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FDA’s cloning report bypasses ethics, exposes European dilemma

As the FDA inches toward approving food products from cloned animals, the EU stays mute, setting up another potential trade conflict.

After many years of delay, the US Food and Drug Administration (FDA) has apparently completed a study into the risks of meat and milk from cloned animals and their progeny, supporting their safety. In clearing the way for such products, the agency kicks off a national public debate. But Europe, too, now faces a difficult question: should it start writing ethics into its food laws?

FDA’s Center for Veterinary Medicine’s (CVM) Draft Risk Assessment of the health of animal clones, their progeny and the food products derived from them, and the Proposed Risk Management Plan that goes along with it, took more than eight years to complete. In the next few months, a public debate will take place before the Bush administration decides whether to follow its regulator’s suggestions and allow the sale of meat and milk from cloned cattle, swine and goats without additional measures because they are indistinguishable from products derived from animals that are conventionally bred.

In a commentary elsewhere in this issue, FDA staffers involved in preparation of the Draft Risk Assessment explain their reasoning and cite the empirical evidence that led them to their conclusion (see p. 39). Even before publication of the result, however, some US organizations were already up in arms.

On October 12, 2006, the Center for Food Safety, a Washington, DC–based lobby group highly critical of all forms of biotech, filed a petition asking the FDA to treat food products from cloned animals and their offspring as “animal drugs,” mandating producers to prove their safety before putting them on the market. The petition also asks for the creation of an advisory committee by the Health and Human Services Department to address the ethical issues of animal cloning.

The complaint could be seen as just another attempt to hamper agricultural biotech—if not for the fact that this time the Center seems to have powerful allies. Also signing the petition were the Humane Society, the largest animal protection organization in the US, with nearly 10 million members, and the Consumer Federation of America (CFA), an alliance of organizations with total membership of more than 50 million, both based in Washington, DC.

Even more powerful are public opinion polls showing that substantial portions of the US public are uncomfortable with having products from animal clones on their plates. In fact, the International Food Information Council (IFIC), a Washington, DC–based nonprofit organization supported by the food, beverage and agricultural industries, recently concluded that consumers overall oppose animal cloning, including the use of cloned animals for breeding. An IFIC-commissioned poll published in November 2006 found that only 9% of respondents would “very likely” buy products from cloned animals if the FDA had deemed them safe; almost 60% would not touch them regardless, compared to 40% if the question was about genetically engineered animals.

Numbers like these make it easy to understand why some industries have been less than enthusiastic about green lights for cloned animal breeders. “Within the EU dairy industry there are serious concerns that this development may harm the healthy, nature-based image of dairy products,” says Joop Kleibeuker, secretary general of the European Dairy Association (EDA, Brussels). For that reason, he says, EDA can understand the cautious stance taken by the Washington, DC–based International Dairy Foods Association and main US dairy product producers quite well.

According to Carol Tucker Foreman, a former assistant secretary for food and consumer services at the US Department of Agriculture who is now director of food policy at the CFA, the issue boils down to this: “The FDA didn’t hear a substantial majority of the population say that safety is really not the right question.” But the more important questions are moral and ethical, and about the consumer’s right to know, she points out. “It is naïve to believe that people will set aside these objections just because a government agency says it is safe. FDA in effect is telling the American public: if a scientist can cook it up, then you have to eat it. I don’t think the public will buy it.”

What happens next in the US will be watched closely from across the Atlantic, where Europe is waiting to see if history will repeat itself. In the 1990s, European governments had to adjust to consumers who thought laws had been too embracing of genetically modified crops. This time, with US consumers more critical and even some industry leaders skeptical, some think Europe may dodge the bullet.

A few weeks ago, on December 18, the directorate general for health and consumer protection of the European Commission received recommendations based on a multiyear project called “Cloning in Public.” The report, based on a long series of studies and meetings, outlines the regulatory dilemma facing the EU once the US has made its final move.

According to Peter Sandøe, a professor of bioethics at the Royal Veterinary and Agricultural University in Copenhagen, who led the project, Europe can either stay put or start building cloning regulation sensitive to ethical concerns now, the right course depending heavily on whether cloning will really take off.

If agricultural animal cloning turns out to be mostly hype, as many in the European breeding industry suspect, Europe’s current collection of national and union-wide legislation will mostly suffice, Sandøe says. If US animal breeders prove their European colleagues wrong, however, and large stocks of superior farm animals start to spread, a replay of the 1990s could begin. The EU would be unable to legally block imports of animal clones, pressure from lobby and consumer groups would grow and retailers would end up demanding clone-free milk from suppliers, putting a damper on any attempt by European industry to keep up with the rest of the world.

The alternative route doesn’t sound very attractive either. It involves agonizing internal debate to unite 25 member states behind ethics-based regulation that will be hard to enforce, with subsequent international trade wars about import barriers not based on science-based safety assessments. All that could turn out to be much ado about nothing if, in fact, animal cloning will not create an agricultural revolution after all.

“If large numbers of cloned animals will be used for animal production, then clearly European consumers will at the very least expect that products from those animals are labeled as such,” Sandøe says, summarizing the choice. However, if just a few clones will be used in animal breeding programs, the controversy may never materialize. “I don’t think people will care about eating the [second-or later-generation offspring] of clones,” he adds.

Faced with such a dilemma, it’s no surprise that the European Commission is holding on just for now. “EU legislation in place for animal breeding, novel foods and animal welfare [is] considered sufficient to cover any cloning-related issues that are likely to arise,” says Philip Tod, spokesperson for Markos Kyprianou, EU commissioner for health and consumer protection. He adds, “The Commission is continually monitoring the developments in cloning, as well as the international situation. The Commission will not hesitate to take the necessary steps if there is deemed to be a need for further scientific assessment or risk management, or a review of the legislation to reflect new developments.”

doi:10.1038/nbt0107-7

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