BIO Urges FDA Approval of GE Salmon

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Technology Makes Better Nutrition Available in a Sustainable Way 

Following a thorough and rigorous regulatory process spanning more than two decades, the time has come for regulatory approval of the first genetically engineered (GE) food animal. 

The Biotechnology Industry Organization (BIO) submitted comments on April 26, 2013, to the U.S. Food and Drug Administration (FDA) regarding its draft Environmental Assessment (EA) of the GE AquAdvantage Salmon.

The FDA published the draft EA and preliminary Finding of No Significant Impact (FONSI) in the December 26, 2012 Federal Register.  April 26 marks the end of an extended 120-day comment period on the EA, the final step in a regulatory process that has come under scrutiny for impeding investment in the U.S. animal biotech industry. 

“BIO’s members are developing advances in agriculture to feed a growing population and are closely watching this application, as it impacts future applications and the ability of the United States to be a leader in innovation,” says Dr. David Edwards, BIO’s Director of Animal Biotechnology. 

BIO’s comments emphasize that the application of various technologies to animal agriculture is not something that is new.  “Using the best science and technology in agriculture has long allowed us to more efficiently and sustainably produce food and fiber for a growing population,” says Edwards. 

The United Nation’s Food and Agriculture Organization reports that by 2050 an expanded world population will be consuming two thirds more animal protein than it does today.

“Review of these technologies should take into account that they are just another extension of the application of technology to food production,” says Edwards. “Years of research, including publicly funded research, have concluded that this application of animal biotechnology can provide benefits to consumers, the environment and job creation.” 

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

“All of the necessary scientific steps have been completed and the charge of the FDA to evaluate safety and efficacy of the DNA construct on the intended animal is fulfilled,” says Edwards.  “This evaluation has been thorough.  It is past time to provide a decision and let the market determine whether it supports this innovation that produces healthy food in a sustainable manner by using inland farms to help us meet global protein needs.”

“It is now time to move forward with a decision if we want to keep this technology in the United States.”

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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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.