CRS Report to Congress

Donna U. Vogt, Specialist in Social Sciences
Mickey Parish, Congressional Science Fellow
Domestic Social Policy Division
June 2, 1999

Summary

The use of biotechnology to produce genetically engineered foods can potentially provide greater yields of nutritionally enhanced foods from less land with reduced use of pesticides and herbicides. This technology has both critics and supporters. Concerns presented to Congress include potential detrimental effects to human and animal health and the environment, and violation of religious customs. Supporters, including individual companies, trade organizations, scientific professional societies, and academic groups, promote benefits such as enhanced crop yields, better nutritional content in food, less pesticide use, and greater agricultural efficiency. They want Congress to defend the U.S. competitive position in export trade of food biotechnology products. Calls for "right-to-know" labeling or other federal regulatory requirements, on the other hand, spark concerns about possibly impeding innovation and adding costs.

In the United States, the regulation of biotechnology food products does not differ fundamentally from regulation of conventional food products. Three federal agencies are primarily responsible for the regulation of genetically engineered foods - the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA). Each federal agency is assigned certain regulatory responsibilities. FDA provides voluntary pre-market consultations with food companies, seed companies, and plant developers to ensure that biotechnology derived foods meet regulatory standards for safety. USDA's Animal and Plant Health Inspection Service (APHIS) licenses field testing of crops prior to commercial release of newly developed plant strains. EPA registers pesticides in U.S. commerce (including plants engineered to produce pesticides) and establishes levels at which pesticides in foods are permitted. The White House outlined this multi-agency approach to regulating the products of biotechnology in a 1986 document entitled Coordinated Framework for Regulation of Biotechnology.

Some critics are concerned about genes from genetically modified plants escaping into the environment through cross fertilization. Others fear the potential overuse of Bt, a natural insecticide, will cause insects to develop resistance to its toxic effects. They want more testing on the long-term environmental and health impact of crops that are altered to produce it. Industry groups, however, contend that current regulations more than adequately ensure human health and safety. The United States is leading the world in privately funded biotechnological research, genetically modified products, and sales of the technology. Some suggest that foreign countries' resistance to genetically engineered crops can be traced to their desire to allow their domestic industry time to develop a competitive position in this trade. U.S. officials resisted an attempt to limit trade in bioengineered products at a meeting in Colombia in February 1999 negotiations over a "biosafety protocol." Some in Congress would exercise more oversight over the regulation of these food crops, fund more public research, and encourage the Administration to negotiate the easing of trade barriers and harmonizing standards. 

Contents

Introduction

The Science of Genetic Engineering

• Use of Biotechnology to Produce Food
• Genetically Modified Whole Food Products
• Future products

Federal Responsibilities for Regulating Genetically Modified Foods

• Food and Drug Administration
• U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS)
• U.S. Department of Agriculture, Food Safety and Inspection Service (FSIS)
• Environmental Protection Agency

Issues

• Labeling for Public Health and Religious Practices
  • Public Health Concerns
  • Religious Practices
  • Labeling
• Environmental Issues
  • Bt Resistance and Intervention Strategies
  • EPA's Proposed Plant-Pesticide Regulation
  • Liability
• Economic Concerns
• International Trade Issues
• Biosafety Protocol
• Trade Relations with the European Union (EU)
• Trade Relations with Canada
• Trade Relations with Japan
• International Harmonization

Concluding Remarks

FOOTNOTES

List of Tables
Table 1. Overview of Agency Responsibilities
Table 2. EPA Registered Plant-Pesticides
Table 3. Exemptions of Viral Coat-Proteins a from Requirements of a Tolerance

 Food Biotechnology in the United States:
Science, Regulation, and Issues

Introduction

Genetic modification of agricultural crops promises the availability of food products with more desirable traits, such as higher quantities of vitamins or lowered amounts of saturated fats for consumers, reduced use of pesticides and other chemicals for environmentalists, and increased yields for growers. Traditional plant breeding, the conventional method to modify plants' genes, has produced similar benefits. But recent biotechnological innovations allow scientists to select specific genes from one plant or animal and introduce them into another to confer desirable traits. This produces the new plant or animal more quickly than conventional methods, and creates plants and animals with traits not found previously in nature. Proponents argue that advances in genetics and new technologies can produce foods with greater yields to feed the growing world population in the 21^st century. Critics are concerned that this technology produces uncertainties about potential long-term impacts on public health and the environment, and increases problems related to trade.

The 106th Congress will consider issues associated with food biotechnology because the federal government under statute and through regulation attempts to ensure that food manufacturers produce safe products. Congress is being asked to consider whether federal regulations adequately manage genetic engineering risks to public health and safety, and the environment. This report discusses the science of food biotechnology, and the federal structure by which it is regulated. Because U. S. farmers are adopting this technology at a rapid rate, some observers advocate a more active role for the federal government to ensure that farmers have equal access to this technology. Others are concerned that federal officials should play a more active role in protecting the environment, funding more research, and participating in international trade negotiations to ensure that trade continues to expand for genetically engineered crops. Trading partners often label food products that have been genetically modified as genetically modified organisms (GMOs). Many of those partners have labeling requirements for GMOs to allow consumers the "right to know" their food content.

Several congressional committees oversee federal governance of genetically engineered foods and biotechnology. In the Senate, food biotechnology issues are considered by the Committees on Agriculture, Nutrition, and Forestry; Health, Education, Labor and Pensions; Environment and Public Works; and Governmental Affairs. In the House, food biotechnology issues are considered by the Committees on Agriculture; Commerce; Government Reform; and Science. The Appropriations Committees of both House and Senate have oversight responsibility on how the major federal agencies set and enforce policies affecting the safety of genetically engineered foods. 

The Science of Genetic Engineering

Biotechnology is defined as the use of biological processes for the development of products such as foods, enzymes, drugs, and vaccines. Biotechnology is the new label for a process that humans have used for thousands of years to ferment foods such as beer, wine, bread, and cheese. In these cases, biological processes are used to alter raw food products to produce more stable foods. Presently, the term biotechnology is used to describe genetically engineered foods that contain genes modified by modem technologies.

When plants breed in the wild, genetic changes occur spontaneously and result in a haphazard transfer of a large number of genes within closely related species. Traditional plant breeding is more selective and creates plants with improved yields or some other desirable trait among closely related species. Often, unwanted genes conferring undesired characteristics may be transferred along with the desired characteristics. Breeding itself takes time due to the need to backcross each plant to eliminate undesirable traits.

Modem genetic engineering gives greater control of the process and transfers specific genetic material into the cells of a plant. This method can reduce the likelihood of unexpected results. Also, plant breeders can use the newer genetic techniques to move genes among unrelated species to yield plants with novel traits that could not be produced by traditional breeding.

Several techniques are employed by genetic engineers. All involve DNA transfers from one plant or animal to another. DNA, deoxyribonucleic acid, is the chemical from which genes are constructed. Specialized laboratory techniques, generally referred to as recombinant DNA (rDNA) techniques are used to manipulate DNA isolated from animal, plant, or microbial cells and to introduce the engineered DNA sequences into another organism. The laboratory techniques of genetic engineering may involve direct cellular uptake of DNA, forced introduction of DNA into a cell, or the use of a non-pathogenic carrier to transmit genetic material into a cell. Additionally, some microbial cells in immediate contact can transfer DNA directly from one cell to another. Plants may also be genetically modified by fusion of whole cells.1

After plant cells are genetically modified, tissue culture techniques are used to encourage growth of the modified cells into whole plant systems with leaves, stems, and roots. New food plant characteristics depend on which genes are transferred, whether these genes are switched on (expressed), and the interaction between genes and the cellular environment in which they reside.

Use of Biotechnology to Produce Food

The first wave of agricultural biotechnology food products is not substantially different from those foods already familiar and available to consumers. These modified agricultural commodities have, for the most part, directly benefitted agricultural producers with increased yields and reduced production costs. According to an industry trade association, genetically engineered food crops planted and marketed by U. S. farmers include corn, canola, rice, tomatoes, potatoes, and soybeans. Peppers, sunflowers and peanuts are in the pipeline for approval. Other genetically engineered food crops, such as sugar beets, wheat, squash, papayas, berries, bananas, and pineapples, have been developed in laboratories, and will go through the approval process for marketing within the next few years. Non-food plants that are being genetically modified include trees, for pulp wood, and cotton, although cotton seed oil may be used in food products.

Genetically Modified Whole Food Products. Some of the products referred to above have been genetically modified to be either resistant to pesticides, 2 or to make their own pesticides. Those modified to resist pesticides allow farmers to use a herbicide for weed control without killing the food crop. This use reduces competition from weeds for nutrients and increases yields. Other products of bioengineering produce insecticides within their cells. Crops such as corn, cotton, and potatoes, have been genetically engineered to make their own pesticide.

Farmers have rapidly accepted these genetically engineered field crops. Farmers are increasing their acreage of herbicide resistant crops because the use of these plants reduces the need to plow, decreases the amount of chemical herbicide needed, produces higher yields, and can deliver a cleaner and higher grade of grain and product. 3 Of the total 1998 crop, approximately 25% of planted corn was genetically modified, 38% of planted soybeans, 45% of cotton, and 42% of canola. 4 In 1998 in the United States, herbicide tolerant soybeans became the dominant bioengineered crop, with 4.1 million acres planted (about 36% of the total U.S. acreage planted in soybeans). Herbicide resistant crops of soybeans, corn, and cotton accounted for most of the acreage planted in biotech crops.

