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KayDee Gilkey FDA’s Draft Guidance on Animal Genomic Editing
by KayDee Gilkey, click here for bio

Program: Open Range
Date: February 13, 2017

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The FDA recently released a draft guidance concerning genome editing which mimics what happens in natural selection — not bringing in new genes but rather just tweaking an animal’s DNA — to create polled Holsteins for example.

 

Cooperative Extension Specialist at the University of California-Davis Dr. Alison Van Eenennaam shares an example of what might regulated under this proposed FDA guidance

 

VanEenennaam: “We have a strange scenario now — where a polled Hereford doesn’t have to go through regulatory review but if I make a polled Holstein using genome editing it does. But if I make a polled Holstein by crossing an Angus over the top of a Holstein it doesn’t have go through review. It is a very strange rule. There is a public comment period at the moment open for the next 90 days I think. For people to weigh in on whether they think that a polled Holstein is a drug or is actually just a cow — or any of the other edits we can do. The reason I think that it is important is that some of the edits that have been done are things like pigs that are resist to PRRS and we can really use this technology to tweak an animal’s genome to help with things like disease resistance or animal welfare traits like polled. We’re not introducing new DNA. To me, DNA is not a drug — or I would argue that we are all junkies. What exactly is the rationale for introducing this new animal drug paradigm for regulating DNA?”

 

Find this story online at aginfo.net to find the link to the Federal register to comment on this draft guidance before April 19th.

 

https://www.regulations.gov/document?D=FDA-2008-D-0394-0279

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