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Hayward, Andrew --- "The Hazardous Substances and New Organisms Act, precaution, and the regulation of GMOs in New Zealand" [2005] NZJlEnvLaw 5; (2005) 9 NZJEL 123

Last Updated: 16 February 2023

123

The hazardous substances and New Organisms act, Precaution, and

the Regulation of gmOs in New Zealand

Andrew Hayward*

This article analyses the regulation of GMOs in New Zealand under the Hazardous Substances and New Organisms Act. The HSNO Act came into force for new organisms in 1998 and since that date has served as the country’s primary regulator of GMO import and use. The article gives particular regard to the precautionary principle, and the role it should play in GMO regulation. The origins and interpretation of the precautionary principle are considered, as are the risks associated with GMOs. The specific application of precaution in the New Zealand context is discussed, and the HSNO Act is assessed based upon this context. The article concludes that the integration of the precautionary principle into the HSNO Act is not strong enough to effectively prevent the potential risks of GMOs, and that the poor differentiation between low-risk and high-risk GMOs within the Act should be amended.

1. INTRODUCTION

Genetic engineering poses a dilemma for New Zealand lawmakers. The technology has the potential to help eliminate pests, conquer diseases, increase yields, and boost the economy.1 The technology also has the potential to create pests, eliminate biodiversity, and cripple the economy. Universities and industries promote genetic engineering as a necessity for progress, but

*BSc Biology (Hons), Emory University (USA).

1 Report of the Royal Commission on Genetic Modification (“Royal Commission”), at 2: http://www.mfe.govt.nz/publications/organisms/royal-commission-gm/. Please note that all ULRs in this article are as of 20 October 2005.

92 per cent of the population is opposed to its release.2

The Hazardous Substances and New Organisms Act 1996 (HSNO or “the Act”) came into force for new organisms in 1998. The Act was considered one of the strongest regulatory structures in the world.3 In spite of the cloud of scientific uncertainty surrounding all genetically modified organisms (GMOs), the Act was to provide case-by-case analysis of their risks and benefits, while protecting an economic and environmental bottom line.

The question yet to be answered is whether the Act has succeeded. Does the HSNO ultimately protect this bottom line or has it shown cracks after seven years in force? Can the Act adequately balance the needs of the modern “knowledge economy” while taking due account of the will of the majority of New Zealanders?

In Part 2 of this article, I will discuss the risks and benefits of GMOs. I intend to illustrate the value of separating GMOs into two categories of risk based upon their intended use. I will also differentiate those risks that are novel to GMOs from those that are held in common with traditional products. Part 3 will explore the precautionary principle and how it should affect GMO regulation. Here I will illustrate the necessity of precaution for successful GMO regulation. In Part 4, I will analyse the provisions of the HSNO Act that apply to GMOs. Part 5 will briefly discuss two New Zealand cases that have interpreted the Act. Finally, Part 6 will provide a critique of the HSNO and its enforcing body ERMA.

I will show that while the HSNO is a strong piece of legislation, it is excessive in its regulation of low-risk GMOs. Simultaneously, the weak iteration of the precautionary principle in the Act inhibits its ability to fully protect New Zealand from the potential adverse effects of high-risk GMOs.

2. UNDeRsTaNDINg gmO RIsKs

2.1 Background

The Hazardous Substances and New Organisms Act defines a genetically modified organism to be:4

  1. A S Gunn and K A Tudhope, “The Report of the Royal Commission on Genetically Modified Organisms: Ethical, Cultural and Spiritual Issues of Field Release” (2002) Sept/Oct Organic NZ 12. As cited in Paul Havemann, “Genetic Modification, Ecological Good Governance and the Law: New Zealand in the Age of Risk” 10 JCULR 8, at 27.
  2. L E Newstrom et al, “Environmental Risks to the New Zealand Flora from Transgenic Crops: the Role of Gene Flow” (Landcare Research Contract Report: LC0203/065, July 2003).
  3. Hazardous Substances and New Organisms Act 1996 (“HSNO 1996”). In force for new organisms 1 July 1998, in force for hazardous substances 2 July 2001, s 2.

any organism in which any of the genes or other genetic material –

(a) Have been modified by in vitro techniques; or

(b) Are inherited or otherwise derived, through any number of replications, from any genes or other genetic material which has been modified by in vitro techniques.

The Act, however, fails to define “in vitro techniques”. We can derive an equivalent definition by considering a GMO to be any living organism that is produced using “genetic modification”.5 As defined by the Royal Commission on Genetic Modification, genetic modification means:6

the use of genetic engineering techniques in a laboratory, being a use that involves –

(a) the deletion, change or moving of genes within an organism; or

(b) the transfer of genes from one organism to another; or

(c) the modification of existing genes or the construction of new genes and their incorporation into any organism; or

(d) the utilisation of subsequent generations or offspring of organisms modified by any of the activities described in paragraphs (a) to (c).

GMOs can be separated into two categories of risk based upon their intended use. These categories are (1) low risk – applying to GMOs used in complete institutional containment, and (2) high risk – applying to GMOs with restricted movement outside of institutional containment and to GMOs released from containment. This separation of risk is appropriate for understanding GMOs and will prove useful when analysing the effectiveness of the HSNO.

It is also helpful to further separate risks into those that are novel to GMOs and those that are not, as “any liability regime should treat like with like”.7 It is important to examine, as suggested by the New Zealand Law Commission, what about GMOs “is unlike any other potentially hazardous human activity or technology, and thus would justify a separate legal regime”.8 While the Law

  1. The Royal Commission further describes the process: “The wanted gene is added to plasmids, small molecules in bacterial cells that contain DNA that is not part of the chromosomes of the cell ... The plasmids to which the wanted gene has been added are put in with cells (usually bacteria) where the wanted gene is to go. The plasmids get inside the bacteria and add their genes to the genes of the bacteria. This means the bacteria now have the wanted gene as well as their own. These bacteria are then used to transfer the new genes into plant or animal cells.” See Royal Commission, supra note 1, at 363.
  2. Royal Commission, supra note 1, at 5.
  3. Law Commission, Liability for Loss Resulting From the Development, Supply or Use of Genetically Modified Organisms, Study Paper No 14, May 2002, Wellington, New Zealand, at 4, para 17.
  4. Ibid.

Commission focused particularly on the issue of liability, this treatment of “like with like” is a logical means to regulate any activity. What, if anything, is truly unique about GMOs?

2.2 Low-risk gmOs

Genetic modification, as defined by the HSNO, has been occurring in the laboratory setting since the discovery of recombinant DNA in the early 1970s.9 The process is made possible by the use of restriction enzymes – naturally occur- ring proteins – that can be used to cut DNA into fragments. These restriction enzymes cut DNA at specific locations, and so can allow the isolation of a single gene. The isolated gene, in turn, can be introduced into the DNA of another organism, making that organism transgenic. Any organism containing DNA from another organism by such means has necessarily been created using the “in vitro techniques” described in the HSNO.

In its simplest form, genetic modification of this kind can be done by anyone with the proper tools. The isolation of DNA from cells requires only the application of a series of chemicals, which are provided for research institutions in simple “kits” with step-by-step instructions. The DNA can then be cut using any number of available enzymes and inserted into bacteria that are specifically constructed to uptake the loose DNA. This process can be completed from start to finish in only a few days.

The use of genetic modification at this level has gone largely unregulated since its inception, and has become a very basic step in most cellular biology research. In New Zealand, genetic modification was a tool of laboratory researchers for more than a decade with only institutional oversight.10 The technology allows scientists to discover the function of individual genes within an organism, which in turn helps science to build an understanding of how life functions. The technology can be practically applied to discover the root causes of diseases and enable the development of medicines.

More recently, the use of this technology has expanded to allow scientists to modify not only the DNA of simple unicellular organisms, but also to create plants and animals with altered genetic traits.

Before the HSNO, the Advisory Committee on Novel Genetic Techniques (ACNGT) oversaw all transgenic research in New Zealand.11 Institutional Biological Safety Committees (IBSCs) were delegated the authority to approve low-risk GM experiments in 1982, so long as they notified ACNGT of their decisions.12

  1. The patent for the procedure was granted in 1980, leading to widespread use of the technology. See National Human Genome Research Institute, “The Human Genome Project Timeline”: http://www.genome.gov/Pages/Education/Kit/main.cfm.
  2. Royal Commission, supra note 1, at 2.
  3. Ibid, at 104. ACNGT was established in July 1978.
  4. Ibid.

The benefits from laboratory-scale GE research are extensive. The technology has been used in New Zealand to identify genes and gene function, to investigate disease resistance in pests, to understand and treat human disease, and for basic science education. The biotechnology sector in New Zealand employs some 2,500 highly skilled workers, and produced $675 million of revenue for universities in 2004.13

Much of New Zealand’s GE research focuses on improving pest control and on understanding and protecting herd species from disease. Landcare Research, for example, engages in laboratory-scale genetic modification to sequence possum genes and produce proteins for vaccination trials. To do this research, GM products produced overseas are imported and tested on possums in contained New Zealand facilities.14

Contained GE research also helps to protect animals that are valuable to the economy. A recent project undertaken by AgResearch Limited, for example, involves the production of a customised virus to facilitate the identification of proteins that help provide immunity to nematode infection for sheep and cattle.15 Gene sequencing techniques, which are facilitated by the use of GM bacteria, have also enabled researchers to separate genetic populations of endangered native species to aid species conservation.16

The risks of GMOs in containment are negligible. In the past 30 years of contained genetic modification, no adverse ecological effects have occurred. Bacteria and animal cell lines used in research laboratories are chosen so that they will not survive or reproduce outside of the laboratory setting. Typically, such cultures require a growth medium with very specific nutrient content, without which the cells cannot survive.17 Higher order transgenic organisms are disposed of on site, along with all associated heritable materials. All laboratory equipment that has the potential to facilitate transgene escape is sterilised or destroyed.

  1. Statistics New Zealand, “Biotechnology Survey 2004”, published 13 April 2005: http:// www2.stats.govt.nz/domino/external/pasfull/pasfull.nsf/web/Hot+Off+The+Press+Biotech nology+Survey+2004?open.
  2. Royal Commission, supra note 1, at 106.
  3. ERMA New Zealand, “M13 phage (GMO05/ARW029)”: http://www.ermanz.govt.nz/search/ registers.html?id=11289.
  4. Royal Commission, supra note 1, at 106.
  5. Ibid.

