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Web Content Viewer (JSR 286)

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Web Content Viewer (JSR 286)

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Web Content Viewer (JSR 286)

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Web Content Viewer (JSR 286)

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Web Content Viewer (JSR 286)

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Foods Made with Cultured Animal Cells

Taking a small number of cells from living animals and growing them in a controlled environment to create food is an emerging area of food science.  Advancements in cell culture technology are enabling scientists to use animal cells obtained from livestock, poultry, or seafood to produce food products. 

The role of the USDA Food Safety Inspection Service (FSIS), along with and the U.S. Department of Health and Human Services’ Food and Drug Administration (FDA), is to ensure that regulatory oversight is in place so that food developers bring safe and properly labeled products to the market. In 2019, the FSIS and FDA established a formal agreement on how we would use our regulatory tools to help ensure that foods comprising or containing cultured animal cells entering the U.S. market are safe and properly labeled. This agreement laid out which parts of the process each agency will oversee and was the first step toward both developing the framework to support safe production of these foods and providing clarity to industry on the requirements for producing, distributing, and selling these foods in the U.S.

FSIS and FDA have held public meetings to better understand the science of animal cell culture technology, potential hazards, labeling considerations, and to listen to consumer concerns.  FSIS and FDA will continue their open communication and engagement with stakeholders to foster innovation while ensuring the safety of our Nation’s food supply.

The Science of Making Foods with Cultured Animal Cells

There is a long history of scientific advances in biology, biochemistry, and engineering that have led to the innovations enabling the growth of animal cells outside of the animal itself, in a controlled environment, for food.  The process, while complex, can be broadly summarized in a few steps.

  • Step 1: Scientists typically start with a sample of cells from the tissue of an animal or fish, a process that typically does not permanently harm or kill the animal. Some cells from the sample are selected, screened, and grown to make a “bank” of cells to store for later use.
  • Step 2: To make food, a small number of cells are taken from the cell bank and placed in a tightly controlled and monitored environment (e.g. a very large, sealed vessel) that supports growth and cellular multiplication by supplying appropriate nutrients and other factors.
  • Step 3: After the cells have multiplied many times over into billions or trillions of cells, additional factors (e.g., protein growth factors, new surfaces for cell attachment, additional nutrients) are added to the controlled environment to enable the cells to differentiate into various cell types and assume characteristics of muscle, fat, or connective tissue cells.
  • Step 4: Once the cells have differentiated into the desired type, the cellular material can be harvested from the controlled environment and prepared using conventional food processing and packaging methods.

There are currently no food products made from cultured animal cells in the U.S. market.  Manufacturers are generally working on scaling up their processes to consistently produce amounts large enough to be competitively priced. 

Regulatory Oversight of Foods Comprised of or Containing Cultured Animal Cells

On March 7, 2019, the FDA and FSIS agreed to establish a joint regulatory framework for human foods made from cultured cells of livestock and poultry to help ensure that any such products brought to market are safe, unadulterated and truthfully labeled.  Under this agreement, the FDA oversees cell collection, cell banks, and cell growth and differentiation. FDA transitions oversight to USDA oversight during the harvesting stage of the cell-culturing process. FSIS will then oversee the further processing, labeling, and packaging of these products. As part of the formal agreement, the FDA and FSIS are working to develop detailed procedures to facilitate coordination of shared regulatory oversight related to the harvest of the cultured animal cells.

FDA: Cell collection, banking, growth and differentiation. FDA and FSIS: Harvest. FSIS: Product processing, packaging, and labeling.

Regulatory oversight of human foods comprised of or containing cultured animal cells depends on the animal species used as the original source of cultured cells, and it is based on the agencies’ existing jurisdiction over products.

  • FDA is responsible for regulating all live animals to be used as food up until processing. 
  • For those animals intended for human consumption and regulated under the Federal Meat Inspection Act (FMIA) (i.e., cattle, sheep, swine, goats, and fish of the order Siluriformes) or the Poultry Products Inspection Act (PPIA) (i.e. chicken, turkeys, duck, geese, guineas, ratites, and squab), FSIS is responsible for regulation during processing, packaging, and labeling. 
  • For foods made from the cultured cells of animals not regulated under the FMIA or PPIA (e.g. all seafood other than Siluriformes fish and game meat) or foods intended for animal consumption, FDA is responsible for regulation during processing.  FDA has issued applicable requirements under both the Federal Food, Drug, and Cosmetic Act (FFDCA) and Public Health Service Act. 

Therefore, food products made from the cells of species regulated by FSIS under the FMIA and PPIA will be regulated by the FDA during cell collection, selection, and growth and by the FSIS during subsequent processing and labeling.  Food products for human consumption made from cells of species not subject to FSIS jurisdiction (e.g., seafood other than Siluriformes and game meat) and food products for animal consumption will be regulated solely by FDA. 

To view the USDA-FSIS and FDA pre-recorded webinar, please visit: Overview of FDA and USDA Roles and Responsibilities for Cultured Animal Cell Human and Animal Food and Feed Products Webinar. Registration is required

FDA Regulatory Oversight

As described in the March 2019 formal agreement, FDA’s approach to regulating products derived from cultured animal cells will involve a thorough pre-market consultation process and inspections of records and facilities. FDA will ensure that covered entities comply with applicable requirements, including facility registration and FDA’s Current Good Manufacturing Practices and preventive control requirements.

