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New Zealand Journal of Environmental Law |
Last Updated: 25 January 2023
1
A History of Biotechnology Regulation in New Zealand
Janet Hope*
This article traces the history of New Zealand’s approach to regulating genetic modification technology from the early 1970s to the end of the 20th century. It highlights the influence of New Zealand’s unique characteristics — its geographic isolation, size, cultural heritage and peculiar economic liabilities and opportunities
I. INTRODUCTION
Over the past several years, issues surrounding genetic modification (GM) technology have been the subject of intense international debate. New Zealand’s experience of this debate is of particular interest because although in broad terms
* BSc (Hons), LLB (Hons), Grad Dip Leg Prac; PhD candidate, Law Faculty, Australian National University, Canberra 0200 (HopeJ@law.anu.edu.au). The bulk of this manuscript was written while the author was an honorary research fellow at the Department of Physics and Theoretical Physics, University of Auckland, in 2000. I am grateful to Associate Professor Peter Wills of that Department for helpful discussions and access to materials.
the issues have been the same in New Zealand as elsewhere, the nature and extent of public involvement in the New Zealand debate has been unique. In particular, New Zealand’s recent Royal Commission on Genetic Modification represents an international high watermark for public participation in GM policy development.
At the time the Royal Commission was established, legislation regulating GM technology had been in force in New Zealand for only two years. By world standards, regulation of GM technology in New Zealand was relatively strict. Yet New Zealanders were not satisfied with the regulatory regime which had grown up over the previous quarter century, instead choosing to throw existing regulatory arrangements open to question in a national public forum. To understand why, it is necessary to examine the history of New Zealand’s regulatory approach. This article traces the history of GM regulation in New Zealand from the early days of the technology through to the start of the Royal Commission’s work in July 2000. It does not assume that the reader is familiar with the issues and institutional context of the GM debate in New Zealand or elsewhere. Rather, it is intended to help anyone who has not so far engaged with these issues to acquire sufficient background understanding to participate meaningfully in ongoing
public discussion.
The article does not cover the outcome of the Royal Commission or the response of the New Zealand government to its recommendations. Readers who are interested in taking up the story where this article leaves off are directed to the Report of the Royal Commission itself, and to the internet sites of those government departments and agencies responsible for GM regulation in New Zealand.1
II. EARLY HISTORY TO LATE 1980s
1. Early New Zealand History
Located in the South Pacific Ocean on the boundary between the Indo-Australian and Pacific plates, New Zealand has a rich volcanic soil and a temperate climate.
1 A free electronic version of the Report of the Royal Commission on Genetic Modification is available at http://www.gmcommission.govt.nz/. Useful websites include the Ministry for the Environment, http://www.mfe.govt.nz/; Ministry of Research, Science and Technology, http://www.morst.govt.nz/; Environmental Risk Management Authority, http:// www.erma.nz.govt.nz/; Australia New Zealand Food Authority, http://www.anzfa.govt.nz/. See also Janet Hope, “Commentary: New Zealand Royal Commission on Genetic Modification” (2001) 18(5) Environment and Planning Law Journal 441; Janet Hope, “New Zealand’s Royal Commission on Genetic Modification: A Critical Review” (submitted to International Journal of Sustainable Development on 6 May 2002).
For 50 million years its landmass remained isolated, resulting in the evolution of unique flora and fauna. The first humans to settle in New Zealand were Polynesians, arriving over a period of several hundred years up until the mid- fourteenth century; modern Maori are descendants of the last wave of migrants. Maori did not introduce many animals or plants to New Zealand. They practised deliberate environmental management, imposing restrictions (rahui) on the use of particular resources from time to time. Nevertheless, the arrival of humans in New Zealand affected its ecology: forest cover was reduced and some species became extinct.2
Europeans began to settle in New Zealand during the early nineteenth century. In 1840, Maori leaders and representatives of the British Crown signed the Treaty of Waitangi, which gave Britain the right to govern New Zealand while guaranteeing certain rights to Maori. Europeans introduced large numbers of mammals, birds and fish and even more plants, and accelerated changes to New Zealand’s landscape and ecology. Forest cover was further reduced, many more species became threatened or extinct, and New Zealand’s ecology came to be dominated by non-native species. Some of these species came to form the basis of New Zealand’s modern economy, while others became serious pests.3
Before and during European settlement, Maori maintained detailed traditional knowledge (matauranga Maori) about native species. Lacking access to this knowledge, Europeans built instead on the work of early European explorers documenting unique native flora and fauna; by the early 1900s New Zealand had its own small biological research capacity, located mainly in museums and university colleges.4 In the 1930s, the government increased support for agricultural and industrial development by employing more of its own scientists. The Department of Scientific and Industrial Research established New Zealand’s first molecular biology research laboratory in the late 1950s, but New Zealand’s biological science community remained small. Then from the late 1960s, the government began to dismantle its internal scientific infrastructure. Many scientists left New Zealand. Molecular biologists who stayed worked almost exclusively in universities.5 Funding
for their research came from the New Zealand Medical Research Council (NZMRC), a counterpart of the Medical Research Council in the United Kingdom and the National Institutes of Health (NIH) in the United States.
2. Limited Early Regulation of rDNA Research
In the early 1970s, twenty years after the structure of DNA first became known, scientists learned how to cut and rejoin strands of DNA to create recombinant DNA (rDNA) molecules and began conducting the first successful cloning experiments. Some prominent scientists expressed concern about rDNA research, worrying that the new techniques might not be safe and fearing a public backlash if the scientific community appeared to be acting irresponsibly.6 In 1974 the US National Academy of Sciences proposed a moratorium on rDNA experiments until the NIH could develop safety guidelines. The Academy established the Recombinant DNAAdvisory Committee (RAC), many of whose members were scientists directly involved in rDNA research, to advise the NIH. The following year scientists from around the world — including New Zealand — met at Asilomar, California. They agreed there should be a moratorium on rDNA experiments, and proposed a set of safety recommendations to guide rDNA research.7
New Zealand scientists shared international concerns; there were also specific fears that rDNA experiments conducted in New Zealand might have created a new plant pathogen.8 In 1975, the NZMRC asked researchers to follow a new code of practice for in-vitro rDNA research and experiments involving novel genetic technology.9 The code of practice was voluntary, but the NZMRC had power to withhold funding, and researchers agreed to comply.
In 1977 the Minister for Science and Technology set up a working party to decide how rDNA research should be regulated in New Zealand. The working party recommended a committee to provide advice on safety measures and monitor the types of experiments being conducted; enforcement of reporting requirements and safety guidelines would remain with individual research institutions. The committee model was like that adopted by the United States (RAC), the United Kingdom (Genetic Manipulation Advisory Group) and Australia
(Recombinant DNA Monitoring Committee): in effect, the scientific community would mostly be allowed to continue regulating itself. Cabinet accepted the working party’s recommendations, and in 1978 it passed a resolution establishing the Advisory Committee on Novel Genetic Techniques (ACNGT). The ACNGT had responsibility for contained (laboratory) experiments involving new genetic techniques. The Cabinet resolution imposed an indefinite moratorium on experiments outside strict containment (field trials and releases).10
This distinction between contained and uncontained experiments assumed that scientists knew what containment really meant in relation to rDNA research, and how it could be achieved. It also assumed that accidental escape of genetically modified organisms (GMOs) from the laboratory was the only really important issue raised by rDNA research. At the time both assumptions were largely shared by the scientific community worldwide. They were not seriously questioned by regulatory authorities in New Zealand or elsewhere.11
The ACNGT made no provision for public participation. When it began work, New Zealand had not yet passed legislation allowing public access to official information.12 The ACNGT reported to the Minister, but its reports were never widely published. The New Zealand public was aware of safety and environmental issues generally — in 1972 New Zealand had become one of the first countries in the world to have an environmental political party13 — but public attention was strongly focused on the nuclear debate; most New Zealanders were not familiar with issues surrounding rDNA research.
The method of risk assessment used by the ACNGT, known as the Brenner system, evaluates risk according to three factors: probability that the genetically modified organism (GMO) will gain access to susceptible human cells, probability that the foreign gene will be expressed as a protein within those cells and probability that the protein product of the foreign gene will damage the individual’s health.14 The outcome of this evaluation is a number, which defines a risk category from 0 (no risk) up to 4 (high risk); the category determines the safety measures to be applied. When the ACNGT was established, available methods for assessing risk were crude: nobody had really tried to develop risk assessment methods until
the mid 1970s, and when they did it was mainly in response to nuclear safety concerns.15 But the simple biological model on which the Brenner system was based was beginning to be out of date before the ACNGT even began work.16 Although the ACNGT recognised that the Brenner system had serious limitations,17 it never abandoned this method of risk assessment.
