USDA-FSIS and FDA are Holding a Public Meeting
Cellular agriculture has quickly metamorphized from an internet curiosity to a serious policy issue, and producers and consumers alike are looking for greater clarity about what this new technology might mean for their business, as well as their dinner table. According to Docket No. FSIS-2018-0036 on the USDA website, the USDA Food Safety and Inspection Service (USDA-FSIS) and the Food and Drug Administration (FDA) are seeking to address policy concerns by hosting a public meeting “to discuss the potential hazards, oversight considerations, and labeling of cell cultured food products derived from livestock and poultry tissue”. To attend the event, whether in in person or via webinar, you need to register.
The October meeting will be held over two days, with day one (Oct 23rd) focusing on potential hazards and critical control points for food safety. Day two will focus on labeling considerations. See the General topics for Discussion at the Joint Public Meeting for both days. While the public meeting is being held in October, public comment is available until November 26, 2018.
The introduction of cell-culture based food products is likely to bring substantial changes to meat processing and the livestock production agriculture sector. The public meeting offered by USDA-FSIS and the FDA is an opportunity for producers to voice questions, concerns, and contribute input to the ongoing discussion surrounding the regulation and labeling of cell-cultured food products.
Due to the increasing complexity of modern food production and governance, the conversation around cell-cultured food technology might be confusing. This article will provide you with useful background information on the scientific history and current state of cell-culture technology in food production. In addition, an overview of the implications of this technology on meat product labeling, meat production, and livestock agriculture will be provided.
Current State of Cell-culture Meat Production
The application of cell-culture based food production is possible through utilizing bioengineering processes that have already been well established in both food and pharmaceuticals. Application of cell-culture technology into meat production shares similar objectives with the modern livestock and meat production industries: maximize production and minimize inputs. In traditional livestock production, improvements to efficiency of tissue production has been accomplished through selective breeding, specialized nutrition programs, improved housing facilities, and advanced veterinary care Cell-cultured meat production seeks to further improve efficiency by optimizing the energy and resource expenditures devoted to building fat and muscle, while eliminating the need to fuel growth of other animal tissues that are considered low value food products in the current American marketplace.
The field of cell-cultured tissue production has been well established in the bioengineering and pharmaceutical production. The application of this technology to meat production, however, has emerged only recently. Pioneering efforts in cell-cultured meat production were inspired two Australian bioengineers who showcased this possibility at an art exhibit in the early 2000s. Specifically, production of cell-cultured meat featured in the art exhibit involved the construction of muscle utilizing embryonic stem cells, on specialty scaffolding, and application of appropriate nutrition and stimulation were able to form muscle fibers that make up the meat product. This conceptual demonstration inspired others to consider the possibility of scaling their technique to an industrial level. Small working groups of tissue engineers and meat scientists continued to advance the field from the mid-2000’s to the mid-2010’s, either through spin-offs projects on medical research grants or through direct funding from private investors and government research agencies. In 2009, it was reported that the first in vitro pork fillet was produced at Eindhoven University in Holland; however, the fillet was not considered to be fit for human consumption. In 2013, a momentous breakthrough occurred when the first ever cell culture-based beef burger was presented to a celebrity chef at a widely publicized taste test. This event drew journalists, scientists, meat processors, and venture capitalists from around the globe, and their contributions ultimately generated hundreds of millions of dollars that have been invested in cell-culture based agriculture in recent years. To date, while there are now several dozens of cell-culture based meat production companies, including JUST, Memphis Meats, and Mosa Meats, these companies have yet to roll out a product that is ready for public distribution.
The Issue with Labeling and Regulation
Even though cell-culture based meat products are not yet ready for market, the issue of what to call them has already arisen. Standards of identity and labeling for foods have been a controversial topic for as long as agricultural societies have been marketing food to consumers. A familiar example of this controversy is the presence of numerous dairy and dairy-type products seen in the market place. In addition to ‘milk’ produced by livestock, alternative ‘milk’ products are found from soy, almond, and other alternatives that provide the consumer with numerous choices of nutrient-dense liquids to offer their families. The meat industry is not exempt from this food labeling and marketing paradox. For example, ground beef ‘burger’ patties versus plant-based ‘burger’ patties compete for market share and provide consumers with nutritious choices of similar form. However, the labeling controversy contributes to persistent confusion about nutritional value, production methods, and safety of food products among consumers.