Various companies have targeted different genetic modifications to produce tomatoes that remain firm for a longer time and are reputedly more flavorful than traditional tomatoes. Calgene's Flavr Savr tomato was one of the first genetically engineered consumer-ready foods to receive federal approval for production and marketing in the United States. Another tomato engineered by Zeneca is used for production of a reduced-price tomato paste for sale in the United Kingdom.

Biotechnology is also used to produce experimental "transgenic" animals, in which the genetic material has been deliberately modified and to produce "clones" in which animals are reproduced artificially but the DNA is not modified. In agriculture, transgenic animals may be altered to produce higher yields of specific products (meat, milk etc.) or to bring about commodities with enhanced characteristics, such as less cholesterol or reduced fat content. Although cloning has been used to reproduce animals for scientific purposes since the 1950s, its usefulness for the reproduction of identical livestock animals was only recently investigated. In 1995, sheep were cloned from embryonic cells in Scotland. In 1996, a substantial breakthrough followed when a sheep, Dolly, was cloned from an adult, nonembryonic cell. 5 Japanese scientists are creating high-value beef cattle through cloning. They have successfully cloned at least 19 calves from adult bovine cells. Because the cost of some premium beef roasts can be between $100 and $200 per pound in Japan, the Japanese cattle industry can support the expense of cloning prize beef cattle. 6 But even with those prices, the cost of genetically engineering cattle on a large scale could be prohibitive.

At this time, most of the research on transgenic animals in agriculture is experimental. The Biotechnology Industry Organization (BIO), an industry trade organization, estimates that the only transgenic animals that will be marketed within the next 6 years are transgenic fish that can grow to market size more rapidly than traditional farm-raised fish. Experiments are also being conducted to produce transgenic animals that yield human pharmaceuticals such as vaccines, growth hormones, blood-clotting factors, monoclonal antibodies and other drugs. Enhancement of milk from cows, goats and sheep to contain these drugs is the target of much of this research. 7

Animal products also have been changed by biotechnology. A food processing agent, chymosin (also called rennin) is an enzyme required to manufacture cheese. It was the first genetically engineered food additive to be used commercially. Traditionally, processors obtained chymosin from rennet, a preparation derived from the fourth stomach of milk-fed calves. Scientists engineered a non-pathogenic strain (K-12) of E. coli bacteria for large-scale laboratory production of the enzyme. This microbiologically produced recombinant enzyme, identical structurally to the calf derived enzyme, costs less and is produced in abundant quantities. Today about 60% of U.S. hard cheese is made with genetically engineered chymosin. 8 In 1990, FDA granted chymosin "generally-recognized-as-safe" (GRAS) status based on data showing that the enzyme was safe. 9 The final enzyme product is purified by removing potentially harmful substances, including the gene for antibiotic resistance used to engineer the microorganism that produces chymosin.

Bovine somatotropin (BST), also known as bovine growth hormone (BGH), occurs naturally in cows. When recombinant bovine somatotropin (rBST), is injected supplementally into dairy cattle, milk production may increase 10% to 15% (see text box). Genetically engineered microorganisms produce a consistent and affordable supply of this hormone as opposed to isolating the compound from limited bovine sources. According to an industry trade association, it is possible that up to 30% of U.S. dairy cows are injected with recombinant BST to increase milk yield. 10

Future products. Experts indicate that the "second wave" of genetically modified food products will target consumer and animal health issues and improve the nutrition content of certain foods. For example, vitamin A shortages that are a significant health concern in developing countries could be addressed by increasing the vitamin A content in canola oil. Genetically engineered soybeans, peanuts, and sunflowers may contain reduced levels of saturated fats or have altered fatty acid compositions for enhanced health benefits and to improve vegetable oil stability without the need for chemical hydrogenation. (Hydrogenation is used to create fats that are solid at room temperature - margarine, solid Crisco, etc.) Fruits may also be genetically engineered to contain vaccines. These fruits could be delivered without special care to developing countries which often don't have refrigeration necessary for current vaccines. 11 Genetically engineered salmon, trout, and flounder achieve market size in half the time of non-genetically engineered fish. Commercialization of such fish may help curtail over-fishing of native fish, as well as reduce consumer prices. In addition, scientists are using genetic engineering to make high-value products, such as special oils and chemicals. Rapeseed plants have been genetically modified to produce 35% more of a fatty acid, laurate, for use in soaps, detergents and other household items. Other plants and animals are being engineered to produce pharmaceuticals, specialty chemicals, and biologic agents.

Federal Responsibilities for Regulating Genetically
Modified Foods

During the 1970s, the development of new techniques for transferring genes raised concerns about potential hazards. At the Asilomar Conference in February 1975, scientists working with this technology tried to reach a consensus to self-regulate research involving rDNA technology until its safety could be assured. The National Institutes of Health (NIH) became involved in 1976 when it published research guidelines using rDNA techniques. Until 1984, the NIH Recombinant DNA Advisory Committee was the primary federal entity that reviewed and monitored DNA research. However, a legal challenge forced the Reagan Administration to consider and propose policies to guide activities of federal agencies responsible for reviewing biotechnology research and its products. 12 In 1984, the White House Office of Science and Technology Policy (OSTP) published the "Coordinated Framework for Regulation of Biotechnology," a framework proposing that genetically engineered products would continue to be regulated according to their characteristics and novel features and not by their method of production. It also proposed that new biotechnology products be regulated under the existing web of federal statutory authority and regulation. 13

In 1986, OSTP finalized this framework. The framework identified lead agencies to coordinate activities when and if jurisdictions overlapped. For example, the Food and Drug Administration (FDA) is responsible for regulating food and feeds in the market that have been modified through genetic engineering. The U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), regulates importation, interstate movement, and environmental release of transgenic plants that contain plant pest components. It licenses, through permits, the field testing of food crops prior to commercial release. But agencies' responsibilities overlap as some plants have been modified to contain plant-pesticides. The Environmental Protection Agency (EPA) registers certain pesticides produced in transgenic plants prior to their distribution and sale and establishes pesticide tolerances for residues in foods. 14 APHIS and EPA together established procedures to review and approve field tests of modified plants and microorganisms. FDA has post-market authority to remove a food from the market. Table I shows an overview of federal agencies' responsibilities.

Table 1. Overview of Agency Responsibilities

Food and Drug Administration

The Federal Food, Drug, and Cosmetic Act (FFDCA) gives FDA broad authority to regulate foods by prohibiting the entry into interstate commerce of adulterated or misbranded foods. It is the legal responsibility of food manufacturers to produce foods that are not adulterated, unsafe, filthy, or produced under unsanitary conditions. FDA has authority to inspect foods and food facilities, both domestic and imported, to ensure that they are manufactured and held under acceptable conditions and are properly labeled. FDA can seize products or request that they be removed from the market if they do not meet federal requirements.

The Act also requires that "food additives" not be marketed unless they have received approval from FDA. But substances added to foods that are considered generally-recognized-as-safe or GRAS substances do not need agency approval. First articulated in the OSTP framework document in 1986, FDA determined in 1992 that bioengineered foods pose the kinds of scientific and regulatory issues that are not substantively different from those raised by non-bioengineered foods. Thus, FDA regulates foods that have been genetically modified or engineered no differently than foods created by conventional means.

In a May 1992 policy statement FDA described how its regulatory authority applies to new plant varieties and derived food products, including those developed through genetic engineering. The agency decided that companies developing genetically engineered foods would have to go through a special review in FDA only if:

• the gene transfer produces unexpected genetic effects;
• the levels of toxicants in the food are significantly higher than present in other edible varieties of the same species;
• nutrients in the bioengineered food differ from those in traditional varieties;
• the sources of the newly introduced genetic material come from a food plant associated with allergies;
• the food from the new variety differs significantly in composition from food of comparable varieties;
• the food contains marker genes that theoretically may reduce the therapeutic effects of clinically useful antibiotics;
• the plants are developed to make substances like pharmaceuticals or polymers, and will also be used for food; or
• the food to be used for animal feed has changes in nutrients or toxicants.

So far, most genetically modified foods have not required pre-market approval, although a few have had their composition changed significantly such that they were labeled differently. Most proteins from genes transferred into foods to give them new traits are either GRAS or otherwise exempt from regulation. A GRAS substance is excluded from the definition of a food additive. 15

FDA has, however, instituted a voluntary consultation process whereby the developer can resolve any safety or regulatory issues prior to marketing. To the extent that the agency is aware, all companies are making use of this process prior to marketing new products from engineered plants. By the end of 1998, developers had consulted with FDA officials on 42 products: 11 times for corn; 6 each for tomatoes and canola; 5 for cotton seed; 4 for potatoes; 3 for soybeans; 2 each for sugar beets and squash; and once for flax, radicchio, and papaya.

On a food product's label, the FFDCA requires producers of foods to describe the product by its common name and reveal important facts associated with claims made or suggested. The agency interprets the FFDCA as not giving it authority to mandate labeling based solely on a consumer's "right to know" the method of production if the final product is considered "safe." Therefore, the agency does not mandate labeling to indicate the method by which a new variety was developed (e.g., that it was genetically engineered). However, the FFDCA does require that all information on labels be truthful and not misleading. Special labeling may be required if the developed food significantly differs from its conventional counterpart such that the common name would no longer apply. For example, FDA required the renaming of a canola oil whose fatty acid composition had been altered by engineering. The new name, "high laurate canola," describes what is different about the oil but not its production method.