Because the ACNGT was established by Cabinet resolution, not legislation, it had no authority outside the public sector. At the time practically all molecular biologists in New Zealand worked in the public sector: New Zealand did not experience any significant growth in private sector research in the late 1970s, although in the United States academic scientists were beginning to form partnerships with business to establish private biotechnology companies.18
3. Regulation of GMOs Outside the Laboratory
By the time the ACNGT was established in 1978, the international scientific community was already backing away from its initial safety concerns. In the laboratory, familiarity had eroded fear, while in the public arena, scientists’ display of self-restraint at Asilomar — and policy-makers’ perceptions of the commercial potential of biotechnology — had averted the possibility of heavy-handed official interference. Scientists began to complain that the new guidelines hindered research. In 1979 a meeting of the RAC concluded that any risks associated with rDNA research were negligible. Many members had strong personal and financial interests in favour of this conclusion.19
After the Asilomar conference, GMOs created for laboratory research had generally been “crippled” for safety reasons.20 By the mid 1980s, this was no longer true. In 1980 the US Supreme Court had ruled that genetically altered life forms could be patented.21 Exclusive patent rights meant that the development
of GMOs could be made profitable despite needing substantial resources; together with important changes in US federal patent policy, the ruling paved the way for commercial exploitation of rDNA techniques. Scientists began work on GMOs which were intended to thrive outside the laboratory. By 1985 biotechnology companies in the US were ready to begin field trials of crop plants engineered to be resistant to insects, viruses and bacteria. Some were not prepared to wait for Environmental Protection Agency (EPA) approval: the first field trials were performed surreptitiously in 1985.22 The following year the EPA approved the first legal US field trial of a genetically engineered tobacco crop.23
Around the world, GM regulation lagged behind scientific and commercial developments. In the US, where the biotechnology industry already had significant policy influence, the Office of Science and Technology Policy (OSTP) decided not to establish any new body with specific responsibility for regulating genetic engineering, deeming regulation by existing agencies within a framework co- ordinated by the OSTP to be adequate. Agencies were directed to make decisions according to the nature of the end product being regulated rather than the process used to make the product, an approach which was consistent with the prevalent view that GMOs as a class posed no special threat.24
In New Zealand the moratorium on field trials and releases of GMOs remained in place, and the ACNGT continued to be responsible only for contained experiments. In 1986 the Minister for Science and Technology established the Field Release Working Party (FRWP) to make recommendations about how field testing and release of GMOs might be regulated. Its report, based substantially on input from the scientists whose work was to be subject to regulation,25 recommended a statutory committee to assess all applications to field test or release GMOs; but because preparing legislation would take time, the FRWP also recommended establishing an interim committee. At the time, the Ministry for the Environment (MFE) was conducting studies and consultations in response to public and industry pressure for reform of the piecemeal legislative regime relating to hazardous substances and new organisms. GMOs were a class of new organisms; policy development for GMOs could be incorporated into the process. In addition, the Minister for the Environment was thought less likely to be biased on the GMO issue than the Minister for Science and Technology or the Minister for Agriculture.26 The FRWP therefore recommended that the Minister
for the Environment be responsible for both the legislation and the interim committee.
In 1988, following consultation with Maori and the general public, the Minister for the Environment established the Interim Assessment Group (IAG) under s 33 of the Environment Act 1986.27 The IAG was responsible for assessing all applications for work with GMOs outside strictly contained conditions — i.e. for field trials, glass house trials and large-scale fermentation — while the ACNGT continued to oversee contained experiments. All public sector researchers were obliged to apply to the IAG for approval to conduct field trials. Like the ACNGT, the IAG had no legal authority outside the public sector; private sector researchers were encouraged to comply voluntarily with IAG procedures, which were based on principles set out in a discussion document published in 1988 by MFE.28 These principles included a right to be informed and a right to comment on applications, for both the scientific community and the public.
The IAG published a checklist of issues to be addressed in applications. Once an application had been submitted and checked for completeness, the applicant placed a notice in national and local newspapers. Members of the public could obtain a copy of the application from the IAG, and were allowed thirty working days to make submissions. The IAG met as needed to discuss applications and review submissions; it used the Brenner system but also took into account broader issues when they arose. Its decisions took the form of recommendations to the Minister for the Environment, who then passed on the final decision to the applicant.29
With the establishment of the IAG, the ten year moratorium on field testing of GMOs in New Zealand was lifted. The first New Zealand GMO field trials — of GM potatoes — were conducted in the summer of 1988–89.30
III. LATE 1980s TO MID-1990s
1. Genetically Modified Food Safety
In the United States and Britain, biotechnology companies were satisfied with the results of field trials of GM crop plants. They began to seek official approval to market GM foods. But approvals could not be granted because there was no existing framework for regulating GM food products: the question of how GM food should be regulated was still open.
In 1990 chymosin, an enzyme used in cheese making, became the first GM product to enter the food supply.31 In the same year the concept of “substantial equivalence” first surfaced internationally. Substantial equivalence refers to a comparison between the new food product to be regulated and other similar products already on the market: if the chemical composition and nutritional value of a new food is “substantially equivalent” to that of an already existing food, regulators presume for the purposes of further evaluation and labelling that the new food is safe. In 1992 the US Food and Drug Administration (FDA) introduced GM food safety assessment based on the principle of substantial equivalence. The degree and type of similarity needed for two products to be considered substantially equivalent was never clearly defined; nor did the FDA conduct its own tests to determine substantial equivalence, instead accepting company test results.32 In 1993 the FDA declared that GM foods were “not inherently dangerous” and did not require any special regulation. This hands-off policy was consistent with that of other US regulatory agencies, the Environmental Protection Authority (EPA) and the US Department of Agriculture (USDA). In 1990 the OSTP had made non-regulation of GMOs the default position in the US, stating that deliberate releases should not be subject to federal oversight except where specific information showed regulation was needed;33 by 1992, all US regulatory agencies were moving away from case-by-case assessment, and whole classes of GMOs and GM products were exempted from regulation entirely.34
Over the next four years the concept of substantial equivalence became entrenched internationally. It was formally adopted by the OECD in 1993 and the WHO in 1994 — the same year the FDA gave its first marketing approval
for a GM food (the FlavrSavr tomato). In 1996 the concept of substantial equivalence was endorsed by the United Nations food standards body, the Codex Alimentarius Commission.35
In December 1995 New Zealand signed a treaty with Australia establishing a joint system for developing food standards in Australia and New Zealand; the joint Australia New Zealand Food Authority (ANZFA) began work in 1996.36 GM foods which had been approved by an overseas regulatory authority (including the FDA) were not required to undergo independent safety assessment. Between 1996 and 1999, ANZFA allowed the release of eighteen GM food products onto Australian and New Zealand markets, including potatoes, sugar, wheat and corn.37
2. Intellectual Property and Biosafety
Widespread deregulation of genetic engineering and its products during the late 1980s and early 1990s was a triumph for the argument that there was nothing really new or different about genetic engineering. But in the same period the novelty of genetic engineering techniques formed the legal basis for continued strengthening of intellectual property protection. From 1987 the US Patent and Trademark Office considered non-naturally occurring, non-human living organisms (plants and animals) to be patentable subject-matter.38 Harvard researchers were granted the first animal patent in the US in 1988.39 Their invention, a mouse genetically engineered to be highly susceptible to cancer, received a European patent in 1990.40 By the mid-1990s, human beings were the only living things not generally regarded as patentable subject-matter. In 1994 the World Trade Organisation General Agreement on Tariffs and Trade (GATT) included provisions concerning Trade-Related Aspects of Intellectual Property Rights (TRIPS). The overall effect of TRIPS was to strengthen international patent protection of GMOs.41
Ever-strengthening patent protection for living organisms encouraged biotechnology companies to go in search of new species with properties which might be commercially exploited, enlisting the help of indigenous people in developing countries, where the greatest biodiversity was found, to provide essential local knowledge.42 In 1991 Merck entered into a bilateral agreement with a Costa Rican government agency, INBio, promising compensation in return for access to Costa Rica’s genetic resources. The Merck-INBio bioprospecting agreement became a model for other arrangements involving indigenous people around the world.43
But while deregulation and intellectual property protection strengthened the position of the biotechnology industry, other international developments were taking place with potentially the opposite tendency. In 1987, the precautionary principle (which had originated in domestic West German legislation during the 1970s) was explicitly adopted for the first time in the international arena.44 By 1990, the
U.N. Secretary-General was able to report that the principle had been endorsed in “virtually all recent international forums”.45 The form of the principle varies from one instrument to another, but its essence is that scientific uncertainty should not be used as an argument against taking measures to protect the environment. The recent history of risk assessment, especially in the United States, had shown that scientific uncertainty could be a powerful political tool for avoiding environmental regulation;46 adopting the precautionary principle was a conscious rejection of this approach.
In 1992 the precautionary principle was incorporated as Principle 15 of the Rio Declaration on the Environment and Development.47 The next year the United Nations Convention on Biological Diversity came into force, with New Zealand as a signatory.48 In 1994 and 1995 biosafety experts appointed by parties to the Convention recommended adoption of an international biosafety protocol including
M. 818 (entered into force on 29 December 1993).
provisions relating to GMOs. The first attempts to negotiate the protocol were made in 1996.49
3. Growing Public Awareness of GM Technology
Through the late 1980s to mid-1990s, public awareness of genetic engineering gradually increased around the world. As early as 1987 radical environmental groups opposing genetic engineering had targeted field trials in the US,50 but it was the often sensationally reported successes of the industry itself which attracted most public attention. In 1989 and 1990 the creation of the National Centre for Human Genome Research in the US and the launch of the $US 3 billion Human Genome Project were announced with enormous fanfare.51 In 1990 the first human gene therapy trial set off a round of discussion in the media and in academia which was repeated in 1993 with the first cloning of human embryos and in 1996-1997 with the cloning of “Dolly the sheep” from an adult cell.
