New Zealand Journal of Environmental Law
Last Updated: 25 January 2023
The Precautionary Principle and Genetic Engineering in New Zealand: Legal and Ethical Implications
The Government decision to allow medical and laboratory experiments involving genetic engineering and to reopen applications for field trials of genetically modified organisms in 2003 reflects the significant inter- linkages between science, politics and economy. Albeit proclaimed, little respect is shown to both the high level of uncertainty inherent to the new scientific field of genetic engineering and the crucial limitations of technological application with regard to the complexity of nature.
It is the intention of this article to investigate the requirements of a precautionary approach to meet those uncertainties and limitations. By examining the risks imposed by genetic modification, it becomes apparent that the legal and institutional framework in place does not recognize sufficiently the limits of knowledge. The application of a risk assessment and risk management strategy cannot provide for a secure decision- making basis. It is argued that in order to comply with the requirements of a precautionary approach, a wider systems-based interdisciplinary analysis has to be put in place. Both expert views and public perception have to be taken into account and complemented by the recognition of ecological reality and adoption of a sound ethical basis as provided for by an ecocentric perspective.
Nature is not only more complex than we think. It is more complex than we can think.1
Nothing will be more important to human well-being and survival than the wisdom to appreciate that however great our knowledge is, our ignorance is also vast. In this ignorance we have taken huge risks and inadvertently gambled with survival. Now, that we know better, we must have the courage to be cautious for the stakes are very high.2
Genetic engineering — GE — has recently become one of the most intensively debated issues in relation to scientific progress, politics, economics, ethics and law. Especially since the Government’s response on 31October 2001 to the Royal Commission on Genetic Modification to allow field trials and laboratory experiments to go ahead (subject to the subsequent moratorium on releases until 29 October 2003), the debate among opponents of GE has been intensified.
One of the major focus points in this debate is the inherent problem of genetic engineering in regard to risk, uncertainty and unpredictability of its effects on natural ecosystems and human health. The outcomes, possible risks and their magnitude remain unclear and controversial. Because of both, genetic complexity and uncertainty of cause and effects, the need for a strong precautionary approach has been widely expressed. With its report to the New Zealand Government, the Royal Commission on Genetic Modification has provided a certain guideline for the handling of this new technology. With its decision, the Government adapted this “Preserving Opportunities” attitude of the Commission.
Although some commentators argue that the regulation of genetic technology is an oxymoron since genetic engineering is simply out of control,3 the Commission basically expressed satisfaction with the regulatory framework in place. Not surprising, therefore, no significant changes will be undertaken by the Government. With regard to the risks imposed by this new technology and the concern expressed by opponents to it, the focus of this paper is to examine the regulatory and legal framework relating to genetic engineering in New Zealand and to assess the demands of a substantial application of the precautionary principle and a
sound ethical basis.
Part II provides a closer look at the ethical and philosophical underpinnings including Maori perspectives of this new technology. The legal implications
including the national and international framework and the institutions in place in New Zealand to regulate applications to research (development, field-testing and release of genetically modified organisms) are examined in part III. The meaning, implications and application of a precautionary approach are the core issue of part IV before the final conclusion and recommendations made in part V.
II. STATEMENT ON BIOTECHNOLOGY WITH A SPECIAL FOCUS ON GENETIC ENGINEERING
1. Scientific Definition
Biotechnology can be described as a technique for using the properties of living organisms like plants, animals and microorganisms to make products or services. These techniques include the selection of natural strains of organisms that can carry desirable traits, making hybrids by fusing cells from parental sources, using chemicals and radiation to create mutant strains, or genetically engineering plants, animals and microorganisms to produce specific phenotypic characteristics.4 The principal focus of this paper is on recent controversial developments in biotechnology relating to genetic engineering — particularly in the area of scientific research and its regulation in New Zealand.
“Genetic Engineering itself allows a gene or genes in any living thing to be removed, turned off or shuffled around. It also allows genes to be removed from one species to another — also called transgenic modification.”5 Genes (lengths of DNA molecules that contain a distinct package of genetic information) within DNA can be extracted from virtually any organism, specific sequences can be isolated and the arrangement of proteins in those fragments determined. Those DNA pieces can be replicated millions of times, attached to DNA from any other organism and inserted into another life form.
The technology that enables genes to be manipulated is referred to as recombinant DNA (rDNA) technology. When these recombinant DNA technologies are applied to alter the genetic composition of an organism, the organism becomes genetically modified (GM). Organisms of this type are termed as genetically modified organisms (GMOs).
