U.S. Sen. Todd Young (R-IN) recently voiced concern with leaders of the U.S. Senate Appropriations Committee that commercialization of an FDA-approved product is being hindered by a provision in the agriculture appropriations bill for fiscal year 2020.
If the provision’s language is enacted, AquaBounty Technologies would immediately cease production and slash jobs for many of Sen. Young’s constituents in Delaware County, Ind.
“The provision in the bill would ban the sale of bioengineered salmon in the U.S. until FDA completes a labeling study of the mandatory bioengineering disclosure for the salmon under USDA’s Bioengineered Food Disclosure rule. If adopted, this unprecedented provision would greatly undermine regulatory certainty in the entire biotechnology industry,” wrote Sen. Young and U.S. Sen. Mike Braun (R-IN).
The provision resulted from an announcement in March by the U.S. Food and Drug Administration (FDA) to deactivate an import alert on genetically engineered salmon and salmon eggs from entering the United States.
Lifting the ban, according to Sen. Young’s office, allowed for the creation of more jobs and healthier food options for voters in Indiana.
Sens. Young and Braun also said that if the provision becomes federal law, the language would set a troubling precedent regarding the function and authority of federal regulatory agencies.
“For Congress to intervene to prohibit commercialization of an FDA-approved product on grounds other than safety or efficacy is an unprecedented action that not only undermines FDA’s scientific expertise, but it also casts serious doubt for every other FDA-approved product and their continued ability to commercialize,” the senators wrote.
At the same time, they wrote, effectively banning a first-in-class product “for no legitimate reason will cast a chilling effect on the willingness or ability of other researchers and developers to invest in the United States.”
Sen. Young and his colleague requested that Senate appropriators “strike this provision” from the agriculture appropriations legislation.