2.3 high-risk gmOs

One downstream application of contained genetic engineering is the creation of animals and crops for use outside of containment. This possibility has been realised only in the last decade.18 GE crops in particular have found increasingly widespread use, and there has been a concurrent increase in the consumption of these crops by humans and other animals.

From 1978 until 1988 there existed a New Zealand-wide moratorium on field release of GMOs.19 The moratorium was lifted in 1988 with the establishment of the Interim Assessment Group (IAG), which had to approve any research that occurred outside of laboratory containment.20 The private sector voluntarily complied with IAG. A second moratorium occurred from 2000 to 2003, allowing the Royal Commission on Genetic Modification to perform a review of current GMO legislation and for its suggestions to be implemented.

Microbiologists, biotech companies, and Nobel Laureates have heralded the potential of GM crop cultivation for more than a decade.21 The source of this potential lies in the limitless range of organisms from which novel genetic traits can be chosen.

Traditional plant breeding is heavily reliant upon those genes already present in a plant species. Introducing new characteristics into a plant is a long and tedious process, and one that substantially mirrors the process of evolution. These traditional techniques, slow though they are, have allowed the development of agricultural human societies. In more recent times, breeders have discovered that plants can be hybridised with less genetically similar species, allowing for offspring with a broader range of characteristics. Today, this variation can be still further amplified by forcing genetic changes to plants and animals by a process called “mutational breeding”.22 Despite the random nature of mutational breeding, the possible results are still far more limited than with genetic engineering.

  1. GM crops were first made available to the market in 1994 in the form of the FlavrSavr tomato. Monsanto introduced Roundup Ready soybeans and Bt-cotton for widespread use in 1996. See Kathleen Marrs, “Genetically Modified (GM) Foods: What Are They and Why Do We Need Them?”: http://www.biology.iupui.edu/biocourses/Biol540/8agbiofull2k4.html.
  2. Royal Commission, supra note 1, at 105.
  3. Ibid.
  4. AgBioWorld, “25 Nobel Prize Winners in Support of Agricultural Biotechnology” – an online declaration of support for agricultural biotechnology that includes the signatures of 25 Nobel prize winners. Available at: http://www.agbioworld.org/declaration/nobelwinners. html.
  5. Bergelson et al, “Promiscuity in Transgenic Plants” (1998) 395 Nature 25.

Most first-generation GE crops have been developed to express pesticide or herbicide resistance. For example, crops have been developed with resistance to insects like the gypsy moth and the cotton borer. Commonly called Bt-crops, these crops produce a toxin derived from a bacterium, Bacillus thuringiensis, that is toxic to the insects. The use of Bt-crops can prevent crops loss to insects and so can increase total crop yields.23

While Bt-crops are prominent in GM-producing countries like the United States, Argentina and China, these crops are still limited to testing in most of the rest of the world. The United Kingdom, for example, did not allow its first commercial GE crop production until March 2004.24 Bayer, the company that developed the crop, withdrew its commercialisation effort one month later, stating that constraints on the approval made the crop economically non- viable.25

Most of the oft-touted benefits of genetic engineering will come from what are called second- and third-generation GE crops. These envisioned crops can be modified to grow in climates that are usually unfavorable to the growth of staple foods. For example, cold-resistance genes isolated from fish have been inserted into food crops, allowing them to survive colder climates.26 The same process can be used to introduce drought-resistance genes into crops, allowing them to grow in the arid regions of the world that are often in the most desperate need of food.27

GE crops may also benefit the environment. By creating crops like Bt- corn and Bt-cotton, it is possible that less natural habitat has to be destroyed for agricultural use.28 GE crops may also reduce pesticide applications and improve soil conditions, decreasing the need for soil tillage and increasing field lifespan.29 All of these uses may help prevent habitat loss, which is the most immediate threat to global biodiversity.30

  1. Holly Saigo, “Agricultural Biotechnology and the Negotiation of the Biosafety Protocol” (2000) 12 Geo Int Envt’l LR 799.
  2. Andy Coghen, “Britain Gives Go-ahead for First GM Crop” New Scientist.com (9 March 2004): http://www.organicconsumers.org/ge/gaia031104.cfm.
  3. John Mason, “Bayer Withdraw Commercialization of GM Maize” UK Indymedia (30 March 2004): http://www.indymedia.org.uk/en/regions/oxford/2004/03/288237.html.
  4. See E R Hightower et al, “Expression of Antifreeze Proteins in Transgenic Plants” (1991) 17

Plant Mol Biol 1013–21.

  1. See E T Yeo et al, “Genetic Engineering of Drought Resistant Potato Plants by Introduction of the Trehalose-6-phosphate Synthase (TPS1) Gene from Saccharomyces cerevisiaea” (2000) 10 Mol Cells 236–38.
  2. See Jonathan Adler, “The Cartagena Protocol and Biological Diversity: Biosafe or Bio- sorry?” (2000) 12 Geo Int Envt’l LR.
  3. See L L Wolfenbarger and P R Phifer, “The Ecological Risks and Benefits of Genetically Engineered Plants” (2000) 290 Science 2088.
  4. See Adler, supra note 28.

There are no GE crops currently grown in New Zealand outside of containment. That said, one of the GE “field crops” likely to benefit the New Zealand economy in the future is GE timber. New Zealand has a strong exotic timber industry, which yielded $2.45 billion in exports in 1999.31 Second- and third-generation innovations may allow for timber that can grow faster, can produce better wood, and is resistant to pests. There may also be a market for yet unexplored GE crops like GE kiwifruit. New Zealand-specific applications of GE technology will be discussed further in Part 3.

There also exists the possibility of far-reaching benefits of GE products in the domain of bioremediation. Examples include the development of transgenic bacteria able to break down persistent pollutants, like PCBs and chlorine, which escape into the environment.32 Another possibility is the creation of customised viruses that attack pest species like rats and rabbits. The rabbit haemorrhagic disease (RHD, formerly called the rabbit calicivirus) was illegally introduced in New Zealand in 1997, and resulted in a vast decrease in rabbit populations. RHD was not a GMO, but if the effectiveness of the still-loose virus diminishes then the creation of a genetically modified variant may be an option for controlling invasive rabbit populations.33

The risks posed to human health and the environment once a GMO is released from containment are quite variable, depending on the type of organism and the nature of the genetic modification. These risks, however, are universally greater than with GMOs in containment. Once genetic information escapes into the environment it can no longer be controlled or contained.

Throughout this section, comparison will be made between the risks of GM products and their non-GM counterparts. This comparison serves a two- fold purpose. First, there is an understanding in international law that two like- products should receive the same regulatory treatment. This has guided WTO decisions such as Beef Hormones 34 and Shrimp-Turtle 35. Some regulatory bodies have not acknowledged any unique risks borne by GMOs, and so regulate them

  1. Statistics New Zealand, “Timber and Forest Products”: http://www.stats.govt.nz/quick-facts/ industries/timber-forest-prdcts.htm.
  2. See Todd Zwillich, “A Tentative Comeback for Bioremediation” (2000) 289 Science 2266.
  3. G Norbury, “Advances in New Zealand Mammalogy 1990–2000: Lagomorphs” (2001) 31

J Royal Society NZ 83: http://www.rsnz.org/publish/jrsnz/2001/7.php.

  1. EC – Measures Affecting Meat and Meat Products, WT/DS26&48/AB/R, adopted 13 February 1998 (“Hormones”).
  2. 35 WTO Appellate Body Report on U.S. – Import Prohibition of Certain Shrimp and Shrimp Products, WT/DS58/AB/R, adopted 12 October 1998.

as though they were regular crops. The US Food and Drug Administration, for example, ruled in 1992 that GMOs did not bear any novel risks, and so did not require a unique regulatory framework.36 The second reason to compare GM and non-GM goods is that identification and characterisation of the novel risks will help to generate good regulatory law.

While the risks to human health derived from eating GM products probably create the most active public concern, assessing these particular risks is the domain of Food Standards Australia New Zealand (FSANZ), not the HSNO, and so they will not be addressed. For ease of understanding, I will separate the remaining risks into the categories of (1) GM plant and animal risks, and (2) GM micro-organism risks.

(a) GM plant and animal risks

The majority of first-generation GE crops have been developed to confer resistance to weeds and pests. A paramount concern of GE detractors is the possible development of insects and weeds that are resistant to these modifications. Such concerns are not without foundation. The experience of the Roundup Ready crops provides a good example. These crops are modified to be resistant to the herbicide glyphosate, and have been grown since 1996 in varieties that include canola, maize, cotton, and soybean.37 Since 1996, eight weed species have developed resistance to glyphosate, three of them in the United States.38 One species, glyphosate-resistant horseweed, was first discovered in 2000, and can now be found in at least ten US states.39

Despite 20 years of use of the pesticide, no resistance to glyphosate was found in weed species until after the introduction of glyphosate-resistant crops.40 However, the recent eruption of resistance is not the direct result of the genetic modification of Roundup Ready crops. Rather, the most likely cause is the correlating increase of glyphosate application since these crops were introduced. Use has increased by 14-fold in maize crops, 12-fold in cotton crops, and almost 10-fold in soybean crops.41 “Weed shifts are an inevitable consequence of weed control. All control strategies, whether manual, mechanical or chemical, select for weeds that are able to survive that tactic.”42

  1. David Schnier, “Gentically Modified Organisms & the Cartagena Protocol” (2001) 12

Fordham Envt’l LJ 377, at 384.

  1. Vijay Nandula et al, “Glyphosate-resistant Weeds: Current Status and Future Outlook” (2005) 16 Outlooks on Pest Management (Pesticide Outlook) 183–187.
  2. Ibid.
  3. University of Purdue, “Horseweed”: http://www.btny.purdue.edu/weedscience/marestail/ index.htm.
  4. See Nandula, supra note 37.
  5. Ibid. Increases shown are from 1995 to 2002 (maize and soybean) and 1995 to 2001 (cotton).
  6. Bob Hartzler, “Are Roundup Ready Weeds in Your Future?” (3 Nov 1998) Iowa State Weed Science : www.weeds.iastate.edu/mgmt/.

