ANIMAL CLONING AND GENETIC MODIFICATION: A
PROSPECTIVE STUDY
Report 2 to
Institute for Prospective Technological Studies (IPTS)
Seville
September 2005
Cloned animals
Socio-economic issues
Ann Bruce1
Renate Gertz2
Cecilia Oram3
Jonathan Suk1
Joyce Tait1
Chris Warkup3
Bruce Whitelaw4
1
Innogen (ESRC Centre for Social and Economic Research on Innovation in Genomics),
University of Edinburgh, High School Yards, Edinburgh, Scotland
2
AHRC Centre for Studies in Intellectual Property and Technology Law, University of
Edinburgh, Old College, Edinburgh, Scotland
3
Genesis Faraday Partnership, Roslin BioCentre, Roslin, Midlothian, Scotland
4
Roslin Institute, Roslin, Midlothian, Scotland
Acknowledgements
We would like to thank our colleagues in the Specific Support Action “Farm Animal
Cloning and the Public” for their help with this project and the participants of a twoday workshop held in Seville in June 2005, co-organised by the IPTS and the above
mentioned SSA. We would also like to thank the participants of the one day hearing
held at Innogen as part of this project. A special thanks to Eileen Mothersole for the
secretarial expertise she provided.
Table of Contents
Executive Summary .................................................................................................. 1
SECTION 1 INTRODUCTION ................................................................................... 3
1.1 Introduction...................................................................................................... 3
SECTION 2 OVERVIEW OF THE LEGAL FRAMEWORK......................................... 4
2.1 Definitions used ............................................................................................... 4
2.1.1 Cartagena Protocol ................................................................................... 4
2.1.2 EU ............................................................................................................ 4
2.1.3 Canada ..................................................................................................... 5
2.2 The regulation of animal cloning in the EU ...................................................... 5
2.2.1 Directive 86/609 on animals used for experiments .................................... 5
2.2.2 Regulation 258/97 on novel foods............................................................. 6
2.2.3 Food Safety Legislation ............................................................................ 6
2.2.4 Animal Breeding Legislation ..................................................................... 7
2.2.5 The regulation of animal cloning in Europe ............................................... 8
2.2.6 The regulation of interspecies cloning ..................................................... 11
2.2.7 Summary ................................................................................................ 11
2.3 The regulation of animal cloning worldwide ................................................... 11
2.3.1 USA ........................................................................................................ 11
2.3.2 Canada ................................................................................................... 13
2.3.3 Australia ................................................................................................. 14
2.3.4 New Zealand .......................................................................................... 15
2.3.5 China ...................................................................................................... 15
2.3.6 Korea ...................................................................................................... 16
2.3.7 Japan...................................................................................................... 16
2.3.8 Singapore ............................................................................................... 16
2.3.9 Argentina ................................................................................................ 16
2.4 International regulation of animal cloning ....................................................... 16
2.5 Summary ....................................................................................................... 17
2.6 Patenting cloned animals............................................................................... 17
2.6.1 Europe .................................................................................................... 17
2.6.2 USA ........................................................................................................ 18
2.6.3 Canada ................................................................................................... 18
2.6.4 Australia ................................................................................................. 18
2.6.5 New Zealand .......................................................................................... 18
SECTION 3 – RISKS AND RISK ASSESSMENT .................................................... 20
3 Risks from cloned animals ................................................................................ 20
3.1 Introduction.................................................................................................... 20
3.2 Technical summary ....................................................................................... 20
3.3 Food safety issues......................................................................................... 20
3.4 Environmental risks from releases to the environment................................... 21
3.4.1 Likelihood ............................................................................................... 21
3.4.2 Consequence ......................................................................................... 21
3.5 Disease risk to current animals ...................................................................... 22
3.6 Risks of inbreeding ........................................................................................ 22
3.7 Risk assessment ........................................................................................... 23
3.7.1 Introduction ............................................................................................. 23
3.7.2 FDA’s Draft Risk Assessment on Animal Cloning ................................... 23
3.7.3 EU Regulatory Risk Assessment of Cloning ........................................... 26
3.8 Summary of risk assessment ......................................................................... 27
SECTION 4 INTERNATIONAL TRADE AND LABELLING ISSUES ........................ 28
4 International trade ............................................................................................ 28
4.1 Introduction.................................................................................................... 28
4.2 Labelling issues ............................................................................................. 28
4.2.1 Codex Alimentarius................................................................................. 28
4.2.2 The World Trade Organisation ................................................................ 29
4.2.3 National labelling regulations .................................................................. 30
4.2.4 Traceability ............................................................................................. 31
4.2.5 Summary of labelling issues ................................................................... 32
4.3 Summary of trade issues ............................................................................... 32
SECTION 5 ANIMAL WELFARE ............................................................................. 33
5 Welfare of cloned animals ................................................................................ 33
5.1 Introduction.................................................................................................... 33
5.1.1 General properties of cloned animals...................................................... 33
5.1.2 Physiological issues................................................................................ 35
5.1.3 Health issues .......................................................................................... 35
5.1.4 Behavioural issues.................................................................................. 35
5.1.5 Summary ................................................................................................ 35
5.2 Regulation on animal welfare ........................................................................ 36
5.2.1 Europe .................................................................................................... 36
5.2.2 USA ........................................................................................................ 37
5.2.3 Canada ................................................................................................... 38
5.2.4 Australia ................................................................................................. 39
5.2.5 New Zealand .......................................................................................... 39
5.2.6 Summary of welfare legislation ............................................................... 39
SECTION 6 PUBLIC ATTITUDES ........................................................................... 40
6.1 Introduction.................................................................................................... 40
6.2 European attitudes to cloning animals ........................................................... 40
6.3 Ethical discussions around animal cloning ..................................................... 41
SECTION 7 EU POLICY CONTEXTS ..................................................................... 43
7.1 Ethical policy ................................................................................................. 43
7.2 Research funding policy ................................................................................ 43
7.3 Agricultural context ........................................................................................ 43
SECTION 8 CASE STUDIES .................................................................................. 45
8 Case Studies .................................................................................................... 45
8.1 CASE STUDY ONE: Cloning to produce pigmeat, beef and milk ................... 46
8.1.1 Aim ......................................................................................................... 46
8.1.2 Markets................................................................................................... 46
8.1.3 Technical aspects ................................................................................... 46
8.1.4 Drivers .................................................................................................... 46
8.1.5 Regulation .............................................................................................. 47
8.1.6 Special issues......................................................................................... 47
8.1.7 Public attitudes ....................................................................................... 48
8.1.8 EU competitiveness ................................................................................ 48
8.1.9 Alternative approaches ........................................................................... 48
8.2 CASE STUDY TWO: Cloned pets ................................................................. 51
8.2.1 Aim ......................................................................................................... 51
8.2.2 Markets................................................................................................... 51
8.2.3 Technical aspects ................................................................................... 51
8.2.4 Drivers .................................................................................................... 51
8.2.5 Regulation .............................................................................................. 51
8.2.6 Special issues......................................................................................... 51
8.2.7 Public attitudes ....................................................................................... 51
8.2.8 EU Competitiveness ............................................................................... 51
8.2.9 Alternative approaches ........................................................................... 51
8.3 CASE STUDY THREE: Cloning endangered species of animals ................... 53
8.3.1 Aim ......................................................................................................... 53
8.3.2 Markets................................................................................................... 53
8.3.3 Technical aspects ................................................................................... 53
8.3.4 Drivers .................................................................................................... 53
8.3.5 Regulation .............................................................................................. 53
8.3.6 Special issues......................................................................................... 53
8.3.7 Public attitudes ....................................................................................... 53
8.3.8 EU Competitiveness ............................................................................... 53
8.3.9 Alternative approaches ........................................................................... 53
SECTION 9 REFLECTIONS ................................................................................... 55
9.1 Conclusions ................................................................................................... 55
SECTION 10 REFERENCES .................................................................................. 57
SECTION 11 APPENDICES ................................................................................... 59
Appendix 1 Acronyms.......................................................................................... 59
Table of Figures
Figure 1 Roadmap demonstrating the drivers encouraging availability of meat and
milk from cloned animals in the EU .................................................................. 49
Figure 2 Roadmap demonstrating the drivers discouraging availability of meat and
milk from cloned animals in the EU .................................................................. 50
Figure 3 Roadmap demonstrating the drivers for cloned pets.................................. 52
Figure 4 Roadmap demonstrating the drivers for cloned endangered species ........ 54
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Executive Summary
Somatic Cell Nuclear Transfer (cloning) technology is being applied to animals in a
variety of commercial contexts including:

Agricultural use for food production

Pets and sports animals

Endangered species
The first mammalian species cloned using nuclear transfer was sheep, in 1996.
Cloned animals already on sale somewhere in the world include cloned pet cats,
cloned horses and at least one rodeo bull. Individuals from some endangered
species have also been cloned e.g. mouflon, banteng and African wildcat and cloning
technology has been applied to restoring endangered breeds of cattle. Cloned
livestock (especially pigs and cattle) are expected to be used within the food chain
somewhere in the world before 2010 in the estimation of the commercial companies
themselves. It is likely that, within this timescale, it would not be economic for cloned
animals to be used directly for food or milk production, but that clones would be used
as parents of slaughter pigs, beef cattle and possibly also milk-producing dairy cows.
This report considers only cloned animals, animals which are both cloned and GM
are considered in Report 3.
Food production
Cloned animals for the food sector are being developed primarily in USA,
Australia/New Zealand and Asia. We are not aware of any company developing this
technology for use in the food chain in the EU.
Possible applications of cloning to food production include:

Cloned elite boars of very high genetic merit for widespread use in pig meat
production using Artificial Insemination. Cloned sires would be the parents or
grandparents of slaughter pigs. A small advantage in economic performance
could be realised over a very large number of animals.

Identification of extremely high merit beef animals for carcase quality traits at
slaughter and clone male cattle from the cells of these carcases for use to breed
the next generation.

Cloned high-value dairy bulls (possibly as ‘insurance’ against death of the original
animal or for use as a method of exporting animals)

Cloned dairy cows of high merit. This would allow management of the whole herd
to be tailored to a particular genotype.
European and international regulation of cloned animals and their offspring and
products appear to be unclear. There is some uncertainty as to whether cloned
animals fit the legal definitions of GM organisms and hence whether GM legislation
applies to cloned animals. In the EU, the other main relevant regulatory regimes
relating to food safety are Food Safety Regulation and Novel Foods Regulation. Of
the EU member states, Denmark is alone in legislating specifically on cloned animals
and has done so very recently. In the Netherlands, animal biotechnology is regulated
in such a way that the regulation covers both experimental and commercial use of
cloned (and GM) animals.
Novel Foods Regulation is likely to require case-by-case risk assessment. Analyses
to date have detected no differences between meat and milk from cloned and noncloned animals. There is currently no scientific method to distinguishing meat and
milk from cloned and non-cloned animals (or their progeny) There appears little
prospect for developing such a test as there is no obvious basis for it. Any labelling
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requirement would therefore require traceability regimes. These may be enforceable
in small, niche markets but may be difficult to enforce in international commodity
markets.
There is currently no established regulatory system for international trade in cloned
animals, their progeny and products and there is currently no guidance from Codex
Alimentarius. There would therefore appear to be the potential for development of
trade disputes. Recommendations from the US Food and Drugs Administration are
likely to be influential. These recommendations have been expected imminently for
some time.
Pets
Commercial services for cloning cats are available in the USA. Similar services exist
for various sports animals in the USA and there is company offering a commercial
service to clone horses in France. Dogs have been cloned on an experimental basis
in Korea. The total number of cloned pets or sports animals world-wide is currently
very small. Cloning is used to replace animals which die or to allow castrated animals
to reproduce and it is difficult to evaluate what the likely uptake of this technology will
be.
European legislation covers the welfare of cloned pets and companion animals but
there is no specific legislation relating to cloning per se or the importation of cloned
animals. Some horse racing bodies have banned the use of cloning.
Endangered species
Commercial companies offering a service of cloning endangered species exist in
USA, Brazil and France. Cloning to preserve endangered species offers a chance to
regain genes lost through the death of an animal but will not increase the amount of
genetic diversity and does not address other issues such as loss of habitat. Its use
may be limited to niche applications.
Welfare and ethics
Welfare of cloned animals and the ethics of cloning are likely to be controversial.
Many cloned animals display a range of physiological disorders (collectively known
as Large Offspring Syndrome) which in some cases can have a severe impact on
welfare. Some claim that these welfare problems have been overcome but others
remain sceptical. Data to resolve this issue is not currently available. In general,
experimental applications of cloning are clearly regulated in the EU and agricultural
applications are subject to Farm Animal Welfare Regulation. However, standards for
clear assessment of animal welfare are not well developed so there is some
uncertainty as to how the welfare regulation might affect the use of cloned farm
animals
Attitudes of the European public to cloned animals appear to be more negative than
positive, however, there is little data available to understand what underlies this
attitude and how stable the attitude is with respect to different applications and
circumstances.
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SECTION 1 INTRODUCTION
1.1 Introduction
The purpose of this report is to identify potential socio-economic impacts (benefits
and risks) and new policy implications arising from the development of animal
Somatic Cell Nuclear Transfer (SCNT) cloning and of the commercialisation of
products from SCNT, for the EU. Furthermore, the aim is to compare regulatory
frameworks and visions world-wide.
SCNT cloning is being developed for a number of different applications such as
production of meat and milk for human consumption, cloning pets and sports animals
and cloning endangered species or breeds. A full description of the applications of
cloning are given in Report 1. Cloning may also be used as an experimental tool to
understand fundamental biology, but this application was excluded from our remit.
Cloning is frequently used in conjunction with genetic modification and these
applications are considered separately in Report 3. Ethical questions and public
concerns are only briefly considered in the report as they are the subject of a larger
EC Specific Support Action on “Farm Animal Cloning and the Public”. Within this
report the term ‘cloning’ should be understood to mean SCNT cloning unless
otherwise stated and the term ‘animal’ should be understood to refer to non-human
animals only.
Issues raised by the development of genetically modified animals are covered
separately in Report 3.
This report is in 11 sections:

Section 1 is an introduction

Section 2 gives an overview of the regulatory framework with specific emphasis
on the EU

Section 3 considers the risks from cloning and the risk assessment methods
adopted by regulatory bodies

Section 4 considers issues around international trade in clones and the products
from clones and labelling

Section 5 considers the issues around physiological animal welfare

Section 6 considers public attitudes

Section 7 considers the policy contexts and visions around cloning

Section 8 considers three Case Studies of applications of cloning

Section 9 Reflections

Section 10 References

Section 11 Appendices
This study was conducted in March-September 2005. The scientific aspects were
investigated by staff at Roslin Institute, the commercialisation activities by staff at
Genesis Faraday Partnership, legal aspects by staff at the Centre for Studies in
Intellectual Property and Technology Law, the socio-economic aspects by staff at the
Innogen Centre. The methodology consisted primarily of literature and web surveys.
A one-day ‘hearing’ was held at Innogen on Sept. 5th to bring a number of different
types of expertise to bear on the subject, including experts in innovation processes.
Additionally, useful interchange of information took place with the Specific Support
Action “Farm Animal Cloning and the Public” including a two-day workshop held in
Seville in June 2005, co-organised by the IPTS and the above mentioned SSA.
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SECTION 2 OVERVIEW OF THE LEGAL FRAMEWORK
2.1 Definitions used
Several of the regulatory and legal systems governing biotechnology explicitly deal
with GMOs (genetically modified organisms) or LMOs (living modified organisms). In
most cases, these definitions are ambiguous with regards to whether or not cloned
animals would be included.
2.1.1 Cartagena Protocol
For example, in the Cartagena Protocol’s definitions:
g) "Living modified organism" means any living organism that possesses
a novel combination of genetic material obtained through the use of
modern biotechnology;
(h) "Living organism" means any biological entity capable of transferring
or replicating genetic material, including sterile organisms, viruses and
viroids;
(i) "Modern biotechnology" means the application of:
a. In vitro nucleic acid techniques, including recombinant
deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells
or organelles, or
b. Fusion of cells beyond the taxonomic family, that overcome natural
physiological reproductive or recombination barriers and that are not
techniques used in traditional breeding and selection;1
In this instance, it would appear that SCNT and other cloning techniques would not
yield ‘living modified organisms’ since it is unlikely that a clone can be deemed to
possess a ‘novel combination of genetic material’ (unless mitochondria are so
defined) or to be a fusion of cells beyond the taxonomic family. This is despite the
fact that cloning techniques could be deemed to fall within the Protocol’s definition of
‘modern biotechnology’.
2.1.2 EU
Concerning the EU, in Directive 2001/18/EC, the definition given for GMO is:
‘genetically
modified organism (GMO) means an organism, with the
exception of human beings, in which the genetic material has been
altered in a way that does not occur naturally by mating and/or natural
recombination’
Within the terms of this definition:

genetic modification occurs at least through the use of the techniques listed in
Annex I A, part 1;

