January 21, 2020
The Regulation of Cell-Cultured Food Products
Written by Chloe Marie – Research Specialist
Cell-cultured “meat” is currently not commercially produced or available in the United States; however, it likely is only a matter of time before this product will be available to consumers as many food technology companies have invested substantially into the making of cell-based food products as an alternative to meat derived from slaughtered animals. As the technology for this product continues to develop, federal and state governments along with the agricultural industry have begun discussing and debating how to best regulate the production, processing, and marketing of cell-cultured food products.
For example, the National Conference of State Legislatures identified a total of 26 states that have either passed or introduced cell-cultured food product legislation, including the states of Arkansas, Kentucky, Louisiana, Missouri, Montana, South Dakota, and Wyoming, among others. The issue of adequate labeling and marketing of cell-based “meat” has been widely debated among the various state legislatures and many have restricted the use of meat terminology to describe artificial or plant-based food products. This article, however, will not consider the appropriate terminology of cell-cultured “meat” at the state-level and will address instead actions taken at the federal level to oversee the regulation of the cell-cultured food process.
This article also intends to supplement a prior article, dated March 2019, that was written by Research Fellow Brigit Rollins and Staff Attorney Rusty Rumley from our partner, the National Agricultural Law Center, on the regulation of “cell-cultured meat”.
What is Cell-Cultured “Meat”?
First and foremost, the process of growing cell-cultured “meat” consists of taking a small sample of meat tissue from a live animal. The cells are then banked and isolated in a medium containing a nutrient-rich solution designed to boost their proliferation and growth. Once enough cells have grown, they are separated into different types of cells depending on the kind of product desired. For example, some cells may be cultured for creating muscle, fat, or connecting tissue. The cells are then loaded into a bioreactor used to grow and expand the number of these cells until they become “meat.” These cells can subsequently be harvested and processed into food for human consumption.
Food technology companies have stressed that “meat” obtained through the process of cultured cells is the same biologically as the meat manufactured through the traditional manner. Advocates of this new process claim it will eliminate concerns that some individuals have with regard to animal welfare and environmental issues associated with modern agriculture. Certainly, as with many other new technologies, questions have been raised as to the regulatory structure that is appropriate. Who should regulate the production, processing and marketing of cell-cultured “meat?”
A Regulatory Debate: USDA v. FDA
Both the Food Safety and Inspection Service (FSIS) within the U.S. Department of Agriculture (USDA) and the U.S. Food & Drug Administration (FDA) have general authority over distinct aspects of food safety, inspection, and labeling. Specifically, USDA FSIS is responsible for the regulation of most meat, poultry, and egg products while FDA is charged with regulating the safety of all other foods. It is unclear which of these agencies would have authority to regulate cell-cultured food products. This lack of clarity has led different stakeholders to advocate for a particular regulatory system based upon their viewpoints.
In this regard, the U.S. Cattlemen’s Association (USCA) petitioned USDA FSIS in February 2018 calling for a prompt development of requirements relating to beef and meat labeling. USCA was concerned over the absence of a clear definition of what constitutes beef or meat and therefore that the general public and consumers would be misled about the origin of these alternative “meat” products due to the absence of proper labeling requirements. More particularly, USCA sought to restrict the definition of the terms “beef” to product from cattle born, raised, and harvested in a prescribed manner and that the definition of “meat” only includes tissue or flesh of animals reared in the traditional manner. USCA also made the request to exclude from these definitions any “synthetic products made from alternative proteins,” such as plant or insect-based products, or any lab-grown “meat” product. In addition, USCA requested that these requirements be applied not only to U.S. beef and meat products but also to those coming from abroad. USCA also asked that the beef and meat definitions be added to the FSIS Food Standard and Labeling Policy Book. At the moment, this petition is still being reviewed by USDA FSIS.
Similarly, the American Farm Bureau Federation along with the American Sheep Industry Association, National Cattlemen’s Beef Association, National Chicken Council, National Pork Producers Council, National Turkey Federation and the North American Meat Institute issued a letter, dated July 26, 2018, asking President Donald Trump to give full jurisdiction to USDA FSIS for the regulation of cell-cultured meat. The industry group emphasized that USDA is “uniquely equipped” to oversee the production, processing, and marketing of cell-based food products.
A month later, Memphis Meats, a California-based food company, and the North American Meat Institute called for the Trump administration, USDA FSIS, and FDA to establish a comprehensive regulatory framework for cell-cultured food products. In a letter dated August 23, 2018, they stated that “both the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) have roles to play in regulating cell-based meat and poultry products. To ensure the regulatory system protects consumers while fostering innovation, it is imperative that the agencies coordinate and collaborate in their efforts, consistent with established policy.”
In an effort to provide clarification, USDA FSIS and FDA officials initiated a discussion with the public over a two-day period on October 23 and 24, 2018, to address possible ways to govern and label cell-cultured meat and poultry products. Subsequent to the meeting, USDA Secretary Perdue and FDA Commissioner Gottlieb issued a joint statement on November 16, 2018, indicating their intention to share responsibility for the regulatory oversight of cell-cultured meat and food products. Both agencies recognized that each of their expertise and research knowledge in the development of cell-cultured food products would be highly beneficial for their proper regulation. Interestingly enough, and according to the agencies, “[b]ecause [they] have the statutory authority necessary to appropriately regulate cell-cultured food products derived from livestock and poultry the Administration does not believe that legislation on this topic is necessary.”
Regulating Cell-Cultured “Meat” Products: A Joint Collaboration between USDA and FDA
Following this statement, USDA FSIS and FDA announced on March 7, 2019, the details of a formal agreement that provides further explanation on the question of who regulates what and allocates responsibilities and defines the roles and powers of each agency in overseeing cell-cultured meat production, processing and labeling.
FDA shall be responsible at first for conducting premarket consultations and assessing whether the cell-cultured meat is safely produced. The agency will then be responsible for supervising cell collection from live animals and banking. FDA shall also oversee the proliferation and differentiation of the cells. In addition, FDA will be tasked with performing inspection and follow-up activities to make sure that those food companies duly comply with their regulatory obligations.
Once the cells are ready to be harvested, FDA will shift its regulatory authority to USDA FSIS, which will in turn be responsible for product processing, packaging and labeling. Specifically, USDA FSIS will be in charge of monitoring and inspecting all facilities involved in the development of cell-cultured meat and will approve marking inspection. At any time, USDA FSIS and FDA must communicate information to each other in order to ensure the proper safety of the cultured cells. USDA FSIS agreed to work collaboratively with FDA on developing new labeling requirements through a rulemaking process as well as guidance to the industry.
References
American Farm Bureau Federation et al., Letter Re: Cell Cultured Meat (July 26, 2018)
Memphis Meats and North American Meat Institute, White House Letter (August 23, 2018)
Additional Resources
This material is based upon work supported by the National Agricultural Library, Agricultural Research Service, U.S. Department of Agriculture.
