Written by Ana Martinez Juan
Cloning animals means creating animals by using the genetic material from a cell from another animal. It is a form of asexual reproduction performed in a laboratory. The closest natural analogy to a clone is identical twins. As identical twins, clones and cell donor animals share exactly the same genetic information (DNA). Cloning does not involve any genetic modification. In fact, the clone is a near exact genetic copy of the donor animal. Currently, cloning is used for research purposes in the EU.
At present food from clones is regulated and subject to a European Union (EU) authorisation under the Regulation (EC) No 258/97 on Novel Food. According to this regulation, food products from cloned animals have been subject to a pre-market authorisation. Member States report that no cloning is taking place on their territory for food production, so no application has been submitted so far and therefore no authorisation granted.
The Commission adopted a proposal for a new Regulation on novel foods in January 2008 streamlining the approval process of the 1997 Novel Food Regulation. Inter-institutional discussions started in 2009. The European Parliament (EP) adopted amendments on first reading (legislative resolution of 25 March 2009) and on second reading (legislative resolution of 7 July 2010) following the Council’s position at first reading on 15 March 2010. To help to find a balanced solution the Commission adopted an opinion on the EP’s amendments to the Council’s position on 11 October and a report on animal cloning for food production on 19 October 2010. However no agreement could be reached and the conciliation committee failed in March 2011.
Subsequently, the Commission included in its work programme for 2012 new legislative initiatives on cloning which were outlined in its relevant roadmap . As a result of the work programme, the Commission adopted two proposals for directives on cloning of animals on 18 December 2013.
The draft directive on cloning of animals aims to ban temporarily the use of the cloning technique on EU farmed animals (bovine, porcine, ovine, caprine and equine) and the placing on the market of live animal clones and embryo clones. The draft directive on the placing on the market of food from animal clones aims to ban the imports into the EU of food such as meat or milk from animal clones. Cloning will be allowed for purposes such as research, conservation of rare breeds and endangered species or for use in the production of pharmaceuticals and medical devices, where the technique can be justified.
International aspects are also involved. The proposals were notified under the Technical Barriers to Trade Agreement of the Wold Trade Organisation (WTO) and were sent to the Sanitary and Phytosanitary Standards Committee of the WTO for information. Regarding current negotiations on the Transatlantic Trade and Investment Partnership , Members have expressed caution with regard to several sensitive issues, for instance differing perceptions towards Genetically Modified Organisms and cloning and with regard to safety standards, invoked in the EU’s precautionary principle .
The legislative procedures are on-going in the EP. It can be estimated that the draft legislation will enter into force in 2016 at the earliest.
When speaking of cloning of animals some concerns emerge: ethical principles, the conditions such that animals’ health and welfare are guaranteed, the respect of the genetic diversity and the negative perception that EU citizens have of the cloning technique used for food production. This EPRS keysource aims at showing publications on these concerns, views of the new proposals for directives and analysis on cloned animals.
Overviews
The Commission’s press release , MEMO and citizens’ summary (published on 18 and 19 December 2013), explain the key points of the proposals for directives.
The Foreign Agricultural Service of the United States Mission to the European Union also provides an overview of the new Commission’s proposals on its webpage animal cloning .
Regarding the topic of cloning of animals, the European Food Safety Authority (EFSA) devotes a webpage on FAQ on cloning . EFSA’s role in the area of food and feed safety is to carry out risk assessment and provide objective scientific advice to support such decisions.
In the same way, national food safety authorities, ministries and scientific institutes provide information and FAQs on cloning of animals. For instance:
The Roslin Institute (where Dolly the sheep was created ) devotes a webpage on FAQs of cloning .
The Food Safety Authority of Ireland: FAQs animal cloning . Last reviewed 1 November 2012.
The Food Standard Agency of the UK: Cloned animals .
Institut National de la Recherche Agronomique (INRA, France): Questions sur les aliments issues des animaux clonés (April 2007) and Bovins de garde (January 2013)
Centre d’analyse stratégique (France): Le clonage animal (La note d’analyse n° 225, May 2011. 12 p. )
Ministère de l’agriculture, de l’agroalimentaire et de la forêt (France): FAQ Clonage animal à des fins alimentaires .
