THE ANIMALS (SCIENTIFIC PROCEDURES) ACT 1986



THE ANIMALS (SCIENTIFIC PROCEDURES) ACT 1986

OUTLINE OF THE PROVISIONS OF THE ANIMALS (SCIENTIFIC PROCEDURES)

ACT 1986

ANIMALS (SCIENTIFIC PROCEDURES) ACT 1986

OUTLINE OF THE PROVISIONS OF THE ANIMALS (SCIENTIFIC PROCEDURES)

ACT 1986

Introduction

The Animals (Scientific Procedures) Act l986 applies throughout the United Kingdom. In Great Britain, it is administered by the Home Office and in Northern Ireland by the Department of Health and Social Services. The Act regulates " any experimental or other scientific procedure applied to a protected animal which may have the effect of causing that animal pain, suffering, distress or lasting harm".

This summary explains the Act and describes:

How applications for licences and certificates are considered;

The terms and conditions attached to licences and certificates;

Arrangements for external review of applications

The responsibilities of certificate holders, licensees and named persons;

Additional guidance may be issued by the Secretary of State on specific issues. This may either be published in the normal way or attached as an appendix to the Annual Report of the Animal Procedures Committee.

Definitions

The Animals (Scientific Procedures) Act defines a 'protected animal' as any living vertebrate, other than man and also the invertebrate Octopus vulgaris. The Act therefore protects all such animals when they are used for scientific procedures; protection extends to certain immature forms:

(i) mammals, birds and reptiles from halfway through gestation or incubation;

(ii) fish and amphibians from the time at which they commence independent feeding.

The Home Secretary has powers to extend the definition of a protected animal or to alter the stage of development at which immature forms become protected. An animal is regarded as living until permanent cessation of its circulation or destruction of its brain.

The regulations refer only to protected animals undergoing or expected to undergo regulated procedures or which are kept in order to breed animals for use in such procedures. A procedure is considered regulated if it is conducted for a scientific purpose and may result in pain, suffering, distress or lasting harm. These terms include death, disease, injury, physiological or psychological stress, significant discomfort or any disturbance to normal health, whether immediately or in the long term. A procedure is considered regulated if it comprises a combination of non-regulated techniques which cumulatively may have a similar effect. It is also regulated if carried out on an immature form when that animal may subsequently reach a stage of development at which it would otherwise be protected, irrespective of any effect on the parent animal. This therefore includes the breeding of animals with harmful or potentially harmful genetic defects.

This definition stands, even if any pain, suffering, distress or lasting harm which would otherwise have resulted is mitigated or prevented by use of anaesthetic or sedative agents or any other method of alleviating pain or discomfort. In fact giving an anaesthetic or analgesic etc. to sedate, restrain or dull the perception of pain is itself a regulated procedure.

Procedures not regulated include:

the ringing, tagging or marking or any other humane procedure carried out solely to enable an animal to be identified, providing it causes only momentary pain. Methods of marking such as toe clipping are regulated if carried out for a scientific purpose.

A clinical test to evaluate a veterinary product in accordance with the Medicines Act 1968 or an Order under it.

Procedures carried out as acts of recognised veterinary, agricultural or animal husbandry practice, for example, taking blood or other tissue samples for diagnosis and giving established medicines by injection; these are done for the benefit of the animal. Similarly, husbandry practices which may cause pain, like castration, are excluded unless they form part of a scientific study.

Humane killing

The killing a protected animal is a regulated procedure if the animal is killed for a scientific purpose in a designated establishment using a method which is not exempted by Schedule 1 to the Act. The Home Secretary has power to amend this Schedule by Order. Killing a protected animal by a method listed in Schedule 1 is not considered a regulated procedure and need not be authorised by a project or a personal licence. Such killing must be performed by a competent person. Other methods of killing may be allowed provided that they are performed by competent persons either as regulated procedures specified in both project and personal licences, or when authorised by a special condition in the certificate of designation.

Codes of Practice

The Home Office has issued a Code of Practice for the Housing and Care of Animals used in Scientific Procedures, which is obtainable from HMSO. Additional recommendations are contained in MAFF Codes of Recommendations for the Welfare of Livestock (relating to farm animals, including domestic fowls) and in a series of voluntary guidelines published by the Universities Federation for Animal Welfare.

