into the environment, the primary responsibility falls on the Department of Agriculture and the Environmental Protection Agency. Since the 1986 publication of the Coordinted Framework the number of open field trials of generally modified plants has increased dramatically. In 1987 five field trials were conducted, as compared with 1803 in 1994. During this time we have also experienced the product approval of the 'Flavr-Savr' Tomato, and its field production. Currently there are numerous experiments with genetically modified fish in progress on a large scale, and probably ready for production, with targets in both the US and Europe. The introduction of micro-organisms for non-agricultural use remains slow. One reason for this is the conservative approach taken by the Environmental Protection Agency, even though they have begun to see the value of microbes for environmental clean-up.
The Environmental Protection Agency's statutory authority for regulation of microbial products falls under two Federal statutes, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the Toxic Substances Control Act (TSCA). The most confounding element for potential product applications is that these statutes have differing requirements for regulatory oversight, and differing procedures regarding notification and permitting. Neither statute was specifically written to address the problems of biotechnology. Because their historical approach was a process orientation and not product based, the EPA has only recently been able to come forward with proposed new rules. However, in the current political environment in the United States it is unlikely that any new rule-making will occur during the new two years.
The Department of Agriculture outlined its approach in the 1986 Coordinated Framework and has subsequently published several statements of clarification and rule-making. The central office within the Department with jurisdication over biotechnology products is the Animal and Plant Health Protection Service (APHIS). In 1987 rule-making, APHIS established procedures for the insurance of permits for the field testing of new plant varieties derived from recombinant DNA technology. Subsequently hundreds of trials were safely performed on a number of plant varieties. In light of this extensive experience with field trials, in November 1992 APHIS published a proposal that would require only notifcation to APHIS, rather than prior approval, for field trials of transgenic plants that meet certain (highly restrictive) criteria designed to insure that the plants are not plant pests. These proposals have now been modified and published in the form of final rules. Extensive information is available in the Federal Register notice of