Signaling a new level of acceptance for one of the most sophisticated and provocative aspects of modern science, the Bush Administration is expected to announce today that new varieties of foods developed through biotechnology will be regulated exactly like all other foods.
The announcement, slated to be made by Vice President Dan Quayle at a press conference today, sets the stage for a new generation of genetically engineered fruits, vegetables and grains to reach grocers' shelves.
"These new technologies will benefit all Americans by providing foods that are tastier, more varied, more wholesome and that can be produced more efficiently," Health and Human Services Secretary Louis W. Sullivan said in a statement prepared for delivery today.
Sullivan and David A. Kessler, Food and Drug Administration commissioner, were scheduled to join Quayle in the announcement of the policy developed by the White House Council on Competitiveness, which Quayle heads.
"The policy . . . will ensure the safety of these foods while facilitating their availability as quickly as possible," Sullivan's statement said.
By treating foods created through genetic engineering and other "biotech" methods the same as other foods, the FDA will be considering the food itself and not the production process. It will still require pre-market clearance or review if substances have been added to the food or if changes made in the food raise safety questions.
But it apparently will not consider genetic manipulation by itself as an additive or a safety problem. Many genetically engineered foods, it said, may need no FDA review or clearance for marketing.
That is welcome news to companies in the nascent agricultural-biotechnology industry, which for the past decade have faced a tangle of regulations and reviews in the development phase of their products. While the newly stated policy appears to smooth the way to market, agricultural biotech companies are still hoping that other federal agencies, such as the Department of Agriculture and Environmental Protection Agency, soon will streamline their regulations and oversight of genetically engineered products.
Despite today's announcement, it still may be another year before consumers get to taste the first fruits of genetic engineering.
Calgene, the Davis, Ca.-based company expected to be first to market a food developed through biotechnology, said it hopes to begin selling its FlavrSavr brand of tomatoes by the second half of 1993. It will take that long, company officials have said, to grow enough successive generations of the plants for large-scale production.
Other companies, including Monsanto and DNA Plant Technology, are developing new varieties of tomatoes through biotechnology that, like Calgene's, are designed to taste better and last longer. In every living thing, genes determine all characteristics--including, in food crops, color, shape, vulnerability to pests and drought and, of course, taste. By manipulating genetic materials, scientists can enhance or introduce desired traits and minimize or eliminate others.
In the near future, ag-biotech companies hope to sell potatoes that won't soak up grease when they're turned into potato chips or French fries, and oil-producing plants that can fend off insects by themselves or resist harmful effects of weed-killing chemicals.
Despite the announcement, which Administration officials characterize as a clarification and logical extension of historical food-regulation policies, such companies still face many hurdles to full commercialization of their products.
Chief among them is public acceptance. The policy comes as a blow to some consumer and environmental groups that long have advocated strict regulatory control of all genetic engineering. Many of those groups will continue to seek strict oversight and are calling for specific labeling of any food produced through genetic manipulation, said Rebecca Goldberg, of the Environmental Defense Fund.
Goldberg said that while the Calgene tomato "is, if not desirable, at least not odious," activists are "not just concerned with first product, but with product number 151 or number 929." She said she is wary of a policy that places the responsibility for assessing a product's risks in the hands of its makers.
The FDA will issue guidelines for companies developing these new products to identify situations that would trigger review by the agency before the foods could be sold commercially.
But clearly, the policy delineates the federal government's view that biotechnology techniques are a tool and "do not raise new or unique safety issues that warrant additional regulatory oversight," by the FDA, an Administration source said.
Judging the products by content and characteristics is consistent with past regulatory practices, said Mike Taylor, the FDA's deputy commissioner for policy. "Historically, new strains of fruits and vegetables have not been subject to any kind of pre-market review by government," he said.
In the first half of this century, many people considered cross-bred and hybrid food crops dangerous. Jim McCamant, editor of the Berkeley-based AgBiotech Stock Letter, said: "It seems to us that it was silly of those people to be worried about" such things as nectarines and tangelos. In the same way, he said, the genetic engineering techniques being used today will seem commonplace in another few decades.
While some view the power of genetic engineering as a threat, others see it as a promise. In the past, investors lured to ag-biotech companies by the perceived promise have often become disenchanted by lengthy research and development periods and especially by the uncertainty of federal regulatory policies. Today's announcement, said McCamant, will reassure investors who can help support the companies financially.
"The American biotechnology industry leads the world in the development and application of recombinant DNA techniques," FDA Commissioner Kessler, also in a statement scheduled for release today, said. Helping U.S. businesses maintain that lead was a concern of the Council on Competitiveness, established by President Bush to review the policies and practices of federal agencies and assess their impact on the economy.
"We will soon see the same remarkable contributions to the food supply that the new biotechnology has brought to pharmaceuticals during the past decade," Kessler added. "This FDA policy is an example of this Administration's commitment to both protect the public health and foster technological innovation."
The FDA regulates food products differently from drugs.
Drugs, without exception, require pre-market testing and their safety and efficacy must be demonstrated before they can be approved for marketing.
Foods, on the other hand, are generally allowed on the market without such scrutiny. New substances added to foods, however, may come under pre-market review if concerns are raised about their safety, or if they fall under the category of food additives, such as colors, flavors or preservatives.
The FDA does have the authority, however, to remove from the marketplace any food "ordinarily injurious to health" or anything added to food that "may render it injurious to health."
Substances that are intentionally added to food through genetic manipulation and that raise safety questions may be regulated as food additives and subject to pre-market clearance. "Additives" might be questioned if they are not substantially similar to substances commonly found in food, such as proteins, fats, and carbohydrates, or if they have no history of safe use in food.
No "foreign" substances are added to Calgene's tomato. Simply put, the Calgene scientists have developed a technique to thwart the gene that causes the tomato to rot. First, the gene was identified, cloned and reinserted--backward--into the tomato. The two opposite genes cling to one another and block the rot-producing function. Because the tomato doesn't decay as quickly, it can be picked later and still arrive fresh at the supermarket.
In the guidelines to be issued by the FDA, concerns that would require pre-market review include:
* Whether the concentration of any naturally occurring toxic substance in the plants has been increased. (As an example, Taylor cited solanine, which is naturally found in potatoes. "Too much of it can make you sick to your stomach," he said. "It's very high in green potatoes, which is why we're not supposed to eat green potatoes.")
* Whether the changes have introduced an allergen--a substance capable of causing allergic reaction--or other potentially dangerous substances not commonly found in the plant.
* Whether the levels of important nutrients changed.
* What effects the plants would have on the environment.
Cimons reported from Washington and Walters from Los Angeles.