Agritope, Inc.; Availability of Determination of Nonregulated Status for Cherry Tomato Line Genetically Engineered for Modified Fruit Ripening

Background

On November 20, 1995, the Animal and Plant Health Inspection Service (APHIS) received a petition (APHIS Petition No. 95-324-01p) from Agritope, Inc., (Agritope) of Beaverton, OR, seeking a determination that a cherry tomato line designated as 35-1-N that has been genetically engineered for modified fruit ripening does not present a plant pest risk and, therefore, is not a regulated article under APHIS' regulations in 7 CFR part 340. On January 23, 1996, APHIS published a notice in the Federal Register (61 FR 1743-1744, Docket No. 95-097-1) announcing that the Agritope petition had been received and was available for public review. The notice also discussed the role of APHIS and the Food and Drug Administration in regulating the subject tomato line and food products derived from it. In the notice, APHIS solicited written comments from the public as to whether the subject tomato line posed a plant pest risk. The comments were to have been received by APHIS on or before March 25, 1996. During the designated 60-day comment period, APHIS received a total of 21 comments on the petition for cherry tomato line 35-1-N from individuals, a seed company, a State department of agriculture, and a university. All of the comments were in support of the subject petition.

Analysis

Cherry tomato line 35-1-N has been genetically engineered to contain the sam-k gene derived from Escherichia coli bacteriophage T3 that encodes an enzyme, S-adenosylmethionine hydrolase (SAMase), which alters the ethylene biosynthetic pathway and delays ripening of the tomato on the vine. When exposed to exogenous ethylene the fruit of line 35-1-N ripen normally. The subject cherry tomato line also contains the nptII gene from the prokaryotic transposon Tn5, which encodes the enzyme neomycin phosphotransferase II and is used as a selectable marker for transformation. Expression of the introduced genes is controlled in part by the 3' region of the nopaline synthase gene from the plant pathogen Agrobacterium tumefaciens. The A. tumefaciens vector system was used to transfer the added genes into the Large Red Cherry parental line. Cherry tomato line 35-1-N has been considered a regulated article under APHIS' regulations in 7 CFR part 340 because it contains regulatory gene sequences derived from the plant pathogen A. tumefaciens. However, evaluation of field data reports from field tests of the subject tomato line conducted under APHIS permits or notifications since 1992 indicates that there were no deleterious effects on plants, nontarget organisms, or the environment as a result of the subject tomato plants' release into the environment.

Determination

Based on its analysis of the data submitted by Agritope and a review of other scientific data, comments received, and field tests of the subject tomato line, APHIS has determined that cherry tomato line 35-1-N: (1) Exhibits no plant pathogenic properties; (2) is no more likely to become a weed than cherry tomato cultivars 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 harm threatened or endangered species or other organisms, such as bees, that are beneficial to agriculture; and (5) will not cause damage to raw or processed agricultural commodities. Therefore, APHIS has concluded that cherry tomato line 35- 1-N and any progeny derived from hybrid crosses with other nontransformed tomato varieties will be just as safe to grow as traditionally bred cherry tomato lines that are not regulated under 7 CFR part 340. The effect of this determination is that Agritope's cherry tomato line designated as 35-1-N 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 the subject tomato line or its progeny. However, the importation of cherry tomato line 35-1-N or seeds 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). Based on that EA, APHIS has reached a finding of no significant impact (FONSI) with regard to its determination that Agritope's cherry tomato line 35-1-N 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 4th day of April 1996. Lonnie J. King, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 96-8904 Filed 4-9-96; 8:45 am] BILLING CODE 3410-34-P