The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012

• (a) references to a certificate issued by the Secretary of State under section 7(1) were to a section 2C licence authorising the holder to carry on an undertaking involving the activity mentioned in section 2B(2)(b),

• (b) references to a designated breeding establishment were to a place specified in such a licence,

• (c) references to a certificate issued by the Secretary of State under section 7(2) were to a section 2C licence authorising the holder to carry on an undertaking involving the activity mentioned in section 2B(2)(c), and

• (d) references to a designated supplying establishment were to a place specified in such a licence.

Personal licences

19

• (1) This paragraph applies in relation to a personal licence granted under section 4 which is in force immediately before these Regulations come fully into force.

• (2) The licence is to be treated as including the conditions in Part 3 of this Schedule (the “deemed conditions”).

• (3) The existing conditions of the licence which correspond to the conditions set out in Appendix E of the Home Office guidance (standard conditions for personal licences) cease to have effect.

• (4) If any of the deemed conditions is inconsistent with an existing condition which does not cease to have effect under sub-paragraph (3), the deemed condition prevails.

• (5) For the purposes of this paragraph the existing conditions of the licence are the conditions contained in the licence by virtue of section 10 immediately before these Regulations come fully into force.

• (6) The Act applies to the deemed conditions as it applies to conditions included in a licence by virtue of section 10.

Project licences

20

Paragraphs 21 to 28 apply in relation to a project licence granted under section 5 which is in force immediately before these Regulations come fully into force.

21

Except as provided by this Part of this Schedule, the amendments made by regulation 9 do not apply in relation to the licence.

22

Section 5E(2) to (4) (termination of licence on death of licence holder) applies to the licence as it applies to a licence granted after these Regulations come fully into force.

23

• (1) Where the licence classifies the severity of a regulated procedure specified in the licence as “unclassified”, it is to be treated as classifying the severity of that procedure as “non-recovery”.

• (2) Where the licence classifies the severity of a regulated procedure specified in the licence as “substantial”, it is to be treated as classifying the severity of that procedure as “severe”.

24

• (1) The licence is to be treated as including the conditions set out in Part 4 of this Schedule (the “deemed conditions”).

• (2) The following existing conditions of the licence cease to have effect—

• (a) the conditions which correspond to the conditions set out in Appendix D of the Home Office guidance (standard conditions for project licences), and

• (b) any additional conditions which authorise an exception from, or otherwise relate to, one of those conditions (subject to paragraph 29(4)).

• (3) If any of the deemed conditions is inconsistent with an existing condition which does not cease to have effect under sub-paragraph (2), the deemed condition prevails.

• (4) For the purposes of this paragraph the existing conditions of the licence are the conditions contained in the licence by virtue of section 10 immediately before these Regulations come fully into force.

• (5) The Act applies to the deemed conditions as it applies to conditions included in a licence by virtue of section 10.

25

• (1) This paragraph applies to condition 13 in Part 4 of this Schedule (restrictions on use of certain descriptions of animal).

• (2) Nothing contained in the licence immediately before these Regulations come fully into force is to be treated as authorising an exception from the condition.

• (3) The Secretary of State may under this paragraph authorise an exception from the condition if he or she is satisfied of the matters specified in paragraph 25(2) or (3) of Schedule 2C to the Act (whichever is relevant).

• (4) The Act applies to an authorisation under this paragraph as if the authorisation were included in the licence.

• (5) This paragraph is without prejudice to the Secretary of State’s power to authorise an exception from the condition by variation of the licence after these Regulations come fully into force.

26

• (1) The following requirements apply in relation to the licence (despite anything to the contrary in the licence).

• (2) The licence holder must meet the requirements in section 5C(2)(a) to (c).

• (3) The programme of work specified in the licence may only be carried out for one of the purposes specified in section 5C(3)(a) to (g).

• (4) Regulated procedures must not be applied to any of the following unless authorised by the Secretary of State under paragraph 27—

• (a) endangered primates,

• (b) non-endangered primates,

• (c) endangered animals other than primates.

• (5) Regulated procedures must not be applied to great apes.

• (6) Section 15A applies as if in subsection (3)(b), at the end there were inserted “and there is a scientific justification that the purposes of the programme of work specified in the licence cannot be achieved if a method of killing appropriate to that description of animal under Schedule 1 is used.”

