In a precedent setting case, the High Court has upheld the appeal by GE Free NZ in Food and Environment against ERMA and AgResearch.

After 12 weeks of deliberation, Justice Clifford found that ERMA erred in receiving the applications from AgResearch and has declared them invalid. The decision sets aside the decisions by ERMA to proceed with the applications. ERMA is to take no further steps toward hearing and assessing the applications.

In October 2008 GE Free NZ went to the High Court to appeal a decision by ERMA NZ to notify four applications submitted by AgResearch that ranged from importing genetically engineered embryo's created overseas, to field trialing and commercial production of pharmaceuticals in milk, development of animals to model disease and virtually ‘anything else’ that would be of commercial interest.

"It is fantastic news that our concerns about the broad and indefinite nature of these applications have been upheld.” says Claire Bleakley, president of GE Free NZ in food and environment. “The cruelty and unregulated exploitation of animals for unsound GM research is not acceptable to New Zealanders."

The decision instructs ERMA to immediately halt processing the applications made by AgResearch who sought the right to modify nine species of animals, for an unlimited period, for commercial ventures anywhere in New Zealand.

“This was not the ‘case by case’ regulation of ethical research that government promised the public, following the Royal Commission on Genetic Modification, but a wholesale rush to commercialisation that would likely devastate New Zealand’s export and tourism image,” says Jon Carapiet spokesperson for GE Free NZ in food and environment.

The plans directly contradict the recommendations of the Royal Commission to not use food animals as bioreactors. Given the potential to damage rather than develop the economy and to dramatically increase the incidence of unethical treatment of animals, the decision is cause for AgResearch to comprehensively rethink how it serves its mission to ‘create sustainable wealth for the New Zealand pastoral and biotechnology sectors’. Neither AgResearch nor overseas investors must be allowed limitless scope to exploit New Zealand as a GE play ground and threaten the very core of the New Zealand Brand.

“There is an urgent need for Government to direct Crown Research Institutes, like AgResearch, to comply with a Biotechnology Strategy that does not include genetic modification, but one that builds on our existing reputation and supports clean, natural and sustainable production,” says Jon Carapiet.

“In developing the country’s approach to gene technology, it is vital we learn from the history of Mad Cow Disease, Foot and Mouth, Swine Flu, animal deformity through cloning, the failure and bankruptcy of previous GE-animal commercial ventures, and the public distaste for extreme animal cruelty.”

“This is a precedent-setting case and an amazing win for the public of New Zealand that protects our farmers and exporters," says Claire Bleakley. "We would like to thank all who supported and helped us in the process of the case."

Ends.

Jon Carapiet 0210507681

Claire Bleakley 06 -3089842 /027 348 6731

References:

www.gefree.org.nz

www.issues.co.nz/gefreenz

Extracts from the Decision and Background

IN THE HIGH COURT OF NEW ZEALAND WELLINGTON REGISTRY- CIV-2008-485-2370

UNDER the Judicature Amendment Act 1972 AND UNDER the Hazardous Substances and New Organisms Act 1996

BETWEEN GE FREE NZ IN FOOD AND THE ENVIRONMENT INCORPORATED

Plaintiff

AND ENVIRONMENTAL RISK MANAGEMENT AUTHORITY First Defendant

AND AGRESEARCH LIMITED Second Defendant

Hearing: 9-10 March 2009

Judgment: 5 June 2009

From “Discussion”

To enable effective public participation, sufficient particularity is required at the application stage. Where the generality of an application precludes this, therefore, it is not an answer that ERMA might subsequently “impose more stringent controls, narrow down the organism description or restrict the purposes for which the approval is given”.

[149] On balance, therefore, and whilst I recognise the strength of ERMA’s response to GE Free’s Applications, I have concluded that in this instance the Applications are simply too generic to enable the risk assessment called for by HSNO to be meaningfully undertaken

From “Outcome”

[150] GE Free’s application for review is granted. I find that ERMA erred in law in receiving the Applications for determination under HSNO. In terms of my discretion as to remedy, I think the error is such that ERMA cannot continue to treat the Applications as if they were valid. I therefore order that ERMA’s decision to accept the Applications as applications under s 40 of HSNO is set aside and ERMA is to take no further steps towards hearing and assessing the Applications.

