A bid for the USDA, not FDA, to regulate GE animals for food

In a move celebrated by the hog industry, the Trump administration proposed on Monday to put the USDA in charge of regulating genetically engineered livestock and poultry, a duty now performed by the FDA. The Biden administration would make the final decision on the transfer of power since it will take office before the end of the 60-day comment period on the proposal.

Agriculture Secretary Sonny Perdue said the proposal was part of a multiyear modernization of federal oversight of agricultural biotechnology that began in the Obama years. In June 2019, President Trump signed an executive order telling the FDA, USDA and EPA, which share authority over biotechnology, to update their regulations and, referring to gene-edited crops and livestock, to use their powers “to exempt low-risk products of agricultural biotechnology from undue regulation.”

The biotech industry said animal biotechnology could provide the pathway to preventing livestock diseases, adapting to climate change and reducing greenhouse gas emissions. It is essential that “appropriate safety measures remain in place and that consumers are confident in the rigor of the (regulatory) system,” said Dana O’Brien, of the Biotechnology Innovation Organization, a trade group.

“If we do not put these safe biotechnology advances to work here at home, our competitors in other nations will,” said Perdue. “Our livestock producers need all the tools in the toolbox to help protect against animal diseases and continue to meet the challenge of feeding everyone now and into the future.”

The hog industry has campaigned for two years to put USDA in charge of GE livestock, arguing that the FDA moved too slowly. While biotech crops — with USDA oversight — are marketed in abundance, the FDA has approved two GE animals for human consumption, a salmon in 2015 and a pig this month, intended for medical and food use. A quarter of U.S. pork is exported annually and hog farmers fear they will lose sales if competitors develop disease-resistant hogs or use biotechnology to produce pork at a lower cost.

“Today’s announcement is a big step forward for America’s farmers,” said Howard Roth, president of the National Pork Producers Council. “This announcement represents a critical milestone to ensuring American agriculture maintains its global competitive edge.”

Under the administration proposal, the FDA would retain authority over GE animals developed for non-agricultural purposes, such as medical or pharmaceutical use. It also would continue to regulate dairy and shell eggs.

“This proposal raises serious concerns,” said Thomas Gremillion of the Consumer Federation of America, who suggested skepticism was merited. “USDA has shown its commitment to relinquish its oversight authority to biotechnology developers, issuing a rule early this year that allows bioengineered crop developers to self-determine whether their products qualify for exemptions from regulation and that will result in regulators and the public having no idea what genetically engineered products are on the market.”

Food animals including cattle, sheep, hog, horses, catfish and domesticated fowl would be covered by the USDA proposal. “Under this contemplated regulatory framework, USDA would in most instances provide end-to-end regulatory oversight from pre-market reviews through post-market food safety monitoring for animals modified or developed using genetic engineering intended for use as human food,” said the advance notice of proposed rulemaking prepared for the Federal Register.

The USDA advance notice of proposed rulemaking is available here.

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