The Home Office Inspectorate

Administration of the Act is carried out by Inspectors, appointed by the Secretary of State, who hold either medical or veterinary qualifications. The Inspectorate is a part of the Constitutional & Community Policy Directorate and comprises a Chief Inspector who is based in a London office, and Inspectors at regional offices located at Cambridge, Swindon, Shrewsbury and Dundee. It is the duty of Inspectors to advise the Secretary of State on applications for certificates and licences and licences under the Act and to recommend whether they be approved or granted subject to certain conditions. Inspectors are willing to provide advice to those preparing applications for licences and maintain regular contact with those in authority at establishments which they visit. Unannounced visits are made to places where regulated procedures are carried out in order to determine whether appropriate authority is in place and the conditions of licences are being observed. Breaches of the conditions of certificates and licences are required to be reported to the Secretary of State. If an Inspector considers that a protected animal is undergoing excessive suffering he/she may require it to be immediately killed by an appropriate method.

Designation of Scientific Procedure Establishments

At places where regulated scientific procedures are performed, a certificate of designation must be held by a person who represents the governing authority of the establishment and who is ultimately responsible for ensuring that the conditions of the certificate are observed.

The Certificate of Designation must name:

1. one or more persons responsible for day-today care of the animals - The Animal Care and Welfare Officer(s);

2. one or more veterinary surgeons to provide advice on animal health and welfare.

Where the facilities are considered appropriate and the persons nominated are suitably qualified, a certificate will be issued which carries certain conditions. These include:

ensuring that animals are kept with due regard to their physiological and ethological needs and that their well-being is regularly monitored;

providing the Inspector with reasonable access to all listed parts of the establishment;

ensuring the named persons discharge their duties effectively;

maintaining the fabric of the establishment in accordance with the Code of Practice;

ensuring that all scientific procedures conducted at the establishment are authorised by project and personal licences;

maintaining a record of all project and personal licence holders;

ensuring that staffing is appropriate to ensure the well-being of all protected animals;

arranging adequate care if the named persons are unavailable for any reason, such as leave or sickness;

ensuring someone competent is always available to kill animals humanely by an authorised method appropriate to the species;

unless specifically authorised on a project licence, ensuring that animals held or used have been obtained in accordance with the requirements of Schedule 2.

ensuring that all primates, dogs and cats are clearly marked by an agreed method;

maintaining records of the source, use and final disposal of protected animals;

ensuring that animal care staff and licensee applicants, receive appropriate education and training;

notifying the Inspector of any proposed change to the title of the establishment, the certificate holder, the named persons, the species of animal accommodated or the use of rooms listed.

Certificates of designation remain in force until suspended or revoked, although the holder may at any time seek a variation of the certificate, for instance permission to keep different animals or to alter the rooms where they are kept. A change of certificate holder will require the issue of a new certificate.

The holder of a certificate of designation is required to pay certain fees annually; these currently consist of a flat rate annual fee and a fee for each personal licensee based at the establishment at any time during the preceding calendar year.

Regulated procedures at places other than designated establishments

Certain regulated procedures can be carried out in places which are not designated. This is normally done only when temporary authority is required or when the procedures need to be performed in places where designation would be unrealistic or inappropriate, such as rivers, woods or moorland. Such authority is specifically included in project and personal licences, often with an additional special condition to enable adequate supervision.

The Named Animal Care and Welfare Officer

The Act requires that there must be at least one person named as having responsibility for the day-today care of the animals. This is often a senior animal technician. Sometimes several people may be named, each responsible for a discrete part of the establishment. This person must notify the personal licensee, or arrange for the care or destruction of any protected animal, if its health or welfare give rise to concern. Additional responsibilities include:

being aware of the standards of husbandry and welfare set out in the Code of Practice and taking ensuring these are met;

ensuring that suitable records are kept of the health of the animals;

ensuring that records are maintained of environmental conditions in animal rooms and of all animals bought, bred, supplied, issued, used, killed or otherwise disposed of;

knowing which areas of the establishment are listed in the certificate of designation and the purposes for which they are designated;

ensuring that every protected animal in all designated areas is checked at least daily by a competent person;

being familiar with project licences in use, including adverse effects and humane endpoints;

knowing how to contact all project or personal licence holders, the named or deputy veterinary surgeon(s), and the certificate holder;

being aware of the methods of killing permitted in Schedule 1, together with any other approved methods listed in the certificate of designation and either being competent in their use or knowing how to contact someone who is.

