k. NVS Guidance

RCVS Guidance for Named Veterinary Surgeons employed in Scientific Procedure Establishments and Breeding and Supplying Establishments under the Animals (Scientific Procedures) Act 1986

(Issued November 2004)

INTRODUCTION

1) The Guidance sets out the role of 'Named Veterinary Surgeon' ["the NVS"] under the Animals (Scientific Procedures) Act 1986 ["the 1986 Act"] and provides advice to veterinary surgeons deputising for the NVS. The 1986 Act is a UK wide Act, administered by the Home Office in Great Britain and the Department of Health, Social Services and Public Safety (DHSSPS) in Northern Ireland. The Guidance is issued after consultation with the Home Office and the Laboratory Animals Veterinary Association and taking into account the 1986 Act and associated statutory guidance.

2) Scientific procedure establishments and breeding and supplying establishments are required to have a veterinary surgeon who accepts responsibility under the 1986 Act to provide advice on the health and welfare of animals within these establishments. The name of the NVS is recorded on the establishment's certificate of designation.

3) Scientific procedure establishments are places at which project licences are held and include universities (university departments and medical schools), colleges of further education, government research establishments, pharmaceutical and other industrial research and development laboratories, and contract research laboratories. No regulated procedures may be carried out unless there is a project licence covering the work to be carried out and detailing the procedures, and a personal licence holder with authority to carry out those procedures. A breeding establishment is one where the common laboratory species, as listed in Schedule 2 to the 1986 Act are bred for use in regulatedprocedures. A supplying establishment is one from which Schedule 2 animals which have not been bred on the premises are kept and supplied for use in regulated procedures. Some establishments may fall into more than one of these categories.

4) Veterinary surgeons are expected to undergo specific training for the role of NVS (see paragraph18 and 19).

DUTIES AND RESPONSIBILITIES

5) The NVS should:-

a) Ensure there are adequate arrangements for the provision of veterinary cover and services at all times (see paragraph 21);

b) provide advice on animal health and welfare to the certificate holder, project and personal licence holders, and animal care staff;

c) notify the personal licence holder of animals whose condition gives cause for concern and, if necessary, arrange for or carry out humane killing if this is required (see also paragraph 39);

d) determine whether an animal remains alive at the end of regulated procedures when this is an option (see also paragraph 41);

e) certify, as necessary, fitness of animals to leave the establishment (see also paragraph 42);

f) participate in the establishment's ethical review process; and,

g) ensure that appropriate records are maintained.6) The NVS is appointed by the certificate holder and named on the certificate of designation of an establishment. He or she has responsibilities associated with the 1986 Act (including paragraphs 5b-g). By application to the Home Office, the certificate holder may seek to appoint additional NVSs, each having separate areas of responsibility and usually specified project work or locations.

7) Under this Guidance the NVS has veterinary care responsibilities to the RCVS (paragraph 5a).

Contracts and visits

8) A veterinary surgeon may be contracted as the NVS on a full-time or part-time basis depending upon, for example, the size of the establishment and the nature and complexity of the research programmes. The contractual hours and resources (e.g. the assistance given by other veterinary surgeons) should be adequate to enable the NVS to have sufficient time to fulfil his or her role. Whether full-time or part-time the responsibilities and statutory duties of the NVS are the same.

9) Whether the appointment is full-time or part-time, the NVS must arrange to visit the facilities on a regular basis for both advisory and veterinary care roles, rather than waiting to be called out in an emergency. In this way the NVS should become familiar with the animals, the research workers and their areas of scientific interest, as well as the procedures carried out on animals within the establishment. The frequency of these visits should be determined by the NVS according to the number and species of animals involved and the nature and severity of procedures performed. An appropriate schedule of visits should be agreed in advance in consultation with the responsible staff of the establishment, in particular with the Named Animal Care and Welfare Officer(s) ("the NACWO") and the certificate holder. The visiting schedule should be regularly reviewed and amended as necessary.

10) The job description and/or contract of the NVS should define the responsibilities involved and provide a reporting structure that gives the NVS direct access to the certificate holder at the establishment.

11) The names of the veterinary surgeons deputising for the NVS are not included on the certificate of designation. Therefore, they should be recorded at the establishment and made known to the certificate holder, the NACWO, licensees and other relevant staff in the establishment. The means of contacting an appropriate veterinary surgeon at any time should be clearly defined and available.

Insurance

12) The NVS and deputising veterinary surgeons are required to have professional indemnity insurance or equivalent arrangements. Such cover may be held individually or through an employer. The chosen level of indemnity related to NVS duties should be discussed with the Insurance providers, for example the Veterinary Defence Society. The level of cover can then be confirmed.

Liaison and reporting

13) The certificate holder is ultimately responsible for ensuring that the facilities, animal welfare and care, staffing levels and expertise in the establishment meet the requirements of the 1986 Act and the Codes of Practice. The NVS is answerable to the certificate holder in an advisory role and for providing the contracted service. Therefore the NVS should make reports (it is suggested at least annually) directly to the certificate holder.

14) Periodic meetings with the Home Office Inspector are desirable and may assist the NVS to fulfil the statutory role. The NVS should be available for discussion with the Home Office Inspector if the latter makes a request.

15) The NVS at a scientific procedure establishment should liaise closely with his/her colleagues at other associated establishments (e.g. where a research project involves collaboration between two or more establishments) and, especially if animal health problems arise in recently acquired animals, with colleagues at supplying and breeding establishments.

Conflict of interest

16) Where the NVS also holds a project licence, another veterinary surgeon must be agreed with the Home Office as responsible for providing independent veterinary advice regarding the health and welfare of the animals involved. If there is any other significant conflict of interest, the NVS should consider the need for independent veterinary advice.

Confidentiality

17) The NVS and veterinary surgeons deputising for the NVS must maintain client confidentiality as set out in the Guide to Professional Conduct. Contracts and client records, together with project and personal licences, should be stored securely to prevent any unauthorised access.

Training and continuing professional development

18) The Home Office requires that a new NVS attend a course, approved by the RCVS, specifically on the role of the NVS, either before or within one year of accepting appointment. In any event a new NVS should undertake training on the needs of the laboratory animals on which he or she will provide advice.

19) The NVS and veterinary surgeons assisting or deputising for the NVS are expected to participate in continuing professional development relevant to the species held and used and the type of scientific work carried out at the establishment.

Training of other staff

20) The NVS should be familiar with the range of scientific procedures carried out under project licences and may take part in the training of technicians and personal licence holders on animal welfare and health. In particular the NVS may be involved in the training of minor procedures, surgical methods, anaesthetic regimens, peri-operative care and assessment of competence.

PROVISION OF VETERINARY SERVICES

Comprehensive veterinary service

21) The NVS should ensure there are appropriate arrangements for the provision of veterinary services, including 24-hour emergency cover (see RCVS Guide to Professional Conduct for details). The NVS may delegate these duties to suitably competent deputies. The certificate holder is responsible for providing the necessary resources for the provision of such cover and services. Staff at the designated establishment are expected to contact the NVS or delegated deputy, to seek veterinary advice or assistance, as appropriate; but the RCVS Guide does not stipulate that staff of the designated establishment must be on site 24 hours a day.

22) The delivery of veterinary treatment and services should take into consideration the experimental procedures which the protected animals are being or will be subjected to, and that data, or other products, being collected as part of the programme of work may be compromised as a result of the veterinary intervention.

23) As a minimum the NVS should: -

a) advise on the health and welfare of protected animals in the establishment;

b) advise on suitable preventive medicine and health screening programmes;

c) advise on the provision of appropriate facilities, environmental conditions and trained staff for the care of sick or injured animals;

d) provide for diagnosis and treatment of disease, and advise on the control of any disease outbreaks;

e) arrange for the provision of an appropriate veterinary diagnostic laboratory service, advise on interpretation of results, and conduct or arrange post mortem examinations for diagnostic purposes as appropriate;

f) advise on the evaluation of the breeding performance of colonies, in conjunction with the NACWO (see paragraph 56); and,

g) direct the use of all prescription only medicines and controlled drugs for use on protected animals in the establishment (as set out e.g. in the Medicines Act 1968; the Misuse of Drugs Act 1971 and subordinate legislation). (See paragraphs 28-31).

