My task is to review federal and state regulation of genetically engineered organisms in the environment. This is not easy, because no single legislative act governs this type of activity. Instead, an array of statutes and regulations governs the various aspects and particular products of genetic engineering. This array has been criticized as a "patchwork," with the somewhat negative connotation that significant uncertainty is involved and, in addition, that certain situations may escape regulation.

But, before focusing on the regulatory system, we need to keep in mind a few points. First, genetic engineering is a cross-cutting technology. Products from the technology—drugs, devices, animals, agricultural chemicals, and so forth—will be used in many different industries. Second, at the federal and state levels, there exists already a vast array of product-directed statutes and regulations.