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FSIS & FDA release agreement to oversee cell-cultured proteins

How will cell-cultured proteins be regulated and inspected moving forward? FSIS and FDA provide the regulatory framework in a newly released joint agreement.

Amanda Radke

March 8, 2019

4 Min Read
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USDA’s Food Safety Inspection Service (FSIS) and the Food and Drug Administration (FDA) announced a formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry.

According to a USDA news release, “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. 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.”

Jennifer Houston, National Cattlemen’s Beef Association (NCBA) president said, “The formal agreement announced today solidifies USDA’s 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. All product labels will also be subject to USDA’s pre-approval and verification process.

Related:Industry pushes for USDA regulation of fake meat

“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. Ensuring that all lab-grown fake meat products are safe and accurately labeled remains NCBA’s top priority.”

NCBA has developed a one-page document, which explains what the agreement entails and how the USDA and FDA will provide oversight of these lab-grown protein products.

You can view the document by clicking here.

Based on the agreement, NCBA says more clarity is needed regarding how antibiotics are used in lab-grown fake meat production. The organization also expresses concern about the food safety risks, noting that FDA’s premarket consultations to evaluate production processes are lacking in detail.

NCBA also calls for manufacturers to provide evidence to justify their claims of equivalence to real beef. And they would like manufacturers to provide samples for independent scientists to provide objective analysis of cell-cultured proteins.

Additionally, with this agreement, the USDA mark of inspection would be stamped on these products, similar to how beef is stamped and labeled on its packaging. USDA’s FSIS would oversee the cell harvest stage, production and labeling of the products, while FDA would oversee cell collection, cell banks, cell growth and differentiation.

“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. "We look forward to continued collaboration with FDA and our stakeholders to safely regulate these new products and ensure parity in labeling.”

“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,” said Frank Yiannas, FDA deputy commissioner for food policy and response.

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,” he said.

Kenny Graner, United States Cattlemen’s Association (USCA), expressed concerns about the regulatory framework of this joint agreement.

“We are encouraged by USDA and FDA preemptively formalizing a joint regulatory framework prior to the commercialization of these products. Further, we’re pleased with language in the formal agreement that will allow USDA FSIS pre-market labeling authority,” he said.

“However, we’d like to reiterate our position that the term ‘meat,’ and more specifically ‘beef,’ refers to products derived exclusively from the flesh of a bovine animal harvested in the traditional manner. Under the formal agreement, it appears that USDA FSIS will issue the USDA meat inspection stamp to be used on these products.

“USCA is strongly opposed to the utilization of any of the three purple-inked USDA meat inspection stamps for cell-cultured product. A new stamp should be created for cell-cultured products that is inspected by USDA and by state inspection agencies, using a different format and color ink on the stamp. Neither the federal or state meat inspection stamps should appear on the cell-cultured protein products, retail packaging or wholesale containers.

“We look forward to continued dialogue with USDA, FDA, livestock stakeholders, and cell-cultured foods manufacturers to implement a regulatory framework that ensures consumer safety and avoids intentional consumer confusion.”

To better understand all sides of this regulatory and labeling discussion, you can watch the recorded webinar of the joint public meeting that was held in October 2018 by clicking here.

The formal agreement can be read here.

My take on this topic continues to be that the manufacturers of these cell-cultured proteins have not been transparent about their production process, and it is frustrating to see the grand, sweeping claims these companies are making about their products in regard to safety, antibiotics, sustainability and even animal welfare.

As an industry, we need to continue to work closely with FDA and FSIS to ensure these products are regulated, overseen with diligence, labeled clearly, substantiated with objective evidence and proven with great transparency for consumers.

The opinions of Amanda Radke are not necessarily those of beefmagazine.com or Farm Progress.


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