Regulation of Cell-Based Meats: update on some new developments

As 2018 ends, I’m writing with a brief update on recent activity regarding the emerging field of cell-based meats and efforts by the U.S. government to establish a framework for regulation of such food products.

As I have previously reported, on September 13, 2018, the USDA published a notice in the Federal Register announcing that it and FDA would jointly hold a two-day public meeting October 23-24 entitled “The Use of Cell Culture Technology to Develop Products Derived from Livestock and Poultry”. The goals of the meeting were to focus on several specific questions relating to jurisdiction, potential risks posed by the manufacturing process, provisions for facility inspection and product labeling, among others.

I attended the first day of this public meeting, which was devoted to “Oversight, Hazards and Controls”. The second day, held on October 24, focused on “Labelling” issues, but due to a prior commitment, I was not able to stay in Washington for the second day of the meeting.  This two-day session followed a sparsely-attended meeting on October 22 of FDA’s Science Advisory Board with an agenda largely addressing these issues: although I did not attend that meeting, it and the topics discussed at that meeting were frequently mentioned during the October 23 joint meeting.

I wasn’t able to post any detailed observations or comments on the meeting in its immediate aftermath, but I’ll offer a few brief comments here. First, I think all attendees where glad to see the FDA and USDA cooperating on this meeting and in their efforts to oversee the industry (more on that below). But I was also struck by the fact that neither agency seemed inclined to propose new regulations to cover this industry, and in fact most of the discussion about possible regulatory programs focused on “downstream” programs for facility inspection rather than “upstream” or pre-market review and approval of proposed food products.

Predictably, there was also discussion about potential risks, most of which were brought up by the environmental or public interest groups in attendance. Several of these commenters mentioned potential risks that to my knowledge had not previously been suggested in the public debate, such as the risk that cell-based products that originated from animal stem cell cultures might contain cancer tissue or other mutations that might have harmful effects in the food product.  In general, I feel that some of those risks are overstated or don’t go much beyond the hypothetical, and that those risks which can be foreseen with a better level of probability can be managed by known techniques, such as well-established protocols for biological containment and aseptic technique.

My thoughts on such hypothetical risks and other issues can be found in the comments I submitted to the public docket before the close of the comment period on December 26, 2018. You can find my comments here; and the page for the entire public docket can be found here.  As of this writing, 315 comments were received in the public docket, from a range of commenters including industry, agricultural trade groups, public interest groups and private citizens.

Following the October public meeting, and before the comment period was even closed, USDA and FDA issued a statement on November 16, 2018 to announce that the agencies would work together to develop a regulatory framework for cell-based meats. The statement said:

“Drawing on the expertise of both USDA and FDA, the Agencies are today announcing agreement on a joint regulatory framework wherein FDA oversees cell collection, cell banks, and cell growth and differentiation. A transition from FDA to USDA oversight will occur during the cell harvest stage. USDA will then oversee the production and labeling of food products derived from the cells of livestock and poultry.”

The details of this cooperative effort, and what it means for the cell-based meat industry, of course remain to be seen. However, it is certainly a positive development to see the agencies working together, so that a divisive turf battle, which would adversely affect all stake-holders, will not develop.

I’ll continue to follow this emerging field in the new year, and comment in new blog posts as appropriate.

D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels, industrial biotechnology and related fields. 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.