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Rachel Massey is a writer for the Environmental Research Foundation. Editor's Note: This is the fourth and final article in a series reviewing the problems with genetically engineered crops. This article reviews the regulation of GE crops. Biotechnology corporations want the world to believe that the U.S. government has fully tested genetically engineered crops for ecological and human health hazards. Even though three federal agencies -- the Food and Drug Administration, the Department of Agriculture, and the Environmental Protection Agency -- are responsible for regulating genetically engineered foods, there is no guarantee that those foods have been systematically tested for harmful effects. In the rush to promote genetic engineering, safety testing has fallen through the cracks. Biotechnology corporations would also like us to believe that genetically engineered foods have been embraced by the public. In fact, genetically engineered foods are not labeled, so the public has no knowledge -- and no choice -- about purchasing and eating them. U.S. Food and Drug Administration The Food and Drug Administration (FDA) issued its basic policy statement on genetically engineered foods in 1992. Under this policy, the FDA considers genetically engineered foods to be "generally recognized as safe" (abbreviated GRAS), unless the manufacturer tells the FDA there is reason for concern. Foods considered GRAS are not subject to pre-market safety testing. According to the FDA, the need for safety testing depends on the characteristics of a food, not on the methods used to produce it. In other words, the fact that a food was produced using genetic engineering is not sufficient to trigger safety tests. The FDA's 1992 policy says that a genetically engineered food must be labeled if it "differs from its traditional counterpart such that the common or usual name no longer applies to the new food, or if a safety or usage issue exists to which consumers must be alerted." For example, a tomato containing peanut genes might need to be labeled so that people with peanut allergies could avoid it. But the FDA allows biotechnology corporations to decide whether a hazard of this sort exists. Under this policy, we can find out the fat, cholesterol, sodium, potassium, carbohydrate, and protein content of our breakfast cereal, but we can't find out whether it contains antibiotic-resistance genes, viral promoters, or proteins normally produced only by bacteria. In 1998, a coalition of non-governmental organizations, scientists, and others filed a lawsuit against the FDA for failing to fulfill its regulatory duties. The suit forced the FDA to release internal documents showing the agency's own scientists had strongly opposed the 1992 policy. The lawsuit also forced the FDA to release details of its safety evaluation of the first genetically engineered food that entered U.S. supermarkets, the Flavr Savr tomato. Calgene, the company that developed the Flavr Savr, submitted to FDA officials the results of three safety tests in which rats were fed either ordinary tomatoes or engineered tomatoes. After 28 days, researchers examined the rats' stomachs. The results were inconsistent. The first study showed no unusual effects. In the second study, some of the rats fed genetically engineered tomatoes developed gastric erosions (damage to the lining of the stomach). In the third study, gastric erosions appeared in some of the rats fed ordinary tomatoes, as well as in some of the rats fed engineered potatoes. According to Calgene, the gastric erosions were unrelated to eating genetically engineered tomatoes, but the company was unable to explain what caused them. An FDA staff scientist who reviewed the data said there were "doubts as to the validity of any scientific conclusion(s) which may be drawn from the studies' findings" because Calgene could not explain the variations in the test results. In spite of the misgivings expressed by its own staff, the FDA categorized the Flavr Savr tomato as GRAS and approved it for sale. (The Flavr Savr did not sell well, so it has since disappeared from stores.) The FDA is more concerned about protecting trade secrets than protecting the public's right to know what is in its food.In January 2001, the FDA proposed new regulations for genetically engineered food. In its proposal, the FDA said it does not know of "any new scientific information that raises questions about the safety of bioengineered food currently being marketed," and stated once again that genetically engineered foods are "generally recognized as safe." To make this claim, the FDA had to ignore scientific information explicitly brought to its attention during the previous year. For example, the nonprofit Center for Food Safety and partner organizations filed a legal petition in March 2000 asking the FDA to require safety testing, environmental impact assessments, and labeling for all genetically engineered foods. The petition contained a thorough review of new scientific evidence on safety concerns associated with these foods. The proposed regulations still fail to require either pre-market safety testing or labeling. Instead, the FDA's new proposed regulations would simply require producers to notify the agency 120 days before bringing a new genetically engineered food to market. This "pre-market biotechnology notice" would include information such as whether a product contains antibiotic-resistance marker genes and whether it is likely to produce allergic reactions. The FDA says it will make a list of these notices available to the public, but that the list may not be complete. In some cases, the FDA says, the existence of a pre-market biotechnology notice could be considered "confidential commercial information." As a result, under the proposed regulations a company could still market a genetically engineered food without notifying the public. In other words, the FDA is more concerned about protecting trade secrets than protecting the public's right to know what is in its food. The proposed regulations are open for public comment until May 3, 2001. The FDA has also proposed to institute non-binding guidance for voluntary labeling. This guidance is clearly not intended for companies using genetically engineered crops, which have nothing to gain by telling consumers what is in their food. Instead, the guidance undermines consumers' right to know what they are buying and threatens to limit the free speech of organic and other food producers, by discouraging the use of labels with phrases such as "biotech free" or "no genetically engineered materials." The FDA says these labels would be misleading because ordinary foods could be contaminated with the products of genetic engineering. The agency also says these phrases could imply that non-engineered food is superior to engineered food, which, the FDA says, would also be misleading. U.S. Department of Agriculture The U.S. Department of Agriculture (USDA) is responsible for regulating "plant pests" -- organisms that could cause harm to plants. According to the USDA, genetically engineered plants may be plant pests if they contain genetic material from organisms, such as some bacteria, included on an official plant pests list. Plants engineered with genes from an organism not on the list may escape USDA regulation entirely. Even when genes from a listed plant pest are involved, it is up to the manufacturer to decide whether or not to report the engineered plant to the USDA as a pest. Under USDA rules, genetically engineered crops that are considered plant pests must be approved for field testing before they are approved for commercial planting. After conducting field tests, the crop developer can apply for "nonregulated status." With that status, a crop can be planted commercially without further oversight from the USDA. It is up to the developer to decide what data to submit with its application for nonregulated status. According to a recent article in American Scientist, many tests that companies submit to the USDA are poorly designed, so that even if adverse ecological effects occur, the tests may not reveal them. U.S. Environmental Protection Agency Crops can be engineered to kill certain insects by adding a gene derived from the bacterium Bacillus thuringiensis (Bt). Under its authority to regulate pesticides, the Environmental Protection Agency (EPA) is responsible for evaluating the health and environmental consequences of these engineered plants, which are themselves pesticidal. The EPA has registered pesticidal crops for five years, but it does not have a standard testing system tailored to the hazards posed by genetically engineered crops. The EPA says it is reviewing existing registrations for Bt corn and cotton this year to decide whether it is safe to continue growing them. Of course, it would have been better to conduct a thorough review of likely environmental effects before, rather than after, allowing these crops to be planted on a large scale. When the EPA registers a chemical pesticide for use on food crops, it establishes a tolerance level -- an amount of pesticide residue that is allowable on food. However, the EPA has exempted Bt pesticides engineered into crops from this requirement. As we discussed in Engineering the Landscape, pesticidal crops can promote the development of Bt-resistant pest populations. Despite ample scientific knowledge about this danger, the EPA waited until December 1999 to issue requirements for resistance management. These requirements are designed to slow, not stop, the development of resistance. In the past five years, corporations have introduced a powerful new technology into our food system without understanding the basics of how it works. We might expect our government agencies to gather thorough data on how this technology can affect our health and our environment. Instead, these agencies have refused to gather crucial safety information, and have worked to limit, not promote, our access to information about what we are eating.
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