Seeds of Opportunity: An Assessment of the Benefits, Safety, and Oversight of Plant Genomics and Agricultural Biotechnology

Prepared By Chairman Nick Smith
U.S. House of Representatives
Committee on Science
April 13, 2000

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The Subcommittee on Basic Research of the Committee on Science held a series of three hearings entitled, "Plant Genome Research: From the Lab to the Field to the Market: Parts I-III," to examine plant genomics, its application to commercially-important crop plants, and the benefits, safety, and oversight of plant varieties produced using biotechnology. The testimony and other information presented at these hearings and information gathered at various briefings provides the basis for the findings and recommendations in this report.

Almost without exception, the crop plants in use today have been genetically modified. The development of new plant varieties through selective breeding has been improving agriculture and food production for thousands of years. In the 19th century, the basic principles of heredity were discovered by Gregor Mendel, whose studies on inheritance in garden peas laid the foundation for the modern science of genetics. Subsequent investigations advanced our understanding of the location, composition, and function of genes, and a critical breakthrough revolutionized the field in 1953, when James Watson and Francis Crick described the double helix structure of deoxyribonucleic acid (DNA), the substance of heredity. This groundbreaking research set the stage for deciphering the genetic code and led to the rapid advances in practical application of genetics in medicine, animal science, and agriculture.

The development of the science of genetics in the 20th century was a tremendously important factor in the plant breeding programs that have produced the remarkable diversity of fruits, vegetables, and grains that we enjoy today and that provide food security for the poor nations of the world. Traditional cross-breeding has been very useful in improving crop plants, but it is a time consuming process that results in the uncontrolled recombination of tens of thousands of genes, commonly producing unwanted traits that must be eliminated through successive rounds of backcrossing. Improving crops through traditional methods also is subject to severe limitations because of the constraints imposed by sexual compatibility, which limit the diversity of useful genetic material.

With the arrival of biotechnology, plant breeders are now able to develop novel varieties of plants with a level of precision and range unheard of just two decades ago. Using this technology, breeders can introduce selected, useful genes into a plant to express a specific, desirable trait in a significantly more controlled process than afforded by traditional breeding methods.

U.S. farmers have been quick to adopt plants modified using new biotechnology, including commercial crops that resist biologically insect and viral pests and tolerate broad-spectrum herbicides used to control weeds. As our knowledge of plant genetics expands, new varieties of plants with improved nutrition, taste, or other characteristics desired by consumers will become available. The federally-funded plant genome program provides much of the essential basic research on plant genetics required to develop new varieties of commercially important crops through advanced breeding programs.

For over two decades, the application of biotechnology has been assessed for safety. Oversight of agricultural biotechnology includes both regulatory and nonregulatory mechanisms that have been developed over the last five decades for all crop plants and conventional agricultural systems. Federal regulation of agricultural biotechnology is guided by the 1986 Coordinated Framework for Regulation of Biotechnology, which laid out the responsibilities for the different regulatory agencies, and the 1992 Statement on Scope, which established the principle that regulation should focus on the characteristics of the organism, not the method used to produce it. Three federal agencies are responsible for regulating agricultural biotechnology under existing statutes: the U.S. Department of Agriculture (USDA), which is responsible for ensuring that new varieties are safe to grow; the Environmental Protection Agency (EPA), which is responsible for ensuring that new pest-resistant varieties are safe to grow and consume; and the Food and Drug Administration (FDA), which is responsible for ensuring that new varieties are safe to consume.

Although biotechnology has had an uninterrupted record of safe use, political activists in Europe have waged well-funded campaigns to persuade the public that the products of high-tech agriculture may be harmful to human health and the environment. As a result of these efforts, public confidence in the safety of agricultural biotechnology has been seriously undermined in Europe. Many European countries have established new rules and procedures specifically designed to address "genetically-modified organisms," and these have had a detrimental impact on international trade in agricultural products.

The controversy over agricultural biotechnology now has spread to the United States, the world’s largest grower of plants and consumer of foods produced using this technology. At the core of the debate is food safety, particularly the possibility that unexpected genetic effects could introduce allergens or toxins into the food supply. The use of antibiotic resistance markers also has been criticized as dangerous to human health. As a result, there have been calls for both increased testing and labeling requirements for foods created using biotechnology.

