47664 Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Notices

Public Information and Records

Integrity Branch, Information Resources

and Services Division at the address

provided, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding

holidays. It is suggested that persons

interested in reviewing the application

file, telephone this office at (703-305-

5805) to ensure that the file is available

on the date of intended visit.

Authority: 7 U.S.C. 136.

List of Subjects

Environmental protection, Pesticides

and pest, Product registration.

Dated: August 26, 1997.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

[FR Doc. 97–23685 Filed 9–9–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–30394A; FRL–5726–6]

Monsanto Company; Approval of a

Pesticide Product Conditional

Registration

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces

Agency approval of an application

submitted by Monsanto Company to

conditionally register the product

YieldGard for a changed use pattern

pursuant to the provisions of section

3(c)(7)(B) of the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA), as amended.

FOR FURTHER INFORMATION CONTACT: By

mail: Michael Mendelsohn, Regulatory

Action Leader, Biopesticides and

Pollution Prevention Division (7501W),

Office of Pesticide Programs, 401 M St.,

SW., Washington, DC 20460. Office

location and telephone number:

Westfield Building North Tower, CS #1,

Environmental Protection Agency, 2800

Crystal Drive, Arlington, VA 22202,

703–308–8715; e-mail:

mendelsohn.mike@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: 

Electronic Availability: Electronic

copies of this document and the Fact

Sheet are available from the EPA home

page at the Environmental Sub-Set entry

for this document under ‘‘Regulations’’

(http://www.epa.gov/fedrgstr/).

EPA issued a notice, published in the

Federal Register of November 1, 1995

(60 FR 55574; FRL–4979–7), which

announced that Monsanto Company 700

Chesterfield Parkway North St. Louis,

MO 63198, had submitted an

application to register the product

Bacillus thuringiensis subsp. kurstaki

(B.t.k.) Insect Control Protein (EPA File

Symbol 524–UIO).

The product was announced as

containing the plant pesticide active

ingredient Bacillus thuringiensis subsp.

kurstaki delta-endotoxin as produced in

corn by a cryIA(b) gene and its

controlling sequences, an active

ingredient not included in any

previously registered product.

Subsequent to this, the Agency

approved a seed increase registration for

this active ingredient on May 28, 1996,

under EPA Registration No. 524–492.

The full commercial use application

from Monsanto was approved on

December 20, 1996, as YieldGard

(formerly Bacillus thuringiensis subsp.

kurstaki (B.t.k.) Insect Control Protein)

for use on field corn (EPA Registration

Number 524–489), the chemical was

amended to read ‘‘Bacillus thuringiensis

CryIA(b) delta endotoxin and the

genetic material necessary for its

production in corn at 0.023-0.029

percent.’’

This registration was conditionally

granted to allow additional use of the

active ingredient for food and feed in

field corn in accordance with FIFRA

section 3(c)(7)(B). This use is

conditional upon data development in

the area resistance management research

and Collembola and Daphnia magna

toxicity testing and limited by resistance

management and expiration provisions

of the registration.

A conditional registration may be

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

FIFRA for a product involving a

changed use pattern where certain data

are lacking, on condition that such data

are received as specified by EPA and the

applicant has submitted satisfactory

data pertaining to the proposed

additional use and the amended

registration would not significantly

increase the risk of any unreasonable

adverse effect.

The Agency has considered the

available data on the risks associated

with the proposed use of Bacillus

thuringiensis CryIA(b) delta endotoxin

and the genetic material necessary for

its production in corn, 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 health and safety

determinations which show that use of

Bacillus thuringiensis CryIA(b) delta

endotoxin and the genetic material

necessary for its production in corn

consistent with the terms and

conditions of registration during the

period of conditional registration will

not cause any unreasonable adverse

effect on the environment.

This product is conditionally

registered in accordance with FIFRA

section 3(c)(7)(B). This registration will

automatically expire on midnight April

1, 2001. EPA will reevaluate the

effectiveness of Monsanto’s resistance

management plan before April 1, 2001,

and decide whether to convert the

registrations to a non-expiring

registrations. If the conditions are not

complied with the registration will be

subject to cancellation in accordance

with FIFRA section 6(e).

More detailed information on this

conditional registration is contained in

an EPA Pesticide Fact Sheet on

Monsanto’s Bacillus thuringiensis

CryIA(b) delta-endotoxin and the

genetic material necessary for its

production in corn.

A copy of the fact sheet, which

provides a summary description of the

chemical, use patterns and

formulations, science findings, and the

Agency’s regulatory position and

rationale, may be obtained from the

National Technical Information Service

(NTIS), 5285 Port Royal Road,

Springfield, VA 22161.

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 (7506C), Office of Pesticide

Programs, Environmental Protection

Agency, Rm. 1132, CM #2, Arlington,

VA 22202 (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 (A101), 401 M St., SW., Washington, D.C.

