| Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 | ||||
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Chapter 2: THE MAIN PROVISIONS SCOPE OF THE ACT 2.1 The Animals (Scientific Procedures) Act 1986 regulates any experimental or other scientific procedure applied to a "protected animal" [Section 1] that may have the effect of causing that animal pain, suffering, distress or lasting harm [Section 2]. A procedure so defined by the Act is referred to in this Guidance as a "regulated procedure". 2.2 The Act requires that, before any regulated procedure is carried out, it must be part of a programme specified in a project licence and carried out by a person holding appropriate personal licence authorities. In addition, work must normally be carried out at a designated scientific procedure establishment [Sections 3 and 6]. 2.3 Regulated procedures can only be authorised and performed if there are no scientifically suitable alternatives that replace animal use, reduce the number of animals needed or refine the procedures used to cause less suffering - these are known as the 3Rs. In addition, the likely benefits (to humans, other animals or the environment) must be weighed against the likely welfare costs to the animals involved. 2.4 The Act requires that applications for licences to carry out procedures on animals be considered on a case by case basis. 2.5 The Act also controls the breeding and supply of certain types of animal (where the animals are intended for use in regulated procedures) [Section 7]. The types of animal are listed in Schedule 2 to the Act.
DEFINITION OF A PROTECTED ANIMAL 2.6 The Act defines a "protected animal" as any living vertebrate, other than man [Section 1(1)]. The invertebrate species Octopus vulgaris has been added by means of the Animals (Scientific Procedures) Act (Amendment) Order 1993. 2.7 Protection extends to certain immature forms from the following stages of development:
2.8 Under Section 2(2)(c), protection is also provided when regulated procedures are applied at an earlier stage of development if:
For example, licences are required for virus propagation in embryonated bird eggs if inoculation takes place before the mid-point of incubation and if the embryo is allowed to survive into the second half of the incubation period. 2.9 Gestation and incubation periods, and the times at which larval stages become capable of independent feeding, vary widely between species. A thorough knowledge of the developmental stages for the types of animal being used, and the stage of development that will be attained in the course of the work, is necessary before planning or performing procedures using foetal, larval or embryonic forms. 2.10 The Secretary of State may, by making an Order in Parliament, extend the definition of a protected animal or alter the stage of development at which immature forms become protected [Section 1(3)]. 2.11 A protected animal is regarded as being alive until permanent cessation of its circulation or the destruction of its brain has occurred [Section 1(4)]. As brain destruction is incomplete in decerebrate animals, such animals are considered to be living for the purposes of the Act. They are therefore protected. Appropriate licence authorities are required both for the decerebration and for the use of animals so prepared for experimental or other scientific purposes. 2.12 Throughout the Guidance, unless otherwise stated, all references to "animals" should be taken, according to the context, as referring to:
DEFINITION OF A REGULATED PROCEDURE 2.13 A "regulated procedure" is defined by Section 2(1) of the Act as "any experimental or other scientific procedure applied to a protected animal which may have the effect of causing that animal pain, suffering, distress or lasting harm". 2.14 "Pain, suffering, distress and lasting harm" encompass any material disturbance to normal health (defined as the physical, mental and social well-being of the animal). They include disease, injury and physiological or psychological discomfort, whether immediately (such as at the time of an injection) or in the longer term (such as the consequences of the application of a carcinogen). 2.15 Regulated procedures may be acts of commission (such as dosing or sampling) or of deliberate omission (such as withholding food or water). 2.16 In countries implementing European Directive 86/609/EEC, a common threshold has been standardised for regulating the use of animals for experimental or other scientific purposes. Regulation starts at the "skilled insertion of a hypodermic needle". The Home Office has determined equivalent thresholds for the regulation of other classes of procedure, such as psychological stress, dietary manipulations and environmental changes. The Home Office can advise potential applicants on a case by case basis about thresholds established in these and other contexts. 