Some overviews about several aspects of the cloning:
The regulatory challenge of animal cloning for food: the risks of risk regulation in the European Union / Maria Weimer. EJRR 1, 2010. 9 p.
In this article the author describes and analyses the regulatory developments at EU level concerning the marketing of foods produced from cloned animals. As they are on the verge of commercialisation in countries outside the EU, especially in the United States, foods from cloned animals are likely to reach the European consumers in the foreseeable future. By considering the discussion on animal cloning in the broader context of EU’s regulation of genetically modified organisms and of nanotechnology, the author identifies the legal and political problems of current regulatory options.
Agro-biotechnology: cloning farm animals a killer application?: risks and consequences of the introduction of cloned animals for food production / Christoph Then and Ruth Tippe; a Testbiotech report prepared for Martin Häusling, MEP. Biotech, May 2010. 48 p.
This report identified several levels that are affected by cloning animals for food production and that will need specific regulation: animal welfare, transparency and traceability, farm production, food production, food safety and food market.
Farm animal cloning: the current legislative framework: a review describing the existing law, and its practical application within and beyond the EU / Christian Gamborg, Jennifer Gunning & Mette Hartlev. Danish Centre for Bioethics and Risk Assessment, 2005. 38 p.
This report reviews the state of the existing legislative framework and the actual practice of animal biotechnology regulation within and outside the European Union (EU). Unless stated otherwise, “farm animal cloning” refers in the report to the cloning of farm animal species such as cattle, sheep and pigs by somatic cell nuclear transfer (as opposed to embryo splitting) ‘Applications of this may be pursued in biomedicine as well as agriculture.
Analysis
Cloning of animals / Laura Zandersone. European Parliament, Ex-Ante Impact Assessment Unit, 2014. 8 p.
This note seeks to provide an initial analysis of the strengths and weaknesses of the European Commission’s Impact Assessment accompanying the two proposals for directives, adopted on 18 December 2013.
Impact assessment accompanying the proposals for directives of 18 December 2013 ( SWD(2013) 519 final) . Impact assessment Executive summary . Impact assessment board opinion .
Animal welfare
Cloning: remains a concern for animal welfare . Eurogroup for Animals, 6 February 2013. 16 p.
In this brochure, Eurogroup for Animals explains its concerns about the cloning of animals and expresses its opposition to the cloning of animals.
Welfare of genetically modified and cloned animals used for food / a report by Dr R. D. Kirkden and Professor D. M. Broom. Compassion in World Farming, 2012. 142 p.
Compassion in World Farming has commissioned this report to objectively explain and discuss current knowledge regarding welfare implications for animals, in particular dams and their offspring during cloning and genetic modification. Farm animals are sentient beings with the ability to express positive and negative emotions, such as happiness and fear. The impact on welfare of any emerging technology must therefore be considered. This report summarises recent experiments and current techniques, and addresses welfare issues such as survival rates and any associated abnormalities produced by cloning and genetic modification.
Farm animal cloning: a Compassion in World Farming report 2010 . Compassion in World Farming, 2010. 56 p.
This report examines the consequences of cloning for farm animal welfare, highlights key advice on the issue from scientific and ethical advisory bodies and makes recommendations regarding the future of farm animal cloning.
Cloning techniques and scientific knowledge
A review of potential analytical approaches for detecting cloned animals and their offspring in the food chain / Susan Pang. Government UK Chemist Programme 1 May 2011 – 31 May 2012, 2012, 34 p.
This report provides an overview of the process of animal cloning and reviews the current scientific knowledge pertaining to genetic anomalies and biomarkers that may be characteristic of cloned animals. Such biomarkers, may be applied for detecting food products derived from cloned animals and their offspring in the food chain.
Animal cloning and transgenesis / Louis-Marie Houdebine, in OECD, Challenges for Agricultural Research , OECD 2011. 28 p.
