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6-Regulation: Details on New Zealand's new GE regulations



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                                  PART I
-------------------------------- GENET-news --------------------------------

TITLE:  GM Announcement
SOURCE: Government of New Zealand
        Marian Hobbs, Minister for the Environment
        http://www.beehive.govt.nz/hobbs/gm/
DATE:   Feb 12, 2003

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GM Announcement

Government announces proposals for genetic modification regulation [link]
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.

New category for release of new organisms [link]
The government is proposing a new category for the release of new
organisms, including genetically-modified organisms (GMOs), into New Zealand.

Conditional release - how it would work [link]
The new category of conditional release being proposed by the government
would allow the Environmental Risk Management Authority (ERMA) to impose
conditions on the release of new organisms, including genetically
modified organisms.

Minister's call-in powers extended [link]
The government is proposing to add cultural, spiritual or ethical effects
to the list of grounds under which the Minister for the Environment could
step in to decide on an application for the introduction of a new
hazardous substance or new organism that had been made to the
Environmental Risk Management Authority (ERMA).

Strict civil liability and a civil penalties regime included in changes [link]
Government proposals for changes to legislation governing new organisms
(including genetically modified organisms) include amendments to the HSNO
Act to impose both a strict civil liability and civil penalties regime in
cases where an activity breaches the law, Environment Minister Marian
Hobbs said.

Amendments to improve HSNO Act operations [link]
The government has announced its proposed changes to the Hazardous
Substances and New Organisms Act 1996 to improve the way it works for
decisions on organisms that are new to New Zealand.

About the Hazardous Substances and New Organisms (HSNO) Act 1996 [link]
The Hazardous Substances and New Organisms Act - generally known as the
HSNO Act - was passed in June 1996 and was aimed at streamlining and
updating the system for managing the risks from hazardous substances and
new organisms (including genetically-modified organisms) in New Zealand.

"Fast-track" for emergency medicines [link]
The government has announced changes it wants to make to the law to speed
up the assessment and approval of animal and human medicines, vaccines
and pesticides that contain new organisms - including genetically-
modified organisms - or hazardous substances and that may be required in
an emergency.

Proposals to streamline laboratory research using low-risk GMOs [link]
The government is proposing a series of amendments to the Hazardous
Substances and New Organisms (HSNO) Act 1996 to streamline the decision-
making process for contained laboratory research in genetically-modified
organisms (GMOs) and to tighten the law relating to the regeneration of
animals from tissue and to the modification of human cell lines.

Institutional Biological Safety Committees [link]
The Environmental Risk Management Authority (ERMA) is the organisation
responsible for saying yes or no to applications to develop, test, import
or release genetically modified organisms in New Zealand. However it can,
under the HSNO Act, delegate decisions about low-risk genetic
modifications being done in contained laboratories to Institutional
Biological Safety Committees (IBSCs) based at certain research institutions.

Work progressing on Treaty principles amendments to HSNO [link]
The government says work is proceeding to decide how the Hazardous
Substances and New Organisms (HSNO) Act 1996 can be amended to more
appropriately reflect the Treaty of Waitangi relationship between Maori
and the Crown.

Next steps [link]
The proposed changes to the Hazardous Substances and New Organisms (HSNO)
Act 1996 announced today will now go to the Parliamentary Counsel Office
to be drafted into a bill. That is scheduled to be introduced to
Parliament by the middle of April and to be referred to a select
committee where the public will again have an opportunity to make
submissions on the proposed legislation.

Other work underway to implement decisions [link]
Today's announcements of the government's proposals for amending the
Hazardous Substances and New Organisms (HSNO) Act 1996 are the latest
steps in implementing the recommendations of the Royal Commission on
Genetic Modification (RCGM).

About the Royal Commission on Genetic Modification [link]
The Royal Commission on Genetic Modification was established in May 2000
to report to the government on the options available to New Zealand to
deal with genetic modification and to advise on appropriate changes to
the relevant laws and policies.

Public consultation on amendments to the HSNO Act [link]
In September 2002, the Ministry for the Environment circulated a public
discussion paper Improving the operation of the HSNO Act for new organisms.


