Summary of this Part

This Part describes the requirements and process by which the GTR will:
  • approve facilities (through ‘certifying’ the facility to a certain level of containment) so that dealings with GMOs can take place within the contained facility; and
  • accredit organisations that are able to demonstrate that they have established, and will maintain, an operational Institutional Biosafety Committee (IBC) in accordance with the GTR’s guidelines. Companies, research institutions and government departments will need to gain accreditation from the GTR before they will be permitted to undertake any research or commercial activities involving gene technology.

Key provisions in this Part and major changes as a result of consultation on the draft Bill

Certification of facilities (Division 2)

Much of the current research work with GMOs occurs in facilities such as laboratories or animal houses. At present, GMAC requires that this work only occur in facilities that are of a certain “containment” level. That is, the facility must provide a level of physical containment for the work, with the appropriate level of containment depending on the nature of the work being undertaken.

This is done through the design of the facility, and the equipment and procedures used in the facility. Currently, GMAC issues technical guidelines about the requirements for physical containment levels PC2, PC3 and PC4, (PC4 being the highest level of containment). The GMAC guidelines describe matters such as required laboratory procedures, laboratory equipment and signs, laboratory planning and construction, and decontamination procedures.

We have received a great deal of positive feedback on the effectiveness of these arrangements. In designing the new provisions, we have attempted to capture the essence of the current arrangements and not add unnecessary additional requirements.

Division 2 essentially provides a regulatory framework for the current GMAC system of certification of containment facilities.

In summary, the system of certification will operate as follows:
  • the GTR may require, as a condition of licence, that work is only conducted in facilities of a certain containment level;
  • organisations may apply to have a facility certified to a certain containment level (e.g. Physical Containment Level PC2, PC3 or PC4) to enable them to conduct contained work with GMOs. The application would need to meet the formal requirements which will be set out in guidelines to be issued by the GTR;
  • the GTR may certify a facility to a specified containment level if the facility meets the containment requirements specified in guidelines issued by the GTR;
  • the certification of a facility is subject to any conditions specified in writing by the GTR. For example, the GTR may require re-certification after a certain period of time (for example, 5 years). This is the current practice of GMAC inrelation to certification of facilities; and
  • the GTR may vary the certification already provided to a facility by adding or removing conditions, and may also suspend or cancel a certification.

    If a university wished to conduct research work involving viral vectors which can infect humans, they would need to apply for a licence under Part 5. After assessing the licence application, the GTR may decide that the only way the risks can be adequately managed is to apply a condition requiring that the work only occur within a facility certified to Physical Containment Level PC4. To meet the conditions of licence, the University would either have had its facilities certified previously to PC4, or would have to seek certification of the facilities to that level. An application for certification would only need to be made by the University once (not every time they seek a licence to undertake work), unless they wished to upgrade their facilities and seek certification to a higher containment level.

Accredited organisations (Division 3)

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At present, significant work is done by Institutional Biosafety Committees (IBCs) which are established within Universities, other research institutions and companies. The responsibilities of IBCs include: overseeing work within institutions; providing information and advice about the work to GMAC; and inspecting laboratories.

It is important that the current valuable role of the IBCs is maintained under the new arrangements. In articulating the role of IBCs in legislation, we are also conscious of the need to:
  • distinguish the role of the IBCs and the GTR;
  • minimize the exposure of individual members of the IBCs to liability, since they are generally voluntary committees within larger organisations;
  • recognise that it is the responsibility of the organisation to establish and maintain IBCs;
  • ensure that the IBCs are established, and operate, in accordance with guidelines issued by the GTR;
  • ensure that IBCs are actively supported by the parent organisation; and ensure that IBCs have a level of independence from the organisations in which they sit. One way of doing this
  • is appointing lay people to sit on IBCs, as currently occurs.
Some stakeholders consider that private companies should not be allowed to establish IBCs. We think that the emphasis of the GTR should be on ensuring that its guidelines for accreditation and the operation of the IBCs are well developed, rigorous and the subject of monitoring by the GTR. If these key objectives are achieved, the IBCs will be an effective and useful adjunct to the GTR, regardless of whether the parent organisation is a University, research institute or company.

With these objectives in mind, Division 3 provides for the Accreditation of Organisations. In summary, the system of Accreditation of Organisations will operate as follows:
  • an organisation (such as a University, company or Government department) may apply for accreditation if it can prove that it has established and will be able to maintain an IBC in accordance with guidelines issued by the GTR;
  • the GTR may accredit organisations, taking into account:
    • whether the organisation has established an IBC in accordance with guidelines issued by the GTR;
    • whether the organisation will be able to maintain an IBC in accordance with the guidelines; and
    • whether the organisation has indemnity arrangements in place for IBC members who are either volunteers or laypeople;
  • the accreditation of an organisation may be subject to conditions;
  • and the GTR may vary, cancel or suspend the accreditation.
The IBCs will never be responsible for performing the licensing functions of the GTR. The GTR will always be responsible for undertaking risk assessments, issuing licences, determining the classes of dealings with GMOs that are exempt or notifiable low risk dealings, and monitoring compliance with the legislation.

The role of the IBCs will be to assist the GTR in the performance of these statutory functions as follows:
  • reviewing all proposals for new research within the institution;
  • assisting applicants to prepare licence applications in accordance with the GTR’s guidelines and providing advice to the GTR regarding the IBC’s assessment of the proposal;
  • in relation to notifiable low risk dealings, assisting the proponent to identify whether the proposed work falls within a class of dealings prescribed as notifiable low risk. If this were the case, the IBCs would notify the GTR about the work and oversee the work in accordance with the GTR’s guidelines;
  • regularly auditing procedures relating to GMOs within organisations and institutions;
  • inspecting facilities;
  • notifying the GTR of any breaches of the legislation that come to light; and
  • notifying the GTR of any accidents or incidents, and the steps taken to deal with them.
The Accreditation of Organisations, and the establishment of IBCs, will not abrogate the GTR’s responsibility to monitor compliance with the legislation. All accredited organisations and IBCs will be independently monitored by the GTR, including through annual reports.

For a clause by clause explanation of this Part please refer to the Explanatory Memorandum to the Gene Technology Bill 2000