• (7) A neuromuscular blocking agent must not be used unless authorised by the Secretary of State under paragraph 27.

• (8) The Act applies to the requirements imposed by this paragraph as if they were provisions of the Act.

27

• (1) The Secretary of State may authorise the application of regulated procedures to endangered primates only if he or she has verified that the following conditions are met—

• (a) Condition 1 or 2 of Schedule 2B to the Act, and

• (b) Condition 3 of that Schedule.

• (2) The Secretary of State may authorise the application of regulated procedures to non-endangered primates only if he or she has verified that the following conditions are met—

• (a) Condition 4 or 5 of Schedule 2B to the Act, and

• (b) Condition 6 of that Schedule.

• (3) The Secretary of State may authorise the application of regulated procedures to endangered animals other than primates only if he or she has verified that the following conditions are met—

• (a) Condition 7 of Schedule 2B to the Act, and

• (b) Condition 8 of that Schedule.

• (4) The Secretary of State may authorise the use of a neuromuscular blocking agent only if he or she is satisfied of the matters specified in section 17(2).

• (5) The Act applies to an authorisation under this paragraph as if the authorisation were included in the licence.

28

• (1) This paragraph applies if the Secretary of State is considering—

• (a) a variation of the licence, or

• (b) if the licence was granted for a period of less than 5 years, its renewal.

• (2) The following provisions apply in relation to the licence as proposed to be varied or renewed as they apply in relation to a project licence granted after these Regulations come fully into force—

• (a) section 5C (restrictions on grant of project licence);

• (b) section 15A(7) (methods of killing not specified in Schedule 1 to the Act);

• (c) section 17(2) (neuromuscular blocking agents).

• (3) Accordingly, on the variation or renewal of the licence paragraph 26 ceases to apply in relation to it.

Re-use of protected animals

29

• (1) This paragraph applies to any consent given by the Secretary of State under section 14 which has effect immediately before these Regulations come fully into force.

• (2) The consent continues to have effect after these Regulations come fully into force, subject to sub-paragraph (3).

• (3) In a case to which section 14(6) applies, the consent does not continue to have effect after these Regulations come fully into force unless it was given under section 14(6) by virtue of regulation 1(3)(a).

• (4) Where a consent to which this paragraph applies takes the form of an existing additional condition of a project licence (within the meaning of paragraph 24), paragraph 24(2)(b) does not apply in relation to that condition.

30

In the application of section 14(4) to a project licence granted before these Regulations come fully into force, paragraph (b) applies as if for “was classified by the Secretary of State under section 5B(3)(c)” there were substituted “is classified in the project licence”.

Setting free and re-homing protected animals

31

In section 17A(1)(a), the reference to the Secretary of State’s consent does not include a consent given before these Regulations come fully into force, unless it was given under section 17A by virtue of regulation 1(3)(b).

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.

PART 3 — Conditions in personal licences

1

In exercising his or her responsibilities, the licence holder shall act at all times in a manner that is consistent with the principles of replacement, reduction and refinement.

2

The licence holder is entrusted with primary responsibility for the welfare of the animals on which he or she has performed regulated procedures; the licence holder must ensure that animals are properly monitored and cared for.

3

The licence holder must not apply a regulated procedure to an animal if the procedure may cause the animal severe pain, suffering or distress that is likely to be long-lasting and cannot be ameliorated.

4

The licence holder must not apply a regulated procedure to an animal unless the holder has taken precautions to prevent or reduce to the minimum consistent with the purposes of the procedure any pain, suffering, distress or discomfort that may be caused to the animal.

5

Where the licence holder is applying a regulated procedure to an animal the holder must ensure that any unnecessary pain, suffering, distress or lasting harm that is being caused to the animal is stopped.

6

Where the licence holder is applying or has applied a regulated procedure which is causing the animal severe pain, suffering or distress the holder must take steps to ameliorate that pain, suffering or distress.

7

The licence holder shall ensure that where the holder applies a regulated procedure death as the end-point of the procedure is avoided as far as possible and is replaced by an early and humane end-point.

8

In all circumstances where an animal which is being, or has been, subjected to a regulated procedure is in severe pain, suffering or distress which is likely to be long-lasting and cannot be ameliorated, the licence holder must ensure that the animal is immediately killed in accordance with section 15A.