The pre-market consultation process includes evaluating the production process and produced biological material, including tissue collection, cell lines and cell banks, manufacturing controls, and all components and inputs.  The FDA encourages firms working on the culture of animal cells for food use to contact the agency early in the development phase to begin discussions. For human food, firms may contact the Center for Food Safety and Applied Nutrition, Office of Food Additive Safety at AnimalCellCultureFoods@fda.hhs.gov.  If the firms intend to market the cultured meat, or any of the byproducts generated during the production of cultured meat, the firm should contact the Center of Veterinary Medicine, Division of Animal Feeds, at Animalfood-premarket@fda.hhs.gov. The FDA believes that both the agency and individual firms will benefit from ongoing discussions as the firms make technical and strategic decisions and as the agency begins to implement the consultation process.

After a successful pre-market safety consultation, the FDA intends to conduct routine inspections on an ongoing basis, as well as other oversight activities at cell banks and facilities where cells are cultured, differentiated, and harvested.  These inspections will help to ensure that potential risks are being managed and that biological material exiting the culture process is safe and not adulterated within the meaning of the FFDCA.

In conducting inspections and other oversight activities, the FDA will be able to draw on the results of the pre-market consultation and a thorough assessment of production records maintained by the facility. Should FDA inspections uncover areas of noncompliance, the agency will take appropriate action. The FDA also will ensure that labeling of cell cultured products derived from animal species not subject to USDA jurisdiction is truthful and not misleading, consistent with coordinated FDA and FSIS principles for product labeling and claims.

USDA Regulatory Oversight

During the cell harvesting stage, when cells are removed from a sealed growth environment and prepared for traditional food processing, the FDA and FSIS will work together to coordinate the transfer of regulatory oversight to FSIS. FSIS will carry out inspections at establishments where cells derived from livestock and poultry are harvested. These establishments will be required to have USDA grant of inspection and meet all applicable FSIS regulatory requirements, including the requirements for ensuring sanitation and developing and implementing Hazard Analysis and Critical Control Points systems.  The design of the facility must also meet USDA regulatory requirements.

FSIS inspectors will review batch records produced during cell culturing and verify compliance with applicable FSIS regulatory requirements during product processing, packaging, and labeling to verify the cellular products are safe, wholesome, unadulterated, and truthfully labeled. If cells are shipped to other establishments for further processing into human food products, these establishments also will be subject to FSIS inspection.

FSIS inspection of cell harvest and processing will occur at a frequency of at least once per shift, the inspection frequency also required for processing traditional meat and poultry products. This level of verification is necessary for products to receive the USDA mark of inspection. Finally, the FSIS will ensure that cell-based products are labeled truthfully and consistent with coordinated FDA and FSIS principles for product labeling and claims.  Under the requirements of the FMIA and PPIA, all labeling of food products made from the cultured cells of livestock or poultry must by preapproved by FSIS.

Imports of FSIS-Regulated Meat and Poultry Products

Like imports of traditionally produced meat and poultry products, imports of meat and poultry products made from the cultured cells of livestock and poultry must originate from eligible countries and from establishments or plants that are certified to export to the United States. A country becomes eligible to export to the United States following an equivalence process, through which FSIS determines whether its inspection system achieves the same level of public health protection as is applied by FSIS in the United States.  Additionally, the foreign food safety inspection system must provide standards equivalent to the FSIS to ensure other non-food safety requirements (such as accurate labeling, and assurance that meat and poultry products are not economically adulterated) are met.

Imports of meat and poultry products made from the cultured cells of livestock and poultry will also be subject to all of the other FSIS requirements for imports, including labeling requirements and reinspection by FSIS at an official import establishment.  These imports also will be subject to applicable requirements of the USDA Animal and Plant Health Inspection Services (APHIS) and U.S. Customs and Border Protection.

Imports of FDA-Regulated Products

Like all FDA-regulated foods, imports of foods comprising or containing cultured fish or seafood cells must meet the same legal requirements as domestically produced foods, including requirements related to the absence of unapproved food additives, color additives, or other substances that may adulterate the food.

Imported foods comprising or containing cultured fish or seafood cells must also meet specific agency requirements and are subject to oversight through multiple programs, including:

  • registration of any foreign facilities that engage in manufacturing, processing, packaging, or holding of the food,
  • prior notice to the FDA that the food is being imported or offered for import, and
  • implementation of a foreign supplier verification program by the importer to ensure that their foreign supplier is producing food in a manner that provides the same level of public health protection as FDA’s preventive controls regulations and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.

Imported food products are subject to FDA inspection when offered for import at U.S. ports of entry. The FDA may detain shipments of products offered for import that appear to be in violation of FDA requirements.

More information about FDA’s requirements for imported food can be found here:

Petition from the U.S. Cattlemen’s Association

On February 9, 2018, FSIS received a petition from the U.S. Cattlemen’s Association (USCA) regarding the labeling of traditionally produced meat products, as opposed to products cultured from the cells of livestock or made from plants or insects.  Specifically, the USCA requested that FSIS:

  • Limit the definition of “beef” to product from cattle born, raised, and harvested in the traditional manner;
  • Limit the definition of "meat" to the tissue or flesh of animals that have been harvested in the traditional manner;
  • Add these definitions to the FSIS Food Standards and Labeling Policy Book.

The comment period for this petition has closed, but the comments submitted may be reviewed on Regulations.gov.  FSIS is still considering the petition and the comments received.

Announcements and Public Meetings

The FDA and FSIS have held public meetings to better understand the science of animal cell culture technology, potential hazards, labeling considerations, and to listen to consumer concerns.  The FDA and FSIS will continue their open communication and engagement with stakeholders to foster innovation while ensuring the safety of our Nation’s food supply.

Announcements
FDA and FSIS Public Meetings

 

Last Modified Jul 31, 2020