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FDA, USDA agree to split cell-cultured meat oversight duties

By RACHEL LANE

WASHINGTON, D.C. — The cell-cultured meat industry will be regulated by both the USDA and U.S. Food and Drug Administration (FDA). The announcement came in mid-November, after months of representatives from both claiming their agency would be best suited to the regulatory process.

The FDA already regulates cell-cultured work regarding pharmaceutical companies. The USDA regulates most of the meat industry, with frequent inspections. Farm organizations have claimed the cell-cultured meat industry needs to have the same inspections in place to make sure the products are consistently safe for consumers, not to check the process once every five years.

It would also be unfair to traditional farmers to need to meet certain standards while the cell-cultured industry could meet a different set of standards, they say.

While some of the details still need to be refined, the FDA will oversee the cell collection, cell banks and cell growth and differentiation. Sometime during the cell-harvesting stage, the USDA will begin overseeing the process. The USDA will monitor the production and labeling of food products derived from the cells of livestock and poultry.

“The agencies are actively refining the technical details of the framework, including robust collaboration and information sharing between the agencies to allow each to carry out our respective roles,” said the joint statement released Nov. 15. “USDA and FDA are confident that this regulatory framework can be successfully implemented and assure the safety of these products.”

USDA Secretary Sonny Perdue said the purpose of the regulatory framework is to keep people safe and that everyone in both agencies, as well as the people in the food industries, have the same goal: To be able to feed 9 billion people safely by 2050.

“We’ll need to produce the same amount of food over the next 50 years as we have since the beginning of civilization,” he said. Technology is going to play a large part in making that happen.

Scott Gottlieb, commissioner of the FDA, said technology has advanced rapidly over the last few years and cell-cultured products can take many forms: cell-cultured seafood, leather and other innovative food products that can only be imagined at this time.

“It won’t be long till there are cell-cultured burgers on menus,” he noted.

The decision removes uncertainty in the cell-cultured meat industry, said Brian Spears, CEO of New Age Meats. He has expressed concern that other countries are moving forward more quickly with support and regulations regarding cell-cultured meat.

He has been asked to move his company to other countries offering him more support, but he wants it to remain in the United States. The decision about regulatory oversight is a move in the right direction; Spears said the decision reduces uncertainty and allows the company to start moving forward to create its products.

Mark Dopp, senior vice president of Regulatory and Scientific Affairs at the North American Meat Institute, said oversight by the USDA Food Safety and Inspection Service (FSIS) is needed.

“That the inspection system FSIS administers is more rigorous than the one administered by FDA is undeniable. Administration officials have said as much,” he explained.

Dopp said the USDA mark is respected globally as a sign that food is safe, and the cell-cultured meat industry should have the opportunity to benefit from the mark. USDA oversight would also protect the companies from different state regulations – something the FDA cannot provide.

Peter Licari, JUST chief technology officer, said both agencies should be involved in the regulatory process.

The conversation about the products from the new technology is far from over. How to label the product – is it meat? – will continue. How to address labeling requirements is also a concern. Should every item use to grow the cells be listed, or only the ones that are measurable in the end product? Or, as with livestock farming, is stating that the food item contains cell-cultured meat enough information?

The USDA and FDA want to find the answers to these questions soon, because such products may be available for commercial sale within three years.

11/28/2018