The greatest public concern over genetic engineering at this time centred around ethical rather than safety considerations. But the general publicity gave dissenting scientists their first real opportunity to be heard on safety issues since the mid-1970s. For example, in November 1994 an international group of scientists at the Third World Network conference in Penang, Malaysia, released a statement pointing out the need for greater regulation and control of genetic engineering.52 In 1997 a survey conducted in 15 European Union countries plus Canada, Japan and New Zealand included results about public attitudes to genetic engineering.53 New Zealanders were found to have a higher level of background knowledge and understanding of biotechnology compared with people in other countries, and they rated genetic engineering as an important issue. New Zealanders were also generally pragmatic about biotechnology applications, but did not consider that experts knew enough about the technology for it to provide
any clear benefit to New Zealand. Thus, in 1997, New Zealanders were beginning to be interested in genetic engineering, but most were still undecided in their views.
4. General Developments in New Zealand
In the decade to the mid-1990s, New Zealand scientists incorporated genetic engineering techniques into their research, but GM technology had basically no impact on New Zealand industry.54 Despite some movement away from commodity trading towards new industrial and commercial activities, the New Zealand economy remained heavily dependent on agriculture.55 There was no venture capital available for formation of start-up biotechnology companies. Nor was there an established chemical or pharmaceutical industry from which new branches specialising in biotechnology could have grown. The absence of any substantial industry presence meant that New Zealand policy-makers were not under the same kinds of pressures to favour industry concerns experienced by policymakers in the US or in Britain.
In the late 1980s, new legislation brought about major structural changes in the New Zealand public sector.56 Existing government science groups were reorganised into Crown Research Institutes in 1992. The long-standing trend away from government involvement in basic molecular biology research was reversed, but existing information and funding pathways between science and industry were disrupted and not immediately replaced.57 Political alliances between science and industry which influenced GM policy elsewhere were therefore largely absent in New Zealand.
Changes to the public sector were accompanied by significant changes in governance. In the early 1990s New Zealand adopted a mixed member proportional (MMP) electoral system; this system tends to increase the political focus on particular issues relative to party and electoral matters, and to increase the diversity of select committee membership so that the legislative process is less dominated by party politics.58 At one level, the Royal Commission on Genetic
Modification was the result of a sustained focus on GM issues in the New Zealand political arena led by a minor party (the Greens). It is therefore arguable that without MMP, the Royal Commission would never have been established.
Another relevant development in New Zealand during this period was the highly successful trial production of organic peas and kiwifruit for export conducted in 1990 and 1991 by Watties and the New Zealand Kiwifruit Marketing Board. These trials signalled the start of rapid growth in export focused organic and integrated pest management (IPM) farming, aimed at producing large yields with minimal agrochemical residue.59 The success of organic and IPM farming was significant because it meant that, unlike many other countries which do not enjoy the geographic isolation of New Zealand, by the turn of the century New Zealand had a genuine, economically attractive alternative to GM farming.
Finally, the early to mid 1990s saw major legislative change affecting environmental management in New Zealand.60 In 1991 the Resource Management Act (RMA) broke new ground with its focus on sustainable management. The RMA was directed to managing the environmental effects of activities rather than the activities themselves, so that the person carrying out an activity had full responsibility for avoiding adverse effects instead of relying on compliance with approved procedures. Other important legislation included the Biosecurity Act 1993, and the Hazardous Substances and New Organisms Act 1996, discussed below.
5. Operations of the Interim Assessment Group
When the IAG was established in 1988, the RMA was still being drafted. It was expected to include provision for a permanent statutory committee to replace the IAG. When Parliament passed the new legislation three years later, Part XIII described a “Hazards Control Commission” to help control hazardous substances and new organisms. But this part of the RMA was never brought into force. By the time the IAG was eventually replaced, it had been operating for nearly a decade.
A high proportion of applications received by the IAG came directly or indirectly from foreign companies wanting to field test their genetic engineering products in New Zealand.61 They were attracted to New Zealand for various reasons. In the case of crop plants, New Zealand had relatively few pests. More importantly, its southern hemisphere location allowed testing to be completed
more quickly by taking advantage of a second growing season. In the case of animals, New Zealand’s excellent animal health status, especially the absence of scrapie in sheep, was the major factor.62 Perhaps New Zealand’s no-fault liability laws and distance from the applicants’ home countries were also considerations.63 The IAG’s work raised a number of issues which are still relevant to the GMO debate in New Zealand. A proportionally large number of submissions were from Maori who were strongly opposed to genetic engineering involving human genes, and to a lesser extent any genetic engineering which crossed species barriers.64 The notion of whakapapa (genealogy) is central to practical and spiritual aspects of Maori culture: it defines the basic structure of relationships between generations and between species.65 Genetic manipulation was perceived as
interfering with whakapapa.
Maori concerns also focused on consultation. Consultation with Maori is necessary to give effect to the principles of the Treaty of Waitangi, but achieving genuine consultation was far from straightforward.66 One problem was identifying who should be consulted. Traditional Maori social and political structures are based around whanau, hapu and iwi. These groupings have different but sometimes overlapping responsibilities for local, regional and national issues. Organisations claiming to speak on behalf of a group may not be regarded as representative by everyone in the group, and because the Treaty partner is tangata whenua (the local people) rather than any national entity, a decision by any given iwi cannot be treated as a precedent for later consultations.67
Another problem was that people being consulted had to be well informed. But both providing and absorbing information require significant resources — and how to determine when someone is sufficiently informed?68 These and other difficult issues were not confined to consultation with Maori. The IAG was committed in principle to the public’s right to be informed and to comment on applications. This was a step forward, but most New Zealanders remained
unfamiliar with genetic engineering issues.69 Given the technicality of the applications, 30 days for submissions was very tight. The IAG’s deliberations were private. And though legislation now gave the public some access to official information,70 the IAG’s reports to the Minister did not reveal the weight attached to particular considerations.71
Public participation in IAG decision-making was also limited because of the commercial sensitivity of information provided by applicants. The Official Information Act 1982 allows information to be withheld if making the information available would disclose a trade secret or could prejudice the commercial position of the person who supplied the information.72 Attempting to strike a balance between public access to information used for assessments and industry concerns over disclosure, the IAG asked applicants to submit confidential information in a separate marked document; it would recommend the material be withheld from public scrutiny provided this would not deprive the public of any significant information about environmental or other risks.73
The IAG’s risk assessment involved a risk-benefit analysis of information provided by the applicant in response to a checklist. The checklist included questions about the characteristics of the GMO in question, ecological and environmental considerations as well as social, cultural and economic impacts of the proposal. Besides the applicant’s information, the IAG considered information from the EPA and USDA regarding scientific evidence of environmental effects. Its main focus in relation to field trials was minimising the risk of heritable material leaving the test site; possible risks associated with very low level gene leakage were not considered important.74 In general, the IAG took the view that genetic engineering was not really dangerous — or at least, that the dangers were sufficiently well understood for research to continue under minimal control. When it received strong objections to one application on the ground that the proposal had clear economic benefits only for the overseas applicant, the IAG argued
approval should be declined — not because the risks outweighed benefits, but in order to protect the future development of genetic engineering in New Zealand.75 As to whether the IAG was an appropriate forum for developing GM policy,
the IAG itself acknowledged that the matters raised in submissions had the potential to sustain a far wider debate.76 In 1992 and 1993, reports by the Parliamentary Commissioner for the Environment criticised existing arrangements for regulation of biotechnology in New Zealand. The reports pointed out the fragmentation of regulatory systems, the inadequacy of information bases, the absence of any central body of expertise, poor risk management tools and the lack of compliance monitoring.77
IV. LEGISLATIVE REGULATION OF GMOs, 1998–2000
1. Hazardous Substances and New Organisms Act 1996
In 1992 MFE released a discussion paper entitled “Hazardous Substances and New Organisms — Proposals for Reform”. In November 1994, the Hazardous Substances and New Organisms (HSNO) Bill was introduced into Parliament. The HSNO Act (“the Act”) became law on 10 June 1996. For the first time, New Zealand had a legislative framework for the regulation of GMOs.
The Act established the Environmental Risk Management Authority (“ERMA”, “the Authority”), an independent regulatory body responsible for implementing the Act. Substantive provisions of the Act relating to new organisms came into force on 1 July 1998. On that date the IAG and ACNGT stopped receiving applications.78 ERMA took over assessment of applications for the importation, development, field testing or release of GMOs: none of these activities were now legally allowed without ERMA’s approval (s. 25).
This section provides an overview of the Act with respect to its scope and purpose, its manner of addressing Maori perspectives, and the decision-making framework established by the Act. The next section deals with ERMA’s performance between the time the relevant parts of the Act came into force and
the announcement of the Royal Commission, including specific issues relating to Maori views, public participation and compliance enforcement.
