HC Deb 11 December 2001 vol 376 cc833-6W
Dr. Kumar

To ask the Secretary of State for the Home Department if he will make a statement on the implications of the Biocidal Products Regulation for animal testing. [20924]

Angela Eagle

It is not possible for the Home Office to give an estimation of the impact of the Biocidal Products Directive (98/8/EC), which came into force in the United Kingdom in April 2001, on the scale and nature of animal use.

As a consequence of it coming into force, there will be a requirement for all biocidal products and their active substances to be authorised for use and therefore the new testing requirement may increase animal use in this area.

To minimise duplicate testing, Article 13 of the Directive requires authorisation holders to take all reasonable steps to share data. Furthermore, the Article also allows for member states to oblige applicants to share data, specifically to avoid unnecessary and duplicate testing on animals.

It continues to be our aim to reduce, refine and replace the use of animals in scientific procedures and to ensure that the benefits to humans, other animals or the environment outweigh the costs to the animals involved. In August 2000 the Home Office announced the agreement of a cross-Government concordat to increase data sharing in all United Kingdom regulatory safety testing.

Dr. Kumar

To ask the Secretary of State for the Home Department what steps his Department has taken to assess the effects of genetic modification in laboratory animals on the animals' welfare. [20920]

Angela Eagle

The production of genetically modified animals (as well as their use in experiments or other scientific procedures) is controlled under the terms of the Animals (Scientific Procedures) Act 1986. In deciding whether to grant a licence to produce, breed or use genetically modified animals, the 1986 Act requires, as with ordinary animals, that the likely benefits of the programme are weighed against the likely adverse effects on the animals concerned (the cost/benefit assessment) and that there are no alternatives which either replace animal use entirely, reduce the number of animals needed or refine the procedures to minimise pain and suffering (3Rs). We must also be satisfied that the procedures are likely to achieve the stated objectives.

Since the genetic modification of animals was first achieved, the number of genetically modified animals produced and used under the terms of the Act has increased considerably, and is likely to continue to increase. The production and use of such animals allows new areas of medical and other scientific research to be explored; provides the potential for investigating a wide variety of conditions including cancer, cystic fibrosis and multiple sclerosis; and allows the quality of the science in many areas of research and testing to be improved.

It is not always possible to predict the likely welfare effects of novel genetic modifications. However, project licence authorities are framed to permit only apparently healthy genetically modified animals to be produced or maintained unless, and exceptionally, a specific scientific justification is made and accepted for the production of genetically modified animals whose welfare may be compromised.

The vast majority (over 95 per cent) of GM animals produced and used are mice.

Dr. Kumar

To ask the Secretary of State for the Home Department how many of each type of animal have been used in laboratory testing in each year since 1997. [20922]

Angela Eagle

The number of animals, listed by species, used in scientific procedures for each year since 1997 for which figures are available, is given in Table 1A in the annual publication "Statistics of Scientific Procedures on Living Animals, Great Britain", copies of which are in the Library. Table 5A in the same publication gives the numbers of each type of animal used in non-toxicological work, which is primarily research, and Table 10A gives the numbers of animals used in toxicological work, consisting mainly for safety testing and quality of control of medical and veterinary pharmaceuticals and other products.

Dr. Kumar

To ask the Secretary of State for the Home Department how much the Government have invested in developing alternatives to animal testing in the last five years. [20923]

Angela Eagle

Most of the work done on alternatives is neither done by the Government nor with Government money. The budget the Home Office has made available to the Animal Procedures Committee for research in this area over the last five years is as follows:

£
Year Budget made available
1997–98 182,000
1998–99 259,000
1999–2000 259,000
2000–01 265,000
2001–02 280,000

By "alternatives", we are referring to the development and promotion of alternatives which (1) replace animal use, (2) reduce the number of animals used or (3) refine the procedures involved to minimise suffering (3Rs).

This money is not the only money spent by Government Departments on alternatives. In 1999, the Home Office asked the Department of the Environment, Transport and Regions, the Department of Trade and Industry, the Ministry of Defence, the Department of Health, the Scottish Office, the Welsh Office and the Northern Ireland Office for an indication of the level of each Department's funding of alternatives. Unlike the Home Office, the funding of alternatives by other Government Departments is neither ring-fenced nor clearly demarcated from the funding of other areas of science. The Home Office was, however, provided with an estimated figure, totalling over£2 million, for the yearly expenditure across Government for research into alternatives.

Dr. Kumar

To ask the Secretary of State for the Home Department how many Home Office inspectors there are with responsibility for scrutinising the impact of the Animal (Scientific Procedures) Act 1986; and what their duties are. [20921]

Angela Eagle

There are currently 22 inspectors appointed under the Animals (Scientific Procedures) Act 1986. Plans have recently been announced to further increase the number of inspectors to 33 over the next three years. Five more inspectors will be taking up post in the new year and an additional six will be appointed in 2003.

The duties of an inspector are set out as follows in section 18 (2) and 18 (3) of the 1986 Act.

18 (2) It shall be the duty of an inspector:

  1. (a) to advise the Secretary of State on applications for personal and project licences, on requests for their variation or revocation and on their periodical review;
  2. (b) to advise him on applications for certificates under this Act and on requests for their variation or revocation:
  3. (c) to visit places where regulated procedures are carried out for the purpose of determining whether those procedures are authorised by the requisite licences and whether the conditions of those licences are being complied with;
  4. (d) to visit designated establishments for the purpose of determining whether the conditions of the certificates in respect of those establishments are being complied with;
  5. (e) to report to the Secretary of State any case in which any provision of this Act or any condition of a licence or certificate under this Act has not been or is not being complied with and to advise him on the action to he taken in any such case.
18 (3) If an inspector considers that a protected animal is undergoing excessive suffering he may require it to be immediately killed by a method appropriate to the animal under Schedule 1 to this Act or by such other method as may be authorised by any personal licence held by the person to whom the requirement is addressed.

The Inspectorate plays an active part in promoting the 3Rs (of reduction, refinement and replacement) in animal experimentation by, for example, preparation of Codes of Practice for the care and use of animals, the provision of technical expertise to others leading initiatives in this area, and participation in numerous awareness raising events.

Dr. Kumar

To ask the Secretary of State for the Home Department how many licences have been issued for the use of GM(a) mice and (b) other animals in laboratory testing in each year since 1977. [20919]

Angela Eagle

Project licences for particular programmes of scientific research have only been granted since 1987, when the Animals (Scientific Procedures) Act 1986 came into force. Prior to this date live animal research was authorised via a personal licence system which did not set out the scientific issues in detail.

Home Office records do not show the subdivision of project licences into those that authorise the use of genetically modified (GM) animals and those which do not. It would not be possible to obtain the requested information by other means without disproportionate effort or with any guarantee of completeness. We can only say that a growing number of GM animals are used as models within some licensed programmes, often in conjunction with other live animal models.

However, since 1988 annual statistics published by the Home Office have contained information on the overall use of GM animals in scientific procedures. The detail provided has increased over the years, and the latest publication entitled 'Statistics of Scientific Procedures on Living Animals Great Britain 2000' (Cm 5344) contains a great deal of related data. Table 3 of the publication provides comprehensive data on scientific procedures by species of animal, primary purpose (including breeding) and genetic status. Copies are available in the Library.