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Toad genes in potatoes, frog genes in salmon, glow-in-the dark mice, no-shear sheep, and mutant cows—a worldwide conspiracy is in the works. At least, that’s what you would think from the amount of public discussion surrounding genetic engineering (GE) and genetically modified organisms (GMOs) in New Zealand. New Zealanders take pride in “clean, green New Zealand” (a widely used slogan). The anti-GE lobbyists are getting mileage from this phrase, with ominous warnings that if New Zealand does not declare itself to be GE-free, it will lose its “clean, green” status in the eyes of the world.

The Green Party, a small but significant power in the government, has kept the GE issue in the public eye, issuing more than 40 press releases on the subject in the past 2 years. Anti-GE lobbyists (including members of the Green Party) commonly make statements like, “We just don’t know what these GE organisms are likely to do to the environment.” Unfortunately, scientists have been slow to challenge these emotive statements.

“We [scientists] have been perceived as being secretive and have lost the public’s trust”, admits Michael Berridge of the Malaghan Institute of Medical Research (Wellington South, New Zealand). “We need to work on rebuilding that trust. We aren’t doing anything secretive.” He points out that the GE controversies have been blown out of proportion in New Zealand. “No one in New Zealand is releasing any genetically modified organisms into the environment. The assumption is being made that all GMOs are dangerous, which isn’t true. Work being done in New Zealand mostly involves naturally occurring genes, which break down in the environment like any other natural substance.”

John Lea, general manager of Celentis Analytical (a commercial unit of AgResearch, located in Hamilton), agrees. “I can understand people’s fears about genetic engineering, but it is a perceived threat rather than an actual one. There is a need for regulation on GE work, to keep everyone safe. What we need in New Zealand is a peer-reviewed approval process, which ensures a high level of safety, but is not too long or costly. The current system is too onerous.”

New Zealand has some of the most stringent GE laws in the world. Under the Hazardous Substances and New Organisms Act 1996 (HSNO), each laboratory must submit a 13-page application to the Environmental Risk Management Authority (ERMA) to obtain permission for individual genetic modifications that they wish to make. This regulatory process may take 1–2 months (even longer in some instances). Researchers in low-risk areas find these requirements to be time-consuming and unnecessary, and the costs associated with these frequent applications place further financial burdens on institutions already struggling on meager budgets.

ERMA can delegate some of its power of approval to Institutional Biological Safety Committees (IBSCs), which are set up by individual institutions and report back to ERMA. The IBSCs can authorize some low-risk GE work, defined under HSNO regulations as low-risk genetic modification work carried out under PC1 or PC2 conditions (physical containment levels 1 and 2). PC1 conditions apply to situations in which individual and community risk is low and the microorganism is unlikely to cause human, plant, or animal disease. PC2 covers research for which there is a moderate individual risk and a limited community risk, and the microorganism may cause human, animal, or plant disease but is unlikely to be a serious hazard to laboratory workers, the community, livestock, or the environment (1, pp 112–113).

Researchers in New Zealand would like to see the role of the IBSCs changed to encompass a wider range of powers that could reduce regulatory costs and time involved in getting approval. Many of the applications now being submitted for approval in New Zealand would not be necessary in other countries such as the United States, Australia, and the United Kingdom, where GMOs that meet PC1 criteria are exempt from approval requirements for development.

The RCGM
The Green Party was the driving force for establishing a commission of inquiry, the Royal Commission on Genetic Modification (RCGM), to hear submissions from all interested parties, including researchers in the private and public sectors, food producers and exporters, environmentalists, Maori, church groups, and the general public. In October 1999, Jeanette Fitzsimons, coleader of the Green Party, presented a petition to the government with 92,000 signatures calling for an inquiry into GE and a moratorium on the release and field trials of GMOs while the issue was investigated further.

