FDA Asked to Review Biotech Tomato : Genetic engineering: The California company’s request is the first for an altered food product.
For the first time, the Food and Drug Administration has been asked to clear the way for a genetically engineered food product to be sold.
Calgene, a Davis, Calif.-based agricultural biotechnology company, on Monday filed a petition asking the FDA to issue an advisory opinion declaring its “Flavr Savr” tomato is a “whole food”--that is, without additives. Such a declaration would give Calgene clearance to market the Flavr Savr without regulation.
The tomato uses an “antisense” gene--already under FDA review--that blocks the tomato’s natural tendency to soften. Calgene says its engineered tomatoes will not only last longer in stores and on the shelf, but will taste better because they can be allowed to vine-ripen.
The FDA’s response could be another year or more away; it is unlikely that the tomato, if approved, would begin showing up in produce sections before 1993. But the filing and the FDA’s reaction are being closely watched by some activist groups and by several large companies, such as Monsanto and Du Pont, that are developing their own genetically engineered foods.
For the entire burgeoning agricultural biotech business, in fact, the FDA review of the antisense gene and tomato will be crucial tests of regulatory and consumer reaction. If the tomato enters the marketplace without regulation or public antipathy, it would establish regulatory precedence and--if Calgene’s taste claims are borne out--set the stage for consumer acceptance of other genetically engineered products.
The tomato, and the company behind it, may be the best possible first test of the waters for genetically engineered food products.
Even biotechnology’s harshest critics agree that, of all such food products now in development, the antisense tomato appears to present the fewest safety issues.
The issues are more legal and regulatory in nature, said Rebecca Goldberg of the New York-based Environmental Defense Fund. Goldberg’s group has been very wary of projects at several companies, including Calgene, to develop crops that are resistant to common pesticides, pests and diseases.
But the antisense tomato, “if it really tastes better,” is a product that consumers may actually want, she said. “If genetically engineered products are products that consumers want, that’s fine. Perhaps we should have more tomatoes and fewer BSTs,” she said, referring to bovine somatotropin, a genetically engineered drug still awaiting FDA approval that increases cows’ milk production.
Calgene has been very careful to avoid the public relations fiasco that Monsanto, Eli Lilly and other large companies have faced with BST. It has meticulously prepared the way for the tomato.
Its chief executive, Roger Salquist, has spent countless hours meeting with consumer groups and talking to the media about the tomato and the technology. The company had 18 months of informal talks with the FDA before last November, when it submitted its request for review of the antisense gene.
And the company has been steadily building other businesses that bring in income while its genetically engineered products are wending their way through the long regulatory process. Later, those businesses could serve as marketing and distribution arms for the products.
The FDA opinion on the tomato may hinge in large part on how it views the kanamycin resistance gene at the heart of the tomato and other crops in development at Calgene. That gene, called a “marker” gene, is a naturally occuring gene. In the case of the tomato, the gene that is responsible for softening or rotting has been cloned, reinserted backwards, and operates to thwart the rotting.
The Environmental Defense Fund was one of only a few negative responses to a highly unusual call by the FDA for public comment on the antisense gene.
On Monday, Salquist said he believes that chances are “quite high” that the FDA will view the gene as safe and the tomato as a whole food.
