Jeremy K. Brown - Comment

Document ID: FDA-2011-N-0899-0036
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: December 27 2012, at 12:00 AM Eastern Standard Time
Date Posted: December 31 2012, at 12:00 AM Eastern Standard Time
Comment Start Date: December 26 2012, at 12:00 AM Eastern Standard Time
Comment Due Date: February 25 2013, at 11:59 PM Eastern Standard Time
Tracking Number: 1jw-82rx-lknp
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The Finding of No Significant Impact makes assumptions that are not warranted from past experience. For instance;"the approval would only allow AQUADVANTAGE Salmon to be produced and grown-out in the physically contained freshwater culture facilities specified in the sponsor’s NADA." Experience with drugs (which is the bizarre category applied here) shows extensive "off label" use as a routine occurence with no intervention or oversight by agencies. "physically contained facilities" do not have a good track record. In the US, Grass Carp originated from physically contained facilities, and Aqua Bounty has a record of negligence in the 'escape' of Aquavantage salmon from their facility in Panama. These fish will get out if permitted. A FONSI is not warranted under these circumstances.

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