Biotechnology has grown from one company in the U.S. in 1971 to over 1500 today. Initially, the focus was on research. The first biotechnology product was a pharmaceutical (insulin, in the U.S.). As the industrial potential of the science became more evident, interest shifted to other industrial sectors. The first Ag biotech product was related to the pharmaceutical industry, a swine vaccine marketed by Syntro Corp. Rapid advances have since been made in the use of recombinant organisms for a variety of purposes including agricultural, pollution control and waste treatment. All of these applications involve the release of the biotechnology product to the environment.

Enhanced interest as a result of the advent of biotechnology resulted in improvement in existing techniques. Increased research to improve both the processes and the microbes that were being utilized and the end product have improved. Prior to biotechnology, transgenic organisms resulted from cross breeding or mating. Genetic modifications to microorganisms to increase the range of compounds degraded and the rate of degradative ability were achieved by classical methods (e.g. transformation, UV mutagenesis). With the application of the tools of molecular biology, it is possible to rapidly develop specialized organisms tailored for particular uses. To date, these organisms have been developed for use in agriculture, pollution control and waste management. They have been released to the environment in agricultural situations. Although waste treatment and pollution control have been active areas of research and development, no releases of engineered organisms have occurred (Levin and Gealt, 1994).

Agricultural releases have become commonplace. Over 2000 releases have occurred, depending on how one defines the term, "Release" (GeneExchange, 1994a,b; Beck and Ulrich, 1993; PIP, 1993; Chasseray and Duesing, 1993).

Risk is defined as the magnitude and likelihood of adverse effect (Levin and Strauss). This requires estimation of the hazard (i.e., what harm will the agent cause) and the exposure (what population will be exposed to the agent, at what concentration, and for how long). For agricultural products and products intended for field release, environmental concerns require primary consideration, although human health issues are also involved. Products used for industrial purposes raise worker safety and health issues.

The major issues related to evaluating the risk of environmental application of transgenic products are the type (i.e., what organism and for what purpose) and the scale (i.e., small scale field trial or commercial application). Releases vary in purpose, and this affects the scale and overall experimental design. To date, the only large scale, commercial use of an engineered plant or viable microbe has been in China (Chen, 1992).

Public perception of the risks and benefits of biotechnology can play an important role in the industries' attempts to test and market products. Despite the growing number of tests, the general lack of basic scientific understanding with respect to environmental introductions has fueled the existing feelings of uneasiness with which the public views high technology (Hogan and Kendall, 1994; Office of Technology Assessment, 1987; Zehendorf, 1994).

Development of agricultural biotechnology products has resulted in the development of U.S. Risk Assessment protocols. The first field test of an engineered organism was for a bacterium which would protect plants against frost. The successful test was conducted in 1986 (Levin and Strauss, 1993). Since that time over 2000 field tests of plants and microorganisms have been conducted in the U.S. (Geneexchange, 1994b). In most cases the test (ranging in size from 0.25 to 10 acres) is designed to demonstrate that a product is efficacious and hence commercially viable.

Requirement for risk assessment for large scale, commercial use of transgenic organisms are less well defined. It cannot be assumed that the data requirements for field tests will suffice for commercial scale releases or that the data will be applicable (Tiedge et al., 1989; Burke et al., 1994.

This symposium describes risk assessment research conducted to aid in evaluating the risks associated with agriculture and environmental (e.g., biotreatment) biotechnology products. Prior to this volume, the USEPA has conducted a series of symposia describing USEPA projects. This symposium including all USEPA and USDA biotechnology risk assessment projects that are environmentally oriented. A similar program (PROSAMO) exists in Europe and publishes annual reports.

