FDA hosted a hearing on Tuesday, September 21 to discuss the hypothetical labeling of genetically engineered (GE) salmon. Just fifteen hours earlier the FDA finished hearing the debate on GE salmon approval, which gave the impression that FDA was moving faster on the issue than it actually is. This compressed schedule caused frustration among experts, leading George Kimbrell of the Center for Food Safety to say “it is inappropriate to hold hearings on labeling before [GE salmon] are approved.”
In oral statements made before the FDA panel, Food and Water Watch (FWW) speaker Patty Lovera and the Alexis Baden-Mayer of Organic Consumers Association were not in favor of GE salmon, although if approved, Lovera recommended mandatory labeling of GE salmon. When pushed by the FDA panel on the material reasons for labeling, pro-labeling advocates often cited a lack of data on allergenicity of GE salmon or consumer preference. In a major break with other consumer advocacy groups, Gregory Jaffe from the Center for Science in the Public Interest indicated a preference for no GE labeling.
Salmon fillets in the grocery store (source: http://www.ctbites.com/home/2009/10/14/the-fresh-market-opens-in-westport.html)
If GE salmon is approved, the FDA has indicated that labeling will be based only on material differences in GE salmon compared to non-GE salmon, and not based on consumer preferences for GE labeling. These views may not be consistent with surveys that show 70% of American consumers want GE food to be labeled, from data reported by Jaffe.
Industry groups, including Richard Carnevale of Animal Health Institute, stood in line to argue that there were no material reasons why GE salmon should be labeled. The CEO of AquaBounty, Richard Clothier gave a series of other arguments against mandatory labeling, including the “slippery slope” that may lead to labeling of all GE foods and if labeling “complicated the process it would be a pity.” It appears that all stakeholders, including the FDA, realize this is a complicated process, and are willing to work through the difficult decisions.
If GE salmon is approved, consumers will have the ultimate say in its success. Salmon is the 3rd most consumed seafood product in the US and its popularity and high market price will likely continue,whether or not consumers know what kind of salmon they are eating. It remains to be seen if the aquaculture industry realizes that the rising interest in communicating where and how our food is raised may be a benefit as opposed to a liability. Elliot Entis, the founder of AquaBounty, indicated he would be in favor of voluntary labeling as a type of product branding. Entis was in favor of calling their salmon “Panama Reds,” although one can only wonder if this is just a red herring.
– Dave Love
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.
AquaBounty's AquaAdvantage Salmon (http://www.aquabounty.com/PressRoom/)
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
Biotech firms have touted the potential of genetically engineered (GE) crops to address the global hunger crisis. Many hopes (and many more dollars) have been invested in the promise of GE technology to increase crop yields. According to a new report by the Union of Concerned Scientists (UCS), this technology has thus far failed to deliver.
To better understand these new findings, it is worth elucidating some of the murky terminology. In a recent radio interview, plant pathologist Dr. Pamela Ronald explains “there is nothing that [the typical American family] will eat tonight that is not genetically modified.” She goes on to clarify her use of the term: all but the most wild of crop varieties have been “genetically modified,” in the traditional sense, through conventional plant breeding between compatible species (to complicate matters, the term “genetically modified,” or GM, often refers to GE foods). This is in contrast to GE, or “transgenic” crops, created in laboratories by combining the genetic information of distinct, usually unrelated (a plant and a bacterium, for example), species. Read More >