Delegation

To other veterinary surgeons

24) Where colleagues provide some of the veterinary services and/or deputise for duties associated with the Act, the NVS should make appropriate arrangements to ensure that delegated services are delivered. The NVS should make clear which duties and tasks are being delegated, how these should be fulfilled and how the delivery of such services should be documented. The NVS should liaise with the colleagues involved to ensure they are appropriately briefed on the scientific objectives of projects at the establishment and on the constraints and humane end-points in these projects.

25) When procedures regulated under the 1986 Act are conducted at places other than designated establishments, such as on farms or at fisheries, a local veterinary practitioner will often provide veterinary services. Good liaison between the NVS, the local practitioner, and the licence holders involved is strongly recommended to ensure neither welfare nor science is compromised. At the end of the regulated procedures the local veterinary surgeon may be able to provide any certification needed (see paragraphs 44-46).

To persons who are not veterinary surgeons

26) The NVS may delegate some veterinary procedures or treatment to animal care staff, within the provisions of the Veterinary Surgeons Act 1966. Special instructions should be given and these must adequately inform animal care staff on the appropriate and responsible use of minor medical treatments, for example, dealing with and recording minor injuries or topical lesions in group-housed animals. Where written instructions are not provided the NVS must ensure staff are adequately informed verbally.

27) Periodically, the NVS should check that delegated procedures or treatments and preventive medicine programmes have been carried out to a satisfactory standard and appropriate records kept. Where minor medical treatments are initiated, varied or discontinued by animal care staff, the action taken, the justification for the action, and the outcome should be recorded and the records regularly reviewed by the NVS.

Prescription only medicines and controlled drugs

28) The NVS is responsible for the appropriate storage, administration and safe disposal of prescription only medicines and controlled drugs obtained by him or her (including by prescription) for therapeutic purposes.

29) The Veterinary Medicines Regulations 2009 do not apply in relation to a product intended for administration in the course of a procedure licensed under the Animals (Scientific Procedure) Act 1986, except that, if the animals are to be put into the human food chain, the only products that may be administered to the animals are—

a) authorised veterinary medicinal products administered in accordance with their marketing authorisation, or

b) products administered in accordance with an animal test certificate granted under paragraph 9 of Schedule 4.

30) The NVS is expected to give guidance on the use of anaesthesia and analgesia.

31) Where carcasses of treated animals may be destined for the food chain, due regard must be paid to laws relating to tissue residues. If substances with no Maximum Residue Limit (MRL) have been used, at any stage in the procedures, the animal should not be allowed to enter the food chain.

32) European Parliament Directive 2001/82, as amended, provides that no animal may enter the food chain if it has been administered a substance that is not listed in the Table of allowed substances in Commission Regulation 37/2010 (this table replaces Annexes I, II or III of Council Regulation (EEC) 2377/90). Where a Maximum Residue Limit (MRL) has been set, any residue must be at concentrations lower than or equal to the MRL.

RESPONSIBILITIES ASSOCIATED WITH THE 1986 ACT

Advice to the certificate holder

32) Under the 1986 Act the prime responsibility of the NVS is to advise the certificate holder on veterinary matters. The following should be considered the minimum areas for which advice should be given:

a) maintenance of health status and suitable preventive medicine protocols, and an appropriate programme for monitoring the health and welfare and quality of animals, and their environment;

b) provision of care, e.g. suitable environmental controls, development and monitoring of social and environmental enrichment programmes, or where there are concerns that staffing levels may compromise animal welfare;

c) maintenance of animals needing special attention, for example immuno-compromised mice ;

d) provision of specialist veterinary facilities, in particular for aseptic surgery and post-operative care, quarantine, acclimatisation and other special animal welfare needs (usually, the NVS will be involved in the design and planning of new facilities for such purposes);

e) appropriate methods of euthanasia and means of assessing competence;

f) appropriate humane methods of identification; and,

g) whether animals are fit to go to a non-designated establishment (see paragraphs 42-43).The NVS should also be asked to direct the use of all prescription only medicines and controlled drugs for use on protected animals in the establishment (as set out e.g. in the Medicines Act 1968; the Misuse of Drugs Act 1971 and subordinate legislation).

