Despite the many serious warning signs, federal agencies have not addressed how—or even if—they intend to regulate GE animals. While a number of federal statutes apply indirectly to GE animals, none specifically addresses this new technology, and government agencies have failed to develop regulations (as opposed to a nonbinding “guidance” like the one issued in January 2009 [1]) for how they might be regulated. Neither the U.S. Department of Agriculture (USDA) nor the U.S. Food and Drug Administration (FDA) have developed standards for GE animals that might be imported into the United States (2).

Among the most worrying threats that remain unresolved by government regulation:

• The potentially destructive environmental impacts of escaped transgenic animals have yet to be closely examined or controlled for by regulators
• The distinct lack of animal welfare standards related to transgenics in agriculture puts animals at risk from a technology that is often imprecise and known to cause health problems and cruel and inhumane suffering in livestock
• The human health effects of using pharmaceutical produced in GE animals are disturbing, yet not adequately assessed.

Despite widespread concern about the risks of GE meat and milk entering the human food supply, regulations fail to ensure the separation of transgenic animal products; likewise, there are no laws regarding the fate of unused products, and few means for public input on this key issue. Dead animals from these genetic engineering operations could end up being rendered for cosmetics, animal feed, and even pet food.

The chief regulatory authority for GE animals invoked by the FDA Center for Veterinary Medicine (CVM) in the New Animal Drug Application (NADA) statute. Under NADA, the genetic materials inserted into some GE animals have been considered new animals “drugs” because they “affect the structure or function” of animals. Developed with conventional drugs in mind, the law is riddled with shortcomings when applied to GE animals, including risk assessment problems, lack of criteria for assuring human food safety, and difficulty regulating the offspring of GE animals. Additionally, the FDA lacks clear authority to address the broader environmental and ecological concerns related to GE animals, making this statute woefully inadequate.

The USDA has some authority regarding GE animals, but it remains unclear whether the agency will develop an approval process for GE animals. The Animal Health Protection Act gives the USDA’s Animal and Plant Health Inspection Service (APHIS) power to regulate the movement of and environmental release of some GE animals, but the law only covers “livestock” and may exclude other animals. The statue applies narrowly to genetic modifications that may cause livestock diseases or pest problems, and only covers the importation and interstate movement of GE livestock (3). The Animal Welfare Act was developed to promote humane treatment of research animals, but farm animals are exempt, so it is unclear whether livestock would be covered when they are used to produce chemicals or pharmaceuticals.  The overall regulatory landscape is frighteningly barren: without specific guidance relating to GE animals, it is unclear how these laws can be applied, and in their current state, they are clearly insufficient to address the many risks inherent in engineering livestock.

Equally troubling is the regulatory system’s lack of transparency. The licensing process under the Investigational New Animal Drug (INAD) applications at FDA, for instance, is privileged information. The public has no way of knowing when, or for which product, an INAD application has been filed. This confidentiality enables applicants to skirt the questions and novel issues raised by the introduction of GE animals. Furthermore, the U.S. no labeling requirements for GE foods or animals, leaving consumers in the dark as to whether the meat or milk they purchase is from a GE animal. This lack of labeling also makes it all but impossible to track potential health impacts from consuming such products.

---------------------------------------------------------------

1 U.S. Food and Drug Administration, “Guidance for Industry on Regulation of Genetically Engineered Animals Containing Heritable recombinant DNA Constructs,” Docket No. FDA-2008-D-0394, Federal Register 74, no. 11 (January 16, 2009): 3057-58.

2 “AgResearch Aims to Spread GE Animals Around NZ.” Press release, August 8, 2008, Scoop Independent News.

3 Pew Initiative on Food and Biotechnology, “Regulating Genetically Engineered Animals,” in Issues in the Regulation of Genetically Engineered Plants and Animals (Washington, D.C.: Pew Initiative on Food and Biotechnology, April, 2004).