United States Environmental Protection Agency EPA745-F-93-003 June 1993 Office of Pollution Prevention and Toxics EPA's Biotechnology Oversight Program Under the Toxic Substances Control Act ------- What is Biotechnology? In different forms, biotechnology has been going on for centuries. People have long sought to change the inherited characteristics of crops and domestic animals. For example, farmers carefully select seed from their best plants for the next year's planting; good milk cows are chosen for breeding; plants are cross-bred to produce valuable new hybrids. Biotechnology is the modification of the genetic material of plants, animals, and microorganisms such as bacteria, viruses, and fungi, in order to achieve certain desired products or results. Today, these efforts are taken a step further to the direct modification of genetic material in the laboratory. Modern biotechnology developed / in the early 1970s with new tech- (L- niques that allowed genetic ' ^*~ material to be moved between organisms. Biotechnology promises significant advances in medicine, agriculture, cleanup of toxic wastes, energy production, mining, and numer- ous other fields. Applications of biotechnol- ogy have already revolutionized the search for vaccines, as well as advancing the develop- ment of treatments for cardiovascular illness, cancer, mental disorders, and many other medical problems. The potential for improvements in other fields is equally promising. ------- How Biotechnology is Regulated Different types of biotechnology products are covered by laws administered by the U.S. Food and Drug Administration (drugs, foods, food additives, and medical devices), the U.S. Department of Agriculture (plants, plant pests, and certain veteri- nary products), and the U.S. Environ- mental Protection Agency. EPA administers biotechnology regulatory programs under two statutes: the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) which covers chemical and biological pesticides, and the Toxic Substances Control Act (TSCA). This pamphlet describes EPA's biotechnology oversight program under TSCA. (See the end of this pamphlet for contacts and references for the other federal biotechnology programs.) TSCA authorizes EPA to regulate chemical substances — including combinations of chemical substances such as certain types of living organisms — that present an unreasonable risk of injury to health or the environment. TSCA does not cover substances which are subject to other federal statutes. TSCA contains special requirements relating to new chemical substances. Under EPA's New Chemicals Program, manufacturers and importers must submit health and safety information to EPA before introducing any new chemical substance into the marketplace. (This information is referred to as premanufacture notification, or PMN.) EPA regulates biotechnology products under TSGA under the terms of a coordinated federal policy issued in 1986. Under this policy, EPA focuses its biotechnology oversight program on microorganisms that contain or express new ------- combinations of traits. This includes "intergeneric microorganisms" that are deliberately engineered to contain combinations of genetic material from different genera (groups of closely related species). EPA considers these to be new microorganisms subject to the Agency's oversight. To determine the safety of these products, EPA has specified a series of reporting steps and evalua- tions, similar to the procedures of the Agency's PMN program for new chemicals. EPA reviews information on new microorganisms prior to their introduction into the marketplace. In addition, researchers are requested to notify EPA prior to any environmental testing involving the introduction into the environment of new microorganisms. If EPA determines that the product may pose an unreasonable risk to health or the environment, EPA can also modify the conditions of use to include additional safeguards for controlling the microorganism. EPA can delay or restrict the manufacture or distribution of a biotech- nology product if the Agency believes that the risks to public health and the environment exceed the benefits of the product. In evaluating the information submitted on a product, EPA considers the expected benefits of the product as well as the following risk factors: the types of organisms being used for the genetic , modification; characteristics of the microorganism in question; the stability of the new genetic insert in the environment; possible effects on the environ- ment; and potential exposures of workers and consumers to the biotechnology product. ------- How Biotechnology Works For over 10,000 years people have been using some form of biotechnology to develop and maintain - characteristics that are considered desirable in other species. With rare exceptions, the tools available have been limited to selecting organisms with desired traits and enhancing or perpetuat- ing them through conventional breeding programs. The techniques of modern biotechnolo made new tools available. With these now possible to move genetic material fro organism to another. Thus, genetic inform' tion expressing desirable traits can be move between microorganisms, plants, and animals. This type of exchange of genetic material was -not previously possible using the conventional techniques of selection and breeding. How do biotechnology techniques work? Within every cell — the basic building block of all organisms — are found a variety of materials, including genetic material called DNA that contains a The public also has the opportunity to become involved in the review of a biotechnology product. When EPA receives notification for a new microor- ganism, public notice is given in the Federal Register and members of the public are welcome to comment on the notification. The public may also request, or EPA may decide to convene, a public meeting of EPA's Biotechnology Science Advisory Committee. The United States is a world leader in biotechnol- ogy. The