“Clifford J”

Background

The applications by AgResearch sought to use any or all of 18 domestic livestock and laboratory animals genera of which 9 types -deer, goat, cow, pig, sheep, alpaca, llama, buffalo and horse would be farmed outdoors. AgResearch stated:

AgResearch is submitting four applications with common or overlapping organism descriptions and controls. This application should be read with the other applications. All of the applications are for approval of activities in containment and together they will allow AgResearch to do the following with organisms fitting the organism description in this application:

• GMC07012 (this application): Import into containment livestock and laboratory animal species (live animals, sperm, embryos – importation of live animals into containment will be rare). Maintain those animals for research, breeding and production. Import animal cell-lines (including human and monkey cell-lines) and E. coli for use in the development (genetically modification) of livestock and small animals under GMD07012 [sic] and GMD07074.

• GMD08012: Develop livestock and laboratory animals in indoor containment. Maintain those species for research, breeding and production. Develop animal cell-lines (including human and monkey cell-lines), E. coli and yeast for use in the genetic modification of livestock and laboratory animals.

• GMD07074, this application: Develop livestock species in outdoor containment. Maintain those livestock for research, breeding and production.

• GMF07001: Field test livestock in outdoor containment. Maintain those livestock for research, breeding and production.

AgResearch could use any technique available, now or in the future, to effect such genetic modification and could do so using genetic material from the specified livestock, small animals, humans and monkeys, E. coli and yeast organisms as specified in the Applications. Each of those approvals could be implemented at Ruakura, or at yet to be located facilities.

The High Court case taken by GE Free NZ in food and environment against the Environmental Risk Management Authority (ERMA) and AgResearch a Crown Research Institute (CRI) is being heard on Monday 9th March, 2009.

GE Free NZ took the action after AgResearch made a series of four applications that seek to develop, import and commercialise genetically modified animals from nine species of animals (alpacas, buffalo, cows, deer, goats, horses and donkeys, sheep, pigs). The generic applications seek approval at any location and for an indefinite period to allow commercial production of biopharmaceuticals, nutraceuticals and diseased animals for research.

“These four generic applications seek the right to commercialise unspecified GE animals as bio factories anyway, anywhere, anytime, anyplace that could be profitable. They are so broad that they make it impossible for people to know if and how they will be affected now or in the future”. said Claire Bleakley president of GE Free NZ in food and environment.

“Previous applications for genetic modification have been continually stretching all the statutory boundaries. The international best-practice approach of case-by-case risk assessment is being abandoned. Applications are getting broader with no ability to know what kind of risk may result,” said Jon Carapiet, spokesperson for GE Free NZ in food and environment.

To date the trials on GE animals in New Zealand have been plagued with deformities, as well as sudden death from congenital heart and organ failure. Early abortions are common with many foetuses suffering from excessive abdominal fluid (hydrops) resulting in a very low to zero birth rate.

New Zealand has been exposed to the commercial risks of the 9-year GE sheep trial conducted by Scottish company PPL in which some 3000 GE animals had to be destroyed after the product failed in clinical trials and caused severe immune reactions in human subjects.

GE Free NZ believes that these applications are so universal in scope and lacking in detail that it is impossible to reasonably assess the risks. New Zealand farmers, food producers, exporters and concerned members of the public are unable to make a submission on how they will be impacted- for better or for worse.

The case being taken before the High Court seeks for all the applications to be withdrawn by ERMA and returned to the applicant.

ENDS:

Jon Carapiet 021 0507681

Claire Bleakley 06-3089842 027 348 6731

Papers have been filed in the High Court, Wellington, on the applications for genetically modified animals made to the Environmental Risk Management Authority (ERMA).

The four applications by AgResearch seek indefinite commercial approval for genetic modification of 18 animal species using human and monkey cell lines e-coli and yeast, viral vectors. These animals will be farmed at unspecified sites around the country.

