Select Committee on Animals In Scientific Procedures Report




1.1  During the eighteenth and nineteenth centuries, a number of pieces of legislation relating to animal treatment were passed in the UK. In 1781 the statutory surveillance of the treatment of cattle at Smithfield was introduced and this was soon followed by the licensing of slaughterhouses with attention being paid to humane killing methods. In 1822 a Bill was passed which stated that "if any person or persons having the charge, care or custody of any horse, cow, ox, heifer, steer, sheep or other cattle, the property of any other person or persons, shall wantonly beat, abuse or ill-treat any such animal, such individuals shall be brought before a Justice of the Peace or other magistrate".

1.2  Many other anti-cruelty Acts followed including the 1876 Cruelty to Animals Act and the 1911 Protection of Animals Act. The 1876 Act regulated vivisection and introduced a licensing and inspection system. The 1911 Act made it an offence to "cruelly beat, kick, ill-treat, over-drive, over-ride, overload, torture, infuriate or terrify any animal". It also forbade the causing of unnecessary suffering, but with certain categories of exemptions, one of which was vivisection.

1.3  The 1876 Act remained in force in the regulation of animal experiments until 1986. Since then, animal procedures in the UK have been regulated under the Animals (Scientific Procedures) Act. Some of the principal features of the Act are set out below:

    (i)  the Act covers all non-human vertebrates and the common octopus (Octopus vulgaris). Mammals, birds, reptiles, amphibians and fish are protected, while invertebrate creatures such as squid, insects and protozoa are excluded;[5]

    (ii)  the Act regulates any experimental or scientific procedure which may have the effect of causing a protected animal "pain, suffering, distress or lasting harm";[6]

    (iii)  the Act requires that all regulated procedures are carried out under three licences: a personal licence for the scientific investigator; a licence for the establishment where the procedure is to take place; and a project licence which details the numbers and types of animals to be used, the exact procedures to be performed, and the overall purpose of the project;[7]

    (iv)  the key element of the Act is commonly known as the cost/benefit analysis. This is applied to all proposed animal research in a project licence, and is defined as the weighing of "the likely adverse effects on the animals concerned against the benefit likely to accrue".[8] The analysis, and hence the decision whether to grant a licence or not, is made by the Secretary of State on the advice of the Inspectorate;

    (v)  in addition, a project licence should not be granted if there is a "reasonably practicable method not entailing the use of protected animals", that is, an animal experiment should not be licensed if there is a realistic non-animal method.[9] Where animals are used, the procedures must use "the minimum number of animals, involve animals with the lowest degree of neurophysiological sensitivity, cause the least pain, suffering distress or lasting harm, and are most likely to produce satisfactory results";[10]

    (vi)  there is an Inspectorate, whose members advise on the granting of licences and carry out inspections of designated establishments.[11] The Inspectorate currently make some 2,100 visits each year, of which about two thirds are unannounced (Q. 130);

    (vii)  an independent committee, the Animal Procedures Committee (APC), advises the Secretary of State on the operation of the Act.[12] The APC currently has 22 members, and includes a barrister, philosophers and representatives from industry, academia, funding bodies, and animal welfare and anti-vivisection groups.[13] The APC considers some of the most controversial project licence applications, such as the use of non-human primates in procedures of substantial severity, and the use of animals to practise microsurgery.[14] In its deliberations, the APC is enjoined to have regard "both to the legitimate requirements of science and industry and to the protection of animals against avoidable suffering and unnecessary use in scientific procedures".[15] The APC publishes an annual report which is laid before Parliament;[16]

    (viii)  Statistics of Scientific Procedures on Living Animals (the Statistics) for Great Britain are published annually by the Home Office. Equivalent statistics for Northern Ireland are published annually by the Department of Health, Social Services and Public Safety;[17]

    (ix)  Section 24 of the Act prevents the Inspectorate, or any other official who receives confidential information in the course of carrying out duties under the Act, from disclosing that information. In practice, this means that there is no requirement for the details of any animal procedure to be made public. The Inspectorate are also prohibited from making public details of any breaches of the Act, although a summary of infringements is included with the annual Statistics.

