Monsanto Co.; Availability of Determination of Nonregulated Status for Canola Genetically Engineered for Glyphosate Herbicide Tolerance

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.

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