Global Policy Forum

The Food and Drug Administration (FDA) has plans to approve the “AquAdvantage Salmon,” the first-ever genetically engineered animal. It is being evaluated through the FDA’s “New Animal Drug Approval” (NADA), a procedure intended to assess new animal drugs, not genetically engineered animals. As a drug is inserted at the one-cell stage of development, the animal is considered as a drug and is thus not required to be analyzed in reference to human health, animal welfare or environmental impacts. If this approval goes ahead, the GE meat process is likely to become concealed from consumers and as Friends of the Earth notes, FDA’s approval “will open the floodgates for other genetically engineered animals, including pigs and cows, to enter the food supply.” 

February 12, 2013

If you’re one of the 91 percent of Americans who opposes genetically engineered (GE) meat, you may have limited time to act: The Food and Drug Administration (FDA) has proposed approval of the first-ever GE animal, called “AquAdvantage Salmon.” If this first approval proceeds, the process is likely to become top secret in the future: we won’t find out about new GE animals until after they’re approved for human consumption, and they won’t be labeled. Welcome to the new world of genetically engineered meat — unless we act now.

The Process

The problems begin with FDA’s bizarre decision to consider GE meat using its “New Animal Drug Approval” (NADA) process, a process designed for evaluation of new animal drugs (hence the name), not genetically engineered animals. The GE salmon themselves are, according to this analysis, the animal drug. As food blogger Ari LeVaux explains on Civil Eats, “the drug per se is AquaBounty’s patented genetic construct... Inserted at the animal’s one-cell stage, the gene sequence exists in every cell of the adult fish’s body.”

Of course, NADA was not designed to analyze the human health or environmental consequences of new animal drugs, and because the animals are the drugs in this process, their welfare is also ignored. In all three areas, there is ample reason for concern.

Human Health

Since they aren’t consumed by humans, new animal drugs are not evaluated for their human health impact, so perhaps it’s unsurprising that FDA’s analysis in this area has been almost nonexistent. Health and consumer rights advocates have raised alarms, noting among other concerns, that: 1) these animals will require massive doses of antibiotics to keep them alive in dirty, crowded aquaculture conditions, and we don’t know these antibiotics’ effect on human health; 2) the limited testing that has been conducted was carried out by or for AquaBounty and included shockingly small sample sizes; and 3) what studies have been done indicated increased allergic potential and increased levels of the hormone IGF-1, which is linked to various cancers — an outcome ignored in FDA’s approval according to the Consumers Union, Food & Water Watch, and the Center for Food Safety.

Our Environment

The process of examining new drugs’ environmental impact is also lax, so it’s also not surprising that FDA bungled this analysis as well. As just one glaring example, the agency looked only at how one small pilot project in Canada and Panama will affect U.S. waters, ignoring its legal obligations to consider the likelihood of salmon escaping as the pilot program expands—an expansion the company has already announced. Similarly, FDA suggests that the GE salmon’s lack of fear and rapacious appetite means that they could not survive escape. Another possibility, ignored by FDA and feared by environmental groups including Friends of the Earth, is that escapees would “wreak havoc on the ecosystem.” The Center for Food Safety (CFS) points out that every year “millions of farmed salmon escape, outcompeting wild populations for resources and straining ecosystems.” Regarding GE salmon, CFS continues: “Research published in the Proceedings of the National Academy of Sciences notes that a release of just sixty GE salmon into a wild population of 60,000 would lead to the extinction of the wild population in less than 40 fish generations.” FDA totally ignores this scenario and its vast implications for our aquatic ecosystems.

Animal Welfare

Animal welfare is the one area where we might expect NADA to do a passable job because the process is supposed to guarantee drug safety in the target animal. Sadly, FDA ignored animal welfare in its decision to recommend approval of GE meat, perhaps because it considers the GE animals to be drugs, not animals. In 2010, the American Anti-Vivisection Society and Farm Sanctuary detailed more than a dozen concerns with the AquAdvantage salmon, any one of which should have precluded approval. Yet, in its proposal, FDA ignored animal welfare concerns entirely.

Here are just a few of our concerns, none of which were addressed in FDA’s proposal:

1. Although AquaBounty supplied limited animal welfare data, its own application indicates that it engaged in “extensive culling” of deformed, diseased, dying, and dead fish from its analysis. This would be like studying smoking’s impact only on long-distance runners who had shown no signs of cancer or heart disease.
2. All aquaculture causes physical deformities and makes fish sick; nevertheless (and even after culling the sickest animals), the limited data supplied by AquaBounty indicates that AquAdvantage fish are even sicker and more prone to abnormalities and death losses than other farmed fish
3. Even within these parameters, there were problems with the studies. For example, sample sizes provided were tiny and included limited data, and all analysis was done by the company (do you recall how this worked out with the tobacco companies?).
4. Salmon in the wild are remarkable animals, swimming thousands of miles, including up streams and waterfalls; and of course, they feel pain and have similar cognitive, emotional, and behavioral complexity to other animals. AquAdvantage salmon will be crammed into tanks in grossly unnatural conditions, and slaughter will be completely unregulated (see video below). Imagine living your entire life, day and night, in an elevator with 20 other people — you can’t even stand up; you live in a pile of everyone else’s limbs and excrement. That’s aquaculture.

Brave New World

The scariest thing about approving GE animals through NADA is that once a type of technological drug advance is approved (here, genetic animal engineering), future approvals become much easier and much less transparent: the process that protects corporate drug development secrets will protect the GE process, resulting in reduced scrutiny and no transparency at all for future approvals. The American public will probably not even find out about future GE animals until after they’re approved for sale. As Friends of the Earth notes, FDA’s approval “will open the floodgates for other genetically engineered animals, including pigs and cows, to enter the food supply.” 

Conclusion

FDA’s process for approving genetically engineered meat is rotten to the core, and the effects of such a bad process on human health, our environment, and animals cannot be overstated. In the 2010 process, FDA received more than 400,000 comments and letters from more than 300 health, consumer advocacy, environmental, animal protection, and other organizations. All were ignored. We have one more chance before litigation becomes necessary.