Livestock groups are aggressively pushing for regulation of the budding sector of gene-edited animals to be moved from FDA to USDA, potentially setting up another jurisdictional battle between the two agencies.
The industry argues that FDA is too slow in its review of animals created via biotechnology, and that USDA is better positioned to take on the issue because of its experience regulating genetically engineered plants. It points out that just a single species has been approved by FDA — GE salmon — after a lengthy review that lasted more than 20 years.
Industry insiders told POLITICO they’re frustrated by the lack of clarity from FDA about how biotech animals are regulated, which they say has discouraged developers from seeking approval for new types of animals with tweaked DNA.
Under the agency’s current framework, these animals are regulated as a “drug” as outlined by the Food and Drug Act….That logic applied to animal biotechnology, however, would mean that farms would be considered drug manufacturing centers if the operations raised genetically engineered livestock.
Proponents of biotechnology acknowledge that another obstacle stands in the way of getting these products to market: public perception.
Read full, original article: Livestock groups want USDA to handle regulations of gene-edited animals (Behind paywall)