ANIMALS (SCIENTIFIC PROCEDURES) ACT 1986 Personal Licence Application Form (Notes) Use this form for new applications and/or amendments and/or reviews Please read the notes below carefully before completing the application form. They explain what information is needed in each section. It is an offence under the Animals (Scientific Procedures) Act 1986 knowingly or recklessly to provide false or misleading information in support of this application. YOU MAY NOT BEGIN A PROCEDURE COMING WITHIN THE SCOPE OF THE ACT UNTIL YOU HAVE OBTAINED APPROPRIATE AUTHORITY IN A PERSONAL LICENCE FROM THE SECRETARY OF STATE. SUBMISSION OF THIS APPLICATION FORM IS ONLY THE START OF THE PROCESS. YOUR PERSONAL LICENCE MAY ONLY BE USED IN CONJUNCTION WITH A VALID PROJECT LICENCE. Before completing the form you must refer to Home Office Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 which explains the provisions of the Act and the purpose of the controls imposed by the Secretary of State. This guidance is still subject to revision; you should check the Home Office website regularly for current information. Only one copy of the application is required. PART 1 - To be completed by the personal licence applicant To become a personal licence holder you must: be at least 18 years old; have satisfactorily completed the appropriate accredited training modules (see Section 8)) To amend your personal licence you must: have satisfactorily completed the appropriate accredited training modules if adding species or Categories. (see Section 8) Section 2 Information in this section is needed so that we can link this application with any previous personal licence records. Section 3 – contact details This is to identify the establishment that will be your main place of work and that will pay your personal licence fee and maintain your personal training and competence file. If you change your main place of work, you must apply to amend your licence accordingly. a. Give both the title and administrative address of your primary availability establishment. This will be an establishment authorised by the Home Office for the conduct of regulated procedures under the Act (a user establishment). We will use this address to write to you. If this is not your professional address you will need to make sure that the Home Office Liaison Contact (HOLC) and Named Training and Competency Officer (NTCO) know your contact details so that they can forward information. b. If you supply a professional e-mail address you will be added to the distribution list for electronic mailings that are sent to users by the Home Office from time to time. These disseminate information on current issues that may be of interest or relevance to licensees. This is an optional section. c. Your professional telephone number will be used to contact you directly should there be any queries about your personal licence application. Working at other designated establishments Your personal licence will allow you to work at any licensed establishment in the UK but you must have permission from the Project Licence Holder and the Establishment Licence Holder to do so. You must contact the Named Training and Competency Officer (NTCO) at any additional establishment before starting work there. You may also work at places that are not included on an establishment licence (POLEs) but this must only be as part of an authorised programme of work. Which projects may I work under? Category E or F licences may limit you to working under a specific project licence. For categories A, B, C and D you can work on any project as long as the categories of techniques and species of animals you are using are authorised by both your personal licence and the project licence (at a place authorised by that project licence) and the project licence holder and establishment have consented to your work. Section 4 No one under 18 may hold a licence. Please give day, month and year of birth in that order. We also use this information to correctly identify you. Section 6 Unless you are requesting an exemption from standard training requirements, you should enclose copies of the certificates awarded on successful completion of formal training by one or more of the accredited training bodies (module certificates). Please do not send us the original certificates. Certificates must be dated within 5 years of the date of application. This applies if you are applying for a personal licence for the first time or if you are applying to add species or Categories. Anyone applying for a licence more than 5 years after revocation of the previous licence or applying to add species or Categories that have not been authorised within the previous 5 years should expect to be required to undergo the full formal training programme. See notes at Section 8 for guidance on formal training requirements. Exemptions from modular training Exemption from all accredited modular training requirements will be considered only if you have acceptable equivalent formal training; typically you have held a personal licence