On August 9-10, 2018, the Animal Law & Policy Program held a Clean Meat Regulatory Roundtable at Harvard Law School in collaboration with the Food Law & Policy Clinic.

As the science behind Clean Meat and other forms of cultured cellular agriculture continues its rapid development, mainstream public discourse already has turned to debating the potential benefits and barriers to these products. Major news features on the topic appear almost weekly, while bestselling books tout the impact such products could have on climate change, global resource use, human health, and animal welfare.

While companies working to create Clean Meat products are busy focusing on cost, scalability, and attributes such as color, texture, smell, elasticity, and shelf life, investors are pouring tens of millions of dollars into such research–including high-profile entrepreneurs such as Bill Gates and Richard Branson, alongside agribusiness titans Cargill and Tyson Foods (the world’s largest conventional meat producer). At the same time, nonprofit organizations The Good Food Institute and New Harvest are providing this emerging sector with strategic support and scientific assistance, while also educating the media, consumers, and decision-makers about these potentially revolutionary innovative products. Some involved are making enthusiastic claims about just how quickly Clean Meat products might enter the marketplace.

In a recent CNN feature entitled How close are we to a hamburger grown in a lab?, one company’s CEO declared that “before the end of 2018 is an accurate timeline” to expect these products in U.S. restaurants. While such predictions may seem ambitious from a scientific and price perspective, from a legal and regulatory standpoint they also may appear overly optimistic. Indeed, several threshold (even existential) regulatory hurdles remain before Clean Meat products could be approved for nationwide public sale and consumption. Even experts who eagerly support cellular agriculture have differing opinions regarding the optimal pathways toward securing regulatory approval. There also is no clear agreement as to precisely how the U.S. regulatory apparatus will classify Clean Meat products, or how the relevant federal agencies will carve up jurisdiction among themselves (labeling, safety, inspection), let alone how long it will take the first product to navigate the process and obtain final approval.

It is heartening that the FDA recently was reported as stating, “Given information we have at the time, it seems reasonable to think that cultured meat, if manufactured in accordance with appropriate safety standards and all relevant regulations, could be consumed safely.” Yet influential opposition already is mobilizing, with Congress recently attempting to use a spending bill to grant the USDA sole authority over clean meat inspection and labeling.

The potential benefits of Clean Meat and other cellular agriculture products are far too important to be left to political influence. Believing it is vital to scrutinize these regulatory questions as thoroughly and objectively as possible, we are convening experts and stakeholders from science, industry, government, law, academia, and advocacy to participate in a closed-door roundtable to confidentially assess the regulatory landscape, identify potential challenges, and hopefully recommend strategic paths forward. If consensus can be reached on any of these matters (and the participants are amenable), we may compile and publish the recommendations in a white paper or other report. Such a public document not only would lend weight to those ideas, but also may help ensure that no individual party rushes through the regulatory door unprepared to the detriment of the entire sector.

The Roundtable resulted in public comments jointly submitted to FDA and USDA on December 26, 2018 by the Animal Law & Policy Program and Food Law and Policy Clinic. Those recommendations on how regulatory jurisdiction for cultivated meat and poultry products should be allocated between the two agencies were closely adhered to when the FDA and USDA subsequently announced a “formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry” on March 7, 2019.

Participants and Bios