. SERVICE Pe aD 0 ada for the Housing and Care of Pigs Intended for use as Xenotransplant Source Animals 1. General introduction to this Code of Practice 1.1. In the response to "Animal Tissue in Humans"©, the report of the Advisory Group on Xenotransplantation, the Government acknowledged the need to: minimise, as far.as possible, any risk of disease transmission to xenograft recipients from the animals reared for xenotransplantation. The Government also accepted that it is essential that high health status source animals be maintained in biosecure facilities. 1.2. The report of the Advisory Group also recommended that a Code of Practice be issued under the Animals (Scientific Procedures) Act 1986 that: has regard for the welfare of source animals used for xenotransplantation; and includes consideration of, and advice on, the potential conflicts between animal welfare and the requirement for animals of a closely defined nS status. 1.3. Under the terms of the Animals (Scientific Procedures) Act 1986 (ASPA), the Secretary of State may issue Codes of Practice for the welfare and care of animals used for experimental or other scientific purposes. This Code, issued under Section 21 of the Act, makes provision for the welfare, care and accommodation of animals used as source animals for clinical xenotransplantation. The Code applies to source production units, holding facilities and tissue harvest areas. 1.4. It is issued following extensive consultations within the scientific community, and with organisations concerned with the welfare of animals. Representatives of the British Laboratory Animal Veterinary Association (BLAVA), Pig Veterinary Society (PVS), Institute of Animal Technology (IAT), the Laboratory Animal Science Association (LASA), Royal Society for the Prevention of Cruelty to. Animals (RSPCA), the Universities Federation for Animal Welfare (UFAW), and a number of other experts were invited to consider suitable standards of welfare for pigs used in xenotransplantation programmes. 1.5. The recommendations on housing and care of pigs in European and UK legislation, including Annex II of European Council Directive 86/609 EEC, European Council Directive 91/630/EEC, the Agriculture (Miscellaneous Provisions) Act 1968, and Schedule 3 of the Welfare of Livestock Regulations 1994 (S.I. 1994/2126) have been given due consideration. 1.6. The recommendations of the expert group were based on an agreed consensus of present knowledge and practices and following due consideration of existing guidelines. This Code is very closely based on these recommendations, and has the support of those who participated in its formulation. 1.7. The areas and issues where pig welfare may be compromised by the need for animals of high health status, hereafter referred to as qualified pathogen free (QPF) status, have been clearly identified, and the recommendations made minimise the associated welfare costs. 1.8. Some flexibility in interpretation of the recommendations may be permitted following consultation and with the agreement of an Inspector appointed under the terms of Section 18 of the 1986 Act: for example to allow the introduction of innovative enriched housing systems where improved welfare can be demonstrated without JD compromise to the QPF status required for use in a xenotransplantation programme. 1.9. The degree of biosecurity, hereafter referred to as biosecure barrier conditions, recommended in this Code of Practice has been set at a level at which the risk of disease transmission or breakdown can been minimised, but where satisfactory standards of animal welfare can be maintained. 1.10. Issues of welfare concern raised during consultations on this Code have included the use of surgical derivation (hysterotomy/hysterectomy) and. medicated/segregated early weaning (MEW/SEW) procedures. These practices may be required to enable an animal of suitable health status to be produced for use in a xenotransplantation programme. 1.11. This Code of Practice does not define the qualified pathogen free (QPF) status of animals required for xenotransplantation programmes. The Code does not provide details of monitoring programmes nor details of pathogens from which the source animals, that is those used for organ harvest, must be demonstrably free. Advice on the specific biosecure barrier conditions for animals in xenotransplantation programmes and guidance on the required QPF status of and surveillance programmes for source animals is the responsibility of, and can be obtained from, the Department of Health. 1.12. This Code of Practice makes provision for the care of all pigs maintained in biosecure barrier facilities for the production of xenotransplant tissues for clinical use whether or not they have been genetically modified. 1.13. In implementing this Code, compliance with all other relevant UK legislative requirements with regard to xenotransplantation and pig welfare is expectseavde ,fo r those specific circumstances identified in this Code where, due to the requirements of biosecure barriersp,i g welfare may be subject to limited compromise. Application of the Codeof Practice 1.14. This Code applies throughout the United Kingdom. In Great Britain, it is administered by the Home Office. In Northern Ireland, it is administered by the Department of Health and Social Services on behalf of the Secretary of State for Northern Ireland. Where the Code speaks of the Sone oeS tate" or "the Home Office" it means, in Northern Ireland, the Department of Health and Social Services. _ a 1.15. Establishments where genetically modified pigs arre ep roduced, held for use, and used as organ donors must be designated under Section 6 of the 1986 Act as scientific procedure establishments, with the production units also designated under Section 7 as designated breeding establishments. 