Faculty Research Repository

Imagine a system of government where the President is accorded a great deal of deference in matters of legislation. A combination of these two elements - “president and legislation” - immediately gives us cause for pause, considering our deliberate tripartite system of checks and balances. Imagine also the advancement of a completely new technology, like cloning. As industry works to perfect the new technology, the question inevitably becomes who is best placed to regulate this industry. As we explore our options, should one of the options be for the Office of the President to set regulations? These are the questions that areas, such as biotechnology, faces or will face.

As biotechnology has evolved, the public has become increasingly concerned that processes for approving bio-tech foods are not transparent. The power to approve biotech foods is delegated to administrative agencies, which receive considerable deference from the courts. Added to this judicial deference is the documented involvement of the President's office in setting policy in this area.

Justice Kagan labeled Presidential involvement in administrative agencies' decisions as “Presidential Administration.” “Presidential Administration,” according to Justice Kagan, refers to the President directly setting policies by providing directives to administrative agencies. Tracing this practice from President Reagan to President Clinton, Justice Kagan explains that presidents have regularly used the administrative process to set policies as well as take ownership of administrative policies. This Article explores the issues inherent in presidential control of administrative regulatory processes related to genetically modified foods. In that context, especially, congressional silence is unsatisfactory because it unevenly shifts the balance of power to influential interest groups and to the President's office. This awkward balancing has been made all the more evident by Monsanto Co. v. Geertson Seeds Farms, the Supreme Court's first decision regarding genetically altered crops. Monsanto and other cases illustrate the legal and ethical complexities of balancing of the public's interest with that of biotech companies and monitoring federal agencies. Thus far, the balancing of interests has erred in favor of biotech companies. The standards applied by the courts for evaluating biotech foods are insufficient and vague. What is more, the procedures in place for overseeing and regulating biotech products are needlessly complex and inefficient.

This Article points out deficiencies in the regulation of bioengineered foods and demonstrates that regulating agencies have sponsored a policy that fails to concentrate on the potential harm to human health; rather, the policy focuses on market aggrandizement. The “substantial equivalence” doctrine applied by regulating agencies when evaluating bioengineered products is under particular scrutiny in this Article. Under the substantial equivalence test, bioengineered products have been assumed to be safe by virtue of the initial presidential command, construing bioengineered foods as equivalent to natural foods. This standard, however, is a false equivalence since bioengineered products contain foreign and unknown agents. Continued practice of this type of Presidential control, without consistent input from experts, could lead to greater harm to the population. Considering the high stakes, a more precautionary standard is warranted.

Accordingly, this article is divided into the following parts: Part I discusses the application of the Presidential ad-ministration doctrine to biotechnology; it identifies the flaws with that particular approach and explains why a better approach is needed. Part II outlines the sources of laws and the agencies responsible for regulating genetically altered foods. Part III discusses the Supreme Court's first ruling regarding genetically modified crops in Monsanto Co. v. Geertson Seeds Farms as an example of the conflicts congressional silence creates. Part IV discusses problems with the current judicial standard of review applied to agencies' decisions. Part V explores the detrimental impact of biotechnology on poor farmers, both in the United States and abroad. Part VI proposes better paradigms for dealing with bioengineered foods and calls for specific congressional guidance in that area. Finally, Part VII presents the European approach as a potential model for grassroots lobbying.