No CRS summary available for this bill.
This section directs the Secretary of Agriculture and the Secretary of Health and Human Services to jointly revise, not later than 90 days after enactment, the Memorandum of Understanding entitled “Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species” entered into March 7, 2019. The revision assigns the Secretary of Agriculture responsibility for implementing the amendments made by this Act and assigns the Secretary of Health and Human Services responsibility for (1) conducting premarket consultation processes on production materials, processes, and manufacturing controls; (2) overseeing initial cell collection, qualified cell banks, and cell proliferation and differentiation up to harvest; (3) ensuring compliance with FDA facility registration, current good manufacturing practices, preventive controls, and food-component requirements; (4) developing additional cell bank and culturing facility standards to ensure biological material exiting the culture process is safe; and (5) conducting inspections, follow-up activities, and enforcement actions.
This section establishes definitions, labeling requirements, and regulatory standards for cell-cultivated protein products and plant-based alternative protein products. It defines a cell-cultivated protein product as any human food made wholly or in part from cell culture or DNA of an amenable species or live bird using animal cell culture technology and grown outside the live animal or bird. It revises misbranding provisions in the Federal Meat Inspection Act and the Poultry Products Inspection Act to require labels to display the words “cell-cultivated” in uniform size and prominence immediately adjacent to the product name, state that the product is derived from sources other than meat or poultry, and include a disclaimer that the final product is not derived from or does not contain naturally produced meat or poultry. It applies the inspection, labeling, and other requirements of both Acts to cell-cultivated protein products in the same manner as meat, meat food products, poultry, and poultry products. It defines a plant-based alternative protein product under the Federal Food, Drug, and Cosmetic Act as any food made wholly or in part from plant species that approximates the texture, flavor, and appearance of meat or poultry and is manufactured to appear as such, and requires labels to bear the phrase “plant-based alternative protein product” followed by the food name and a statement that the product is not derived from or does not contain naturally produced meat or poultry. Not later than 180 days after enactment, it directs the Secretary of Agriculture, in consultation with the Secretary of Health and Human Services, to develop common standards of identity for these products consistent with the new statutory definitions.