Do Kingdoms Matter? Regulation of Animal Breeding Technologies.

Internationally, there is a patchwork of national regulations around genetically engineered (GE) plants and animals. Some countries regulate selected technologies through specific definitions of what constitutes a technology that results in a genetically engineered organism. Other countries regulate based on the characteristics of the final product. Additionally in some countries GE animals are regulated differently from GE plants.

In the United States, GE animals are subject to a mandatory pre-market evaluation by the Food and Drug Administration’s (FDA) Center for Veterinary Medicine under the new animal drug provisions of the Federal Food Drug and Cosmetic Act. The act defines drugs as “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” The rDNA construct in the resulting GE animal is thus a regulated article that meets the drug definition; the GE animal itself is not a drug. This suggests the presence of an rDNA construct in the animal (i.e. drug) is the trigger for a mandatory pre-market, product-based evaluation.

However, the FDA definition of GE animals is those animals modified by rDNA techniques, including the entire lineage of animals that contain the modification. This suggests the regulatory trigger is the use of rDNA techniques in the development of the animal. It is therefore unclear whether animals modified using rDNA techniques but which do not carry an rDNA construct (i.e. drug) or novel combination of genetic material in their genome are a regulated article. This adds considerable uncertainty to the commercialization prospects of animals produced using genome editing technologies.