In this file:
· USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry
· Beef, pork groups mostly pleased with USDA-FDA agreement to regulate lab meat
· As USDA and FDA Agree on Oversight, Aggies Rail Against ‘Fake Meat’
USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry
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Source: USDA Office of Communications
Mar 7, 2019
WASHINGTON, March 7, 2019 — 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) today announced a formal agreement 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. 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.
“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.”
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.
To view the recorded webinar from the public meeting on the FSIS website at www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings/past-meetings.
To view the Formal Agreement, visit the FSIS website at www.fsis.usda.gov/formalagreement or the FDA website at www.fda.gov/Food/InternationalInteragencyCoordination/DomesticInteragencyAgreements/UCM632752.htm.
The FSIS, an agency within the U.S. Department of Agriculture, is the public health agency responsible for ensuring that nation’s meat, poultry, and egg products are safe, wholesome, and accurately labeled.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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Beef, pork groups mostly pleased with USDA-FDA agreement to regulate lab meat
By Larry Lee, Brownfield
March 7, 2019
The FDA and USDA formalized their agreement to jointly oversee lab-created meat products made from the cells of livestock and poultry.
Collin Woodall with the National Cattlemen’s Beef Association tells Brownfield the announcement is a very big deal because lab meat producers need to be regulated like the beef industry to make sure they don’t have a cost advantage over beef. “More importantly, having USDA engaged means that they will be able to approve the label that goes on that product so that will help us prevent the term ‘clean meat’ from being affixed to those packages.”
Dr. Dan Kovich, with the National Pork Producers Council, says the dual regulation by USDA and FDA is important. “They’ll be jointly regulating these products. I think that’s in the best interest of everyone. Producers to ensure there’s a level playing field, consumers so they’re clear that it’s a safe product and how it’s manufactured and derived.”
U.S. Cattlemen’s Association President Kenny Graner says they are pleased with language in the formal agreement, but they want a new inspection stamp created for cell-cultured products using a different format and color than what is used on real meat...
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As USDA and FDA Agree on Oversight, Aggies Rail Against ‘Fake Meat’
By Chuck Abbott, Successful Farming
Agriculture.com - 3/8/2019
In a step that moves a new industry closer to commercial reality, the premier federal food-safety agencies agreed on Thursday on how to jointly regulate cell-based meat, a laboratory-grown protein that farm groups call “fake meat.” The FDA will oversee cell collection and growth, while the USDA will oversee harvesting and processing, and have final say over labeling.
Despite farm groups’ opposition to cell-based meat, the FDA-USDA agreement was welcomed across the board as a wise collaboration that will take advantage of the expertise of both agencies. Ag groups generally cloaked their objections in statements that called for accurate labels and maintaining consumer confidence in the food supply.
Although cell-based meat is not yet approved for sale anywhere in the world, more than three dozen companies are racing to be the first on the market. There is intense speculation on how soon the breakthrough will come. Last month, Uma Valeti, the chief executive of San Francisco-based Memphis Meats, said his company “will be ready to go to market tomorrow” once the U.S. regulatory framework is in place. He expects to start small.
In their memorandum of understanding, the FDA and USDA said they will develop a more detailed regulatory framework and will determine if statutory or regulatory changes are needed. “The parties will develop joint principles for product labeling and claims to ensure that products are labeled consistently and transparently,” they said, although the USDA’s Food Safety and Inspection Service will be in charge of labeling. The FSIS has pre-approval authority, meaning companies will have to obtain the agency’s approval of the labels on their products before they can sell them.
“The framework announced today will ensure cell-based meat and poultry products are wholesome, safe for consumption, and properly labeled,” said the North American Meat Institute, speaking for the meat industry. The trade group said cell-based meat probably satisfies the USDA’s definition of meat and meat products.
An array of farm groups say such terms as “meat,” “beef,” “poultry,” and “roast” should be used only for flesh from livestock. The U.S. Cattlemen’s Association, an early advocate of restricting traditional meat terminology to livestock, said the USDA ought to create a new inspection stamp for cell-based meat so that there won’t be any confusion about the source. The larger National Cattlemen’s Beef Association (NCBA) said, “Ensuring that all lab-grown fake meat products are safely and accurately labeled remains NCBA’s top priority.” The two largest U.S. farm groups, the American Farm Bureau Federation and the National Farmers Union, say cell-based products should not be called meat...
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