FDA clears path for genetically engineered salmon, allowing for AquaAdvantage salmon eggs to be imported to the company’s land-based facility in Indiana.
The FDA released a statement on Friday that it has deactivated a 2016 import alert that prevented GE salmon from entering the U.S.
Shares in the biotech firm that can grow land-based salmon to market size in about half the time grew by nearly 120 %.
Approval
The FDA’s approval of the application related to AquAdvantage salmon followed a comprehensive analysis of the scientific evidence, which determined that the GE Atlantic salmon met the statutory requirements for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act, the department wrote.
However, in 2016, Congress directed the FDA not to allow into commerce any food that contains GE salmon until it issued final labelling guidelines for informing consumers of the GE salmon content in the food. The FDA complied with this requirement by implementing an import alert in 2016 that prevented GE salmon from entering the U.S.
With Congress’ enactment of the National Bioengineered Food Disclosure Standard, the U.S. Department of Agriculture (USDA) was charged with implementing a mandatory standard for disclosing whether a food is “bioengineered” and FDA was divested of its authority over voluntary labelling to indicate the presence of GE content in human foods. The FDA no longer has the authority to issue labelling guidance on this topic; however, the FDA believes this Congressional mandate has been satisfied by the USDA’s issuance of final regulations implementing that law in late 2018 because the law and regulations require that human food containing GE salmon bear labelling indicating that it is bioengineered. Therefore, the FDA is deactivating the import alert that prevented food from AquAdvantage Salmon, including salmon eggs used to grow the fish, from entering the U.S.
In December, the USDA issued the standard, requiring manufacturers, importers and certain retailers to disclose whether a product was bioengineered using either text, a symbol, an electronic or digital link, and/or a text message.
Satisfied
On Friday, FDA Commissioner Scott Gottlieb said because of the 2016 law and the USDA’s standard, his agency “no longer has the authority to issue labelling guidance.”
“However, the FDA believes this Congressional mandate has been satisfied by the USDA’s issuance of final regulations implementing that law in late 2018 because the law and regulations require that human food containing GE salmon bear labelling indicating that it is bioengineered,” Gottlieb said in a statement.
The FDA will now allow AquaAdvantage salmon eggs, produced by AquaBounty, to be imported to the company’s land-based facility in Indiana and raised into salmon for food.
Immediately start the process
Chief Executive Officer of AquaBounty Sylvia Wulf said: “We are delighted that FDA has lifted the import alert, which will allow AquaBounty to begin producing and marketing AquAdvantage Salmon in the United States. As FDA notes in this announcement, our salmon was approved by the agency over three years ago based upon a very comprehensive science-based review process, which established that our salmon was safe, nutritious, and environmentally sound and met all other regulatory requirements. We will immediately start the process to import AquAdvantage eggs from our hatchery in Canada to begin grow out at our Indiana facility.”
The Company expects to have AquAdvantage Salmon growing in its new Rollo Bay farm facility on Prince Edward Island, Canada, this quarter with harvest projected to be in the summer of 2020.
AquaBounty is also establishing operations outside North America with projects currently in process in Brazil, Argentina, Israel, and China
