Regulatory Issues

The longstanding, often contentious, debate over genetically engi­neered foods has led to a parallel dispute over whether such foods should be regulated, licensed, or otherwise controlled by governmental agencies. That dispute has been resolved in two quite different ways in the United States and Europe. In this country, the federal government has taken the position that GM foods must meet the same standards of safety that apply to other foods. First, experimental plantings of engineered seeds must be approved by the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture and, if federal funds are involved in the project, by the National Institutes of Health Recombinant DNA Advisory Committee (NIH-RAC). Then the products of such research must be approved by the U.S. Food and Drug Administration (if they are intended for human consumption), by APHIS (if they are designed for purposes other than human con­sumption), and by the U.S. Environmental Protection Agency (if there is any possibility that the products may result in the release of pollut­ants to the environment). Once a GM food product has passed those regulatory hurdles, it may be sold to farmers, marketed to consumers, made available to industry, or offered for sale in any other way with no further restrictions or labeling required. In fact, the only effort in the United States to require labeling of GM foods was an initiative referendum held in the State of Oregon in 2002; Measure 27 proposed requiring any food containing GM products made available to Oregon consumer to be so labeled. Voters rejected the proposal by a vote of 73 percent to 27 percent.

The situation in Europe has been very different. As early as April 1990, the parliament of the European Union (EU) began to adopt regulations to be used in the approval of GM foods. Over the next decade, EU states approved nine discrete GM food products under the provisions of those decisions. By 1997, however, a number of member states of the EU had changed course and began to ban the sale of GM foods, including those that had already been approved in 1990. The bans were motivated to some extent by a philosophi­cal concept sometimes known as the precautionary principle. The precautionary principle says that governmental agencies may be justified in taking regulatory action even when some scientific un­certainty remains about the possible risks and consequences of a practice. For example, many people today believe that it is appro­priate to take action to reduce carbon dioxide emissions by humans because of the possible disastrous environmental consequences of burning fossil fuels. Many European governments and agencies have argued that the precautionary principle should be invoked in the case of GM foods: Even though their health and environmental consequences are not known for certain, those consequences could be serious enough that people should move slowly in developing and using those products.

By June of 1999, environmental ministers of the EU had estab­lished an informal, de facto ban on GM foods based on this philoso­phy. That agreement prohibited both the planting of new GM crops within the European states and the import of GM foods for at least four years.

The EU's action outraged the United States. The United States argued that the decision to ban the import of GM foods was a vio­lation of free-trade agreements between the United States and the European Union. Those agreements, U.S. representatives claimed, prohibited bans by any nation on the free flow of products between countries. In early 2003 the Bush administration filed a formal complaint against EU practices with the World Trade Organization (WTO). It was joined in this action by 12 other nations; Argentina, Canada, Egypt, Australia, New Zealand, Mexico, Chile, Colombia, El Salvador, Honduras, Peru, and Uruguay.

By the time the WTO complaints were lodged, however, the EU had already been rethinking its position on GM foods. A March 2000 decision by the EU's highest judicial body, the European Court of Justice, played a role. According to the court's ruling, France did not have the right to ban three GM crops that had already been approved by the EU in 1990. Gradually, member states began to adopt the posi­tion that GM foods could be grown and imported provided that they met very strict labeling and traceability standards. These standards were ultimately enshrined in Directive 2001/18/EC, which, among other things, stated (1) that all foods containing more than 0.9 per­cent genetically modified organisms (GMOs) must be so labeled, and

(2) that all GM foods must contain traceability tags. A traceability tag used in GM foods is a piece of DNA that has no effect on human health, the environment, or the organism into which it is inserted, but that provides an "address" of the company that made the product. The traceability tag allows a governmental agency to track down the manufacturer of some food product if it is discovered to have some deleterious effect on human health or the environment.

These genetically modified seedlings contain DNA "tags" that make it possible to trace their producer. (Simon Fraser/Photo Researchers, Inc.)

In May 2004 the ban on GM food in the European Union officially came to an end with approval by the European Commission of a GM corn made by the Swiss company Syngenta. In 2006, the EU set

standards for the acceptance of GM foods that included two require­ments. First, each product submitted for approval had to be shown to be safe for humans, other animals, and the environment. Second, every product had to be available on a "freedom of choice" basis. That is, every farmer and consumer was to have complete freedom in deciding whether or not to use a GM crop or food. Manufacturers were required to provide data needed to allow people to make those decisions.

Genetically modified crops and foods remain a subject of dispute in most parts of the world. Many farmers and consumers see these products as a valuable addition to the world's food supply. Critics con­tinue to worry that such products may pose problems for the health of humans and other animals and be a threat to the environment.