1 Animal cloning for
food production
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15277/10
COM(10) 585
| Commission Report on animal cloning for food production
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| Legal base | —
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| Document originated | 19 October 2010
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| Deposited in Parliament | 22 October 2010
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| Department | Environment, Food & Rural Affairs
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| Basis of consideration | EM of 18 November 2010
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| Previous Committee Report | None
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| To be discussed in Council | No date set
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| Committee's assessment | Politically important
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| Committee's decision | For debate in European Committee A
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Background
1.1 The Commission observes that cloning[1]
is a relatively new breeding technique which allows for the asexual
reproduction of animals which have shown good productivity, low
incidence of disease and the ability to cope with the production
environment. It says that the aim of this report is to assess
the technology as it applies to food production, looking at such
aspects as food safety and the health and welfare of the animals,
as well as the ethical and trade implications and the rights of
consumers.
The current document
ANIMAL WELFARE ISSUES
1.2 The Commission notes that opinions produced by the European
Food Standards Authority (EFSA) over the last two years or so
suggest that, although no differences had been found in the food
safety of milk and meat from clones and their offspring as compared
with that from conventionally bred animals, cloning presents a
number of welfare problems. First, a large number of cloned embryos
fail to develop to term, and a significant proportion of those
which do die during (or shortly after) birth from cardiovascular
failure, respiratory problems, liver or kidney failure, immuno-deficiencies
or musculoskeletal abnormalities, with the mortality rate being
considerably higher than in sexually produced animals. It says
that the overall success rate for cloning procedures is less than
10% in bovine animals and between 5 and 17% in pigs, though it
adds that studies outside Europe show that the survival of the
progeny of clones (around 85%) does not differ to any significant
extent from conventionally bred animals.
1.3 The Commission adds that the EFSA has also highlighted important
welfare issues for surrogate cattle dams which suffer from late
gestational losses and more difficult delivery. In addition, clones
may be unusually large, giving rise to "large offspring syndrome"
(LOS), which is a common problem in cattle and sheep clones (but
not in pigs), and some abnormalities may not show up until later
in life, whilst other underlying frailties may not do so until
the animal is stressed in some manner. The Commission suggests
that, in order to assess correctly the impact of cloning on animal
welfare, it is important to consider how the technique is likely
to be used within the livestock sector: thus, whilst the cloning
of the fastest growing and high yielding animals may lead to a
higher proportion suffering from health and welfare problems,
the cloning of conventionally bred animals which are resistant
to certain diseases or which can easily adapt to difficult environmental
conditions, may have some possible welfare benefits.
ETHICS
1.4 The Commission notes that the European Group on Ethics in
Science and New Technologies (EGE) published in 2008 a report
on the ethical aspects of animal cloning for food production,
which expressed doubts on its justification, given the current
level of suffering and health problems of surrogate dams and animal
clones, and said that further research was also needed in relation
to the progeny of clones. It observes that the basic issue raised
by the EGE concerns the moral status attributed to animals, which
are seen by society either as mere possessions or to be given
respect in varying degree, such attitudes being influenced strongly
by cultural and religious traditions.
1.5 The Commission suggests that, in the case of
moral subjects, actions which affect health or welfare are seen
as difficult to accept, the view being that animals should be
used only under specific conditions where pain is minimised and
authorised in well-justified circumstances, based on the 3Rs (reduction,
refinement and replacement) principle and on the five freedoms
defined by the Farm Animal Welfare Council (freedom from hunger,
thirst and malnutrition, from fear and distress, from physical
and thermal discomfort, from pain, injury and disease, and from
constraints on normal patterns of behaviour). It adds that there
is an even stricter line which arises where animals are given
a moral value in themselves, and (like humans) are regarded as
moral entities because of their sentient capacities, those subscribing
to it concluding that they should not be used for human purposes
at all.
SITUATION IN THE MEMBER STATES
1.6 The Commission says that imports, trade and use
of products from clones (food, semen and embryos) are covered
by general EU legislation, but, as this does not include any notification
obligations (apart from a pre-market authorisation for meat and
milk under the Novel Foods Regulation (258/97)), it is not possible
to gain a complete picture of the overall situation. It says that,
apart from Denmark (which has imposed a ban on cloning for commercial
purposes), no other Member State has any specific legislation
on the use of cloning, though some have provisions relating to
possible pain and suffering associated with reproduction techniques.
However, a number of Member States —
including the UK — use cloning technology for research purposes
only.
