Sec. 2. Revised memorandum of understanding between Secretary of Agriculture and Secretary of Health and Human Services regarding regulation of cell-cultivated protein product
254 words·~1 min read·
/bill/119/s/4464/is/section-2A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Not later than 90 days after the date of the enactment of this Act, the Secretary of Agriculture and the Secretary of Health and Human Services shall jointly revise 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, so that with respect to the regulation of cell-cultivated protein products— the Secretary of Agriculture shall conduct such activities as are necessary to implement the amendments made by this Act; and the Secretary of Health and Human Services shall— conduct premarket consultation processes to evaluate production materials and processes and manufacturing controls, including oversight of tissue collection, cell lines and banks, and all components and inputs; oversee the initial cell collection and the development and maintenance of qualified cell banks; oversee the proliferation and differentiation of cells up to the time of harvest; ensure that the appropriate entities comply with applicable requirements of the Food and Drug Administration, including facility registration, the current good manufacturing practices and preventive controls regulation, and requirements applicable to substances that become a component of food or otherwise affect the characteristics of food; develop additional requirements for cell bank and cell culturing facility conditions and processes to ensure that biological material exiting the culture process is safe; and conduct appropriate inspections and follow-up activities, including taking enforcement action if necessary, to ensure that cell bank and cell culturing facilities are in compliance with applicable laws (including regulations).