The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012

PART 2 Conditions in section 2C licences

1.  The licence holder shall ensure that the regulated activities carried on at the establishment are carried on in a manner that is consistent with the principles of replacement, reduction and refinement.

2.—(1) The licence holder shall ensure that a register is maintained of those who are competent to kill protected animals. A person’s name shall not be included in the register unless the person has been adequately educated and trained in the killing of animals.

(2) The register must specify, in relation to each person named, the descriptions of animals that the person is competent to kill and the methods of killing that the person is competent to use to kill each such animal.

(3) The licence holder shall ensure that each person so registered is supervised when killing animals at the establishment until he or she has demonstrated the requisite competence.

(4) The licence holder shall ensure that at all times the number of persons who are so registered and are present at the establishment is sufficient to enable any protected animal being kept at that place that needs to be killed to be killed expeditiously.

(5) The register shall, on request, be submitted to the Secretary of State or made available to an Inspector.

3.  The licence holder shall notify the Secretary of State of any proposed change in:

(a) the full name of the holder; or

(b) the full name and qualifications of the named person responsible for compliance; or

(c) the full name and qualifications of the named animal care and welfare officer; or

(d) the full name and qualifications of the named veterinary surgeon; or

(e) the full name and qualifications of the named information officer; or

(f) the full name and qualifications of the named training and competency officer; or

(g) the areas appearing on the schedule of premises for the establishment or the class of use within those areas; or

(h) the types of protected animals to be held and/or used in regulated activities at the establishment.

4.—(1) All protected animals must at all times be provided with adequate care and accommodation appropriate to their type or species.

(2) Any restrictions on the extent to which such an animal can satisfy its physiological and ethological needs shall be kept to the absolute minimum.

(3) Unless otherwise authorised by the Secretary of State an environment, housing, freedom of movement, food and water appropriate for the health and well-being of each protected animal shall be provided.

(4) The licence holder shall ensure that the installations and equipment at the establishment are suitable for the species of protected animals kept at the establishment and for the regulated procedures, if any, carried out at the establishment. The design, construction and method of functioning of the installations and equipment must be such as to enable regulated procedures to be performed in a manner that provides reliable results, uses the minimum number of animals and causes the minimum degree of pain, suffering, distress and lasting harm to the animals used.

(5) 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 defect discovered and any avoidable pain, suffering, distress or lasting harm discovered is eliminated as quickly as possible.

(6) The holder shall ensure that the conditions under which any protected animal is transported are appropriate for the animal’s health and well-being.

(7) Unless otherwise authorised by the Secretary of State the licence holder shall ensure that at least the following standards are met—

(a) any applicable standard concerning the care and accommodation of animals or installations and equipment, which is set out in Annex 3 of the Animals Directive;

(b) any additional or higher standard concerning the care and accommodation of animals which is set out in any code of practice issued or approved under section 21 that was in force on 9 November 2010.

(8) For the purposes of subparagraph (7)(a) a standard set out in Annex 3 of the Animals Directive is not to be treated as being an “applicable standard” if the Annex specifies a date from which the standard is to have effect and that date has not been reached.

5.  The licence holder shall ensure that the establishment shall be appropriately staffed at all times to ensure the well-being of the protected animals. Staff shall be adequately educated and trained before they perform any function relating to the care of the protected animals and shall be supervised when performing any such function until they have demonstrated the requisite competence.

6.—(1) The licence holder is required to have established, and to maintain, an Animal Welfare and Ethical Review Body.

(2) The Animal Welfare and Ethical Review Body must consist at least of—

(a) the named animal welfare officer and named veterinary surgeon,

(b) if this licence authorises the application of regulated procedures to protected animals at the establishment, the holder of a project licence which specifies the establishment as a place where regulated procedures may be carried out, or another person with suitable scientific credentials acceptable to the Secretary of State, and

(c) such other persons as may be specified in guidance issued by the Secretary of State.

(3) The Animal Welfare and Ethical Review Body must carry out the tasks mentioned in Article 27.1 of the Animals Directive and any other advisory and reviewing tasks specified in this licence or in guidance issued by the Secretary of State.

(4) The licence holder shall ensure that whenever the Animal Welfare and Ethical Review Body provides advice a record is made of the advice and of any decisions taken in response to the advice. Such records shall be kept for a minimum period of three years and shall, on request, be submitted to the Secretary of State or made available to an Inspector.

7.  If this licence authorises the breeding of protected animals, the holder is not authorised to breed, at the establishment, non-human primates from any animal not bred in captivity unless the holder has in place a strategy acceptable to the Secretary of State for increasing the proportion of primates bred from animals bred in captivity. Any substantial changes to the strategy that are proposed shall be submitted to the Secretary of State for approval.

8.—(1) Records shall be maintained, in a format acceptable to the Secretary of State, of the source, use and final disposal of all protected animals bred, kept or used at the establishment for any regulated activities.

