Palm professed to have no knowledge of the salmon controversy, according to people in the meeting. Palm promised to get back to them within a week. Five months later, dozens of calls and emails have gone unreturned. I’ve fared no better; Palm did not respond to my request for a statement.
Sources within the FDA have repeatedly asserted that the scientific review process is complete and the agency is not the source of the holdup. The media office says the application itself has not been formally approved. DeLancey referred me to the executive branch, to the White House and OMB. The OMB referred me back to the FDA. The White House declined to respond to requests for comment.
“There is much more at stake here than just a fish,” the letter asserted. “The inexplicable regulatory bottleneck that has been encountered by the AquAdvantage salmon suggests that the FDA’s science-based regulatory review process for the products of animal biotechnology has no predictable timeline and is holding up the development of an industry that promotes economic growth, innovation, competitiveness, and job creation in the United States.”
China has launched an $800 million public-private investment into transgenic animals, and genetically modified animals are being developed in India, New Zealand, and across Latin America, including in Cuba. But North America has become a dead zone.
James Murray, an animal scientist at the University of California–Davis has developed goats that make milk with diarrhea-preventing lysozyme, a bacteria-fighting protein that could save children’s lives. With no government or private money on the horizon, he’s set up his lab in Brazil, a more biotech-friendly locale. “When you don’t have a regulatory pathway forward and the government doesn’t support research in this area, what company will invest in this field?” he asked. “None. The AquaBounty situation is just confirmation of a hopelessly politicized process.”
The future of animal genetics is so dire, universities are killing off courses. “My program started off doing genetic engineering,” said Alison Van Eenennaam, a University of California–Davis animal scientist who co-authored a scathing article for Nature Biotechnology on the broken approval process. “I couldn’t get any government funding for my work in this area, so I shut the program down. Why would I train graduate students for jobs that won’t exist?”
A question remains whether the White House or FDA could face legal challenges for intervening in a scientific evaluation process that is supposed to be insulated from politics. The Federal Food, Drug & Cosmetic Act requires that the Health and Human Services secretary approve the AquaBounty application within six months after compliance with Section 512. The company holds letters from earlier this year from the FDA advising that every major component of its application has been successfully addressed.
The FDA, apparently caught in the political crossfire, appears to be in violation of its own scientific integrity guidelines, adopted last February. Scientists and staffers involved in the process say they have been instructed not to discuss the application. Key provisions of the guidelines require the agency to shield its staff from “political influence” and to allow the “FDA staff to communicate their personal scientific or policy views to the public, even when those views differ from official Agency opinions.”
The FDA has referred any questions about the logjam to the White House. The chief spokesperson for the OSTP, which is empowered by the executive branch to ensure that scientists are insulated from political concerns, has not responded to requests for comment.
“I think the credibility of our regulatory process is destroyed if someone at the White House or even at the FDA can essentially, arbitrarily pocket veto an application,” said Stotish.
But that’s what’s going on, say those monitoring science policy—even those critical of the AquaBounty salmon. The Union of Concerned Scientists, which has campaigned against bioengineering, expressed its concern that the science approval process is being compromised by politics.
“If the statutes say the decision is supposed to be made based on science, and promptly, the government should follow that,” Francesca Grifo, who helped craft UCS’s scientific Integrity reports, told me. “Despite what the President might have said about scientific integrity, we’ve seen White House interference on what should be science regulatory decisions. They have a legal responsibility to follow their own guidelines.”