2. State-of-the-Art Technology, Research and Policy
Biotechnology, especially in the field of genetic engineering, is one of the fastest growing industries in the world. With the speed comes a technological dexterity of biotechnology, which is awesome. Some consider the development as the future technology. Biotechnology has already permeated a wide area of our modern life and is a core area of scientific research. Research in medicine, pharmacy, pharmacology, agriculture, and veterinary medicine for instance bases heavily on genetic modification. The growth of biotechnology has caught the attention of the private industry, research centers and governments worldwide. Al Gore refers to Genetic Engineering as “the pot of gold at the end of the biotechnology rainbow”.6 More and more genetics — and biology — research projects, and even entire University departments, are dependent on private industry to keep going. Even government grants demand promises of practical implication for every bit of research in a very short time frame. Dr Richard Strohman, past chair of the Department of Molecular Biology at the University of Berkeley, points out: “[A]cademic and corporate researchers have become indistinguishable. Every country in the post-industrial world now requires scientists to show that their work is useful in the day-by-day world. This insistence that everything be greeted with immediate usefulness is counterproductive beyond measures.”7 And the obsession to do whatever is possible regardless of whether it is desirable is no longer unusual in modern science. Which has led to, as Stan Rowe, a Canadian ecologist, describes it, a “know how” rather than a “know why” kind of approach to science.8
In New Zealand, the majority of investments in scientific research and development are sourced from government. These funds are expended largely in the Universities and in Crown Research Institutes (CRIs). Expenditure in biomedical and biological research (on a per capita basis) is significantly higher in the United States. But the major differences in investments derive from the private sector. Recent estimates indicate that public and private company expenditure exceeds US government-sourced expenditure on health research and biotechnology, by a factor of approximately ten.9 This major input of resources has accelerated the rate of development and application of the recombinant-based technologies with current major expensions occurring in the area of genomics
and bio-informatics. “It is reasonable to assume that these high rates of investment will continue to drive major new initiatives in biological and biomedical research and that much of these will be heavily based on the application of the new recombinant technologies.”10
A current example is the founding of the Liggins Institute11 — a University research Institute — owned by the University of Auckland — which manifests the close symbiosis of academic research, business and science.
One may therefore ask in what direction this technology is heading to. The novelty and uniqueness of biotechnology sciences was described by Andy Kimbrell as following:
We’ve taken flounder genes and put them into tomatoes. We’ve taken human genes and put them into salmon. We’ve taken the fluorescent genes from fireflies and put them into tobacco plants. It is very important to understand that we are crossing boundaries at will. There is no time in history that I am aware of, where flounders mated with tomatoes, where humans mated with mice, where salmons mated with chicken. This is a completely new arena.12
For billions of years, life has followed the principle that each living organism exchanged DNA only with others of its kind. But today, scientists can deliberately bypass species barriers and introduce foreign DNA into an organism at will. “GE (genetic engineering) is based on recombining genes from very widely different sources. And also transferring genes between organisms that are not just different species, but are different kingdoms. So that species that had no possibilities of interbreeding and very, very low probability of exchanging genes in nature, are now unrestricted due to these new laboratory operations.”13
George Orwell once warned that the “logical end” of technological progress is to “reduce human beings to something resembling a brain in a bottle”.14 David Orr states that “Orwell’s nightmare is coming true and in no small parts because of research conducted by our most prestigious universities”.15 Illustratively, the University of Auckland states that:
GM technologies are crucial for the successful conduct of research and teaching in the field of biochemistry, clinical biochemistry, molecular biology medicine and some areas of engineering. Accordingly, use of these technologies and their products is widespread in New Zealand, as it is in the rest of the developed world. There are no non-GM alternatives to most of the GM products used in the therapy of disease.16
What has to be noted is that genetic engineering is a very new science and research has only recently embarked on that issue. But especially in this field it becomes very obvious that scientists are crossing borders deliberately and entering areas of unpredictable outcome and uncontrollable risk. Once the door was pushed open there is now a wide variety of research projects covering almost every sector of natural sciences and medicine.
Current research projects entrench for example the cloning of genes, the sequencing of entire genomes, even the human genome, the development of the DNA chip technology, the further research on the production of proteins and diagnosis of human genetic and infectious diseases by using materials generated by recombinant technology, the curing of genetic defects by introducing an additional DNA sequence and xenotransplantation, further modification of plants and animals by the addition or deletion of genes or by regulation of existing genes. Other projects concern the use of transgenic plants to produce medically important proteins and for bio-remediation and for the synthesis of precursors for industrial use, the development of technologies to avoid the rejection of transplanted organs, the modification of the composition of proteins in food crops to improve nutritional value, and the development of model animal and plant systems to be used to develop new knowledge applicable to medicine and to economically important animals and plants by the use of recombinant technologies to alter their genetic material.17
These lists outline only some of the research implications of genetic engineering and provide an understanding for the scope of the research field.
3. Risks and Benefits
The outlined fields of research indicate the further development of this science. However, the existing scope has already provoked a highly controversial debate
among supporters and opponents of this modern technology over its impact and danger for both humans and the environment.
