Animal Research Regulation 1995



Part 1 Preliminary
1   Name of Regulation
This Regulation may be cited as the Animal Research Regulation 1995.
2   Commencement
This Regulation commences on 1 September 1995.
3   Definitions
(1)  In this Regulation:
approved means approved for the time being by the Director-General.
Director-General means the Director-General of the Department of Agriculture.
ethics committee means an animal care and ethics committee.
ethics subcommittee means an animal care and ethics subcommittee.
impounding authority 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.
Panel means the Animal Research Review Panel constituted by the Act.
prescribed offence means:
(a)  an offence under the Act, the Exhibited Animals Protection Act 1986, the Prevention of Cruelty to Animals Act 1979, the National Parks and Wildlife Act 1974 or the Non-Indigenous Animals Act 1987 (or under the regulations in force under any of those Acts), 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) of this definition, or
(d)  an offence committed outside of New South Wales that, if committed in New South Wales, would have been an offence for which the penalty (or maximum penalty) is imprisonment for 2 years or more.
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 entitled Australian code of practice for the care and use of animals for scientific purposes, and published by the Australian Government Publishing Service, 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 the Code.
cl 3: Am 9.7.1999; 15.10.1999.
4   Code of Practice
The provisions of:
(a)  the Australian Code, and
(b)  Schedule 1 to this Regulation,
are prescribed as a Code of Practice for the purposes of section 4 of the Act.
Part 2 Animal Research Review Panel
5   Qualifications of certain members of the Panel: sec 6
(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 Conference are:
(a)  experience in animal research, and
(b)  involvement in animal welfare.
(2)  For the purposes of section 6 (2) (b) of the Act, the prescribed qualification for persons nominated by the Australian Pharmaceutical Manufacturers’ Association is experience in animal research.
(3)  For the purposes of section 6 (2) (c) of the Act, the prescribed qualification for persons nominated by the Royal Society for the Prevention of Cruelty to Animals, New South Wales, is membership of the Society as at the date of nomination.
(4)  For the purposes of section 6 (2) (d) of the Act, the prescribed qualification for persons nominated by the Animal Societies’ Federation (NSW) is membership of a member group of the Federation as at the date of nomination.
Part 3 Animal care and ethics committees and subcommittees
6   Constitution and procedure for ethics committees for research establishments (other than school-based establishments) and licensed animal suppliers
(1)  An ethics committee for an accredited research establishment (other than a school-based establishment) or licensed animal supplier must have at least 4 members.
(2)  At least one of the members of the committee must be a person who fulfils the requirements of section 13 (5) of the Act (independence and no involvement with animal research).
(3)  In addition to the requirements of subclauses (1) and (2):
(a)  the membership of an 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 those members must fall within the membership Categories C and D specified in Clause 2.2.2 of the Australian Code.
(4)  Schedule 2 has effect with respect to the constitution and procedure of the committee.
cll 6–8: Am 9.7.1999.
7   Constitution and procedure for ethics committees for school-based establishments
(1)  An ethics committee for a school-based establishment must have at least 4 members.
(2)  At least one of the members of the committee must be a person who fulfils the requirements of section 13 (5) of the Act (independence and no involvement with animal research).
(3)  Each member of the committee must be a person who fulfils the requirements of one or more of the following paragraphs, and between them the members must fulfil all of the requirements of those paragraphs:
(a)  a person actively involved in animal use for teaching,
(b)  a person with identified experience and expertise in the husbandry and management of animal species used for teaching,
(c)  a person with no direct involvement with animal use for teaching,
(d)  a person with approved qualifications in veterinary science or with qualifications and experience to provide comparable expertise,
(e)  a person with a demonstrable commitment to, and established experience in, furthering the welfare of animals, who is not associated in an official capacity with the school or any other accredited research establishment otherwise than in the person’s capacity as a member of such a committee.
(4)  If the committee has more than 6 members, at least 2 of the members must be persons who fulfil the requirements of subclause (3) (e).
(5)  The committee must be of such a composition and size as will ensure that the variety and volume of animal research to be considered by it can be adequately examined.
(6)  Schedule 2 has effect with respect to the constitution and procedure of the committee.
cll 6–8: Am 9.7.1999.
8   Constitution and procedure for ethics committees for holders of animal research authorities
(1)  An ethics committee appointed by the Director-General for the purpose of supervising the animal research carried out by holders of animal research authorities must have at least 4 members.
(2)  At least one of the members of the committee must be a person who fulfils the requirements of section 13 (5) of the Act (independence and no involvement with animal research).
(3)  In addition to the requirements of subclauses (1) and (2), the membership of an ethics committee must comply with the requirements of Clauses 2.2.2–2.2.8 of the Australian Code.
(4)  Schedule 2 has effect with respect to the constitution and procedure of the committee.
cll 6–8: Am 9.7.1999.
