ukpga/1986/14 — Animals (Scientific Procedures) Act 1986

Animals (Scientific Procedures) Act 1986 1986 c. 14 An Act to make new provision for the protection of animals used for experimental or other scientific purposes. [20th May 1986] Be it enacted by the Queen’s most Excellent Majesty, by and with the advice and consent of the Lords Spiritual and Temporal, and Commons, in this present Parliament assembled, and by the authority of the same, as follows:— Preliminary Protected animals. 1 1 Subject to the provisions of this section, “ a protected animal ” for the purposes of this Act means any living vertebrate other than man and any living cephalopod . 2 Any such vertebrate in its foetal, larval or embryonic form is a protected animal only from the stage of its development when— a in the case of a mammal, bird or reptile, two-thirds of the gestation or incubation period for the relevant species has elapsed; and b in any other case, it becomes capable of independent feeding. 2A Any living cephalopod in its embryonic form is not a protected animal. 3 The Secretary of State may by order— a extend the definition of protected animal so as to include any description of invertebrates other than cephalopods ; b alter the stage of development specified in subsection (2) above; c make provision in lieu of subsection (2) above as respects any animal which becomes a protected animal by virtue of an order under paragraph (a) above. 4 For the purposes of this section an animal shall be regarded as continuing to live until the permanent cessation of circulation or the destruction of its brain. 5 In this section “ vertebrate ” means any animal of the Sub-phylum Vertebrata of the Phylum Chordata and “ invertebrate ” means any animal not of that Sub-phylum. Regulated procedures. 2 1 Subject to the provision of this section, “ a regulated procedure ” for the purposes of this Act means any procedure applied to a protected animal for a qualifying purpose which may have the effect of causing the animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice. 1A A procedure is applied to an animal for “a qualifying purpose” if— a it is applied for an experimental or other scientific purpose (whether or not the outcome of the procedure is known); or b it is applied for an educational purpose. 2 A procedure applied to an animal for a qualifying purpose is also a regulated procedure if— a it is part of a series or combination of ... procedures (whether the same or different) applied to the same animal; and ab each of the other procedures in the series or combination is applied for a qualifying purpose; and b the series or combination may have the effect mentioned in subsection (1) above; and c the animal is a protected animal throughout the series or combination or in the course of it attains the stage of its development when it becomes such an animal. 2A A procedure applied to an animal for a qualifying purpose is also a regulated procedure if— a at the time the procedure is applied the animal has not attained the stage of its development when it is a protected animal; b the animal is to be allowed to live until after it attains that stage of its development; and c the procedure is likely to have the effect mentioned in subsection (1) after the animal attains that stage (whether or not it is also likely to have that effect before the animal attains that stage). 3 Anything done for the purpose of, or liable to result in, the birth or hatching of a protected animal is also a regulated procedure if it may as respects that animal have the effect mentioned in subsection (1) above. 3A The modification of an animal’s genes is a regulated procedure if— a the animal is a protected animal and the modification may have the effect mentioned in subsection (1); or b the animal is to be allowed to live until after it attains the stage of its development when it is a protected animal and the modification may have the effect mentioned in subsection (1) after it has attained that stage (whether or not it is also likely to have that effect before the animal attains that stage). 3B The breeding of an animal is a regulated procedure if— a the animal is bred from an animal whose genes have mutated or been modified or from a descendant of an animal whose genes have mutated or been modified; b the animal is to be allowed to live until after it has attained the stage of its development when it is a protected animal; and c after the animal has attained that stage the animal may experience pain, suffering, distress or lasting harm of a level mentioned in subsection (1) by reason of the mutation or modification referred to in paragraph (a). 3C For the purposes of subsections (3A) and (3B), references to the modification of an animal’s genes include the modification before the animal comes into being of any genetic material by virtue of which it comes into being 4 In determining whether any procedure may have the effect mentioned in subsection (1) above the use of an anaesthetic or analgesic, decerebration and any other procedure for rendering an animal insentient shall be disregarded; and the administration of an anaesthetic or analgesic to a protected animal, or decerebration or any other such procedure applied to such an animal, for the purposes of any experimental or other scientific procedure shall itself be a regulated procedure. 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Killing a protected animal is a regulated procedure only if— a it is killed for experimental or other scientific use; b the place where it is killed is— i a place that is specified in a licence granted under section 2C, or ii a place that is specified in a project licence by virtue of section 5(3), and c the method employed to kill the animal is not— i a method that is appropriate to that description of animal under Schedule 1, or ii in a case within paragraph (b)(i), a method that is specified as being appropriate to that description of animal in the licence granted under section 2C. 8 Notwithstanding anything in this section, the following are not regulated procedures— a non-experimental agricultural practices; b non-experimental clinical veterinary practices; c practices undertaken for the purposes of recognised animal husbandry; d the administration of any substance or article to an animal for research purposes in accordance with an animal test certificate granted under the Veterinary Medicines Regulations 2011 or the Veterinary Medicines Regulations 2013 ; e the ringing, tagging or marking of an animal, or the application of any other humane procedure for the primary purpose of enabling an animal to be identified, provided that it causes only momentary pain or distress (or none at all) and no lasting harm. 8A References in this section to “a procedure” include both invasive and non-invasive procedures. 9 Schedule 1 to this Act may be amended by orders made by the Secretary of State. Principles of replacement, reduction and refinement 2A 1 The Secretary of State must exercise his or her functions under this Act with a view to ensuring compliance with the principles of replacement, reduction and refinement. 