the techniques listed in Annex I A, part 2, are not considered to result in genetic
modification2
Annex I A, part 1, describes an inter alia list which includes ‘2) techniques involving
the direct introduction into an organism of heritable material prepared outside the
organism including micro-injection, macro-injection and micro-encapsulation.’ This
creates some ambiguity with regards to cloning, since SCNT might be said to fit
1 http://www.biodiv.org/biosafety/articles.asp?lg=0&a=bsp-03
2 Directive
2001/18/EC
4
(visited August 10, 2005)
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within this range of techniques. However, in order to include cloning, Annex IA, part
1,1) would need to be neglected, since it includes ‘recombinant nucleic acid
techniques involving the formation of new combinations of genetic material…and
their incorporation into a host organism in which they do not naturally occur…’. Here,
cloning would not seem to fit. Also an enucleated egg as used in cloning is unlikely to
be considered an organism. Still, the classification of cloned animals as genetically
modified has its proponents and remains in doubt.
2.1.3 Canada
Perhaps the clearest definition for regulatory purposes comes from Canada, where
Health Canada and/or Environment Canada, sometimes with the Canadian Food
Inspection Agency (depending on end use), initiate risk analyses following requests
made by notifiers to release biotechnology-derived animals. By using the term
biotechnology-derived, Canada has developed a system that covers both cloned and
GM animals, since this term includes both these as well as additional ones such as
chimeric animals and interspecies hybrids.3
2.2 The regulation of animal cloning in the EU
Animal cloning, i.e. the reproduction of genetically identical “copies” of an animal
through Somatic Cell Nuclear Transfer (SCNT) technology and its possible range of
applications has not yet been regulated as such at an EU level. As noted above,
there is considerable doubt as to whether animal clones would be considered
genetically modified organisms, under the relevant EU Directives and hence GM
regulation is unlikely to apply to cloned animals. There are however, a number of
regulations relating to use of animals for experiments, animal breeding regulation and
regulation of novel foods which might apply to cloned animals.
2.2.1 Directive 86/609 on animals used for experiments
If animal cloning is still in its experimental stage, it falls under the directive regulating
the use of animals for experimentation, Directive 86/609/EC, amended by Directive
2002/65/EC of the European Parliament and of the Council of 23 September 2002,
concerning the distance marketing of consumer financial services, which includes
guidelines for the accommodation and care of animals in its technical annexes.
Directive 86/609/EC applies to the use of animals for the development, manufacture
and quality, effectiveness and safety testing of drugs, foodstuffs and other
substances or products. It also regulates the protection of the natural environment in
the interests of humans or animals. Regarding the care and accommodation of
animals, Member States must ensure that all animals are provided with hygienic
living conditions; any restriction on the animal's normal behaviour is limited to the
absolute minimum; the physical conditions in which animals are kept are checked;
the well-being of the animal is observed by a competent person to prevent any
suffering and that any unnecessary suffering is eliminated as soon as possible. If an
animal is subjected to an experiment in which it will, or may, experience pain which is
likely to be prolonged, that experiment must be specifically declared and justified to,
or specifically authorised by, a national authority. Experiments must only take place if
there is no alternative method that does not entail the use of animals.
In addition, for European funded research there are also specific guidelines. Decision
No 182/1999/EC of the European Parliament and of the Council of 22 December
1998 concerning the Fifth Framework Programme of the European Community for
research, technological development and demonstration activities (1998 to 2002):
3
Moreau & Jordan (2005)
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“Modification of the genetic heritage of animals and animal cloning will be
envisaged within the current framework programme only for objectives
which are justified on ethical grounds and to the extent that the
operations involved are effected on an ethical basis, with respect for the
well-being of animals and the principles of genetic diversity.”
2.2.2 Regulation 258/97 on novel foods
The main piece of European legislation that may apply to cloning animals for food
production is Regulation (EC) No 258/97 on novel foods and novel food ingredients.
The primary intention for establishing the Novel Food Regulation is to protect the
functioning of the internal market within the Community and to protect public health.4
The purpose of this Regulation is to guarantee the safety of food consumption and
provide information to consumers. Regulation 258/97 does not consider
environmental aspects, but leaves those for other legislation to deal with. Novel foods
are defined as foods and food ingredients that were not used for human consumption
to a significant degree within the Community before 15 May 1997. Further, six
categories were established for novel foods and food ingredients to fall under:

Containing or consisting of genetically modified organisms (GMOs) within the
meaning of Directive 90/220/EEC, or

Produced from, but not containing, GMOs, or

With a new or intentionally modified primary molecular structure, or

Consisting of, or isolated from, micro-organisms, fungi or algae, or

Consisting of, or isolated from plants, or food ingredients isolated from animals,
except for foods and food ingredients obtained by traditional propagating or
breeding practices, and having a history of safe use, or

To which a production process not currently used has been applied, where that
process gives rise to significant changes in the composition or structure of the
food or food ingredient, which affects its nutritional value, metabolic effect or level
of undesirable substances. 5
Food derived from cloned animals could fall under the fifth category, as cloned
animals can be defined as not having been obtained through traditional breeding
practices. Accordingly, to be placed on the market, food derived from cloned animals
would need to fulfil three basic criteria: it must not present a danger to the consumer,
mislead the consumer or differ from foods or food ingredients that it is intended to
replace to an extent that its normal consumption would be nutritionally
disadvantageous for the consumer.6 There is, however, some lack of clarity as to
whether meat and milk (i.e. foods) derived from cloned animals will be covered by the
regulation, since the regulation only refers to ‘food ingredients’. It is also very unlikely
that meat and milk from the progeny of clones would fall under this legislation.
2.2.3 Food Safety Legislation
The Commission's guiding principle is an integrated approach called from farm to
fork which covers all sectors of the food chain, beginning with the feed production
and continuing with primary production, food processing, storage, transport and retail
sale. In January 2000, the Commission adopted a White Paper on food safety. While
4
Recital 2, Regulation (EC) No 258/97
5
Article 1 (2), Novel Food Regulation
6
Article 3 (1) Novel Food Regulation
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the principles of food safety and consumer protection are established through
national legislation in all Member States and many third countries, the European
Parliament and the Council adopted Regulation (EC)178/2002 which establishes the
General Principles and requirements of Food Law as well as the European Food
Safety Authority (EFSA), which is the body responsible for risk assessment regarding
food and feed safety, providing independent scientific advice on existing and
emerging risks. Regulation (EC)178/2002 clearly distinguishes between risk
assessment and risk management, leaving risk management to the EU institutions.
Any food derived from cloned animals would have to be in accordance with
Community food safety legislation, however, there are no specific regulations
concerning cloned animals.
2.2.4 Animal Breeding Legislation
According to current legislation, there are no particular zootechnical rules on the
treatment of cloned breeding animals, also, no legislation exists regulating semen
and ova from the offspring of cloned cattle.
Accordingly, the general zootechnical legislation applies to both cloned animals and
the offspring of the same. This general legislation includes rules on the promotion of
free trade in breeding animals and their genetic material considering the
sustainability of breeding programs and preservation of genetic resources. The basic
aim of the legislation is free trade in breeding animals and their genetic material as
well as the legal right of entering a herd-book of the same breed. These aims are
reached by a harmonised recognition of breeding associations; by entering herdbooks; through pedigree certificates and performance testing and genetic evaluation.
Respective legislation exists for each type of breeding animal. Legislation for bovine
species can be found in Council Directive 77/504/EEC on pure-bred breeding
animals of the bovine species and amended by Council Directive 91/174/EEC and
Council Directive 94/28/EC, Commission Decision 84/247/EEC on Recognition of
breeding organisations, Commission Decision 84/419/EEC on Entering in herdbooks;
Commission Decision 2005/379/EC on Pedigree certificates; Commission Decision
86/130/EEC on Performance testing and genetic evaluation amended by
Commission Decision 94/515/EC; Council Decision 96/463/EC on INTERBULL and
Council Directive 87/328/EEC on Acceptance for breeding.
Legislation for porcine species, pure-bred and hybrid, can be found in Council
Directive 88/661/EEC on the zootechnical standards applicable to breeding animals
of the porcine species; Commission Decision 89/501/EEC and Commission Decision
89/504/EEC on Recognition of breeding organisations; Commission Decision
89/502/EEC and Commission Decision 89/505/EEC on Entering in herdbooks;
Commission Decision 89/503/EEC and Commission Decision 89/506/EEC on
Pedigree certificates; Commission Decision 89/507/EEC on Performance testing and
genetic evaluation and Council Directive 90/118/EEC and Council Directive
90/119/EEC on Acceptance for breeding.
Legislation for pure-bred sheep and goats can be found in Council Directive
89/361/EEC concerning pure-bred breeding sheep and goats; Commission Decision
90/254/EEC on Recognition of breeding organisations; Commission Decision
90/255/EEC amended by 2005/375/EC on Entering in herdbooks; Commission
Decision 90/258/EEC on Pedigree certificates; Commission Decision 90/256/EEC on
Performance testing and genetic evaluation and Commission Decision 90/257/EEC
on Acceptance for breeding.
Legislation for equidae can be found in Council Directive 90/427/EEC on the
zootechnical and genealogical conditions governing intra-Community trade in
equidae; Commission Decision 92/353/EEC on Recognition of breeding
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organisations; Commission Decision 92/354/EEC on Coordination between breeding
organisations; Commission Decision 96/78/EC on Entering in herdbooks;
Commission Decision 93/623/EEC on Identification documents (passports) and
Commission Decision 96/79/EC on Pedigree certificate for semen, ova, embryos.
It seems unlikely that any of this animal breeding legislation will have an impact on
cloned animals as there are no provisions prohibiting a specific type of breeding or
reproduction. The only problem which remains unanswered is the question whether
cloned animals can be entered into herdbooks. Focussing solely on the necessity for
the animal to be purebred, a cloned animal could be entered into a herdbook, if the
parent animal, from which the nucleus was taken, is purebred. Since the animal into
which the embryo is implanted does not pass on its genetic material to the embryo,
the question whether this animal is purebred or not should have no effect.
The import from third countries is regulated by Council Directive 94/28/EC, while
pedigree certificates in this connection are regulated by Commission Decision
96/509/EC and Commission Decision 96/510/EC in combination with Council
Directives 90/675/EEC and 91/469/EEC laying down the principles governing the
organisation of veterinary checks on products entering the Community from third
countries.
A voluntary Code of Good Practice has also recently been agreed among European
farm animal breeders (www.code-efabar.org). The Code sets out the goals of animal
breeding organisations, the way in which these goals are pursued and the rules and
standards that govern the activities of breeders. The Code is intended to be both
transparent and verifiable so that it is both easy to understand and simple to apply.
The Code currently emphasises that neither SCNT cloning nor GM is currently
undertaken by European breeders, due to both technological problems and lack of
public appetite.
2.2.5 The regulation of animal cloning in Europe
If cloned animals are considered not to fall under GM legislation, no EU-wide
legislation with regard to cloning animals for commercial purposes is currently in
existence. Therefore, the regulatory frameworks of member states need to be taken
into consideration.
All member states apart from the Netherlands, Denmark, Norway and Germany have
similar legislation, i.e. animal cloning in its experimental stage is regulated through
animal experimentation laws, while animal cloning as an applied science remains
unregulated.
i. Germany
German legislation divides between animal cloning in its experimental stage and
animal cloning as a commercial undertaking. While two statutes exist regarding the
protection of animals, the Animal Breeding Statute (Tierzuchtgesetz) and the Animal
Protection Statute (Tierschutzgesetz), neither of them mentions cloning of animals in
particular. Para 7 I deals with animal experiments, however, the definition clearly
shows that only experiments involving living animals are considered. The
implantation of a cloned embryo, however, is not covered by this paragraph.
Paragraph 11 b deals with the breeding of animals that have been genetically
modified in any way, including those that have been cloned. However, paragraph 11
b only applies once the cloning of animals has exceeded the experimental stage.
This means that the legislation only comes into effect once animal cloning is applied
commercially. Animal cloning research is not regulated. Also, under current law, a
prohibition of animal cloning research would constitute a limitation of the liberty of
science and thus violate the German constitution.
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ii. Netherlands
While the Animal Experiments Act which came into force on 12 January 1977,
requires the permissibility for all animal experiments to be judged according to ethical
aspects, the Animal Health and Welfare Act from 1992 does not allow biotechnology
applications to animals to be carried out without a permission (licence). Thus all
research projects attempting animal cloning need to apply for a special permission to
the Minister of Agriculture, Nature Management and Fisheries. After discussing the
application with the Biotechnology Committee, the Minister will give or withhold the
permission. The Committee will only give a positive advice if the goal of the research
or applications are of substantial importance for society; if there are no alternatives to
reach the goal; and if the importance of the goal of the research or application
outweighs the possible damage to the health, welfare and integrity of the animals.
Since 1997, only one cloning permission has been granted (research aimed at
production of human collagen type II in milk from genetically modified cows).
iii. Italy
In 1997, the then Minister of Health signed an Ordinance in Italy, prohibiting “any
form of experimentation or intervention [ ] pursuing the objective of human or animal
cloning”. As a reason for issuing the Ordinance, the Ministry cites “the alarming [ ]
coverage of repeated episodes of animal cloning [ ] or of scientific declarations on the
possibility of extending this practice to the human species.” However, in January
2002, the Minister of Health prolonged the ban on human cloning, but lifted the
prohibition on cloning animals.
iv. Finland
No specific legislation regarding animal cloning exists in Finland. The only regulation
that applies to the cloning of animals is animal welfare legislation. Currently, there
are no plans to further regulate the area. In practice, however, any animal experiment
needs approval by either an ethics committee or by an agency (Lensstyrelsen),
depending on the nature and amount of possible harm.
v. Sweden
The situation in Sweden is very similar to the one in Finland. No specific legislation
for animal cloning exists; the only possible regulatory instruments to be applied are
statutes regulating animal welfare. Also, there are no plans to further regulate the
area. Approval for animal experiments needs to be obtained from an ethics
committee.
vi. United Kingdom
As in most other European countries, animal cloning has not been regulated
specifically, but falls under animal welfare legislation. Animals used in experiments
(including GM and cloned animals) are protected by the Animals (Scientific
Procedures) Act 1986 (A(SP)A). Experiments must be approved by the Home Office
and there must be a clear scientific reason to perform them.7 Approval is granted on
the basis of balancing of the potential benefits of the research and the suffering
inflicted upon the experimental animals.
vii. Denmark
Denmark and Norway are currently the only European countries contemplating or
having introduced legislation on animal cloning. At this moment, animal cloning has
not been specifically addressed by Danish legislation, but is covered by the Animal
Welfare Act and the Animal Testing Act. If genetic modification is also employed,
7
AEBC (2002) p.56.
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then the Gene Technology Act applies in addition. In a parliamentary motion in May
1997, political concerns with regard to animal cloning were expressed with the
Danish parliament requesting regulation on animal cloning from the Government.8
This request was answered favourably and the Government expressed its intention
to restrict animal cloning to research and that this research should not result in a fully
developed animal. Although it is unclear whether this governmental intention is
legally binding, researchers have respected it in practise.9 Consequently, research
on animal cloning has been performed, but up till now no cloned offspring has been
born.
The Government established a preparatory committee upon advice by the Parliament
in November 2002 to follow up on the motion of May 1997. This preparatory
committee issued a report in October 2003, making recommendations for regulating
animal cloning10 to the extent that cloning and genetic modification of animals must
meet the principle of proportionality. Accordingly, animal welfare issues and
increased risk of environmental damage need to be balanced against the advantages
of the technology. However, the committee did not support the use of animal cloning
to produce animals for food production.11
In February 2005, the Government issued a Bill on cloning and genetic modification
of animals.12 Section 1 of the bill states that cloning and genetic modification of
animals must only take place if it is considered to be of substantial benefit and only
with the purpose of performing basic research aimed at improving health and
environment, creation and breeding of animals producing substances essentially
benefiting health and environment, and teaching at institutions of higher education.
The Bill was recently passed by the Danish Parliament.
Also, a license from the Animal Experiments Inspectorate is required in each case.
Import and breeding of cloned or genetically modified animals for other purposes
than animal experiments (e.g. food production etc), however, is not covered by the
bill due to the EU-directive on deliberate release prohibiting restrictions on the import,
deliberate release and marketing of genetically modified organisms.13 The Directive
does not cover cloned animals that are not genetically modified, but for reasons of
legislative harmonisation, the Danish Government has proposed the inclusion of
cloned animals in the legislation.
viii. Norway
In May 2004 Norway amended its existing legislation on gene technology by adding
several provisions on animal cloning and thus became the first European country to
legislate animal cloning.14 The new section 11a of the Act prohibits cloning of
vertebrates and crustaceans through processes not occurring in nature, but allows an
exception for biological and medical research and other medical activities for the
8
Folketing Motion of 23rd May 1997
9
A parliamentary motion is normally considered to be binding for the government until the
next general election, whereas it is disputed whether it is binding after a general election
Ministeriet for Videnskab, Teknologi og Udvikling, “Genmodificerede og klonede dyr”, 2003.
There is an English summary in the report
10
The committee did not have a unanimous position on how to define an ”essential purpose”.
One member had a more restrictive position that the other committee members
11
12
Justitsministeriets lovforslag L 8 om kloning og genmodificering af dyr m.v.
13
Directive 2001/18/EC on the deliberate release into the environment of genetically modified
organisms and repealing Council Directive 90/220/EEC
14
Act No 22 of May 7 2004 amending Act No 38 of April 2 1993
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purpose of obtaining new medical treatments for humans and animals. Cloning of
primates, however, is prohibited without exemptions. Before applying the exemption,
a proportionality test must be applied, i.e. the possible benefits must be balanced
against the possible harm regarding animal integrity and welfare. Thus the
Norwegian law emphasises animal integrity as an independent value which exceeds
mere animal welfare issues.
ix. France
There is no national legislation regulating animal cloning in France. The only
procedure in place is an evaluation by the INRA ethical committee.
x. Spain
In Spain, no legislation regulating animal cloning exists. Rather, animal cloning is
regulated indirectly through the law on animal experimentation and the law
concerning transgenic animals. Permission for animal research is required from an
institutional ethics committee.
xi. Portugal
Animal cloning is not regulated at all in Portugal.
2.2.6 The regulation of interspecies cloning
Interspecies cloning can be defined as transferring cell nuclei of one species into
enucleated oocytes of another species, and then establishing pregnancy in a species
other than the nuclear donor. The first question which needs answering is whether
interspecies cloning fulfils the requirements of the definition for GM organisms and
thus allows the cloned animal to fall under the GM legislation.
Accordingly, the same legislation is likely to apply to cloned animals achieved
through interspecies cloning as to all other cloned animals.
2.2.7 Summary
Animal cloning is currently legislated as a process in Norway and in Denmark. In
most European countries, experimental use of cloned animals is regulated but
commercial use is not. The exception is the Netherlands where regulation of animal
biotechnology includes commercial applications and Germany where animal cloning
research is not regulated but commercial applications are. Any food products derived
from cloned animals are likely to fall under the Novel Foods Regulations. Application
of cloning to endangered species, pet animals or horses would only be regulated
whilst these remain an experimental procedure. Some horse racing bodies have
however banned the use of cloning in horse breeding whereas there are no
limitations in other areas, such as show-jumping.
2.3 The regulation of animal cloning worldwide
Having examined the regulation of animal cloning in Europe, the way in which other
countries have managed the issue will now be examined.
2.3.1 USA
In the United States of America, the general attitude towards biotechnology tends to
be more liberal than the European approach which uses the precautionary principle.
According to the Coordinated Framework for Regulation of Biotechnology Products,
the primary responsibility for regulating biotechnology is shared between three
agencies, the Food and Drugs Administration (FDA), The US Environmental
Protection Agency (EPA) and the US Department of Agriculture (USDA). Their
responsibilities are complementary, and in some cases overlapping. In addition, with
regard to the use of biotechnology products for food, the FDA has broad authority
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under the Federal Food, Drug and Cosmetic Act to regulate foods and food
ingredients produced in or imported into the USA.
One of the main differences between European and US legislation which needs to be
taken into account is the fact that in the USA products, not processes, are usually
regulated. Applied to animal cloning, this would mean that only legislation regarding
the finished product, i.e. the cloned animal, could be expected, not legislation
regulating the process, i.e. the cloning technique itself. As a result of this distinction,
if the animal were cloned for food uses, the cloned product would have to meet food
safety standards; if it was cloned to produce pharmaceuticals, the finished drug
products would have to meet drug standards, and finally if the cloned animal had a
tissue purpose, such as the source of heart of liver transplants for humans, the body
part in question would need to meet biologics regulation.
Just as in transgenic animals, the range of agencies within the US that can be
expected to take an interest in cloned animals includes:

The Animal and Plant Health Inspection Service (APHIS) of USDA which has
jurisdiction over livestock used in biomedical research, teaching, or testing, to
oversee compliance with the regulations for animal care and use promulgated by
APHIS under the Animal Welfare Act (9 CFR Parts 1–4).

The Office of Laboratory Animal Welfare of the National Institutes of Health (NIH)
which has responsibility for the general administration and coordination of the
Public Health Service Policy (1996) on the Humane Care and Use of Laboratory
Animals, including livestock and poultry used in biomedically-related research
activities.

The Center for Veterinary Medicine (CVM) in the Food and Drug Administration
(FDA) which has asserted primary jurisdiction over products of animal
biotechnology involving: (1) modifications that affect the performance of the
animal or attributes of products derived from the animal through the action of the
expression product of an inserted gene and (2) animals modified to produce
drugs, biologics, or other substances of commercial value. However, conditions
of use, but CVM’s jurisdiction is not exclusive.

The Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation
and Research (CBER) in FDA which also have jurisdiction over the products to
the extent they involve human drugs or biologics.

The Center for Veterinary Biologics in the USDA’s Animal and Plant Health
Inspection Service (APHIS) which has jurisdiction over products to the extent
they are modified to produce animal biologics.

The Center for Food Safety and Applied Nutrition (CFSAN) in FDA which has
jurisdiction over milk, eggs and other edible products (other than meat and
poultry products) to oversee compliance with limits on residues in the edible
tissue and ensure the general wholesomeness and safety of the food.

