APPENDIX B

STANDARD CONDITIONS: DESIGNATED SCIENTIFIC PROCEDURE ESTABLISHMENTS

The authority conferred by this certificate is subject to the following conditions. Certificates may be revoked or varied for a breach of conditions.

For the purpose of these conditions, "Inspector" means a person appointed under the terms of Section 18 of the Animals (Scientific Procedures) Act 1986.

1. The areas within the establishment approved by the Secretary of State for the housing of protected animals or the performance of regulated procedures shall be maintained to at least the standards set out in the Home Office Code of Practice for the Housing and Care of Animals used in Scientific Procedures, except where variations are authorised by the Secretary of State.

2. Unless authorised by the Secretary of State, there shall be no variation of the use of the approved areas of the designated establishment that may have adverse consequences for the welfare of the protected animals held.

3. Unless otherwise authorised by the Secretary of State:

(i) only the types of protected animals specified in the certificate may be kept in the establishment for use in experimental or other scientific purposes; and

(ii) these animals may only be kept and used in the areas listed in the schedule to the certificate.

4. The establishment shall be appropriately staffed at all times to ensure the well-being of the protected animals.

5. Unless otherwise authorised in a project licence, regulated procedures shall not be carried out on any of the types of animal listed in Schedule 2 of the Animals (Scientific Procedures) Act 1986 (as amended) unless the animals have been bred at or obtained from an establishment designated by a certificate issued under Section 7 of that Act.

Furthermore, unless otherwise authorised in a project licence, regulated procedures shall not be carried out on cats or dogs unless the animals have been bred at and obtained from a breeding establishment designated by a certificate issued under Section 7 of the Animals (Scientific Procedures) Act 1986.

6. Records shall be maintained, in a format acceptable to the Secretary of State, of the source, use and final disposal of all protected animals accommodated in the establishment for experimental or other scientific purposes. Such records shall, on request, be submitted to the Secretary of State or made available to an Inspector. The certificate holder shall, on request, submit to the Secretary of State a summary report, in a form specified by the Secretary of State, of the source, use and disposal of all protected animals accommodated in the establishment for experimental or other scientific purposes.

7. Records shall be maintained, in a format acceptable to the Secretary of State and under the supervision of the Named Veterinary Surgeon, relating to the health of all protected animals kept for experimental or other scientific purposes and accommodated or used in the establishment. These records shall be readily available, on request, for examination by an Inspector.

8. For the purpose of this condition, "marked" means clearly identifiable by a method acceptable to the Secretary of State.

(i) Each cat, dog and non-human primate in the establishment which is used, or intended for use, in regulated procedures shall be marked, and particulars of the identity and origin of all such animals shall be entered into the records referred to in 6 above.

(ii) Every cat, dog and non-human primate in the establishment which is used, or intended for use, in regulated procedures shall be marked before it is weaned except where:

(a) the animal is transferred from one establishment to another before it is weaned; and

(b) it is not practicable to mark it beforehand,

in which case, the receiving establishment shall maintain records attesting the identity and origin of the animal's mother until the animal is marked.

(iii) Any unmarked cat, dog or non-human primate which is taken into the establishment after weaning shall be marked as soon as possible.

9. In accordance with the Code of Practice for the Housing and Care of Animals used in Scientific Procedures, all protected animals must at all times be provided with adequate care and accommodation appropriate to their type or species. Any restrictions on the extent to which such an animal can satisfy its physiological and ethological needs shall be kept to the absolute minimum; and the health and well-being of protected animals, and the environmental conditions in all parts of the establishment where protected animals are kept, shall be checked at least once daily by competent persons. Arrangements shall be made to ensure that any suffering or defect discovered is remedied as quickly as possible.

9A. The certificate holder shall nominate and be responsible for the performance of named persons, acceptable to the Secretary of State, as required by Section 6(5) of the Animals (Scientific Procedures) Act 1986.

10. The person(s) named in the certificate as responsible for the day to day care of animals (the Named Animal Care & Welfare Officer(s)) shall ensure that any protected animal which is not the immediate responsibility of any personal licensee and which is found to be in severe pain or severe distress which cannot be alleviated shall be promptly and humanely killed by a competent person using an appropriate method under Schedule 1 to the Act or another method authorised in the certificate of designation.