2 For the purposes of this Act— a the principle of replacement is the principle that, wherever possible, a scientifically satisfactory method or testing strategy not entailing the use of protected animals must be used instead of a regulated procedure; b the principle of reduction is the principle that whenever a programme of work involving the use of protected animals is carried out the number of protected animals used must be reduced to a minimum without compromising the objectives of the programme; c the principle of refinement is the principle that the breeding, accommodation and care of protected animals and the methods used in regulated procedures applied to such animals must be refined so as to eliminate or reduce to the minimum any possible pain, suffering, distress or lasting harm to those animals. Licensing of undertakings Prohibition of unlicensed undertakings 2B 1 A person must not, whether for profit or otherwise, carry on at any place an undertaking which involves one or more of the activities mentioned in subsection (2) unless the person is authorised to do so by a licence under section 2C. 2 The activities are— a the applying of regulated procedures to protected animals; b the breeding of relevant protected animals with a view to— i their use in regulated procedures, or ii the use of their tissues or organs for scientific purposes, or the breeding of protected animals (other than relevant protected animals) primarily for purposes within sub-paragraph (i) or (ii); c the keeping of relevant protected animals which have been bred elsewhere and are to be supplied with a view to — i their use elsewhere in regulated procedures, or ii the use elsewhere of their tissues or organs for scientific purposes. 3 In this section “relevant protected animal” means a protected animal of a description specified in Schedule 2 to this Act. Licensing of undertakings 2C 1 A licence under this section is a licence granted by the Secretary of State which authorises the holder to carry on at a specified place an undertaking which involves the activities mentioned in subsection (2) of section 2B or such of those activities as are specified in the licence. 2 The Secretary of State may grant a licence under this section only if satisfied that the person who is to be the holder and the place that is to be specified are in compliance with the requirements of this Act . 3 An application for a licence under this section shall be made to the Secretary of State in such form and shall be supported by such information as the Secretary of State may reasonably require. 4 A licence under this section shall not be granted unless the application nominates for inclusion in the licence pursuant to subsection (5) persons appearing to the Secretary of State to be suitable for that purpose. 5 A licence under this section shall specify— a a person to be responsible for overseeing the welfare and care of the animals kept at the place specified in the licence; b a veterinary surgeon with expertise in laboratory animal medicine, or other suitably qualified person, to provide advice on the welfare and treatment of those animals; c a person to be responsible for ensuring that the persons dealing with those animals have access to any information they need about the species concerned; d a person to be responsible for ensuring that the persons dealing with those animals are adequately educated and trained and are supervised until they have demonstrated the requisite competence; and e a person to be responsible for ensuring that the conditions of the licence are complied with. 6 If the Secretary of State thinks fit, the same person may be specified under two or more of the paragraphs of subsection (5). 7 If it appears to any person specified in a licence pursuant to paragraph (a) or (b) of subsection (5) that the health or welfare of any animal kept at the place specified in the licence gives rise to concern, that person shall— a notify the person holding a personal licence who is in charge of the animal; or b if there is no such person or it is not practicable to notify that person, take steps to ensure that the animal is cared for and, if it is necessary for it to be killed, that it is killed in accordance with section 15A (manner in which protected animals are to be killed). 8 In any case to which subsection (7) applies the person specified in the licence pursuant to paragraph (a) of subsection (5) may also notify the person (if different) specified pursuant to paragraph (b) of that subsection; and the person specified pursuant to either paragraph of that subsection may also notify one of the inspectors appointed under this Act. 9 A licence under this section shall continue in force until revoked. 10 Where— a there has been or is to be a significant change to the structure or function of the place specified in a licence under this section, and b the change may have a negative effect on animal welfare, the Secretary of State shall vary the licence as appropriate (or if necessary revoke it). Personal and project licences Prohibition of unlicensed procedures. 3 No person shall personally apply a regulated procedure to an animal unless— a he holds a personal licence qualifying him to apply a regulated procedure of that description to an animal of that description; b the procedure is applied as part of a programme of work specified in a project licence authorising the application, as part of that programme, of a regulated procedure of that description to an animal of that description; and c the place where the procedure is carried out is a place specified in ... the project licence. Personal licences. 4 1 A personal licence is a licence granted by the Secretary of State qualifying the holder personally to apply regulated procedures of specified descriptions to animals of specified descriptions .... 2 An application for a personal licence shall be made to the Secretary of State in such form and shall be supported by such information as he may reasonably require. 3 Except where the Secretary of State dispenses with the requirements of this subsection any such application shall be endorsed by a person who— a is for the time being specified in a relevant section 2C licence by virtue of section 2C(5)(d); b has knowledge of the education, training, experience and character of the applicant; ... 3A For the purposes of subsection (3)(a), a section 2C licence is “relevant” if it authorises the holder to carry on an undertaking which involves the applying of regulated procedures to protected animals. 4 No personal licence shall be granted to a person under the age of eighteen. 4A The Secretary of State shall not grant a personal licence to a person unless he is satisfied that the person— a has appropriate education and training ... for the purpose of applying the regulated procedures that the licence would qualify the person to apply ; and b is competent to apply those procedures in accordance with the conditions which are to be included in the licence and to handle and take care of laboratory animals. 5 A personal licence shall continue in force until revoked but the Secretary of State shall review each personal licence granted by him at intervals not exceeding five years and may for that purpose require the holder to furnish him with such information as he may reasonably require. Project licences: general 5 1 A project licence is a licence granted by the Secretary of State which specifies a programme of work and authorises the application, as part of that programme, of specified regulated procedures to animals of specified descriptions at a specified place or specified places. 