Further “regulations or guidance” may also be needed on the development and maintenance of qualified cell banks, plus how oversight of the proliferation and differentiation of cells through the time of harvest will work in practice, according to a formal agreement released Thursday.
However, the agencies are still operating within existing parameters, Jessica Almy, director of policy at the Good Food Institute (GFI), a non profit that promotes cell-cultured and plant-based meat, told FoodNavigator-USA.
"The formal agreement is a logical next step from the agencies' announcement last year. It provides some more guidance as to how the agencies plan to proceed and indicates that further details are forthcoming.
"The language about regulations or guidance does not necessarily mean there will be rulemaking with public notice and comments; the agency might instead proceed with guidance to the industry. What the formal agreement makes clear -- which is critically important -- is that the agencies are proceeding under their existing statutory authorities."
Brian Sylvester, special counsel at law firm Wiley Rein, added: “This leaves open the possibility that the Agencies may ultimately choose to undertake rulemaking, which would necessarily include opportunities for public comment.”
He added: “Many critical questions core to developing a functioning regulatory review process remain to be answered: how will the FDA and USDA initiate their respective application processes, how long will it take to obtain premarket approval, and what will inspections of production facilities look like? Further, how should the food products be labeled? The devil will be in the details.”
Premarket consultation processes
Under the agreement, the FDA will oversee cell collection, cell banks, and cell growth and differentiation, with a transition from FDA to USDA’s FSIS (food safety and inspection service) oversight to occur during the cell harvest stage. FSIS will then oversee the production and labeling of foods derived from these cells.
The FDA will conduct a premarket consultation process to evaluate production materials/processes and manufacturing controls, to include oversight of tissue collection, cell lines and banks, and all components and inputs.
It will also oversee initial cell collection and the development and maintenance of qualified cell banks, “including by issuing regulations or guidance and conducting inspections, as appropriate,” and oversee proliferation and differentiation of cells through the time of harvest, “including by issuing regulations or guidance and conducting inspections, as appropriate.”
At harvest, it will then help coordinate the transfer of regulatory oversight to USDA-FSIS, providing information FSIS needs to determine whether harvested cells are eligible to be processed into meat or poultry products that bear the USDA mark of inspection.
It will also ensure that firms register production facilities, apply cGMPs and preventive controls, and may develop additional requirements for cell bank and cell culturing facility conditions and processes to ensure safety. It will conduct inspections of cell bank and cell culturing facilities, but will not inspect activities solely regulated by USDA.
In turn, USDA-FSIS will require each establishment that processes cells into foods, or packages and labels these foods, to obtain a grant of inspection, and will then oversee the inspection regime. It will also require product labels to be pre-approved and verified through inspection – as they are for meat from slaughtered animals - and as needed, may develop additional requirements to ensure the safety and accurate labeling of these foods.
GFI: Agreement represents a significant step forward in providing a transparent and predictable regulatory path to market for cell-based meat’
So does this provide much more clarity than previous statements?
Cell-based meat start-ups welcomed the news, with Just Inc noting that, “Consumers must have confidence that cultured meat products are safe for consumption and appropriately labeled,” and Memphis Meats co-founder and CEO Uma Valeti MD noting that it had “long advocated for joint oversight of cell-based meat and poultry by both USDA and FDA.”
The GFI's Jessica Almy said the agreement was a “significant step forward in providing a transparent and predictable regulatory path to market for cell-based meat.”
She also argued that, “State legislatures ought to pay attention to USDA's clear statement that it will require premarket approval of cell-based meat and poultry labels under the Federal Meat Inspection Act and the Poultry Products Inspection Act. That means not only is state legislation on labeling unnecessary but it is also preempted by federal law."
USCA: ‘Neither federal or state meat inspection stamps should appear on cell-cultured protein products’
However, United States Cattlemen’s Association president Kenny Graner – while welcoming the collaboration between the agencies – said USCA remains “strongly opposed to the utilization of any of the three purple-inked USDA meat inspection stamps for cell-cultured product.”
He added: “A new stamp should be created for cell-cultured products that is inspected by USDA and by state inspection agencies, using a different format and color ink on the stamp. Neither the Federal or State meat inspection stamps should appear on the cell-cultured protein products, retail packaging or wholesale containers.”
Read the agreement HERE.