Slides Posted from BIO World Congress Presentation on Updating U.S. Biotechnology Regulations

I’ve posted my slides from my presentation last month at the 2016 BIO World Congress on Industrial Biotechnology. My talk was entitled “Updating the Coordinated Framework: What does it mean for biofuels and bio-based chemicals?”, and you can find the slides here.

The presentation described the ongoing effort, initiated by the White House in July 2015, to review and update (“modernize”) the federal government’s Coordinated Framework for Biotechnology Regulation, which has been in place since 1986 with only relatively minor revisions since that time. Since beginning this effort in July, the White House Office of Science and Technology Policy (OSTP) has convened an interagency Working Group, it has coordinated several public meetings to discuss the Framework and how it regulates biotech products, and it has commissioned the National Academy of Sciences to conduct a study predicting the future landscape of biotechnology products. In addition, both EPA and USDA have held public hearings and/or public comment periods on specific topics within their biotechnology regulatory programs.

Although this interagency effort remains in progress, the original charge from the White House was to come up with results and recommended changes to the Framework within one year. OSTP says it will meet this goal by publishing its recommendations and any proposed revised regulations by the summer of 2016. Until then, it is hard to know exactly what will be the result of the process, but in my talk, I predicted the outcomes would include:

  • Few, if any, significant changes in agency regulations that might affect industrial biotechnology, other than the possibility of substantial revisions to the USDA biotechnology rules to broaden their scope to allow the agency to assess noxious weed risks and other potential ecological impacts.
  • Clarification of how new technologies such as synthetic biology, gene-editing methods like CRISPR, and other new tools of biotechnology might be treated under the agency regulations in the Framework.
  • Greater communication and coordination between the agencies, including the possible creation of a central clearinghouse for regulatory information.
  • The possibility that the agencies may need to address the substantial volume of comments that can be expected from the sector of the general public opposed to some aspects of biotechnology, and the risk that this could lead to stricter biotechnology regulations, particularly in agriculture and foods.
  • The likelihood that industrial biotechnology will be impacted to a greater extent by other regulatory changes, such as the political fate of the Renewable Fuel Standard, the possible (although likely limited) impact of any TSCA reform bill that Congress may pass, and the ongoing efforts by FDA and the Association of American Feed Control Officials to better harmonize their review processes for new animal feed ingredients.

I’ll report on any further developments in this process as they occur later this year.

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.