Who Will Regulate Lab-grown Meat and Milk?

David Parry/PA Wire via Science Magazine

Like most people, we hold reservations about the idea of putting meat, milk, and egg whites made from laboratory cellular agriculture on the market. Will the proteins be safe for humans to consume? Might there be some unforeseen environmental impact even worse than that of raising cattle where rainforests once stood? Are there ethical considerations that outweigh the hope of freeing the chickens that are kept in cages their whole lives just to harvest their eggs?

We don’t have any answers, but are learning more about the whole process this week from Elizabeth Devitt at Science Magazine, where she writes about the fledgling industry and its potential regulators:

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.

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.

Read the rest of the article here.

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