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Dear Malcolm

COVERING LETTER TEXT FROM MRS BECKETT

I am pleased to enclose the government response to the report of the Agriculture and Environment Biotechnology Commission ‘Animals and Biotechnology’. This response is submitted on behalf of the UK Government and the Scottish Executive.

We welcome the publication of ‘Animals and Biotechnology’ and thank members of the AEBC for their hard work in producing this report. The AEBC have chosen a very sensitive topic for their second report - Animals and Biotechnology. We welcome the AEBC’s early look at these issues and consider that the AEBC report provides a welcome contribution to the wider debate on GM issues.

A copy of this letter goes to Robin Cook, SCI(BIO), Sir John Krebs, Professor David King, Ross Finnie and Mike German.

Sincerely

Margaret

GOVERNMENT RESPONSE TO ANIMALS AND BIOTECHNOLOGY: A REPORT BY THE AEBC

This document sets out the Government’s response to the recommendations of the Agriculture and Environment Biotechnology Commission’s report ‘Animals and Biotechnology’

Introduction:

Government set up the Agriculture and Environment Biotechnology Commission (AEBC) in 2000 to look at social and ethical issues relating to the developments in biotechnology which have implications for agriculture and the environment and to provide strategic advice to Government on this important policy area. Its first report ‘Crops on Trial’ was published in September 2001. In this its second report it has taken a strategic look at the issues associated with animals and biotechnology and investigated the regulatory system to see if it could cope with future developments in GM and cloned animals in agriculture and the environment.

The Commission includes members with a range of interests from all sides of the GM debate. In preparing this report the AEBC gathered information about public attitudes and values, commissioned a literature survey and qualitative research on contemporary attitudes and sensibilities towards animals, reviewed the present legislation, consulted stakeholders and recruited a public reference group.

The AEBC has made seven recommendations in its report: one on legislation and enforcement, one on consumer choice, two on monitoring, one specific to fish being kept in contained premises, one to set up a new strategic, statutory advisory body and one to provide funding for engaging the public in decision making. This response deals with each recommendation in turn. Recommendations appear in bold text with the Government’s response set out below.

General response

Government welcomes the publication of the AEBC’s report and their early consideration of the issues associated with animals and biotechnology. The Government notes that the AEBC generally concluded that the issues facing GM and cloned animals should be considered in the same way as for animals selected through established breeding procedures, and agrees with this finding. Government notes however that the report is lacking in the consideration of GM in international development and global trade contexts.

Government recognises the rising trend in the number of scientific procedures involving the use of genetically modified animals which is now at over 600,000 per annum in the U.K. The vast majority (over 95%) of GM animals produced and used are mice. These figures reflect the growing importance of GM animals in allowing new areas of scientific research to be explored.

GM technologies allow a gene or sequence to be deleted, inserted or transferred in order to produce animals with particular characteristics. This technology has the potential to be used to breed livestock, companion and other animals which have improved production or performance characteristics or which exhibit beneficial traits e.g. resistance to disease, tolerance to environmental conditions.

The report is particularly helpful in setting out the possible applications of GM technology involving animals whilst also seeking to gauge the policy implications of possible public attitudes to such applications.

Recommendation 1

A new strategic advisory body should be set up by statute to examine issues raised by the use of genetic biotechnology on farm animals in the context of its use on other animals and current livestock farming practices.

Government agrees with the AEBC that the possible applications of biotechnology to farm animals needs to be considered. Government considers that animal welfare issues raised by the use of genetic biotechnology already fall to a number of advisory bodies including the Farm Animal Welfare Council (FAWC), the Companion Animal Welfare Council (CAWC) and the Animals Procedures Committee (APC). The AEBC’s report suggests a list of tasks that could be included in the remit of these bodies but it is not clear what a further body would add to the existing regulatory and advisory framework. Government would welcome further clarification from the AEBC on how a new statutory body would complement the existing infrastructure.

Government will invite the FAWC to establish a joint working party with members of the CAWC, the APC and a representative from DfID to give further detailed consideration to AEBC’s recommendations and in particular to consider whether there is a case for a new statutory advisory body to examine issues raised by the use of genetic biotechnology on farm animals in the context of its use on other animals and current livestock farming practice and the wider international aspects.