(a) Scope of the Act as it relates to GMOs
There are some important limitations to the Act’s coverage of GMOs. Cloned animals are not GMOs under the Act, and nor is a genetically altered human being. Examples of GMOs covered by the Act include plants modified for resistance to particular diseases or herbicides, GM vaccines and transgenic animals (and their offspring).79 The Act regulates GMOs which are deliberately introduced into New Zealand from overseas or are made in a New Zealand laboratory, but does not regulate GMOs being taken through New Zealand in containment on their way elsewhere (s. 51); it does not deal with accidental imports, for example parasites of imported animals, or with spontaneous arrivals, for example windborne pollen from overseas, nor does it directly cover food or medicine produced using genetic engineering techniques.
Some of these matters are dealt with under other legislation. The Biosecurity Act 1993 provides for exclusion, eradication and management of pests and unwanted organisms. The Food Act 1981 gives ANZFA the authority to regulate food. Other relevant legislation includes the Agricultural Compounds and Veterinary Medicines Act 1997, the Medicines Act 1981, the Conservation Act 1987 and the RMA. None was initially drafted with genetic engineering specifically in mind.
(b) Purpose and general values underpinning the HSNO Act80
The purpose of the Act (s. 4) is “to protect the environment, and the health and safety of people and communities, by preventing or managing the adverse effects of hazardous substances and new organisms”. Part II, especially ss. 5 to 7, lists specific principles and matters to be recognised and taken into account by ERMA and others exercising powers, functions and duties under the Act.
Section 5 provides:
Principles relevant to purpose of Act — All persons exercising functions, powers, and duties under this Act shall, to achieve the purpose of this Act, recognise and provide for the following principles:
(a) The safeguarding of the life-supporting capacity of air, water, soil, and ecosystems:(b) The maintenance and enhancement of the capacity of people and communities to provide for their own economic, social, and cultural well- being and for the reasonably foreseeable needs of future generations.
In Parliament the Minister for the Environment described these two principles as “environmental” and “economic”, respectively, emphasising that neither principle is to be preferred over the other.81 Other references to these principles in parliamentary debate imply that environmental and economic considerations are to be regarded as separate and competing rather than interdependent. This view may reflect the alignment of environmental and business interest groups during consultation on the Bill, but conceptually it is flawed. By contrast the definition of “environment” in s 2(1) of the Act does acknowledge the interdependence of environmental, social, economic and cultural values.
Section 6 provides:82
Matters relevant to purpose of Act — All persons exercising functions, powers, and duties under this Act shall, to achieve the purpose of this Act, take into account the following matters:
(a) The sustainability of all native and valued introduced flora and fauna:(b) The intrinsic value of ecosystems:
(c) Public health:
(d) The relationship of Maori and their culture and traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna, and other taonga:
(e) The economic and related benefits to be derived from the use of a particular hazardous substances or new organism:
(f) New Zealand’s international obligations.
Compared with the words “recognise and provide for” in s 5, the requirement in s 6 to “take into account” is relatively weak,83 but within the section none of the matters listed takes precedence over any other. Where there is conflict, the
section gives no guidance as to how it should be resolved. Paragraphs (a), (b) and (c) presuppose scientific understanding of complex biological phenomena extending across traditional disciplinary boundaries. Paragraph (d) is discussed together with s 8 below.
The inclusion of “economic and related benefits” at paragraph (e), as a mere matter to be taken into account in achieving the purpose of the Act, reinforces the argument that on the face of the Act, economic factors are less important than the overall aim of protecting people and the environment. Paragraph (f) refers to New Zealand’s international obligations. There is no comprehensive international agreement relating to GMOs, but New Zealand is party to several relevant instruments.84
Section 7 provides:
Precautionary approach — All persons exercising functions, powers, and duties under this Act ... shall take into account the need for caution in managing adverse effects where there is scientific and technical uncertainty about those effects.
Section 7 is the first direct incorporation of the precautionary principle into New Zealand legislation. But the wording of the section falls short of incorporating the principle in its strongest form. For example, it does not by itself reverse the burden of proof concerning the likelihood of adverse effects of a GMO.85
The effect of the section is not clear from what was said in Parliament about the HSNO Bill. In the Third Reading Speech, the Minister for the Environment said that s 7 does not spell out any particular level of caution or protection;86 similarly, the Select Committee member who reintroduced the Bill into Parliament regarded the precautionary approach as simply requiring “adequate quality and quantity of information”. But he added: “in respect of new organisms the legislation is very conservative. ... Probably when we learn about genetically modified organisms ... and become a little more comfortable with them ... we will decide that it is too conservative. It is certainly not appropriate to be anything other than very conservative at this stage of the genetically modified organisms debate.”87 Other members of Parliament disagreed with the Minister that s 7 provided no guidance as to how cautious ERMA should be, taking the words “precautionary
approach” at face value.88 A further difficulty with s 7 is determining what constitutes “scientific and technical uncertainty”.
Taken together, ss. 5 to 7 of the Act do not provide any clear indication of the level of protection required to be given to people and the environment under the Act. Parliament left ERMA to decide, in consultation with the public, how conservative its approach should be. Its decision was to be incorporated into the methodology provided for in s 9, discussed below.
(c) Taking account of Maori perspectives under the HSNO Act
Section 8 of the Act requires all persons exercising powers and functions under the Act to take into account the principles of the Treaty of Waitangi. Together with para. 6(d) above, s 8 obliges ERMA to consider Maori views on applications relating to GMOs.
Interpretation of the Treaty of Waitangi evolves over time; principles of the Treaty are derived from legal precedent. They include principles of partnership, self-determination and self development, the right and responsibility of Maori to make decisions on the use, control and protection of natural resources, and obligations of good faith and good governance on the Crown. Genuine consultation with Maori is necessary to give effect to these principles.89
Until the mid 1980s, no New Zealand legislation incorporated explicit requirements to consult with Maori. Political protest then forced the government to take its Treaty obligations more seriously, and in 1985 the Waitangi Tribunal, which had until then been limited to hearing grievances relating to actions since its establishment in 1975, was given jurisdiction extending back to 1840.90 Environmental legislation began to include consultation provisions similar to those in the Act. Many of these provisions are regarded by Maori as tokenistic; the obligation to consult is often expressed in weak language. This is certainly the
case in ss. 6 and 8 of the Act, which use the formulation “take into account”. Even where legislation uses stronger language, enforcement of the requirement involves expensive court action.91
Before the Royal Commission, ERMA made some effort to incorporate Maori views in its decision-making. During 1997 it established a committee, Nga Kaihautu Tikanga Taiao (Nga Kaihautu), to help fulfil its obligations under para. 6(d) and s 8 of the Act. Nga Kaihautu was to provide specialised advice on the principles of the Treaty of Waitangi, on adverse effects and risks of particular concern to Maori, Maori approaches to risk and whether individual applications succeeded in addressing issues of concern to Maori.92 But it had no political mandate from the Maori community. ERMA’s success or otherwise in incorporating Maori perspectives in its decision making is discussed below.
(d) Decision-making process and methodology
(i) ERMA and ERMA New Zealand
Part IV of the Act establishes ERMA as a body corporate consisting of between six and eight members appointed by the Minister for the Environment (ss. 14 and 15), who is required to ensure that ERMA’s membership includes “a balanced mix of knowledge and experience in matters likely to come before the Authority” (s. 16). ERMA’s main function is to make decisions on applications under Part V of the Act. It is supported by ERMA New Zealand, an organisation which is headed by a Chief Executive appointed under the Act.
(ii) Application process
The application process for approval to import, develop, field test or release a GMO under Part V of the Act begins with the applicant providing information to ERMA, including a detailed risk assessment and evidence that the applicant has undertaken any necessary consultation with the public, including Maori.93 Once the application is properly lodged it must be publicly notified, unless it is categorised as “low risk”.94
Following notification, members of the public have up to 30 working days to make submissions on the application. ERMA, the applicant or anyone making a submission can ask for a public hearing. When conducting a hearing ERMA has
some of the powers of a Commission of Inquiry, including the power to summon witnesses. After the hearing, ERMA considers the application and any submissions and makes its assessment. ERMA’s decision on each application is publicly notified together with its reasons, again unless it is categorised as “low risk”.
Where the decision on an application is likely to have significant economic, environmental, international or health effects, or significant effects in an area in which ERMA lacks sufficient knowledge or experience, the Minister for the Environment may “call in” an application and make a decision (ss. 68 to 73).
The possible outcome of an application depends whether it is an application for release or containment. In the case of release applications, ERMA must either decline or approve the application. It cannot impose conditions, on the ground that the act of releasing a GMO is inherently uncontrolled and irreversible. ERMA can decline an application if it does not have enough information to determine the adverse effects. In the case of applications to import, develop or field test a GMO in containment, ERMA can decline, approve or approve with controls.
(iii) Decision-making methodology
Section 9 of the Act requires ERMA to develop a methodology to be published and applied consistently with respect to each application. The methodology, in the form of an Order-in-Council, must be developed in accordance with the same public consultation and Parliamentary procedures as regulations made under the Act and has the same legal status.95 ERMA released a proposal for its methodology following public consultation in January 1998, and in August it published the final Methodology Order in annotated form.96
ERMA’s decision-making under Part V of the Act is guided by the provisions of the Act, the Methodology Order, the notes accompanying the Methodology Order, regulations and protocols issued by ERMA from time to time. In some circumstances the risks associated with a GMO will be so high that ERMA is
... Rather than delegate the entirety of this decision to the Authority, the House decided... that there [should be] full public scrutiny. ... How risk averse we are as a community is a social, political, and cultural judgment. Technical experts — the sorts of people whom we will be appointing to the Environmental Risk Management Authority — have no special wisdom when it comes to these ... judgments. It is in respect of this matter that the duly elected representatives of the people should have a say and... the public at large should have a say.” Simon Upton (Minister for the Environment), HSNO Bill: Third Reading, Hansard, 23 May 1996.
required to decline an application automatically; in all other cases, the essence of ERMA’s assessment is to decide whether the positive effects of approving the application would outweigh the adverse effects.
