From 12 July 1999, the following amendments to the Animal Research Act 1985 and the Animal Research Regulation 1995 will take effect:

Animal Research Authorities

The need for establishments to issue "Authorities" for researchers to conduct research has been maintained. Modifications, however, have been made to the requirements for issuing these authorities so that the issuing of an authority can be combined with the issuing of AEC approval for a research project.

Applications for Animal Research Authorities

The requirements for information that must be provided in applying for an authority (and thus AEC approval) have been clarified. The application must include:

• The information required by Clause 2.2.11 of the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes.
• Information about any application made to another AEC for a similar project (including information about any refusal of such an application).
• Identification of the location at which the research is to be conducted.
• Information about the cancellation of any Animal Research Authority or Animal Suppliers Licence held by the applicant.
• Accredited establishments must approve a form for applications for Animal Research Authorities, taking into account the above requirements.

(Section 25; Regulation Clause 16A)

Animal Research Authority Forms

Animal Research Authorities must contain the following information when they are issued:

• The location of the land on which the research is to be carried out.
• A description of both the type of animal research and the approved research project.
• The AEC which approved the project.
• Any conditions on the Authority.
• The identification of the person who issued the Authority.
• The identification of the person to whom the Authority was issued.
• The date on which the Authority was issued.

(Section 26)

Animal Research Authorities may still only be issued for a period of 12 months.

Fees for Animal Research Authority Applications

Accredited Research Establishments may charge a maximum fee of $100 per application from an independent researcher for an Animal Research Authority.

The Director-General’s AEC will charge $100 per application for an Animal Research Authority up to a maximum of $300 per calendar year. Subsequent applications made in the same year will not carry a fee.

(Section 25; Regulation Part 4, Division 2 and 2A)

Complaints about Animal Research Authority Holders

A comprehensive complaints mechanism has been added to deal with complaints made to the Director-General of NSW Agriculture about holders of Animal Research Authorities. Complaints can be laid against an authority holder if research is carried out:

• in contravention of the authority
• in contravention of the approval or directions of the AEC
• in contravention of the Code of Practice
• with animals that have not been obtained from a licensed animal supplier (apart from exempt animals)
• by a person who is disqualified under the Act.

The Director-General refers all complaints to the Animal Research Review Panel forinvestigation. Following this investigation, the Director-General may either dismiss thecomplaint, caution the authority-holder or suspend or cancel the authority.(Section 28).

Cancellation of an Animal Research Authority by the Director-General disqualifies anindividual for 12 months from receiving another Authority. (Section 17).

Animal Research Licences/Independent Researchers

To streamline administration, the need for an independent researcher (an individual operating outside an accredited research establishment) to obtain an Animal Research Licence has been removed. Animal Ethics Committee (AEC) scrutiny and supervision of independent researchers will be maintained and, as is the case for researchers within establishments, independent researchers must be issued with an Animal Research Authority for each research project in which they participate.

Accredited Research Establishments must keep records for seven years of all Animal Research Authorities granted to independent researchers and provide these records to the Director-General of NSW Agriculture on an annual (calendar year) basis. The details to be recorded are listed in Clause 16D of the Animal Research Regulation.(Section 25).

Independent Animal Research Authority holders who are overseen by the Director-General’s AEC will be required to submit annual returns on animal use to the Director-General (replacing the same requirement that was previously placed on Animal Research Licence Holders). (Regulation Clause 26).

Animal Suppliers Licences

Animal Suppliers require an AEC

Each Licensed Animal Supplier will be required to appoint an AEC to supervise their animal supply activities. (Section 13,14, 39 and 40).

Cancellation of an Animal Suppliers Licence by the Director-General (following the investigation of a complaint) disqualifies an individual for 12 months from holding an Animal Suppliers Licence. (Section 17).

Exemptions from supply requirements

Establishments and individuals breeding animals for their own use will not require Animal Suppliers Licences as long as certain conditions are met. These conditions are:

• The supply of animals is for a research purpose approved by the AEC.
• The AEC approves the way in which the animals are managed and cared for.
• The AEC is satisfied that the use of animals is to be within the establishment (or by the individual) only.
• The AEC has approved the breeding and management of the animals as part of a protocol.

There have been some additional changes that relate to animals that have been exempted from the licensing requirements for animal supply. Previously, privately owned and unowned animals that could be classed as exempt animals if, amongst other requirements, the procedures to be undertaken were "unlikely to have lasting adverse consequences tothe animal".

