Environmental statements; availability, etc.: Nonregulated status determinations— Novartis Seeds et al.; genetically engineered sugar beets,

[Federal Register: August 20, 1998 (Volume 63, Number 161)]

[Notices]

[Page 44604-44605]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr20au98-27]

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 98-079-1]

Novartis Seeds and Monsanto Co.; Receipt of Petition for Determination of Nonregulated Status for Sugar Beet Genetically Engineered for Glyphosate Herbicide Tolerance

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

SUMMARY: We are advising the public that the Animal and Plant Health Inspection Service has received a petition from Novartis Seeds and Monsanto Company seeking a determination of nonregulated status for a sugar beet line designated as GTSB77, which has been genetically engineered for tolerance to the herbicide glyphosate. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. In accordance with those regulations, we are soliciting public comments on whether this sugar beet line presents a plant pest risk.

DATES: Written comments must be received on or before October 19, 1998.

ADDRESSES: Please send an original and three copies of your comments to Docket No. 98-079-1, Regulatory Analysis and Development, PPD, APHIS, Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comments refer to Docket No. 98-079-1. A copy of the petition and any comments received may be inspected at USDA, room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons wishing access to that room to inspect the petition or comments are asked to call in advance of visiting at (202) 690-2817 to facilitate entry into the reading room.

FOR FURTHER INFORMATION CONTACT: Dr. James White, Biotechnology and Biological Analysis, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-5940. To obtain a copy of the petition, contact Ms. Kay Peterson at (301) 734-4885; e-mail: Kay.Peterson@usda.gov.

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 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 June 22, 1998, APHIS received a petition (APHIS Petition No. 98- 173-01p) from Novartis Seeds (Novartis) of Research Triangle Park, NC, and Monsanto Company (Monsanto) of St. Louis, MO, (Novartis/Monsanto) requesting a determination of nonregulated status under 7 CFR part 340 for a sugar beet (Beta vulgaris L.) line designated as GTSB77, which has been genetically engineered for tolerance to the herbicide glyphosate. The Novartis/Monsanto petition states that the subject sugar beet line should not be regulated by APHIS because it does not present a plant pest risk.

As described in the petition, GTSB77 has been genetically engineered to express an enolpyruvylshikimate-3-phosphate synthase (EPSPS) enzyme derived from Agrobacterium sp. strain CP4 (CP4 EPSPS), and the b-D-glucuronidase (GUS) protein from Escherichia coli. The CP4 EPSPS protein confers tolerance to the herbicide glyphosate, and the GUS protein serves as a marker in the plant transformation process. The subject sugar beet line also expresses a novel protein known as 34550, which has no known biological activity, and was apparently created when a truncated glyphosate oxidoreductase (gox) gene fused to sugar beet DNA. The Agrobacterium tumefaciens method was used to transfer the added genes into the parental sugar beet proprietary line A1012, and expression of the added genes is controlled in part by gene sequences derived from the plant pathogens figwort mosaic virus and cauliflower mosaic virus.

The GTSB77 line has been considered a regulated article under the regulations in 7 CFR part 340 because it contains gene sequences from plant pathogens. The subject sugar beet line has been field tested since 1996 under APHIS permits and notifications. In the process of reviewing the permit applications and notifications for field trials of this sugar beet 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

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approve the new or different use. Accordingly, a submission has been made to EPA for registration of the herbicide glyphosate for use on sugar beet. 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. Novartis and Monsanto have begun consultation with FDA on the subject sugar beet 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 Novartis/Monsanto GTSB77 sugar beet 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 13th day of August, 1998. Joan M. Arnoldi, Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 98-22455Filed8-19-98; 8:45 am]

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