The regulatory concerns about genetic modification of animals that I wrote about a while ago have moved towards a Congressional spotlight. Pigs have been genetically modified to resist porcine reproductive and respiratory syndrome virus by deleting a gene. Does deleting a gene make them genetically modified – yes and no, depending on which regulatory agency you ask.
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Because CRISPR-Cas9 can introduce genetic changes without leaving traces of how it is introduced it meets most of the USDA’s concerns about introducing pests into our food supply. Further testing has demonstrated the stability of the genetic change also allaying USDA concerns about the impact of these modifications over several generations. So from their point of view, these genetically modified pigs are not genetically modified at all. As I characterized them previously, they are biosimilar. Biosimilar enough to introduce into our food supply.
The FDA takes a different position. For them, biosimilar is not the same; changing a single base pair, turning off or deleting a gene, inserting a foreign gene are all genetic modifications. More importantly, these genetic modifications are considered a drug, subject to the same regulatory process and testing as any other drug.
Read full, original post: FDA And USDA Clash Over Definition Of Genetically Modified Food
