Chapter 6: PERSONAL LICENCES

INTRODUCTION

6.1 A personal licence is the Secretary of State's endorsement that the holder is a suitable and competent person to carry out, under supervision if necessary, specified procedures on specified classes of animal [Section 3].

6.2 It does not authorise the holder to carry out any regulated procedure unless this is part of the programme of work authorised by a project licence [Section 3]. The place of work must be stipulated in both the personal and project licences.

APPLICATION FOR PERSONAL LICENCES

6.3 An applicant for a personal licence must:

• be at least 18 years of age [Section 4(4)]
• have appropriate education and training (including instruction in a relevant scientific discipline) and experience for the purpose of competently handling the protected animals, applying the specified regulated procedures to the specified classes of animal, and taking responsibility thereafter for the welfare of the animals [Section 4(4A)]; and
• be competent to apply those techniques in accordance with the conditions included in the licence [Section 4(4A)].

6.4 A personal licence applicant will normally be expected to provide evidence of appropriate education, training and experience. Typically, this will comprise:

• at least five GCSEs or Standard Grade passes (including a biological science), or equivalent vocational qualifications; and
• a certificate attesting to successful completion of training modules 1, 2 and 3 for the relevant species; and, in appropriate cases, module 4 (see Appendix F).

6.5 Applicants may request exemption from these requirements if suitable evidence is supplied of relevant, comparable education, training or experience.

6.6 A personal licence applicant must normally be sponsored by a personal licence holder who holds a position of authority at the place where the applicant is to be authorised by the licence to carry out regulated procedures [Section 4(3)]. The sponsor must be able to certify that the applicant's qualifications and character are satisfactory for the work for which a licence is sought, and that the appropriate accredited training has been successfully undertaken or that any exemptions requested from the general training requirements are justified and supported.

6.7 When an applicant does not have English as a first language, the sponsor is expected to confirm that the applicant understands the provisions of the Act.

6.8 Proposals to revise the structure of the personal licence are under consideration at time of writing. These aim to:

• improve the link between personal licence authorities and the mandatory training requirements;
• reinforce the responsibility of the project licence holder to provide supervision and training for personal licensees until technical competence is attained; and
• reduce unnecessary bureaucracy.

SPECIFIED PROJECTS

6.9 Generally, personal licensees are not restricted to work under the project licence specified at the time the application is made. They may, unless restricted by a condition of issue on the personal licence, work under any project licence at the designated establishments at which their personal licence is valid providing the techniques and species to be used are authorised on their personal licence and they are working under the direction and control of the relevant project licence holder.

6.10 In some cases (for example, in order to ensure adequate supervision or training), an additional condition of issue may be applied restricting the personal licensee to working on a limited range of project licences. Undergraduate personal licence holders, for example, may be restricted to working only with specific project licences issued for education and training purposes.

SPECIFIED PLACES

6.11 The personal licence specifies the designated scientific procedure establishments [Section 6(1)], and any places other than designated establishments, at which the licensee may perform regulated procedures. The first named should be the designated place where the licensee is based, and is referred to as the 'primary availability' (see paragraph 5.5 above). An annual fee is paid by the certificate holder for the establishment at which the licensee has primary availability [Section 8]: see paragraphs 4.44-4.47. Additional 'secondary availabilities', for which no fees are charged, may be specified on the licence.

6.12 Exceptionally, a place specified in a personal and a project licence may be a place other than a designated establishment [Section 6(2)]: see paragraphs 2.65 and 2.66 above.

CONDITIONS OF USE

6.13 Personal licence holders are personally accountable to the Home Office for compliance with the terms and conditions attached to their licence. The standard conditions of issue for personal licences form Appendix E to this Guidance. The Secretary of State may also attach additional conditions: for example, to restrict or qualify the licence authorities.

6.14 Personal licensees must be familiar with, and abide by, the authorities granted in the project licences under which they will be working: the objectives, plan of work, protocols, endpoints and the conditions of issue.

6.15 Before carrying out a regulated procedure, it is the responsibility of personal licensees to ensure that the procedure is authorised by a project licence and is being carried out at a place specified in both the project and personal licence; and that they have the correct techniques and species specified on their personal licence. Failure to comply with these basic requirements is a common, avoidable cause of non-compliance with licence authorities (see paragraphs 7.14-7.18).