Confusion surrounding nutritional value of food products and food production methods are likely at the forefront of the labeling argument for most producers, particularly given evidence that 64% of consumers do not recognize animal meats as a high-quality source of protein. Producers are also aware that labeling concerns extend to production techniques surrounding food products and consumer goods. Meat production methods, regardless of origin from livestock or cell-culture, are likely to be scrutinized by American consumers; many Americans still hold negative attitudes toward certain technology in food production, with genetically modified foods as the primary example of this aversion. This perception can play a critical role in how newly developed products may be perceived when placed next to traditional food products, particularly from animal sources. This emphasizes the point that labeling is a concern for all involved in meat production, not just livestock producers.
Food product labeling is currently regulated as it pertains to certain methods of production (Certified Organic) or food safety. The current debate about labeling for cell-culture meat products is directly related to food safety. To reference our previous ‘burger’ example, in the ‘burger’ industry, USDA-FSIS enforces the labeling and safety requirements for animal sources of protein, whereas plant sources of protein are regulated by FDA. This dynamic may change when the two ‘burger’ choices exist from the same (animal) protein source. Several names and labels have recently surfaced in the media to describe cell-culture based protein foods that originate from animal muscle cells. Some of the popular nomenclature includes the following: “in vitro” meat, “lab-grown” meat, “cultured” meat, “test-tube” meat, “fake” meat, “clean” meat, and most recently, “cell-based” meat. Labeling a food product as “meat” may also influence the regulatory body that oversees production. Remember, products that are currently labeled as “meat”, that are produced and sold in the United States, are regulated by USDA-FSIS. Some have proposed that “clean” or “cultured” meat products, although labeled as “meat” by companies producing cell-cultured food products, be regulated by the FDA, which traditionally oversees plant-based food items. So how will the new meat product be labeled? And, who should regulate cell cultured meat products? These are important questions to consider when discussing the future of food products that originate from alternative proteins and cell-cultured meat products alike as they progress toward becoming a reality in your local markets.
Regardless of an individual’s personal views on alternative protein foods, this new technology is progressing rapidly, and it may compete for future market share in the meat sector. In an attempt to clarify the “meat” labeling question, the state of Missouri (MO) recently took a step to clearly define that “meat” sold in the state of MO had to come from “livestock or poultry carcass[es] or part[s] thereof” (Senate Bill 627 & 925). This legislation agrees with perspectives shared by the National Cattlemen’s Beef Association (NCBA) and the Missouri Cattlemen’s Association. While this bit of legislation in Missouri was sparked by plant-based products being labeled as “meat”, the argument on a national level remains to be determined. What will be in a package of beef in the future? Groups opposed to this type of legislation argue that this law is unconstitutional and violates first amendment rights. However, according to the United States government (21 U.S. Code § 601(j)), meat “is made wholly or in part from any meat or other portion of the carcass of any cattle, sheep, swine, or goats”. It is this term ‘in part’ that plays a significant role in interpretation of the law, hence the labeling dilemma.
Concerns about regulation and labeling have been emphasized by numerous livestock organizations, not just the NCBA. These organization include: National Pork Producers Council (NPPC), National Chicken Council (NCC), National Turkey Federation (NTF), American Sheep Industry Association (ASIA), and the American Farm Bureau Federation (AFBF). In response to a meeting hosted by the FDA on July 12th of 2018, this group of concerned meat and livestock organizations directly addressed the current regulation quandary in a group letter to President Trump on July 26, 2018. This letter indicates the signatories’ support for the USDA to regulate cell-culture based meat products. The group supports current role of USDA in regulation and preservation of fair competition in the meat market place. Through the current role of the USDA in facilitating daily inspection and food safety among current meat production, this group suggests that consistency of this role across all meat products will prevent confusion among consumers from misleading regulations and labeling. In contrast, the U.S. Cattlemen’s Association (USCA) is currently pushing for separate labels altogether to be used on cell-cultured versus farm-raised meat products. The USCA argues that the labeling of cell-cultured products as “beef” detracts from the brand that cattle producers have worked hard to acquire and uphold for their product. Similarly, cell-cultured meat production stakeholders, including Memphis Meats, sent a joint letter to the White House on August 23rd requesting that cell-cultured food products be regulated by FDA during the product development phase, however, it was also requested in their letter to transition monitoring responsibility to the USDA to ensure post-market safety and labeling compliance. Leaders representing the North American Meat Institute supported letters submitted to the current administration from both the livestock and cell-cultured meat production focused groups. The regulatory debate surrounding cell-cultured meat products is quite dynamic; stakeholder alliances that are evolving may indicate that this debate is far from being settled.