SITUATION IN THIRD COUNTRIES
1.7 The Commission says that the United States is
the most advanced country as regards the cloning of animals for
food production, though a voluntary moratorium on the marketing
of meat and milk from cloned animals (but not on that from their
offspring, or from semen and embryos from clones) is in place
there. It adds that the situation is evolving in other countries,
such as Argentina, Brazil and Japan, and that China has expressed
an interest in the technique. Based upon information provided
by the three major US companies selling clones to farmers, the
Commission observes that, although precise figures are not available,
products from the offspring of clones have entered the food chain
in the US and elsewhere, and that, although there is an economic
incentive for farmers not to introduce clones into the food chain,
the fact that tracing of clones is not mandatory means that there
can be no guarantee that their milk does not enter the food chain
(although it is unlikely that it would be used for food purposes).
Against this background, the Commission says that it will strengthen
the dialogue with the EU's trading partners in order to explore
whether common ground can be found on cloning.
PUBLIC PERCEPTION AND STAKEHOLDER OPINIONS
1.8 The Commission says that an opinion poll it carried
out in 2008 showed that a majority had a "broadly negative"
perception of the use of cloning for food production, many being
concerned about the lack of information on the long-term consequences
and about the ethical considerations. There was also a feeling
that cloning for food production would not benefit the consumer,
and that this would not be more efficient in the long run or lower
the cost for consumers. However, 44% thought that cloning can
be justified in certain circumstances, such as improving resistance
to disease or preserving rare species. The Commission also notes
that animal rights groups have campaigned strongly against cloning
for food production in the EU, and have stressed the need to apply
strict measures to products from the offspring of clones, even
if such animals are produced through conventional breeding techniques,
and for them to be included in the EU's approach to cloning for
food.
1.9 The Commission says that it has discussed the
use of cloning with the agri-food sector, including the possibility
of a voluntary moratorium for a limited period on the use of clones
and their offspring, in order to prevent future regulatory options
being compromised by their appearance on the market. However,
the Association of European farmers and agri-cooperatives (COPA-COGECA)
takes the view that this would not be appropriate, because there
are currently no means, nor controls, to ensure full traceability
of imported products, or to legally pursue those who break the
moratorium. Also, the European meat processing industry believes
that products from cloned animals and/or their offspring are being
sold within the EU, and that a traceability scheme would be very
costly.
1.10 The Commission observes that both the European
Parliament and the Council expect it to work on a separate proposal
on all aspects of cloning. In the meantime, the Council has extended
pre-market approval under the Novel Foods Regulation to food from
the offspring of clones, whilst the Parliament has reiterated
its request for a total ban on animal cloning, on imports of live
clones and their offspring, and on the import of semen and embryos
from clones.
TRADE ISSUES
1.11 The Commission notes that breeding of the European
bovine herd takes place mainly through artificial insemination,
and that about 2.5% of bovine semen used is imported, almost all
from the US and Canada. On the basis of the information available,
it estimates that about 600,000 (or approximately 2%) of the calves
born in the EU in 2010 are progeny of US or Canadian bulls, and
it also points out that 747 consignments of bovine embryos were
imported in 2009 (though imports of live animals were much less
common).
1.12 The Commission points out that live animals,
animal products and food are covered by multilateral agreements
under the World Trade Organisation (WTO), notably the General
Agreement on Tariffs and Trade (GATT), the Agreement on Sanitary
and Phytosanitary Measures (SPS) and the Agreement on Technical
Barriers to Trade (TBT). It says that the relevance of each of
these provisions would depend upon the justification and nature
of any legislation drafted, but that it would in any case be necessary
to avoid any measures involving less favourable treatment of imports
or which ran counter to the requirement to eliminate quantitative
restrictions. It adds that, although exemptions are allowed in
line with international standards or based on scientific evidence,
there is no such evidence which could justify on health grounds
restrictions on food from clones and their offspring, and that
the most relevant exemptions would be those relating to animal
welfare. However, it stresses that WTO exemptions are subject
to strict requirements, including proof that they are needed to
attain the objective in question: this would involve showing there
is no less restrictive way of doing so ,and the measure being
applied in a non-discriminatory, non-arbitrary and non-trade-restrictive
manner.
LEGAL ASPECTS
1.13 The Commission points out that the applicable
EU veterinary and zootechnical law does not distinguish
between animals produced by different reproduction technologies,
as from a genetic perspective this does not affect the genome
or susceptibility to infectious diseases: and certificates accompanying
traded animals and animal products do not contain information
about the technology by which the animal was produced. On the
other hand, the relevant Council Directive (98/58/EC) on the protection
of farmed animals does enable cloning to be examined from a welfare
perspective, as does the corresponding European Convention, whilst
the Treaty on the Functioning of the EU states that animal welfare
needs must be fully taken into account in implementing EU policies
in a number of areas, including agriculture. Other EU legislation
relating to clones includes the traceability requirements
for food producing animals and the Novel Foods Regulation,
whilst, in the case of organic farming, forms of artificial
reproduction (apart from artificial insemination) must not be
used.
