Study Sought Before Sale of Gene-Altered Tomato

Calgene has asked the Food and Drug Administration for extra scrutiny of one of its genetic engineering tools, a gene it calls the kan marker, in a show of the company’s sensitivity to public fears about the safety of genetically altered food.

Calgene, a Davis, Calif.-based biotechnology company, said it has asked the FDA for formal approval of the use of the gene as a food additive--a ruling that the FDA itself seemed to make unnecessary last year when the agency said it would not require genetically altered foods to be reviewed under the laws governing food additives.

Calgene anticipates marketing its FlavrSavr tomato--which uses the kan gene--sometime this year, thus becoming the first company to sell a genetically engineered food product to the public.

The tomato is designed to stay fresh longer than other commercially available tomatoes. Calgene is also using the marker gene in cotton and oilseed products under development.

“We have elected to ask the FDA to formally apply the comprehensive standards of food additive review to our kan . . . because of continued misrepresentation and public misunderstanding of the scope and rigor of FDA review of new food products,” said Roger Salquist, chief executive of Calgene, in a statement.

The agricultural biotechnology industry--of which Calgene is considered the leader--applauded the FDA last May for its stance on genetically engineered food products.

However, the move drew harsh criticism from some longtime biotech foes who organized dozens of chefs and food handlers across the country in a planned boycott of Calgene’s tomato.

The marker gene and tomato already have been subjected to considerable scrutiny by federal regulatory agencies. Last October, the U.S. Department of Agriculture said it no longer would regulate the tomato--allowing the company to grow and ship it without further permits or approvals.

Although the FDA’s new policy no longer requires review of the tomato, Calgene is still pursuing its request for a formal FDA ruling approving the tomato.

“We want the public to know that the FDA has looked every way from Sunday at this and has not shirked its duty to review” the gene and the tomato, Salquist said Monday in an interview.