1.4  Subsequent to the passing of the 1986 Act there have been a number of developments with regard to its implementation. In its 1996 annual report, presented to the incoming government in August 1997, the APC published an interim review of the operation of the Act. It concluded that the Act did not require radical reform but recommended a number of changes so as, inter alia, to help the Inspectorate and give the public a better understanding of the cost/benefit assessment; to document the consideration of non-animal methods in project licences; to provide appropriate training for those involved in the killing of animals; to publicise how infringements of the Act are handled by the Home Office; and to increase the size of the Inspectorate and its administrative support. The Government accepted these and other recommendations: some have already been implemented; others await implementation.

1.5  Since the 1997 review by the APC, a number of other regulatory developments have taken place, including:

  • a ban on the testing of finished cosmetic products on animals (6 November 1997);
  • a ban on the use of great apes (6 November 1997) - though none had in fact been used since the passing of the 1986 Act;
  • a ban on the testing of alcohol and tobacco products on animals (6 November 1997);
  • a de facto ban on the testing of cosmetic ingredients (16 November 1998);
  • a ban on the use of animals to produce monoclonal antibodies by the ascites method, save in exceptional cases (from 1 January 1999);[18]
  • the introduction of the Ethical Review Process (ERP) (from 1 April 1999);
  • a ban on the acute oral Lethal Dose 50% (LD50) test (OECD test guideline 401) save in exceptional circumstances (21 October 1999);[19] and
  • a change in the balance of membership of the APC intended to ensure its greater independence.



1.6  The official annual publication of statistics on the use of animals in Great Britain is based on the detailed forms returned by project licence holders at the end of each year, or on termination of their licence.[20] The forms collect a large amount of data including:

  • species used;
  • number of procedures carried out and number of animals used. On the relatively small number of occasions where an animal is used for two or more procedures, 2.7% of occasions in 2000, each procedure is counted separately - so that the number of animals used each year is slightly less than the reported number of procedures;
  • primary purpose, classified as one of: fundamental biological research; applied studies (human medicine or dentistry, and veterinary medicine); protection of man, animals or the environment by toxicological or other safety or environmental evaluation; education and training; forensic enquiries; direct diagnosis; and breeding;
  • source of animals;
  • stage of development, genetic status, and breeding (including all genetically modified animals); and
  • target body system (e.g. nervous system, multiple systems).

1.7  The most recent Home Office report was published in 2001 and relates to the year 2000. It shows that there has been a significant downward trend in the number of animals used in the UK over the last 25 years, so that the number now is only just over half of what it was then. However, in 2000 the number of animal procedures increased, compared to the previous year, by 58,000 (2.2%) to 2.71 million. This increase is due to the number of genetically modified ("GM") animals counted solely because of the genetically modified status, even though many of these GM animals are not actually used in any scientific experiment.[21] Without the inclusion of these GM animals, the number of animal procedures in 2000 would have decreased, compared to the total the previous year ,by approximately 15%.

1.8  The creation and use of GM animals continues to increase. In Great Britain in 2000 there were 581,740 procedures in which GM animals were used or bred, 14% more than in 1999. Around 99% of these were on mice. The number of scientific procedures involving GM animals, which would be classified as scientific procedures under the Act if normal, non-GM animals had been used, was 118,551.[22]

1.9  Most procedures are carried out on mice (59%), followed by those on rats (20%), fish (9%), birds (4.5%), guinea pigs (2%), ungulates (hooved mammals) (2%) and rabbits (1.5%). Other figures include dogs (0.3%), non-human primates (0.13%) and cats (0.07%).

1.10  Most procedures are carried out for the purposes of fundamental biological research (32%), applied human medicine (27%) and breeding (26%). Applied veterinary medicine comprised 7% of procedures, and protection of man, animals or the environment 6%.

1.11  Action on 39 infringements was completed in 2000, compared to 28 in 1999 — a summary of information on infringements is included with the annual Statistics.[23]



1.12  In 1959, two British scientists, the zoologist William Russell and the microbiologist Rex Burch, published The principles of humane experimental technique, a study of the ethical aspects of animal research commissioned by the Universities Federation for Animal Welfare (UFAW). They said that all animal experiments should incorporate, so far as is possible, the Three Rs: replacement, reduction and refinement. They have been defined as:[24]

    Replacement of conscious, living vertebrates by non-sentient alternatives;

    Reduction in the number of animals needed to obtain information of a given amount and precision; and

    Refinement of procedures to reduce to a minimum the incidence or severity of suffering experienced by those animals which have to be used.

