![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}
Monsanto Co.; Receipt of Petition for Determination of Nonregulated Status for Genetically Engineered Corn
[Federal Register: December 18, 1996 (Volume 61, Number 244)] [Notices]
[Page 66650-66651]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
Notices
Federal Register
This section of the FEDERAL REGISTER contains documents other than rules or proposed rules that are applicable to the public. Notices of hearings and investigations, committee meetings, agency decisions and rulings, delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents appearing in this section.
[[Page 66650]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service [Docket No. 96-095-1]
Monsanto Co.; Receipt of Petition for Determination of Nonregulated Status for Genetically Engineered Corn
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 the Monsanto Company seeking a determination of nonregulated status for a corn line designated as MON 802 that has been genetically engineered for insect resistance and 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 corn line presents a plant pest risk.
DATES: Written comments must be received on or before February 18, 1997.
ADDRESSES: Please send an original and three copies of your comments to Docket No. 96-095-1, 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. 96-095-1. 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 Lackey, BSS, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-7612. To obtain a copy of the petition, contact Ms. Kay Peterson at (301) 734-7612; e-mail: mkpeterson@aphis.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 November 12, 1996, APHIS received a petition (APHIS Petition No. 96-317-01p) from the Monsanto Company (Monsanto) of St. Louis, MO, requesting a determination of nonregulated status under 7 CFR part 340 for an insect-resistant and herbicide-tolerant corn line designated as MON 802. The Monsanto petition states that the subject corn line should not be regulated by APHIS because it does not present a plant pest risk.
As described in the petition, corn line MON 802 has been genetically engineered to express a CryIA(b) insect control protein derived from the common soil bacterium Bacillus thuringiensis subsp. kurstaki (Bt). The petitioner states that expression of the Bt deltaendotoxin protein protects the subject corn line from leaf and stalk feeding damage caused by the European corn borer throughout the growing season. Corn line MON 802 also expresses the CP4 EPSPS protein isolated from Agrobacterium sp. strain CP4 and the GOX protein cloned from Achromobacter sp. strain LBAA, which, when introduced into a plant cell, confer tolerance to glyphosate, the active ingredient in the herbicide Roundup<Register>. The cryIA(b), CP4 EPSPS, and gox genes were introduced into the subject corn line by the particle acceleration method and their expression is controlled in part by the intron from the corn hsp70 gene and by gene sequences derived from the plant pathogens cauliflower mosaic virus and Agrobacterium tumefaciens. The selectable marker gene nptII is present in the subject corn line under the control of its own bacterial promoter. Monsanto's corn line MON 802 is currently considered a regulated article under the regulations in 7 CFR part 340 because it contains gene sequences derived from plant pathogenic sources. The subject corn line has been evaluated in field trials conducted since 1993 under APHIS notifications. In the process of reviewing the notifications for field trials of this corn 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[[Page 66651]]
all pesticides, including insecticides, be registered prior to distribution or sale, unless exempt by EPA regulation. Accordingly, Monsanto has submitted to the EPA an application to register the plant pesticide active ingredient Bt CryIA(b) delta-endotoxin and the genetic material necessary for its production in corn. In cases in which the genetically modified plant allows for a new or different use pattern for an herbicide, the EPA must approve the new or different use. Monsanto has submitted to the EPA an application to register Roundup<Register> herbicide for use on corn. 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 EPA has granted exemptions from the requirement of a tolerance for residues of the CryIA(b) and CP4 EPSPS proteins and the genetic material necessary for their production in all plants, and Monsanto has submitted to the EPA a request for an exemption from the requirement of a tolerance for the GOX enzyme. 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. Monsanto has completed consultation with the FDA on the subject corn 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 Monsanto's corn line MON 802 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 12th day of December 1996. Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service. [FR Doc. 96-32079 Filed 12-17-96; 8:45 am] BILLING CODE 3410-34-P