2 A place may not be specified in a project licence unless it is a place at which a person is authorised by a section 2C licence to carry on an undertaking involving the applying of regulated procedures to protected animals. 3 But subsection (2) does not apply in any case in which it appears to the Secretary of State, on the basis of a scientific justification, that the programme or procedures authorised by the project licence require a different place to be specified. 4 A project licence may specify a programme of work which consists of multiple generic projects if the projects— a are to be carried out to satisfy regulatory requirements, or b use animals for production or diagnostic purposes, in accordance with established methods. Application for a project licence 5A 1 An application for a project licence must— a specify the programme of work the applicant wishes to be specified in the project licence; b specify the regulated procedures, the descriptions of animal and the place or places the applicant wishes to be specified in the project licence; c include information on the matters set out in subsection (1A) ; d include such other information as the Secretary of State may reasonably require; and e be accompanied by a project summary. 1A The matters referred to in subsection (1)(c) are— a the relevance of, and justification for, the regulated procedures specified in the application; b the proposed application of methods to replace, reduce or refine the use of animals in those procedures; c the proposed severity classification of the procedures specified in the application (see section 5B(3)(c)); d the relevance of, and justification for, the use of animals in those procedures; e the following matters in relation to the animals to be used in those procedures— i their estimated number; ii their type and species; iii their life stages; iv their origin; f the proposed housing conditions, husbandry conditions and care conditions of those animals; g the steps proposed for the avoidance, reduction or alleviation of pain, suffering or distress in those animals, from birth to death where appropriate, including, in particular— i the planned use of anaesthesia, analgesia or other methods of relieving pain; ii the use of humane end-points; h any proposed experimental or observational strategy or statistical design for minimising the following where appropriate— i the number of animals to be used; ii their pain, suffering or distress; iii the environmental impact of the procedures; i the cumulative effects of any proposed reuse on those animals; j any proposed methods of killing those animals; k the steps proposed for the avoidance of any unjustified duplication of procedures where appropriate; l the competence of persons involved in the proposed programme of work. 2 A project summary is a statement, in non-technical language, which (subject to subsection (3)(a))— a describes the proposed programme of work and states the objectives of the programme, the predicted harm and benefits of the programme and the number and types of animal to be used in the programme; b demonstrates that the proposed programme of work would be carried out in compliance with the principles of replacement, reduction and refinement. 3 A project summary must not contain— a any information of a confidential nature or any information the publication of which may lead to the infringement of any person’s intellectual property rights; b names or addresses or any other information from which the identity of the applicant or any other person can be ascertained. 4 If the Secretary of State receives an incomplete or incorrect application for a project licence the Secretary of State must, as soon as practicable, inform the applicant of the following matters— a the fact that the application is incomplete or incorrect; b the additional information that needs to be provided by the applicant to complete or correct the application; and c the fact that the period mentioned in subsection (7) will not begin until the Secretary of State has received the additional information. 5 Subsections (6) to (9) apply if the Secretary of State receives a complete and correct application for a project licence or receives information from an applicant that completes or corrects an application for a project licence. 6 The Secretary of State must as soon as practicable— a acknowledge receipt of the application or (as the case may be) receipt of the information; and b inform the applicant of the effect of subsections (7) to (9). 7 Within the period of 40 working days beginning with the day on which the Secretary of State receives the application or (as the case may be) the information, the Secretary of State must— a grant a project licence to the applicant (in the terms specified in the application under subsection (1)(a) and (b) or in those terms with such modifications as the Secretary of State thinks appropriate); or b serve on the applicant a notice under section 12(1) indicating the Secretary of State’s intention to refuse the project licence. 8 On one occasion within the period mentioned in subsection (7), the Secretary of State may by notice to the applicant extend the period by up to 15 working days. 9 The Secretary of State may exercise the power in subsection (8) only if, and to the extent that, the Secretary of State considers its exercise is justified by the complexity or multi-disciplinary nature of the proposed programme of work. Determining an application: evaluation of the programme of work 5B 1 A project licence must not be granted unless the Secretary of State has carried out in accordance with this section a favourable evaluation of the programme of work to be specified in the licence. 2 For this purpose, the evaluation of a programme of work is favourable only if it verifies— a that carrying out the programme of work is justified from a scientific or educational point of view or is required by law; b that the purposes of the programme of work justify the use of protected animals; and c that the programme of work is designed so as to enable the regulated procedures applied as part of it to be applied in the most humane and environmentally sensitive manner possible. 3 In carrying out the evaluation of a programme of work the Secretary of State must— a evaluate the objectives of the programme of work and its predicted scientific benefits or educational value; b assess the compliance of the programme of work with the principles of replacement, reduction and refinement; c classify as “non-recovery”, “mild”, “moderate” or “severe” the likely severity of each regulated procedure that would be applied as part of the programme of work (see section 5BA) ; d carry out a harm-benefit analysis of the programme of work to assess whether the harm that would be caused to protected animals in terms of suffering, pain and distress is justified by the expected outcome, taking into account ethical considerations and the expected benefit to human beings, animals or the environment; e assess any scientific justification which is relevant (by virtue of sections 5(3), 15A(7) or 17(2), paragraphs 1(4), 2(4) or 3(3) of Schedule 2B or paragraph 25(2), (3) or (5) of Schedule 2C) to the question of whether or on what terms a project licence may be granted in respect of the programme of work; f assess whether there is any justification for an exemption under paragraph 