1998-1999-2000

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

SENATE

GENE TECHNOLOGY BILL 2000

SUPPLEMENTARY EXPLANATORY MEMORANDUM

Amendments to be Moved on Behalf of the Government

(Circulated by the authority of the Minister for Health and Aged Care, 
the Hon Dr Wooldridge MP)

ISBN:  0642 454639

GENE TECHNOLOGY BILL 2000

OUTLINE

These amendments will amend the Gene Technology Bill 2000 (the Bill).

The Bill represents a major component of a national scheme established by Commonwealth, State and Territory legislation to protect the public health and safety of people and to protect the environment from risks associated with gene technology. The scheme will operate by identifying and assessing risks posed by, or as a result of, gene technology, and by managing any risks through the regulation of certain dealings with genetically modified organisms (GMOs).

The effect of these amendments is to:

(a)	improve consistency with the Inter-Government Agreement on Gene Technology (the Gene Technology Agreement). Since the introduction of the Bill into Parliament, the text of the Gene Technology Agreement has been settled between officials from the Commonwealth and all States and Territories and the Gene Technology Agreement will shortly be circulated to all governments for signature.  The Gene Technology Agreement is defined in the Bill as commencing on signature by the Commonwealth and all States and Territories.  By contrast, the Gene Technology Agreement provides that the Agreement commences on signature by the Commonwealth and at least 4 States (including Territories).  Amendments to the definition of Gene Technology Agreement are therefore proposed to improve consistency; and

(b)	clarify the intention that the GMO Register will only contain GMOs that have previously been licensed by the Gene Technology Regulator, and that GM products (which are not live, viable GMOs, but which have been prescribed under the Bill as GMOs) may also be included on the Register.

FINANCIAL IMPACT STATEMENT

The amendments to the Bill have no significant financial impact. 

NOTES ON CLAUSES

Amendment (1)

The amendment deletes the current definition of “Gene Technology Agreement” and inserts a new definition.  The amendment provides that “Gene Technology Agreement” means the Gene Technology Agreement made for the purposes of this Act between the Commonwealth and at least 4 States, as in force from time to time.
This amendment aligns the definition of “Gene Technology Agreement” in the Bill with the  wording in the Inter-Governmental Agreement on Gene Technology (the Gene Technology Agreement) and ensures that once the Gene Technology Agreement commences, in accordance with the commencement provisions of the Agreement, it also commences for the purposes of the Gene Technology Bill 2000.

Amendment (2)

This amendment deletes subclause (1) of Clause 78 and replaces it with “The Regulator may, by writing, determine that a dealing with a GMO is to be included on the GMO Register if the Regulator is satisfied that:
(a)	the dealing is, or has been, authorised by a GMO licence; or
(b)	the GMO concerned:
(i)	is a GM product; and
(ii)	the GM product is a genetically modified organism only because of regulations made under paragraph (c) of the definition of genetically modified organism”.

The purpose of the GMO Register is to enable certain dealings with GMOs to be undertaken without the requirement for a licence to be held by a named individual or organisation.  For example, if a GMO has been growing in Australia for a long period of time, is used by a very large number of people (for example, a genetically modified flower that is grown and sold in Australia and is used by millions of people including those who sell the flower and buy the cut flower) and has been demonstrated to be safe, then the Regulator may enter the GMO on the Register with the effect being that anyone may deal with the GMO, without the need for there to be a single licence holder. Entries on the Register would then be included on the Record of GMOs and GM product dealings, along with all other dealings with GMOs approved by the Regulator and other agencies regulating genetically modified products. 

The requirement for prior licensing of a GMO (before it is placed on the Register) currently exists in Clause 78 of the Bill.  This amendment enables the GTR to determine in writing that, GM products (that have been declared to be GMOs under the Act) may also be included on the GMO Register.  This ensures that an appropriate level of regulation is also able to be applied to non-viable GM products that pose negligible biosafety risks.