Current regulation of GE animals under @US_FDA is overly intensive — rather than proportionate to the actual risk of negative consequences — wasting government resources and inhibiting innovation by making it excessively burdensome for developers to bring GE animals to market.
Compared to GE plants, which are already regulated by USDA with at least *131* approved (specifically, deregulated) since 1992, FDA has only ever approved *TWO* GE animals.
However, even USDA's proposed rule doesn't go far enough. It should actually regulate GE animal traits based on whether the product — like cows without horns — creates new risks, not on the process used to create them.
If a genetic trait for disease resistance exists in some cows, then it doesn’t matter whether breeders use conventional methods or genetic engineering to combine it with traits for good milk production and make a healthier dairy cow.
In product-based reg there could be initial safety review for any potential for the trait to harm animal/human health; if no plausible potential for harm, animal is deregulated. If yes, USDA conducts further safety review to determine whether harm actually results in practice.
W/o becoming fully product-based, the current rule would benefit from allowing exemptions for GE animals with changes that mimic naturally-occurring ones. USDA is proposing expedited review for this category, but a similar category of GE plants gets full exemptions under USDA.
For context, conventionally-bred animals have no pre-market regulation at all. Our system accepts risk that conventional breeding may result in harmful traits because the risk has proven very low, & bc we have many mechanisms for regulating once animal products are on the market.
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