Harmonize US gene-edited food regulations

We express our concern that the United States Food and Drug Administration’s draft Guidance for Industry #187 entitled “Regulation of Intentionally Altered Genomic DNA in Animals” is not fit for purpose as it relates to food animals that could otherwise have been developed through traditional breeding techniques.

The proposal to regulate all food animals whose genomes have been intentionally altered using modern molecular technologies, including gene editing tools, as veterinary drugs does not make sense for alterations that are a normal part of conventional breeding programs. All food animals harbor millions of genomic variants (e.g. SNPs and INDELS), be they spontaneous or intentionally induced. There is no justification for regulating those that are “intentional” as animal drugs.

Dietary DNA is generally regarded as safe (GRAS), and it is a routine ingredient of food obtained from any species, irrespective of its sequence. Referring to DNA variants as “drugs” is likely to confuse or frighten consumers who might mistakenly infer that there are biologically active substances in their food.

FDA’s proposed approach of requiring extensive pre-market risk evaluations for animals with intentional genomic alterations that could have been obtained using conventional breeding runs counter to the OSTP Coordinated Framework for Biotechnology policy which reads, “Exercise of oversight in the scope of discretion afforded by statute should be based on the risk posed by the introduction and should not turn on the fact that an organism has been modified by a particular process or technique”. Breeder intention is not associated with product risk.

We consider that FDA's proposed regulatory approach for gene-edited animals will thwart attempts by public sector researchers and small companies to use gene editing to solve zoonotic disease and animal welfare problems in the United States.