How Should Ethics Affect FDA Regulation of Genetically Engineered Animals?
UVA Law Faculty Affiliations
This short policy piece was published by the Food Drug Law Institute's policy forum. It examines the ethical and cultural foundations of calls for regulation of genetically engineered (GE) animals. The regulation of GE animals in the United States is an issue with which regulators have been grappling for more than two decades. The Food and Drug Administration (FDA) has been studying the issue at least since 1993 when AquaBounty Technologies approached the agency seeking regulatory guidance for its GE fish, AquAdvantage Salmon. Throughout that time, FDA has been criticized for not sufficiently considering the ethical issues concerning GE animals. Much of that criticism, however, is based on an emotional response to the technology as well as a misunderstanding of the ethical analysis FDA is required to apply. While that emotional response can be viewed as entirely natural, and sincerely held, it should not influence FDA regulation of GE animals.FDA’s mission is to determine the safety, and at times, efficacy, of products. Thus, its focus should not be on the use of a technology, e.g., genetic engineering, but rather on the individual results of the use of that technology. FDA has studied GE animal products for many years and has consistently found that the risks involved with the technology itself do not rise to the level that would merit regulation such as mandatory labeling of GE animal products or precautionary-based regulation.