9   Constitution and procedure for ethics subcommittees
(1)  A subcommittee of an ethics committee must include at least one member of the ethics committee.
(2)  The procedures to be followed by an ethics subcommittee are the same as those to be followed by the ethics committee by which it is appointed.
10   (Repealed)
cl 10: Rep 9.7.1999.
Part 4 Accreditation and licensing
Division 1 Applications for accreditation: sec 18
11   Prescribed particulars
(1)  For the purposes of section 18 (2) (b) of the Act, the particulars to be included in an application for accreditation as a research establishment are as follows:
(a)  the names of the directors of the corporation,
(b)  if the corporation or any director of the corporation has been convicted, in the 3 years immediately preceding the application, of a prescribed offence—details of the offence and any penalty imposed,
(c)  if the corporation is not a corporation referred to in paragraph (d)—such other particulars as are required by the approved form,
(d)  if the corporation is the Department of Education and Training, the Association of Independent Schools, the Catholic Education Commission (New South Wales) or a school-based establishment—such other particulars as are required by the approved form.
(2)  The particulars referred to in subclause (1) (c) must include all of the following matters (in the case of an initial application) but only such of those matters as have changed since the previous application was made (in the case of a second or subsequent application):
(a)  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,
(b)  a description of the areas where animals for research or supply are or 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 application and the annual turnover of each species,
(c)  the number of holders or proposed holders of animal research authorities supervised by the ethics committee for the corporation,
(d)  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,
(e)  particulars of the animal care, husbandry and research procedures adopted by the corporation,
(f)  a list of the suppliers of animals to the corporation.
(3)  The particulars referred to in subclause (1) (d) must include all of the following matters (in the case of an initial application) but only such of those matters as have changed since the previous application was made (in the case of a second or subsequent application):
(a)  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 and activities undertaken by, the committee,
(b)  the name and address of the school or schools at which animal research is carried out,
(c)  a description of the areas where animals for research are or 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 application and the annual turnover of each species,
(d)  a list of the suppliers of animals to the school or schools.
(4)    (Repealed)
cl 11: Am 9.7.1999; 15.10.1999.
12   Prescribed fee
(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:
(a)  if the holders or proposed holders of animal research authorities referred to in clause 11 (2) (c) are less than 10—$250, or
(b)  if the holders or proposed holders of animal research authorities referred to in clause 11 (2) (c) are 10 or more (but not more than 75)—$500, or
(c)  if the holders or proposed holders of animal research authorities referred to in clause 11 (2) (c) are more than 75—$1500.
(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 school, or
(b)  the accreditation is only for the purpose of allowing animal research to be carried out in a school or schools.
cl 12: Am 9.7.1999.
13   Changes in particulars to be notified
(1)  A corporation that is an accredited research establishment must give written notice to the Panel of a notifiable detail within 30 days of any of the following events:
(a)  a change in the directors of the corporation,
(b)  any prescribed offence of which the corporation or any director of the corporation is convicted.
Maximum penalty: 10 penalty units.
(2)  In this clause, a notifiable detail means:
(a)  in the case of a change in directors—details of the change, or
(b)  in the case of a prescribed offence of which the corporation or a director of the corporation is convicted—details of the offence and of any penalty imposed.
cl 13: Subst 9.7.1999.
Division 2 Applications to Director-General for animal research authorities: sec 25A
pt 4, div 2 (cll 14–16): Subst 9.7.1999.
14   Prescribed particulars
For the purposes of section 25A (2) (b) of the Act, the particulars to be included in an application to the Director-General for an animal research authority are the matters listed in Clause 2.2.11 of the Australian Code.
pt 4, div 2 (cll 14–16): Subst 9.7.1999.
15   Prescribed fee
For the purposes of section 25A (2) (f) of the Act, the prescribed fee to accompany an application to the Director-General for an animal research authority is:
(a)  if the application is the first, second or third application for an authority made by the applicant in the same calendar year—$100, or
(b)  if the application is the fourth or more application for an authority made by the applicant in the same calendar year—nil.
pt 4, div 2 (cll 14–16): Subst 9.7.1999.
16   Changes in particulars to be notified
The holder of an animal research authority issued by the Director-General must give written notice to the Director-General of details of any prescribed offence of which the holder is convicted, and any penalty imposed, within 30 days of the conviction or imposition of any such penalty (whichever is the later).
Maximum penalty: 10 penalty units.
pt 4, div 2 (cll 14–16): Subst 9.7.1999.
Division 2A Applications to accredited animal research establishment for animal research authorities: secs 25B and 25C
pt 4, div 2A (cll 16A–16D): Ins 9.7.1999.