Two techniques, cloning and transgenesis, offer new possibilities to improve the exploitation of farm animal genomes. Cloning is a way to generate genitors having the same genome as that of their genetic parents. This allows the prolonged use of genitors having a high value genome validated by the properties of their offspring born after sexual reproduction. Transgenesis is a way to introduce known new traits into genitors in only one generation. This implies foreign gene addition to a genome or specific inactivation of endogenous genes. Cloning and transgenesis are thus opposite but complementary techniques.
Ethics
Ethical aspects of animal cloning for food supply / European Group on Ethics in Science and New Technologies, January 2008. 56 p.
The European Group on Ethics in Science and New Technologies (EGE) expressed doubts that animal cloning for food production purposes can be justified considering the current level of suffering and health problems of surrogate dams and animal clones. The EGE does not see convincing arguments to justify the production of food from clones and their offspring. If in the future food products derived from cloned animals were to be introduced to the European market, the EGE recommends that the requirements in the following topics: food safety, animal welfare and health, traceability and global trade. (See abstract on pages 4-6).
Avis sur la consommation de produits issus d’animaux clonés et de leur progéniture . Conseil National de l’Alimentation (France). Avis n° 62, Octobre 2008. 50 p.
This opinion provides information on ethics and moral concerns of cloning and on economic and politic questions on cloning.
The ethical aspects of animal cloning for food supply: proceedings of the round-table debate / European Group on Ethics in Science and New Technologies, September 2007. 132 p.
Issues discussed during the debate included the latest developments in animal cloning, ethical implications, animal welfare and health considerations, consumer perspectives, animal breeding and food market, labelling and international trade.
Ethics, Morality and Animal Biotechnology / Roger Straughan. Biotechnology and Biological Sciences Research Council, 2007. 28 p.
This article discusses the following issues: current developments in animal biotechnology, moral and ethical concerns, animal ethics and intrinsic and extrinsic concerns about animal biotechnology.
Impacts (economic, supply chain and trade, traceability)
Contribution to the economic impact assessment of policy options to regulate animal cloning for food production with an economic simulation model / Koen Dillen… (et al.). Joint Research Centre, 2013. 54 p.
In the context of the impact assessment of the new Directives proposal, the JRC was requested to simulate via a modelling exercise the economic impacts of selected policy options that could result in de facto trade disruptions. This study presents a first attempt to quantify the likely effects of different policy measures for animal cloning for food production on the international trade and the EU domestic markets particularly on production and prices.
Impact in the EU and third countries of EU measures on animal cloning for food production / ICF GHK. Directorate General Health and Consumers, December 2012. 160 p.
In this report you will find information on the cloning of livestock animals (health, safety, environmental aspects, economy) the supply chain and trade, traceability systems for food products and for clones, approach appraisals on traceability, labeling and environmental impacts.
An economic analysis of the impact of cloning on dairy herd composition / Leslie J. Butler and Marianne McGarry Wolf. Presentation to 13th ICABR Conference (International Conference on Applied Business Research), Ravello Italy, June 18-20, 2009. 20 p.
This paper provides information on reproductive technologies, the cost of cloning and consumer’s perceptions and attitudes.
International aspects (WTO, Trade and Transatlantic Trade and Investment Partnership)
ENVI Relevant Legislative Areas of the EU-US Trade and Investment Partnership Negotiations (TTIP) / European Parliament, Policy Department A Economic and Scientific Policy, November 2014. 96 p.
This study, prepared by Policy Department A, aims to support Members of the Committee on Environment, Public Health and Food Safety in monitoring on-going negotiations for a Transatlantic Trade and Investment Partnership. It analyses the main differences between EU and US legislation in eight areas, namely: human medicines and medical devices, cosmetics, food and nutrition, sanitary and phyto-sanitary, nanomaterials, cloning, raw materials and energy, and motor vehicles. (See pages 58-62)
Animal cloning for food supply EU regulation in the shadow of the WTO / Maria Weimer. Bundesinstitut fur Risikobewertung. June 2014. 14 p.
This PowerPoint presentation provides useful and essential information on the new proposals for directives (global trade context, consultations, opinions, legal basis and WTO aspects).
European Institutions and other bodies
European Food Safety Authority
EFSA provides scientific advice in order to evaluate the impact of the animal cloning on food safety, animal health and welfare and the environment. EFSA adopted several scientific opinions and statements.
