FDA and USDA Split the Cell-Cultured Burger

The jurisdictional skirmish over the regulation of cell-cultured meat products appears to have been resolved with the recent announcement by the Food and Drug Administration and the US Department of Agriculture of a joint regulatory framework in which the two agencies would share jurisdictional responsibilities. However, after the two agencies released some initial details of the agreement, there remains some uncertainty as to whether Congress will sign-off on the final arrangement.

In a joint announcement late last week, Secretary Sonny Perdue and FDA Commissioner Scott Gottlieb explained that, under the framework, FDA would oversee the early stages of the cell-culture process, including cell collection, cell banks, and cell growth and differentiation. A transition from FDA to USDA oversight then would occur during the cell harvest stage, and USDA would oversee the production and labeling of food products derived from the cells of livestock and poultry. The joint announcement also noted that the technical details of the framework are being refined, including ensuring that there is robust collaboration and information sharing between the agencies to allow each to carry out their respective roles.

While expressing confidence that this regulatory framework can be implemented successfully and assure the safety of these products, the joint USDA and FDA announcement also signaled to Congress that legislative action on this issue is unnecessary. “Because our agencies have the statutory authority necessary to appropriately regulate cell-cultured food products derived from livestock and poultry the Administration does not believe that legislation on this topic is necessary,” the statement declared. This has been a message that the Trump Administration has conveyed to Congress throughout the debate over the jurisdictional issue.

Congress: Let Us Decide What’s Necessary

The USDA-FDA joint regulatory framework counters pending language in the FY 2019 House Agriculture Appropriations bill that would grant USDA full regulatory jurisdiction over cell-cultured meat products. While the joint announcement would seem to compel the removal of this language from the bill, key appropriators seem hesitant to take that step, according to some initial reactions compiled by Politico.

Rep. Robert Aderholt (R-AL), Chairman of the House Agriculture Appropriations subcommittee indicated that he would like to learn more about the plan before deciding to remove the language from the bill. His spokesperson stated in the Politico article, “As I have seen over the years when jurisdictional battles brew, that talk is cheap when written words matter.”

A similar sentiment was expressed by Sen. John Hoeven (R-ND), Chairman of the Senate Agriculture Appropriations subcommittee. His spokesperson noted that he is gathering more information to “ensure that the agreement works.”

Meanwhile, Rep. Sanford Bishop (D-GA), the presumptive incoming chairman of the House Agriculture Appropriations subcommittee, also supports the language in the bill that provides USDA with full regulatory authority over cell-cultured meat products, so his input also will be crucial.

What’s the Cell-Cultured Forecast?

The subcommittee faces a December 7 deadline to pass an FY 2019 agriculture appropriations bill. While deliberations over this provision certainly will be monitored closely, it is highly unlikely that it will prevent the overall bill from moving forward.

After it considers the dynamics of the joint regulatory framework and gauges stakeholder reactions, it is likely that the subcommittee members will remove the language from the bill. However, it is possible that, in removing the language, the subcommittee replaces it with non-binding report language that outlines any remaining concerns over the joint regulatory framework.

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