Cell-Cultivated Meat: An Overview

Cell-cultivated meat is developed in a lab, grown from a sample of animal cells that does not require the slaughter of animals. Developing cell-cultivated meat involves five steps: (1) taking a biopsy of animal cells, (2) cell banking, (3) cell growth, (4) harvesting, and (5) food processing. Introduction of Cell-Cultivated Meat into the U.S. Market The first cell-cultivated meat product developed for human consumption was created in 2013 by a scientist from Maastricht University in the Netherlands. In 2022, the U.S. Drug and Food Administration (FDA) provided premarket review and approval for two companies, GOOD Meat and UPSIDE Foods, to sell cell-cultivated chicken in U.S. markets. On June 30, 2023, the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) issued the first-ever grants of inspection to the two companies to produce cell-cultivated chicken in their facilities, and to label their products as “cell-cultivated chicken.” This was the first time that FDA and USDA regulators had approved companies to produce cell-cultivated meat products to be sold in the United States. In July 2023, UPSIDE Foods and GOOD Meat sold the first cell-cultured chicken at restaurants in San Francisco and Washington, DC, respectively. USDA and FDA are jointly regulating the production and labeling of the new food products. U.S. Regulation of Cell-Cultivated Meat In February 2019, Congress directed FDA and USDA to establish a formal agreement that would delineate each agency’s responsibilities for regulating cell-cultivated meat. In March 2019, the two agencies issued an agreement outlining the regulatory roles for each agency. Under the formal agreement, FDA is to issue regulations or guidance on inspections for companies involved in cell collection, cell lines, and the differentiation process. FDA is to ensure that companies producing cell-cultivated meat products follow current Good Manufacturing Practices and preventive control regulations to ensure that the substances leaving the culturing process are safe and not adulterated. At the point of harvest, FDA transfers oversight to USDA. Companies harvesting cells for human food will be subject to FSIS regulations on sanitation, Hazard Analysis and Critical Control Point verification, and testing to ensure that the products are unadulterated, wholesome, and properly labeled under the Federal Meat Inspection Act and the Poultry Products Inspection Act. The Global Market and Commercialization More than 150 companies worldwide are involved in the cell-cultivated meat industry, 43 of which are in the United States. The United States and Singapore are the only countries that allow cell-cultivated meat products to be sold to consumers. The industry has benefitted from private and public investment in research. The Good Food Institute estimated that from 2010 to 2022, approximately $3 billion in private capital was invested in cell-cultivated meat and seafood companies. In the last 10 years, the National Science Foundation (NSF) has issued roughly $5 million in research grants and the USDA National Institute of Food and Agriculture (NIFA) has issued approximately $12 million of research grants for cell-cultivated meat projects. Most of these research grants were awarded to universities. The cell-cultivated meat industry faces various hurdles in commercializing the technology, such as scaling up production, matching the taste and texture of traditional meat, and reducing the cost of finished products. Congressional Context In the 116th Congress, legislation was introduced addressing cell-cultivated meat, but none was enacted. Members of Congress did not introduce bills on cell-cultivated meat in the 117th Congress or, to date, in the 118th Congress. However, two amendments submitted to the House Rules Committee for the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 (H.R. 4368), would prohibit the use of funds for research on cell-cultivated meat. The Rules Committee has not yet voted on a rule for H.R. 4368. Congress may or may not take any action concerning cell-cultivated meat products. If Congress chooses to act, it might consider the following policy strategies: (1) determining how federal labeling laws will interact with state labeling laws, (2) supporting federal research, and (3) setting international standards for the cell-cultivated meat industry. This report provides an overview of the science of cell-cultivated meat, the industry, the regulatory framework for cell-cultivated meat products, congressional interests, and potential policy considerations.