The review even went to the OMB at the Executive Office, which under normal circumstances would have no input on individual applications. Its authority is usually limited to reviewing new regulations. However I’ve been told that, because of the politicized nature of this case, the White House wanted to be involved. According to Talking Points Memo and my sources, OMB signed off on release of the EA that summer.
The approval was derailed when anti-GMO organizations circulated a report that the salmon at AquaBounty’s Canadian facility had tested positive for a salmon virus two years previously. The company had reported the incident to Canadian authorities but not to the FDA—which reportedly did not make officials happy. The FDA immediately put a hold on the release of the draft EA. It took months before the agency determined the incident had been isolated and had nothing to do with AquaBounty’s technology.
While that controversy was being addressed, Food and Water Watch, Consumers Union, and the Center for Food Safety submitted a formal petition in February 2012, demanding the FDA reclassify AquaBounty’s AquAdvantage salmon and its components as a food additive, setting up the possibility of a different regulatory regime that would have resulted in the process starting over at square one. The FDA stood firm, reaffirming its commitment to the evaluation by the CVM.
Finally, on April 19, 2012, the FDA circulated a draft EA that was an almost exact copy of what had been approved months before. The “approval of the AquaAdvantage Salmon,” the document states, “… will not jeopardize the continued existence of the United States populations of threatened or endangered Atlantic salmon, or result in the destruction or adverse modification of their critical habitat.”
For AquaBounty, the end again seemed in sight.
“It’s a lengthy process, especially when you are dealing with a first-in-kind product that cuts across many dimensions,” the FDA’s Hamburg told the New York Times. A revised environmental assessment, she said, would be issued “very soon”—in a matter of days, weeks at most.
Then the gears of government and communication between the federal officials and AquaBounty shut down completely.
Late spring was a challenging time at the White House. The GOP primaries had just wrapped up, and Republicans were coalescing around Mitt Romney, who appeared to be a formidable candidate. The president’s popularity remained lackluster. A late June Newsweek/Daily Beast poll showed that 54 percent of Americans thought Obama was doing a poor job—one of the lowest approval ratings of his presidency.
The main concern, politicos mused at the time, was a lack of enthusiasm by his political base, whose turnout would be critical if Obama hoped to squeeze out a victory during distressed economic times. Environmental activists were particularly ambivalent. They were upset about the president’s unwillingness to block the Keystone pipeline and shale gas exploration using hydraulic fracturing.
And some of them were incensed about what they considered weak-kneed regulatory oversight by the FDA on chemicals and GMOs, which they believed had gotten a pass during the Bush administration. In late March, the FDA, citing “sound science,” rejected a petition by the Natural Resources Defense Council to introduce tough restrictions on bisphenol A (BPA), a controversial plastic additive. “The FDA is out-of-step with scientific and medical research,” the NRDC wrote in a blistering rebuke. “The agency has failed to protect our health and safety.”
The last thing the Obama re-election effort needed was a messy dustup over the first genetically modified animal. But that was brewing. Union of Concerned Scientists’ Margaret Mellon, a foe of bioengineering, had already publicly warned of “a firestorm of negative response” if the FDA approved the salmon.
With political opposition bubbling in Congress and anti-GMO activists mobilizing in cyberspace, AquaBounty’s president and CEO, Ronald Stotish, encountered FDA Secretary Hamburg at an industry event in Boston.
“You’ve been great,” he quoted her as saying. “You’ve been patient and taken the high road.” She pointedly did not repeat her statement of a month before that the publication of the EA would be coming any day now.
Her comment set off alarm bells within the industry. Was there a new holdup? Stotish and Jim Greenwood, president of the biotech industry trade group BIO, met on July 11 with HHS Secretary Kathleen Sibelius’ senior adviser Andrea Palm. Palm is known as a “fixer”—she coordinates policy with politics, often working directly with Valerie Jarrett, the president’s most trusted adviser. Sources say the White House had been hearing regularly from anti-GMO organizations.