[T]he U.S. Food and Drug Administration (FDA) has proposed mandatory premarket new animal drug regulatory evaluation for all food animals whose genomes have been intentionally altered using modern molecular technologies including gene editing technologies. This runs counter to U.S. biotechnology policy that regulatory oversight should be triggered by unreasonable risk, and not by the fact that an organism has been modified by a particular process or technique.
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The prohibitive cost, and open-ended timeframe, of achieving regulatory approval has limited the development of improved [GMO] animal varieties by public sector scientists and small companies. Despite nearly 35 years of research and the approval of multiple [GMO] crop varieties, not a single transgenic food animal has successfully made its way to U.S. consumers.
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At the end of the day, food animals with intentional genomic alterations produce food, and if the food they produce is not biologically active via an oral route of administration it does not make sense to regulate these intentional genomic alterations as drugs
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Given that no single GMO food animal product is currently commercially available in the United States, animal breeders are perhaps the group most aware of the chilling impact that regulatory gridlock can have on the deployment of potentially valuable breeding techniques. This would suggest that the FDA’s regulatory approach is unfit for purpose as there does not appear to be a viable path for safe products to come to market.
Read full, original article: Proposed U.S. regulation of gene-edited food animals is not fit for purpose
