Current Litigation Issues Associated With Biotechnolgy
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.
Consider the University of California "ice-minus" experiment. The research underwent review by the National Institutes of Health (NIH),including the preparation of an environmental assessment. The experiment then was reviewed by EPA for an experimental use permit, including the preparation of an environmental assessment by EPA. It was also reviewed under the California Environmental Quality Act,1 including the preparation of an environmental assessment. Those Pseudomonas syringae with ice-plus deletions were probably the most assessed little bugs on earth; there was not much left that we could find out about them unless we were allowed to conduct the experiment.