Proponents argue that genetic modification “holds exciting promises, not only for conquering diseases, eliminating pests and contributing to the knowledge economy, but for enhancing the international competitiveness of the primary industries so important to our country’s (New Zealand’s) economic well-being”.18 The Royal Commission claims biotechnology as the new frontier within innovative technologies and therefore praises the continuation of research as critical to New Zealand’s future. The Prime Minister of New Zealand, Helen Clark, has pointed out that science is critical to ensuring New Zealand developed a knowledge-based society. “We cannot afford to turn our back on science, which has the potential to inform our medical, biotechnology and industry strategies, but nor can we ignore the concerns raised about aspects of genetic modification.”19 Also, proponents point out that “recent advances in biotechnology promise tremendous benefits, including fast-growing, resilient crops, more nutritious food, new medicines, and even new technologies for environmental decontamination”.20 It is argued that use of genetically modified crops could help farmers worldwide to minimize the enormous amounts of chemical fertilizers, water, machinery, and fuel necessary to produce food. Thus, food can be produced at lower costs and with less chemicals considered harmful to human health and the environment.21 One promise is that by using genetically modified organisms, which have beneficial characteristics, developing states may find that they can meet increasing demands while practicing even more environmentally benign agricultural methods. Not only might the supply be increased, but foods could be engineered to have higher nutritional value (possessing more vitamins, healthy fats and oils) or could be engineered to stay fresh longer in tropical states.22 Biotechnology is also supposed to hold the potential to save the environment through example microorganisms controlling pollution and waste-water disposal.23 Another benefit that might arise is the ability to extract genetic material from remains of extinct animals or plants for purposes of cloning
new ones, allowing the reintroduction of these species into their native habitat.24 In particular, it is claimed that biotechnology has already been used to stop the loss of biodiversity by setting up a worldwide system of “seed-banks” to store germplasm. (= ex situ preservation as opposed to in situ preservation)
Another potential benefit relates to environmental clean up. For decades tiny bacteria (microbes) have been used to treat domestic sewage, industrial waste — water and other environmental pollutants by essentially feeding upon large, complex, harmful molecules, and thereby breaking them down into smaller, harmless ones.25 After the 1990 oil spill by the Exxon-Valdez off the coast of Prince William Sound, Alaska, Exxon used microbe-enhanced fertilizer to help cleaning beaches and shorelines of the oil debris.26
But this process — referred to as bio-remediation — as well as other uses of genetic engineering has one substantial drawback: unpredictability. It is the scientific inability to exactly predict the precise outcome and the effects of the development or release of a genetically modified organism into the environment, which causes a strong opposition to biotechnology. The release of genetically engineered plants and organisms into an external ecosystem or the environment per se can have significant detrimental environmental impacts. Plants with “artificial genes” could well have a disruptive effect on a finely tuned ecosystem. “The hazards are unpredictable and may be irreparable, because no one knows which elements constitute an ecosystem. Interactions such as gene transfer (jumping genes), an excessive population increase, or a change of engineered plants in the environment can disturb the existing flora and fauna.”27 Especially for New Zealand with its distinct and unique natural environment, which is already heavily threatened by introduced species such as possums, rats, etc., the outcome might be devastating. Fears have also arisen over various other aspects: unknown toxins, antibiotic resistance, religious, ethical or cultural infringements, allergic reactions, or counterfeit freshness. For instance, critics note, that xenotransplants may allow for a plentiful supply of engineered organs for thousands of needy human recipients, but they may also potentially contaminate humans with viruses and retroviruses.28
“Unlike hazardous chemicals or wastes, genetically engineered organisms are potential hazards with “legs”, capable not just of spreading but of proliferating.”29 There also is a strong indication that the rise of biotechnology, especially in
the areas of agricultural products and pharmaceuticals, has paralleled the loss of biodiversity. Although this cannot be proven yet, there is growing recognition among commentators that the two are inextricably linked albeit in ways that are not always immediately apparent.30 Biodiversity acts as a form of raw material for biotechnology and for that, conversely, biotechnology can directly modify biodiversity within the environment. One significant threat to biodiversity is gene erosion and gene uniformity caused by the usage of genetically engineered crops. Due to the growth of intensive farming, especially the bulk manufacture of seeds, an increasing number of people are nourished by a decreasing number of plant species. Approximately ninety-five percent of human nutrition is derived from no more than thirty plants and three major crops — wheat, rice and maize.31 Ancient cultivators have used at least 500 major vegetables and crops. This number has been narrowed down to 40 major plantation vegetables and crops.32 This phenomenon is leading to shrinkage in biological diversity through the widespread and permanent extinction of plant varieties, a process generally defined as “genetic erosion” or “genetic wipeout”.33 Related to the narrowing of genetic diversity by mono cropping is the spread of genetic uniformity, which holds the threat of an increasing possibility of epidemics.
There may be even more adverse environmental effects of genetically modified crops. Crops engineered to be resistant to herbicides may result in greater use of herbicides by farmers. Moreover, transgenic plants might alter the balance of an eco-system in ways that cannot be predicted and that, in the long-term, can be very harmful to the environment. Murphy warns: “For instance, genetic engineering might inadvertently generate new, more virulent strains of a virus or pathogenic bacteria harmful to the environment.”34
A current example of the unpredictability of effects caused by growing genetically modified crops manifests the agreement made by Crown Research Institute HortResearch to decontaminate and sterilize a 2,000 sq m site where GM tamarillos were grown in Kerikeri.35 Although it is feared by ERMA that this
action could harm the public’s perception of GM, the reason for proceeding is to make sure, that “there is nothing there of any significance that would be a risk or threat to the environment”. (Dr. John Shaw, HortResearch’s head of science) The agreement was based on the possible risk, that the genetically altered DNA in the soil at that site would transfer to related species planted there. However, the Government decision aims to put more stringent conditions on field tests to avoid contamination. It seeks to force researchers to contain or destroy plants with reproductive material, remove contaminated soil and ensure that all trials are strictly monitored. This is surely an ambitious goal. However, the practicability and mere possibility remains highly questionable, since it is rather difficult to detect the exact timing and scope of the reproductive period of plants.36
Herbicide resistant traits of a transgenic plant could also transfer pollination to weeds, creating uncontrollable “super-weeds”.37 Increased use of pesticides and insecticides could cause insects to mutate into insecticide-resistant “super- bugs”.38 Further, by genetically manipulating crops so as to poison insects, it may be inevitable that harmless or even beneficial insects are poisoned, thus, actually increasing the pest population and decreasing the biological diversity among insects as well.39
Jeremy Rifkin summarizes this development as following:
We are embarking on what is surely going to be the most radical experiment on the Earth’s systems in all of history. What we are talking about over the next ten years is the release of thousands and thousands of novel organisms, transgenic plants and animals proliferating all over the world. This really is a second genesis, artificially designed in the laboratories and placed into the ecosystems.40
The risks and benefits mentioned above are still widely and controversially debated among scientists and no reliable data is available to verify the claim of genetic engineering being beneficial. Nevertheless, this part’s focus was to highlight the difficulties in assessing the beneficial or risky potentials and to give rise for further debate.
