The use of existing authorities has enabled federal oversight of environmental and food risks from molecularly-modified crops, and avoided the difficulty of implementing new regulatory policies and agencies. In the 1980s, the NRC, various professional scientific groups, and congressional hearings provided science-based guidance for the oversight of molecularly-modified organisms. For example, the NRC published in 1989 "Framework for Field Testing of Genetically Modified Organisms." The NABC held an open forum on "Food Safety and Nutritional Quality" in 1990, and broadly distributed the report of that meeting.

Almost a decade of favorable food experience has accrued with fermentatively-produced chymosin (FPC), a product of molecular biotechnology used for cheese-making. In 1990, it became the first food product approved by the FDA. Today, FPC has an 80 to 90 percent market share in cheese-making in the U. S. and Canada. It is approved as 'vegetarian', 'kosher', and 'halal', and is fifty-fold more pure than the traditional product -- rennet, from the stomachs of slaughtered calves.

In 1992, the FDA published its policy document "Statement of Policy: Foods Derived from New Plant Varieties." Its regulatory policy is based on substantial similarity between the molecularly-modified product and its unmodified parent. The NABC has criticized the implementation process (but not the policy) in letters to the Vice-President, FDA Commissioner, Secretary of Agriculture. EPA Administrator, and Secretary of Health and Human Services. The NABC, an organization committed to open dialogue, was concerned about the absence of opportunity for public discussion of the policy prior to its publication. The FDA is holding three sessions across the country to clarify its regulatory process and experience and to listen to the public, to determine if there are significant risks that are not being assessed.

The FDA should make its voluntary consultation mandatory and be as forthcoming as possible, providing information on pre-market approvals, including key safety data, so as to build trust. Its July 1999 "Foods Derived from New Plant Varieties Derived Through Recombinant DNA Technology" is such an example.

An organization seeking to market a new product (usually a company) has the responsibility to obtain, and show to the regulatory agency, data on safety or favorable benefit-to-risk statistics. This process, well established for agrochemicals and pharmaceuticals, is used for molecularly-modified organisms.

Some have suggested the need for more public-sector involvement in food-safety research, to assure further the safety of foods from both traditional and molecular-biotechnology sources. The public would need to fund such research.

One or more of the agencies mentioned previously regulates all products of molecular biotechnology. At an October 6-7, 1999 hearing on agricultural biotechnology by the Senate Agriculture, Forestry and Nutrition Committee, representatives of the regulatory agencies stated that there was no evidence that any genetically-engineered crop is unsafe as a food source. A representative of the Consumer's Union agreed, but stated also that the absence of evidence of danger is not assurance of safety.

The workshops at the 1999 NABC Annual Meeting in Lincoln, Nebraska did not identify concern over food safety as an issue.

At the Senate hearing, the EPA representative stated that the agency had considered the effects of the Bt crops on nontarget organisms at the time of approval, and concluded that risk to insects, such as the monarch butterfly, was not significant in comparison to risks from other pest-control methods. They are reassessing the issue, and a preliminary discussion of the 1999 data tends to confirm their earlier conclusions.

The network of regulatory agencies has several years of successful experience with genetically-engineered crops. There is no evidence of need for significant changes in the regulatory system for food sources modified by molecular processes -- other than mandatory, not voluntary, consultation and improvements in communication, with a more transparent output.

In the view of many academic scientists, the system is being overworked for biobased pesticides.

Labeling is a contentious issue. The right to know is important. FDA policy will require labeling of food products entailing substantial changes. For example, products made from rice which has had major increases in beta-carotene or iron presumably would be labeled because of the substantial change in nutrient composition. Similarly, foods from plants with an added protein that is a recognized allergen would be labeled, if they were even approved.

Should foods from plants with no substantive compositional changes and no demonstrated beneficial or negative health effects, such as those from genetically-engineered plants to-date, be labeled? Does such labeling help the consumer select more healthful foods? If a large number of consumers demand labeling of food from sources modified by molecular processes, then a maximum content of that source in the food product would need to be established; for example, a maximum of 5 percent of non-organic content allowed in organic foods may be appropriate. Without labeling, organic foods (which at this time exclude genetically-engineered sources) may be an option for consumers who do not wish to consume foods from molecularly-modified sources, albeit at a generally increased cost.

- From The National Agricultural Biotechnology Council Report, No. 11, "World Food Security and Sustainability: The Impacts of Biotechnology and Industrial Consolidation," 1999.