The first scientific opinion was adopted on 15 July 2008: Food Safety, Animal Health and Welfare and Environmental Impact of Animals derived from Cloning by Somatic Cell Nucleus Transfer (SCNT) and their Offspring and Products Obtained from those Animals . EFSA identified animal health and welfare as the main concern arising from animal cloning by cell nucleus transfer (SCNT) technique. EFSA also stated that there are meaningful animal health and welfare troubles for surrogate mothers and clones, than can be more prevalent and serious for conventionally bred animals. To the contrary, EFSA was unable to identify any risk respecting food safety and the environment.
EFSA’s second statement was published on 23 June 2009: Further Advice on the Implications of Animal Cloning (SCNT) . Although this statement included new publications on SCNT, EFSA confirmed that the conclusions and recommendations of the 2008 opinion are still valid. This statement was updated on 17 September 2010: Update on the state of play of animal cloning . The Scientific Committee concluded that, based on a peer reviewed scientific literature available, the conclusions and recommendations of its scientific opinion and statement were still valid.
The latest EFSA’s statement was published on 5 July 2012: 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 . This statement was 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. EFSA concluded that no new information has become available “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”
European Parliament
European Parliament Resolution of 14 January 2014 on the food crisis, fraud in the food chain and the control thereof. 2013/2091(INI) .
European Parliament Resolution of 6 July 2011 ( P7_TA(2011)0327 ) on the Commission Work Programme 2012, requested a legislative proposal to prohibit food from clones, offspring and descendants. 2011/2627(RSP) .
European Parliament Resolution of 23 June 2011 on the CAP towards 2020: meeting the food, natural resources and territorial challenges of the future. 2011/2051(INI) .
European Parliament Resolution of 3 September 2008 on the cloning of animals for food supply. 2008/2598(RSP) .
The MEPs have addressed numerous written questions to the Commission on the cloning of animals .
European Union must protect consumers and animals and ban food from cloning / European Parliament Intergroup on the Welfare and Conservation of Animals. 6 February 2014. Position paper on the two proposals for directives.
Stakeholder views
NGO’s
Compassion in World Farming (UK) “believes the Commission’s proposals need to be supported by all European Governments and should also include a ban on the use of the offspring of clones, and on meat and milk from these animals. Failure to do this risks perpetuating the cruelty of animal cloning”.
Much awaited draft legislation on cloning: too weak to protect consumers and animals . Eurogroup for Animals, 18 December 2013. 2 p.
In this position paper, Eurogroup for Animals welcomes these long awaited proposals which call for a ban on cloning, however as the legislation stands, there are too many gaps which will allow cloning to continue unchecked against the wishes of Europe’s citizens and which will result in cloning physically taking place in the European Union.
COPA-COGECA reacts to EU commission ban on use of cloning for food production for five years . 18 December 2013. 1 p.
Position paper on cloning of animals for food production . Transatlantic Animal Welfare Council. 2012. 4 p.
Transatlantic Animal Welfare Council lists its concerns about cloned animals such as health and welfare of dams and health and welfare of cloned animals and analyses the EU vs USA debate on cloning of animals.
Consumers
EU consumers have little appetite for cloning: BEUC Position Paper / The European Consumer Organisation (BEUC), October 2014. 11 p.
The European Consumer Organisation considers the new Commission’s proposals fall short of EU consumers’ expectations. Whereas the vast majority of Europeans have little appetite for food produced with the use of cloning and would overwhelmingly want food from the offspring of clones to be labelled (83%), the Commission proposals merely suggest a (temporary) ban on the cloning of animals for food supply and on the sale of food from clones in the EU. They do not say a word about food from cloned animals’ offspring and descendants.
Food and the Transatlantic Trade & Investment Partnership (TTIP): BEUC position / BEUC, May 2014. 13 p.
Regarding animal cloned BEUC calls on the negotiation partners to guarantee consumers the right to be informed about and choose the food they eat through compulsory labelling of food containing GMOs and of food from cloned animals and their offspring.
