Questions are emerging about the breakdown of the federal government’s science integrity process in the wake of the Food & Drug Administration’s long-delayed release of its approval of the first genetically modified animal for human consumption.
The AquAdvantage salmon developed by AquaBounty Technologies of Massachusetts—an Atlantic salmon modified with a growth hormone gene from Chinook salmon so it grows to maturity faster—had been winding its way through the federal approval process for 17 years. Two years ago, the FDA had said it was going to release its environmental assessment, the final document in the approval process, within weeks. It was finally and quietly posted on the FDA’s website only last Friday—just hours before the long holiday weekend—and published in the Federal Register on Wednesday.
The release came, FDA sources say, in response to the publication of an investigation in Slate by the Genetic Literacy Project two days before, on December 19. The GLP, which I head, had reported that the FDA had definitively concluded last spring that the fish would have “no significant impact” on the environment and was “as safe as food from conventional Atlantic salmon.” However, the draft assessment, dated April 19, 2012, was not released—blocked on orders from the White House.
The seven month delay, sources within the government say, came after discussions late last spring between Health and Human Services Secretary Kathleen Sibelius’ office and officials linked to Valerie Jarrett at the Executive Office, who were debating the political implications of approving the GM salmon. Genetically modified plants and animals are controversial among the president’s political base, which was thought critical to his reelection efforts during a low point in the president’s popularity.
The GLP posted a version of the suppressed preliminary approval document on its website, leaked by government staffers upset about the politicization of the process and the White House’s interference.
The hurried release of the Environmental Assessment last Friday capped a frenzied two days behind the scenes at the White House and FDA. Within hours after the Slate article and leaked document were posted, an administration official notified the FDA that the administration was dropping its indefinite hold. “The White House had no place to hide,” said a government source. The “final” draft environmental assessment is identical to the document leaked to the GLP, but is dated May 4—two weeks later.
Its release paves the way for a 60-day public review. 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 GM salmon could be on dinner tables by 2014.
According to sources, the White House political block—a direct violation of numerous ethics regulations and possibly of federal laws—was instituted over the objections of scientists at the FDA, but with the awareness of HHS Secretary Sibelius, her senior adviser Andrea Palm and the Office of Science and Technology Policy and its director John Holdren, who is responsible for enforcing “science integrity” across government agencies.
The OSTP had overseen an inter-agency review process that was completed by early spring. According to sources, Holdren stood by as the White House openly meddled.
The revelations have come as an embarrassment to the administration, say sources. As president, Barack Obama had pledged to change “the posture of our federal government from being one of the most anti-science administrations in American history to one that embraces science and technology.”
To publicly guarantee that, the White House had issued a science integrity memorandum in 2009 pledging, “Political officials should not suppress or alter scientific or technological findings and conclusions,” and putting Holdren in charge of enforcement.
FDA scientists and staffers say they were instructed not to discuss the decision to approve the salmon—a violation of the agency’s scientific integrity guidelines adopted last February that require the FDA to shield its staff from “political influence” and to allow officials and scientists to “communicate their personal scientific or policy views to the public, even when those views differ from official Agency opinions.”
A question remains whether the White House, OSTP or the FDA could face legal challenges for intervening in a scientific evaluation process. The Federal Food, Drug & Cosmetic Act, under which genetically modified animals are regulated, requires that the HHS secretary approve an application within six months after compliance with Section 512 of the act. That provision appears to have been breached. The FDA had advised AquaBounty last winter that every major component of its application has been successfully addressed—before the White House injected itself into the process.
Rick Weiss, chief spokesperson for OSTP wrote in an email that he would “try to address” the OSTP’s role in the holdup and Holdren’s involvement in the process, but then did not.
FDA spokesperson Siobhan DeLancey did not respond to requests for comments. An FDA spokesperson has told Rosie Mesels of the Los Angeles Times that the seven-month long delay (supporters of the GM salmon claim it has been more than two years) was an agency “oversight,” blaming it on the its internal “quality control process”.
“That’s not true,” said one FDA source. “It was pure politics.”
The political genie is now out of the bottle. In a bi-partisan display of pork barrel politics, Congressional officials in Northwest salmon country are making it clear that they will pull out all stops to block the FDA from issuing a final approval letter.
Sen. Lisa Murkowski (R-Alaska), well-funded by Alaska fishing organizations, has repeatedly tried to tie up the FDA in red tape. In a video released by her office last week outlining her renewed opposition, she let it slip that the demand for better science was nothing more than a smokescreen for efforts to simply kill the idea. “I just don’t believe that these fish should be approved.”
“The notion that consuming Frankenfish is safe for the public and our oceans is a joke,” Sen. Mark Begich (D-Alaska) said in a statement. [The FDA] report is by no means the final say on this issue.”