In November 1999, the Green Party’s dreams were realized, when the incoming coalition government agreed to implement this policy. The GE debate has become a hot political issue, with the Green Party calling for New Zealand to announce itself to be “GE free”. Even though the Green Party is a minority party, it holds significant political leverage because the coalition must have third-party support to pass legislation and continue governing. During the current term of Parliament, the Green Party with its seven parliamentary seats has assumed the role of the third party, causing anxiety among the scientific community, who are concerned about the future of GE research in New Zealand

When the RCGM and a voluntary moratorium on release of genetically engineered organisms were announced in April 2000, the Green Party claimed it as a victory. The work of the commission finally got under way in April 2000, after 14 months of intensive campaigning and involvement in public discussions on GE and after the government had developed formal guidelines for them to follow.

The commission consisted of four highly respected New Zealanders: the Right Honourable Sir Thomas Eichelbaum, of Wellington, former Chief Justice of New Zealand; Dr. Jacqueline Allan, of Auckland, a medical practitioner; Dr. Jean Sutherland Fleming, of Dunedin, a scientist; and the Right Reverend Richard Randerson, of Auckland, bishop of the Anglican Church. Their task was “to receive representations upon, inquire into, investigate, and report upon the following matters:

• the strategic options available to enable New Zealand to address, now and in the future, genetic modification, genetically modified organisms, and products; and
• any changes considered desirable to the current legislative, regulatory, policy, or institutional arrangements for addressing, in New Zealand, genetic modification, genetically modified organisms, and products” (1).

The commission was to meet with 107 interested parties over the next 14 months. The RCGM schedule also included extensive consultations with the Maori—28 workshops, 10 regional Hui (conferences) throughout the country, and a national Hui held at the at Turangawaewae Marae (meeting house), Ngaruawahia, in April 2001.

AgResearch in the limelight
In May 2001, AgResearch, a New Zealand life science company, made headlines for its involvement in GE. The New Zealand High Court ordered the suspension of AgResearch work involving some transgenic cattle that were genetically engineered to produce human myelin basic protein (MBP) in their milk. The court ruled that ERMA had not followed the correct process in approving the experiment, and it set an injunction on the research. As soon as the decision was announced, the Green Party called publicly for the cows that were pregnant with transgenic calves to be destroyed, claiming the experiment to be unnecessary and inhumane. A stay of execution was issued, allowing the cattle to remain alive until ERMA reviewed the decision. Two weeks later, the reviewed application was approved, and the GE project was allowed to continue.

Since September 2000, a number of protests have been staged outside the AgResearch research facility in Ruakura. The perimeter fence has been subjected to paint bombs and graffiti, and an effigy of a cow was burned in front of the research center.

“When you’re working at the leading edge of technology, you get these protests. There will always be the radical element in protestors,” says Lea. “Our facility has a high level of security, and we don’t expect to have any serious problems.”

AgResearch’s scientists are world leaders in cloning cattle and sheep, and their work has highlighted the difficulties that researchers face when using GE technology in New Zealand. The MBP research has taken 2¹/₂ years to get approval, although it is undertaken in high-containment facilities with little risk to the environment and involves changing just one gene from the estimated 80,000 found in the cattle genome. Court costs and application fees ran into the hundreds of thousands of dollars, money that could have been used to further the research instead of fighting through the bureaucratic legal system.

The transgenic research, if successful, has the potential to produce large quantities of large-molecule therapeutic agents that cannot be synthesized by other methods in a cost-effective way. “I believe that GE is the next revolution for science, and you can’t stop it,” says Lea. “We are in a position to lead the world in this new scientific frontier.”

Commission results
Scientists and researchers in New Zealand have been holding their breaths for the past 18 months while awaiting the outcome of the RCGM. There were fears that the commission would recommend the cessation of GE in any form, given the high level of emotional anti-GE media attention during the commission’s deliberation process.