FDA will require special labeling for foods if they pose special safety or usage issues. For example, if a food had a new protein introduced into it to which people were allergic, FDA would require the label to reveal that information. In its 1992 policy statement, the agency noted that labeling would be required if genes were introduced from foods that were commonly allergenic, unless the developer could scientifically demonstrate that the protein was not responsible for the allergenicity of the original food. Examples of commonly allergenic food include milk, eggs, wheat, shellfish, tree nuts, and legumes. In one case, a developer demonstrated that DNA transferred to soybeans from a Brazil nut caused the production of a protein responsible for an allergic reaction. Consequently, the private developer discontinued research on that particular modified soybean. FDA has asked that developers of genetically modified food demonstrate that the introduced proteins do not share structural similarity to known allergens and are not resistant to digestive enzymes and acid.

In addition, developers often use antibiotic-resistance marker genes to select transformed plant cells used to create new food. Some scientists are concerned that these marker genes could be transferred from plants and incorporated into pathogenic microorganisms and create antibiotic resistance in those microorganisms leading to a significant increase in resistance to clinically important antibiotics. 16 On September 4, 1998, the FDA released for comment a guide on evaluating the safety of using antibiotic-resistance marker genes in the genetic modification of foods. The agency is asking developers to evaluate the potential toxicity of the encoded protein and whether it could cause allergenic reactions, and to assess whether its presence in the food would compromise the therapeutic efficiency of orally administered antibiotics. Comments were due to FDA by December 7, 1998, and the agency currently has them under consideration.

U.S. Department of Agriculture (USDA), Animal and Plant Health
Inspection Service (APHIS)

APHIS issues permits for the importation and domestic interstate shipment of certain plants, animals, and microbes that have the potential for creating pest problems in domestic agriculture. The agency has historically regulated pests that attack plants - any living stage of any insect, mite, nematode, slug, snail, protozoa, and/or other invertebrate animal, bacteria, fungi, or parasitic plant or reproductive part. It is also interested in viruses - infectious substances that would directly or indirectly injure or cause disease or damage plants or plant parts or any processed, manufactured, or other plant products. 17

For new plants that could become pests, APHIS issues site specific permits for field tests or for release into the environment. The agency reviews permit applications and prepares an environmental assessment in which it evaluates the probable environmental impact of the release. The permit application process requires that the developer disclose information about the development of the plant and that appropriate facilities and control measures are in place during transport and field tests. If the agency reaches a "Finding of No Significant Impact" (FONSI), a permit is issued. 18 Before decisions are made, APHIS seeks concurrence with states on regulatory actions.

In 1993, APHIS introduced an expedited procedure for approving limited permits so that field testing of six crops could begin without a completed formal application that included an environmental assessment. For genetically engineered plants that meet certain eligibility requirements and performance standards, the sponsoring company need only submit a "notification" letter to the agency, a modified and abbreviated application which describes the gene, where the tests will take place, and the characteristics of the plant. The agency has 30 days to process the application before the sponsor can proceed with the field test. In 1997, APHIS expanded the expedited procedure to cover many more crops. In 1998, 99% of all applicants used the expedited process.

After tests are completed and an application is submitted, APHIS has 120 days to decide that the product does not pose a risk of being a plant pest and whether a product is ready for full "release" onto the market. APFUS then completes an environmental assessment before making its decision.

U.S. Department of Agriculture, Food Safety and
Inspection Service (FSIS)

Developers of transgenic animals must submit data to FSIS to prove that the livestock and poultry involved in biotechnology experiments are not adulterated and can be slaughtered and sold as food with other beef and poultry. Prior to approving slaughter and sale, FSIS inspectors look at the number, age, sex, and other factors. The ultimate disposition of transgenic animal carcasses, whether by rendering, slaughter for food, or other disposal is of concern to regulators.19

Environmental Protection Agency

The EPA regulates pesticides. Pesticides are broadly defined as any substance or mixture of substances intended for "preventing, destroying, repelling, or mitigating" pests. EPA currently refers to "plant-pesticides" as plants that produce pesticides within their tissues.' Scientists have also genetically engineered plants that are resistant to specific herbicides. Although herbicide resistant plants are not "plant-pesticides," they are subject to EPA regulation since they can affect the use of herbicides.

EPA regulates plant-pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and FFDCA. Under FIFRA, EPA determines the risk the plant-pesticide poses to humans and the environment and approves registration of those substances for particular uses that will not generally cause unreasonable adverse effects. This determination involves balancing risks from the pesticide with benefits associated with its use.21 A pesticide (including plant-pesticides) cannot be sold or distributed in the United States unless it is registered with EPA.

If the plant producing the plant-pesticide is a food crop, EPA must establish a "safe level" of pesticide residue allowed, a tolerance level, under the authority of Section 408 of the FFDCA. A "safe level" of the pesticide residue is defined as that level at which there is "a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information."22 Because no tests of the registered (approved) plant-pesticides have shown toxicity to humans so far, EPA has given them an exemption from the requirement for a tolerance level. 23

Table 2. EPA Registered Plant-Pesticides

EPA has registered few plant pesticides. Table 2 shows that EPA has registered three genetically modified crops containing plant-pesticides: potatoes, cotton, and corn (including field corn, sweet corn, and popcorn). Table 3 shows that EPA has exempted from the requirement for a tolerance several genetically engineered viral coat proteins that can be used in food commodities. So far, all but one EPA-approved prodcuts contain a "Bt" delta-endotoxin. The delta-endotoxins are proteins, one of the many toxins that may be naturally produced by the bacterium, Bacillus thuringiensis, and are species-specific, affecting only certain insects. They are also virtually harmless to humans and animals. When a susceptible insect consumes the protein, its digestion is severely disrupted, further feeding stops, and the pest eventually dies, usually within 2 days.

(a) Viral coat proteins are components of the outer cell wall that encloses a virus' genetic material. Expression of the coat protein in the plant confers resistance to the virus by a mechanism known as cross-protection.

In 1994, EPA proposed a rule to refine its regulatory oversight of plant-pesticides. As a part of the rule, EPA included in its definition both the plant-pesticide and the genetic material transferred into the plant. Under this rule, EPA proposes to exempt several categories of plant-pesticides from FIFRA and FFDCA section 408 requirements.24 Under this rule, EPA proposes to exempt: (1) plant-pesticides derived from plants sexually compatible with the recipient plant; (2) plant-pesticides that act by primarily affecting the plant; 25 and (3) plant-pesticides based on a coat protein from a plant virus. These rules will be designed to exempt certain categories of substances that EPA believes are low risk based on familiarity and presence in the food supply, e.g., plant hormones and coat proteins from plant viruses. These proposed exemptions result in little or no effects on plants produced by conventional plant breeding. They could, however, affect research into innovative plants, according to critics, because of the additional regulatory burden that the rule would represent. The rule has not yet been finalized. 

Issues

Congress' attention will likely be drawn to a number of biotechnology issues due to public concern. Issues include concerns about public health, religious issues, labeling, the environment, the economic impact of this technology, and international trade competitiveness.

Labeling for Public Health and Religious Practices

Public Health Concerns. Many consumers express wariness of new "supercrops" and novelty foods, fearing that introduced genes could prove allergenic or harmful to human health. For example, if new genes inadvertently caused a plant to produce toxins at higher levels than are present naturally, there could be long-term health consequences for humans. 26 Some consumers are worried that a gene introduced into plants to protect against pests could also cause the plant to alter its pollen, thereby affecting the health of humans prone to some sensitivities.

Some critics are dismayed that FDA is placing all the responsibility on manufacturers to generate safety data, as it does normally under its pre-market approval system, and is reviewing only the conclusions of industry-sponsored studies, rather than conducting its own tests. 27 Critics have asked that more tests be conducted for chronic effects prior to products being placed on the market to ensure that all uncertainties regarding human health be explored. 28 Proponents argue that additional testing of genetically engineered foods is unnecessary because all foods must meet the same federal safety standards regardless of whether they are genetically engineered.

There is a growing movement among consumer groups that advocate the labeling of all genetically modified foods (GMO foods) that were produced through the process of genetic engineering. This position reflects a policy of "consumer sovereignty" or the "right to know," which supports the disclosure of all relevant information on a label so consumers may make food choices based on their own values. 29

Bio-engineering generally uses an antibiotic-resistance marker gene to identify whether the gene transfer process has been successful. The marker, along with the desired genes, are transferred into the modified food. Because the markers resist antibiotics, there is concern that normal bacteria could incorporate antibiotic resistance in the human or animal intestine after consumption of the food. In the United Kingdom (UK), that concern was brought to the attention of the U.K. Advisory Committee on Novel Foods and Processes. It advised that all new GM0 foods containing antibiotic resistance genes should be reviewed on a case-by-case basis. 30

Religious Practices. Others, particularly religious groups, are concerned that foods might contain genes from animals, such as swine prohibited by some religions, and they maintain that they have a right to know if foods contain those genes. 31 Both the kosher (Jewish) and halal (Muslim) communities have mechanisms in place to determine which products are acceptable to their adherents, and thus have not concerned themselves with secular labeling issues. 32 However, both Orthodox Rabbis and Muslim leaders have ruled that simple gene additions that lead to one or a few new components in a species are acceptable for kosher and halal law. 33 The Muslim community has not yet resolved whether a gene derived from swine is an exception to the above acceptance. For example, both groups have raised no objection to the use of bioengineered chymosin (rennin) in the production of cheese. The status of more significant changes in the genetic makeup of species remains to be decided. However, cloning, in particular, raises serious ethical/moral issues for religious leaders of all faiths. That discussion has involved a much broader range of clergy within the respective communities as well as other communities without dietary laws.

