BIO calls FDA delay of salmon approval ‘a blow to science and business'

WASHINGTON, D.C., Feb. 13, 2013 - The U.S. Food and Drug Administration (FDA) announced today that it is extending for 60 days the comment period for the genetically engineered AquAdvantage Salmon.

“As President Obama stated in last night’s State of the Union Address, ‘Now is not the time to gut these job-creating investments in science and innovation,’” said Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood.

“Today’s decision by the FDA represents another blow against science and another setback for a small American technology company that is working to protect our environment, promote sustainable production practices and provide healthy food to Americans.”

The FDA published the draft Environmental Assessment (EA) and preliminary Finding of No Significant Impact (FONSI) pertaining to AquaBounty Technologies’ application for AquAdvantage Salmon in the December 26, 2012 Federal Register.

At that time, it was stated, “…FDA believes that a 60-day comment period is appropriate and does not intend to grant requests for extension of the comment period.” The comment period, originally slated to end on Feb. 25, 2013, now runs until April 26, 2013.

A letter signed by 28 anti-hunger, farmer, and animal agriculture organizations was sent last week to FDA Commissioner Margaret Hamburg, urging that FDA not extend the existing 60-day public comment period. “Extending the comment period does not make sense since all relevant data pertaining to the application has been in the public realm for more than two years,” the letter says.

The AquAdvantage salmon is genetically engineered to reach its market weight in half the time of conventionally raised salmon thus contributing to more sustainable aquaculture systems. It was developed by Massachusetts-based AquaBounty Technologies, a Biotechnology Industry Organization (BIO) member.

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