Agriculture Secretary Sonny Perdue has floated the possibility of USDA and the Food and Drug Administration splitting regulatory responsibilities over gene-edited animals.
“We’re actually in the process of working with FDA currently to help divide up the responsibilities, hopefully with an agreeable type of consensual [memorandum of understanding] with FDA” over new breeding techniques, Perdue said at a press conference at USDA’s Agricultural Outlook Forum.
That division would result in USDA having regulatory oversight over “food animal breeding,” with FDA responsible for “any other animals,” he said.
At another point, however, Perdue seemed to indicate the effort was not that far along. “We’re in the process of continuing to build good relations with FDA,” he said, pointing to the USDA-FDA MOU on cell-cultured food as a potential template. “I think we came to a good place there of utilizing the skill sets of FDA in the early type of petri-dish environment and then moving to USDA regulatory environment when we harvest that cell-based protein.”
Asked whether USDA and FDA officials had met to discuss an MOU, a USDA spokesperson said, “We are always in discussion with various FDA officials on a number of issues dealing with American agriculture.”
A spokesperson for FDA said the agency "continues to engage with our federal partners in the regulation of agriculture biotechnology products.
"Under the Coordinated Framework for the Regulation of Animal Biotechnology and the Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products, each agency has a role to play within its existing statutory structure. Together, we are committed to overseeing this space in a manner that fosters innovation, promotes consumer confidence and protects the public health."
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Dana O’Brien, executive vice president of food & agriculture at the Biotechnology Innovation Organization (BIO), said, “It’s encouraging to hear Secretary Perdue note that they are looking to work with FDA to find a solution, and we’ll continue to support the government in that process. If we are to truly realize the benefits of animal biotechnology — such as the ability to eradicate animal disease and drive sustainability — we need a new system that is science-based and allows innovation to thrive.”
The current process "is unworkable, as evidenced by the lengthy time it took to approve just one animal food product," O'Brien said.
FDA has been regulating intentional genomic changes as animal drugs, which the biotech and agriculture industry have criticized for stifling innovation.
Perdue echoed that complaint. Without improvements in the regulatory structure, “these new techniques are going to go to Argentina, Brazil, Canada, China and other places, which I think makes the U.S.A. a follower rather than a leader in the new technologies,” he said. “We believe that they are demonstrated to be safe.”
In an opinion piece published in Agri-Pulse, O’Brien said BIO has shown USDA and the White House “how FDA and USDA could partner to share regulatory oversight. And we have even shown the White House how the President could move animal biotechnology oversight to USDA — an approach championed by key livestock and scientific stakeholders.”
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