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FDA moves genetically engineered salmon forward

Last week, the U.S. Food & Drug Administration (FDA) decided to allow AquaBounty Technologies, an American company, to commercialize its genetically engineered AquAdvantage Salmon in the U.S. market.

The AquAdvantage Salmon was developed by Massachusetts-based AquaBounty Technologies. It is genetically engineered to reach its market weight in half the time of conventionally raised salmon while using 25% less food and contributing to more sustainable aquaculture systems.

“We are taking another important step by deactivating a 2016 import alert that prevented GE 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.,” said Scott Gottlieb, FDA Commissioner. “With Congress’ enactment of the National Bioengineered Food Disclosure Standard, the U.S. Department of Agriculture 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.”

With the FDA’s deactivation of the import alert, AquAdvantage Salmon, including salmon eggs used to grow the fish, can now enter the U.S. for commercialization.

“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,” Gottlieb said. “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.”

The Biotechnology Innovation Organization (BIO) was pleased with the announcement by FDA.

“While long overdue, this milestone paves the way for future innovations that contribute to a more sustainable food supply for a growing world population and lessen the impact on our environment,” BIO said in a statement. “Going forward, BIO will continue to work with FDA to support greater clarity in the regulatory process and an efficient, predictable pathway to product approval. By implementing a transparent, science-based and risk-appropriate regulatory path, the United States and American companies can lead the way in developing biology-driven solutions to society’s biggest challenges.”

 

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