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By Jessica A. Knoblauch

A U.S. District Court judge took the U.S. Food and Drug Administration (FDA) to task on Jan. 10 for withholding government documents related to the agency's approval of genetically engineered (GE) salmon. The judge's decision is a big win for public transparency, but it's also a small step toward finally doing a proper evaluation of the risks posed by GE animals—which could one day end up on our dinner plates.

In 2015, the FDA approved GE salmon made from the DNA of three different animals: Atlantic salmon, deep water ocean eelpout, and Pacific Chinook salmon. The GE version is intended to grow faster than conventional farmed salmon, reportedly getting to commercial size in half the time.

Even though this is the first time any government in the world has approved a GE animal for commercial sale and consumption, so far the FDA has taken a lackadaisical approach to evaluating the salmon's potential for harm to wild salmon and the environment. If the GE salmon were to escape, it could threaten wild salmon populations by outcompeting them for scarce resources and habitat, by mating with endangered salmon species, and by introducing new diseases.

The world's preeminent experts on GE fish and risk assessment, as well as biologists at U.S. wildlife agencies charged with protecting fish and wildlife, heavily criticized the FDA for failing to evaluate these impacts. But the FDA ignored their concerns, so in March 2016, Earthjustice filed a lawsuit against the agency.

As part of the lawsuit, the FDA is required to compile a record of documents that illuminate the path the agency followed to reach its decision to approve the GE salmon—much like a student is required to show their work for a math problem in middle school. A complete record is essential in all cases. But it is especially important here because the FDA has so far refused to release most of the documents related to its decision, despite repeated requests for that information from Earthjustice's diverse set of clients under the Freedom of Information Act.

The public has a right to know how the agency came to this seemingly ill-informed decision, especially because the FDA's approach will likely serve as a precedent for the assessment of future GE food animals. Withholding that information is illegal because government agencies like the FDA are funded by taxpayer dollars, which means that any records they create, with only limited exceptions, can and should be available to the public and to citizens seeking to hold the government accountable in court.

Last month, a U.S. District Court judge agreed, concluding that: "the government is wrong to assert that these types of materials … should be excluded" from the record. The FDA is now required to fully complete the record with all relevant documents no later than July 2017. In addition to working to ensure the timely completion of that process, we will thoroughly review the full basis for the agency's decisions.

"There's no way to know what exactly is in these documents until we see them," says Earthjustice attorney Brettny Hardy. "But they will undoubtedly provide a far more complete picture of how we got here, including information that raises legitimate questions about the agency's decision."

Jessica Knoblauch is a former award-winning journalist who now serves at the helm of Earthjustice's editorial team, which tells stories through the organization's blog, quarterly magazine and website.

Living Oceans Society

A 2009 memo from Fisheries and Oceans Canada (DFO) entered into evidence at Canada’s federal Cohen Inquiry into the collapse of Fraser River sockeye Dec. 15 reveals that salmon at the AquaBounty facility in Prince Edward Island have tested positive for the Infectious Salmon Anaemia (ISA) virus.

The genetically-engineered (GE) salmon, currently under review by the U.S. Food and Drug Administration for potential sale to American consumers, tested positive for the ISA virus in November 2009. An email from a senior DFO fish health official was sent to the Canadian Food Inspection Agency, notifying the agency of the positive test results.

“AquaBounty’s genetically modified fish are in a closed, land-locked facility,” said Catherine Stewart of Living Oceans Society, the group whose research uncovered the evidence. “This suggests the virus could only have entered such a facility through eggs or smolts, proving once again that Canada must take action to both ban egg imports and implement more rigorous testing for ISA.”

In the notification to the food health authority, DFO notes that based on molecular strain testing at two separate laboratories, the virus appears to be a new strain of ISA. The email also states,“With respect to international exports of live fish or eggs from this facility, DFO would identify that the facility has tested positive for ISAv should we be asked to sign a fish health certificate for export.”

Download a .pdf of the DFO email by clicking here. The DFO email will be posted to the Cohen Commission website as Exhibit 2083.

Ms. Stewart will be attending Cohen Inquiry hearings into ISAv Friday, Dec. 16 and Monday, Dec. 19.

For more information, click here.

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