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: 

Federal Register / Vol. 70, No. 201 / Wednesday, October 19, 2005 / Notices 60827 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

Unit II. of this notice. 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 identification (ID) number 

OPP–2004–0182. 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. 

In accordance with section 3(c)(2) of 

FIFRA, a copy of the approved label, the 

list of data references, the data and other 

scientific information used to support 

registration, except for material 

specifically protected by section 10 of 

FIFRA, are available for public 

inspection in the Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

Agency, Rm. 119, Crystal Mall #2, 

Arlington, VA (703) 305–5805. Requests 

for data must be made in accordance 

with the provisions of the Freedom of 

Information Act and must be addressed 

to the Freedom of Information Office 

(A–101), 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. Such 

requests should: Identify the product 

name and registration number and 

specify the data or information desired. 

A paper copy of the fact sheet, which 

provides more detail on this 

registration, may be obtained from the 

National Technical Information Service 

(NTIS), 5285 Port Royal Rd., 

Springfield, VA 22161. 

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. 

Electronic versions of the MON 863 

Fact Sheet and Biopesticide Regulatory 

Action Document, as well as the 

YieldGard Plus Fact Sheet are available 

at http://www.epa.gov/bioopesticides/. 

II. Did EPA Conditionally Approve the 

Application? 

A conditional registration may be 

granted under section 3(c)(7)(C) of 

FIFRA for a new active ingredient where 

certain data are lacking, on condition 

that such data are received by the end 

of the conditional registration period 

and do not meet or exceed the risk 

criteria set forth in 40 CFR 154.7; that 

use of the pesticide during the 

conditional registration period will not 

cause unreasonable adverse effects; and 

that use of the pesticide is in the public 

interest. 

The Agency has considered the 

available data on the risks associated 

with the proposed use of Bacillus 

thuringiensis Cry3Bb1 protein and the 

genetic material necessary for its 

production (Vector ZMIR13L) in event 

MON 863 corn, and information on 

social, economic, and environmental 

benefits to be derived from such use. 

Specifically, the Agency has considered 

the nature and its pattern of use, 

application methods and rates, and level 

and extent of potential exposure. Based 

on these reviews, the Agency was able 

to make basic health and safety 

determinations which show that use of 

Bacillus thuringiensis Cry3Bb1 protein 

and the genetic material necessary for 

its production Vector ZMIR13L in Event 

MON 863 corn during the period of 

conditional registration will not cause 

any unreasonable adverse effect on the 

environment, and that use of the 

pesticide is, in the public interest. 

Consistent with section 3(c)(7)(C) of 

FIFRA, the Agency has determined that 

these conditional registrations are in the 

public interest. Use of the pesticides are 

of significance to the user community, 

and appropriate labeling, use directions, 

and other measures have been taken to 

ensure that use of the pesticides will not 

result in unreasonable adverse effects to 

man and the environment. 

The Agency has considered the 

available data on the risks associated 

with the proposed use of YieldGard Plus 

Bacillus thuringiensis Cry3Bb1 protein 

and the genetic material necessary for 

its production (Vector ZMIR13L) in 

Event MON 863 corn stacked with 

Bacillus thuringiensis Cry1A(b) delta 

endotoxin and the genetic material 

necessary for its production in corn via 

conventional breeding, and information 

on social, economic, and environmental 

benefits to be derived from such use. 

Based on these reviews, the Agency 

was able to make basic environmental, 

health, and safety determinations which 

show that use of YieldGard Plus 

[Bacillus thuringiensis Cry3Bb1 protein 

and the genetic material necessary for 

its production (Vector ZMIR13L) in 

Event MON 863 corn stacked with 

Bacillus thuringiensis Cry1A(b) delta 

endotoxin and the genetic material 

necessary for its production in corn via 

conventional breeding], consistent with 

the terms and conditions of registration 

during the period of conditional 

registration, will not significantly 

increase the risk of unreasonable 

adverse effect on the environment. 

The YieldGard Plus product is 

conditionally registered in accordance 

with FIFRA section 3(c)(7)(B). If the 

conditions are not complied with the 

registration will be subject to 

cancellation in accordance with FIFRA 

section 6(e). 