WELFARE OF PROTECTED ANIMALS

6.16 Personal licensees bear primary responsibility for the welfare of animals to which they have applied regulated procedures. They must not allow an animal to experience pain, suffering, distress or lasting harm beyond that authorised by the project licence.

6.17 This responsibility involves:

• taking primary responsibility for the welfare of protected animals on which regulated procedures have been conducted;
• having an appropriate knowledge of the techniques and species involved; the likely consequences of the regulated procedures for the animals; and the signs of pain, suffering, distress or lasting harm in the species;
• taking precautions to prevent or reduce to the minimum (consistent with the purposes of the authorised regulated procedures and protocols) any pain, distress or discomfort to the protected animals used in procedures [Section 10(2)]; 'precautions' include the use of sedatives, tranquillisers, analgesics or anaesthetics in accordance with the project licence protocols and the requirements of Schedule 2A to the Act [Section 10(2A)];
• notifying the project licence holder, without delay, if it appears that the severity limit of a protocol in the project licence has been, or is likely to be, exceeded;
• obtaining veterinary advice and treatment, where necessary, for the animals;
• making suitable arrangements for the care and welfare of any animal during any period of absence;
• ensuring that, where a protected animal which is being, or has been, subjected to any regulated procedure is in severe pain or severe distress which cannot be alleviated, the animal is painlessly killed immediately by a method appropriate to the animal under Schedule 1 to the Act (or by such other method as may be authorised by their personal licence) [Section 10(2)];
• requiring the humane killing by an appropriate method of any animal which, at the conclusion of a series of regulated procedures, is suffering or is likely to suffer adverse effects (pain, suffering, distress or lasting harm) as a result of the regulated procedures applied [Section 15];
• ensuring that the responsibility for any animal kept alive after being subjected to a series of regulated procedures is, when appropriate, clearly transferred to another suitable person [Section 10(3D)]: see also paragraphs 6.18, 8.16and 8.31.

6.18 Where two or more personal licensees have applied regulated procedures to the same animal (for example, one personal licensee surgically prepares the animal and another licensee later administers test substances), it must be clear at all times which licensee has primary responsibility for the animal. Normally, responsibility is retained by the licensee who applied the last of the regulated procedures.

RECORD KEEPING AND CAGE LABELLING

6.19 Personal licence holders should maintain an adequate record of all regulated procedures performed, and whether they were supervised, and make this available to the holder of the relevant project licence and, on request, a Home Office inspector. Details should be kept of any resulting morbidity or mortality to allow informed judgements to be made with respect to technical competence, and also supervision and training needs.

6.20 Personal licensees must also ensure that all cages, pens or other enclosures are clearly labelled in a way that enables those with responsibilities under the Act to identify the relevant project licence number, the protocol (the project licence 19b number or short title), the date the protocol was started, and the responsible personal licensee. Labelling can be carried out by the use of coded-systems providing that appropriate provision is made for them to be easily decoded by others with responsibility for the care of the animals or responsibilities under the Act (including Home Office inspectors).

SUPERVISION AND TRAINING

6.21 It is recognised that new personal licence holders will need to gain competence in carrying out procedures. Until competence is attained, the Secretary of State requires that the personal licensee accept supervision and training arrangements put in place by the project licence holder, or by competent personal licensees nominated by the project licence holder. Further details can be found in paragraph 2.83 above.

DELEGATION OF AUTHORITIES

6.22 A personal licence applicant, or more usually a personal licence holder already competent in the relevant technique, may request authority from the Secretary of State to use unlicensed assistants to perform (under his or her direction and control) defined regulated procedures which do not require technical knowledge or special skills [Section 10(4)]. These procedures would not be expected to produce any immediate welfare problem in the protected animals. Such assistants must be appropriately trained, instructed and supervised.

6.23 If delegation is permitted, the necessary authority will be conferred by an appropriate additional condition of issue added to the personal licence. The personal licensee remains accountable to the Home Office for the competent performance of the procedures and the welfare of the protected animals.

6.24 Examples of regulated procedures for which delegation authority may be sought and granted, providing the personal licensee is available to offer advice and assistance if required, include:

• filling food hoppers and water bottles with previously mixed diets or liquids of altered constitution or to which test substances have been previously added;
• placing animals in a pre-defined, altered environment (for example, inhalation chambers, pressure chambers and aquatic environments);
• pressing the exposure button to deliver previously determined doses of irradiation to an animal;
• pairing/grouping associated with the breeding of animals with harmful genetic defects;
• withdrawal of contents from an established ruminal fistula;
• operating automated machinery that carries out inoculation of eggs;
• placement of animals in restraining devices (for example, metabolism crates or metabolism cages) as defined by the project licence;
• withdrawal of food and/or water, as defined by the project licence;
• placement of avian eggs into pre-set chillers at the termination of a procedure.

