Part 1 Preliminary
1 Name of Regulation
This Regulation is the Animal Research Regulation 2021.
2 Commencement
This Regulation commences on 1 September 2021 and is required to be published on the NSW legislation website.Note—This Regulation replaces the Animal Research Regulation 2010 which is repealed on 1 September 2021 by the Subordinate Legislation Act 1989, section 10(2).
3 Definitions
(1) In this Regulation—approved means approved for the time being by the Secretary.ethics committee means an animal care and ethics committee.prescribed offence means—(a) an offence under—(i) the Act, or(ii) the Exhibited Animals Protection Act 1986, or(iii) the National Parks and Wildlife Act 1974, or(iv) the Prevention of Cruelty to Animals Act 1979, or(v) the regulations in force under an Act referred to in subparagraph (i)–(iv), or(b) an offence under the Biosecurity Act 2015, or the regulations under that Act, relating to a dealing with a non-indigenous animal within the meaning of that Act, or(c) an offence committed in New South Wales for which the penalty or maximum penalty is imprisonment for 2 years or more, or(d) an offence committed outside of New South Wales that, if committed in New South Wales, would have been an offence referred to in paragraph (a) or (b).school means a government school or non-government school.school-based establishment means a corporation that carries on, or proposes to carry on, the business of animal research solely to allow animal research to be carried out at a school.the Act means the Animal Research Act 1985.the Australian Code means the document published by the Australian Government entitled Australian code for the care and use of animals for scientific purposes as in force from time to time.Note—The Act and the Interpretation Act 1987 contain definitions and other provisions that affect the interpretation and application of this Regulation.(2) Words and expressions defined in the Australian Code have the same meanings in this Regulation as they have in the Code.
4 Code of Practice—the Act, s 4
The following are prescribed as a Code of Practice—(a) the Australian Code,(b) this Regulation, Schedule 1.
Part 2 Accreditation and licensing
Division 1 Accreditation
5 Prescribed particulars—the Act, s 18(2)(b)
The following are prescribed as the particulars to be included in an application by a corporation for accreditation as a research establishment—(a) if the corporation has directors—the full names of the directors of the corporation,(b) details of all prescribed offences the corporation or a director of the corporation has been convicted of in the 3 years immediately preceding the application and details of the penalty imposed for each offence,(c) particulars of the ethics committee for the corporation, including—(i) the terms of reference, and(ii) the qualifications of committee members, and(iii) meetings of the committee, and(iv) decisions of the committee, and(v) procedures of the committee, and(vi) inspections made by the committee,(d) a list of the suppliers of animals to the corporation,(e) a description of —(i) the areas where animals will be housed or used, and(ii) the facilities and accommodation provided or intended to be provided for each species of animal, and(iii) the number of animals held at the time of the application and the annual turnover of each species,(f) if the corporation is the Department of Education, The Association of Independent Schools of New South Wales Limited, Catholic Schools NSW Limited or a school-based establishment—(i) the name and address of the school or schools at which animal research is carried out, and(ii) other particulars that may be required by the approved form,(g) if the corporation is not a corporation referred to in paragraph (f)—(i) the number of holders or proposed holders of animal research authorities supervised by the ethics committee for the corporation, and(ii) the number of staff involved in the care of animals for research and the training programs provided or intended to be provided for the staff, and(iii) particulars of the animal care, husbandry and research procedures adopted by the corporation, and(iv) other particulars that may be required by the approved form.
6 Application fees—the Act, s 18(2)(d)
(1) The prescribed fee to accompany an application for accreditation as a research establishment is to be determined as follows by the number of holders or proposed holders of animal research authorities—(a) if the number is less than 10—$350,(b) if the number is 10 or more but not more than 75—$700,(c) if the number is more than 75—$2,000.(2) For the purposes of the Act, section 62(2)(d), a corporation is exempt from the operation of the Act, section 18(2)(d) and therefore from payment of the prescribed fee, if—(a) the corporation is a corporation referred to in section 5(f), or(b) the corporation is not a corporation referred to in section 5(f), but the accreditation is only for the purpose of allowing animal research to be carried out in schools.
7 Changes in particulars to be notified—the Act, s 62
A corporation that is an accredited research establishment must, within 30 days after each of the following events, give written notice to the Secretary setting out the following details—(a) a change in the directors of the corporation—details of the change,(b) a change in the membership of the corporation’s ethics committee—details of the change,(c) the conviction of the corporation or a director of the corporation for a prescribed offence—details of the offence and of the penalty, if any, imposed.Maximum penalty—10 penalty units.
