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Abstract: In June 1986, the federal government, through the Office of Science and Technology Policy, published its Coordinated Framework for Regulation of Biotechnology. Unfortunately, the failure to agree on clear, common definitions of fundamental terms such as "release into the environment" and "genetically engineered" microorganism has led to confusion and violations of the regulations. A novel organism with new traits created in a laboratory might present a risk similar to that presented by an existing species imported from a different continent. A genetically engineered microorganism under development for use in the environment must be field tested many times before it will be ready for the market. An efficient method for allocating scarce governmental resources available for biotechnology regulation would be to create risk categories subject to different levels of regulatory scrutiny, depending on the magnitude of the hazards involved First, no genetically engineered microorganism will be released into the environment without at least an abbreviated review by a federal agency. Most of the worst-case scenarios for deliberate release experiments involve the proliferation and widespread dispersal of the genetically engineered microorganism. The federal government, in drafting its Coordinated Framework for Regulation of Biotechnology, attempted to balance the interests of those seeking protection of the public health and the environment with the interests of the industry in avoiding a stifling regulatory burden.
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