Hi guys!
-- David Ishee's goal was to use TRANSIENT crispr, so he could fix a single point mutation that makes all dalmatians sick
( Mutations in the SLC2A9 Gene Cause Hyperuricosuria and Hyperuricemia in the Dog https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2573870/ ; Estimated Frequency of the Canine Hyperuricosuria Mutation in Different Dog Breeds https://www.ncbi.nlm.nih.gov/pubmed/21054540 ).
So he asked the FDA for guidance how this would be regulated (if at all, see crispr mushroom). According to scientific logic, you are just mutating a T to a C and that shouldn't be of much concern. Especially now, that new "High-fidelity CRISPR–Cas9 nucleases with no detectable genome-wide off-target effects" http://www.nature.com/nature/journal/v529/n7587/full/nature16526.html are available.
Now there is a new draft for a law, and they ask the public to comment. https://www.geneticliteracyproject.org/2017/01/23/is-the-fda-being-nonsensical-uc-davis-animal-geneticist-criticizes-new-guidance-genetically-altered-animals/
In short, they don't want to regulate on an individual basis ("each GMO is different and has to be individually more or less checked" -> does it confer selective advantage, is it producing a novel toxin or is it just GFP?)
or on the process ("all GMOs are bad and have to be checked for 10-15 years" - see the GM salmon) but on the INTENT. Of course with the loophole of radiation breeding. Which makes absolutely no sense in my mind. If you have high skills and know what you are doing it's illegal and unafforadble to regulate for dog breeders.
They are stopping innovation by doing so.
A nice link, related http://www.strike-the-root.com/51/walker/walker6.html
Here is a possibility to show the FDA you care, to present hard scientific facts, etc.
https://www.regulations.gov/document?D=FDA-2008-D-0394-0279
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