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6-Regulation: Government of New Zealand announces new GM regulations

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TITLE:  Government announces proposals for genetic modification regulation
SOURCE: The government of New Zealand/Hon Marian Hobbs, Press Release
DATE:   Feb 12, 2003

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Government announces proposals for genetic modification regulation

The government has announced changes it wants to make to the main
legislation covering genetic modification (GM) in the latest step in its
programme to implement the recommendations of the Royal Commission on
Genetic Modification.

The proposed changes are to the Hazardous Substances and New Organisms
(HSNO) Act 1996 and related Acts. They are designed to underpin the
government's overall policy of proceeding with caution with GM while
preserving opportunities.

"The decisions will give New Zealand an extended regulatory framework to
allow it to better take advantage of the social and economic benefits of
genetically-modified and other new organisms, which we may choose to use,
while at the same time ensuring potential risks are managed effectively,"
Environment Minister, Marian Hobbs said.

The changes being proposed include a new category of approval for new
organisms, including genetically-modified organisms, called 'conditional

"This new category would ensure a regulatory framework is maintained for
new organisms by allowing the Environmental Risk Management Authority
(ERMA) to attach controls on a case-by-case basis to any approvals to
release new organisms," Marian Hobbs said.

"It would allow the ERMA to consider applications to conduct certain
research outside strict containment such as monitoring the impacts of
released organisms. It would also allow ERMA to impose controls designed,
for example, to prevent the dissemination of the organism into the wider
environment. The conditional release category would also allow ERMA to
specify where and how organisms are used.

"This will not automatically mean that all new organisms will be approved
for conditional release and it will certainly not mean that GM organisms
will automatically be released.

"To back up the cautious approach inherent in this new category, measures
are also being introduced to enforce the rules and provide for deterrent
penalties against those who breach them."

Other proposed changes to the act would streamline the approval process
for the import and development of low-risk genetically modified organisms
in contained laboratory conditions. The system for medicines that contain
new organisms would also be simplified for those meeting the criteria for
'low-risk', with those products needing only one approval rather than the
two required at the moment.

There is also provision for a rapid approval system for products required
urgently to deal with a human or animal health or biosecurity emergency.

Cultural, spiritual and ethical effects have also been added to the list
of circumstances under which the Minister for the Environment may step in
to decide on an application to develop or release a new organism or
hazardous substance - a process known as Ministerial call-in.

Another set of amendments is designed to improve the way the Act operates
for decision making on new organisms in the light of experience with the
Act since 1998.

The law change proposals are the latest step in a series of government
decisions implementing the recommendations of the Royal Commission on
Genetic Modification.

These include the establishment of Toi te Taiao: The Bioethics Council,
public funding for research into the environmental, economic and social
implications of genetic modification, and setting up a review of the ERMA
to ensure it has the expertise and resources it needs to make decisions
on GM research, development and use.

The government is also drawing up a comprehensive strategy setting out a
vision and goals for biotechnology (including GM) in New Zealand.

Media contact:
Trevor Henry, press secretary
tel +64 4 471 9131; +64 21 843 679

More information is available at: