Clean Meat – How an Emerging Technology Will Be Regulated

By: Dr. Luke Grocholl, Regulatory Affairs Expert, MilliporeSigma - Flavors & Fragrances

The Case for Clean Meat

Several cubes of meat on a white surface A recent UN report estimates that 14.5% of all anthropogenic global greenhouse gasses are a result of livestock.1 Raising livestock for slaughter not only consumes considerable energy resources, but also requires tremendous land: an estimated 70% of current deforestation and 60% of biodiversity loss is directly linked to agriculture.2 Additionally, meat production is highly inefficient: it takes an estimated 7 kg of grain to produce 1 kg of meat, so the impact of livestock production must be added to the resources needed to grow, process, and transport feed. In light of these concerns, it is unsurprising that there is a strong drive to find alternatives to current meat production to help meet the consumption needs of a growing population.

One way to reduce the environmental and resource impact of the meat industry is to grow meat directly rather than raise livestock. Here at Merck KGaA, Darmstadt, Germany we have a clean meat innovation project that is supporting just this—growing meat from stem cells in the lab. Like any true innovation project, clean meat requires a new regulatory approach to help ensure product safety for consumers.

Lab-Grown Meat- What’s in a Name?

One of the challenges facing the cultured meat industry is what to call it. With the growing popularity of plant-based protein products like Impossible Burgers3 or Beyond Sausage4, many US states proposed laws restricting terms like meat, sausage, or burger to only products derived from slaughtered livestock. Although most of these laws have either failed to pass or have been suspended pending a federal review, the debate of naming alternative proteins continues. Issues in product naming are not limited to the US, as restrictions on the use of similar terms have been debated in the EU parliament. Even if the end-product naming convention is officially settled, there are still many unofficial names associated with lab-grown meat including clean meat, artificial meat, or in vitro meat. Currently, cultured meat is the most generally accepted term, and the name that will be used in this article.

Who Regulates Cultured Meat in the US?

Regulatory management of cultured meat in America is complex. Unlike most regions, food production in the US is overseen by two regulatory agencies: the Food & Drug Administration (FDA) and the US Department of Agriculture (USDA). The FDA is part of the Department of Health and Human Services, overseeing dairy, seafood, produce, packaged food, bottle water, eggs, food additives, processing aids, and food-contact materials. The US Department of Agriculture (USDA), on the other hand, oversees meat production, but the distinction between these agencies it is not always clear-cut. For example, although the USDA oversees meat production, the FDA is responsible for exotic meat such as wild game. Further complications arise in the seafood industry, where the FDA regulates seafood, but the USDA regulates farm-raised catfish. More blurred lines emerge with eggs: they fall under the FDA as long as they are in the shell, but the processing of egg products falls under USDA jurisdiction. Additionally, when food containing both meat and non-meat components is produced, the regulatory agency responsible for its oversight is determined by the proportion of meat in the final product.

Knowing which of the regulatory agencies oversees cultured meat is critical, as the regulatory framework and requirements are different between them. The FDA, for example, conducts periodic inspections whereas USDA representatives are often located on-site and conduct continuous, daily inspections of production. In order for cultured meat to be successful, the industry requires clarity from governing bodies. The process for cultured meat production lies outside of the current parameters distinguishing FDA from USDA oversight. For cultured meat, stem cells are extracted from animals like livestock. The USDA has clear regulatory oversite on the processing of livestock into food such as the activities in meat packing plants, in this case, however, the stems cells are extracted without slaughter. The cells are then managed in banks and grown in laboratory conditions. Although there is no direct analogy to other foods, this process could be thought of as similar to cheese or yogurt fermentation which falls under FDA jurisdiction. The end product is meat (regulated by the USDA), possibly with other ingredients (regulated by the FDA) like edible polymer scaffolds. Even if the manufacturing requirements were clear, without clear understanding of the oversite agency, the end cultured meat cannot even be properly labelled, as the FDA and USDA have their own labelling requirements.

Agreement on Cultured Meat Regulation, At Last

With such a complicated situation, it is not a surprise that a combined approach was needed. In March 2019 the USDA and FDA announced an agreement to jointly manage cultured meat. Under this agreement, the FDA will oversee collection of stem cells and the management of cell banks as well as cell growth, including any scaffold or other tools used, and finally cell differentiation. In other words, all the steps to cultured meat before it is actually meat will fall under the FDA. At this point the USDA will take over and oversee the processing of cultured tissue into meat, and labelling of the final product. Under this agreement, cultured meat facilities are subject to FDA inspections rather than having on-site USDA inspectors like abattoirs and meat processing plants. The final meat product, however, is subject to the same safety standards and labelling requirements as any traditional meat product. This USDA/FDA agreement covers all cultured meat derived from livestock and poultry, so other cultured meat products, like cultured seafood, falls under FDA oversight alone. Regulatory oversight outside the US is clearer, as most regions, such as the EU, Israel, and Japan, have a single agency that oversees all food.

Regulatory Challenges for Cultured Meat Ingredients

The US regulatory agreement does not solve all regulatory challenges. As this is a novel and evolving technology, it requires both new raw materials, and for raw materials to be used in new ways. This means many of the ingredients used for growing cultured meat have not yet been reviewed or approved for food consumption. Cell culture media (CCM) for example, is proving to be a significant challenge. Manufactured cell lines are not unfamiliar to the food industry in fermentation products such as cheeses, where the cells are isolated and then added to more familiar food cultures. For cultured meat however, the food product itself is grown in CCM. As such, there is a risk that some traces of the CCM could remain in the end product, as well as the risk of the CCM introducing unwanted contaminants to the cultured meat.

“Food grade” CCM could address this concern by offering CCM that is safe for human consumption at levels that would be found in cultured meat, but such products are not currently available. Another way they could be accepted in commercial products is for CCMs used in cultured meat production to have regulatory approval from the FDA as a new food additive. Gaining approval for a new food additive can be a very expensive and lengthy process, particularly if there are no substantially equivalent ingredients it could be compared to. The food additive submission requires preclinical and clinical studies to evaluate potential safety hazards of the food at the expected level of consumption. Regions outside of the US such as the EU, Canada, China, and Japan require a similar approach.

Every ingredient used in manufacturing cultured meat requires examination of whether there is a risk (or intent) for it to remain in the final food, as well as determination of the amount expected in the end product. If the ingredient has not been approved for food use already, which is likely with an emerging technology like cultured meat, then each ingredient needs an application for use in food in every global region where the product is intended for sale. This is a daunting proposition, but the promise of delivering meat at a significantly lower environmental impact as well as the elimination of growth hormones and antibiotics used in traditional meat accounts for the wide interest with start-up firms in the US, Europe, Israel, and Japan.

Endnote – Kosher & Halal

With the large and growing halal food market as well as the emergence of Israel-based start-ups, one question often posed is the halal or kosher nature of cultured meat. Both religious standards have clear rules on not only which animals are allowed for consumption, but also how the animals must be slaughtered and prepared. With a slaughter-free product like cultured meat, the route for religious approval is not completely clear. Although there are currently no commercially available cultured meat products, halal and kosher authorities are already reviewing technology to determine if it could be incompliance with their dietary requirements.5,6 One proposed route to kosher or halal cultured meat is extract the stem cells used for the production from an animal that was slaughtered in accordance with Islamic or Jewish requirements for halal/kosher. If an immortal stem cell line could be created from these original cells, the end product could meet religious requirements. In this way, the emerging technology of cultured meat could respect ancient traditions while providing safe, environmentally friendly food, though it may then loose its appeal to the potential vegan/vegetarian market. Furthermore, creating sustainable immortal cell lines has its own technical challenges. Further research and emerging technologies will likely yield other challenges and greater possibilities as cultured meat continues its journey from concept to dinner.

Learn more about the Merck KGaA Innovation Center and its work on cultured meat.

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