Loyola University Chicago School of Law, JD 2020
Following a public meeting in October, the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) agreed to share joint regulation of cell-culture “meat” technology. This decision came on the tail end of public squabble between the two regulatory bodies regarding the oversight of cell-culture, or lab-produced meat. The regulatory framework for this type of quasi-agriculture has been unclear, especially after the White House Office of Science and Technology Policy issued the Coordinated Framework for the Regulation of Biotechnology initiative that attempted to coordinate the roles of various agencies involved in emerging biotechnology. The new, definitive regulatory structure has been thoroughly praised and welcomed by top cell-culture meat companies, who have expressed open frustration with the older, confusing framework, claiming that it hindered both consumer protection and technological innovation.
Regulatory Confusion and Overlap Between the FDA and USDA
The battle between the two regulatory bodies began when the FDA first solicited comments on cell-culture meat technology, while the USDA asserted its oversight authority over new meat products being introduced to consumers. The problem is that both agencies are tasked with the responsibility of monitoring the quality of the United States’ food supply to ensure products we consume are unadulterated, wholesome, and properly labeled. The Food Safety Inspection Service (FSIS) is a branch of the USDA that implements the Federal Meat Inspection Act pursuant to 21 U.S.C. 601 and 21 U.S.C. 451. It is responsible for ensuring the safety and quality of meat sold in the United States. The FDA is one of the regulatory agencies in the U.S. responsible for monitoring the safety of potentially-consumable biotechnology, pursuant to the Coordinated Framework for the Regulation of Biotechnology. While there appears to be a clear delineation in the responsibilities of the FDA and USDA at first glance, the unique nature of cell-culture meat production allows both agencies to assert regulatory control over this meat.
Cell-culture meat is cell-based. It is produced using poultry and livestock cells that have the ability to self-renew, otherwise known as stem cells. The stem cells are placed into bioreactor tanks and fed nutrients and oxygen to promote muscle tissue growth. FDA’s experience regulating cell-culture technology and living biosystems makes it an apt body to regulate meat that is grown via non-traditional and non-agricultural methods. However, because cell-culture meat is derived from poultry and livestock cells, it is technically a meat product that would otherwise be regulatable under USDA authority.
At the time of the announcement, the agencies did not release further details about the specifics of the regulatory framework, or the breakdown of responsibilities, but the proposal for oversight could look something like this: “after pre-market safety has been established with FDA, [the] USDA [would] regulate cell-based meat and poultry products, as it does with all other meat and poultry products, applying relevant findings from FDA’s safety evaluation to ensure products are safe, wholesome and properly labeled.” The proposed framework is a hand-off system, where the FDA will oversee cell collection, cell banks, and cell growth and differentiation. When tissue growth has finished, oversight will transfer to USDA, which will then regulate the production and labeling of cell-cultured meat. Once in the marketplace, cell-culture meats will be treated similarly to carcass-derived meats. Although the announcement lacked formalized terms for the oversight, various public and private entities, like the U.S. Cattlemen’s Association and Memphis Meats, welcomed the proposal. Both generally support the proposed regulatory and labelling practices as well as the recognized importance of pre-market safety testing.
Shifting Trends in Meat Consumption Force the Availability of Alternatives
It is to crucial determine a regulatory framework for this type of meat, because “cell-cultured meat developers are part of a new wave of alternatives to traditional meat production, appealing to consumers’ concerns over the environmental impact of cattle feedlots and hog manure lagoons, [as well as] the billions of tons of feed grains they consume each year.” The move toward “clean meat,” or meat grown via non-agricultural methods, comes in response to the shifting trends in meat consumption. Many Americans currently forego meat in favor of plant-based alternatives that are readily available and do not contribute to environmental and humanitarian concerns. Proponents of lab-grown meat note that “avoiding slaughtering animals will reduce both suffering and greenhouse emissions – and is a sustainable option to feed growing populations hungry for protein.” Although this type of meat is not yet available to consumers, a number of U.S. cell-cultured meat companies are developing products that could be available in certain markets within the next three years.