OPTIONS
1.14 The Commission concludes that, whilst it is
scientifically accepted that there are no food safety concerns
about food produced from clones or their offspring, the animal
welfare risks provide a solid basis for it to initiate legislation.
After identifying a range of options — including preserving
the legal status quo; a total prohibition on the cloning of farm
animals for food on EU territory, on the use of clones and on
the placing on the market of food from them, including imports;
on the placing on the market of the offspring of clones and food
arising from such offspring, and on the use of reproductive material
from clones — it says that it will propose to:
- suspend temporarily the use
of the technique in the EU for the reproduction of all food producing
animals, the use of clones of these animals, and the marketing
of food from clones;
- establish the traceability of imports of semen
and embryos to allow farmers and industry to set up data banks
of offspring in the EU.
It adds that the measure would be based on the appropriate
legal basis, with a review clause after five years, and that cloning
would remain possible for all purposes other than food production
(such as research, the production of pharmaceuticals, and the
conservation of endangered species or breeds). Also, it will during
the review period monitor the scientific and technical development
of cloning in order to assess whether, when and under which conditions
these provisional conditions could be removed.
The Government's view
1.15 In his Explanatory Memorandum of 18 November
2010, the Minister of State at the Department for Environment,
Food & Rural Affairs (Mr Jim Paice) says that the Government's
general view is that all regulation should be proportionate and
enforceable, safeguarding the principles of food safety and consumer
choice and guided by the principles of better regulation and evidence-based
decision-making. He adds that it recognises that cloning is not
a traditional breeding technique, and that approval therefore
needs to be sought under the Novel Foods Regulation before food
from clones themselves can be marketed, but it agrees that controls
should not apply to immediate offspring or later generations where
these are conceived by traditional breeding techniques. Also,
whilst recognising that cloning is a relatively new technique,
requiring the welfare of clones and their surrogate dams to be
protected, it believes that existing EU legislation is sufficient
to deal with welfare issues.
1.16 The Minister suggests that a ban, or temporary
prohibition, on cloning, the use of clones and the marketing of
food from clones is disproportionate in terms of food safety and
animal welfare, and he says that the UK will oppose the proposed
temporary suspension because insufficient evidence has been produced
to justify it, adding that the UK would need to see an Impact
Assessment which demonstrates the need for, and benefit of, a
new regulation. He also notes that the proposed traceability system
would require semen and embryos from cloned animals imported from
third countries to be identified as such on import certificates,
and that the cloned status of the parent would need to be included
on the import certificate. However, he suggests that the value
of any subsequent information system is open to question because
it would not deal either with offspring of clones already present
within the EU or with imported food derived from animals with
clones in their ancestry. He also points out that, if confined
to providing additional information on import certificates, implementation
would be relatively straightforward, but that adding information
to pedigree certificates would need amending legislation.
1.17 The Minister concludes by saying that an Impact
Assessment will be prepared when the Commission makes a formal
legislative proposal, but that a temporary ban on the use of cloning
techniques within the EU would have little impact in the UK, as
there are no companies here currently offering a commercial cloning
service. However, he adds that it is important not to deny to
UK industry technology which is available elsewhere in the world,
and which could be useful in bringing about more rapid access
to desirable traits, including resistance to disease. He also
notes that, although indicating on import certificates whether
semen or embryos derive from cloned animals would involve negligible
cost, if would be very expensive is this led to pressure to amend
official traceability schemes.
Conclusion
1.18 Compared with many similar documents, this
is a well presented report, which deals in a balanced and sensible
manner with a range of issues arising on this subject, and which
suggests that, although food safety may not be an issue in relation
to the cloning of animals for food production, this can give rise
to a number of welfare and ethical concerns. It also concludes
by saying that the Commission intends to put forward certain legislative
proposals, including a temporary suspension of cloning in the
EU for the reproduction of all food-producing animals, the use
of clones of these animals, and the marketing of food from clones.
1.19 This is evidently a topic of undoubted public
interest, and we note the Government's reservations about aspects
of the immediate course of action proposed by the Commission.
In view of this, we think this would be good opportunity for the
House to explore these issues further, and we are therefore recommending
that the report be debated in European Committee A.
1 Cloning is defined as replication by somatic cell
nuclear transfer to create genetic replicas. The report does not
cover embryo splitting or any form of genetic modification. Back
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