Labeling. Some have suggested that labels that say "no biotechnology used" would allow consumers a choice about whether to purchase products produced by the new technology, and to better make judgements about compliance with ethical and religious beliefs and lessen objections to its use. 34 Others favor voluntary labeling. A study showed that under Vermont's 1995 mandatory rBST labeling rule retailers rather than producers paid the expense of enforcement to ensure that all milk produced using rBST was so labeled. A federal appeals court overturned this requirement, and since the spring of 1997, Vermont has authorized voluntary labels for rBST-free dairy products. 35

The food industry generally opposes this type of labeling because consumers may interpret these to be "warning labels," implying that the foods produced through biotechnology are less safe or nutritious than conventional foods. Food production interests believe that consumers, thinking that a product is different from conventional foods, may not gain the benefits from foods that have been modified genetically because they are uneasy with the technology and may not try the products.

Currently, no federal agency requires foods to be labeled as genetically modified. The U.S. regulatory agencies assumed that these genetically engineered foods are similar to traditional counterparts except for the modified genes. Each agency, as with other foods, relies on industry data and rarely completes its own independent experiments comparing different foods. FDA has, however, said that it may require that all foods containing genes from commonly allergenic foods be labeled as containing potential allergens. Federal agencies focus on the end product rather than on the process by which a product is made. The framework allows the federal agency to assess scientifically whether there is a risk from a GMO food product or any new food product to human health and the environment. 36 Recently, FDA began investigating the use of voluntary labeling for products that contain GMOs to ease tensions with trading partners, such as the European Union. 37

Defenders of the agencies' policies suggest that to date genetically modified foods are similar to non-GM0 foods and are easily regulated under the current policy structure. If they are substantially different, these foods must be regulated as if they were food additives and receive FDA approval before being marketed. They state that current GMOs are not a risk as no scientific evidence shows an effect on human or animal health. For instance, most plant toxins are acute toxins and are well known, and tests have been developed to quickly detect them. 38 So defenders argue that there are no proven long-term health consequences for humans. However, few long-term studies have been completed.

On May 27, 1998, FDA was sued by a group of concerned citizens over the agency's "traditional" policy on the sale of genetically modified foods (Alliance for Bio-Integrity v. Shalala, D.D.C., No. 1:98CV01300, May 27, 1998). The group claimed that FDA's refusal to require labeling and safety testing raises health and environmental concerns and makes it difficult to comply with religious dietary laws. The suit identified 36 genetically modified foods being consumed daily without the knowledge of U.S. consumers. The suit cites both the First Amendment's protection of religious freedom and the Religious Freedom Restoration Act of 1993, which requires that federal laws or regulations not impede the free exercise of religion. The plaintiffs say that FDA's policy failed to abide by the public notice and comment procedures of the Administrative Procedures Act, and allows genetically modified foods into the marketplace without being identified as such. The suit also claims that FDA's policy is a burden to consumers' abilities to follow religious dietary laws. The lawsuit challenges FDA's policy that genetically modified foods are considered safe unless they contain substances identified in the policy which are allergens or would change the character of the food. The plaintiffs want the agency to carry out the same testing and safety evaluations conducted for food additive petition approval because, they argue, changes that might occur as a result of genetic engineering might include unwanted, unpredictable new toxins and/or carcinogens, elevated levels of inherent toxins and/or carcinogens, and/or degradation of nutritional quality. In particular, they want FDA to require the labeling of these foods because the foods have been changed "materially" and allegedly violate the FFDCA. The suit states that "FDA is permitting unpredictable changes to the characteristics of certain foods which may be difficult for consumers to detect." 39 On August 7, 1998, FDA, through the Department of Justice, asked the U.S. District Court for the District of Columbia to dismiss this case because it felt that such charges are not unique to genetic engineering and the same changes occur in foods that have not been modified. Both sides were required to present their rebuttal briefs to the Court by April 30, 1999.

Environmental Issues

Proponents of bioengineered crops claim that genetic modification can be less harsh on the environment than other technologies. They suggest that fewer agricultural chemicals might be needed to grow pesticide tolerant or insect resistant crops and that land would need less repeated tilling, which could lead to less erosion and soil infertility. 40 Supporters of genetic modification think that new developments contribute to environmentally sustainable development and greater food production. While they believe government regulatory efforts adequately ensure consumer and environmental health, they are aware of growing consumer concerns and some want to increase transparency of the regulatory and development process.

Critics have expressed strong concerns about the long-term risks and consequences of cross-pollination and of the disruption to the "cellular ecology" of plants. They state that the U.S. policy is based on the assumption of safety but there is little research on ecological or food safety risks. Scientists have shown that genetically modified rapeseed (canola) pollen was spread to wild radish weed relatives in nearby fields. The experiment demonstrated that it was possible to create new strains of weeds resistant to herbicides. 41 If such weeds emerged widely, farmers would need new, different, or stronger herbicides to counter their spread. Such super weeds could severely decrease crop productivity. Furthermore, some scientists have expressed concern that the widespread use of genetically engineered plants could alter the ecology of natural plant communities and of wildlife food chains. Certain seed and herbicide companies agree with these critics, their point of view shaped by the possibility of development of "super weeds," rendering their products useless. 42

 Bt Resistance and Intervention Strategies. Concerns revolve around plants engineered to produce within their cells an insecticide called Bt that is produced naturally by strains of the bacterium Bacillus thuringiensis. The release of a recent study that showed in a laboratory that Bt corn pollen when eaten by Monarch butterfly larvae kill or stunt their growth has engendered public concern.43 Another concern is that large scale planting of crops containing Bt might lead to faster resistance development by insects. Critics of this technology state that large-scale production of engineered corn, soybeans and other foods will cause pests to develop resistance to Bt, thereby limiting its usefulness. It is not unusual for insects to develop resistance to pesticides that have been used for long periods of time. Organic farmers, in particular, are concerned because they do not have as many crop protection tools available as conventional farmers, and the loss of effectiveness of Bt could be a serious blow to their production. Due to these concerns, on February 18, 1999, Greenpeace, the Center for Food Safety, and some organic farmers sued EPA over its registrations of plant-pesticides.44 The suit calls on EPA to cancel all existing registrations for Bt crops, to cease the approval process for any new registrations, and to perform an environmental impact assessment analyzing the cumulative impacts from the current registrations.

Prior to these complaints, EPA determined that resistance to Bt can be slowed by requiring farmers to plant significant numbers of non-Bt seeds near the genetically modified resistant plants in designated separate areas called "refuges." The non-Bt plants allow pests to grow that will not develop Bt resistance. Since these pests will interbreed with their counterparts that eat Bt plants, there is less likelihood that a resistant super-pest could develop. If the "refuge" system is used by farmers, EPA estimates that the eventual development of resistance to Bt by insect pests could be extended 10 or more years.45

EPA now requires the use of insect resistance management (IRM) plans for some crops. EPA originally granted all the plant-pesticides conditional registrations. With the registrations for corn and cotton to expire in 2001, as a condition of reregistration, companies will be required to develop effective IRM plans for these crops. Once the re-registration applications are submitted, EPA will evaluate the information and could impose new conditions. Critics of the technology want mandatory IRM plans, for they claim that if the plans are voluntary, farmers will either not plant the nonresistant refuges or plant refuges that are too small to be effective.46

There is a voluntary IRM plan in place for potatoes, as recommended by a 1995 scientific advisory panel, and Monsanto is requiring compliance by growers who contract with it for the seeds. 47 Ongoing evaluation of IRM may result in additional mandatory requirements.

EPA's Proposed Plant-Pesticide Regulation. Opposition to EPA's November 1994 proposed rule on "plant-pesticides" was evident at two House Agriculture subcommittee hearings on March 3 and March 24, 1999. Opponents are primarily concerned that the proposed rule is not based on scientific evidence and is too broad in scope for it defines all plants as "plant-pesticides" and then exempts from the rule, those plants that are not genetically engineered.

Critics contend that the regulation is not scientifically defensible because EPA defines both the pesticidal substance and "the genetic material necessary for production of the substance," as a plant-pesticide. Although genetic material may lead to the production of a pesticidal substance within the plant, critics advise that genetic material, in and of itself, does not have pesticidal properties. They are concerned that the inclusion of "genetic material" in the plant-pesticide definition sets a precedent that will lead to unnecessary and burdensome regulatory activities.

Others contend that the proposed rule, if finalized as currently written, would regulate plants based upon the process used to develop them (genetic engineering) rather than on the pesticidal substance contained within the plant. Regulating the process rather than the product appears to depart from policies followed previously by FDA and USDA. The proposal is also strongly opposed by 11 scientific professional societies because they want EPA to regulate only those plants whose safety to humans in food is questionable. 48 They state that the rule is an unneeded regulatory burden that will dampen the entrepreneurial spirit that is the basis for the agricultural biotechnology revolution.

