- remains a concern for animal welfare Cloning - remains a concern for animal welfare Intergroup for the welfare and conservation of animals Kirsty Reid – 6 February 2013

What is cloning Cloning is a form of reproduction to make a genetically identical animal without the normal sexual reproductive process. Dolly the sheep, born in 1996, was the first cloned mammal, created by scientists at the Roslin Institute, near Edinburgh. Scientists have now cloned cats, sheep, cows, pigs, mice, goats and horses. Courtesy of RSPCA

Eurogroup Position Eurogroup is opposed to the cloning of animals and urges the EU to introduce: An immediate ban on the cloning of animals for food production A ban on the import and sale of animal clones, their offspring and food products from animal clones and their offspring A ban on the import and sale of semen and embryos from animal clones

Problems with Cloning The cloning process is inefficient, wastes animals’ lives and has a huge potential to cause pain, suffering and distress at all stages of the process: Invasive techniques Suffering of the surrogate dams High levels of ill health and mortality in the early stages of life Invasive reproduction techniques Once a cloned embryo has been produced, it is implanted into a surrogate mother who carries out the pregnancy. In pigs the transfer of the embryo into the surrogate mother is performed by a surgical procedure. In cattle embryo transfer is sufficiently stressful that UK legislation requires a general or epidural anaesthetic. Suffering of surrogate dams Large offspring syndrome is common in cloned calves and lambs. Cloned calves are often 25% heavier than normal which leads to painful births for the surrogate mothers and to most deliveries being performed by caesarean section. Mortality during pregnancy A substantial proportion of clones die during pregnancy or are stillborn. A 2007 study reported that 25% of cows pregnant with cloned embryos at day 120 of gestation develop hydroallantois (malfunction of uterus or placenta) and their pregnancies have to be terminated. Inefficiency and wastage of life Cloning is a wasteful process. Cloning is estimated to use four surrogate mothers for every clone born alive. A 2004 paper reported that only 13% of cloned calf embryos transferred to recipient cows results in calves delivered at full term. A more recent paper refers to the process as “inefficient and highly prone to epigenetic errors”. Post-natal mortality of cloned animals Many clones die in the early stages of life. The EGE Opinion states that around 20% of calves do not survive the first 24 hours after birth, and an additional 15% die before weaning. The high rates of mortality and ill health are due to a range of factors including: • Immune deficiencies – clones often die of infections soon after birth • Respiratory problems • Cardiovascular failure • Liver failure • Kidney abnormalities • Musculoskeletal abnormalities. Photo courtesy of CIWF

Problems with Cloning Farm animals are already seen by some as commodities rather than sentient beings. The routine use of cloning would greatly reduce genetic diversity within livestock populations The development of animal clones for food production is being pursued without public awareness Genetic selection aims to increase productivity with insufficient attention to their welfare. More productive animals are also those with the highest welfare problems.   Routine use of cloning technologies in animal farming would make farmers dependent on patented technologies owned by big companies, compromising food sovereignty. Farm animals are already seen by some as commodities rather than sentient beings. Cloning would compound this view, leading to less concern for animal welfare and less willingness to address welfare issues. The routine use of cloning would greatly reduce genetic diversity within livestock populations, increasing the chances of whole herds being wiped out by disease to which they would all be equally susceptible. The development of animal clones for food production is being pursued without public awareness and in spite of well-documented public concerns relating to the use of biotechnology in food Genetic selection of farm animals has aimed to increase productivity with insufficient attention to their welfare. As a consequence, the more productive animals are also those with the highest welfare problems. They are the ones destined to be used for cloning, exacerbating the welfare problems which already exist.   Routine use of cloning technologies in animal farming would make farmers dependent on patented technologies owned by big companies, compromising food sovereignty.

Legislative position The Protocol for the protection and welfare of animals: ‘pay full respect to the welfare requirements of animals’ Council Directive 98/58 concerning the protection of animals kept for farming purposes: Natural or artificial breeding or breeding procedures must not be practised. The Protocol for the protection and welfare of animals, annexed to the EC Treaty, recognises animals as sentient beings and requires Community and Member States , when formulating and implementing agriculture policies to ‘pay full respect to the welfare requirements of animals’ Council Directive 98/58 concerning the protection of animals kept for farming purposes: 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 practised. No animal shall be kept for farming purposes unless it can reasonably be expected, on the basis of its genotype or phenotype, that it can be kept without detrimental effect on its health or welfare.

European Food Safety Authority EFSA report providing advice on the implications of animal cloning on food safety, animal health and welfare and the environment - 15th July 2008 (and further reports in 2009, 2010, 2012). The EFSA opinion acknowledges the many animal health and welfare concerns associated with the cloning of animals for food production, here are a few: An increase in failed pregnancies and increased frequency of problems during pregnancy. Mortality and morbidity of clones are higher than in sexually produced animals. A proportion of clones that do survive until birth show some adverse physiological effects which can be temporary and or contribute to death or disorders. The EFSA opinion acknowledges the many animal health and welfare concerns associated with the cloning of animals for food production, here are a few: An increase in failed pregnancies and increased frequency of problems during pregnancy (hydrops (malfunction of uterus or placenta), dystocia (difficult birth) and consequential Caesarean section) are observed which are likely to affect the future fertility of the surrogate dam. Mortality and morbidity of clones are higher than in sexually produced animals. A proportion of clones that do survive until birth show some adverse physiological effects which can be temporary and or contribute to death or disorders. The causes of death and pathological conditions in cloned animals may be attributable to developmental defects or to other causes including infections.

