The meeting – announced as key stakeholders in the emerging cell-cultured meat industry met at an industry conference to discuss plans to form a trade organization – will “focus on the potential hazards, oversight considerations, and labeling of cell cultured food products derived from livestock and poultry,” according to a statement issued Monday.
“This is an important opportunity to hear from the agricultural industry and consumers as we consider the regulatory framework for these new products,” said USDA Secretary Sonny Perdue. “American farmers and ranchers feed the world, but as technology advances, we must consider how to inspect and regulate to ensure food safety, regardless of the production method.”
FDA Commissioner Scott Gottlieb added: “Recent advances in animal cell cultured food products present many important and timely technical and regulatory considerations for the FDA and our partners at USDA.”
The first day of the meeting will focus primarily on the potential hazards that need to be controlled for the safe production of animal cell cultured food products and oversight considerations by regulatory agencies, while the second day will focus on labeling, said the agencies, who are also inviting further public comment on the issue (in addition to comments submitted following the FDA’s July 12 meeting on the same topic).
Memphis Meats, NAMI: FDA and USDA both have roles to play
The meeting follows a letter sent to the White House last month in which cell-based met start-up Memphis Meats and the North American Meat Institute (NAMI) proposed “a combined meeting between the White House, USDA, FDA, and both conventional and cell-based meat and poultry industry stakeholders,” to thrash out who should regulate cell-based meat and what to call it.
Existing law and practice, coupled with “longstanding precedent,” demonstrate that the FDA and the USDA both have roles to play, they added, with the FDA best placed to handle pre-market safety evaluations, and the USDA best placed to handle matters thereafter.
FDA has extensive expertise evaluating products produced using cell culture technology, while USDA has a longstanding role in inspecting meat and poultry products, they explained.
“Historically, for evaluations relating to meat or poultry products, USDA has provided input to FDA as part of this process. Given USDA’s expertise in regulating meat and poultry, that role should continue.
“After pre-market safety has been established with FDA, USDA should regulate cell-based meat and poultry products, as it does with all other meat and poultry products, applying relevant findings from FDA’s safety evaluation to ensure products are safe, wholesome, and properly labeled.
As for nomenclature, they said: “Recognizing a shared desire to support innovation and feed the world, moving forward we will use the term ‘cell-based meat and poultry’ to describe the products that are the result of animal cell culture.”
Cattlemen: 'USCA remains concerned about the use of the term 'meat'
The US Cattlemen's Association said that it was advocating “a three-prong approach in the jurisdiction of this product – involving Congress, USDA, and FDA,” but said it would “continue to push for accurate labeling that maintains the integrity of the word 'U.S. Beef.’
"USCA remains concerned about the use of the term 'meat,' but the commitment to come to the table to propose solutions is a step in the right direction."
Attorney: I think a lot of this can take place without substantial rule making
So what might the regulatory framework look like?
Brian P. Sylvester, a former USDA regulatory lawyer and special counsel in Wiley Rein’s food, drug and medical device law practice, told FoodNavigator-USA that the joint meeting was an exciting development given the previous tensions between the agencies over who might be in charge.
He added: “The way they handled cloning was a good example of how I think things might work for cell-based meat [whereby] the FDA did a pre-market risk assessment of the technology and the USDA took over day to day oversight and labeling. Or I could see this as being similar to the voluntary consultation process for biotechnology [whereby developers consult with FDA on safety issues and can ask FDA to review their scientific and regulatory assessments and secure a ‘No Questions’ letter if the agency is satisfied].
“But USDA would likely lean heavily on the FDA as it pertains to this technology.”
This might require no more than a memorandum of understanding between the departments, he added: “I think that a lot of this could take place without substantial rule-making, although there could be some rule-making needed in terms of the inspection requirements, because these are currently tailored towards animals slaughtered for food.”
But given that the USDA has no experience of inspecting cell-based production facilities, why involve it at all post market? And given the production process would likely be consistent once established, would it make sense to have USDA inspectors in cell-based plants full time?
“FDA certainly would be capable of doing it,” he added, “But given the realities of the marketplace and the political climate they need to find a compromise.”
As for the nature of inspections, he said, “Inspectors wouldn’t be standing in a room staring at a bioreactor, but what that [an inspection] might look like will be fleshed out and better understood during this consultation process. Maybe they don’t need to be there all the time, for example.”
Is it 'meat'?
So what does he make of the term ‘cell based meat’?
The term is more feasible than ‘clean meat’ from a regulatory perspective because it does not imply any value judgements or disparage conventional meat, and could meet the ‘truthful and not misleading’ criteria, he added. “But I think the jury is still out.”
As to whether cell-based meat is, well, meat, Sylvester said he agreed with Memphis Meats that it meets USDA's current statutory definitions.
Clean meat, cell-based meat, cell-cultured meat, lab-grown meat, in-vitro meat, new meat?
The term 'clean meat’ – coined because cell-based meat is cultured in a sterile environment and because it has a lower environmental footprint (like 'clean energy') - has become more widely used in the media over the past year as the Good Food Institute has sought to popularize the term.
However, it has had some pushback, given its tacit implication that regular meat is 'dirty,’ coupled with confusion over what it means, although it’s clearly more consumer-friendly than ‘synthetic,’ 'lab-grown’ and 'in-vitro’ meat.
So will 'cell-based' meat - a term preferred by the North American Meat Institute and cell-based meat firm Memphis Meats - find favor with consumers and regulators?