Division 2 Animal research authorities
8 Prescribed particulars—the Act, ss 25A(2)(b) and 25B(2)(a)
The matters listed in clause 2.7.4 of the Australian Code are prescribed as the particulars to be included in an application for an animal research authority.
9 Application fees—the Act, ss 25A(2)(f) and 25C(2)
(1) For the purposes of the Act, section 25A(2)(f), the prescribed fee is $500.(2) For the purposes of the Act, section 25C(2), the prescribed maximum application fee is $500.
10 Changes in particulars to be notified—the Act, s 62
(1) The holder of an animal research authority who is convicted of a prescribed offence must give written notice setting out details of the offence and the penalty, if any, imposed—(a) to the Secretary if the animal research authority was issued by the Secretary, or(b) if the animal research authority was issued by an accredited research establishment, to the accredited research establishment.(2) The written notice must be given within 30 days of the conviction or imposition of a penalty for the offence, whichever is the later.Maximum penalty—10 penalty units.
11 Keeping of records of applications by independent researchers—the Act, s 25C(3)
For the purposes of the records of applications by independent researchers required to be kept by accredited research establishments under the Act, section 25C—(a) the prescribed period is 7 years after the application is made, and(b) the prescribed particulars are as follows—(i) the applicant’s full name, postal address, email address and contact telephone and facsimile numbers, if any,(ii) the location of all premises used to hold animals for use in the research,(iii) the types of animals held,(iv) the name and identifying number of the research project concerned,(v) the species of animals used by the applicant for research,(vi) the type of research being conducted by the applicant,(vii) whether the research was approved, approved subject to conditions or not approved by the ethics committee of the accredited research establishment.
Division 3 Animal suppliers’ licences
12 Prescribed particulars—the Act, s 37(2)(b)
The following are prescribed as the particulars to be included in an application for an animal supplier’s licence—(a) details of all prescribed offences the applicant or, if the applicant is a corporation, a director of the corporation has been convicted of in the 3 years immediately preceding the application and details of the penalty imposed for each offence,(b) the full name of the manager or proposed manager, if any, of the applicant’s animal supply operations,(c) particulars of the ethics committee for the applicant, including—(i) the terms of reference, and(ii) the qualifications of committee members, and(iii) meetings of the committee, and(iv) decisions of the committee, and(v) procedures of the committee, and(vi) inspections made by the committee,(d) a description of—(i) the areas where animals will be housed or used, and(ii) the facilities and accommodation provided or intended to be provided for each species of animal,(e) the number of staff involved in the care of animals,(f) particulars of the animal care and husbandry procedures adopted by the applicant,(g) data about—(i) the reproduction for each species of animal supplied or intended to be supplied, and(ii) the number of animals held at the time of application, and(iii) the annual turnover of each species,(h) a list of—(i) the persons to whom animals have been supplied by the applicant for use in connection with animal research, and(ii) the sources from which animals have been acquired or are intended to be acquired by the applicant for the purpose of supply,(i) other particulars that may be required by the approved form.
13 Application fees—the Act, s 37(2)(d)
(1) The prescribed fee to accompany an application for an animal supplier’s licence is $300.(2) For the purposes of the Act, section 62(2)(d), a school is exempt from the operation of the Act, section 37(2)(d) and therefore from payment of the prescribed fee, if—(a) the school requests the exemption, and(b) the Secretary is satisfied requiring payment of the fee would be an unreasonable imposition on the school.
14 Changes in particulars to be notified—the Act, s 62
The holder of an animal supplier’s licence must, within 30 days after each of the following events, give written notice to the Secretary setting out the following details—(a) a change in the directors of the holder if the holder is a corporation—details of the change,(b) a change in the membership of an ethics committee appointed for the holder—details of the change,(c) the conviction of the holder or, if the holder is a corporation, a director of the corporation for a prescribed offence—details of the offence and of the penalty, if any, imposed.Maximum penalty—10 penalty units.
Division 4 Exemptions—the Act, s 62(2)(d)
15 Certain schools may carry on animal research without accreditation
(1) A non-government school is exempt from the operation of the Act, section 46(1) if—(a) the school belongs to, or is associated with, a relevant Association accredited under the Act, and(b) all animal research carried out at the school is carried out with the authority of an ethics committee for the relevant Association and in accordance with the Code of Practice.(2) In this section, relevant Association means either of the following—(a) The Association of Independent Schools of New South Wales Limited,(b) Catholic Schools NSW Limited.