EPA and critics agree, however, that toxic anti-pest substances produced by plants used for food must be proven safe. EPA points to an example of potato leaves that naturally contain a pesticidal substance that could cause birth defects. Since humans do not eat potato leaves, there is no need to regulate the substance; however, if spinach were genetically modified to contain the potato-leaf toxin, regulation would be needed.

Another perception of the rule is that the term "plant-pesticide" has a negative connotation. This negative label may be particulary irksome to U. S. trading partners whose consumers are already wary of this new technology. Even EPA is seeking another label for "plant pesticides." The term "plant-expressed protectant" has been suggested as an alternative label. A comment period for a new name/label was open until May 24, 1999, and submitted comments are now being reviewed by the agency.

Liability. There is also concern about liability. Who would pay if other crops or fields were ruined because of cross-pollination with these new seeds? An opponent of biotechnology, Jeremy Riffin, says, "The insurance industry has quietly let it be known that it would not insure the release of genetically engineered organisms into the environment against the possibility of widespread environmental damage, because the industry lacks a risk-assessment science - a predictive ecology - with which to judge the risk of any given introduction." 49 According to Dr. L. Val Giddings, Vice President for Food and Agriculture, Biotechnology Industry Organization, the industry representatives directly dispute this claim, and say there is insurance available.

Economic Concerns

Critics are concerned about the growing presence of large agricultural conglomerate companies controlling the supply of seeds containing bioengineered traits. Growers' profits from bioengineered crops more than tripled from 1996 to 1997. 50 In 1996, U.S. farmers had planted mostly Bt cotton, Bt corn, and herbicide tolerant soybeans. In 1997, they expanded acreage for those crops and added herbicide tolerant cotton and potatoes. 51 It is likely that planted acreage will continue to increase. Adoption rates vary by year, crop product, and location, and they will depend on the level of infestation of a targeted pest. They also depend on world commodity prices. Supporters of this technology cite convenience and lower costs as the main reasons for high farmer adoption rates. 52 But critics complain about the consolidation of patent ownership of this new technology which they believe constitutes monopolistic power in the marketplace. Their distrust is based in part on concern about the dependency such concentration brings to the agricultural sector and the possible abuse from such control.

The reasons for this concern vary. The concentration of control of patents in agricultural biotechnology raises concerns for some farmers and consumers that multinational corporations want to simplify the regulatory processes of governments to gain easier approval for their products without adequate review. Because so much of the technology is held by private companies, some regulators and researchers are concerned about how difficult it can be to obtain necessary information for appropriate regulation.

Others are concerned that large companies can conduct field experiments, sell seeds to farmers, and market genetically engineered products without appropriate attention to tests for the safety of consumers and the environment. Critics want more testing before farmers expand their planted acreage. There is uncertainty about how much testing is required, whether it should focus on the new genes themselves or on the substances they produce in the plant. Federal agencies can ensure adequate safety testing of biotechnology products by requiring companies to review impacts or by conducting tests for themselves. A witness before the House Agriculture Committee hearing on March 3, 1999, stated that the key to public confidence is making analyzes of these tests publically available. However, this witness added that there are far fewer analyzes available because Congress failed to appropriate funding for APHIS's Office of Biotechnology since 1996. 53

Private monopolistic power is a concern. Seed companies have long sought to control their product by limiting farmers from saving seeds for future planting. Enforcing such prohibitions has been difficult. A new invention can make enforcement easier. On March 3, 1998, a U.S. patent was granted to the Delta and Pine Land Company and the Agricultural Research Service of USDA for a method of genetically engineering plants to produce sterile seed. 54 This technology, called the "technology protection system," was subsequently dubbed the "terminator" gene technology by opponents. It has since received wide publicity. The terminator gene is likely to be bred into many GMO seeds by 2005. Some question whether the future availability of seed genetically modified to contain "terminator genes" could interfere with agricultural practices of many farmers from developing countries who save seed from one year to the next. Critics, however, see these new products as the means by which developing country farmers will become dependent on multinational corporations and be driven further into poverty without resources to purchase new seed each year. 55 Supporters of bioengineered seed point out that hybrid seeds, used since the 1960s "green revolution," also require farmers to purchase new seeds each year. In addition, supporters claim that the production of sterile-seed products lessens the opportunity for outcrossing of engineered pollen into wild relatives and prevents "super weeds." Others doubt that newly developed technologies such as the "terminator gene" will significantly affect agricultural practices in developing countries, since most of those economies cannot support an investment in those seeds anyway. 56

There also appears to be concern about how much control companies wield over research in food and agricultural biotechnology. Companies hold patents and own specific germplasm 57 and research techniques needed for plant research. Some companies claim partial ownership of a food product created using their patented technologies. Biotechnology researchers have raised concerns that some private company scientists are not permitted to share innovations in research.

Most food biotechnology research is financed with private, not public money, and the total amount spent is confidential. One newspaper reported that Monsanto estimates that research and development time and costs to create a commercial product are about 10 years and about $300 million. For every genetically engineered seed that goes to field trials, 10,000 have failed along the way. 58 Corporations charge steep prices for this technology, claiming the need to recoup their investment to be able to research the third and fourth wave of products.

Most identifiable public funding for food biotechnology research is for plant genome research being sponsored by the U.S. Department of Agriculture (USDA). Federal funding for USDA's biotechnology research grew 7% between FY1998 and FY1999; the Clinton Administration has requested an 11% increase for FY2000. The Administration does not track federal food and agricultural biotechnology funding of research as a fine item in federal budget analyses. Consequently, the total amount of public funding for this research is unclear. 59

Public research funding under the authority of the Bayh-Dole Act of 1985 60 allows universities receiving grants for plant genomics research to hold the intellectual property rights for any useful discoveries. The Act has accelerated the linkages between university research and the creation of consumer products and contributed to the international competitiveness of U. S. industries. It has also encouraged research on minor-use crops.

International Trade Issues

At the present time, the United States is leading the world in biotechnological research, development of genetically modified organisms (GMO), and sales of the technology worldwide. The United States has no immediate challengers to this trading position. Some trade experts suggest that trading partners whose policies strongly reflect consumer concerns about the new technology are merely attempting to allow their own domestic industry time to develop a competitive position in this trade. For example, the European Union (EU) has now required that all GMOs be labeled as such. The United States, however, claims that there is no scientific basis to presuppose that genetically modified food products are more risky or substantially different from other products. U.S. officials believe that decisions on trade should be science-based and U.S. regulatory policy reflects this thinking. Such competition for leadership in biotechnology has influenced trade relationships among U.S. trading partners. It was reflected in the failed negotiations over an international biosafety protocol, and in trade relationships between the United States and the EU, Canada, Japan, and other countries.

Biosafety Protocol. On June 4, 1993, President Clinton signed the Convention on Biological Diversity, an international agreement negotiated at the 1992 Earth Summit in Rio de Janeiro under the auspices of the United Nations. This diversity agreement, ratified so far by 174 countries but not by the United States, calls for protecting a variety of plants and animals found in the wild. A second meeting in Indonesia in November 1995, at the Conference of the Parties to the Convention on Biological Diversity (COP-2), countries agreed to fund negotiations for a "biosafety protocol."

In February 1999, at the sixth and final meeting of the negotiating group in Cartegena, Colombia, representatives of the participating countries failed to reach a consensus on a protocol that had the objective of "furthering the safe transfer, handling, and use, especially in trans-boundary instances, of living modified organisms (LMOs) resulting from modern biotechnology that may have adverse effects on human health, animal health, the environment, biological diversity, conservation and sustainable use of biological diversity, and the socioeconomic welfare of societies." 61

At the center of the debate over this protocol was the definition of an LMO product and whether importers could force prior consent agreements and other documentation onto exporters as is currently done for hazardous chemicals and pesticides. The hazardous chemical consent accord applies narrowly to a set of industrial chemicals and pesticides that are associated with clearly defined risks. Industrialized countries do not believe that LMOs represent the same types of risks, and they believe requiring an "advance informed agreement" (AIA) would create unnecessary paperwork that could obstruct trade. They believe that the protocol should cover only LMOs that have been shown to cause risks to health and the environment, not all bioengineered products. There also was concern over whether countries would be able to regulate the labeling and packaging of bioengineered products according to their own laws, or whether the protocol would affect the rights and obligations of trading countries party to other international agreements. Some countries also want to know which party might be responsible for damages to health and the environment caused by transgenic products sold to developing countries.

U.S. food industry groups are concerned about the negative impact that domestic regulations and AIAs would have on trade. In a December 1998 letter to the President, U.S. food industry groups expressed concern over the extent of barriers that the biosafety protocol would bring, i.e., shipping delays due to the protocol's notification and approval requirements; complex, lengthy, and costly risk assessments for foods, beverages, and consumer products prior to import approval; a myriad of documentation and potential labeling mandates; and unnecessary delays in meeting global food needs. 62

The U.S. government has been supportive of a protocol that mitigates actual risks to the environment associated with LMOs. Although it participated fully in the discussions, the United States had limited influence on the negotiations because the Senate had not ratified the 1992 biodiversity convention. The United States held " observer status" only, with no voting rights, at the Cartegena meeting. However, many U.S. government officials present at the negotiations worked with representatives from Argentina, Australia, Canada, Chile, and Uruguay to propose that provisions of the protocol should apply only in two instances: (1) when an LMO is imported to be field tested; and (2) when the LMO is banned domestically or severely restricted in the country of export. Other questions had arisen over whether the agreed-to protocol would have restricted trade with other non-member countries, including the United States; whether it would have compromised other trade agreements like the North American Free Trade Agreement or those administered by the World Trade Organization; or whether advanced informed agreements would apply only to the first shipment of a particular LMO or to every shipment.