26(2) of Schedule 2C; g assess whether carrying out the programme of work would give rise to any scientific reason for an exemption under paragraph 11(5) of Schedule 2C; h determine, on the assumption that a project licence is granted in respect of the programme of work, whether and (if so) when the programme should be retrospectively assessed under section 5F. 4 In carrying out the evaluation of a programme of work the Secretary of State must consider— a expertise in the area of science for which it is intended that protected animals will be used (including expertise in the application of the principles of replacement, reduction and refinement when working in that area of science); b expertise in experimental design (including expertise in statistics where appropriate); c expertise in veterinary practice in laboratory animal science or, where appropriate, expertise in wildlife veterinary practice; d expertise in animal husbandry and care in relation to the species of protected animals that are intended to be used. 5 For the purposes of subsection (3)(c) a series of regulated procedures applied to an animal for a particular purpose is to be treated as constituting a single regulated procedure. 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 The Secretary of State must determine that a programme of work should be retrospectively assessed under section 5F if the programme would involve— a the application of regulated procedures to primates; or b the application of regulated procedures the likely severity of which has been classified under section (3)(c) as “severe”. 8 The evaluation of a programme of work must be carried out with a degree of detail appropriate for the type of programme and must be carried out in an impartial manner. 9 The Secretary of State must publish information as to the process by which he proposes to evaluate programmes of work under this section. Determining an application: classification of the severity of the procedure 5BA 1 This section applies for the purposes of classifying the likely severity of a regulated procedure under section 5B(3)(c). 2 The likely severity of the procedure is to be determined by the degree of pain, suffering, distress or lasting harm expected to be experienced by an animal during the course of the procedure. 3 A procedure that falls within a description set out in column 1 of the following Table is to be assigned to the category that is specified in column 2 of the Table in relation to that description— Description of procedure performed on animal Category of severity A procedure that does not cause any significant impairment of the well-being or general condition of the animal. A procedure as a result of which the animal is likely to experience short-term mild pain, suffering or distress. Mild A procedure that is likely to cause moderate impairment of the well-being or general condition of the animal. A procedure as a result of which the animal is likely to experience short-term moderate pain, suffering or distress or long-lasting mild pain, suffering or distress. Moderate A procedure that is likely to cause severe impairment of the well-being or general condition of the animal. A procedure as a result of which the animal is likely to experience severe pain, suffering or distress or long-lasting moderate pain, suffering or distress. Severe A procedure performed entirely under general anaesthesia from which the animal will not regain consciousness. Non-recovery 4 The assignment of a procedure to a category in accordance with subsection (3)— a must be based on the most severe effects likely to be experienced by the animal after all appropriate refinement techniques have been applied, and b must take into account any manipulation of the animal. 5 When assigning a procedure to a category in accordance with subsection (3), the Secretary of State— a must first assign the procedure to a category on the basis of factors relating to the type of procedure only (“step 1”), and b must then determine whether to assign the procedure to a different category on the basis of additional factors (“step 2”). 6 The following factors relating to the type of procedure must be taken into account for the purposes of step 1— a the type of manipulation or handling involved in the procedure; b the nature and intensity of the pain, suffering, distress or lasting harm that would be caused by the procedure; c the duration, frequency and number of techniques to be used in the procedure; d the cumulative effects of the procedure; e the extent to which the animal used in the procedure would be prevented from expressing their natural behaviour, including any restrictions on their housing, husbandry or care. 7 Where the procedure is of a description that has been assigned by Schedule 2AA to a particular category of severity, the procedure is to be assigned to that category for the purposes of step 1. 8 The following additional factors must be taken into account for the purposes of step 2— a the species and genotype of the animal to be used in the procedure; b the maturity, age and gender of the animal; c the habituation of the animal with respect to the procedure; d if the animal is to be reused, the actual severity and cumulative severity of each previous procedure; e the methods used to reduce or eliminate pain, suffering and distress, including refinement of housing, husbandry and care conditions; f use of humane end-points. 9 The factors to be taken into account for the purposes of subsection (5) must be considered on a case-by-case basis. 10 Section 5B(5) applies for the purposes of this section as it applies for the purposes of section 5B(3)(c). Determining an application: further provision 5C 1 A project licence must not be granted except to a person who undertakes responsibility for the overall implementation of the programme of work to be specified in the licence. 2 A project licence must not be granted to a person unless the Secretary of State has verified that— a the person has received instruction in a scientific discipline relevant to the programme of work to be specified in the licence; b the person has specific knowledge relating to the species of animal that is to be subjected to regulated procedures as part of that programme of work; and c the person has appropriate education and training for the purpose of designing programmes of work involving the application of regulated procedures. 3 A project licence must not be granted unless the Secretary of State has verified that the programme of work to be specified in the licence is to be carried out for one of the following purposes— a basic research; b translational or applied research with one of the following aims— i the avoidance, prevention, diagnosis or treatment of disease, ill-health or other abnormality, or their effects, in man, animals or plants; ii the assessment, detection, regulation or modification of physiological conditions in man, animals or plants; or iii the improvement of the welfare of animals or of the production conditions for animals reared for agricultural purposes; c the development, manufacture or testing of the quality, effectiveness and safety of drugs, foodstuffs and feed-stuffs or any other substances or products, with one of the aims mentioned in paragraph (b); d the protection of the natural environment in the interests of the health or welfare of man or animals; e research aimed at preserving the species of animal subjected to regulated procedures as part of the programme of work; f higher education or training for the acquisition, maintenance or improvement of vocational skills; g forensic inquiries. 