within the previous 5 years giving authority to use animals of the same species and one or more techniques in the same Categories for which you are applying. Completion of Module 1 only will be considered if you can provide evidence that you have acquired equivalent knowledge and competence to that gained from successful modular training by other means, for example: veterinary surgeons with demonstrable practical experience of the relevant species; animal technicians highly experienced with the relevant species; holders of qualifications of an appropriate level and quality in laboratory science from outside the UK; experienced overseas researchers with acceptable evidence of appropriate training and competence. In such cases you should be given on-site training in local procedures. You should undertake refresher training as appropriate to ensure that your knowledge is current. Some species-specific training may be accepted for additional, closely related species with appropriate supporting evidence. In these cases you must then provide evidence that you have undertaken local training of equivalent content and quality to that provided by an accredited training course in the biology, husbandry and handling of the additional species, and that you can recognise the signs of wellbeing and pain, distress or suffering. This evidence must be provided in writing, indicating the standing of the trainer and assessor and must be endorsed by the NTCO. An acceptable trainer is likely to teach the subjects / species on formal accredited courses. You may wish to approach your training provider / Accrediting Body to request formal certification to include the additional species if appropriate. For example: If you have formal theoretical and practical skills training with both rats and mice then you may also apply to use hamsters or gerbils; If you have evidence of training with sheep you may also apply to use goats. If you are applying for an exemption from formal training, in every case you should provide a clear justification in Section 6b supported by additional evidence in Section 6c or by letter as appropriate. We cannot consider an exemption request without such information. Section 7 – Other relevant experience and training Where you are applying to work under a training and education licence - Category E, for example if you are applying for a licence to attend a microsurgery training course, you should use this section to explain briefly: your current position within your profession why it is necessary for you to undertake the training course how the skills you acquire will be used to maintain or improve vocational skills. You should also use this section to provide supplementary information if you are applying for Category D, as described in detail under Section 8. Section 8 – Procedures for which authority is sought a. Procedure Qualification for the categories of procedures will normally be by virtue of training. The existing UK Modular Training framework will be used until such time as Accrediting Bodies have revised modular training in line with EU considerations. The table below lays out the standard training requirements for new applicants for different categories of licence. Category Comments A Applicants for these two categories should submit copies of certificates for: Minor/minimally invasive procedures not requiring sedation, analgesia or general anaesthesia module 1; and B Minor/minimally invasive procedures involving sedation, analgesia or brief general anaesthesia Plus – Surgical procedures conducted under brief non-recovery general anaesthesia Surgical procedures involving general anaesthesia C Plus – administration and maintenance of balanced or prolonged general anaesthesia species-specific modules 2 and 3 as appropriate. It is expected that applicants will apply for both Categories A and B If you apply for Category C, you will also request categories A and B. You should submit a copy of a module 4 certificate in addition. Module 4 is not species-specific. D Use of neuromuscular blocking agents Applicants must provide evidence of training, qualifications and experience as explained in detail below and in Home Office Guidelines on the use of Neuromuscular Blocking Agents (NMBAs). E Procedures conducted in accordance with Project Licence (insert number) Requirements are dependent upon training incorporated as part of the course. Consult your course provider for advice. F Other (a free text field) You must always consult your local Inspector for advice before requesting Category F. Illustrative examples of the techniques that are encompassed by Categories A-D are at Annex 1. If you are unsure if a procedure you intend to conduct is authorised by a Category, you should seek advice from your local Home Office Inspector. Completion of modules 1-3 will qualify for Categories A + B; Completion of modules 1-4 will qualify for Categories A + B + C. Applicants for Category D should have completed modules 1-4 and must supply supplementary information in Section 7 to explain how they are