00-22807. Mycogen c/o Dow and Pioneer; Receipt of Petition for Determination of Nonregulated Status for Corn Genetically Engineered for Insect Resistance and Glufosinate 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 Mycogen Seeds c/o Dow AgroSciences LLC and Pioneer Hi-Bred International, Inc., seeking a determination of nonregulated status for corn designated as line 1507, which has been genetically engineered for insect resistance and tolerance to the herbicide glufosinate. 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 November 6, 2000.

ADDRESSES:

Please send your comment and three copies to: Docket No. 00-070-1, Regulatory Analysis and Development, PPD, APHIS, Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

Please state that your comment refers to Docket No. 00-070-1.

You may read any comments that 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 [phone] 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 http://www.aphis.usda.gov/​ppd/​rad/​webrepor.html.

FOR FURTHER INFORMATION CONTACT:

Dr. Susan Koehler, Biotechnology Assessments Section, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [phone]. To obtain a copy of the petition, contact Ms. Kay Peterson at [phone]; e-mail: [e-mail].

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 § 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 § 340.6 describe the form that a petition for a determination of nonregulated status must take and the information that must be included in the petition.

On May 15, 2000, APHIS received a petition (APHIS Petition No. (00-136-01p) from Mycogen Seeds c/o Dow AgroSciences LLC (Mycogen c/o Dow) of Indianapolis, IN, and Pioneer Hi-Bred International, Inc. (Pioneer) of Johnston, IA, requesting a determination of nonregulated status under 7 CFR part 340 for corn designated as Zea mays L. cultivar line 1507 (line 1507), which has been genetically engineered for resistance to certain lepitopteran insect species and tolerance to the herbicide glufosinate. The Mycogen c/o Dow and Pioneer 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 1507 has been genetically engineered to express a Cry1F insecticidal protein derived from the common soil bacterium, Bacillus thuringiensis subsp. aizawai (Bt aizawai). The petitioners state that the Cry1F protein is effective in controlling the larvae of such common pests of corn as European corn borer, southwestern corn borer, black cutworm, and fall armyworm. The subject corn line also contains the pat gene derived from the bacterium Streptomyces viridochromogenes. The pat gene encodes the phosphinothricin acetyltransferase (PAT) protein, which confers tolerance to the herbicide glufosinate. Expression of these added genes is controlled in part by gene sequences from the plant pathogens cauliflower mosaic virus and Agrobacterium tumefaciens. Microprojectile bombardment was used to transfer the added genes into the recipient inbred corn line Hi-II.

Corn line 1507 has been considered a regulated article under the regulations in 7 CFR part 340 because it contains gene sequences from plant pathogens. This corn has been field tested since 1997 in the United States under APHIS notifications. In the process of reviewing the notifications for field trials of the subject corn, 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 § 403 of the Plant Protection Act (Title IV, Pub. L. 106-224, 114 Stat. 438, 7 U.S.C. 7701-7772), plant pest is defined as any living stage of any of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product: A protozoan, a nonhuman animal, a parasitic plant, a bacterium, a fungus, a virus or viroid, an infectious agent or other pathogen, or any article similar to or allied with any of the foregoing. 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. 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. Pesticide petitions have been filed with EPA to establish a regulation for an exemption from the requirement of a tolerance for residues of Bt aizawai Cry1F and the genetic material necessary for its production in or on all raw agricultural commodities.

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. The petitioner has begun consultation with FDA on the subject corn line.

In accordance with § 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 FOR FURTHER INFORMATION CONTACT 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. After analyzing the available information, including comments received from the public, APHIS will prepare an environmental assessment to examine any potential environmental impacts associated with a determination of nonregulated status for the subject corn line. The environmental assessment will be made available for public comment for a period of 30 days. After reviewing and evaluating the comments on the environmental assessment and other data and 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 Mycogen c/o Dow and Pioneer insect-resistant and glufosinate-tolerant corn line 1507 and the availability of APHIS' written decision.

Authority: Title IV, Pub. L. 106-224, 114 Stat. 438, 7 U.S.C. 7701-7772; 7 U.S.C. 166 and 1622n; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

Done in Washington, DC, this 30th day of August 2000.

Bobby R. Acord,

Acting Administrator, Animal and Plant Health Inspection Service.