FDA Delay of Salmon Approval is a Blow to Science and Business

  • Contact: Karen Batra
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Now is not the time to gut job-creating investments in science and innovation


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.

“This is another delay in what has been an unreasonably long regulatory process hindered by those who refuse to stand behind science,” said Greenwood. “The genetically engineered salmon, developed to provide a sustainable source of heart-healthy protein, has been proven in countless scientific studies to be safe for human consumption and for the environment.” 

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 development of AquAdvantage salmon is based on more than two decades of scientific research, making it the most studied line of Atlantic salmon,” Greenwood says.

“Innovations in agricultural biotechnology have helped improve farmers’ lives, lessened agriculture’s impact on the environment and contributed to a more sustainable food supply for a growing world population. Continued delays in the approval process will have dire impacts on this beneficial sector of our economy.”

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.

 
For More Information:
The AquAdvantage Salmon Draft Environmental Assessmentand
FDA’s Preliminary Finding of No Significant Impact of the AquAdvantage Salmon

About BIO
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO's blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.