FDA and GE fish – the danger of rubber-stamp approval

American consumers may soon be eating an unlabeled, genetically engineered (GE) salmon created by the company Aquabounty.  If approved, it would be the first GE animal in history allowed for human consumption. The biotech industry claims that the GE fish is safe; after all they couldn’t sell it without permission from the U.S. government.  But when you understand the complicated bureaucracy twisted to review this unprecedented product, you understand that their assurances of safety aren’t very reassuring.

In the United States, there is no law specifically intended to regulate the products of genetic engineering.  Rather, GE products are reviewed and “approved” through a variety of pre-existing, outdated laws never intended for regulating biotechnology.  The FDA, EPA and USDA all have different roles for different processes.

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Without a comprehensive regulatory framework, there are major oversight gaps.  For example, FDA classifies GE animals, like the GE salmon, as an “animal drug.”  The Federal Food Drug and Cosmetic Act (of 1938) defines a “drug” as essentially something that affects the structure or function of the animal.  According to the FDA, the engineered genetic code in the salmon is thus a “drug.”  The FDA only reviews that drug in the context of the health of the animal and the human consumer, ignoring any resulting environmental or economic impacts.

The possibility that a GE animal might become an invasive species and destroy the natural ecosystem is ignored by FDA.  And if approved, the GE salmon will very likely have major effects on native salmon populations.  These GE salmon are grown using genes from two other types of fish in order to speed its growth, and if escaped, could out-compete native species. One study found that if just sixty GE fish escape, it could result in the extinction of 60,000 native fish in less than forty fish generations.  

Recognizing both the potential profit and the grave environmental concerns presented by its GE animal product, Aquabounty developed a smokescreen to pacify public outrage and scientific alarm.  The company managed to crack open the door of regulatory approval by proposing a highly specific production plan, producing the GE salmon eggs on Prince Edward Island, Canada, and then flying the eggs to a guarded facility in Panama to be grown to market size and butchered.  From Panama, the fish would be shipped by truck to American dinner tables.  FDA swallowed Aquabounty’s bait, reviewing only those two facilities in Canada and Panama. 

These facilities, by themselves, do have significant inherent risks.  Just recently an environmental organization filed an administrative complaint in Panama, alleging that the Aquabounty facility violated numerous Panamanian environmental laws and lacked even basic monitoring and reporting requirements for wastewater disposal.  And last week, three groups in Canada filed a lawsuit against their government for failing to consider the GE fish as an invasive threat.

Despite the FDA’s ongoing review of Aquabounty’s current operations, no company actually farms salmon in this manner.  It doesn’t take an economist to know that flying salmon from research-sized facilities in two different countries thousands of miles apart is not a viable business plan.  Rather, salmon are farmed in crowded, industrial net pens on the open ocean, exposed to the elements, which cause millions to escape every year.  Aquabounty even knows this.  It has plans to expand its operations globally once approval is given.  In fact, documents obtained from Freedom of Information Act requests show that applications for permits to grow the fish elsewhere in the U.S. have already been filed.

In plain language, Aquabounty has asked the FDA to review two small research facilities. Aquabounty will claim that this limited approval means the product is safe and ramp up production.  Meanwhile, no meaningful review of the long term health or environmental implications will be conducted.

Perhaps most shameful, FDA is a willing participant in this ruse.  Nearly two million people demanded FDA reject the GE salmon application for commercial approval.  It is yet to be seen if Aquabounty will succeed in their plans or what the impacts might be.  The one thing that is certain: if approved, the fish will escape.  As the Fish and Wildlife Service (.PDF) stated, “history dictates that fish held in aquaculture facilities either land- or water-based, escape.” 

Kimbrell is senior attorney for the Center for Food Safety.

 

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