suitable, through training, qualifications and experience to use neuromuscular blocking agents (see Home Office guidance on use of NMBAs). Typically this will be evidence that you are: o competent to undertake current anaesthetic techniques in the animal species with which you propose to work; and o have read and can comply with the guidance on use of neuromuscular blocking agents as set out in Home Office guidelines; and o you have witnessed the use of neuromuscular blocking agents and are familiar with the procedures for achieving and maintaining anaesthesia under such regimes. Category E is for applicants who intend to attend an education and training course conducted under a single project licence. You should consult your course provider for details of pre-course formal training requirements and which species to request. Please see notes under Section 6 for other information that you may need to provide. If you intend to conduct work under other project licence authorities, you will need to apply for the relevant Categories and species and supply copies of the necessary formal training certificates. Category F is for the rare occasions where the regulated procedures you wish to conduct do not fall within the scope of one of the preceding categories or formal training requirements. You must consult your local Home Office Inspector for advice before making such an application. b. Animal(s) The description of animals for which you seek authority will generally be the same as that on the certificates for species-specific modules you have undertaken, or very similar. Below are examples of acceptable descriptions: Mice Rats Guinea pigs Hamsters Gerbils Rabbits Dogs Cats Non-human primates – old world or macaques Fish - may be categorised eg 1. Zebra fish 2. Freshwater fish 3. Single species of fish (please specify) Ferrets Horses Pigs or minipigs Mini Goats, sheep Cattle Amphibians Cephalopods Reptiles Non-human primates – new world or marmosets Birds (may be categorised eg poultry, waterfowl, small birds (caged and wild), large birds Avian eggs For animals taken from the wild, describe the species by their common name, e.g. fox, badger For other species use the common name or grouping, for example deer, camelids, seals You should list the species or common name for each species of rodent rather than use the common grouping ‘rodents’. Section 9 Any application that is unsigned or undated will be returned without further assessment. PART 2 – Named Training and Competency Officer details and endorsements (for new applications only; use PART 3 for amendment requests or reviews) Section 12 – Address for correspondence This will normally be the same as the address for the primary availability establishment. Section 13 In order to make the endorsement, you will normally have met the applicant or been supplied with appropriate evidence for you to be confident in signing. The named TCO is responsible for ensuring that all people dealing with animals are adequately educated and trained and are provided with supervision until they have demonstrated the requisite competence. You must endorse the application to confirm that the applicant’s qualifications and character are satisfactory for the work for which a licence is sought, and that you support any exemptions requested from the general training requirements. Applicants should have attained a minimum standard of education; typically this will be at least five GCSEs or Standard Grade passes (including a biological science), or equivalent vocational qualifications or experience. Where an applicant does not have English as a first language, the named TCO is expected to confirm that the applicant understands the provisions of the Act. To prevent delays in processing applications, you should check that applicants have successfully and recently completed the necessary formal training. See notes in Sections 6 and 8 for details of the requirements and potential exemptions. PART 3 – Named Training and Competency Officer details and declarations (for amendment requests/reviews) Section 17 In order to make the endorsement, you will normally have met the applicant or been supplied with appropriate evidence for you to be confident in signing. The named TCO is responsible for ensuring that people dealing with animals are adequately educated and trained and are provided with supervision until they have demonstrated the requisite competence. In order to minimise delays in processing applications, you should check that: either the applicant has the required module training (see notes under Sections 6 and 8); and/or the personal licence authority currently authorised allows regulated procedures and use of the animals equivalent to those described in Section 8 of the application form; and/or the licensee qualifies for a training exemption. The applicant must enclose copies of any certificates to support adding species or categories. Annex 1 – Illustrative examples of techniques in each category Category A Number A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 