For the first time, the Food and Drug Administration on Wednesday approved a genetically engineered food, clearing the way for a Davis, Calif., company to sell its laboratory-designed tomato.
Calgene Inc. said the tomato, designed with its "FlavrSavr" gene and bearing its MacGregor label, could be in food stores in 10 days, with consumers in the Midwest and parts of California getting the first chances to buy them. The tomato is billed as better tasting; it can be ripened on the vine and will stay fresh longer.
The FDA's long-anticipated approval ends a five-year process and gives birth to a new era of food production that supporters contend will lead to more nutritious and environmentally safer--and potentially less costly-- ways to feed the world's hungry. It was also a signal for opponents to launch what they vowed would be a vigorous, nationwide campaign urging consumers not to buy the tomato or any other genetically engineered food.
The FDA said the Calgene tomato is just as safe as conventionally bred tomatoes. "We have approached our review of this product with scientific rigor and a commitment to full, public disclosure of that science," FDA Commissioner David Kessler said in a statement. "Consumers can be confident that we remain committed to assuring that foods produced by genetic engineering are as safe as food in our grocery stores today."
The tomato was developed using Calgene's patented "antisense" technology: The tomato's gene that initiates rotting was cloned and reinserted in reverse, thus slowing the rotting process. This antisense technology could be used to neutralize rotting or other undesirable traits in other crops as well.
Such tools of genetic engineering are allowing developers to modify plants faster and with greater precision than traditional methods of cross-breeding plants or animals for desired traits.
Calgene's ability to disseminate the FDA's assurances of safety and win consumer acceptance of the tomato is seen as a critical first step in developing a market for the next generations of genetically engineered food products. As many as 50 genetically modified crops--including insect-resistant corn and potatoes that absorb less fat when fried--are in various stages of development, although none has been submitted for FDA review.
Several organizations of produce growers and grocers, and other companies working to develop food crops through laboratory manipulation of genes, praised the FDA action, calling it a boon for consumers.
On the other hand, three public-interest groups Wednesday expressed their disappointment, particularly with the FDA's reiteration that it would not require explicit labeling of genetically engineered foods or products made from them.
The Union of Concerned Scientists and the Environmental Defense Fund decried as inadequate the agency's oversight of genetically engineered foods, contending that future products might pose health and safety risks that would be overlooked by the agency. Those groups again called for labeling regulations, saying that future products might contain substances harmful to some consumers.
The FDA has said its process for reviewing all foods has built-in safeguards, regardless of the process used to develop them.
Another opponent, the Pure Food Campaign, a group led by longtime biotechnology foe Jeremy Rifkin, vowed to file suit against the FDA because of its review policies, and to organize boycotts and tomato-dumping demonstrations as its initial salvos in a "tomato war." Rifkin urges a longer safety testing period and mandatory labeling.
Roger Salquist, who as Calgene's chief executive has shepherded the tomato through the precedent-setting and often-frustrating approval process, was in a celebratory mood Wednesday.
"The consumer who wants a better-tasting tomato . . . (doesn't) want to be dictated to . . . as to what they can and can't buy in a supermarket," Salquist said.
The Grocery Manufacturers of America, the largest trade group of companies that manufacture and market brand-name grocery products, again affirmed its support of the FDA approval process and the use of biotechnology in the development of food products.
However, individual grocery chains and stores, as well as distributors and restaurateurs, will be taking careful note of consumer reaction, especially in light of the response to a Pure Food Campaign-led drive this year against bovine somatotropin, a biotech drug designed to increase cows' milk production. When the FDA approved the Monsanto-developed drug for sale this year, Rifkin's group successfully persuaded dozens of grocery chains around the country to pledge not to accept dairy products from cows treated with the drug.
On Wednesday, some Southern California produce distributors said Calgene's tomato will face stiff competition from new varieties of vine-ripened tomatoes that, although selling at a premium above artificially ripened tomatoes, will still cost less than Calgene's MacGregors.
Calgene's tomatoes could be priced as high as $2.50 a pound, twice that of many premium, traditionally bred tomatoes. Still, Calgene expects that within three years, its tomato will have captured 15% of the $3.5-billion market for fresh tomatoes. That would mean $500 million in sales--far outstripping the estimated $25 million to $30 million cost of developing the tomato.
Ironically, Calgene's biggest hurdle in selling the tomato may be of its own doing. Farmers contracted by Calgene to grow the tomato did not plant enough acreage, Salquist said, "because we didn't know when the approval would come through."
There will be small quantities of the tomatoes available for the next six weeks in as yet unspecified markets in California and the Midwest. After that, there could be a small gap in availability until the company is able to increase harvests, Salquist said.