(c) Ethical values
Besides environmental concerns, ethical issues play a major role in the debate about genetic modification technology. The question of whose and which values should complement science in informing decision-making and how to integrate those values into decisions on questions with scientific and technical complexities is a highly controversial area.41
There is a sharp division between two basically conflicting paradigms of ethical underpinnings of GE. On one end of the spectrum environmental ethics play an important role, which cannot be overemphasized. Environmental ethics extend the ethics of care and responsibility from people (bioethics) to animals, plants, the natural environment and its ecology through various means: animal rights, intrinsic value of ecosystem (ecocentrism), increasing awareness of the fragility of the earth’s ecosystems, questioning the choices that humans make and the possible or likely consequences of those choices. The antithesis of this ecological view is the reductionist worldview of modern science, which breaks systems into smaller and smaller pieces in order to advance knowledge. Nature is seen as raw material for humans to exploit and to redesign as the universe for their benefit. Humans are seen as separate from nature and in control of it (anthropocentrism). Since the reductionist worldview looks strictly at the parts and equals the whole to the sum of the parts it does not have the capacity to look at the big picture. Some commentators have assumed that recent industrial, agricultural, medical and military advances and applications of science, especially in the area of information technology, robotics, nanotechnology and genetic engineering have been proceeding largely in an ethical vacuum. Fox notes “science without ethics is blind”.42 In the same context Rifkin describes:
Genetic engineering increasingly views life from the point of chemical composition at the genetic level. From this reductionist perspective, life is merely the aggregate representation of chemicals that give rise to it and therefore they see no ethical problems whatsoever in transferring one, five, or a hundred genes from one species into the hereditary blueprint of another specimen. For they truly believe that they are only transferring chemicals coded into genes and not anything unique to a specific animal. By this kind of reasoning all of life becomes desacrialized. All of life is reduced to a chemical level and becomes available for manipulation.43
An attempt to compromise this reductionist view is provided by the ethical concerns of bioethics. Bioethics deal with the ethical issues associated with research on human subjects, with human health and the relationship between humans. In the case of genetic engineering this strand looks at the possibilities of biotechnology, as they will increase the choices for the individual. “For example, genetic testing informs choices about what children to conceive or bear, or how to respond to known increased risks of some diseases, new birth technologies that give new options for dealing with fertility or constructing families. Xenotransplantation will give some individuals the option of a therapy to prolong life.”44
However, focused primarily on human well being, bioethics does not to a full extent provide for an alternative to the perils held by this narrow utilitarian, anthropocentric thinking. Hence, there is an urgent need to make ecologically focused ethics an integral part of the scientific method in order to properly address risks and benefits. It is crucial that a responsible ethical position is articulated. Here it is strongly encouraged to apply an environmental ethics based on ecological wisdom. “Environmental ethics draws deeply on the understanding of the values that should be attributed to the natural environment, to the things other than human beings, living and non-living.”45 Ecological wisdom requires judgment on the meaning of science and knowledge and how best to apply it. Ecological wisdom sees humans as part of nature and incorporates therefore respect for all living things, and “respect for the boundaries of nature within which we are content to live, and respect for the connections and the processes that allow life to continue”.46 Arne Naess, the Norwegian philosopher, who introduced the concept of “deep ecology”, described it as recognizing the right of all living things to reach their full potential. Particularly in regard to the interference with natural ecosystems he writes: “[O]nly rarely can scientists predict with any certainty the effect of a new chemical on even a single small ecosystem.”47 Faced with this “scientific ignorance, the burden of proof should rest with anyone who intervenes in the natural environment.” The ecosystems in which we intervene are generally in a particular state of balance, which assumingly are of more service to mankind than states of disturbance and their resultant unpredictable and far reaching changes. In general, it is not possible to regain the original state after an invention has wrought serious, undesired consequences.48
Ecological science shows that introducing a new organism into an ecosystem is likely to create large and unpredictable effects on the whole system, with some other species becoming extinct, and changes in total biomass and chemical cycles. “There are claims that our scientific understanding has already outstripped our powers of moral comprehension and that the pace of change in biotechnology is happening so fast that ethical reflection has often not been possible.”49 Nicholas states that:
genetic modification is a development of new tools that enable us to change and create life forms in ways that were not previously possible. This gives us the possibility of acting in the world in more powerful ways than previously, and to change life forms and ecological relationships. ... As humans develop the technology to change genes, there is a strong sense that we are entering new moral territory.50
As sciences continue to expand the possibilities of action on nature through genetic modification, humans must again reconsider their relationship with nature and how they conceptualize it. Therefore it is suggested that an ecological worldview is applied to genetic engineering encouraging the essential logic that no benefit could be great enough to trade-off the disruption of the fundamental processes of life.
