The Food and Drug Administration held a public meeting July 12 on the regulation of laboratory-grown foods. By holding the meeting, FDA made its case to be the sole arbiter for the safety and labeling of items such as meat and seafood proteins produced from animal cell cultures.

The FDA and the U.S. Department of Agriculture have been at odds over which agency should regulate this new technology. Those in the industry saw the meeting as FDA’s way to place its controlling thumbprint on the matter.

The meeting, held at FDA’s Center for Food Safety in College Park, Maryland, brought together FDA leaders, industry stakeholders and scientists to discuss trends in how the future of food may include these products.

As alternative meat products enter the market, their regulation has become a top issue for the food industry. Livestock groups have demanded that USDA regulate these products and, like the dairy industry complaining that almond, soy and other such alternative beverages should not be labeled as “milk,” many cattle and hog organizations say these alternative products should not be labeled as “meat” and should be held to higher regulatory standards.

Food safety first

FDA Commissioner Scott Gottlieb opened the meeting, saying his agency wants to ensure food safety, promote innovation and to continue dialogue with consumers about their food choices.

“Past experience with novel technologies and our extensive background in cell culture technology in the medical product space will help inform our approach to evaluate the safety of these cell-based food products,” Gottlieb said.

Director of the Center for Food Safety Susan Mayne, told the audience in the meeting she shared Gottlieb’s commitment to food safety and innovation.

“These are still early days, but make no mistake FDA has been preparing for this for quite some time,” Mayne said. “This is not our first rodeo, so to speak. We have multiple authorities and programs that can support efforts to bring products with new ingredients in the market.”

FDA has evaluated a variety of foods produced by cell culture, Mayne said, including microbial creations such as probiotics and antifungal products.

“We have both premarket and post-market programs for evaluating the safety of substances used in the production and manufacture of foods. So we are ready to face the challenges and to support the promise of this and other emerging technologies,” Mayne said.

She also noted she has been attending food tech conferences “to help prepare the center for the technological advances that we know are in the early stages of development but will soon be coming to us here at the FDA.”

FDA’s science board will hold a meeting on the subject of cell-based foods this fall, which will be organized by the office of FDA’s chief scientist, Mayne said.

New terms

Stakeholders gave a series of talks on the issue, using a plethora of different terms to describe these cell-based products.

The words “clean meat,” “cultured tissue,” “food produced from cultured cells,” were used along with “cell-based meat.”

During the public phase of the meeting, representatives of many of the top livestock groups along with anti-animal agriculture groups were heard, including the National Cattlemen’s Beef Association, North American Meat Institute, National Milk Producers Federation, Food and Water Watch, Good Food Institute, and Compassion Over Killing. Many of the livestock groups wanted USDA to regulate the industry while the anti-animal groups preferred FDA.

For example, Rhonda Miller, Ph.D., professor in the meat science section in the Department of Animal Science at Texas A&M University and past president of the American Meat Science Association, said that because of limited data on the safety of these products, “meat scientists do not have enough information about ‘cultured tissue’ to determine whether it should be called meat.”

Another speaker was Maggie Nutter, a director of the U.S. Cattlemen’s Association from Sweet Grass, Montana. She argued for a clear label to differentiate cell-based product from that product raised on the hoof.

“When other products use the term ‘meat’ or ‘beef,’ they are taking advantage of the years of hard work the beef producers’ checkoff has put in to advertise the benefits of beef.” Nutter said, adding such products should have their own checkoff program to fund advertising.

Oversight important

Danielle Beck, director of government affairs for the National Cattlemen’s Beef Association, pressed for USDA oversight.

“While NCBA applauds the pointed questions FDA has posed regarding risks, hazards and manufacturing methods of lab-grown meat food products, we believe that the more pertinent question that must first be answered is that of jurisdiction,” Beck said. “NCBA respects the expertise of the FDA, however, the appropriate agency to ask the questions under discussion today is the agency that will ultimately have jurisdiction over lab-grown meat food products.

“While there may be some ongoing debate internally among FDA and USDA, NCBA believes that the law governing oversight of meat food products is clear, and that any fair reading of the law places lab-grown meat food products within the primary jurisdiction of the USDA’s Food Safety and Inspection Service.

“Meat food products derived from animal cell culture fall within the statutory and regulatory definition of a meat food product laid forth under the Federal Meat Inspection Act.”

The National Pork Producers Council, while making a statement at the FDA meeting, also issued a statement calling on USDA to assert its oversight of “laboratory-produced cultured protein and gene editing in livestock production.

“NPPC urges the Trump administration to establish a level playing field by establishing regulatory authority over laboratory-produced cultured protein products with the USDA’s Food Safety and Inspection Service, where they will be required to comply with the same regulatory standards, including continuous inspection, process controls, ante-mortem and postmortem inspection of source animals and other requirements, as conventionally produced red meat and poultry products.

NPPC President Jim Heimerl, a Johnstown, Ohio, producer, said, “While we know very little about the production methods of laboratory-produced cultured products, alternative protein companies are clearly working to present their products as real meat while seeking FDA oversight that would allow them to avoid rigorous inspection, labeling scrutiny and other regulations faced by livestock agriculture.”

“These companies—and their unsubstantiated claims about the sustainability, safety and ethics of their products—must be accountable to the same group that regulates the real meat they are striving to mimic.

“It’s deeply disturbing to U.S. pork producers to see the FDA adopt a Luddite-like regulatory approach that threatens the global competitiveness of U.S. agriculture,” Heimerl said. “Common sense regulations have helped make U.S. pork the global leader, and we can’t afford to cede such an important innovation to the rest of the world.”

The FDA is collecting public comments on lab-grown food technology until Sept. 25. Those wishing to do so may submit electronic comments to docket folder FDA-2018-N-2155.

Larry Dreiling can be reached at 785-628-1117 or ldreiling@hpj.com.

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