16A   Prescribed particulars
For the purposes of section 25B (2) (a) of the Act, the particulars to be included in an application to an accredited research establishment for an animal research authority are the matters listed in Clause 2.2.11 of the Australian Code.
pt 4, div 2A (cll 16A–16D): Ins 9.7.1999.
16B   Prescribed maximum fee
For the purposes of section 25C (2) of the Act, the prescribed maximum fee is $100.
pt 4, div 2A (cll 16A–16D): Ins 9.7.1999.
16C   Changes in particulars to be notified
The holder of an animal research authority issued by an accredited research establishment must give written notice to the establishment of details of any prescribed offence of which the holder is convicted, and any penalty imposed, within 30 days of the conviction or imposition of any such penalty (whichever is the later).
Maximum penalty: 10 penalty units.
pt 4, div 2A (cll 16A–16D): Ins 9.7.1999.
16D   Prescribed period and particulars for keeping of records of research by independent researchers: sec 25C (3)
For the purposes of section 25C (3):
(a)  the prescribed period is 7 years after the application is made, and
(b)  the prescribed particulars are as follows:
(i)  the applicant’s 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 protocol 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.
pt 4, div 2A (cll 16A–16D): Ins 9.7.1999.
Division 3 Applications for animal suppliers’ licences: sec 37
17   Prescribed particulars
(1)  For the purposes of section 37 (2) (b) of the Act, the particulars to be included in an application for an animal supplier’s licence are:
(a)  if the applicant (or, in the case of an applicant that is a corporation, any director of the corporation) has been convicted, in the 3 years immediately preceding the application, of a prescribed offence—details of the offence and any penalty imposed,
(b)  such particulars as are required by the approved form.
(2)  The particulars referred to in subclause (1) (b) must include all of the following matters (in the case of an initial application) but only such of those matters as have changed since the previous application was made (in the case of a second or subsequent application):
(a)  the name of any manager or proposed manager of the applicant’s animal supply operations,
(a1)  particulars (if any) 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,
(b)  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,
(c)  the number of staff involved in the care of animals,
(d)  particulars of the animal care and husbandry procedures adopted by the applicant,
(e)  reproductive data 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,
(f)  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.
(3)    (Repealed)
cl 17: Am 9.7.1999.
18   Prescribed fee
(1)  For the purposes of section 37 (2) (d) of the Act, the fee to accompany an application for an animal supplier’s licence is $200.
(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 Minister is satisfied, on the advice of the Director-General, that requiring payment of the fee would be an unreasonable imposition on the school.
19   Changes in particulars to be notified
(1)  The holder of an animal supplier’s licence must give written notice to the Panel of a notifiable detail within 30 days of any of the following events:
(a)  in the case of a corporation—a change in the directors of the corporation,
(b)  any prescribed offence of which the holder (or, in the case of a corporation, any director of the corporation) is convicted.
Maximum penalty: 10 penalty units.
(2)  In this clause, a notifiable detail means:
(a)  in the case of a change in directors—details of the change, or
(b)  in the case of a prescribed offence of which the corporation or a director of the corporation is convicted—details of the offence and of any penalty imposed.
cll 19: Subst 9.7.1999.
Division 4 Exemptions
20   Certain schools may carry on business of animal research without accreditation: sec 46
(1)  A non-government school is exempted 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,
(b)  the Catholic Education Commission (New South Wales).
cll 20: Subst 9.7.1999.
21   School students may carry out animal research without authorities: sec 47
A student at a school is exempted 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.
cl 21: Am 9.7.1999.
22   Animals may be supplied to holders of animal supply licences: sec 48
A person is exempted from the operation of section 48 (1) of the Act with respect to the supply to a licensed animal supplier of animals for use in connection with animal research, so long as the person complies with the requirements of Part 4 of Schedule 1.
cl 22: Am 15.10.1999.
Part 5 Miscellaneous
23   Definition of “corporation”: sec 3
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,
(b)  the Catholic Education Commission (New South Wales).
24   Definition of “exempt animal”: sec 3
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.
25   Form of inspector’s certificate of identification: sec 49
For the purposes of section 49 (5) of the Act, the form of an inspector’s certificate of identification is set out in Form 1 in Schedule 4.
26   Records to be kept
(1)  This clause applies to an accredited research establishment (other than a school-based establishment) and to the holder of an animal research authority issued by an ethics committee appointed by the Director-General.
(2)  A person to whom this clause applies must, by 30 September in each year, send a report to the Director-General on the person’s work and activities during the period of 12 months ending on 30 June in that year.
Maximum penalty: 10 penalty units.
(3)  The report must be in the approved form and must contain the following information for the period to which it relates:
(a)  the number and kind of animals that have been allocated during that period to each project for which a proposal has been submitted,
(b)  the number and kind of animals that have been allocated more than a year ago to each project for which a proposal has been submitted and that are still allocated to that project as at the end of that period,
(c)  the objective of each project for which animal research has been carried out during that period,
(d)  the techniques developed or adopted during that period to reduce the total amount of pain or stress caused to animals in research or to reduce the number of animals used, or both.
