Updating the Biotechnology Coordinated Framework: New Developments

As I’ve reported in previous blog posts, in July 2015 the White House Office of Science and Technology Policy issued a memorandum to the heads of the EPA, the U.S. Department of Agriculture, and the Food and Drug Administration, directing these agencies to begin a review of their biotechnology regulations under the 1986 “Coordinated Framework”, to determine whether revisions, updating, or other changes might be needed in view of new technologies and other developments since the adoption of the framework, as well as “to modernize the Federal regulatory system for the products of biotechnology and to establish mechanisms for periodic updates of that system”. As I’ve previously reported, and as covered elsewhere in the media, these agencies held a series of public meetings running from the fall of 2015 through March 2016, and solicited public comment on these questions.

Last Friday, September 16, the White House announced that EPA, FDA, and USDA have released two documents resulting from this process. The first is billed as “A Proposed Update to the Coordinated Framework for the Regulation of Biotechnology”, and the second is entitled “National Strategy for Modernizing the Regulatory System for Biotechnology Products”. The notice from OSTP said that
“Together, these documents present a comprehensive summary of the current roles and responsibilities of the three primary regulatory agencies with respect to the regulation of biotechnology products and a vision for ensuring that the Federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology”.

I have not yet had the chance to review them in detail (the first document runs 60 pages), and I will plan to post a more detailed analysis on the blog in the days to come. But at first glance, these documents don’t contain a great deal of new information and certainly (in spite of the title of the first document) do not appear to contain any proposals for significant revisions or amendments to the regulations. The first document simply restates well-known agency jurisdiction, albeit in convenient tabular form, and perhaps better identifying potential areas of overlap for some product categories. It also reprints the various “case studies” that were presented at the public meetings in March 2016. And the second document primarily discusses ways in which these three agencies keep the public informed about their activities and the contents of their regulations, along with proposals for how such transparency could be improved in the future. To be sure, the documents characterize one goal of the effort as the mission to “update the Coordinated Framework … by clarifying current roles and responsibilities”, so by this token, the first of these documents can be seen as fulfilling this mission, while not offering very much new information.

I plan to follow up this post with a more complete analysis of these documents, and the status of the OSTP effort to update the Coordinated Framework, in the days to come.

D. Glass Associates, Inc.is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99 and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.