16 School students may carry out animal research without authorities
A student at a school is exempt from the operation of the Act, section 47(1) if all the animal research carried out by the student is carried out under the supervision, and in accordance with the directions, of the holder of an animal research authority.
17 Dogs and cats may be supplied to holders of animal supply licences
A person is exempt from the operation of the Act, section 48(1) in relation to the supply to a licensed animal supplier of dogs or cats for use in connection with animal research if the person complies with the requirements of Schedule 1, Part 3.
Part 3 Miscellaneous
18 Definition of “corporation”
For the purposes of the Act, section 3(1), definition of corporation, paragraph (b), the following bodies of persons are prescribed—(a) The Association of Independent Schools of New South Wales Limited,(b) Catholic Schools NSW Limited.
19 Definition of “exempt animal”
For the purposes of the Act, section 3(1), definition of exempt animal, paragraph (a), the animals referred to in Schedule 3 are prescribed, but only in relation to a procedure, test, experiment, inquiry, investigation or study referred to in that Schedule in relation to the animal.
20 Qualifications of certain members of Panel—the Act, s 6(2)(a)–(d)
(1) For the purposes of the Act, section 6(2)(a), the prescribed qualifications for persons nominated by the New South Wales Vice-Chancellors’ Committee are—(a) experience in animal research, and(b) involvement in animal welfare.(2) For the purposes of the Act, section 6(2)(b), the prescribed qualification for persons nominated by Medicines Australia is experience in animal research.(3) For the purposes of the Act, section 6(2)(c), the prescribed qualifications for persons nominated by the Royal Society for the Prevention of Cruelty to Animals, New South Wales are—(a) membership of the Society as at the date of nomination, and(b) involvement in animal welfare.(4) For the purposes of the Act, section 6(2)(d), the prescribed qualifications for persons nominated by the Animal Societies’ Federation (NSW) are—(a) membership of a member group of the Federation as at the date of nomination, and(b) involvement in animal welfare.
21 Animal care and ethics committees and subcommittees—the Act, ss 13(4) and 15(2)
(1) The following ethics committees must have at least 4 members—(a) an ethics committee for an accredited research establishment,(b) an ethics committee for a licensed animal supplier,(c) an ethics committee appointed by the Secretary for the purpose of supervising the animal research carried out by holders of animal research authorities.(2) In addition to the requirements of subsection (1)—(a) the membership of each ethics committee must comply with the requirements of clauses 2.2.2–2.2.8 of the Australian Code, and(b) if an ethics committee has more than 4 members—at least one third of the members must fall within membership Category C or Category D as set out in clause 2.2.4 of the Australian Code.(3) Schedule 2 contains provisions relating to the constitution and procedure of the ethics committees referred to in subsection (1).(4) An animal care and ethics subcommittee must include at least one member of the ethics committee that recommended its appointment.(5) The procedures to be followed by an animal care and ethics subcommittee are the same as the procedures to be followed by the ethics committee that recommended its appointment.
22 Form of inspector’s certificate of identification—the Act, s 49(5)
The following form is prescribed as the certificate of identification for an inspector—I CERTIFY THAT [insert name of inspector], whose signature and photograph appear below, is an inspector under the Animal Research Act 1985.
Secretary
Signature of inspector
23 Records of approved lethality tests—the Act, s 56A(1)
For the purposes of the Act, section 56A(1)—(a) the prescribed period is 7 years after the record is made, and(b) the prescribed particulars for each lethality test are as follows—(i) the species of animal concerned,(ii) the number of animals concerned,(iii) the type of procedure,(iv) the justification for the approval of the lethality test,(v) alternatives or modifications being developed, if any, to replace the need to carry out the lethality test.
24 Reporting requirements—the Act, s 62
(1) This section applies to the following persons—(a) accredited research establishments, other than school-based establishments,(b) holders of animal research authorities.(2) A person to whom this section applies must, by 31 March in each year, send a report in the approved form to the Secretary on the person’s work and activities during the period of 12 months ending on 31 December in the previous year.Maximum penalty—10 penalty units.(3) If the ethics committee of an accredited research establishment supervises the carrying out of animal research by an independent researcher, the report must include information relating to the independent researcher’s work and activities.(4) If a domestic dog or a domestic cat is used in connection with animal research, the report must set out whether—(a) the animal has been kept for that use, or(b) the animal has been dealt with in some other way, including whether it has been euthanased or rehomed.
