Part 1 Preliminary
1 Name of Regulation
This Regulation is the Animal Research Regulation 2010.
2 Commencement
This Regulation commences on 1 September 2010 and is required to be published on the NSW legislation website.Note—This Regulation replaces the Animal Research Regulation 2005 which is repealed on 1 September 2010 by section 10 (2) of the Subordinate Legislation Act 1989.
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 the Act, the Exhibited Animals Protection Act 1986, the National Parks and Wildlife Act 1974, the Non-Indigenous Animals Act 1987 (an Act repealed by the Biosecurity Act 2015) or the Prevention of Cruelty to Animals Act 1979 (or under the regulations in force under any of those Acts), or(a1) an offence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(b) an offence committed in New South Wales for which the penalty (or maximum penalty) is imprisonment for 2 years or more, or(c) 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 within the meaning of the Education Act 1990.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.(2) Words and expressions that are defined in the Australian Code have the same meanings in this Regulation as they have in that Code.(3) Notes included in this Regulation do not form part of this Regulation.cl 3: Am 2014 (788), Sch 1 [1]; 2015 No 24, Sch 8.3 [1] [2].
4 Code of Practice
For the purposes of section 4 of the Act, the Australian Code and Schedule 1 to this Regulation are prescribed as a Code of Practice.
Part 2 Accreditation and licensing
Division 1 Accreditation
5 Prescribed particulars
For the purposes of section 18 (2) (b) of the Act, the particulars to be included in an application by a corporation for accreditation as a research establishment are as follows:(a) the full names of the directors of the corporation,(b) details of any prescribed offence that the corporation or any director of the corporation has been convicted of in the 3 years immediately preceding the application and details of any penalty imposed for the offence,(c) particulars of the ethics committee for the corporation, including the qualifications of its members and terms of reference, meetings, decisions and procedures of, and inspections made by, the committee,(d) a list of the suppliers of animals to the corporation,(e) a description of the areas where animals will be housed or used, the facilities and accommodation provided or intended to be provided for each species of animal, 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 and Training, 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) any 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 any training programs provided or intended to be provided for such staff, and(iii) particulars of the animal care, husbandry and research procedures adopted by the corporation, and(iv) any other particulars that may be required by the approved form.cl 5: Am 2018 (748), cl 3 (2).
6 Application fees
(1) For the purposes of section 18 (2) (d) of the Act, 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—$2000.(2) A corporation is exempt from the operation of section 18 (2) (d) of the Act, and therefore from payment of the prescribed fee, if:(a) the corporation is a corporation referred to in clause 5 (f), or(b) the corporation is not a corporation referred to in clause 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
A corporation that is an accredited research establishment must within 30 days after any 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 any penalty imposed.Maximum penalty: 10 penalty units.
Division 2 Animal research authorities
8 Prescribed particulars
For the purposes of sections 25A (2) (b) and 25B (2) (a) of the Act, the particulars to be included in an application for an animal research authority are the matters listed in section 2.7.4 of the Australian Code.cl 8: Am 2014 (788), Sch 1 [2].
9 Application fees
(1) For the purposes of sections 25A (2) (f) of the Act, the prescribed fee is $500.(2) For the purposes of section 25C (2) of the Act, the prescribed maximum fee is $500.
10 Changes in particulars to be notified
The holder of an animal research authority who is convicted of a prescribed offence must, within 30 days of the conviction or imposition of a penalty for the offence (whichever is the later) give written notice setting out details of the offence and of any penalty 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.Maximum penalty: 10 penalty units.
11 Keeping of records of research by independent researchers
For the purposes of section 25C (3) of the Act:(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 and contact telephone and facsimile numbers (if any),(ii) the location of any premises used for the holding of 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
For the purposes of section 37 (2) (b) of the Act, the following particulars are to be included in an application for an animal supplier’s licence:(a) details of any prescribed offence that the applicant (or, in the case of an applicant that is a corporation, any director of the corporation) has been convicted of in the 3 years immediately preceding the application and details of any penalty imposed for the offence,(b) the full name of any manager or proposed manager of the applicant’s animal supply operations,(c) particulars of the ethics committee for the applicant, including the qualifications of its members and terms of reference, meetings, decisions and procedures of, and inspections made by, the committee,(d) a description of the areas where animals for supply are or will be housed and 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 reproduction for each species of animal supplied or intended to be supplied, the number of animals held at the time of application and the annual turnover of each species,(h) a list of the persons to whom animals have been supplied by the applicant for use in connection with animal research and sources from which animals have been acquired or are intended to be acquired by the applicant for the purpose of supply,(i) any other particulars that may be required by the approved form.