Furthermore, genetic engineering evokes a wider range of ethical questions
— still to be responded: Are there any limits to what we can do? How far do we think it is appropriate to change humans and to “choose” the genetic make-up for future generations? What are scientific and social functions of species integrity? What does it express? Are there some things we should never do even if it is safe? What does it mean to “play God”? What are acceptable risks and to whom? Underlying these concerns is the idea that humans are permanently violating the natural order and the natural evolution of life. “A predominant feeling is that humans have acquired huge powers to design and dictate life itself and that, given human nature, this technology is likely to be used in a harmful manner.”51 British Nobel Prize winner Joseph Rotblat even saw “the future of humanity at stake”. Jeremy Rifkin notes that “critics argue that genetic engineering reduces life to DNA sequences which can be recombined at will to create commercial products”.52 Since science is exclusively focused on the pursuit of material benefit for humanity,
the consequential desire for quick review, quick implementation, and quick reward has led to an exaggeration of the benefits and a denial of risks. To change that seriously threatening pattern, an ecologically sound ethics based on an ecocentric fundament as described above has to be applied to scientific work as an integral part of it.
4. “Institutionalized Ethics” — Institutional Ethical Framework
The predecessor of the Royal Commission on Genetic Modification, the Independent Biotechnology Advisory Board, has identified the use of GM as “one of the biggest ethical issues we face”. An approach to face the ethically difficult implications of genetic engineering is to apply an institutionalized ethical framework.
In New Zealand the Health Care Council Ethics Committee (HRCEC) has authority to approve all Health Research Council funded research involving human subjects, and has delegated that authority to Regional Health Ethics Committees and to some Institutional Committees. The HRCEC structure was established in the Health Research Council Act. In 1995 the Genetic Technology Advisory Committee (GTAC) was established as a subcommittee. GTAC’s terms of reference are to review protocols which involve the introduction of nucleic acids and genetically modified or manipulated organisms, viruses or cells into human subjects for the purpose of gene therapy or cell making and the use of those substances for cancer treatment.53
Research involving assisted human reproduction is the responsibility of the National Ethics Committee on Assisted Human Reproduction (NECAHR). This institution, appointed by the Minister of Health, would be responsible for ethical approval of research that involves genetic technology in human reproduction. Ethical approval for research involving animals is given by the Minister of Agriculture via the National Animal Ethics Advisory Committee (NAEAC) and the Institutional Animal Ethics Committee.54
The Environmental Risk Management Authority (ERMA)55 is an expert body whose task it is to make decisions on the importation, development and release of new organisms including GMOs. It may grant or decline approvals, place controls upon certain approvals and monitor those controls.56 ERMA is charged with assessing the safety of new organisms, and as such has authority in the area of
genetic modification. But there is little scope within the terms of the HSNO Act for ERMA to consider wider ethical issues, nor is there any specified ethical framework within the Authority must work. Therefore ERMA has set up guidelines in relation to the approval process of genetically modified organisms carried out under the HSNO Act 1996.57 These guidelines are relevant to all work done under the HSNO Act involving genetically modified organisms, except for:
Deriving from the HSNO Act, No. 21 of the Hazardous Substances and New Organisms (Methodology) Order 1998 recognizes guiding principles set down in the HSNO Act:
Decisions by the Authority must be in accordance with the specific requirements of the Act and the regulations made under the Act.
In detail the guiding principles, which flow from this section of the Methodology Order, are as follows:
[T]o protect the environment, and the health and safety of people and communities by preventing or managing adverse effects of ... New Organisms. (Section 4)58
Determinations by the Authority will recognize and provide for the following principles relevant to the purpose of the Act:
a) the safeguarding of the life-supporting capacity of air, water, soil and ecosystems;
b) the maintenance and enhancement of the capacity of people and communities to provide for their own economic, social and cultural well-being and for the reasonable and foreseeable needs of future generations. (Section 5)
Determinations by the Authority shall take account of the following matters relevant to the purpose of the Act:
a) the sustainability of all native and valued introduced flora and fauna;
b) the intrinsic value of ecosystems;
c) public health;
d) the relationship of Maori and their culture and traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna and other taonga;
e) the economic and related benefits to be derived from the use of a particular hazardous substance or new organism;
f) New Zealand’s international obligations. (Section 6)
The guidelines do not have formal status under the HSNO Act — they serve as mere guidelines, not instructions, since views on cultural, ethical and social boundaries are not fixed but evolve continually. Due to the fact that the guidelines are intentionally broad in scope as to encompass all matters within the concept of “social and cultural” decisions they don’t provide any obligations to be complied with by all those involved in GMO research, investigations and field work. Therefore it is not surprising that the ethical guidelines are only concerned with general observations like the demand of dealing sensibly with work on genetic modified organisms on a basis of a transparent and open process, careful analysis, a sound appreciation of criteria and constraints.59
Concerning this piece-meal approach to the ethical surveillance of genetic modification the recommendation of the Royal Commission to establish Toi te Taioao: a Bioethics Council as adopted by the Government’s decisions, can be welcomed. The Bioethics Council is meant to act as an advisory body on ethical, social and cultural matters in the use of biotechnology in New Zealand, to assess and provide guidelines on biotechnological issues involving significant social, ethical and cultural dimensions and to provide public participation in the Council’s activities. This could provide a helpful and welcome solution to the confusing existing system since it provides a panel to discuss ethical issues. But it is important that the right people are appointed to the Council, that the public is effectively involved and the council actually has some influence on the final outcome. It is suggested that it is especially important to address a mixed panel of experts and lay people to that Council to facilitate communication and integration of different views to avoid one-dimensional expert views.60 Black describes the importance of including a wide range of views — but particularly lay views — and facilitating the communication between them as follows “[I]t is that the languages of science, commerce, ethics, ecology, law are foreign to each other; neither can hardly understand what the other is saying, let alone why they are saying it ... This is because the different participants speak different languages.”61
Although lay views are often seen as irrational, based on ignorance, as mere emotions or prejudices, Black suggests to develop a forum in which a wide range
of groups can participate simultaneously, debating directly and in public to make the boundaries separating science and the public more fluid.62 To facilitate the integration of scientific and non-scientific views the idea of scientific objectivity overruling lay “irrationality” — the technocratic view — has to be replaced with one that recognizes different rationalities. If these requirements are taken into account by establishing the Bioethics Council the Council can well help to facilitate the ethical controversies surrounding the discussion about genetic technology. Furthermore — as suggested by the Royal Commission — Maori representation is essential to the Council. But rather than taking a simply consultative approach as the council advises, Maori should be represented equally within the panel.
