HERNDON, Va. _ FDA Commissioner David Kessler said Friday thathis agency will issue an opinion on Calgene Inc.'s Flavr Savr tomatowithin 90 days. Kessler made the prediction at the close of a three-dayFood Advisory Committee meeting that reviewed geneticallyengineered food policies using the Flavr Savr as a case study.After hearing presentations from FDA reveiwers and Calgenescientists, a majority of committee members said that the Flavr Savrwas safe for human consumption and that FDA policies are basicallysound.Kessler said he wanted a panel of experts to confirm that FDA's Centerfor Food Safety and Applied Nutrition (CFSAN) followed the rightprocedures and reached the right conclusions regarding the tomato'ssafety. "I did not hear any dissent on the safety evaluation of the FlavrSavr tomato today," said Kessler.FDA policy addresses itself to answering three specific questions aboutthe genetic modification of a food: whether the change creates a newsubstance, whether it produces levels of nutrients or toxicants that aresignificantly different from those found in the natural form of the foodand whether it introduces known allergens into the food. "In listeningto the panel today I heard a reaffirmation that those are the rightquestions," said Kessler.The April 6-8 meeting was historic. It was the first time an FDAadvisory committee has met to discuss a genetically modified foodproduct and may serve to open the floodgates for a slew of newproducts being developed by biotechnology firms.Several times during the day, Kessler steered committee memberstoward a discussion of scientific issues and away from broader policyconsiderations.But five representatives from consumer and environmental groups whotestified said that the FDA has failed to address social and public policyissues that are as important as the scientific data. At least onecommittee member agreed with them. "We're discussing issues withthe potential for changing the relationship between humans and natureon a scale of the industrial revolution," said Joan Gussow, a professorfrom Columbia University's Teachers College. "I'm deeply troubled bythe narrowness of our discussion."Activists criticized FDA policies as incomplete. They said allgenetically modified foods should be labeled and all companies shouldbe required to notify the FDA of intent to sell a genetically modifiedproduct. Until such policies are firmly in place, they said the tomatoshould not be approved.Their concern: due to a loophole in the FDA policy published in theFederal Register in May 1992, it is left up to companies to determinewhether or not their product is generally recognized as safe (GRAS).Activists and at least two panel members argued that while Calgenewas stringent in its interpretation, other companies might not be socareful.But Gustaaf de Zoeten, chairman of the department of plant pathologyat Michigan State University and a consultant to the FDA panel, saidthat Calgene should not be "held hostage" just because the FDA hasnot finalized its policies.Kessler said that the FDA is currently working on a pre-marketnotification policy but that the agency's authority to require labeling ofbiotechnology products is limited. "We can require labeling of biotechfoods if it introduces a new substance that alters the food or if there areconsequences from the use of the food, such as there is an allergen,"said Kessler.If a biotechnology-derived product is no different than other productson the market, in composition or in the consequences of its use, theFDA does not have the statutory authority to require labeling. AlthoughCFSAN scientists concluded that the Flavr Savr is not materiallydifferent from other tomatoes, Calgene plans to label the product.If approved, the Flavr Savr will be marketed with circular, silver-dollarsized labels that state it came from "MacGregor's Farm" and that it hasbeen genetically engineered for better taste and slower softening. Inaddition, consumers will have access to a four-page pamphletdescribing how antisense DNA and selective-marker genes enableFlavr Savr to remain longer on the vine than conventional tomatoeswhich are picked green and gassed with ethylene to produce a redcolor.Calgene has paid a heavy price for being the first company to attemptto deliver a genetically modified whole food to the American people.Despite the imminent end of five years of regulatory limbo, the mostdifficult task may yet lie ahead for Calgene.Achieving profitability in a competitive tomato market, survivingattacks from activist groups such as Jeremy Rifkin's Pure FoodCampaign, assuring a scientifically illiterate public that geneticengineering is safe and persuading consumers to fork over up to $2 apound for the allegedly superior taste of Flavr Savrs are but a few ofthe hurdles Calgene has yet to clear. And the company must face theseobstacles with less than one year of cash in the bank.In spite of the challenges that loom on the horizon, Calgene executivesand employees have opened up a new frontier with their efforts to winapproval of the Flavr Savr. Concluded Marion Nestle, professor andchair of the Department of Nutrition at New York University and amember of the FDA Food Advisory Committee: "I think the biotechindustry and the FDA owe Calgene a debt of gratitude."

-- Lisa Piercey Washington Editor

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