To do this ERMA must evaluate risks, costs and benefits. The notion of risk incorporates both the likelihood of adverse consequences and the seriousness or magnitude of those consequences; costs and benefits include both monetary and non-monetary considerations. The weight given by ERMA to different sources of information depends on ERMA’s view of the quality of the information and its relevance. (The Methodology implicitly treats scientific information as being the most relevant kind of information, requiring ERMA to begin its evaluation with a consideration of the scientific evidence.)
When evaluating its assessment of risks associated with a GMO, ERMA must take into account the nature and probability of occurrence of each adverse effect, the degree of risk, the options and proposals for managing identified risks and the degree of uncertainty associated with the relevant information. When evaluating costs and benefits, ERMA must take into account whether the costs and benefits are monetary or non-monetary, their magnitude or expected value and the degree of uncertainty associated with expected values. Significantly, it must also take into account the distribution of costs and benefits over time, space, and groups in the community and may include “opportunity costs” and other positive or negative effects of declining the application.
In general the Methodology indicates that ERMA’s attitude to risk will lie on a continuum within the range of risk averse to risk neutral. The Act, while emphasising the need for caution in the face of uncertainty, leaves open the question how cautious; the Methodology says there will be a presumption in favour of caution and extends the precautionary approach in s 7 of the Act beyond scientific and technical uncertainty to other sources of uncertainty.
More specifically, the Methodology says ERMA will be more cautious and risk averse depending on whether the risk has certain characteristics. If exposure to the risk is involuntary, if the risk will persist over time, if it is subject to uncontrollable spread and likely to extend its effects beyond the immediate location of incidence, if potential adverse effects are irreversible or if the risk is not known or understood by the general public and there is little experience or understanding of possible control measures, ERMA must be more reluctant to grant approval for the application (cl. 33). The Methodology also refers specifically to risks to human health or well-being, including the human foetus, and risks to the survival of native species or their habitats as justifying a more cautious and risk averse approach.
In the case of live GMOs, most or all of these characteristics can be expected to be present. Nevertheless, the Methodology assumes that although there may be organisms whose risks are inherently incapable of being satisfactorily managed, and which should therefore not be introduced into New Zealand, with most
applications the issue is likely to be establishing conditions for effectively managing the risks. Thus, there is a basic tension between the general assumption that the risks associated with GMOs can be adequately managed and the specific acknowledgement of risk characteristics which should engender special caution.
(iv) Public access to information
The release and withholding of information by ERMA is governed by the Act, the Official Information Act and other legislation. Applicants are able to classify some information as commercially confidential and can specify how long it should be treated as such, but within these bounds ERMA requires the public release of enough information so that people wishing to make submissions on publicly notified applications can be properly informed. Also, ERMA must be able to publicly explain the rationale for its decisions.
Given the protective purpose and public participation focus of the Act, it might be asked why applicants should be allowed to keep any information confidential. Apart from any suggestion that ERMA retains something of the original “national net benefit” approach to its duties, causing it to make concessions to industry in order to increase the chances that New Zealand will gain economic benefits from genetic engineering, one good reason to allow some withholding of commercially sensitive information is that if ERMA insisted on its release it might be much more difficult to achieve full compliance with the Act.
2. ERMA’s Performance under HSNO
(a) Why we need to look at ERMA’s operations
At the time ERMA started work in July 1998, it would have been difficult to predict the outcome of particular GMO applications. The Act provides little direction. The Methodology Order had to be consistent with the Act and could not introduce additional considerations which might have fettered ERMA’s discretion; therefore it had to be a collection of fairly high level statements rather than a detailed decision-making code.97 As the Minister for the Environment commented in his Third Reading Speech on the HSNO Bill: “The way in which any methodology is applied will have a powerful influence on the weighting to be attributed to any of the matters dealt with in [ss. 5 to 7 of the Act], and the overriding issue of risk aversion that lies at the heart of this legislation”.98 Therefore,
it is necessary to look at ERMA’s operations to see how the Methodology has been applied and whether the basic tension mentioned above has been resolved.
(b) ERMA’s operations with respect to GMOs
From 1 July 1998 to the announcement of the Royal Commission in mid 2000, GMO applications dominated ERMA’s decision-making under Part V of the Act.99 At the time the Royal commission began work, all GMO applications had been approved with controls. This outcome might suggest that ERMA was prepared to accept a high level of risk associated with GMO experiments. In fact ERMA never found it necessary to decide how much risk it should tolerate for the sake of particular benefits. This was because in each case ERMA took the view that if it was prepared to impose strict enough control measures, the risks associated with the application could be brought down to a negligible level. For this reason, ERMA’s published decisions give little guidance as to how the difficult process of weighing up risks, costs and benefits of GMO applications will be carried out in practice.100
ERMA’s confidence that all the physical and biological risks associated with GMOs can be effectively managed with controls is significant. It reveals an underlying belief in scientists’ claims to understand the nature of those risks. This belief is reflected in ERMA’s view that horizontal gene transfer and kanamycin (antibiotic) resistance are not significant issues in containment,101 and even more strongly reflected in ERMA’s willingness to accept detailed technical descriptions as a basis on which to approve field testing of GMOs which have not yet been developed.102 Thus, ERMA’s assumption has been that the prevalent scientific model of genetic engineering and its effects is adequate.
This assumption highlights a fundamental tension in the Act. On one hand, the Act says it exists to protect people and the environment and emphasises the need for a precautionary approach in the face of scientific uncertainty. On the other hand, the Act clearly envisages that ERMA will grant approvals for GMOs to be imported, developed, field tested and even released. If ERMA took seriously the idea that the prevalent scientific model may be seriously flawed, and that there may be risks associated with GMOs which are not yet known, it might decide that adopting a precautionary approach meant declining all GMO applications. In that case many of the Act’s provisions would be without effect.
Understandably ERMA has felt that it cannot go so far. But the alternative — relying on safety measures based on a contentious scientific model — undermines the protective and precautionary objectives of the Act.
This tension has not escaped the attention of the general public. As ERMA continued to receive applications it found that submissions repeatedly raised the same generic issues irrespective of the details of the application. These issues went to the basic question whether genetic engineering should be allowed in New Zealand at all. To its credit ERMA was careful to give proper consideration to submissions. It found that more and more time was being taken up with submissions opposing genetic engineering generally at the expense of particular applications. At the same time people making submissions were becoming frustrated by ERMA’s unwillingness to address their fundamental concerns.103
(c) Illustration: changing Maori attitudes towards GMOs
The gradual shift in Maori attitudes to GMO applications from relative indifference to strong opposition in the course of ERMA’s operations illustrates this growing dissatisfaction. Between mid 1998 and late 1999 issues relating to Maori took up at least half of ERMA’s time.104 Early applications escaped close scrutiny. All Maori consulted on these applications gave their support, based mostly on information provided by applicants. At the time, Nga Kaihautu was struggling to become operational and, like most New Zealanders, Maori were still largely unaware of the genetic engineering debate.105
As more applications were received, Nga Kaihautu became more proactive in pointing out the deficiencies of applications and raising questions about the quality of consultation with Maori. In late 1998 Nga Kaihautu asked ERMA to decline an application by a Scottish based company, Pharmaceutical Proteins Limited, seeking approval to increase its flock of GM sheep. The sheep had been engineered to produce a human protein in their milk which the applicant claimed could be used to treat congenital emphysema. Two iwi groups had been consulted and were prepared to support the application, but Nga Kaihautu was concerned that the benefits of the application had been presented to Maori as certain rather than speculative. It pointed out that transfer of genes between species was in conflict with traditional Maori beliefs, values and customs. In the end the two iwi neither supported nor opposed the application.106 The process highlighted the
105 Ibid, at 105–6.
106 Ibid, at 106.
difficulty of making sure local Maori were properly informed without usurping their right to make an independent decision. The same kind of difficulty arises in achieving public participation generally.
An application by one of New Zealand’s Crown Research Institutes represented a turning point in Maori attitudes. AgResearch Ruakura applied to produce a herd of cattle with human genes for Multiple Sclerosis research. This application was the first to be opposed by an iwi and the first time a public submission had been received from Maori. Ordinary Maori attended the public hearing.107 This application is discussed further under heading vi, below.