Advice to the project licence holders

33) The NVS should advise on:-

a) strategies to minimise the severity of regulated procedures, and how particular adverse effects may be controlled, e.g. refinements to methods of dosing and sampling; clinical monitoring; use of anaesthesia and analgesia; appropriate humane end-points;

b) the health status needed and suitability of animals for planned studies;

c) the impact of the procedures proposed on the animals, and any specific husbandry and care needs during the procedures; and,

d) the fate of animals at the end of regulated procedures or at the end of use at that establishment (see paragraphs 41-46).34) To provide suitable up to date advice, it is essential to hold (and hold securely) copies of, or have ready access to, all project licences and any conditions attached. The NVS should expect that his or her advice on these issues would be sought, normally at an early stage of drafting a project licence and for any subsequent substantive amendments.

Advice to personal licence holders

35) For research workers using animals the NVS should provide:-

a) practical advice on techniques, particularly surgical approaches and suitable anaesthetic regimens and peri-operative care;

b) advice on the recognition of pain, suffering distress and lasting harm , and ill-health, and physiological and behavioural disturbances in animals (such as arise from fear or boredom);

c) advice on the recognition and assessment of severity and any potential breach of the severity limit; and,

d) advice on the recognition of humane end-points.36) Advice may involve consultation with other named persons and experts.

Advice to the animal care staff

37) Commonly a senior animal technician holds the position of NACWO and is the main point of contact on matters relating to the general care and husbandry of animals in the establishment. He or she is likely to be the person who contacts the NVS in cases where the health or welfare of an animal gives rise to concern. The NVS should foster a good working relationship with the NACWO(s) and other animal care staff.

38) The NVS should provide advice on maintaining health status and animal welfare issues, including socialisation and enrichment.

Animals giving rise to concern

39) Under the 1986 Act, if the NVS considers that the health or welfare of any protected animal gives rise to concern, he or she must notify the personal licence holder. If there is no personal licence holder (as when the animal has not undergone a regulated procedure), or if one is not available, the NVS must take steps to ensure that the animal is cared for and, if necessary, that it is humanely killed using an appropriate method. Normally problems should be resolved through discussion with the personal licence holder or project licence holder involved. There may be occasions when it is advisable to consult the certificate holder or consult or notify the Home Office Inspector.

40) The NVS should be familiar with relevant methods of humane killing listed in Schedule 1 to the 1986 Act, and with the associated Code of Practice, together with any additional approved methods set out in the conditions of the certificate of designation.

Fate of animals at the end of regulated procedures

41) At the end of a series of regulated procedures for a particular purpose (typically a project licence protocol) which does not specify that the animal will be killed, the 1986 Act requires that the relevant personal licence holder must, in the first instance, decide whether the animal should be killed or not. In the great majority of instances this decision is made at a designated establishment (if not see paragraphs 44-46), and if the personal licence holder's decision is that the animal need not be killed then the project licence holder is obliged to pass the matter to a veterinary surgeon, normally the NVS. If the (N)VS determines that the animal is not suffering and is not likely to suffer adverse effects from the procedures done, then the animal may be discharged into the care of the (N)VS within the designated establishment. No certificate is necessary and the principle of veterinary direction can be applied. The decision of whether an animal may remain alive can be taken by a person the NVS considers able to do so and according to specific criteria, which the NVS has defined. These criteria would normally be specified in the project licence. Should the animal subsequently move off the designated establishment veterinary certification (see paragraphs 42-43) will be needed.

