Tackling Agbiotech Regulation
The regulation of food products, agricultural crops, livestock, and the environmental use of biotechnology lagged behind the development of medicinal products and diagnostics via biotech methods. Debate regarding the nature of organisms modified by rDNA technology as compared to classical plant breeding approaches continued unabated.
For example, a report that was published in 1993 and prepared by the OECD Environmental Directorate in collaboration with the Directorate for Science, Technology, and Industry stated that foods or food components developed by biotechnology do not lead to foods that are inherently less safe than those developed by conventional techniques.
However, there were others who began to use the term “genetically modified organisms” to refer to those organisms that were modified by recombinant DNA technology. These organisms were implied to be more risky than those developed by the more imprecise traditional plant-breeding techniques. As a result, a new regulatory scheme emerged.
As Max Schmidt, former Commissioner of FDA, once stated: “dogs bark, cows moo, regulators regulate.” Thus began a debate on how much regulation was appropriate.
Additionally, the question of what degree of change in a product should initiate consumer labeling as a potential safety measure became contentious. For example, if a cloned gene was introduced into a turkey, should soup containing 4% turkey meat be labeled as containing a genetically modified organism? Should gelatin from such turkey bones be labeled as genetically modified? The regulatory complexity introduced by the new genetics was illustrated in a report entitled “Strategies for Assessing the Safety of Foods Produced by Biotechnology.”
The report, a joint study by WHO and the United Nations’ Food and Agriculture Organization, noted the following:
“A new paradigm for safety evaluation, with emphasis on molecular, biological, and chemical data and the use of these data to determine the need for appropriate toxicity tests, is recommended. This new paradigm for safety assessment should be applied to all forms of genetic modification of plants, including traditional plant breeding.
“The components of the safety assessment process are essentially suggestions as to the information that may be requested, rather than requirements specifying what should be provided. The detail required will depend on the nature of the genetic modification.”
I strongly recommend that regulatory frameworks covering biotechnology be based on sound science and established by regulators intimately familiar with the field. Furthermore, scientific risk/benefit analysis of regulatory frameworks should be carried out periodically to ensure safety while minimizing regulatory burdens that impede innovation.
Finally, it is important to recognize that the regulatory framework created by the FDA in the 1980s for biologics and diagnostics derived from biotechnology stimulated both the development of biotechnology and the resultant novel products for enhancing human health.