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Update on the state of play of Animal Health and Welfare and Environmental Impact of Animals derived from SCNT Cloning and their Offspring, and Food Safety of Products Obtained from those Animals

EFSA Journal 2012;10(7):2794 [42 pp.]. doi:10.2903/j.efsa.2012.2794
European Food Safety Authority Acknowledgment EFSA wishes to thank the members of the Working Group on cloning: Henrik Callesen, Andras Dinnyes, David B. Morton, Heiner Niemann, Jean-Paul Renard, and Vittorio Silano for the preparatory work on this scientific output; the EFSA staff: Reinhilde Schoonjans, Daniela Maurici and Per Have for the support provided to this scientific output; and the Scientific Committee members: Boris Antunovic, Susan Barlow, Andrew Chesson, Albert Flynn, Anthony Hardy, Michael-John Jeger, Ada Knaap, Harry Kuiper, David Lovell, Birgit Nørrung, Iona Pratt, Alicja Mortensen, Josef Schlatter, Vittorio Silano, Frans Smulders and Philippe Vannier for their comments. Contact scientific.committee@efsa.europa.eu
Type: Statement of EFSA On request from: European Commission Question number: EFSA-Q-2011-01270 Approved: 25 June 2012 Published: 05 July 2012 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

The European Food Safety Authority (EFSA) received in December 2011, a request from the European Commission for an update on the possible scientific developments for cloning of farmed animals for food production purposes. The present Statement follows the EFSA 2009 and 2010 Statements and the EFSA 2008 Scientific Opinion, and is based on peer reviewed scientific literature published since the EFSA 2010 Statement, information made available to EFSA following a call for data, and discussions with experts in the field of animal cloning. As reported before, Somatic Cell Nuclear Transfer (SCNT) can produce healthy clones, but a portion of the animal clones suffered from developmental abnormalities likely due to epigenetic dysregulation (incomplete nuclear programming) and died at various stages of development. For some of the live animal clones, in particular calves and piglets, health and welfare were compromised specifically within the perinatal and juvenile period. Also some of the surrogate dams were affected due to abnormal pregnancies. Food products from healthy clones, i.e. meat or milk, did not differ from products from healthy conventionally bred animals. The offspring of clones and their food products showed no differences with conventional offspring or products. Data on clones of farmed species for food production other than cattle and pigs have remained limited and do not allow for the assessment of food safety or animal health and welfare aspects. The cloning efficiency, defined as the number of live offspring as a proportion of the number of transferred embryos, remained about 6-15 % for cattle and about 6 % for pigs. When compared with in vitro fertilisation (IVF), for which the background percentage of live offspring per transferred embryo is 45-60%, the efficiency of cattle SCNT relative to IVF is 13-25%. To overcome the relatively low cloning efficiency researchers continue to amend cloning procedures, with limited improvements shown by some researchers.

© European Food Safety Authority, 2012

Summary

The European Food Safety Authority (EFSA) received in December 2011, a request from the European Commission for an update of the possible scientific developments of cloning of farmed animals for food production purposes.

The present Statement follows the EFSA 2009 and 2010 Statements and the EFSA 2008 Scientific Opinion, and is based on peer reviewed scientific literature published since the EFSA 2010 Statement, information made available to EFSA following a call for data, and discussions with experts in the field of animal cloning.

Cloning by Somatic Cell Nuclear Transfer (SCNT) in cattle and pigs has produced healthy clones and healthy offspring that are similar to their conventional counterparts based on parameters such as physiological characteristics, behaviour and clinical status. With respect to food safety, there were no indication that differences exist for products (i.e. meat and milk) of healthy clones and their offspring compared with those from healthy conventionally bred animals. Data on clones of farmed species for food production other than cattle and pigs have remained limited and do not allow for the assessment of food safety or animal health and welfare aspects.

Health and welfare were compromised in a proportion of clones, mainly observed as increased mortality within the postnatal and juvenile period of calve and piglet clones, as well as in a proportion of the surrogate dams that were affected by abnormal pregnancies. For cattle and pig clones, epigenetic dysregulation remained the main source of anomalies throughout development. The majority of reports published over the last 2 years covers research to try to overcome this dysregulation. So far, no major breakthroughs have been reported on improved overall cloning procedures that would result in an increase of the SCNT cloning efficiency calculated as the number of live offspring as a proportion of the number of transferred embryos. This efficiency is still in the range of 6-15% for cattle and of 6% for pigs, albeit occasionally higher success rates were reported. If the comparator for cattle cloning is in vitro fertilisation (IVF), the background (i.e. the percentage of live offspring per transferred embryo from IVF) is 45-60% and the efficiency of SCNT when compared to IVF can be calculated as 13-25%.

No new elements have emerged that would change the previous EFSA Opinion on the possible environmental impact of cloning: i.e. cloning in itself of farmed animals poses no particular threats for genetic diversity or biodiversity; and from the limited data available there are no indications that would suggest new or additional environmental risks from farmed animal clones when compared to conventionally bred farmed animals. There is also no information available to suggest that such risk may exist.

No new information has become available since the EFSA 2009 and 2010 Statements and the EFSA 2008 Scientific Opinion that would lead, at this point in time, to a reconsideration of the conclusions and recommendations related to the food safety, animal health and welfare aspects, and environmental aspects of animal cloning of the 2008 Scientific Opinion and the 2009 and 2010 Statements of EFSA.

Keywords

Somatic Cell Nuclear Transfer (SCNT), Embryonic Cell Nuclear Transfer (ECNT), Food Safety, Animal Health and Welfare, Risk Assessment, Efficiency, Cattle, Pig, Cloned Animal