September 22, 2010
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