6.25 Consideration may be given to the delegation of other tasks that may be undertaken by assistants only in the presence of a suitably authorised personal licensee and on animals rendered insentient by decerebration or general anaesthesia that is to persist until death:

• administration of substance(s) or the removal of body fluids through established cannulæ or catheters as authorised by the project licence;
• administration or recording of electrical stimuli through electrodes implanted by a personal licence holder.

6.26 During the performance of surgical procedures, unlicensed assistants may only perform the simplest of duties in the presence of, and in response to instructions from, the personal licence holder who is performing the procedure. Such duties may include the retraction of wound margins and the cutting of sutures or ligatures. Assistants without appropriate personal licence authorities may not make or close surgical incisions, or perform any other intervention requiring specific knowledge or technical skill.

6.27 The Home Office should be consulted if there is any doubt as to whether or not a regulated procedure may be considered to be delegable. In all cases, specific authority to delegate must be contained in the personal licence.

DURATION, REVIEW AND VARIATION OF PERSONAL LICENCES

6.28 A personal licence continues in force until it is revoked [Section 4(5)].

6.29 All personal licences must be reviewed by the Secretary of State at intervals of not more than five years [Section 4(5)]. Other than when the review is brought forward to coincide with an amendment request, the personal licensee will be advised when the review process is being undertaken and requested to confirm the appropriateness of personal details, authorised techniques and species, and additional conditions.

6.30 The personal licences of those who are known to have retired or have reached the age of 70 years will be reviewed annually to ensure that authorities are still required, that competence is being maintained, and that the personal licensee is supported by the general systems of control which should apply to all licensees working at the designated establishment. The Home Office policy on licensees who are past retirement age is set out in the Report of the Animal Procedures Committee for 1991.

6.31 As part of the review process, the Secretary of State consults the Inspectorate for advice on whether and on what terms licence authorities should continue.

6.32 The personal licence remains in force during the review process. Failure to respond to correspondence concerning the review of a personal licence may result in its revocation by the Home Office, subject to the right to make representations [Section 12] - see Appendix H.

6.33 A licence holder may, at any time, request the addition of new techniques, new species, or new or additional availabilities (or the deletion of unwanted authorities or places).

6.34 The licensee should, when necessary, provide:

• evidence of relevant, additional modular training (or evidence to support an exemption request);
• a statement by a sponsor describing current competence and arrangements for supervision and training;
• evidence that the certificate holder at any new, additional designated place supports the request.

6.35 Any amendments requested cannot come into force unless and until the licence is re-issued with the amendments incorporated. Licensees should await the return of the amended personal licence, and check its provisions, before exercising new authorities.

6.36 The Act makes provision for the suspension of personal licence authorities if it appears to the Secretary of State to be urgently necessary for the welfare of any protected animal [Section 13]. Similar considerations apply in relation to the certificate of designation (see paragraph 4.72 above) and project licences (see paragraph 5.77; also paragraphs 2.69 and 2.70 above).

6.37 A personal licence may be returned by the holder to the Home Office for revocation at any time (for example, on leaving employment at the designated establishment). Subject to due process, the Secretary of State can also vary or revoke personal licences at any time:

• as a result of a breach of a condition of the licence [Section 10(7)]. The licence might be revoked if it is considered that it is no longer appropriate to entrust the holder with the responsibilities of a licensee; or it might be varied to remove authorities, to place additional restrictions on the authorities, or to add new conditions;
• in any other case in which it appears to the Secretary of State appropriate to do so [Section 11]: for example, if the certificate holder for a designated place specified on the licence requests that the availability at that establishment be revoked. If it is the 'primary availability' (see paragraph 5.5 above) which is to be revoked this will effectively revoke the licence, unless a new primary availability is approved by the Home Office within 28 days;
• at the request of the licence holder.

6.38 Section 12 of the Act sets out the right to make representations when the Secretary of State intends to vary or revoke a licence other than at the request of the holder (see Appendix H).

6.39 When a personal licence is revoked, the normal fee will be charged to the certificate holder of the primary availability at the end of the financial year.

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