[Federal Register Volume 64, Number 23 (Thursday, February 4, 1999)]
[Notices]
[Pages 5628-5629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2656]


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 Notices
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
 and investigations, committee meetings, agency decisions and rulings, 
 delegations of authority, filing of petitions and applications and agency 
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  Federal Register / Vol. 64, No. 23 / Thursday, February 4, 1999 / 
Notices  

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 98-089-2]


Monsanto Co.; Availability of Determination of Nonregulated 
Status for Canola 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 
Monsanto Company's canola line designated as RT73, 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 Monsanto 
Company in its 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: January 27, 1999.

ADDRESSES: The determination, an environmental assessment and finding 
of no significant impact, and the petition 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. Subhash Gupta, Biotechnology and 
Biological Analysis, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, 
MD 20737-1236; (301) 734-8761. 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 August 4, 1998, the Animal and Plant Health Inspection Service 
(APHIS) received a petition (APHIS Petition No. 98-216-01p) from 
Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination 
that a canola (Brassica napus L.) line designated as Roundup 
Ready canola line RT73 (canola line RT73), 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 October 16, 1998, APHIS published a notice in the Federal 
Register (63 FR 55573-55574, Docket No. 98-089-1) announcing that the 
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 canola and food products derived from it. In the notice, 
APHIS solicited written comments from the public as to whether this 
canola line posed a plant pest risk. The comments were to have been 
received by APHIS on or before December 15, 1998. APHIS received no 
comments on the subject petition during the designated 60-day comment 
period.

Analysis

    Canola line RT73 has been genetically engineered to contain a CP4 
EPSPS gene derived from Agrobacterium sp. strain CP4, and a modified 
goxv247 gene derived from Ochrobactrum anthropi strain LBAA. The CP4 
EPSPS gene encodes a 5-enolpyruvyl-shikimate-3-phosphate synthase (CP4 
EPSPS) protein, and the goxv247 gene encodes a glyphosate 
oxidoreductase (GOXv247) protein. The CP4 EPSPS and GOXv247 proteins 
confer tolerance to the herbicide glyphosate. Expression of the added 
genes is controlled in part by gene sequences derived from the plant 
pathogen figwort mosaic virus, and the Agrobacterium tumefaciens method 
was used to transfer the added genes into the parental canola Westar 
variety plants.
    The subject canola 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 canola conducted under APHIS permits and 
notifications since 1995 indicates that there were no deleterious 
effects on plants, nontarget organisms, or the environment as a result 
of the environmental release of canola line RT73.

Determination

    Based on its analysis of the data submitted by Monsanto, and a 
review of other scientific data and field tests of the subject canola, 
APHIS has determined that canola line RT73: (1) Exhibits no plant 
pathogenic properties; (2) is no more likely to become a weed than 
canola 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. Therefore, APHIS has concluded that the 
subject canola and any progeny derived from hybrid crosses with other 
nontransformed canola varieties will be as safe to grow as canola in 
traditional breeding programs that are not subject to regulation under 
7 CFR part 340.
    The effect of this determination is that Monsanto's canola line 
RT73 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 canola or its progeny. However, importation of canola line RT73 
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.

[[Page 5629]]

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 Monsanto's canola line RT73 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 29th day of January 1999.
Thomas E. Walton,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-2656 Filed 2-3-99; 8:45 am]
BILLING CODE 3410-34-P