FDA lifts import ban on genetically engineered salmon, advocates for safe biotechnology

USA – The U.S. Food and Drug Administration has lifted an import ban on genetically engineered salmon as part of the efforts in advancing development of safe biotechnology innovations in the country.

The 2016 import ban prevented genetically engineered salmon from entering the US until the agency finalizes on guidelines on how it should be labelled.

The move allows AquaBounty Technologies to start farming its GE AquAdvantage salmon in the country.

Following a prolonged regulatory battle with AquaBounty, the FDA approved GE AquAdvantage salmon, whose DNA is modified to grow large enough for consumption in 18 months instead of the typical three years.

The agency requires additional labeling of genetically engineered foods if there is a material difference such as a different nutritional profile between the altered food and its natural counterpart, but it said it found no such difference in GE salmon.

FDA said the AquAdvantage Salmon met the statutory requirements for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act.

The decision will enable AquaBounty, a majority-owned subsidiary of biotechnology company Intrexon to import AquAdvantage salmon eggs to be raised at its Indiana facility into salmon for food.

According to FDA’s 2015 review, the GEE salmon 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.

Efforts to advance safe biotechnology innovations

According to a statement from the FDA Commissioner Scott Gottlieb, M.D, the agency is committed to helping food developers bring biotechnology innovations to market and ensure that safe products are available for consumers.

FDA said that it is mandated to ensure all foods available for purchase in the US, whether developed using traditional breeding techniques or biotechnology, meet the FDA’s high safety standards.

According to USDA’s regulations implemented in 2018, human food containing GE salmon should bear labeling indicating that it is bioengineered.

The US Congress enacted the National Bioengineered Food Disclosure Standard, charging the USDA to implement a mandatory standard for disclosing whether a food is “bioengineered”.

Last year, FDA announced Plant and Animal Biotechnology Innovation Action Plan to support innovation in plant and animal biotechnology.

“The FDA is committed to supporting innovation and ensuring safety in the biotechnology space, including the use of IGAs in animals.

We’re interested in the promise that newer technologies can have for bringing innovative products, such as these, to market while also helping to ensure they are safe and effective,” said FDA in a statement.

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