U.S. Senator Mike Enzi, R-Wyo., sent a letter asking how the U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) will implement a policy to oversee food produced using animal cell culture technology that is derived from livestock and poultry cells.
Biotechnology companies are developing a process to take cells from an animal, such as a cow, and grow the cells in a laboratory into tissue for human consumption.
Addressed to USDA Secretary Sonny Perdue and FDA Acting Commissioner Ned Sharpless, the letter notes it is important that a clear and functional regulatory framework be in place to ensure safety and proper labeling before this product becomes available to the public
Last month, the agencies released a formal agreement describing the intended regulatory roles for each agency, which states that the FDA will have oversight of cell collection, cell banks, and cell growth and differentiation. Oversight responsibility will transition from FDA to USDA during the cell harvest stage, and USDA will oversee production and labeling of these novel food products derived from livestock and poultry cells.
In the letter, Enzi asked how the agencies will coordinate their joint regulatory oversight to ensure that each agency’s expertise is appropriately leveraged.
“I respectfully request that you provide specific details on the anticipated content of the information FDA will provide, including a clear explanation of any implications it may have on the labeling of these novel food products, which the agreement states is to be overseen by USDA,” Enzi wrote. “I also urge USDA and FDA to prioritize the publication of additional information on this regulatory framework.”