4 Schedule 2B (which requires the Secretary of State to verify that additional conditions are met before granting a project licence that would authorise the use of endangered animals, primates, cats, dogs or equidae) has effect. 5 The Secretary of State must not grant a project licence that would authorise the application of regulated procedures to great apes. Granting a project licence 5D 1 This section applies where a project licence is granted in relation to a programme of work. 2 The project licence must— a specify the name of the person to whom the licence is granted; and b contain a statement that the person is responsible for the overall implementation of the programme of work and for ensuring that the programme is carried out in compliance with the conditions of the licence. 3 The project licence must specify the name of any person who at the time the project licence is granted holds a section 2C licence granted in respect of a place specified in the project licence. 4 The project licence must state how the Secretary of State classified the likely severity of each of the regulated procedures specified in the licence (see section 5B(3)(c)). 5 The project licence must state what determination the Secretary of State made as to whether and, if so, when the programme of work should be retrospectively assessed under section 5F (see section 5B(3)(h)). 6 The Secretary of State must publish a copy of the project summary that accompanied the application for the project licence before the end of the period of six months beginning with the day on which the project licence was granted . 7 But before doing so the Secretary of State must alter the copy so that— a it states what determination the Secretary of State made as to whether and when the programme of work should be retrospectively assessed under section 5F; and b it includes such additional information as the Secretary of State thinks appropriate in order to assist a person who reads the summary. Duration of a project licence and further evaluation etc 5E 1 Unless revoked and subject to the following provisions of this section, a project licence shall continue in force for such period as is specified in the licence and may be renewed for further periods but (without prejudice to the grant of a new licence in respect of the programme in question) no such licence shall be in force for more than five years in all. 2 A project licence shall terminate on the death of the holder unless a qualifying person notifies the Secretary of State of the death within seven days of becoming aware of it. 3 Where the Secretary of State receives a notification under subsection (2) the project licence shall, unless the Secretary of State otherwise directs, continue in force until the end of the period of 28 days beginning with the date of the notification. 4 For the purposes of subsection (2), a person is a “qualifying person” in relation to a project licence if— a the person is the holder of a section 2C licence granted in respect of a place specified in the project licence; or b in a case where the project licence does not specify a place in respect of which there is a section 2C licence, the person is the holder of a personal licence who was engaged on the programme in question. 5 A project licence may not be varied or renewed unless the Secretary of State has carried out a further favourable evaluation of the relevant programme of work; and for this purpose section 5B applies with any necessary modifications. 6 The Secretary of State must establish and publish conditions which he or she will take into account in determining whether to vary or renew a project licence. Retrospective assessment of programme of work 5F 1 This section applies where— a a project licence is granted in respect of a programme of work; and b the Secretary of State made a determination under section 5B(3)(h) that the programme of work should be retrospectively assessed under this section. 2 At the time determined by the Secretary of State under section 5B(3)(h), the Secretary of State must assess the following matters— a whether the programme of work has been carried out; b whether the objectives of the programme of work have been achieved; c the amount of harm caused to animals by the carrying out of the programme of work (including the number of animals subjected to regulated procedures as part of the programme of work, the species of animals subjected to those procedures and the severity of those procedures); and d whether any lessons can be learnt from the programme of work which may contribute to the further implementation of the principles of replacement, reduction and refinement. 3 Following the assessment the Secretary of State must— a alter the copy of the relevant project summary published under section 5D(6) so that it includes a report on the assessment; and b publish the copy as altered before the end of the period of six months beginning with the day on which the assessment was completed . 4 The Secretary of State may by notice require the holder or former holder of the licence to provide the Secretary of State with specified information, or information of a specified kind, for the purpose of enabling the Secretary of State to assess the matters mentioned in subsection (2). 5 Information required to be provided by a notice under subsection (4) must be provided within such period as may be specified. Documents to be kept by Secretary of State 5G 1 Where a person applies for a project licence the Secretary of State must keep the documents specified in subsection (2) at least until the end of the period of three years beginning immediately after— a the expiry of the project licence (if the application for the licence is successful); or b (if not) the period mentioned in section 5A(7), taking into account any extension of that period under section 5A(8). 2 The documents referred to above are— a the application for the licence and the documents submitted in support of it; b documents setting out the results of the evaluation carried out under section 5B and of any evaluation carried out under section 5E(5); c the project licence itself, or the notice (served under section 12(1)(a)) of intention to refuse the application for the licence; d documents containing information provided for the purposes of any assessment under section 5F; e documents setting out the results of any such assessment (if completed before the end of the three-year period mentioned in subsection (1)); and f any other documents prepared or received by the Secretary of State in relation to the licence which the Secretary of State considers should be kept. 3 If section 5F applies in relation to a project licence and the assessment under that section is not completed until after the end of the three-year period mentioned in subsection (1), the Secretary of State must keep the documents specified in subsection (2)(a), (b), (c), (d) and (f) until the assessment is completed. ... Scientific procedure establishments. 6 1 Subject to subsection (2) below, no place shall be specified in a project licence unless it is a place designated by a certificate issued by the Secretary of State under this section as a scientific procedure establishment. 