The Food Safety and Inspection Service (FSIS) in USDA which has jurisdiction
over meat and poultry derived from genetically modified animals to oversee
compliance with residue limits and ensure the general wholesomeness and
safety of the food.15
As regards the regulation of products related to animal cloning, the situation in the
US is currently not well defined. As the National Academy of Science report stated in
2002:
15
Vanderbergh et al.2002, 162
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“It is unclear whether any agency has jurisdiction to make market access
decisions or establish conditions of use for cloned animals. FDA has said
that it may have jurisdiction over human cloning through its new drug
authority and that it expects human cloning experiments to be covered by
investigational new drug applications (IND’s). CVM has not taken a public
position on its regulatory jurisdiction over animal cloning, but it is for now
constrained not to take a position that is different in principle from the
FDA position on human cloning. CFSAN and FSIS have jurisdiction to
oversee the general wholesomeness and safety of the edible tissue of a
cloned animal, just like any other animal.”16
In October 2003, the FDA published a draft risk assessment of animal cloning. The
assessment included issues of animal health and development as well as food safety
issues of products derived from cloned animals. The draft states that food products
derived from animal clones and their offspring are likely to be as safe to eat as food
from their animals bred through traditional methods. Furthermore, the results of the
study also showed that healthy adult clones were virtually indistinguishable from their
conventional counterparts. In 2004, the FDA stated that it was developing a
regulatory policy for cloned meat and milk, and in the meantime asked companies
not to market food from cloned animals. Companies have adhered to this voluntary
moratorium. The policy has not yet been published, at least in part, due to the fact
that the Acting Commissioner had not been officially nominated as Commissioner by
the Senate. This nomination finally took place on 18 July 2005, but the nominee
subsequently resigned on 23 September. To date, the final statement on the safety of
cloned meat and milk has not yet been released.
There were two legislative efforts to date to regulate the pet cloning sector, one on a
state and one of national level. In February 2005, the American Anti-Vivisection
Society (AAVS) asked the USDA to force cloning firms to register as research
facilities with the result that they would then have to adhere to the Animal Welfare
Act. The USDA, however, refused this request, referring to pet cloning companies,
and stated that such companies did not perform research as such but provided a
production service. Instead, the USDA announced that Genetic Savings & Clone, a
company cloning pet cats would require an exhibitor’s licence when displaying their
clones at animal shows. In California, Assembly member Lloyd E. Levine brought a
bill sponsored by Californians Against Pet Cloning to the California State Assembly to
prohibit pet cloning, but the Assembly Business and Professions Committee voted
against the bill in May 2005.
Since there are no laws specifically covering animal cloning, the issue is regulated
through the interpretation of laws which came into existence long before techniques
such as cloning were created. The United States uses health and safety laws written
prior to the advent of modern biotechnology to review genetically engineered
products. To date, the United States has not issued any new legislation for these
products.
2.3.2 Canada
In the absence of specific regulation, two types of legislation regulate animal cloning
in Canada, namely environmental legislation and food regulation.
The Canadian Environmental Protection Act, 1999 (CEPA), co-administered by the
federal ministries Environment Canada and Health Canada, allows the federal
government to address pollution issues. This includes substances ranging from
chemicals to living organisms that are the products of biotechnology. Thus CEPA
16
Vanderbergh et al. 2002, 162-3
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regulates new substances that are not regulated under other legislation specifically
listed in CEPA, Schedules 2 and 4. For example, CEPA currently applies to terrestrial
animals which are the product of biotechnology such as transgenic animals. CEPA
also applies to cloned animals. Accordingly, cloned animals using somatic cell
nuclear transfer technique (SCNT) can be considered as "new" under CEPA and
may require notification under the New Substances Notifications Regulations of
CEPA.17
The federal department responsible for regulating biotechnology-derived products
subject to the Food and Drugs Act is Health Canada. Foods derived from
biotechnology, which includes foods derived from cloned animals, are considered to
be novel foods and regulated under Division 28 of the Food and Drug Regulations
(Novel Foods Regulation) under the Food and Drugs Act. This Novel Foods
Regulation requires that notification be made to the Health Products and Food
Branch (HPFB) by the company that wants to sell the product prior to the marketing
or advertising of a novel food. Pre-market notification permits Health Canada to
conduct a thorough safety assessment of all biotechnology-derived foods to
demonstrate that a novel food is safe and nutritious before it is allowed in the
Canadian marketplace.18
Health Canada has an interim policy on foods derived from cloned animals. Until
more is known about the products of this technology, Health Canada will consider
foods produced from livestock developed using SCNT and the progeny of such
livestock to be captured under the definition of “novel food” in the Food and Drug
Regulations in that they have been obtained by a reproductive technology which has
not previously been applied to generate animals that would be used to manufacture
foods (meat, eggs, milk, etc.) and which may result in a major change in these foods.
They are therefore subject to the regulations in Division 28, Part B, of the Food and
Drug Regulations (Novel Foods). Developers producing cloned animals through
SCNT must, therefore, not sell the products or by-products of any cloned animals or
their progeny in the human food supply in Canada unless they have been subjected
to the pre-market safety assessment required of novel foods.
2.3.3 Australia
In Australia, animal biotechnology is regulated both on a federal and on a
state/territory level. On a federal level, the National Office of Gene Technology
Regulator (OGTR) implements the Gene Technology Act 2000 and the Gene
Technology Regulations 2001, which, however, expressly exclude animal cloning in
Reg. 4. Techniques not constituting gene technology:
“For paragraph (c) of the definition of gene technology in section 10 of the
Act, gene technology does not include somatic cell nuclear transfer if the
transfer does not involve genetically modified material.”
Currently no national regulation exists concerning the use of animals for scientific
purposes, including cloned animals. Animal Ethics Committees were established at
state/territory level to approve scientific procedures involving animals. However, the
Australian Government has a policy process in train to develop a government
position on the sale of non-GM cloned animals as food.19
17
Bourbonnière, 2004
18
Kochhar et al. 2005
19
Dr Ian Mackay, Director, Food Safety and Surveillance Section Australian Government
Department of Health and Ageing, personal communication
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Food Standard 1.5.2 foods produced using gene technology regulates the sale of
genetically modified foods in Australia and New Zealand and was incorporated into
the Food Standards Code on 13 May 1999 and in an amended form on 7 December
2000. According to the definition, Standard 1.5.2. covers food which has been
derived or developed from an organism which has been modified by gene
technology. Thus, food derived from cloned animals which have not been genetically
modified, is not covered under the provisions of the Australia New Zealand Food
Standards Code nor State and Territory Food or Health Acts.
2.3.4 New Zealand
Animal cloning is not expressly regulated in New Zealand. The Hazardous
Substances and New Organisms Act (HSNO) Act 1996 regulates new organisms in
New Zealand. Passed in June 1996, it brought a whole range of laws under one
piece of legislation. It represents a significant reform of environmental legislation in
that it gives consideration of the environment equal status in decision making with
other factors such as health or agriculture. It also provides explicitly for the regulation
of genetic modification. The Act, however, does not cover cloning or products derived
from clones. According to the Animal Welfare Act, animals used for experiments or
for the production of biological products should be carried out in accordance with an
approved Code of Ethical Conduct, and require approval from a local Animal Ethics
Committee.
In 2002 The New Zealand National Animal Ethics Advisory Committee (NAEAC)
permitted the Government’s biggest science company a licence in partnership with
an Australian company to clone livestock commercially in New Zealand.20 The
NAEAC is currently considering recommending modifications to existing legislation in
reference to the model of UK legislation.
The Food Standards Australia New Zealand is responsible for food safety
assessment in both New Zealand and Australia. GM animals are assessed through
the comparative ‘substantial equivalence’ approach. Whether this will also be
adopted remains unclear. The FSANZ website hints that cloning may be on the
agenda in the near future:
“We
also participated in an international specialist workshop on animal
cloning held in Europe that examined issues around the safety of food
from cloned animals. This is an issue on which we have undertaken
some preliminary work in order to establish the current state of research
on cloning in Australia and New Zealand. It is apparent that we may need
to address the regulatory issues associated with this technology sooner
than originally anticipated.”21
2.3.5 China
There is no specific legislation regarding animal cloning. On a governmental level,
the Ministry of Public Health published some relevant guidelines, however, without
any compulsory effect. According to latest news, animal cloning for medical research
etc is permitted.
20
Seamark, 2003
21
http://www.foodstandards.gov.au/mediareleasespublications/publications/annualreport/fsanza
nnualreport20032004/ourregulatorymeasures/fosteringinternation2762.cfm (site visited June
2, 2005)
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2.3.6 Korea
While South Korea was the fifth country worldwide to clone animals, no legislation
regarding animal cloning exists. While altogether twelve attempts to legislate on
bioethics were made between 1997 and March 2003, none succeeded. 22
2.3.7 Japan
In 1997, The Council for Science and Technology Policy of the Japanese
government published a report, “The Basic Plan on Life Science Research and
Development” which stated that cloning of farm animals should be promoted, as it did
not directly involve issues of human ethics. In 2000, the Science Academy of Japan
established a committee to assess cloning applications and issued a report on the
guidance regarding research on cloning with a commercial perspective. However, the
commercial application in breeding and food industry has not yet taken place.23
Currently, there are no legislation or governmental guidelines on animal cloning.
Recently, the Japanese Farm Ministry announced that beef and milk from cows
cloned from the cells of adult animals are safe, which might be a signal that Japan is
likely to lift a ban on their consumption in the near future. Similar conclusions have
been reached by the Ministry of Agriculture, Forestry and Fisheries and the Japanese
Health Ministry.24
2.3.8 Singapore
There is currently no legislation specifically governing animal cloning or patenting of
animal cloning (either procedures used or actual animals). There are several
guidelines in place with regards to research on and handling (which includes care
and use) of transgenic animals, issued by the Genetic Modification Advisory
Committee (GMAC) and the National Advisory Committee for Laboratory Animal
Research (NACLAR) respectively.25
2.3.9 Argentina
In Argentina, animal cloning has not been regulated, however, extensive legislation
exists for genetically modified organisms, such as 57/03. Norma para Proyectos de
Experimentación y/o Liberación al Medio de Organismos Animales Genéticamente
Modificados. (law concerning the experiments and release of genetically modified
animal organisms).
2.4 International regulation of animal cloning
The Cartagena Protocol on Biosafety was negotiated under the auspices of the
Convention on Biological Diversity and was adopted on 29 January 2000. It entered
into force on 11 September 2003 and provides rules for the safe transfer, handling
and use of “living modified organisms” (LMOs). The Protocol aims at addressing the
threats LMOs pose to biological diversity and possibly to human health.26 As
22
Sung-Goo et al., 2003
23 Mouquet,
2004
24
http://64.233.183.104/search?q=cache:irg6mto9OPkJ:www.fountainagricounsel.com/feedstuff
s_11_0 (site visited July 2005)
2.htm+japan+%22animal+cloning%22+legislation+-%22human+cloning%22&hl=da
visited July 2005)
25
(site
GMAC guidelines: http://www.gmac.gov.sg NACLAR Guidelines: http://tinyurl.com/aprwq
(sites visited July 2005)
26
Zarilli, 2005
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discussed in 2.1, animal cloning does not appear to fall within the scope of the
Cartagena Protocol, since a cloned animal does not fit the definition of an LMO.
2.5 Summary
Regulation of animal cloning falls broadly into two categories, regulation of animal
welfare and regulation of foods derived from cloned animals. Animal welfare
regulation applied to animal experiments or specifically to cloned animals is
addressed in this section and broader animal welfare regulation is addressed in
section 5. Animal welfare regulation usually contains an element of ethical
consideration, most often at the level of a cost-benefit analysis of the harm to the
animal versus the benefit to humans. In contrast, novel foods regulations only
consider safety aspects.
Regulation of cloning worldwide is not well developed. The FDA in the USA is
perhaps the furthest developed in considering regulation of foods from cloned
animals but, to date, only draft indications have been published. It was noted in
Report 1 that the uncertainty surrounding regulation in the USA is considered one of
the greatest barriers to commercial development of cloning for food production by
companies. Indications from the draft FDA report are however, that in the USA
regulation of food from cloned animals is unlikely to be required. In Canada, food
from cloned animals will be covered under the Novel Foods legislation and will
require prior safety assessment. Milk and meat from the progeny of clones is,
however, unlikely to be covered by this legislation. Safety of food from cloned
animals has been considered in Japan but there appears to be no regulation in place.
There are indications that Australia and New Zealand are giving consideration to
regulation of food from cloned animals but to date, no information has been
published. In some jurisdictions, such as Norway and Denmark, the experimental use
of cloned animals is regulated.
2.6 Patenting cloned animals
Patenting of animals is considered in greater detail in Report 3 considering GM
animals. In this report, a brief summary is given on the patentability of cloned animals
under different jurisdictions.
2.6.1 Europe
The European Patent Convention (EPC) states that “European patents shall be
granted for any inventions which are susceptible of industrial application, which are
new and which involve an inventive step” (Article 52(1)). However, the EPC also
provides exceptions to patentability, such as Article 53 (b) which states that plant or
animal varieties or essentially biological processes for the production of plants or
animals are not patentable, but elaborates further that this provision does not apply
to microbiological processes or the products thereof. Animal cloning does not fall
under the Article 53 (b) exemption, as it cannot be considered to be an essentially
biological process – the technique of SCNT is not a natural biological process.
Therefore, animals produced by SCNT are likely to be patentable. Patents already
exist for the techniques of SCNT.
In 2000, EC Biotechnology Directive (98/44/EC) finally came into force. Article 3
states that inventions are patentable if they are new, involve an inventive step and
are likely to have industrial application.27 With regard to cloning, the Directive
expressly states that human cloning cannot be the subject matter of a patent, but is
silent with regard to animal cloning. Article 4 provides that animal varieties and
biological processes for the production of animals are not patentable, however,
27
De Simone and Serratosa, 2005
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inventions concerning animals are patentable if the invention is not confined to one
particular animal variety. The Directives include a non-exclusive list of unpatentable
processes, for example, human cloning, germ-line modifications, embryo processes,
transgenic processes, etc. This allows the conclusion to be drawn that, in the
absence of specific regulation, animal cloning can be subject to patenting. However,
since the list can be supplemented, it remains possible for animal cloning to be
added to the list of unpatentable processes. Also, according to Article 6 (1),
inventions must not be contrary to morality or ordre public. Also, Article 6 (2) states
that “on the basis of paragraph 1, the following, in particular, shall be considered
unpatentable: (d) processes for modifying the genetic identity of animals which are
likely to cause them suffering without any substantial medical benefit to man or
animal, and also animals resulting from such processes.”
The European Commission’s second report on the Directive was been published on
14 July 2005, but does not mention animal cloning. 28
2.6.2 USA
The patentability of inventions under US law is determined by the Patent and
Trademark Office (USPTO) in the Department of Commerce. Under the current
regulation, patenting cloned animals is not prohibited in the USA.
2.6.3 Canada
In Canada, the patenting of life forms has evolved chiefly as a result of court or
patent office rulings rather than through amendments of the Patent Act. The situation
is therefore complex and subject to change but the current position appears to be
that there is a possibility to patent cloned animals if they are at the same time
genetically modified.
2.6.4 Australia
Traditional methods of creating new life forms such as hybridisation or selective
breeding are excluded from patenting.29 However, there is no explicit exclusion of
cloned animals and accordingly, the cloning of animals could be subject to patenting
in Australia.
2.6.5 New Zealand
Patents in New Zealand are governed by the Patents Act 1953. For a
biotechnological invention to be patentable under the Act, it must satisfy the same
criteria as any other invention - it must fall within the definition of invention specified
in the Patents Act, namely, it must be useful, be novel and not be obvious.
The Patents Act does not expressly provide for biotechnology inventions. Also, the
New Zealand Parliament has never expressly considered the patentability of plants
and animals. Thus, currently the Intellectual Property Office of New Zealand (IPONZ)
is accepting patent applications directed to plants and non-human animals, if they
meet the normal criteria for patentability. Applications for parts (e.g. organs) of plants
or animals obtained by means of cloning, cell lines generated from plants or animals,
the isolated genetic material of plants or animals, and novel means for producing
such products may also be acceptable. Applications are not accepted for plants and
animals as they occur naturally. Section 17 of the Patents Act 1953, however,
provides that the Commissioner of Patents may refuse to grant a patent if the
28
http://europa.eu.int/comm/internal_market/en/indprop/invent/com_2005_312final_en.pdf
(site visited July 2005)
“IPR protection of biological innovations”, Trade Related Aspects of Intellectual Property
Rights, Staff Research Paper, Productivity Commission
29
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Commissioner considers that use of the invention would be “contrary to morality”.
This exception is rarely exercised and has not been the subject of any court decision
in relation to biotechnology patents. It therefore seems likely that cloned animals and
the procedures by which they are produced would be patentable.
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SECTION 3 – RISKS AND RISK ASSESSMENT
3 Risks from cloned animals
3.1 Introduction
The first cloned mammal through SCNT was reported less than 10 years ago in
1996. Since then many cloned animals have been generated. However the total
number of cloned animals is very small compared to the total number of animals bred
using natural reproduction regimes. Given these two considerations, very few studies
directly evaluating risk have been performed to date.
3.2 Technical summary
Cloned animals are reproductions of other animals which have been generated
through normal breeding processes. Any differences between the original animal and
that of the clone will be the result of infrequent mutations acquired in the donor cell
and environmental effects. Mutations also occur in a normal breeding population.
Therefore, cloned animals are essentially similar to animals produced through normal
breeding (the only difference being in the process of generation). Thus, no significant
risk above that associated with non-cloned animals is expected.
Nevertheless, cloning technology has yet to be perfected and many clones are born
with abnormal phenotypic characteristics compared to the donor animal. Usually this
is referred to as the Large Offspring Syndrome (LOS). Currently, some commercial
companies claim that this concern has been largely overcome but documentary
evidence is still awaited. Offspring of cloned animals produced by natural mating
regimes do not show LOS. Scientific analysis of cloned animal or their products,
although limited in the number and extent of studies, indicate that cloned animals are
essentially similar to normal counterparts.
The amount of data on risk of cloned animals is very limited, reflecting the limited
number of cloned animals that exist. Although for many situations the prediction is of
low risk, there is still need for more experimental studies to provide evidence for this
assertion.
The following description of risk from cloned animals is divided into food safety
issues, environmental risks upon release, disease of cloned animals and inbreeding
concerns.
Offspring of a cloned and non-cloned animal, since this is a normal mating between
two animals, will not carry any additional risk not already associated with the given
species or within the population in which the parental animals reside.
3.3 Food safety issues
Cloned animals, unlike GM animals, contain no exogenous DNA and therefore will
only produce proteins and other biological and chemical constituents which are
normally present in animals of that species. Thus, there are no food safety risks
above that encountered with non-cloned animals anticipated for cloned animals, i.e. if
products from the donor animal are acceptable then products from the cloned animal
or its offspring should be acceptable.
The safety of food products derived from cloned animals is currently attracting
interest and is the subject of several studies around the world. These studies usually
analyse the chemical composition of a product, e.g. meat, milk. The conclusions to
these studies have generally indicated to date that cloned animal products are
essentially similar to that of normally bred animals. However, the total number of
studies remains small, the numbers of animals in each study are small and the
studies usually focus on animals from one donor animal. Therefore, only a limited
interpretation of the data is possible.
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The seminal publication on analysis of products from cloned animals was published
this year through a joint venture of US and Japanese researchers (Tian et al. 2005).
In this study the meat and milk of four cloned beef cows was compared to that of four
age and parity matched beef cows; a similar number of dairy cattle were also studied.
All animals were managed under the same conditions and received the same diet.
No statistical differences were detected in the 100 parameters measured; all
parameters for both cloned and normally-bred animals were within the normal
industry standards for products already approved for human consumption.
Independently conducted trials are well underway to compare the progeny of cloned
and non-cloned pig sires for a wide range of production and carcass traits. Early
results of these studies were recently reported by Viagen as showing no statistically
significant differences between the offspring of clones and conventionally produced
pigs for a wide range of traits including production traits, chemical composition and
blood chemistry (presentation by Scott Davies, “Animal Cloning – Application and
commercial issues” at Workshop on Animal Cloning: Technology, Application and
Ethics, Seville, June 2005).
Note that even though the positive conclusions to these studies are anticipated by
the scientific community to be correct, considerably more scientific evidence is
required to provide a robust, defendable argument.
3.4 Environmental risks from releases to the environment
Cloned animals are copies of animals that are or have existed. The likelihood and
consequence of release to the environment are therefore equivalent to that
encountered for the original animal from which the donor cells were isolated. In the
following assessment we have considered four groups of animals; commercial
breeding animals; pets and companion animals; fish and wild animals. Note that
cloning of the latter has not been accomplished, however the cloning of endangered
species is an indication that this technology could be applied to this type of animal.
No studies addressing these assumptions have been performed.
3.4.1 Likelihood
For commercial breeding animals there is negligible likelihood of survival and
reproduction after release given the absence of a natural breeding population outside
of the farm environment.
For pets and companion animals the likelihood of survival is very low given the
adaptation of these animals to human interaction (and pampering) in contrast to the
survival characteristics developed by feral animals, e.g. contrast a pet dog with a
wild-dog. The likelihood of reproduction is high but should be considered with survival
issues. Mating with feral examples of previously domesticated animals, e.g. cats
around farms, is likely but the consequence negligible given the origin of these feral
animals. Overall the likelihood of survival and reproduction is low.
For fish the likelihood of survival is low due to predation. The likelihood of
reproduction is high but should be considered with survival issues. Overall the
likelihood of survival and reproduction is low.
For wild animal the likelihood of survival and reproduction is high, i.e. like with like.
3.4.2 Consequence
For commercial animals interbreeding with the equivalent wild population, on the rare
situations that this exists (e.g. feral goats) could significantly affect the gene pool in
that species but is no different from interbreeding with non-cloned animals in these
situations.
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For pet and companion animals, interbreeding with the equivalent wild population, on
the rare situations that this exists (e.g. feral goats) could significantly affect the gene
pool in that species. In most situations it is realistic to predict that the gene pool
provided by the cloned animal would be less fit for survival in the wild and therefore
would not survive, e.g. lack of predator evasion behaviour, reduced foraging
characteristics. The same applies to non-cloned pet and companion animals.
For fish, interbreeding with the equivalent wild population, which is more likely to
exist compared to companion animals, could significantly affect the gene pool in that
species. In most situations it is realistic to predict that the gene pool provided by the
cloned animal would be less fit for survival in the wild and therefore would not
survive, e.g. lack of predator evasion behaviour, reduced foraging characteristics.
The same risk of reduced fitness and survival characteristics applies to other noncloned farmed fish.
For wild animals no significant risk is expected as the cloned animal would be a copy
of a captured wild-animal, therefore the gene pool provided by the cloned animal
would be essentially similar to that of the non-cloned wild population.
To re-emphasise, the risk associated with a cloned animal is equivalent to that of the
non-cloned donor animal of that species. To illustrate this statement, although one
can estimate that over the many centuries since humans domesticated animals for
agricultural or companion reasons there have been many releases, no significant
effect on equivalent wild populations, where they exit, has occurred. The exception to
this may be the release of domesticated cats and dogs into farm and rural
environments. In many cases this has generated a feral animal population rather
than replaced a wild population, or in some cases is existing alongside a wild
population.
At present definitive scientific scrutiny of likelihood and consequence of release is
limited and usually restricted to predictive modelling. It is hard to see how such
studies could be tested beyond a deliberate release. Rather, as our ability to model
becomes more sophisticated then our predictions will become more reliable. There
has been some effort in this regard with respect to release of GM fish; similar
predictive modelling could be applied to cloned animals.
3.5 Disease risk to current animals
No risk above that normally encountered in that given species or within the
population in which the parental animals reside is expected. Nevertheless, it would
be prudent to perform studies to provide supportive evidence.
‘Dolly’, contrary to the generally held belief, died of a commonly encountered viral
infection. At the same time, other non-cloned animals in the same location died of
this disease.
3.6 Risks of inbreeding
There is a significant risk of inbreeding (the consequence of limited genetic reassortment through breeding between two non-related animals). This can be easily
overcome by breeding with other animals, including other cloned animals derived
from cells isolated from a different donor animal.
This consideration is not relevant for animals that are not used to reproduce or when
reproduction is limited, e.g. this includes most envisaged commercial uses of cloned
animal.
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3.7 Risk assessment
3.7.1 Introduction
When considering risk assessment for products of cloning, it is equally necessary to
consider the progeny of clones, since it is widely expected that progeny are more
likely to enter the food supply, particular in the near future.30
Formal, legally binding risk assessment procedures have yet to be established in
most countries surveyed. There are a few key reasons for this. First, it is because
national and international legislation governing animal cloning is often not in place.
Second, cloning technology is just entering a stage in which its utility to livestock
agriculture is feasible and economical. Third, as is the case with transgenic animals,
there is a paucity of data on which to base binding risk assessment approaches.
Nevertheless, in recent years some high-profile initiatives, mostly coming from the
United States, have considered the risk assessment of products derived from cloned
animals. As the first such initiatives, these will likely be influential in international and
national regulatory arenas.
It can be expected that the comparative approach to food safety assessment, will be
the basis for risk assessment of animal clones and their progeny: ‘This approach, first
developed primarily for use in the safety assessment of food from transgenic plants,
is now generally accepted for food from both transgenic and cloned animals as
well.’31
3.7.2 FDA’s Draft Risk Assessment on Animal Cloning
i. Findings of the FDA’s Draft Executive Summary Risk Assessment on Animal
Cloning
Perhaps the most prominent risk governance exercise concerning animal cloning has
been performed by the Food and Drug Administration (FDA) and its Center for
Veterinary Medicine (CVM). On October 31, 2003, it published a draft executive
summary entitled ‘Animal Cloning: A Risk Assessment’. This document drew upon a
broader report that the FDA had commissioned from the National Academy of
Sciences which, with regards to cloning, concluded that ‘there is no current evidence
that food products from adult somatic cell clones or their progeny present a food
safety concern.’32
The FDA’s draft risk assessment on animal cloning ended with two concluding
statements, one on animal health and the other on food consumption risks. With
regards to the former, it concluded:
“SCNT can pose an increased frequency of health risks to animals involved in the
cloning process, but these do not differ qualitatively from those observed in other
ARTs [assisted reproductive technologies] or natural breeding. In particular, the
frequency of live normal births appears to be low, although the situation appears to
be improving as the technology matures. In particular, cattle and sheep appear to be
subject to a set of syndromes referred to as LOS [large offspring syndrome] that do
not appear to be present in swine or goats. Surrogate dams are at risk of
complications from birth if the foetus suffers from LOS. Clones exhibiting LOS may
require additional supportive care at birth, but can recover and mature into normal,
healthy animals. Most clones that survive the perinatal period are normal and healthy
30
E.g. Kelly (2005)
31
Kelly (2005, p. 61)
32
Vanderbergh et al. 2002, 9.
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as determined
examinations.”33
by
physiological
measurements,
behavior,
and
veterinary
Concerning food consumption risks:
“Edible products from normal, healthy clones or their progeny do not
appear to pose increased food consumption risks relative to comparable
products from conventional animals. Confidence in this conclusion is
relatively high due to empirical evidence from bovine clones, and the
consistency of empirical observations among the other species. Progeny
of clones are likely to be as safe to eat as their non-clone counterparts
based on underlying biological assumptions, evidence from model
systems, and limited, but consistent empirical observations in the species
evaluated. Additional data on the health status of progeny, and
composition of milk and meat from clones and their progeny would serve
to further increase the confidence in these conclusions”.34
As regards food safety, it is important to note that the assessment states the level of
certainty of these conclusions are, from highest to lowest, for cattle, pigs, goats and
sheep clones. Furthermore, it was noted that ‘edible products from the progeny of
healthy clones are likely as safe to eat as similar products from the progeny of noncloned animals…’35
ii. Risk Assessment Approach of the FDA - CVM
The FDA’s risk assessment was comparative and qualitative in nature.
Consequently the FDA argued that the strongest conclusions that can made are
assessments such as ‘likely to be as safe as’ or ‘as safe as’. For animal health, this
means that risk assessments are geared towards determining whether animal
cloning procedures are ‘as safe as’ other assisted reproductive technologies.
Concerning food safety, risk assessments are focused on determining whether food
products derived from animal clones are ‘likely to be as safe as’ food products from
non-clones.36
The FDA calls its risk assessment for food consumption risks a two-pronged
approach, since it involves both the Critical Biological Systems Approach described
below as well as the Compositional Analysis Method. This method:
“…assumes
that food products from healthy animal clones and their
progeny are not materially different from corresponding products from
conventional animals and are as safe to consume as their conventional
counterparts. It relies on the comparison of individual components of
edible products.”37
The rationale for the two-pronged approach is that it is necessary in order to
determine whether ‘subtle hazards’ pose any risks. The FDA begins by assuming
that only healthy clones would end up in food chains (consistent with the same
regulations that apply to conventional animals). Furthermore, it argues that
33 FDA
(2003a, p.11)
34
FDA (2003a, p.11)
35
FDA (2003a, p.10)
36
FDA (2003a, p.2)
37
FDA (2003a, p.6)
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‘regulatory communities have traditionally assumed that it is highly unlikely that
‘silent’ pathways producing intrinsic toxicants exist in food animals’.38 Thus:
“…the
only hazards that could arise in animal clones would be from
incomplete or inappropriate reprograming of the genetic information from
the donor somatic nucleus (i.e. epigenetic effects). These would allow a
clone to develop with apparently normal appearance and functions, but
with sub-clinical physiological anomalies, and are referred to as ‘subtle
hazards’”39
The Critical Biological Systems Approach divides the lifecycle of animal clones into
five developmental nodes:

Developmental Node 1 incorporates the initial technical steps involved in SCNT,
from cell fusion through foetal development.

Developmental Node 2 encompasses the perinatal period, including late
gestation, labour induction in the dam, delivery, and the critical few days after
birth.

The third developmental node, Juvenile Development and Function, covers the
period of rapid growth between birth and the onset of puberty.

The Reproductive Development and Function Node includes puberty and
reproductive function throughout the reproductive life of clones.