2.17 An experimental or other scientific procedure applied to a protected animal is also a regulated procedure if it is part of a series or combination of otherwise non-regulated procedures that together may have the effect of causing that animal pain, suffering, distress or lasting harm [Section 2(2)]. For example, multiple or cumulative minor changes to the environment may cause sufficient disturbance to be regulated, even if the individual changes do not warrant regulation. The Home Office can advise on a case by case basis when specific combinations of procedures would be regulated. 2.18 Anything done for the purpose of, or liable to result in, the birth or hatching of a protected animal that may as a result of the procedure experience pain, suffering, distress or lasting harm is also a regulated procedure [Section 2(3)]. Thus,
are regulated if the intention is to maintain the animals produced beyond midway through gestation or incubation. (Paragraphs 2.7 and 2.8 above define stages of development. Paragraphs 8.13and 8.14 deal with release of genetically modified lines from the controls of the Act.) 2.19 Under Section 2(4), procedures are regulated even if any pain, suffering, distress or lasting harm that would otherwise have resulted are controlled or alleviated by:
Thus, procedures are regulated, even when performed under general anaesthesia, if the effect on a normal conscious animal would be to cause pain, suffering, distress or lasting harm. 2.20 Furthermore, the administration of an anaesthetic or analgesic or other measure to sedate, restrain or dull the perception of pain in a protected animal is itself a regulated procedure if it is carried out for an experimental or other scientific purpose [Section 2(4)]. 2.21 Under Section 2(7), the humane killing of a protected animal is a regulated procedure only if:
2.22 The removal of organs, blood or other tissue from a protected animal for an experimental or other scientific purpose under general anaesthesia is also considered to be a regulated procedure even if the animal is not allowed to recover consciousness, as neither has the circulation ceased nor has the brain been destroyed before the procedure is commenced. Exsanguination, with or without general anaesthesia, is not therefore a recognised humane method of killing listed in Schedule 1 to the Act. 2.23 Removal of blood or other tissues from freshly killed animals, where the circulation has ceased or the brain has been destroyed, is not a regulated procedure.
PROCEDURES WHICH ARE NOT REGULATED BY THE ACT 2.24 In addition to procedures which do not reach the threshold for regulation (see paragraph 2.16), the controls of the Act do not extend to any of the following:-
But even in situations where the 1986 Act does not extend specific protections, the provisions of the Protection of Animals Act 1911 (Scotland 1912) apply. This is the general legislation protecting animals against unnecessary cruelty. Recognised veterinary, agricultural or animal husbandry practice 2.25 The Veterinary Surgeons Act 1966 regulates veterinary practice, and the Royal College of Veterinary Surgeons provides guidance on recognised veterinary practice and standards of professional conduct. The Royal College should be consulted on the interpretation of what constitutes recognised veterinary practice and professional standards. The clinical investigation and management of health or welfare problems is considered to constitute recognised veterinary practice, if undertaken for the benefit of that animal or group of animals or their progeny. 2.26 Recognised agricultural and husbandry practices (such as castration of farm animals), performed in accordance with other animal welfare legislation and regulations, and being used to manage or conserve the animals, are not regulated procedures unless they are part of a scientific study. Identification of animals 2.27 The ringing, tagging or marking of an animal or the use of any other humane procedure for the sole purpose of enabling an animal to be identified is not a regulated procedure if it causes only momentary pain or distress and no lasting harm [Section 2(5)]. 