2 Subsection (1) above shall not apply in any case in which it appears to the Secretary of State that the programme or procedures authorised by the licence require him to specify a different place. 3 An application for a certificate in respect of a scientific procedure establishment shall be made to the Secretary of State in such form and shall be supported by such information as he may reasonably require. 4 A certificate shall not be issued under this section— a except to a person occupying a position of authority at the establishment in question; and b unless the application nominates for inclusion in the certificate pursuant to subsection (5) below a person or persons appearing to the Secretary of State to be suitable for that purpose. 5 A certificate under this section shall specify— a a person to be responsible for the day-to-day care of the protected animals kept for experimental or other scientific purposes at the establishment; and b a veterinary surgeon or other suitably qualified person to provide advice on their health and welfare; and the same person may, if the Secretary of State thinks fit, be specified under both paragraphs of this subsection. 6 If it appears to any person specified in a certificate pursuant to subsection (5) above that the health or welfare of any such animal as is mentioned in that subsection gives rise to concern he shall— a notify the person holding a personal licence who is in charge of the animal; or b if there is no such person or it is not practicable to notify him, take steps to ensure that the animal is cared for and, if it is necessary for it to be killed, that it is killed by a method which is appropriate under Schedule 1 to this Act or approved by the Secretary of State. 7 In any case to which subsection (6) above applies the person specified in the certificate pursuant to paragraph (a) of subsection (5) above may also notify the person (if different) specified pursuant to paragraph (b) of that subsection; and the person specified pursuant to either paragraph of that subsection may also notify one of the inspectors appointed under this Act. 8 A certificate under this section shall continue in force until revoked. Breeding and supplying establishments. 7 1 A person shall not at any place breed for use in regulated procedures (whether there or elsewhere) protected animals of a description specified in Schedule 2 to this Act unless that place is designated by a certificate issued by the Secretary of State under this section as a breeding establishment. 2 A person shall not at any place keep any such protected animals which have not been bred there but are to be supplied for use elsewhere in regulated procedures unless that place is designated by a certificate issued by the Secretary of State under this section as a supplying establishment. 3 An application for a certificate in respect of a breeding or supplying establishment shall be made to the Secretary of State in such form and shall be supported by such information as he may reasonably require. 4 A certificate shall not be issued under this section unless the application nominates for inclusion in the certificate pursuant to subsection (5) below a person or persons appearing to the Secretary of State to be suitable for that purpose. 5 A certificate under this section shall specify— a a person to be responsible for the day-to-day care of the animals bred or kept for breeding at the establishment or, as the case may be, kept there for the purpose of being supplied for use in regulated procedures; and b a veterinary surgeon or other suitably qualified person to provide advice on their health and welfare; and the same person may, if the Secretary of State thinks fit, be specified under both paragraphs of this subsection. 6 If it appears to any person specified in a certificate pursuant to subsection (5) above that the health or welfare of any such animal as is mentioned in that subsection gives rise to concern he shall take steps to ensure that it is cared for and, if it is necessary for it to be killed, that it is killed by a method appropriate under Schedule 1 to this Act or approved by the Secretary of State. 7 In any case to which subsection (6) above applies the person specified in the certificate pursuant to paragraph (a) of subsection (5) above may also notify the person (if different) specified pursuant to paragraph (b) of that subsection; and the person specified pursuant to either paragraph of that subsection may also notify one of the inspectors appointed under this Act. 8 A certificate under this section shall continue in force until revoked. 9 Schedule 2 to this Act may be amended by orders made by the Secretary of State. Licences: general provisions Fees. 8 The holder of a section 2C licence shall pay such periodical fees to the Secretary of State as may be prescribed by or determined in accordance with an order made by him. ... Consultation. 9 1 Before granting a section 2C licence or a project licence under this Act the Secretary of State shall consult one of the inspectors appointed under this Act and may also consult an independent assessor or the Committee for the Protection of Animals Used for Scientific Purposes established by this Act. 1A Before granting a personal licence under this Act the Secretary of State may consult one of those inspectors, an independent assessor or that Committee. 2 Where the Secretary of State proposes to consult an independent assessor he shall notify the applicant of that fact, and in selecting the assessor he shall have regard to any representations made by the applicant. Conditions 10 1 Schedule 2C makes provision as to the conditions that must be included in a licence granted under this Act. 2 A licence granted under this Act may include such other conditions as the Secretary of State thinks fit. 3 Breach of a condition in a licence does not invalidate the licence; but as to the consequences of a breach, see section 11 (failure to comply with licence conditions etc ). 4 If a personal licence includes a condition permitting the holder to use assistants to perform, under the holder’s direction, tasks not requiring technical knowledge, nothing done by an assistant in accordance with the condition contravenes section 3. Failure to comply with licence conditions etc 11 1 Subsections (2) to (5) apply where it appears to the Secretary of State that the holder of a licence under this Act is failing or has failed to comply with— a a condition of the licence, or b a provision of this Act. 2 The Secretary of State may issue the holder of the licence with a notice (“a compliance notice”) which— a specifies the condition or provision that the Secretary of State considers the holder is failing or has failed to comply with; b specifies the action the Secretary of State considers should be taken by the holder to ensure that the failure is not continued or repeated; c specifies any action the Secretary of State considers should be taken by the holder to eliminate or reduce any consequences of the failure; d requires the holder to take that action within such time as is specified in the notice; and e explains the effect of subsection (3). 