Another threat often attached to GE crops is the loss of genetic diversity within a crop species. This diversity loss occurs because all plants containing, for example, the Bt-gene, are bred from a very small and selective set of plants that successfully express the novel gene. As more and more farmers plant these crops, more and more crop diversity is eliminated. This diversity of genetic material is replaced with plants that all share the same strengths (the transgene) and the same weaknesses – “Uniformly resistant plants may instead be uniformly vulnerable”.43

Fears of crop diversity loss from the overplanting of GE crops, though legitimate, are simply rehashed criticisms of any kind of monoculture. The Irish potato famine, for example, which caused the starvation of up to one million people in 1845, was a result of monoculture practices that left potatoes uniformly vulnerable to a novel fungus.44 Today, the Cavendish banana (popular in Western countries) is similarly under severe threat from the Panama virus, and may be extinct in as few as 10 years.45

Despite the dangers of resistance-development and monoculture, these are not novelties of GE crops. The possibility of resistance developing is both widely accepted and understood, and so the existence of such resistance does not lend itself to the development of new law. Similarly, although GE crops may require particular caution because they promote monoculture, such caution can be promoted as a part of existing agricultural controls.

On the other hand, transgenic crops carry the unique possibility of escape of genetic information to surrounding plant species. For example, rather than developing resistance by selective pressure, plants can develop resistance through the direct acquisition of novel genes. Such genetic leakage occurs by a process called “outcrossing”, wherein domesticated plants crossbreed with genetically similar wild relatives. Outcrossing may be particularly dangerous because it allows weeds to develop resistance to multiple pesticides over time. The existence of outcrossing is accepted by the companies that produce GM crops.46 When outcrossing occurs in nature, it serves as an important means for crops to maintain their biodiversity. What is unique about the outcrossing of GM crops, as compared to regular crops, is the nature of the genes that are being exchanged. These genes can come from any living organism, and can confer characteristics that a plant would never be able to naturally acquire. Furthermore, research has shown that GE crops may be up to 20-fold more

  1. Saigo, supra note 23, at 794.
  2. Raoul Robinson, Return to Resistance: Breeding Crops to Reduce Pesticide Dependence

(Free eBook 1996) at 189.

  1. BBC News, “Bananas Could Split for Good” BBC News (16 Jan 2003): http://news.bbc. co.uk/1/hi/sci/tech/2664373.stm.
  2. Kathleen Hart, “Herbicide-resistant Oilseed Rape Leads to Hardy Transgenic Weeds” (1998)

Pesticide and Toxic Chemical News 13 Aug 1998.

likely to outcross than non-GE crops with the same trait as developed by traditional breeding.47 The only explanation found for this change was the process of transgene introduction.

The propensity of transgenic plants to outcross is a particular concern because these crops tend to have characteristics that give them an evolutionary advantage. If a closely related undomesticated species crosses with a GE crop, the resultant hybrid species may have the ability to outcompete surrounding plants. Eventually, this might lead to the dominance of only a few subspecies, and a resultant elimination of species biodiversity.

The legacy of StarLink corn provides a good example of the danger of invasive transgenes. StarLink contained a Bt-toxin encoding protein, Cry9C.48 Due to lingering concerns about the possible allergenicity of this protein, the FDA approved StarLink corn for use only as animal feed. Despite this constraint, StarLink corn was eventually detected in Taco Bell taco shells, leading to the recall of nearly 300 food products in the United States.49

In 2000, to contain the further spread of StarLink corn into the human food supply, Aventis agreed to buy up the next year’s stock. Despite this fact, trace amounts of StarLink corn were found in shipments of corn to Japan, where a zero-tolerance policy had hastily been erected. StarLink could not be eliminated from the US grain supply because farmers had mixed their seeds. Pure StarLink-free stocks were no longer available.50 By the estimates of Aventis itself, contaminated corn supplies accounted for 3.7 per cent of total US corn supplies in 2001. The economic costs of the contamination were staggering.51

In September 2003, despite StarLink being taken off the market, the Cry9C transgene was discovered in native corn populations of Mexico.52 Mexico, a centre of corn genetic diversity, prohibits the cultivation of all GM corn for fear of gene flow into indigenous varieties. Despite this fact, the crops of Mexico had been contaminated.

  1. Bergelson, supra note 22. In this laboratory study, the traditional breeding used was “mutational breeding”, a method by which random changes are introduced into the plant by exposure to a mutagen. Mutational breeding is often cited as a more imprecise mechanism to change the genetic make-up of a plant than by genetic engineering.
  2. William Lin, Gregory Price, and Edward Allen, “StarLink: Where No CRY9C Corn Has Gone Before” [Winter 2001–2002] Choices 34.
  3. Ibid.
  4. Ibid, at 35.
  5. Initial costs to Aventis for the buy-back were estimated at 100 million USD. This does not include the costs of product recalls or lost grain exports. See Kara Sissell, “Aventis to Pay Growers for Grain Mix-up” 163(5) Chemical Week 10.
  6. Indigenous and Farming Communities in Oaxaca, Puebla, Chihuahua, and Veracruz et al, “Nine Mexican States Found to be GM Contaminated” (Media Release, Mexico City, 9 October 2003).

The risk that transgene escape presents to plant biodiversity also applies to animals, though perhaps to a lesser extent. “The risk of escape of a transgene through vertical gene flow is different for plants and animals. Plants distribute their pollen and seeds using wind, insects, and animals ... Animals mate and therefore ‘contain’ their eggs and sperm to a greater extent. Fish reproduction falls somewhere between these two examples. It would seem to be easier to contain the outcrossing of transgenic animals than transgenic fish or plants.”53

(b) GM micro-organism risks

As the process of genetic engineering makes apparent, genes are not forever confined to their hosts. A particular concern about micro-organisms is the ability of bacteria to readily exchange genetic information with other bacteria. This peculiar ability is called “horizontal gene transfer”. Many bacteria have the ability to both exchange DNA and to take up loose DNA from the surrounding environment, and to further integrate this DNA into their own genomes.

During the last two decades, the World Health Organization has reported an increase in the outbreak of novel infectious diseases.54 These novel diseases frequently have the sobering trait of being resistant to available antibiotics. The increase in antibiotic resistance has been directly attributed to horizontal gene transfer.55

Horizontal gene transfer becomes a significant concern once organisms are released from containment. Until recently, companies used antibiotic resistance genes as “markers” to isolate GM organisms that had successfully integrated novel DNA. In the event that these GMOs are used as food, there is widespread concern that the transgenes might escape to bacteria in the gut of humans and animals, allowing the bacteria to acquire antibiotic resistance.

Very little is known about the likelihood of horizontal gene transfer occurring. Studies have, however, investigated the lifespan and invasiveness of bacteria after they have integrated a transgene.56 One such study showed that a population of resistant E. coli bacteria inoculated into a rye field eventually migrated to a depth of 60 cm, where the bacteria reached a flow of groundwater. The bacteria were still detectable at the field site 13 years later.57

This example demonstrates the persistence of the transgene once released

  1. Royal Commission, supra note 1, at 51.
  2. Beatrix Tappeser, Manuela Jäger, and Claudia Eckelkamp, Survival, Persistence, Transfer: An Update on Current Knowledge on GMOs and the Fate of Their Recombinant DNA (Paper prepared by the Institute For Applied Ecology, Freiburg, Germany, May 1998) at 1.
  3. Ibid.
  4. Ibid, at 6.
  5. R E Sjogren, “13-Year Survival Study of an Environmental Escherichia-coli In-field Mini- plots” (1995) 81 Water, Air and Soil Pollution 315–335.

into the environment. While the possibility of horizontal gene transfer is not unique to GMOs, these organisms have a tendency to contain genes that would give other organisms an evolutionary advantage. “The extent and consequences of horizontal gene transfer are apparent in the evolution of antibiotic-resistant microorganisms ... [b]ut the actual and potential frequencies of gene transfer are poor indicators of risk. What remains essential to assessing risk is identifying all potential selective pressures that a recombinant gene might be suited to neutralize. New evidence suggests that current knowledge of evolutionary theory is inadequate to predict the fate of recombinant organisms or recombinant genes.”58

Scientists can now remove antibiotic resistance marker genes before plants are released into the environment, and so the presence of resistance marker genes is being phased out of GM-crops. However, horizontal gene transfer is by no means limited to the exchange of antibiotic resistance genes – any gene can undergo the process.

(c) Universal GMO concerns

Many advocates of genetic engineering consider the process to be a simple extension of traditional breeding methods. This view, however, is oversimplified. From a methodological viewpoint, differences between the processes become very apparent. Molecular pathologist Dr Michael Antoniou has broadly stated that “from the standpoint of the fundamental principles of genetics and the limitations in the technology, GM is neither more precise nor a natural extension of traditional cross breeding methods”.59

An example of the limited control genetic engineers have over the outcome of their work is a lawsuit brought against Monsanto in 1997.60 Farmers in Mississippi claimed that Monsanto’s Roundup Ready cotton had been both dropping its cotton bolls before harvest and also producing deformed bolls.61 Monsanto denied that the crop failure was a result of their modification of the cotton, instead blaming abnormally hot weather in the region. Despite this claim, Monsanto eventually paid a settlement to the farmers.

The true risk posed by transgenes in the environment is very difficult to assess. “Unlike a toxic spill, for example, which involves a defined amount of a particular substance in a limited location, GMOs may have the ability to

  1. J A Heinemann, “Assessing the interkingdom DNA transfer” (1997) Nordic seminar on antibiotic resistance marker genes and transgenic plants, the Norwegian biotechnology advisory board, 17–28. As cited in Tappeser, supra note 54.
  2. Michael Antoniou, Genetic Engineering and Traditional Breeding Methods: A Technical Perspective (1995) as cited in Schnier, supra note 29.
  3. Saigo, supra 23, at 791.
  4. Jeffrey L Fox, “Farmers Say Monsanto’s Engineered Cotton Drops Bolls” (1997) 15 Nature Biotechnology 1233.

replicate without limit. In addition, there is the possibility of gene transfer from one species to another.”62 Furthermore, “there may be some damage that would be, for all practical purposes, impossible to compensate or rectify such as the loss of biodiversity or the spiritual pollution of traditional foods” (emphasis added).63

3. gmOs aND PReCaUTION

3.1 what is Precaution?

