The comment period has now been extended by an additional 60 days. The comment period will now end on 26 April 2013.
The FDA stated in its announcement that “the Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.”
Ron Stotish, Chief Executive Officer of AquaBounty, stated: “This is an administrative action and, although we are not pleased, we do not believe this materially affects our chances for approval. There have been no new facts introduced, and it is the position of the Company that an approval will be granted.
“The FDA panel of experts concluded in September 2010 that AAS is indistinguishable from other Atlantic salmon, is safe to eat and does not pose a threat to the environment under its conditions of use. There has been neither new information nor a clear legal or regulatory issue raised by the FDA since that time.”