| Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 | ||||
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Chapter 8: SOURCES AND DISPOSAL OF ANIMALS
8.1 The Act places restrictions on the acquisition and use in regulated procedures of certain types of animal. It also makes stipulations about the disposal of protected animals. These are explained in this Chapter. Notes on the use, continued use and re-use of animals are provided in paragraphs 5.55-5.66 above.
8.2 Unless the Secretary of State has granted a specific exemption, these animals cannot be used:
8.3 The Act sets limits on the Secretary of State's powers to allow exemptions [Section 10(3)]:
8.4 Additional administrative controls require that, unless otherwise authorised by the Secretary of State, breeding and supplying establishments designated under Section 7 may only obtain animals of the types listed in Schedule 2 to the Act from other designated sources. 8.5 Applicants seeking permission to obtain such animals from non-designated sources are generally required to demonstrate that no suitable animal can be obtained from a designated source. Suitability may be determined by particular factors including strain, age, weight and health status.
ENDANGERED SPECIES 8.6 Additional controls apply to the acquisition and use of endangered species, as listed in Appendix 1 of the Convention on International Trade in Endangered Species of Fauna and Flora. These are set out in Annex A to Council Regulation (EEC) No. 3626/82, as amended by Commission Regulation (EEC) No. 969/88 and Commission Regulation (EEC) No. 1970/92 and Annex C.1 to the Council Regulation. 8.7 The Secretary of State must be satisfied that the use of such animals will be in conformity with the Council Regulation. Lawful purposes are shown at paragraph 8.3 above.
NON-HUMAN PRIMATES 8.8 Additional controls are set for the acquisition and use of non-human primates:
8.9 Approval for the acquisition of non-human primates from overseas, or from other non-designated sources, will only be given if the conditions at the breeding or supplying centre are acceptable to the Home Office. The Home Office can advise on the nature and format of the information required. 8.10 Approval is also conditional upon life-time health records being supplied with the animals and made available to the Home Office upon request. 8.11 Project licence holders must maintain and make available to the Home Office, on request, records relating to the non-designated centres from which the animals are obtained. 8.12 Each batch of animals acquired from overseas must be separately authorised, and the transport arrangements must be acceptable to the Home Office. The Home Office must also be supplied with details of the health status of the animals on, and after, arrival at the designated establishment.
RELEASE FROM CONTROLS 8.13 Animals may be released from the controls of the Act under certain circumstances. These are described in the remainder of this Chapter (and, in the case of release to the wild, at paragraphs 5.51-5.54 above). 8.14 In the case of genetically modified animals, it is recognised that not all lines may be or remain at a biological disadvantage. There are provisions for their release from the controls of the Act. The Secretary of State will consider the discharge of animals on a case by case basis where the animal line is demonstrably not predisposed to pain, suffering, distress or lasting harm. This will normally require evidence of at least two generations of the animals living a normal life-span and displaying no welfare problems attributable to their genotype.
DISPOSAL OF ANIMALS 8.15 Animals that have been used in regulated procedures must be humanely killed when, at the end of the series of regulated procedures, they are suffering or are likely to suffer adverse effects as a result of the procedures applied [Section 15]. Where this is not the case and appropriate provision is made on the relevant project licence, a veterinary surgeon must determine whether they can be kept alive [Section 10(3D)]. Usually, this is the Named Veterinary Surgeon or exceptionally (where no veterinary surgeon is available) another suitably qualified person. 8.16 Any animal kept alive after being subjected to a series of regulated procedures at a designated establishment must continue to be kept at the establishment under the supervision of a veterinary surgeon or other suitably qualified person [Section 10(6D)] unless:
8.17 Authority must also be obtained from the Home Office for the release of the animal to the wild or for its discharge from the controls of the Act [Sections 10(6D) and 10(3B-3D)]. 8.18 Under certain circumstances animals may be subjected to 'continued use' or 're-use', but only with the express consent of the Secretary of State (see paragraphs 5.57-5.66 above). 8.19 If a named person is concerned about the health or welfare of any animal, that person should either notify the relevant personal licensee or, if this is not possible, either ensure that the animal is cared for or (if necessary) that it is killed by a Schedule 1 method [Sections 6(6) and 7(6)]. 8.20 An inspector who considers that a protected animal is undergoing excessive suffering can require that it be immediately and humanely killed by a method appropriate to that animal under Schedule 1 to the Act or by such other method as may be authorised by a personal licence held by the person to whom the instruction is given [Section 18(3)]. Such events are reported to the Secretary of State, with advice on any further action that might be taken. 8.21 The humane killing of a protected animal by a method listed in Schedule 1 and appropriate to the type of animal is not a regulated procedure and does not require authorisation by a project or a personal licence. However, a condition of issue on certificates of designation requires that, at designated establishments, such killing must be performed by a competent person [Sections 10(5) and 10(6)]. Such a person must be properly trained [Section 10(5A)] and a register of competent persons must be maintained by the certificate holder. 8.22 When it is intended to kill humanely any protected animal which has been bred or kept for use but which has not undergone any regulated procedures (such as surplus stock), it must be done competently using either an appropriate Schedule 1 method or another method authorised by an additional condition on the certificate of designation [Section 10(5)]. No personal licence authority is required. 8.23 The Secretary of State's approval is needed for the use of methods not listed in Schedule 1. This applies regardless of whether such a method is to be applied to a protected animal:
8.24 Project and personal licence authorities are required :
BREEDING PROGRAMMES 8.25 Overbreeding of laboratory animals occurs when the stock intended for use in scientific procedures proves unsuitable for such use or surplus to requirements. Most of the surplus animals are culled by Schedule 1 methods. 8.26 Overbreeding should be minimised as far as reasonably possible. In addition to commercial pressures or cost recovery arrangements which act as incentives against overproduction, users should be encouraged to:
8.27 The local ethical review process provides a forum for establishments to:
8.28 The topic of overbreeding is discussed in Chapter 5 of Annex F of the Report of the Animal Procedures Committee for 1997 (in its review of the operation of the Act). Further practical advice has been drawn up by a taskforce and published by the Laboratory Animal Science Association (June 1998).
CERTIFICATION REQUIREMENTS 8.29 The Act contains certification requirements. Certification is normally performed by the Named Veterinary Surgeon. 8.30 At the conclusion of the series of regulated procedures for a particular purpose, if a protected animal is suffering or is likely to suffer adverse effects as a result of the regulated procedures applied, the person who applied those procedures (or the last of them) shall cause the animal to be immediately and humanely killed [Section 15]. This applies to all genetically modified animals and harmful mutants, except when their 'continued use' has been authorised (see paragraphs 5.57-5.59 above) or when they can be discharged from the controls of the Act (see paragraph 8.14 above). 8.31 In other circumstances, Section 10(3D)(a) of the Act requires that at the conclusion of the series of regulated procedures a veterinary surgeon (or, if none is available, another suitably qualified person) shall determine whether the animal should be killed or kept alive. The licensee must document how this has been done, but need not obtain a formal certificate of fitness from a veterinary surgeon. The welfare of the animal is thereafter entrusted to the Named Veterinary Surgeon or another suitably qualified person. Where the determination is to be done by someone other than the Named Veterinary Surgeon, the alternative arrangement must be agreed with the Home Office. Additional permission and formal certification are required if the animal is to be removed from the designated establishment (see paragraphs 8.16 and 8.17 above). 8.32 Formal certification of fitness is required:-
8.33 It is expected that certification will normally be done by the Named Veterinary Surgeon (or, in certain circumstances, another suitably qualified person), and will conform to the guidance of the Royal College of Veterinary Surgeons on certification and the "Twelve Principles of Certification" drafted by the RCVS, the British Veterinary Association and the Ministry of Agriculture, Fisheries and Food. Additional information can also be found in the RCVS "Code of Practice for Named Veterinary Surgeons employed in Scientific Procedure Establishments and Breeding & Supplying Establishments under the Animals (Scientific Procedures) Act 1986". Updated guidance will be found on the RCVS website. 8.34 The certificates should be retained for a minimum of five years. 8.35 The certifying veterinary surgeon will need to advise on compliance with other regulations which relate to the release of animals into the food chain (for example, residue levels, withdrawal times, genetic modification and novel substances).
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