Calgene Inc. announced Tuesday that it has asked FDA to issuea formal approval for use of the kanamyacin-resistant (kanR)selectable marker gene as a processing aid under the foodadditive provisions of the Federal Food Drug and Cosmetic Act.
The voluntary move by Calgene comes as its geneticallyengineered Flavr Savr tomato is getting closer to themarketplace.
The Davis, Calif., company (NASDAQ:CGNE) asked FDA inNovember 1990 to issue an advisory opinion on the use of thekanR gene in genetically engineered plants. Now, Calgene hassent a letter to FDA asking for more than an opinion; thecompany wants the kanR gene formally approved as a foodadditive.
"We want to demonstrate to the public that the FDA is exertingoversight in this area by voluntarily taking the productthrough the most rigorous federal approval process that theCenter for Food Safety has," Roger Salquist, Calgene's chiefexecutive officer, told BioWorld. "And that is the food additivepetition process."
Salquist said that getting formal approval from FDA won't takeany longer than getting an advisory opinion since Calgene hasalready supplied the agency with all the necessary data. Hesaid the company expects to hear from FDA sometime in thenext three or four months and that the Flavr Savr tomato willbe on the market on schedule this year.
"We want to prove beyond a shadow of a doubt that thisproduct is safe," Salquist said.
Last October, the U.S. Department of Agriculture (USDA)announced that it would no longer regulate Calgene's Flavr Savrtomato, allowing for production and shipment of the productanywhere in the U.S. without further permits or approvals. TheFlavr Savr tomato currently contains the kanR gene. ButCalgene had already decided to request advisory opinions fromFDA, regardless of the USDA decision. The company has soughttwo advisory opinions from FDA to date: the 1990 request foran opinion on the kanR gene as a food additive and an August1991 request for an opinion confirming the Flavr Savr tomatoas food.
Calgene's stock closed Tuesday at $18.63, down 13 cents ashare.
-- Lisa Piercey Business Editor
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