1.13  The Three Rs are widely accepted by the international scientific community — almost all those who use animals have said in evidence that they agree with the principle that reduction, refinement, and replacement should take place wherever possible. Many of those who disagree with the use of animals in scientific procedures also agree with the principle of the Three Rs, but are concerned that they are not always implemented. Some anti-vivisectionists dispute the Three Rs concept on the basis that both reduction and refinement tacitly acknowledge that animals should continue to be used. Dr James Kirkwood, giving evidence with UFAW, considered that refinement tended to be overlooked, and that better use could be made of research into animal cognition.[25] Dr Alan Goldberg, from Johns Hopkins University, said that he preferred the term "humane science" (Q. 1516). Despite these various reservations, the Three Rs have had an international impact on the debate surrounding animal experiments. We discuss the Three Rs in greater detail in Chapter 7.



1.14  During the course of the Inquiry, the Committee heard oral evidence about the regulatory system in France, Japan and the United States, and also visited France and the United States.[26]

1.15  Virtually all witnesses agreed that the UK has the tightest system of regulation in the world. Not only does the 1986 Act require personal, institutional, and project licences, but the UK is the only country to require an explicit cost/benefit assessment of every application to conduct animal research.[27] All experimental protocols are reviewed both by the local Ethical Review Process and by the Inspectorate. All establishments are subject to frequent inspection. In Great Britain, there are currently 25 Inspectors (Q. 1869), who inspect over 250 establishments.[28] An average facility would be visited about 4 times per year (Q. 1890). The number of inspectors is due to increase to 33 over the next two years.

1.16  Inspectors in the UK deal exclusively with animals used in scientific procedures, and have considerable expertise in laboratory animal science. In both the US and in France, inspectors are generalist veterinarians who are responsible for animals on commercial farms and in zoos and circuses, and may have little direct expertise in laboratory animal science.



1.17  Animal procedures in the United States are regulated in three ways.[29] First, the Animal Welfare Act (1966 as amended), which is enforced by the Animal and Plant Health Inspection Service of the United States Department of Agriculture (USDA). Following an amendment passed in May 2002, the Animal Welfare Act no longer covers procedures on rats, mice and birds. All other warm-blooded animals are covered. The Animal Welfare Act also requires that each institution has an Institutional Animal Care and Use Committee (IACUC) which is responsible for the day-to-day enforcement of the Act. Institutions are subject to twice-yearly unannounced visits by the USDA Inspectorate, who have the power to impose fines. There are 96 USDA Inspectors to monitor around 8,800 institutions.

1.18  Second, the Public Health Service Policy on Humane Care and Use of Laboratory Animals, given statutory mandate by the Health Research Extension Act 1985. This is enforced by the Office of Laboratory Animal Welfare (OLAW). This applies to any experimenter or institution which is in receipt of federal funds, and which uses any vertebrate (including rats, mice and birds). This Act also requires each institution to have an IACUC. OLAW enforces the standards set out in the Guide for the Care and Use of Laboratory Animals published by the Institute for Laboratory Animal Research. This system was described to us by OLAW as "enforced self-regulation": institutions have to deposit a "written assurance" of compliance, but inspections are only carried out "for cause", that is, when there is specific reason to believe that animal welfare has been compromised. OLAW has the power to withhold federal funding.

1.19  Third, most large companies and major universities receive accreditation from AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care). AAALAC is a non-governmental, not-for-profit association, which accredits over 600 institutions in 18 countries, including four in the UK. Standards are high, but accreditation is voluntary. The system works largely by self-evaluation and peer review. Inspections by AAALAC occur once every three years, with prior notice. The sanction is loss of accreditation, and we were told that this would affect the institution's ability to attract work and research funding.

1.20  The effect of this complex system of regulation is that some institutions are inspected by three bodies, while others (those which are privately funded, use only rats, mice and birds, and choose not to apply for AAALAC accreditation) are subject to no federal regulation at all. The number of animal procedures not covered by regulation is difficult to quantify.

