Calgene, Inc.; Availability of Letter Concluding Consultation

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The Food and Drug Administration (FDA) is announcing the availability of a letter from FDA to Calgene, Inc., notifying the firm that the agency has concluded that FLAVR SAVR TM tomatoes have not been significantly altered when compared to varieties of tomatoes with a history of safe use. FDA also is announcing the availability of a written summary of the consultation between Calgene and the agency concerning FLAVR SAVR TM tomatoes, which consultation was conducted in accordance with the agency's policy on foods derived from new plant varieties. FDA is publishing this document to bring to closure the public process that began with a May 1992 notice announcing a request from Calgene for an advisory opinion concerning FLAVR SAVR TM tomatoes.