2.28 This threshold of "momentary pain" and "no lasting harm" differs from the threshold set for regulated procedures (see paragraph 2.16). For example, the micro-chipping or ear-marking of rodents is not regulated by the Act if it is performed solely to identify the animal. Similarly, blood or DNA sampling solely to establish the identity or provenance of an animal would not be regulated if the intervention caused no more than momentary discomfort or distress. But such sampling is regulated when the purpose is to confirm that an animal has been genetically modified and when the method is judged likely to cause pain, suffering, distress or lasting harm. 2.29 Methods of marking or identification, such as toe-clipping, which can cause suffering in excess of this threshold are regulated when carried out for an experimental or other scientific purpose. The Secretary of State will only consider authorising such practices when no milder method will suffice [Section 5(5)]. Medicines Act 1968 2.30 The administration of substances to animals in order to evaluate a veterinary product in accordance with Section 32 of the Medicines Act 1968 or an Order under Section 35(8)(b) of that Act is not a regulated procedure [Section 2(6) of the 1986 Act]. 2.31 Authorities under the Medicines Act do not extend to the deliberate induction of disease, the withholding of established treatments from control groups, or the taking of blood or other tissue samples beyond those necessary for the clinical investigation and clinical management of the condition to be treated. In some circumstances (for example, where a control group is having efficacious treatment withheld or where additional blood samplings are required to investigate pharmacokinetics), licences under the 1986 Act may also be necessary. Humane killing by methods listed in Schedule 1 2.32 The killing of a protected animal by an appropriate, humane method listed in Schedule 1 of the Act is not a regulated procedure, even if the killing is performed to provide material for scientific or other experimental purposes [Section 2(7)]. 2.33 The Home Office has published a Code of Practice entitled "The Humane Killing of Animals under Schedule 1 to the Animals (Scientific Procedures) Act 1986". This provides detailed information on the methods to be used, how death should be confirmed, and safeguards to be adopted to ensure that these are performed competently.
THE PURPOSE OF THE PROCEDURE 2.34 The purpose of the procedure, as well as the level of suffering caused, determines whether or not licence authorities under the Act are required. For example, the taking of a blood sample or the forceful removal of a feather to provide material solely to identify an individual, or its provenance, would not be regulated under the Act. However, the same type of sampling to provide data for an experimental or other scientific purpose (for example, to study population dynamics or to determine whether or not the animal had been genetically modified) would be regulated by the Act. 2.35 The Home Office should be consulted when there is any doubt as to whether a proposed intervention is regulated by the Act.
LICENCES AND CERTIFICATES 2.36 Control of regulated procedures, and of places designated under the Act, is exercised primarily by:
2.37 No regulated procedure may be applied to a protected animal unless the procedure, the type of animal used and the place where the work is to be done are specifically authorised in both the relevant project and personal licence [Section 3]. 2.38 Before granting a project or personal licence or issuing a certificate of designation, the Secretary of State shall consult an inspector appointed under Section 18 of the Act as to whether and on what terms authorities should be granted [Section 9(1)]. The Secretary of State may also consult an independent assessor or the Animals Procedures Committee [Section 9(2)] (see paragraphs 2.93-2.99). 2.39 Copies of the licence and certificate application forms, and notes on their completion, are available from the Home Office on paper or disk. They are also available on the Home Office website http://www.homeoffice.gov.uk/ccpd/aps.htm. 2.40 Anyone considering making an application is strongly encouraged to make early contact with the Inspectorate. Discussions of early proposals can save applicants time when preparing applications for work that may not be licensed or that may need substantial redrafting. 2.41 It is an offence to supply, knowingly or recklessly, false or misleading information to obtain, or help someone else to obtain, a licence or certificate [Section 23]. 2.42 All licences and certificates are issued subject to a number of standard conditions (see Appendices B-E) and, in some circumstances, additional conditions may be included [Section 10(1)]. For example, the Secretary of State may apply additional conditions to:
2.43 Breaches of conditions of issue of licences and certificates can lead to administrative action (including variation or revocation of the relevant authorities) and, in some circumstances, to prosecution (see Chapter 7).