13 Application fees
(1) For the purposes of section 37 (2) (d) of the Act, the prescribed fee to accompany an application for an animal supplier’s licence is $300.(2) A school is exempt from the operation of section 37 (2) (d) of the Act, and therefore from payment of the prescribed fee, if:(a) the school requests the exemption, and(b) the Secretary is satisfied that requiring payment of the fee would be an unreasonable imposition on the school.
14 Changes in particulars to be notified
The holder of an animal supplier’s licence must, within 30 days after any 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, the conviction of a director of the corporation) for a prescribed offence—details of the offence and of any penalty imposed.Maximum penalty: 10 penalty units.
Division 4 Exemptions
15 Certain schools may carry on animal research without accreditation
(1) A non-government school is exempt from the operation of section 46 (1) of the Act with respect to the carrying on of the business of animal research:(a) if the school belongs to, or is associated with, a relevant Association that is accredited under the Act, and(b) so long as any 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 clause, relevant Association means any of the following:(a) the Association of Independent Schools of New South Wales Limited,(b) Catholic Schools NSW Limited.cll 15: Am 2018 (748), cl 3 (2).
16 School students may carry out animal research without authorities
A student at a school is exempt from the operation of section 47 (1) of the Act with respect to the carrying out of animal research, so long as the animal research 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 section 48 (1) of the Act with respect to the supply to a licensed animal supplier of dogs or cats for use in connection with animal research, so long as the person complies with the requirements of Part 3 of Schedule 1.
Part 3 Miscellaneous
18 Definition of “corporation”
For the purposes of paragraph (b) of the definition of corporation in section 3 (1) of the Act, the following bodies of persons are prescribed:(a) the Association of Independent Schools of New South Wales Limited,(b) Catholic Schools NSW Limited.cll 18: Am 2018 (748), cl 3 (2).
19 Definition of “exempt animal”
For the purposes of paragraph (a) of the definition of exempt animal in section 3 (1) of the Act, 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 such an animal.
20 Qualifications of certain members of Panel
(1) For the purposes of section 6 (2) (a) of the Act, the prescribed qualifications for persons nominated by the New South Wales Vice-Chancellors’ Committee are experience in animal research and involvement in animal welfare.Note—The New South Wales Vice-Chancellors’ Committee was formerly known as the New South Wales Vice-Chancellors’ Conference.(2) For the purposes of section 6 (2) (b) of the Act, the prescribed qualification for persons nominated by Medicines Australia is experience in animal research.Note—Medicines Australia was formerly known as the Australian Pharmaceutical Manufacturers’ Association.(3) For the purposes of section 6 (2) (c) of the Act, the prescribed qualifications for persons nominated by the Royal Society for the Prevention of Cruelty to Animals, New South Wales are membership of the Society as at the date of nomination and involvement in animal welfare.(4) For the purposes of section 6 (2) (d) of the Act, the prescribed qualifications for persons nominated by the Animal Societies’ Federation (NSW) are membership of a member group of the Federation as at the date of nomination and involvement in animal welfare.
21 Animal care and ethics committees and subcommittees
(1) For the purposes of section 13 (4) of the Act, 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 subclause (1):(a) the membership of each ethics committee must comply with the requirements of sections 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 those members must fall within membership Category C or Category D as set out in section 2.2.4 of the Australian Code.(3) Schedule 2 contains provisions relating to the constitution and procedure of each such ethics committee.(4) For the purposes of section 15 (2) of the Act, 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 those to be followed by the ethics committee that recommended its appointment.cl 21: Am 2014 (788), Sch 1 [3].
22 Form of inspector’s certificate of identification
For the purposes of section 49 (5) of the Act, the following form is prescribed: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 approvals of lethality tests
For the purposes of section 56A (1) of the Act:(a) the prescribed period is 7 years after the record is made, and(b) the prescribed particulars in relation to each lethality test that is approved 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,(v) any alternatives or modifications being developed to replace the need to carry out the lethality test.
24 Reporting requirements
(1) This clause 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 clause 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) In the case of an accredited research establishment whose ethics committee 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) In the case of a domestic dog or a domestic cat used in connection with animal research, the report must include information as to whether the animal has been retained for that use or whether it has been dealt with in some other way (including, for example, whether it has been euthanased or rehomed).cl 24: Am 2018 (748), cl 3 (3) (4).
