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

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 Sec. 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. Paragraphs (b) and (c) of Sec. 340.6 describe the form that a petition for determination of nonregulated status must take and the information that must be included in the petition. On August 4, 1998, APHIS received a petition (APHIS Petition No. 98-216-01p) from Monsanto Company (Monsanto) of St. Louis, MO, (Monsanto) requesting a determination of nonregulated status under 7 CFR part 340 for a canola (Brassica napus L.) line designated as RT73, which has been genetically engineered for tolerance to the herbicide glyphosate. The Monsanto petition states that the subject canola line should not be regulated by APHIS because it does not present a plant pest risk. As described in the petition, canola line RT73 has been genetically engineered to express a CP4 EPSPS gene derived from Agrobacterium sp. strain CP4, and a gox gene derived from Ochrobactrum anthropi strain LBAA. The CP4 EPSPS gene encodes a 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) protein, and the gox gene encodes a glyphosate oxidoreductase (GOX) protein. The EPSPS and GOX proteins confer tolerance to the herbicide glyphosate. The Agrobacterium tumefaciens method was used to transfer the added genes into the parental canola Westar variety plants, and expression of the added genes is controlled in part by gene sequences derived from the plant pathogen figwort mosaic virus.

Canola line RT73 has been considered a regulated article under the regulations in 7 CFR part 340 because it contains gene sequences from plant pathogens. The subject canola line has been field tested since 1996 under APHIS permits. In the process of reviewing the permit applications for field trials of this canola line, APHIS determined that the vectors and other elements were disarmed and that the trials, which were conducted under conditions of reproductive and physical containment or isolation, would not present a risk of plant pest introduction or dissemination. In the Federal Plant Pest Act, as amended (7 U.S.C. 150aa et seq.), ``plant pest'' is defined as ``any living stage of: Any insects, mites, nematodes, slugs, snails, protozoa, or other invertebrate animals, bacteria, fungi, other parasitic plants or reproductive parts thereof, viruses, or any organisms similar to or allied with any of the foregoing, or any infectious substances, which can directly or indirectly injure or cause disease or damage in any plants or parts thereof, or any processed, manufactured or other products of plants.'' APHIS views this definition very broadly. The definition covers direct or indirect injury, disease, or damage not just to agricultural crops, but also to plants in general, for example, native species, as well as to organisms that may be beneficial to plants, for example, honeybees, rhizobia, etc. The U.S. Environmental Protection Agency (EPA) is responsible for the regulation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 et seq.). FIFRA requires that all pesticides, including herbicides, be registered prior to distribution or sale, unless exempt by EPA regulation. In cases in which genetically modified plants allow for a new use of an herbicide or involve a different use pattern for the herbicide, EPA must approve the new or different use. Accordingly, a submission has been made to EPA for registration of the herbicide glyphosate for use on canola. When the use of the herbicide on the genetically modified plant would result in an increase in the residues of the herbicide in a food or feed crop for which the herbicide is currently registered, or in new residues in a crop for which the herbicide is not currently registered, establishment of a new tolerance or a revision of the existing tolerance would be required. Residue tolerances for pesticides are established by EPA under the Federal Food, Drug and Cosmetic Act (FFDCA), as amended (21 U.S.C. 301 et seq.), and the Food and Drug Administration (FDA) enforces tolerances set by EPA under the FFDCA. FDA published a statement of policy on foods derived from new plant varieties in the Federal Register on May 29, 1992 (57 FR 22984-23005). The FDA statement of policy includes a discussion of FDA's authority for ensuring food safety under the FFDCA, and provides guidance to industry on the scientific considerations associated with the development of foods derived from new plant varieties, including those plants developed through the techniques of genetic engineering. Monsanto has completed consultation with FDA on the subject canola line. In accordance with Sec. 340.6(d) of the regulations, we are publishing this notice to inform the public that APHIS will accept written comments regarding the Petition for Determination of Nonregulated Status from any interested person for a period of 60 days from the date of this notice. The petition and any comments received are available for public review, and copies of the petition may be ordered (see the ADDRESSES section of this notice). After the comment period closes, APHIS will review the data submitted by the petitioner, all written comments received during the comment period, and any other relevant information. Based on the available information, APHIS will furnish a response to the petitioner, either approving the petition in whole or in part, or denying the petition. APHIS will then publish a notice in the Federal Register announcing the regulatory status of the Monsanto RT73 canola line and the availability of APHIS' written decision.

Authority: 7 U.S.C. 150aa-150jj, 151-167, and 1622n; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.2(c).

Done in Washington, DC, this 9th day of October 1998. Craig A. Reed, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 98-27828 Filed 10-15-98; 8:45 am] BILLING CODE 3410-34-P