The RCGM report, which supported continued use of GE technology, was released on July 30, 2001, after which the commission was disbanded (1). The four-volume report can be summarized in four words: “proceed, but with caution”. Among the 49 recommendations made were :

• Establish Toi te Taiao: the Bioethics Council to provide cultural, ethical, and social guidelines for the use of GM, gene therapy, and xenotransplantation, particularly in medical and research fields.
• Change the HSNO Act 1996 to ease the regulatory requirements for low-risk GMOs: Assess approval on a per-project rather than a per-organism basis and cover areas not currently included (such as importing GMOs and using human cell lines and tissue cultures).
• Clarify the roles of various government regulatory bodies so that imported GMOs such as vaccines would not have to get approval from more than one regulatory body.
• Appoint a Parliamentary Commissioner on Biotechnology to undertake general biotechnology auditing and to promote public education on biotechnology.

The Green Party has expressed its concern that the report is contradictory. “The Report says we should keep our options open,” says Fitzsimons, “but the recommendation to proceed with caution effectively takes our options away. Once we lose our GE-free status, we can’t get it back again.” The Green Party is particularly unimpressed with the commission’s recommendations on field trials and food safety issues. “We believe that GE is a powerful tool that has the ability to do a lot of good, but also a lot of harm,” says Fitzsimons. “We support the use of GE in research, diagnostics, and the manufacture of medicines in a contained laboratory, but draw the line at the release of living organisms into the environment.”

The scientific community is generally happy with the report. “The report is very positive from a research perspective,” says Berridge. “If the recommendations are implemented, there will be savings in both time and money by having a short form that covers a project that could involve multiple GMO developments instead of having a 13-page form for each GMO development.”

Other reductions in regulatory requirements are also likely. ERMA currently oversees the importation of low-risk GMOs, a lengthy and expensive process. If the report recommendations are implemented, low-risk GMO importation will be handled by the IBSCs, thereby reducing the regulatory costs.

No other changes are foreseen, apart from these recommendations. ERMA will continue to be the regulatory body responsible for ultimate authorization of GE research in all but low-risk areas. Field trials will remain strictly controlled, with public consultation occurring before any release of GE organisms into the environment. This allows for anyone with concerns—organic farmers, for example—to have their say and also be informed about any potential for contamination of their crops.

GE in the 21st century
Is the GE issue resolved? Far from it. Even though the recommendations made by the Royal Commission support the continuation of GE, a review process must still be undertaken. The government is taking 3 months to decide what recommendations will be implemented; and there will, no doubt, be more discussions. For one thing, an election is scheduled for 2002, and the Green Party is extremely unlikely to take the GE rulings lying down. As I write this article, the Green Party has initiated a public protest in Auckland, with thousands of New Zealanders marching to show their opposition to the use of GE.

Maori groups have voiced their opposition to the use of GE on the basis of their cultural beliefs. Some Maori factions are also claiming that the report is unconstitutional, and they may challenge its validity. Despite this vociferous opposition to the RCGM report, the government is unlikely to ignore the findings of the RCGM. The opposition party, the National Party, has pledged its support for implementing the recommendations of the report. An independent survey of the public, commissioned by the RCGM, showed that only 2% of New Zealanders identified GE as an important issue without being prompted. It also showed that ~65% of respondents approved of using GE in medical research, and 64% supported its use in medicines and vaccines (1, pp 179–182).

The future of GE in New Zealand looks bright. The RCGM has highlighted that New Zealand has too much to lose to ban GE altogether. New Zealand has a great deal to offer the rest of the world when it comes to GE technology. Research can be done in New Zealand for a lesser cost than in the United States or Europe, and the country has some of the world’s leading scientists working in genetic research on cattle and sheep. New Zealand is also free of “mad cow disease” (bovine spongiform encephalopathy) and foot-and-mouth disease.

In the commission’s own words,

Reference

1. Eichelbaum, T.; Allan, J.; Fleming, J.; Randerson, R. Report of the Royal Commission on Genetic Modification; New Zealand Royal Commission on Genetic Modification, Department of Internal Affairs: Wellington, New Zealand, 2001.

Pauline Hamilton is a pharmacist and freelance writer based in Oamaru, New Zealand (hamlin@es.co.nz).