5. Maori Perspective
Maori have a particular interest in the area of genetic modification. But the view of Maori of the use and application of genetic engineering is not uniform. While many Maori consider genetic modification as unacceptable, some seem to believe that the potential economic benefits for Maori are considerable enough to warrant their use. Some Maori understand the respect for the environment as having a reverence for the land and indigenous flora and fauna. Any use of biotechnology undermines this respect and is perceived as culturally insensitive. Labour’s Maori MPs expressed their views by saying: “We are not opposed to science. We are concerned about the dangers of compromising the social, cultural and environmental integrity of our country for short-term commercial gain.”63
Others express their concerns differently. Here the concern takes a more relative character where the issue is one of preserving what might be useful for the future. Not to squander with what might turn out to be a valuable source in the future was seen to be important.64
To understand the Maori view on biotechnology or scientific progress it is important to understand Maori concepts and values. Maori express a specific spiritual and cultural view of the relationship between the natural world and the human world. It is a relationship premised in whakapapa where all living things are connected by genealogy.65 Plants, animals, genetic material, people and other
natural phenomena such as lakes and rivers possess mauri (life-force), have their own whakapapa and are descendants from gods and goddesses.66 Andrea Tunks describes this concept as a “genealogical web”. “The web forms the inherent spirituality of all things in the universe and is the basis of their interconnection.”67 But Maori values, beliefs and attitudes are not uniform68 and there is no single cosmology. Another key concept is kaitiakitanga, which relates to the decision- making authority governing natural resources. Kaitiakitanga embraces the ideas of guardianship and has both a spiritual and practical dimension.
Concerning genetic modification the question is what effect this technology has on mauri of the genetic resources, and whether it opposes cultural or spiritual grounds of Maori in terms of whakapapa. As it is a relationship of interdependence it is imperative that the reciprocal obligations inherent in that relationship are not disturbed by the mixing of genetic material between species that would naturally not interbreed. Therefore, the research in the field of transgenic genetic engineering and xenotransplantation raises particular ethical issues for Maori. The mixing of genetic material in this context interferes with whakapapa and is an anathema to Maori cultural and spiritual beliefs. Gibbs notes: “[M]ixing genes from human and non-human species or from different species may be thought to be breaching sacred barriers and interfering with the notion of whakapapa.”69
Furthermore, the deliberate release or escape of GMOs into the environment may be seen “as a defilement of the mauri of the environment, an insult to the mana of the kaitiaki and, therefore, a significant impact on taonga”.70 Maori also have expressed particular concerns over the genetic manipulation of native species, which are the subject of a tribal claim to the Waitangi Tribunal known as the “Indigenous Flora and Fauna Claim” (WAI 262).71 Where an indigenous specimen has had foreign genes introduces, iwi as kaitiaki or guardians, may believe that the species’ integrity has been interfered with and therefore also the spiritual integrity or mauri of the species.
Finally it is to be noted that many Maori do not believe in scientific progress, which is exclusively the result of rational thinking and careful observation. Their knowledge is holistic as it integrates values and facts. Maori understand reality in its physical and spiritual context and their economy differs widely from western
utilitarian and marked-led approach where knowledge and economy are closely linked.72
By making decisions on applications for GMOs ERMA is required to take into account the principles of the Treaty of Waitangi (Te Tiriti o Waitangi) (s. 8 HSNO Act) and the relationship of Maori and their culture and tradition with their ancestral lands, water, sites, waahi tapu, valued flora and fauna, and other taonga (S. 6 HSNO Act). A special ERMA committee, Nga Kaihautu Tikanga Taiao, provides input to the Authority in Maori perspectives concerning:
Although these provisions within the HSNO Act exist, the question remains if Maori issues are properly addressed. It is suggested that Maori views are not only heard as provisions, but are given significant weight in the assessment of the impacts of any application for approval of GMOs. The weight given to Maori perspectives should at least equal the weight given to scientific perspectives.
III. LEGAL IMPLICATIONS OF GENETIC ENGINEERING
1. Legal Definitions and Regulatory Framework
This part covers the legal aspects associated with genetic modification technology in New Zealand and within the international regulatory regime. It also covers the institutional arrangements relating to the approval processes, moratorium and risk assessments, that are in place to administer the relevant laws.
The primary legislative regime that controls the use of genetic modification technology in New Zealand is the Hazardous Substances and New Organism Act 1996 (HSNO Act) and the Hazardous Substances and New Organism Amendment Act 2000. In addition to the HSNO Act there are various other statutes that interrelate and apply to specific genetically engineered products, namely:
(2000) 4 NZJEL 81, at 116.
