The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012
| Jurisdiction | UK Non-devolved |
| Citation | SI 2012/3039 |
| Year | 2012 |
2012 No. 3039
Animals
The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012
Made 18th December 2012
Coming into force in accordance with regulation 1(2) to (4)
The Secretary of State is designated1for the purposes of section 2(2) of the European Communities Act 19722in relation to the protection of animals used for experimental and other scientific purposes.
The Secretary of State makes the following Regulations under the powers conferred by that section, as read with paragraph 1A of Schedule 2 to the 1972 Act.
These Regulations make provision for a purpose mentioned in that section and it appears to the Secretary of State that it is expedient for the references to an Annex to Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes to be construed as a reference to the Annex as amended from time to time.
In accordance with paragraph 2(2) of Schedule 2 to the 1972 Act a draft of these Regulations was laid before Parliament and approved by a resolution of each House of Parliament.
Citation and commencement
1.—(1) These Regulations may be cited as the Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012.
(2) These Regulations come into force on 1 January 2013, subject to sub-paragraphs (3) and (4).
(3) The following provisions come into force for the purposes specified on the day after the day on which these Regulations are made—
(a)
(a) regulation 14, for the purposes of the Secretary of State granting consents under section 14(6) of the Animals (Scientific Procedures) Act 1986;
(b)
(b) regulation 18, for the purposes of the Secretary of State granting consents under section 17A of that Act;
(c)
(c) paragraphs 5, 7, 12, 14, 16, 25, and 27 of Schedule 3 (and regulation 42 so far as relating to those paragraphs), for the purposes of the Secretary of State granting authorisations under those paragraphs.
(4) Paragraphs (a) and (d) of regulation 26(9) come into force on 1 January 2015.
Amendment of the Animals (Scientific Procedures) Act 1986
2. The Animals (Scientific Procedures) Act 19863is amended as follows.
Protected animals
3. In section 14(definition of “protected animal”)—
(a) in subsection (1) at the end insert “and any living cephalopod”;
(b) in subsection (2)(a) for “half” substitute “two-thirds of”;
(c) after subsection (2) insert—
“2A Any living cephalopod in its embryonic form is not a protected animal.”;
(d) in subsection (3)(a) for “invertebrates of any description” substitute “any description of invertebrates other than cephalopods”.
Regulated procedures
4.—(1) Section 25(definition of “regulated procedure”) is amended as follows.
(2) In subsection (1) for the words from “experimental” to the end substitute “procedure applied to a protected animal for a qualifying purpose which may have the effect of causing the animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice.”
(3) After subsection (1) insert—
“1A A procedure is applied to an animal for “a qualifying purpose” if—
(a) it is applied for an experimental or other scientific purpose (whether or not the outcome of the procedure is known); or
(b) it is applied for an educational purpose.”
(4) In subsection (2)—
(a)
(a) for the words from the beginning to “animal” (in the first place it occurs) substitute “A procedure applied to an animal for a qualifying purpose”;
(b)
(b) in paragraph (a) omit “such”;
(c)
(c) after paragraph (a) insert—
“(ab)
“(ab) each of the other procedures in the series or combination is applied for a qualifying purpose; and”.
(5) After subsection (2) insert—
“2A A procedure applied to an animal for a qualifying purpose is also a regulated procedure if—
(a) at the time the procedure is applied the animal has not attained the stage of its development when it is a protected animal;
(b) the animal is to be allowed to live until after it attains that stage of its development; and
(c) the procedure is likely to have the effect mentioned in subsection (1) after the animal attains that stage (whether or not it is also likely to have that effect before the animal attains that stage).”
(6) After subsection (3) insert—
“3A The modification of an animal’s genes is a regulated procedure if—
(a) the animal is a protected animal and the modification may have the effect mentioned in subsection (1); or
(b) the animal is to be allowed to live until after it attains the stage of its development when it is a protected animal and the modification may have the effect mentioned in subsection (1) after it has attained that stage (whether or not it is also likely to have that effect before the animal attains that stage).
