EFSA's final scientific opinion on the implications of animal cloning on food safety, animal health and welfare and the environment, adopted on 15 July, concludes that "for cattle and pigs, food safety concerns are considered unlikely," but acknowledges that the scientific committee's work was challenging due to the lack of data on the subject.
The opinion only concerns risk assessments on clones of cattle and pigs and their offspring, as assessment for other animals is not possible based on current knowledge, according to the committee.
"The committee wants to strongly highlight the issue of uncertainties characterising this risk assessment," said Vittorio Silano, the chair of the EFSA Scientific Committee, when presenting the opinion on 24 July. These uncertainties arise from the limited number of studies available, the small sample sizes investigated and the absence of a uniform data approach to allow consideration of all relevant issues, he added.
Therefore, Silano said, the opinion should be updated and reconsidered in the light of new data and developments in cloning.
The opinion puts a lot of emphasis on animal health and welfare. The committee notes that "significant animal health and welfare issues" exist for cloned animals compared to conventionally bread ones.
Interestingly, an EU Directive on the protection of animals kept for farming purposes states that "natural or artificial breeding or breeding procedures which cause or are likely to cause suffering or injury to any of the animals concerned must not be practiced".
"The reality is that everyone involved understands that healthy food comes from healthy animals," said John Collins, a member of EFSA's scientific committee, commenting on the opinion.
The committee recommends, among other issues, further investigation into the "susceptibility of clones and their offspring to diseases and transmissible agents when reared and kept under conventional husbandry conditions".
As for the environmental impact, the committee said none is foreseen, underlining that there is not enough data available on this aspect either. Regarding biodiversity, the opinion notes that "cloning does not appear to have a direct effect on genetic diversity in that no new genetic modifications are introduced, but there could be an indirect effect due to overuse of a limited number of animals in breeding programmes".
Asked how much consideration the United States Food and Drug Administration (FDA) gave to animal health and welfare before giving a positive opinion on the market authorisation of food products from clone offspring in early 2008, Silano said the FDA was not really looking into animal welfare aspects as that is not part of its mandate.
He also added that the EU and US regulatory systems are quite different regarding the animal welfare aspects of the food sector and acknowledged that this could lead to differences in their approach to hazard management.
