AgrEvo USA Co.; Availability of Determination of Nonregulated Status for Rice Genetically Engineered for Glufosinate Herbicide Tolerance

Background

On November 25, 1998, the Animal and Plant Health Inspection Service (APHIS) received a petition (APHIS Petition No. 98-329-01p) from AgrEvo USA Company (AgrEvo) of Wilmington, DE, seeking a determination that rice (Oryza sativa L.) designated as Liberty Link Rice Transformation Events LLRICE06 and LLRICE62 (rice transformation events LLRICE06 and LLRICE62), which have been genetically engineered for tolerance to the herbicide glufosinate, do not present a plant pest risk and, therefore, are not regulated articles under APHIS' regulations in 7 CFR part 340. On January 26, 1999, APHIS published a notice in the Federal Register (64 FR 3924-3925, Docket No. 98-126-1) announcing that the AgrEvo petition had been received and was available for public review. The notice also discussed the role of APHIS, the Environmental Protection Agency, and the Food and Drug Administration in regulating the subject rice transformation events and food products derived from them. In the notice, APHIS solicited written comments from the public as to whether rice transformation events LLRICE06 and LLRICE62 posed a plant pest risk. The comments were to have been received by APHIS on or before March 29, 1999. APHIS received four comments on the subject petition during the designated 60-day comment period from the following: a farmers rice cooperative; a State rice growers association; a State rice research board; and a State university rice research station. All of the comments were in support of the subject petition.

Analysis

Rice transformation events LLRICE06 and LLRICE62 have been genetically engineered to contain a bar gene derived from Streptomyces hygroscopicus strain HP632. The bar gene encodes the enzyme phosphinothricin-N-acetyltransferase (PAT), which confers tolerance to the herbicide glufosinate. Expression of the bar gene is controlled by 35S promoter and terminator sequences derived from the plant pathogen cauliflower mosaic virus. The direct gene transfer method was used to transfer the added genes into the parental rice varieties M202 (LLRICE06) and Bengal (LLRICE62). The subject rice transformation events have been considered regulated articles under APHIS' regulations in 7 CFR part 340 because they contain gene sequences derived from a plant pathogen. However, evaluation of field data reports from field tests of these rice transformation events conducted under APHIS notifications since 1997 indicates that there were no deleterious effects on plants, nontarget organisms, or the environment as a result of the environmental release of rice transformation events LLRICE06 and LLRICE62.

Determination

Based on its analysis of the data submitted by AgrEvo, and a review of other scientific data and field tests of the subject rice transformation events, APHIS has determined that rice transformation events LLRICE06 and LLRICE62: (1) Exhibit no plant pathogenic properties; (2) are no more likely to become weeds than rice varieties developed by traditional plant breeding; (3) are unlikely to increase the weediness potential for any other cultivated or wild species with which they can interbreed; (4) will not harm threatened or endangered species or organisms that are recognized as beneficial to agriculture; and (5) will not cause damage to raw or processed agricultural commodities. Therefore, APHIS has concluded that the subject rice transformation events and any progeny derived from hybrid crosses with other rice varieties will be as safe to grow as rice in traditional breeding programs that are not subject to regulation under 7 CFR part 340. The effect of this determination is that AgrEvo's rice transformation events LLRICE06 and LLRICE62 are no longer considered regulated articles under APHIS' regulations in 7 CFR part 340.

Therefore, the requirements pertaining to regulated articles under those regulations no longer apply to the subject rice transformation events or their progeny. However, importation of the subject rice transformation events 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 rice transformation events LLRICE06 and LLRICE62 and lines developed from them 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 20th day of April 1999. Craig A. Reed, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 99-10510 Filed 4-26-99; 8:45 am] BILLING CODE 3410-34-P