Gene Editing: Breeding or Genetic Engineering?

The FDA defines “genetically engineered animals” as those animals modified by rDNA techniques, including the entire lineage of animals that contain the modification, and regulates them under the new animal drug provisions of the federal Food, Drug and Cosmetics Act.  In this context, the recombinant DNA (rDNA) construct is the new drug, not the animal itself. It is unclear whether the use of new gene editing technologies, such as CRISPRs, in animals will trigger FDA regulatory oversight. Is it the use of rDNA techniques in the development of a new genotype, or the presence of an rDNA construct in the genome of an animal that triggers regulatory oversight? In 1992 the Office of Science and Technology Policy wrote that regulatory oversight of biotechnology products should not turn on the fact that an organism has been modified by a particular process or technique but rather, “oversight will be exercised only where the risk posed by the introduction is unreasonable, that is, when the value of the reduction in risk obtained by additional oversight is greater than the cost thereby imposed." It is not evident what unreasonable or even unique risks are posed by animals that carry a new genotype (or possibly a genotype/allele that already exists in a species) produced using gene editing techniques as compared to those that occur spontaneously and form the basis of all animal breeding programs. Given the importance of enabling safe innovation, there is an urgent need to determine the appropriate regulatory framework for gene editing.