Genetically Engineered Animals: Frequently Asked Questions

Genetic engineering has the potential to greatly improve the health and welfare of agricultural animals.  GE animals may be disease resistant, parasite resistant, and withstand stress.  The beneficial trait can likely improve their well being because they will be more productive.  Such animals may need fewer veterinary interventions, use of special feed supplements, or other growth stimulants.

BIO supports animal welfare as a high priority in the conduct of research and development with genetically engineered animals.  Research institutions, biotech companies and producer groups engaged in the growing field of animal biotechnology place animal well-being as a top priority.  The humane care and use of animals in genomics, cloning and genetic engineering is guided by rigorous regulatory review by the U.S. Department of Agriculture in accordance to the Animal Welfare Act.  In many cases, third party and international organizations have established animal welfare guidelines for use by companies engaging in the genetic engineering of animals.

Regulatory Process

Why regulate GE animal and their products?

It is important that the technology is approved as safe for humans, animals and the environment. 

Industry recognizes that any new technology can create doubt and mistrust in some sectors.  To forestall that doubt and to, in part, ensure consumer acceptance, strong regulation based upon an internationally recognized approval process will lead to more efficient commercialization of GE animals, processes and products.

The federal government set the precedent for science-based oversight of biotechnology through the development of its GE plant regulatory framework.  

Are all GE animals subject to regulation by the U. S. Food and Drug Administration (FDA)?

Yes.  The FDA has stated in Guidance 187 that any animal containing an rDNA construct intended to alter its structure or function is subject to regulation by FDA prior to commercialization.  However, based on risk, there are some GE animals for which the FDA may not require a formal approval. In general, these include laboratory animals used for research. On a case-by-case basis, the FDA may consider exercising enforcement discretion for GE animals of very low risk, such as it did for an aquarium fish genetically engineered to express fluorescence (tradenamed “GloFish”). The FDA has stated that it does not anticipate exercising enforcement discretion for any GE animal of a species traditionally consumed as food, and expects to require approval of all GE animals intended to go into the human food supply.

How many GE animals or their products are approved?

There is only one approved product in the world from a GE animal.  That product is called ATryn®, a human pharmaceutical developed to prevent blood clots.  This drug is produced in the milk of GE goats.  It was first approved by the European Medicines Evaluation Agency (EMEA) of the European Commission in August 2006.  It was also approved in the United States by the FDA in February 2009.  In addition, as noted above, a type of aquarium fish that expresses fluorescence is marketed under regulatory discretion.

What will be the next approved product in the United States?

BIO does not know what the next approved product will be in the United States.  However two companies discuss their regulatory progress publicly.  AquaBounty Technologies, a BIO member, has publicly announced its application with the FDA to seek approval for a rapid-growth salmon, the AquAdvantage™ salmon.  The fish grows at two times the rate of conventional salmon to the same mature weight while producing safe and healthful salmon for human consumption, and reducing environmental impact.

In addition, the Enviropig™, whose developer, the University of Guelph is a BIO member, has publicly announced its application with the FDA.  The Enviropig™ produces dramatically lower levels of phosphorus pollution than traditional pigs, and has a decreased impact on the environment.  

The FDA finalized its regulatory guidance document in January 2009.  What is the purpose of the guidance and what did the FDA say?

The purpose of the FDA Guidance for Industry 187 (the FDA Guidance) is to clarify the FDA regulatory framework for GE animals based on the New Animal Drug process of the Food, Drug and Cosmetic Act.

The FDA laid out a process for the science-based review of applications and how they would lead to an approval.  The proposed framework is similar to international guidelines published by the Codex Alimentarius Commission on July 4, 2008. 

Why is the Guidance important?  

The FDA Guidance is the first policy statement published by the U.S. government describing how it regulates GE animals and their products.  This system will ensure the products made available through this science will go through a thorough and transparent application process before being approved for the marketplace.

Why is the New Animal Drug (NAD) framework the regulatory process supported by the biotechnology industry, food chain, producer groups, patient groups and consumer groups?  

FDA’s regulatory pathway, the NAD approval process, provides the following key elements of regulation for these animals:

The NAD pathway criteria can be applied to all genetically engineered animals equitably, including those agricultural animals developed for biomedical purposes and not for food.