(2) Such records shall include at least the following information—

(a) the number and the species of animals bred, acquired, supplied, used in procedures, or discharged from the control of the Act;

(b) the origin of the animals, including whether they are bred for use in procedures;

(c) the dates on which the animals are acquired, supplied, or discharged from the control of the Act;

(d) from whom the animals are acquired;

(e) the name and address of the recipient of animals;

(f) the number and species of animals which died or were killed in each establishment. For animals that have died, the cause of death shall, when known, be noted; and

(g) where this licence authorises the applying of regulated procedures to protected animals, the projects in which animals are used.

(3) Such records shall be kept for a minimum of five years from the date of final disposal of the animal and, on request, be submitted to the Secretary of State or made available to an Inspector.

(4) The licence 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 final disposal of all protected animals bred, kept, or used at the establishment for any regulated activities.

9.—(1) For the purposes of this condition, an “individual history file” is a file kept in relation to a dog, cat or non-human primate which contains particulars of the animal’s identity; particulars of the animal’s date and place of birth (if known); a statement as to whether the animal was bred for use in regulated procedures; any relevant reproductive, veterinary and social information about the animal; a record of the programmes of work, if any, which have involved the use of the animal in regulated procedures; and in the case of a primate, a statement as to whether the animal is the offspring of primates bred in captivity.

(2) The licence holder shall ensure that for each dog, cat and non-human primate held at the establishment an individual history file is established and kept up to date. In the case of such an animal bred at the establishment the individual history file shall be established as soon as is reasonably practicable after the animal’s birth. Where such an animal is transferred to the establishment an individual history file shall be established in relation to the animal as soon as is reasonably practicable after its transfer (unless the animal is transferred from a place specified in another section 2C licence and an individual history file previously established in relation to the animal is provided in accordance with conditions included in that other licence).

(3) The licence holder shall ensure that if a dog, cat or non-human primate kept at the establishment is transferred to a place specified in another section 2C licence, the individual history file kept in relation to the animal is provided to the holder of that other licence.

(4) The licence holder shall ensure that if a dog, cat or non-human primate kept at the establishment is transferred otherwise than to a place specified in another section 2C licence, the person to whom the animal is transferred is provided with a copy of any veterinary and social information about the animal that is included in the animal’s individual history file.

(5) The licence holder shall ensure that if a dog, cat or non-human primate kept at the establishment dies at that place, is set free from that place or is transferred otherwise than to a place specified in another section 2C licence, the individual history file for the animal is kept for a period of three years following its death, setting free or transfer.

(6) A copy of any individual history file required to be kept by this condition shall, on request, be submitted to the Secretary of State or made available to an Inspector.

10.—(1) The licence holder shall ensure that before any unmarked dog, cat or non-human primate is weaned at the place specified in the licence the animal is marked. The licence holder shall ensure that before any unmarked dog, cat or non-human primate that has not been weaned is transferred from the establishment to a place specified in another section 2C licence, the animal is marked unless it would not be reasonably practicable to do so. Where an unmarked dog, cat or non-human primate that has not been weaned is transferred to the establishment, the establishment shall maintain records attesting the identity and origin of the animal’s mother until the animal is marked.

(2) The holder shall ensure that any unmarked cat, dog or non-human primate which is taken into the establishment after weaning shall be marked as soon as possible.

(3) The holder shall ensure that where a dog, cat or primate at the establishment is marked it is done in the least painful manner possible.

(4) The holder shall comply with any request made by the Secretary of State for an explanation of why any dog, cat or primate at the establishment has not been marked.

(5) For the purpose of this condition, “marked” means provided with a permanent means of individual identification and “unmarked” refers to an animal that has not been provided with a permanent individual identification mark.

11.—(1) Inspectors shall be provided with access at all reasonable times to all parts of the establishment which are concerned with the use, holding, breeding or care of protected animals.

(2) The licence holder must give any necessary assistance to inspectors carrying out visits by virtue of section 18(2A)(b); and to experts of the European Commission carrying out duties under Article 35 of the Animals Directive.

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

13.  Unless otherwise authorised by the Secretary of State—

(a) only the types of protected animals specified in the licence may be kept in the place or places specified in the licence for the purpose of the regulated activities specified in the licence; and

(b) for the purpose of the regulated activities specified in the licence, these animals may only be kept, bred and used in the areas listed in the schedule to the licence.

14.  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 bred, kept or used at the establishment for any regulated activities. Records shall, on request, be submitted to the Secretary of State or made available to an Inspector.

15.  The licence holder shall nominate and be responsible for the performance of named persons, acceptable to the Secretary of State, as required by section 2C(5) .

16.  Arrangements to ensure that animals are given adequate care must be made in the event that the named persons referred to in condition 15 above are not available for any reason.

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

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

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

20.  If this licence authorises the applying of regulated procedures to protected animals, the holder shall take all reasonable steps to prevent the performance of unauthorised procedures in the establishment.

21.  The licence holder shall 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 at the establishment.

22.  Where this licence authorises the applying of regulated procedures to protected animals, the licence 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 section 2C licence holder will, during that period, assume responsibility for ensuring compliance with the terms and conditions of the project licence.

23.—(1) This condition applies where this licence authorises the applying of regulated procedures to protected animals.

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

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

(b) the Secretary of State consents under section 17A to the animal no longer being kept at the establishment; or

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

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

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