Food from cloned animals: consumers left in the dark: press release / BEUC, December 2013. 1 p. Version in French .
BEUC representatives say the new proposals are unfortunately a near duplicate of previous efforts which failed three years ago.
Resolution on the approach to food and nutrition related issues in the Transatlantic Trade and Investment Partnership / Transatlantic Consumer Dialogue, October 2013. 8 p. P
age 5, Food products from cloned animals.
TACD revised Resolution on food products from cloned animals / Transatlantic Consumer Dialogue, November 2008. 5 p.
The Transatlantic Consumer Dialogue mentioned the following concerns: food safety, animal welfare, ethical considerations and consumers right to know.
Europeans’ attitudes towards animal cloning: analytical report. Flash Eurobarometer 238 / conducted by the Gallup Organization, upon the request of Directorate General Health and Consumers. Directorate General Communication, October 2008. 105 p. Summary of the report (17 p.)
Some findings. A large majority of EU citizens (81%) said they knew the term animal cloning, and answered correctly that “cloning is making an identical copy of an existing animal” (80%). Faced with several statements regarding the ethics of animal cloning, the vast majority of EU citizens agreed that: the long-term effects of animal cloning on nature were unknown (84%), animal cloning might lead to human cloning (77%), animal cloning was morally wrong (61%) and cloning might decrease the genetic diversity within livestock populations (63%). Eight out of 10 EU citizens (83%) said that special labelling should be required if food products from the offspring of cloned animals become available in the shops.
Biotechnology. Special Eurobarometer 341 / conducted by TNS Opinion & Social on request of European Commission; survey co-ordinated by Directorate General Research, October 2010. 385 p. The report is also available in French and German . Chapter 2.3 Awareness of animal cloning (pages 52-73).
Europeans and Biotechnology in 2010: winds of change? / George Gaskell… (et al.). European Commission Directorate-General for Research, 2010. 176 p.
See chapter 3.2 Animal cloning for food production (pages 41-46). In addition there are several figures about cloning in the report. For instance: Figure 15: Awareness of animal cloning for food production, EU27 (page 42); Figure 16: Perceptions of animal cloning for food products as beneficial, safe, inequitable and unnatural, EU27 (excluding DKs) (page 43); Figure 25: Principles of governance for animal cloning (DKs excluded) (page 73); Table 6: Segmentation of the European public on principles of governance for animal cloning, EU27 (DKs excluded) (page 71).
Case studies and surveys
Public and private preferences for animal cloning policies / Kathleen R. Brooks and Jayson L. Lusk. Journal of Agricultural and Resource Economics 37(3), 2012. 17 p.
Data on individuals’ private shopping choices are often used to draw conclusions about their desires for food policies. The purpose of this paper is to test this often-implicit assumption using data from a nationwide survey about animal cloning. We find that although individuals’ private choices indicate a strong desire to avoid meat and milk from cloned cattle, public choices predict that only 40.29% have a positive WTP for such a ban. The results suggest caution is necessary when inferring public preferences from private choices.
The prospects for acceptance of animal cloning in the European food chain: early insights from an Irish Sentinel Group / Cathal Murphy… (et al.). AgBioForum, 14(2), 2011. 11 p.
The present study canvassed the opinions of expert stakeholders within the Irish arena. Respondents surveyed did not identify animal cloning as an impending food priority issue, and there was little evidence of in-depth awareness regarding the advanced developmental stage of this technology.
Third countries
According to the Commission’s impact assessment and based on the responses received to tue questionnaire on cloning activities, cloning for food production takes place in USA, Canada, Argentina, Brazil and Australia. In Canada the situation on cloning is similar to that in the Union, i.e. food produced from food is considered novel and requires pre-market approval. In the other countries, clones, their progeny and reproductive material are subject to the same regulation as conventional animals regarding the food safety, animal health and welfare. Clones are registered by private companies (USA, Canada and Brazil) but Argentina and Australia report that clones are not registered. The positions of third countries are summarised in Annex III, Paragraph 2 of the impact assessment.
Argentina
Argentina Biotechnology Annual Report / United States Department of Agriculture, Foreign Agricultural Service, September 2014 2013. 27 p. See chapter 2: Animal Biotechnology (pages 22-27).
