GE mosquitoes and salmon show the need for better regulation

There’s been a lot of news lately about risky genetically engineered animals in the queue for federal review. British biotechnology firm Oxitec continues to pursue permission to release its genetically engineered mosquitoes into the Florida Keys in what would be the first release of these engineered bugs into the wild in the U.S. Meanwhile, AquaBounty is assuring its shareholders that it is “confident that the FDA is advancing towards approval” on its application to sell unlabeled genetically engineered salmon to U.S. consumers. If approved, this “frankenfish” would be the first genetically engineered animal approved by the U.S. government for human consumption.

Oxitec’s planned scenario for its genetically modified mosquitoes in the Florida Keys has been compared to “the opening chapter of a Michael Crichton novel.” The analogy seems apt: in order to eliminate the threat of dengue fever (of which there wasn’t a single case in the Keys last year), Oxitec plans to release millions of modified male mosquitoes that will disseminate self-destructing genes and kill off disease-spreading bugs before adulthood — and therefore before they can bite people.

Local residents and environmental groups have understandably been skeptical toward this approach. Last month, a coalition of concerned groups sent Florida Governor Rick Scott a letter detailing their concerns. In it, they note Oxitec’s checkered history of releasing genetically engineered insects around the world without proper study of their environmental or health impacts and emphasize their refusal to be “Oxitec’s next guinea pigs.”

Keys residents and environmentalists are especially worried that the inaccuracies inherent to sorting tiny Aedes aegypti pupae could cause the release of more biting female mosquitoes than expected. Previous lab tests point to a reasonable expectation that a significant number of females could be accidentally released, meaning “Oxitec’s technology might not even work in limiting the spread of disease while still exposing Keys residents to possible risks.” Phil Lounibos of the Florida Medical Entomology Laboratory has expressed similar concerns, calling the planned release “surprising because there is not supporting background evidence that we’ve seen showing that this will solve the dengue problem.” Add to this the potential ecological imbalances associated with such a large project, and the already high risk and uncertainty are dangerously multiplied.

Similar concerns are mounting over AquaBounty’s efforts to push approval of the “frankenfish,” salmon genetically modified to produce excessive growth hormones that cause the fish to grow to market size at nearly two times regular speed. A proposed Senate amendment last week, for which 46 senators voted, highlighted widespread qualms regarding the lack of proper environmental review around the FDA’s upcoming decision on whether unlabeled genetically engineered salmon can be sold for human consumption in the U.S. As Friends of the Earth reminded the FDA in a letter last Friday with other environmental groups, the agency should complete a comprehensive and independent environmental impact statement on genetically engineered salmon before any decision on approval is made, echoing our citizens’ petition request last year.

In a statement on the proposal, Matt Tinning, Executive Director of the Marine Fish Conservation Network observed that: “The FDA has no expertise in safeguarding the health of marine ecosystems or the wellbeing of fishing communities. This amendment would have ensured that NOAA, our nation’s ocean science and fisheries management agency, be required to consider those potential impacts.”

Despite the sensitive environmental and public health risks surrounding these genetically modified organisms, the FDA retains sole authority over their approval, curiously classifying both Oxitec’s mosquitoes and the “frankenfish” under the rubric of “animal drugs.” Friends of the Earth has for years been fighting this strange interpretation.

Because of the lack of a clear, federal regulatory framework regarding genetically engineered animals, the FDA has used current laws applying to “animal drugs” to evaluate GE mosquitoes and salmon. The FDA asserts that modified genes “change the composition and function” of an animal, tenuous reasoning that allows them to approve genetically engineered animals whose environmental impacts the agency does not have the expertise to evaluate.

Such a reading is patently dangerous. As Friends of the Earth’s food & biotechnology campaigner Eric Hoffman observes, typical animal drugs like food additives “can’t reproduce in the wild, bite humans, spread disease, or fly to another part of town.” Neither are these drugs, as is the case with the “frankenfish,” normally intended to be consumed by humans.

Compounding these issues is the FDA’s insistence on complete opaqueness and confidentiality during the approval process. In spite of genetically engineered animals’ potentially enormous environmental, public health, and economic consequences, the FDA approval process remains non-transparent and closed to public input.

Emerging genetic biotechnologies carry promise but also significant, unforeseen risks. Using an antiquated regulatory structure to deal with their novel challenges places the public and our ecosystems in unnecessary danger. The upcoming FDA decision on genetically engineered salmon and the pending review of Oxitec’s mosquitoes present an opportunity for the U.S. to set a global precedent and finally write laws that directly and fully assesses the risks posed by these new technologies.