Recommendation 2

New methods and funding should be used to engage the public in decisions about genetic biotechnology

Government agrees that engagement of the public in decisions about genetic biotechnology is important. The revised Directive (2001/18/EC) on the deliberate release into the environment of GMOs contains mandatory requirements for consulting the public on the experimental release or placing on the European Community market of any GMO, including GM animals. Regulations implementing the Directive in England came into force on 17 October 2002. The devolved administrations expect to complete this implementation in the rest of the UK early in 2003.

The AEBC, which is publicly funded, was established to engage with the public and advise on these matters. One of the AEBC's duties is to consult stakeholders and the public on a regular basis on the issues which it is considering. In preparing this report the AEBC gathered information about public attitudes through qualitative social research and by using public reference groups.

The Chairman and some of the members of the AEBC are on the Steering Board for the public debate on GM issues which was initiated by Ministers this summer. This debate will have three components: a public debate organised independently of the Government, a review of the science on GM issues, and a study of the costs and benefits associated with GM. The Government wants an open and balanced dialogue that will help to deepen understanding of the issues surrounding this technology. The public may take the opportunity of the forthcoming public debate to raise matters around the use of GM animals. The relevant Commission members, with the experience of having prepared this particular report, will be well placed to tap into this subject matter if it is raised.

The Government would be grateful if AEBC would advise it and the FAWC-led working party on what further methods and funding should be applied to decisions in genetic biotechnology involving animals.

Recommendation 3

GM, cloned and conventional animals should be governed by the same regulations wherever possible. The 1911 Protection of Animals Act should be updated and other piecemeal animal welfare legislation consolidated. Provision will be needed to protect farm animals from developments which substantially alter their nature in unacceptable ways. The effectiveness of the interpretation and enforcement of existing farm animal welfare regulations should be reviewed.

The Government agrees with the AEBC’s conclusion that the law relating to the welfare of farmed animals and human health and environmental risks is in principle adequate to meet the concerns about GM farm animals. The production of a genetically modified animal with the intention of substantially altering its nature is controlled under the terms of the Animals (Scientific Procedures) Act 1986. The 1986 Act is widely viewed as the most rigorous piece of legislation of its type in the world. Amongst other things, it requires that project proposals are assessed on a case-by-case basis and that licences are only granted where the benefits likely to accrue from the planned research outweighs the costs to the animals that will be used. In addition, Ministers may seek the advice of the APC on licence applications which raise novel, contentious or sensitive issues, or that might require a change of policy. Should an application for a development which could possibly substantially alter an animals nature in an unacceptable way be put forward, then this could be referred to the APC. Where such an application was likely to enter the food chain both Defra and the Food Standards Agency would be consulted. Transboundary movements of GM animals from one country to another would be covered by the relevant requirements for safe transfer, handling and use of the Cartagena Protocol on Biosafety, when the Protocol enters into force.

GM animals which fall within the definition of livestock are covered by the Agriculture (Miscellaneous Provisions) Act 1968 and in Northern Ireland the Welfare of Animals Act (Northern Ireland) 1972, under which it is an offence to cause unnecessary pain or distress to any livestock kept on agricultural land. There are also provisions in the Welfare of Farmed Animals (England) Regulations 2000 and in Northern Ireland the Welfare of Farmed Animals regulations (NI) 2000 to address the welfare concerns arising from both natural and artificial breeding procedures. Also the commercial use of cloning would be classified as an invasive procedure and thus be covered by the Veterinary Surgeons Act.

Government agrees with the recommendation that the 1911 Protection of Animals Act should be updated and other piecemeal welfare legislation consolidated. Government has carried out an extensive review of the animal welfare legislation and there are currently proposals for a new Animal Welfare Bill. It will provide an update to the 1911 Protection of Animals Act and consolidate other relevant legislation on these issues. The new Animal Welfare Bill will also include a section on the uses of biotechnology in animal breeding. The new Bill will not cover the production and use in scientific procedures of GM animals which will continue to be regulated by the 1986 Act.

The issue of effective enforcement of existing farm welfare regulations will be looked at in the course of developing the new Animal Welfare Bill. In the meantime responsibility for enforcement is shared between local authorities, Defra and the devolved administrations.

Recommendation 4

Post-commercialisation monitoring of GM and cloned farm animals should be planned to look for unexpected welfare or health problems.