1.16. As understanding of how best to care for animals evolves, or should the brosectife barrier requirements be changed, the recommendations contained in this Code of Practice may need to be updated. The Secretary of State will keep this Code of Practice under review and will issue revised versions as necessary. LCOME L} 2. General welfare requirements for pigs 2.1. Pigs are intelligent, inquisitive animals that have retained many of the complex behavioural characteristics of their wild ancestors. This includes rooting and exploratory behaviour, and social interactions within small, stable groups. They have limited thermo-regulatory ability, but their hearing and, in particular, their olfactory abilities are highly developed. Housing, husbandry and general management of pigs must take account of these physiological and behavioural needs. 2.2. Therefore, to achieve high standards of welfare for pigs, the systems of accommodation, husbandry and care should ensure that the animals have: - 2.2.1 company of their own kind, allowing pigs to live in stable groups with other familiar individuals; 2.2.2 adequate amounts of space, in both a lying area (in which all pigs must be able to lie down together) and the general ‘loafing’/dunging area, in order to allow all pigs to move around freely; 2.2.3 adequate quantities of clean, fresh water continuously available; 2.2.4 housing which protects against physical discomfort, providing a clean, dry, comfortable lying area, suitable non-abrasive, non-slip flooring, and an enclosure without sharp protrusions or other characteristics likely to cause injury; 2.2.5 a thermally comfortable environment, ensuring that the temperature remains within the pigs’ thermoneutral range; 2.2.6 an acceptable atmosphere, maintaining appropriate ventilation and ensuring that aerial contaminants (e.g. ammonia, inhalable dust) are kept within non-aversive limits; 2.2.7 appropriate lighting for a period equivalent to normal daylight hours, and providing a period of darkness; 2.2.8 environmental enrichment, providing straw or other suitable materials for manipulation, to satisfy pigs’ behavioural needs in terms of rooting and investigative behaviour; 2.2.9 competent, knowledgeable stock-persons who understand the pigs’ needs and behaviours, and are dedicated to ensuring their well-being at<all times by preventing or minimising any fear, distress and discomfort; 2.2.10 competent, knowledgeable, specialist veterinary care, by those with experience and understanding of pig health and welfare. 2.3. The requirement to maintain a qualified pathogen free (QPF) status may, to some extent compromise the animals' behavioural needs. Justification is required if this proves essential for the production of a suitable animal for use in a xenotransplantation programme, and efforts must be made to minimise and eliminate where possible any deviation from best welfare practices. Housing and environment Animal accommodation 2.4. Animal facilities shall provide a suitable environment for the pigs to be housed, including provision for exercise and social contact, and should incorporate facilities sufficient for the activities carried out within it. The Home Office Inspectorate should be consulted at the planning stage, or when substantial alterations to the designated premises are proposed. 2.5. When planning and siting facilities, these should be designed to be self-contained. If the animal facility forms part of a larger complex, consideration should be given to the activities in the adjacent buildings and any possible effect these may have on the welfare and health status of the animals. 2.6. To enable an animal of suitable QPF status to be produced for use in a xenotransplantation programme, some form of biosecure barrier system will be required. The term “barrier” identifies a concept rather than a definitive qualitative standard. The concept requires beginning with an animal of defined health status, that is QPF, and maintaining the animal under conditions that minimise microbial contamination. A barrier system consists of several essential elements: - stocking with animals known to be free of pathogens (QPF), appropriate design of housing, effective environmental controls, regular monitoring of health status, and the proper implementation of appropriate operating procedures. As each element of a barrier system can compromise the welfare of animals, the potential problems of each element should be identified, and strategies adopted to minimise any adverse consequences for the animals. Security 2.7. The pig accommodation and its support facilities should be designed to prevent animals escaping. It is also necessary to protect animal facilities against illegal entry by unauthorised persons: advice about security should be sought and taken from Crime Prevention Officers in the local police force, or other experts, during the design of new facilities or modifications of existing premises. - Animal rooms 2.8. For the purpose of this Code, animal rooms are deemed to be the rooms normally used to house stock or breeding animals and animal treatment areas. 