PROJECT LICENCES 2.44 A project licence may only be issued if the programme of work is for one or more of the permissible scientific purposes defined by Section 5(3) of the Act (see paragraph 5.9). 2.45 In deciding whether and on what terms to grant a project licence, the Secretary of State must weigh the likely adverse effects on the animals involved against the benefit (to humans, other animals or the environment) likely to accrue from the programme of work [Section 5(4)]. This is discussed at Appendix I. The Secretary of State must be satisfied that to achieve the purpose of the study there are no suitable alternatives that do not require the performance of regulated procedures on animals, and that full use will be made of reduction and refinement strategies to minimise the number of animals used and the likely pain, suffering, distress or lasting harm to be caused [Section 5(5)]. Authorities cannot be granted when appropriate replacement, reduction and refinement alternatives are reasonably and practicably available. 2.46 The Secretary of State also requires that, before a licence is granted, the application has completed the local ethical review process at the designated establishment where the work will be performed (see paragraphs 4.13-4.17), and that, when appropriate, project licence applicants have completed a relevant, accredited training course (see Appendix F and paragraphs 2.73-2.76). 2.47 The holder of a project licence undertakes overall responsibility for:
2.48 Project licences are valid for a maximum of five years. If a programme of work needs to continue beyond this point, then a new licence must be negotiated and obtained. 2.49 Project licences are covered in more detail in Chapter 5.
PERSONAL LICENCES 2.50 A personal licence is the Home Secretary's endorsement that the holder is a suitable and sufficiently competent person to carry out specified regulated procedures, under supervision where necessary, on specified classes of animal as part of a programme of work authorised by a project licence. 2.51 Personal licence holders assume primary responsibility for the welfare of the animals on which they perform regulated procedures. 2.52 Satisfactory completion of an appropriate training course is normally required before a personal licence is issued. Such courses do not however ensure technical competence, and further training and supervision are generally required after a personal licence is granted. The training requirements for new applicants are discussed in paragraphs 2.71-2.76 (see also Appendix F). 2.53 Although personal licences continue in force until revoked, the Secretary of State is required to review each personal licence at intervals not exceeding five years. The licence holder must, for that purpose, provide such information as is reasonably required. This may include details of the project licences used in conjunction with the personal licence, and confirmation that the personal details and techniques shown are still appropriate. 2.54 Personal licences are covered in more detail in Chapter 6.
CERTIFICATE OF DESIGNATION 2.55 Any place where regulated procedures are applied to protected animals must be designated as a 'scientific procedure establishment' [Section 6(1)], except where otherwise authorised by the Secretary of State on both the project and personal licences. A certificate of designation confers the necessary authorities. 2.56 The Act also regulates establishments that breed and/or supply for use in regulated procedures the types of animal listed in Schedule 2 to the Act [Section 7]. Again, a certificate of designation confers the necessary authorities.
2.57 Individual establishments may need to be designated as a combination of scientific procedure establishment, breeding establishment and supplying establishment. 2.58 Certificates of designation remain in force until revoked. 2.59 The Secretary of State has issued Codes of Practice for the housing and care of animals used in scientific procedures, and for animals held in designated breeding and supplying establishments. Whilst failure to comply with these codes is not in itself an offence, it can be taken into consideration in criminal or civil proceedings [Section 21(4)]. In addition, the Secretary of State requires, through conditions added to certificates, that unless otherwise authorised the standards of accommodation and care within designated establishments meet or surpass the minimum provisions of these codes. 2.60 All certificate holders are required to nominate one or more Named Animal Care & Welfare Officers (NACWOs) to be responsible for the day to day care of the animals; and one or more Named Veterinary Surgeons, or another suitably qualified person, to be responsible for providing advice on animal health and welfare. The limited circumstances in which the Secretary of State may be prepared to accept someone other than a veterinary surgeon in the latter role are reviewed in paragraphs 4.65-4.67. 2.61 Certificate holders are responsible for the standards of accommodation and care in the establishment. At scientific procedure establishments, they must ensure that only authorised regulated procedures are performed. They are also liable for the payment of annual fees to the Home Office [Section 8]. 2.62 The Secretary of State also requires that certificate holders maintain local ethical review processes (see paragraphs 4.13-4.17). 2.63 Certificate holders must ensure that inspectors appointed under the Act are given full and prompt access to designated premises (see paragraphs 4.41-4.43). A police officer with an appropriate warrant also has right of entry [Section 25]. There is nothing in the Act that prevents certificate holders allowing others access to their facilities, but the Act makes no provision for requiring certificate holders to do so. 2.64 Certificates of Designation are discussed in detail in Chapter 4.
