| Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 | ||||
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Chapter 4: CERTIFICATES OF DESIGNATION
CATEGORIES OF DESIGNATION 4.1 Unless the Secretary of State grants a specific exemption, places where regulated procedures are performed must be designated as scientific procedure establishments under Section 6 of the Act. (See paragraphs 2.65 and 2.66 above on places other than designated establishments.) Project and personal licences specify the places where regulated procedures may be performed. 4.2 Places where animals of a description specified in Schedule 2 to the Act are bred for use on regulated procedures, or are kept for supply for use in regulated procedures or to other designated sources, must be designated as breeding and/or supplying establishments under Section 7 of the Act. Unless the Secretary of State grants a specific exemption, cats and dogs must be obtained from designated breeding establishments. Genetically modified animals (and harmful mutants) must be bred at or obtained from establishments that are also designated as scientific procedure establishments (since the breeding of such animals is a regulated procedure). 4.3 A single establishment may therefore need to be designated as any combination of these three categories of designation:
For example, a designated scientific procedure establishment may also be a designated breeding establishment if it breeds animals listed at Schedule 2 for use in regulated procedures conducted there or elsewhere. Similarly, an establishment breeding harmful mutant or genetically modified animals must also be a scientific procedure establishment. Breeding establishments may also be supplying establishments. 4.4 Certificates of designation contain a Schedule of Premises detailing the areas to be used for the accommodation, care and use of animals for experimental or other scientific purposes. It provides summary details of the type of use to be made of each area. Certificates must specify persons to be responsible for the day to day care of animals and veterinary surgeons (or other suitably qualified persons - see paragraphs 4.65-4.67) to be responsible for the welfare of the animals.
THE CERTIFICATE HOLDER 4.5 Applicants for certificates of designation must represent the governing authority of the establishment [Section 6(4)] - for example, a university registrar, the director of a research institute or the chief executive officer of a business. Some large organisations have appointed a full-time certificate holder. 4.6 In making an application, he or she is agreeing to assume overall responsibility to the Home Office for compliance with the terms and conditions of a certificate. The standard conditions for scientific procedure establishments are set out at Appendix B, and for breeding and supplying establishments at Appendix C. When an establishment is both a user, and a breeding or supplying establishment, both sets of conditions apply to the animal facilities listed in the relevant Schedules to the certificate. 4.7 Additional conditions of issue may be imposed by the Secretary of State [Section 10(1)]. These may, for example, add further restrictions on the use or care of animals, or set requirements (specific to that establishment) for the management and control of work under the Act. It is also by such means that the Secretary of State might authorise the use of humane killing methods (other than those listed at Schedule 1) for the culling of stock animals, or the acquisition from non-designated sources of stock animals of the types listed at Schedule 2. 4.8 The applicant must be the person at the establishment who can best discharge these duties and responsibilities and must:
4.9 Certificate holders should be selected on the basis, not of their job title, but of their ability and determination properly to discharge responsibilities under the Act. They will need the time, resources and the right management systems. It is not a role that can be discharged passively: proactive and effective leadership and management are essential. Certificate holders must be visible to, and approachable by, those who work with animals at the designated establishment. They must actively establish, nurture and reflect a 'culture of care' that should pervade every designated establishment 4.10 Figure 1 (in Chapter 3) illustrates the central role played by the certificate holder. Communication with those with responsibilities under the Act, and co-ordination of their activities, are key certificate holder functions. 4.11 Applicants for certificates of designation are advised and normally expected to complete module 1 of an accredited training course (see Annex to Appendix F) but training may be developed specifically for certificate holders (see paragraph 2.79 above).
