EEUU: Give Genetic Engineering Some Breathing Room

The Innate potato is one example of new genetic engineering techniques that are more precise and versatile than ever. These advances promise a new generation of improved crops, animals, and microorganisms that will be attractive to the public. But the new techniques also raise critical questions about public policy. How will the various regulatory agencies approach them as a matter of law and regulation? What will be the regulatory costs, time, and effort required to bring them to market? And, further out, how will regulatory agencies approach the emerging field of synthetic biology, which involves the design and construction of new biological components, devices, and systems, so that standardized biological parts can be mixed and assembled?

Based on recent history, the answers to such questions are not comforting. Most of the federal agencies involved have ignored both common sense and the consensus of the scientific community, and policymakers and federal bureaucrats have crafted regulations that have created formidable regulatory delays and expense. The public and private sectors have squandered billions of dollars on complying with superfluous, redundant regulatory requirements that have priced public sector and small company research and development out of the marketplace.

Numerous national and international scientific organizations have repeatedly addressed whether there are unique risks associated with genetic engineering. Their conclusions have been congruent: There are no unique risks from the use of molecular techniques of genetic engineering.

Perhaps the most comprehensive and unequivocal analysis of the risks of genetically engineered plants and microorganisms is the 1989 National Research Council report “Field Testing of Genetically Modified Organisms.” It emphasized that the more modern molecular techniques “are more precise, circumscribed, and predictable than other methods. They make it possible to introduce pieces of DNA, consisting of either single or multiple genes that can be defined in function and even in nucleotide sequence. … With organisms modified by molecular methods, we are in a better, if not perfect, position to predict the phenotypic expression.” Close to three decades later, the techniques that were the focus of the report are still widely used, and the newer refinements are even more precise and predictable.

In 2000, the National Research Council released another report weighing in on the scientific basis of federal regulation of genetically engineered plants. It concurred with earlier assessments by other groups that “the properties of a genetically modified organism should be the focus of risk assessments, not the process by which it was produced.” Various distinguished panels around the world have continued to make the same points about genetic engineering and “genetically modified organisms.” 

Thus, there has been a broad consensus in the scientific community, which has been reflected in statements of federal government policy going back more than 25 years, that the newest techniques of genetic modification are essentially an extension, or refinement, of older, less precise, and less predictable ones, and that oversight should focus on the characteristics of products, not on the processes or technologies that produced them.

In spite of such guidance, regulatory agencies have generally chosen to exercise their discretion to identify and capture molecular genetic engineering as the focus of regulations. Those choices have drastically affected the progress of agricultural R&D.