Animal Biotechnology and the Slow Road to Approval

It's been a couple of years since Eric Hallerman, PhD, Professor and Head of the Department of Fish and Wildlife Conservation at Virginia Tech University in Blacksburg, VA, wrote a guest blog post for us (below) on the state of animal biotechnology science, the products of animal biotechnology that could one day make it to the marketplace, and what it means for consumers, so we thought it would be a good time to check in on where we are now with the technology. It might surprise you to learn that while innovation and research continues, animal biotechnology products such as the fast-growing salmon are still awaiting FDA approval. One thing we can be sure of: When the first product of animal biotechnology enters the marketplace, the checks and balances imposed by regulators, scientists, and the public will ensure that every question has been answered. For those of you who missed it, Dr. Hallerman's 2011 post, which is still relevant today, is below. As these issues continue to receive attention, it is important to know the research that is behind these technologies and weigh the benefits along with any potential risks.

Originally posted on July 7, 2011.

Animals long have been selectively bred for agriculture, leading to dramatic improvement in growth rate, milk or egg yield, and other productivity-related traits. With advances in gene transfer techniques comes the prospect of producing animals with improved nutrition, safety and quality, made possible through biotechnology, or genetic engineering. Genetic engineering is the use of recombinant DNA techniques to insert DNA from one plant, animal, or microorganism into another. Genetic engineering may be used to enhance food production or quality (e.g., faster growth, improved disease resistance); to produce pharmaceutical products for therapeutic use; to enhance human interaction with animals (e.g., new color varieties of aquarium fish); to develop animal models for biomedical research; or to produce industrial or consumer products (e.g., fibers for multiple uses).

Atlantic salmon, photo courtesy of NOAA

Many different animal species have been genetically engineered. Examples of interest to agriculture include: fast-growing Atlantic salmon; pigs and tilapia fish with enhanced ability to utilize soybean meal while reducing phosphorus excretion; and catfish and carp with enhanced resistance to bacterial diseases. In 2009, the FDA approved the first genetically engineered animal producing a pharmaceutical product: a goat that produces recombinant human antithrombin III - an anticoagulant, or blood thinner - in its milk.  However, as explored in a recent commentary published by the Council on Agricultural Science and Technology, no genetically engineered animal intended for use as food by humans has yet received regulatory approval. 

Why is it that no such food products have come forward? The first reason is the technical challenge of producing animals that reliably transmit the introduced gene from generation to generation and exhibit the improved performance trait. A second is the difficulty of securing support for the several generations of breeding needed for the development of the genetically engineered animal. Moreover, there are controversies regarding food safety, animal welfare, and environmental safety of animals produced through biotechnology; depending on the application, some of these issues are well based in science; others are not. Because of these controversies, there is considerable uncertainty about gaining regulatory approval for commercialization of animals produced through biotechnology.

Some animals produced through biotechnology pose benefits for improved food production, animal welfare, and food security. Production of some genetically engineered animals, such as pigs that utilize soybean meal more effectively, pose clear improvements in agricultural sustainability. Some genetically engineered animals, such as the fast-growing Atlantic salmon, will need special production systems in order to advance sustainability. Sustainable application of genetic engineering of animals will require careful oversight and commercialization, as well as communication on the part of regulators, the food industry, and other stakeholders. It is a pivotal moment for possible commercialization of animal biotechnology - a regulatory decision on the first application for a genetically engineered animal for food - the fast-growing Atlantic salmon- is currently before the Food and Drug Administration, but Congress may thwart science-based regulatory oversight with a bill prohibiting any FDA funds from being used to approve the fast-growing salmon. The outcome of conflict between the legislative and regulatory branches of the government may have implications not just for that product, but more broadly for animals produced through biotechnology.