The Named Veterinary Surgeon

The named veterinary surgeon is required to monitor the health or welfare of all protected animals in the establishment and when concerned to notify the personal licensee, or make arrangements for its care or destruction. Additional responsibilities include:

visiting all parts of the establishment designated in the certificate sufficiently frequently to effectively monitor the health status of the animals;

maintain regular contact with the certificate holder and the named animal care and welfare officer(s);

having thorough knowledge of the prevention, diagnosis and treatment of disease which may affect the species kept, and of their husbandry and welfare requirements;

providing a comprehensive 24-hour veterinary service throughout the year;

supplying and directing the use of controlled drugs and other prescription-only medicines for use on protected animals in the establishment;

maintaining records relating to the health of all protected animals: this should include a written record of advice or treatment given and be readily available to the named animal care and welfare officer, the certificate holder and the Inspector,

being familiar with project licences in use, including severity limits and severity conditions, adverse effects and humane endpoints,

being able to advise licensees and others on appropriate methods of anaesthesia, analgesia and euthanasia, surgical technique, choice of species, and on the recognition of pain, suffering, distress or lasting harm;

being aware of the methods of killing permitted in Schedule 1, together with any other approved methods listed in the certificate of designation and either being competent in their use or knowing how to contact someone who is.

where appropriate, certifying that an animal is fit to travel to a specified place, to be used in further regulated procedures, to be released to the wild-, or to be released for non-scientific purposes.

to nominate deputies to provide cover for any absences and ensure that their identity is known to the certificate holder, the named animal care and welfare officer and other relevant staff;

Designation of establishments for the breeding and supplying of animals for use in scientific procedures

Schedule 2 to the Act requires that, whenever possible, animals used in scientific procedures shall have been specifically bred or obtained for that purpose. Specifically, any mouse, rat, guinea-pig, hamster, rabbit, quail or primate used or held for use in a regulated procedure must be obtained only from a designated breeder or supplier and any cat or dog must have been bred at and obtained from a designated breeding establishment. Dogs, cats or primates must be individually identified and appropriate records kept. A certificate of designation is granted only when the required standards of animal husbandry and care are met and these are comparable with those in designated scientific procedure establishments.

Project Licences

Project licences authorise programmes of work involving regulated procedures on animals which may be carried out in specified places and by those with appropriate personal licences. Article 8 of the Council of Europe requires such procedures to be carried out under general anaesthesia unless this would thwart the object of the experiment, or its induction and maintenance would be more traumatic than the experiment itself; if anaesthesia is not possible other measures must

be taken to minimise pain, suffering, distress or harm.

The project licence defines the work which may be performed and its justification. It is not concerned with technical competence, since this is the purpose of the personal licence. Project licences can vary in scope - from large licences covering, for example, the screening of drugs for medicinal use and involving many licensees using a range of animals to smaller licences authorising a single research student to investigate part of one system of one species and using few animals.

Application forms for project licences request details of the proposed work so that justification for the application can be assessed. These include:

a statement of the status, qualifications and experience of the project licence holder;

the purpose and scientific justification for the study;

a full description of the procedures which would be involved;

an estimate of the number of animals of each species which may be required;

assessment of potential severity.

A project licence will only be granted if:

the likely adverse effects (pain, suffering, distress or lasting harm) of the procedures proposed are considered to be justified by the benefit likely to accrue,

the purpose of the study cannot be reasonably achieved without using protected animals and

the proposal uses the minimum number of animals, involves animals with the lowest degree of neurophysiological sensitivity and has the least adverse effect.

Fundamental research, where the only immediate benefit sought is increase of knowledge, is permitted.

