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Over FDA objections, Trump administration says USDA can regulate GE livestock

Since the dawn of agricultural biotechnology in the 1990s, the FDA has overseen GE animals and USDA has regulated GE plants.

The Trump administration, in a move sought by the hog industry, pushed through an interdepartmental memorandum before leaving office that allows the USDA to regulate food-bearing GE livestock. FDA commissioner Stephen Hahn publicly objected on Tuesday and said his agency “has no intention of abdicating our public health mandate” over animal biotechnology.

Since the dawn of agricultural biotechnology in the 1990s, the FDA has overseen GE animals and USDA has regulated GE plants. Hog farmers, worried about competition on the global pork market, complain of FDA foot-dragging and say the USDA is the more appropriate regulator. Consumer groups say the FDA would be more even-handed.

The Biden administration will make the final decision. A public comment period runs through Feb. 26 on a USDA proposal to set the boundaries of yet-to-be-written regulations governing GE cattle, sheep, hogs, goats, horses, mules, catfish, chickens, turkeys, geese, and other domesticated fowl developed for human consumption. The USDA envisions “end-to-end regulatory oversight” that stretches from genetic engineering of food animals through growth, slaughter, and marketing of them.

“America has the safest and most affordable food supply in the entire world, thanks to the innovation of our farmers, ranchers, and producers,” said Agriculture Secretary Sonny Perdue. “Establishing a new, transparent, risk- and science-based regulatory framework would ensure this continues to be the case.”

Although the USDA announced the memorandum of understanding with the HHS on Tuesday, one day ahead of the inauguration of President Biden, it was signed on January 13 by Perdue and HHS assistant secretary Brett Giroir, head of the Public Health Service. Hahn told HHS leaders on January 11 that he would not sign the memorandum out of concern about its legality and the potential health risks, reported Politico last week.

“FDA has no intention of abdicating our public health mandate,” said Hahn on social media on Tuesday, after announcing the agency “does not support” the transfer of jurisdiction. “FDA remains undeterred in our steadfast commitment to ensure that animal agricultural biotechnology products undergo independent and science- and risk-based evaluation by our career experts. We’ll continue to work with developers to advance animal agricultural biotech.”

Scott Gottlieb, FDA commissioner for the first two years of Trump administration, said the memorandum “is an unprecedented usurping” of FDA authority. “This move threatens the health and well-being of Americans and should be immediately reversed,” he said on social media.

U.S. farmers have embraced GE crops. Almost all the corn, soybeans, cotton, and sugar beets grown in America are genetically engineered. The FDA has approved two GE animals for human consumption, a salmon in 2015 and a hog, last month, for food and biomedical uses.

One in four pounds of U.S.-grown pork is exported. The National Pork Producers Council says half-a-dozen nations, from Argentina to China, soon could use gene editing to create hogs that are disease-resistant or cheaper to raise, to the detriment of American farmers.

“NPPC has been calling for this decision for more than three years to ensure that U.S. agriculture maintains its competitive edge globally,” said the trade group. “We look forward to working with the Biden administration to implement (this) technology.”

Similarly, the Biotechnology Innovation Organization, speaking for the biotech industry, said it looked forward to working with the Biden administration “to implement an updated regulatory framework.”

“Oversight of animal biotechnology needs to be clear and workable for technology developers in order to maintain America’s position as a global leader in agricultural innovation,” said BIO.

Under the Trump administration memorandum, the FDA would retain control over GE animals for biomedical and pharmaceutical purposes.

The memorandum of understanding is available here.

Produced with FERN, non-profit reporting on food, agriculture, and environmental health.
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