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— OPINION —
In June 2023, the U.S. Department of Agriculture Food Safety and Inspection Service (USDA-FSIS) issued new Directives and a Notice regarding the regulation of cell cultured food products derived from cell lines of USDA-amenable species. These newly-released USDA-FSIS documents — Directive 7800.1, Directive 5730.1, and Notice 31-23 — address the inspection, sampling, and responsibilities of establishments producing cell-cultured meat and poultry products also commonly referred to as cultivated meat.
With the publication of these Directives and Notice, we now have much more clarity on how USDA-FSIS plans to execute its regulatory obligations in this space, fresh off the heels of the agency’s June 2023 issuance of federal grants of inspection to two U.S. cell-cultured chicken manufacturers and approval of their cell-cultured chicken labeling. USDA’s actions also both follow FDA’s relatively recent issuances of “no-questions” letters to both companies finding that the companies’ products “are as safe as comparable foods produced by other methods.” According to FDA Commissioner Robert Califf and the FDA’s director of the Center for Food Safety and Applied Nutrition, federal agencies are “committed to supporting innovation in the food supply” and working collaboratively with USDA-FSIS in a joint regulatory framework.
Meat from cells?
In 2013, Dutch scientist Mark Post showcased the first cell-cultured meat burger on live television. Since then, the industry has ballooned to more than 150 companies and counting on 6 continents, propelled by $2.6B in investments, by some estimates.
Harnessing cell culture technology to produce food or cellular agriculture refers to the production of agricultural products from cell cultures, like meat, poultry, and seafood ex vivo, grown outside the animal. Each company’s manufacturing process for animal cell-based food products varies, in part, depending on the type of cell line used (e.g., livestock, poultry, fish or seafood) and the nature of the final product (e.g. nuggets or steak). That said, at a high level, the key manufacturing stages include (1) target tissue or cell procurement, selection, isolation, preparation and storage, (2) cell proliferation, as well as possible cell differentiation, during biomass production (in a specially designed bioreactor) (3) cell harvesting, and (4) processing and formulation of food products. Each stage can potentially include various sub-steps dependent upon on the source and desired final food type. Manufacturers aim to produce a finished product that replicates the characteristics of muscle harvested from food-producing animals.
How Are Cell-Cultured Foods Regulated?
USDA-FSIS and FDA jointly regulate cell-cultured food products derived from cell lines of livestock and poultry under a 2019 Formal Agreement. FDA oversees the pre-harvest production phase of the animal cell culture technology process for all cell-cultured foods. For cell-cultured meat and poultry derived from cell lines of USDA-amenable species, jurisdiction then shifts to USDA-FSIS at the point of harvest. Consistent with the Formal Agreement, any company producing USDA-regulated cell-cultured foods must obtain a federal grant of inspection from USDA-FSIS. That agency oversees the harvesting, processing, packaging, and labeling of such foods. In particular, USDA-FSIS subjects labels under its purview to preapproval and is developing new labeling requirements for cell-cultured meat products consistent with its 2021 Advanced Notice of Proposed Rulemaking (ANPR).
For all other cell-cultured foods falling outside USDA-FSIS oversight– such as most seafood and meat from non-USDA-amenable species (such as elk, deer, antelope, and certain other species). FDA maintains oversight for the duration of the entire production process.
What’s in the New USDA Directives and Notice?
The new USDA-FSIS Directives clarify the regulatory oversight of cell-cultured meat and poultry products pursuant to the 2019 Formal Agreement. Companies producing such products should review the directives in depth, and highlights are presented below.
In addition, USDA-FSIS Notice 31-23 discusses food safety and process controls. Among other things, raw products samples will be tested for Aerobic Count (AC), Salmonella, chemical residues, speciation, and pathology. Food contact surfaces and environments at facilities producing raw products will be tested for AC and Salmonella. Ready-to-eat product samples will be tested for AC, Listeria monocytogenes (Lm), chemical residues, speciation, and pathology. Food contact surfaces and environments at facilities producing raw products at establishments producing Ready-to-Eat products will be tested for AC and Lm. Samples will be at least 60 grams and collected from every other batch until at least 10 samples are collected.
Cell-cultured meat and poultry products have officially arrived in the U.S. marketplace and are poised to enter the market more broadly in the coming years. Already, USDA-FSIS approved labeling and issued grants of federal inspection services to two U.S. cell-cultured poultry manufacturers in June 2023. These companies also both recently received FDA “no-questions” letters finding that the companies’ products “are as safe as comparable foods produced by other methods.” As these products move to market, companies should take care to comply with a complex dual jurisdiction environment and obtain regulatory approvals necessary from both FDA and USDA-FSIS.
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Breaking news for everyone's consumption