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Genetically Engineered Foods: Fears and Facts An Interview with FDA's Jim Maryanski Genetic engineering of fruits and vegetables and FDA's policy concerning these foods have been the subject of many consumer questions recently. To help answer the questions, FDA Consumer writer Mary Alice Sudduth talked to James Maryanski, biotechnology coordinator in FDA's Center for Food Safety and Applied Nutrition. Q: What is "new biotechnology" in reference to food plants, and how does it differ from old biotechnology? A: All plant breeding involves genetic manipulation of plants. There are hundreds of new plant varieties introduced every year in the United States, and all have been genetically modified through traditional plant breeding techniques--such as cross-fertilization of selected plants--to produce desired traits. This is "old biotechnology." The new biotechnology--known variously as gene splicing, recombinant DNA, or genetic engineering--is actually an extension of traditional plant breeding. It involves direct modification of DNA, a living thing's genetic material. This new technique is more precise, making it possible to direct and predict changes without introducing extraneous, undesirable traits. The new technique also will allow scientists to introduce genes from essentially any organism into a plant. Q: Why do we need these plants and the foods they produce? A: Plant breeders have a limited pool of genes--and, therefore, traits--available for use in improving plants. By looking at bacteria and animals, scientists can find other traits that may expand the number of potentially useful traits. These may include size, solids content, or resistance to certain viruses or fungi. Q: Under what circumstances will FDA require labeling of genetically engineered foods? A: One important area is that of potential allergens. If a gene from a food that commonly causes allergic reactions, like fish or peanuts, is inserted into tomatoes or corn, where people would not expect to find allergens, then the vegetables would have to be labeled to alert sensitive consumers. If companies can demonstrate scientifically that the allergenic component was not transferred to the vegetable, no special label will be required. FDA's policy states that proteins taken from commonly allergenic foods are presumed to be allergens unless demonstrated otherwise. Labeling also could be required if the nutritional content of the food is changed. Tomatoes are a major source of vitamin C, and if someone develops a tomato that no longer contains vitamin C, then that will have to be disclosed. So we envision a number of circumstances where labeling will be necessary, and we'll use the same labeling regulations we've always used under the FD&C Act. We've invited public comment on this issue, because we anticipate consumers will have diverse opinions about genetic engineering and about what information should appear on labels. Q: FDA has emphasized the importance of proper labeling of foods and has initiated legal action against certain products--Citrus Hill "fresh" orange juice, for example--because of misleading labeling. How does this differ from labeling biotechnology-derived foods? Isn't the fundamental issue the same--full disclosure? A: The law says labeling for foods must disclose information that's material, as well as avoid false or misleading statements. It's our view that the method by which a plant is developed by a plant breeder is not material information in the sense of the law. For example, we do not require sweet corn to be labeled "hybrid sweet corn" because it was developed through cross-hybridization. And plant breeders have many other traditional techniques through which they coax nature to change genes that would not occur otherwise. A process called somoclonal variation allows breeders to take advantage of natural mutations in plant cells that produce desired traits. Through embryo rescue, breeders nurture embryos produced by crossing two plant varieties that would not breed naturally, producing potentially useful plants that would not have survived on their own. Historically, we have not required this information to be on labels. It would not be practical. If genetic engineering or any other technique changes the composition of a tomato in a way that it's really not the same tomato anymore, then it would have to be called something different. It would have to have a different varietal name, or, if it was a significant difference, it may not even be called a tomato. We are reviewing the comments from the public on this issue to see if there is a basis for modifying our policy. However, if we were to require labeling of all genetically engineered fruits and vegetables, it would not be merely a matter of putting a sticker on a tomato or a banana. Producers would have to segregate the genetically engineered foods from other varieties, whereas normally those are all just lumped into a barrel. And then what happens when you make tomato paste, and that tomato paste is used to make pizzas? Does the label have to follow along through the food processing chain? It would increase the cost of these foods to consumers and would disrupt our complex food distribution system. Q: Are there environmental risks involved in producing genetically altered foods? A: Potential environmental risks from these crops are the same as those that occur in plants developed by traditional methods. There are many complex issues--such as potential transfer of traits to other plants and potential adverse effects on other organisms, particularly endangered species--that need to be taken into account. For example, if a plant has many wild relatives, it could pass a gene to one of those, resulting in an outcross plant species with some undesirable traits. The wild plants could develop into a fast-growing weed species, for instance. For some crops, like tomatoes, this really isn't a risk in the United States because there are few, if any, wild relatives of tomatoes that could be bred accidentally. But there are other plants, such as soybeans and squash, where there will be potential for an outcross species. Whether outcrossing is a problem depends on the trait that's introduced, as well. Environmental risks are looked at during the research and development phase. Right now, crops developed using recombinant DNA methods are reviewed by the U.S. Department of Agriculture's Animal and Plant Health Inspection Service. If FDA acts on a food additive petition or GRAS [generally recognized as safe] petition for a new ingredient, we will do an environmental assessment. We will look at what the other agencies have done, and, to the extent possible, we will rely on their information. If there are other issues, they will have to be considered. Q: How can consumers be sure companies producing these foods will test them adequately and take all necessary measures to ensure they are safe for consumption and will not harm the environment? A: All the companies that we've talked to are doing the kinds of tests that we would think need to be done. In May, FDA published a notice in the Federal Register providing a guide for companies that establishes a standard of care. What's happening now is that companies are coming to us and telling us the kinds of tests they're proposing based on the guidance in our Federal Register notice. And they're asking for our advice. Q: How long will it be before most of the foods now being developed through new biotechnology are available to consumers? A: That's a good question. People have this perception that all these things are just coming out of the