[Federal Register Volume 64, Number 5 (Friday, January 8, 1999)]
[Notices]
[Pages 1177-1178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-362]


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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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