WASHINGTON _ Despite apparently smooth sailing for CalgeneInc.'s genetically engineered Flavr Savr tomato at an FDA meetingunderway in Herndon, Va., the Davis, Calif., company's stock wasdown $2.13 a share Thursday to close at $12.63. Yesterday's losserased Wednesday's gain of almost $2 a share spurred by news thatFDA scientists have determined that the tomato and the selectablemarker used to produce it are safe. (See BioWorld, April 4, 1994.)The conclusions of reviewers from the FDA's Center for Food Safetyand Applied Nutrition (CFSAN) were distributed to meeting attendeeson Wednesday.Calgene's shares slumped after Merrill Lynch biotechnology analystMaureen McGann lowered her intermediate rating on the stock(NASDAQ:CGNE) from "above average" to "neutral." McGann saidthat factoring in FDA approval of the Flavr Savr, Calgene stock isfairly valued in the $15 to $17 range and she changed her rating on thebasis of price. Ironically, this assessment sent the shares tumbling outof that range. McGann maintains a long-term rating of "above average"and continues to recommend accumulation of the shares for long-termappreciation.The FDA Food Advisory Committee has now completed the secondday of its three-day discussion using the Flavr Savr tomato as a casestudy to test the soundness of procedures and guidelines developed bythe FDA in its first-ever review of a genetically engineered whole food.The committee has been given the task of advising the FDA on theprocess used to evaluate the Flavr Savr, not on CFSAN's conclusionsabout the tomato itself."This is going very well from our perspective," said Tom Churchwell,president of Calgene Fresh Inc., the Evanston, Ill.-based producemarketing arm of Calgene. "The FDA has convened a panel ofqualified scientists to hear how its policy works to elicit good scienceabout new food products."In August 1991, Calgene requested an advisory opinion from the FDAon the Flavr Savr that would establish the genetically engineeredproduct as a tomato and subject to the same regulation as other non-engineered tomatoes. In January 1993, Calgene requested that the FDAapprove the kan r gene (including its protein by-product, APH(3')II) asa food additive.Calgene scientists presented their data to the committee on Thursday,followed by presentations from the CFSAN scientists who reviewedCalgene's applications. At times, it seemed the committee strayed fromits charted course, as some members asked detailed scientific questionsabout the Flavr Savr rather than the review process."It seems to me we are reevaluating the FDA's evaluation," acommittee member complained at one point in the discussion.Committee chair Edward Brandt, professor and co-director of theCenter for Health Policy at the University of Oklahoma, struggled tokeep the meeting on track. "We're not here to vote on the tomato andwe're not here to give advice on the tomato," he reminded thecommittee. "Our charge is to give advice about the process."Calgene scientists recounted the experiments and tests they haveconducted during the last five years since they first contacted the FDAand began discussing how to establish the safety of a geneticallyengineered food. Many experiments were conducted voluntarily by thecompany, such as animal studies which involved pumping largequantities of tomato puree into the stomachs of rats to see if geneticallyengineered tomatoes cause toxicities which regular tomatoes do not.(Both Calgene and the FDA concluded that they don't.)Topics covered in Thursday's presentations included details about theexact genetic modification made to the Flavr Savr, nutrients andnaturally occurring toxicants found in the Flavr Savr and safety andtoxicity data about the whole tomato, the kan r gene and its protein by-product, APH(3')II.The sheer volume of data and the length of the regulatory process madeclear the enormous amount of time and money that both Calgene andthe FDA have expended in attempting to prove the safety of the FlavrSavr. Nina Federoff, a consultant to the panel and a staff scientist in thedepartment of embryology at the Carnegie Institute of Washington,expressed dismay at the prospect of every new food produced usingmolecular biology techniques undergoing a similarly slow and rigorousreview."I have a deep concern that we will, in our initial concern for doing itright, lock in a regulatory process that is not only unnecessary but veryexpensive for both the taxpayer and either the company or theindividual investigator who is trying to produce a new variety or aslightly altered plant," Federoff told committee members. "I amconcerned that there are many things that will be beneficial to theenvironment or to agriculture but will not have the profit margin thatwill motivate a company to tackle creating that change that couldbenefit all of society."On Friday, the last day of the advisory committee meeting, theschedule calls for a discussion of environmental considerations relatingto the Flavr Savr, including its U.S. Department of Agriculture status asa non-regulated food and a review of its environmental impact.An hour and a half of public comment time is scheduled and speakerssigned up Wednesday for an allotted five minutes to state their views.Committee members will hear from at least fourteen people includingrepresentatives from the following organizations: the Union ofConcerned Scientists, DNA Plant Technology Corp., theEnvironmental Defense Fund, the Center for Consumer Research, theFoundation on Economic Trends (Pure Food Campaign), theInternational Food Biotechnology Council and the Produce MarketingAssociation.According to Churchwell, at least 10 of the speakers will likely expresssupport for the FDA guidelines. The guidelines being judged at thismeeting, the FDA Policy on Foods Derived from New Plant Varieties,were first published in the Federal Register on May 29, 1992. Thecommittee is slated to end the meeting Friday with a discussion andclarification of how well the FDA formulated and then followed the1992 guidelines.Calgene will not be allowed to market its tomato until it has finalapproval from FDA Commissioner David Kessler. If the FoodAdvisory Committee does not raise serious questions about the processand if Kessler accepts the judgment of CFSAN scientists, the kan rfood additive regulation would be published in the Federal Register andthe Flavr Savr advisory opinion would be issued in the form of a letter.Calgene said last October that it believes the two events will occursimultaneously. n
-- Lisa Piercey Washington Editor
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