Cultivated Meat & Seafood – Regulations
We've looked at cultivated meat and seafood in this series. In this post, we discuss the safety and future regulations of these products from a U.S. perspective
What is cultivated meat and seafood?
Cultivated meat and seafood is meat and seafood grown outside of the animal from specific animal cells in a bioreactor.
You can learn more about the cultivation process from our previous blog.
Do federal agencies recognize cultivated meat and seafood as "real" meat and seafood?
Yes, United States (U.S.) regulatory agencies acknowledge that cultivated meat and seafood contain cells and nutrients recognized as meat and seafood products under current definitions. Meaning, cultivated meat and seafood will be regulated under the framework already in place.
Who will be regulating cultivated meat and seafood in the United States?
In the U.S., the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture Food Safety and Inspection Service (USDA-FSIS) will jointly regulate cultivated meat and seafood.
The current structure of these departments means each agency will take on specific animal species undergoing cultivation, certain phases of the cultivation, harvesting, and packaging processes, and will consider if animals or humans will be consuming the resulting cultivated meat and seafood (1).
Let's break this down.
Regardless of animal species, the FDA will oversee:
- Cell collection
- Cell development
- Cell selection
- Cell growth
The FDA will continue to oversee the processing and labeling of most cultivated seafood and cultivated game meat and cultivated meat and seafood destined for animal consumption.
Under the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA), USDA-FSIS will oversee the processing and labeling of cattle, sheep, swine, goats, Siluriformes Order fish (e.g., catfish), chicken, turkeys, ducks, geese, guineas, ratites, and squab cultivated meat (1,2).
What will be regulated?
The FDA will require a pre-market consultation before cultivated meat and seafood are available for sale. This process includes safety evaluations of the production processes and produced biological tissues (including tissue collection), cell lines and cell banks, manufacturing controls, and all components and inputs (e.g., raw materials, growth media, etc.) (1).
They will also ensure all companies producing cultivated meat and seafood comply with all requirements, register their facilities, and follow Current Good Manufacturing Practices (1,2).
The FDA will routinely inspect facilities and oversee activities to ensure manufacturers are managing potential risks and the food production process remains safe.
The USDA-FSIS will oversee processing and labeling. So, when the cells are ready to be harvested from the bioreactor, the FDA will turn over regulatory authority to the USDA-FSIS for the cultivated animal products they oversee.
The companies manufacturing cultivated food that fall under the USDA-FSIS's prevue will need inspection grants and to meet all regulatory requirements.
USDA-FSIS inspector will review records from cell production to ensure manufacturers satisfy all regulations, so we know that cultivated meat products are safe, unadulterated, and truthfully labeled (1).
Will there be a safety assessment of cultivated meat and seafood?
The FDA is developing a food safety assessment group as part of the pre-market consultation development process. Accordingly, experts in the food safety assessment group will work with manufacturers to establish safety profiles for cultivated meat and seafood (1,2).
Will regulators look at growth factors?
Regulators will most likely evaluate growth factors as one aspect of the safety profile.
All meat and seafood contain growth factors at some level. Growth factors are naturally present in all animal cells and are required for normal physiological processes so that cells can survive and grow. It's currently not an area regulators focus on because we've been safely eating meat and seafood for millennia.
For cultivated products, scientists add growth factors to the cells to facilitate cell growth. Currently, it is unclear how much growth factor manufacturers will add, how much will remain in the final product, how the remaining growth factor level will compare to levels found naturally in traditional meat and seafood products, and whether or not it will present a safety concern.
Before cultivated meat is available, regulators will work with scientists to determine a safe level of growth factors allowed in the meat and seafood.
We know all meat and seafood currently contain naturally occurring hormones and growth factors, so the regulators will ensure that cultivated meat and seafood don't contain a higher than the necessary amount of the growth factors.
How will regulators handle labeling?
Currently, the USDA-FSIS is taking comments to help regulators create an accurate naming standard. The naming standard will impact how these meats and seafood are referred to when regulated, labeled, and marketed (1,2).
The good news.
Putting in place systems to evaluate the current safety profiles and to ensure the long-term safety of cultivated meat and seafood products paves the way for cultivated meat and seafood to hit the shelves. While there is still much to work out, we know the right people are putting in place the framework needed to ensure safety.