In the U.S. the Food and Drug Administration have released a document stating that meat and milk from cloned adult animals and their offspring is safe for human consumption, as reported in Nature. Egenis researcher Dr Matt Reed comments on international differences in regulatory regimes.
Ten years after the world was introduced to Dolly, the U.S. Food and Drug Administration (FDA,) released a nearly 700 page document, stating simply that meat and milk from cloned adult animals and their offspring is safe for human consumption and virtually indistinguishable from traditionally reproduced animals. The FDA is seeking public comment on its assessment over the coming months. It may publish a final decision by the end of the year.
Farmers in the UK announced the birth of a calf whose genetic mother is the clone of an American prizewinning dairy cow. The calf, Dundee Paradise, was born after farmers imported frozen embryos from the clone and implanted them into surrogates last year. The cloned animal was created as a genetic copy of a pedigree Holstein dairy cow called Vandyk K Integ Paradise, which has twice won the World Dairy Expo, a US cattle-showing competition.
“This has exposed an immediate lack of regulation in the UK” said Dr Reed “DEFRA were not ready for this. People have anticipated that this would happen but never expected it to happen so quickly because of the cost of creating the clone. It is reminiscent of when the first GM crops were produced. There was then an absence of regulation….. the regulators were not ready but the pressure groups and NGOs were ready.”
“The difference between the approach taken in the US and Europe highlights the cultural differences in the regulatory systems” said Matt. “The situation in the USA is more industry lead than in Europe where the precautionary principle tends to be employed: in Europe the EU starts by viewing it as a problem whereas in the US regulators tend to announce that the science says it’s safe, and challenge the public to show that it’s not via the consultation process.”
The birth of Dundee Paradise forced the EU to look at how they might regulate the issue. The UK’s Food Standards Agency have classified meat and milk from cloned animals as novel foods, which must pass stringent safety tests before they can be marketed. But the regulations do not address the issue of milk and meat from the progeny of cloned animals.
Dr Reed explained: “Will the offspring of a cloned animal will be considered a cloned animal. Will they be subject to the same regulations? Cloned animals will present enormous challenges to regulators”
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