Regulatory Landscape of Cell-cultured Meat in the US and Beyond

Photo: University of Oxford, Oxford Martin School

As it stands, cultivation of cell-cultured meat at a commercial scale is still under development. But as products become available to consumers, various aspects of cell-cultured meat production will be overseen by regulatory agencies. In the US, Food and Drug Administration (FDA) and the Department of Agriculture (USDA) will be responsible for the regulation of cell-cultured meat. In 2018, the two agencies announced that they will collaborate to oversee the “production of cell-cultured food products derived from livestock and poultry,” with the FDA regulating cell collection and growth and USDA overseeing the later stages of production and labeling.

However, a report by the US Government Accountability Office (GAO) published in April 2020 pointed out that the details of this regulatory pathway — defining key terms, clarifying roles, responsibilities, and point of transfer between the two agencies — have not yet been specified. A webinar jointly hosted by FDA and USDA in July outlined the roles and responsibilities each of the two agencies would be responsible for. FDA will be overseeing the tissue collection, cell banking, and cell culture with routine inspections. The agency will also be responsible for premarket consultation, facility registrations, and regulation of manufacturing processes and preventative controls. After harvest, cells will be removed from the sterile environment and undergo conventional food processing, and regulatory oversight will be transferred to the USDA Food Safety and Inspection Service (FSIS). FSIS will oversee compliance with regulations in processing, packaging, and labeling of harvested cellular material. Under the Federal Meat Inspection Act and Poultry Products Inspection Act, FSIS will require pre-approval and verification for labeling of cell-cultured meat.

Labeling could be a major pain point as cell-cultured meat companies approach product launch. While the legal landscape of labeling has been largely centered around plant-based products, here we can find some insight and potential challenges ahead for cell-cultured meat.

In February 2018 the US Cattlemen’s Association submitted a petition to the USDA regarding beef labeling requirements. While this petition was primarily in response to plant-based products, the association mentioned cell-cultured meat in the document and acknowledged its threat to the conventional meat industry. In a move to protect the conventional meat industry, the Cattlemen’s Association requested that cell-cultured meat and plant-based products be excluded from the definitions of “beef” and “meat,” claiming that use of such terms should be limited to meat slaughtered from animals “in the traditional manner.”

The petition cited Section 601(n) of the Federal Meat Inspection Act, under which any product would be considered misbranded if the labeling is “false or misleading.” The claim made here is that calling cell-cultured meat “meat” would be misleading to its customers. However, cell-cultured meat may have the same cellular and nutritional composition as conventionally produced meat, although it is grown directly from animal cells rather than harvested from animals.

To date, there is no official response to this petition from the USDA, and a lack of clear guidance at the federal level has prompted multiple state-level action. In 2019, nearly 30 states considered legislation limiting the use of terms such as “burger,” “hot dog,” and “sausage” to slaughtered animal meat. Arkansas, for example, enacted legislation that defined beef as “flesh of a domesticated bovine” and explicitly excluded “product grown in a laboratory from animal cells” from the definition of meat. The state legislature of Louisiana passed a similar “Truth in Labeling of Food Products Act” adopting the same definition of beef as Arkansas. This bill gives the state agriculture commissioner the authority to enforce such regulations and penalize any violations, with a fine of up to $500 for each violation. In Missouri, penalties include a $1,000 fine and as much as a year in prison.

The Washington State legislature saw a much more aggressive bill that could prohibit the sale and advertising of cell-cultured meat. The bill would also restrict any use of state funds and facilities — including state universities — for the research and development of cell-cultured meat. The bill cites “insufficient information about cell-cultured meat to authorize its sale safely” in Washington; however, one of the sponsors of this bill has received contributions from beef and dairy farmers’ associations in the state.

Considering the political nature of this issue, uncertain regulatory landscape and similar legal challenges are expected to continue as the conventional meat industry is challenged by emerging cell-cultured meat companies.

The debate over labeling restrictions of cell-cultured meat have shifted into that of censorship and free speech. In June 2020, the Animal Law and Policy Clinic at Harvard Law School submitted a petition to FSIS urging the agency to adopt a labeling policy that protects commercial free speech under the First Amendment.

