The quest for artificial meat inches forward—the company Memphis Meats announced today it has developed chicken and duck meat from cultured cells of each bird, producing “clean poultry.” The firm provided few details, although participants at a tasting reportedly said the chicken tasted like, well, chicken. Below is a repost of a story originally published 23 August 2016 on some of the regulatory challenges and questions facing Memphis Meats and other companies pursuing artificial meats.

The first hamburger cooked with labmade meat didn’t get rave reviews for taste. But the test tube burger, rolled out to the press in 2013, has helped put a spotlight on the question of how the U.S. government will regulate the emerging field of cellular agriculture, which uses biotechnology instead of animals to make products such as meat, milk, and egg whites.

So far, none of these synthetic foods has reached the marketplace. But a handful of startup companies in the United States and elsewhere are trying to scale up production. In the San Francisco Bay area in California, entrepreneurs at Memphis Meats hope to have their cell-cultured meatballs, hot dogs, and sausages on store shelves in about 5 years, and those at Perfect Day are targeting the end of 2017 to distribute cow-free dairy products. It’s not clear, however, which government agencies would oversee this potential new food supply.

Historically, the U.S. Department of Agriculture (USDA) regulates meat, poultry, and eggs, whereas the Food and Drug Administration (FDA) oversees safety and security for food additives. FDA also approves so-called biologics, which include products made from human tissues, blood, and cells, and gene therapy techniques. But emerging biotechnologies may blur those lines of oversight, because some of the new foods don’t fit neatly into existing regulatory definitions. “Cellular culture raises a lot of questions,” says Isha Datar, CEO of New Harvest, a New York City–based nonprofit founded to support this nascent industry.

To help provide answers, the White House last year launched an initiative to review and overhaul how U.S. agencies regulate agricultural biotechnology. And the National Academies of Sciences, Engineering, and Medicine in Washington, D.C., is working on a broader study of future biotechnology developments and regulation, with a report slated for release at the end of this year. (Editor's Note: The report was released on March 9, 2017)

In the meantime, industry leaders are thinking about how their potential lab-based foods might be handled by regulators. One approach, they tell Science Insider, is to show that their product is similar to an existing product that testing has already shown to pose no hazards. “Most food regulation is about aligning new products with something that’s already recognized as safe,” Datar notes.

That’s the approach already taken by companies that use microbes and other biotechnologies to produce enzymes and proteins that are added to foods, notes Vincent Sewalt, senior director, product stewardship and regulatory, for DuPont Industrial Biosciences, based in Palo Alto, California. For example, yeast can be used to produce specific amylases, which are enzymes added to baked goods to prolong freshness. Such additives require premarket approval from FDA “unless you can demonstrate they are substances generally recognized as safe,” Sewalt says. To meet that standard—known in the industry as GRAS—companies start by selecting microbial strains that are known to be nontoxigenic and nonpathogenic, then use those strains to produce their products. “And that can be safely done as long as you’ve selected a safe strain and demonstrated that safety through repeated toxicology studies,” Sewalt says.

That strategy might also work for companies experimenting with using engineered yeast to produce single proteins to create egg whites, without cracking open a chicken's egg. In this case, egg white proteins are already considered to be a GRAS ingredient.

The same scenario might also work for Perfect Day, the startup that’s using yeast to make milk proteins, and then adding other ingredients to create a cow-free “milk.” Those milk proteins, caseins and whey, are already recognized as safe because they’re identical to the milk proteins we get from cows, says Datar, also a founder of the company.

The product can’t legally be called milk, however, because FDA has standards of identity that specifically define milk as lacteal secretions from a cow. “That definition completely leaves out any kind of beverage produced by fermentation or other tools of molecular biology,” says Phillip Tong, former director of the Dairy Products Technology Center and professor emeritus at California Polytechnic State University, San Luis Obispo. “When these definitions were promulgated, nobody ever thought we’d be able to do something like this,” he adds.

Meaty complications

The regulatory situation gets more complicated with cell-cultured meat, in which cells taken from animal muscle are grown on special scaffolds until they form enough tissue strands (about 20,000) to make a meatball or hamburger. It is not quite animal, not exactly a food additive—yet intended as food.

“It’s uncharted territory,” says Nicole Negowetti, policy director for the Good Food Institute, a Washington, D.C., nonprofit that supports cultured and plant-based food alternatives. For example, “from my understanding, the USDA regulations are based on food from animal slaughter, so [they don’t] make sense for these products,” she says.

Although cellular agriculture advocates tend to dwell on the process—because they say it could lead to safer, more humane, and more sustainable food production—FDA looks only at the final product. So, whether the end product is genetically modified corn, soybean, or maybe meat, Negowetti says the product should be regulated by FDA if it is meant to be a food.

But meat from cell cultures could also fall under FDA oversight for drug manufacturing, she notes. Because FDA defines a drug as something that includes human cells, tissues, and tissue-based products, it might not be so much of a stretch to say animal tissue could be included in that definition, too, she adds.

There also could be arguments made for regulating cell-cultured meat under FDA’s New Animal Drug Application process. Under this scheme, the agency regulates drugs given to animals or added to their food. So if companies manipulate meat cultures to improve the flavor, fat content, or other qualities, that could be considered the same as giving a drug to an animal.

Safety advantages?

Although biotechnology may make it harder to define new food products, it could also facilitate more precise safety measures, DuPont’s Sewalt says. For instance, he says that as genome sequencing becomes faster, so could the process of figuring out whether gene insertions or deletions in new organisms pose health risks or other concerns. There’s also the possibility of explicitly designing in safety, such as by engineering egg white proteins so they don’t trigger allergic reactions. And, in the future, the potential to insert barcodes in genes and the development of in-line ID kits, that recognize specific strains of cell lines, could make it easier to verify new organisms and their protein products, and track products through supply chains.

For the moment, however, which government agencies will oversee these changes remains unclear. As biotech creates more overlap among regulatory systems, Datar suggests it would be ideal to create a single regulatory agency. “Right now,” she says, “our system is set up in a way that promotes imitation as opposed to innovation.”