"We are hoping to have our case heard as soon as possible" says Claire Bleakley from GE Free NZ in food and environment.

GE Free had warned ERMA last week about the possibility of court action.

ENDS

Claire Bleakley (06) 3089842 / 027 348 6731

AgResearch must withdraw their applications to ERMA to commercialise GE animals, out of respect for widespread public opposition to the plans.

A nation-wide survey of over 1000 people* shows a majority of New Zealanders are emphatically opposed to GE animals. The survey confirms concerns that AgResearch’s proposals go against community values, threatening New Zealand’s future and the national interest.

“The public are saying ‘no’ to AgResearch’s plans to commercialise GE animals. Their plans will forever undermine New Zealand’s Brand reputation, but they do not have a right to do that,” says Jon Carapiet from GE Free NZ in food and environment.

“The New Zealand public own Brand New Zealand ; not AgResearch or Fonterra. Actions that undermine the value and integrity of that image harm the wider community, exporters and the country as a whole.”

The survey shows GE animals are unacceptable to twice as many New Zealanders as those supporting them (27%). One in five people surveyed (18%) ‘don’t know’ and demand more information on exactly what AgResearch is planning. But two out of three people (67%) who express an opinion are clear in their opposition to GE animals.

From comments gathered in the survey it is clear that even amongst people supporting GE animals, many would oppose the commercial production of pharmaceuticals in cloned animals. Their basis for support is only for research into cures for serious diseases and on the provision that no animals suffer.

“AgResearch’s applications do not meet these basic criteria,” says Jon Carapiet.

“Even supporters express a clear expectation that the public will be fully informed on a case-by-case basis for each experiment, with transparent and fully independent scrutiny. And most New Zealanders don’t support them at all.”

But AgResearch are deliberately cutting the public out of the process by making ‘generic’ applications for indefinite and wide-ranging commercial approvals. As a result of an approval by ERMA the public will continue to be denied basic information.

AgResearch must accept that their plans are unacceptable for most New Zealanders. They should withdraw the applications, and look for projects that can meet community cultural values and ethical standards, and which keep New Zealand’s Brand reputation intact.

ENDS

Contact: Jon Carapiet 0210507681

References:

The Colmar Brunton Omnijet survey was commissioned by Soil and Health and SAFE in September 2008. The survey includes hundreds of verbatim comments explaining reasons for supporting or opposing GE animals. For details contact:

Stefan Browning at www.organicnz.org 021 725 655

Hans Kriek, at SAFE: 027 446 2711

AgResearch’s press statement attacking criticism of its application for GM animals is misleading and deliberately underplays serious issues.

In the AgResearch analysis “Fact and Fiction” issued to journalists, they make a significant if accidental error in claiming to know little about 300 GM sheep run in New Zealand by PPL; underplaying issues of liability and clean-up costs.

In fact there were 3000 GM sheep involved in these field trials. When PPL hit financial problems and product-trials failed the whole GM flock was destroyed. The situation exposed the public to potential costs for clean-up of contaminated soil. But in fact no research was done on the soil or to properly study the animals from this extensive experiment. The lack of scientific data is astonishing. At that time former Prime Minister Jim Bolger backed independent scientists in calling for tissue samples to be taken and studied. But there was no funding for this and nothing was done.

It is worrying that AgResearch claims to know little of this debacle because its own ventures with other biotech investors could have similar results.

No bond or proof of financial security is required from the investor-partners, and no commercial insurer will cover such risks. Liability for unexpected damage from AgResearch’s plans is socialised and falls on the New Zealand public who overwhelmingly reject their vision. The public opinion survey conducted for The Royal Commission on Genetic Modification found only 1% (one percent) of people named farm animals, or research using animals as the area they most approved of for GM)*.

Other points presented as ‘facts’ by AgResearch are also misleading.

They avoid mentioning that the applications cover commercial production, not just ‘research and development’ (Point 35, Fact or Fiction), and deliberately play down that their proposals are on a much greater scale than anything they have done before.

