By David Edwards, PhD
Director, Animal Biotechnology, BIO
One year ago, I was pleased to testify before the U.S. Food and Drug Administration’s (FDA) Veterinary Medicine Advisory Committee (VMAC). The FDA convened its VMAC meetings on September 19-21, 2010 to discuss an application for a genetically engineered (GE) salmon.
Developed by Massachusetts-based AquaBounty Technologies, a BIO member, the AquAdvantage salmon has been genetically engineered to grow year-round. Conventional salmon only grow in warmer months. This makes the AquAdvantage Salmon ready for market in half the time. This type of beneficial technology makes fish-farming more sustainable and available to land-locked producers, and better provides for a rapidly growing demand for heart-healthy protein.
The VMAC meetings are part of a rigorous regulatory process required to assess such technologies before being approved for commercialization. In addition to the testimony I gave, the Committee heard from many scientists and independent experts about the product’s safety, effectiveness, and environmental benefits. The Committee also examined 15 years of scientific evidence that had been thoroughly reviewed by the FDA experts.
After the arduous review – the most scrutiny ever for any fish – the FDA concluded that food from these salmon is exactly the same as food any other Atlantic salmon. The FDA scientists declared that the GE salmon is safe to eat and does not pose a threat to the environment. One year later, approval remains elusive, but the U.S. animal biotechnology sector – still in its infancy – is still hopeful.
As I pointed out to the VMAC last September, the application of technology to animal agriculture is not new. From the beginning of time, man has used selective breeding to develop heartier crops and animals with desirable traits. The AquAdvantage salmon application 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.
In other promising research, animal biotechnology can be used to produce pigs that can save lives by generating human compatible donor tissues, cells and organs. Cattle can be bred to be “prion-free” and resistant to mad cow disease, spider silk generated in the milk of genetically engineered goats is twice as strong as Kevlar and the “Enviropig” utilizes natural phosphorus in feed more efficiently and reduces its environmental footprint.
To learn more about these technologies, read BIO’s newly updated report, Genetically Engineered Animals and Public Health – Compelling Benefits for Health Care, Nutrition, the Environment and Animal Welfare.
Some fear that these benefits will never be realized because of political interference, misinformation spread by anti-science activists or delays in a very rigorous approval process. The fact is, other countries want these technologies and are willing to provide an encouraging and hospitable environment for research and development. Governments worldwide are realizing that these technologies are part of providing for their citizens.
The U.S. government, too, must see the promise of science applied to real world problems, and action on these initiatives is bound to follow. Just last week, President Obama signed the “America Invents Act.”
This legislation is aimed at helping American entrepreneurs and businesses bring technologies to market sooner, creating new businesses and new jobs. Biotechnology can create good-paying jobs in regions all across the country.
In addition, the President announced the development of a “Bioeconomy Blueprint” designed to harness biological research innovations to address national challenges in health, food, energy, and the environment. The Blueprint will focus on reforms to speed up commercialization and open new markets, strategic R&D investments to accelerate innovation and regulatory reforms to reduce unnecessary burdens on technology developers. This Administration should take the opportunity to turn these great ideas into solutions, and biotechnology developers are ready to fulfill the challenge.
Over the years, innovations in agricultural biotechnology have helped improve farmers’ lives, lessen agriculture’s impact on the environment, contributed to a more sustainable food and energy supply, and provided for the production of novel therapies and cures for our growing world. As the FDA considers approval of a genetically engineered food animal, we remain hopeful that this progress will pave the way for future technologies.