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

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Animal and Plant Health Inspection Service, USDA.




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 line developed by Monsanto Company, 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. We are making this environmental assessment available to the public for review and comment.


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


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. 02-006-1, 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. 02-006-1. If you use e-mail, address your comment to 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. 02-006-1” on the subject line.

You may read the extension request, the environmental assessment, and any comments 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 (202) 690-2817 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​ppd/​rad/​webrepor.html.

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Dr. James White, Plant Protection and Quarantine, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-5940. To obtain a copy of the extension request or the environmental assessment, contact Ms. Kay Peterson at (301) 734-4885; e-mail:

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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.


On November 20, 2001, APHIS received a request for an extension of a determination of nonregulated status (APHIS No. 01-324-01p) from Monsanto Company (Monsanto) of St. Louis, MO, for a canola (Brassica napus L.) transformation event designated as glyphosate-tolerant canola event GT200 (GT200), which has been genetically engineered for tolerance to the herbicide glyphosate. The Monsanto request seeks an extension of a determination of nonregulated status that was issued for Roundup Ready® canola line RT73, the antecedent organism, in response to APHIS petition number 98-216-01p (see 64 FR 5628-5629, Docket No. 98-089-2, published February 4, 1999). Based on the similarity of GT200 to the antecedent organism RT73, Monsanto requests a determination that glyphosate-tolerant canola event GT200 does not present a plant pest risk and, therefore, is not a regulated article under APHIS' regulations in 7 CFR part 340.


Like the antecedent organism, canola event GT200 has been genetically engineered to express an enzyme, 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS), from Agrobacterium sp. strain CP4, and the glyphosate oxidoreductase (GOX) gene/protein from Ochrobactrum anthropi strain LBAA, both of which impart tolerance to the herbicide glyphosate. The subject canola and the antecedent organism were produced through use of the Agrobacterium tumefaciens method to transform the parental canola variety Westar. Expression of the added genes in GT200 and the antecedent organism is controlled in part by gene sequences derived from the plant pathogen figwort mosaic virus.

Canola event GT200 and the antecedent organism were genetically Start Printed Page 9248engineered using the same transformation method and contain the same enzymes that make the plants tolerant to the herbicide glyphosate. Accordingly, we have determined that canola event GT200 is similar to the antecedent organism in APHIS petition number 98-216-01p, and we are proposing that canola event GT200 should no longer be regulated under the regulations in 7 CFR part 340.

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, GT200 has been approved for commercial use in Canada since 1996, with no subsequent reports of deleterious effects on plants, nontarget organisms, or the environment as a result of its environmental release.

Should APHIS approve Monsanto's request for an extension of a determination of nonregulated status, canola event GT200 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 or its progeny.

National Environmental Policy Act

An environmental assessment (EA) has been prepared to examine any potential environmental impacts associated with this proposed extension of a determination of nonregulated status. 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 Monsanto's extension request and the EA are available upon request from the individual listed under FOR FURTHER INFORMATION CONTACT.

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Done in Washington, DC, this 22nd day of February 2002.

W. Ron DeHaven,

Acting Administrator, Animal and Plant Health Inspection Service.

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[FR Doc. 02-4805 Filed 2-27-02; 8:45 am]