Regulating Cell-Cultured Meat: A Battle of the Agencies

Editors’ Note: This is a new feature in The 10-Q, which abstracts and highlights outstanding business law papers written by Temple Law students. The following is derived from a paper, which won the Jack M. Golden and Frieda Golden Prize.

According to the Food and Agricultural Organization of the United Nations, world food production will need to increase by 70% by 2050 in order to feed what will then be an estimated population of 9.6 billion. Feeding that many people with traditional meat production would require nearly double the amount of deforestation and increase greenhouse gas emissions by 77%. Such dramatic increases would not be sustainable for a rapidly growing population.

Cell-cultured meat (“CCM”) provides an alternative to address the food shortage and environmental harms stemming from an unsustainable food production system by offering to cut dramatically carbon emissions and land use for meat production. However, as CCM companies gear up to hit the market, the regulatory system’s resistance to fitting such products within the existing regulatory framework will be tested.

Cell-cultured meat is produced by in vitro cultivation of animal cells. Although the cell-culture production process is currently more expensive than conventional meat production, the cost of developing cell-cultured meat has continued to drop exponentially. Current estimates project that mass production could be feasible within the next 5 years. However, with no formal regulatory plan in place to oversee CCM production, inspection, or labeling, CCM producers have been left in regulatory limbo.

As a result, both the U.S. Department of Agriculture’s Food Safety and Inspection Service and the Food and Drug Administration’s Center for Food Safety and Applied Nutrition initiated a highly contentious jurisdictional battle to claim regulatory authority over CCM in early 2018. The USDA argued that the Fair Meat Inspection Act (“FMIA”) granted it authority to “inspect and develop labeling requirements for meat and other animal products,” while the FDA fought back by saying that its broad grant of authority by the Federal Food, Drug, and Cosmetic Act (“FDCA”) to regulate “food, articles used for food, and articles used for components of any such article” afforded it a stronger jurisdictional claim. However, the novel features of CCM posed challenges because CCM products do not fall squarely within either the FMIA or the FDCA.

Notwithstanding the regulatory turf war between the USDA and FDA, a joint public meeting was held in October 2018 to discuss the future of CCM regulation, including the potential for joint agency regulation. While the future of this partnership remained in flux for several months after the joint public meeting, the year-long battle of the agencies finally came to a head earlier this year. In March 2019, the FDA and USDA released their highly anticipated memorandum of understanding (“MOU”) to announce their division of powers in jointly regulating CCM.

Under the MOU, the FDA will conduct pre-market consultations and oversee the collection and growth of cultured cells for use in CCM, while the USDA will oversee the processing of those cells into meat, including the implementation and enforcement of labeling requirements. While the MOU has been a crucial step toward establishing a cell-cultured meat regulatory framework, CCM companies should not expect to see a formal detailed plan anytime in 2019. In the meantime, CCM producers will have to wait patiently for the USDA and FDA to release a fully detailed and flushed out framework.

Dina Gayanova (LAW ’19) is an incoming associate at Buchanan Ingersoll & Rooney PC, where she will be a member of the firm’s Healthcare Group.

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