1.1 The Act and the Regulations, together with corresponding State legislation, provide the legislative foundation for Australia’s nationally consistent scheme for the regulation of gene technology.

1.2 The objectives of the national laws are to protect the health and safety of people, and to protect the environment, by identifying risks posed by, or as a result of, gene technology, and by managing those risks by
regulating certain dealings with genetically modified organisms (GMOs).

1.3 The national laws prohibit dealings with GMOs, other than a limited range of permissible, authorised dealings. They establish a statutory officer, the Regulator, who is responsible for administering these laws. Part
of that role includes responsibility for promoting compliance with the laws, and prosecuting non-compliance.

1.4 By encouraging good compliance practices by regulated organisations, particularly through the promotion and implementation of best practice techniques, the possibility of adverse environmental or human health
outcomes associated with gene technology is reduced.

1.5 The Regulator strongly encourages all organisations conducting dealings with GMOs to obtain accreditation.

Institutional Biosafety Committees (IBCs)

1.6 Fundamentally, best practice is achieved when organisations regularly and routinely seek, and obtain assistance from, a properly constituted, resourced and maintained IBC, whose members are able to provide professional and unfettered advice on risks related to the gene technology work of the organisation.

1.7 IBCs assist organisations by advising on the identification and management of the risks associated with dealings with GMOs undertaken by the organisation, including the containment of GMOs and providing an interface with the OGTR.

1.8 Either having an IBC, or having access to one, is a pre-requisite to an organisation obtaining and maintaining accreditation.

1.9 IBCs are required to be consulted and used by organisations in certain situations regardless of whether an organisation is accredited. For example, the Regulations require that the dealing has been assessed by an IBC, even if the dealing is undertaken by an organisation which is not accredited.

1.10 IBCs therefore play an integral role in assisting compliance with Australia’s national scheme laws. They are an important quality assurance system for regulated organisations.

1.11 It should be noted, however, that the role and responsibilities of IBCs and accreditation are limited in two important respects:
    1.11.1 Firstly, IBCs are not intended to be responsible for the conduct of the organisations that they assist. Ultimately, the Regulator encourages organisations to make representations to the Regulator on their own behalf. IBCs are intended to provide relevant advice to assist with the identification and management of risks associated with GMOs without attracting liability for damages in the course of providing this advice.

    1.11.2 Secondly, accreditation does not automatically allow an organisation to conduct dealings with GMOs. If an accredited organisation wishes to work with GMOs it must ensure the correct approval or assessment is obtained before commencing this work. Further information about approval/assessment processes can be obtained from the OGTR website.
1.12 Information about the application process for accreditation and the technical and procedural requirements that must be addressed in an application, together with helpful hints to assist applicants to prepare their
applications, is set out in Part 2 of this explanatory document.

What happens when an organisation becomes accredited?

1.13 Upon accreditation, the Regulator issues the organisation with an instrument of accreditation. The instrument shows that the organisation has met the requirements for accreditation.

1.14 The instrument will set out:
  • the name of the accredited organisation; and
  • any conditions of the accreditation.
1.15 Generally, a range of conditions will be imposed on the organisation at the time of accreditation. The organisation must comply with the conditions, on an ongoing basis, in order to maintain the accreditation. The conditions ensure that the standards of review and compliance initially attained by the organisation in the course of gaining accreditation are maintained by the organisation on an ongoing basis.

Note: Further information about conditions of accreditation and how organisations can maintain their accreditation can be found in Part 3 of this explanatory document.