25 Waiver and refund of fees
The Secretary may waive or refund all or part of any fee payable under the Act or this Regulation in any circumstances the Secretary considers appropriate.
26 Savings
Any act, matter or thing that, immediately before the repeal of the Animal Research Regulation 2005, had effect under that Regulation continues to have effect under this Regulation.
Schedule 1 Supplementary provisions of Code of Practice
(Clause 4)
Part 1 Additional conditions to be observed in relation to animal research conducted in schools
1 Functions of ethics committees
(1) An ethics committee for a school 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) A proposal is not to be considered by the ethics committee unless it includes the following information:(a) the matters listed in section 2.7.4 of the Australian Code,(b) the name of the animal welfare liaison officer.(3) An ethics committee must ensure that a list of its approved procedures is sent to each school under its supervision.
2 Animal welfare liaison officer
(1) For each school there is to be an animal welfare liaison officer.(2) The animal welfare liaison officer for a primary school is to be the Principal for the school.(3) The animal welfare liaison officer for a secondary school is to be the person that the Principal for the school appoints.
3 Responsibilities of animal welfare liaison officers
The duties of the animal welfare liaison officer are as follows:(a) to submit proposals for teaching procedures that involve the use of animals for the approval of the ethics committee for the school,(b) to liaise with the ethics committee for the school on all matters concerning teaching procedures that involve the use of animals,(c) to ensure that all teaching procedures at the school that involve the use of animals comply with the requirements of this Part,(d) to ensure that 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.
4 Responsibilities of class teacher
A class teacher who uses animals in the course of teaching must ensure that any activity involving the animals that is included on the relevant list of approved procedures is 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
5 Application of Part
This Part applies to dogs and cats only.
6 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.
7 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 at least daily after that, until it is supplied for animal research.(2) Immediate veterinary attention must be sought for any animal that shows any 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) Within 3 days of arrival, each animal must be given a comprehensive clinical examination by a veterinary practitioner and any vaccination or treatment, including the humane killing of the animal, considered necessary by a veterinary practitioner, to ensure that no animal that is injured, sick or unsuitable is supplied for animal research.
8 Keeping of records
(1) A licensed animal supplier must ensure that the approved records are kept for each animal acquired by the supplier.(2) Those records are to include a document containing the particulars set out in clause 11 (1) in relation to the animal.(3) The records for an animal:(a) must be prepared within 24 hours of the animal being received by the supplier, and(b) must be readily accessible to such of the supplier’s staff as have responsibilities in relation to the animal.(4) The results of any examination of an animal, details of any vaccination or treatment given to an animal and, if the animal dies, the date on which it died and the cause of its death must be entered on the records for the animal.(5) The records for an animal must accompany the animal when it is supplied for animal research.
9 Release of animals
(1) A licensed animal supplier:(a) must release an animal to its owner on receiving adequate proof of that ownership, and(b) may release an animal to any other person.(2) In the event that 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
10 Application of Part
This Part applies to dogs and cats only.
11 Animals supplied by persons generally
(1) A person may supply to a licensed animal supplier, and a licensed animal supplier may accept from any person, any animal for use in connection with animal research, but only if the animal is accompanied by a document that contains the following particulars:(a) the species, breed or type, sex, approximate estimated age, and colour of the animal,(b) details of any identification on the animal at the time of supply,(c) proof of identification (including full name and address) of the person supplying the animal,(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.(2) Despite subclause (1), an impounding authority may not supply to a licensed animal supplier, and a licensed animal supplier may not accept from an impounding authority, any animal for use in connection with animal research.(3) Subclause (2) applies not only to supply effected directly but also to supply effected indirectly by means of an agent or intermediary.(4) In this clause: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
12 Delegation of functions of ethics committees
An ethics committee may delegate any of 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.
sch 1: Am 2014 (788), Sch 1 [2].
Schedule 2 Constitution and procedure of ethics committees
(Clause 21 (3))
Part 1 Provisions with respect to constitution
1 Chairperson of ethics committee
(1) Of the members of the ethics committee one must be appointed as Chairperson of the ethics committee.(2) A person who is the Chairperson is taken to have vacated office as Chairperson if the person:(a) resigns that office by instrument in writing 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 such term as is specified in his or her instrument of appointment.