Government agrees that there should be post-commercialisation monitoring. As with any other GMO, for GM animals released onto the market there will be post market monitoring requirements under Directive 2001/18/EC. EU guidance on post market monitoring has now been agreed. There is also an ACRE sub group working on this and advice will be issued.

Government takes a risk-based approach to enforcement on animal welfare and animal health and will monitor as appropriate. The welfare of GM and cloned animals is monitored in the same way and under the same legislation as conventional animals.

Recommendation 5

Arrangements should be made to maintain consumer choice about whether to purchase meat or other products from GM and cloned animals.

Government agrees that consumer choice is important. Under Regulation 258/97/EC on novel foods and novel ingredients (the ‘Novel Foods Regulation’), any products derived from GM and cloned animals have to be approved before they can be placed on the market in Europe. This involves a rigorous assessment of the safety of such products. This Regulation also includes labelling provisions for products derived from genetically modified animals.

Proposals for revised rules on the approval, traceability and labelling of genetically modified food and feed products are currently being negotiated in Brussels. The European Commission has also issued a discussion paper on possible changes to the Novel Foods Regulation.

Under new proposals for the transboundary movement of GMOs exporters must ensure that information is provided which identifies that the product contains or consists of GMOs.

No applications have been received for approval of meat or other products derived from GM or cloned animals.

Recommendation 6

The commercial production of GM fish in offshore aquatic net pens should not be permitted
while there is significant uncertainty about the environmental consequences of the fish escaping to the wild and about containment of the fish in net pens.

Government welcomes this recommendation, which is in line with Government’s policy. The UK has in place a comprehensive regulatory regime for the containment or deliberate release of genetically modified organisms. Any proposal to keep GM fish in nets, tanks or cages in the sea or in rivers, lakes or streams would be considered on a case-by-case basis and would have to be underpinned by a detailed risk assessment demonstrating no adverse effects on human health or the environment. Given these requirements it is difficult to envisage any circumstances in which we would permit such an activity to take place. This position has been stated clearly in responses to Parliamentary Questions of November 2001. There are no GM fish being held in aquatic net-pens in the UK and no approval has yet been sought or granted for the commercial production of GM fish.

At the 5th North Sea Conference at Bergen in March 2002 Ministers also agreed to take all possible actions, in accordance with the requirements of Directive 2001/18/EC and comparable national legislation, to ensure that the culture of genetically modified marine organisms is confined to secure, self-contained, land-based facilities in order to prevent their release to the marine environment.

Recommendation 7

The international movement of GM and cloned animals and reproductive material should be monitored.

Government has signed up to the global rules governing environmental safety aspects of movements of GMOs, including animals, from one country to another that are set out in the Cartagena Protocol on Biosafety. The necessary 50 ratifications for the Protocol to enter into force are expected to be achieved by the middle of 2003. Under Article 7 of the Protocol, the advanced informed agreement procedure applies to the first intentional transboundary movement of LMOs (living modified organisms) for intentional introduction into the environment of the party of import. Existing EU legislation is compatible with the Protocol and new EU legislation for those aspects of the Protocol without existing counterpart EU legislation is currently being negotiated. The UK will ratify the Protocol once all the necessary legal processes are complete.

With certain limited exceptions, commercial movement of animals and germplasm within the EU and importation from non-EU countries is subject to harmonised animal health rules which are implemented into national legislation, for example the Animals and Animal Products (Import and Export)(England and Wales) Regulation 2000 and equivalent legislation in Scotland and Northern Ireland. Import of non-harmonised animals and germplasm are subject to national animal health rules. These rules set down the animal health conditions that must be met before such animals or germplasm can be imported into Great Britain or certified for export to other EU Member States and provide for checks to be made on the animals at their premises of destination or in the case of imports from non-EU countries at approved Border Inspection Posts. Similar rules apply to the import of other animal products from third countries. There is no specific provision relating to the importation or checking of GM or cloned animals, germplasm or other products under current animal health import rules.

Establishments licensed under the Animals (Scientific Procedures) Act 1986 require Home Office permission to acquire GM animals from overseas laboratories or to transfer such animals abroad. The actual transfer must comply with all relevant regulations regarding the welfare of animals in transit and comply with requirements for the import/export of animals.

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