25 Waiver and refund of—the Act, s 62
The Secretary may waive or refund all or part of a fee payable under the Act or this Regulation in the circumstances the Secretary considers appropriate.
26 Savings
An act, matter or thing that, immediately before the repeal of the Animal Research Regulation 2010, had effect under that Regulation continues to have effect under this Regulation.
27 Repeal
This Regulation is repealed on 1 September 2023.
Schedule 1 Supplementary provisions of Code of Practice
section 4
Part 1 Additional conditions to be observed in relation to animal research conducted in schools
1 Application of Part
This Part applies to an ethics committee for a school.
2 Functions of ethics committees
(1) The ethics committee has the function of preparing, in consultation with the Panel, a list of approved procedures that links each procedure with an appropriate educational objective.(2) The ethics committee must not consider a research proposal unless it includes the following information—(a) the matters listed in clause 2.7.4 of the Australian Code,(b) the name of the animal welfare liaison officer.(3) The ethics committee must ensure a list of its approved procedures is sent to each school under its supervision.
3 Animal welfare liaison officer
(1) Each school must have an animal welfare liaison officer.(2) The animal welfare liaison officer for a primary school is the Principal for the school.(3) The animal welfare liaison officer for a secondary school is the person appointed by the Principal for the school.
4 Responsibilities of animal welfare liaison officers
The duties of the animal welfare liaison officer are as follows—(a) to submit proposals for teaching procedures involving the use of animals for the approval of the ethics committee,(b) to liaise with the ethics committee on all matters concerning teaching procedures involving the use of animals,(c) to ensure all teaching procedures at the school involving the use of animals comply with the requirements of this Part,(d) to ensure appropriate records are kept of all animal research carried out at the school,(e) to promote awareness of the requirements of this Part within the school.
5 Responsibilities of class teachers
A class teacher who uses animals for the purposes of teaching must ensure all activities involving animals that are included on the relevant list of approved procedures are to be entered in a school register, together with the teacher’s name.
Part 2 Conditions to be observed by licensed animal suppliers in relation to dogs and cats generally
6 Application of Part
This Part applies to dogs and cats only.
7 Animals to be held by supplier for at least 5 days
No animal may be supplied for animal research until it has been held for at least 5 working days by the licensed animal supplier.
8 Veterinary examination
(1) Each animal must be examined by a competent person within 24 hours of arrival at the premises of the licensed animal supplier and, until it is supplied for animal research, at least daily after the initial examination.(2) Immediate veterinary attention must be sought for an animal showing one or more of the following signs—(a) nasal discharge,(b) ocular discharge,(c) coughing,(d) vomiting,(e) diarrhoea,(f) convulsions,(g) lameness,(h) inability to stand or walk,(i) bleeding.(3) To ensure no animal that is injured, sick or unsuitable is supplied for animal research, each animal must be given the following within 3 days of arrival—(a) a comprehensive clinical examination by a veterinary practitioner,(b) vaccinations or treatment considered necessary by the veterinary practitioner, including the humane killing of the animal.
9 Keeping of records
(1) A licensed animal supplier must ensure records in the approved form are kept for each animal acquired by the supplier.(2) The records must include a document containing the particulars set out in section 12(2) in relation to the animal.(3) The records for the animal must also include the following—(a) the results of examinations of the animal,(b) details of vaccinations or treatment given to the animal,(c) if the animal dies, the date on which it died and the cause of its death.(4) The records for the animal—(a) must be created within 24 hours of the animal being received by the supplier, and(b) must be readily accessible to all of the supplier’s staff who have responsibilities in relation to the animal.(5) The records for an animal must accompany the animal when it is supplied for animal research.
10 Release of animals
(1) A licensed animal supplier—(a) must release an animal to its owner on receiving adequate proof of ownership, and(b) may release an animal to another person.(2) If an animal is released, the licensed animal supplier must enter the following particulars on the records for the animal—(a) the date on which the animal was released,(b) the full name of the person who authorised the animal’s release,(c) the full name and address of the person to whom the animal was released.
Part 3 Conditions to be observed in relation to supply of dogs and cats to licensed animal suppliers
11 Application of Part
This Part applies to dogs and cats only.