sky and landing in the grocery stores next week, and that's just not true. There are products, like the Flavr Savr tomato, that are nearing commercialization. Assuming all the safety questions are answered, it probably will be introduced within the next year. USDA has received a request to rule on whether a variety of virus-resistant squash may be grown without USDA oversight, so one would assume it's close to commercialization. But most of the products--such as insect-resistant produce, vegetables with increased amino acids, and low-caffeine coffee--are two to five years away. We're going to see a gradual introduction of these products over the next several years, not an avalanche. Q: What about the possibility of plants containing animal genes? A: Several experimental plants have been developed that have copies of genes found in animals, such as the "antifreeze protein" gene from the Arctic flounder that may make tomato paste freeze and thaw better. However, there really aren't any plants with animal genes, that we know of, that are going to be marketed foods in the near future. So we have a good deal of time to think about the issue of animal genes. We believe the safety of the proteins produced by these genes should be evaluated based on their characteristics. If, for example, the flounder antifreeze protein is a component of fish fillet, it likely would be safe to eat as a component of tomato paste. But proteins derived from animals that have not been consumed safely will be treated as new food additives. Q: Has FDA considered the ethical or religious implications of injecting animal genes into plants? How will this affect vegetarians? A: FDA is considering these issues. There are thousands of genes in a plant. When a scientist adds new genes from an animal, it gives that plant several new proteins. But these proteins would not seem to give animal characteristics to the vegetable. A breeder does not actually take something from the animal and introduce it into the plant. For example, a scientist copies the fish "antifreeze protein" and modifies the gene. We know the characteristic of the fish gene, and we can tinker with it to make a different version. The copy is what is introduced into the plant, and the new gene works just like any other plant gene. So you don't really have pieces of animals in vegetables. You have pieces of plant DNA that are the same as, or nearly the same as, pieces of animal DNA. One of the things people probably don't realize is that there are genes in humans and animals that are in plants. There is a gene that occurs in rice that also occurs in the human brain. Vegetarians would not avoid rice because of that. Our current view is that these modifications will not result in foods that violate any ethical or religious considerations. However, we recognize people will have different views, and we specifically invited comment on this issue. We're also trying to get comments from various religious and other authoritative leaders so that we can get some sort of official opinion. Q: What values will these genetically engineered plants have--more nutrients, better taste? A: Both of those, and many agronomic values: better processing, freeze resistance. That's what using a flounder gene is all about--making a tomato freeze and thaw better. That protein also is being used as a model for developing a food additive to use in ice cream so ice crystals don't form. In addition, scientists actually will be able to make food safer. They'll be able to reduce the natural toxins. We're already looking at ways to identify the allergenic proteins in foods like milk. But those things are many years in the future. Right now, it's more a matter of giving fruits and vegetables better shelf life and shipping properties. Most of the traits will have economic values for farmers and processors. Q: Surveys of consumer attitudes have shown that most people will eat genetically engineered foods, but that a considerable portion will not. Is it FDA's role to ensure public acceptance of these foods? A: No, it is not. Our role is to tell the public how we ensure the safety of foods under the FD&C Act. We tell people about the important scientific questions that need to be answered and about the kinds of tests that should be done. But we can't be proponents of the products. We can't say genetically engineered food is something consumers should buy. However, we can explain to the public how these foods are the same and how they are different from other varieties. The U.S. government has a policy to foster biotechnology, and FDA recognizes that there are immense potential benefits to be derived from this science. It's not our responsibility to promote individual products, but we see that this technology does have beneficial applications. We are encouraging industry by working with them to ensure that safety questions are resolved. We're expecting rigorous testing and will not accept unsafe products. n Splicing to the Nitty Gritty FDA's policy for genetically engineered foods covers all foods produced from new plant varieties developed by any method of plant breeding. The policy is based on the Food, Drug, and Cosmetic Act's requirements of post-market surveillance of foods and pre-market approval of new substances. This system has ensured the safety of foods and food additives for many years. Under the FD&C Act, GRAS substances (those "generally recognized as safe") are excluded from the requirement for pre-market approval. But a new substance introduced via breeding for which safety has not been established must be approved as a food additive before marketing. Genetically engineered food crops that do not contain substances significantly different from substances already in the diet will not require approval as food additives. A substance that is significantly different from those already in consumers' diets will have to be approved by FDA. All foods are subject to FDA's post-market authority under the "adulteration" provisions of the act, and producers have a legal duty to ensure that the foods they place on the market meet the safety standards of these provisions. Adulterated foods are subject to seizure; producers and distributors who fail to meet their statutory duties are subject to injunction or criminal prosecution. These provisions have been FDA's primary tools for ensuring the safety of new varieties of fruits, vegetables and grains. New plant varieties routinely go through many years of testing and evaluation before marketing, and foods from these plants are tasted and tested. Plants developed by genetic engineering are being subjected to the usual tests for quality (Is the fruit firm? Does it look good?) and agronomic traits, such as improved processing and pest resistance. In addition, companies are using new tools of molecular biology and genetics to look at the very nature of these genetic changes. Biotechnology not only allows scientists to make new products, it also provides better tools to assess safety. In addition, companies are testing for known plant toxins, comparing levels in new varieties with levels in parent varieties. For example, tomatine is a natural toxin in tomatoes, but when using traditional breeding techniques, scientists don't usually look for it. However, the developer of a tomato that is genetically engineered to stay fresh longer is evaluating tomatine levels in that tomato. FDA has told companies that they will need to do more tests on the first foods developed using new biotechnology, to ensure that these foods are safe. But as developers gain more experience with these techniques, they will not need to do as many tests. --M.A.S.