While there is no leading case on the constitutionality of state laws that limit the use of the word “meat,” there are some legal conditions that need to be met to restrict commercial speech. The First Amendment does not protect commercial speech that is misleading or concerns unlawful activity, and a substantial government interest in restricting speech needs to be demonstrated. From a scientific perspective, labeling cell-cultured meat “meat” when it is expected to have an identical composition as conventionally produced meat, would not be misleading or unlawful.

The GAO report notes other challenges in establishing regulatory standards for this emerging industry. One such example is the scarcity of publicly available research on cell-cultured meat, as well as the sensitive nature of the technology behind its production, which is often trade secret or intellectual property. Regulatory agencies, which have to define industry-wide standards, will have to rely on the information that companies are willing to provide on this matter. On this note, the role of organizations such as The Good Food Institute and New Harvest will be instrumental for informing policy makers and regulatory agencies.

Another aspect to consider regarding regulation of cell-cultured meat is the use of genetic modification. Currently, genetic modifications of food and livestock are overseen by the FDA. Recently, the agency approved a line of genetically modified pig for human consumption. Last December, USDA proposed to transfer oversight of genetically modified livestock under its jurisdiction, a move which the former FDA commissioner Stephen Hahn refused to sign off. While FDA is to be responsible for oversight of cell-cultured meat prior to harvest, a lengthy approval process could prompt industry stakeholders to call for USDA to regulate this area, as is the case with genetically modified livestock.

As for labeling, the National Bioengineered Food Disclosure Law requires food manufacturers and retailers to disclose the use of genetically modified ingredients starting January 1, 2022.

In Europe, cell-cultured meat is considered a novel food product and will need to be approved by the European Food Safety Authority (EFSA). The novel food legislation took effect in 2018, and only authorized products may be placed on the market. There is an existing list of authorized novel foods, and products not on the list are approved on a case-to-case basis. An extensive approval process involves safety assessment by the EFSA and implementation by the European Commission based on EFSA’s opinion. This procedure could take anywhere from 18 to 24 months or longer. The Commission has also suggested that it may impose a post-market monitoring for cell-cultured meat.

The use of gene editing technology such as CRISPR-Cas9 falls under GMO regulations, which supersedes the Novel Food Regulation. In such a case, the approval process will be more complex and time-consuming, as extensive research is required to support authorization applications. Additionally, products must be labelled as GMO.

EU member states involved in the decision-making process can veto authorizations and even opt out altogether. Different appetite for cell-cultured meat and attitudes on the use of genetic engineering could not only hinder the approval process but also the public acceptance of cell-cultured meat across the European continent. For instance, the French minister of Agriculture has expressed his distaste for cell-cultured meat, tweeting that meat “comes from life, not from laboratories.”

Singapore, which also established a regulatory framework for novel food, approved cell-cultured chicken by Eat Just for human consumption and more products are likely to expand in Asia. Aleph Farms, which recently unveiled its cultivated rib-eye steak, announced its partnership with Mitsubishi to introduce cell-cultured meat to Japan. While consumer acceptance and regulatory approval are still on the horizon, Aleph Farms will scale up production and distribution using Mitsubishi’s manufacturing capacities; it plans to start selling cell-cultured meat in Asia next year.

Beyond Asia, Aleph Farms is also looking to expand its reach in South America. The company has partnered with BRF, a global food company based in Brazil, and signed a memorandum of understanding to co-develop and produce cell-cultured meat on Aleph Farms’ proprietary platform.

This partnership points to a potential business model for cell-cultured meat companies, in which they offer the technology for cultivation and R&D capacities, leaving the distribution and supply chain to established food companies. For the cell-cultured meat companies, a strategic partnership allows for wider reach and recognition without establishing a distribution system from the ground-up. For the food companies, partnering with cell-cultured meat companies could add an environmentally sustainable option to their product line. In the long term, investing in cell-cultured meat is not only a competitive advantage against other traditional food companies, but also a sustainable alternative to the current food system.

written by: Nahee Kim for Helikon Consulting

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Scientific consulting in alternative proteins — plant-based proteins, cellular agriculture, and cell-based meat

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Helikon Consulting

Helikon Consulting

Scientific consulting in alternative proteins — plant-based proteins, cellular agriculture, and cell-based meat

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