In later applications the same Maori who had been supportive of early applications changed their minds. It was clear that as Maori became more informed about the issues surrounding GMOs they were likely to become less rather than more supportive. This trend coincided with a sharp increase in general public awareness of the genetic engineering debate in New Zealand following intense media attention early in 1999. Perhaps Maori concerns over intellectual property protection for GMOs in response to proposed changes to the Patents Act 1953 (WAI 262) also helped focus concerns.108
The kinds of concerns Maori have shown relate to the effects of GMO applications on Treaty of Waitangi issues, the environment, Maori culture and health and well-being. In relation to the environment Maori want to preserve traditional food and natural resources, valued flora and fauna and natural habitats and the purity of water, land and air. Cultural concerns include non-interference with whakapapa, preservation and maintenance of traditional Maori knowledge, maintenance and control of traditional practices including kaitiakitanga (guardianship), and protection of the mauri (spiritual integrity or life force) of people, Maori culture, language and knowledge, animals and plants, land, waterways and air. Health and well-being includes not only physical health but also psychological and spiritual health.109
The difficulties encountered by ERMA in identifying and taking into account Maori cultural values and perceived risks associated with GMOs prompted ERMA to commission a “generic issues project” to examine these issues and suggest a more effective way of dealing with them.110 Meanwhile, although they did have a distinct cultural and ethical basis, in practice Maori objections largely paralleled the objections of many of the general public. The use of human genetic material causes particular concerns for both Maori and non-Maori, but there are other
resonances. Non-Maori have expressed concern about the well-being of future generations, the impact of genetic engineering on human health and on indigenous flora and fauna and the arrogance of scientists “playing God”.111 Even the Maori notion of psychological health may have some parallel in the wider community with the concepts of community morale and the value placed by New Zealanders on the country’s “clean green image”.
(d) Public participation
The attention given to Maori issues in relation to particular applications has caused some non-Maori to feel that their cultural, spiritual and ethical concerns have been overlooked.112 Whether or not this is justified, it is true that the public participation focus of the Act was not fully realised. This was partly due to the conceptual tension referred to earlier and to differences in levels of awareness and understanding among members of the public. But it was mostly due to the fact that the vast majority of applications were dealt with not by ERMA itself through the public notification and hearing process but under delegation to more than 20 different institutional biosafety committees. An overwhelming number of these “low risk” applications were approved.113
With respect to applications dealt with directly by ERMA, the objective of public participation was enhanced by ERMA’s increasingly detailed explanations of its decisions over time.114 It also seems that public participation can have a significant indirect impact. When over 1400 submissions were received in response to Monsanto’s application to field test Roundup Ready wheat in early 2000, Monsanto reacted by withdrawing its application.115 The previous maximum number of submissions on an application was 30.116
Monsanto’s application raised another issue relevant to public participation. ERMA New Zealand decided not to release to the public confidential information on the genetic construct Monsanto intended to test. This decision was appealed to the Ombudsman; at the time the Royal Commission was announced the Ombudsman had not reached a conclusion on the appeal.117 So in practice,
resolving the conflict between the public participation elements of the Act and applicants’ desire to protect commercially sensitive information has proved difficult.
(e) Compliance
One final matter is worth noting in relation to ERMA’s operations up to the start of the Royal Commission. The Act was the first form of genetic engineering regulation in New Zealand which allowed for compliance monitoring, although the issue of compliance with regulations had been raised in New Zealand in 1985 in connection with unauthorised privately funded genetic experiments involving staff of a university medical school.118
In May 2000 ERMA reported the results of a nationwide check on GM research following reports of unauthorised research at universities and Crown Research Institutes.119 ERMA found 580 GM research projects with appropriate approvals and a further 309 without. ERMA New Zealand’s CEO commented that the results showed “failure by some in the scientific community to adequately engage with the HSNO process”. However, no penalty action was taken. Without judging the seriousness of this level of non-compliance, it is possible to say that ERMA should take another type of risk into account in its decision-making: the risk that scientists will ignore precautions.
While considering risks associated with human misbehaviour, ERMA should also look at the possibility of deliberate outside sabotage. In 1999 ERMA conducted an inquiry into damage to a Crop and Food Research (Crown Research Institute) field trial of GM potatoes following a break-in by environmental protesters (the “Wild Greens”). Controls imposed by ERMA had been designed to secure the site from inside, not to protect it from illegal entry;120 but ERMA should have known about the dangers of vandalism, as similar protests had been conducted overseas since field testing began.121 In this case the protesters presumably did not intend to damage the environment by releasing GMOs. But in general, the possibility of industrial sabotage intended to pre-empt New Zealand’s decision on whether to stay GM free should not be dismissed.
There have also been instances of accidental non-compliance. In 1999, ERMA discovered that Crown Research Institute (Crop and Food Research) trials involving GM canola performed between November 1996 and November 1997 in Canterbury on the South Island may have spread GM canola through holes
which developed in the netting designed to contain the field trial.122 When such accidents happen, it is very difficult — if not impossible — to determine the extent of any damage.
(f) Bleakley v Environmental Risk Management Authority123
At the time the Royal Commission was announced in June 2000, there had been no judicial consideration of the provisions of the Act governing ERMA’s decision- making with respect to GMOs. However, it is appropriate to include here some mention of the High Court’s May 2001 decision in the case of Bleakley v Environmental Risk Management Authority, as the case drew together many of the issues discussed in this section. The case is also of historical interest as the first appeal from a decision by ERMA to approve an application for field testing of GMOs.124
The application in question was lodged by AgResearch. It sought approval to field test cattle genetically modified to express human protein at AgResearch’s Ruakura facility in the Waikato. Ngati Wairere, the tangata whenua (local indigenous people) of the area, objected to the field testing on the basis that GM involving different species interfered with the whakapapa (genealogy) and mauri (life force) of the species involved and was therefore contrary to their tikanga (protocols).125 Following a public hearing and further consultation between AgResearch and Ngati Wairere, a special committee of ERMA approved the application.126 The decision was appealed to the High Court under s 126 and otherwise under Part VIII of the HSNO Act.
As the Act does not provide for judicial review of the merits of ERMA’s decision-making, the High Court was confined to considering whether ERMA’s decision contained errors of law. Twenty-three such errors were alleged by the appellants, relating to ERMA’s treatment of Maori and treaty issues; disposal of
surrogate cows and milk; effects on people and communities; scientific uncertainty and application of the precautionary principle; application of the Methodology Order; use of an external scientific adviser; and precedent effects of declining or approving the application.127
In relation to the first of these matters, the appellants alleged that ERMA had misdirected itself in law in applying ss. 6(d) and 8 of the Act. With respect to s 6(d), they alleged that in approving the application, ERMA had mistakenly interpreted “taonga” (treasures) to be limited to tangible matters, and had failed to take into account the relationship of Maori and their culture and traditions with their spiritual taonga, especially the values of whakapapa and mauri. In separate judgments, McGechan and Goddard JJ. held that the expression “other taonga” in s 6(d) was not limited to physical or tangible taonga, but included intangible cultural and spiritual taonga. AgResearch maintained that spiritual taonga were already catered for by the words “culture and traditions”, but the court rejected this argument, holding that the words “culture and traditions” in s 6(d) were intended not to limit the meaning of “other taonga”, but to emphasise the special nature of the relationship of Maori with the relevant matters in the subsection and to ensure that the relationship of Maori with taonga was not read down, dissipated or minimised by those charged with exercising functions, powers and duties under the Act.128
With respect to s 8, which required ERMA to “take into account” the principles of the Treaty of Waitangi, the court held that ERMA had acknowledged that the Treaty imposed a duty of active protection on the Crown in relation to taonga of Maori, including intangible beliefs, but had decided that it would be unreasonable to give the duty a “determinant” weight. The court affirmed this aspect of ERMA’s decision, noting that ERMA had not determined that Maori spiritual matters and beliefs could never prevail, which would have been an error of law, but rather that the adverse effects on Maori were not such as to outweigh the wider benefits of the project in this particular case. ERMA was entitled to reach this conclusion: the requirement to “take into account” Treaty principles did not amount to giving Maori a right of veto on GMO applications.129
The High Court also considered whether ERMA had had proper regard to the matters in ss. 4, 5 and 6 of the Act. The context was ERMA’s consideration of whether AgResearch’s proposed arrangements for the disposal of surrogate cows and milk posed a threat to the environment or to public health and its consideration of any adverse effects that might arise if the GMO were to escape from containment. The High Court held that ERMA’s conclusions as to the effects on the environment and on public health demonstrated it had had regard to the
effects of the proposed field tests on the matters included in ss. 5(a) and 6(a), (b) and (c). Whilst there was no express discussion in ERMA’s decision of the matters set out in sections 5(b) and 6(d), ERMA had imposed controls which in themselves indicated that it had recognised and catered for the relevant effects. Given that ERMA had reached the view on the evidence that there was no danger of escape of the new organism through the disposal of milk, it was not necessary for it to consider the wider pollution issues.130
In relation to ERMA’s handling of scientific uncertainty and application of the precautionary principle, the appellants argued that ERMA had relegated the question of scientific uncertainty and long-term adverse impacts to the release phase instead of treating them as relevant to the application for field testing, and that this meant ERMA had not applied the precautionary approach required by s 7 of the Act. The High Court held that s 7 of the Act had to be interpreted so as to make sense in the context of an application under s 45. Although s 7 imposed an obligation to take into account the need for caution in managing adverse effects where there was scientific and technical uncertainty about those effects, and ERMA had instead treated the provision as requiring caution over the risk of adverse effects occurring, the court took the view that in practice ERMA’s decision included the required approach.131
In relation to ERMA’s use of an external scientific adviser, the appellants had been concerned that ERMA had not given its appointed scientific adviser all the submissions and additional material that had been placed before ERMA, and that the adviser was not present at the public hearing of the application. The High Court held there was no basis for a legitimate expectation that the scientific adviser would have a greater role than was the case or that the role of the adviser involved a question of natural justice. There had therefore been no error of law in this regard.132
The High Court did find that ERMA had made an error of law in having regard to the potential precedent effect of declining approval for the application. ERMA had been concerned that if Maori objections to the mixing of genetic material from different species were given a determinant weight in its decision- making, it would be necessary to decline all further applications involving GMOs on the same basis. Although the court held that this approach was in error, and that ERMA was obliged to proceed case-by-case, it considered that the error was immaterial because ERMA had not dealt with Maori concerns as an absolute barrier, but as one factor to be weighed with others under the Act. Thus, ERMA had in fact reached a balanced conclusion on the basis of the correct process.133