Environmental concerns also have been raised. It has been suggested, for example, that widespread use of plants engineered with built-in protection against insect and viral pests could accelerate the development of pesticide-resistant insects or could have a negative impact on populations of beneficial insects, such as the Monarch butterfly. It also has been argued that the use of herbicide-tolerant plants could increase herbicide use and that "superweeds" could be developed through cross-pollination between these plants and nearby weedy relatives.

Extensive scientific evaluation worldwide has produced no evidence to support these claims. Far from causing environmental and health problems, agricultural biotechnology has tremendous potential to reduce the environmental impact of farming, provide better nutrition, and help feed a rapidly growing world population. Crops designed to resist pests and to tolerate herbicides and environmental stresses, such as freezing temperatures, drought, and high salinity, will make agriculture more efficient and sustainable by reducing synthetic chemical inputs and promoting no-tillage agricultural practices. Stress-tolerant crops also will reduce pressure on irreplaceable natural resources like rainforests by opening up presently nonarable lands to agriculture. Other plants are being developed that will produce renewable industrial products, such as lubricating oils and biodegradable plastics, and perform bioremediation of contaminated soils.

Biotechnology will be a key element in the fight against malnutrition worldwide. Deficiencies of vitamin A and iron, for example, are very serious health issues in many regions of the developing world, causing childhood blindness and maternal anemia in millions of people who rely on rice as a dietary staple. Biotechnology has been used to produce a new strain of rice—Golden Rice—that contains both vitamin A (by providing its precursor, beta-carotene) and iron. The Subcommittee heard about other research aimed at improving the nutrition of a wide variety of food staples, such as cassava, corn, rice, and other cereal grains, that can be a significant help in the fight for food security in many developing countries.

The merging of medical and agricultural biotechnology has opened up new ways to develop plant varieties with characteristics to enhance health. Advanced understanding of how natural plant substances, known as phytochemicals, confer protection against cancer and other diseases is being used to enhance the level of these substances in the food supply. Work is underway that will deliver medicines and edible vaccines through common foods that could be used to immunize individuals against a wide variety of enteric and other infectious diseases. These developments will have far-reaching implications for improving human health worldwide, potentially saving millions of lives in the poorest areas of the world by providing a simpler medicine production and distribution system.

Set against these benefits, however, is the idea that transferring a gene from one organism to an unrelated organism using recombinant DNA techniques inherently entails greater risks than traditional cross breeding. The weight of the scientific evidence leads to the conclusion that there is nothing to substantiate the view that the products of agricultural biotechnology are inherently different or more risky than similar products of conventional breeding.

The overwhelming view of the scientific community—including the National Academy of Sciences, the National Research Council, many professional scientific societies, the Organization for Economic Cooperation and Development, the World Health Organization, and the research scientists who appeared before the Subcommittee—is that risk assessment should focus on the characteristics of the plant and the environment into which it is to be introduced, not on the method of genetic manipulation and the source of the genetic material transferred. These risk factors apply equally to traditionally-bred plants.

Years of research and experience demonstrate that plant varieties produced using biotechnology, and the foods derived from them, are just as safe as similar varieties produced using classical plant breeding, and they may even be safer. Because more is known about the changes being made and because common crop varieties with which we have a broad range of experience are being modified, plants breeders can answer questions about safety that cannot be answered for the products of classical breeding techniques.

FDA has adopted a risk-based regulatory approach consistent with these principles and with the long history of safe use of genetically-modified plants and the foods derived from them. Its policies on voluntary consultation and labeling are consistent with the scientific consensus and provide essential public health protection.

Unlike FDA regulations on food, USDA has instituted plant pest regulations, and EPA proposes to institute new plant pesticide regulations, that target selectively plants produced using biotechnology and apply substantive regulatory requirements to early stages of plant research and development. These regulations add greatly to the cost of developing new biotech plant varieties, harming both an emerging industry and the largely publicly-funded research base upon which it depends. Regulations and regulatory proposals that selectively capture the products of biotechnology should be modified to reflect the scientific consensus that the source of the gene and the methods used to transfer it are poor indicators of risk.

In the international arena, the United States should work to ensure that access to existing markets for agricultural products are maintained. The United States should not accept any international agreements that endorse the precautionary principle—which asserts that governments may make political decisions to restrict a product even in the absence of scientific evidence that a risk exists—and that depart from the principle of substantial equivalence adopted by a number of international bodies.

Finally, the Administration, industry, and scientific community have a responsibility to educate the public and improve the availability of information on the long record of safe use of agricultural biotechnology products. This is critically important to building consumer confidence and ensuring that sound science is used to make regulatory decisions.

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