Biotech: Profits Outstrip Science, Regulation, and Public Understanding Biotech is worth covering because people have strong concerns about it -- concerns about the safety of the food they eat and the safety of releasing new organisms into the environment. But if anyone thought that scientific or public concerns would keep genetically engineered food crops and other organisms from being released into the environment and the supermarkets, they are behind the times. It has already happened. It has happened with comparatively little attention from government regulators, from the public, and (until recently) from the media. Roughly half the soybeans and a quarter of the corn planted in the United States in 1999 were genetically modified. Corn and soy, the two crops most likely today to be bioengineered, are the foundation of hundreds of food and nonfood products. Most products on the supermarket shelves today have some biotech ingredients. In recent years, however, debate has flared over the possible health and ecological effects of biotech crops and food products. While U.S. companies have been quick to market with biotech crops, and U.S. farmers quick to adopt them -- consumers have been slower to accept them, and resistance from European nations has taken on the dimensions of a trade war. Media attention in recent years has tended to focus on the narrow and the negative -- ignoring the much broader picture. We read about a few studies suggesting that Bt corn may harm monarch butterflies -- but hear little about the many other studies suggesting such harm may be negligible. Background and Context Using conventional breeding methods, new strains and hybrids could be created only by crossing members of the same or closely related species. With today’s detailed understanding of the biochemistry of life, gene-splicers can go far beyond what is possible in nature -- taking the anti-freeze trait that keeps a flounder alive and putting it into strawberries, for example. The implications are profound. The new-found ability of humans to engineer life itself raises many burning ethical, religious, philosophical, economic, political, emotional, and ecological issues. Biotechnology is really a range of techniques and applications ranging from DNA fingerprinting and the manufacture of drugs to cloning. This backgrounder focuses primarily on agricultural biotech -- the use of genetically modified food crops and organisms. You will hear terms like "recombinant" DNA technology, "genetically modified" (GM), or "genetically engineered" (GE), or "transgenic." Such terms are often used interchangeably. Issues 1. Do genetically engineered crops and organisms present any significant threats to human health? The biotech industry and much of the scientific community say, in essence, "No." Consumer and food safety groups, however, are not so sure. Much of current federal policy is based on the doctrine of "substantial equivalence." Biotech advocates argue that, for the most part, corn or tomatoes with a few genes added are still just corn or tomatoes. If the FDA determines that a new product is substantially equivalent to one already in the food supply, the product need not under current law be subject to additional regulatory controls such as labeling or toxicity testing. But consumer advocates argue that biotech foods involve such radical departures from conventional breeding that health consequences can not be predicted. They invoke the precautionary principle ("Better safe than sorry") to argue that health effects testing should be done before they are marketed -- as it is with pesticides, food additives, and drugs. Even some consumer groups will acknowledge, as does the Food Policy Institute, that "there have been no confirmed cases of disease or illness associated with human consumption of GM foods in the published literature... ." But, they will add, the potential for harm to health may still be there. One of the biggest concerns is the possibility that GM foods may cause unexpected allergic reactions in some people. Because specific proteins in the final food product are one of the things most readily changed, and because specific proteins can cause allergic reactions, this makes sense. The biggest risks may come if consumers are unaware of what they are consuming. That is, if a person allergic to Brazil nuts eats a GM soy bean with genes for Brazil nut traits spliced into it, they may have no warning that what they are consuming is risky for them. Typically, however, the FDA denies approval to GM foods containing common allergens or requires them to be labeled. Another issue is antibiotic resistance. When packages of genes for new traits are inserted into existing organisms, scientists often include genes for antibiotic resistance as markers. Only a small fraction of such operations succeed, and by dousing an array of samples with antibiotics, scientists can pick out the successful ones because they survive. That antibiotic-resistance trait usually stays with the plant or animal when it goes into the field commercially. The concern is that if such traits drift genetically into other organisms in the ecosystem (especially bacteria), the effectiveness of the drugs in saving human lives might be reduced. The problem in the brave new world of biotech is that we may not yet be smart enough to ask the right questions about human health effects. For example, Monsanto’s GM bovine growth hormone (BGH) product, Posilac®, was approved largely on the strength of assertions that virtually none of the Posilac growth hormone came through in the final milk product reaching consumers. Yet later research developed some evidence suggesting BGH milk might contain higher levels of a different hormone called IGF-1, which does stimulate human growth and even cause cancer. 