1.21  The success of the regulation is also reliant on the effectiveness of the local Institutional Animal Care and Use Committee. These committees approve proposals for animal experiments and monitor animal welfare standards. They are required to have a lay member, external to the organisation, who represents the local community.[30] Some of these committees are undoubtedly excellent, but recent research has shown that they are not consistent in their assessment of whether a protocol should be permitted.[31] These committees are similar to the Ethical Review Process in the UK, except that they are concerned with "Animal Care and Use", not ethics. Only once during our visit to the US was it suggested that the IACUC should consider ethical aspects of experimentation.[32]

1.22  Conversely, animal rights groups note that much more information about individual animal procedures is available in the US than in the UK. Information on particular procedures and inspections is placed on the internet, although this is also now subject to review because of the violent activities of some animal rights groups.[33]



1.23  Animal procedures in France are subject to the same European legislation as applies in the UK, Directive 86/609/EEC.[34] The French Ministry of Agriculture is responsible for the law which is enforced by the decentralised Veterinary Service.[35] The main controls are the institutional and personal licences.[36]

1.24  An institutional licence is granted following an inspection of the premises and lasts for 5 years. In addition to giving details of housing facilities for the animals, it must state the reason for the use of animals but only in very broad terms, for example, "To prove the safety and efficacy of new drugs".

1.25  A Personal Licence is granted following the receipt of the relevant application form — there is no formal interview or visit by the Veterinary Service. Personal Licences, which include outline details of proposed protocols (akin to the Project Licence in the UK), are usually less than 10 pages long. They are usually approved within a month, and often within 2 weeks. Students do not need licences, but train under the direction of a licensed Professor.

1.26  Under this system, each researcher is responsible for the suitability of protocols, but protocols are not specified on the licence. The Veterinary Inspectors considered that this made it difficult for them to assess whether replacement, reduction and refinement methods were seriously considered. Recently, non-compulsory ethics committees have begun to be introduced which discuss individual protocols and give consideration to the Three Rs.

1.27  In France, there is at least one Veterinary Inspector in each Département. In the Paris area there are three Inspectors, two of whom work part-time, who monitor 150 institutions and over 1,500 licensed scientists. We were told that this makes the enforcement of care and welfare standards difficult. The Veterinary Inspectors considered that the system was essentially based on trust.



1.28  We draw attention to points made by the British Embassy, Tokyo.[37] The system in Japan is one of self-regulation. Animal experiments are regulated by a single clause within the recently amended (1 December 2000) "Law for the Humane Treatment and Management of Animals". This clause merely places a burden on all those using animals to cause minimal distress and suffering (Q. 247). There is no formal inspection, and no reporting requirement for the numbers of animals used.[38]



1.29  Developing trends in regulation, in animal science, and in the public debate have led us to consider the questions:

We then consider the following key issues:

  • The role of the Inspectorate;
  • The weighing of harms and benefits (the "cost/benefit analysis");
  • The administration of licences;
  • The Animal Procedures Committee;
  • The Ethical Review Process;
  • The development of the Three Rs;
  • Genetically modified animals;
  • Public information;
  • Openness and Section 24 of the 1986 Act; and
  • The Home Office Statistics.

Section 1(1) of the 1986 Act. In this report "animal" refers to an animal protected under the Act. Back

6   Section 2(1). Back

7   Sections 3-8. Back

8   Section 5(4). Back

9   Section 5(5)(a). Back

10   Section 5(5)(b). Back

11   Section 18. Back

12   Section 19. Back

13   In this report we distinguish between broadly different points of view, although we recognise that these categories are not discrete. "Animal rights groups" consider that animals have intrinsic rights which preclude their use by humans, such that all animal experiments should immediately be discontinued. "Animal welfare groups" may or may not accept the need for animal experiments, but, regardless of their ultimate aims, accept the position that animals are likely to be used in scientific procedures for the time being, so efforts should be concentrated on minimising the number of animals used, and improving the welfare of those that are used. "Anti-vivisectionists" are those who are opposed to all animal experiments - this group encompasses all animal rights groups and some, but not all, animal welfare groups. For further discussion, see Professor Stephen Clark, "Thinking about biotechnology: towards a theory of just experimentation" (p. 111). Back