Negotiations also were stymied when there was no consensus on how to handle potential liability and compensation if LMOs caused human or environmental or socioeconomic harm. Some proposed that a liability scheme could have included a requirement of importing or exporting companies to be bonded. Others wanted to see the creation of an international liability fund, but the decisions on liability were postponed for four years.

Trade Relations with the European Union (EU). 63 Europe has been much more hesitant than the United States to accept genetically modified crops, particularly for planting and use in processed products. Consumer distaste for consumption of the products, environmental reaction to feared modifications, farmer resistance to planting GMO seeds because of uncertainty regarding their markets, and a lack of investment capital for developing new products are some of the reasons why there are trade problems with the United States.

Most EU consumer groups support recent EU regulations that require labeling of genetically modified food and food products. These groups have a strongly held belief that consumers have a right to know how their food is produced and question the long-term safety of consuming genetically engineered foods. Observers have commented that the poor handling by government officials of the "mad cow disease" crisis, caused by consumption of beef infected with bovine spongiform encephalopathy (BSE), left residual doubts about the truthfulness of governments' assurance of the safety of GMO foods. These concerns and the response to them from individual governments have become a major trade issue between the United States and the EU.

Five EU directives and regulations govern the development, production, release, and marketing of genetically modified plants, animals, and foods (see text box above). At each stage in the development of a food, EU member countries' governments and advisory committees assess and register GMOs. Before a crop can be field tested, released or marketed, either a license or consent must be obtained from a member government, after officials and advisors have a chance to review a risk assessment of the product. The assessment must show that any negative effects are not greater than effects from conventional crops. All long-term effects on the environment and ecology need to be monitored. The products must then be labeled.

The United States has repeatedly criticized the EU regarding its directives requiring labeling and considers them barriers to trade. U.S. officials claim that science has shown no evidence that food products made from GMOs approved for cultivation are a threat to human, animal, or plant health. They argue that these products should not have to carry information that they are GMOs on the food label or in the ingredient list. One difficulty with labeling requirements is the additional cost associated with segregating GMO products from non GMO products and labeling them accordingly. Part of this cost arises when companies that process products with GMO materials must generate reference information against which food products can be tested. Each product might require PCR (polymerase chain reaction) testing, a common but complex laboratory technique used to detect genes modified by rDNA methods. 64 At times these tests can reveal proprietary information, thereby placing a company at a competitive disadvantage through disclosure of protected intellectual property. The EU counters that these labeling rules and tests are needed to address consumer concerns about biotechnology and are based on the "principle of precaution" that should prevail over authorization of all new foodstuffs. The EU may establish a threshold (possibly 3% of content) for the permissible level of genetically modified ingredients in foods from farm to plate. 65 U.S. officials have argued against this position before the World Trade Organization's Committee on Technical Barriers to Trade and elsewhere.

Several EU countries continue to block entry of GMO products based on concerns for their environment and consumer safety. Austria and Luxembourg have essentially refused to permit one product into their countries - Novartis corn. In mid October 1998, the EU's Scientific Committee on Plants refused to approve a genetically modified high-starch potato developed by a Dutch firm.

The United Kingdom (UK) wants mandatory monitoring of the effects of GMO products after marketing approval is granted to determine whether the product is safe for health and the environment. 66 On May 21, 1999, after showing confidence for this existing case-by-case assessment system and reviewing several reports, a U.K. Ministerial Group on Biotechnology and Genetic Modification recommended that two officially appointed commissions work alongside the Food Standards Agency to monitor and fund research on biotechnology, establish a national surveillance unit for monitoring health aspects of GMOs and other novel foods, and institute a more transparent system with guidelines for the cultivation of GMO crops. UK retail stores already carry over 750 processed foods that have labels indicating that they contain genetically engineered products. Data indicate that sales of genetically engineered products, in spite of boycotts, are no different than sales of traditional products.

Some critics have suggested that there are several different problems with the EU acceptance of GMO products. Economically, the EU was slow in investing in food biotechnology, and is currently at a competitive disadvantage with the U.S. industry. However, with a lack of transparency and predictability in the EU approval system, U.S. firms have had difficulty in expanding into EU markets. During the lengthy period necessary to gain approvals, the EU has begun to develop its own biotech industry. Others suggest that obstacles to EU acceptance of food biotechnology are based on several business conditions in the EU: a shortage of venture capital, extended lags in developing new products, a small demand for GMO products, and a lack of complementary skills, assets, and technologies necessary to commercialize new products. Since no consensus has developed within the EU over a common biotechnology policy, few wanted to risk development of food products which might not be allowed in the market place. National priorities of Member States make it difficult to share knowledge with other states. The EU Commission has tried to create a transnational technology community but individual states within the EU have sovereignty over this policy. So the Commission has adopted a case-by-case approach to environmental release with requirements to notify Member States of evidence that the classification and containment measures have worked.

U.S. companies also complain about the slow EU process for approving imports of genetically modified products. For example, the EU so far has approved 4 of 11 GMO corn varieties for import. With postponement rather than rejection of GMO applications, the United States cannot formally protest under the World Trade Organizations (WTO) rules because the EU has not taken any official action against these imports.

Trade Relations with Canada. Canada is the top trading partner of the United States, and both are partners along with Mexico in the 1994 North American Free Trade Agreement. Canada and the United States often have similar positions on world trade issues. Canada joined Argentina, Australia, Chile, and Uruguay in supporting the U.S. negotiating position on the Biosafety Protocol. The United States clearly did not want exports of genetically modified soybeans and corn to need advance permission from the importing country to ship those commodities.

The United States and Canada, in ongoing bilateral talks, are discussing issues related to the regulation of GMOs. At a July 1998 meeting, representatives of the Canadian Food Inspection Agency, Health Canada, and the USDA's APFUS met to discuss the harmonization of regulatory requirements for approval of transgenic plants within the two countries. Participants agreed to joint review sessions and exchanges of information. The next scheduled meeting is to be in June 1999.

Trade Relations with Japan. In 1996 Japan began importing genetically engineered products and currently imports six crop categories from the United States: herbicide tolerant soybeans and rape seed; pest-resistant potatoes, corn, and cotton; and delayed ripening tomatoes. U. S. companies hope to increase sales to Japan; however, a consumer movement has raised questions over GMOs product safety. In parts of Japan, such as in Kanagawa Prefecture's city of Fujisawa, the use of genetically manipulated foodstuffs in school lunches has been banned because of concerns over the effects of long-term consumption on human health. 67 The Japanese government has proposed labeling regulations for all genetically modified products. So far, no action has been taken on the proposal.

 International Harmonization. The United Nations has discussed, for many years, the transfer and safety of GMOs. Efforts by the United Nations Environmental Program (UNEP) produced a set of technical guidelines for the release of GMOs entitled, International Technical Guidelines for Safety in Biotechnology. These guidelines and the voluntary code of conduct created by the United Nations Industrial and Development Organization (UNIDO) have all contributed to international discussions on how rules should be harmonized. The most consistent focus on these issues has been in the Organization for Economic Cooperation and Development (OECD), which established a working group in the early 1980s to harmonize the technical rules for trade in products produced with GMOs.

In other international fora, the Codex Alimentarius Commission (Codex) working group on food labeling is considering draft recommendations for labeling of foods developed through biotechnology. Since 1984, one of Codex's sponsoring organizations, the United Nations Food and Agriculture Organization (FAO), has established various guidelines for developing countries for the transfer of technology and trade. It has also provided member countries with guidance on biosafety regulations, risk assessments of biotechnology products, and mechanisms and instruments for monitoring use and compliance to ensure that there will be no harmful effects on the environment or people. The next round of multilateral trade negotiations on agriculture in the World Trade Organization (WTO), expected to begin in 1999, may debate transparency in the rules that govern trade in genetically modified foods.

The Transatlantic Economic Partnership, an EU-United States business and government group, created an action plan in November 1998 that would allow the two trading partners to consult and negotiate on specific issues. For biotechnology, the EU and the United States have established a group to monitor the dialogue on various technical issues that may affect trade carried out in existing groups. The group may consider a pilot project to see if the United States and EU scientific assessments could be used in trading partner countries. The group will also seek to increase scientific and regulatory cooperation, and promote transparency and information exchange for consumers.

Concluding Remarks

Recombinant DNA technology is producing revolutionary changes in agriculture. Supporters of this technology emphasize the potential benefits from these changes including the promise of higher yields and nutritionally enhanced foods from genetically modified commodities with reduced environmental impact. Opponents of the use of rDNA technology in agriculture are concerned about possible hazards to human, animal, and environmental health. They advocate more safety testing and labeling of products. Many are concerned about the possible consolidation and control of agricultural biotechnology by a handful of multinational corporations.

