Read on Twitter
Trump Administration just put out executive order moving regulation of GMO and CRISPR animals from FDA to USDA.
A wish list item of the pork industry among others. USDA is softer regulator and might not really regulate CRISPR animals at all.
Aaaand...FDA strongly objects.
1/7 https://twitter.com/SteveFDA/status/1351616813705154562
A wish list item of the pork industry among others. USDA is softer regulator and might not really regulate CRISPR animals at all.
Aaaand...FDA strongly objects.
1/7 https://twitter.com/SteveFDA/status/1351616813705154562
This has been brewing for a while. Back in 2014, we wrote about "hornless cattle" made via gene editing.
If you're just moving genes around within on species, the hope of industry was that the animals might not have to be regulated at all
2/
https://www.technologyreview.com/2014/09/02/74158/on-the-horns-of-the-gmo-dilemma/
If you're just moving genes around within on species, the hope of industry was that the animals might not have to be regulated at all
2/
https://www.technologyreview.com/2014/09/02/74158/on-the-horns-of-the-gmo-dilemma/
So the animal biotech companies, along with trade organization @IAmBiotech started lobbying congress to shift authority to USDA, which already decreed that CRISPR plants can do straight to market.
3/ https://www.technologyreview.com/2018/03/12/144764/farmland-gene-editors-want-cows-without-horns-pigs-without-tails-and-business-without/
3/ https://www.technologyreview.com/2018/03/12/144764/farmland-gene-editors-want-cows-without-horns-pigs-without-tails-and-business-without/
FDA scientists took a look at one of the early gene-edit large animals and found it was not what it appeared to be, not what company said it was.
Evidence that regulation kind of helps at this early stage of the technology.
4/ https://www.technologyreview.com/2019/08/29/65364/recombinetics-gene-edited-hornless-cattle-major-dna-screwup/
Evidence that regulation kind of helps at this early stage of the technology.
4/ https://www.technologyreview.com/2019/08/29/65364/recombinetics-gene-edited-hornless-cattle-major-dna-screwup/
Actually, FDA built a whole new team, 15 people, in a new division of bioengineering and cellular therapy to handle the coming biotech animals. According to the agency, this is in part to help animal developers, who often have never gotten a product approved before.
5/
5/
Recently, in the magazine, we featured one big time commercial effort to create infection and pandemic resistant pigs using CRISPR.
6/ https://www.technologyreview.com/2020/12/11/1013176/crispr-pigs-prrs-cd163-genus/
6/ https://www.technologyreview.com/2020/12/11/1013176/crispr-pigs-prrs-cd163-genus/
Regulation by USDA would change the game -- speed it up a lot probably. Have to see if Biden reverses this cations
7/
7/
