Genetically Engineered (GE) Animals

Applications, Regulations, Implications, and Labeling

(Webinar length:  1h 14m)

Overview:

Although genetically engineered (GE) plant varieties are grown widely in many countries, no GE animals have yet been approved for food purposes anywhere in the world despite the potentially transformative nature of this technology. FDA regulates GE animals under the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act, and the National Environmental Policy Act. The FDA uses a hierarchical risk-based approach to assess GE animals and their edible products. As with plants, this approach is event-based, meaning that each time a GE animal is generated as the result of the insertion of a recombinant DNA construct at a new genomic location(s), that new event requires a separate evaluation within the confines of its limitations for use. In the seven-step regulatory process described by FDA, the agency examines the safety of the recombinant DNA (rDNA) construct to the animal, the safety of food from the animal and any environmental impacts posed (collectively the ‘safety’ issues), as well as the extent to which the performance claims made for the animal are met (‘efficacy’).

The journey of the first GE food fish to go through this regulatory process, the fast-growing “AquAdvantage” Atlantic salmon, will be discussed, inclusive of the many political interventions encountered along the way. The current regulatory approach in the United States, coupled with the unpredictable time frame, has stymied commercial investment in the development of GE animals for agricultural applications. The implications of this regulatory bottleneck will be addressed especially as it relates to the geographic location of future investment and adoption of this technology.  Finally the principles of food labeling in the United States will be described and the arguments for and against mandatory GE labeling will be discussed, with special reference to the upcoming California GE food labeling initiative (Proposition 37).

Areas covered in the webinar:

  • Current status of research and development in GE animals
  • Regulation of GE animals – U.S.
  • Case study: AquAdvantage salmon
  • Implications for geographic location of future investment and adoption of this technology
  • Labeling of food from GM animals
  • FDA position on food labeling
  • Process versus product based labeling
  • Mandatory versus voluntary labeling
  • Arguments for and against mandatory GE labeling
  • The California GE food labeling initiative (Proposition 37)

Who will benefit from this webinar:

  • Animal agriculture
  • Livestock and fish producers
  • Animal protein supply chain members
  • Food processors
  • Food retailers
  • Food distributors
  • Government regulators
  • Legislative staff involved with GMO issues
  • Media representatives
  • Legal professionals
  • Educators

Presenter--Dr. Alison L. Van Eenennaam

Dr. Alison Van Eenennaam is an Extension Specialist in Animal Genomics and Biotechnology in the Department of Animal Science at the University of California at Davis. She received a Bachelor of Agricultural Science from the University of Melbourne in Australia, and both an MS in Animal Science, and a PhD in Genetics from UC Davis. The mission of her extension program is “to provide research and education on the use of animal genomics and biotechnology in livestock production systems.” Her public outreach focuses on the development of science-based information outlining the uses of biotechnologies in livestock production systems, including the controversial biotechnologies of genetic engineering and cloning. She uses a variety of media including YouTube (see “Animal Biotechnology” video) to inform general public audiences about science and technology. She served as a member (2005-2009) of the United State Department of Agriculture’s National Advisory Committee on Biotechnology and 21st Century Agriculture. She was appointed as a temporary voting member of the AquAdvantage genetically-engineered salmon Veterinary Medicine Advisory Committee (VMAC) for the Commissioner of the Food and Drug Administration (September 2010).  In 2010 she was the recipient of the American Association of Public and Land-Grant Universities National Award for Excellence in Extension.

  • Item #: 0905cGEAnimals
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Price $289.00