Editors' Summary: As Superfund litigation proliferates and cleanup costs soar, the extent to which comprehensive general liability (CGL) policies cover the liability of PRPs for response costs incurred in the cleanup of hazardous waste becomes increasingly crucial.

Thanks to recent legislation and court decisions, bankruptcy law and hazardous waste law now overlap substantially. Bankruptcy law creates a process to convert the bankrupt's estate into cash and distribute it among creditors. Bankruptcy trustees have a fiduciary duty to maximize assets available to satisfy creditors. At the same time, environmental law seeks to make funds available for hazardous waste cleanup that is frequently expensive.

Editors' Summary: CERCLA, otherwise known as the full employment act for lawyers, has generated a prodigious amount of litigation since its enactment in 1980. Coherently summarizing the entirety of CERCLA case law in one article is a monumental task. Undaunted, the authors have produced an overview of the eight years of CERCLA litigation, covering everything from abatement actions to transporter liability.

It is time to demystify alternative dispute resolution (ADR). The confusion surrounding ADR stems from focusing on its theoretical potential and limitations rather than on its successful application to real-life programs and statutes. Now that there is a growing body of experience with mediation, and to a lesser degree with other forms of ADR,¹ the dialogue should be expanded to include the record and experience of people who are participating in building that record.²

My approach today will be to discuss risk and risk regulation in a general way. First, I want to discard some red herrings that seem to play far too great a role in the public's discussion of health risks: jobs and profits.

One of the problems in discussing "biotechnology" or "genetic engineering" is a definition of the subject matter. A U.S. Office of Technology Assessment definition of biotechnology was "any technique that uses living organisms (or parts of organisms) to make or modify products, to improve plants or animals, or to develop microorganisms for specific uses."¹ Genetic engineering could apply to any process that results in the derivation of living things which are genetically suited for some application.

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.

I am not a biotechnology expert, but I will provide my personal views on the subject, arising from my involvement with the U.S. Environmental Protection Agency's (EPA) biotechnology regulation, through its Office of Toxic Substances.

First, I would like to give you my own perspective on the current status of EPA's biotechnology regulation. Second, I will consider an example of risk assessment, and finally, I will discuss the future direction of EPA's regulation.

I would like to discuss the regulatory structure and principles of regulation at the U.S. Department of Agriculture USDA).

At USDA, we operate under several regulatory principles. First, we believe that products developed through genetic engineering do not differ fundamentally from those produced by conventional means. Second, we strongly believe that the product and the risk, not the process, should be regulated. Third, we believe that existing statutes are adequate and appropriate for regulating biotechnology.

Science's ability to engineer genes has far outpaced society's ability to structure the legal institutions to regulate that capability. Despite all that has been said, in my view the current regulatory scheme is a morass of bewildering complexity, overlapping jurisdiction, and great uncertainty. Everyone acknowledges the need for certainty, but on any given experiment both the U.S. Environmental Protection Agency (EPA) and the United States Department of Agriculture (USDA) may decide to exercise jurisdiction and review the procedure.