April 01, 2021

An agreement signed in the last days of the Trump administration would shift regulatory authority over genetically modified livestock.

A Department of Agriculture spokesman said in February that decision is among many under review by the Biden administration. In March, USDA officials also provided notice they were seeking comments on the potential changes.

On Jan. 19, leaders in the USDA and Department of Health and Human Services signed an agreement that the USDA would take over portions of the Food and Drug Administration’s oversight of genetic modifications in agricultural animals and biotechnology for agricultural animals.

“Under this framework, USDA would safeguard animal and human health by providing end-to-end oversight from pre-market reviews through post-market food safety monitoring for certain farm animals modified or developed using genetic engineering that are intended for human food,” a USDA announcement states.

The FDA would retain authority over genomic alterations for nonagricultural purposes and over dairy products, eggs, some meat products, and animal feed derived from modified animals, the announcement states. The memorandum also states that the FDA would implement a streamlined risk-based approach to oversight of intentional genomic alterations in animals.

Previously, the USDA had authority over genetic engineering of plants, while the FDA regulated all genetic engineering of animal species.

USDA officials proposed the change Dec. 27, 2020, which at least some livestock industry leaders welcomed. Representatives from the National Pork Producers Council submitted comments in support of the change, which stated the USDA would encourage innovation better than FDA regulators and claimed that the FDA’s regulation of genetic modifications as drugs had slowed development in the U.S. in comparison with competitors in other countries.

USDA officials announced March 7 they were reopening the proposal’s comment period, which had expired Feb. 26. The agency is accepting comments through May 7 under docket number APHIS-2020-0079.

On the day the memorandum was signed, Stephen M. Hahn, MD, then FDA commissioner, said via Twitter that the FDA did not support the agreement signed by the HHS.

“FDA has no intention of abdicating our public health mandate,” he wrote. “We’ll continue to stay focused on executing our vital public health mission entrusted to us by the American people.”

He said FDA officials remained committed to ensuring animal agriculture biotechnology products would undergo independent, scientific, risk-based evaluations by career experts who could determine whether the products are safe and effective.

FDA officials have been regulating intentional genomic alterations in animals as drugs. In guidance documents, they note that the Federal Food, Drug, and Cosmetic Act defines a drug as an article “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals,” and that includes any article other than food that affects the structure or function of the body.

In December 2020, FDA officials approved a genetic modification that allows production of pigs without detectable amounts of alpha-gal, a sugar molecule that triggers a rare allergy in humans.