Thursday, U.S. Senators Todd Young (R-Ind.) and Mike Braun (R-Ind.) wrote a letter to Chairman Richard Shelby (R- Ala.) and Vice Chairman Patrick Leahy (D-Vt.) of the Senate Appropriations Committee voicing concern on a provision in the FY 2020 Agriculture Appropriations bill. This provision would prohibit the commercialization of a product approved by the FDA in 2015 after an extensive review process. If this language is enacted, AquaBounty Technologies would immediately cease production and put Hoosiers out of jobs in Delaware County.
This provision comes in reaction to the U.S. Food and Drug Administration (FDA)’s announcement in March that it will deactivate an import alert on genetically engineered (GE) salmon and salmon eggs from entering the United States. Lifting this ban allowed for the creation of more jobs and healthier food options for Hoosiers while boosting Albany’s economy.
“We are deeply concerned to learn of language in the base text of the FY 2020 Agriculture Appropriations bill that would seek to prohibit the commercialization of an FDA-approved product for reasons other than safety or efficacy,” said the Senators.
“If passed into law, this language would set a troubling precedent regarding the function and authority of federal regulatory agencies. There are a great number of important agriculture innovations in the research, development, and regulatory pipeline behind the bioengineered salmon. To effectively ban 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.
“For innovators to lack the certainty as to whether Congress will intervene and prohibit the sale of other approved products, absent any evidence of issues relating to safety or efficacy, will ultimately stifle innovation in American agriculture. Because of these inappropriate processes and substantial negative effects, we would ask you to strike this provision,” the Senators continued.
The full text of the letter is available below and here.
The Honorable Richard Shelby
Chairman
Committee on Appropriations
U.S. Senate
Washington, D.C. 20510
The Honorable Patrick Leahy
Vice Chairman
Committee on Appropriations
U.S. Senate
Washington, D.C. 20510
Dear Chairman Shelby and Vice Chairman Leahy,
We are deeply concerned to learn of language in the base text of the FY 2020 Agriculture Appropriations bill that would seek to prohibit the commercialization of an FDA-approved product for reasons other than safety or efficacy.
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.
The bioengineered salmon, which is the subject of this provision, is likely the most studied food in the world. FDA rigorously reviewed the salmon for nearly 20 years to ensure food and environmental safety, ultimately finding that the salmon was “as safe to eat,” and, “as nutritious,” as conventional farm-raised Atlantic salmon. On those grounds, FDA approved the bioengineered salmon for sale domestically in late 2015.
Since FDA’s approval, there has been absolutely no evidence to contradict those findings. 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.
Moreover, in 2016, Congress enacted the bipartisan Bioengineered Food Disclosure Act, which directed USDA to develop a meaningful disclosure system to inform consumers of the presence of bioengineered food ingredients. The final rule issued by USDA in December 2018 expressly identifies bioengineered salmon as being covered under the rule. To direct FDA to conduct a labeling study of USDA’s disclosure system is unprecedented and inappropriate.
FDA’s labeling study authority is exclusively a drug authority, intended to assess the comprehension of drug labels. To direct its use for a food label is extraordinary and abuses the purpose and function of the study authority. Additionally, when FDA lifted the import alert on bioengineered salmon after USDA issued its final rule implementing the Disclosure Act, the agency made clear that “FDA no longer has the authority to issue labeling guidance on this topic.”
If passed into law, this language would set a troubling precedent regarding the function and authority of federal regulatory agencies. There are a great number of important agriculture innovations in the research, development, and regulatory pipeline behind the bioengineered salmon. To effectively ban 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.
For innovators to lack the certainty as to whether Congress will intervene and prohibit the sale of other approved products, absent any evidence of issues relating to safety or efficacy, will ultimately stifle innovation in American agriculture. Because of these inappropriate processes and substantial negative effects, we would ask you to strike this provision.
Sincerely,