(a) Hazardous Substances and New Organisms (HSNO) Act 1996
Key laws relating to genetic engineering and environmental protection from risks related to GMOs are the HSNO Act and the Biosecurity Act 1993. The HSNO Act is the primary tool used to manage the potential adverse effects of GMOs. The purpose of the HSNO 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.73 Under the HSNO Act GMOs are regulated as part of the regulation of new organisms. The Act also establishes the Environmental Risk Management Authority (ERMA)74 and provides decision- making framework and criteria for applications for new organisms in relation to
Two principles, which are explicitly promoted under section 5 of the Act, require all persons exercising functions, powers and duties under the Act to recognize and provide for the following as relevant to the purpose of the Act:
The Act also requires in s. 6 to take into account a number of matters to achieve the purpose of the Act.
The HSNO Act provides for a methodology to be established for making decisions under the Act.78 This Methodology has been established in 1998 and is called the Hazardous Substances and New Organism (Methodology) Order. The Act is only concerned with living or viable organisms. Therefore some products that have been made using genetic modification technology, imported to New Zealand but no longer contain viable or living organisms would not be required to go through the approval process set out in the Act. For example the approval process in HSNO would not have been sought for the processing or importation of tomato paste that has been processed from genetically modified tomatoes.
New organisms under the Act include amongst other things “genetically modified organisms, which have not been previously approved by the Authority for release in NZ”.79 Genetically modified organisms are defined as
any organism in which any of the genes or other genetic material, which
a) has been modified by in vitro techniques, or
b) is inherited or otherwise derived, through any number of replications from any genes or other genetic material, which has been modified by in vitro techniques.80
Once approval has been given in accordance with the HSNO Act, an organism ceases to be a new organism and anyone can “freeload” on that approval in terms of importing or manufacturing it. It is important to note that it is the organism not the applicant, which receives approval. Any new organism present in New Zealand before 29 July 1998 in contravention of the previous regime is a new organism. The HSNO Act does not provide for any controls on new organisms once they are released into the environment. A released new organism is allowed to move, or to be moved within New Zealand free of any restrictions other than
those imposed by other Acts.
Additional to the provisions of the HSNO Act 1996, the HSNO Amendment Act 2000 covers four implications, designed to:
Although the HSNO is the key statute that controls the use of GM technology, it interacts to a greater or lesser extent with a number of other statutes:
(b) The Biosecurity Act 1993
The Biosecurity Act 1993 is the principal statute for the exclusion, eradication, and effective management of pests and unwanted organisms. With regard to genetically modified organisms or any kind of new organisms as defined above, the Biosecurity Act also provides for the effective management of risks associated with the importation of risk goods and for the registration of containment facilities and facility operators. New organisms are treated as risk goods under the Act.
Particularly when enforcing the control requirements applying to new organisms approved for importation, development, or field-testing in containment set by ERMA, there is a close relationship between the Biosecurity Act and the HSNO Act for new organisms. The Biosecurity Act and HSNO Act are complementary and the two approval processes are parallel. ERMA therefore encourages applicants to apply both to ERMA and to the Ministry of Agriculture and Forestry (MAF) to get an approval under the Biosecurity Act at the same time. New organisms for which containment approval has been granted in accordance with the HSNO Act are considered to be “restricted organisms” under the Biosecurity Act and are required to be held in containment facilities approved under this Act. If they are not held in containment they are unauthorized goods under this Act. If ERMA has declined approval to import an organism, this new organism becomes an unwanted organism under the Biosecurity Act. An unwanted organism is an organism that a MAF Chief Technical Officer believes is capable or potentially capable of causing unwanted harm to any natural or physical resources or human health and includes:
a) any new organism for which ERMA has declined approval to import that organism,
b) any organism specified in the Second Schedule of HSNO.
It does not include any organism approved for importation under HSNO unless:
a) the organism has escaped from containment, or
b) a chief officer, after consulting with ERMA and taking into account any comments made by it concerning the organism, believes, that the organism is capable, or potentially capable of causing unwanted harm to any natural or physical resources or human health.
(c) Medicines Act 1981
Medical Applications for human use must comply with the HSNO to the extent that they are being developed in New Zealand using GMOs or imported containing a viable organism. Consent for the distribution of medicines is given under the
Medicines Act 1981 on advice from the Medicines Assessment Advisory Committee. These medicines may include GMOs such as the recombinant cholera vaccine, and the rotavirus vaccine, products derived from GMOs (human insulin) and discrete compounds synthesized with the aid of GMOs. Medicines that are or include GMOs also require approval from ERMA for release in New Zealand under the HSNO Act.
(d) Food Act 1981 and Animal Products Act 1999
Any food developed in New Zealand using GMOs or imported containing viable organisms, whether it is for human or animal consumption must comply with the criteria and requirements of HSNO. Furthermore food for human consumption must also comply with the requirements of the Food Act 1981 and the Animal Products Act 1999, which will replace the Meat Act in 2002. There has not been approval from ERMA for the release of GMOs including food in New Zealand to date. The Ministry of Health has the prime responsibility for food regulation in NZ. Food standards are set out by the Australia New Zealand Food Authority (ANZFA). This Authority develops Food standards for recommendation to the Australia New Zealand Food Standard Council. To regulate food produced using gene technology, the Council has approved Standard A 18, which requires food produced gene technology to be safety assessed by ANZFA. The Council also requires such foods to be labelled if they are not substantially equivalent to their conventional counterparts and contain new or altered genetic material. In July 2000 ANZFA decided to extend the current labelling requirements for genetically modified foods in Australia and NZ by requiring labelling based on the presence of genetically modified material in foods. Food containing 1% or more of GM ingredients must be labelled by 1 December 2001.
