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The FDA issues a correction to its GMO salmon approval documents, which highlights once again how little the agency knows about the world’s first GMO food animal

The story below is yet another example of the poor science and data manipulation that characterize GMO approvals worldwide.

FDA corrects misleading data on GMO salmon

By Tim Schwab
Food & Water Watch, 8 April 2016
http://www.foodandwaterwatch.org/insight/fda-corrects-misleading-data-gmo-salmon
[links to sources are at the URL above]

* The FDA issues a correction to its GMO salmon approval documents, which highlights once again how little the agency knows about the world’s first GMO food animal

Last Friday night, the FDA posted a “corrected” version of its GMO salmon approval documents to remove some of the bogus information the agency had originally published about the fast growth rates of the genetically engineered fish.

The partial correction, made in response to Food & Water Watch inquiries, raises new questions about the independence and rigor of the regulatory science at the FDA—and about the basis for its approval of the world’s first-ever GMO animal approved for consumption, a fish that doesn’t appear to be able to do what is claimed—grow fast.

When FDA approved GMO salmon last November, the agency trumpeted that the fish can reach market weight faster than conventional salmon. But this assertion is not supported by independent science, and the salmon industry has openly challenged these growth-rate claims, saying that conventionally bred commercial varieties of non-GMO salmon grow as fast or faster than AquaBounty’s GMO salmon. FDA’s approval documents included new data that the agency said addressed any lingering growth-rate questions (check out page 111).

The FDA’s graph shows that GMO salmon grow about twice as fast as conventional salmon, but the agency’s presentation is highly misleading because of mislabeled and omitted data.

The FDA graph does not make an apples-to-apples comparison of the growth rates of GMO and non-GMO salmon grown in the same conditions. A key data set previously published in a Canadian draft risk assessment, which showed far less impressive growth rates, is missing from FDA’s graph. (Compare the Canadian graph at page 129 to FDA’s graph).

GMO salmon were growing so slow, in fact, that Canadian government scientists made note of the highly inconsistent performance, commenting, “….Whether it is due to differing environmental conditions…generational effects, or a combination of these and other factors, is not known.” They recommended that additional research be done.

Food & Water Watch sent all of this information to the FDA in May 2015. When FDA approved GMO salmon in November 2015, we contacted the agency about its apparent misrepresentation of data. Yet last Friday, the FDA sent Food & Water Watch a response letter indicating that it had not seen the Canadian presentation of the data and, in classic form, said it would not comment on the discrepancy. Nevertheless, FDA issued a partial correction, removing some of the agency’s erroneous text but leaving the misleading graph in place.

Oddly, FDA’s letter went on to volunteer previously unpublished data that the agency said supported the growth-rate benefit of GMO salmon—but which actually drives home the point that GMO salmon are exhibiting greatly diminished growth rates. The new data shows that GMO salmon grown in AquaBounty’s Panamanian facility reach 134 grams in size after about six months, but FDA’s approval document showed they reached 261 grams in the company’s Canadian facility. Non-GMO salmon grew consistently in both locations, reaching around 75 grams. This raises questions—yet again—about problems with AquaBounty’s gene technology. Why are GMO salmon performing so inconsistently and so poorly in commercial facilities? How much do we really know about this fish?

You might be noting that GMO salmon did, in fact, grow significantly faster than non-GMO salmon in these two trials (sponsored by AquaBounty). Among other reasons, this is because the slow-growing non-GMO salmon used in AquaBounty’s studies are not representative of the commercial Atlantic salmon that are widely grown in the salmon industry, which have benefitted from many decades of selective breeding and almost certainly grow as fast or faster than AquaBounty’s GMO salmon. Not surprisingly, the salmon industry has widely rejected GMO salmon, saying they won’t grow it.

The weak and conflicting science around AquaBounty’s growth rates, unfortunately, speaks to problems found throughout FDA’s regulatory review. Last Thursday, Food & Water Watch and other groups filed a lawsuit against the FDA that seeks to overturn FDA’s approval of GMO salmon because of the agency’s weak scientific review of environmental issues.