130 Ibid, paragraphs [97], [98], [100], [102], [105] to [107], [114] and [120] per McGechan J.
131 Ibid, paragraphs [164] to [167] per McGechan J. 132 Ibid, paragraph [265] per McGechan J.
133 Ibid, paragraphs [282] to [285] per McGechan J.
Despite the High Court’s findings on the foregoing matters, ultimately the appeal succeeded on the basis that ERMA had failed to state the specific criteria in the Methodology Order on which it had relied in coming to the view that the application for field testing GM cattle complied with the Act and methodology. The High Court considered this failure to be a material error of law. ERMA’s decision was set aside and ERMA was directed to reconsider and decide the application applying the Methodology Order and stating the relevant criteria.134
V. EVENTS LEADING TO A ROYAL COMMISSION ON GENETIC MODIFICATION
1. GM Food
In 1992 only one country in the world had been growing GM crops commercially; by the time the ERMA started work the number had risen to nine. Twenty-eight million hectares of GM crops were planted globally in 1998, 71% engineered to be herbicide resistant and 27% to be insect resistant.135 These developments were met by increasing opposition from scientists, religious leaders, environmental and public interest groups and members of the public.
In May 1998 a coalition of claimants of diverse interests and backgrounds filed a lawsuit against the FDA to obtain mandatory safety testing and labelling of GM foods.136 In November a global network of physicians and scientists was established. Its members were concerned about conditions they believed to be hampering impartial comprehensive interdisciplinary evaluation of the safety of new applications of science and technology, particularly genetic engineering.137 From late 1998 to mid 1999 a series of European Union retail chains declared themselves GM free, and in response many suppliers, including large grain traders, moved to eliminate or segregate GM grains in order to retain their highly lucrative access to European supermarkets.138
This growing public sentiment against genetic engineering came to a head in New Zealand later than in Europe. In July 1998 Revolt Against Genetic Engineering (RAGE, later known as GE-free New Zealand) was established. RAGE was an
134 Ibid, paragraphs [212] to [214], [217], [218], [226], [230], [231] to [233], [236], [325] and
[328] per McGechan J and at paragraph [330] per Goddard J.
umbrella group set up to co-ordinate activity against the introduction of GM foods to New Zealand. Its members included some who had been active internationally such as Greenpeace, Friends of the Earth and Physicians and Scientists for Responsible Application of Science and Technology, but it was initiated and driven by New Zealand consumer groups.139 Between 1998 and 2000 RAGE made submissions to ERMA on each GM crop application hearing. But it was not until April 1999 that the debate over genetic engineering reached critical mass and was taken up in earnest by the New Zealand media; one of the first events to receive attention was the declaration of New Zealand’s first GM free zone, Waiheke Island in Auckland’s Hauraki Gulf.140
Both internationally and in New Zealand, public concern focused on GM food. Earlier in the decade the major issue relating to GM food had been safety testing. Now the debate expanded to include the issue of labelling. Consumers were no longer prepared to trust assurances by scientists and governments that food was safe. The BSE-infected beef scare in Britain had shaken public confidence in regulatory authorities all over the world. In any case consumers were not concerned only with safety: they wanted to know what they were eating for environmental, ethical and religious reasons. These were process considerations, and the product-focused regulatory regime for food which had been adopted in the US and elsewhere did nothing to address such concerns.
When ERMA began work New Zealand not only did not require labelling of GM food, but it had no GM food safety standard. In August 1998 the Australia and New Zealand Food Standards Council (ANZFSC, made of up Health Ministers from State, federal and national governments) decided to accept ANZFA’s recommendation to adopt a standard. ANZFA’s proposal (P97) became Standard A18. It was gazetted in Australia on 13 August as Amendment 40 to the Food Standards Code, and in New Zealand on 20 August as a Mandatory Standard. Standard A18 was notified to the World Trade Organisation under the Technical Barrier to Trade and Sanitary and Phytosanitary agreements.
The new standard was to take effect in May 1999, but by March almost none of the companies selling GM food had applied for approval to continue doing so. ANZFA decided to amend Standard A18 to allow GM food to remain on the market after May 1999 without an approval, provided an application had been submitted by the end of April, the food had been approved by an overseas regulatory agency (such as the FDA) and there was no specific evidence to indicate the food was unsafe. RAGE sought judicial review of the decision, but was unsuccessful.141
Genetically Modified Food Standard A18 came into effect on 13 May 1999. From that date it became illegal in Australia and New Zealand to sell any food produced using gene technology unless an application had been made to ANZFA and approval subsequently given by ANZFSC. The approval process allowed for public comment on applications and requires ANZFA to undertake scientific risk assessment. Standard A18 did contain a provision for labelling, but only where the nature of the food was “significantly changed” by gene technology. In December 1998 a meeting of ANZFSC announced a new policy, that GM foods should be labelled even if they are not substantially different from foods produced by conventional methods. From May to June 1999 ANZFA and the New Zealand Ministry of Health carried out public consultation on the issue of GM food labelling. The consultation coincided with a national day of action in New Zealand, organised by RAGE, in which items thought to contain GM food products were labelled with stickers on supermarket shelves.142 In August ANZFSC made the decision to adopt mandatory labelling for GM foods and instructed ANZFA to prepare a draft standard. In October ANZFSC considered an amendment to Standard A18 to incorporate mandatory labelling provisions, but it delayed final acceptance on the grounds that further public consultation and more information on implementation costs and procedures would be needed.
At the time the Royal Commission began work, Japan, Australia and New Zealand had all begun to implement labelling regulations for GM food. The movement towards labelling was given a significant push when on 29 January 2000 agreement was finally reached at Montreal on a Biosafety Protocol to the United Nations Convention on Biological Diversity. The protocol gives each country the right to unilaterally apply the precautionary principle to GM foods. But these developments have occurred late in the GM food story. By 2000, the United States had allowed planting of GM varieties of tomato, soybean, cotton, corn, canola, squash and potato; there had been extensive commercial growing of genetically modified crops in Argentina, Canada and China; and in Europe, marketing approval had been granted for GM tobacco, soybean, canola, corn and chicory, although only GM corn had been grown commercially.143
2. IBAC and calls for a Royal Commission
The fierce debate over GM food in New Zealand spilled over into a general debate as to whether the government’s existing approach to genetic engineering regulation was appropriate. In late 1998, when it was becoming clear to ERMA through submissions that the public had fundamental concerns about genetic
engineering which could not be fully dealt with under the HSNO Act, the New Zealand Greens made the first calls for a Royal Commission into genetic engineering.144
The government’s overt response was dismissive. It regarded existing regulation as adequate and well established. In May 1999, the Minister for Conservation described the Greens’ Genetic Engineering Moratorium and Commission of Inquiry Bill as “a Luddite Bill... driven by the politics of fear”.145 But the same month, Cabinet established the Independent Biotechnology Advisory Council (IBAC). Its mandate was to investigate generic environmental, economic, ethical, social and health issues relating to genetic engineering; to communicate with the public, consult with interested groups and monitor public opinion; to publish reports; to establish expert working groups where appropriate; to inform government decisions; and to respond to requests for advice or analysis from the Minister of Research, Science and Technology.146 IBAC claimed to be independent and apolitical, although several of its ten members were directly involved in genetic engineering, it had no consumer representative, its chairman was a known advocate of genetic engineering and its commercialisation, and meetings were held in secret.147
IBAC developed and released a booklet entitled “The Biotechnology Question” which requested public feedback on genetic engineering issues.148 It identified groups with which it intended to consult, including industry, environmental, religious and scientific groups, and conducted focused discussions with members of the public. In September 1999 the Minister of Research, Science and Technology agreed to a temporary moratorium on commercial release of GM food crops pending an investigation by IBAC into economic, trade and other implications of commercial release for New Zealand.149
IBAC’s early work had drawn some criticism in relation to its supposed lack of impartiality, and those members of the public who were dissatisfied with existing regulations were not content with IBAC as a solution. In October 1999, the leader of the Greens presented a petition in Parliament calling for a Royal Commission which had over 90,000 signatures.150 In December IBAC released
its discussion paper on the first New Zealand commercial release of GMOs.151 The paper was confined to economic and trade considerations and avoided fundamental issues relating to safety, ethics, environmental impact, animal welfare, intellectual property laws and liability for accidents or irreversible adverse effects. It also treated commercial release as inevitable. This assumption in particular was not favourably received by some New Zealanders, who had endured intense pressure from the US and other allies over New Zealand’s anti-nuclear stance and regarded New Zealand’s continuing nuclear free status as proof of the country’s independence.152
New Zealand’s position on the issue of nuclear technology had been determined following a Royal Commission in 1976. People opposed to genetic engineering pointed to that Royal Commission as an appropriate model for resolving genetic engineering issues. A Royal Commission is generally regarded as the most prestigious and politically independent form of public inquiry.153 It has a legislative basis (the Commissions of Inquiry Act 1908), is appointed by Parliament, is chaired by a judge and has the power to call and cross-examine witnesses. It is not composed of technical experts, although it has technical expertise available to it, and it makes a public report of its findings and recommendations. One disadvantage of a Royal Commission from the point of view of those seeking tighter regulation of genetic engineering is that the legislative provisions which determine who has the right to appear before the Commission are relatively strict.154
3. Announcement of a Royal Commission
In February 2000 New Zealand’s newly elected centre-left government announced that the Royal Commission would go ahead. For the next few months the government was involved in negotiations with industry and the scientific community over the terms of a moratorium to be in force for the length of the Royal Commission’s inquiry. The government’s intention, which did eventually prevail, was that the moratorium should be voluntary, as the legislative process would have been time-consuming and would have brought up many of the same issues intended to be examined by the Royal Commission. The moratorium was
to apply to all applications for release of GMOs and also to applications for field testing of GMOs, with some limited exemptions. No field tests involving heritable materials would be allowed and no new field tests would proceed unless they had a medical purpose or promised very substantial benefits to New Zealand. For example, field testing of a GM grain to be sold overseas would not qualify, whereas field testing of GM possum control agents might. Any field tests already approved under the Act would continue with increased monitoring. (Given the ostensible aims of the Act, it is arguable that the approach to field testing taken by ERMA under the moratorium should have been adopted from the beginning.)