2.9. Animal rooms should be constructed of durable impervious materials, with easily cleanable surface materials resistant to attack from the chemicals used to clean or fumigate the rooms. Consideration should be given to the use of materials that are least likely to crack and craze. Floor finishes should be non-slip, and not injuriously abrasive, whether wet or dry. All joints between doorframes and walls shoulbde sealed. 2.10. Services should be installed in such a way thatt hey. are either buried within the fabric of the building, boxed in, or clear of wall surfaces for ease of cleaning. When the fabric of the building is penetrated, for example by holes or pipe-work, the holes created should be sealed. 2.11. Building design, and proposed working practices, should take into account the fact that building maintenance may disturb animals, and may compromise the health status of the animals. Whenever possible, services should be installed to be accessible from outside and with fittings that can be removed:by the staff for maintenance or repair elsewhere. If possible, provision should be made for the upgrading or replacement of services.| pring the life span of the building, for instance by the insertion of spare ducting in the walls. 2.12. Animal house design should ensure that the animals can be noe easily. In barrier units, where access may be restricted, suitable arrangements should be made to allow the animals to be clearly viewed from outside thoee.a rricr, for example by incorporation of windows or television cameras. : 2.13. Precautions should be taken in animal rooms to minimise the exposure of personnel to hazards thatm ay arise from the incorrect handling of animals, for example bites and scratches, allergens and infections. 2.14. There should be special provision to house separately animals that are ill, injured or seccivine veterinary | treatment. Where possible these animals should remain within sight or sound of Sa pigs. 2.15. According to the microbiological quality and genetic status of the animals, Sigee nt levels of separation and physical barriers may be required between breeding and other areas. Appropriate working practices must be adopted to minimise any risk of breakdown of barrier security. 2.16. Adequate arrangements should be made for the receipt of incoming animals. Animals brought into the facility should not put at risk animals that are already there. Space should be provided for acclimatisation and quarantine, where appropriate. 2.17. Source animals for clinical xenotransplantation should be maintained in a biosecure barrier system which 4 meets similar standards to animal containment level 3 outlined by the Advisory Committee on Dangerous Pathogens. All potential sources of contamination should be identified, and controlled including air input, water, food, bedding material, equipment, personnel and working practices. All materials entering the unit must be sterilised or otherwise effectively decontaminated. The animal rooms must be maintained under positive pressure relative to the surrounding areas, and input air must be filtered using a HEPA (high efficiency particulate absorption) filter (or equivalent). 2.18. Ventilation systems should have sufficient capacity and flexibility to meet the demands of different stocking densities. Treatment rooms/operating theatres 2.19. General veterinary treatment rooms should be provided. Surgery and euthanasia must not be performed in rooms where animals are normally housed, unless in the case of euthanasia of a badly injured animal where welfare may be further compromised by moving the animal. 2.20. To minimise disruption to the animals, mmor procedures, such as blood sampling and simple dosing procedures, may be performed in the animal holding areas. 2.21. All establishments should have access to facilities for diagnostic investigation, post-mortem examinations and the collection of samples for examination elsewhere. 2.22. Where surgery is to be performed, suitable operating facilities must be provided, including separate preparation areas for the animals, equipment and staff. It is not expected that animals used for tissue harvest will subsequently be allowed to recover from general anaesthesia. 2.23. Within a xenotransplant source animal unit three additional specialist.areas are likely to be required, a surgical derivation area, an isolator rearing facility and a tissue harvest.area. Surgical derivation area 2.24. This area will be used to facilitate the initial productionof high health status animals and will consist of an animal holding area and an area for surgically harvesting piglets from the sow under general anaesthesia by hysterectomy or hysterotomy. The reception holding area should be of similar construction to animal holding areas, with appropriate environmental controls, and animals provided with similar standards of husbandry and care to those animals held within the main facility. Isolator rearing facility 2.25. Following surgical derivation, piglets will be maintained and reared in isolators for a period of time; usually a few weeks, until they are sufficiently robust to enter the main unit. This facility should include a clean area with adequate space for servicing the isolators and caring for the animals that they contain, areas for assembly of the isolators, a ventilation system which allows the safe venting of fumigants and other sterilising agents, and adequate storage space for materials and equipment. Tissue harvest area 2.26.1. The precise technical specifications for the tissue harvest areas will be determined by the Department of Health and set out in other guidance or reference documents, but suitable facilities for holding animals prior to and during the induction of anaesthesia must be provided. 