3 If a compliance notice has been issued and it appears to the Secretary of State that the holder of the licence has failed to comply with it, the Secretary of State may revoke the licence (unless the compliance notice has been withdrawn, or the notice has been varied and the holder is in compliance with the notice as varied). 4 If it appears to the Secretary of State that— a remedial action needs to be taken to safeguard the welfare of protected animals for the time being kept by or on behalf of the holder of the licence, and b the holder of the licence is not willing or able to take that action, the Secretary of State may take that action (whether or not a compliance notice has already been issued). 5 If the Secretary of State does not act under subsection (2) or (4) the Secretary of State may suspend, revoke or vary the licence. 6 A licence under this Act may also be suspended, revoked or varied by the Secretary of State in any case in which it appears to the Secretary of State that it is appropriate to do so or at the request of the holder. 7 A reference in this section to suspending a licence is a reference to suspending the operation of the licence either for a specified period or until further notice. Right to make representations. 12 1 Where the Secretary of State proposes— a to refuse a licence under this Act; b to revoke or vary a licence under this Act otherwise than at the request of the holder; or c to suspend a licence, otherwise than at the request of the holder, under section 11, he shall serve on the applicant or the holder a notice of his intention to do so. 2 The notice shall state the reasons for which the Secretary of State proposes to act and give particulars of the rights conferred by subsection (3) below. 3 A person on whom a notice is served under subsection (1) above may make written representations and, if desired, oral representations to a person appointed for that purpose by the Secretary of State if before such date as is specified in the notice (not being less than twenty-eight days after the date of service) he notifies the Secretary of State of his wish to do so. 4 The holder of a licence ... who is dissatisfied with any condition contained in it may, if he notifies the Secretary of State of his wish to do so, make written representations and, if desired, oral representations to a person appointed for that purpose by the Secretary of State; but the making of such representations shall not affect the operation of any condition unless and until it is varied under section 11 above. 5 The person appointed to receive any representations under this section shall be a person who holds or has held judicial office in the United Kingdom or a a person who satisfies the judicial-appointment eligibility condition on a 5-year basis; b an advocate or solicitor in Scotland of at least 5 years’ standing; or c a member of the Bar of Northern Ireland or solicitor of the Court of Judicature of Northern Ireland of at least 5 years’ standing, and the Secretary of State may, if he thinks fit, appoint a person with scientific or other appropriate qualifications to assist the person receiving the representations in his consideration of them. 6 The person appointed to receive any such representations shall after considering them make a report to the Secretary of State; and the Secretary of State shall furnish a copy of the report to the person who made the representations and take it into account in deciding whether to refuse the application or to revoke, suspend or vary the licence , as the case may be. 6A Where subsection (1)(c) applies and the suspension is for a specified period of twelve months or less, this section has effect as if— a in subsection (3), for the words “may make written representations and, if desired, oral representations to a person appointed for that purpose by the Secretary of State” there were substituted “may make written representations to the Secretary of State”; and b subsections (5) and (6) were omitted. 7 The Secretary of State may by order make rules with respect to the procedure to be followed in the making and consideration of representations under this section, including provision requiring any such representations to be made within a specified time. 8 A notice under subsection (1) above may be served either personally or by post. Suspension in cases of urgency. 13 1 If it appears to the Secretary of State to be urgently necessary for the welfare of any protected animals that a licence ... under this Act should cease to have effect forthwith he shall by notice served on the holder suspend its operation for a period not exceeding three months. 2 If during that period a notice of proposed variation or revocation of the licence ... is served under section 12 above but at the end of that period— a the time for notifying the Secretary of State under subsection (3) of that section has not expired; or b representations are to be or are being made in accordance with that subsection; or c such representations have been made but the Secretary of State has not received or has not completed his consideration of the report of the person to whom the representations were made, he may by notice served on the holder further suspend the licence ... until he is able to decide whether to vary or revoke it but no further suspension shall be for longer than three months at a time. 3 A notice under this section may be served personally or by post. Duty to ensure welfare of animals not adversely affected by revocation or suspension 13A Where the Secretary of State revokes or suspends a licence under this Act, the Secretary of State must take steps to ensure that the revocation or suspension does not have an adverse effect on the welfare of the protected animals for the time being kept by or on behalf of the holder of the licence. Additional controls Re-use of protected animals 14 1 A protected animal that has been subjected to one or more regulated procedures must not be used for a further regulated procedure unless the Secretary of State has consented to such further use and the following conditions are met. 2 The first condition is that— a the actual severity of the regulated procedure, or each of the regulated procedures, previously applied to the animal has been classified in accordance with conditions included in a project licence by virtue of paragraph 23 of Schedule 2C, and b in a case where more than one regulated procedure has previously been applied to the animal, the actual severity of no more than one of those procedures has been classified as “severe”. 3 The second condition is that a veterinary surgeon with knowledge of the lifetime experience of the animal has advised that the animal’s general state of health and well-being has been fully restored following the application of the previous procedure or procedures. 4 The third condition is that— a the further procedure is to be applied as part of a programme of work specified in a project licence; and b the likely severity of the further procedure was classified by the Secretary of State under section 5B(3)(c) as “non-recovery”, “mild” or “moderate”. 5 For the purposes of subsection (1), the consent of the Secretary of State may relate to the specific animal concerned or may relate to animals used in specified procedures or specified circumstances. 