The Food and Drug Administration today released an electronic version of its environmental assessment for a genetically modified salmon developed by AquaBounty Technologies—effectively giving its preliminary seal of approval on the first transgenic animal to be considered for federal approval.
According to sources within the FDA, the environmental assessment had been approved by the all the relevant agencies on April 19, 2012, but had been blocked for release on orders from inside the executive branch. The delay has raised both legal and ethical issues of political interference in science and the independent work of federal agencies.
The decision by the White House to rescind its order to block the FDA from releasing the environmental assessment came within hours after the publication of an investigative report by the Genetic Literacy Project and a story in Slate on Wednesday.
“There was no place for the White House to hide anymore,” said one FDA insider.
The environmental assessment was posted online this morning. It has gone to the printer and is expected to be officially published in the Federal Register next Wednesday. That paves the way for a public review period, which could last 30 to 90 days. The FDA will then evaluate the public comments and consider a second review period. Unless some dramatically new information emerges from the public responses, the FDA could issue its formal approval sometime in 2013. The GM salmon could be on dinner table by 2014.
