Genetic engineering is a technology that has transformed, and will continue to transform, the relationships among humans and between us and the rest of the natural world. For the most part, it is impossible to even begin to predict the full implications of the power to successfully (or unsuccessfully, as the case may be) tinker with the genetic make-up of living organisms and our food. Generally speaking, when transformative technologies are introduced into society, there is a lag time between their introduction and their proper control and regulation. People, organizations, and agencies need time to understand the technology and comprehend its full range of possible effects before knowing how to regulate it most effectively to support its benefits and minimize its harmful effects.

At this stage in the development of genetically engineered food and crops, the government has not made an effort to appropriately regulate the technology. Instead, it has merely taken existing laws and stretched them beyond their original intents in an attempt to regulate this new technology. The result is that the public is not adequately protected from the potential risks to human and environmental health and safety presented by genetically engineered food.

Genetically engineered food and crops are regulated through a patchwork of laws spanning three governmental agencies—the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA). A brief look at how these agencies have divvied up regulatory control of genetic engineering in agriculture illustrates both the continuing complexity of this issue and the inadequacy of the current regulatory structure. Though this discussion is far from comprehensive, even this brief overview reveals many of the flaws of the current system.

1. The FDA and GE Food

Food products containing genetically modified ingredients fall under the regulatory umbrella of the FDA. The FDA has primary responsibility for regulating food additives and new foods other than meat products under the authority of the Federal Food, Drug, and Cosmetic Act (FDCA). The FDCA gives the FDA the power to remove unsafe foods from the marketplace and make producers legally responsible for the safety of the foods they market. The FDA can also require pre-market approval of food additives, unless they are generally recognized as safe. The FDA can exercise these powers over “adulterated” food, which is defined as food that contains an added substance unless either: a) the FDA has approved the safety of the substance by issuing a specific food additive regulation, or b) the substance is generally recognized as safe. Under these regulations, the FDA is able to protect consumers by requiring manufacturers to provide scientific evidence to support the safety of adulterated food.

In 1992, the FDA decided that it would not regulate the majority of genetically engineered food (foods derived from new plant varieties produced by genetic engineering) as adulterated food. Consequently, manufacturers are not required to earn FDA approval for foods produced with genetically engineered ingredients, except under special circumstances when food safety questions exist sufficient to warrant formal pre-market review. Instead, the FDA established an advisory process, whereby manufacturers consult with the agency about the human health risks of their products. Until recently, this consultation process was voluntary. Therefore, although the FDA could require safety testing of all genetically engineered food, they choose not to. In fact, the regulations of 1992 specifically exempt these experimental foods from the FDA’s power to regulate food additives even though, as is clear from the discussions above, genetic engineering is used to add some foreign element to the plant. Manufacturers are consequently free to use genetically engineered products in food and need not guarantee the safety of the foods they market.

In addition, the FDA has not used its power under the FDCA to require the labeling of all genetically engineered foods. Producers of food are required to describe the product by its common name and to reveal all important facts associated with claims made or suggested on the label, but currently, the fact that a food product contains genetically engineered ingredients has not been determined to meet the requirement that it be labeled.

The FDA believes that genetically engineered foods are “substantially equivalent” to non-GE foods and therefore does not give them special scrutiny. Opponents of genetically engineered food, who recognize the threats to human and environmental health, and those familiar with the basic technology of genetic engineering, maintain that, in fact, genetically engineered foods are different. By tinkering with the genetic material of plants and attempting to control traits and characteristics with procedures whose outcome is usually unpredictable, scientists have created new risks and concerns involved with genetically engineered foods. Because of these new risks, GE foods require closer regulation than non-adulterated foods.

2. The Environmental Protection Agency (EPA)

The EPA also plays a role in the regulatory structure of genetically modified crops and food. The EPA regulates pesticides according to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), under which they are responsible for regulating the distribution, sale, use and testing of pesticides to protect humans and the environment. Genetic engineering is often used to insert genes thought to confer pesticide resistance into plants, and the EPA is responsible for regulating the pesticides produced by these genetically engineered plants. However, as part of the patchwork of regulations of genetically engineered food and crops, the EPA regulates the pesticide, but not the plant. For example, in the case of corn genetically engineered to produce Bt, EPA regulates the Bt toxin, but the USDA regulates the genetically engineered corn. The EPA does not subject plants that are engineered with traits other than pesticide resistance, such as herbicide tolerance, to environmental review.

Under FIFRA and other EPA regulations, developers of plants genetically engineered to produce pesticides must submit raw health and safety test data to the EPA. The test data is publicly available during a thirty-day notice and comment period before the crop is approved. Though this system forces developers to provide some safety data (which is more than is required by the FDA), the EPA has not done a comprehensive environmental review of the health and safety implications of genetically engineered Bt crops. As greater acreages of genetically engineered crops are being planted across the United States, the risks to environmental health are going unmonitored. The long-term effects of releasing genetically modified plants into the environment should be evaluated.

3. The United States Department of Agriculture (USDA)

The third part of the United States’ regulatory web is the USDA. The USDA regulates genetically engineered plant products under the Federal Plant Pest Act, which is administered by the Animal and Plant Health Inspection Service (APHIS). APHIS administers a permit system whereby companies, academic institutions, or scientists who want to move or field test genetically engineered plants must obtain the proper permits. APHIS must also complete an environmental assessment of the possible environmental impacts of field tests under the National Environmental Policy Act (NEPA). Once the genetically engineered crop is ready for commercial sale, the developers must petition the USDA for an exemption from the Plant Pest Act. Developers receive permits certifying that the genetically engineered plant is not a pest, and therefore is not in need of further regulation.

As with the other governmental agencies, the USDA seems to begin with the assumption that genetically modified plants, ready for commercial sale, do not require special attention. Even with a NEPA assessment to the effect that a genetically modified plant harms the environment, as long as it also produces benefits, the USDA could certify it for sale.

This is the jumble of laws that make up the current regulatory framework for ensuring environmental and human health and safety. Though such a system might be adequate for a non-transformative, predictable technology, it is inadequate in light of the concerns that have been raised about the widespread cultivation and consumption of genetically engineered crops and food. Federal agencies are not demanding safety testing. Instead, the agencies seem to assume that these products pose no risk and thus do not require close regulation. All of these laws and regulations have been applied ad hoc to the new technology, and consequently, they cannot possibly address the full range of genetic engineering’s possible effects. It is clear that the interests of the corporations and the producers have been put ahead of the safety concerns of consumers.

The most appalling aspect of the regulatory structure is that the agencies involved, in fact, have the legal power to take more of an interest in the regulation of genetically engineered food and crops, but have made conscious decisions not to. For example, the FDA under FDCA could, using logical reasoning, say that foods that have genes added to them through genetic engineering are foods containing additives, subject to the adulterated food regulations. This would place the burden on industry to provide scientific evidence of the safety of the substances added to genetically engineered foods. This standard would treat genetically engineered foods to the same regulation as other foods with additives instead of exempting them, which is the current FDA practice.

In addition, the level of scientific understanding in this field is limited. Unpredictable results and effects are part of the genetic engineering process. In light of these facts, the regulatory structure should provide a cautious approach to the environmental release and human consumption of genetically engineered products. If, at some future point, industry is able to prove the safety of these products, then the current lax attitude of the regulators may be justified. Until that time, genetically engineered food and crops should be regulated and evaluated under standards reflective of their true nature as potentially hazardous experiments. The current system does not go far enough to protect consumers from the possible risks of the technology.

This article is an excerpt from a piece that was originally published in the Virginia Environmental Law Journal, Volume 20, No. 2, 2001 p.267-294.