PREVENTING REGULATION BY LITIGATION
Biotechnology offers the potential for great benefits including more nutritious food, new vaccines and simpler, more accurate diagnostic agents.
Unfortunately, the potential benefits of agricultural biotechnology may be denied to society as a result of court action. An alliance of plaintiffs' attorneys and a coalition of environmental activist groups are attempting to use litigation as a means of stopping the use of agricultural biotechnology in the United States.
The lawsuit, which alleges damages to six farmers who are purportedly representative of small farmers and farm groups, was brought against Monsanto and nine other companies named in the suit, including DuPont, Novartis A.G., Dow Chemical and Astra Zeneca, PLC.
This suit raises the public policy question of whether a group of litigants, not federal regulatory agencies, should have the power to delay or preclude the widespread introduction and use of new technologies.
So far, this lawsuit is not an example of Regulation by Litigation since the federal government is not currently involved. Instead, the group of attorneys and activists are attempting to usurp the authority of the Legislative and Executive branches of government to determine whether bioengineered foods should be allowed in the U.S.
The Potential for Federal Involvement
One of the key allegations of the lawsuit is that bioengineered seeds were marketed without sufficient testing to ensure safety to both consumers and the environment. However, since USDA, EPA and FDA regulate bioengineered seeds and food products, the suit challenges the federal government's three-agency review process. Thus, it appears likely that the federal government may become involved in the lawsuit.
Although an in-depth discussion of the federal government's regulation of agricultural biotechnology is beyond this scope of this paper, it should be noted that the three-agency regulatory process was established about 15 years ago through the Coordinated Framework for Biotechnology. The Framework was developed the way regulatory regimes are supposed to be developed; through research and analysis by federal scientists, policy decisions by federal officials based on statute, Federal Register notices, and public comment.
It is important that, if called upon, federal officials defend not only the existing three-agency regulatory regime but also their authority, as granted by Congress, to set national safety standards and processes for agricultural biotechnology.
If the determination of what constitutes adequate testing of agricultural biotechnology products is taken away from the expert regulatory agencies, then the entire system of federal regulation, along with the opportunities for public participation and Congressional oversight, is threatened.
Consequently, USDA, EPA and FDA, either independently or jointly, should file an amicus curie brief with the court defending their regulatory regime and opposing the litigation.
Why Regulation By Litigation Should be Avoided
The St. Louis Dispatch recently captured the core issue of Regulation by Litigation and the concern that lawyers and judges should not be shaping the future of science. As The Dispatch stated on December 16, 1999: