Lab-Based Oversight

After months of debate among livestock ‌groups and the emerging cell-cultured ‌protein industry, Agriculture Secretary Sonny Perdue and Food and Drug Administration Commissioner Scott Gottlieb have announced both USDA and FDA will play a role in regulating cell-cultured food products.

The two agencies have held both separate and joint meetings on the issue since last summer, after livestock groups demanded USDA take a lead position in inspecting meats derived from cell cultures, while leaders in the emerging cell-cultured industry wanted FDA to take a lead role in inspections. In October, USDA and FDA held a two-day joint meeting on the issue and opened a public comment period that extended to Dec. 26.

USDA and FDA already share roles in the inspection of food. USDA’s Food Safety and Inspection Service oversees inspection of meat and poultry products, while FDA regulates most other food products.

SHARED RESPONSIBILITIES. The two agency heads announced an agreement on a joint regulatory framework in which FDA will oversee cell collection, cell banks, cell growth and differentiation. USDA will then oversee the production and labeling of food products derived from cells of livestock and poultry.

“And, the agencies are actively refining the technical details of the framework, including robust collaboration and information sharing between the agencies to allow each to carry out our respective roles,” the agency heads state.

The decision comes as several companies are investing more heavily in products that come from cattle or poultry cells that are then developed in a lab. Tyson Foods and Cargill Protein, two of the largest meat companies in the world, are among those businesses that are investing in start-up companies beginning to make such products commercially viable.

Perdue and Gottlieb say that kind of dual regulatory oversight will take advantage of FDA’s expertise in cell-culture technology as well as USDA’s expertise in regulating livestock and poultry products for human consumption. Given the two agencies also have statutory authority in these areas, they state they believe legislation on cell-cultured products is necessary.

INDUSTRY REACTION. The decision is in line with a request by the North American Meat Institute and one of the major companies developing cell-cultured products, Memphis Meats, which jointly wrote President Donald Trump in August asking for FDA and USDA to share regulatory responsibilities for what they called “cell-based meat.”

The announcement will leave USDA with the sticky function of defining what exactly to call or label cell-cultured products, which is going to be considered critical for both educating consumers about future products on the shelf and also marketing those products.

Groups such as the National Cattlemen’s Beef Association (NCBA) and U.S. Cattlemen’s Association--often at odds on certain issues--are both adamant that cell-cultured proteins should not be called “meat” or “beef.” NCBA President Kevin Kester testified on that topic at the two-day hearing in October.“Lab-grown fake meat manufacturers must not be permitted to use the term ‘beef’ and any associated nomenclature,” Kester said at the hearing. “NCBA firmly believes that the term ‘beef’ should only be applicable to products derived from livestock raised by farmers and ranchers.”Companies that are starting to develop cell-cultured proteins from beef, poultry and fish cells dub their products “clean meat,” which their lobbying organization, The Good Food Institute, prefers over “lab-based” or “lab-grown” products.

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