Law has historically been limited to the regulation of known effects. An example of this approach in environmental law is the 1972 United Nations Conference on the Human Environment, held in Stockholm. “[T]he Stockholm Conference Report required that substances introduced into the sea must ‘result’ in ‘deleterious effects’ before they could be defined as marine ‘pollution’.”64 The Report further stated that harm must be demonstrated with scientific certainty. Therefore, actions that had the potential or likelihood to cause harm “were not within the meaning of pollution”.65

This perception of risk began to change with scientific insight into the long- term and cumulative damage caused by pollutants and chemicals – damage that could not be attributed conclusively to a single source. In 1984, the North Sea Conference convened to address widespread environmental degradation of that sea. The Conference concluded that it was impossible to empirically prove the causes of the ecological damage. However, it was found that the limited available knowledge of pollution showed that certain toxic substances in high enough concentration had the potential to cause irreversible harm to the sea.66 Therefore, the Conference concluded that the successful protection of the North Sea necessitated precautionary limitation of inputs that were “persistent, toxic, and liable to bio accumulate”.67 This was to be achieved by application of “Vorsorgeprinzip”, or the “precautionary principle”.68

The first international iteration of precaution appeared in the 1987 Montreal

  1. Law Commission, supra note 7, at 4.
  2. Ibid.
  3. James Hickey Jr and Vern Walker, “Refining the Precautionary Principle in International Environmental Law” (1995) 14 Va Envt’l LJ 423, at 429.
  4. Ibid.
  5. “History of the North Sea Conferences”, Progress Report presented to the 4th International Conference on the Protection of the North Sea, Esbjerg, Denmark, 8–9 June 1995.
  6. Ibid.
  7. Ibid.

Protocol on Substances that Deplete the Ozone Layer.69 The protocol was hastily drafted in response to the discovery of the ozone hole in 1985. At the time of this discovery, scientists had shown in the laboratory that CFCs could destroy ozone, and they further theorised that CFCs could find their way into the atmosphere. However, upon the drafting of the Montreal Protocol there was still no proof that the ozone hole was actually created by this mechanism.70 Despite this fact, the Protocol has received nearly unanimous assent.71

“The Montreal Protocol was the first global environmental treaty to address an environmental problem that was still only theoretical.”72 While precaution is not mentioned in the articles of the protocol, it states in the preamble that signatories are “[d]etermined to protect the ozone layer by taking precautionary measures to control equitably total global emissions of substances that deplete it ...” (emphasis added).73

The threat posed by ozone-depleting chemicals at the time of the Montreal Protocol is remarkably similar to the threat posed by GMOs today. Scientists have shown that events like horizontal gene transfer can occur under laboratory conditions, but are unsure to what extent these events occur in nature. Furthermore, there is evidence that GMOs can be persistent and invasive – for instance, in the case of the Cry9C gene – but it is not known just what extent of damage this invasive nature may cause.

One of the most widely recognised statements of the precautionary principle can be found in Principle 15 of the 1992 Rio Declaration on Environment and Development, which states:74

In order to protect the environment, the precautionary approach shall be widely applied by states according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.

  1. Montreal Protocol on Substances that Deplete the Ozone Layer, adopted in September 1987 (entered into force 1 January 1989) (Montreal Protocol).
  2. Elizabeth R DeSombre, “The Experience of the Montreal Protocol: Particularly Remarkable, and Remarkably Particular” (2000–2002) 9 UCLA J Envt’l L & Pol’y 49.
  3. The Montreal Protocol has been ratified by 189 countries as of October 2005. For current status of the protocol see United Nations Environment Programme Ozone Secretariat: http:// www.unep.org/ozone/index.asp.
  4. DeSombre, supra note 70, at 50.
  5. Montreal Protocol, supra note 71, preamble.
  6. Rio Declaration on Environment and Development (Report of the United Nations Conference on Environment and Development, Rio de Janeiro, 3–15 June 1992) UN Doc A/CONF.151/26 (“Rio Declaration”).

The precautionary principle thus serves to lower the burden of proof neces- sary before a State takes action to regulate an activity, as long as the activity meets certain baseline criteria. These criteria have come to be known as the “trigger” for the application of precaution.75 The trigger, in the case of the Rio Declaration above, is twofold: there must exist both a potential of serious or irreversible harm and also some scientific ground upon which this potential is based, even if there is no scientific consensus.76

Once precaution is triggered, its mandate is simple: a State should not use the lack of scientific consensus as a reason to avoid taking measures to eliminate or minimise any possibility of harm. The question remains, do GMOs constitute a trigger?

The answer lies in the very nature of GMOs, discussed in Part 2. Once a transgene escapes into the environment, this escape cannot be undone and furthermore, damage that a GMO causes to the biodiversity of a species is also irreversible. The genetic information contained in species is often the result of thousands of years of evolution, it is not something that scientists can recreate in a laboratory. Therefore, the risks borne by GMOs are indeed both serious and irreversible. There is also a lack of scientific consensus as to the likelihood of these potential dangers occurring.

3.2 applying the Precautionary Principle in New Zealand

[W]e’re not trying to stop people getting medicines they need but we support a moratorium on genetically engineered organisms in our environment ... [A] cautious approach is best when effects are not known or well understood. This declaration is a symbolic gesture of support to all who care about the future of our city, country and planet.77

– Councillor Derek Shaw, GE Free Nelson

The Royal Commission on Genetic Modification seems to cast aside the pre- cautionary principle, stating simply that there appeared to be no consensus as

  1. John S Applegate, “The Precautionary Preference: An American Perspective on the Precautionary Principle” 6 Hum & Ecological Risk Assessment 413, as cited in Kurt Buechle, “The Great, Global Promise of Genetically Modified Organisms: Overcoming Fear, Misconceptions, and the Cartagena Protocol on Biosafety” (2001) 9 Ind J Global Leg Stud 283.
  2. The European Commission described the trigger as the potential of risk “even if this risk cannot be fully demonstrated or quantified or its effects determined because of the insufficiency ... of the scientific data”. See Commission of the European Communities, Communication from the Commission on the Precautionary Principle COM(2000) 1, Brussels, 2 February 2000 (“Communication”), at 13.
  3. Nelson City Council, “Nelson – Proud to be a GE-Free City”: http://www.nelsoncitycouncil. co.nz/environment/ge_free.htm.

to the meaning of the principle and that the meaning often appears to rest with the speaker who invokes it.78 This is a disappointing finding, and particularly strange considering that the principle has been found worthy of inclusion in many international agreements and in the HSNO.

Other sources often differentiate between a weak and a strong precautionary approach. The weak approach would justify that precautionary measures be taken only after the risks and benefits of an action are weighed, and the benefits are not so great as to offset the potential risk. The strong approach, on the other hand, treats any potential of environmental damage as unacceptable, no matter the benefits to be garnered.79

“The strong approach ... interprets the precautionary principle rigidly as seeking to prevent damage in the absolute sense. Here, the precautionary principle would not allow for any scientific research in the field of genetic engineering to go ahead at the present state of knowledge, whether be it development, field- test or release into the environment.”80 While at first glance this understanding of precaution seems to make sense (why not prevent potential harm in the absolute?), it is seriously flawed. Such an absolute precautionary approach inherently prevents the accumulation of enough knowledge to overcome the current insufficiency. The ultimate end of such an approach would be stagnation of current technology, which in itself has had a disastrous environmental impact.

Parties with otherwise good intentions often reiterate this misunderstanding of the precautionary principle when they call for a ban of any and all GMOs. For example, Greenpeace New Zealand correctly stated in its submission to the Commission on Genetic Modification that the precautionary principle mandated action to prevent harm to the environment without the requirement of full scientific certainty. However, the organisation went further, positing that:81

Invoking the precautionary principle, Aotearoa/New Zealand will ban:

  1. Royal Commission, supra note 1, at 67.
  2. Christina Voigt, “The Precautionary Principle and Genetic Engineering in New Zealand: Legal and Ethical Implications” (2002) 6 NZ J Envt’l L 43, at 93.
  3. Ibid.
  4. Royal Commission, supra note 1, at 66.

Precautionary and anti-progress are not one and the same. The principle is misunderstood when it is stated to merit the banning of all threatening goods. Rather, it is better considered as part of the overall risk-assessment process. On the opposite side of the spectrum, however, simply carrying out a risk assessment and taking account of the risks this assessment reveals is also not an appropriate application of precaution. The principle mandates a specific type of action: avoid or minimise the possibility of harm, even if there is scientific uncertainty regarding its likelihood.

The European Commission found that decisions invoking the precaution- ary principle should be proportional to both the risk involved and also the level of protection chosen by the State.82 It is particularly important that the local conditions of a State are taken into account, as these conditions affect the probability that a GMO will cause damage.

Ultimately, precaution is an application of good common sense with accom- panying legal weight. Most first-generation GE crops are ensconced in trouble. There is prevalent uncertainty about how they will react to their environment and what kind of damage they will cause. Furthermore, these crops offer little benefit to New Zealand. A successful precautionary regime would probably not approve such goods, but would not be so restrictive that future products that are better understood and more tailored to the needs of New Zealand will be rejected out of hand.

In New Zealand, the factors that should influence how precaution is ultimately applied are (1) the New Zealand biota, (2) the acknowledgement of Maori concerns, (3) current environmental threats to the country, and (4) economic and educational interests.

The uniqueness of New Zealand was one of seven values that the Royal Commission on Genetic Modification found most pertinent to the regulation of GMOs. “The environment of any country is unique, and New Zealand’s is made more so by its geographical isolation, its relatively low population density, and the ecosystem, flora and fauna specific to this nation. Decisions need to be tailor-made to fit those features and circumstances which are uniquely ours.” 83 Exotic and invasive species (including humans themselves) have caused disastrous losses of biodiversity in New Zealand. The extinctions to date include 32 per cent of land and freshwater birds, several amphibians and reptiles, and at least 11 plant species.84 Today, about 1,000 species are considered threatened

  1. See Communication, supra note 76, at 4.
  2. Royal Commission, supra note 1, at 11.
  3. The New Zealand Biodiversity Strategy, February 2000, at 34: http://www.biodiversity.govt. nz/picture/doing/nzbs/contents.html.

with extinction.85 The New Zealand public is acutely aware of the necessity to protect those native species that remain, and so precaution could demand a higher threshold of safety when a GMO may threaten such species.

Thus, a fairly logical example of the application of risk assessment in com- bination with the precautionary principle would be to prevent the cultivation of those crops that pose the greatest risk to the environment, in terms of the likelihood to outcross for example, while allowing crops that pose a negligible risk of outcrossing to be grown.86 It should be noted, for instance, that no native species of New Zealand are likely to outcross with prominent food crops like corn and wheat. As New Zealand has no native biodiversity in these crops, the risks of biodiversity loss are not comparable to what may be suffered by Mexico as a result of the escape of the StarLink gene.

Of course, this is only one factor to be considered, as outcrossing could still occur between conventionally grown non-native crops and their GE counter- parts. It should demonstrate, however, that there are shades of risk, and the precautionary principle allows for varied legislative action taken in concert with this varied risk.

