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================== Electronic Edition ==================
---March 1, 2001---
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Biotech--The Basics, Final Part

by Rachel Massey*

Biotechnology corporations want people in the U.S. and around the world to believe that the U.S. government has fully tested genetically engineered crops for ecological and human health hazards. Three federal agencies -- U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), and U.S. Environmental Protection Agency (EPA) -- have responsibility for genetically engineered foods, but there is no guarantee that a genetically engineered food sold in the U.S. has been tested for ecological or human health effects. In the rush to promote genetic engineering, safety testing has fallen through the cracks.

Biotechnology corporations also want 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 U.S. Food and Drug Administration (FDA) issued its basic policy statement on genetically engineered foods in 1992. Under this policy, FDA considers genetically engineered foods to be "generally recognized as safe" (GRAS), unless in the judgment of the manufacturer there is some reason for concern.[2, pg. 22990] Foods considered GRAS are not subject to pre-market safety testing.

FDA states that 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.[2, pgs. 22984-5]

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."[2, pg. 22991] For example, it says a tomato containing peanut genes might need to be labeled so that people with peanut allergies could avoid it.[2, pg. 22991] But FDA allows biotechnology corporations to decide whether a hazard of this sort exists. Under FDA's no-labels 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. (See REHN #716, #717, #718.)

In 1998 a coalition of non-governmental organizations, scientists, and others filed a lawsuit against FDA for failing to fulfill its regulatory duties. During the suit, FDA was forced to release internal documents that showed FDA staff scientists had strongly opposed the 1992 policy.[3] (See REHN #685.)

The lawsuit also forced 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 three safety tests to FDA in which rats were fed engineered tomatoes. After twenty-eight days of the Flavr Savr tomato diet, researchers examined the rats' stomachs. The three studies produced inconsistent results that Calgene was unable to explain. 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 genetically engineered tomatoes and in some of the rats fed ordinary tomatoes.[4]

Calgene concluded these stomach problems were unrelated to eating genetically engineered tomatoes, but it had no explanation for why they appeared. An FDA staff scientist who reviewed Calgene's 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 results among the three tests.[4] In spite of the doubts expressed by its own staff, FDA categorized the Flavr Savr tomato as GRAS and approved it for sale. (The Flavr Savr did not sell well, so it has disappeared from stores.)[1, pgs. 83-84]

In January 2001, the FDA proposed new regulations on genetically engineered food. These proposed regulations still fail to require either pre-market safety testing or labeling of genetically engineered foods.[5] FDA says "there does not appear to be any new scientific information that raises questions about the safety of bioengineered food currently being marketed," and states once again that genetically engineered foods are "generally recognized as safe."[6, pgs. 4708-9]

To make this claim, FDA had to ignore scientific information that had been brought to its attention explicitly during the previous year. In March 2000, the Center for Food Safety and partner organizations filed a legal petition asking FDA to start requiring pre-market safety testing, environmental impact assessments, and labeling for all genetically engineered foods. The petition included a thorough review of new scientific evidence on safety concerns associated with genetic engineering.[7]

The main new requirement in FDA's proposed regulations is that producers of genetically engineered foods must notify FDA 120 days before bringing a new genetically engineered food to market. This notification, known as a pre-market biotechnology notice (PBN), would include various information, such as whether the product contains antibiotic-resistance marker genes and whether it is likely to produce allergic reactions. FDA says it will make a list of PBNs available to the public, but the list may not be complete. In some cases, FDA says, the existence of a PBN could be considered "confidential commercial information."[6, pg. 4723] As a result, under the proposed regulations a company could market a genetically engineered food without any public notification. FDA's proposed regulations are open for public comment until April 3, 2001.[5]

FDA has also proposed to create 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." FDA says these labels will be misleading on most foods, because ordinary food could be contaminated with the products of genetic engineering. In addition, FDA says these phrases could imply that non-engineered food is superior to engineered food, which, FDA says, would be misleading.[8, pg. 4840]

U.S. Department of Agriculture

Under the Federal Plant Pest Act, the U.S. Department of Agriculture (USDA) is responsible for regulating "plant pests" -- organisms that could cause harm to a plant. USDA considers genetically engineered plants to be possible plant pests if they contain genetic material from organisms, such as some bacteria, included on an official list of plant pests.[1, pg. 109] Plants engineered without the use of genes from a recognized plant pest may escape USDA regulation entirely. Even when genes from a plant pest are involved, the manufacturer has discretion to decide whether the engineered plant is itself a plant pest. USDA does not tell manufacturers what data to take into account when they make this decision.[1, pgs. 110-111]