2. Do genetically engineered crops present any significant threats to the environment? The answer to this key question may be still largely unknown. As anybody familiar with Kudzu or zebra mussels can tell you, the unpredictable (or at least unpredicted) effects of exotic species introduced into an ecosystem can be devastating. It might seem reasonable to regard new GM crop strains with at least as much suspicion as we might regard any other new organism being introduced into our environment. But, GM organisms aside, many would argue that current U.S. controls on any introduced species, even conventional ones, are too weak to prevent devastation. U.S. controls are probably tightest on the introduction of pests that could harm agriculture, under laws such as the Federal Plant Pest Act, enforced by the USDA’s Animal and Plant Health Inspection Service (APHIS). But the focus of these laws is on protecting agricultural crops, not wild ecosystems. EPA regulates GM organisms when they have pesticidal properties, under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and amendments -- but lacks jurisdiction to regulate other GM organisms released into the environment. GM organisms not covered under these categories could be released into the environment with little control at all. One family of concerns about GM organisms is whether they will cross- breed with natural relatives once they are released into the environment. This could mean that the GM traits would be picked up by wild or unconfined populations of the organism, with ecological consequences that could be harmful. For example, what if the herbicide- tolerance trait in GM soybeans somehow managed to find its way to some weed species (a hypothetical example, so far) -- creating a "superweed" resistant to weed-killers? Or, to take a more likely example, what if farm-raised GM salmon escaped into the wild and interbred with the wild salmon stocks which are such a treasured resource? Another family of concerns is about possible unintended effects of the GM traits themselves. Will Bt corn (corn genetically modified to make it pesticidal) kill non-target insect species like monarch butterflies? Or will its widespread use promote the evolution of insect strains resistant to Bt? 3. What are the potential benefits of genetically engineered crops? Do they outweigh potential risks? Looking at much of the media coverage of biotech, you might get the impression that the plants and products it produces are as terrible as the plague. Think again. For all its risks, uncertainties, and drawbacks, biotechnology has already done enormous good for our society, and promises to do far more to improve people’s lives in the future, according to the biotech industry. Medicine has been one of the earliest arenas where GM technologies have been applied. According to the Biotechnology Industry Organization (BIO), "more than 200 million people have been helped by more than 90 biotechnology drug products and vaccines." And that does not include new diagnostic testing, new strains of test animals, gene therapies, organ transplants, or space-age stuff like biosensors. More biotech drugs products and vaccines are coming. Some 350 are in human clinical trials now and hundreds more are being developed -- holding promise of treatment for cancer, Alzheimers, heart disease, diabetes, multiple sclerosis, AIDS, and obesity, according to BIO. Biopesticides hold out the promise of reducing agriculture’s dependence on environmentally harmful chemical pesticides. Genetically engineered crop varieties hold the promise of vastly increasing agricultural productivity and the nutritional value of foods, feeding millions of undernourished people worldwide and reducing prices for consumers. Micro-organisms have for decades done a major share of the work of environmental clean-up -- not only of conventional wastes such as those treated in sewage plants, but also of toxic chemicals in water and soil. Bioengineering holds the promise of increasing the effectiveness of such methods, making them safer and cheaper. 4. Are controls adequate to protect the environment and human health? GM crops have been released into the environment, and GM products released into the marketplace, without any major new federal legislation to address broadly any special challenges of protecting the environment and human health in the face of this revolutionary technology. The industry is pleased. Moreover, the regulatory structure cobbled together on the basis of existing law is ill-fitted to the new technologies, based primarily on industry self-policing, and often limits federal agencies to the most passive oversight role. As the sciences that make genetic engineering possible began to coalesce in the 1970s, the National Institutes of Health addressed public concerns by forming the Recombinant DNA Advisory Committee (RAC), which adopted a set of guidelines for research. These guidelines were almost the only controls on genetic engineering until the mid-1980s. As long as genetic engineering was happening more in the lab than the fields and markets, and as long as NIH was the principal funding agency, those guidelines sufficed. In response to a lawsuit from biotech gadfly Jeremy Rifkin, the Reagan White House in 1984-86 adopted a "Coordinated Framework" (49 FR 50856) for federal oversight of biotech. It set a policy that biotech products should be regulated according to their characteristics rather than according to the technology that produced them, without any new legislation. This framework