PLACES OTHER THAN DESIGNATED ESTABLISHMENTS (PODES) 2.65 Exceptionally, a place specified in the personal and the project licence may be a place other than a designated scientific procedure establishment [Sections 6(1) and 6(2)]. 2.66 The Secretary of State may grant such authority if it is inappropriate to designate the place - for example, where procedures must take place at a field site. Such authorities are coupled to additional project licence conditions that require the licensee to notify the Home Office prior to any procedure being performed. This allows a Home Office inspector to be present when the work is carried out. Additional safeguards are also applied to ensure the welfare of any animals that are to be left unattended or released to the wild following regulated procedures (see paragraphs 5.51-5.54).
RIGHT TO MAKE REPRESENTATIONS 2.67 Where the Secretary of State proposes to refuse an application for a licence or certificate, or to vary or revoke an existing licence or certificate, he must give the applicant or holder at least 28 days notice of the intention to do so [Section 12(1)]. Within that period:
2.68 Certificate holders or licensees who are dissatisfied with the conditions attached to licences or certificates can make representations [Section 12(4)]. The rules under which representations are made are set out in Appendix H. Under Section 12(2), any notice of the revocation or variation of a licence has to be accompanied by details of the right to make representations, as set out in that Appendix.
SUSPENSION OF AUTHORITIES 2.69 The Secretary of State can suspend certificates or licences for a period up to 3 months where it appears to be urgently necessary for the welfare of any animal [Section 13]. The period of suspension can only be extended, for periods up to 3 months at a time, if the Secretary of State has informed the holder of an intention to vary or revoke and the licence or certificate holder has advised that representations are to be made or these are being considered. There is no right under Section 12 of the Act to make representations against the suspension itself.
2.70 When the suspension of a project licence or certificate of designation at a scientific procedures establishment necessitates ongoing work being stopped, any animal that is being used (or that has been used and is being held under the authorities and protections of the licence or certificate) must be humanely killed. The only exception is when a veterinary surgeon or other suitably qualified person certifies that the animal is not suffering, and is not likely to suffer, adverse effects as a consequence of the procedures and can remain alive. Unless otherwise agreed with the Home Office (see paragraph 8.14), all genetically-modified animals and harmful mutants are required to be humanely killed.
OTHER PROVISIONS Training requirements 2.71 Section 4(4A) of the Act requires that personal licences be issued only to individuals who have received appropriate education and training. Article 14 of European Directive 86/609/EEC requires that those with responsibility for the care and use of animals for experimental or other scientific purposes be appropriately trained. 2.72 The Directive specifically requires that persons carrying out or supervising the conduct of experiments have received instruction in a scientific discipline relevant to the experimental work being undertaken; are capable of handling and taking care of protected animals; and can satisfy the national authority that they have attained a level of training and competence sufficient for carrying out their tasks. 2.73 The Home Office has addressed these requirements through mandatory training for applicants for personal and project licences. Modules cover relevant legislation, ethics, the design and management of programmes of work, the performance of regulated procedures, anaesthesia and surgery, and the handling and use of animals. The Home Office Statement on Education and Training, published as part of the 1992 Report of the Animal Procedures Committee, is reproduced at Appendix F. 2.74 Training requirements apply to first-time applicants for personal and project licences; to those seeking personal or project licences who have not held similar authorities for a significant period of time; and, in some circumstances, to personal licence holders seeking to extend their technical authorities. 2.75 Independent bodies accredit and oversee the training courses. The Home Office takes no part in the delivery of such training. 2.76 Evidence that appropriate training has been successfully completed must be provided when licence applications are made. Exemptions from the training requirements will only be granted where it can be shown that the individual concerned already has the knowledge and skills that would be gained on the course. 