The Post-Pubertal Maturation Node consists of all non-reproductive functions of
sexually maturing or mature clones, including growth, weight gain, disease
frequency, aging, and, where available, lifespan.40
The FDA assessed animal safety/health by looking at abnormalities occurring to
animals at the various developmental nodes ‘emphasis was placed on the clones’
development and probability of normal development, compared with ARTs, such as
artificial insemination (AI), in vitro fertilisation (IVF), and blastomere nuclear transfer
(BNT).’41
The FDA concluded that for cloned animals, qualitatively different risks to those
generated by modern agricultural practices were not observed, however it also
acknowledged that animal clones tend to experience higher frequencies of these
risks.
iii. Note on Transgenic Clones in FDA’s Risk Assessment
Importantly, the FDA risk assessment excluded clones from transgenic donor cells,
arguing that ‘transgenic clones are considered to occupy a different ‘’risk space’’ from
‘’just clones’’ because the transgenic event is accompanied by a series of constructspecific risks.’42
iv. Note on the progeny of animal clones
The FDA risk assessment and the CVM assume that, for economic reasons,
‘founder’ animal clones will not enter the food chain directly, but rather via their
progeny (which are defined as animals having at least one cloned animal as a
38
FDA (2003a, p.5)
39
FDA (2003a, p.6)
40
FDA (2003a, p.1)
41
FDA (2003a, p. 2)
42
FDA (2003a, p.2)
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parent). The two-pronged approach is used to assess potential risks of food coming
from cloned animals and their progeny.
One assumption that the FDA makes in relation to the progeny of clones is that the
generation of cells that become ova and sperm naturally resets epigenetic signals for
gene expression, effectively clearing the genome of incomplete or inappropriate
signals.’43
Based on this assumption and the somewhat limited available supporting evidence,
the risk assessment states that “edible products from the progeny of healthy clones
are likely to be as safe to eat as the corresponding products of progeny from
conventional animals”.44
v. CFSAN
It was not possible to find any guidance published by CFSAN concerning risk
assessment approaches for foods coming from cloned animals.45
3.7.3 EU Regulatory Risk Assessment of Cloning
i. Note on EU Legislation & Risk Assessments
Without EU legislation in place, there are also no standardised approaches to the risk
assessment of products coming from, or consisting of, animal clones or their
progeny. It is likely that the EFSA would have jurisdiction over such products and
assess the risks similarly to the risks posed by foods derived from, or consisting of,
GM animals, however formal risk assessment procedures for the latter have yet to be
established.
Concerning risk assessment, as in the US it has been argued that the progeny of
clones are more likely to enter the food chain than cloned animals themselves. This
has led some to argue that the first level of risk to be assessed is the safety of
meat/milk coming from clones, and the second level of risk is the progeny of clones.46
Likewise, it was suggested by an advocate of the technology that the FDA’s draft risk
assessment on animal cloning could help ‘”European countries to make up their
minds on this issue”.47 However, whether European policymakers would choose to
follow the thinking of the US remains to be seen.
ii. Comment on Lack of EU Legislation and Impact on Biotechnology Industry
One paper from a group generally in favour of biotechnology has argued that the lack
of EU legislation and guidance on cloned animals (as well as GM animals) will
ultimately be harmful to EU industry:
“The obstacles to biotech development originate from both the lack of
financial support for the basic research that can create great new ideas
and generate business opportunities, as well as the lack of the regulatory
and financial infrastructures that are required for success of a long-term,
high-risk business.”48
43
FDA (2003a, p.10)
44 FDA
(2003a, p.10)
45
Website scanned was: http://www.cfsan.fda.gov/~lrd/biotechm.html#pres (site visited July
2005)
46 Galli
et al. (2004, p.52)
47
Galli et al. (2004, p.52)
48
Galli et al. (2004, p. 52)
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The same paper argued that plurality within the EU has resulted in:
“…a
deliberate delay in taking any action or making any decision on
issues deriving from biotechnologies, like cloning… this policy will
ultimately be detrimental to the European biotechnology industry”.49
iii. French Approach to Risk Assessment
The French agency for food safety, AFSSA, is examining food safety of products
from cloned animals and is expected to issue a report in the near future. For the
meantime, a key initiative within France is that the INRA has imposed a moratorium
to ensure that no products derived from embryo or somatic cloning or cloned animals
enters the human food chain.
The INRA has also run a research programme on ‘Risk assessment of products from
cloned livestock.’ This study is examining Holstein cattle created via SCNT and
examined risks to animals, risks to offspring from clones, risk to food products from
clones, and socio-ethical aspects of cloning. The final report is due sometime in
2005/2006.50
iv. UK approach
In the UK, it has been reported that “cloned meat and milk would be classed as novel
foods and so would need a special license, but unlike GM food would not need to be
labelled.”51
3.8 Summary of risk assessment
The risk assessment of products derived from cloning is at an early stage, due to the
novelty of such products, a lack of legislation governing animal cloning, and a
general lack of data upon which to base risk assessments. The limited scientific
analysis available indicates that clones do differ slightly from each other but that this
variation is within the normal range expected by the breeding industry.
The most prominent initiative has been by the FDA in the United States, which
considered the animal health and food consumption risks of cloning (SCNT). The risk
assessment approach adopted by the FDA seeks to identify ‘subtle hazards’ by
comparing edible products from healthy clones and their progeny with the same
products from conventional counterparts. In a Draft Executive Summary, the FDA
argued that the qualitative risks (and not their frequency) to animal health were not
different from other assisted reproductive technologies and that the food
consumption risks from healthy clones or their progeny do not pose greater risks than
conventional animals.
In Europe, the European Food Standards Agency (EFSA) would have jurisdiction
over food products from cloned animals, however in the absence of European
legislation, formal risk assessment procedures have not been published.
EU
member states including France and the UK have also started to consider risk
assessment, but have not to date released any definitive statements. Whether or not
European regulators follow the FDA’s lead remains to be seen. In the meantime,
some biotechnology advocates fear that without proper guidance, the European
biotechnology industry will suffer.
49
Galli et al. (2004, p. 52)
50
Information about the INRA research programme is from a presentation given by Jean-Paul
Renard to the European Science & Technology Observatory in Seville, Summer, 2005.
51 Turner
(2002, p. 51), citing (Cohen & Concar, 2001)
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SECTION 4 INTERNATIONAL TRADE AND LABELLING ISSUES
4 International trade
4.1 Introduction
Extensive international trade exists in food products (such as meat, milk and milk
products) as well as international transfer of breeding animals whether as semen,
embryos or live animals. In the absence of established regulatory systems and risk
assessment approaches, products derived from cloned animals may find themselves
in a particularly ambiguous situation with respect to international trade.
4.2 Labelling issues
Rising consumer concerns regarding the safety of genetically engineered food have
caused a number of countries around the world to introduce rules for labelling food
products derived from biotechnology. In August 2001, 28 countries and the European
Union had either introduced or announced plans to adopt voluntary or mandatory
labelling regimes. Labelling in general has been regulated on an international level to
prevent labels from creating barriers to trade. The most important international
labelling regulations are established by the World Trade Organisation and by the
World Health Organisation.
However, while genetically modified food and food ingredients are already
commercially exploited and placed on the market, food derived from cloned animals
is not yet commercially available. Therefore, a discussion of the labelling of food
derived from cloned animals will be speculative.
4.2.1 Codex Alimentarius
The Codex Alimentarius Commission was created in 1963 by the Food and
Agriculture Organisation (FAO) of the United Nations and World Health Organisation
to develop food standards, guidelines and related texts such as codes of practice
under the Joint FAO/WHO Food Standards Programme. At an international level, the
Codex Alimentarius is the most important regulation of food safety and labelling. Its
significance for consumer health protection was highlighted in 1985 by the United
Nations Resolution 39/248, whereby guidelines were adopted for use in the
elaboration and reinforcement of consumer protection policies. The guidelines advise
that:
“Governments should take into account the need of all consumers for
food security and should support and, as far as possible, adopt standards
from the ... Codex Alimentarius”. 52
The Codex Alimentarius consists of a collection of internationally adopted food
standards presented in a uniform manner, designed to ensure that consumers
receive products that meet internationally accepted quality levels, are safe and do not
present a health hazard. Standards are stipulated for individual foods and for food
groups.
FAO and WHO have provided expert scientific advice on the safety aspects of foods
derived from biotechnology since 1991. While not officially part of the Codex
Alimentarius Commission structure, the FAO/WHO Expert Consultations in this area
provide independent scientific expert advice to the Commission and its specialist
Committees and Task Forces. FAO and WHO maintain separate websites
highlighting this work from the points of view of the two parent organisations.
To date, however, the Codex Alimentarius has not provided any guidance on
labelling food derived from cloned animals.
52
See http://www.codexalimentarius.net/web/index_en.jsp (site visited July 2005)
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4.2.2 The World Trade Organisation
The World Trade Organisation (WTO) is the body responsible for regulating trade
between nations. The WTO came into being in 1995. One of the youngest of the
international organisations, the WTO is the successor to the General Agreement on
Tariffs and Trade (GATT), a series of post-war trade treaties intended to facilitate
free trade established in 1947, which it transformed into an enforceable global
commerce code. The GATT principles and agreements were adopted by the WTO,
which was charged with administering and extending them. Unlike the GATT, the
WTO has a substantial institutional structure. The WTO had 76 members at its
creation. A further 72 members joined over the following ten years, the latest (as of
12 December 2004) being Cambodia on 13 October 2004. The WTO has two basic
functions: as a negotiating forum for discussions of new and existing trade rules, and
as a trade dispute settlement body.53
Within the framework of the WTO, two agreements dealing with food safety, animal
and plant health and safety, and with product standards could possibly apply to
labelling food products from cloned animals: the Technical Barriers to Trade
Agreement (TBT) and the Sanitary and Phytosanitary Measures Agreement (SPS),
both established in 1994. While neither of these two agreements provides any direct
regulation on genetically engineered food, food safety measures which affect
international trade are addressed. The decision on which of the two agreements
applies has to be decided on a case-by-case basis. Broadly speaking, if a measure
aims at protecting human, animal or plant life from food-borne risks, then the SPS
Agreement would probably apply. If, however, the measure is chiefly intended as an
instrument of consumer information rather than one of health protection, the TBT
Agreement would probably apply. Also, GATT Articles III, XI and XX providing
general regulatory constraints on government actions relating to standards and other
regulations, may apply.
i. SPS Agreement
In practice, measures falling under the SPS Agreement usually take the form of
technical specifications, import bans and information remedies such as labelling. The
SPS Agreement allows countries to set their own standards, but also requires
regulations to be based on science and that they are applied only to the extent
necessary to protect human, animal or plant life or health. Furthermore, they should
not arbitrarily or unjustifiably discriminate between countries where identical or similar
conditions prevail.
The SPS Agreement encourages member countries to use international standards,
guidelines and recommendations where they exist. They may, however, use
measures which result in higher standards if there is scientific justification and based
on appropriate assessment of risks if the approach is consistent and not arbitrary. To
some extent, an application of the precautionary principle is permitted through Article
5.7 allowing temporary precautionary measures.
The agreement includes provisions on control, inspection and approval procedures.
Governments must provide advance notice of new or changed sanitary and
phytosanitary regulations, and establish a national enquiry point to provide
information. The agreement complements that on technical barriers to trade.54
Both the SPS Agreement and the TBT Agreement encourage the international
harmonisation of food standards. A product of the Uruguay Round of multinational
53
See http://www.wto.org/ (site visited July 2005)
54
See http://www.wto.org/english/tratop_e/sps_e/sps_e.htm (site visited July 2005)
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trade negotiations, the SPS Agreement cites Codex standards, guidelines and
recommendations as the preferred international measures for facilitating international
trade in food.
The labelling of food derived from cloned animals, if used primarily to protect human
health, would fall under, and would need to be compatible with, the SPS Agreement.
ii. TBT Agreement
The TBT Agreement primarily covers standards and technical regulations adopted
after 1 June 1995 as well as measures adopted before that date but still in effect. A
standard is defined as a document approved by a recognised body for common rules
or guidelines, the compliance with which, however, is not mandatory. Compliance
with technical regulations, on the other hand, is mandatory.55
The agreement recognises countries’ rights to adopt the standards they consider
appropriate. Moreover, members are not prevented from taking measures necessary
to ensure their standards are met. In order to prevent too much diversity, the
agreement encourages countries to use international standards where these are
appropriate, but it does not require them to change their levels of protection as a
result.
The agreement says the procedures used to decide whether a product conforms with
national standards have to be fair and equitable and discourages any methods that
would give domestically produced goods an unfair advantage. The agreement also
encourages countries to recognise the testing procedures other member states
employ. That way, a product can be assessed to see if it meets the importing
country’s standards through testing in the country where it is made.
If labels on food products derived from cloned animals are meant to provide
consumers with information, then the TBT Agreement would apply.
Currently, there are no labelling requirements for food products derived from cloned
animals. However, should such a regime be introduced by individual nations, the
labelling regime would most likely need to comply with the TBT Agreement in order
for the labelling regime not to constitute a barrier to international trade. The SPS
Agreement would appear less likely to apply on current evidence, due to the lack of
indications for safety concerns regarding food derived from cloned animals.
4.2.3 National labelling regulations
i. European Union
The only legislation relating to the labelling of genetically modified organisms is
Regulation (EC) No 1830/2003 concerning the traceability and labelling of genetically
modified organisms, amending Directive 2001/18/EC. Regulation (EC) No1830/2003
which provides a definition for the terms used in Article 3. Under paragraph 1, the
definition for ‘genetically modified organisms’ refers back to Article 2(2) of Directive
2001/18/EC. Accordingly, the term ‘genetically modified organisms’ means “an
organism, with the exception of human beings, in which the genetic material has
been altered in a way that does not occur naturally by mating and/or natural
recombination”. Cloning, however, no matter whether achieved through embryo
splitting or through SCNT, does not alter the genetic material in any way. Rather,
either technique produces an animal genetically identical to the original animal. Thus
Regulation (EC) No1830/2003 and Directive 2001/18/EC would not apply to cloned
animals.
55
See http://www.wto.org/english/tratop_e/tbt_e/tbt_e.htm (site visited July 2005)
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ii. USA
The FDA has not reached the final conclusion of the risk assessment into the safety
of food products derived from cloned animals. Once the study is concluded, however,
the FDA intends to outline their views on how animal cloning should be regulated, if
at all, including whether food derived from cloned animal should be labelled. If,
however, the preliminary conclusion regarding the safety of products from cloned
animals remains, i.e. that they are to be considered virtually the same as traditional
food products, labelling would not be needed and there would be little regulation. 56
iii. Canada
Currently, no labelling requirements exist under the Food and Drugs Act either for
genetically modified foods or for food derived from cloned animals. Some companies
choose to label their products, but, this only happens under the companies’ voluntary
policy. Labelling will only be required when the genetically modified products present
a health or safety concern, not otherwise. 57
iv. Australia and New Zealand
In Australia and New Zealand, as mentioned above, only genetically modified food is
covered by Food Standard 1.5.2. and its labelling requirements. There are no
provisions for labelling food derived from cloned animals.
4.2.4 Traceability
To be traceable something must a have a tag or mark. This mark must be unique or
at least highly restricted in occurrence. For an animal or product the only mark would
be its DNA, present as its genetic material. All other cellular components will be
common to all animals of that species, or at the very least be common to large
numbers within a given species.
Cloned animals are reproductions of other animals which have been generated
through normal breeding processes. Thus they will carry an exact copy (see below)
of the DNA that is present in the donor animal. There are two caveats to this: (1) the
mitochondrial DNA in the clone will differ from that in the donor (but this also occurs
in normal breed between a father and his offspring); and (2) the rare appearance of
mutations acquired in the donor cell and due to environmental effects. Mutations also
occur in a normal breeding population and can not be predicted. Therefore, cloned
animals are essentially genetically similar to animals produced through normal
breeding (the only difference being in the process of generation).
Thus, the opportunity to genetically trace a cloned animal is very limited. It would be
impossible if the genome sequence of the donor animal was not available.
To use the genome sequence to trace an animal’s heritage requires that a method of
determining the sequence is available. This can be done but the cost of genome
sequencing is very expensive at present. Although this cost is predicted to fall with
time, it is likely that cloned animals will be in use for breeding purposes long before
the cost of genome sequencing comes practical for routine use. Furthermore, even
with this technology, given that mutations can occur in any animal (cloned or notcloned), this assay would not be able to prove that one animal was cloned or not, just
give an estimate of how likely it is that a given animal is cloned or not.
Tracing a cloned animal’s heritage will therefore be restricted to a paper audit trail.
56 http://www.thecampaign.org/News/jan04n.php
57
(site visited July 2005)
http://www.anarac.com/labeling_gm_foods_in_canada.htm (site visited July 2005)
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4.2.5 Summary of labelling issues
Currently, there is little indication that cloned animals and food products derived from
cloned animals (let alone their progeny) will require to be labelled. Furthermore, there
is currently no practical scientific method of detecting cloned animals, progeny of
clones or products derived from clones, nor does there appear to be any prospect of
developing such a method in the near future. Requiring labelling of cloned animals
and their products is likely to be viewed as a trade limiting measure, although
labelling is allowed if it is considered necessary.
4.3 Summary of trade issues
A topic as politically and morally contentious as cloning has significant potential to
create trade disputes. The basis of much of the international regulation around trade
depends on demonstrating safety risks from food products. However, to date, such
risks have not been demonstrated from products from cloned animals. Furthermore,
as section 6 suggests, much of the objection to cloning technology is on moral and
ethical grounds rather than on the basis of risk. For example, where animal cloning
has been regulated in Europe (Norway and Denmark), the basis for this regulation
has apparently been moral and ethical concerns rather than safety concerns. From
the perspective of global trade, this is potentially problematic: concerning the ethical
aspects of biotechnology, the FAO/WHO (2003) notes that there are no
internationally agreed frameworks for considering ethical aspects relating to the use
of modern biotechnology, despite acknowledging the importance of issues relating to
environmental ethics, animal welfare, transparency and public deliberation in
decision making.
Thus, with absences of, or differences in, global regulatory and risk assessment
approaches to cloned animals, and with many regulatory systems not yet
established, there exists a very strong probability of trade disputes over the trade of
cloned farm animals, and even (perhaps especially) of the trade of semen and
embryos from clones.
In the US and Asia, where regulatory guidelines are liberal, numerous commercial
groups are pushing ahead with developing cloned animals for research and for
agricultural purposes, creating the potential that firms will attempt to export products
to markets more resistant to such products, including the EU.
As the scientific and regulatory community in the US generally regards products from
cloned animals as safe as conventional counterparts, trade wars might loom. The
example of trade in cattle semen demonstrates this potential:
…market pressures are heavy. The trade in cattle semen and eggs
between Europe and the US and Canada is about $100 million per year,
and there is high demand in Britain for imported bull semen for artificial
insemination.58
No laws currently exist in Britain (and probably in the EU) to prevent the import of
semen from cloned stud bulls.59 However, with public opinion generally cautious in
these markets, there exists the possibility that bans or moratoriums could be
demanded in order for proper regulatory and trading systems to be established. If
that were to happen, cloned animals might replace genetically modified crops as the
next transatlantic trade dispute.
58
Williams (2002)
59
Williams (2002)
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SECTION 5 ANIMAL WELFARE
5 Welfare of cloned animals
5.1 Introduction
The remit of this report was to consider only physiological aspects of animal welfare
and not to address wider aspects of well-being, ethics, etc. We are following a
definition of welfare that includes three aspects:

