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.

EDWARD LEE ROGERS: I am concerned about whether the Coordinated Framework for Regulation of Biotechnology¹ is adequate. I am not sure that it is efficacious to talk in terms of intergeneric organisms, or whether it is practical to use a pathogen/nonpathogen distinction as the basis for choosing the level of review.

I would like to analyze some of the international aspects of biotechnology and its regulation. To preface my discussion, I will note first some some general points.

I would like to address the protection of intellectual property as it relates to biotechnology. My office is not competent to assess human risk and environmental risk issues, so I will not discuss them. But there are some other risks that we have not considered at this conference, namely, the risk in terms of U.S. competition and competitiveness in the world market.

MICHAEL BAGDASARIAN: Microbial ecologists estimate that of all microorganisms present in our environment, not more than twenty percent of the species have been isolated and classified. This means that the other 80 percent is an array of completely unknown organisms.

When the first human beings left the Garden of Eden, God told them to be fruitful, multiply, and cover the face of the earth. We might describe this event today as a major release of a novel organism from a containment facility. Imagine the environmental impact statement! How did God—or the angels He consulted—assess the risks? How did they weigh the benefits and costs?

Oh, boy. Another government study and plan. Just when you thought you had cleared off enough shelf space for those 20-pound bookends your sister bought for you on her last vacation.

What is there to induce anyone to take seriously the self-analysis issued last June by the U.S. Environmental Protection Agency (EPA) entitled "A Management Review of the Superfund Program"? Or the follow-up implementation plan which EPA submitted to Congress in September?

Editors' Summary: Large oil spills during 1989 in Alaska and elsewhere focused attention on the government's authority to recover compensation for natural resource damages. As if oil spills were not enough, in July 1989 the issue became hotter yet, when two decisions of the Court of Appeals for the District of Columbia overturned key elements of the Interior Department's regulations for placing a value on the natural resources damaged.