Technique Variation in the composition, constituents, quantity and/or availability of the diet and/or drinking water which may cause pain, suffering, distress or lasting harm Administration of substances by intravenous, subcutaneous, intradermal, intramuscular or intraperitoneal injection; by the oral route (including by gavage); by inhalation; by immersion; in the aqueous medium or topically to the skin, conjunctiva or surface of eye Administration of substances or withdrawal of fluids via previously implanted cannula, catheter, or delivery or access system Withdrawal of blood from superficial blood vessels by non-surgical methods Collection of cells or secretions from the oral or nasal cavities, the vagina or rectum, or the external structures of the eye. Breeding and maintenance of genetically altered animals Anaesthesia code AA Non-surgical implantation of a microchip or telemetry device Restraint by physical means, or by confinement within a restricted area, of a nature or duration that may cause pain suffering distress or lasting harm Cannulation of blood vessels, ducts or cavities by non-surgical means Killing by dislocation of the neck other than as specified in a method of killing on Schedule 1 Decapitation other than as specified in a method of killing on Schedule 1 AA Comments Includes withholding of food and/or water, and administration of substances by addition to food or the drinking water AA AA This does not include the surgery or anaesthesia required for placement. Includes use of stomas or similar AA Does not include venesection or tail tip removal AA AA This regulated procedure involves pairing to produce a new individual and keeping alive an individual with potential for harm AA This includes restraint using fixation devices previously implanted under separate authority and confinement in a metabowl, primate chair or sling AA Includes genitourinary tracts AA AA A12 A13 A14 A15 A16 A17 A18 A19 A20 A21 A22 A23 A24 Manipulation of germ cells, gametes, fertilized ova or preimplantation embryos with the intention of producing genetically altered animals Exposure to ionising and/or non-ionising radiation Exposure to infectious or toxic agents in the environment AA Non-surgical placement or removal of electrodes, probes or other devices that may cause pain, suffering, distress or lasting harm Stimulation via electrodes previously placed under separate authority Locomotor or maze testing that may cause pain suffering distress or lasting harm Forced learning procedures that may cause pain suffering distress or lasting harm Exposure to other animals (including con-specifics) with the intention of producing aggression, abnormal behaviour or fear/anxiety Exposure to environmental conditions that may cause pain suffering distress or lasting harm. AA Application of, or exposure to, physical stimuli that may cause pain suffering distress or lasting harm Administration of substances or withdrawal of fluids/tissues from tracts or cavities or body structures by non-surgical means Physical damage to superficial tissues Maintaining an animal in an environment which may restrict the animal’s ability to satisfy its physiological and ethological needs AA Includes microinjections and electroporation AA AA This includes situations where the agents may be transmitted by contact, inhalation, or in feed or on grazing AA This does not include the surgery required for placement AA Includes rotorod tests, elevated and plus mazes and open field test in potentially compromised animals. For example the use of water baths, electric shocks and exposure to noxious substances AA AA AA AA AA AA This includes social deprivation, housing in conditions outside of the Code of Practice Guidelines that may cause pain suffering distress or lasting harm, housing in a barren environment and housing in permanent darkness, changes in the gaseous environment such as hypoxia or warming/cooling to a stressing extent Includes auditory, thermal or pressure exposure, inflation of gastrointestinal balloon that has been placed under separate authority Includes the respiratory system peritoneal cavity, gastrointestinal, urogenital tracts, subcutaneous pouches. Includes abrasion of skin or mucus membrane A25 Non-surgical embryo transfer AA Category B Number Technique B1 Induction of general/local anaesthesia by use of agents and by routes suitable for the species, nature and duration of the procedure B2 Withdrawal of blood from superficial blood vessels by direct puncture or by removal of a tail tip or scab Administration of substances by intravenous, subcutaneous, intradermal, intramuscular or intraperitoneal injection; by the oral route (including by gavage); by inhalation; by immersion; in the aqueous medium; or topically to the skin, conjunctiva or surface of eye Administration of substances or withdrawal of fluids via previously implanted cannula, catheter, or delivery or access system AB/AC Biopsy of superficial tissues or tail tip removal. Collection of cells or secretions from the oral or nasal cavities, the