The experiences of the animal, such as pain or pleasure

Normal biological functioning of the animal

The nature of the species and ensuring the animal can exhibit its full-range of
behaviours

(following Duncan and Fraser,1997).
The first cloned mammal was reported less than 10 years ago in 1996. Since then
many cloned animals have been generated however the total number of cloned
animals is insignificant compared to the total number of animals bred using natural
reproduction regimes. Given these two considerations, very few studies directly
evaluating welfare have been performed to date.
The majority of studies investigating the physiological aspects of cloned animals’
welfare have focussed on the developing cloned embryo in utero and the newborn
animal, with an emphasis on addressing the Large Offspring Syndrome (LOS).
5.1.1 General properties of cloned animals
Cloned animals are reproductions of other animals which have been generated
through normal breeding processes. We will discuss welfare issues in three areas
specific for cloned animals: abnormal foetal growth; cloned and non-cloned adult
animals; and genetic differences between donor and cloned animal. To summarise:
Foetal welfare - historical concerns over LOS are slowly being reduced as the
technology is refined by commercial companies. Nevertheless, this remains an issue
of concern. LOS is considered to be due to an inappropriate pattern of gene activity
(sometimes referred to as epigenetic effect).
Welfare of adult cloned animals should be the same as non-cloned animals of the
same species or breeding population or group, however, due to LOS welfare
concerns are evident.
As the numbers of cloned animals increase the potential for very minor genetic
changes to appear is a real possibility. The rate of genetic change is unknown.
Genetic change also occurs in normally bred populations but may occur at a slower
rate than in cloned animals.
Offspring of a cloned and non-cloned animal are not expected to exhibit any welfare
issues above that already encountered in that species or population of animals. The
limited examples of such offspring support this assertion.
i Foetal physiological welfare issues
The act of culturing cloned embryos in vitro stresses the normal cell growth and
development process which can result in physiologically abnormal embryos. Usually
this manifests as over-sized animals, associated with a high foetal mortality rate. This
phenomenon, termed LOS, has been extensively studied and commercial companies
believe they have for the main part overcome this concern (although no publicly
accessible data to support these assertions is available yet). It was generally
accepted that more than 90% of animals in a cloning study would suffer from LOS in
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one way or another.60with similar pathological concerns being observed in about 50%
of animals exposed to an in vitro step (but not cloning), e.g. Lazzari et al (2002).
LOS is considered to be an epigenetic effect – an effect that manifests in altered
gene activity but is not due to mutation of the genome. Over time, the prediction is
that this concern should be excluded through refined in vitro culture procedures.
ii Cloned and non-cloned adult animals
Cloned animals are essentially similar to animals produced through normal breeding
(the only difference being in the process of generation). It is likely that the vast
majority of cloned animals will fall into this category. Thus welfare concerns for the
cloned animal will be the same as that of the donor animal.
The exception to this is where an animal shows LOS. The phenotypic consequence
of LOS can persist through to adulthood. LOS is more common in some species than
others, e.g. it is more common in sheep and cattle than pigs. Whether this reflects
differences in the potential of epigenetic events to affect phenotype in these species
or as yet fundamental differences in the in vitro culturing conditions between the
different species is not known.
iii Welfare issues as a result of genetic differences between cloned and non-cloned
animals
The cloned animal is expected to be an identical genetic copy of the donor animal.
Within an animal there are two types of cells: germ cells and somatic cells. The germ
cells are few in number and comprise the sperm and egg depending on the sex of
the animal. Germ cells contain sophisticated enzymatic machinery that repairs
damaged DNA thus ensuring the integrity of the genome in these special cells.
Somatic cells make up the rest of an animal’s body and do not posses this enzymatic
activity. Somatic cells as they divide can, at a low frequency, acquire genetic
changes. For example, in an adult animal mutations acquired in somatic cells over
the lifetime of the animal can result in the development of cancers in the older
animal. To-date, all cloned animals have been generated from somatic cells.
It is, therefore, possible that the use of somatic cells as donors in cloning will mean
that, in some animals, the genetic make-up will not be identical to that of the donor.
The number of changes (mutations) will be very small, but within an extended
population of animals could manifest in an unexpected phenotype in some animals.
The consequence of such a mutation can not be predicted as it is a random event.
No direct evidence for such a mutation risk has been documented; however since the
genome of a cloned animal has not yet been sequenced and compared to that of the
donor animal, minor genetic changes may have arisen but not identified.
Mutations also occur in normally bred animals. The unknown issue is whether the
mutation accumulation rate of cloned animals will be similar or greater, possibly even
significantly greater than that of normally bred animals.
iv Offspring of cloned animals
Where two animals that have been derived from the same donor animal are mated
then inbreeding will occur. Inbreeding carries established welfare concerns.
Wilmut, I. and Griffin, H. (2001) ‘Why no-one should be attempting to clone a child. Roslin
Institute Annual Report 2000-2001 , pp22-25, available at;
60
(http://epublications.roslin.ac.uk/0001annrep/child.html)
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Offspring generated by mating between a clone and non-cloned animal will have no
welfare issues above that already present in that group or population of animals.
These animals should be treated as non-cloned in all respects.
5.1.2 Physiological issues
A cloned animal being a direct genetic copy of the donor animal should carry no
physiological concerns beyond that already existing in the donor animal.
Unfortunately, this is not the observed situation. Cloned animals exhibit LOS, causing
growth defects that can result in severe welfare concerns and often death.
LOS appears random and is more prevalent in some species compared to others,
e.g. it is more common in sheep and cattle compared to pigs. Cloned animals that do
not show LOS do not exhibit obvious physiological concerns. Indeed, biochemical
analysis of products from such animals, indicates values within the range expected
for the species or breeding population (Tian et al.).
This aspect requires further scientific study.
5.1.3 Health issues
There is no obvious reason to expect cloned animals to be more susceptible to
disease that non-cloned animals. Obviously cloned animals suffering form LOS will
be more susceptible than healthy cloned or non-cloned animals.
This is an aspect that requires more scientific study; experimental design would
easily incorporate analysis of physiological issues.
5.1.4 Behavioural issues
Assessment of behaviour requires that a comparison is made with ‘control’ or
standard animals. With respect to comparison of non-clone and cloned animals this
requires similar housing and husbandry. Often this is not the case. In addition, the
numbers of cloned animals at any one location or generated from a given donor
animal is restricted. Due to these issues our knowledge of whether cloned animals
display different behavioural properties to that of non-cloned animals within a given
population has not been clarified.
The anticipation is that nature, the environment, will modify a clone such that it is
different from the donor animal. In contrast, if clones were to be similar in behaviour,
after excluding influencing aspects such as co-housing, then our understanding of
behavioural traits will need to be re-examined.
Interestingly this aspect has received more attention than that of the health of cloned
animals (beyond the extensive study of LOS). The seminal study was reported by a
US group in 2003 (Archer et al. 2003). Further studies have been initiated but have
yet to be completed. In this report two groups of cloned animals, comprising five and
four pigs, were compared to two groups of 4 naturally bred animals. The sample size
highlights the limitations associated with the studies done to-date. A variety of
behavioural traits were assessed including: food preference, temperament,
vocalisation and escape, and positioning given different environments such as
play/fighting and standing on concrete. A statistical analysis was performed on the
data accumulated. The authors concluded that the cloned pigs were as variable as
naturally bred animals.
5.1.5 Summary
Clones often display LOS and suffer physiologically as a consequence. However,
apart from cloned animals suffering from LOS, there is no evidence that cloned and
non-cloned differ with regard to welfare issues. This conclusion must be tempered by
the very limited scientific data available. Given that it is unlikely that large numbers of
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cloned animals will be generated within the next 5-10 years, it is not clear how this
data will be generated.
5.2 Regulation on animal welfare
5.2.1 Europe
In May 1999, the Amsterdam Treaty came into force, including a protocol on animal
welfare. In this protocol, legal stipulations in favour of animal welfare are introduced
into law and politics for the first time. Consequently, when drawing up new policies
and legislation for agriculture, transport, research and the single market, both
European institutions and member states have to consider the welfare of animals.
The principal instrument of animal welfare legislation with regard to experiments is
Council Directive 86/609 from 1986 “on the approximation of laws, regulations and
administrative provisions of the Member States regarding the protection of animals
used for experimental and other scientific purposes”. This legal instrument focuses
on what is generally called the “Three R’s”: replacement, reduction and refinement.
Thus the Directive specifies that:
“experiments may not be performed if another scientifically satisfactory
method of obtaining the result is sought, not entailing the use of an
animal, is reasonably and practically available … In a choice between
experiments, those which use the minimum number of animals, involve
animals with the lowest degree of neuro-physiological sensitivity, cause
the least pain, suffering, distress or lasting harm and which are most
likely to provide satisfactory results shall be selected. All experiments
shall be designed to avoid distress and unnecessary pain and suffering to
the experimental animals.”
Once animal cloning has progressed beyond the experimental stage and is
commercially employed, the European Convention for the protection of animals kept
for farming purposes (1976; ETS 87), applies, providing a framework setting
principles for the keeping, care and housing of animals, in particular in intensive
breeding systems. A Standing Committee (T-AP) composed of Representatives of
the Parties to the Convention, is responsible for the elaboration and adoption of more
detailed recommendations to the Parties concerning the different species of animals
for the implementation of the principles set out in the Convention. In 1992, a Protocol
of Amendment to the Convention (ETS 145) was opened for signature. This Protocol
provides for the extension of the scope of the Convention to the breeding of animals
produced as a result of genetic modifications or novel genetic combinations.
Accordingly, natural or artificial breeding and breeding methods in which the animals
are or could be caused suffering or injury cannot be undertaken. Also, animals are
only allowed to be kept for agricultural purposes if there is a well-founded expectation
based on their phenotype or genotype that they can be kept without damaging effects
on their health and wellbeing. Given the welfare concerns which exist with regard to
cloned animals, this may act as a restriction on the use of cloned animals.
Based on the Convention, the European Directive on the Protection of Animals Kept
for Farming Purposes (98/58/EC) provided general rules for the protection of animals
of all species kept for the production of food, wool and skin or other farming
purposes. They reflect the so-called 'Five Freedoms' as adopted by the Farm Animal
Welfare Council:

Freedom from hunger and thirst

Freedom from discomfort

Freedom from pain, injury and disease
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
Freedom to express normal behaviour

Freedom from fear and distress
Legislative instruments:

European Convention on the Protection of Animals kept for Farming Purposes,
1976 (ETS 087)

European Convention for the Protection of Vertebrate Animals used for
Experimental and Other Purposes, 1986 (ETS 123)

Protocol of Amendment to the Convention ETS 123, 1998 (ETS 170)

Directive 86/609/EEC of 24 Nov. 1986 on the protection of animals used for
experimental and other scientific purposes

Protocol on the protection and welfare of animals to the Treaty of Amsterdam
amending the Treaty on European Union, the Treaties establishing the European
Communities and certain related acts, signed on 2 October 1997

Directive 98/58/EC concerning the protection of animals kept for farming
purposes

Decision 2003/584/EC concerning the conclusion of the Protocol of Amendment
to the European Convention for the protection of vertebrate animals used for
experimental and other scientific purposes.
5.2.2 USA
In the USA, the Animal Welfare Act (AWA)is the primary federal legislation that
regulates animal property, seeking to provide protection for “any live or dead dog,
cat, nonhuman primate, guinea pig, hamster, rabbit, or other warm-blooded animal,
which is being used, or is intended for use for research, teaching, testing,
experimentation, or exhibition purposes, or as a pet.” However, “birds,
rats…mice…bred for use in research, and horses not used for research purposes
and other farm animals, such as, but not limited to livestock or poultry, “ are excluded
from the Act’s protection. This means effectively that cloned and GM farm animals
are exempt from this Act, as are any cloned pets that are not in experimental
facilities. The protection offered to animals by the Animal Welfare Act includes
housing, feeding, cleanliness, ventilation and veterinary care. All facilities using
laboratory animals covered under the AWA must register with, and be inspected by,
the United States Department of Agriculture's enforcement arm, the Animal and Plant
Health Inspection Service (APHIS). It is the responsibility of APHIS, through random,
unannounced inspections to ensure that institutions are complying with all USDA
regulations. The AWA also mandates the use of anaesthesia or painkilling drugs for
potentially painful procedures and for postoperative care unless the research
precludes it.
The Animal Welfare Act also requires that each institution using animals for research
must establish an Institutional Animal Care and Use Committee (IACUC), which is
responsible for evaluating the total animal care programme, as well as for scrutinising
all proposed animal experiments. The committee must include at least one person
who is unaffiliated with the institution and one veterinarian. Researchers proposing a
procedure must explain to the committee in writing the number of animals they plan
to use, why a certain species is necessary, and what steps will be taken to prevent
unnecessary suffering. The committee has the power to reject any research proposal
and stop ongoing projects if it believes USDA standards are not being met.
Researchers seeking funds from the US government must follow its rules regarding
animal welfare. All institutions receiving grants from the U.S. Public Health Service
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(PHS) must adhere to its animal welfare assurance Policy. Under the terms of the
policy, not only must institutions adhere to the AWA, they also must follow the
detailed recommendations on animal care and treatment that are contained in a book
called the Guide for the Care and Use of Laboratory Animals. The PHS policy covers
all animals, including rats and mice, and has several key elements.
One is that each institution must document that it has an animal care committee to
review the use and care of animals in research. (Usually, this same committee
satisfies the Animal Welfare Act requirement mentioned earlier).
Another is that institutions must file (and update annually) Animal Welfare
Assurances with the NIH office. The Animal Welfare Assurance includes:

