FDA Approval Could Pave the Way for Future Science-based Technologies
As part of the U.S. Food and Drug Administration’s rigorous, scientific regulatory review governing genetically engineered (GE) animal technologies, the FDA’s Veterinary Medicine Advisory Committee (VMAC) hosted a rigorous discussion about a GE salmon on September 19-21.
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.
BIO President and CEO Jim Greenwood applauded the VMAC’s recommendation and the FDA process for assuring the safety and efficacy of GE animal products.
“Over the years, innovations in agricultural biotechnology have helped improve farmers’ lives, lessen agriculture’s impact on the environment and contributed to a more sustainable food supply for a growing world,” says Greenwood. “As the FDA considers its first genetically engineered food animal, we’re hopeful that this process will pave the way for future technologies currently in the pipeline.”
“FDA is the world leader in science-based reviews of products benefiting human and animal health, and the regulatory process for GE animals finalized by FDA in January 2009 is the gold standard for how to bring these products to market in a safe and science-based manner,” Greenwood added.
The VMAC is tasked with reviewing and evaluating data on the safety and effectiveness of new animal drugs for use in the treatment and prevention of animal diseases and increased animal production, and making appropriate recommendations to the FDA Commissioner regarding scientific issues and regulatory policies.
As part of the VMAC discussion, evidence and testimony was presented today by independent experts about the salmon’s safety, effectiveness, and environmental benefits based on data from 14 years of scientific study.
“The application of technology to animal agriculture is not something that is new. It has allowed us to more efficiently and sustainably produce food and fiber for a growing population,” said Dr. David Edwards, BIO’s Director of Animal Biotechnology, in testimony before the Committee earlier today. “The application being considered today 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.”
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.
“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,” says Edwards. “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.”
For More Information
- FDA’s analysis and other summary documents related to the AquAdvantage® Salmon are posted here: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/UCM224762.pdf
- Visit AquaBounty’s Pressroom to get more information on the AquAdvantage® Salmon:
- Visit BIO’s Online GE Animal Resource Center at http://bio.org/foodag/animal_biotech/#genetic.
- BIO’s Livestock Biotech Summit, September 28-30, 2010 in Sioux Falls, S.D., will explore global solutions through animal biotechnology. This conference is open to the media; Program details are posted online at www.bio.org/livestockbiotechsummit.