20460. Such requests should: (1)

Identify the product name and

registration number and (2) specify the

data or information desired.

Authority: 7 U.S.C. 136.

List of Subjects

Environmental protection, Pesticides

and pests, Product registration.
Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Notices 47665

Dated: August 26, 1997.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

[FR Doc. 97–23686 Filed 9–9–97; 8:45 am]

BILLING CODE 6560–50–F 

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–30394B; FRL–5740–4]

Novartis Seeds; Approval of a

Pesticide Product Conditional

Registration

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces

Agency approval of an application to

conditionally register the product

Northrup King Insect Resistant Corn

containing a new plant pesticide active

ingredient not included in any

previously registered product pursuant

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

the Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA), as amended

and the subsequent amendment of this

product for a changed use pattern

pursuant to section 3(c)(7)(B) of the

Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA), as amended.

FOR FURTHER INFORMATION CONTACT: By

mail: Michael Mendelsohn, Regulatory

Action Leader, Biopesticides and

Pollution Prevention Division (7501W),

Office of Pesticide Programs, 401 M St.,

SW., Washington, DC 20460. Office

location and telephone number:

Westfield Building North Tower, CS #1,

Environmental Protection Agency, 2800

Crystal Drive, Arlington, VA 22202,

703–308–8715; e-mail:

mendelsohn.mike@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: 

Electronic Availability: Electronic

copies of this document and the Fact

Sheet are available from the EPA home

page at the Environmental Sub-Set entry

for this document under ‘‘Regulations’’

(http://www.epa.gov/fedrgstr/).

EPA issued a notice, published in the

Federal Register of November 1, 1995

(60 FR 55574; FRL–4979–7), which

announced that Northrup King

Company, 7500 Olson Memorial

Highway, Golden Valley, MN 55427,

submitted an application to register the

transgenic plant pesticide product

Northrup King Insect Resistant Corn

(EPA File Symbol 67979–R). The

Northrup King Co., has changed and is

now known as Novartis Seeds, P.O. Box

12257, Research Triangle Park, NC

27709–2257. This product contained the

plant pesticide active ingredient

Bacillus thuringiensis subsp. kurstaki

delta-endotoxin as produced in corn by

a CryIA(b) gene and its controlling

sequences, an active ingredient not

included in any previously registered

product. 

The application from Northrup King

(now known as Novartis Seeds) was

approved on May 14, 1996, as Northrup

King Insect Resistant Corn for seed

propagation only (EPA Registration

Number 67979–1) the chemical was

amended to read ‘‘Bacillus thuringiensis

delta endotoxin as produced by a

CryIA(b) gene and its controlling

sequences as found on plasmid vector

pZO1502 at 0.00475-0.0006 percent.’’

A conditional registration may be

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

FIFRA for new active ingredients 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 delta endotoxin as

produced by a CryIA(b) gene and its

controlling sequences as found on

plasmid vector pZO1502, 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 delta

endotoxin as produced by a CryIA(b)

gene and its controlling sequences as

found on plasmid vector pZO1502

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.

This product was conditionally

registered in accordance with FIFRA

section 3(c)(7)(C). The registration was

originally to expire in May 1997.

However, as outlined further in this

document, this product was amended

pursuant to section 3(c)(7)(B) of FIFRA

to allow commercial use and thus, the

expiration date was extended to April 1,

2001. EPA will reevaluate the

effectiveness of Novartis Seeds

resistance management plan before

April 1, 2001, and decide whether to

convert the registration to a nonexpiring registration. If the conditions

are not complied with the registration

will be subject to cancellation in

accordance with FIFRA section 6(e).

Consistent with section 3(c)(7)(C), the

Agency has determined that this

conditional registration was in the

public interest. Use of the pesticide is 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 product was amended on August

5, 1996 to include in the already

registered uses a new use for

commercial use in field corn.

This registration was conditionally

amended to allow additional use of the

active ingredient for food and feed in

field corn in accordance with FIFRA

section 3(c)(7)(B). This use is

conditional upon data development in

the area resistance management research

and Collembola and Daphnia magna

toxicity testing and limited by resistance

management and expiration provisions

of the registration.

A conditional registration may be

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

FIFRA for a product involving a

changed use pattern where data are

lacking, on condition that such data are

received as specified by EPA and the

applicant has submitted satsifactory

data pertaining to the proposed

additional use and the amended

registration would not significantly

increase the risk of any unreasonable

adverse effect.

More detailed information on this

conditional registration is contained in

an EPA Pesticide Fact Sheet on Bacillus

thuringiensis delta endotoxin as

produced by a CryIA(b) gene and its

controlling sequences as found on

plasmid vector pZO1502.

A copy of the fact sheet, which

provides a summary description of the

chemical, use patterns and

formulations, science findings, and the

Agency’s regulatory position and

rationale, may be obtained from the

National Technical Information Service

(NTIS), 5285 Port Royal Road,

Springfield, VA 22161.

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