FDA’s proposal to label GM salmon for production outside the US is unenforceable, and its failure to extend labelling in the market borders on public deception. Prof. Joe Cummins
This report has been submitted to the US FDA
The Food and Drug Administration (FDA) held a public hearing regarding the labelling of food derived from AquAdvantage’s genetically modified (GM) Atlantic salmon. The purpose of the hearing was for FDA to explain the relevant legal principles for food labelling and to solicit information and views from the public.
In a separate but related process, FDA held a public Veterinary Medicine Advisory Committee (VMAC) meeting and sought public input on safety and environmental impact of AquAdvantage salmon . VMAC met on 19-20 September 2010, and considered comments including the advice that commercial release of AquaAdvantage salmon is too hazardous to consider in the absence of animal feeding studies  (AquaAdvantage Salmon Ready for Commerce? SiS 48). The VMAC committee failed to come to agreement, leaving the important issues undecided. The FDA discussion on labelling of the AquAdvantage salmon was convened on 21 Sept, but the input of comment was extended until 22 November 2010.
The labelling issues considered by FDA include the following:
1. Which facts about the AquAdvantage salmon seem most pertinent for FDA’s consideration of whether there are any “material” differences between foods from this salmon and foods from other Atlantic salmon. (Keep in mind that the use of genetic engineering does not, in and of itself, constitute a "material" difference under the law.)
2. If FDA determined there are “material” differences”, how would that difference be described on a food labelling in a way that is truthful and not misleading. (Keep in mind that it is the difference in composition, or in functional, organoleptic (odour, taste or texture) or other material properties that must be described, not the underlying production process.) Information about changes in the attributes of the food itself, such as its nutritional value, functional properties (e.g., storage) or organoleptic qualities may be important.
When commenting on these issues, FDA requests that respondents include support for their answers with relevant data, where appropriate, and/or references to the relevant legal principles.
In the VMAC briefing packet , Section 3.4 of the Environment Assessment presents information on labelling of the product, including several warning statements expected to appear on the product label: “fish must be reared in land-based, highly contained systems that prevent their release into the environment” and the “fish cannot be reared in conventional cages or net pens deployed in open bodies of water.” Presumably this may mean that the GM salmon will be labelled prior to marketing for sale as food, at which time, the labels will be removed to conceal the GM origins of the salmon to be sold as food. The introduction of transgenes and their products into the GM salmon is not considered to be a material change in Atlantic salmon even though such changes would never have appeared in natural Atlantic salmon throughout its evolutionary history.
Even if production labelling is imposed for GM salmon by the FDA, it is not clear how the FDA can impose such regulation on sovereign countries such as Canada and Panama, where the actual production of GM salmon is proposed to take place. In fact, the FDA approach seems to be an invitation to produce GM salmon in an uncontrolled manner outside its jurisdiction in the USA. The land-based production of GM salmon is essential because the production of farmed salmon in offshore pens or cages has been found to contribute to the decline of wild salmon . However, there is no assurance that GM salmon will not be produced in pens or cages in the future.
As the FDA regards the GM salmon to be a veterinary drug, the most prominent concern has been the failure to produce evidence of its safety based on animal feeding experiments with comprehensive tissue necropsy analysis. In terms of other tangible material differences, the most immediate is the introduction of food allergens following modification of a food organism with genes from another species, and even from one closely related, such as the transfer of a harmless protein from bean to pea [5, 6] (Transgenic Pea that Made Mice Ill, SiS 29). Fish are, of course, already among the prominent food allergens, but the introduced transgene product in the GM salmon may raise the level of food allergy hazard considerably.
A further material difference is the elevated level of insulin-like growth factor produced as a by-product of the transgenic growth hormone. The insulin-like growth factor is associated with cancer-promotion. The FDA regards the observed growth factor not sufficiently elevated to promote cancer in humans . Nevertheless, the elevated growth factor is a material difference and a concern particularly for children, whom the FDA ignored in its analysis.
As the FDA plans to label the GM salmon to provide instructions on the manner the fish are to be produced, the simplest, most logical course of action is to label those GM salmon in the marketplace. Labelling the GM salmon in the market should also facilitate global export of all farmed salmon to most of the countries in the world that require labelling of GM foodstuff. Labelling will also allow essential epidemiological post-market monitoring of populations that might consume the minimally tested GM fish, as would be required for any newly introduced drug.
The United States and Canada have obstinately rejected public demand for labelling GM food and feed to allow free consumer choice; they maintain that GM crops are substantially equivalent to conventional crops. In contrast, the European Union and a number of Asian countries have required transgenic food to be labelled in the market based primarily on the precautionary principle that GM food has not been proven to be risk-free.
In North America, it is frequently claimed that no person has been injured by consuming GM food; but that claim is empty because the foods have not been labelled so it is impossible to identify those who have consumed GM food from others who have not.
Most of the discussion over the legal issues surrounding labelling of GM foods focuses on the right of consumers to know what they are eating. In the US, risk assessment refers to the process of measuring risk (defined as potential adverse effects), while risk management refers to measures taken to avoid the occurrence of risks. While public participation may be deemed inappropriate at the risk assessment stage on grounds that the task belongs to experts and is not subject to democratic or unscientific input, the same cannot be said of risk management, which can and should accommodate diverse perspectives, including those of the public. While the United States has generally accepted the precautionary principle as a guiding tenet of domestic law, American regulators (and hence consumers) are still much more tolerant of risk in the service of biotechnological advancement than their European counterparts; which is why there is no current federal law requiring labelling of GMOs or GM food products .
A view on “risk assessment” has been presented based extensively on scientific information supplemented with “risk assessment policy” judgments to bridge gaps and uncertainties in the scientific evidence . Even though people have a right to know what they are eating, that right seems to have been usurped in North America by “experts”. Between the two extremes of USA and EU, Taiwan and Japan represent a limited application of the precautionary approach. In both countries, the GM foods subject to labelling requirement are designated by a competent authority, and the scope is much more restricted than European Union regulations. Another common feature is the exemption of highly processed products .
In 2004, Prof. Margaret Gilhooley of Seton Hall Law School, South Orange, New Jersey reviewed the genetic engineering of foods, and emphasized the need for avoiding deception in the sale of GM foods. She discussed the implication of the escape of farmed GM salmon, noting that such escape would alter the wild fish populations. Labelling the GM salmon in the market would avoid the deception involved in the sale of the salmon. Adequate disclosures are needed to boost the confidence of consumers , which is currently at low ebb.
GM AquAdvantage salmon must be labelled in the market. The transgenic fish have not been studied adequately, as they should have been, using animal feeding experiments followed by comprehensive tissue necropsy. Material differences between GM salmon and unmodified Atlantic salmon do exist. Labelling GM salmon in the market place will allow necessary post-market monitoring of potential harmful effects of the GM salmon on human populations. The FDA should reconsider its tolerant acceptance of risks in the service of biotechnological advancement. It is worth mentioning that FDA has been subject to extensive criticism in recent years on its drug regulatory activities . It should ensure that the GM salmon will be identified as such in the market, to avoid deceiving the public over the consuming of unlabelled GM food.
Article first published 14/10/10
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susan Comment left 15th October 2010 01:01:10
GM Aquaadvantage salmon is the next step down from Atlantic salmon. 10 years ago while cooking for a large production, I purchased 50# of Atlantic salmon. Prepared it and cooked it in a large convection oven. When the oven doors were opened the smell from antibiotics was disgusting. I never purchased this item again. A bold saucier would be required to mute the stink from that product. Now we are going to raise giant fatty fish in factory tanks. Which of course will require more antibiotics. Waiter there is a drug in my mutation.