August 30, 2011

Do Genetically Engineered Foods Really Need to Be Regulated Less?

Michael Crupain, MD, MPH

Michael Crupain, MD, MPH

Guest Blogger


Nina Federoff, president of the American Association for the Advancement of Science (AAAS) and professor at Penn State University penned an opinion piece in the New York Times recently, asking for less regulation of genetically engineered (GE) crops. Professor Federoff would like to see more grant money available for research and more scientists working on the development of GE foods, but she states in her article that the regulatory bars of the EPA, USDA, and FDA are set too high and are stifling scientists from making innovations.

Ignoring the rest of her argument that GE seeds dramatically improve crop yields (they don’t and in fact agricecological farming methods are not only better for the environment but better for yields), reduce the use of chemicals (they don’t; pesticide use has increased since the introduction of GE crops in the U.S.), improve the lives of farmers (not in India or the U.S.), and have not been shown to cause harm to the environment (she forgot about the development of superweeds, pollution of waters, and harm to soil), let’s focus on her idea that regulations are too complicated and stringent. As you will see, this is simply not the case. In fact, regulations may be too lax, as they allow corporations driven by profit, not protecting public health, to drive the research (or lack thereof) to demonstrate safety, and, as well explained in many of the above articles, the U.S. experience with GM crops has indeed led to environmental problems.

How are GE plants intended for use as Foods Regulated?

GE foods are essentially regulated the same way that all foods are. There are no new extra-burdensome laws or requirements for these foods. In fact the methods of making foods are not regulated at all; instead regulations apply to the final product’s characteristics and its intended use. In other words, the regulatory agencies are not interested in how a gene gets into a plant; they are interested in that gene’s effect on public health and the environment. All new plants are regulated the same way, regardless of whether traditional methods or new GE methods are used to create them. (EPA regulations are a slight exception to this, as you will see.)

Up to three agencies may be involved in the regulation of GE foods: FDA, USDA, and the EPA. The level of involvement of each of these agencies depends on what the inserted gene product is and its intended use. Since this discussion is centered on GE plants intended for foods, for this article we will discuss the case when the intended use is for human consumption.

FDA’s Role

The FDA is charged with ensuring the safety and properly labeling of plant-based foods.  In 1992, the FDA first outlined the logic for why it could apply standard food regulations to GE foods, since the FDA is interested in a foods’ characteristics and intended use, not method of manufacture. The primary concern for the FDA when regulating new plants is that substances added to the food (food additives) are not toxic. Food additives, which would include any constituent that has been introduced or had its levels increased in food by any method, must go through a premarket approval process. Food additives are Generally Regarded As Safe (GRAS), however, and are exempt from the premarket approval process. There are countless materials that qualify as GRAS, including many naturally occurring products (proteins, fats, carbohydrates, and minerals), as well as many manmade chemicals. The company producing the plant is responsible for determining if it contains a food additive that requires premarket approval or not.

Since FDA has no specific requirements for GE foods and there may be a number of questions regarding the need of these foods to go through premarket approval, FDA recommends that companies go through voluntary consultation process with FDA. The consultation is to protect public health by ensuring that new plant species do not have “significantly increased levels of plant toxicants or anti-nutrients, reductions of important nutrients, new allergens, or an unapproved food additive.”

At the conclusion of the consultation process the developing firm must submit a safety summary to the FDA, and if the FDA is satisfied with the firm’s assessment of the regulatory issues, it will issue a letter confirming that the firm can proceed with marketing their product. If, however, the FDA concludes that there are problems with additive safety, labeling, allergenicity or other issues, then the FDA may require the firm to complete a premarket approval or other regulatory steps. While this may appear complex, these steps are supposed to ensure that the new plant products are safe for human consumption.


The Animal and Plant Health Inspection Service (APHIS) is the division of USDA responsible for protecting agriculture from pests and diseases. Under the Plant Protection Act, APHIS generally considers all GE plants to be “regulated articles,” because they have the potential to be “plant pests.” A plant pest is something that injures, damages, or causes disease in a plant or plant product. Firms cannot introduce “regulated articles” into the environment for a “field test” without first either notifying APHIS or applying for a permit, depending on the level of risk. When a “regulated article” is field-tested, there are strict guidelines regarding how it is to be transported and planted. The results of a field test should determine if the GE plant might: expose other plants to pathogens or be a pathogen; be a weed or cause increased weediness in other plants; effect plants that it can interbreed with or transfer genetic material to plants that it can’t interbreed with. Once a plant has been proven safe for the environment, a firm can apply to have the plant deregulated. If APHIS approves the deregulation, from the USDA’s perspective the plant is safe to be commercialized.


The EPA regulates all pesticides regardless of the methods used to produce them. If a GE plant is made that produces a pesticide (called a biopesticide or a Plant-Incorporated Protectant), the EPA, under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act, will evaluate the biopesticides for safety (the EPA does not regulate the plant itself–only the biopesticide). This safety review includes an evaluation of the possibility of harm to human health (including setting tolerance levels in food) and the environment. Biopeseticides introduced into a sexually compatible plant, without significant changes to the biopesticide gene, are exempt from regulation.

The initial step for getting a GE plant producing a biopesticide to market is to prove its safety in both the laboratory and in field experiments. Field experiments require firms to receive an “Experimental Use Permit” from the EPA. Once studies are completed and a firm concludes that their plant product does not pose a threat to human health, animal health, the health of other plants and water supplies they can submit their plant for registration. At this point the EPA will review the studies and determine if the plant is safe for commercialization.

As you can see, the regulatory process for GE foods is not simple, but contrary to Federoff’s assertion, it is indeed targeted at the hazards that genes introduced into plants can present. While innovation is important, the primary goal of these government agencies should be to protect the public health. In light of the numerous negative effects and uncertainties regarding GE plants effects on health and the environment, and lack of any clear evidence that GE foods will be able to safely “feed the world,” there is no reason that the regulatory hurdle for bringing these new foods to market should be lowered.

Read Michael Crupain’s original post in

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