SUMMARY: Consumers Union, the policy and mobilization arm of Consumer Reports, comments on the Food and Drug Administration’s notice of availability of Draft Guidance for Industry on the Regulation of Intentionally Altered Genomic DNA in Animals. While Consumers Union (CU) would prefer that all “animals whose genomes have been altered intentionally” be required to go through rigorous safety assessments for both human health and environmental impacts, based on legislation specific to genetically engineered animals, we support FDA treating them in the interim as New Animal Drugs, since there is a required safety assessment process associated with new animal drugs. In other words, CU feels that gene-edited animals should be treated like other genetically engineered animals.

Given the potential for unanticipated effects stemming from the use of gene editing techniques, all gene-edited animals should be required to be analyzed through whole genome sequencing, as well as epigenetic profiling, to detect off-target effects. This should be followed by a battery of “–omics” testing (transcriptomics, metabolomics, proteomics, etc.), as recommended by both Codex Alimentarius and the National Academy of Sciences, and animal testing to determine the potential health impacts of the intended and unintended changes to the animal as a result of the genetic engineering process. In addition, all food products derived from genetically engineered animals should be required to be labeled, so there is transparency for consumers and any post-market unexepected health effects can be identified.