Section 1668 of the 1990 Farm Bill required the Secretary of Agriculture to establish a competitive grants program in biotechnology risk assessment research to provide a better scientific basis for regulatory decision making. To collect required information for the development of risk assessment protocols and to understand the risks associated with the release of transgenic organisms into the environment, the USDA initiated the BIOTECHNOLOGY RISK ASSESSMENT RESEARCH AWARDS PROGRAM in 1992. Grant applications are solicited each year from throughout the U.S. Approximately ten proposals are funded each year. Grants are generally awarded for a period of 24 to 36 months. Research areas funded include:

1. Escape of transgenes to wild and weedy species

2. Risks of genetically engineering plants to be virus resistant

3. Risks to ecosystem stability of plants engineered to be insect resistant

4. Risks of genetically modified plants and microbes to native plant- and soil-associated microbes

5. Risk assessment tools for plant-associated bacteria

6. Risk assessment of aquatic ecosystems

7. Risks of genetically engineered animal vaccines

8. Risks of genetically enhanced viral biopesticides

9. Risks associated with using fungal plant pathogens as herbicides

To date, a total of $5.1 million has been awarded to 29 individual projects.

The USEPA initiated a similar risk assessment program in 1993. This program is called Risk Assessment of Environmental Releases of Biotechnology Products-Research Issues. The focus of the program was less on agricultural applications and more on ecology of transgenic organisms and on the development of protocols for risk assessment. Funded research areas include:

1. Microbial growth, survival, gene transfer and expression

2. Microbial ecology and monitoring

3. Transgenic plants

4. Biological control

5. Environmental effects

6. Mitigation and risk control strategies

7. Human health effects

To date, proposals have been funded for a total of $11.1 million.

Environment Canada in cooperation with AFAG Canada has supported a variety of projects to work cooperatively with the USEPA and other federal U.S. agencies. The signing in 1986 of the Memorandum of Understanding on Science and Technology between the Canadian Minister of the Environment and the USEPA Director authorized the exchange of data, funds and personnel between government agencies. Cooperation with U.S. counterparts was predicted upon the signing of the North American Free Trade Agreement and the Canada-U.S. Trade Agreement. In addition, industrial lobbies in both countries have called for harmonization of regulations and data requirements. Many of the projects supported by AFAG Canada and Environment Canada have focused upon the collection of data that can be used in the risk assessment process.

This volume presents the papers from the USEPA/USDA/Environment Canada/AFAG Canada-All Investigators Meeting held in June, 1994 in College Park, Maryland. Not all studies supported by these agencies are presented since some projects had not yet collected adequate information for a full presentation. Additional meetings will be held in Gulf Breeze, Florida in 1995 and at an undetermined location in the year 1996.

Beck, C.I. and T.H. Ulrich. 1993. Environmental release permits. Bio\technology 11:1524-1529.

Burke, T., R. Seidler and H. Smith. 1994. Ecological implications of transgenic plants. Molecular Ecology 3:(1)1-89.

Chasseray, E. and J. Duesing. 1993. Field trials of transgenic plants. AGRO Food Ind. 1-10. Basel Sw.

Chen, Z.L. 1992. Field releases of recombinant bacteria and transgenic plants in China. 53-54. Biosafety results of field tests of genetically modified plants and microorganisms. Biol. Land und Forst. Braunschweig, Germ.

Economidis I. 1990. Biotechnology R&D in the EC. Commission of the European Comm. Brussels.

GeneExchange. 1994a. Experimental releases of genetically engineered organisms. 4#4: 12. Union of Conc. Sci. Washington, D.C.

GeneExchange. 1994b. Experimental releases of genetically engineered organisms. 5#2: 12. Union of Conc. Sci. Wash., D.C.

Hogan, T.J. and P.A. Kendall. 1992. Consumer attitudes about the use of biotechnology in agriculture and food protection. N.C. State Univ., Raleigh, N.C.

Levin, M. and M. Gealt. 1994. Biotreatment of Industrial Wastes. McGraw Hill, 1994.

Levin, M.A. and H. Strauss. 1993. Overview of risk assessment. In: Risk Assessment in Genetic Engineering. Levin, M.A. and Strauss H., eds. 1-17. McGraw Hill, NY, NY.

Office of Technology Assessment. 1987. Public Perception of Biotechnology. Wash., D.C.

PIP Newsletter. 1993. Field release of modified plants. Sept. 1993.

Tiedge, J.M., R.K. Colwell, Y.L. Grossman, R.E. Hodson, R.E. Lenski, R.N. Mack, and P.J. Regal. 1989. The planned introduction of genetically engineered organisms: Ecological considerations and recommendations. Ecology, 70(2): 298-315.

Zehendorf, B. 1994. What the public thinks about biotechnology. Biotechnology 12:870-873.