FDA approves application for AquaBounty salmon facility

Import alert for genetically engineered salmon remains in place preventing U.S. production.

April 27, 2018

2 Min Read
FDA approves application for AquaBounty salmon facility

The U.S. Food & Drug Administration approved April 26 a supplemental New Animal Drug Application (NADA) submitted by AquaBounty Technologies Inc.

The supplemental NADA requested FDA approval to raise AquAdvantage Salmon — a product under an application previously approved in 2015 — at a land-based contained facility near Albany, Ind. While the Indiana facility is approved for production, FDA said the company is prohibited from importing the eggs necessary for producing genetically engineered (GE) salmon at the facility because of a requirement in FDA’s current appropriations law.

Under the Federal Food, Drug & Cosmetic Act (FD&C Act), FDA is required to review NADAs for safety and effectiveness. Because AquaBounty met these and other statutory requirements, FDA is approving the supplemental application.

In 2015, FDA approved a NADA related to the AquAdvantage Salmon, but this approval specified that only AquaBounty’s facility on Prince Edward Island in Canada — where the salmon eggs are produced — and the company’s growout facility in Panama — where fish hatch from the eggs and grow to maturity — could be used for producing AquAdvantage Salmon. FDA’s newest approval applies to a specific set of conditions and requirements, which are described in the environmental assessment and an appendix to the supplemental NADA approval letter.

FDA said the approval does not authorize the production or growout of AquAdvantage Salmon in any other domestic or international facilities.

In 2016, FDA issued Import Alert 99-40 in response to a specific provision in the 2016 Omnibus Appropriations Act stating that FDA may not allow the introduction or delivery for introduction into interstate commerce any food that contains GE salmon until final labeling guidelines for informing consumers of such content are published. FDA considers salmon eggs to meet the definition of food under the FD&C Act. The provision was also included in the 2017 and 2018 omnibus appropriation bills.

In 2016, after FDA issued Import Alert 99-40, Congress passed the National Bioengineered Food Disclosure Law, which charged the U.S. Department of Agriculture with promulgating regulations regarding the labeling of food derived from “bioengineered” sources, which has implications for this import alert and the labeling of this product, FDA said. At this time, FDA’s import alert remains in effect, meaning that AquaBounty cannot import AquAdvantage Salmon — including its eggs or any food from the salmon — into the U.S.

FDA provided the following links for additional information:

FDA Approval: Supplemental NADA 141-454;

Environmental Assessment: Supplemental NADA 141-454;

Finding of No Significant Impact: Supplemental NADA 141-454;

AquAdvantage Salmon (Background);

Questions & Answers on FDA’s Approval of AquAdvantage Salmon;

AquAdvantage Salmon Approval Letter & Appendix (2015), and

Import Alert 99-40: Genetically Engineered (GE) Salmon.

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