Other factors taken into account in considering whether to grant a project licence include:

the suitability of experimental design in relation to the stated objectives;

the consideration given by the applicant to minimising the number of animals used, refining procedures to minimise suffering and replacing animals with alternatives;

the justification for using the animal model proposed and the sources from which Schedule 2 animals are to be obtained;

whether the proposed anaesthetic and analgesic techniques etc. are appropriate;

whether the facilities at the establishment are adequate for the scientific procedures;

whether the place where the work is to be done has adequate facilities.

A project licence may be valid for no more than five years. Applications may then be made to continue programmes of work. The licence also terminates on the death of the licence holder

The severity of procedures

Applicants for project licences must assess the severity likely to result from the procedures, although this inevitably involves an element of subjectivity. A distinction must be made between assessed severity of individual procedures (or series of procedures) and the overall severity of the project. Even work of mild severity will only be permitted if it can be justified. Research into life-threatening disease may necessitate a high severity, difficult to justify in other research.

When assessing the severity of a series of regulated procedures account should be taken of the contribution of all procedures (regulated or otherwise) applied to each animal or group of animals, any likely adverse effects, actions taken to mitigate these and any agreed endpoints. Assessments should describe the maximum severity expected to be experienced by any animal. Procedures are regarded as unclassified if the animal is rendered insentient throughout, either by decerebration or general anaesthesia followed by killing without recovery of consciousness.

Licence holders are expected to be familiar with the signs of pain, discomfort and distress in the species they are using. It is often possible to reduce the severity of procedures by using predetermined endpoints and wherever possible project licence applications should specify particular actions which the applicant intends to take in order to mitigate adverse effects. These may include withdrawing an animal from a procedure, or humane killing.

Conditions in both project and personal licences require the holder to minimise as far as possible any pain, suffering or distress. Project licences place an upper limit on the severity of procedures allowed on any one animal. The licence holder is required to notify the Inspector if any protected animal suffers significantly more as the result of a regulated procedure than has been authorised. Where the severity limit for a procedure seems likely to be exceeded, the licence holder should either terminate the procedure or advise the Inspector.

Re-use of animals

Normally, when a protected animal has undergone a series of regulated procedures, it is humanely killed; however a veterinary surgeon may be authorised to determine whether it is in a fit condition to be kept alive, but retained at a designated establishment. The Act sets out precise conditions under which protected animals may be re-used in more than one procedure. Re-use is not encouraged and must always be specifically authorised in advance. Use of an animal as a matter of necessity, in a series of regulated procedures for a particular purpose, is not regarded as re-use. Permission may be obtained for surgically-prepared animals to be re-used for subsequent procedures provided that the purpose remains the same and that the surgical preparation was essential for each of the subsequent uses. However if the procedures are unrelated or a different animal could equally well have been chosen for the second or subsequent procedures, use of the same animal is regarded as re-use. For example if, by choice, repeated samples of normal blood were taken from a rabbit even ‘though each sample could equally well have come from a fresh rabbit, this would be regarded as re-use and would require specific authority.

When a protected animal has been subjected to a series of regulated procedures for a particular purpose (the first use), which included general anaesthesia, then the animal may only be re-used:

if the procedure, or each procedure for which the anaesthetic was given, consisted only of surgical preparation for a subsequent procedure; or

if the general anaesthetic was given solely to immobilise the animal, for instance, for the safety and/or comfort of the animal and/or the operator; or

if, during subsequent re-use, the animal is kept under general anaesthesia from which it is not allowed to recover consciousness.

Where a protected animal has been subjected to a series of regulated procedures for a particular purpose (the first use) which did not include general anaesthesia then, provided the first use is complete and the animal has fully recovered, permission may be given for the animal to be used for further regulated procedures.

Referral of licence applications to an external assessor and to the Animal Procedures Committee

Applications for certificates and licences are assessed by one or more Inspectors. Sometimes, before a licence or certificate is granted, it may be referred to an external assessor and/or the Animal Procedures Committee. The Animal Procedures Committee considers all project licence applications involving:

tobacco or tobacco products (unless animals are terminally anaesthetised);

work of substantial severity on primates; and

the acquisition or maintenance of manual skills for microsurgery.

Currently project licences for acquiring or maintaining manual skills are granted only for the teaching of microsurgical techniques using rats under terminal anaesthesia.