14   The use of animals to develop other surgical skills has been prohibited since 1987. Back

15   Section 20(2). Back

16   Section 20(5). Back

17   Section 21(7). Back

18   The ascites method involves the injection of a severe irritant and hybridoma cells (cells cloned from the fusion of a cancerous cell with a healthy antibody-producing cell) into the body cavity of a mouse or rat. Large amounts of monoclonal antibody-rich fluid are produced and this is collected. However, the procedure is widely agreed to cause considerable suffering. Back

19   The LD50 test was devised in 1927 to assess the acute oral toxicity of substances. It involves feeding increasing doses of a test substance to animals to discover what dose kills 50% of them within a given time. There is no limit either to the number of animals used, or to the quantity of the dose. This has now been substantially replaced by the Fixed Dose Procedure which uses approximately one quarter of the animals required by the LD50 and reduces the severity of the test. The LD50 test is still occasionally used, for example by the Ministry of Defence (MOD), but its use is subject to special justification (see Q. 1583 and paras 2-3 of the memorandum supplementary to the MOD's oral evidence). Back

20   Home Office Statistics of Scientific Procedures on Living Animals, Great Britain, 2000. These statistics, published by the Home Office, apply only to Great Britain. Statistics for Northern Ireland are collected and published along similar lines by the Department of Health, Social Services and Public Safety. In Northern Ireland in 2000 14,124 animals were used, a fall of 1% since 1999, though the number of procedures increased by 1%. Nearly 60% of animals used were rats and mice, and no procedures were carried out on primates. There were 13 licensed establishments, which received a total of 157 visits from the Northern Ireland Inspectorate. Back

21   See Chapter 8, Genetically Modified Animals. Back

22   See Table 3.3 of the Statistics. This figure includes procedures classified as: "Generation of founder animals", "Used in further regulated procedures", "Used in production and other procedures" and "Used in safety evaluation studies".  Back

23   See pp. 96-97 of the Statistics. Currently, only the number of infringements is reported, together with a short commentary on the types of infringements encountered. Some infringements are technical and have no impact on animal welfare, others are more serious. From next year infringements will be divided into three categories to provide a clearer indication of the severity of the infringements. Back

24   Grayson, L., Animals in Research: For and Against (London: British Library, 2000), p. 204. Back

25   Qs 615-17. See also para. 3.3. Back

26   Written evidence was also received from the British Embassy, Bonn, about regulation in Germany. We note that a proposal to incorporate animal welfare into the Basic Law was recently approved by both Houses of the German parliament (p. 47 and p. 359). Back

27   For further details on the international comparison of regulatory systems, see written memorandum by the Research Defence Society paras. 5-7. See also the European Science Foundation Policy Briefing 15, "The use of animals in research" (August, 2001), available at (July 2002). Back

28   The number of certificates of designation in force in Great Britain on 31st December 2000 was 258 (see the Statistics, p. 96). The Animals (Scientific Procedures) Act 1986 applies to the whole of the UK. The regulation of the Act in Northern Ireland, including inspection and the gathering of statistics, is devolved to the Department of Health, Social Services and Public Safety. Back

29   See the transcript of the meeting on 4th July 2001, and the note on the visit to the United States in Appendix 3. Back

30   In the UK, Ethical Review Process committees are encouraged, but are not required, to have a lay member. We discuss this further in Chapter 6. Back

31   Scott Plous and Harold Herzog, 'Reliability of Protocol Reviews for Animal Research', Science 293 (27th July 2001), pp. 608-09. Back

32   This occurred during our visit to Huntingdon Life Sciences in New Jersey. We consider that this is a good example of how regulation in the UK can even have a positive impact on animal welfare in other jurisdictions. Back

33   See, for example, Nature, 415, 14 February 2002, p. 723. Back

34   This regulates, among other things, care and accommodation standards for animals, personal and institutional licences, training, and the requirement to publish statistics on animal use. Back

35   See also the transcript of the meeting on 4th July 2001, and the note on the visit to Paris in Appendix 3. Back

36   Two institutions in France also receive AAALAC accreditation. Back

37   See transcript of the meeting on 4th July, 2001. We did not visit Japan. Back

38   No institutions in Japan receive AAALAC accreditation, although one application is in the process of being prepared. Back

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