Novartis Seeds and Monsanto Co.; Availability of Determination of Nonregulated Status for Sugar Beet Genetically Engineered for Glyphosate Herbicide Tolerance

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 98-079-2]

Novartis Seeds and Monsanto Co.; Availability of Determination of

Nonregulated Status for Sugar Beet Genetically Engineered for

Glyphosate Herbicide Tolerance

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that the

Novartis Seeds and Monsanto Company's sugar beet line designated as

GTSB77, which has been genetically engineered for tolerance to the

herbicide glyphosate, is no longer considered a regulated article under

our regulations governing the introduction of certain genetically

engineered organisms. Our determination is based on our evaluation of

data submitted by Novartis Seeds and Monsanto Company in their petition

for a determination of nonregulated status and an analysis of other

scientific data. This notice also announces the availability of our

written determination document and its associated environmental

assessment and finding of no significant impact.

EFFECTIVE DATE: December 23, 1998.

ADDRESSES: The determination, an environmental assessment and finding

of no significant impact, the petition, and all written comment

received may be inspected at USDA, room 1141, South Building, 14th

Street and Independence Avenue SW, Washington, DC, between 8 a.m. and

4:30 p.m., Monday through Friday, except holidays. Persons wishing to

inspect those documents are asked to call in advance of visiting at

(202) 690-2817 to facilitate entry into the reading room.

FOR FURTHER INFORMATION CONTACT: Dr. James White, Biotechnology and

Biological Analysis, PPQ, APHIS, 4700 River Road Unit 147, Riverdale,

MD 20737-1236; (301) 734-5940. To obtain a copy of the determination or

the environmental assessment and finding of no significant impact,

contact Ms. Kay Peterson at (301) 734-4885; e-mail:

Kay.P[email protected].

SUPPLEMENTARY INFORMATION:

Background

On June 22, 1998, the Animal and Plant Health Inspection Service

(APHIS) received a petition (APHIS Petition No. 98-173-01p) from

Novartis Seeds (Novartis) of Research Triangle Park, NC, and Monsanto

Company (Monsanto) of St. Louis, MO, (Novartis/Monsanto) seeking a

determination that a sugar beet (Beta vulgaris L.) line designated as

GTSB77, which has been genetically engineered for tolerance to the

herbicide glyphosate, does not present a plant pest risk and,

therefore, is not a regulated article under APHIS' regulations in 7 CFR

part 340.

On August 20, 1998, APHIS published a notice in the Federal

Register (63 FR 44604-44605, Docket No. 98-079-1) announcing that the

Novartis/Monsanto petition had been received and was available for

public review. The notice also discussed the role of APHIS, the

Environmental Protection Agency, and the Food and Drug Administration

in regulating the subject sugar beet line and food products derived

from it. In the notice, APHIS solicited written comments from the

public as to whether this sugar beet line posed a plant pest risk. The

comments were to have been received by APHIS on or before October 19,

1998. APHIS received one comment on the subject petition during the

designated 60-day comment period. The comment was from an organization

representing North American sugar beet processors, and it was in

support of the petition.

Analysis

The GTSB77 sugar beet line has been genetically engineered to

express an enolpyruvylshikimate-3-phosphate synthase (EPSPS) enzyme

derived from Agrobacterium sp. strain CP4 (CP4 EPSPS), and the

b- D-glucuronidase (GUS) protein from Escherichia coli. The

CP4 EPSPS enzyme confers tolerance to the herbicide glyphosate, and the

GUS protein serves as a marker in the plant transformation process. The

subject sugar beet line also expresses a novel protein known as 34550,

which

[[Page 1178]]

has no known biological activity, and was apparently created when a

truncated glyphosate oxidoreductase (gox) gene fused to sugar beet DNA.

Expression of the added genes is controlled in part by gene sequences

derived from the plant pathogens figwort mosaic virus and cauliflower

mosaic virus. The Agrobacterium tumefaciens method was used to transfer

the added genes into the parental proprietary sugar beet A1012 line.

The subject sugar beet line has been considered a regulated article

under APHIS' regulations in 7 CFR part 340 because it contains gene

sequences derived from plant pathogens. However, evaluation of field

data reports from field tests of this sugar beet line conducted under

APHIS permits and notifications since 1996 indicates that there were no

deleterious effects on plants, nontarget organisms, or the environment

as a result of the environmental release of the GTSB77 sugar beet line.

Determination

Based on its analysis of the data submitted by Novartis/Monsanto,

and a review of other scientific data and field tests of the subject

sugar beet, APHIS has determined that sugar beet line GTSB77: (1)

Exhibits no plant pathogenic properties; (2) is no more likely to

become a weed than herbicide-tolerant sugar beet developed by

traditional breeding techniques; (3) is unlikely to increase the

weediness potential for any other cultivated or wild species with which

it can interbreed; (4) will not cause damage to raw or processed

agricultural commodities; and (5) will not harm threatened or

endangered species or other organisms, such as bees, that are

beneficial to agriculture, or have an adverse impact on the ability to

control nontarget insect pests. Therefore, APHIS has concluded that the

subject sugar beet line and any progeny derived from crosses with other

sugar beet varieties will be as safe to grow as sugar beets that are

not subject to regulation under 7 CFR part 340.

The effect of this determination is that the Novartis/Monsanto

GTSB77 sugar beet line is no longer considered a regulated article

under APHIS' regulations in 7 CFR part 340. Therefore, the requirements

pertaining to regulated articles under those regulations no longer

apply to the subject sugar beet line or its progeny. However,

importation of GTSB77 sugar beet or seeds capable of propagation are

still subject to the restrictions found in APHIS' foreign quarantine

notices in 7 CFR part 319.

National Environmental Policy Act

An environmental assessment (EA) has been prepared to examine the

potential environmental impacts associated with this determination. The

EA was prepared in accordance with: (1) The National Environmental

Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2)

regulations of the Council on Environmental Quality for implementing

the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA

regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA

Implementing Procedures (7 CFR part 372). Based on that EA, APHIS has

reached a finding of no significant impact (FONSI) with regard to its

determination that the Novartis/Monsanto GTSB77 sugar beet line and

lines developed from it are no longer regulated articles under its

regulations in 7 CFR part 340. Copies of the EA and the FONSI are

available upon request from the individual listed under FOR FURTHER

INFORMATION CONTACT.

Done in Washington, DC, this 30th day of December 1998.

Craig A. Reed,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 99-362 Filed 1-7-99; 8:45 am]

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