3B The breeding of an animal is a regulated procedure if—
(a) the animal is bred from an animal whose genes have mutated or been modified or from a descendant of an animal whose genes have mutated or been modified;
(b) the animal is to be allowed to live until after it has attained the stage of its development when it is a protected animal; and
(c) after the animal has attained that stage the animal may experience pain, suffering, distress or lasting harm of a level mentioned in subsection (1) by reason of the mutation or modification referred to in paragraph (a).
3C For the purposes of subsections (3A) and (3B), references to the modification of an animal’s genes include the modification before the animal comes into being of any genetic material by virtue of which it comes into being”.
(7) Omit subsections (5) and (6).
(8) For subsections (7) and (8) substitute—
“7 Killing a protected animal is a regulated procedure only if—
(a) it is killed for experimental or other scientific use;
(b) the place where it is killed is—
(i) a place that is specified in a licence granted under section 2C, or
(ii) a place that is specified in a project licence by virtue of section 5(3), and
(c) the method employed to kill the animal is not—
(i) a method that is appropriate to that description of animal under Schedule 1, or
(ii) in a case within paragraph (b)(i), a method that is specified as being appropriate to that description of animal in the licence granted under section 2C.
8 Notwithstanding anything in this section, the following are not regulated procedures—
(a) non-experimental agricultural practices;
(b) non-experimental clinical veterinary practices;
(c) practices undertaken for the purposes of recognised animal husbandry;
(d) the administration of any substance or article to an animal for research purposes in accordance with an animal test certificate granted under the Veterinary Medicines Regulations 20116;
(e) the ringing, tagging or marking of an animal, or the application of any other humane procedure for the primary purpose of enabling an animal to be identified, provided that it causes only momentary pain or distress (or none at all) and no lasting harm.
8A References in this section to “a procedure” include both invasive and non-invasive procedures.”
Principles of replacement, reduction and refinement
5. After section 2 insert—
“Principles of replacement, reduction and refinement
2A.—(1) The Secretary of State must exercise his or her functions under this Act with a view to ensuring compliance with the principles of replacement, reduction and refinement.
(2) For the purposes of this Act—
(a)
(a) the principle of replacement is the principle that, wherever possible, a scientifically satisfactory method or testing strategy not entailing the use of protected animals must be used instead of a regulated procedure;
(b)
(b) the principle of reduction is the principle that whenever a programme of work involving the use of protected animals is carried out the number of protected animals used must be reduced to a minimum without compromising the objectives of the programme;
(c)
(c) the principle of refinement is the principle that the breeding, accommodation and care of protected animals and the methods used in regulated procedures applied to such animals must be refined so as to eliminate or reduce to the minimum any possible pain, suffering, distress or lasting harm to those animals.”
Licensing of undertakings
6. After section 2A insert—
“Licensing of undertakings(2B) Prohibition of unlicensed undertakings(1) A person must not, whether for profit or otherwise, carry on at any place an undertaking which involves one or more of the activities mentioned in subsection (2) unless the person is authorised to do so by a licence under section 2C.(2) The activities are—(a) the applying of regulated procedures to protected animals;(b) the breeding of relevant protected animals with a view to—(i) their use in regulated procedures, or(ii) the use of their tissues or organs for scientific purposes,or the breeding of protected animals (other than relevant protected animals) primarily for purposes within sub-paragraph (i) or (ii);(c) the keeping of relevant protected animals which have been bred elsewhere and are to be supplied with a view to —(i) their use elsewhere in regulated procedures, or(ii) the use elsewhere of their tissues or organs for scientific purposes.(3) In this section “relevant protected animal” means a protected animal of a description specified in Schedule 2 to this Act.(2C) Licensing of undertakings(1) A licence under this section is a licence granted by the Secretary of State which...
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