defined regulatory roles for federal agencies under existing law that have continued until today. A 1989 report by the National Academy of Sciences’ National Research Council only bolstered this policy with findings that "no conceptual distinction" existed between biotech gene-splicing and conventional breeding, and that "evaluation should be of the product and not the process by which the product is obtained." Under the Coordinated Framework, federal jurisdiction for oversight of food biotech are divided among the Food and Drug Administration, the Department of Agriculture, and the Environmental Protection Agency. The FDA has legal authority (under the Federal Food, Drug, and Cosmetic Act and other laws) to ensure that foods in interstate commerce are safe to eat and unadulterated. In 1992, the FDA codified the "substantial equivalence" policy in a Federal Register notice (57 FR 22984) that in effect conferred "generally recognized as safe" status on genetically engineered foods as a class. There were exceptions: labeling would be required for foods containing genes from allergenic foods, for example. For most biotech food crops, the policy has meant no official safety review by the FDA before they arrive at the supermarket. (FDA does have authority to pull them from the market if they are later found unsafe.) It has also generally meant no labeling to identify foods with biotech ingredients. If a company has developed a new genetically modified plant or animal (other than a pest-protected plant, or a potential plant pest), they have no legal obligation even to notify any federal agency before they release it into the environment or put it on supermarket shelves. FDA has relied on a "voluntary consultation" by industry instead of regulation. It has also relied on companies to determine whether their own products are "substantially equivalent" to conventional ones. The USDA’s main food-safety jurisdiction is over meat, poultry, and eggs. The USDA agency responsible for safety to consumers of bioengineered meat, poultry, and egg products is the Food Safety Inspection Service (FSIS). Another USDA agency, the Animal and Plant Health Inspection Service (APHIS) is responsible for protecting U.S. agriculture from pests and diseases. APHIS regulates new bioengineered organisms as potential pests (although many bioengineered organisms are developed to counter pests). EPA gets into the biotech arena by virtue of its mandate to regulate pesticides under FIFRA and FQPA. In addition to conventional chemical pesticides, EPA also regulated "plant-pesticides" -- organisms (sometimes crops) that have been genetically altered to boost their pesticidal properties. EPA assesses any risks the plant-pesticides may pose either to people or to the environment. 5. Should biotech-based products be labeled? Current FDA policy, going back at least to 1992, is not to require any special labeling of most biotech-produced food products. The European Union, by contrast, requires most GM foods to be labeled as such. A joint U.S.-EU panel in December 2000 recommended labeling. In January 2000, during the final hours of the Clinton administration, the FDA published a "draft guidance" opening its labeling policy to reconsideration, but left labeling voluntary and imposed strict limits on producers wishing to label their food as GM-free. The law gives FDA authority to keep food from being "misbranded," and that includes labeling which is "misleading." Under its 1992 policy, the FDA considers it misleading to label a food as GM-based or GM-free when it makes no significant difference in the qualities of the food itself. (The FDA does require labeling when a GM food contains likely allergens.) A federal district court upheld this position, backhandedly, in September 2000, when it dismissed a challenge by consumer groups to the 1992 policy. The court held that since it was a policy and not a rulemaking, it did not require notice and comment and was not subject to legal challenge. Localizing the Story 1. Are corn, soy, or other crops that possibly are bioengineered grown anywhere near you? Talk to farmers about their views of the issue. What do local conservation and naturalist groups say? Organic farmers and gardeners? University researchers on agriculture, wildlife, entomology, ecology, etc.? 2. What products containing bioengineered crops are likely being sold in your local supermarkets? Drugstores? Hardware stores? Is there any way of knowing? How? What do storekeepers say? Consumers? Local consumer and farm groups? Sources and Key Players Agencies - Food and Drug Administration (FDA) FDA’s main biotech-related jurisdiction is over the safety to consumers of food and animal feed derived from plant crops. The FDA has authority for foods other than those regulated by the Agriculture Department -- i.e., foods other than meat, poultry, and eggs. Most of this work takes place within FDA’s Center for Food Safety and Applied Nutrition (CFSAN). FDA also regulates food and drugs consumed by animals. FDA Press Office: (202) 205-4144 (print media), (301) 827-3434 (Broadcast Media). http://vm.cfsan.fda.gov/~lrd/biotechm.html. - U.S. Department of Agriculture (USDA). USDA National Agricultural Library -- Biotechnology Information Resource Web site. Links to selected sources, services, and publications covering many aspects of agricultural biotechnology. http://www.nal.usda.gov/bic/ Animal and Plant Health Inspection Service, Biotechnology Permits Branch. Web site full of links related to permitting, notification, and deregulation. http://www.aphis.usda.gov/biotech/. APHIS press office: (301) 734-7799. Food Safety Inspection Service press office: (202) 720-9113. - U.S. Environmental Protection Agency (EPA) EPA press office: (202) 260-4355. EPA Office of Pesticide Programs, Biopesticides and Pollution Prevention Division, (703) 308-8712, http://www.epa.gov/pesticides/biopesticides/. Publications - Reporters Guide to Genetic Engineering, published by the green- leaning Environmental Media Services and funded by four foundations. It features clear lay-language explanations of technical material, a large list of experts with phone numbers, and surprisingly little bias: http://www.ems.org/food/media_guide.html. EMS: Tom Lalley, (202) 463-6670, tlalley@ems.org. - Editors’ and Reporters’ Guide to Biotechnology -- a fairly thorough explanation of biotech’s benefits, giving the industry perspective, published by the Biotechnology Industry Organization. http://www.bio.org/aboutbio/guide2000/guide00_toc.html. BIO: Dan Eramian, (202) 857-0244 x2501, deramian@bio.org, or Lisa Dry, (202) 857-0244 x5199, ldry@bio.org. - Genetically Modified Pest-Protected Plants: Science and Regulation, Committee on Genetically Modified Pest-Protected Plants, National Research Council, April 2000. An expert committee of the National Academy of Sciences found little reason for environmental or health concerns with plant-pesticides -- but noted a lack of public acceptance of GM products and lack of public confidence in the regulatory system and made recommendations for addressing those problems. Press copies may be available from Bill Kearney, (202) 334-2138, news@nas.edu. - Field Testing Genetically Modified Organisms: Framework for Decisions (1989), National Research Council, http://www.nap.edu/books/0309040760/html/. Food Biotechnology in the United States: Science, Regulation, and Issues, by Donna U. Vogt and Mickey Parish, Congressional Research Service, June 2, 1999, http://www.usinfo.state.gov/topical/global/biotech/crsfood.htm. Groups - Biotechnology Industry Organization (BIO) . Many associations and companies from a broad range of biotech-related industries are collected under the umbrella of the (BIO), whose members are listed at http://www.bio.org/aboutbio/biomembers.html. BIO press contacts: Dan Eramian, Charles Craig, Lisa Dry, (202) 857-0244. - Council for Biotechnology Information. This group was founded by major biotech corporations and associations. Their Web site (http://www.whybiotech.com/) is loaded with news and information, mostly with a pro-biotech slant. Phone: (202) 467-6565. - American Crop Protection Association. This is the principal trade association of the pesticide industry. http://www.acpa.org/public/issues/biotech/indexbiotech.html. Site includes issue papers and list of spokespersons and experts. Press contact: Margaret Speich, (202) 872-3863, margaret@acpa.org. - Grocery Manufacturers of America. Has a big stake in issues like labeling. Numerous position papers on biotech at http://www.gmabrands.com/news/docs/listwhitepaper.cfm. Press contact: Peter Cleary, (202) 337-9400. - Council for Agricultural Science and Technology (CAST). CAST membership consists of some 38 scientific and professional societies, many of which have strong ties to agriculture. Press contact: Cindy Lynn Richard, (202) 408-5383, crichard@cast-science.org, http://www.cast-science.org/biotechnology/index.html. - Institute of Food Technologists. Partly a scientific and professional organization for an array of specialties, but also similar to a trade organization in its focus on food. Strongly favors biotech food. Press contact: Rosetta Newsome (312) 782-8424 x228, http://www.ift.org/resource/policy/biotechreport.shtml. - Center for Food Safety. This DC-based group lobbies and litigates primarily on biotech food issues and organic standards. Press contact: Andrew Kimbrell, (202) 547-9359, http://www.centerforfoodsafety.org/. - Genetically Engineered Food Alert. A coalition of seven environmental and consumer groups focused on this issue. Press contact: David King, (202) 887-8838, dking@environet.org, http://www.gefoodalert.org/. - Alliance For Bio-Integrity. A consumer-oriented group which emphasizes the risks of biotech. The group is a focal point of religious objections to biotech (e.g., the need of people on a kosher diet to know what is in their food). Steven M. Druker , (515) 472-5554, http://www.bio-integrity.org/. - Organic Consumers Association (formerly The Campaign for Food Safety). A grass-roots activist organization focused on food safety and organic farming. Press contact: Ronnie Cummins, (218) 226-4164. http://www.purefood.org/gelink.html. - Union of Concerned Scientists. This long-established group is usually a source of sound scientific information, and has focused on biotech issues. It has a definite pro-environment and -consumer tilt. Press contact: Jane Rissler, (202) 223-6133. http://www.ucsusa.org/. - Council for Responsible Genetics. Describes itself as "a non-profit bio-ethics organization devoted to fostering public debate about the social, ethical, and environmental implications of the new genetic technologies." Press contact: Martin Teitel, (617) 868-0870, http://www.gene-watch.org/. - Consumer Federation of America (Food Policy Institute). A non-profit research, education, and advocacy group devoted to consumer issues. See their January 11, 2001, report, "Breeding Distrust: An Assessment and Recommendations for Improving the Regulation of Plant Derived Genetically Modified Foods" (Executive summary online at http://www.consumerfed.org/). Press contact: Art Jaeger or Carol Tucker Foreman, (202) 387-6121. Reprinted with permission. Published in Environment Writer newsletter February 2001, by the National Safety Council's Environmental Health Center.