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Lab-Grown Meat Raises Regulatory Questions (#GotBitcoin?)

Specifically, who should oversee it: the USDA or the FDA? The uncertainty creates a challenge for startups. Lab-Grown Meat Raises Regulatory Questions

Who decides whether meat developed in a laboratory is safe to eat and, if it is, how it can be marketed?

That’s the question regulators face as scientists develop new meats grown from animal cells. This cell-culture technology, developers say, is a way to make burger patties without slaughtering bovines, and chicken strips without ruffling a feather.

Cell-cultured meats are likely still years away from appearing in supermarkets and restaurants. But a clear regulatory framework is crucial for startups like Memphis Meats Inc., Mosa Meat and Finless Foods Inc. to avoid any costly missteps during development.

“The biggest challenge for any new technology is regulatory uncertainty,” says Brian Sylvester, special counsel with Wiley Rein LLP, who previously worked as a regulatory lawyer for the U.S. Department of Agriculture. He isn’t currently representing any meat companies, but he has been discussing representation of the cell-culture startups.

Some startups believe the Food and Drug Administration, which regulates cell-culture technology in pharmaceuticals, would look more favorably on their technology than the USDA, which oversees the network of slaughterhouses and processing plants that produce meat the traditional way. Cattlemen and hog and poultry farmers want the new meats to be regulated by the USDA, which they say would ensure a level playing field.

The regulators are trying to work this out between themselves.

Labels Matter

Cell-cultured meat companies isolate livestock, poultry or fish cells that have the capacity to renew themselves in a laboratory. The cells are placed inside bioreactor tanks similar to fermenters, where they are fed oxygen and nutrients. Within a few weeks, they grow into muscle that can be prepared and eaten just like traditional meat.

This new technology is shaking up the $200 billion U.S. meat market. Meat processors Cargill Inc. and Tyson Foods Inc. have invested in developers of cell-cultured meats, along with Bill Gates and Richard Branson. Livestock producers, meanwhile, are pushing lawmakers and regulators to investigate whether these products are safe and asking that they be clearly labeled as something other than conventionally raised meat.

Startups use terms such as “clean meat” and “slaughter-free meat” for their cell-cultured products, raising livestock producers’ hackles. Some livestock groups have called for regulations restricting terms such as “meat” and “beef” to conventionally raised and slaughtered livestock.

The products don’t fall neatly into existing U.S. food regulation. While the USDA oversees slaughterhouses, meat processing and egg production, the FDA has jurisdiction over most seafood and the safety of food ingredients—including those used in feed for livestock and poultry. In the medical industry, the FDA also regulates other cell-cultured products like skin grafts and tissue transplants.

Both agencies have laid claim to cell-cultured meat. The FDA “has equity in the lab, and if it is commercialized as a product, the USDA has the responsibility to inspect that,” said Sonny Perdue, secretary of the USDA, in an interview last week. “It needs to be clearly delineated who does what.”

“We’ve been looking at biotech products for the last 20 years,” said Susan Mayne, director of the FDA’s Center for Food Safety, speaking at The Wall Street Journal Global Food Forum last week. “Cell-cultured meat is really in that same framework.”

In late October, the agencies plan to hold a joint meeting to discuss a regulatory framework for cell-based meat production and gather input from startups and traditional meat producers.

Room For Both?

Officials from the two agencies have discussed sharing oversight of cell-cultured meat. And some in the industry recommend a compromise. Memphis Meats and the North American Meat Institute, which represents traditional meat companies, in late August proposed that the FDA evaluate the safety of cell-cultured meat’s ingredients and technology, and the USDA inspect facilities and regulate products.

But that isn’t appetizing to some livestock growers, who say any food safety problems that might arise from cell-cultured meat could also damage the market for conventionally raised beef, pork and chicken. Groups representing cattle ranchers, hog farmers and poultry producers in July urged the Trump administration to place meat made via cell culture under the USDA’s jurisdiction.

“If cell-cultured protein companies want the privilege of marketing their products as meat and poultry products to the American public, in order to ensure a fair and competitive marketplace, they should be happy to follow the same rules as everyone else,” representatives for the groups wrote in a letter.

The Good Food Institute, a Washington-based trade group that promotes cell-cultured meat, is pushing for a leading role for the FDA based on the agency’s jurisdiction over fish and its general “expertise” on new food technologies.

Some food industry officials say cell-cultured meat developers need to strike a balance between lobbying for regulation that isn’t onerous, and a level of oversight that will make consumers comfortable with the new meat’s safety and nutrition.

“They’d like to be able to hit that bull’s-eye where there’s enough confidence in the process, but not mountains of red tape,” says Robert Hibbert, a partner at Morgan Lewis & Bockius LLP, and previously a senior USDA attorney, who represents traditional meat companies.

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