12 Animals supplied by persons generally
(1) A person may supply to a licensed animal supplier, and a licensed animal supplier may accept from a person, an animal for use in connection with animal research only if the requirement in subsection (2) is satisfied.(2) The animal must be accompanied by a document containing the following particulars—(a) the species, breed or type, sex, approximate estimated age, and colour of the animal,(b) details of identification on the animal at the time of supply,(c) proof of identification of the person supplying the animal, including the person’s full name and address,(d) a declaration signed and dated by the person supplying the animal, which states—I am the owner/authorised agent of the owner of the animal described above, and I give my approval to it being supplied alive for use in research conducted in accordance with the Animal Research Act 1985 which governs the conditions under which animal research may be conducted.(3) Despite subsection (1)—(a) an impounding authority must not supply an animal for use in connection with animal research to a licensed animal supplier, and(b) a licensed animal supplier must not accept an animal for use in connection with animal research supplied by an impounding authority.(4) Subsection (3) also applies to supply effected indirectly through an agent or intermediary.(5) In this section—means—(a) an impounding authority within the meaning of the Impounding Act 1993, or(b) a pound operator within the meaning of the Companion Animals Act 1998.
Part 4 Miscellaneous
13 Delegation of functions of ethics committees
An ethics committee may delegate its functions to a subcommittee other than the following functions relating to research proposals—(a) considering the proposal,(b) approving or refusing to approve the proposal,(c) revoking a previous approval of a proposal.
Schedule 2 Constitution and procedure of ethics committees
section 21(3)
Part 1 Provisions relating to constitution of ethics committees
1 Chairperson of ethics committee
(1) One member of the ethics committee must be appointed, by the person or body that appointed the committee, as Chairperson of the ethics committee.(2) The member who is the Chairperson is taken to have vacated office as Chairperson if the member—(a) resigns the office by written notice addressed to the ethics committee, or(b) ceases to be a member of the ethics committee.
2 Term of office
Subject to this Schedule, a member of the ethics committee holds office for the term specified in the member’s instrument of appointment.
3 Filling of vacancy in office of member
If the office of a member of the ethics committee becomes vacant, a person may, subject to this Regulation, be appointed to fill the vacancy.
4 Vacancy in office of member
The office of a member of the ethics committee becomes vacant if the member—(a) dies, or(b) is absent from 4 consecutive meetings of the ethics committee of which reasonable notice has been given to the member, except—(i) if the member was on leave granted by the ethics committee, or(ii) if, within 4 weeks after the last meeting from which the member is absent, the member is excused by the ethics committee for being absent from the meetings, or(c) becomes a mentally incapacitated person, or(d) is convicted—(i) in New South Wales—of an offence punishable by imprisonment for 12 months or more, or(ii) elsewhere than in New South Wales—of an offence that, if committed in New South Wales, would be an offence punishable by imprisonment for 12 months or more, or(e) resigns the office by written notice addressed to the ethics committee, or(f) completes a term of office and is not reappointed.
Part 2 Provisions relating to procedure of ethics committees
5 General procedure
The procedure for the calling of meetings of the ethics committee and for the conduct of business at the meetings is to be determined by the ethics committee.
6 Quorum
(1) The quorum for a meeting of the ethics committee is one representative from each member category, subject to additional requirements determined by the ethics committee under section 5.(2) In this section—member category means a category of member referred to in clause 2.2.4 of the Australian Code.
7 Presiding member
(1) The Chairperson is to preside at meetings of the ethics committee.(2) If the Chairperson is absent, the members of the ethics committee present may elect another member of the ethics committee to act as Chairperson for the meeting.
8 Decision making
A decision made in accordance with clause 2.3.11 of the Australian Code at a meeting of the ethics committee at which a quorum is present is a decision of the ethics committee.
9 Minutes and other records
(1) The ethics committee must cause full and accurate minutes to be kept of the proceedings of each meeting of the ethics committee.(2) The ethics committee must also record in its minutes the reasons for all decisions it makes concerning research proposals.(3) The ethics committee must keep each of its minutes and other records for a minimum of 7 years after the minute or record is made.
10 Periodic reports
An ethics committee must give a written report of its work and activities to the person or body by which it was appointed at the intervals, not exceeding 12 months, directed by the person or body.