9

The licence holder may apply a regulated procedure without the use of general or local anaesthesia only if the holder is satisfied that—

• (a) the procedure will not inflict serious injuries capable of causing severe pain; and

• (b) the use of general or local anaesthesia would be more traumatic to the animal than the procedure itself or would frustrate the purposes of the procedure.

10

When anaesthesia (whether general or local) is used, it shall be of sufficient depth to prevent the animal from being aware of pain arising during the procedure.

11

If the licence holder applies a regulated procedure to an animal with the use of general or local anaesthesia the holder must, unless it would frustrate the purpose of the procedure, use such analgesics or other pain-relieving methods as may be necessary to reduce any pain that the animal may experience once the anaesthesia wears off.

12

The licence holder must use analgesia or another appropriate method to ensure that the pain, suffering and distress caused by regulated procedures are kept to a minimum.

13

It is the responsibility of the personal licence holder to notify the project licence holder as soon as possible when it appears either that the severity limit of any procedure listed in the project licence or that the constraints upon adverse effects described in the project licence have been or are likely to be exceeded.

14

The licence holder shall ensure that suitable arrangements exist for the care and welfare of animals during any period when the personal licence holder is not in attendance.

15

The licence holder shall ensure that, whenever necessary, veterinary advice and treatment are obtained for the animals in his or her care.

16

The licence holder shall ensure that all cages, pens or other enclosures are clearly labelled. The labelling must be such as to enable Inspectors, named veterinary surgeons and named animal care and welfare officers to identify the number of the project licence authorising the procedures, the project licence protocol in which the animals are being used, the date the protocol was started, and the responsible personal licence holder.

17

In order to ensure that regulated procedures are performed competently, the licence holder shall not apply regulated procedures unless given the appropriate level of supervision by the project licence holder or an experienced personal licence holder deputed by him/her for such time as may be needed to achieve competence.

18

The licence holder is authorised to delegate to assistants, who do not themselves possess the requisite personal licence authority but are under his or her control, the delegable tasks which form an integral part of the regulated procedures the licence holder is authorised to perform by this licence. The tasks must not require technical knowledge or skill, and delegation shall be in accordance with any relevant guidance published by the Secretary of State under section 21.

19

The licence holder must take all reasonable steps to ensure appropriate personal and project licence authorities exist before performing regulated procedures. The licence holder must be aware of the nature of the authorities given by this licence and the project licence, and of the conditions of issue attached to the licences.

20

The licence holder shall maintain a record of all animals on which procedures have been carried out, including details of supervision and declarations of competence by the project licence holder as appropriate. This record shall be retained for at least five years and shall, on request, be submitted to the Secretary of State or made available to an Inspector.

21

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.

22

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

PART 4 — Conditions in project licences

1

The licence holder is responsible for the overall implementation of the programme of work specified in this licence and for ensuring that the programme of work is carried out in compliance with the conditions of the licence.

2

The licence holder shall ensure that the specified programme of work does not involve the application of any regulated procedure to which there is a scientifically satisfactory alternative method or testing strategy not entailing the use of a protected animal.

3

The licence holder shall ensure that regulated procedures are not applied to an animal as part of the specified programme of work if the data to be obtained from the application of those procedures is already available in a Member State and has been obtained there by procedures which satisfy any relevant regulatory requirements of the EU.

4

The licence holder shall ensure that the regulated procedures applied as part of the programme of work specified in this licence are those which to the greatest extent use the minimum number of animals; involve animals with the lowest capacity to experience pain, suffering, distress or lasting harm; cause the least pain, suffering, distress or lasting harm; and are most likely to provide satisfactory results.

5

The licence holder shall ensure that the regulated procedures applied as part of the programme of work specified in this licence are designed so as to result in the death of as few protected animals as possible; and to reduce to the minimum possible the duration and intensity of suffering caused to those animals that die and, as far as possible, ensure a painless death.

6

The licence holder shall ensure that the appropriate level of supervision is provided for all personal licensees carrying out regulated procedures under the authority of this licence.

7

The licence holder shall ensure that a regulated procedure is not applied to an animal as part of the programme of work specified in this licence if the procedure may cause the animal severe pain, suffering or distress that is likely to be long-lasting and cannot be ameliorated.

