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FDA and USDA Release MOU for Regulated Cell-Cultured Foods that Fall Under USDA Jurisdiction
On March 7, 2019, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) released a Memorandum of Understanding (MOU) that broadly outlines how the two Agencies plan to work together to regulate the production of cell-cultured foods produced from cell lines derived from USDA-amenable species. The Agencies are to be applauded for quickly setting in motion a pathway to commercialization and for ensuring America’s continued leadership in bringing innovative foods to market. However, the devil will be in the details as the Agencies work to address questions regarding the functioning of the regulatory review process.
The March 7, 2019 MOU follows a November 2018 announcement from the FDA and USDA indicating that foods produced from cell lines derived from USDA-amenable species would be subject to dual Agency oversight and expertise. As we predicted, the MOU confirms that the FDA will exercise regulatory oversight up until the “point of harvest”. FDA will oversee cell collections, cell cultures, and cell propagation through commercial-scale growing operations. By contrast, USDA will oversee the subsequent processing of the cultured meat and the resulting meat products, including the inspection of processing operations and the labeling of food products derived from the cells of USDA-amenable species.
In addition to establishing the Agencies’ cooperative approach to the regulation of cell-cultured food products, the MOU provides some insight into the likely inspection burdens on industry. In particular, the MOU states that USDA will “require each establishment that harvests cells cultured from livestock or poultry . . . for the purpose of producing human food required to bear the USDA mark of inspection, processes those cells into such human food products, or packages and labels such products, to obtain a grant of inspection, as required by the FSIS regulations.” USDA will further be charged with conducting “inspection in establishments where cells cultured from livestock and poultry subject to the FMIA and PPIA are harvested, processed, packaged or labeled, in accordance with applicable FSIS regulations (including sanitation and physical product inspection, Hazard Analysis and Critical Control Point (HACCP) verification, product testing, and records review), to ensure that resulting products are safe, unadulterated, wholesome and properly labeled.” For its part, the FDA will be charged with conducting inspections of facilities that host cell collections as well as growing operations through harvest pursuant to the Federal Food, Drug, and Cosmetic Act.
Importantly, the MOU leaves open the possibility of federal rulemaking, stating that “this document sets forth the Parties’ shared commitment to . . . a joint process by which the Parties will identify any changes needed to statutory or regulatory authorities to effect the intended regulatory oversight.” This possibility is furthered by the fact that not all conventional agriculture stakeholders are sold on cell-culture technology and could push for onerous oversight in the form of new federal rules and a lengthy rulemaking process that involves public comment periods and could take upwards of 2 years or more. Nonetheless, regardless of whether or not a rulemaking is on the horizon, industry stakeholders should be preparing to engage with the FDA and USDA to craft an appropriately tailored regulatory review process.
The Regulatory Conversation – How Did We Get Here?
The issuance of the March 7, 2018 MOU builds on a regulatory conversation about cell-cultured foods that began in earnest last winter.
Cellular agriculture captured the attention of regulators and policymakers in February 2018 when the United States Cattlemen’s Association (USCA) filed a petition with the USDA’s Food Safety and Inspection Service (FSIS) requesting that the USDA undertake rule-making on beef labeling to clarify the difference between beef derived from cattle and “beef” products created through cell culture technology. To date, the USDA has received over 6,100 comments on this petition.
The FDA subsequently held a public meeting on July 12, 2018 focused on safety considerations in cellular agriculture, marking the very first time the U.S. government formally engaged stakeholders in the industry. At that meeting, conventional meat stakeholders raised the question of jurisdiction and made clear that they viewed USDA as the appropriate agency to exercise regulatory oversight.
Later in the summer, on August 23, 2018, the North American Meat Institute and Memphis Meats co-signed a letter to President Donald Trump proposing a pathway through which the FDA and USDA could maintain joint jurisdiction over cell-based food products. More specifically, the letter suggested that the FDA could exercise oversight of premarket safety evaluations for cell-based meat and poultry products and that the USDA could then regulate the products like other meat and poultry products. On the heels of that letter, the FDA and USDA held a joint public meeting on October 23 and 24, 2018 focused on potential hazards and labeling. The Agencies subsequently issued a call for stakeholder feedback. The comment period closed on December 26, 2018.
The FDA and USDA are continuing to review stakeholder feedback received in the recent public comment period and there is no current formal call for comments. However, the March 7th MOU provides a window for industry stakeholders to begin making plans to engage with the FDA and USDA on the details of a regulatory approach for cell-based food technology.
As explained above, the MOU simply memorializes the agreement first announced in November 2018 that the FDA and USDA would work together to oversee cell-cultured foods produced from cell lines derived from USDA-amenable species. Many critical questions core to the development of a functioning regulatory review process still need to be addressed.
For example, the MOU notes that, “as needed” the Agencies will “develop additional requirements for cell bank and cell culturing facility conditions and processes to ensure that biological material exiting the culture process is safe and not adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act.” The MOU further states that the Agencies might develop additional requirements with respect to inspections and labeling.
In addition to addressing whether federal rulemaking may be required for labeling or inspection, additional outstanding questions include: how the FDA and USDA will initiate their respective application processes, whether these processes will permit self-certification, and if not, how long it will take to obtain premarket approval, and how and when inspections of the production facilities will be executed. Further, the manner in which food products will be labeled remains undecided given that traditional interests may continue to advocate for new standards of identity.
In answering these questions, the Agencies are counting on industry stakeholders—ranging from producers to life sciences companies—operating in the cellular agriculture sector to shed light on the nuances of cell-culture technology. Stakeholder engagement with the Agencies will serve to assist regulators in crafting an appropriately tailored regulatory review process. Additionally, to the extent we can work with the Agencies on the frontend to educate them on how cell-culture technology works in the food space, we can likely stem the development of onerous oversight. Accordingly, it will be important for companies in this space to have a good handle on how current rules, like food safety and labeling rules, can be applied to their products to understand where adjustments may be needed.
Wiley Rein lawyers are active thought leaders at the forefront of this technology and stand ready to help you navigate the evolving regulatory terrain of this burgeoning sector. Should you have any questions, please feel free to contact Brian P. Sylvester, special counsel at Wiley Rein who previously served as a regulatory lawyer at the USDA.
 The phrase “foods produced from cell lines derived from USDA-amenable species” refers to all products subject to the Federal Meat Inspection Act and the Poultry Products Inspection Act (i.e., chicken, pork, beef, etc.). To the extent a cell cultured product is produced from cell lines derived from USDA-amenable species, the MOU outlining dual FDA-USDA oversight applies.