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1998-1999-2000
THE PARLIAMENT OF THE
COMMONWEALTH OF AUSTRALIA
SENATE
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.
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.