8

The licence holder shall ensure that where a regulated procedure is being applied to an animal as part of the programme of work specified in this licence, any unnecessary pain, suffering, distress or lasting harm that is being caused to the animal shall be stopped.

9

The licence holder shall ensure that where a regulated procedure is applied to an animal as part of the specified programme of work, death as the end point of the procedure is avoided as far as possible and is replaced by an early and humane end point; and as soon as the purpose of the procedure has been achieved, the procedure is stopped and appropriate action is taken to minimise the suffering of the animal.

10

The licence holder shall ensure that where a regulated procedure has been applied to an animal as part of the programme of work specified in this licence, a suitably qualified person classifies the severity of the procedure as “non-recovery”, “mild”, “moderate” or “severe” using the criteria in Annex 8 of the Animals Directive. For the purposes of this condition, a series of regulated procedures applied to an animal for a particular purpose is to be treated as constituting a single regulated procedure.

11

Where a series of regulated procedures are applied to an animal for a particular purpose the licence holder shall ensure that the animal is killed at the end of the series unless a veterinary surgeon or other competent person has determined that the animal is not suffering and is not likely to suffer adverse effects, as a result of the regulated procedures.

12

Regulated procedures shall not be carried out on any stray animal of a domestic species as part of the programme of work specified in this licence.

13

Except with the authorisation of the Secretary of State, regulated procedures shall not be carried out as part of the programme of work specified in this licence on any of the following type of animal—

• (a) any feral animal of a domestic species;

• (b) any animal taken from the wild;

• (c) a marmoset unless it is the offspring of marmosets bred in captivity or has been obtained from a self-sustaining colony of marmosets;

• (d) any animal of a description specified in Schedule 2 to the Act unless it has been bred for use in procedures.

14

If the application of regulated procedures to animals taken from the wild is authorised in this licence the holder shall ensure—

• (a) that animals taken from the wild are captured by a competent person using a method which does not cause the animal avoidable pain, suffering, distress or lasting harm; and

• (b) that an animal taken from the wild which is found to be injured or in poor health is not subjected to a regulated procedure unless and until it has been examined by a veterinary surgeon or other competent person; and, unless the Secretary of State has agreed otherwise, action has been taken to minimise the suffering of the animal.

15

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.

16

If the licence holder becomes aware of a failure to comply with any conditions of the licence the holder must take appropriate steps to rectify the failure (if it is capable of being rectified); and keep a record of the steps taken.

17

All authorised procedures shall be carried out under general or local anaesthesia unless—

• (a) anaesthesia would be more traumatic to the animal concerned than the procedures themselves; or

• (b) anaesthesia would be incompatible with the purposes of the procedures.

18

The licence holder shall ensure adherence to the severity limits as specified in the project licence and observance of any other controls described in the licence. If these constraints appear to have been, or are likely to be, breached, the holder shall ensure that the Secretary of State is notified as soon as possible.

19

The licence holder shall maintain a contemporaneous record of all animals on which procedures have been carried out under the authority of the project licence. This record shall show the procedures used and the names of personal licensees who have carried out the procedures. The record shall, on request, be submitted to the Secretary of State or made available to an Inspector.

20

The licence holder shall send to the Secretary of State, before 31 January each year (and within 28 days of the licence having expired or been revoked), a report in a form specified by the Secretary of State, giving details of the number of procedures and animals used, and the nature and purpose of the procedures performed under the authority of the project licence during the calendar year.

21

The licence holder shall maintain a list of publications resulting from the licensed programme of work and a copy of any such publication shall be made available to the Secretary of State on request. The list shall, on request, be submitted to the Secretary of State or made available to an Inspector, and it shall be submitted to the Secretary of State when the licence is returned to him on expiry or for revocation.

22

The project licence holder shall submit such other reports as the Secretary of State may from time to time require.

23

The project licence holder shall ensure that details of the programme of work and regulated procedures specified in the licence, and any additional conditions imposed on those procedures, are known to—

• (a) all personal licensees performing those procedures;

• (b) the named person responsible for compliance;

• (c) the named animal care and welfare officers responsible for the day to day care of the animals;

• (d) the named veterinary surgeon, on request; and

• (e) the named information officer and named training and competency officer, on request.

