and procedures for 

cumulating effects from substances 

found to have a common mechanism on 

EPA’s website at http://www.epa.gov/ 

pesticides/cumulative/. 

EPA is applying the principles of 

public participation to all pesticides 

undergoing 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 flumiclorac pentyl, 

which pose no risk concerns, have low 

use, affect few if any stakeholders, and 

require no risk mitigation. Once EPA 

assesses uses and risks for such low risk 

pesticides, the Agency may go directly 

to a decision and prepare a document 

summarizing its findings, such as the 

flumiclorac pentyl TRED. 

The tolerance reassessment program 

is being conducted under 

Congressionally mandated time frames, 

and EPA recognizes the need both to 

make timely decisions and to involve 

the public in finding ways to effectively 

mitigate pesticide risks. Flumiclorac 

pentyl, however, poses no risks that 

require mitigation. The Agency 

therefore is issuing the flumiclorac 

pentyl TRED, its risk assessments, and 

related support documents 

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 TRED. All 

comments should be submitted using 

the methods in Unit I. of the 

SUPPLEMENTARY INFORMATION, and must 

be received by EPA on or before the 

closing date. These comments will 

become part of the Agency Docket for 

flumiclorac pentyl. Comments received 

after the close of the comment period 

will be marked ‘‘late.’’ EPA is not 

required to consider these late 

comments. 

EPA will 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 

TRED in the Federal Register. In the 

absence of substantive comments 

requiring changes, the decisions 

reflected in the TRED will be 

implemented as presented. These 

decisions may be supplemented by risk 

mitigation measures when EPA 

considers its cumulative assessment of 

pesticides. 

B. What is the Agency’s Authority for 

Taking this Action? 

Section 408(q) of the 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: October 5, 2005. 

Peter Caulkins, 

Acting Director, Special Review and 

Reregistration Division, Office of Pesticide 

Programs. 

[FR Doc. 05–20708 Filed 10–18–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[OPP–2004–0182; FRL–7727–6] 

Pesticide Product Registrations; 

Conditional Approval 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: This notice announces 

Agency approval of applications 

submitted by Monsanto Company, to 

conditionally register the pesticide 

products, Event MON 863: Corn 

Rootworm Protected Corn (ZMIR13L) 

and YieldGard Plus containing a new 

active ingredient not included in any 

previously registered products pursuant 

to the provisions of section 3(c)(7)(C) of 

the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA), as amended. 

FOR FURTHER INFORMATION CONTACT: 

Mike Mendelsohn, Biopesticides and 

Pollution Prevention Division (7511C), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8715;e-mail 

address:mendelsohn.mike@epa.gov. 

SUPPLEMENTARY INFORMATION: