Dairy cattle naturally grow long and dangerous horns. So as a protective measure, farmers permanently remove calves’ small horns through a painful procedure. Recently, scientists have used modern genetic editing techniques to create dairy cattle that never develop horns, and so never need to be “dehorned”. The regulatory fate of these genetically dehorned cattle may be bound up with numerous more controversial cases from the same rapidly diversifying field: the genetic editing of animals. Or, at least so it could be under draft FDA guidance which closed for public commentary in June 2017. The FDA’s challenge is to chart a flexible regulatory course. One which will support the potential of gene-editing technology, while staking out the boundaries of acceptable risks – i.e. the ethical boundaries – of the looming “CRISPR zoo” . Here we review the background to the draft guidance, as well as the scathing comments it received from disparate interest groups. The comments show that to foster public trust in how gene-editing technologies are used, it is imperative that the FDA re-engage with all stakeholders, including the public at large.
In their draft guidance, the FDA proposed to regulate “intentionally altered genomic DNA” of animals as a drug being evaluated for use in animals. The originally altered animal, and all its progeny, would be subject to the animal drug regulations. They put out a call for comments on these proposed amendments. As we discuss here, a mere handful of the 151 comments they received were supportive, and most were extremely critical, including those from the National Association of State Departments of Agriculture (NASDA). We argue that the FDA’s proposals as they stand are unsatisfactory and should be withdrawn.