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OCA Testimony to the FDA Concerning Genetically Modified Salmon

Hi, I'm Alexis Baden-Mayer. I'm here on behalf of the 250,000 active members of the Organic Consumers Association.

GE salmon should not be approved for human consumption based on the data FDA has collected from AquaBounty. The data does not show that GE salmon is similar enough to normal salmon to be considered safe.

The FDA's policy of using the process for animal drugs to review GE animals is entirely inappropriate and needs to be replaced before people start eating genetically engineered animals.

But, putting that issue aside, OCA has a number of concerns about the accuracy and interpretation of the data FDA used as the basis for its decision that GE salmon is safe to eat.

First, it is important to note that the FDA did not require food safety data on genetically engineered salmon DNA.

The human health impacts of consuming the "AquaBounty construct" are unknown and are not being investigated. Since 1992, the FDA has operated under the legal fiction that there is no risk associated with the human consumption of genetically engineered DNA. As the FDA explains, under this policy, because DNA is Generally Recognized as Safe, engineered DNA is considered safe, as well.

I'd like to call your attention to a human study conducted by the UK's Food Standards Agency that found that a single meal of genetically engineered soy can result in "horizontal gene transfer," where the bacteria of the gut takes up the soy's modified DNA. Research must be done to determine whether this would happen to people who eat AquAdvantage Salmon and what the health implications would be.

Instead of researching the safety of consuming GE salmon DNA, the FDA food safety review was a simple quacks-like-a-duck-style comparison of GE and normal salmon for hormone levels, nutrition and allergenic potency. Even using this elementary analysis, the data used to support the FDA's conclusion that GE salmon is similar enough to normal salmon to be considered safe is seriously flawed.

1. The FDA didn't always segregate and sometimes didn't even collect data from AquaBounty on the actual fish that people will be eating, the Panama-raised triploid, monosex AquAdvantage Salmon. Instead, each of the food safety studies look at genetically engineered salmon, in general. The FDA refers to this as ABT salmon, as opposed to AquAdvantage Salmon.

2. The FDA did not require AquaBounty to show that GE salmon is the same as normal salmon when raised under the same conditions. In addition to AquaBounty's control salmon, the FDA compared GE salmon to farmed salmon raised under unknown conditions and data from other salmon studies.

3. AquaBounty tested only a few fish, making it less likely that its food safety studies would reveal statistically significant differences between genetically engineered and normal salmon.

4. AquaBounty's detection levels were sometimes too low to produce food safety data for comparison.

5. AquaBounty selected which fish to test and unblinded samples, which may have biased the food safety data.

Even with all the flaws and biases that are likely to have hidden some of the differences, the data showed that genetically engineered and normal salmon do not have the same hormone levels, nutrition or allergenic potency.

GE salmon has 40% more IGF1, a hormone linked to prostate, breast and colon cancers in humans.

GE salmon is less nutritious than normal salmon. It has the lowest omega-3 to omega-6 ratio of all the salmon in the studies FDA reviewed.

GE salmon have mean allergenic potencies that are 20% and 52% higher than normal salmon, increasing the risk of potentially deadly allergic reactions.

With all that we know and all that we know we do not know about GE salmon, there is no other way to protect public health than to keep it out of the food supply.

Thank you for the opportunity to comment today. I hope you will read my written comments, including the 12,000 letters sent by individual members of the OCA.