Cultivated meat is making headlines. In this post, we look at the safety and regulatory framework around cultivated meat.
What’s the media saying about cultivated meat?
The U.S. Food and Drug Administration (FDA) has completed a second pre-market consultation for human food made using animal cell cultures, also known as cultivated meat. The pre-market consultation is one of the first steps to getting the food approved by the federal government for sale in the United States.
The next steps for companies include working with the U.S. Department of Agriculture (USDA) to ensure that food and food production meets and/or exceeds their safety regulations.
While this is exciting for cultivated meat companies, what does this mean for consumers? In this post, we take a high-level look at cultivated meat and seafood.
What are cultivated meats and seafood?
Cultivated meat and seafood is a type of meat created by scientists growing specific animal cells outside of an animal.
Scientists create cultivated meat and seafood using an emerging branch of biotechnology called cellular agriculture (1). Cellular agriculture replicates the biological cell growth process to create meat and seafood.
Traditionally, meats come from animals like cows, pigs, and chickens born, raised, slaughtered, butchered, and packaged for use and distribution.
Seafood foods like fish, shrimp, and crab are either farm-raised or wild-caught, slaughtered, processed, and packaged for use and distribution.
Cultivated meat and seafood only need specific cells grown outside of an animal to create familiar meat products.
Learn more about cultivated meat: https://go.msu.edu/jzC5
How does cellular agriculture work to create cultivated meat and seafood?
- Scientists obtain cells, often by a small biopsy, from the animals they want to make cultivated meat and seafood from.
- Depending on the product and animal species, scientists may use technologies to modify these cells in a way that allows them to grow effectivelly outside of the animal in a bioreactor.
- Scientists put the cells in a bioreactor that may contain scaffolding to provide a matrix for cells to attach to and grow.
- The cells “feed” off growth media, which includes the nutrients and growth factors needed to promote cell growth.
- The cultivated meat and seafood are harvested from the bioreactor and ready for processing, distribution, and sale.
Read more about the technology making cultivated meat possible: https://go.msu.edu/FzC5
Which organizations in the United States regulated cultivated meat and seafood?
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) 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 down how the FDA and USDA will regulate cultivated meat and seafood.
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).
Why is the pre-market consultation by the FDA important?
The FDA requires a pre-market consultation before cultivated meat and seafood are available for sale.
The pre-market consultation 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).
While the FDA doesn’t approve a product, when they are satisfied that a product has met its safety threshold, it will inform the company that they have no further questions, which allows the company to proceed. If the FDA does have additional concerns, the company will need to satisfy those concerns before it can proceed.
Does the FDA do more than conduct pre-market consultations on cultivated meat and seafood?
Once production begins, the FDA will 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.
What will the USDA-FSIS oversee for cultivated meat?
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 falls 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).
Learn more about the U.S. regulatory process for cultivated meat and seafood: https://go.msu.edu/nzC5
Will cultivated meat and seafood be available for purchase in grocery stores soon?
Not immediately. While technology advances rapidly, we’re still years away from cultivated meat and seafood being mainstays in grocery stores.
Learn more about what we can anticipate from cultivated meat and seafood in the coming years: https://go.msu.edu/8zC5
Is cultivated meat and seafood safe?
All current evidence points to safety. However, cultivated meat and seafood remain in their infancy, so we will learn more as the science progresses.
The good news.
As companies work with regulatory agencies to demonstrate safety, we move closer to having truly innovative meat and seafood options available to us.
If you have any questions about foods and ingredients, please reach out to us on Twitter, send us an email, or submit your idea to us at go.msu.edu/cris-idea.