The U.S. Government Accountability Office (GAO) released a report titled “Food Safety: FDA and USDA Could Strengthen Existing Efforts to Prepare for Oversight of Cell-Cultured Meat.” This report was requested by Rep. Rosa DeLauro (D-Conn.), and concerns the federal oversight of cell-cultured (or cell-based) meat, poultry and seafood, specifically the extent to which FDA and USDA are cooperating.
Based on the GAO’s findings from a literature review, analysis of documentation from FDA, USDA and stakeholder groups, review of public comments and site visits to select cell-cultured meat firms, the GAO outlined several recommendations for executive action, including a more effective collaboration between the FDA and USDA and identification of specific outcomes and a method for monitoring and evaluating progress towards those outcomes. In addition, the GAO noted that the USDA/FDA interagency agreement on cell-cultured meat does not cover cell-cultured seafood other than catfish. FDA and USDA purportedly have agreed that those seafood products will be regulated exclusively by FDA – a decision that GAO recommended be formally documented so as to provide greater clarity to industry.
As readers of this blog know, for meat and poultry (and catfish, which is also under the jurisdiction of USDA), a major issue has been which agency, FDA or USDA should regulate these cell-cultured products. After several meetings, hearings, etc., FDA and USDA announced that the Agencies had come to an agreement that FDA would oversee the early phases of cell-cultured meat production, i.e., obtaining cell samples, cell selection, storage, and cell growth/product through the point of harvest and at that point, USDA would take over the oversight for meat and poultry (not for seafood other than catfish). The memorandum of understanding (MOU) was short on details.
GAO noted that the Agencies have created three working groups: a pre-market assessment working group lead by FDA, a working group that is focused on developing joint principles for product labeling and claims led by USDA, and a working group that addresses procedures for the transfer of inspection authority, co-led by FDA and USDA. However, GAO concluded that developing a strategy as to how to evaluate the safety of cell-cultured meat, poultry and seafood products is hindered by a lack of information about technologies used in production. Specifically, information about the technology being used and the eventual commercial production methods as well as the final products is lacking. Questions that remain include:
- Use of source animals used for biopsy samples (and how frequently will new cells need to be collected).
- Use of genetic engineering: Some companies plan to use genetic engineering to select/create desirable traits in the cells used to culture, whereas other companies have represented that they will not use such techniques.
- Use of antibiotics: Initially, many companies represented that they would not use (or need) antibiotics in the production of cell-cultured meat. However, there is uncertainty as to whether the large-scale production of cell-cultured products will be possible without their use.
- Other unknowns include the composition of the growth medium, use of scaffolding, and product composition. This type of information is needed for evaluation of safety.
- Naming of the final products is also uncertain. As we have previously reported, the traditional (animal) industry (and farmers) has opposed naming the cell-based products using terms that have been used for products derived from whole animals. Several states have enacted laws reserving the meat and poultry terms for the traditionally produced products. At this time, it is not clear whether those laws will stand.
- Environmental benefits: Proponents of cell-cultured meat claim that cell cultured meat is environmentally friendly. However, there exists disagreement about the potential benefits, and absent information about scaled up production, use and disposal of growth media, possible need for antibiotics, etc., it is not possible to evaluate the potential environmental, animal welfare and health impact.