They say their products are not expected to enter the ‘conventional’ (sic) food chain, (Point 1 Fact or Fiction) but there are already non-GM nutriceuticals in supermarkets. Benefits claimed by AgResearch for the applications indicate they are targetting a broader market than the “unconventional" food chain, (whatever that may be) in the medium-term. This is significant given they are seeking approvals for an 'indefinite period'.

Contrary to AgResearch’s hype (Point 3 Fact or Fiction), many resource-poor farmers overseas have not been helped by GM. Thousands of poor Indian farmers have committed suicide, often by drinking RoundUp herbicide because of debts arising from crop failures, and costly chemical inputs. Policy analyst Davindra Sharma*, in an open letter to the Prime Minister of India writes “We all know for sure now that Bt cotton (the first GM crop to be commercialised in the country) was one of the significant factors in pushing more and more farmers to commit suicide in Vidharba, Andhra Pradesh and Karnataka. And yet, no lessons have been learnt”. Commercial GM crops have been shown not to yield more, and companies driven by IP above ethics are now even patenting genes for drought resistance and characteristics for which they may be able to charge license fees.

It also clear that AgResearch will put New Zealand at the ‘bleeding edge’ of a speculative pharming bubble rather than at the cutting edge of ethical biotechnology that respects New Zealand’s brand –reputation and community values. Their emphasis on just one product: Atryn- reveals that that this is the only product of transgenic animals that has been approved, and also that alternative production methods are available that are far less cruel to animals.

AgResearch also fail to address the fact that the Royal Commission on GM specifically recommended against using as ‘bioreactors’ animals like sheep and cattle that we use in food. Analysis of the submissions to the Commission, and the issues it deliberated on shows there is a lot more behind their recommendation than simplistic concerns about mix-ups leading to animals entering the food supply.

Since the Royal Commission reported, the New Zealand Bioethics Council has been established and projects such as those planned by AgReseaerch have been further considered. The BioEthics Council has called for an ethical review of using animals with human genes as disease-models, saying*: “ (The) use of human genes in an animal to create an organism that can act as a ‘model’ for a human disease has the potential to develop an organism that will carry a significant burden of suffering, independently of and additional to any subsequent research. The Council holds the view that such interventions, where they will lead to organisms developing past the first half of gestation or development, and/or being born, should be subject to ethical review.”

The applications from AgResearch provide no evidence that such a review has been considered or has taken place. It is not good enough for AgResearch to attack those raising these issues as a way to justify extreme science compromised by lust for profit and ‘cost efficiencies’.

Ends

Jon Carapiet – Spokesperson GE Free NZ in food and environment

0210507681

References

“Fact or Fiction” PR sheet from AgResearch

*Report of the Royal Commission on Genetic Modification, appendix 3, p 184 Table 6.1

*http://www.thesouthasian.org/archives/2006/gm_crops_farmer_suicides_and_n.html

* New Zealand Bioethics Council, August 2004 Report: The Cultural, Ethical and Spiritual Dimensions of the Use of Human Genes in Other Organisms, p 32

AgResearch claims two Maori Authorities want to go into business partnership with them to farm transgenic animals in New Zealand, and that some participants at hui want Maori human genes to be used.

The unnamed Maori Authorities are cited in support of claimed benefits to Maori from AgResearch’s applications for wide ranging and indefinite genetic modification of animals. (Application GMD 8012 (p.90.)

But GE Free NZ believes Maori may have been misled about the scope and far-reaching effects of AgResearch’s proposals, and by promises of miracle cures that could in the process accidentally create new diseases, including those like BSE linked to prions.

“Whoever the Maori Authorities are, they are not reflecting widely held concerns and values amongst Maori and most other New Zealanders about ethical uses of biotechnology” says Jon Carapiet from GE Free NZ in food and environment.

AgResearch say that during nationwide consultations with Maori some participants called for Maori human genes to be used in the GE projects. Currently Maori genes are specifically excluded from use because of cultural values protected under the Treaty of Waitangi. AgResearch quotes one hui-participant as saying “ we need a robust debate on the issue about “no Māori genes” being used in this type of research. Would we benefit from our genes being used? Especially if it leads to helping our people.”