(4)  In the case of an accredited research establishment, the report must also contain the following information:
(a)  the number of meetings held by the ethics committee for the establishment,
(b)  the number of proposals prepared by the establishment and approved by the ethics committee for the establishment,
(c)  the number of ongoing proposals prepared by the establishment and reviewed and reapproved by the ethics committee for the establishment,
(d)  the number of projects terminated before completion by the ethics committee for the establishment,
(e)  the number of proposals revoked by the ethics committee for the establishment.
cl 26: Am 9.7.1999.
26A   Prescribed period and particulars for keeping of records of approvals of lethality tests: sec 56A
For the purposes of section 56A:
(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.
cl 26A: Ins 9.7.1999.
27   Repeal
(1)  The Animal Research Regulation 1990 is repealed.
(2)  Any act, matter or thing that, immediately before the repeal of the Animal Research Regulation 1990, had effect under that Regulation continues to have effect under this Regulation.
Schedule 1 Supplementary provisions of the 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 clause 2.2.11 of the Australian Code, and
(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 such person as the Principal for the school may appoint.
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.
5–9   (Repealed)
sch 1: Am 9.7.1999; 15.10.1999.
Part 2
10–21   (Repealed)
Part 3 Conditions to be observed by licensed animal suppliers in relation to dogs and cats generally
22   Application of Part
This Part applies to dogs and cats only.
23   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.
24   Veterinary examination
(1)  Each animal must be examined by a competent person within 24 hours of arrival, and at least daily thereafter, 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 surgeon and any vaccination or treatment, including the humane killing of the animal, considered necessary by a veterinary surgeon, to ensure that no animal that is injured, sick or unsuitable is supplied for animal research.
25   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 the documents referred to in Part 4 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 on 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.
26   Release of animals
(1)  A licensed animal supplier:
(a)  must release an animal to its previous 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 name of the person who authorised the animal’s release,
(c)  the name and address of the person to whom the animal was released.
Part 4 Conditions to be observed in relation to the supply of dogs and cats to licensed animal suppliers
27   Application of Part
This Part applies to dogs and cats only.
28   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 complies with subclause (2).
(2)  The document referred to in subclause (1) must contain 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 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 hereby 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 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.
(4)  Subclause (3) applies not only to supply effected directly but also to supply effected indirectly by means of an agent or intermediary.
29, 30   (Repealed)
Part 5 Miscellaneous
31   Delegation of functions of ethics committees
An ethics committee may delegate any of its functions to its ethics subcommittees 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
(Clauses 6, 7, 8)
Part 1 Provisions with respect to constitution
1   Chairperson of the 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 must, subject to this Regulation, be appointed to fill the vacancy.
4   Casual vacancies
(1)  A member of the ethics committee is taken to have vacated office 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.
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 (except the ethics committee for a school-based establishment) is one representative from each member category, subject to any additional requirements determined by the ethics committee under clause 5 of this Schedule.
(2)  The quorum for a meeting of the ethics committee for a school-based establishment is the lowest number of members who between them fulfil all the requirements listed in clause 7 (3) (a) to (e) (Constitution and procedure for ethics committees for school-based establishments), subject to any additional requirements determined by the ethics committee under clause 5 of this Schedule.
(3)  In this clause, member category means a category of member referred to in Clause 2.2.2 of the Australian Code.
7   Presiding member
(1)  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.
(2)  The person presiding at any meeting of the ethics committee has a deliberative vote and, in the event of an equality of votes, a second or casting vote.
8   Voting
A decision made in accordance with Clause 2.2.21 of the Australian Code at which a quorum is present is the 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 the 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 9.7.1999.
Schedule 3 Animals exempted from licensing requirements for supply
(Clause 24)
sch 3, hdg: Subst 9.7.1999.
1   Definition
In this Schedule:
authorised researcher 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 Director-General—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
Unowned 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 to 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 to 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   Bred for the purpose animals
(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 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 (as defined in 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 committee, and
(c)  the 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   Observation studies
All animals are exempt animals for the purposes of any procedure, test, experiment, inquiry, investigation or study of a kind described as Category 1 (Observation Studies) in the document entitled Animals in Schools—Animal Welfare Guidelines for Teachers published by the New South Wales 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 Director-General, 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.
sch 3: Am 9.7.1999; 15.10.1999.
Schedule 4 Forms
Form 1
(Clause 25)
CERTIFICATE OF IDENTIFICATION
I CERTIFY THAT .........., whose signature and photograph appear below, is an inspector under the Animal Research Act 1985.
    
 
(photograph)
 

.........................Director-General of the Department of Agriculture
  

.........................Signature of Inspector