The government announced the Royal Commission’s membership and terms of reference on 17 April 2000. The Commission would be chaired by a former Chief Justice. The other three appointed members were a scientist (a senior lecturer from the medical school of New Zealand’s oldest university), an ethicist with an academic background in religious studies and a general medical practitioner from Auckland with knowledge of Maori as well as scientific and technical issues. The objectives of the Royal Commission were to “inquire into and report on strategic options available to enable New Zealand to address genetic modification now and in the future”. The Commission was also permitted to recommend changes in existing legislative, regulatory, policy or institutional arrangements for addressing genetic modification technologies and products. It was given 12 months to report, starting work in June 2000.
VI. CONCLUSION
With the announcement of the Royal Commission on Genetic Modification, the government suspended its commitment to existing policy in order to make room for a thorough public discussion of the issues surrounding GM technology for the first time anywhere in the world. Over fourteen months from June 2000, the Royal Commission received more than 10,000 written submissions. Formal hearings lasted thirteen weeks, involving over one hundred “interested persons” and nearly three hundred witnesses, many of whom came from outside New Zealand. In addition, the Commission conducted a public opinion survey and held numerous meetings and hui (conferences) throughout the country. The depth and breadth of consultation on GM issues carried out by the Royal Commission was in itself an unprecedented achievement.
The Report of the Royal Commission has been critically analysed elsewhere.155 For the purposes of this brief history, it remains only to identify some of the themes which have characterised the New Zealand debate over the past quarter-
century. The first and most obvious theme is that of increasing formality of GM regulation over time, from a voluntary code of practice developed within the scientific community and enforced only by the threat of withdrawn funding, to a full-scale legislative regime with provision for compliance monitoring and the imposition of criminal sanctions. The second theme is that of growing public participation in GM decision-making — in principle, if not always in practice. Early decisions about GM regulation in New Zealand were made with no provision for public notification, no opportunity for public comment and no public access to information about decisions or the reasons for those decisions; by contrast, the procedures of the IAG and more recently the HSNO Act make generous provision for public participation. In practice, however, public participation in decision- making is still limited by resource and cultural barriers to consultation, restrictions on the availability of information due to commercial sensitivity, and not least by adherence to a model of risk assessment which classifies certain applications of GM technology as “low risk” and therefore undeserving of public scrutiny. Although regulatory authorities in New Zealand and elsewhere continue to place undue faith in scientists’ ability to predict what might go wrong in the application of GM technology, this faith is starting to be questioned as reductionist thinking — the assumption that the whole is merely the sum of its parts — begins to be challenged within mainstream science and also as the range of issues considered to be relevant to the GM debate continues to expand. This expansion is the third theme characterising the GM debate in New Zealand: early notions of risk were confined to scientific questions about the likelihood of creating new human pathogens, and risk assessment methods reflected this narrow approach, but by the start of the Royal Commission, definitions of “risk”, “costs” and “benefits” had grown broad enough to include many matters on which scientists cannot be regarded as experts. The inclusion of non-scientists as members of ERMA reflects this trend.
In many respects developments in New Zealand have followed developments in other countries. For example, public awareness of GM technology rose sharply in New Zealand in the late 1990s largely as a result of overseas controversy relating to GM food safety. However, in other important respects New Zealand’s position is unique and often seems to involve the juxtaposition of extremes. New Zealand’s heavy economic reliance on exotic agriculture, its willingness to adopt new technology, its eagerness to overcome the disadvantages of size and isolation in order to participate fully in a world community which is increasingly driven by industrial interests — these characteristics contrast with New Zealand’s recognition of the need to protect its unique biological heritage, its competitive advantage with respect to organic and GM free farming, its legal and moral obligations to take account of the views of a sophisticated and vocal indigenous minority and its pride in national independence. An example serves to illustrate how peculiar national circumstances can cut both ways in the GM debate. New Zealand’s scientific community is very small. As a result, it has been unable to
dominate the policy debate in New Zealand to the extent possible in other countries where the scientific community is large, well resourced and well-connected; individual scientists who happen to take an anti-establishment line have had at least some chance of affecting public opinion. On the other hand, nearly all molecular biologists in New Zealand trace their professional family tree back to the same roots; arguably this means that even had scientists in the early days of self-regulation been fully committed to avoiding professional conflicts of interest, it would have been impossible because there were simply not enough people with appropriate expertise to choose from.
One factor which has strongly influenced the direction of the New Zealand debate has been the involvement of Maori from a relatively early stage. Maori cultural and spiritual objections to genetic engineering, together with the weight required to be given to Maori views under the Treaty of Waitangi, have forced regulatory authorities to take generic objections to GM technology seriously. Arguably, to a large extent they have driven the trends towards increasing public participation and expansion of the range of issues considered relevant to GM policy development. It is interesting to consider whether the power of genetic determinism — the idea that genes are the most important determinant of an organism’s characteristics — as a rhetorical tool employed by science and industry to convince the public of the importance of genetic research in this case actually helped generate opposition to GM technology. Would Maori have objected so strongly to GM technology if its proponents had not described it in such drastically reductionist terms, which Maori inevitably perceived as interfering with whakapapa?
The key unresolved problem at the heart of the GM debate at the start of the Royal Commission — and still — is that of irreducible uncertainty. Early GM regulation did not take any kind of uncertainty seriously, but over time, the problem of scientific, technical and other kinds of uncertainty in GM decision-making has been acknowledged. The difficulty is that attempts to address uncertainty fall into one of two categories: either uncertainty is to be removed entirely by the acquisition of further information, or if uncertainty still remains, decision makers are to act “cautiously”. But in relation to complex systems — including biological and social systems, both relevant to GM decision-making — uncertainty is always present: it cannot be eliminated because we are not yet close to understanding how such systems work. Regulators must therefore, if they accept the fact of irreducible uncertainty, fall back on the injunction to act cautiously. Unfortunately, it is not at all clear what this means either in general or in any particular case, and the fundamental reason for this lack of clarity is an unwillingness on the part of society as a whole to make difficult choices among competing values. We cannot have our GM cake and eat it, but it seems we have yet to realise this.
What next for the GM debate? In October 2001, the New Zealand government responded to the Royal Commission’s recommendations by promising to legislate
a two-year moratorium on the commercial release of GMOs in New Zealand. On 21 May 2002, the Hazardous Substances and New Organisms (Genetically Modified Organisms) Amendment Bill 2002 was introduced into Parliament and shortly enacted to come into force on 27 May 2002. One purpose of the Act was to impose a two-year restriction (from 29 October 2001 to 29 October 2003) on ERMA considering or approving applications to import new GMOs for release or to release GMOs from containment.156 The Greens, unhappy with the limited term of the moratorium, announced they would not enter into any coalition with Labour after the pending general election unless the release of GMOs was prohibited indefinitely. The balance of power in the New Zealand Parliament is such that the Greens’ stance made GMO field trials a key election issue.157 The outcome of the election was re-election of Labour who were able to form a coalition government without the inclusion of the Greens’. The government affirmed that the moratorium would not be extended but that a more rigorous assessment regime would be adopted. The only other outcome, that can be predicted with certainty, is that the debate over GM technology and its applications will continue, in New Zealand and elsewhere.
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URL: http://www.nzlii.org/nz/journals/NZJlEnvLaw/2002/2.html