Currently, regulation of safe food production is handled between FDA and USDA-FSIS. FDA inspected food is governed by the Food Safety Modernization Act (FSMA) whereas USDA-FSIS establishments comply with the Pathogen Reduction Act and HACCP-based inspection. Although complying with these regulatory acts have similar goals in safety, some of the regulatory statutes differ in design and methods of regulatory compliance. Companies producing cell culture-based meat products argue that the food is produced in a sterile environment, and therefore, should not be subjected to USDA-FSIS oversight, hence the verbiage “clean” meat. It should be similarly noted that meat from healthy livestock is also produced in a ‘sterile’ environment. The act of cutting into the carcass, and thus exposing tissue to outside contaminants, is what initiates the risk of food-borne pathogen contamination. Regardless of the environment where cell-cultured meat is manufactured, the product that is being consumed will eventually be exposed to the same packaging materials and storage conditions as traditional wholesale and retail “meat” products. This inevitable exposure would place cell-cultured meat products at similar risks of contamination as meat derived from whole tissue cuts of livestock. Food safety concerns should remain at the top of the list when considering how to handle regulations among all methods of meat production.
Are Livestock in Limbo?
Major meat packers, including Tyson and Cargill, are recognizing the potential market impacts of alternative protein sources through proactive investment in cell-cultured meat companies and technologies. Partnerships with meat packers may expand in cell-cultured meat production, as JUST (a start-up company specializing in plant-based protein and cellular agriculture) plans to issue commercial product licenses to traditional meat processing companies in exchange for royalties and prepayments. Livestock producers, on the other hand, have a distinct, yet potentially overlapping, set of interests with respect to cell-culture meat production technology.
Relationships of livestock producers to meat packers currently takes on a variety of forms. In the poultry industry, many of the birds raised for meat production are owned by the meat packer, such as Tyson or Perdue. This ownership of animals and meat is referred to as vertically integrated. In the pork industry, vertical integration occurs in full ownership or through contracted relationships with meat packers. These integrated relationships may benefit from the support of their integrators, like Tyson, should the packer choose to differentiate between the meat products they offer. However, they may also face further competition within their own supplier system. For pork, this means that the demands for further processed meats, such as sausages and deli products, may be met more so through the utilization of cell-cultured meat products, as sales of whole pork cuts continue to struggle, outside of bacon. The beef industry is largely segmented, in contrast, and traditionally does not utilize an integrated relationship model with packers. This leaves beef cattle producers without an established relationship with a packer are much more vulnerable to market fluctuations and additional competition from products bearing a brand they have worked hard to promote as a quality product (i.e. “beef”). This may be why the NCBA and USCA have been very vocal in the labeling debate, as discussed earlier, in order to protect the associations with a name they have created. This vulnerability to market trends and fluctuations would be similar for less popular meat products, such as sheep, goat, and other exotic meat choices. Regardless, the relationship between meat packers and cell-culture meat product start-up companies will directly affect integrated and partially integrated producers. Conversations among the packers and the poultry and swine producers are necessary to understand the impacts of this investment interest in cell culture-based meat production.
Interest in strategic engagement with the burgeoning cell-culture meat industry is growing among livestock producers. Indeed, new livestock markets may be created in conjunction with cell culture-based meat production. For example, cellular agriculture depends on cell lines from healthy animals. This dependence will continue to mean a reliance on livestock production, but with an emphasis on fewer animals meeting specific needs. Livestock producers who provide cell lines for cellular agriculture companies may therefore open new windows of opportunity for entrepreneurial producers, focusing on the diversity and specialty (genetics, welfare, health, nutrition) of their livestock products over quantity. In such a system, Kobe beef may transition from being a luxury to one of the most widely consumed meat products. Traditional livestock producers may also find economic opportunities in this expanding industry by leveraging their unique knowledge and expertise in product development, consultation, biosecurity, logistics, supply chains, agribusiness management, and sales. Animal feed growers and processors, on the other hand, may find opportunities in providing feedstock for cell culture growth mediums.
The future of cell-cultured meat and food production could signify dramatic changes to global agricultural markets, however, livestock producers have long weathered risk, uncertainty, and fluctuation in the market by embracing change, innovation, and strategic adaptation. To quote Bill Northey, USDA Under Secretary for Farm and Foreign Agricultural Services, “Farmers are problem solvers, they think outside [of] the box.” To be sure, many questions about the meaning and potential of cellular agriculture for traditional agriculture producers and consumers have yet to be answered. Participation in the conversations being held now, and likely those in the future, will be an important step for producers and consumers to make their voices heard as this discussion moves forward. Penn State Extension is continuing to monitor this evolving industry and stands ready to provide science-based consultation, support, and partnership for all stakeholders.