techniques of modern biotechnology offer ------- blueprint for the organism. The blueprint informa- tion is arranged in segments of DNA called "genes" that relate to a particular function or produce a particular chemical product The complete complement of DNA in an individual organism (its "genome") can be thought of as a tape containing all the information necessary to build an organism and cany out its functions. Like any tape, DNA can be cut and spliced. Information from one point on the tape can be moved to another point or to the tape of another organism, using various techniques. One (technique, called "recombinant DNA," uses enzymes TOfcut and splice genes. In another technique, "cell fuaom" two or more cells from different organisms are/fused into a single cell. \H- The^new biotechnology techniques are more powerfulfecfinore precise than traditional breeding techniques. The tools of modern biotechnology have the advantage of permitting greater control over the design and production of biotechnology products, minimizing the likelihood of unexpected effects. our society and the world at large the potential for improvements in human health and environmental quality. At the same time, any technology that deals so directly with the basic processes of life inevitably raises compelling questions. The novelty of modern biotechnology has raised legitimate concerns on the part of the public and a strong interest in an active government role in regulating new products. EPA's biotechnology oversight program attempts to strike a balance between the concerns that biotechnology raises and the promise that it offers. ------- What Is Biotechnology Used For? Biotechnology products can consist of genetically engineered organisms themselves or of chemical substances made using genetically engineered organ- isms. Below are some of die applications of biotechnol- ogy products that come under EPA's TSCA review. Current Applications Biotechnology products are already in use or under development in several agricultural and industrial applications, such as die following: • Enhanced nitrogen-fixation — Nitrogen is an essential element for plant growth. Some microorganisms can be genetically engineered to;enhance their ability to "fix" atmospheric nitrogen in a form that plants can use as fertilizer. Seeds are coated with diese genetically engineered microorganisms before planting; die microorganisms dien colonize die roots as they grow, enhancing die ability of die plant to obtain nitrogen and grow better. • Specialty chemicals— Microorganisms are genetically engineered to enhance dieir production of complex products such as enzymes, which are widely used in the detergent, starch, and textile industries. Future Applications Research is underway to develop biotechnology products for applications such as die following: • Bioremediatim — Naturally occurring microorganisms are already being used to break down contaminants in die environment and convert diem to harmless substances. Researchers are working to genetically engineer microorganisms in such a way as to improve their ability to clean up chemical contamination. • Biosensors— Biotechnology could be used to develop improved biosensors to detect die presence and concentration of contaminants in die environment. Ultimately, biological material may even prove useful in developing new kinds of semiconducters ("biochips"). ------- For More Information on Biotechnology: U.S. Congress, Office of Technology Assessment, New Developments in Biotechnology, 1: Ownership of Human Tissues and Cells — Special Report, OTA-BA-337 (Wash- ington, DC: U.S. Government Printing Office, March 1987). U.S. Congress, Office of Technology Assessment, New Developments in Biotechnology, 2: Public Perceptions of Biotechnology — Background Paper, OTA-BP-BA-45 (Washington, DC: U.S. Government Printing Office, May 1987). U.S. Congress, Office of Technology Assessment, New Developments in Biotechnology, 3: Field-Testing Engineered Organisms: Genetic and Ecological Issues — Special Report, OTA-BA-350 (Washington, DC: U.S. Government Printing Office, May 1988). U.S. Congress, Office of Technology Assessment, New Developments in Biotechnology, 4: U.S. Investment in Biotechnology —Special Report, OTA-BA-360 (Washing- ton, DC: U.S. Government Printing Office, July 1988). U.S. Congress, Office of Technology Assessment, New Developments in Biotechnology, 5: Patenting Life — Special Report, OTA-BA-370 (Washington, DC: U.S. Govern- ment Printing Office, April 1989). U.S. Congress, Office of Technology Assessment, Mapping Our Genes — The Genome Projects: How Big, flow .Fort? OTA-BA-373 (Washington, DC: U.S. Government Printing Office, April 1988). (The above reports are available from the U.S. Government Printing Office, Superintendent of Documents, Washington, D.C. 20402-9325 (202-783- 3238) and the National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161- 0001 (7034874650).) ' 7 ------- National Research Council, Field Testing Genetically Modified Organisms: Framework for Decisions (Washington, DC: National Academy Press, 1989). For More Information on EPA's Biotechnology Program Under TSCA: Office of Science and Technology Policy, "Coordinated Framework for Regulation of Biotechnology; An- nouncement of Policy and Notice for Public Com- ment," Federal Register (51 FR 23302), June 26,1986. TSCA Hotline: 202-554-1404. For Information on Other Federal Biotechnology Programs: Contacts: i. U.S. Department of Agriculture, Animal and Plant Health Inspection Service (APHIS), Biotechnology and Environmental Coordination Staff (regulatory issues), Tel: 301-436-5762 U.S. Department of Agriculture, Office of Agricul- tural Biotechnology (agricultural research issues), Tel: 703-235-1505. U.S. Environmental Protection Agency, Office of Pesticide Programs, Tel: 800-858-7378 or 806-743-3091. U.S. Food and Drug Administration, Office of Biotechnology, Tel: 301443-7573. « U.S. GOVERNMENT PRINTING OFFICE: 1993—721-069 8 ------- |