The genetic revolution has seen extraordinary innovation recently, including the development of low cost and very precise genome editing tools and “gene drives” that could assure that genetically engineered organisms transmit desired traits to all of their offspring, even when the other parent lacks such traits. These tools are leading to development of transformational new products—such as genetically engineered mosquitos that could in principle eliminate malaria, which each year kills more than 400,000 people globally. Also under development are products that could control Lyme disease without pesticides, control insect- and tick-borne livestock disease in developing countries, reduce or eliminate shortages of organs for human transplantation by designing pigs suitable for supplying such organs, and help restore threatened and endangered species.
Partly because of this explosion of new technology, the White House Office of Science and Technology Policy (OSTP) in September proposed revisions to the federal framework governing regulation of biotechnology products.[1] This Coordinated Framework, first issued in 1986, holds that risks to public health, safety and the environment emanate from products and not use of biotechnology per se in developing the products. It also holds that extant authorizing statutes provide adequate authority to regulate biotech products. The Coordinated Framework has served as the underpinning of the program that the Environmental Protection Agency, the Food and Drug Administration, and the U.S. Department of Agriculture use to assure the safety of food from genetically engineered plants.
In announcing the proposed revisions, OSTP solicited public comment until November 1, at 5 p.m. Despite the short comment period (which likely signals that the Obama Administration plans to finalize these revisions before leaving office), this public comment period may be the best opportunity to advise federal agencies about how they should manage the regulation and oversight of products developed with biotechnology.[2]
The OSTP’s announcement solicited public comment about what “clarification could be provided” regarding which biotech products are the responsibility of which agency and fall within the authority of specific statutes, as well as regarding interagency communication and coordination. Interestingly, it also acknowledged more fundamental policy issues, including the need to minimize delays, support innovation, protect health and the environment and promote the public trust in the regulatory systems for biotechnology products. Resolving these governance issues effectively may be key to ensuring that the genetic revolution results in production and marketing of biotech products that improve peoples’ lives.