Since the technology potentially can provide greater yields, farmers are rapidly planting genetically modified seeds. As the U.S. experience with this new technology grows, it may become necessary to amend regulatory policies to protect public safety and the environment while allowing genetically modified crop development to progress. The agencies involved in regulating genetically modified foods (FDA, APFHS, and EPA) are implementing policies based upon a 1986 framework document that coordinates their regulatory activities for biotechnology products. This framework applies the same set of regulations to all food products and does not differentiate between foods that are produced with rDNA technologies and those that are produced by traditional methods.

U.S. businesses dominate the food biotechnology industry worldwide. Such domination has contributed to problems with certain trading partners. For example, the EU lacks a transparent and predictable regulatory system for its genetically engineered products. Without such a system in place, policy issues relating to modified foods have become contentious between the trading partners. Congress continues to closely monitor these events. 

 FOOTNOTES

1.  J. Grosser and F. Gmitter, "Protoplast Fusion And Citrus Improvement," Plant Breeding Reviews, (Ed., J. Janick). v. 8, Chap. 10, (Timer Press: Portland, OR., 1990).

2. The term "pesticide" is the general category of substances that are toxic to pests; herbicides, insecticides, and rodenticides are all pesticides.

3. James Clive. "Global Review of Commercialized Transgenic Crops." International Service for the Acquisition of Agri-biotech Applications Briefs, no. 8, 1998, ISAAA: Ithaca, NY.

4. Statistics come from the following sources: Terri Dunahay, Economic Research Service, January 20, 1999; A.S. Moffat, "Toting up the Early Harvest of Transgenic Plants," Science v. 282: p. 2176-2178; M. Pollan, "Playing God in the Garden," New York Times Magazine, October 25, 1998, p. 44-51, 62-63, 92-93; R. Ortiz, "Critical Role of Plant Biotechnology for the Genetic Improvement of Food Crops: Perspectives for the New Millennium," Electronic Journal of Biotechnology (on the web, [www.ejb.com]), v. 1, no. 3, December 15, 1998; J. Bernice, "Medicine Man," Farm Journal, mid-January 1998, p. 22; Genetic Engineering News, February 1, 1999: "Cancer Vaccine Made in a Plant-based System", p. I were collected from: Science (1998), v. 282, p. 2176; Michael Pollan, NY Times Magazine, October 1998; R. Ortiz, Electronic J Biotechnology (on the -web, [www.ejb.com]), v. 1, no. 3, December 15, 1998; S.D. Moore, "Agro-chemical Rivalry Heats Up: AHP-Monsanto Pact Raises Pressure," The Wall Street Journal Europe, June 5-6, 1998, p. 10.

5. Wilmut I., A. E. Schnicke, J. McWhir, AJ. Kind, and K.H.S. Campbell. "Viable Offspning Derived from Fetal and Adult Mammalian Cells." Nature, v. 385, February 1997: p. 810-813.

6. Dennis Normile. "Bid for Better Beef Gives Japan a Leg Up on Cattle." Science, December 11, 1998, p. 1975-1976.

7. Craig Charles. 'Near-term Benefits of Cloning Likely To Be Medical."Washington Post, March 29, 1997.

8. BIO: Website of the Biotechnology Industry Organization, Washington DC. [www.bio.org/library/foodrep8.html].

9. FDA classifies food additives into four categories: GRAS additives (gencrally-recognized-as-safe) are exempt from regulation because their extensive use has produced no known harmful effects; direct additives are intentionally added to foods; prior-sanctioned substances are substances which were approved by FDA or USDA before the passage of the 1958 food additives amendment to the FFDCA (Section 409, 21 U.S.C. 348); and indirect additives, sometimes called food contact substances, are often trace substances that leach from packaging materials and migrate to food during processing or storage.

10. BIO:Website of the Biotechnology Industry Organization, Washington, D.C. [www.bio.org/whatis/ foodwclcome.html].11 Carol 0. Tacket, "Vaccines from Edible Plants," paper presented at the 1998 FDA Science Forum, Biotechnology: Advances, Applications and Regulatory Challenges, Washington, December 8, 1998.

11. Carol O. Tacket, :Vaccines from Edible Plants," paper presented at the 1998 FDA Science Forum, Biotechnology: Advances, Applications and Regulatory Challenges, Washington, D.C. [www.bio.org/whatis/foodwelcome.html].

12. Foundation on Economic Trends v. Heckler, 587 F. Supp 753 (D.C. 1984) 756 F.2d 143 (D.C. 1985).

13. U.S. Congress. Office of Technology Assessment. New Developments in Biotechnology - Field Testing Engineered Organisms, Genetic and Ecological Issues, no. 3, OTA-BA-350 (Washington, DC, May 1988) p. 60.

14. EPA defines "plant-pesticides" as a "pesticidal substance that is intended to be produced and used in a living plant, or in the product thereof, and the genetic material necessary for the production of such a pesticidal substance." The DNA is not itself a pesticide. The plant uses the DNA to produce a pesticidal substance which is toxic to pests.

15. Affirmation petitions for "generally-recognized-as-safe" (GRAS) status must be filed to gain FDA's formal agreement with a sponsor's independent determination that a substance is GRAS. FDA considers that bioengincered substances intentionally added to food arc food additives. FDA must review and approve any food additives that do not have GRAS status before foods containing new additives can be introduced onto the market.

16. Some are also concerned that consurning a food containing the antibiotic resistance gene at the same time as an antibiotic could compromise the efficiency of the antibiotic. Margaret Mellon, Union of Concerned Scientists, conversations with the authors, March 8, 1999. Other scientists consider this a minor risk due to the degradation of genes in food by stomach acids.

17. 7 CFR 340, et seq.

18. U.S. Congress. Office of Technology Assessment. New Developments in Biotechnology - Field Testing Engineered Organisms, Genetic and Ecological Issues, no. 3, OTA-BA-350 (Washington, DC, May 1988): chapter 3.

19. At the FDA Science Forum on December 9, 1998, Dr. Steve Sundlof of the Food and Drug Administration stated that appropriate disposition of transgenic animals is becoming a concern as their numbers increase. He recommended that companies needing to dispose of carcasses consult with Center for Veterinary Medicine.

20. EPA has proposed new nomenclature in the Federal Register, "Plant-Pesticides, Proposed Rule, Supplemental Notice of Availability of Information," April 23, 1999 (V. 64, No.78) to amend 40 CFR parts 152, 174 and 180.

21. International Life Sciences Institute, Health and Environmental Sciences Institute, An Evaluation of Insect Resistance Management in Bt Field Corn: A Science-Based Framework for Risk Assessment and Risk Management, Washington, D.C. 1998.

22. Section 408 of the FFDCA as amended by the Food Quality Protection Act of 1996.

23. 40 CFR 180.1155. The plant-pesticides registered so far contain Bacillus thuringiensis, listed in Table 2, and have exemptions from the tolerance requirements.

24. 40 CFR 152.20

25. An example of a plant-pesticide acting to affect the plant would be the modification of hairs on tomato plants to inhibit aphids from feeding on the plant.

26. In August 1998, Dr. Arpad Pusztai, a scientist from the United Kingdom, told a television team that a potato that he had genetically engineered to contain a lectin (a naturally occurring insect resistant protein) had led to harmful health effects in rats. (The 10-day feeding trials showed rats with weakened kidney, thymus, spleen, stomach wall, and immune system damage. The rats' brain size decreased.) Hs research was disowned by the institute for which he worked and he was forced to resign. On February 16, 1999, The Guardian reported that 21 scientists who reviewed the data from the experiments found it credible and protested this treatment. Michael Sean Gillard, Laurie Flynn, and Andy Rowell, "Food Scandal Exposed," The Guardian, February 12, 1999, p. 1. Other scientists think that the quality of the potatoes fed to the rats may not have been consistently monitored and may itself have caused these problems ("Seeds of Discontent," The Economist, February 20, 1999, p. 75-77.)

27. FDA typically uses data generated by individual companies to make regulatory decisions for food additives, drugs, medical devices, and biologics.

28. H. Lehman and J.F. Hurnik, "Concerns about the Ethics of Genetic Modification." Paper presented at the Fifth World Congress on Genetics Applied to Livestock Production, August 7-12, 1994. Proceedings, v. 20, as found at [http://www.oac.uoguelph.ca/www/CRSC/faculty/eac/Ichman.htm]

29. Paul B. Thompson, "Food Biotechnology's Challenge to Cultural Integrity and Individual Consent," Hastings Center Report, 27, no. 4 (July-August 1997), p. 34-38.

30. Overseas Development Institute, The Debate on Genetically Modified Organisms: Relevance for the South, Briefing Paper (London, U.K.: Overseas Development Institute, January 1999), [www.oneworld.org/odi/].

31. Eric Flamm, Office of Policy, Food and Drug Administration, conversation , conversation with authors, January 28 , 1999. Mr. Flamm also said that the arguments about religious freedom issues are theoretical so far because there are no products on the market that insert genes from animals into plant species.

32. Joe Regenstein, Professor of Food Science, Cornell University, conversation with the authors, February 12, 1999.

33. Chaudry, N.M. and J.M. Regenstein, "Implications of Biotechnology and Genetic Engineering for Kosher and Halal Foods," Trends in Food Science Technology, v.5, 1994, p, 165-168.

