With unclear regulatory guidelines, lab-grown meat products face an uncertain future
Memphis meats, a company based in the United States, has recently announced that it is developing artificial chicken and duck meat from cultured cells of both the birds. This is a part of their “clean poultry” program. With the development of artificial meat and the possibility of it going main stream right around the corner, the question of regulation pops up almost instantaneously. While the first hamburger made from lab meat didn’t get any taste reviews back in 2013, it definitely started a discussion about the regulation of cellular agriculture – an emerging field that uses biotechnology to create animal products like meat, milk, and eggs.
While synthetic foods made in the lab are far from reaching grocery store shelves right now, companies like Memphis Meats and Perfect Day are hoping to get their products on the market in the forthcoming years. It is still unclear as to which agencies would regulate the production and distribution of such products.The U.S. Department of Agriculture (USDA) regulates meat, poultry, and eggs, and the Food and Drug Administration (FDA) oversees the safety and security of food additives. FDA also approves so-called biologics, which include products made from human tissues, blood, and cells, and gene therapy techniques. But, products from the cellular agriculture field pose a unique problem since these new foods do not fall under the 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.
The National Academy of Science, Engineering, and Medicine in Washington, D.C. along with the White House initiative to review U.S regulatory agencies, is working actively to provide answers to the problem of regulation of future biotechnology developments. While the authorities work towards clear regulatory standards, industry leaders in cellular-agriculture based food products are working to show how their products are similar to existing products that are shown to pose no hazards.
This approach is already emulated by companies that use microbes and other biotechnologies to create proteins and enzymes that are later added to food products as noted by Vincent Sewalt, senior director, product stewardship and regulatory, for DuPont Industrial Biosciences. Vincent gives the example of how yeasts can be used to produce specific enzymes that are added to baking goods to prolong their freshness. Additives like these require FDA approval before use. “unless you can demonstrate they are substances generally recognised 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 and 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,” Stewart says.
A scenario like this might also work for start-ups like Perfect Day, which uses yeast to make milk proteins and then adds other ingredients to create cow-free milk. And since those proteins are already recognised as safe, all Perfect Day needs to do is to show its product’s similarity to what is already preapproved by the FDA.However, the product cannot be legally called Milk since FDA identifies milk as being lacteal secretions of 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.
The situation of regulation gets more complicated when it comes to cell-cultured meat, wherein cells from animal muscle tissues are taken and grown on special scaffolds until they form enough tissue strands to make a meatball or hamburger. This is neither an animal product nor a food additive.
“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.While cellular agriculture advocates highlight the safe, sustainable, and more humane process of creating cell-culture meat, it ultimately boils down to FDA’s decision to regulate it by considering it a proper food item.
She also notes that cell-culture meats could also fall under the FDA oversight for drug manufacturing since 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.
One could also make an argument for regulating cell-cultured meat under FDA’s Animal Drug Application process that regulates drugs given to animals or added to their food. If companies are manipulating meat cultures to improve the flavour, fat content, and other qualities, this could be considered the same as giving drugs to an animal to make the end product better.
“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 “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 recognise specific strains of cell lines, could make it easier to verify new organisms and their protein products, and track products through supply chains.”
However, at the moment, the agencies that will oversee and regulate these products remain unclear. As biotechnological advancements are made and more such products start to surface, 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.”
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