Argentina was the first country in Latin America to develop two generations of genetically modified cows capable of producing Human Growth Hormone. The cloned (but also transgenic) calves, Pampa Mansa II, Pampa Mansa III and Pampero, developed by the Biosidus Company, carry a gene that produces human growth hormone in milk. The milk produced by just one cow can meet the demand of the entire country.
Australia
Australia Agricultural Biotechnology Annual / United States Department of Agriculture, Foreign Agricultural Service, September 2014. 27 p. See chapter 2: Animal Biotechnology (pages 24-27).
In Australia, the cloning of livestock is currently restricted to small numbers of elite breeding stock, predicted to be less than 100 beef and dairy cattle and a few sheep within a confined research environment. The work is being carried out by public and private research institutions and universities.
Brazil
Brazil – Agricultural Biotechnology Report / United States Department of Agriculture, Foreign Agricultural Service, November 2014. 18 p. See chapter 2: Animal Biotechnology (pages 14-18).
Brazil has a well developed research system for cloned animals under the national coordination EMBRAPA. Cloning research started in the late 1990s in Brazil, mostly focused on cattle.
Canada
Does Internet use affect public perceptions of technologies in livestock production? / Anahita Hosseini Matin, Ellen Goddard. Agricultural and Applied Economics Association Joint Symposium: Social Networks, Social Media and the Economics of Food, May 2014. 33 p.
Novel technology applications such as cloning and genetic modification in livestock production have not been widely supported by the public. In this study the relationships between attitudes towards animals, internet use and potential uses of genomics (and vaccination) in beef and pork are examined.
A comparative analysis of consumers’ WTP for milk and meat from cloned animals in Canada / Anahita Hosseini Matin … (et al.). Poster prepared for presentation at the Agricultural & Applied Economics Association’s 2012 AAEA Annual Meeting. 2 p.
USA
The U.S. Food and Drug Administration (FDA): Animal cloning and Consumer FAQs .
Animal Biotechnology in the United States: the regulation of animal clones and genetically engineered animals / Larisa Rudenko, in OECD, Challenges for Agricultural Research , OECD 2011. 14 p.
The implementation of genetic engineering in animals is a rapidly developing field. In January 2009, the US FDA issued the final version of its Guidance on the Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs. This document clarifies the FDA’s statutory and regulatory authority, and provides recommendations to producers of GE animals to help them meet their obligations and responsibilities under the Federal Food, Drug, and Cosmetic Act.
The US FDA and animal cloning: risk and regulatory approach / Larisa Rudenko, John C. Matheson. Elsevier, Theriogenology 67, 2007. 9 p. This article is available on the website 2WAYS project.
The Food and Drug Administration’s Center for Veterinary Medicine issued a voluntary request to producers of livestock clones not to introduce food from clones or their progeny into commerce until the agency had assessed whether production of cattle, swine, sheep, or goats by somatic cell nuclear transfer posed any unique risks to the animal(s) involved in the process, humans, or other animals by consuming food from those animals, compared with any other assisted reproductive technology currently in use. The article describes the methodology used by the agency to analyse data and draw its conclusions, the plans the agency has proposed to manage any identified risks, and the risk communication approaches the agency has used.
Animal cloning and the FDA: the risk assessment paradigm under public scrutiny / Larisa Rudenko, John C. Matheson and Stephen F. Sundlof. Nature Biotechnology vol. 25, n° 1, 2007. 5 p.
This article shows that the evidence gathered thus far (ultimately to be published in the Draft Risk Assessment on Animal Cloning) indicates that there are no unique risks associated with animal cloning.
Related legislative procedure(s)
1) Proposal on the cloning of animals of the bovine, porcine, ovine, caprine and equine species kept and reproduced for farming purposes ( COM(2013) 892 final ). (Legislative Observatory, procedure file: 2013/0433(COD) – ordinary legislative procedure);
2) Proposal on the placing on the market of food from animal clones ( COM(2013) 893 final ). (Legislative Observatory, procedure file: 2013/0434(APP) – consent procedure).