European Group on Ethics in Science and New Technologies Published a report on the 17 January 2008 on the ethical issues around the subject of cloning EGE comments supporting Eurogroup’s position "Considering the current level of suffering and health problems of surrogate dams and animal clones, the EGE has doubts as to whether cloning animals for food supply is ethically justified.” "At present, the EGE does not see convincing arguments to justify the production of food from clones”

Public concerns The Commission Eurobarometer survey on cloning - 9th October 2008. Some interesting facts: A majority (58%) of EU citizens were not willing to accept animal cloning for food production. Three quarters agreed that there are ethical grounds for rejecting animal cloning As many as 69% agreed that animal cloning would risk treating animals as commodities A majority said it was unlikely that they would buy meat or milk from cloned animals even if a trusted source stated that such products were safe to eat. The result of a Special Eurobarometer in 2010 (341) again indicated opposition to cloning for food: A majority (67%) of Europeans feel uneasy about animal cloning. A majority (63%) disagree that animal cloning in food production is safe for their health and that of their family. A large majority (70%) disagree that animal cloning in food production should be encouraged.

Commission Report on Cloning October 2010 Novel food dossier (2008) Proposal foresaw to include animals cloned for food. However they were against the inclusion of offspring. Commission Report on Cloning October 2010 Report on cloning on possible avenues to legislate on cloning for food production. The document recognised the option of banning products from cloned animals, but advised against banning those from the offspring of cloned animals as it did not consider it feasible to trace the origin of these products. It supported a 5 year moratorium on cloning. 2 proposals December 2013

Commission proposals  On the 18 December 2013, the European Commission adopted two proposals: the cloning of animals of the bovine, porcine, ovine, caprine and equine species kept and reproduced for farming purposes (COM(2013)892) on the placing on the market of food from animal clones (COM(2013)893)   The proposals foresee to provisionally prohibit the cloning of animals and also the placing on the market of the animal clones or embryo clones and provisional prohibitions whereby member states shall ensure that food from animal clones is not placed on the market. Concerns: Cloning technique may continue for other purposes (Pharmaceuticals etc) Offspring not included Commission does not foresee any expenses for themselves, which would mean no proposed guidance development (for penalties for e.g.), inspections, monitoring? Problems can be expected with lack of harmonisation across the Member States

European Parliament Resolution (2008) Against the cloning of animals for food Novel Foods Dossier (2008) Ban on animal cloning in the EU for food production and for production of reproductive material for food production, Regulation as regards electronic identification of bovine animals and deleting the provisions on voluntary beef labelling (2013) MEPs want to ensure that beef derived from cloned animals or their descendants is labelled as such within 6 months of entry into force of the Regulation. Motion for a Resolution from December 2013

European Parliament Motion for a Resolution from December 2013 Calls on a Commission Proposal that must contain at the very least the provisions: (i) a ban on animal cloning in the EU for food production and for production of reproductive material for food production, (ii) a ban on food from cloned animals whatever their origin, (iii) a ban on any supply of clones in the EU for food production, (iv) traceability measures for semen and embryos from cloned animals and for the live offspring of cloned animals, and (v) as of 6 months after the entry into force of the future Regulation, the introduction of labelling requirements for fresh meat of the offspring from cloned cattle and, as of 2 years after entry into force of the Regulation and without prejudice to a Commission report on feasibility, for all other foods from the offspring of cloned animals.

Council Novel foods dossier (2008): The Council prefers to keep food products from cloned animals in the novel food regulation, and called for products from offspring to be included Regulation as regards electronic identification of bovine animals and deleting the provisions on voluntary beef labelling (2013) : EP position ‘fiercely’ rejected by Council (and Commission)

Trade The EU has the ability to trace animals and their products (semen and embryos) from within the EU and third countries. Council Directive 88/407/EEC lays down the animal health requirements applicable to trade in and imports of semen, outlining conditions for approval of semen collection and storage centres, Regulation (EC) No 178/2002 includes the general principles and requirements of traceability of animals, required at all stages of production, processing and distribution. High costs associated with the production of animal clones. It is certain that animal clones will not be used for meat production, but as a source for semen and embryos. It is possible for the EU to revise this legislation to take into account cloned animals and their products to ensure they are controlled correctly and do not enter the EU market and food chain. The EU has the ability to trace animals and their products (semen and embryos) from within the EU and third countries. Council Directive 88/407/EEC lays down the animal health requirements applicable to trade in and imports of semen, outlining conditions for approval of semen collection and storage centres, which may be adapted to include indication whether from clones or their offspring. Regulation (EC) No 178/2002 includes the general principles and requirements of traceability of animals, required at all stages of production, processing and distribution. High costs associated with the production of animal clones. It is therefore certain that they will not be used for meat production, but as a source for semen and embryos. Thus consequently, farms buying these semen and embryos will be fully aware of where they come from making traceability fully feasible. In the EU, farmers are required to follow EU rules related to this for cattle.