11. In any case where it appears to the Named Veterinary Surgeon(s) or to the Named Animal Care & Welfare Officer(s) responsible for the day to day care of the animals that the health or the welfare of a protected animal kept for experimental or other scientific purposes at the establishment gives rise to concern, he or she shall notify the personal licensee responsible for the animal. If there are no such licensees or if one is not available, the Named Veterinary Surgeon or the Named Animal Care & Welfare Officer responsible for the day to day care of the animal shall take steps to ensure that the animal is cared for or, if necessary, humanely killed by a competent person using an appropriate method under Schedule 1 to the Act or another method authorised in the certificate of designation.

12. Arrangements to ensure that animals are given adequate care must be made in the event that the Named Persons referred to in 9A above are not available for any reason.

13. Adequate security measures shall be maintained to prevent the escape of protected animals and to prevent intrusions by unauthorised persons.

14. Quarantine and acclimatisation facilities shall be provided and used as necessary.

15. Adequate precautions against fire shall be maintained at all times.

16. The certificate holder shall take all reasonable steps to prevent the performance of unauthorised procedures in the establishment, and make adequate and effective provision for regular and effective liaison with and between those entrusted with responsibilities under the Act and with others who have responsibility for the welfare of the protected animals kept there.

17. In any case where it is intended to kill a protected animal that has been kept at the establishment for scientific purposes but is not required to be killed under the terms of a project licence, the method of killing employed must be one that is appropriate under Schedule 1 to the Act or otherwise authorised in the certificate. The certificate holder shall ensure that a person competent to kill animals in accordance with this condition is available at all times. A register shall be maintained of those deemed by the certificate holder to be competent to kill by Schedule 1 methods and by any other method specified in the certificate; these methods of killing shall only be entrusted to and performed by such people. The register shall, on request, be submitted to the Secretary of State or made available to an Inspector.

18. Inspectors shall be provided with access at all reasonable times to all parts of the establishment which are concerned with the use, holding or care of protected animals.

19. The certificate holder shall take steps to provide such education and training as is necessary for all licensees and others responsible for the welfare and care of protected animals at the establishment.

20. The certificate holder shall notify the Secretary of State of any proposed change in:

(i) the title of the designated establishment; or

(ii) the full name of the certificate holder; or

(iii) the full name(s) and qualifications of the Named Animal Care & Welfare Officer(s) responsible for the day to day care of the protected animals; or

(iv) the full name(s) and qualifications of the Named Veterinary Surgeon(s); or

(v) the areas appearing on the Schedule of Premises for the designated establishment or the class of use within those areas; or

(vi) the types of protected animals to be used, or kept for use, in regulated procedures.

21. The certificate holder shall notify the Secretary of State of the death of a project licence holder within seven days of its coming to his or her knowledge when, unless the Secretary of State directs otherwise, the project licence shall continue in force for 28 days from the date of notification. The certificate holder will, during that period, assume responsibility for ensuring compliance with the terms and conditions of the project licence.

22. A protected animal which, having been subjected to a completed series of regulated procedures, is kept alive shall continue to be kept at the designated establishment under the supervision of a veterinary surgeon or other suitably qualified person unless:

(i) it is moved, with the authority of the Secretary of State, to another designated establishment;

(ii) a veterinary surgeon certifies, and the Secretary of State accepts, that it will not suffer if it ceases to be kept at the designated establishment; or

(iii) its re-use in another procedure is authorised by the Secretary of State.

23. The certificate holder is required to have instituted, and to maintain, local ethical review processes acceptable to the Secretary of State. Details of the processes and records of the outputs from the processes shall, on request, be submitted to the Secretary of State or made available to an Inspector. Any substantial changes to the processes that are proposed must be submitted to the Secretary of State for approval.

24. A copy of these conditions shall be readily available for consultation by all licensees and named persons in the establishment.

25. The certificate holder shall pay such periodical fees to the Secretary of State as may be prescribed by or determined in accordance with an Order made by him.

26. The certificate remains the property of the Secretary of State, and shall be surrendered to him on request.

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