Availability of Determination of Nonregulated Status for Genetically Engineered Corn

Background

On April 3, 1995, the Animal and Plant Health Inspection Service (APHIS) received a petition (APHIS Petition No. 95-093-01p) from the Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination that corn designated as MON 80100 that has been genetically engineered for insect resistance does not present a plant pest risk and, therefore, is not a regulated article under APHIS' regulations in 7 CFR part 340. On June 7, 1995, APHIS published a notice in the Federal Register (60 FR 30061-30062, Docket No. 95-041-1) announcing that the Monsanto petition had been received and was available for public review. The notice also discussed the role of APHIS, the Environmental Protection Agency (EPA), and the Food and Drug Administration in regulating the subject corn line and food products derived from it. In the notice, APHIS solicited written comments from the public as to whether corn line MON 80100 posed a plant pest risk. The comments were to have been received by APHIS on or before August 7, 1995. APHIS received nine comments on the Monsanto petition, from farmers, industry, universities, a growers association, and a State department of agriculture. All the commenters expressed support for the subject petition. Analysis

Monsanto's corn line MON 80100 has been genetically engineered to express a CryCIA(b) insect control protein derived from the common soil bacterium Bacillus thuringiensis subsp. kurstaki (Btk). Btk proteins are effective against certain lepidopteran insects, including European corn borer (ECB), a major corn pest. Results of field tests conducted by Monsanto under permits and notifications granted by APHIS and under an experimental use permit obtained from EPA indicate that corn plants producing the CryCIA(b) protein were protected throughout the growing season from leaf and stalk feeding damage caused by ECB. In addition to expressing the CryCIA(b) protein, the plants also express the selectable marker enzyme 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS). The cryIA(b) gene and the CP4 EPSPS marker gene were introduced into the subject corn line by a particle acceleration method and their expression is under the control of the enhanced 35S promoter derived from the plant pathogen cauliflower mosaic virus. The subject corn line has been considered a regulated article under APHIS' regulations in 7 CFR part 340 because it contains certain gene sequences derived from plant-pathogenic sources. However, evaluation of field data reports from field tests of corn line MON 80100 conducted since 1992 indicates that there were no deleterious effects on plants, nontarget organisms, or the environment as a result of the subject corn plants' release into the environment.

Determination

Based on its analysis of the data submitted by Monsanto and a review of other scientific data, comments received from the public, and field tests of the subject corn, APHIS has determined that corn line MON 80100: (1) Exhibits no plant pathogenic properties; (2) is no more likely to become a weed than lepidopteran-insect-resistant corn developed through traditional breeding techniques; (3) is unlikely to increase the weediness potential of any other cultivated plant or native wild species with which it can interbreed; (4) should not cause damage to raw or processed agricultural commodities; (5) is unlikely to harm organisms beneficial to the agricultural ecosystem; and (6) when cultivated, should not reduce the ability to control insects in corn and other crops. APHIS has also concluded that there is a reasonable certainty that new varieties developed from corn line MON 80100 will not exhibit new plant pest properties, i.e., properties substantially different from any observed in the field tested corn line MON 80100, or those observed in corn in traditional breeding programs.

The effect of this determination is that an insect-resistant corn line designated as MON 80100 is no longer considered a regulated article under APHIS' regulations in 7 CFR part 340. Therefore, the notification requirements pertaining to regulated articles under those regulations no longer apply to the field testing, importation, or interstate movement of corn line MON 80100 or its progeny. However, the importation of the subject corn line or seed capable of propagation is still subject to the restrictions found in APHIS' foreign quarantine notices in 7 CFR part 319.

National Environmental Policy Act

An environmental assessment (EA) has been prepared to examine the potential environmental impacts associated with this determination. The EA was prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321 et seq.), (2) Regulations of the Council on Environmental Quality for Implementing the Procedural Provisions of NEPA (40 CFR parts 1500-1508), (3) USDA Regulations Implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372; 60 FR 6000-6005). Based on that EA, APHIS has reached a finding of no significant impact (FONSI) with regard to its determination that the subject corn line and lines developed from it are no longer regulated articles under its regulations in 7 CFR part 340. Copies of the EA and the FONSI are available upon request from the individual listed under FOR FURTHER INFORMATION CONTACT.

Done in Washington, DC, this 28th day of August 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 95-21847 Filed 9-1-95; 8:45 am] BILLING CODE 3410-34-P