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The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) and the U.S. Department of Health and Human Services’ (HHS) Food and Drug Administration (FDA) announced a formal agreement on March 7 to jointly oversee the production of human food products derived from the cells of livestock and poultry.

FSIS and FDA released a formal agreement to address the regulatory oversight of human food produced using this new technology. The formal agreement describes the oversight roles and responsibilities for both agencies and how the agencies will collaborate to regulate the development and entry of these products into commerce.

The agreement on joint oversight says the FDA will regulate the first stages of the process, including cell collection and growth, before handing off oversight of production and labeling to the USDA. The agencies say they'll continue working out details of how to regulate the products.

The U.S. Department of Agriculture said meat from cultured animal cells will have to undergo agency inspection, as with other meat and poultry products. Carmen Rottenberg of the USDA said she expects inspections to be similar to those for other meat-processing plants, but noted that a lot remains unknown since companies haven't yet scaled up to commercial production.

This shared regulatory approach will ensure that cell-cultured products derived from the cell lines of livestock and poultry are produced safely and are accurately labeled.

Rottenberg also says the agency expects a new label will be required for cell-cultured meat, meaning it likely won't be able to simply use terms like "ground beef" or "hamburger."

“Consumers trust the USDA mark of inspection to ensure safe, wholesome and accurately labeled products," said USDA Deputy Under Secretary for Food Safety Mindy Brashears said in a press release. "We look forward to continued collaboration with FDA and our stakeholders to safely regulate these new products and ensure parity in labeling.”

National Cattlemen’s Beef Association (NCBA) President Jennifer Houston said the agreement solidifies the USDA role lead oversight role in the production and labeling of lab-grown fake meat products.

"This is what NCBA has been asking for, and it is what consumers deserve. Under the terms of the agreement, USDA will be responsible for inspecting all facilities that harvest, process, package, or label cell-cultured products derived from livestock or poultry," said Houston. "All product labels will also be subject to USDA’s pre-approval and verification process.

In NCBA's compiled a list of "Fake Meat Facts" Identifying questions that were covered and what NCBA learned from the agreement. 

NCBA considers the USDA inspection of facilities "a win for consumers." 

However, the agreement didn't satisfy NCBA questions regarding antibiotics used in production, food safety risks when products are produced to scale, safety of the finished product, how it compares to real meat and if independent scientists have analyzed the product.  

NCBA wants more clarity on how antibiotics are used and wants manufacturers to provide evidence of the products' equality to real meat. NCBA also wants manufacturers to make samples available for independent, objective analysis.

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"We look forward to working collaboratively with the USDA and FDA on next steps, including the development of a more detailed framework concerning the cell harvest stage," Houston said. "Ensuring that all lab-grown fake meat products are safe and accurately labeled remains NCBA’s top priority.”

The North American Meat Institute (Meat Institute) applauded the regulatory framework of cell-based meat products. The Meat Institute appreciates the agencies’ collaborative efforts to establish a regulatory system that protects consumers, prioritizes product safety, and fosters innovation, according to a statement from the Meat Institute. 

Meat Institute President and CEO Julie Anna Potts said the framework will "ensure cell-based meat and poultry products are wholesome, safe for consumption, and properly labeled."

“We support a fair and competitive marketplace that lets consumers decide what food products make sense for them and their families, and this agreement will help achieve these goals by establishing the level playing field necessary to ensure consumer confidence,” Potts said.

The agreement outlines the significant role USDA should play in regulating cell-based meat and poultry products – a position the Meat Institute affirmed in written comments and oral testimony to the agencies. USDA’s Food Safety and Inspection Service (FSIS) conducts rigorous, daily inspection of all federal meat and poultry plants, and its strong label approval process gives consumers confidence that products are accurately labeled and not represented to be something they are not.

“We thank the agencies for developing a comprehensive regulatory framework that reflects the strengths and experience of FDA and USDA,” Potts added. 

Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response said, “We recognize that our stakeholders want clarity on how we will move forward with a regulatory regime to ensure the safety and proper labeling of these cell-cultured human food products while continuing to encourage innovation. Collaboration between USDA and FDA will allow us to draw upon the unique expertise of each agency in addressing the many important technical and regulatory considerations that can arise with the development of animal cell-cultured food products for human consumption.”

Under the formal agreement, the agencies agree upon a joint regulatory framework wherein FDA oversees cell collection, cell banks, and cell growth and differentiation. A transition from FDA to FSIS oversight will occur during the cell harvest stage. FSIS will oversee the production and labeling of human food products derived from the cells of livestock and poultry.

On Oct. 23-24, 2018, FSIS and FDA held a joint public meeting to discuss the use of cell culture technology to develop products derived from livestock and poultry. The public meeting focused on the potential hazards, oversight considerations, and labeling of cell cultured food products derived from livestock and poultry.

Carol Spaeth-Bauer at 262-875-9490 or carol.spaeth-bauer@jrn.com. Follow her on Twitter at cspaethbauer or Facebook at https://www.facebook.com/carol.spaethbauer.

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