We all have to live with the impact of decisions made in 1992 about how to regulate this technology and what standards to set. On May 27, 1992 The New York Times reported that Vice President Quayle announced details of a new government policy for streamlining regulation of food produced through genetic engineering. "Mr. Quayle told a briefing of industry executives that the policy was part of the Bush Administration's 'regulatory relief' program, said the U.S. was the world leader in biotechnology and 'we want to keep it that way.'" It is difficult to persuade the public that in that case our government put food safety considerations ahead of competitiveness in an emerging international market. During FDA's consideration of an appropriate regulatory structure for GE foods, officials of the Agency had to acknowledge and deal with the fact that a decision to require prior approval of GE foods would suck up huge amounts of the Agency's very limited resources. This would either require additional funding from Congress, which was not a reasonable expectation, shifting funds from other parts of FDA, also not likely to happen, or seriously slowing the marketing of the GE products. Given this dilemma, FDA, gave management of resources precedence over assurance of safety. The result is the "consultative" process. Seven years later, faced with growing opposition, the agency now asks the public for its views on the process. My answer is the process began under a cloud of political influence peddling and managerial bean counting and FDA has done nothing to dispel that cloud. I believe the science of food biotechnology offers civil society great potential benefits. It could help feed a world population that will grow by 1.5 billion people in the next 20 years. It could help address the nutritional needs of the 400 million women of child bearing age who suffer from anemia as a result of iron deficiency, reducing the threat of physical and mental retardation. It could help assure adequate vitamin A to the 100 million children now deficient in that nutrient and therefore susceptible to infection and blindness. Agricultural biotechnology may help reduce toxic contaminants such as aflatoxin in peanuts. It holds the promise for reducing pesticide use and increasing the productivity of poor soil. The promise is great. But the benefits are not just unrealized, they are little more than visions of what might be, maybe, sometime in the far distant future. None of the nutritionally enhanced products are close to market.

The first challenge is to develop a regulatory process that will assure that the benefits of genetically engineered food outweigh any risks and that the technology is used in a manner that benefits civil society. My organization and others have just begun a project that seeks to develop an optimum regulatory regime. I think it will have to include the following: First, the U.S. government, beginning with the president, must make a clear statement that human safety will be the primary component of decision making in approving GE foods and that FDA, USDA and EPA will be assigned sufficient resources to assure the safety of GE foods. There must be no question that safety is being compromised to meet trade or regulatory reform goals. Second, FDA should review and approve every GE product prior to marketing. Last week, the Center for Science in the Public Interest suggested that the agency could require varying amounts of information from the producer, depending on the specifics of the product. For example:

• For GMOs made from gene transfers between closely related species, or if the donor organism is a traditional food and does not cause allergies, a company would have to notify FDA and provide specified summary data. There could be a specified period-60 to 90 days-during which FDA would review and could demand additional information.

• For GMOs containing genes from an organism that causes allergic reactions, FDA would require thorough testing for allergenicity. GMOs containing a gene for a common allergen would be prohibited.

• For GMOs in which gene products were different from traditional foods or were present in significant quantity, food-additive petitions and more extensive safety testing, possibly including animal feeding studies, would be required.

Third, consumers must have and will have a role in this debate. Th only question is whether consumer influence will be built into the process from the beginning or whether it will be manifested through lawsuits and street demonstrations and ballot boxes.

One way to build in meaningful public visibility and consumer participation would be for FDA to establish an advisory committee on genetically engineered foods. This committee, separate from the Food Advisory Committee, would include representatives from all of the stakeholder groups and provide the agency ongoing counsel on shaping the necessary questions and policy. I am a member of the National Advisory Committee on Meat and Poultry Inspection, made up of representatives of all stakeholder groups. The committee meets regularly, sometimes debates furiously, but has been able to work with the agency to devise appropriate policies. FSIS knows-and so does the public-what issues are before the agency.

There are two important aspects of this committee. First, it is extremely diverse, assuring all points of view are heard. Second, the agency comes to the committee early on before it has made a determination of the best way to proceed on policy. The agency has the opportunity to hear all concerns and discuss them at length before the staff returns to draft policy.

Fourth, in addition to policy development, this field needs an independent scientific research establishment that can raise key regulatory questions and sponsor research into them. The Health Effects Institute, funded by government and industry, but independent of both, has helped develop the data necessary for good regulatory decision making on clean air issues. This type of institution is sensitive to the needs of the regulatory agency but not captive to it or industry.

FDA has also asked for the public's views on how to handle the labeling of GE products. The first thing that needs to be said in this regard is that labeling is not a substitute for safety. No one wants a policy that allows the industry to escape rigorous safety testing by applying a warning label and declaring caveat emptor. No GE food should be on the market until it has been shown to be safe.

But the public's right to know must be served. Consumers can't make rational market place decisions without adequate information. Even assuming the food is safe, consumers may want or need to avoid it for other reasons--because they have extreme allergies and want to take extra steps to avoid risk; because they have religious or ethical concerns; because they believe the environmental issues around GE foods are important and unaddressed.

Even industry groups are now suggesting a voluntary labeling system may be appropriate. They endorse allowing a GE-free label claim for those who are prepared to meet some standard. Industry fears that a mandatory label specifying that a product contains genetically modified organisms will be the kiss of death to any product bearing it. That might be true today. But, if it is true, it is because the public is not confident that government has done due diligence to assure the product is safe. The mandatory review and approval process I've suggested should eliminate industry concerns that people will assume a labeled product is less safe than its traditional counterpart.

Of course, once the GE products offering enhanced nutrition and taste that industry promises finally come to market, they may find labeling more palatable. Consumers should not have to wait for that. FDA should require the labeling of GE foods and begin the process of establishing a regime for what must be labeled and how. Once again, if FDA were to establish an advisory committee on biotechnology, that committee could help the agency work out the details of the labeling system.

Again, on behalf of Consumer Federation of America, I commend FDA for conducting these public meetings and for inviting me to provide my views on this subject.

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