11 Authentication of documents
A document requiring authentication by the ethics committee is sufficiently authenticated if it is signed by—(a) the Chairperson, or(b) another member of the ethics committee who is authorised to do so by the Chairperson.
12 First meeting of ethics committee
The person or body that appoints the members of an ethics committee may call the first meeting of the ethics committee in the way the person or body thinks fit.
Schedule 3 Animals exempt from requirements relating to supply
section 19
1 Definitions
In this Schedule—means the holder of an animal research authority.relevant ethics committee means—(a) for an animal research authority issued by the Secretary—the ethics committee that supervises the animal research carried out by the authorised researcher, or(b) for an animal research authority issued by an accredited research establishment—the ethics committee of the establishment.
2 Unowned animals
Animals that are not owned by a person are exempt animals for the purposes of a procedure, test, experiment, inquiry, investigation or study to be carried out by an authorised researcher if the relevant ethics committee is satisfied—(a) the procedure, test, experiment, inquiry, investigation or study—(i) is innocuous and non-invasive, and(ii) will not have foreseeable lasting adverse consequences for the animal, and(b) appropriate arrangements exist for long-term welfare of the animal after the procedure, test, experiment, inquiry, investigation or study has been completed.
3 Privately-owned animals
Privately-owned animals are exempt animals for the purposes of a procedure, test, experiment, inquiry, investigation or study to be carried out by an authorised researcher if the relevant ethics committee is satisfied—(a) the procedure, test, experiment, inquiry, investigation or study—(i) is innocuous and non-invasive, and(ii) will not have foreseeable lasting adverse consequences for the animal, and(b) the animal will remain under the effective control of its owner while the procedure, test, experiment, inquiry, investigation or study is being carried out.
4 Animals supplied by Commonwealth or interstate organisations
Animals of a kind that are obtained from a Commonwealth or interstate organisation are exempt animals for the purposes of a procedure, test, experiment, inquiry, investigation or study to be carried out by an authorised researcher if the organisation is approved by the Panel in connection with the supply of animals of that kind.
5 Animals bred for purpose
(1) Animals bred by an authorised researcher are exempt animals for the purposes of a procedure, test, experiment, inquiry, investigation or study to be carried out by an authorised researcher if—(a) the use of the animals for those purposes is approved by the relevant ethics committee, and(b) the animals are kept in a way approved by the ethics committee, and(c) the ethics committee is satisfied—(i) the researcher intends to breed a strain or type of animal that is not otherwise available for a specific research project, and(ii) if the animals are supplied directly to another authorised researcher—no person, including the authorised researcher who bred the animals, is to receive a financial benefit.(2) Animals bred within an accredited research establishment or by an independent researcher are exempt animals for the purposes of a procedure, test, experiment, inquiry, investigation or study to be carried out by an authorised researcher if—(a) the use of the animals for those purposes is approved by the relevant ethics committee, and(b) the animals are kept in a way approved by the ethics committee, and(c) the ethics committee is satisfied—(i) the animals are being supplied for use only in the establishment, or by the researcher, as the case may be, and(ii) the breeding and management of the animals is part of a protocol approved by the committee.(3) In this section—independent researcher has the same meaning as in the Act, section 25C(5).
6 Deer
Commercially farmed deer are exempt animals for the purposes of a procedure, test, experiment, inquiry, investigation or study to be carried out by an authorised researcher.
7 Fish
Commercially hatched fish are exempt animals for the purposes of a procedure, test, experiment, inquiry, investigation or study to be carried out by an authorised researcher.
8 Animals in schools
All animals used in schools are exempt animals for the purposes of a procedure, test, experiment, inquiry, investigation or study of a kind described as Category 1, Category 2 or Category 3 activities in the document entitled SACEC approved activities and their respective categories, as in force from time to time, published by the Department of Education.
9 Animals with certain medical or genetic conditions
(1) An animal is an exempt animal for the purposes of a procedure, test, experiment, inquiry, investigation or study to be carried out by an authorised researcher if—(a) the animal has a medical or genetic condition for which it has not specifically been bred, and(b) the animal has been released by its owner for use in a procedure, test, experiment, inquiry, investigation or study related to its condition and the use has been approved by the relevant ethics committee by a declaration in the approved form, and(c) the relevant ethics committee is satisfied the animal would be detrimentally affected by spending a period of time in a supply unit.(2) In this section—supply unit means premises used by a licensed animal supplier for the receipt, holding and despatch of animals for use in animal research.