FDA Sets VMAC Meeting to Consider Genetically Engineered Salmon

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WASHINGTON, D.C. (Thursday, August 26, 2010) - Genetically engineered (GE) animals have already realized the promise of advancing human health, and now this technology could lead to more sustainable and environmentally friendly food production.

The U.S. Food and Drug Administration (FDA) announced today it will convene its Veterinary Medicine Advisory Committee (VMAC) to consider a salmon that has been genetically engineered to reach its market weight in half the time of conventionally raised salmon.  

The VMAC meeting, part of a rigorous regulatory process required to assess such technologies before being approved for commercialization, is scheduled for September 19-20.  At this meeting, the Committee will hear from independent experts about the product’s safety, effectiveness, and environmental benefits; it will also collect public testimony and examine 14 years of scientific evidence about the salmon before deciding whether or not to recommend regulatory approval.

“The regulatory process for GE animals finalized by FDA in January 2009 ensures the products made available through genetic engineering go through a rigorous review process before being approved for the marketplace,” said Dr. David Edwards, Director of Animal Biotechnology at the Biotechnology Industry Organization (BIO).  

The first 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. 

“As the FDA considers its first GE food animal, we’re hopeful that this process will pave the way for new technologies and their benefits currently in the pipeline,” says Edwards.  “Research with GE animals such as goats, pigs, sheep, chicken, fish and cattle has yielded a variety of products 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.” 

FDA has posted information on the VMAC meeting at http://www.fda.gov/AdvisoryCommittees/Calendar/ucm223823.htm.

* Developing global solutions through animal biotechnology is the theme of BIO’s upcoming Livestock Biotech Summit, September 28-30, 2010 in Sioux Falls, S.D.  Program details are posted online at www.bio.org/livestockbiotechsummit.

** The potential benefits of GE animal technologies have been detailed in the report, Genetically Engineered Animals and Public Health – Compelling Benefits for Health Care, Nutrition, the Environment and Animal Welfare.  For more information, visit BIO’s GE Animals Web Resource Page at www.bio.org and visit FDA’s GE Animals Web Resource Page at www.fda.gov/cvm/GEAnimals.htm.

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.