documentation of institutional commitment

description of the animal care and use programme

implementation procedures
The written assurance must be provided up front if the institution wants a PHS grant.
NIH will even suspend or revoke PHS grants or contracts if an institution does not
remain in compliance. The burden of proof and documentation is always on the
research institution.
5.2.3 Canada
Animals are considered property under Canadian law and thus fall under exclusive
jurisdiction of the provinces. Also, no national legislation exists regulating the use of
animals in scientific research and experimentation. Animals used for scientific
experiments, however, are overseen by the Canadian Council on Animal Care
(CCAC), a national, non-profit body. As seen in EU legislation above, the CCAC has
also adopted the “three R’s” Replacement, Reduction and Refinement. The CCAC is
funded primarily by the Medical Research Council (MRC) and the Natural Sciences
and Engineering Research Council through three-year grants. Compliance with
CCAC guidelines is mandatory for universities and other research bodies relying on
government funding; however, it is voluntary for private and public laboratories.
Together with Health Canada, the federal Canadian Ministry for health, the CCAC
developed an effective and significant enforcement tool on xenotransplantation. This
is based on the suggestion that additional mechanisms be designed in collaboration
with the Treasury Board Secretariat and Industry Canada to ensure all private and
public sector organisations using animals for this purpose participate in the
programme. The tools could include, for example, that Scientific Research and
Experimental Development tax credits involving the use of animals are linked to a
Certificate of Good Animal Practice or that data submitted to the Canadian
Intellectual Property Office must be originated in a CCAC-certified institution.
There is no list of ethically unacceptable procedures involving genetically modified or
cloned animals in Canada. CCAC guidelines, however, state that all protocols for
animal use need to be examined for their ethical merit and need to have undergone a
scientific merit review. If a study has the potential to cause the animals pain or
distress, special attention is warranted. Also, Animal Care Committees should
undertake a proportionality assessment, which means that the negative
consequences of the technology as regard reduced animal welfare and increased
risk of damage to the environment, should be balanced against the advantages that
may be obtained by using the technology, and should not approve research in which
harm to the animals exceeds the scientific promise of the study.
In 1998, the CCAC undertook to bridge the gap between animals in research and
actual production environments to ensure a complete and seamless oversight and
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regulation of animal welfare. The resulting framework was first implemented relating
to the use of animals for xenotransplantation.
5.2.4 Australia
Animal welfare is not regulated on a federal level in Australia, but through
state/territory legislation. The only aspect regulated on a federal level is the use of
animals in research. The Australian Code of Practice for the care and use of animals
for scientific purposes, published by the National Health and Medical Research
Council, and currently in its seventh edition, encompasses all aspects of the care and
use of, or interaction with, animals for scientific purposes in medicine, biology,
agriculture, veterinary and other animal sciences, industry and teaching. It includes
their use in research, teaching, field trials, product testing, diagnosis, the production
of biological products and environmental studies. The Code covers all live, nonhuman vertebrates and higher order invertebrates.
The Code provides general principles for the care and use of animals, specifies the
responsibilities of investigators and institutions, and details the terms of reference,
membership and operation of Animal Ethics Committees, the bodies responsible for
overseeing compliance with the Code. It also provides guidelines for the humane
conduct of scientific and teaching activities, and for the acquisition of animals and
their care, including their environmental needs.
5.2.5 New Zealand
In 1960, the Animals Protection Act was passed in New Zealand. An amendment in
1983 established the National Animal Ethics Advisory Committee and in 1987, the
Animals Protection (Codes of Ethical Conduct) Regulations required that all
organisations undertaking research, testing or teaching using animals be covered by
a code of ethical conduct approved by the Minister of Agriculture. The National
Animal Welfare Advisory Committee (NAWAC) was established in 1989 by the
Minister of Agriculture. Finally, in 1999, the Animal Welfare Act was introduced,
which replaces previous Animals Protection Act and Regulations.
The Animal Welfare Act provides that no research, testing or teaching may be carried
out on a living animal unless the person or organisation carrying out the research
holds an approved code of ethics conduct. Also, no such project may be carried out
unless the approval of an animal ethics committee has been obtained.
5.2.6 Summary of welfare legislation
Most jurisdictions have focussed on legislation with regard to the welfare of animals
used for scientific purposes rather than agricultural purposes. Although legislation on
farm animal welfare exists within the EU, its likely impact on the development of
cloning is not clear. A report by the UK Farm Animal Welfare Council (FAWC 2004)
concluded that there has been little detailed consideration of how Directive 98/58/EC
may be interpreted and enforced (although it notes that attempts have been made in
Germany to do so). There appears to be no one accepted method for evaluating farm
animal welfare. It is therefore possible that animal welfare legislation will become a
focus for discussion around the desirability or otherwise of animal cloning.
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SECTION 6 PUBLIC ATTITUDES
6.1 Introduction
The remit for this report was specifically not to focus on ethical aspects and public
attitudes as these are being covered by the Specific Support Action “Farm animal
cloning and the public”. Therefore, only a very cursory consideration of these aspects
is included in this report. Given the likely importance of these factors to the
development of cloning technology, it was not possible to ignore public attitudes all
together.
Public attitudes have been assessed by opinion poll surveys and in focus groups.
Opinion poll data measure attitude to specific questions at a specific point in time, in
a specific context and may not explain why respondents hold the attitudes that they
do. This can make them difficult to interpret. Focus groups access smaller numbers
of individuals but achieve more in-depth understanding of the motivations for specific
attitudes. On the other hand, focus group results are relevant only to the small
number of individuals who take part and cannot be generalised to the population
level in the same way as a randomly sampled opinion poll. Most of the data
summarised here relate to attitudes in Europe.
6.2 European attitudes to cloning animals
According to the 1999 Eurobarometer survey, cloning animals for medical purposes
is widely rejected whilst cloning human cells and tissues for similar purposes
received moderate support.61 Gaskell (2000) suggests that the public are making
judgements not just on the basis of the biotechnological technique being used but
also taking into account the specific application. Cloning of animals was negatively
viewed in this report in most countries except Portugal, Finland and Spain, although
the reason for these differences is not clear.
In a more recent special Eurobarometer survey62, 31% of the European public
condemned the practice of cloning animals for research into human diseases, 22%
could accept it in exceptional circumstances and 35% could accept it if highly
regulated and controlled. However, the specific question asked was to what extent do
you approve of “Cloning animals such as monkeys or pigs for research into human
diseases”. The responses may be difficult to interpret given the reference to cloning
monkeys which may evoke a much stronger negative response than cloning pigs.
The above survey also found that more citizens in Switzerland (50%), Luxembourg
(49%) and the UK (44%) would condemn this practice than in other countries
surveyed. Approval was highest in Spain (47%), Belgium (46%), Hungary 44% and
Estonia (43%) (percentage indicates the percentage of respondents saying they
would approve of cloning animals for medical purposes for the sake of human health,
if this was highly regulated and controlled), although the reasons for these
differences are not clear.
A recent Eurobarometer survey of attitudes to the welfare of farmed animals63 found
that a majority of those surveyed (55%) stated that animal welfare had not received
enough importance in the agricultural policy of their countries. This may result in
particular sensitivities to the use of cloned animals unless consumers are re-assured
that the welfare issues have been addressed. However, it should also be noted that
the public were also not well aware of the legislation that does exist, with only 44% of
61
Gaskell, 2000
62
Eurobarometer 2005 a
63
Eurobarometer 2005 b
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respondents believing that European Union legislation exists in the area. There was
also a wide range between countries with 73% of respondents in Finland believing
that EU legislation on farm animal welfare exists, compared to only 33-40% in Italy,
Denmark, UK and France. The low awareness of legislation has also been noted in
other scientific areas such as human cloning.64
Generally, there appears to be a negative attitude to cloning, but these surveys are
not able to identify where this attitude arises and how liable it is to change (in either
direction).
Whilst recognising that there will always be a sector of the public who will object in
principle to the process of cloning animals, there is a need to identify what are the
causes of the more widespread negative attitudes. For example, are attitudes
consistent across all possible motivations for cloning? Are there differences
depending on whether farm animals, companion animals or ‘wild’ animals are
involved? Are there any concerns that can be addressed?
6.3 Ethical discussions around animal cloning
Again, since this is not a focus of our report, it is not appropriate to provide a
thorough review of the ethical discussions around cloning. However, we may note
that the ethical discussions around cloning illustrate two different approaches
involving different degrees of ‘principle’. The first type of argument is based around
the consequences of animal cloning rather than invoking issues of principle. With this
type of argument it may be possible to achieve accommodation by addressing the
adverse consequences of animal cloning. The second approach is rooted in
questions of principle and it is therefore unlikely to be addressed by addressing the
adverse consequences of animal cloning.
The first type of approach is illustrated by the UK Farm Animal Welfare Council (an
independent advisory body set up by the UK Government). This Council reported in
199865 on the subject of implications of cloning for the welfare of farmed livestock
and concluded that:
(p5) “We found no aspect of cloning by nuclear transfer which we felt was
intrinsically objectionable to the extent that it might be considered
something that should not be done at all. Nevertheless, the issues of
violation of integrity, unnaturalness, and the creation of ‘artefacts’ offered
extremes which, in the absence of suitable controls, might well result in
significant insult to the nature of welfare of the animals involved”.
The report concluded that there should be a moratorium on the use of cloning by
nuclear transfer in commercial agricultural practice (until the welfare problems have
been resolved) and that regulation to give protection to cloned farmed animal
livestock similar to that enjoyed by research animals should be introduced (neither of
these recommendations has been enacted). The notable feature in the argument
made is that there was no basis for ‘intrinsic’ objections and an opening was left for
the application of cloning.
Other groups come from a principled position where the welfare of animals and the
way in which we think about them is paramount. This approach might be
represented, for example, by the organisation Compassion in World Farming. In its
64
Hargreaves et al. 2003
65
Farm Animal Welfare Council, 1998
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report on cloning66 the following statement is made which seems to indicate a very
strong, resistance to cloning animals:
(p9) “Compassion in World Farming Trust believes that all the evidence
shows that genetic engineering and cloning can have no place in the
future of sustainable animal husbandry. Up to now these technologies
have cost the suffering and the lives of countless farm animals with no
benefit to either farmers or consumers. This waste of animals’ lives and
society’s resources is a strong argument for a moratorium on all such
experiments and a redirection of scientific resources towards research
into animal health and welfare in sustainable agriculture”
From a literature survey from a range of different bodies, the main arguments made
against cloning can be summarised as:

the animal suffering involved

wider dangers of narrowing the gene pool

slippery-slope to humans

commodifying animals

the existence of patents encourages a wrong approach to animals

doing this for the wrong motives (profit)

doing this in secret (in companies)

it’s the wrong way of doing agriculture

cloning may be most applicable to ‘least-cost’ agriculture

cloning may disadvantage small farmers

no benefit to developing countries.
It is notable that ‘risk’ from cloned animals is not currently part of the wider
discussion. However, regulatory efforts tend to focus on risk and to some extent
animal welfare as issues which can be legislated. Ethical issues tend to be very
contentious, reflect considerable disagreement among publics and therefore, in most
cases, may pose particular difficulties for policy makers and regulators.
66
Compassion in World Farming Trust, 2002
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SECTION 7 EU POLICY CONTEXTS
It is beyond the remit of this report to consider the full-range of policy contexts within
which animal cloning exists and only a brief summary of some issues is provided
here.
7.1 Ethical policy
Some attempts have been made within the European policy making context to
address issues around the ethical acceptability of cloning animals, notably through
the Group of Advisers on the Ethical Implications of Biotechnology to the European
Commission.
In May 1997, the Group of Advisers on the Ethical Implications of Biotechnology to
the European Commission published its Opinion on Ethical Aspects of Cloning
Techniques67. In this Opinion, the Group of Advisers reached the conclusion that
cloning farm animals for research is acceptable if carried out under certain ethical
conditions. These conditions include the duty to avoid or to minimise animal
suffering, the duty of reducing, replacing and, whenever possible, refining the
experiment, the lack of better alternatives and finally the human responsibility for the
animals. The Group of Advisers further emphasised the need for maintaining genetic
diversity in farm animal stocks. The reason given for the permissibility of animal
cloning under these conditions was that such research was likely to add to
knowledge and understanding of biological processes.
7.2 Research funding policy
The EU has also addressed issues of cloning under the Fifth Framework Programme
for research. Two projects examined some of the implications of animal cloning,
namely “Mammalian Cloning in Europe: Prospects and Public Policy” and
“Sustainable European Farm Animal Breeding” (SEFABAR). The first project
incorporated a general study of animal cloning which reached the conclusion that, for
further development of animal cloning, the techniques needed further refinement,
risks needed to be limited, that broad social support was required and that significant
commercial interest in the application of cloning as well as a permissive regulatory
environment was needed. The second project studied the role of biotechnology in
livestock breeding to determine sustainable, economic and publicly acceptable
breeding scenarios. The conclusion was reached that, while considerable dialogue
took place, a lack of consensus still existed between breeders and animal welfare
groups.
7.3 Agricultural context
One of the main policy arenas under which cloning is envisaged is the context of
agriculture. In the EU68 this is dominated by:

Enlargement of the EU and the increased range of agricultural production
systems that this has introduced.

Negotiations within the WTO which aim to establish a fair market worldwide for
agricultural products. For the EU this implies facilitating access to its markets
which already face competition from lower-cost producers (for example in Asia
and South America).
67
Opinion of the group of advisers on the ethical implications of biotechnology to the
European Commission. Ethical aspects of cloning techniques, 28 May 1997
68 European
Communities, 2003
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
Reform of the Common Agricultural Policy in order to reduce the burden on the
taxpayer and hence reduced subsidy for agricultural production.
Schakel and van Broekhuizen69 undertook a sociological study of animal breeding
practices in USA, Thailand and several countries in Europe, as part of one of the EC
funded studies referred to in 7.2 (SEFARBAR). Schakel and van Broekhuizen found
that in all countries there is a struggle between meeting the requirement of a
globalised food market and local production practices and requirements. Their
findings included the following:

Norway has a strong emphasis on maintaining rural communities and a political
tradition of collective action. Norwegian animal breeding strategy is based on cooperative action of individual farmers and breeding goals tend to be broad with
relatively little weight on production traits.

Italy has a strong eating culture and cares about food products. Italy cannot
compete on a cost-price basis on world markets and therefore has to compete on
the quality of products, e.g. Parmiggiano-Reggiano cheeses, etc., many of which
have a strong link with the locality in which they were originally produced.

In France, animal breeding practice is strongly embedded in the different regions.
Products such as Label Rouge do not primarily refer to notions of welfare and
ethics but to food quality.

Dutch animal breeders, however, want to be ‘world-players’. Genetic material
comes from all over the world and is distributed all over the world, although there
are some small ‘alternative’ breeders.

In the USA, globalisation pressures are strong with its features of increasing
scale of production, concentration of industries and industrialisation of agricultural
production. Whilst there are initiatives to help small family farmers, these
initiatives are mainly small, scattered and not able to link to distinctive products in
particular areas.
69
Schakel and van Broekhuizen, 2004
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SECTION 8 CASE STUDIES
8 Case Studies
Three case studies are presented to illustrate the range of potential uses of cloning in
food production, the breeding of pets and endangered species. Each Case Study is
followed by a roadmap.
Our approach to mapping is supported by a software programme, Decision
Explorer70, which has been used to develop the examples given here. The roadmaps
are based on the following conventions:

Roadmaps consist of ‘nodes’ or ‘concepts’, joined by ‘links’. Concepts are colourcoded so a range of different attributes and processes can be distinguished on a
single roadmap.

Concepts are expressed as short statements, each covering a single idea or
notion, for example the causes driving the introduction of cloned animals. In a
few instances, the statement may be expressed in terms of two contrasts, so that
where there is ‘…’ in the middle of a concept, this indicates X ‘rather than’ Y.

Links Concepts are linked by arrows indicating a causal link, i.e. A ‘may lead to’
B. Links act in the direction of the arrow and are positive except where a negative
sign is attached to the causal link, in which case the link is negative.
Different colours are used for different types of concept:

Pink – indicates the central concept

Yellow – indicates regulatory issues

Blue – indicates commercial issues

Green – indicates public acceptability issues

Purple – indicates technical issues

Orange – indicates political issues
These maps are a way of summarising the information given in the case studies and
demonstrating clearly the linkages between various aspects of the different
applications of cloning that will enable comparison between cloned and GM animals
(as presented in Report 3).
70
Banxia Software. Decision Explorer, www.banxia.com
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8.1 CASE STUDY ONE: Cloning to produce pigmeat, beef and milk
8.1.1 Aim
Possible applications include:

Cloning individual elite boars of very high genetic merit for widespread use in pig
meat production. Cloned sires would be the parents or grandparents of slaughter
pigs.

Identifying extremely high merit beef animals for carcase quality traits at
slaughter and clone male cattle from the cells of this carcase.