24

The licence holder must obtain the permission of the Secretary of State before—

• (a) any animal undergoing regulated procedures is moved from a place specified in one section 2C licence to a place specified in another section 2C licence; or

• (b) any animal is released for slaughter,

25

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

Signed

Taylor of Holbeach — Parliamentary Under Secretary of State — 18th December 2012

Explanatory note

(This note is not part of the Regulations)

EXPLANATORY NOTE

These regulations amend the Animals (Scientific Procedures) Act 1986 (“the Act”) to transpose EC Directive 2010/63/EU on the protection of animals used for scientific purposes (“the Directive”). The Directive replaces Directive 86/609/EEC which is repealed.

Regulation 3 lengthens the period of gestation that must have elapsed before an animal in a foetal, larval or embryonic form becomes a “protected animal” for the purposes of the Act. Regulation 3 also extends protection to cephalopods.

Regulation 4 amends the definition of a ‘regulated procedure’ in section 2 of the Act so as to include, amongst other things, the modification of an animal’s genes in particular circumstances.

Regulation 5 inserts a new section 2A requiring the Secretary of State to exercise his or her functions with a view to ensuring compliance with the principles of replacement, reduction and refinement. Regulation 5 also inserts definitions of these terms.

Regulations 6, 7 and 8 change the licensing system; the certificates of designation of premises for breeding, supplying and scientific research are now amalgamated into one licence; project and personal licences remain part of the licensing system but there are minor amendments to personal licences to remove the current requirement for the place where regulated procedures are performed to be specified in the personal licence. This will enable personal licence holders to carry out regulated procedures at any place specified in the project licence that authorises the procedures and will obviate the need to amend the personal licence before working at additional places; in addition the holder of a personal licence will be authorised to apply categories of techniques rather than specified individual techniques.

Regulation 9 replaces section 5 of the Act and amongst other things provides that project licences may specify multiple generic projects as set out in article 40.4 of the Directive. There is also a requirement for the applicant for a project licence to provide the Secretary of State with a non-technical summary of the proposed project which will be published if the application is successful. Regulation 9 also provides timescales for acknowledging applications and making decisions whether to grant a project licence. In addition some programmes of work will now be subject to a retrospective assessment regarding whether the severity level of the procedures have been correctly assessed.

Regulation 10 replaces section 10 of the Act relating to the conditions to be included in licences granted under the Act. Regulation 10 also inserts a new Schedule 2C into the Act which sets out certain conditions that must be included in licences granted under the Act. Schedule 2C is divided into three parts: Part 1 sets out the requirements for the conditions to be applied to section 2C licences: Part 2 sets out the requirements for the conditions to be applied to personal licences; Part 3 sets out the requirements for the conditions to be applied to project licences.

Regulations 11, 12 and 13 deal with failure to comply with licence conditions and the right of the licence holder to appeal, regulation 11 inserts a new section 11 which allows Secretary of State to issue a compliance notice and variation, suspension or revocation of a licence.

Regulation 14 replaces section 14 of the Act; the new section provides that an animal that has already been subjected to one or more procedures must not be re-used unless the Secretary of State consents to the re-use and certain conditions are met.

Regulation 15 inserts new section 15A which sets out detailed requirements relating to the killing of animals, protected animals as defined in the Directive have to be killed using a particular method unless the Secretary of State has authorised another method or the animal has been caught in the wild and is killed for its organs or tissues.

Regulation 17 replaces section 17 of the Act to prohibit the use of a neuromuscular blocking agent in the course of a regulated procedure unless (a) the person is expressly authorised to do so by the personal licence and the project licence under which the procedure is carried out; and (b) the agent is used in combination with such level of anaesthesia or analgesia as is determined in accordance with the project licence. It also stipulates that the Secretary of State must not grant a project licence that authorises the use of a neuromuscular blocking agent unless he or she is satisfied, on the basis of a scientific justification, that the purposes of the programme of work specified in the licence cannot be achieved without the use of such an agent.

Regulation 18 inserts a new section 17A prohibiting the setting free or re-homing of protected animals without the consent of the Secretary of State and setting out the conditions which must be met before such consent is given.

Regulation 19 amends section 18 of the Act relating to the duties and functions of inspectors. In relation to visits of inspection the regulation introduces a requirement on the Secretary of State to determine an appropriate risk-based inspection programme to be followed by the Inspectorate.

