Public Sessions Announced For Input On Revising Biotechnology Product Regulations

In the summer of 2015 the Obama Administration announced a process to update the regulatory system for biotechnology products.  After a request for information a series of public consultation events started with an October meeting in Washington, D.C.  It marks the first major update to the process since 1992.  It is the first of three public sessions planned.

Earlier this week the dates and locations for the other two sessions were announced.  One will take place on March 9 at the Environmental Protection Agency’s (EPA) Region 6 office in Dallas, and the other will take place on March 30 at the University of California in Davis.  The specific details for how to participate will be available in the Federal Register soon, but I suspect that the process used at the October 2015 meeting will be instructive.  You will likely have the opportunity to submit comments for up to two weeks following the meeting, whether or not you can attend.

Part of the process involves how best to clarify the roles and responsibilities of the EPA, the Food and Drug Administration (FDA), and the Department of Agriculture (USDA) in the regulation of biotechnology products.  While this is a bit of an oversimplification, at present the EPA is involved with regulating these products as they relate to pesticides and applications of microbial technology.  The USDA is interested in these regulations from the perspective of impacts on plant and animal health, and the FDA is concerned with genetically engineered foods, animals and other products under its domain derived from genetically engineered sources.

Following the three meetings and the associated public comment periods, the agencies will work on an update of their common regulatory framework.  That update will also be subject to public review and comment.  The timeframes for each of these steps will eventually be published in the Federal Register, most likely by the Office of Science and Technology Policy.

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