Determining just what level of mitigation the precautionary principle requires is dependent on the risk-averseness of a State. For New Zealand, for instance, risk may become unacceptable when the products of genetic modification are moved from the well-defined and contained laboratory environment to the open environment. The Royal Commission itself stated that “[W]e agreed that more research is needed into the environmental risks that genetically modified crops and non-food uses might pose for the ecosystems into which they could be released.”87

Etahi wa, me tahuri ke te waka o tauiwi ma, engari ko te kei o te waka o te Maori, me rere tonu kia totkia. [Sometimes the canoe of other races makes changes in its direction, but the steering of the Maori canoe should be in accordance with our traditions, it should travel on its set course.]88

“The traditional Maori worldview considers all parts of the natural world to be related through whakapapa. Genetic modification risks interfering with such relationships, and threatens the sanctity of mauri (life principle) and wairua (spirit) of living things. In this way, genetic modification may affect the ability

  1. Ibid, at 4.
  2. Such methodology is discussed at Royal Commission, supra note 1, at 175.
  3. Ibid, at 112.
  4. A taua (woman elder) at the Christchurch hui, Terehia Kipa (Te Arawa, Tuhoe), as cited in Royal Commission, supra note 1, at 18.

of Maori to be kaitiaka (guardians) of their taonga and, particularly, their ability to care for valued flora and fauna.”89

The importance of acknowledging Maori concerns when making decisions about GE goods is exemplified by the WAI 262 claim currently before the Waitangi Tribunal. The heart of the claim is that Maori representatives should be the ultimate authority on the use of the indigenous resources of New Zealand. The claimants argue that the Crown has failed to protect Maori genetic resources and cultural knowledge in the fields of intellectual property, biodiversity, cultural taonga, and genetic modification.90

The authority of Maori to manage these issues is asserted on the basis of rights to the guardianship and customary use of indigenous flora and fauna. The claim fundamentally questions how the Crown can rightfully allow activities such as genetic modification of indigenous organisms or native species, or bio- prospecting of pharmaceutical companies “without undermining the Crown’s duty of native protection for Maori relationships with all taonga”.91

In their submission to the Royal Commission on Genetic Modification, many of the WAI 262 claimants called for a moratorium upon all GM research.92 These claimants, of course, do not hold such ultimate authority. However, on a case-by-case and precautionary analysis of GM applications, Maori objections must be taken into account. Objection from Maori representatives does not constitute a veto power over any genetic modification, but such an objection should hold significantly more weight when it pertains to modification of indigenous and taonga species.93

Pests present a particular problem for the indigenous plants and animals of New Zealand, as well as its farming economy. For example, 95 per cent of kiwi chicks are killed by stoats and feral cats before they reach adulthood.94 Despite

  1. Law Commission, supra note 7, at 6.
  2. Ibid.
  3. David Williams, “Matauranga Ma¯ori and Taonga” (Report for the Waitangi Tribunal on WAI 262, 2001: http://www.waitangi-tribunal.govt.nz/research/wai262/wai262xxxx.asp.
  4. The Royal Society of New Zealand “Wai 262 Claimants”, The Royal Commission on Genetic Modification – submissions: http://www.rsnz.org/topics/biol/gene/submis/wai262.php.
  5. Royal Commission, supra note 1, at 38.
  6. Hugh A Robertson, “2003: Kiwi (Apteryx spp.) Recovery Plan 1996–2006” Threatened Species Recovery Plan 50, Wellington, Department of Conservation, 22: csl.doc.govt.nz/ Publications/004~Science-and-Research/Biodiversity-Recovery-Unit/PDF/TSRP50.pdf .

the general disapproval of the New Zealand public to genetic engineering, 54 per cent approve of its use for pest control.95

Among applications of genetic engineering currently being considered by Landcare Research are uses for the control of possums, stoats, and wasps. “Landcare stressed the desire to reduce New Zealand’s current reliance on large scale use of broad-spectrum poisons for pest control that left New Zealand exposed to substantial health, environmental and trade risks.”96 To control possums, for instance, New Zealand releases about 2.5 tonnes of 1080 (sodium monofluoroacetate), comprising 90 per cent of the world’s use. Continued use of such broad-spectrum controls may be unsustainable.97

Despite public resistance to GMOs in general (some have suggested that possum control might be used as a wedge for promoting acceptance of other GE goods98), if an effective control agent could in fact be limited to the target species this would be of tremendous benefit to New Zealand species conservation. The RHD virus, discussed in Part 2, illustrates the effectiveness that such controls can have.

While food crops have received the initial investment of companies in the United States and China, New Zealand has a much higher national investment in both cattle (for meat and dairy products), and in sheep (for meat and wool). In 1996 these two livestock accounted for more than 60 per cent of the total agricultural output.99 In 2004, the total livestock production of the country included 39 million sheep and 9.6 million cattle.100

New Zealand is currently a world leader in genetic research of these species.101 Submitters to the Royal Commission argued that given this com- petitive advantage over other nations, further investment in the knowledge economy will be quite beneficial to the nation. Access to genetic research “is part of attracting and retaining high quality staff in an international market, and ensuring high quality scientific education for students.”102

There is also a substantial biotechnology investment in the fundamental

  1. Royal Commission, supra note 1, at 162.
  2. Ibid.
  3. Ibid.
  4. Ibid at 165.
  5. Statistics New Zealand, “Agriculture Overview”: http://www.stats.govt.nz/quick-facts/ industries/agri-overview.htm.
  6. Statistics New Zealand, “Agricultural Production Statistics (Final) (June 2004)”: http:// www2.stats.govt.nz/domino/external/pasfull/pasfull.nsf/web/Hot+Off+The+Press+Agricult ural+Production+Statistics+(Final)+June+2004?open.
  7. Royal Commission, supra note 1, at 108.
  8. Ibid at 109.

understanding of pest biology. “The use of genetically modified organisms for studies in taxonomy, ecology and insect pathology is essential for advancement of fundamental knowledge in ecology and biology.”103

“[G]enetic research would also have important flow-on effects to other parts of the economy by employing a highly skilled workforce, attracting foreign investment and generating valuable intellectual property.”104 In 2001, 35 per cent of government investment in the Foundation for Research, Science and Technology went to research directly involving genetic modification.105 As long as the risks involved remain negligible, New Zealand would best be served to remain at the forefront and boost its knowledge economy in the process. Low- risk GE should not be lamed by over-regulation.

The precautionary principle applies when there exists a substantiated risk the likelihood of which is unknown. Such a risk does not exist when research is conducted in true containment. The New Zealand population showed far less concern regarding laboratory-scale GM, as acknowledged by the Royal Commission. This was not out of a lack of awareness of these technologies but out of a more specific concern for genetically modified foods.106 A disincentive that does not actually improve safety benefits no one.

4. hsNO ReaDINg

4.1 The act Itself

The remote oceanic island geography means that the evolution of the New Zealand flora and fauna proceeded in isolation from other regions. This has led to an extreme susceptibility to impacts from introduced organisms, giving rise to one of the strongest regulatory protocols in the world, the Hazardous Substances and New Organisms Act 1996.107

The Hazardous Substances and New Organisms Act 1996 became law on 10 June 1996, a fruition of the HSNO Bill introduced in November 1994, which in turn was catalysed by a 1992 MFE paper entitled “Hazardous Substances and New Organisms – Proposals for Reform”.108 The HSNO regulates the creation or

  1. Dr Stephen Goldson, AgResearch’s Science Leader of the Biocontrol and Biosecurity Group, as cited in Royal Commission, supra note 1, at 110.
  2. Ibid at 108.
  3. Ibid at 129.
  4. Ibid at 108.
  5. L E Newstrom, supra note 3.
  6. Janet Hope, “A History of Biotechnology Regulation in New Zealand” 2002, 6 NZ J Envt’l L 1, at 17.

importation of GE organisms, but does not regulate food or medicine produced from these organisms. FSANZ regulates foods under authority of the Food Act 1981, while medicines are regulated by the Medicines Act 1981. After the introduction of a GMO into the environment, any subsequent management falls under the Biosecurity Act 1993, as does the management and eradication of a GMO that escapes into the environment.

Those sections of the HSNO that are most important to the regulation of GMOs are ss 4–9. These sections will be discussed as they relate to (1) the purpose of the Act, (2) the precautionary principle, and (3) Maori rights.

The purpose and principles of the Act are provided in ss 4–6, which state:

Section 4. Purpose of Act –

The purpose of this Act 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.

Section 5. Principles relevant to purpose of Act –

All persons exercising functions, powers, and duties under this Act shall, to achieve the purpose of this Act, recognize 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 com- munities to provide for their own economic, social, and cultural wellbeing and for the reasonably foreseeable needs of future generations.

Section 6. Matters relevant to purpose of this 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 an- cestral lands, water, sites, waahi tapu, valued flora and fauna, and other taonga:

(e) The economic and related benefits and costs of using a particular hazardous substance or new organism.

(f ) New Zealand’s international obligations.

Simon Upton, then Minister for the Environment, described the principles set out in s 5 as “the environmental and the economic”, and further stated that neither should take precedence over the other.109 The structure of s 5 is remarkably similar to that of the Resource Management Act (RMA) s 5(2), described by Upton as the legislating of the “environmental bottom line”.110

The hierarchical construction the HSNO also mirrors that of the RMA, where priorities are ordered in descending weight. Section 5 of the HSNO states those matters that all persons shall “recognize and provide for”, while the matters in ss 6–8 need only be “taken into account”.

There is no guidance as to how policymakers should address conflicts that may arise between individual matters of relevance. It is likely that such conflicts will arise, for example, between s 6(b) – the intrinsic value of ecosystems and s 6(e) – the economic benefits of GMOs, or between s 6(a) – the sustainability of flora and fauna and s 6(d) – Maori culture and taonga.111

Section 7. Precautionary approach –

All persons exercising functions, powers, and duties under this Act, including but not limited to, functions, powers, and duties under sections 28A, 29, 32, 38, 45, and 48 of 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 provides the first incorporation of the precautionary principle into New Zealand legislation. The mandate that persons “shall take into account the need for caution” seems to put the priority of precaution on par with that of matters relevant to the act in s 6. The wording of the principle itself, however, is far weaker than that of Principle 15. Describing the precautionary principle as a means for “managing adverse effects” seems to place it in the realm of preventative or reactionary measures rather than precautionary measures. A stronger construction, such as that of the Cartagena Protocol on Biosafety to which New Zealand is a party, states that uncertainty regarding potential adverse effects shall not prevent a decision.112 It is these potential effects that are the traditional realm of the precautionary principle.