Cloning high-value dairy bulls.
In the longer term, use cloning to ensure that all calves born to commercial dairy
cows could be of the desired sex and type. Cloned cattle could also be exported to
countries that do not have an infrastructure that allows export of frozen semen, as is
more usual.
8.1.2 Markets
We have not been able to identify any ‘approved’ commercial use of cloned animals
in the food sector anywhere in the world, but there are growing numbers of cloned
livestock in private hands, particularly in the USA. There is a widely held view in the
industry that cloned livestock will enter the human food chain somewhere in the world
before 2010. Cloned pigs and beef cattle are likely to be used as parents of slaughter
animals rather than meat being produced from clones themselves. Economic
calculations suggest that cloned pigs could be produced profitably but the cost of
cloning dairy cows is still likely to be prohibitively high for widespread use. We have
identified four companies worldwide involved in producing cloned animals for food
production (two in the USA, one in Australia/New Zealand/Asia and one in China –
but note that we experienced significant difficulty obtaining information from Asia).
8.1.3 Technical aspects
Two differing views have been expressed regarding the technical barriers to cloning.
Some people believe there are now few barriers. The technology works and has
been sufficiently improved in efficiency to be economically viable. Conversely, others
have expressed concern that the efficiency of cloning is still rather low, there are
significant welfare issues with the process of cloning and there is still much to learn
about the long-term viability of clones. It is possible that commercial companies have
resolved the welfare issues associated with Large Offspring Syndrome, but until
published information becomes available, this is impossible to verify.
8.1.4 Drivers
Drivers are primarily economic, benefits are given as improved efficiency, reduced
production cost per unit output, improved quality and improved consistency of
product. The market for cloned meat and milk may be primarily in commodity markets
but a niche market for very high quality beef may exist in specific cases, for example
Japanese marbled beef sells at prices (e.g. $100/kg) an order of magnitude higher
than imported Australian or US beef.71
Significant economic benefits have been calculated for the use of cloning for beef
and pigmeat production (although less so for milk production).
71
Inaba and Macer, 2003
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The intellectual property situation for cloning is complex and is cited as a barrier to
developments in cloning. In an endeavour to simplify this, some larger companies
have formed separate holding companies to own and manage the IP.
The majority of factors discouraging the availability of meat and milk from cloned
animals are likely to be related to public acceptability whereas the factors
encouraging the availability of meat and milk from cloned animals is related to a
complex web of regulatory, technical, economic and political issues.
8.1.5 Regulation
In the EU generally animal cloning in its experimental stages is regulated though
animal experimentation laws, whilst animal cloning as a commercial enterprise
remains unregulated. The Netherlands will only allow animal cloning on a ‘No-Unless’
basis – no animal cloning unless the application is of substantial importance for
society and there are no alternative ways of reaching the goal. In Denmark,
legislation restricts animal cloning to research applications and does not allow
applications for agricultural purposes.. Norway was the first country in Europe to
legislate on cloning and has prohibited cloning except for research purposes.
GM regulation may generally not be applicable to cloned animals. Cloned and GM
animals are considered to occupy a different ‘risk-space’ because GM animals
involve a transgenic event which is accompanied by a series of construct specific
risks and brings in a different set of regulations.
Cloned animals for food in the EU are likely to be subject to novel foods regulations
but the situation regarding progeny or grand-progeny of clones is not clear.
Animal welfare legislation in the USA does not apply to farm animals and therefore
excludes cloned animals. Farm animal welfare legislation in the EU could limit the
use of cloning if cloning was viewed as harming welfare. However, there is no clear
definition of good welfare.
The use of clones in food production in the USA is currently subject to a voluntary
moratorium until FDA guidance is available. Lack of regulatory decision from the FDA
on cloning is claimed to be the main barrier to uptake of cloning in the USA. Based
on the draft assessment, there is likely to be no regulatory or labelling requirement
for cloned farm animals in the USA.
Formal, legally binding risk assessment procedures have not yet been established in
any country. The USA is probably at the forefront of initiatives to assess risks from
products derived from cloned animals, although work has also been carried out in
Japan and is currently being undertaken in France. A draft risk assessment published
in the USA concludes that ‘edible products from the progeny of healthy clones are
likely to be as safe to eat as the corresponding products of progeny from
conventional animals’.
It is currently not possible to identify whether an individual animal has been cloned.
Any labelling requirements would rely on traceability.
With differences among national regulatory and risk assessment approaches to
cloned animals, with many regulatory systems not yet established and a lack of
diagnostic tests for policing regulations, there exists a possibility of international trade
disputes over the trade of cloned animals and semen and embryos from clones as
well as meat and milk produced from these animals.
8.1.6 Special issues
Cloned farm animals (particularly cattle) have already been produced using a
different technique (embryo splitting). These are commercially available without any
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extra regulation. Therefore, there may be a need to differentiate among different
technical routes to achieving cloning.
8.1.7 Public attitudes
According to a recent Eurobarometer survey, cloning animals is negatively viewed in
most European countries.
Public statements by industry representatives promoting the technology have sought
to distinguish between GM and cloning, whilst accepting that this distinction may be
lost on the public.
Some objections from pressure groups are on the basis of the suffering involved,
narrowing the gene pool for agricultural animals and potential for developments in
animals to normalise the technology that could then be extended to humans; other,
more intractable objections arise from principled opposition to the technology.
8.1.8 EU competitiveness
There appear to be no European companies planning to use cloned animals in the
food chain. There appears to be no regulation that would prevent importation of
cloned animals (or embryos or their semen) to the EU. Import of meat or milk from
cloned animals would be likely to be subject to the Novel Foods Regulations,
assuming that there was a declaration that the product was from cloned animals
(they would be undetectable otherwise). Legislation prohibiting cloning is likely to
decrease economic competitiveness of producers, compared to jurisdictions that
permit cloning. Competitiveness of European-based international companies
supplying breeding stock could also be affected by the use of cloning, although this is
difficult to predict.
8.1.9 Alternative approaches
These applications primarily represent improvements in ‘efficiency’ rather than novel
developments.
In the following two roadmaps, the drivers encouraging and discouraging the
availability of meat and milk from cloned animals are plotted on two separate maps to
aid clarity.
48
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Figure 1 Roadmap demonstrating the drivers encouraging availability of meat and milk from cloned animals in the EU
Meat and milk f rom
cloned animals
available in the EU
No regulatory
bariers to import of
products f rom cloned
animals by EU
countries
Increasing pressure
on EU f armers f or
least cost
production
Increasing
international
competition in
agricultural
commodity markets
Pressure in WTO to
deregulate markets
in agricultural
products
No special
regulatory barriers
to import of cloned
animals, embry os or
semen by EU
countries
No special barriers
to international
movement of cloned
animals, embry os &
semen
Cloned animals and
products are
produced in the EU
Scientif ic
breakthroughs
No labelling
requirement within
EU
EU Novel f oods
regulations
Semen f rom cloned
animals, cloned
embry os & animals is
imported by EU
countries
Cloned animal
products are
imported by EU
countries
Better understanidng
of cloning process
Cloned animals
developed in
commercial companies
outside EU
Investment in
research by industry
No international
trade agreements on
movement of cloned
animals, embry os or
semen
Public f unding f or
research into stem
cells
Public f unding f or
cloning research
Improved product
quality
Positive economic
evaluation
Improved product
consistency
Potential huamn
benef its f rom stem
cell research
49
Reduced production
cost per unit
No special
international trade
agreements on
movement of products
f rom cloned animals
No f ood risk
demonstrated f rom
products f rom cloned
animals
No regulatory
barriers f or
products f rom cloned
animals within EU
Improved welf are and
ef f iciency of
production of clones
Pressure to reduce
CAP support f or EU
f armers
No special
regulatory barriers
f or products f rom
cloned animals in
international
markets
No method f or
testing f or cloned
animals
No method of testing
f or products f rom
cloned animals
CONFIDENTIAL
Figure 2 Roadmap demonstrating the drivers discouraging availability of meat and milk from cloned animals in the EU
EU welf are
regulations may
prevent EU farmers
f rom producing
cloned animals
Meat and milk from
cloned animals
available in the EU
-
-
-
-
Fear of risks of
consuming products
f rom cloned animals
EU Novel f oods
regulations ... GM
regulations
No EU companies
currently involved
in producing cloned
animals f or
agricultural
production
Pressure to reduce
treatment of animals
as commodities
Concern about poor
animal welf are
Lack of public
acceptability
No requirement to
label products from
cloned animals in EU
Negative
connotations around
cloning
Regulatory
uncertainty
FDA regulatory
requirements f or
products of cloned
animals not yet
published
Welf are concerns
about cloning donor
and recipient
animals (eg need f or
surgery)
Lack of choice
whether to consume
products f rom cloned
animals
Poor welf are of
cloned of f spring
(Large Of f spring
Syndrome)
Association with
human cloning
Involvement of
commercial companies
Association with GM
No international
requirement to label
products f rom cloned
animals
Increasing
production of high
value animal
products f or
domestic consumption
by EU f armers ...
least-cost commodity
products
Pressure to reduce
intensive
agriculture
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8.2 CASE STUDY TWO: Cloned pets
8.2.1 Aim
Aimed at replacing pets that die, particularly if they leave no offspring because they
have been neutered.
A small number of cloned horses, rodeo bulls and mules have also been produced.
Many sports horses are castrated males and therefore once a well-performing animal
has been identified, it is not possible for that animal to reproduce normally. Cloning
may be an attractive alternative.
8.2.2 Markets
A US company has reportedly cloned three cats. A Korean research team has
recently succeeded in cloning a dog. The first cloned cat was reported in February
2002, the first cloned dog in July 2005.
8.2.3 Technical aspects
The physiology of the dog meant that cloning this species has been more difficult
than some others.
8.2.4 Drivers
The desire to clone a pet may be driven by individual decisions in contrast to the
production of meat and milk from clones where economic advantage in a commodity
product may be the driver.
8.2.5 Regulation
There is no specific regulation relating to commercial pet cloning in the USA.
Attempts by the American Anti-Vivisection Society to persuade US Department of
Agriculture to legislate failed, as did an attempt to ban pet cloning in California.
European legislation covers experimental animals and aspects of animal welfare.
There is no legislation on cloning pets per se. Pets are covered by the general animal
welfare legislation. Import of cloned pets into the EU would be governed by
Regulation 998/2003 regarding animal health requirements.
Several horse racing bodies have banned the use of cloning but other sports using
horses (e.g. show-jumping, cross-country, dressage) have not legislated against the
use of cloning.
8.2.6 Special issues
In some countries, there is the potential for cloned horses to enter the human food
chain. Similarly, cloned horses and other animals could be included in pet food.
8.2.7 Public attitudes
No data available, although pets may have higher emotional value than other
animals.
8.2.8 EU Competitiveness
No data available.
8.2.9 Alternative approaches
None obvious.
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Figure 3 Roadmap demonstrating the drivers for cloned pets
Cloned pet dogs and
cats appear in the
EU
Companies are set up
within the EU to
provide service to
clone cats/dogs
-
Welfare concerns
about cloned cats
and dogs
-
EU animal welfare
regulation may
prevent production
of cloned cats/dogs
in the EU
-
Incentive to replace
pets which die
Negative
connotations of
cloning
-
Individual
commissions a clone
of their pet cat/dog
Uncertainty about
economic aspects of
cloning cats/dogs
-
Companies are set up
outside the EU to
provide service to
clone cats/dogs
Pet dogs and cats
have high emotional
value
Cloned dogs and cats
are produced outside
EU countries
-
Cloning dogs is
technically
challenging
Only few cloned cats
produced to date
Only few cloned dogs
produced to date
No international
regulation on
transboundary
movement of cloned
animals
Dog reproduction is
difficult to work
with
Uncertainty about
the technical
aspects of cloning
52
Cloned dogs and cats
could be imported to
EU countries without
special regulation
Potential for
welfare problems to
exist
CONFIDENTIAL
8.3 CASE STUDY THREE: Cloning endangered species of animals
8.3.1 Aim
Cloning individuals from a rare specie is considered potentially useful where a
species (or breed) has a very small number of individuals and one of these dies
(particularly without reproducing). Cloning is a way of recovering the genes lost
through death of individuals and allow these to produce (more) progeny. Cloning will
of course not be a way of increasing the amount of genetic diversity. Cloning
applications to rare species are therefore only likely to have niche applications.
Species which have been cloned include mouflon, banteng and African wild cat.
Cloning has reportedly been considered for the Giant Panda but, to our knowledge,
has not yet been successfully applied.
8.3.2 Markets
Not an economic activity.
8.3.3 Technical aspects
Somatic Cell Nuclear Transfer is technically very challenging for rare species
because their reproductive biology is generally not well understood. Lack of egg
donors and suitable recipients may also be an issue.
8.3.4 Drivers
For endangered species, the main issue determining whether cloning is adopted or
not is the balance between the technical difficulty of cloning endangered species
against the likelihood of potential conservation benefit.
8.3.5 Regulation
No special regulation. May be subject to animal research legislation in some
jurisdictions.
8.3.6 Special issues
None
8.3.7 Public attitudes
Interest groups argue that the main reason that species become endangered is loss
of habitat and cloning will not help with this (and may even be a distraction). No data
are available on general public attitudes.
8.3.8 EU Competitiveness
Not relevant.
8.3.9 Alternative approaches
Maintain populations in other ways.
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Figure 4 Roadmap demonstrating the drivers for cloned endangered species
Cloned animals are
produced in EU zoos
Animal from
endangered species
is cloned to
reinstate lost genes
Endangered animal
species has very
small number of
individuals
Large impact of
death of an
individual animal on
the population
-
-
Cloned animal from
endangered species
has chance to
reproduce and
multiply
Loss of genes from
population of rare
species
Large impact if
individual animal
cannot reproduce
Lack of genetic
variation threatens
endangered species
Cloning success is
low
-
Lack of suitable
recipients for
cloning
Endangered species
is maintained
Cloning is difficult
in practice
-
Few egg donors
available for
cloning
Loss of habitat
threatens endangered
species
Cloning is
technically
challenging
Reproductive system
of rare species not
well understood
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SECTION 9 REFLECTIONS
9.1 Conclusions
There is a widely held view that cloned livestock (especially pigs and cattle) will be
used within the food chain somewhere in the world before 2010. The expectation is
that clones will be used as parents or grand-parents of slaughter pigs and beef cattle
rather than the clones themselves being consumed. The main argument for the use
of cloned parents is economic. Companies have been established and are working in
this area in USA, Australia/New Zealand and China.
Meat (and potentially later milk) from the progeny of cloned animals is the most likely
area in which EU competitiveness may be affected. Commercial sources assert that
welfare concerns around cloned animals have been resolved. However, in the
absence of data in the public domain this is impossible to verify.
Application of cloning to meat products may affect EU competitiveness through:

Competitiveness of European-based international breeding companies selling
breeding pigs and cattle.

Competitiveness of large meat producing companies and whether they can take
advantage of this technology.

Competitiveness of small producers (e.g. family farms) who may not be willing to
adopt this technology, although there are likely to be few technological or
economic barriers for them to do so.

Competitiveness of meat produced in the EU and meat produced elsewhere in
the world. However, it is already difficult for European livestock farmers to
compete with lowest-cost producing countries in for example South America and
Asia.
Consumers may tend to discriminate among production methods used for raw
ingredients rather than processed foods. Therefore, there may be more tolerance of
technological methods of production for processed foods than for raw ingredients.
Raw ingredients are more likely to be locally produced whereas processed foods are
more likely to be based on imported ingredients on a least-cost basis. The net effect
is likely to disadvantage local production.
Cloning as a niche application to endangered species appears to raise few
immediate issues for the EU. Limited cloning of pet dogs and cats has taken place
around the world but is very difficult to evaluate what the uptake of the technology is
likely to be. Potentially, we could envisage import of cloned pets to the EU or, if
economically viable, companies establishing in the EU to clone pets. Similarly, limited
numbers of cloned horses have been produced but it is very difficult to evaluate what
the uptake of the technology is likely to be. The application is in a specialised area
and it is impossible to evaluate the impact cloning would have on, for example, EU
competitiveness with respect to sports horses.
Attitudes of the European public to cloned animals appear to be more negative than
positive. However, there are little data to understand what underlies this attitude and
how stable the attitude is with respect to different applications and circumstances.
The work of the “Farm animal cloning and the public” project to understand these
aspects better is therefore welcomed.
The development of cloning in the commercial environment may have negative
connotations, for example, meat from cloned animals in order to improve production
efficiency may be perceived as providing ‘mere’ economic advantage and therefore
less justified than some other applications of cloning technology. There are likely to
be sectors of the publics for whom animal cloning is unacceptable whatever the
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circumstances. Therefore, it may be expected that there will be pressure to legislate
against the use of cloned animals (either on the basis of welfare or risk concerns).
There is likely to be competition in the public framing of cloning (i.e. the context in
which cloning is placed). It is difficult to envisage who, apart from industry, will be
providing a positive framing, and industry may tend to hold back from taking part in
such debates due to the sensitivity of the issues.
Currently, GM regulation in the EU does not appear to apply to cloned animals.
However, novel foods regulation and welfare regulation are likely to apply. It is
therefore probable that risk assessments will be needed according to novel foods
regulation. However, in the limited data available to date, there are no indications of
major differences between meat and milk from cloned and non-cloned animals. The
forthcoming data expected from INRA comparing cloned and non-cloned animals is a
welcome addition to this knowledge-base.
The welfare of cloned animals produced under commercial conditions is subject to
debate. The application of welfare legislation to farmed animals in the EU does not
clearly define what is acceptable welfare and what is not. It is therefore not clear
what the likely welfare issues will be or how these will be resolved.
There may be pressure to label meat and milk from cloned animals. Since there is no
way of detecting whether products come from cloned animals or not, labelling will
need to be on the basis of traceability. This may be feasible for small, niche markets
but is likely to be unenforceable for large-scale, commodity products. However, this is
a situation that already exists for foods derived from GM crops.
Cloning research is primarily taking place in commercial establishments. Therefore
there is a need to ensure EU capability in cloning is maintained in the public sector, if
only to ensure that academic expertise is available to advise Governments (although
it should be noted that increasingly many academics also hold commercial
contracts).
Whilst public debate is to be welcomed, it should not be assumed that debate will
result in acceptance of the technology. The opposite may well be true as debate may
stir-up anxieties that might not otherwise become apparent and provide a platform to
legitimise ‘in principle’ objections to the technology. There are likely to be a plurality
of opinions about cloning.
Public attitudes (or the action of pressure groups) may encourage legislation on
cloning and this may increase cost and reduce competitiveness. Regulators may be
faced with the dilemma of how to make evidence-based decisions about value-based
issues.
There is no clear regulation on international trade in cloned animals, their progeny
and products from cloned animals. Initial risk assessments suggest that there will be
little or no regulation in some jurisdictions. There is therefore the potential for trade
disputes in this area.
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SECTION 10 REFERENCES
AEBC (2002) Animals and Biotechnology: A Report by the AEBC (London, UK:
Agriculture and Environment Biotechnology Commission)
Archer, G.S., Friend, T.H., Piedrahita, J., Nevill, C.H., Walker, S. (2003) Applied
Animal Behavioural Science, 81, 231-233
Bourbonnière, L. (2004) SCNT cloning: What are the issues? Canadian Food
Inspection Agency, Animal Health and Production Division
Compassion in World Farming Trust (2002) The gene and the stable door:
biotechnology and farm animals, A report for the Compassion in World Farming
Trust written by Dr Jacky Turner
De Simone, F. and Serratosa, J., ‘Biotechnology, animal health and animal welfare
within the framework of European Union legislation’ (2005) ) Rev. sci. tech. Off.
Int. Epiz. 24 (1):89-99
Duncan IJH and Fraser D (1997) ‘Understanding Animal Welfare’ in Appleby MC and
Hughes BO (eds.) Animal welfare, CAB International, Wallingford, UK, pp 1931
Eurobarometer (2005a) Social values, Science and Technology
Eurobarometer (2005b) Attitudes of consumers towards the welfare of farmed
animals
European Communities (2003) New Vision on European Food and Agricultural
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SECTION 11 APPENDICES
Appendix 1 Acronyms
ACGM
Advisory Committee on Genetic Modification (UK)
ART
Assisted Reproductive Technologies
CFSAN
Centre for Food Safety and Applied Nutrition (FDA)
CVB
Centre for Veterinary Biologics
CVM
Centre for Veterinary Medicine (FDA)
EFSA
European Food Safety Authority
ERMA
Environmental Risk Management Authority (New Zealand)
FDA
Food and Drug Administration (USA)
FSANZ
Food Standards Australia New Zealand
FSIS
Food Safety & Inspection Service (USDA)
GMO
Genetically Modified Organism
HSE
Health & Safety Executive (UK)
HSNO Act
Hazardous Substances and New Organisms Act 1996 (New
Zealand)
LMO
Living Modified Organism
LOS
Large Offspring Syndrome
SCNT
Somatic Cell Nuclear Transfer
USDA
United States Department of Agriculture
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