Ag industry, consumer advocates split over USDA animal biotech proposal
A turf war is likely to persist between USDA and FDA over which agency is better suited to regulate genetically engineered animals.
On Jan. 19, the leaders of two U.S. government agencies provided starkly different perspectives about a memorandum of understanding (MOU) regarding regulation of agricultural animal biotechnology.
The MOU “clears a path to bring our regulatory framework into the 21st century, putting American producers on a level playing field with their competitors around the world,” then-outgoing Agriculture Secretary Sonny Perdue said in a statement. “In the past, regulations stifled innovation, causing American businesses to play catch-up and cede market share.”
The MOU was finalized with FDA, outlining responsibilities regarding the regulation of certain animals developed using genetic engineering intended for agricultural purposes including human food, according to USDA.
FDA opposition
The document clearly didn’t sit well with the then-top official at FDA, Dr. Stephen Hahn, who tweeted on Jan. 19 that while the U.S. Department of Health and Human Services (HHS)—of which FDA is a part—signed the MOU with USDA, his agency did not support it.
“FDA has no intention of abdicating our public health mandate,” Hahn proclaimed on Twitter a day before he departed the agency, coinciding with the inauguration of President Joe Biden. “We’ll continue to stay focused on executing our vital public health mission entrusted to us by the American people.”
The MOU was signed by Perdue and Brett Giroir, M.D., assistant secretary for Health and head of the Public Health Service. Due to the change in administration, the top officials mentioned in this story—Hahn, Giroir and Perdue—have moved on from their posts in the U.S. government.
But a turf war is likely to persist between USDA and FDA over which agency is better suited to regulate genetically engineered animals.
FDA career lawyers had objected to the MOU, Politico reported in a Jan. 19 article, citing “people with knowledge of the discussions.” And Hahn in recent days refused to sign off on the MOU, a senior HHS official told Politico.
“This is a last-minute Hail Mary,” the story quoted the senior HHS official. “It is a total ceding of FDA authority to the USDA.”
Shifting authority to USDA
Largely at stake: the regulation of agricultural animals like cattle and swine subject to gene editing—otherwise known as genome editing. These technologies function “like scissors, cutting the DNA at a specific spot,” which enable scientists to add, remove or replace DNA where it was cut, according to the National Human Genome Research Institute.
The recently signed MOU paves the way for USDA to use its authorities under two laws—the Federal Meat Inspection Act and Poultry Products Inspection Act—to create a new program through rulemaking to oversee pre-market human food safety evaluations and monitoring for agricultural animals using genetic engineering. Per the MOU, FDA would continue to use its authority under a separate law—the Federal Food, Drug & Cosmetic Act (FDCA)—to regulate certain things, including table and shell eggs, certain meat products and animal feed that originates from agricultural animals developed using genetic engineering.
The four-page document, as well as a previous advanced notice of proposed rulemaking (ANPR) announced by USDA in December, was interpreted as shifting much authority over regulation of certain genetically engineered animals from FDA to USDA.
But it wasn’t immediately clear how USDA under a new administration would approach the issues. The Biden administration recently imposed a freeze on certain pending regulatory actions.
Asked whether policies implemented by the new Biden administration affect either the MOU or ANPR, a spokesperson for USDA responded the ANPR “is under review.”
As of Jan. 27, the document had drawn 17 comments on the public docket (regulations.gov), including two separate submissions from a Florida resident named Dorian Atchison. “This is outrageous that GM animals and other GM products could be pushed through without independent oversight, and plenty of time for public input,” she wrote.
Urging USDA “not to approve eliminating FDA oversight,” Atchison stated, “We need as much oversight in this area as is possible.”
The ANPR was announced more than a year after then-President Trump signed an executive order on agricultural biotechnology products.