Regulatory Oversight of Agricultural Biotechnology – Working Well and Getting Better

By Don Uchtmann, professor of agricultural law in the Department of Agricultural and Consumer Economics at the University of Illinois.

Genetic engineering has both risks and the potential to provide significant benefits. The "Coordinated Framework for Regulation of Biotechnology" relies on existing federal laws and agencies, principally the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA) and APHIS to assure that genetically engineered products are safe. The vital signs of this regulatory system for agricultural biotechnology, in fact, are surprisingly healthy.

The system certainly appears to have appropriate checks and balances. Overall responsibility is shared between private entities, such as food companies which take seriously their duty to provide safe food because of the liability for providing unsafe food, and government, which exercises regulatory responsibility, but does not displace the primary responsibility of companies to sell only safe food. Decision making generally takes place “in the sunlight” of public scrutiny.

The system also provides opportunities for the public and scientific experts to be heard, and for both the regulated (the researchers & companies) and the intended beneficiaries of regulation (farmers, consumers and the public) to fully participate. The system for regulating agricultural biotechnology in the U.S. has public confidence and the food products that have come to market under that system have never caused proven harm to a consumer, to the author’s best knowledge.

The regulatory system also is dynamic and continues to evolve. It has been tested by controversial issues in the past, for example, difficulties resulting from EPA’s approval of StarLink corn for feed but not food uses, and has managed to evolve and adapt successfully to changing scientific discoveries and political realities. Given these underlying strengths, it is difficult to imagine that a truly erroneous regulatory decision regarding biotechnology would be made, or stand very long if it were made.

The regulatory system, however, can and should be improved, and efforts to do so are being taken on various fronts. Various questions needed to be considered and answered by the regulatory agencies. One of these is whether or not the U.S. Food and Drug Administration can better address the question of whether and how foods containing products resulting from genetic engineering might be labeled.

In January, FDA issued draft guidance on labeling intended to assist manufacturers wishing to voluntarily label their foods as being made with or without the use of bioengineered ingredients. For example, FDA views the terms "derived through biotechnology" and "bioengineered" as acceptable, but views terms such as "GM free," "GMO," and "modified" as potentially misleading or untruthful. .

Another question is whether the FDA should make its 1992 voluntary consultation procedures mandatory. In January the Food and Drug Administration proposed mandatory rules that would tighten the scrutiny of bioengineered foods. The rules would require that manufacturers of plant-derived, bioengineered foods and feeds notify the FDA at least 120 days before the products are marketed.

As part of the notification, the manufacturer would provide information showing that the foods or feeds are as safe as their conventional counterparts. In effect, the proposed rules would make the current practice of voluntary consultations mandatory and require manufacturers to submit safety and nutritional information to FDA.

Another issue is whether the food testing and risk analysis data developed in those consultations can be made more readily available to consumers who want that information. Under the rules proposed in January, FDA’s evaluation process would also become more "transparent." Information submitted by manufacturers, as well as FDA responses, would be posted on the Internet or otherwise made more accessible.

Some philosophical issues also need to be considered. Should there be some rearrangement or consolidation in the agency regulatory roles outlined in the Coordinated Framework? Does the system strike the appropriate balance among three strategies: formal governmental regulation, regulation by consumer choice exercised through the marketplace, and holding companies accountable for the safety of their products?

An important issue is whether the system has struck the correct balance between our society’s conflicting desires for 100 percent safety, on the one hand, and for innovation and new products, such as those resulting from genetic engineering, on the other hand. Still to be answered is to what extent should our domestic regulatory scheme be in harmony with the schemes of trading partners or defer to international trading rules.

The U.S. regulatory system for agricultural biotechnology has served U.S. consumers quite well up to this point. It continues to evolve, as it must, to be an even better system in the future.