Delayed docs on genetically modified salmon released by FDA

AP

This undated 2010 handout photo provided by AquaBounty Technologies shows two same-age salmon, a genetically modified salmon, rear, and a non-genetically modified salmon, foreground.

Long-awaited U.S. Food and Drug Administration documents in the approval process of the first genetically engineered animal for human consumption were published on the FDA website at the start of the holiday weekend on Dec. 21.

The FDA was believed poised to make a decision in 2010, but the approval process stalled. The timing of this release and the cause of previous delays are raising questions. 

The document release came two days after Slate and the Genetic Literacy Project published an investigative story regarding the fishy delays; seven-months-long to two-years-long depending on who you ask, notes the L.A. Times. 

Developed by AquaBounty Technologies (and sometimes refered to as "Frankenfish"), the AquAdvantage animals are Atlantic salmon that have been modified with a Chinook growth gene hormone to mature twice as fast.

Environmental Documents

• Notice of Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning a Genetically Engineered Atlantic Salmon
• AquAdvantage Salmon Draft Environmental Assessment (PDF - 5.4MB)
• AquAdvantage Salmon Preliminary Finding of No Significant Impact (PDF - 51KB)

Despite politicization of the issue, Forbes reports that barring a dramatic new discovery, the modified salmon "could be on dinner tables by 2014." However they also report that a time-sensitive provision of the Federal Food, Drug & Cosmetic Act, which regulates the engineered animals, appears to have been breached.

A 60-day period of public review is now underway, says the FDA.

To encourage public participation consistent with regulations implementing the National Environmental Policy Act (40 CFR 1501.4(b)), the Agency is placing the draft EA and the preliminary FONSI that are the subject of this notice on public display at the Division of Dockets Management (see DATES and ADDRESSES) for public review and comment for 60 days.

Given that the substance of this draft EA was made available to the public in advance of the Agency’s 2010 Veterinary Medicine Advisory Committee meeting and consistent with the Agency’s regulations implementing the National Environmental Policy Act (21 CFR 25.51(b)(3)), FDA believes that a 60-day comment period is appropriate and does not intend to grant requests for extension of the comment period. 

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