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On January 29, the US Food and Drug Administration (FDA or the Agency) issued Import Alert 99-40: Genetically Engineered (GE) Salmon, which bans the import of any human or animal food containing GE salmon until the FDA publishes final labeling guidelines for informing consumers of such content.1

The import alert was issued to comply with language introduced in the Consolidated and Further Continuing Appropriations Act by Senator Lisa Murkowski (R-AK), an act signed into law by President Barack Obama in December 2015. The bill ordered the FDA to block imports of GE salmon until the FDA issued final guidance requiring food derived from GE salmon to be labeled as such. Currently, Alaska is the only state that requires labeling of genetically modified fish.

The mandate in the omnibus bill states, “[d]uring FY16 the FDA shall not allow the introduction or delivery for introduction into interstate commerce of any food that contains genetically engineered salmon until FDA publishes final labeling guidelines for informing consumers of such content.” The law also requires the FDA to allocate at least $150,000 of its funding to developing and implementing guidance to disclose to consumers whether salmon is genetically engineered.

The import ban on GE salmon is significant because it follows only months after the FDA’s November 2015 approval of AquaBounty Technologies’ AquAdvantage genetically modified salmon, which took years of deliberation.2 The AquaBounty modified salmon contains a growth hormone from a Chinook salmon and a gene promoter from a second fish (the ocean pout)—the combination of the two helps the salmon grow large enough for consumption in 18 months, rather than the typical three years. The ban also follows on the heels of the FDA’s issuance of a November 2015 Draft Guidance on the voluntary labeling that indicates whether food has or has not been derived from GE Atlantic salmon.3

Although the ban seems to apply only to AquaBounty at this point because it is the only “approved” GE salmon product, AquaBounty’s CEO Ronald Stotish has stated that the ban has no effect on AquaBounty’s operations because the company is not currently importing its salmon into the United States.4 Therefore, it seems the ban on imports does not currently affect any entities. The ban will be revisited at the end of fiscal year 2016.

We will continue to monitor any developments on this issue.

1US Food & Drug Admin., Import Alert 99-40 (Jan. 29, 2016)
http://www.accessdata.fda.gov/cms_ia/importalert_1152.html.
2See Letter from Bernadette M. Dunham, Director, Center of Veterinary Medicine, US Food & Drug Admin., to Ronald Stotish, AquaBounty Technologies, Inc. (Nov. 19, 2015)
http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/ucm466214.htm.
3See US Food & Drug Admin., Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon (Nov. 2015)
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm469802.htm.
4See AquaBounty Technologies, Inc., Press Release on FDA’s Import Alert for AquAdvantage® Salmon (Jan. 29, 2016) https://www.aquabounty.com/wp-content/uploads/2014/02/2016-01.29-FDAs-Import-Hold-on-AAS.pdf.