After nearly a year of bureaucratic jockeying, FDA and USDA have agreed to work together to establish a regulatory framework in which the two agencies would jointly oversee the production and marketing of cell-based meat and poultry products.
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“Both the USDA and the FDA should jointly oversee the production of cell-cultured food products derived from livestock and poultry,” the agencies announced in mid-November. FDA will oversee cell collection, cell banks, and cell growth and differentiation. USDA oversight will begin from the cell harvest stage, and will continue during the production and labeling of food products. The agencies are “actively refining” the technical details of the framework, and believe they have sufficient statutory authority without the need for additional legislation.
Cell-based meat—also called “clean meat” by supporters and “lab-grown fake meat” by detractors—refers to animal tissue grown or cultured under controlled conditions using muscle or other cells from living animals, such as beef, pork, and poultry. While the process remains costly, supporters say cell-based meat can help fulfill the growing worldwide demand for high-quality protein and be produced in an environmentally friendly and sustainable manner, without the need to raise and slaughter animals.
The regulatory boundaries are somewhat vague. While FDA has purview over most food products, USDA has primary authority over meat, poultry, and most egg products. And FDA, not USDA, is typically involved in labeling disputes.
There are at least two issues of contention: regulatory oversight, namely which government agency or agencies would have jurisdiction over these products and how they should be regulated; and package labeling and claims, including what these products can be called.
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The U.S. meat industry, including cattle growers, have objected to labeling any such products as “meat,” at least without extensive clarifiers, and maintain that USDA should have primary oversight.
Companies developing cell-based meat, on the other hand, insist there is no difference between muscle tissue obtained from a living animal and the same tissue that is grown in culture. They have favored oversight by FDA because that agency already regulates biotechnology products, which are manufactured in bioreactors using similar techniques, as well as beverages and foods produced by fermentation.
Until recently, FDA and USDA officials had also supported these delineations. In July 2018, FDA convened a public meeting at its headquarters to explore the potential safety hazards and regulatory challenges in cell-cultured products.
“Our past experience with novel food technologies and our extensive background in cell-culture technologies in the medical products space will help inform our approach to evaluating the safety of these cell-based food products,” said FDA Commissioner Scott Gottlieb, MD, in kicking off the two-day meeting.
It was evident that FDA had not invited anyone from USDA to participate. “I’m both surprised and disappointed,” commented Tiffany Lee, DVM, director of regulatory and scientific affairs at the North American Meat Institute (NAMI). “Primary jurisdiction over the regulation of cell-cultured meat products rests with the United States Department of Agriculture,” she told the gathering during the public comment portion.
But FDA hadn’t been alone in seeking to carve out its turf; Agriculture Secretary Sonny Perdue had been working Capitol Hill to cement USDA’s role as the sole regulator of cell-cultured meat products.
“Obviously there are some gray lines between FDA and USDA on many things,” Perdue told the House agricultural appropriations subcommittee in April 2018. “But meat and poultry has been the sole purview of USDA. We would expect any product that expects to be labeled as meat would come under that same inspection criteria.”
Lawmakers evidently agreed and, with the reported assistance of staffers from USDA’s Food Safety and Inspection Service, inserted language into the final appropriations bill authorizing USDA to be in charge of regulating “products made from cells of amenable species of livestock…or poultry.” The one-sentence directive charged USDA with issuing rules regarding inspections for manufacturing, processing, and preventing adulteration or misbranding of cell-based foods.
Industry Offers Compromise
Ironically, a solution to the agency oversight problem appears to have been spurred by industry. Memphis Meats, a developer of cultured meat, and NAMI suggested in a joint Aug. 23, 2018 letter to President Trump that FDA and USDA should both play important roles.