In 2018, I wrote several posts about the emerging field of cell-based meats and federal government regulatory issues relating to this new field. Although much of the public and industry debate over this technology has quieted down a bit since that time, there have been some developments since my last post on this topic in December 2018.
As outlined in my previous posts, many observers, particularly in the industry, were concerned that jurisdictional disputes may arise between the two federal agencies having regulatory responsibilities that might apply to meat, poultry and fish products produced by cellular agriculture. These fears were somewhat abated when, in March 2019, the U.S. Department of Agriculture and the Food and Drug Administration entered into a Memorandum of Understanding outlining how they intended to work together to create a workable regulatory framework for cell-based meat products. This MOU, announced on March 7, 2019, applied only to meat and poultry products, and it stated that FDA would retain authority over cell-based fish production (other than catfish, which are currently under USDA jurisdiction). Under the MOU, the agencies agreed that, for the anticipated development of cell-based meat and poultry products, FDA would oversee activities relating to cell collection and proliferation, e.g. cell banks and cell culturing facilities, while USDA would oversee processing, packaging and labeling of cell-based meat products, including facility and product inspection. The MOU further identified areas where the agencies would work together, and it indicated that any emerging regulatory framework would likely rely on existing regulations, but that the agencies would review the possible need for new rules.
The issuance of the MOU seemed to quiet the debate somewhat, and in the months since then there has not been much activity in the public eye regarding an appropriate regulatory framework. To some extent this may be because the technology is still emerging, and aside from the well-publicized (and rapid) growth and public acceptance of plant-based products from companies like Impossible Foods and Beyond Meat, there doesn’t seem that any company is close to wanting to introduce a cell-based meat, poultry or fish product. To my knowledge, there has only been one product in this space which has successfully cleared the U.S. regulatory system, and that is the GRAS Notice submitted by Impossible Foods for the soy leghemoglobin from genetically modified microorganisms that it uses to provide texture to its plant-based meat products, which received FDA’s “no questions” letter in July 2018.
The latest development in this story came on April 7, 2020, when the U.S. General Accountability Office (GAO) released a report it prepared on federal oversight of cell-cultured meat. The GAO is an independent arm of the government that carries out nonpartisan studies of various topics, generally at the request of Members of Congress or other federal officials. This report, entitled “Food Safety: FDA and USDA Could Strengthen Existing Efforts to Prepare for Oversight of Cell-Cultured Meat” was carried out at the request of Representative Rosa DeLauro, who is the Chairwoman of the Subcommittee on Labor, Health and Human Services, Education, and Related Agencies of the House of Representatives Committee on Appropriations. The full report can be downloaded from this site.
Although this report does not break any new ground or move the public debate forward, it offers a fairly complete current overview of the situation. Much of the report is devoted to a detailed summary of the science behind cell-cultured meats, including a discussion of several areas where technological details are unknown or are still being worked out (e.g. will the process make use of genetically modified cells? What types of materials will be used as the scaffolds to grow animal cells into the desired shape and texture?). And the report summarizes the developments on the federal regulatory front since 2018, including the joint meetings and other activities that preceded the March 2019 MOU. The document reports on one development that I had not previously seen reported publicly, which is that In June 2019, FDA and USDA created three working groups to carry out the terms of the interagency MOU. The working groups are comprised of FDA and USDA officials, and were described in the GAO report as follows:
- Pre-market assessment working group. Led by FDA, this group was created to clarify the process FDA will use for pre-market reviews of cell-cultured meat.
- Labeling working group. Led by USDA, this group will focus on developing joint principles for product labeling and claims.
- Transfer of jurisdiction working group. Co-led by FDA and USDA, this group will develop procedures for the transfer of inspection at harvest, among other things.
The GAO report indicates that the work of these groups is still in the early stages, although two of the working groups held meetings in December 2019.
The main recommendation of the report is that, while the March 2019 MOU represents a good start, and that interagency cooperation is essential, both agencies should better incorporate certain “leading practices to enhance and sustain interagency collaboration”. These are seven principles that the GAO had previously developed to guide federal agencies towards more effective collaboration. I won’t attempt to summarize these here – although they doubtlessly provide important and useful guidance to federal agencies, to the layperson they read like common sense advice for conducting effective collaborations that would also be applicable in the corporate world.
Historically, the GAO and its reports have often proven useful in guiding federal policy and public debate on questions of how best to regulate emerging technologies: this has particularly been true at various critical stages in the early growth of the biotechnology industry. Although this report doesn’t provide any new technological insights or make any substantive recommendations for policy or regulation, it does provide a comprehensive overview of many of the issues that have been discussed to date, and will hopefully serve to continue to move regulatory discussions forward.
D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels, industrial biotechnology and related field. 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/djglass99and 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.