AgrEvo USA Co.; Extension of Determination of Nonregulated Status for Corn Genetically Engineered for Male Sterility and Glufosinate Herbicide Tolerance as a Marker

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. Further, the regulations in Sec. 340.6(e)(2) provide that a person may request that APHIS extend a determination of nonregulated status to other organisms. Such a request must include information to establish the similarity of the antecedent organism and the regulated article in question.

Background

On December 15, 1998, APHIS received a request for an extension of a determination of nonregulated status (APHIS No. 98-349-01p) from AgrEvo USA Company (AgrEvo) of Wilmington, DE, for corn designated as transformation event MS6 (event MS6), which has been genetically engineered for male sterility and glufosinate herbicide tolerance as a marker. The AgrEvo request seeks an extension of a determination of nonregulated status issued for corn transformation event MS3, the antecedent organism, in response to APHIS petition number 95-228-01p (61 FR 9142-9143, March 7, 1996, Docket No. 95-076-2). Based on the similarity of corn event MS6 to the antecedent organism, AgrEvo requests a determination that male sterile and glufosinate tolerant corn event MS6 does not present a plant pest risk and, therefore, is not a regulated article under APHIS' regulations in 7 CFR part 340.

Analysis

Like the antecedent organism, corn event MS6 contains a barnase gene derived from Bacillus amyloliquefaciens and a bar gene derived from Streptomyces hygroscopicus. The barnase gene encodes an enzyme that inhibits pollen formation and results in male sterility of the transformed plants. The bar gene encodes a phosphinothricin acetyltransferase (PAT) enzyme that confers tolerance to the herbicide glufosinate. Linkage of the barnase gene, which induces male sterility, with the bar gene, a glufosinate tolerance gene used as a marker, enables selection of the male sterile line independent of plant growth stage. Expression of the added genes is controlled in part by gene sequences derived from the plant pathogens cauliflower mosaic virus and Agrobacterium tumefaciens. While corn event MS6 contains fragments of the bla marker gene, it was concluded that the fragments would not produce an intact protein in any medium. The particle acceleration method was used to transfer the added genes into the parental corn inbred line H99. Corn event MS6 and the antecedent organism were genetically engineered using the same transformation method, with the same gene that makes the plants sterile and the same marker gene, and using the same parental inbred line. Accordingly, we have determined that corn event MS6 is similar to the antecedent organism in petition 95-228-01p and, therefore, should no longer be regulated under the regulations in 7 CFR part 340. The subject corn event has been considered a regulated article under APHIS' regulations in 7 CFR part 340 because it contains gene sequences derived from plant pathogens. However, evaluation of field data reports from field tests of this corn event conducted under APHIS notifications since 1997 indicates that there were no deleterious effects on plants, nontarget organisms, or the environment as a result of its environmental release.

Determination

Based on an analysis of the data submitted by AgrEvo and a review of other scientific data and field tests of the subject corn event, APHIS has determined that corn event MS6: (1) Exhibits no plant pathogenic properties; (2) is no more likely to become a weed than male sterile corn developed by traditional breeding techniques; (3) is unlikely to increase the weediness potential for any other cultivated or wild species with which it can interbreed; (4) will not cause damage to raw or processed agricultural commodities; and (5) will not harm threatened or endangered species or other organisms, such as bees, that are beneficial to agriculture. Therefore, APHIS has concluded that corn event MS6 and any progeny derived from crosses with other corn varieties will be as safe to grow as corn that is not subject to regulation under 7 CFR part 340. Since APHIS has determined that corn event MS6 does not present a plant pest risk based on its similarity to the antecedent organism, AgrEvo's corn event MS6 will no longer be considered a regulated article under APHIS' regulations in 7 CFR part 340. Therefore, the requirements pertaining to regulated articles under those regulations no longer apply to the field testing, importation, or interstate movement of the subject corn event or its progeny. However, importation of corn event MS6 or seeds capable of propagation are 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), as amended (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). Based on that EA, APHIS has reached a finding of no significant impact (FONSI) with regard to its determination that AgrEvo's corn event MS6 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 17th day of March, 1999. Craig A. Reed, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 99-7077 Filed 3-23-99; 8:45 am] BILLING CODE 3410-34-P