Despite this weak wording, Simon Upton stated, “In respect of new organisms the legislation is very constrictive. It is certainly not appropriate

  1. Simon Upton, HSNO Bill: Second Reading, Hansard, 16 April 1996. As cited in Hope, supra note 108, at 19.
  2. Resource Management Act 1991, in force 1 October 1991.
  3. See discussion, para 6.3.4, p 159 infra.
  4. Cartagena Protocol on Biosafety, opened for signature 15 May 2000 (entered into force 11 September 2003), art 10(6).

to be anything other than very conservative at this stage of the genetically modified organisms debate.”113 If courts interpret s 7 simply as an iteration of the precautionary principle as generally understood, these small differences may not be to its detriment.

As well as addressing Maori concerns in s 6(d), section 8 states, “All persons exercising powers and functions under this Act shall take into account the principles of the Treaty of Waitangi”.

To meet the obligations of the Treaty of Waitangi, the Environmental Risk Management Authority (ERMA, discussed below) established Nga Kaihautu Tikanga Taiao in 1997. The purpose of this committee was to advise ERMA on issues of special Maori concern.114 The role of the committee became formalised in the Hazardous Substances and New Organisms (Methodology) Order 1998,115 and later in the HSNO itself (s 24A) by way of the Hazardous Substances and New Organisms Amendment Act 2003.116

Furthermore, in response to the recommendation of the Royal Commission, Institutional Biological Safety Committees are also to include at least one Maori member.

4.2 environmental Risk management authority

Upon inception of the HSNO, the Environmental Risk Management Authority became the sole authority for assessment of proposals to import, develop, or field-test GMOs.117 ERMA is to be made up of six to eight members appointed by the Minister for the Environment, and drawn from a mixed pool of know- ledge and experience.118 Any person seeking to import, create, or release a GMO must apply to ERMA, providing a risk assessment and evidence of Maori and public consultation.

Considering the potential dangers of GMOs, substantial faith is placed

  1. Simon Upton, Minister for the Environment, Hansard 23 May 2996. As cited in Hope, supra note 108, at 20.
  2. Hope, supra note 108, at 22.
  3. Hazardous Substances and New Organisms (Methodology) Order 1998, s 6. “The Authority may appoint a committee to be known as Nga Kaihautu Tikanga Taiao to advise it on issues that may arise in taking into account the matters referred to in sections 6(d) and 8 of the Act.”
  4. Hazardous Substances and New Organisms Amendment Act 2003, s 11.
  5. Section 14 establishes the authority; s 25 prohibits new organisms’ import, development or release without application to the Authority.
  6. HSNO 1996, supra note 4, ss 15–16. The membership is also to have some knowledge and experience in matters relating to the Treaty of Waitangi and tikanga Maori, s 16(2).

in ERMA as a decision-making body. ERMA describes its decision-making process as follows:119

Decision-making by the Authority is quasi-judicial and must occur in accord- ance with the criteria in the HSNO Act. This provides a considerable constraint on what the Authority can or cannot do. Decision-making is independent of political processes and decisions cannot be appealed.

Section 9 of the Act allows the Governor-General to establish a methodology order by which decisions are to be made. This methodology plays a substantial role in how the HSNO works in reality. The weight carried by the methodology is established by s 9(5), which states: “No decision of the Authority under Part 5 of this Act shall be challenged on the adequacy or otherwise of the methodology developed and applied under subsection (1) of this section.”

4.3 methodology Order

The methodology for the ERMA was established by the Hazardous Substances and New Organisms (Methodology) Order 1998. The methodology describes the process of notification, information gathering, and risk assessment by which ERMA is to make decisions.

The Methodology Order has no purely precautionary clause. In fact, “pre- caution” is only mentioned in the annotated form of the Order. Instead, the Act describes ERMA procedures to address “Uncertainty” in ss 29–32:

  1. Where the Authority encounters scientific and technical uncertainty relating to the potential adverse effects of a substance or organism, or where there is disputed scientific or technical information, the Authority –
(a) Must determine the materiality and significance to the application of the uncertainty or dispute taking into account the extent of agreement on the scope and meaning of the scientific evidence; and

(b) May, where the uncertainty or dispute is material or significant, facilitate discussion between the parties concerned to clarify the uncertainty or dispute.

  1. Where any scientific or technical uncertainty or dispute is not resolved to the Authority’s satisfaction during its consideration of the application, the Authority must take into account the need for caution in managing the adverse effects of the substance or (to the extent provided for under the Act) the organisms concerned.

  1. ERMA, “Briefing Report for Incoming Government” July 2002, ER-BR-02-1.
  1. Where the Authority considers that uncertainty arises from an absence of information, or inconclusive or contradictory information, or information from an unreliable source, the Authority may request the applicant to provide further information in accordance with section 58 of the Act and must take full account of any additional information provided.
  1. Where the Authority considers there is uncertainty in relation to costs, benefits, and risks (including, where applicable, the scope for managing those risks), the Authority must attempt to establish the range of uncertainty and must take into account the probability of the costs, benefits, and risks being either more or less than the levels given in evidence.

This embodiment of precaution is very weak. It hardly amounts to that level or precaution envisioned in, for instance, the Cartagena Protocol on Biosafety or the Rio Declaration.120 Furthermore, considering that the methodology dictates how ERMA, the authority of the HSNO, makes decisions, these sections do not seem to even match the weak form of the precautionary principle stated in the main Act. The only further role precaution plays in the assessment process is through s 21 of the Methodology Order, which states: “decisions by the Authority must be in accordance with the specific requirements of the Act and the regulations made under the Act”.

4.4 Low-risk modification and IBsCs

Under s 19, s 35, and s 42 of the Act, ERMA has the power to delegate decision- making to other authorities. Using this power, ERMA allows for the creation of Institutional Biological Safety Committees (IBSCs) to assess applications for importation and development of low-risk GMOs.121 These IBSCs must be comprised of:122

  1. The Biosafety Protocol states: “Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of the living modified organism in question as referred to in paragraph 3 above, in order to avoid or minimize such potential adverse effects.” See Cartagena Protocol on Biosafety, supra note 112.
  2. Criteria for Low-Risk Modification are established by the Hazardous Substances and New Organisms (Low-Risk Genetic Modification) Regulations 1998 and 2003.
  3. See generally ERMA New Zealand Institutional Biological Safety Committees and Low- Risk Genetically Modified Organism Decision Making: http://www.ermanz.govt.nz/no/no- ibsc.asp.

After the Royal Commission on Genetic Modification published its results, it became clear that scientists in biological fields were not satisfied with the burdensome and costly nature of the assessment procedure. “Because of the way HSNO defines ‘new organisms’, a scientist carrying out standard recombination experiments will continually create ‘new organisms’, each of which legally requires a separate application.”123

This led to the recommendation that such applications be carried out on a project-specific rather than organism-specific basis.124 The recommendation was implemented by the addition of s 42A: “Rapid assessment of projects for low- risk genetic modification”.125

4.5 Containment and Limited Release

There comes a point when laboratory innovations need to be tested in the environment, particularly with GE crops. This testing allows further evaluation of the effects of a genetic modification when exposed to the elements, though the need may also arise logistically from the size of the plants being tested or the number of animals. As the dangers of these crops and animals may not yet be known, however, it is important that their isolation is also maintained. The HSNO therefore allows for field-testing of GMOs, and defines field-testing as follows:126

‘Field test’ means, in relation to an organism, the carrying on of trials on the effects of the organism under conditions similar to those of the environment into which the organisms is likely to be released, but from which the organism,

  1. Royal Commission, supra note 1, at 118.
  2. Ibid at 119. Royal Commission Recommendation 6.1: “that applications to develop genetically modified organisms in PC1 and PC2 containment be assessed by the Institutional Biological Safety Committees on a project rather than organisms basis”.
  3. Hazardous Substances and New Organisms Amendment Act 2003. Public Act 2003 No 54, Date of assent 17 October 2003.
  4. HSNO, s 2.

or any heritable material arising from it, could be retrieved or destroyed at the end of the trials; and includes large-scale fermentation of micro-organisms.

Field tests are considered to be use “in containment”, meaning that the organisms involved are restricted to a secure location or facility to prevent escape.127

When it came to evaluating a new organism for uncontrolled release under the original HSNO Act 1996, ERMA had only two decision-making powers: to approve or reject the application. There were no powers to regulate GMOs once they had been approved for release into the environment. Limited or controlled release was not an option because of the uncontrollable and irreversible nature of GMO release. Simply put, “when organisms are released, they reproduce and cannot be controlled”.128

One of the primary conclusions of the Royal Commission was that this omission needed amendment. The Commission therefore suggested that the capacity for conditional release be added to the HSNO.129 These recom- mendations were accepted and conditional release was established under ss 38A–38H of the Act.130 The implications of this decision will be discussed further in Part 6.

  1. TwO (BLEAKLEY ) Cases

For the sake of understanding how the HSNO is interpreted, two cases are briefly summarised below.

5.1 Bleakley v Environmental Risk Management Authority (2001)131

Claire Bleakley, “an environmentalist of no little dedication”132, brought a case against ERMA before the High Court appealing a question of law. The case regarded the decision made by ERMA to approve an application for field- testing of GM cattle.133 The cattle were modified to produce a human protein

  1. Ibid.
  2. P F Fuiava, “Can Local Government Control Land Use involving GMOs?” NZ J Evt’l L 295, at 315.
  3. Royal Commission, supra note 1, at 125. Recommendation 6.8: “that the Hazardous Substances and New Organisms Act 1996 be amended to provide for a further level of approval called conditional release”.
  4. HSNO Amendment Act 2003.

131 [2001] 3 NZLR 213 (“Bleakley 2001”).

  1. Bleakley v Environmental Risk Management Authority (2004) 11 ELRNZ 289 (“Bleakley

2004”), para 6 per Miller J.

  1. See HSNO s 126, “Appeal on question of law”.

in their milk. This appeal was made on the part of Ngati Wairere, a Maori people indigenous to the Waikato area where the research was to take place. Ngati Wairere objected to the research on the grounds that the sharing of genes interfered with whakapapa (genealogy) and mauri (life force) of the species involved. A special committee, established under s 19(2)(b) of the HSNO approved the field trial.