“That debate took place at the Royal Commission on Genetic Modification, but the issue is now back on the table given AgResearch’s plans,”says Jon Carapiet. “Maori must have a say, but the current set-up allows not just Maori values but wider community values to be ignored in the hunt for bigger profits.”

The claimed benefits to Maori of GE animals include cleaning up waterways damaged by dairy run-off. Instead of better farm practices the proposal is to create GE animals and GE bacteria in their gut. "This technical fix is a crazy approach compared to common sense farm management,” says Jon Carapiet.

AgResesearch say “in the medium to long term Maori (are) likely to share in a variety of economic opportunities ranging from operating transgenic farms to involvement in processing and production operations”. But AgResearch’s application pushes the boundaries of ethical science and if approved will mark the end of farming as we know it. As well as concerns of extraordinary animal exploitation and cruelty, basic human values about how we should and shouldn’t use gene technology will be sidelined. New Zealand will become an experimental playground for overseas and local companies wanting to take advantage of our currently disease-free animals and genetically engineer them.

If people thought the Royal Commission on GM and the existence of the Bio-Ethics Council would help navigate a ‘middle path’ and moderate the use of gene technology case-by-case, they were wrong. What is planned is a wholesale transformation.

Public submissions on the AgResearch proposals close in October.

ENDS

Jon Carapiet- 0210507681

References

www.ermanz.govt.nz

page 89/90 of Application GMD 08012

The new AgResearch application for GM animals threatens the very existence of the organisation and could take New Zealand’s agricultural reputation down with it.

AgResearch have applied to genetically modify farm animals from almost every domesticated species* that exists. The range of animals and GM constructs is so varied that they cannot even provide an exhaustive list of the constructs being proposed, or the benefits.

AgResearch have applied to set up facilities in undisclosed secret locations for an unlimited time in Canterbury, Southland and Taranaki. These animals will be producing proteins in their milk which will be isolated for rare disease medicines and nutraceutical supplements.

“The rare disease medicines will have to be clinically trialled. But it is important to remember that the last GM trial for arthritis was almost fatal because of life-threatening immune reactions in the 6 healthy patients. Three were left as amputees. However, there is a real risk GM nutraceuticals might escape trials due to the way they are classified,” said Claire Bleakley of GE Free (NZ) in Food and Environment. "The result of the application could be devastating."

This latest and much larger application follows up on the work done on GM cows since 2000. But the results of this trial are poor and after 8 years there is still no data on the environmental effects or the effectiveness of the gene in milk. The GM Cows have a less than 9% live birth rate with many calves born with serious deformities. The records show that animals that live for the first two days are registered as 'still births' obscuring the fact they have been euthanased.

“These animals are suffering. There are reports of gangrenous udders, deformed calves and many suffer mastitis and are highly susceptible to respiratory and septic conditions,” Ms Bleakley said.

“How can sick animals produce a healthy product? This is cost cutting taken to the extreme, it is cruelty taken to science fiction levels, and to-date recombinant milk clinical trials have failed. No milk has ever been approved for medicinal use."

New Zealand has already experienced the failure of a large GM-animal project. The disastrous GM sheep trial at Whakamaru, left 500 acres of farm land contaminated and 3000 sheep were incinerated, with remains left in offal pits and as ashes.

The sheep suffered from a range of serious diseases and had a dismal animal husbandry record with a 5% lamb rate. Human subjects in clinical trials had immune system reactions and respiratory distress.

“The land was then sold without any clean up or testing done. We can only wait to see if the large animal barns at the facility were built in order to protect the animals from the possibility of some GM created pathogen that could have been created in the soil,” said Ms Bleakley.

The new AgResearch applications seek to use three types of surrogates to carry the GM embryos: GM, conventional, and recipient animals. Recipient animals will be aborted at around 60 days and the foetus cells harvested to produce new embryos.