2.77 There is a specific Home Office training requirement for those taking up the Named Veterinary Surgeon role for the first time, on a full-time or part-time basis. The Home Office has accepted a course, approved and monitored by the Royal College of Veterinary Surgeons, as providing the minimum appropriate training for Named Veterinary Surgeons. This training must be satisfactorily completed within 12 months from the date on which the veterinary surgeon is named on the certificate. Exemption from this requirement may be sought by those holding more advanced qualifications in laboratory animal science, or with recent relevant Named Veterinary Surgeon experience at a designated establishment. There is also a professional requirement for all Named Veterinary Surgeons to maintain their skills and keep up to date through continuing professional development. 2.78 Although at the time this Guidance was published the Home Office had set no formal training requirements for Named Animal Care & Welfare Officers, specific third-party training courses are available that cover the role and responsibilities of NACWOs. Certificate holders are encouraged to make such training available. 2.79 Although it is not a formal requirement, Home Office advice is that applicants for certificates of designation complete module 1 training (see Annex to Appendix F). At the time this Guidance was prepared, certificate holders were collectively considering training appropriate to their role. 2.80 It is strongly recommended that deputy project licence holders successfully complete module 5 (see Annex to Appendix F). 2.81 The Secretary of State may, from time to time, review or revise the training requirements. Supervision and further training 2.82 Personal licence holders must achieve and maintain competence in the regulated procedures applied to the protected animals. The mandatory training is largely theoretical and does not itself ensure technical competence. 2.83 Until technical proficiency and competence are attained, the Secretary of State requires that the personal licensee accepts supervision and training arrangements put in place by the project licence holder, or by competent personal licensees nominated by the project licence holder. The limits of supervisory responsibility should be clear to all involved. The level and extent of necessary supervision and training should be reviewed and agreed periodically by the project and personal licence holders. 2.84 The Home Office regards this as an important responsibility of project licence holders and expects them to be able to demonstrate that appropriate supervision and training are actively provided for the personal licensees working under their direction and control. Confidentiality and freedom of information 2.85 Section 24 refers to disclosure of information obtained in carrying out functions under the Act. 2.86 It addresses the safeguarding of:
2.87 The enactment of Freedom of Information legislation will have consequences for the operation of the 1986 Act and especially Section 24. 2.88 The Home Office will publish supplementary guidance concerning information that may be published or made available. Prohibition of public displays 2.89 Section 16 of the Act makes it an offence for regulated procedures to be performed as an exhibition to the general public, or to be shown on live television for general reception. It is also an offence to publish a notice or advertisement announcing such events. There is no prohibition on the filming of procedures in progress for later editing or broadcast.
SOURCES OF ADVICE TO THE SECRETARY OF STATE Animals (Scientific Procedures) Inspectorate 2.90 Section 18 of the Act establishes the Animals (Scientific Procedures) Inspectorate and sets out an inspector's duties. 2.91 Inspectors advise the Secretary of State about whether and on what terms applications for licences and certificates should be granted, and about their review, amendment or variation. Inspectors visit establishments where regulated procedures are performed, and where animals listed in Schedule 2 of the Act are bred or kept. They do so to monitor standards and compliance with the Act, the published Codes of Practice, and the terms of licences and certificates. These visits are often unannounced. Inspectors must advise the Secretary of State of all instances of non-compliance and on the action that should be taken [Section 18(2)(e)]. 2.92 The Inspectorate has no powers to grant, refuse, revoke or vary licences or certificates. That responsibility lies with the Secretary of State. The administration of the Act is discussed in greater detail at Appendix G. Animal Procedures Committee 2.93 Sections 19 and 20 of the Act establish the Animal Procedures Committee, an independent body created to advise the Secretary of State on matters concerned with the Act and the Secretary of State's powers under it. The Committee may consider and advise on matters of its own choosing, as well as those that are referred to it by the Secretary of State. In its considerations, the Committee must 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 [Section 20(2)]. 2.94 The Committee advises the Secretary of State and has no executive powers. It cannot grant, refuse, revoke or vary licences or certificates. 