                                  PART II
-------------------------------- GENET-news --------------------------------

TITLE:  $10m fines to back GE laws
SOURCE: The New Zealand Herald, by Francesca Mold & Anne Beston
        http://www.nzherald.co.nz/storydisplay.cfm?
        reportID=53009&storyID=3100904
DATE:   Feb 13, 2003

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$10m fines to back GE laws

Researchers who break new rules governing the conditional release of
genetically modified organisms could face a civil law suit or a fine of
up to $10 million.

The Government yesterday confirmed it would proceed with its long-
signalled plan to change the law so that officials have the power to
approve the conditional release of GM organisms.

The conditions, applied on a case-by-case basis, could include
restricting the location and size of GM crops, not allowing flowering to
avoid contamination, importing only one sex of an animal to avoid
breeding and ensuring medical experiments are carried out under strict
monitoring.

The Government also announced the introduction of a strict civil
liability and penalty regime so that scientists who caused environment
damage or other harm by breaching the conditions of their research could
be sued or fined.

Environment Minister Marian Hobbs said the liability regime would send a
strong message to researchers that they would face severe consequences if
they broke the rules.

"We will take you out and penalise you. And it won't be with a wet bus
ticket."

Ms Hobbs said the new law would make it easier for people to take legal
action because they would only have to show the conditions had been
breached. They would not have to prove negligence. The maximum penalties
are yet to be set, but are likely to be up to $10 million or a percentage
of the expected commercial gain of the research.

Yesterday's announcement came as no surprise to anti-GM campaigners
because the Government had signalled its intention to change GM rules
since a Royal Commission recommended proceeding with caution in 2001.

Genetic modification has been an intensely controversial issue for the
past couple of years, with strong community and political opposition to
any relaxation of the rules.

The issue heated up in the run-up to last year's election when the Green
party refused to support any Government that lifted a moratorium on
commercial release of GM.

Concern intensified when activist Nicky Hager released a book during the
election campaign alleging a contaminated corn crop had already been
grown in New Zealand.

The Government believes the changes it is making will strike a balance
between reaping the social and economic benefits of GM technology and
protecting individuals and the environment from harm. But Green co-leader
Jeanette Fitzsimons said it was simply a sign that the Government was
continuing to ignore public opposition to GM in the field, food or
environment.

She said some of the first applications under the new conditional release
category could include GM maize and corn crops, potatoes with pest
resistant properties and potatoes which incorporated a vaccine.

Ms Fitzsimons said the new GM laws would not protect the public from the
mistakes of "genetic engineers". The liability regime was "weak and
disappointing".

Anti-GM group the Sustainability Council of NZ said the Government had
left innocent victims to fend for themselves if a GM release caused harm.

"It has gone against international commitments given in August to make
the polluter pay," said the council's executive director Simon Terry.

The Green party said it would try to influence the proposed law changes
when they reached the select committee stage in April. The Government
hopes to have the amendments passed in time for the lifting of the GM
moratorium in October.

Ms Hobbs said the law changes simply set up a framework and were not
intended to make any decisions about the release of GM organisms in New
Zealand.

The new conditional release category would just be another option for
researchers other than fully contained laboratory experiments and full
commercial release.

State-owned Crop and Food spokesman Howard Bezar said his organisation
was particularly pleased that researchers would be able to propose their
own rules for field trials in consultation with ERMA. Crop and Food has
been discussing GM potato trials for at least two years but Mr Bezar
could not say when those trials might begin once the legislation was passed.

Pro-GM Life Sciences Network chairman Dr William Rolleston was also happy
with the Government's plans but his group would not be leaving anything
to chance.

"Now it comes to the next critical phase which is the actual legislation
and we will be deeply involved in the select committee process," he said.

MAIN CHANGES
* A new conditional release category will allow GM organisms to be
released under strict conditions.
* Researchers who breach the release conditions can be sued or fined.
* The approval process for laboratory experiments with low-risk GM
organisms will be streamlined.
* The law will be tightened to stop tissue samples of animals not present
in New Zealand being imported and used to clone whole animals.
* A new fast-track system will be set up for the quick approval of
medicines and vaccines needed in an emergency.
* The Environment Minister's ability to step in to decide on the
introduction of new hazardous substances or organisms has been extended
to include consideration of cultural, spiritual or ethical effects such
an introduction would cause.