2.26.2. To minimise potential welfare problems in the source animals, and potential compromise to the microbiological status of the harvested tissues, the Tissue Harvest Area should be located adjacent to the Source Production Unit. 2.26.3. However, there may be circumstances in which the viability of the xenotransplantation organ or tissue could be compromised. For example, lengthy journey times post harvest could result in ischaemic damage to the tissues. In such circumstances, where it is considered essential that the source animal requires to be transported to a harvest area close to the transplant centre, this movement should take place a minimum of four weeks prior to harvest, to allow the animal to recover from the effects of transport, and to allow sufficient time for a health screen to be taken to confirm continued suitability for use — that is, to ensure that the health status has not been compromised during the journey. 2.26.4. Live animal travel times should be minimised, and transportation must comply with the relevant transport legislation, with the animals maintained in pairs or groups. 2.26.5. Where Tissue Harvest Areas are separate from the Source Production Unit, suitable holding accommodation must be provided, which meets the same standards as those in the source unit. 2.27. Project and personal licences issued under the Animals (Scientific Procedures) Act 1986 are required to permit tissue harvest from living source animals. Only trained and competent personal licensees may anaesthetise the animals and harvest their tissues. Service areas and SEDPOrY facilities — 2.28. The design and construction of service areas should normally be to the same standard as the animal rooms. The building, working practices and flow patterns, should be planned to prevent cross-contamination between clean and dirty equipment and materials. Corridors should be wide enough for easy movement of personnel and equipment, and should not be used for storage. 2.29. Service areas are subject to rough treatment and wall surfaces should be resistant to impact damage. Surfaces and corners should be easy to clean. Adequate floor drainage should be provided in wash areas, with sufficient ventilation to remove excess heat and humidity. 2.30. Stores must be separate from animal rooms. Adequate storage space should be provided for food, bedding, cleaning materials and other items. Special facilities may be — for handling and storing chemicals. 2.31. Food and bedding stores should be clean and dy In sadn, food stores should be cool and well ventilated. Perishable foods should be stored in cold rooms, refrigerators or freezers. 2.32. A separate collection area should be provifodr ewasdte , prior to its disposal. Special arrangements should be made for handling carcasses. Flow patterns within the unit should facilitate the separatioonf clean and dirty areas to minimise contamination risk. Waste products from genetically modified animals will require to be dealt with in accordance with the Genetically Modified Organisms (Contained Use) Regulations 1992. __ Facilities for staff 2.33.1. Personnel facilities should include staff and record rooms, changing rooms, decontamination areas,f ist aid and toilet facilities and space for storing protective and outdoor clothing. eo 2.33.2. Animal care personnel may be present at times when normal catering facilities may not be available; special arrangements or facilities for meals may therefore be needed. No pig products should be eaten on site. Eating and drinking should be prohibited in all areas other than those staff areas specifically. reserved for such activities. Smoking should not be permitted. 2133.3. Aconeenentt for visitors, including a specified period when visitors would have no direct or indirect contact with pigs, should be well defined and enforced. Staffing 2.34. Sufficient trained and competent staff must be available at all times to care for the animals, including during weekends, holiday periods and when the normal staff are absent e.g. due to sickness. In these circumstances, care must be taken to maintain barrier security. Training 2.35.1. Appropriate training of staff is essential to ensure that high standards of pig husbandry and care are provided, and that barrier security can be maintained. 2.35.2. The holder of the Certificate of Designation is responsible for ensuring that adequate training, and assessment of competence is provided for all animal care staff. This responsibility is commonly delegated to the named person in day-to-day care (Named Animal Care and Welfare Officer - NACWO). The form and content of training will depend on the activities being carried out, although attendance at formal training courses, offering recognised qualifications, is strongly recommended. 2.35.3. Training should include an introduction to the natural history and behaviour of the pig, which will illustrate their needs in a captive breeding system. Pig husbandry, care and welfare, principles of barrier production and maintenance, barrier hygiene, internal management practices, breeding and health record keeping practices should also be included. 