Regulation 20 replaces sections 19 and 20 of the Act dealing with the Animal Procedures Committee which is to be replaced with a new committee to be known as the Committee for the Protection of Animals Used for Scientific Purposes.

Regulation 21 inserts new section 20A providing that the Secretary of State should take such steps as he or she considers appropriate to facilitate the establishment of programmes for the sharing of the organs and tissues of animals killed for use for scientific purposes.

Regulation 22 inserts new section 20B which requires the Secretary of State to support the development of alternative strategies (i.e. scientific methods and testing strategies which do not use protected animals, or which, compared to existing scientific methods and testing strategies, use fewer protected animals or reduce the pain, suffering, distress or lasting harm caused to protected animals).

Regulation 23 inserts new section 21A which deals with the publication of annual statistics in which there is now a requirement to report on the actual severity of the regulated procedures; the origin and the species of any primates used in regulated procedures; and on methods of killing specified which are used but which are not specified in Annex IV to the Directive. (Annex IV methods are set out in Schedule 1 to the Act.).

Section 21A also requires the Secretary of State to send information on the implementation of the Directive to the European Commission by 10 November 2018 and every five years thereafter.

Regulations 24 and 25 provide penalties and deal with powers of entry under the Act.

Regulations 26 to 41 make minor and consequential amendments to the Act and other legislation; schedule 2 to the Act is amended to include frogs (Rana and Xenopus species) and zebra fish in the list of animals that will be “relevant protected animals” for the purposes of new section 2B. Regulation 42 introduces Schedule 3 to the regulations which sets out transitional provisions.

The regulations insert a new schedule 2B into the Act This Schedule provides for additional conditions which must be met before the Secretary of State grants certain project licences. These relate to conditions which must be satisfied before authorisation can be given for the use of endangered and non-endangered primates, the use of endangered animals that are not primates and the use of cats, dogs and equidae.

Footnotes

[^f00001]: S.I. 1993/595.

[^f00002]: 1972 c. 68.

[^f00003]: 1986 c. 14.

[^f00004]: Section 4 was amended by S.I. 1993/2103.

[^f00005]: Section 2(6) was substituted by S.I. 2006/2407.

[^f00006]: S.I. 2011/2159.

[^f00007]: Section 4 was amended by S.I. 1998/1974.

[^f00008]: Section 10 was amended by S.I. 1998/1974 and S.I. 1993/2102.

[^f00009]: Section 14 was substituted by S.I. 1998/1974.

[^f00010]: Schedule 1 was amended by S.I. 1996/3278, S.I. 1997/226.

[^f00011]: Section 332 of 2003 c.44, and section 2006 c. 45.

[^f00012]: 2003 c. 44.

[^f00013]: Section 26 was amended by the Animal Welfare Act 2006, section 64, Schedule 3, paragraph 12(2).

[^f00014]: Section 5(4) of the Dangerous Wild animals Act 1976 was amended the Animals (Scientific Procedures) Act 1986.

[^f00015]: Section 29 was amended by 2006 c. 45 and 2011 c. 16.

[^f00016]: Schedule 1 was amended by S.I. 1996/3278 and S.I. 1997/226.

[^f00017]: Schedule 2 was amended by S.I. 1993/2103 and S.I. 1998/1674.

[^f00018]: Schedule 2A was inserted by S.I. 1998/1974.

[^f00019]: Section 5(4) was amended by section 27(2) of 1986 c. 14.

[^f00020]: 1976 c.38.

[^f00021]: 2005 c. 15.

[^f00022]: 2006 c. 45.

[^f00023]: S.I. 1986/1911.

[^f00024]: Was substituted by Schedule 4 paragraph 6(a) to 2011 c. 16.

[^f00025]: S.I. 1993/2103.

[^f00026]: S.I. 1996//3090.

[^f00027]: S.I. 1998/1974.

[^f00028]: S.I. 2004/1993 (N.I.16).

[^f00030]: S.S.I. 2006/336.

[^f00031]: S.I. 2006/2702.

[^f00032]: S.I. 2006/2927.

[^f00033]: S.R. 2007/68.

[^f00034]: 2011 c. 16 (N.I.).

[^f00035]: OJL 61, 3.3.1997, P.1.