“This practice is highly dangerous. It is possible the aborted foetus was already deformed or carrying defective traits or disabilities that could cause long term suffering to the mothers and babies.”

“Genetically modified milks as medicines have already caused serious problems in clinical trials,” said Ms. Bleakley. “New Zealand cannot go down this track with the danger it poses to the environment and people. It is unbelievable that ERMA has allowed it to get this far. The Minister must 'call in' the applications now, to protect the national interest and save AgResearch from itself.”

ENDS:

Claire Bleakley 027 348 6731/ (06) 3089842.

References:

GMF 07001

GMF 02028, GMF 98001 AgResearch Annual reports 2000 -2007

* Cows, Pigs, Llama’s, buffalo, goats, sheep, horses, deer, alpaca.

The proposals made by AgResearch for New Zealand to become a 'GE-animal farm' for chemicals are a threat to New Zealand's clean green natural image, and national identity.

There are alternative uses of genetics that AgResearch should focus on. To protect the country's reputation for clean natural food they need to comply with a biotechnology strategy that respects our uniqueness and shared values.

"This is the extreme science of Pharmaceutical Animals and damages our Brand image. There has to be a middle path that uses gene technology without unethical or cruel uses of animals," says Jon Carapiet from GE Free NZ in food and environment."This isn't it."

The new applications to ERMA appear like a frenzy of mad scientist dreams for transforming New Zealand into a biotechnology playground. But forcing that vision will be a marketing disaster and undermine our economy.

The economy relies on an existing vision of New Zealand defined by people at home and overseas as clean, green and natural. What is needed is ethical science and commercial projects to fit that.

AgResearch must come up with ideas that protect what consumers around the world most value about products from New Zealand. They propose genetically engineering animals so they can all be made into creatures that lay pharmaceutical 'golden eggs'. In the process they will kill the 'goose' that is already laying, and that New Zealanders most treasure.

Ends

Jon Carapiet 0210507681

Ref:

Purposes of Application

AgResearch seeks approval in this application to field test transgenic animals with a range of genetic modifications and maintain the livestock for research, breeding and for the production of antigens, biopharmaceuticals, enzymes, hormones and other products with commercial applications for release

Eight years ago, AgResearch obtained the first of a series of approvals from the Environmental Risk Management Authority (ERMA), to undertake specific transgenic work with cows. In recent years AgResearch scientists have developed and bred small herds of several transgenic cattle lines. As a result of this work, AgResearch has now developed a world leading capability in transgenic livestock research and development. In addition, AgResearch has freedom to operate with all relevant transgenic technologies and New Zealand is free of certain animal diseases such as transmissible spongiform encephalopathies. This positions AgResearch and New Zealand to take a leading international role in commercial applications of transgenic livestock.

AgResearch wishes to apply its capability in areas which support AgResearch’s Mission to create sustainable wealth in New Zealand’s pastoral and biotechnology sectors. Appendix I is a summary of AgResearch’s 2020 Science strategy, five “Big ideas” that AgResearch is seeking to achieve in response to the challenges or opportunities facing the pastoral sector.

AgResearch is therefore seeking long term approval to develop and field test genetically modified livestock (cows, buffalo, sheep, pigs, goats, llamas, alpacas, deer, and horses).

The purposes for which AgResearch will utilise the approval will depend on the needs of the pastoral sector, commercial opportunities for transgenic livestock-derived products, the applications of transgenic technologies to those needs and consumer attitudes to particular uses of genetic modification. AgResearch believes these purposes will include:

Products with commercial applications: Undertake research and maintain and breed livestock for production of:

therapeutic proteins

proteins for use as diagnostics for human and animal disease

other products derived from livestock with commercial applications

Enhancement of livestock traits: Maintain and breed livestock for research into enhancement of traits of value in livestock including productivity, welfare and sustainability

Animal models of human gene function and physiology: Maintain and breed livestock for use in research as models for human gene function and physiology

Transgenic techniques; gene function: Maintain and breed livestock for research into transgenic techniques and gene function to support the above purposes and, if discoveries of general application are made in the course of such research, for further research into such discoveries.