RESPONSIBILITIES OF THE CERTIFICATE HOLDER 4.12 The certificate holder's responsibilities can be grouped under eight headings, as follows. Ethical review process 4.13 An ethical review process, acceptable to the Secretary of State, must be maintained at each designated establishment. This applies to breeding and supplying establishments as well as scientific procedure establishments. 4.14 The aims of the process are:
4.15 A fuller account of the requirement is set out at Appendix J. 4.16 A description of the proposed local ethical review processes must be agreed with the Home Office and any substantial changes may only be made with the knowledge and consent of the Secretary of State. 4.17 Certificate holders, or their nominees, are required to countersign each request for a project licence confirming that the application has completed the local ethical review process and that suitable facilities will be made available. This signifies that corporate consideration has been given to the proposals and that the certificate holder has mobilised the expertise and advice available within and to the establishment. It is for the certificate holder to decide whether to countersign the proposal and thereby to support the application going forward to the Home Office. Prevention of unauthorised procedures 4.18 At a designated scientific procedure establishment, the certificate holder is responsible for taking all reasonable steps to prevent the performance of unauthorised procedures. Certificate holders must, therefore, put in place systems that ensure compliance with:
4.19 A copy of the Schedule of Premises, and of the conditions attached to the certificate of designation, should be available for consultation by all licensees, named persons and applicants for licences. 4.20 Systems should be established to ensure that protected animals are issued for use in regulated procedures only when appropriate personal and project licence authorities exist. It is strongly recommended that management systems ensure regulated procedures are not carried out until copies of the relevant licence authorities are lodged with the certificate holder, or his or her representatives. If an animal is to be humanely killed by a Schedule 1 method, it should be issued only to a person listed on the establishment's register of competent persons. It is recommended that a copy of Schedule 1 be displayed, and the relevant Home Office Code of Practice be available, in all areas used for this purpose (see paragraph 2.33 above). 4.21 Certificate holders must notify the Home Office of the death of any project licence holder within seven days of it coming to their knowledge [Section 5(8)]. The project licence can remain in force for a further 28 days to allow any work in progress to be completed or an application for a replacement licence to be prepared and considered. During that period, the certificate holder must assume responsibility for the proper conduct of the project. Animal care and accommodation 4.22 Certificate holders must ensure that the use of rooms or other areas is as specified on the Schedule to the certificate. (Details of the approved areas should be made available to those with responsibilities under the Act.) Certificate holders must ensure that:
4.23 The certificate holder must ensure that sufficient trained staff are available to maintain a high standard of animal husbandry and care; and that the persons who take care of protected animals at the establishment, and those who supervise them, have appropriate education and training [Section 10(5A)]. 4.24 The certificate holder must also ensure that licensees, applicants for licences, and others who have responsibilities under the Act (or otherwise come into contact with the animals) have reasonable access to such education and training as is required for them to meet their obligations [Sections 4(4A) and 10(5A)]. Identification of animals 4.25 Certificate holders should take steps to ensure that each cage or confinement area holding animals is properly labelled by the personal licence holder; and that each of those containing protected animals not undergoing a regulated procedure bears a label which carries at least a cage/area reference and an identification of the animals held (by individual or batch, as appropriate) [Sections 10(6) and 10(6A)]. 4.26 In the case of dogs, cats, primates, equidæ and other farm animals and adult birds, each animal accommodated in the establishment must be readily identifiable. In the case of dogs, cats and primates, this must be by a means of permanent identification acceptable to the Home Office. The requirements are:-
4.27 Daily records should be maintained of the environmental conditions in enclosed animal holding areas. 4.28 The certificate holder must retain details of all project and personal licences allowing the performance of regulated procedures at the establishment. The records must cover at least the current and the preceding fee period. 4.29 The certificate holder is responsible for the maintenance of definitive, contemporary records of the source, use and disposal of all protected animals bred or obtained for use, supplied for use, or used in regulated procedures. Such records should account for each protected animal, except in the case of immature forms (foetal, larval or embryonic stages) which may be recorded in batches until they are issued for use in regulated procedures. The records shall include a health record, maintained under the supervision of the Named Veterinary Surgeon (or other suitably qualified person). The Named Veterinary Surgeon's records should be maintained to the proper professional standard. 4.30 The records for which the certificate holder is responsible should provide full and accurate details of the:
4.31 Additional requirements may be imposed in some circumstances. 4.32 These records should be retained for at least five years after the death of the animal or from the date of its release from the establishment, whichever is the longer. 4.33 The records must be made available to an inspector on request. The Secretary of State may, from time to time, require the reporting of summary details. The information contained in these records should also be used by establishments to monitor and continuously improve standards and practices - for example, to allow the prompt identification and early resolution of incidental welfare problems and to minimise animal wastage by better matching breeding programmes to likely demand (see paragraph 8.26). Source of animals 4.34 The Act places restrictions on the acquisition and use in regulated procedures of certain types of animal. These are described in Chapter 8. The certificate holder must ensure that animals are obtained and used only in accordance with these requirements. Disposal of animals 4.35 Many of the requirements relating to the fate of the animals at the end of a series of regulated procedures (including those relating to humane killing and to continued use or to re-use) have implications for project and personal licensees, as well as certificate holders. These are described in Chapter 8. The specific requirements relating to certificate holders are set out below. 4.36 Certificate holders must ensure that any animal kept alive after being subjected to a series of regulated procedures continues to be kept at the establishment under the supervision of a veterinary surgeon or other suitably qualified person unless:
4.37 Under certain circumstances animals may be subjected to 'continued use' or to 're-use', but only with the express consent of the Secretary of State (see paragraphs 5.57-5.66). Certificate holders must ensure that systems are in place to prevent unauthorised use, continued use or re-use of animals. 4.38 When it is necessary to kill humanely any protected animal which has been bred or kept for use in regulated procedures but which has not undergone any regulated procedures (such as surplus stock), the certificate holder should ensure that this be done competently. Culling must be by either an appropriate Schedule 1 method of humane killing or another method authorised by an additional condition on the certificate of designation [Section 10(5)]. At breeding or supplying establishments, this applies only to animals listed in Schedule 2 of the Act. 4.39 The certificate holder must maintain a register of persons competent to apply methods of humane killing listed in Schedule 1 (or other methods specified in the certificate of designation). He or she must ensure that the humane killing of surplus stock animals is entrusted only to those persons. Certificate holders must make arrangements to ensure that someone competent in these methods is always available, and that any necessary equipment is to hand and well maintained. It is recommended that a copy of Schedule 1 is displayed in areas where animals are killed, and that a copy of the associated Code of Practice be readily available for reference (see paragraph 2.33 above). 4.40 Other than when the humane killing is performed for experimental or other scientific purposes under project and personal licence authorities, it is the certificate holder's responsibility to ensure that the relevant provisions are complied with and that appropriate records are maintained of the disposal of the animals. HOME OFFICE INSPECTIONS 4.41 Inspectors must be given access to all parts of the establishment listed on the certificate of designation at any reasonable time (including during unannounced visits of inspection). 4.42 Inspectors must also be provided with reasonable access to parts of the establishment not listed on the Schedule to the certificate, so that they can:
4.43 The Home Office must be informed of local controls or precautions taken to minimise the risk of the transmission of disease. These may influence or determine how inspections are conducted. 4.44Holders of certificates of designation shall pay fees to the Secretary of State as may be prescribed or determined [Section 8]. Such fees are required, by HM Treasury, to recover the costs of operating the Act. These include the costs of the Inspectorate and licensing operation; the Animal Procedures Committee; and the money used to sponsor research on alternatives. The Secretary of State may vary the level of fees, and the basis on which they are charged, by making an Order in Parliament [Section 8]. This Order must be laid to come into force before the start of the period in which the revised fees will be levied. 4.45 A composite fee is currently charged, comprised of an annual fee for the certificate of designation; and an annual fee for each personal licensee with primary availability at the establishment (see paragraph 5.5). No fee is levied with respect to project licences. 4.46 If a personal licence allows work at more than one establishment, the second and subsequent establishments specified do not pay that fee. However, if the 'primary availability' changes during the accounting period, a fee will charged to the certificate holder at each of the establishments at which the licence had primary availability during the year (see paragraph 5.5). 4.47 Invoices are issued each year detailing the fees payable for the previous year. Fees due must be paid to the Home Office within 28 days of the date of issue of the invoice. Non-payment of such a fee may result in the certificate of designation being revoked, subject to the right to make representations.
NAMED PERSONS 4.48 Applicants for certificates of designation must nominate:
4.49 These named persons must be actively involved, on a day to day basis, in safeguarding the welfare of the protected animals bred, kept and used at designated establishments. They should help certificate holders fulfil their responsibilities, and should play a central role in the local ethical review process. The relationships between named persons and others with responsibilities under the Act are shown diagrammatically in Figure 1 (see Chapter 3). Direct lines of communication between named persons and the certificate holder should be provided and used effectively. 4.50 Certificate holders are accountable to the Home Office for the performance and conduct of the named persons. If the Secretary of State considers that the named persons are not suitable, or are not properly discharging their duties under the Act, the certificate of designation may be varied or revoked - unless the certificate holder immediately resolves the problems to the satisfaction of the Home Office or nominates other named persons who can properly discharge the functions. 4.51 Certificate holders should ensure that these persons have been clearly entrusted with the necessary management authorities and that their advice on the welfare of animals is sought and taken by project and personal licence holders, of whatever seniority, both at the planning stage and once work is in progress. To discharge their responsibilities these named persons should have access to licences and other relevant documentation relating to the production, care and use of animals within the establishment. They must be provided with the necessary training and resources. 4.52 The certificate holder must make proper arrangements for the care and welfare of animals when the named persons are not available for any reason. They must be promptly replaced (and the certificate amended) when they leave the post or their responsibilities change, making it difficult or impossible for them to function as named persons. 4.53 There are training requirements for those undertaking Named Veterinary Surgeon responsibilities for the first time (see paragraph 2.77 above). Training courses are also available for Named Animal Care & Welfare Officers (see paragraph 2.78 above). The continuing professional development and training of these key individuals should be actively encouraged. 4.54 Certificate holders must ensure that proper provision is made to cope with any potential conflicts of interest when named persons also function in other capacities under the Act (see paragraphs 3.17-3.19 above).
