The Next Frontier in Food: FDA Regulation of Genetically Engineered Animals

Abstract

Genetically engineered (GE) animals designed for human use, whether to be eaten as food, to produce drugs, or to be enjoyed as pets, carry the potential for enormous benefits and enormous harm. Currently, the Food and Drug Administration’s (FDA) 2009 Final Guidance on GE animals demonstrates that agency believes it may regulate all GE animals regardless of their use under its authority to regulate new animal drugs (NADs), but that it will selectively use its enforcement discretion over only some categories of those animals (primarily those intended for food or to producer drugs). It has also taken the position that the GE nature of an animal for food in itself does not necessitate labeling of the food product, the same position it took for GE crops. In the last few years, it has declined to regulate a GE fish intended for use as a pet, has approved a new animal drug application (NADA) for a GE goat intended to produce a human drug, and is currently considering approval of a GE fish intended to be marketed as food. An examination of these examples demonstrates that the 2009 Guidance is flawed in its approach and underlying assumptions, and that the use of the NAD scheme to regulate this fundamentally new type of animal is inappropriate. FDA’s approach thus far results in insufficient and opaque inquiries into the safety of the GE animal to humans, the animal, and the environment, and vests too much power in the agency’s discretion, rendering its decisions effectively judicially unreviewable. The best solution to this problem would be for Congress to institute a comprehensive statutory and regulatory scheme to govern GE animals, giving FDA authorization to regulate GE animals in a way more tailored to the unique issues they present, vesting in the Environmental Protection Agency authorization to conduct the relevant environmental inquiries, and mandating the labeling of food from GE animals. Such an approach would be more in line with the underlying science of GE, and would restore public trust in FDA’s assurances of the safety of their food and drugs.