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Plant Genetic Systems (America), Inc.; Receipt of Petition for Determination of Nonregulated Status for Corn Genetically Engineered for Male Sterility and Glufosinate Herbicide Tolerance as a Marker
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Plant Genetic Systems (America), Inc.; Receipt of Petition f
[Federal Register: November 16, 1995 (Volume 60, Number 221)] [Notices]
[Page 57570-57571]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service [Docket No. 95-076-1]Plant Genetic Systems (America), Inc.; Receipt of Petition for Determination of Nonregulated Status for Corn Genetically Engineered for Male Sterility and Glufosinate Herbicide Tolerance as a Marker
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 Plant Genetic Systems (America), Inc., seeking a determination of nonregulated status for a corn line designated as event MS3 that has been genetically engineered for male sterility and tolerance to the herbicide glufosinate as a marker. 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 corn line presents a plant pest risk.
DATES: Written comments must be received on or before January 16, 1996.
ADDRESSES: Please send an original and three copies of your comments to Docket No. 95-076-1, 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. 95-076-1. 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.
FOR FURTHER INFORMATION CONTACT: Dr. James White, Team Leader, Biotechnology Permits, BBEP, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1237; (301) 734-7612. To obtain a copy of the petition, contact Ms. Kay Peterson at (301) 734-7612.
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
[[Page 57571]]
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 16, 1995, APHIS received a petition (APHIS Petition No. 95-228-01p) from Plant Genetic Systems (America), Inc., (PGS) of Des Moines, IA, requesting a determination of nonregulated status under 7 CFR part 340 for a male sterile, glufosinate tolerant corn line designated as transformation event MS3 (event MS3). The PGS petition states that corn event MS3 should not be regulated by APHIS because it does not present a plant pest risk.
As described in the petition, corn event MS3 has been genetically engineered with a gene from Bacillus amyloliquefaciens encoding a ribonuclease called barnase, which inhibits pollen formation and results in male sterility of the transformed plants. Corn event MS3 also contains the bar gene isolated from the bacterium Streptomyces hygroscopicus that encodes a phosphinothricin acetyltransferase (PAT) enzyme, which, when introduced into a plant cell, inactivates glufosinate. Linkage of the barnase gene, which induces male sterility, with the bar gene, a glufosinate tolerance gene used as a marker, enables identification of the male sterile line before the plant begins to flower. Event MS3 was transformed via immature embryo electroporation in yellow dent corn material. Expression of the introduced genes is controlled in part by the P35S promoter derived from the plant pathogen cauliflower mosaic virus and the 3'nos sequence from the plant pathogen Agrobacterium tumefaciens. PGS' corn event MS3 is currently considered a regulated article under the regulations in 7 CFR part 340 because it contains the abovementioned gene sequences derived from plant pathogenic sources. The subject corn line has been evaluated in field trials conducted since 1992 under APHIS permits or notifications. In the process of reviewing the applications for field trials of the corn event MS3, APHIS determined 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 the genetically modified plants allow for a new use of an herbicide or involve a different use pattern for the herbicide, the EPA must approve the new or different use. In conducting such an approval, the EPA considers the possibility of adverse effects to human health and the environment from the use of this herbicide. 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 the EPA under the Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 201 et seq.), and the Food and Drug Administration (FDA) enforces tolerances set by the EPA under the FFDCA.
The 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 the 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. 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 PGS' corn event MS3 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 2.17, 2.51, and 371.2(c).
Done in Washington, DC, this 8th day of November 1995. Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 95-28326 Filed 11-15-95; 8:45 am] BILLING CODE 3410-34-P