As we detailed in an earlier blog post, the White House issued a July 2nd executive memorandum on “Modernizing the Regulatory System for Biotechnology Products.” The memo directs the relevant federal agencies – FDA, USDA, and EPA – to update the federal government’s Coordinated Framework for the Regulation of Biotechnology, which was created in 1986 and last updated in 1992. Under the current regulatory system, FDA, USDA, and EPA regulate different aspects of biotechnology products: USDA’s Animal and Plant Health Inspection Service regulates the field testing, movement and importation of biotech crops, FDA regulates biotech foods and EPA regulates genetically engineered microorganisms and crops that contain pesticides.
The White House has emphasized that the Administration will be seeking public input on the updated Coordinated Framework and long-term strategy. The first of three inter-agency public meetings was held on October 30th in Washington, DC. I delivered the following remarks at the meeting, which I then expanded upon in a more thorough written submission to the FDA:
My name is Dr. Nina Fedoroff. I am a molecular biologist and geneticist, and I was one of the first to apply molecular techniques in plant biology commencing in the 1970s. I have been involved in the regulatory issues around modern genetic modifications (GM) since the early 1980s, when I served on the NIH Recombinant DNA Advisory Committee. I was also one of the authors of the 1987 National Academy of Sciences White Paper titled Introduction of Recombinant DNA-Engineered Organisms into the Environment: Key Issues. Then, as now, there was no evidence that unique hazards attend the use of modern GM techniques or in the movement of genes between unrelated organisms. The paper further states:
The risks associated with the introduction of recombinant DNA-engineered organisms are the same in kind as those associated with the introduction of unmodified organisms and organisms modified by other methods.
And concludes that:
Assessment of the risks of introducing recombinant DNA-engineered organisms into the environment should be based on the nature of the organism and the environment into which it is introduced, not on the method by which it was produced.
The President’s recent directive creates an unprecedented opportunity for the EPA, USDA, and FDA to 1) review the evidence that has accumulated in the intervening 30 years of biosafety research and field experience and 2) to move the regulatory system from de facto process-based to truly risk-based.
Going forward, it is critically important to facilitate the use of GM techniques in agriculture. The warming climate, among other factors, is changing pest and disease profiles and distributions. This necessitates far more rapid adaptation responses, particularly for crops, than can be achieved through the older breeding approaches. And because so many different crops and animals are being—and will be—affected, the participation of many more skilled scientists will be necessary to meet these challenges than just those employed by big biotech companies. Tragically, today our public sector agricultural scientists have all but ceased using GM techniques for crop and animal protection and improvement. This is largely because the cost and time involved in obtaining regulatory approval for a GMO release is simply prohibitive.
It is therefore imperative that the present regulatory restructuring yields a framework that is truly risk-based and readily traversed at reasonable cost. The kinds of decision trees that should be developed, albeit based on current knowledge and decades of experience, we already laid out as long ago as the 1989 National Research Council report titled: Field Testing Genetically Modified Organisms: Framework for Decisions. This is especially important in the face of emerging gene modification technologies, such as the CRISPR/Cas system, that provide unprecedented control over what genes are modified and how—something that has never been possible in the entire history of agriculture.
Prior to joining OFW Law, and in addition to her extensive academic research career, Dr. Fedoroff served as Science & Technology Adviser to Secretaries of State Condoleeza Rice and Hillary Clinton, as well as to U.S. Agency for International Development Administrator Rajiv Shah.