July 5, 2018
Authored by: Bryan Cave and Luke Westerman
The next wave of emerging agricultural biotechnology is set for its first regulatory showdown. Cell-cultured meat (“CCM”) allows your steak to be grown in a lab by replicating animal cells. Some CCM products are even created using synthetic products derived from plants, insects, and other non-animal proteins. No matter the type of culture used, CCM products are created without animals born, raised, and slaughtered in the traditional manner. Advocates of this emerging industry have coined the term “clean meat,” but many in the conventional meat food industry feel it should not be called “meat” at all.
On February 9, 2018, the U.S. Cattlemen’s Association (“USCA”) filed a petition with the U.S. Department of Agriculture (“USDA”) requesting that USDA invoke its jurisdiction over CCM and mandate that such products not be allowed to use “meat” or “beef” in their labeling. Indeed, the USCA asserts that such terms should be associated only with meat products “derived from the tissue or flesh of an animal harvested in the traditional manner.” As you might remember, this sounds very similar to the dispute the dairy industry waged over the term “milk.” What makes the CCM issue different is the timing of the dispute. The milk dispute came after a plethora of alternative milk products bombarded the market. Here, CCM products are realistically many years out from making an economical market entry.
The USCA had good reason to be the first to the table as CCM products will directly compete with conventional meat products the USCA has an interest in protecting. The request for USDA to invoke jurisdiction may also seem intuitive seeing that it already regulates the conventional meat food industry. But a quick look at how USDA regulates that industry demonstrates some possible hurdles in trying to exercise similar oversight of CCM production.
The USDA’s role in the regulation of meat and meat products stems from the Federal Meat Inspection Act (“FMIA”). FMIA defines a “meat food product” as:
“any product capable of use as human food which is made wholly or in part from any meat or other portion of the carcass of any cattle, sheep, swine, or goats, excepting products which contain meat or other portions of such carcasses only in a relatively small proportion or historically have not been considered by consumers as products of the meat food industry, and which are exempted from definition as a meat food product by the Secretary under such conditions as he may prescribe to assure that the meat or other portions of such carcasses contained in such product are not adulterated and that such products are not represented as meat food products.”
20 U.S.C. § 601(j) (emphasis added). Because CCM is grown from animal cells in a lab, the absence of a carcass seems to exclude CCM from FMIA’s definition. Even though there may be a derivative argument that CCM is properly regulated under FMIA, such oversight by USDA would look much different than its oversight of the conventional meat food industry. This is because USDA’s oversight under FMIA relates mainly to conditions and inspections of facilities involved in conventional meat food processing, i.e., slaughterhouses and meatpacking establishments, which are not utilized in the production of CCM products. Even the laboratories utilized for CCM production would require vastly different inspection guidelines than currently utilized under FMIA.
But despite USCA’s request, USDA has made no public statements or response to USCA’s petition. Meanwhile, it seems that another agency may be eyeing regulatory oversight of CCM.
In a surprising move, on June 15, 2018, the Food and Drug Administration (“FDA”) issued a notice expressing its interest in regulating the emerging CCM industry. The notice claims FDA jurisdiction over CCM under the Federal Food, Drug, and Cosmetic Act (“FFDCA”), and also touts its involvement in “rapidly evolving areas of technological innovation in food.” The FFDCA gives FDA jurisdiction over “food,” which includes “articles used for food” and “articles used for components of any such article.” The notice goes on to request comments on the issue and sets a public meeting to discuss the issues on July 12, 2018, in College Park, MD.
Although the jurisdictional trigger under the FFDCA seems to provide a colorable argument for FDA regulatory oversight of CCM products, industry groups on both sides of the dispute are sure to make this a hotly contested debate. The National Cattlemen’s Beef Association responded to the FDA’s notice with the following statement:
“NCBA looks forward to participating fully in the public meeting, and will use the opportunity to advocate for USDA oversight of lab-grown fake meat products. The Food and Drug Administration’s announcement disregards the authorities granted to USDA under the Federal Meat Inspection Act, as well as USDA’s significant scientific expertise and long-standing success in ensuring the safety of all meat and poultry products. Under the current regulatory framework, FDA plays an important role in terms of ensuring the safety of food additives used in meat, poultry, and egg products. All additives are initially evaluated for safety by FDA, but ultimately FSIS maintains primary jurisdiction.”
CCM advocates are pushing for FDA oversight in fear of USDA’s possible bias and protection of the conventional meat food industry. But such a move would not be without its challenges. The FDA has demonstrated its skepticism to alternative meat products with its cautious approach to one of the plant-based ingredients in Impossible Foods Inc.’s veggie burger. FDA recently delayed its regulatory decision on the food additive pending its continued safety review, and expects a final decision by July 23, 2018.
The possibility of some sort of dual role oversight by the USDA in conjunction with the FDA should also not be ruled out. So before the “meat” wars begin, the battle over regulatory jurisdiction must be sorted out.