Responsibilities of the Project Licence Holder

The project licence holder is responsible for directing, managing and supervising the project. This entails ensuring:

that the study is conducted in accordance with the Act and the conditions of the project licence;

that work remains within the permitted purposes stated in the licence application;

that only authorised species of animal and numbers of animals are used;

that personal licensees working on the project are authorised to carry out the regulated procedures which they use;

that all licensees are aware of and comply with the severity conditions;

that personal licensees are appropriately trained, guided and supervised;

that full and accurate records are kept;

that personal licensees ensure that all animals involved in the project are appropriately marked or identified.

Although the personal licensee bears primary responsibility for the well-being of all animals undergoing procedures under the terms of his or her licence, the project licence holder is also responsible for the care of these animals, particularly because he or she will often be in a more senior management position.

The project licence holder is also responsible for making the statistical return of procedures for the project by 31 January each year.

Deputy Project Licence Holder

A project licence may be held by only one person; joint applications are not acceptable. Circumstances when a deputy project licence holder may be required include:

where the nature of the project is such that control is best exercised through one or more deputies;

where work is not confined to one place so that the project licence holder needs a deputy for local supervision of the work;

if the project licence holder is likely to be absent for more than a month at a time;

in the rare cases when the project licence holder does not hold a personal licence (when at least one deputy must).

The deputy must be in a position to exercise day-today control on behalf of the project licence holder and must be known to those working on the project.

Personal Licences

The project licence alone is insufficient to authorise the conduct of regulated procedures on living animals. A personal licence is also required, given only to those with appropriate education and training (including instruction in a relevant scientific discipline) who are competent to perform the procedures and to handle and care for the animals concerned.

Similarly a personal licence only grants authority to carry out a regulated procedure if this has also been authorised by a project licence. Like project licences, all personal licences incorporate legally-binding conditions. These include ensuring that performance of any procedure is authorised by a project licence and is carried out at a place specified in both the project and personal licences. Personal licences generally remain in force indefinitely but are reviewed by the Home Office at least once every five years.

Applicants for personal licences must have received appropriate education and training and in addition:

be at least 18 years of age;

be able to take primary responsibility for the animals involved in procedures;

know the techniques required for the species concerned;

know the signs of pain, suffering or distress in all species to be used;

understand and implement the needs for any aftercare following procedures

know how to care for the animals.

First time applicants must also produce a certificate, signed by a sponsor who must be able to assess these requirements and the applicants' character, confirming their suitability to hold a personal licence. The sponsor will normally be a senior member of staff at the applicant's place of work.

Since the personal licence may be seen as a certificate of competence to perform regulated procedures on animals, a personal licensee is not generally restricted to working on a particular projects although new licensees are usually so constrained initially.

Like project licences, personal licences specify the place where procedures may be carried out and licensees who wish to extend or vary the authorisation of their licence to other places or to include additional procedures or species must apply formally for a licence amendment.

The most important responsibility of personal licensees is that they bear primary responsibility for the care of animals on which they have carried out scientific procedures. They must be familiar with the severity limit of procedures authorised by the project licence and the responses to be made to adverse effects

Personal licensees are responsible for ensuring that the animals on which they are working are properly identified and that labels indicate the project licence number, the personal licensee’s name, the procedures which the animals are undergoing and any additional information the Inspector may require.

It is possible to include on the personal licence, authority to delegate to assistants some simple tasks, such as feeding a pre-prepared diet or weighing an experimental animal. In such cases the personal licensee remains responsible for proper conduct of the techniques and for the well-being of the animals.

The Animal Procedures Committee

The Animals (Scientific Procedures) Act 1986 also established a Committee, known as the Animal Procedures Committee, to advise the Secretary of State on matters concerned with implementation and application of the Act. This remit includes oversight of the requirements of science and industry and the protection of animals against avoidable suffering and unnecessary use.

The Committee can promote research relevant to these functions and can seek advice or help from other persons with relevant knowledge or experience. It reports each year to the Secretary of State.

The Committee consists of a Chairperson and at least twelve other persons appointed by the Secretary of State, of which at least two thirds shall have medical, veterinary or biological qualifications and at least one a barrister, solicitor or advocate. No more than half shall have held a project or personal licence during the preceding six years. Animal welfare interests are required to be adequately represented.

BRH. July 2005

................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download