In one of his last acts as the outgoing FDA Commissioner, Stephen Hahn refused to sign a Memorandum of Understanding (MOU) that would have split jurisdiction over genetically engineered animals between FDA and USDA.
The MOU, signed by outgoing Secretary of Agriculture Sonny Perdue and outgoing Public Health Service Director Admiral Brett Giroir, would have moved jurisdiction over GE animals intended for food from FDA to USDA, and left jurisdiction over GE animals intended for human biopharma drug development and gene therapies with FDA. The MOU would also have required FDA to exercise enforcement discretion over GE of “agriculture amenable animals,” thus potentially ceding authority over GE animals with potential medical uses to USDA as well.
Secretary Perdue said that “[a]gricultural biotechnology holds tremendous potential to improve animal health, enhance farm productivity, improve nutrition, and even reduce the need for some animal health measures. USDA and FDA are committed to working together to foster safe use of this promising technology and encourage innovation.”
Commissioner Hahn said that “FDA has no intention of abdicating [its] public health mandate,” and that “FDA remains undeterred in [its] steadfast commitment to ensure that animal agricultural biotechnology products undergo independent and science and risk-based evaluation by our career experts.”
HHS Secretary Alex Azar had supported FDA’s position over that of USDA. HHS said that Azar “was and remains supportive of Commissioner Hahn’s and FDA’s position on the MOU, but at the direction of the White House, the decision was made to execute the MOU.”
At present, FDA has approved only two GE animals for human consumption — Galsafe pigs and GE salmon.
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