Thirteen groups led by the Center for Food Safety are urging the Food and Drug Administration to retain regulatory authority over genetically engineered food animals.
In January, the Trump administration proposed that the FDA, USDA and the U.S. Health and Human Services Department sign a memorandum of understanding. Under it, USDA would have provided end-to-end oversight, from pre-market reviews through post-market food safety monitoring for farm animals modified or developed using genetic engineering that are intended for human food.
However, FDA Commissioner Stephen Hahn refused to sign the MOU, saying he didn’t support it and intended to disregard it.
“FDA remains undeterred in our steadfast commitment to ensure that animal agriculture biotechnology products undergo independent and science- and risk-based evaluations by our career experts,” Hahn said in a Twitter post in January.
Alex Azar, then the Health and Human Services Secretary, “was and remains supportive of Commissioner Hahn’s and FDA’s position on the MOU,” a spokesperson for HHS told the Capital Press at the time.
The letter from the groups urging FDA oversight said the Politico website reported Hahn’s refusal to sign the MOU “amid concerns about its legality and the potential health repercussions of relaxing oversight of certain genetically altered products.”
“We share Commissioner Hahn’s concerns and urge you to instruct USDA officials to remove the MOU from the APHIS (USDA Animal and Plant Health Inspection Service) website as the MOU is invalid,” the groups said in the letter.
In announcing the MOU, former USDA Secretary Sonny Perdue, repeated animal and meat industry arguments that FDA’s safety-oriented regulatory approach impedes rapid commercialization of GE animals.
The animal agriculture industry has demanded regulatory certainty to expedite investment in and commercialization of GE animals, the groups said.
“However, reassigning regulatory authority to an agency avid to market GE products worldwide represents a conflict of interest and very likely could compromise the scientific integrity of novel GE animals,” they said.
The groups cited unintentional and unwanted consequences of gene-editing techniques.
“These unsettling and unanticipated safety issues underscore both how much there is yet to learn about manipulating the genomes of animals, as well as the need for “safety first” regulation. Undoubtedly, FDA, the nation’s food and drug safety authority, is better equipped to fulfill this role than USDA,” they said.
Stringent regulation is required not only to ensure safety, but also to avoid blowback from the “rush-to-market, consequences be damned” mentality of some biotechnology enthusiasts.
That said, FDA also needs to shore up its regulatory regime, they said.