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Federal Regulatory Framework for Cell-Cultured Meat and State Legislative Action

Updated: Nov 5, 2020

By Sarah Everhart

Photo of cows on a farm. Image by Edwin Remsberg.

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Last fall, I posted about about discussions of the U.S. Food and Drug Administration (FDA) and Department of Agriculture Food Safety and Inspection Service (USDA-FSIS) pertaining to the regulation and labeling of cell cultured meats sometimes referred to as “clean meats”.

To briefly recap the agencies’ roles and positions, FDA (pursuant to Federal Food, Drug, and Cosmetic Act ((21 U.S.C. 301, et seq.)), the Public Health Service Act ((42 U.S.C. 201, et seq.)), and the Fair Packaging and Labeling Act ((15 U.S.C. 1451 et seq.))) is responsible for ensuring that food (produce, dietary supplements, processed food, seafood, etc.) and drugs are safe and labelled properly. To carry out this mission for food, FDA conducts inspections of establishments that manufacture, process, pack, or hold foods, with the exception of certain establishments that are regulated exclusively by USDA. In the cell-cultured meat context, FDA felt it was prepared to regulate cell-cultured meats because of its experience in regulating new food technologies and additives.

By contrast, USDA-FSIS (pursuant to the Federal Meat Inspection Act (( 21 U.S.C. 601, et seq.)), the Poultry Products Inspection Act ((21 U.S.C. 451, et seq.)), and the Egg Products Inspection Act ((21 U.S.C. 1031, et seq.))) ensures meat, poultry and egg products are safe by having inspectors present in meat and poultry slaughter and processing establishments and egg products processing plants. As for cell-cultured meat, USDA-FSIS felt it was well suited to regulate cell-cultured meat due to its current role in ensuring a safe meat supply.

On March 7, 2019, the FDA and the USDA-FSIS announced a formal agreement to jointly oversee the production of cell-cultured meats. According to the agencies, they “…recognize that each Party has an important role in the oversight of human food, derived from cell lines of USDA-amenable species and required to bear a USDA mark of inspection.”

Under the newly announced joint regulatory framework, FDA and USDA-FSIS will oversee different aspects of cell-cultured meat during its processing and production. A broad overview of the agreed upon agreement is as follows:

1. FDA will be responsible for conducting a premarket consultation process to evaluate production materials and processes in manufacturing controls, to include oversight of tissue collection, cell lines and banks, and all components and inputs.

2. FDA will also oversee cell growth and at harvest, help coordinate the transfer of regulatory oversight to USDA-FSIS, including, but not limited to, providing information necessary for USDA to determine whether harvested cells are eligible to be processed into meat or poultry products that bear the USDA mark of inspection.

3. USDA- FSIS will oversee the production of cell-cultured meat processing through inspection, as overseen by the daily presence of a federal inspector, as well as the establishment and application of an effective Hazard Analysis and Critical Control Points (HACCP) program.

4. Both FDA and USDA-FSIS have committed to “…develop joint principles for product labeling and claims to ensure that products are labeled consistently and transparently.”

States have also taken action to address cell-cultured meat. On August 28, 2018 Missouri amended its meat advertising law to prohibit “misrepresenting a product as meat that is not derived from harvested production livestock or poultry”. Violation of the Missouri meat advertising law is punishable by a class A misdemeanor. According to the Missouri Department of Agriculture, the Department will not pursue any labeling products that prominently display on the package that the product is “plant-based,” “veggie,” “lab-grown,” “lab-created,” or a comparable qualifier; and/or “made from plants,” “grown in a lab,” or a comparable disclosure. Missouri is facing a legal challenge to the law in federal court filed brought by the Good Food Institute and The Tofurky Company. The Plaintiffs claim the law infringes on the First Amendment, preventing the clear and accurate labeling of plant-based and clean meat products and denying fair and honest competition in the marketplace.

On March 12, 2019 North Dakota passed a law defining meat as “the edible flesh of an animal born and harvested for the purpose of human consumption” and prohibiting the marketing of cell cultured proteins as a “meat food products”. Legislatures in Montana and South Dakota are also debating similar bills.

For more future information on this hot topic, continue to read this blog.

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