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KayDee Gilkey Shifting Rationale of FDA’s Draft Guidance Concerning
by KayDee Gilkey, click here for bio

Program: Land & Livestock Report
Date: February 14, 2017

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Yesterday we began a conversation about the FDA recently released a draft guidance concerning genome editing which mimics what happens in natural selection — so when genome editing makes a polled Holstein the FDA would consider that a drug needing to be regulated.

Cooperative Extension Specialist at the University of California-Davis Dr. Alison Van Eenennaam says it’s the shift in the rationale of the draft that is concerning.

VanEenennaam: “The proposal is any edit is done that is based on human intention. So the fact that I intended to allele to be the non-horn allele in the Holstein makes it as such that it has to go through the new animal drug regulation of the FDA. Basically I have to show that drug is efficient — that it is safe and effective — that is what you have to do for drugs and that it doesn’t have any food safety concerns. The human intention makes it more ideologically regulation rather than science-based based on the than on the risk of the product itself. That is what we have always had is a science-based regulatory system. If we move into an ideologically based regulatory system where the intent of the human is getting being regulated then I think we are on a pretty slippery slope. So that is what concerns me, because to me regulations should be based on risk and products at the same level of risk should be regulated similarly. You shouldn’t be regulated differently due to the process that used to produce a particular product.”

Go to aginfo.net to find the link to the Federal register to comment on this draft guidance before April 19th.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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