2.95 The Committee publishes an annual report, available from The Stationery Office and at the Committee's website http://www.apc.gov.uk. 2.96 The Animal Procedures Committee and its remit are described in more detail in Appendix G. External assessors 2.97 Where issues arising from project licence applications prompt the Secretary of State to seek advice from other experts, the Act makes provision for the appointment of independent assessors [Section 9(1)]. The Secretary of State will notify an applicant if it is intended to refer the application to an external assessor and, in selecting the assessor, will have regard to any representations the applicant may wish to make [Section 9(2)]. In practice, the applicant is normally made aware of the identity of the assessor and the questions that the assessor has been asked to address. 2.98 This option may be exercised in a variety of circumstances. Advice may be sought when the issues raised require specific, expert knowledge not available within the Inspectorate. It may also be appropriate when there is debate within the scientific or welfare communities, or between the Inspectorate and an applicant, as to:
2.99 The assessor's advice, like that of the Inspectorate and the Animal Procedures Committee, only informs the Secretary of State's decision. The Secretary of State is not bound by the advice received. Person appointed to consider representations 2.100 Section 12 of the Act defines the actions to be taken by the Secretary of State when it is proposed to refuse an application for authorities under the Act, or to vary or revoke existing authorities other than with the consent of the holder of the licence or certificate. It also details, along with an Order made in Parliament (Annex to Appendix H), the procedures for making representations against decisions taken by the Secretary of State. 2.101 The Act allows that a person be appointed to consider any representations and to report the outcome to the Secretary of State [Sections 12(5) and 12(6)]. Again, the Secretary of State is not bound by the advice received. 2.102 More information about representations is provided in Appendix H.
SCHEDULES TO THE ACT Schedule 1 - Appropriate methods of humane killing 2.103 The humane killing of a protected animal is not a regulated procedure requiring authorisation by a project or a personal licence if it is performed by a method listed in Schedule 1 as being appropriate to the type of animal. However, at designated establishments, such killing must be performed by a competent person [Section 10(5 & 6)]. This is reinforced by a condition of issue on certificates of designation. Such persons must be properly trained [Section 10(5A)] and a register of competent persons must be maintained by the holder of the certificate of designation. 2.104 The Secretary of State has power to amend Schedule 1 by Order. The Schedule was amended by Statutory Instrument 1996 No.3278 with effect from March 1997. Schedule 1, as amended, is reproduced at Appendix A. 2.105 A Code of Practice relates to Schedule 1 (see paragraph 2.33 above). Certificate holders should make this publication available to those performing Schedule 1 methods and ensure that a copy of Schedule 1 is displayed in areas where they are performed. 2.106 At designated establishments, methods of humane killing (other than those contained in Schedule 1) may be allowed for an experimental or other scientific purpose, provided that they are performed by competent personnel and specified in the appropriate project and personal licences [Section 3]. In the case of surplus stock animals, methods not listed in Schedule 1 may be permitted by additional conditions on the certificate of designation [Section 10(5)]. Schedule 2 - Animals to be obtained only from designated breeding or supplying establishments 2.107 Schedule 2 lists the types of animals that, unless an exemption is granted by the Secretary of State, can only be used for experimental or other scientific purposes if they have been obtained from designated breeding/supplying establishments. Exemptions will only be granted where there is specific justification and normally only when suitable animals are not available from designated sources in the United Kingdom. 2.108 Schedule 2 has been amended by Order on several occasions and is reproduced, as amended, at Appendix A. Schedule 2A - Article 8 of Directive 86/609/EEC (concerning anaesthesia and analgesia) 2.109 Section 10(2A) of the Act requires that the Secretary of State include appropriate conditions on personal licences to ensure that authorised procedures are carried out in accordance with Article 8 of the Directive. This sets out requirements relating to the use of anaesthesia and analgesia. 2.110 The Schedule is reproduced at Appendix A. Paragraphs 5.16 and 5.17 of the Guidance address aspects of anaesthesia. Schedule 3 - Consequential amendments 2.111 Schedule 3 lists the amendments made to other legislation by the introduction of the Act. It is not reproduced at Appendix A. Schedule 4 - Transitional powers 2.112 This Schedule sets out the transitional arrangements for the introduction of the Act. All of the provisions of the Act are now in place. The Schedule is not shown at Appendix A.
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