The Rutabaga That Ate Pittsburgh

Abstract

When the Environmental Protection Agency (EPA) first approved a field test of a bioengineered microbe, one EPA official remarked: "We're not expecting this to be the rutabaga that eats Pittsburgh.' But regulators cannot afford to be wrong. Bioengineered microbes may serve many useful purposes, but they may also cause harm to the environment and to human health. Although the risks of an accident stemming from the deliberate release of bioengineered microbes into the environment may be low, the resulting damage could be substantial. This note examines the possible consequences of two recent trends in biotechnology --the development of bioengineered microbes for environmental release, and the emergence of a vigorous biotechnology industry on federal environmental regulation. These two developments have produced regulatory confusion in an area that can ill afford uncertainty. Biotechnology companies eager to recapture their research investments through the commercialization of bioengineered products are pressing understaffed regulatory agencies to permit the release of microorganisms produced by bioengineering techniques into the environment. ..

In Part I, this note discusses the rapidly evolving science underlying the development of bioengineered microbes and the growing biotechnology industry it has spawned. In Part II, the note reviews the federal government's regulatory response to these developments. The analysis in Part III identifies two crucial flaws in the present system of biotechnology regulation: its uncertainty will stifle commercial development in biotechnology, and it will not produce sufficient data to enable regulators adequately to assess the special risks created by deliberate releases. After examining governmental efforts to assess similar risks in the nuclear power industry, the part argues that regulators of deliberate releases should assemble a central data base of information about each release for use in future risk assessment. In Part IV, the note recommends immediate modification of the regulatory scheme to clarify agency jurisdiction and statutory authority, to stiffen reporting requirements, and to create a centralized data bank.