Certification at designated establishments

42) When a protected animal, which has undergone and completed the regulated procedures, is to move off the designated establishment to a non-designated place such as a slaughterhouse, a family home or a farm, the certificate holder is obliged to request a veterinary surgeon, normally the NVS, to certify that the animal is not likely to suffer adverse effects from those regulated procedures. Guidance is given in the LAVA Guidance on the Discharge of Animals from the Animals (Scientific Procedures) Act 1986 (reference 6).

43) The NVS may also be involved in meeting other regulatory requirements for the transport, import or export of protected animals, including certifying fitness of animals for transport, where appropriate.

Work outside designated establishments

44) The NVS may be called upon to advise project licence holders about the fate of animals that have undergone procedures at non-designated establishments (referred to as "places other than designated establishments" or PODEs), such as at a farm or in the wild.

45) Similar certification to that given to animals leaving a designated place (see paragraphs 42-43) should be provided for animals which come to the end of a protocol at a place which is not designated, but the NVS may be in no position to carry out the certification (because the facts are not within his/her knowledge, e.g. wildlife, farmed fish or farm animals which may be under the care of another veterinary surgeon). If no veterinary surgeon is available at the place another "suitably qualified person" may provide this certification. The project licence holder with advice from the NVS should designate such a "suitably qualified person", who should have proven expertise at judging the health and welfare of the particular type of animals concerned. The NVS should advise on suitable training for such persons. (See reference 6).

46) Particular criteria apply for release to the wild and a distinction has to be made between release at the end of regulated procedures and release with the expectation of gathering further data (e.g. from transmitters). (See reference 6 for further details).

Participation in the ethical review process

47) Under a condition placed on the certificate of designation an establishment must have an ethical review process ["ERP"]. The aims of the process are:

"To provide independent ethical advice to the certificate holder, particularly with respect to project licence applications and standards of animal care and welfare.

To provide support to named people and advice to licensees regarding animal welfare and ethical issues arising from their work.

To promote the use of ethical analysis to increase awareness of animal welfare issues and develop initiatives leading to the widest possible application of the 3Rs (replacement, reduction and refinement)."

['Home Office Guidance on the Operation of the 1986 Act' Appendix J March 2000] (reference 1).

48) The NVS is an obligatory participant in the process. In general terms, the NVS should only advise on matters within his/her professional competence, but may in addition contribute to the ERP in a lay capacity. He or she should advise the ethical review process on: -

a) accommodation and care, particularly for animals with special welfare requirements;

b) the refinement of studies, and choice of species;

c) the health and welfare status of animals;

d) the appropriateness of the procedures proposed;

e) general strategies to minimise the severity of protocols;

f) how particular adverse effects may be controlled; and,

g) appropriate humane end-points.49) Within the ERP, the NVS should assist in promoting high standards of care and welfare, and a culture of care within the designated establishment.

Records

50) It is important to appreciate the full implications of advice given by the NVS in the light of the statutory responsibility to advise on animal health and welfare. Considerable care must be taken to avoid ambiguity and undue delay and sometimes it may be necessary to give advice in writing.

51) The NVS should maintain a written record or copy of formal advice given, which should be readily available for review. This applies whether the advice is given in writing or verbally.

52) The NVS should supervise the maintenance of appropriate animal health records relating to the protected animals. The format of the records should be agreed with the Home Office Inspector and with the certificate holder (see reference 2).

53) Records should be at least sufficient to show any treatments given to animals or groups of animals and, together with records maintained by other named persons, identify and monitor incidence of disease in the colonies, so that control or corrective action can be taken. As well as a written record of advice or treatment given, there should normally be an indication of the result. Results of required microbiological surveillance programmes should also be recorded.

54) Health records should be regularly reviewed by the NVS and any subsequent action record ed.

55) Records should be kept safely and be readily available to the animal care staff and the Home Office Inspector.

