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June 19th, 2013

Stonewalling the Public: FDA’s Secret Approval Process over GE Salmon

By Tim Schwab

In the great debate over genetically engineered (GE) salmon, the Food & Drug Administration (FDA) has locked the public out of key discussions by failing to disclose critical information related to the still-pending regulatory approval. As we wait to hear if the FDA will approve GE salmon this summer, we continue to scratch our heads at the contradictions that FDA can’t — or won’t — explain.

Since the FDA first publicized its review of GE salmon in 2010, independent sources have uncovered document after document that contradict the agency’s glowing findings that the fish is safe to eat, safe to produce, and a solution for fish farmers.

In an attempt to reconcile the striking differences between what the FDA is telling the public and what independent sources are saying, Food & Water Watch has filed numerous Freedom of Information Act (FOIA) requests with the FDA since 2010.

The FDA has been silent, rejecting or sitting on requests for years. Other groups filing FOIAs have been met with the same silence.

Almost exactly one year ago, Food & Water Watch asked the agency for documents related to a major biosecurity breach we discovered at AquaBounty Technologies’ proposed GE-salmon production facility. We found a corporate document from 2008 that said an “unusually severe storm” lead to “lost” GE salmon.

In an effort to understand how FDA failed to discover or disclose this major event, which presents crucial risk-assessment questions related to potential environmentally damaging escapes, we filed a FOIA request, asking the agency for all documents it had related to the “lost” salmon event. Thus far, the FDA has failed to respond.

As independent sources continue to show GE salmon in a less favorable light than FDA, the agency isn’t providing any explanations:

The Guardian newspaper in 2013 reported that AquaBounty’s production facility is little more than a “rundown shed,” which raises serious questions about its security and ability to prevent salmon escapes. In 2010 and in 2012, the FDA told the public that the facility “appeared to be newly built and well-maintained,” based its own visit.

The FDA told the public that AquaBounty’s operations were “disease-free” in 2010, but independent sources later revealed that the company actually had been struggling enormously with a major disease outbreak that required the company to depopulate parts of its egg-production facility and subject itself to months of subsequent government inspections. The FDA actually acknowledged the disease outbreak in 2012, but did not address substantive questions about future disease problems, disease resistance or antibiotic use.

A 2013 scientific study showed that GE salmon can readily breed with another species of fish, creating hybrids that could outcompete wild salmon populations for food (more about this here). The FDA never addressed this ecological concern and, in fact, doesn’t even know what species of fish live in the watershed where GE salmon, if and when they escape, will invade.

The FDA tells the public that there is “no substantial record of weather-related disasters” near the GE-salmon production facility in Panama and dismisses escape threats related to such disasters. However, independent sources show that this facility is located next to a river that has been under a state-of-emergency designation for much of the last few years, in an area prone to extreme weather. There is ample weather data, and news articles the FDA could consult.

The FDA concluded that GE salmon grow fast, as AquaBounty claims, but has never examined the full lifecycle of GE salmon. Independent salmon producers say their non-GE fish grow as fast or faster as GE salmon.

FDA’s astounding lack of transparency and failure to address these damning inconsistencies casts great doubt on the competence, independence and credibility of the agency. Clearly, it isn’t enough for the public to simply trust that FDA is doing its job and providing an appropriate level of regulatory scrutiny. Clearly, FDA isn’t up to the task or regulating the world’s first biotech food animal.

Let’s shut down this regulatory experiment: call your congressional representative.

One Comment on Stonewalling the Public: FDA’s Secret Approval Process over GE Salmon

  1. Jan says:

    It’s very hard to trust government and democracy when there seems to be a great deal of dishonesty and even illegal activities, especially related to this GMO issue in our country.

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