vagina or rectum, or the external structures of the eye Non-surgical implantation of a microchip or telemetry device Restraint by physical means, or by confinement within a restricted area, of a nature or duration that may cause pain suffering distress or lasting harm AB/AC Cannulation of blood vessels, ducts or cavities by non-surgical means Killing under terminal anaesthesia by exsanguination and/or perfusion with fixative Decapitation other than as specified in a method of killing on Schedule 1 Withdrawal of blood by cardiac puncture under terminal anaesthesia Cannulation of the heart and /or major blood vessels, ducts, tracts or cavities under terminal anaesthesia AB/AC B3 B4 B5 B6 B7 B8 B9 B10 B11 B12 Anaesthesia code – for reference only AA/AB/AC Comments General anaesthesia for non-surgical or minor procedures only or for procedures under brief general terminal anaesthesia. Does not include maintenance of balanced anaesthesia AB/AC AB/AC This does not include the surgery or anaesthesia required for placement. Includes use of stomas or similar AB AB/AC This includes restraint using fixation devices previously implanted under separate authority and restraint in a stereotaxic frame, primate chair or sling Includes genitourinary tracts, bladder, trachea AC AC AC AC This includes hollow organs such as the gall bladder and urinary bladder. If complex and/or prolonged surgery B13 Exposure and removal of organs and tissues, including withdrawal of blood from heart or vessels or of body fluids, under terminal anaesthesia AC B14 B15 Exposure to ionising and/or non-ionising radiation Non-surgical placement or removal of electrodes, probes, tags or other devices that may cause pain, suffering, distress or lasting harm Stimulation via electrodes previously placed under separate authority AB/AC AB/AC B17 Application of, or exposure to, physical stimuli that may cause pain suffering distress or lasting harm AB/AC B18 Administration of substances or withdrawal of fluids/tissues from tracts or cavities or body structures by non-surgical means AB/AC B19 Physical damage to superficial tissues AB/AC B20 B21 Endoscopy with or without biopsy Destruction of the brain and spinal cord by mechanical means AB/AC AC B16 AB/AC is needed a Category C licence is required If complex and/or prolonged surgery is needed a Category C licence is required This does not include any surgery required for placement Includes eg auditory, thermal or pressure exposure, inflation of gastrointestinal balloon placed under separate authority Includes the respiratory system (intranasal, intratracheal), thoracic or peritoneal cavities, gastrointestinal, urogenital tracts, subcutaneous pouches, intraarticular, into bones (non-surgically) or intraocular space, cerebrospinal fluid Includes abrasion or incision of skin or mucus membrane Category C Number C1 C2 C3 C4 C5 C6 C7 C8 C9 C10 C11 C12 Technique Induction and maintenance of general/regional anaesthesia by use of agents and by routes suitable for the species, nature and duration of the procedure Biopsy or removal of internal organs or tissues Surgical cannulation of blood vessels, ducts, tracts or hollow organs Subcutaneous, intramuscular or intraperitoneal implantation or removal of any device, tissue, substance or delivery system Exposure, section, partial removal, crush, ligation, occlusion or de-occlusion of vessels, peripheral nerves or ducts Surgical administration of substances or implantation of tissue into or onto organs, cavities, ducts, tracts including into or onto the central nervous system Surgical exposure of tissues, organs, vessels, ducts, tracts or cavities including the central nervous system Surgical biopsy or removal of organs or tissues Implantation of ova, and/ or embryos into the reproductive tract Surgical implantation with or without exteriorisation, and/or removal of cannula, electrodes, microdialysis probes or other devices into discrete areas of the central and peripheral nervous system or other internal tissues or organs Lesioning of discrete areas of the central nervous system, tissues or organs by chemical, thermal or physical means Implantation of fixation devices and/or recording or observation chambers Anaesthesia code AA/AB/AC Comments For balanced and/or prolonged general anaesthesia AB/AC AB/AC AB/AC Includes minipumps and radiotracking devices AB/AC Includes vasectomy, and lesioning by ligation or compression of peripheral nerves AB/AC AB/AC AB/AC AB AB/AC This includes implantation or insertion into muscles or joints AB/AC Includes lesioning using ultrasound or local irradiation AB/AC C13 C14 Transplantation of organs, vessels, ducts, tracts, tissues or nervous tissue Surgical manipulation of the circulatory system AB/AC AB/AC Includes formation of arterio-venous shunts, carotid loops. Technique Induction and maintenance of neuromuscular blockade by the use of neuromuscular blocking agents Anaesthesia code AB/AC/AD Comments Neuromuscular blocking agents may not be used in place of anaesthetic agents Category D Number D1 22/02/2013