02-29755. Aventis CropScience; Extension of Determination of Nonregulated Status for Canola Genetically Engineered for Glufosinate Herbicide Tolerance

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are advising the public of our decision to extend to one additional canola event our determination that a canola event developed by Aventis CropScience, which has been genetically engineered for tolerance to the herbicide glufosinate, is no longer considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms. Our decision is based on our evaluation of data submitted by Aventis CropScience in its request for an extension of a determination of nonregulated status, an analysis of other scientific data, and a comment received from the public in response to a previous notice. This notice also announces the availability of our finding of no significant impact.

EFFECTIVE DATE:

December 23, 2002.

ADDRESSES:

You may read the extension request, the environmental assessment and finding of no significant impact, and the comment received in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call [phone] before coming.

APHIS documents published in the Federal Register, and related information, including the names of organizations and individuals who have commented on APHIS dockets, are available on the Internet at http://www.aphis.usda.gov/​ppd/​rad/​webrepor.html.

FOR FURTHER INFORMATION CONTACT:

Dr. James White, Biotechnology Regulatory Services, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [phone]. To obtain a copy of the extension request or the environmental assessment and finding of no significant impact, contact Ms. Kay Peterson at [phone]; e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There is Reason to Believe Are Plant Pests,” regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered organisms and products are considered “regulated articles.”

The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. Further, the regulations in § 340.6(e)(2) provide that a person may request that APHIS extend a determination of nonregulated status to other organisms. Such a request must include information to establish the similarity of the antecedent organism and the regulated article in question.

Background

On July 25, 2001, APHIS received a request for an extension of a determination of nonregulated status (APHIS No. 01-206-02p) from Aventis CropScience (Aventis) of Research Triangle Park, NC, for a canola (Brassica napus L.) transformation event designated as Topas 19/2 (event Topas 19/2), which has been genetically engineered for tolerance to the herbicide glufosinate. Aventis requested an extension of a determination of nonregulated status issued previously for glufosinate-tolerant canola transformation event T45, the antecedent organism, in response to APHIS petition number 97-205-01p (see 63 FR 6703-6704, Docket No. 97-091-2, published February 10, 1998). Based on the similarity of canola event Topas 19/2 to the antecedent organism, Aventis requested a determination that glufosinate-tolerant canola event Topas 19/2 does not present a plant pest risk and, therefore, is not a regulated article under APHIS—regulations in 7 CFR part 340.

On March 1, 2002, APHIS published a notice in the Federal Register (67 FR 9431-9432, Docket No. 01-101-1) announcing that an environmental assessment (EA) for the Aventis extension request had been prepared and was available for public comment. APHIS received one comment on the subject EA during the designated comment period which ended April 1, 2002. We have provided a response to this comment as an attachment to our finding of no significant impact (FONSI). The EA and FONSI, including the attachment, are available from the person listed under FOR FURTHER INFORMATION CONTACT.

Analysis

Like the antecedent organism, canola event Topas 19/2 has been genetically engineered to contain a pat gene derived from Streptomyces viridochromogenes. The pat gene encodes the enzyme phosphinothricin-N-acetyltransferase (PAT), which confers tolerance to the herbicide glufosinate. The subject canola event and the antecedent organism were developed through use of the Agrobacterium tumefaciens method, and expression of the added genes in Topas 19/2 and the antecedent organism is controlled in part by gene sequences derived from the plant pathogen cauliflower mosaic virus. In summary, canola event Topas 19/2 and the antecedent organism contain the same genetic elements with the exception of the antibiotic resistance marker gene nptII in Topas 19/2, which was used as a transformant selection tool during the developmental process. The parental variety used to develop the antecedent organism was the B. napus var. AC EXCEL, while the B. napus cultivar Topas was used for transforming canola event Topas 19/2.

Canola event Topas 19/2 and the antecedent organism were genetically engineered using the same transformation method and contain the same enzyme that makes the plants tolerant to the herbicide glufosinate. Accordingly, we have determined that canola event Topas 19/2 is similar to the antecedent organism in APHIS petition number 97-205-01p, and, therefore, that canola event Topas 19/2 should no longer be regulated under the regulations in 7 CFR part 340.

The subject canola event has been considered a regulated article under APHIS' regulations in 7 CFR part 340 because it contains gene sequences derived from plant pathogens. However, canola event Topas 19/2 has been extensively field tested in Canada, and after having received the appropriate Canadian approvals, has been marketed commercially in Canada since 1995 with no reports of adverse effects on human health or the environment.

Determination

Based on an analysis of the data submitted by Aventis and a review of other scientific data, APHIS has determined that canola event Topas 19/2: (1) Exhibits no plant pathogenic properties; (2) is no more likely to become a weed than the parental canola variety; (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 canola event Topas 19/2 and any progeny derived from crosses with other canola varieties will be as safe to grow as canola that is not subject to regulation under 7 CFR part 340.

Because APHIS has determined that the subject canola event does not present a plant pest risk based on its similarity to the antecedent organism, Aventis canola event Topas 19/2 will no longer be 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 field testing, importation, or interstate movement of the subject canola event or its progeny. However, importation of canola event Topas 19/2 and seeds capable of propagation is still subject to the restrictions found in APHIS' foreign quarantine notices in 7 CFR part 319.

National Environmental Policy Act

An EA was prepared to examine any potential environmental impacts associated with the extension of a determination of nonregulated status for the subject canola event. 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 FONSI with regard to the determination that Aventis' canola event Topas 19/2 and events developed from it are no longer regulated articles under its regulations in 7 CFR part 340. Copies of the Aventis extension request and the EA and FONSI are available from the individual listed under FOR FURTHER INFORMATION CONTACT.

Done in Washington, DC, this 19th day of November 2002.

Peter Fernandez,

Acting Administrator, Animal and Plant Health Inspection Service.