The High Court could not reconsider a decision based upon its merits, but only upon points of law. The Court found that the Crown had performed its duty regarding the Treaty of Waitangi, and that these considerations should not be given determinant weight. “The obligation on the authority was to take into account the relationship of Maori with their spiritual taonga, and the Authority had done so. There was therefore no error of law in the authority’s approach” (emphasis added).134

Regarding the precautionary principle in particular, the Court found that ERMA had applied precaution throughout its proceedings.135 Ultimately the appeal succeeded on a technicality, but only in so far as ERMA had to reconsider the application by stating the criteria of the Methodology Order used to reach its decision.

5.2 Bleakley v Environmental Risk Management Authority (2004)136

Bleakley appeared before the Court again in 2004, this time regarding a field trial in which sheep, rather than cattle, produced a human protein in their milk. ERMA imposed the provision that all transgenic animals and biological material be incinerated upon completion of the field trial. The trial ended in June 2003, and all animals, embryos, and semen were incinerated on site until March 2004. Containment was then lifted, and the farm reverted to traditional farming. Bleakley sued ERMA, charging that genetic material could remain on the site, particularly as deposited by animal waste. The transgene could thus escape by means of horizontal gene transfer. She argued that the Authority failed to take full account of the risks of horizontal gene transfer and failed to assert its power to amend its approval, and so the land should require further monitoring for a period of 15 years.

Miller J cited the judgment of McGechan J above and Potter J in Mothers Against Genetic Engineering v Minister for the Environment 137, stating: “The court cannot determine the scientific or ethical merits of new organisms. The legislature has struck with evident care a balance between risks and rewards of

  1. Bleakley 2001, supra note 131, para 3 per McGechan J. 135 Ibid, paras 164–172 per McGechan J.

136 (2004) 11 ELRNZ 289.

137 HC Auckland, CIV-2003-404-000673.

genetic engineering in the HSNO, and those who would alter it must look to the legislature for remedy.”138 The case was dismissed.

6. assessmeNT OF The hsNO aCT

6.1 Precaution

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. 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.139

I have already stated that the wording of precaution in the HSNO is weak, and that the acknowledgement of the principle in the Methodology Order is weaker still. The HSNO conveys an understanding of the precaution similar to that of Dr Max Kennedy, who testified before the Royal Commission that risks posed to biodiversity and human health are a normal part of scientific risk assessment.140 He maintained that risk assessment is employed “to consider the unknowns and to try to quantify those unknowns”, and continued, “[s]o the fact that there is debate over it shouldn’t be a surprise and it is not really something that risk assessment is unfamiliar with”.

Again, it is a misconception that considering risks during a traditional risk assessment is equivalent to the response mandated by the precautionary principle (as discussed in Part 2 above). Traditional risk assessment “totally and silently excludes from consideration the unknowns, which result in unanticipated consequences”.141 The precautionary principle does not simply mandate that one conduct a risk assessment, but rather mandates a specific response to uncertainty: err on the side of precaution.

Miller J, in Bleakley (2004) similarly puts his faith in the risk-assessment process: “It will be seen that the policy of the Act is not simply to reject

  1. Bleakley 2004, supra note 132, para 15 per Miller J.
  2. Hope, supra note 108, at 26–27.
  3. Testifying on behalf of the New Zealand Biotechnology Association. Royal Commission, supra note 1, p 67.
  4. Brian Wynne, Expert Discourses of Risk and Ethics in Genetically Manipulated Organisms: The Weaving of Public Alienation, London, 2000. As cited in Voigt, supra note 79, at 91.

applications that are affected by scientific uncertainty, but to assess the materiality of the risk in terms of the probability of occurrence and nature and magnitude of adverse effects.”142

Yet how does one assess the materiality and probability of risks that are uncertain? ERMA has effectively stepped around the precautionary principle through the Methodology Order. This is not to say that the decisions of ERMA have been catastrophic to date. In fact, the restrictions placed on applications for use in containment are very strong. However, when a risk is significant enough to merit digging up or sterilising an entire field, very real benefits for New Zealand should have to exist to justify the planting in the first place.143

The intent of containment is to “restrict an organism or substance to a secure location or facility to prevent escape”.144 For this to be possible, any heritable material involved in a field test must be removable. It is questionable whether this is truly possible. The Royal Commission itself states that such field tests “enable research on the effect of the transgenic organisms on soil ecology in a semi-contained situation” (emphasis added).145

Field tests to date have included the putting to pasture of transgenic animals, as in the Bleakley cases, and the growing of transgenic pine trees that are too large to be contained. These trials indeed have strong containment measures

– for instance, animals are contained with double fencing, and pollen release can be prevented by removal of reproductive structures from the pine trees.146 “The safety of field trials and the adequacy of methods to contain risk, can be adequately assessed and dealt with through risk management programmes by ERMA.”147

Although there have been no proven escapes of GMOs from field trials to date, structural breaches to containment have occurred.148 For example: “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.”149

  1. Bleakley 2004, supra note 132, para 46 per Miller J.
  2. “Chemical clean-up for GM trial site”, New Zealand Herald, 16 Oct 2001. 144 HSNO s 2.
  3. Royal Commission, supra note 1.
  4. Ibid.
  5. Ibid.
  6. ERMA New Zealand: Annual Monitoring Report 2003–2004 (October 2004). 149 Hope, supra note 108, at 30–31.

A HortResearch field-trial incident in 2001 provides a good example of the difficulty of true containment. After completion of a field trial of GM tamarillos, HortResearch agreed to decontaminate and sterilise the 2000-sq m site in Kerikeri where the plants were grown.150 However, HortResearch shelved the idea ten days later, citing further environmental concerns raised by the decontamination scheme.151 When a potential risk is so difficult to manage that the very management scheme (sterilisation) is too dangerous to pursue, should the “contained” field trial have been allowed in the first place?

ERMA indeed does go to great lengths to contain GMO field trials. Ultim- ately, however, complete containment (such as in closed research facilities) is impossible. This does not mean that all or even any trials should be discontinued, even in the face of precaution, as long as they are substantially beneficial and the potential harm is small. However, a truly precautionary outlook is hindered when field trials like these are considered under the HSNO definition of containment.

The possibility of conditional release was added to the Act in response to the recommendation of the Royal Commission. This intermediate step between contained and full release allows ERMA to impose measures on crops that, for instance, are found to be safe during field trials but about which there are lingering concerns.

An example of limited-release conditions applied in the UK by the Ministry for Agriculture, Forestry and Fisheries is the requirement of separation distances for each GE crop. “The separation distances for each crop are set in relation to threshold levels of contamination from cross-pollination, for example for canola the separation distance for 1% contamination is 1.5 metres; for 0.5% contamination the distance is 10 metres; and for 0.1% contamination the separation distance is 100 metres.”152

Separation distances are intended “to secure desired levels of crop purity by limiting cross-pollination between different varieties or types of the same crop”. However, it is important to note that these separation distances are not completely preventative of transgene escape. As Dr Salisbury noted in his testimony to the Royal Commission, “further isolation distances were not intended to prevent outcrossing entirely but to reduce outcrossing to an accept- able level”.153

The initial doctrine of the HSNO, that there should be no limited release,

150 “Chemical clean-up for GM trial site”, New Zealand Herald, 16 Oct 2001. 151 “Plans to decontaminate GE site shelved”, New Zealand Herald, 26 Oct 2001. 152 Royal Commission, supra note 1, at 177.

153 Ibid.

can be thought of as inherently precautionary. It made a fundamental acknow- ledgement that once a gene enters the environment it is there for keeps. ERMA, therefore, was forced to have an extremely acute sense of the risks borne by a crop or animal before any release was to occur. The introduction of limited release has negated this precautionary design.

Part of the argument in favour of limited release is that it will “enable the progress of the release to be monitored, which may include the spread of the organism, the incidence of adverse effects and the effectiveness of ‘controls’ set in place”.154 A specific example cited is the possibility of monitoring the spread of pollen, something that must be contained in a field trial. The problem, of course, is that if pollen spreads, the chance of containing that spread is already lost. It is understandable to monitor for the occurrence of known effects, but the very nature of GMOs, in their current incarnations, means that the effects may not be known.

On the other hand, it is possible that with great enough separation distances (as an extreme example, plants could be grown on opposite sides of the South- ern Alps, or on the North Island but not the South) the chances of outcrossing become negligible to the point that risk becomes acceptable. Limited release could allow for such regulation of the location and extent of crop planting. Furthermore, this type of separation could prevent interbreeding between GE and non-GE animals.

Separation, however, is a very difficult thing to maintain. This is clearly shown by the debacle of StarLink corn. The limited-release provision will have to be used with great caution. It remains to be seen how crops intended for limited release will be handled, as there have been no applications for either conditional or full release of a GMO to date.

6.2 Low-risk gm and the Biotech sector

Submissions received by the Royal Commission illustrate a distinction between contained research and uncontained research, particularly regarding impact upon the environment.155 For example, 65 per cent of respondents to the Commission approved of GM for use in medical research.156 Only a minority of submissions expressed outright opposition to genetic modification for the purpose of laboratory research.157 As discussed in Part 2, no adverse effects of contained genetic modification have ever been manifest. The reason for this is that the modified organisms produced are of low virulence, are unable to

  1. Ibid, at 124.
  2. Ibid, at 103.
  3. Ibid, at 240.
  4. Ibid.

reproduce outside of laboratory conditions, and more importantly are used within a contained environment.158

Universities persistently stressed in their submissions to the Royal Com- mission that genetic engineering is crucial to modern research in biochemistry, molecular biology, medicine, and even engineering.159 To remain intellectually competitive with world universities, and to prevent loss of the most qualified professors to foreign education systems, accepted technologies like genetic engineering should not be shunned.160 “Regulations need to ensure DNA cannot find its way into wild microbial flora. This would not be incompatible with a reduction in the form-filling required of researchers.”161

Many submissions to the Royal Commission stated that there existed un- necessary and excessive compliance costs related to the approval process. This regulation, it was argued, “placed New Zealand scientists at a disadvantage to their overseas counterparts”.162 One witness cited the loss of researchers who, having difficulty developing the transgenic mice that their research mandated, emigrated to Australia where the approval process was less burdensome.163

These positions had a direct influence on the drafting of the HSNO Amend- ment Act 2003. The addition by the amended procedure of rapid assessment of projects for low-risk genetic modification (s 42A) clearly shows that a less burdensome process does not always mean a less functional process.

