Regulatory Process for Animal Biotechnology Safeguards Environment

  • Contact: Karen Batra
  • Phone: 202-449-6382
  • Email: kbatra@bio.org
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FDA:  GE salmon will not have significant impact on the environment

Washington, D.C. (December 15, 2011) – The Senate Commerce, Science, and Transportation Committee’s Subcommittee on Oceans, Atmosphere, Fisheries, and Coast Guard held a hearing today to examine the environmental issues around genetically engineered (GE) fish.  

The U.S. Food and Drug Administration’s regulatory process ensures that products made available through genetically engineered animals go through a rigorous and science-based review process before being approved for the marketplace.  This review includes careful review of any potential impacts on the environment.  

At issue in today’s hearing is the AquAdvantage salmon, 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. 

“The application of technology to animal agriculture is nothing new.  It has allowed us to more efficiently and sustainably produce foods, fuels, cures and breakthrough medicines for debilitating diseases,” said Jim Greenwood, BIO’s President and CEO. “The AquAdvantage salmon is an extension of technology that precisely applies our genomic knowledge to improve the rearing of salmon and the production of a high-quality food to feed a growing population.” 

The first and only U.S. approval for a GE animal product came in February 2009 when the FDA approved ATryn, a therapeutic protein derived from the milk of goats genetically engineered to produce recombinant antithrombin. The AquAdvantage salmon is currently awaiting approval from the FDA. 

“GE animals have already realized the promise of advancing human health, and now this technology could lead to more sustainable seafood production,” says Greenwood.  “Other new technologies in development include GE cattle, goats, pigs and fish that can advance human health, mitigate environmental impact, optimize animal welfare, improve state-of-the-art industrial products and provide sustainable food sources in agriculture and aquaculture.” 

Subcommittee Chairman Mark Begich (D-Alaska) filed a bill (S. 1717) on October 17, “the Prevention of Escapement of Genetically Altered Salmon in the United States (PEGASUS) Act” to ban the interstate and foreign commerce of GE fish.  The Begich bill would make it unlawful to “ship, transport, offer for sale, sell, or purchase genetically altered salmon or other marine fish, or a product containing genetically altered salmon or other marine fish, in interstate or foreign commerce.” 

“Earlier this year, President Obama called for America to lead on new technologies to foster new industries, more jobs and enhanced economic benefit.  Legislative efforts such as S. 1717 create barriers to achieving that goal,” said Greenwood.  “We have the ability to be the world leader in this cutting-edge science, but we must also have government policies that foster innovation, encourage entrepreneurship and embrace science-based solutions.” 

*More Information on this issue is posted online:

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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.