The move follows a recent request for information from the FDA inviting comment on how cell-cultured seafood (which falls within the FDA’s remit) should be labeled.
In a letter to FSIS signed by AMPS Innovation (a coalition of cell-cultured meat startups including Memphis Meats and BlueNalu) and the North American Meat Institute (NAMI), the two say that labeling of cell-cultured meat products should be mandatory.
They also note that historically, in evaluating the labeling of foods developed using new technologies, the FSIS and the FDA have focused on characteristics of the finished product rather than the process by which the food was made.
For cell-cultured products, however, depending on the approach of different players, the characteristics of some products may vary from those of conventional products, and more information is needed to determine how or whether this should impact labeling, they say.
“Given this need for further data, AMPS Innovation and NAMI recommend that FSIS first issue an Advance Notice of Proposed Rulemaking (ANPR) to obtain more information and supporting data on finished product characteristics for cell-based/cultured meat and poultry products, particularly those that may require labeling.
“This information will provide FSIS with substantive data needed to better inform the agency’s decision-making process, while also ensuring that the current labeling standards remain high.”
Will products be ready to come to market before labeling rules are finalized?
Both the FDA and the USDA have been praised for moving quickly. However, an ANPR, followed by a proposed rule - which will be subject to public comment - will take time, something the startups themselves acknowledge in the letter.
"It is possible and likely that cell-based/cultured meat and poultry products may be ready to come to market before FSIS’s rulemaking process concludes.”
Brian Sylvester, special counsel at law firm Covington & Burling LLP, told FoodNavigator-USA that he didn't think an ANPR would extend the timeline in a meaningful way.
"Instead, it could actually be an efficient means of collecting needed data sooner rather than later to lay the foundation for a proposed rule that addresses top-of-mind stakeholder concerns -- on all sides -- and therefore allow for a more streamlined rulemaking process going forward."
He added: "In federal rulemaking, an ANPR is not required. But it can be useful for particularly hot-button or novel issues -- and the labeling of cell-based meat and poultry certainly falls into both camps.
"The FDA and USDA have moved at record pace to develop a regulatory approach for these products, and they are hard at work as we speak meeting amongst themselves in working groups dedicated to this sector, and with leading start-ups in this space. I therefore anticipate that USDA and FDA will make every effort to work with stakeholders to get these products to market when the technology has scaled and products are ready."
Cell-cultured, cultivated, slaughter-free, cell-based, clean, lab-grown, synthetic, fake…
When it comes to terminology to describe meat grown from animal cells outside of the animal, opinions among key stakeholders vary widely, with some startups favoring ‘cell-based’ or ‘cell-cultured,’ and others favoring ‘cultivated’ or ‘slaughter-free.’ ‘Clean meat/seafood’ is still used by some commentators although it carries the tacit implication that the meat from traditionally raised animals is dirty.
Other terms such as ‘fake meat/seafood’ and ‘synthetic/artificial meat/seafood’ are more typically deployed by opponents of the technology.
When it comes to product safety, cell-cultured seafood remains under the sole jurisdiction of the FDA; while the FDA will work together with the USDA to oversee cell-cultured meat and poultry using existing regulatory frameworks.
Under a joint agreement announced in March 2019, the FDA will oversee cell collection, cell banks, and cell growth and differentiation, with a transition to FSIS (USDA) oversight to occur during the cell harvest stage. FSIS will then oversee the production and labeling of foods derived from these cells,