6 But in the case of an animal that has been subjected to a regulated procedure the actual severity of which has been classified as “severe”, the consent of the Secretary of State must relate to the specific animal concerned and the Secretary of State may give consent only if— a the Secretary of State has consulted a veterinary surgeon who has examined the animal about whether consent should be given; and b the Secretary of State is satisfied that there are exceptional circumstances that justify the animal being used for the further regulated procedure. 7 For the purposes of this section, a series of regulated procedures applied to an animal for a particular purpose is to be treated as constituting a single regulated procedure. Killing animals at conclusion of regulated procedures. 15 1 Where a protected animal— a has been subjected to a series of regulated procedures for a particular purpose; and b at the conclusion of the series is suffering or likely to suffer adverse effects as a result of being subjected to the series , the person who applied those procedures, or the last of them, shall ensure that the animal is immediately killed in accordance with section 15A . 2 Subsection (1) above is without prejudice to any condition of a project licence requiring an animal to be killed at the conclusion of a regulated procedure in circumstances other than those mentioned in that subsection. Manner in which protected animals are to be killed 15A 1 Subject to subsections (8) and (9), a person must not intentionally kill a relevant protected animal unless— a the person kills the animal in a place that is specified in a section 2C licence; b the person kills the animal using an appropriate method; and c the person is registered in a register kept by the holder of the section 2C licence (in compliance with a condition included in the licence by virtue of paragraph 2 of Schedule 2C) as being competent to kill animals of that description using that method. 2 An animal is killed using an appropriate method if— a the method used is one that is appropriate to that description of animal under Schedule 1; or b the method used is one that is specified as being appropriate to that description of animal in the section 2C licence granted in respect of the place where the animal is killed. 3 An animal is also killed using an appropriate method if— a the animal is being or has been subjected to a regulated procedure as part of a programme of work specified in a project licence; and b the animal is killed using a method that is specified as being appropriate to that description of animal in the project licence. 4 An animal is also killed using an appropriate method if— a the animal is being or has been used in an agricultural research project the aim of which requires animals to be kept in similar conditions to those in which commercial farm animals are kept; b the animal is killed in a way that complies with Article 4 of Council Regulation (EC) No 1099/2009 on the protection of animals at the time of killing; and c the process of killing is completed by one of the methods listed in sub-paragraphs (a) to (e) of paragraph 1 of Schedule 1. 5 An animal is also killed using an appropriate method if— a the method is applied to the animal while it is unconscious; b the animal does not subsequently regain consciousness; and c the process of killing is completed by one of the methods listed in sub-paragraphs (a) to (e) of paragraph 1 of Schedule 1. 6 A section 2C licence may specify a method of killing as being appropriate to a description of animal only if the Secretary of State is satisfied, on the basis of scientific evidence, that the method is at least as humane as one of the methods of killing that are appropriate to that description of animal under Schedule 1. 7 A project licence may specify a method of killing as being appropriate to a description of animal only if the Secretary of State is satisfied, on the basis of a scientific justification, that the purposes of the programme of work specified in the licence cannot be achieved if a method of killing that is appropriate to that description of animal under Schedule 1 is required to be used. 8 A person may kill an animal in a place not specified in a section 2C licence if— a the place is specified in a project licence in reliance on section 5(3); b the animal is being or has been subjected to a regulated procedure at that place as part of a programme of work specified in that licence; and c that licence specifies a section 2C licence for the purposes of this subsection. Where this exception applies, the reference in subsection (1)(c) or (2)(b) to the section 2C licence mentioned there shall be read as a reference to the section 2C licence specified as mentioned in paragraph (c) above. 9 A person may kill an animal otherwise than in accordance with subsection (1) if it is necessary for the animal to be killed as a matter of urgency for animal welfare, public health, public security or environmental reasons. 10 Where a person applies a regulated procedure to a protected animal and the procedure causes the animal to die, the person is not to be treated for the purposes of this section as having intentionally killed the animal (even if the death of the animal was the likely outcome of the procedure). 11 In this section “relevant protected animal” means a protected animal which— a is being or has been used in a regulated procedure; b is being or has been kept for use in a regulated procedure; c has been bred for use in a regulated procedure; or d is being or has been kept for the purpose of being supplied for use in a regulated procedure. 12 A protected animal that is killed in a place specified in a section 2C licence for the use of its tissues or organs for scientific purposes shall also be treated as a relevant protected animal for the purposes of this section. Prohibition of public displays. 16 1 No person shall carry out any regulated procedure as an exhibition to the general public or carry out any such procedure which is shown live on television for general reception. 2 No person shall publish a notice or advertisement announcing the carrying out of any regulated procedure in a manner that would contravene subsection (1) above. Neuromuscular blocking agents 17 1 A person must not use a neuromuscular blocking agent in the course of a regulated procedure unless— a the person is expressly authorised to do so by the personal licence and the project licence under which the procedure is carried out; and b the agent is used in combination with such level of anaesthesia or analgesia as is determined in accordance with the project licence. 2 The Secretary of State must not grant a project licence that authorises the use of a neuromuscular blocking agent unless the Secretary of State is satisfied, on the basis of a scientific justification, that the purposes of the programme of work specified in the licence cannot be achieved without the use of such an agent. Setting free and re-homing protected animals 17A 1 A person who holds a licence under this Act must not set free a relevant protected animal, or permit any person acting on their behalf to do so, unless— a the Secretary of State has consented to the setting free of the animal; or b the animal is set free during the course of a series of regulated procedures. 2 A person who holds a licence under this Act must not re-home a relevant protected animal, or permit any person acting on their behalf to do so, unless the Secretary of State has consented to the re-homing of the animal. 3 The Secretary of State must not