3 Filling of vacancy in office of member
If the office of any 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) absents himself or herself from 4 consecutive meetings of the ethics committee of which reasonable notice has been given to the member personally or in the ordinary course of post, except on leave granted by the ethics committee or unless, before the expiration of 4 weeks after the last of those meetings, the member is excused by the ethics committee for being absent from those meetings, or(c) becomes a mentally incapacitated person, or(d) is convicted in New South Wales of an offence that is punishable by imprisonment for 12 months or more or is convicted elsewhere than in New South Wales of an offence that, if committed in New South Wales, would be an offence so punishable, or(e) resigns the office by instrument in writing addressed to the ethics committee, or(f) completes a term of office and is not reappointed.
Part 2 Provisions relating to procedure
5 General procedure
The procedure for the calling of meetings of the ethics committee and for the conduct of business at those meetings is to be as 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 any additional requirements determined by the ethics committee under clause 5.(2) In this clause, member category means a category of member referred to in section 2.2.4 of the Australian Code.
7 Presiding member
The Chairperson (or, in the absence of the Chairperson, another member of the ethics committee elected as Chairperson for the meeting by the members of the ethics committee present) is to preside at a meeting of the ethics committee.
8 Decision making
A decision made in accordance with section 2.3.11 of the Australian Code at a meeting of the ethics committee at which a quorum for a meeting of the ethics committee 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 any decision it makes concerning a research proposal.(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 such intervals (not exceeding 12 months) as the person or body may direct.
11 Authentication of documents
Any document requiring authentication by the ethics committee is sufficiently authenticated if it is signed by the Chairperson or by any member of the ethics committee who is authorised by the Chairperson in that behalf.
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 such manner as the person or body thinks fit.
sch 2: Am 2014 (788), Sch 1 [3] [4].
Schedule 3 Animals exempt from requirements relating to supply
(Clause 19)
1 Definitions
In this Schedule:means the holder of an animal research authority.relevant ethics committee means:(a) in relation to an animal research authority that was issued by the Secretary—the ethics committee that supervises the animal research carried out by the authorised researcher, or(b) in relation to an animal research authority that was issued by an accredited research establishment—the ethics committee of the establishment.
2 Unowned animals
Animals that are not owned by any person are exempt animals for the purposes of any procedure, test, experiment, inquiry, investigation or study to be carried out by an authorised researcher if the relevant ethics committee is satisfied that:(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 any procedure, test, experiment, inquiry, investigation or study to be carried out by an authorised researcher if the relevant ethics committee is satisfied that:(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 any kind that have been obtained from a Commonwealth or interstate organisation are exempt animals for the purposes of any 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 that have been bred by an authorised researcher are exempt animals for the purposes of any procedure, test, experiment, inquiry, investigation or study to be carried out by an authorised researcher so long as:(a) the use of the animals for those purposes is approved by the relevant ethics committee, and(b) the animals are kept in a manner approved by the ethics committee, and(c) the ethics committee is satisfied that:(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 any of the animals are supplied direct to another authorised researcher—no person (including the authorised researcher who bred the animals) is to receive a financial benefit.(2) Animals that have been bred within an accredited research establishment or by an independent researcher (within the meaning of section 25C (5) of the Act) are exempt animals for the purposes of any procedure, test, experiment, inquiry, investigation or study to be carried out by an authorised researcher so long as:(a) the use of the animals for that purpose is approved by the relevant ethics committee, and(b) the animals are kept in a manner approved by the ethics committee, and(c) the ethics committee is satisfied that the animals are being supplied for use in the establishment only, or by the researcher only, as the case may be, and the breeding and management of the animals is part of a protocol approved by the committee.
6 Deer
Commercially farmed deer are exempt animals for the purposes of any 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 any 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 any procedure, test, experiment, inquiry, investigation or study of a kind described as Category 1, Category 2 or Category 3 activities in the document entitled Animals in schools: Animal welfare guidelines for teachers, as in force from time to time, published by the Department of Education and Training.
9 Animals with certain medical or genetic conditions
(1) An animal is an exempt animal for the purposes of any procedure, test, experiment, inquiry, investigation or study to be carried out by an authorised researcher so long as:(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 that has been approved by the relevant ethics committee by means of a declaration in a form approved by the Secretary, and(c) the relevant ethics committee is satisfied that the animal would be detrimentally affected by spending a period of time in a supply unit.(2) In this clause:supply unit means premises used by a licensed animal supplier for the receipt, holding and despatch of animals for use in animal research.