56) In breeding colonies, the recording of colony data (see reference 3, paragraph 3.45) is the certificate holder's responsibility. However, the NVS should agree acceptable performance targets with the care staff and should review the records on a regular basis, to provide assurances that problems are not going unnoticed.

GLOSSARY

Breeding ("Breeder") Establishments are designated establishments where the common laboratory species, as listed in Schedule 2 of the 1986 Act are bred for use in regulated procedures. The same establishment can be a user and/or supplying establishment.

A Certificate of Designation is the document providing official approval for use of an establishment for activities controlled by the 1986 Act, and is held by a senior person, the Certificate Holder, representing the establishment. At issue, conditions are placed on the certificate, and the Holder is responsible for ensuring compliance with these.

Designated Establishment is the term given to the place to which a Certificate of Designation issued under the 1986 Act applies.

Named Animal Care and Welfare Officer is the term given to the person named on the certificate as responsible for the day-to-day care of the protected animals in specified designated areas.

A Named Veterinary Surgeon is the veterinary surgeon specified on the certificate of designation. While it is accepted that veterinary surgeons may deputise for the NVS, no deputies may be specified on the certificate.

A Personal Licence is issued to an individual (the "personal licence holder"/licensee) to permit him/her to apply specified regulated procedures that are also authorised by a project licence to specified types of protected animal at a specified place(s). The personal licensee is the person primarily responsible for the care of the protected animals.

A Project Licence authorises a programme of scientific work detailed on the schedule to the licence on specified types of protected animal at a specified place(s), and is issued to an individual (the project licence holder/project licensee).

Protected animals are those covered by the 1986 Act, which briefly is all vertebrates, including immature forms from mid-gestation/incubation or capacity for independent feeding onwards, and Octopus vulgaris.

Regulated procedures (under the 1986 Act) are interventions or omissions applied to protected animals for a scientific purpose, which may cause pain suffering distress or lasting harm.

Schedule 1 (of the 1986 Act) gives a list of methods of humane killing that do not require project and personal licence authority. It was revised in 1997 and has an accompanying Code of Practice.

Schedule 2 (of the 1986 Act) gives a list of types of animals that must be bred or supplied from a designated breeder or supplier if intended for use in regulated procedures.

Scientific Procedure ("User") Establishmentsare designated establishments at which project licences are held and include universities (university departments and medical schools), colleges of further education, government research establishments, pharmaceutical and other industrial research and development laboratories, and contract research laboratories. The same establishment can be a breeding and/or supplying establishment.

Supplying Establishments are designated establishments from which Schedule 2 animals that have not been bred on the premises are kept and supplied for use in regulated procedures. The same establishment can be a breeding and/or user establishment.

User/Breeder Codes of Practice provide guidance on minimum standards for facilities, housing and care at the respective designated establishment.

Veterinary direction (from reference 7) means instructions from a veterinary surgeon who is not necessarily present.

Veterinary supervision (from reference 7) means the veterinary surgeon is on the premises and able to respond to a request for assistance if needed.

Veterinary supervision that is direct and continuous(from reference 7) means that the veterinary surgeon is present and giving his or her undivided personal attention.

REFERENCES/FURTHER READING

1) Home Office Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 [particularly the NVS Section, paragraphs 4.59 - 4.64]. HMSO; London March 2000.

2) Home Office Code of Practice for the Housing and Care of Animals Used in Scientific Procedures. HMSO: London Feb. 1989

3) Home Office Code of Practice for the Housing and Care of Animals in Designated Breeding and Supplying Establishments. HMSO: London Jan.1995

4) The Humane Killing of Animals under Schedule 1 of the Animals (Scientific Procedures) Act 1986. Home Office Code of Practice. HMSO: London Jan. 1997

5) Guidance Notes on the Role of the Named Animal Care and Welfare Officer in the Establishments Designated under the Animal (Scientific Procedures) Act 1986

6) Guidance on the Discharge of Animals from the Animals (Scientific Procedures) Act 1986, LAVA, March 2001

7) RCVS Guide to Professional Conduct (current edition)