Countries that have embraced GE goods (Australia and the United States), and also those that have not (the United Kingdom), exempt genetically modified organisms that are of low risk from requiring approval. Whether this is a cause or an effect of the presence of these countries at the forefront of biotechnology is not immediately obvious. However, universities have a very good history of self-regulation. “It is not uncommon for the University of Auckland Biological Safety Committee to impose extra controls on applications to further reduce the possibility of aerosol generation or to ensure the security of facilities. These controls are over and above the two standard sets of controls imposed by ERMA.”164

  1. Ibid, at 105.
  2. Ibid, at 94. Submissions of University of Auckland and University of Otago. 160 Ibid. Submissions of Lincoln University and University of Auckland.
    1. The Royal Society of New Zealand “Wai 262 Claimants”, The Royal Commission on Genetic Modification – submissions: http://www.rsnz.org/topics/biol/gene/submis/wai262.php.
    2. Professor George Peterson, as immediate past President of the Academy Council and of the Royal Society of New Zealand. Royal Commission, supra note 1, at 118.
    3. Dr Martin Kennedy of the Christchurch School of Medicine, appearing for the Human Genetics Society of Australasia and New Zealand Transgenic Animal Users. Royal Commission, supra note 1, at 94.
    4. Dr John Fraser, Professor of Molecular Medicine at the University of Auckland. Royal Commission, supra note 1, at 114.

6.3 Other Persistent Concerns

There is concern that the acceptance of GE goods, particularly crops and animals, may damage what has been called the “clean green” image of New Zealand. “[O]ur ‘clean and green’ environment is a major selling point in itself and will reap increasing rewards in the 21st century.”165 New Zealand has developed something akin to a brand image, allowing products like meat and fruit to be sold overseas at a competitive advantage, and allowing premiums over other countries.166 “The world looks to New Zealand to be clean and green, its future must be based on that, niche marketing, adding value and providing to the world those things the rest of the world has lost.”167

Separation of GE and non-GE goods is a very difficult proposition. StarLink corn is again the paramount example. Separation could be achieved on a crop- by-crop basis, where, for instance, kiwifruit remain completely GE-free while GE corn crops are allowed. However, while conceptually GE and GE-free goods could coexist, particularly with appropriate regulation in place to prevent the mixing of these goods, the influence of consumer perceptions (as opposed to the reality of this separation) may negate its benefits.168

The United States, with its saturated market of GE goods, nonetheless maintains the highest acreage of organic fruit and vegetable production in the world.169 However, the country has not escaped a loss of consumer base. “Within a few years of the introduction of GM crops, almost the entire $300 million annual US maize exports to the EU and the $300 million annual Canadian rape exports to the EU had disappeared ... In total GM crops may have cost the US economy at least $12 billion net from 1999 to 2001.”170

“Despite all their nice words about keeping New Zealand’s options open, the Commission has recommended a faster path to the field release of GE crops than we had before – destroying our current market advantage of guaranteed GE-Free exports.”171 Although the protection of New Zealand’s image is a

  1. Royal Commission, supra note 1, at 95.
  2. Ibid.
  3. Ibid.
  4. Ibid, at 96.
  5. James J Ferguson, “World Markets for Organic Fruits and Vegetables” (Report prepared for University of Florida Institute of Food and Agricultural Sciences, Florida, May 2004): edis. ifas.ufl.edu/pdffiles/HS/HS21300.pdf.
  6. G Meziani and H Warwick, “Seeds of Doubt” (a Paper prepared by the Soil Association, United Kingdom, 2002), 5: www.greenpeace.org.nz/pdf/ge/SoD.pdf.
  7. Jeanette Fitzsimons, “Preserving opportunities – but closing off options”: http://www.greens. org.nz/docs/press/010730gmj.htm.

relevant concern, it is difficult to apply such concerns to the construction and application of a legal regime.

Some parties have suggested that the HSNO be amended so that local govern- ment submissions to ERMA become of primary consideration.172 Particularly, territorial authorities of the Upper North Island are seeking increased power to protect their intensive local agriculture from contamination with GE crops.173

Section 53(4)(c)(ii) of the Act states that the Authority must notify “any local authority (within the meaning of the Local Government Act 2002) if, in the opinion of the Authority, the local authority is likely to have an interest in the application”. However, by receiving this information the local authority gains no other significant powers, and local authority submissions do not necessarily carry any greater weight in the ERMA decision-making process.174 “ERMA is required to take into account the district plans for GMOs under the RMA and the council’s LTCCP and bylaws for GMOs under the LGA. However, ERMA is not bound by these documents.”175

Dave Brash, of the Ministry for the Environment, defended local government exclusion, stating: “Most local authorities would not have the level of expertise required to establish the specific controls needed for the management of a particular GMO. It is therefore unlikely that any controls placed on a GMO by a local authority would have a sound technical basis. In addition, this would undermine the HSNO regime, which is based on comprehensive scientific, economic and cultural risk assessments.”176

It is possible that district councils could list activities involving GMOs as “prohibited activities”. For instance, the Ngatiwai Trust Board sought to list “any activity involving genetic engineering” as prohibited.177 Such a prohibition could have far-reaching impact on local universities, as well as on the rights of local farmers. However, at least one author suggests that such action would be considered ultra vires, and moreover would certainly involve litigation. It would therefore not be sound policy for a local authority.178 Although the Nelson

  1. For a thorough discussion of this prospect see P F Fuiava, supra note 128. 173 Ibid, at 297.
    1. Ibid, at 306.
    2. Royden J Somerville QC, “Interim Opinion on Land Use Controls and GMOs”, as cited in Fuiava, supra note 128, at 319.
    3. Ministry for the Environment letter of 26 August 2003 from Dave Brash to the Education and Science Select Committee considering the New Organisms and Other Matters Bill, as cited in Fuiava, supra note 128, at 318.
    4. [28 April 2004] Environment Court, Auckland, A057/2004, as cited in Fuiava, supra note 128, at 323.
    5. Fuiava, supra note 128, at 324.

City Council calls itself a GM-free city, “[i]t is a symbolic gesture only and is unlikely to survive a judicial review”.179

The Law Commission enumerated two possibilities that would help determine the need for a liability regime for damage caused by GMOs – either they are substantially different from other potentially hazardous human activities and thus more likely to cause damage, or they are not.180 Based upon my analysis in Part 2 above, it should be clear that GMOs best fit the first category.

The Royal Commission made the rather dubious statement that, “[f]rom a legal liability perspective we have not been persuaded there is anything so radically different in genetic modification as to require new or special remedies”.181 As a result, the Royal Commission did not suggest any novel liability statutes. Instead, the Commission pointed to s 109, which describes criminal violations of the Act. Any further liability, according to the Com- mission, was within the realm of existing tort law.

The Law Commission felt otherwise: “The Law Commission has not identified any liability regime that could ensure that all damage that might be caused by GMOs would be compensated. Genetically modified organisms pose the two possibilities of a low-probability but catastrophically damaging event, and of damage that is very slow in appearing. None of the existing mechanisms are able to guarantee compensation for either circumstance because nothing is likely to be able to compensate catastrophic or irreversible damage, and few remedies will be available for liability claims which may take decades to surface. In either of those situations, the options are that the losses lie where they fall, or that government steps in.”182

The assessment of the Law Commission is logical. Existing tort law has no scope for damages like biodiversity loss or transgene escape. At a more basic level, it seems very strange that the novel risks of GMOs can justify mora- toriums and special provisions in the HSNO Act if they are in fact an everyday affair.

  1. Ibid, at 325.
  2. The Law Commission described four possibilities in total: 1(a) GMOs are substantially different, but the existing liability regime is adequate; 1(b) GMOs are substantially different, and the existing liability regime is inadequate; 2(a) GMOs are no different from other potentially hazardous activities, and the existing liability regime is adequate; or 2(b) GMOs are no different, but the current regime is not adequate. See Law Commission, supra note 7, at 9.
  3. Royal Commission, supra note 1, at 328.
  4. Law Commission, supra note 7, at 17.

Establishing the proper statutory weight of Maori concerns is a contentious issue in many New Zealand laws, and the HSNO Act is no different. Some argue that “[t]he weight given to Maori perspectives should at least equal the weight given to scientific perspectives”.183 However, this contention is a stretch, particularly when applied to activities in institutional containment. The Act itself places Maori concerns as one among many factors on the “take into account” tier. As discussed in Part 3, however, it will be necessary for regulators to give greater weight to Maori concerns regarding cultural taonga and indigenous species.

A fundamental conflict may evolve between the application of conservation genetics to native organisms and Maori protection of cultural taonga. For instance, before the passage of the 2003 HSNO Amendment Act, which entrenched the role of Nga Kaihautu Tikanga Taiao, there were accusations that GM research was done on the kokako, the saddleback, the tuatara, and other native species without any consultation.184 Such a failure to consult breeds distrust, which will harm the ability of researchers to reach compromise with iwi groups.

Similarly, in 1998, Nga Kaihautu Tikanga Kaiao asked ERMA to decline an application for contained release of GM sheep that produced a human protein in their milk. The body asserted that iwi groups had been misled to believe that the benefits to human health from the research were certain, rather than theoretical.185 Since the failure of this appeal, iwi groups have been opposing GM research with more uniformity, illustrating both increased awareness of the issues involved, and perhaps a simultaneous decrease in trust.

As the HSNO does not give other concerns regarding biodiversity any greater value than those of Maori culture or the Treaty of Waitangi, a delicate balance has to be struck: “If the costs, in time and money, of consultation are too high, scientists will move the focus of their research away from areas, such as conservation genetics, that are of interest to Maori and the wider community.”186

7. CONCLUsION

Despite its weak statement of the precautionary principle, the HSNO may be inherently precautionary as a simple result of its thorough nature. During the seven years that the Act has been in effect, no company has felt confident

  1. Voigt, supra note 79, at 61.
  2. Royal Commission, supra note 1, at 126.
  3. Hope, supra note 108, at 27.
  4. Royal Commission, supra note 1, at 127.

enough, or foreseen enough economic benefit, to apply for limited or full GMO release.

The barriers of risk assessment and costs, however, are unlikely to forestall these applications forever. For ERMA to be ready when the applications do arrive, it would be well served to develop a more functional idea of precaution than that of the Royal Commission on Genetic Modification. Precaution is not a closed-door risk assessment, nor is it a 100-metre wall around the country. The principle is both substantive and normative, and the perceptions of those 92 per cent of New Zealanders that oppose GMO release need to be recognised through strong acknowledgement of the precautionary principle.

At the same time, it should be understood that risks and potential risks must first exist if they are to be regulated, and that any regulation should achieve some end. Charging exorbitant fees to allow a university to engage in activities that have a 20- or 30-year history of safety is neither merited by precaution nor welcomed by a growing economy.


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