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Genetically engineered salmon approved to be on the market

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The FDA announced on Friday that they are lifting an import alert on genetically engineered salmon from entering the United States. The original alert was set by Congress in 2016 due to the lack of a bioengineered label. This new technology has allowed the salmon to grow twice as fast with 25 percent less feed. 

In the statement, FDA Commissioner Dr. Scott Gottlieb explains why they lifted the band and the original findings that the salmon would not cause a significant impact on the U.S. environment.

“Today, we are taking another important step by deactivating a 2016 import alert that prevented genetically engineered salmon from entering the U.S. 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.

“However, in 2016, Congress directed the FDA not to allow into commerce any food that contains GE salmon until it issued final labeling 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, USDA was charged with implementing a mandatory standard for disclosing whether a food is “bioengineered” and FDA was divested of its authority over voluntary labeling to indicate the presence of GE content in human foods.

“The FDA no longer has the authority to issue labeling 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 labeling 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.

“With the deactivation of the import alert, AquAdvantage Salmon eggs can now be imported to the company’s contained grow-out facility in Indiana to be raised into salmon for food. As was determined during the FDA’s 2015 review, this fish is safe to eat, the genetic construct added to the fish’s genome is safe for the animal, and the manufacturer’s claim that it reaches a growth marker important to the aquaculture industry more rapidly than its non-GE farm-raised Atlantic salmon counterpart is confirmed.

“Additionally, as part of its approval, the FDA also analyzed the potential environmental impact that an approval of the AquAdvantage Salmon application would have on the U.S. environment and published its final Environmental Assessment and Finding of No Significant Impact in November 2015. Based on the multiple forms of physical and biological environmental containment measures proposed by the company in its application, the FDA found that an approval of the application related to AquAdvantage Salmon would not cause a significant impact on the U.S. environment. Subsequently, the FDA found that multiple forms of containment proposed in the supplemental application to raise the salmon in the company’s Indiana facility also would have no significant impact on the environment.

“The FDA’s approval process for intentional genomic alterations (IGAs) in animals is risk-based and includes an assessment of several elements. The FDA encourages developers of IGAs in animals to approach the agency early in their research and development phase to discuss the specific risk profile of the proposed product and the regulatory pathway for commercialization. The FDA routinely works with sponsors early and often to provide greater clarity in the regulatory process, encourage development and research, and support an efficient and predictable pathway to approval.

 

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