2.35.4. Animal care staff shouldbe trained to recognise normal behaviour, in order that any abnormalities can be identified at an early stage. 2.35.5. Animal care staff are expected, at allt imes, to have a caring and respectful attitude towards animals in their care, and must be trained to become proficient in their handling, restraint and husbandry. 2.35.6. It is recommended that written husbandry, care and safety instructions be provided to staff, which may include reference to other relevant legislation such as the Health and Safety at Work Act. Written details of routine husbandry, breeding programmes, disposal of waste and carcasses, disease surveillance and control programmes, and emergency action plans should be maintained. Standard Operating Procedures for all routine management and husbandry practices should be produced, maintained and regularly reviewed and revised as appropriate. 2.35.7. Training activities should be documented and competencies recorded. The Named Veterinary Surgeon (NVS) 2.36.1. Under section 6(5)(b) of the 1986 Act, it is a requirement for certification as a designated establishment that there is a Named Veterinary Surgeon to provide advice on the health and welfare ofp igs. 2.36.2. The Royal College of Veterinary Surgeons (RCVS) has:published a Code of Practice for Named Veterinary Surgeons. 2.36.3 The RCVS expects, and the Home Office requires, veterinary surgeons accepting appointments as NVS to undertake specific training in order to extend their knowledge and thus meet their statutory role under the Animals (Scientific Procedures) Act 1986. The RCVS recommends that such veterinary surgeons should give serious consideration to attending courses specifically aimed at Named Veterinary Surgeons and follow. a line of post- graduate training leading to a higher qualification. The environment Temperature 2.37.1. Amongst the various environmental variables that can affect the welfare of pigs, temperature is the most important. Pigs should have access at all times to an area, at least equal to the minimum required lying area, which is maintained within the Thermoneutral Zone of the animal. This zone is bounded by the Upper and Lower Critical Temperatures that will be dependent on many factors (including the live-weight of the pig, feed level and type, group size, flooring material and prevailing airspeed) and may consequently differ according to the housing and management system adopted. These Critical Temperatures can be calculated for any given set of circumstances, and representative values are shown in the table below. 2.37.2. Where animals are housed in a single space environment (with no localised heating), the room temperature must be set to remain within this thermoneutral zone. Where there is localised heating and/or kennelling of the lying area to provide a separate microclimate, the room can be significantly cooler without detriment to the pigs. However room temperature should not be allowed to fall to such a value that the desired microclimate cannot be maintained, should not be allowed to exceed the Upper Critical Temperature, and should provide an acceptable working environment for.stock-persons. 2.37.3. The following guidelines assume that pigs are housed on insulated solid flooring without draughts, that dry sows and boars are fed at typical commercial levels to maintain adequate body weight, that growing pigs are fed ad libitum and that animals are housed in groups. Guide to Temperature Requirements (°C) for Lying Area and Holding Room Newbom piglet) - eee Sucking ay, lady a= Newly weaned aaa 21 day Growing pig —_(10kg) ae (20kg) (100kg) ch at , : a Lactating sow ~~ | Determined oy Determined by piglet needs piglet needs Breeding boar a Ale ee ce * for guidance where localised heating supplies microenvironments within the: room.n . The room temperature maximum should not exceed the lying area maximum unless additional cooling ‘provision, ‘such as showers, is provided. Relative humidity 2.38. There are no reported adverse effects resulting from pigs exposed to wide fluctuations of ambient relative humidity. However, lengthy exposure to low humidities should be avoided, with optimal values of 50-g o” recommended™, oS Ventilation 2.39.1. Fast movement of air is another potentially negative environmental variable affecting pig welfare. Dusty environments and high concentrations of ammonia and other noxious or gaseous irritants cause harmful effects on the respiratory system. 2.39.2. The ventilation system should: (i) provide sufficient fresh air of a suitable quality; (ii) regulate temperature, within prescribed limits; (iii) reduce the levels and spread of odours, noxious gases, dust and infectious agents. 2.39.3. In the case of xenotransplant source animals, the air input must be filtered using a HEPA (high efficiency particulate absorption) filter (or equivalent). The ventilation system should incorporate a means of preventing reverse air-flows to prevent contamination. 2.39.4. The distribution system should deliver air as evenly as possible to each pen or animal whilst avoiding draughts. Careful attention should be given to air inlet and outlet positions to ensure good air circulation and avoid draughts and noise disturbance. 