The new Regulation strengthens this provision to read "will not have foreseeable lasting consequences to the animal".

The Regulation reintroduces another group of exempt animals - animals with acquired medical or genetic conditions. The owners may sign a release form allowing the use of animals in research. The release form must be approved by the Director-General of NSW Agriculture. (Regulation Schedule 3)

Fees - Accreditation applications

The fees payable by research establishments on application for accreditation have been changed to reflect the size of the establishments and based on the number of Animal Research Authorities issued. These fees are payable every three years on renewal of accreditation. The fee for institutions with less than 10 Animal Research Authority holders is $250, for those with from 10-75 Animal Research Authority holders it is $500, and for those supervising more than 75 Animal Research Authority Holders, the fee is $1,500. (Regulation Clause 12)

Lethality Testing

The Act now defines lethality tests and requires that specific records be kept on any lethality testing approved. Lethality tests are defined as 'any animal research procedure in which any material or substance is administered to animals for the purpose of determining whether any animals will die or how many animals will die.'

Research establishments must keep records of any lethality tests approved by its AEC and supply those records to the ARRP on an annual basis. The records must be received by 31 January for the period ending on the previous 31 December. The ARRP may make public any of the information provided other than the name of the accredited research establishment providing it.

The information to be recorded for each approved lethality test includes:

• the species of animals
• the number of animals
• the type of procedure
• the justification for the approval
• any modifications or alternatives being developed to reduce or replace the need to carry out the lethality test.

The records of lethality tests must be kept by the research establishment for seven years. (Section 56A)

Animal Ethics Committees

The ability of AECs to delegate functions to subcommittees has been restricted (consistent with the Code of Practice). AECs may delegate any of their functions other than:

• considering the proposal;
• approving, or refusing to approve, the proposal;
• revoking a previous approval of a proposal.

(Regulation Clause 31)

AECs must now record in their minutes the reasons for any decisions they make concerning research proposals. These records and minutes must be kept for a minimum of seven years.

Consistent with the Code of Practice, for AECs with more than four members, one third of the members must be from categories C (animal welfare) and D (independent). (RegulationClause 6 (3))

Also consistent with the Code of Practice, the quorum for AEC meetings must include a representative from each category of membership (veterinarian, researcher, animal welfare and independent).

Decisions of AECs must be made in accordance with Clause 2.2.21 of the Code of Practice - on the basis of consensus. (Regulation Schedule 2)

Schools

Considerable changes have been made in simplifying Schedule 1 of the Regulation and recognising the detail that is provided in the updated Code of Practice in relation to the use of animals for teaching. A particular clarification is that schools AECs must not consider proposals unless they contain information on the matters listed in Clause 2.2.11 of the Code of Practice.

If a schools AEC has more than six members, at least two of the members must be persons with a demonstrable commitment to, and established experience in, furthering the welfare of animals. They must also be people who are not associated in an official capacity with the school or any other accredited research establishment otherwise than in their capacity as members of the AEC. (Regulation Clause 7)

Clarification is given in Schedule 2 of the Regulation in regard to a quorum for Schools AECs. A quorum is the lowest number of members that between them fulfil the requirements of the five categories of membership. (Regulation Schedule 1)

Wildlife studies

Part 2 of Schedule 1 of the Regulation "Conditions to be observed in relation to animal research involving free-living animals" has been omitted. Provisions relatingt o wildlife studies are found in Section 5 of the Code of Practice.

Notification of Changes

A time period of within 30 days has been added to the requirements on Accredited Research Establishments and Animal Supply Licence holders to supply particular details to the ARRP (these details relate to changes in Directors and offences committed). (Regulation Clauses 13 and 19)

Animal Research Authority holders must notify the Director-General (for authorities issued by the Director-General) or the Accredited Research Establishment (for authorities issued by an Accredited establishment) of particular offences of which the Authority holder has been convicted. This notification must be done within 30 days of the conviction. (Regulation Part 4, Division 2 and 2A).

The range of offences that must be notified has been defined. (Regulation Clause 3)

General

The Act no longer requires accredited research establishments or independent researchers to own or occupy the land on which they carry out research. (Section 18)

It is an offence to keep animals with the intention of using them in connection with animal research unless authorised by virtue of being an Accredited Research Establishment, Animal Supplier or Animal Research Authority holder. (Section 47A)

The penalties for a number of offences have also been increased.