Keywords: Animal cloning, food products from cloned animals, food safety, SCNT, FDA, EFSA, CVM, risk assessment, novel food, consumer preferences, labelling, substantial equivalence, WTO law, GATT, 'like products', SPS Agreement, TBT Agreement
Abstract: Following the recent 'green light' from the FDA in the US and from the EFSA in the EU, cloned meat and milk may soon arrive on food shelves. Yet evidence suggests that consumers remain apprehensive about eating such food, for reasons which stand outside the scientific community (including ethical and moral issues). These consumer concerns may be hard to accommodate. Not least, in the US no labelling will be required. Although a more restrictive legislative approach is envisaged in the EU, this could trigger a WTO dispute. If the Dispute Settlement Body of the WTO declared cloned and conventional foods to be 'like products', commercial advantages for the US would ensue, as cloned products would be allowed to be sold onto the markets with no labelling, creating one market combining conventional and cloned foods. In particular, the application of the principle of non-discrimination could oblige the EU to remove any labelling of cloned products. On the other hand, consumer preferences are a factor to be considered in any 'like product' determination and it may be that the consumer hostility towards cloned food in the EU may prove decisive.
While governments and consumers are still laced with the issues o! growth hormones and genetically modified organisms (GMOs) entering the food supply, another challenge is already looming: the human consumption of cloned meat and milk. The regulation of milk and meat from cloned animals and their offspring has raised concerns over food safety. Currently there is a de facto moratorium at international level preventing the selling of such food. In the United States (US), however, the Food and Drug Administration (FDA) has recently declared that cloned food from cattle, swine or goats and their progeny is as safe as conventional food and can be sold to the public.1 The European Food Safety Authority (EFSA) in the European Union (EU) is heading in the same direction.2 However, the European institutions are not united. The European Parliament, for example, has recently reacted against this approach by adopting a resolution banning the cloning of animals for food consumption; opposition which was restated in May 2010.3 There is one difference of substance between the EU and the US. The former is likely to require the labelling of cloned products; the latter does not. Therefore, there is a possibility of a World Trade Organisation (WTO) dispute as US cloned products would have to be labelled to access the EU market, adding to the list of transatlantic disputes relating to modern biotechnology.
Dolly the sheep was the first mammal to be successfully cloned from an adult cell in 1996, by using the Somatic Cell Nucleus Transfer (SCNT) cloning technique.4 This technique has been the object of opinions by the FDA and EFSA.5 A genetic copy of an animal is produced by replacing the nucleus of an unfertilised female egg with the nucleus of an adult (somatic) cell from a donor animal to form an embryo.6 In both EFSA and FDA risk assessments the purpose of cloning is to generate animals for breeding and to use the sexually-reproduced offspring of clones for food production, as in other assisted repro-ductive technologies (ARTs).
The perceived advantages and disadvantages of cloning for breeding are varied. Most of the advantages of cloning animals for food consumption appear to be based on the ability of breeders to more effectively forecast the characteristics of the offspring - such as resistance to disease, suitability to climate, genetic selection, and quality body type - by using a more efficient and predictable breeding process.7 For the proponents of animal cloning, it is hoped that cloning will one day be 'a tool in the toolbox of farmers [...] to help them produce better livestock'.8