[DIYbio] Re: Help forge the new US GMO animals law

I really appreciate what David Ishee is trying to do, we need more people like him.

This FDA proposal is probably just a trick to make all GMOs to fall under their control, by defining every GMO as "drug".

I would instead loosen up the regulation, at least for those animals that live in a human environment and are known not to survive in the wild... Or something on these lines.
Dog are not going to breed with wolves, nor they have a significant role in the ecosystem of a forest... Same for cats, or horses, or cows, etc. Their breeding is also, most of the times, strictly regulated, so there isn't such a big problem with unintentional release of GMO in the environment.

On Tuesday, 24 January 2017 12:22:00 UTC+1, Mega [Andreas Stuermer] wrote:

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