Part 3Teaching and research involving animals

Part 3—Teaching and research involving animals 11—Certain research prohibited except for limited purposes (1) A person must not— (a) apply any substance to the conjunctival sac of a rabbit for the purpose of assessing the relative irritancy of the substance; or (b) expose an animal to any substance for the purpose of assessing the toxicity of the substance against a predetermined level of mortality, unless— (c) the assessment relates to research that has the potential to benefit human or animal health; and (d) the objectives of the assessment cannot practicably be achieved by means that will cause less pain to animals. (2) In proceedings for an offence against subregulation (1), the onus of proving the matters specified in paragraphs (c) and (d) lies on the defendant. 11A—Exemption from section 16 of Act A person is exempt from the operation of section 16(1) of the Act in respect of an activity undertaken— (a) for, or on behalf of, a person who holds a licence under Part 4 of the Act; or (b) under the supervision of a person who holds a licence under Part 4 of the Act or an employee of such a person. 12—Application for licence For the purposes of section 17(2)(b) of the Act, the following information is prescribed in relation to an application for a licence: (a) the name, address and contact details of the applicant; (b) a statement of the purpose or purposes for which the licence is sought; (c) the address of the premises proposed to be used for activities authorised by the licence; (d) details of the type of premises and facilities proposed for the care and handling of the animals used or available to be used under the licence; (e) the proposed arrangements for the provision of veterinary attention to the animals used or available to be used under the licence; (f) in relation to the animal ethics committee proposed to be used under the licence— (i) a statement of whether the committee is— (A) an animal ethics committee established in accordance with section 23 of the Act (whether already established or yet to be established); or (B) a body approved by the Minister as an ethics committee under section 23A of the Act (whether already approved or yet to be approved); and (ii) either— (A) if the animal ethics committee proposed to be used under the licence has, at the time of making the application, already been established in accordance with section 23 of the Act or approved under section 23A of the Act— • the name of the committee; and • the address at which the committee is generally to conduct its meetings; and • the contact details for the Secretary of the committee; or (B) if the animal ethics committee proposed to be used under the licence is a body that is, at the time of making the application, yet to be approved by the Minister under section 23A of the Act as an animal ethics committee— • the name of the body; and • the address at which the body is generally to conduct its meetings; and • the contact details for the Secretary of the body; and • the name of each member of the body; and • the relevant experience and qualifications of each member of the body; and • the terms of reference of the body; and • a copy of the most recent annual report of the body; and • a copy of the most recent external review of the body; and • such other information relating to the body as may be required by the Minister in connection with the application. 12A—Grant of licence For the purposes of section 18(1)(d) of the Act, in determining whether a licence should be granted to a person, the Minister must have regard to whether the animal ethics committee proposed to be used under the licence is prepared to undertake the functions of animal ethics committee under the conditions of the licence. 13—Annual reports by animal ethics committees (1) For the purposes of section 25(1)(e) of the Act, an animal ethics committee established under section 23 of the Act must, within 3 months after the end of each calendar year, provide a report in relation to that year (the relevant calendar year) prepared in accordance with this regulation to— (a) the chief executive; and (b) the licensee who established the animal ethics committee. (1a) For the purposes of section 25(1)(e) of the Act, a body approved by the Minister as an animal ethics committee under section 23A of the Act must provide to the chief executive, within 3 months after the end of each calendar year, the most recent annual report prepared by the committee for the purposes of the Code for the governing body of the institution or institutions for which it acts. (2) A report referred to in subregulation (1) must include the following details in relation to the relevant calendar year: (a) a statement of the number of meetings held by the committee; (b) for each meeting— (i) the name of each member who attended the meeting; and (ii) a summary of the business discussed at the meeting; (c) the number and nature of the projects or activities of licensees that were— (i) assessed by the committee; and (ii) approved by the committee; (d) a summary of any relevant education and training undertaken by— (i) persons involved in the care or use of the animals under the licences; and (ii) members of the committee; (e) details of— (i) adverse incidents or problems (other than trivial incidents or problems) relating to the premises and facilities for the care and handling of animals by the licensees; and (ii) improvements or changes made, or recommended by the committee to be made, to those premises and facilities as a result of those incidents or problems; (f) details of— (i) administrative difficulties experienced by the committee; and (ii) any other problems or factors that have or may have adversely affected— (A) the proper and efficient functioning of the committee; or (B) the ability of the licensees to comply with the Code; and (iii) improvements or changes made, or recommended by the committee to be made, to address the matters referred to in the preceding subparagraphs. (3) A report referred to in subregulation (1) may include any other information in relation to the relevant calendar year that the committee considers appropriate. (4) In this regulation— chief executive means the chief executive of the administrative unit that is responsible for assisting a Minister in the administration of the Act.