Genetically Engineered Animals: Frequently Asked Questions

The NAD pathway has been used by FDA for the last decade, after scientific, regulatory, and legal experts devised this consensus-based framework to ensure coordination among all centers within FDA.  

It is a mandatory process that leads to a formal FDA ‘approval.’  Such formal recognition by the agency is necessary for both domestic and international government and consumer acceptance of the technology, leading to successful commercialization of the technology and products. 

This rigorous, science-based approval process has been demonstrated to be critical to consumer acceptance of the technology and the products that will result.  

The NAD process is consistent with key international guidelines for food safety risk assessment for GE animals that was adopted by the Codex Alimentarius Commission on July 4, 2008. 

Does the FDA Guidance affect international trade?  

International trade has not been affected by release of the FDA Guidance.  In fact, trading partners have active research programs in genetic engineering of animals.  

On July 4, 2008, the 176 member countries of the Codex Alimentarius Commission unanimously adopted international guidelines for the conduct of food safety risk assessment for genetically engineered animals.  

The FDA Guidance describes a framework similar to the Codex-approved guideline for evaluating food safety risk assessment of GE animals.  The international guideline was the end product of work of a task force led by Japan and Australia, which expedited the finished document due to unprecedented support from countries around the world.

What is BIO’s Guidance for Genetically Engineered Animal Stewardship?

The mission of BIO’s Stewardship Initiative is to institute and promote guidelines for the development and use of GE animals, which promote good animal welfare, enhance industry credibility, and comply with current regulatory requirements. 

BIO’s Guidance for Genetically Engineered Animal Stewardship provides information for the development and implementation of stewardship programs for product developers in industry and academia that plan to engage in research, development and commercialization of GE animals.

The Guidance is being developed as a series of educational modules that can be adapted to the specific activities pertinent to the user’s own operations.  The first module on Research and Development has been completed and publicly released.  

Additional modules that are planned for inclusion in the Guidance include Commercialization, Post-Market Monitoring, and Discontinuation - Product Recall. 

For more information:  

Visit FDA’s GE Animals web resource page at http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEn...

BIO commissioned a scientific report entitled “Genetically Engineered Animals and Public Helath:  Compelling Benefits for Helath Care, Nutrition, the Environment and Animal Weflare” by Dr. Scott Gottlieb and Dr. Matthew Wheeler.  It is posted at http://www.bio.org/sites/default/files/2011_ge%20animal_benefits_report.pdf

Visit AquaBounty’s press room for more information on the AquAdvantage™ salmon online at http://www.aquabounty.com/PressRoom/

More information on the Enviropig™ is located on the University of Guelph website at http://www.uoguelph.ca/enviropig/