NAMED ANIMAL CARE & WELFARE OFFICER 4.55 The person named on the certificate as responsible for day to day care is responsible to the certificate holder for the husbandry, care and welfare of the protected animals. The Institute of Animal Technology has published guidelines for Named Animal Care & Welfare Officers and provides opportunities for continuing professional development. 4.56 NACWOs should have expert knowledge and suitable experience of relevant animal technology. A suitable person might, for example, be a senior animal technician with an appropriate animal technology qualification, or an experienced stockman with an appropriate qualification in agricultural science. Several bodies provide training suitable for animal care staff and may be able to assist certificate holders on the selection or training of Named Animal Care & Welfare Officers. 4.57 It is expected NACWOs will ensure that the highest standards of husbandry and care are practised. In designated scientific procedure establishments, this responsibility extends into areas approved for the performance of regulated procedures. If the health or welfare of any protected animal is giving rise to concern, the NACWO must notify the personal licensee who is responsible for the welfare of the animal. If there is no such licensee, or if none is available, the named person must take steps to ensure that the animal is cared for; and, if necessary, that it is humanely killed using a Schedule 1 method, or any other method approved on the certificate of designation, appropriate to the type of animal [Sections 6(6) and 7(6)]. If there is any doubt about what action should be taken, the Named Veterinary Surgeon or a Home Office inspector should be notified. 4.58 Named Animal Care & Welfare Officers should:
NAMED VETERINARY SURGEON 4.59 The Named Veterinary Surgeon must normally be a member of the Royal College of Veterinary Surgeons. The RCVS maintains registers of veterinary surgeons holding specialist and other higher qualifications. Certificate holders may find these useful in helping to identify suitable nominees. There are training requirements for those taking up the Named Veterinary Surgeon role for the first time, whether on a full-time or part-time basis (see paragraph 2.77 above). 4.60 For the purposes of the Veterinary Surgeons Act 1966, the protected animals at the designated establishment are deemed to be under the care of the Named Veterinary Surgeon. Thus, in addition to being accountable to the certificate holder for the provision of expert advice on the health and welfare of protected animals, Named Veterinary Surgeons are also accountable to the Royal College of Veterinary Surgeons for their professional standards and conduct. 4.61 Guidelines on professional conduct for Named Veterinary Surgeons, produced by the Royal College of Veterinary Surgeons, advise that they should:
This is also the view of the Home Office. 4.62 Named Veterinary Surgeons should:
4.63 At a scientific procedures establishment, the Named Veterinary Surgeon should also:
4.64 The Act contains specific requirements for certifying the fitness of animals. These requirements are discussed in detail in Chapter 8.
OTHER SUITABLY QUALIFIED PERSON 4.65The Act makes provision for a person other than a veterinary surgeon to be named on the certificate [Section 6(5)(b)]. The Home Office will consult the Royal College of Veterinary Surgeons when requests are made for "other suitably qualified persons" to be nominated in place of a veterinary surgeon. 4.66 The Secretary of State can permit this in exceptional circumstances where no suitable veterinary surgeon is available and the "other suitably qualified person" has considerable, proven expertise relevant to the health and welfare of the particular types of protected animal held and the range of regulated procedures performed at the establishment. To date, it has been deemed acceptable only when the protected animals involved were embryonated avian eggs or fish. 4.67 With regard to providing advice on health and welfare, and ensuring action is taken to protect animals where there is concern for their health or welfare, the responsibilities of the "other suitably qualified persons" are equivalent to those of Named Veterinary Surgeons. DURATION, AMENDMENT, VARIATION AND SUSPENSION 4.68 Once issued, a certificate of designation remains in force until it is revoked [Sections 6(8) and 7(8)]. 4.69 Certificates of designation may be revoked at any time at the request of the certificate holder. They may also be revoked or varied at any time by the Secretary of State:
4.70 The circumstances under which the Secretary of State is most likely to consider revocation of a certificate include:
4.71 Revocation immediately invalidates all personal and project licence 'availabilities' at that establishment, and animals may no longer be bred, kept for use, or used on regulated procedures. 4.72 The Secretary of State can also suspend certificates where it appears to be urgently necessary for the welfare of any animal [Section 13]. If a certificate is suspended, all procedures at that establishment must stop immediately (see also paragraphs 2.69 and 2.70 above and paragraphs 5.77and 6.36). 4.73 The Secretary of State may also vary the terms and conditions of a certificate of designation: for example, to require that internal controls are improved, or to remove authority for the use of parts of the establishment no longer considered to meet the required standards. 4.74 Section 12 of the Act sets out the right to make representations when the Secretary of State intends to vary or revoke a certificate other than at the request of the holder. This is set out in detail in Appendix H. 4.75 A certificate holder may request that the certificate be amended at any time. Amendments must be requested if there are changes in the title of the establishment, the class of designation, the persons named on the certificate, the list of approved areas, the use of such areas, or the ethical review process. The new authorities will not come into force until a revised certificate is issued by the Home Office.
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