Today is a very special day for those of us that work in the field of animal biotechnology. Today, the FDA announced the long-awaited draft guidance describing a regulatory framework for governing genetically engineered (GE) animals. In addition, USDA is seeking comment on their coordinated role in the regulatory process.
Some of you will remember that back in June, we released at the BIO International Convention, the report Genetically Engineered Animals and Public Health – Compelling Benefits for Health Care, Nutrition, the Environment and Animal Welfare. At that time, I also discussed the importance of this technology and its role in public health on BIOtech Now, BIO’s podcast series. Today’s government action is truly a landmark one because it provides U.S. government draft guidance, that initiates a public comment process. The end result of which will be the development of a final regulatory system for these products which will ensure their safety and efficacy for the American consumer.
This technology holds great promise. Through genetic engineering, animals can produce pharmaceutical proteins and replacement tissues in their milk, eggs, and blood, which can be used in the treatment of human diseases such as cancer, heart attacks, hemophilia, rheumatoid arthritis, pandemic flu, malaria and small pox. In addition, research is being conducted to produce transplant organs in pigs that may be a source of organs for humans.
Genetically engineered animals also can improve food quality and production with improved nutrient and efficiency traits, and contribute to more environmentally-friendly livestock production as animals utilize less resources and release less emissions into the environment. The animals themselves also benefit from these technologies with disease resistance traits and improved animal welfare.
So I hope you will join me, as we take this great step forward. One tiny step for biotechnology, one great step for mankind. And, if you have any questions about genetic engineering, drop them here as a comment and I’ll be happy to answer them.
Managing Director for Animal Biotechnology
p.s. Stop in and check out our genetic engineering resource center.