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 also question whether the 90-day review period under the Toxic Substances Control Act (TSCA)² and the 60-day period under the Federal Plant Pest Act (FPPA)³ are adequate review timeframes for something as complex as a novel organism.

The philosophy of my client, Jeremy Rifkin, is that we have a new technology that is fraught with risk. He recognizes, and we acknowledge in our litigation, that in most instances biotechnology will not present much risk. But the fact remains that the scenario of a great catastrophe is still possible. If the regulators err in a particular review, serious consequences could ensue.