34. Some have suggested that the industry use USDA's organic food labeling regulations, currently under development, as one way of telling consumers that foods are free of biotechnology products. Comment by Alan Goldhammer, scientific director of BIO, February 8, 1999.

35. Jane Kolodinsky, Qingbin Wang, and David Conner, "rBST Labeling and Notification: Lessons from Vermont," Choices, third quarter 1998, p. 3840. U.S. Court of Appeals for the Second Circuit. No. 876 August Term, 1995, (Argued: November 2, 1995 Decided: August 8, 1996) Docket No. 95-7819.

36. The agencies have authority under existing laws to regulate these new products in the same manner as those developed through traditional agricultural and food processing. Food companies have not been required to disclose their method of development on the label. For example, sweet corn does not need to be labeled "hybrid sweet com" because it -was developed through cross-hybridization. Nor did FDA require special labeling for the Flavr Savr tomato, because the new tomato is not significantly different from conventional tomatoes. If a new food contains a protein derived from a food that commonly causes allergic reactions, and the developer cannot demonstrate that the protein is not an allergen, labeling is mandatory to alert sensitive consumers, because they would not expect to be allergic to the food.

37. TDA Eyes Voluntary Label as Middle Ground in GMO Food Dispute," FDA Week, March 26,1999: p.3.

38. International Food Biotechnology Council, "Biotechnologies and Food: Assuring the Safety of Foods Produced by Genetic Modifications," Regulatory Toxicology and Pharmacology, 12, 1990, p. S1-S196.

39. Adrienne Dern, "Justice Department asks court to dismiss lawsuit challenging FDA��s policy on genetically engineered foods," Food Chemical News, August 31, 1998. P. 10-13.

40. John J. Doyle and Gabrielle J. Persley, eds., Enabling the Safe Use of Biotechnology: PriInciples and Practice, Environmentally Sustainable Development Studies and Monograph Series No. 10 (Washington, D.C.: The World Bank, 1996), p. 7. Also several biotechnology companies modified corn to contain Bt, to kill the corn borer and other pests. The corn borer causes huge losses. Corn with Bt had a 7% increase in yield per acre, bringing the farmer, on average, an increased net return per acre of $16.88. Anne Simon Moffat, "Toting Up the Early Harvest of Transgenic Plants," Science, v. 282, December 18, 1998, p. 2176-2178.

41. Martin Brookes, "Running Wild," New Scientist, v. 160, no. 2158, October 31, 1998, p. 38-41.

42. Critics also worry about altered organisms causing unpredictable and costly environmental damage over extended eco-ranges for sustained periods, and point to the cases of Dutch Elm disease, myxomatosis, and gypsy moths to illustrate their point of organisms spreading uncontrollably . Supporters claim that these invaders -were not disease-causing GMOs, but were unpredicted consequences of unplanned introductions into new environments. Given multiple ecological problems related to farming practices such as nutrient runoff, for which there are no liability claims, it seems inappropriate to supporters that GMOs are lumped into these arguments. Critics suggest, however-, that because genetically modified plant-pesticides may be unsafe, their release into the environment is irreversible and unpredicted consequences may be hard to mediate. U.S. Congress, Office of Technology Assessment, New Developments in Biotechnology - Field Testing Engineered Organisms, Genetic and Ecological Issues, no. 3, OTA-BA-350 (Washington, DC, May 1988) chapter 5.

43. Carol Kaesuk Yoon, "Altered Corn May Impend Butterfly, Researchers Say," New York Times, Thursday, May 20, 1999: p. A I and A20.

44. See wcbsite: [www.icta.org/legal/bt2.htm]

45. Environmental Protection Agency. Scientific Advisory Panel on Bacillus thuringiensis (Bt) Plant-Pesticides. Transmittal of the final report of the FIFRA Scientific Advisory Panel on Bacillus thuringiensis (Bt) Plant-Pesticides and Resistance Management, Meeting held on February 9-10, 1998. (Docket Number: OPPTS-00231).

46. As part of the ongoing discussions with EPA and USDA, major see developers (accounting for more than 90% of the U.S. Bt seed corn market) have proposed that by the year 2000, they will require growers in contracts to plant 20% to 50% of their acreage in non-genetically engineered varieties. The agreement among the seed companies call for a 20% refuge requirement in primary cotton-growing areas, with the minimum rising to 50% where Bt corn is grown in proximity to Bt cotton. "Industry Plan for Bt Resistance Management Gets Mixed Reaction," Food Regulation Weekly, v. 18, January, 1999, p. 3-5. EPA is considering this proposal among its other options for implementation of IRM requirements. In the spring of 1999, EPA and USDA are planning a joint workshop to examine existing Bt crop IRM, including methods, implementation, grower��s incentives, remedial actions if insect resistance is discovered, and compliance and enforcement issues. They are also interested in supporting the development and implementation of 6 to 10 USDA Regional Pest Management Centers.

47. Website: [http://www.monsanto.com/ag/asp/Monsanto.asp?MKTID=9999&PDTID=O] contains a statement "We require every grower who decides to plant YieldGard corn to sign an agreement to establish a refuge adjacent to his or her YieldGard acreage to ensure a population of susceptible corn borers to mate with any naturally resistant borers that survive exposure to the Bt."

48. "Appropriate Oversight for Plants with Inherited Traits for Resistance to Pests," A Report from 11 Professional Scientific Societies, Coordinating Society: Institute of Food Technologists, July 1996. [http://ift.micronexx.com/sc/stat_tes/G-061.html?L+mystore+].

49. Jeremy Rifkin, "Genesis 11; Commercial Prospects of Genetic Engineering and Biotechnology," Across the Board, Conference Board, Inc., v. 35, no.6, June 1998, p. 29.

50. Roger N. Bcachy, Statement Presented to the House Committee on Agriculture, Subcommittee on Risk Management, Research and Specialty Crops, on behalf of the Council for Agricultural Science and Technology, March 3, 1999.

51. Clive James, "Global Review of Commercialized Transgenic Crops: 1998," International Service for the Acquisition ofAgri-Biotech Applications Briefs, no. 8, ISAAA: Ithaca, NY; in 1997, profits totaled $315 million, up from $92 million in 1996.

52. Peter A. Riley and Linwood Hoffman, "U.S. Farmers Are Rapidly Adopting Biotech Crops," Agriculture Outlook, August 1998, p. 21-24.

53. House Committee on Agriculture, Subcommittee on Risk Management, Research, and Specialty Crops, Hearing to Discuss Agricultural Biotechnology, 106th Cong., 1st sess., March 3, 1999. Statement of L. Val Giddings, Vice President for Food and Agriculture, Biotechnology Industry Organization, Washington, D.C.

54. U.S. Patent No. 5,723,765.

55. Barnaby J. Feder, "Plant Sterility Research Inflames Debate on Biotechnology's Role in Farming," New York Times, April 19, 1999, p. A 18.

56. Jeffrey Kluger, "The Suicide Seeds," Time, February 1, 1999: p. 44-45; Monsanto Co. announced May 20, 1999 that it would not market the controversial new gene technology until the completion of studies that examine its environmental, economic and social effects. St. Louis Post-Dispatch; May 23, 1999, p. A5.

57. Germplasm refers to the basic genetic material of a species. There are germplasm "banks," for a variety of different life forms, where representative species are stored so that they can be reproduced for future studies that require their genetic material.

58. Rick Weiss, "Seeds of Discord," The Washington Post, Wednesday, February 3, 1999: p. A1 and A6.

59. Cliff Gabriiel, Deputy to the Associate Director of the Science Division, Office of Science and Technology Policy, The White House, conversations with the authors, February 23, 1999.

60. Bayh-Dole Act, P.L. 96-517, §6(a), December 12, 1980, 94 Stat. 3019 (35 §§200 to 212); P.L. 98-620, Title V,§501, November 8, 1984, 98 Stat. 3364 (35§§201 to 203, 206 to 208, 210, 212); P.L. 99-502, §9(c), October 20, 1986, 100 Stat. 1796 (35 § 210).

61. Stephen Joyce, "Biological Diversity, Treaty Parties Back More Integrated, Scientific Path To Conserving Ecosystems," International Environment Reporter, Wednesday, May 27, 1998, v. 2 1, no. I I (Washington, D.C., Bureau of National Affairs, 1998).

62. Joan Murphy, "Food groups warn of trade disruption from proposed biotech treaty," Food Chemical News, December 28, 1998, p. 9.

63. See CRS Report 98-861, US.-European Agricultural Trade: Food Safety and Biotechnology Issues, by Charles E. Hanrahan.

64. Other testing methods include near-infrared spectroscopy (NIRS), which measures light patterns to determine the quantity of a compound, or the enzyme-linked immunosorbent assay (ELISA) which analyzes for a specific antibody reaction that marks the presence of the expected protein (Temi Dunahay, "Testing May Facilitate Marketing of Value-Enhanced Crops," Agricultural Outlook, March 1999, p. 24-25).

65. Bernard Dixon, "The Paradoxes of Genetically Modified Foods," British Medical Journal v. 318, February 27, 1999, p. 547-548.

66. "Tough New GM Food Control Measures Planned in UK," Food Regulation Weekly, v. 2, no. 1, November 16, 1998, p. 19-20.

67. Shigeki Kitaiirna, "Bioengincered Foods on the Rise," Asahi News Service, March 25, 1998.

END