This post continues the series of discussions, beginning with an August 20, 2018 entry, on regulatory issues relating to the anticipated introduction of human food products produced from cultured animal cells (“cell-based meat” products), as replacements for traditional meat, poultry or fish. I submitted comments to the U.S. FDA on September 24, 2018, during the open-comment period that followed the Agency’s July 12, 2018 public meeting on this topic. My comments were based on, and expanded on, the themes discussed in the previous posts. You can access a copy of my complete comments here, but the following is a summary of the points I raised:
- Production of foods from animal cell culture can be carried out using well-established, reproducible and predictable methods, that can lead to safe, sanitary production of nutritious foods for U.S. consumers, that could even be safer than existing practice.
- There is a long history of the safe use of animal cell culture for research and other purposes, which provides a sound basis for adoption of safe techniques for producing human food through cell culture.
- If a premarket review program is to be established, I recommended that it be based on existing law and regulations to the greatest extent possible. FDA should be the lead agency for any program, and the agency should utilize the existing GRAS Notice program, which has worked extremely well to allow reviews of innovative new food ingredients, or to establish a parallel, but similar program for cell-based meats. Any such program should primarily focus on the composition, safety and nutritive value of the end product, although information about manufacturing methods must be part of the technical review.
- I recommended that FDA should coordinate its efforts with the U.S. Department of Agriculture, to be sure that USDA’s scientific expertise is utilized in any reviews carried out by FDA, and that cell-based meats are subject to existing or amended USDA regulations for sanitary production, facility inspection and labeling, for those foods (meats, poultry and catfish) that are within current FSIS jurisdiction. Both agencies should strive to avoid any jurisdictional battles that would create uncertainty that could stifle an innovative, emerging industry.
As of this writing, FDA received 477 comments on regulations.gov in response to this request. I have not studied these in detail, except to note that they were submitted by a broad range of commenters from industry, academia, NGOs and public interest groups, and also from private citizens. A number of private citizens submitted comments in favor of the development of “clean meat” and for FDA’s role in regulation, while there were also a good number of letters from private citizens opposing a regulatory scheme where FDA was the sole agency, and advocating for a role for the USDA. These latter submissions were all identical, as is often the case with agency public comments, and likely originated from the beef industry. Among the public interest group submissions were comments from animal rights groups, favoring the development of cell-based meats as an alternative to the consumption of animals.
In another related development, on September 13, 2018, the USDA published a notice in the Federal Register announcing that it and FDA will jointly hold a two-day public meeting October 23-24 on cell-based meats. This meeting will focus on several specific questions relating to jurisdiction, potential risks posed by the manufacturing process, provisions for facility inspection and product labeling, among others. Public comments on these topics will be accepted through November 26, 2018. I am making plans to attend the first day of this meeting, which will feature discussion of issues pertaining to potential risks and agency oversight, and afterwards I hope to report on the outcome of the meeting.
Finally, there was an interesting article in Monday’s New York Times about the efforts to develop cell-based production processes to manufacture kosher pork products. No mention of regulatory issues, but interesting speculation about what would be needed for a cell-based meat product or its production process to be certified to be meat-free and therefore “pareve” under Jewish kosher law.
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/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.
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