2.39.5. The ventilation system can be used to create differential air pressures within the building as part of a "barrier" system. "Clean" areas are generally maintained at higher pressure and "hazardous" areas at lower pressure than those adjacent, in order to minimise any leakage of "dirty" air into "cleaner" areas. This is effective only if the supply air is itself clean or is suitably filtered to be free from contaminants. Lighting 2.40.1. Pigs should never be kept in constant darkness. Cycles of light and dark should be used so that pigs have ample opportunities to carry out their normal behaviour, and to maintain normal reproductive cycles. 2.40.2. A minimum light period of 8 hours should be provided. Lighting should be of a level to permit routine husbandry tasks to be performed properly and safely. Light levels of 40-80 lux are sufficient . 2.40.3. In farrowing units, provision of continuous low level lighting may be of benefit, and should be provided. Noise 2.41. High levels of noise are potential stressors to pigs. Continuous background noise, such as that deriving from the ventilation system, should be kept to alow level. Unexpected loud noise should be avoided. Emergency alarms and stand-by systems 2.42.1. A technologically dependent animal facility is a vulnerable entity. Such facilities must be appropriately protected to detect hazards such as fires; the breakdown of essential equipment such as ventilation fans, air heaters or coolers; and intrusion by unauthorised persons. : 2.42.2. Animal facilities which rely heavily on electrical or mechanical equipment for environmental control and protection will need a stand-by system to maintain essential services and emergency lighting systems as well as to ensure that alarm systems themselves do not fail to operate. 2.42.3. Emergency alarms and systems must be checked at least weekly. 2.42.4. The heating and ventilation system should be equipped with monitoring devices or alarms to ensure that any faults can be quickly identified and promptly rectified. 2.42.5. Clear operating procedures should be in place, and responsibilities assigned, to ensure that prompt action is taken in the event of an alarm. 3. Animal care and health 3.1. Pigs living within a barriered animal unit are totally dependent on humans for their health and well-being. The physical and psychological state of the animals will be influenced by their surroundings, food, water and the nature and quality of the care and attention provided by the animal house staff. 3.2. The aim is to produce.animals of a qualified pathogen free status suitable for use in a xenotransplantation programme and to maintain animals in good health and physical condition; with a reasonable expression of their behavioural repertoire; and amenable to handling. 3.3. The general well-being of all pigs must be checked at least twice daily by a competent person. Young animals, in particular those subject to surgical derivation or early weaning techniques, should be checked more frequently. 3.4. Animals must..be maintained in groups, or pairs, unless veterinary or defensible husbandry reasons justify single housing. In circumstances where single housing can be justified, and agreed in consultation with the Named Veterinary Surgeon, animals should not be heldai n complete isolation and should remain in visual and/or auditory range of other pigs. ee 3.5. Pigs should have regular exposure to human :c ontact, as this will minimise stress during handling and procedures. However, to reduce-the risk of cross-contamination, the frequency of contact may be reduced from that encountered in conventional pig unitsIt. i s therefore recommended that, when contact is necessary for any reason, staff be encouraged to provide additional socialisatitoimne with the animals. Responsibility for animals _ 3.6. Responsibility for the care and welfare of the pigs falls to: (i) the person undertaking daily care of the animals; a (ii) the person named as responsible for thceda y-to-day care oft ya nimals (NACWO); (iii) the named veterinary surgeon who monitors anda dviseso n the health and welfare of the animals (NVS); (iv) the holders of personal and project licences; and (v) the holder of the certificate of designation. Acquisition of animals 3.7.1 Under section 10(3) of the 1986 Act, unless an exemption has been issued by the Secretary of State, the types of animal listed in Schedule 2 to the Act must be obtained from designated breeding or supplyingS emen. Schedule 2 includes pigs that have been genetically modified. 3.7.2 The introduction of animals listed in Schedule 2 from non-designated sources (either from within UK or from overseas) for a scientific purpose, requires justification and is conditional upon the prior permisso= oft he Secretary of State. 3.7.3 The importation of animals from overseas is also controlled by the Animal Health Act 1981. European Council Directive 92/65/EEC (the BALAI Directive) states the requirements for the movement of some species of commercially traded laboratory animals within the Member States of the European Community. Details of licences, health certificates, rabies and other quarantine requirements should be obtained from the Animal Health Division, MAFF, or the Scottish Office Agriculture, Environment and Fisheries Department (SOAEFD). In Northern Ireland, importation is controlled by the Department of Agriculture. 3.7.4 When the importation of animals is proposed, the use of embryos and semen should be given due consideration, as there are welfare benefits and a reduced risk of biosecure barrier breakdowns using this approach. 10