In the early 1970s a group of scientists — none involved in agriculture or food — raised concerns about the hypothetical hazards that might arise from the use of the newly discovered molecular genetic modification techniques (recombinant DNA technology) that could alter the inheritable characteristics of an organism via directed changes in its DNA.
That led to an initial voluntary moratorium on the use of the new recombinant DNA (r-DNA) techniques, and subsequently the creation by the National Institutes of Health of guidelines for the application of these techniques for any purpose. These “process-based” guidelines, which were applicable exclusively to the use of these new techniques, were in addition to the existing “product-focused” regulatory requirements of FDA, USDA and EPA. For example, without regulatory approval the “intentional release” of “recombinant organisms” into the environment or fermentation (in contained fermenters) at volumes greater than ten liters of was prohibited.
No similar blanket restrictions existed for plants or other organisms similarly modified by traditional techniques, such as chemical or irradiation mutagenesis.
Thus, premature and ultimately ill-founded concerns about the risks of r-DNA organisms in agriculture and environmental applications precipitated the regulation of r-DNA organisms triggered simply by the “process,” or technique, for genetic modification, rather than the “product,” i.e., the characteristics of the modified organism.
The regulatory burden on the use of recombinant DNA technology was, and remains, disproportionate to its risk, and the opportunity costs of regulatory delays and expenses are formidable. Read more