60828 Federal Register / Vol. 70, No. 201 / Wednesday, October 19, 2005 / Notices 

III. Conditionally Approved 

Registrations 

EPA issued a notice, published in the 

Federal Register of March 13, 2002 (67 

FR 11333) (FRL–6827–3), which 

announced that Monsanto Company, 

800 N. Lindberg Blvd., St. Louis, MO 

63167, had submitted an application to 

conditionally register the pesticide 

product, Event MON 863: Corn 

Rootworm Protected Corn (ZMIR13L), a 

plant-incorporated protectant (EPA File 

Symbol 524-LEI), containing Bacillus 

thuringiensis Cry3Bb1 protein and the 

genetic material necessary for its 

production (Vector ZMIR13L) in corn, 

an active ingredient not included in any 

previously registered product. 

The application was conditionally 

approved on February 24, 2003 for the 

product listed below: 

1. Event MON 863: Corn Rootworm 

Protected Corn (ZMIR13L) (EPA 

Registration Number 524–528) for use as 

a plant-incorporated protectant in corn. 

EPA issued a notice, published in the 

Federal Register of April 2, 2003 (68 FR 

16036) (FRL–7286–1), which announced 

that Monsanto Company, 800 N. 

Lindberg Blvd., St. Louis, MO 63167, 

had submitted an application to 

conditionally register the pesticide 

product, YieldGard Plus Corn, a plantincorporated protectant (EPA File 

Symbol 524-LUL), containing Bacillus 

thuringiensis Cry3Bb1 protein and the 

genetic material necessary for its 

production (Vector ZMIR13L) in corn 

and Bacillus thuringiensis CryBacillus 

thuringiensis Cry1A(b) delta endotoxin 

and the genetic material necessary for 

its production in corn via conventional 

breeding. The stacking of Bacillus 

thuringiensis Cry3Bb1 protein and the 

genetic material necessary for its 

production (Vector ZMIR13L) in corn 

andBacillus thuringiensis Cry1A(b) delta 

endotoxin and the genetic material 

necessary for its production in corn via 

conventional breeding resulted in a 

pesticide product involving a changed 

use pattern for its active ingredients 

pursuant to the provision of section 

3(c)(4) of FIFRA. 

The application was conditionally 

approved on October 25, 2003 for the 

product listed below: 

2. YieldGard Plus Corn (EPA 

Registration Number 524–545) for use as 

a plant-incorporated protectant in corn. 

List of Subjects 

Environmental protection, Chemicals, 

Pesticides and pests. 

Dated: October 11, 2005. 

Janet L. Andersen, 

Director, Biopesticides and Pollution 

Prevention Division, Office of Pesticide 

Programs. 

[FR Doc. 05–20905 Filed 10–18–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[OPPT–2005–0053; FRL–7741–9] 

Certain New Chemicals; Receipt and 

Status Information 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: Section 5 of the Toxic 

Substances Control Act (TSCA) requires 

any person who intends to manufacture 

(defined by statute to include import) a 

new chemical (i.e., a chemical not on 

the TSCA Inventory) to notify EPA and 

comply with the statutory provisions 

pertaining to the manufacture of new 

chemicals. Under sections 5(d)(2) and 

5(d)(3) of TSCA, EPA is required to 

publish a notice of receipt of a 

premanufacture notice (PMN) or an 

application for a test marketing 

exemption (TME), and to publish 

periodic status reports on the chemicals 

under review and the receipt of notices 

of commencement to manufacture those 

chemicals. This status report, which 

covers the period from September 12, 

2005 to September 23, 2005, consists of 

the PMNs pending or expired, and the 

notices of commencement to 

manufacture a new chemical that the 

Agency has received under TSCA 

section 5 during this time period. 

DATES: Comments identified by the 

docket ID number OPPT–2004–0053 

and the specific PMN number or TME 

number, must be received on or before 

November 18, 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: 

Colby Lintner, Regulatory Coordinator, 

Environmental Assistance Division, 

Office of Pollution Prevention and 

Toxics (7408M), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–

0001; telephone number: (202) 554–

1404; e-mail address: TSCAHotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

This action is directed to the public 

in general. As such, the Agency has not 

attempted to describe the specific 

entities that this action may apply to. 

Although others may be affected, this 

action applies directly to the submitter 

of the premanufacture notices addressed 

in the 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 identification (ID) number 

OPPT–2004–0053. 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 

EPA Docket Center, Rm. B102-Reading 

Room, EPA West, 1301 Constitution 

Ave., NW., Washington, DC. The EPA 

Docket Center is open from 8:30 a.m. to 

4:30 p.m., Monday through Friday, 

excluding legal holidays. The EPA 

Docket Center Reading Room telephone 

number is (202) 566–1744 and the 

telephone number for the OPPT Docket, 

which is located in EPA Docket Center, 

is (202) 566–0280. 

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.