Editorial: Rethink biotech safety

Peer review, labeling breed confidence

Published Sunday, June 20, 2004

What's the ordinary American to think about genetically engineered foods that make their way to the grocery store?

The U.S. Food and Drug Administration does no independent review of industry testing data. Yet it considers genetically engineered crops to be "substantially equivalent" to traditionally bred crops. It does not require labels. So you have no way to know by looking at the shelves that most processed foods sold today in the United States contain bioengineered corn, soybeans or canola.

To build trust in new gene-splicing, gene-inserting technologies, the United States needs independent review of food safety studies and labeling so consumers can make their own market decisions. This wouldn't be difficult. In the first decade of biotech foods, 1992-2002, food companies voluntarily submitted 50 bioengineered food crops for the FDA's evaluation. American-based food companies selling in Europe, Australia, China and other markets already are required to label their bioengineered products.

Independent review would not be an overwhelming burden. And in the long run it should help, not hurt, the food industry by building consumer confidence, which is why food companies should embrace independent study and labeling.

Here in California, the Flavr Savr delayed-ripening tomato ushered in today's regulatory climate. The company, Calgene, founded by University of California Davis professor Raymond Valentine, bent over backward to make its findings public and volunteered to provide consumer pamphlets and labels on its product. Calgene's actions led the FDA to establish voluntary testing and voluntary labeling, but few companies followed Calgene's example of openness. None does animal testing and few label their products.

Calgene tested, but the FDA left consumers confused. When the company did three feeding studies with rats, the results were less than reassuring. In one test, 11 of 40 female rats fed the Flavr Savr tomato had stomach lesions.

In its safety decision memo, the FDA noted, "There was disparity among the three studies regarding the incidence of rats with gastric erosions. Data and information supplied by Calgene fail to clarify or explain the factors responsible for this disparity."

This disparity clearly cries out for further study.

The FDA dismissed the issue as "not necessary to our determination of whether the Flavr Savr tomatoes are as safe as other currently consumed tomatoes." (A postscript: The Flavr Savr tomato proved not to be that different from other tomatoes and was only on the market for three years.)

The lack of independent scientific study is a major credibility issue. A June 2000 article in Science, "Health Risks of Genetically Modified Foods: Many Opinions but Few Data," surveyed international journals and found only a handful of peer-reviewed studies evaluating health effects of bioengineered foods. The article particularly noted the absence of peer-reviewed studies by biotechnology companies.

Since in the United States companies voluntarily perform safety studies, the article asked an obvious question: "Why have the results not been subjected to the judgment of the international scientific community, as would be the course if such research were published in reputable journals?"

U.S. consumers are whipsawed by exaggerated claims of biotech opponents and biotech crusaders. The FDA needs to give consumers enough information to make informed choices in this changing marketplace. The way to do that is through independent review of food company testing and labels that list as food additives any compounds introduced into foods via genetic engineering.