GE salmon is the same as non-GE salmon? When genetically engineered (GE) Atlantic salmon was approved for human consumption by the FDA, consumer groups responded by clamoring for a new process that would review GE food animals and require the products be labeled as GE. But FDA has decided that GE salmon is equivalent to non-GE farmed Atlantic salmon. Read the article at the New York Times and FDA’s response to Read More >
Water laps gently against the canoe as Felix paddles across Lake Volta. Once he reaches the floating cages, he scoops some pellets that look like typical fish food and sprinkles them over the water. Hungry tilapias dart to the top. They gobble the beads in such a frenzy the surface of the water erupts like a fountain.
Felix is feeding fish as part of a research study in Ghana. The tilapia fingerlings in this one-month growth trial have been divided into four groups. Felix feeds one group by tossing them a cupful of typical tilapia food enriched with vitamins, minerals, wheat, poultry by-products and fishmeal. The other three groups feast on the same feed, but instead of fishmeal, they get varying amounts of insect meal. Like fish, insects can be converted into a high-protein, high-energy feed.
Fingerling Food in Ghana
In a chilly hotel ballroom in the Washington DC suburbs, the FDA this week is considering whether to allow genetically engineered (GE) animals in the human food supply. The test case is an Atlantic salmon that has been engineered with Chinook salmon genes to express a growth hormone. The result is a fast-growing salmon that reaches market sooner than non-GE farm raised salmon.
A cast of stakeholders—industry, advocacy groups, academics, and regulators—are writing the storyline, but the climax— a pending decision by the FDA— is still a month or more away.One thing is clear, this FDA decision on GE salmon will set a precedent for other GE food animals in the US, and may influence regulations and practices in other countries already farming or considering farming salmon.
Is GE salmon a drug?
The approval mechanism for GE salmon, however convoluted it may sound, is as new animal drug. Approval of new animal drugs is under the purview of FDA’s Center for Veterinary Medicine (CVM). This approval process is similar to other GE animals used for pharmaceutical production (e.g. goats that produce drugs in their milk), and for research purposes (e.g. transgenic mice). Several speakers on both sides of the issue, including Bruce Chassy of the University of Illinois who is pro-GE, were confused why FDA did not instead allow its Center for Food Safety and Applied Nutrition (CFSAN) to take charge of regulating GE salmon as a food. One can only speculate that since CVM has been working with the drug sponsor, AquaBounty, for about a decade, certain CVM staff may feel some ownership over the issue. A clear rationale for why CVM and not CFSAN was in charge was not well articulated by FDA.
FDA carefully frames the issue.
To focus the debate, FDA’s CVM will consider just four main questions for GE salmon approval: i) are the inserted genetic elements harmful for salmon health?; (ii) are the salmon safe for humans to heath based on a “reasonable certainty of no harm”?; (iii) are the inserted genetic elements durable, heritable, and affect salmon such that it improves salmon growth rates as matching product claims?; and (iv) are there environmental risks if GE salmon escape? While striving to answer these key questions is admirable, the methods to address each issue use a reductionist view. Therefore the assessment is not designed for systems thinking about the intersection and interactions among diet, health, food production, and the environment.
What is missing from the debate?
What FDA is not considering in its decision is just as important as what it is considering. The FDA is not interested in assessing the food safety of the whole fish but rather its component parts in a non-additive way (i.e. hormones, nutrients and their separate toxicity or allergenicity). The FDA is not considering risk-benefit trade-offs in health from salmon consumption. The FDA will not consider ethical arguments against genetic modification, or biotechnology arguments for increasing food production as means of feeding the world. Animal welfare issues will also not be considered, as admitted by one FDA panelist.
An independent advisory committee was highly critical of the science.
A major component of the FDA hearings on September 20, 2010 was peer-review and recommendations from an independent advisory committed called the Veterinary Medicine Advisory Committee (VMAC). In what many considered a surprise, the VMAC committee was antagonistic of the FDA summary of the sponsor’s environment and food safety studies. On several instances the VMAC committee were concerned about the low sample size and power of the sponsor’s studies. The FDA responded that it had not performed power calculations to identify what an appropriate sample size should have been. Most VMAC committee members felt that larger and better-designed studies of food and environment safety were needed. This is a strong statement that the FDA should not ignore.
More to come from the next day of hearings, so stay tuned..
– Dave Love
I’d like to expand a little on my recent interview for a CNN piece by Elizabeth Landau entitled “Farmed or wild fish: Which is healthier?”
At face value, this question can partialy be answered by comparing the nutritional content in farmed and wild fish and weighing the health benefits of fish consumption against the risks of pollutants present in fish. The Institute of Medicine of the National Academies has expertly covered this topic in Seafood Choices: Balancing Benefits and Risks, and authorities like Dr. Charles Santerre, have produced an excellent seafood consumer guide (Fish for Your Health wallet card) based on Omega-3 fatty acids, mercury and PCBs in fish. These comprehensive benefit-risk analyses and consumer-friendly information are useful and important contributions, though focus solely on human health.
In any discussion of seafood, it is also important to consider the negative impacts of fish farming or wild-caught fishing can have on the environment. These environmental impacts are considered as the basis for progressive fish certification schemes (examples: Friends of the Sea or Marine Stewardship Council) and consumer recommendation lists (example: Monterey Bay Aquarium wallet card) (read more). Sustainability should be an important consumer consideration, though in these certification schemes and consumer guidance materials, human health considerations are often absent.