02-4909. Aventis CropScience; Availability of Environmental Assessment for 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 that an environmental assessment has been prepared for a proposed 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. We are making this environmental assessment available to the public for review and comment.

DATES:

We will consider all comments we receive that are postmarked, delivered, or e-mailed by April 1, 2002.

ADDRESSES:

You may submit comments by postal mail/commercial delivery or by e-mail. If you use postal mail/commercial delivery, please send four copies of your comment (an original and three copies) to: Docket No. 01-101-1, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 01-101-1. If you use e-mail, address your comment to [e-mail]. Your comment must be contained in the body of your message; do not send attached files. Please include your name and address in your message and “Docket No. 01-101-1” on the subject line.

You may read the extension request, the environmental assessment, and any comments that we receive on this docket 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. Hanu Pappu, Plant Protection and Quarantine, 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, 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. The Aventis request seeks an extension of a determination of nonregulated status issued 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 requests 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.

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, the Aventis extension request states that 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 we are proposing 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.

Should APHIS approve Aventis' request for an extension of a determination of nonregulated status, canola event Topas 19/2 would 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 would no longer apply to the field testing, importation, or interstate movement of the subject canola event or its progeny.

National Environmental Policy Act

An environmental assessment (EA) has been prepared to examine any potential environmental impacts associated with the proposed 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). Copies of the Aventis extension request and the EA are available from the individual listed under FOR FURTHER INFORMATION CONTACT.

Done in Washington, DC, this 25th day of February 2002.

W. Ron DeHaven,

Acting Administrator, Animal and Plant Health Inspection Service.