Under USDA's rules, genetically engineered crops that are considered plant pests must first be approved for field testing before they are approved for commercial planting. After conducting field tests, the developer of a genetically engineered crop can apply for "nonregulated status," under which the crop can be planted commercially with no further oversight from USDA. USDA leaves it up to the developer to decide what data to submit in support of its application for nonregulated status.[1, pg. 111] According to a recent article in American Scientist, many tests that companies submit to USDA are poorly designed, so they are unlikely to reveal any adverse effects that may occur.[9]

U.S. Environmental Protection Agency

As we saw in REHN #716, 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 U.S. Environmental Protection Agency (EPA) is responsible for evaluating the health and environmental consequences of these engineered plants, which are, themselves, pesticidal.

EPA has registered pesticidal crops for five years, but the agency makes these registration decisions on a case-by-case basis; it does not have a standard testing system tailored to the hazards posed by genetically engineered crops.[1, pg. 176] EPA says it is reviewing existing registrations for Bt corn and cotton this year, in order to decide whether it is safe to continue growing them.[10]

When 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, thus far EPA has exempted all pesticidal crops from this requirement.[1, pg. 106]

Pesticidal crops are likely to promote the development of Bt-resistant pest populations. (See REHN #637, #718.) Despite ample scientific knowledge about this danger, EPA waited until December 1999 to issue requirements for resistance management. Under these requirements, companies selling Bt corn are responsible for making sure that farmers grow "refuges" of ordinary corn alongside their pesticidal crops. The idea is that some pest insects will eat only the ordinary corn, so they will be sheltered from the evolutionary pressure that promotes the development of resistant pest populations.[1, pgs. 106-7]

In the past five years, corporations have introduced a powerful new technology into our food system without understanding the basics of how this technology works. Government agencies have refused to gather crucial data on how this technology can affect ecosystems and human health. Once again, we are flying blind.

    Rachel Massey is a consultant to Environmental Research Foundation.

  1. Thomas O. McGarity and Patricia I. Hansen, Breeding Distrust: An Assessment and Recommendations for Improving the Regulation of Plant Derived Genetically Modified Foods. Report prepared for the Food Policy Institute of the Consumer Federation of America, January 11, 2001. Available at

  2. U.S Food and Drug Administration (FDA), "Statement of Policy: Food Derived from New Plant Varieties," Federal Register Vol. 57, No. 104, May 29, 1992, pgs. 22984-23005. Available at

  3. Marion Burros, "Documents Show Officials Disagreed on Altered Food," New York Times December 1, 1999. Available at

  4. Fred A. Hines, "Flavr Savr Tomato (Pathology Review PR-152; FDA Number FMF-000526): Pathology Branch's Evaluation of Rats with Stomach Lesions from Three Four-Week Oral (Gavage) Toxicity Studies (IRDC Study Nos. 677-002, 677-004, and 677-005) and an Expert Panel's Report." Memo to Linda Kahl, Biotechnology Policy Branch, June 16, 1993. Available at (186K).

  5. See Joseph Mendelson, "The Food and Drug Administration's New Proposal on Genetically Engineered Foods: First Draft Analysis," January 17, 2001. Available at Also see this web site for information on writing to FDA about the proposed regulations.

  6. U.S. Food and Drug Administration (FDA), "Premarket Notice Concerning Bioengineered Foods," Federal Register Vol. 66, No. 12, January 18, 2001, pgs. 4706-4738. Available at

  7. Center for Food Safety and others, "Citizen Petition Before the United States Food and Drug Administration." Available at

  8. U.S. Food and Drug Administration (FDA), "Draft Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering; Availability," Federal Register Vol. 66, No. 12, January 18, 2001, pgs. 4839-4842. Available at

  9. Michelle Marvier, "Ecology of Transgenic Crops," American Scientist Vol. 89, No. 2 (March-April, 2001), pgs. 160-167. Available at

  10. See Union of Concerned Scientists, "Bt Crop Renewals,"

Thanks to Charles Benbrook, Caroline Cox, Michael Hansen, Ellen Hickey, Sheldon Krimsky, and Joseph Mendelson for reviewing portions of this series.


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