In a 1980 landmark decision, the Supreme Court of the United States ruled that genetically engineered lifeforms such as bacteria were patentable. The significance of this decision to the emerging biotechnology industry—an industry predicated on intellectual property rights—was incalculable. The characteristically research-intensive, capital-intensive biotechnology industry now had the economic incentive to push the technology of genetic engineering to previously unimagined extremes. The genetic engineering and recombinant DNA applications pursued by the biotechnology industry over the past ten years have engendered a spectrum of perplexing inquiries concerning ethical and moral values; agricultural, ecological and environmental matters; global competitiveness and economic priorities; and regulatory and public policy issues. This Comment will focus upon the regulatory and public policy issues associated with the biotechnology industry. Although the specific issue to be discussed is the introduction of genetically engineered organisms into the environment, it will become evident that virtually all the other above-mentioned issues are intrinsically and inevitably linked to regulatory philosophy and public policy values.

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