(e) Resource Management Act (RMA) 1991
Section 142 of the HSNO Act defines the relationship to other Acts. The most important aspect of this provision is the impact of the HSNO Act on local authorities where issuing resource consents or setting up district, regional or city plans or policies.81 Persons exercising powers and functions under the RMA relating to the storage, use, disposal, transportation, field-testing or release into the environment of new organisms are required to comply with the HSNO Act and any regulations made under the Act. Williams presumes that this has the
effect that district plans should contain minimum performance standards in relation to any substance containing a new organism, which has been the subject of specific requirements pursuant to a HSNO approval or regulation.82 This may result in more stringent resource consent conditions or plans than provided for under the HSNO Act. Nevertheless, much discretion in this area is transferred to local government authorities and depends on their understanding of and responsibility for regulating aspects of GMO-handling.
(f) Voluntary and statutory moratorium
During the time of the Royal Commissions inquiry and the long-awaited Government decision a voluntary moratorium was established between the Government and relevant industry and research groups. The moratorium applied to field test and release applications of GMOs made in accordance with the HSNO Act 1996. During the moratorium-period all field-trials were put on hold.
With the Government decision the voluntary moratorium expired. Now medical and laboratory experiments are allowed again on new field trials but bans on commercial releases for genetically modified organisms remain under the HSNO (Genetically Modified Organisms) Amendment Act 2002 until 29 October 2003. After that date, scientists can make fresh applications for field tests of GM organisms under stringent conditions to avoid contamination.
The decision to ban commercial releases of GMOs was introduced to give the Government time to research socio-economic, ethical and environmental concerns. However, the law will lapse after October 2003 unless the Government renews it.
2. International Framework
(a) United Nations Convention on Biological Diversity (CBD)
The key document concerning potential environmental, economic and social consequences of a proliferating international biotechnology industry is the United Nations Convention on Biological Diversity (CBD).83 The CBD signed at the 1992 United Nations Earth Summit in Rio de Janeiro, has three stated objectives:
a) the conservation of biological diversity,
b) the sustainable use of its components, and
c) the fair and equitable sharing of the benefits arising out of the utilization of genetic resources.84
The CBD obligates parties to develop national strategies, plans on the conservation of biodiversity, which shall include, among other things: “... measures to facilitate access to genetic resources for environmentally sound uses”85 and the transfer of advanced technologies to other nations. The CBD requires parties “as far as possible and as appropriate to prevent the introduction of, control or eradicate of those alien species which threaten eco-systems, habitats and species”.86
In addition, parties to the convention must: establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risks of human health.87 Under the CBD biotechnology is defined as any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.88 The language of Art. 8 (g) is sufficiently broad and tentative to justify almost any level of biotechnology regulation. In regard to Biotechnology the CBD is more concerned with regulating further progress than taking any preventative or precautionary measures.
In a fundamental anthropocentric perspective the Convention calls for the equitable sharing of the benefits out of the utilization of genetic resources and providing appropriate access and transfer to/of genetic resources.89 Boyle notes critically a “trade off between conservation and economic equity is at the heart of the convention”.90 The reason for that conflict over the central objectives of the CBD is seen by Gillespie as the want of Northern countries of a convention that retained their access to raw biodiversity of other countries, whereas Southern countries desired one that involved considerations of development, sovereignty, and equity.91 He states critically: “As a result, the final document ... [has] tended to be a pastiche of vague commitments, ambiguous phrases, some awkward
85 CBD, Art.15 (2).
(2000) 4 NZJEL 1, at 4.
compromises, a lack of harmonized responses or best practices, weak or non- existent planning processes, inexperience and a capacity limitation among users, and “confusing property rights over genetic resources”.92
In addition to that serious flaw and generality much is left to the discretion of the individual state-members of the Convention. Therefore the success of the CBD is heavily dependent on the understanding of the member-states of the relation between the conservation of biodiversity and the threats provided by intensive use of genetic modification technology.
(b) Biosafety protocol
The Convention provided specifically for the negotiation and adoption of an international Biosafety Protocol. Art. 19 (3) of the CBD calls upon the parties to “consider the need and modalities of a protocol setting out appropriate procedures, including in particular, advanced informed consent in the field of the safe transfer, handling and use of any living modified organism resulting from biotechnoloy that may have an adverse effect on the conservation and sustainable use of biotechnological diversity”.93 The parties to the CBD negotiated over the course of five years and on January 24, 2000 they adopted the text of the Cartagena Protocol on Biosafety.94 As of October 2000, 75 states and the EU have signed the Biosafety Protocol. New Zealand has recently signed the Protocol. But New Zealand will only become bound by the Protocol once it has ratified it, although as a signatory New Zealand will be required to refrain from acts that would defeat the objective and purpose of the Protocol, until such time as it has taken a decision on ratification. The Protocol must be ratified by 50 states before it will enter into force, a process expected to take about two years.95
Different from the CBD, the Protocol is an important achievement in may respects. As a general matter, it creates an international framework for addressing the environmental risks and effects of some genetically engineered products, setting as its objective:
[T]o contribute to ensuring an adequate level of protection in the field of safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.96
Specifically, the Biosafety Protocol only allows trade in genetically modified products to proceed essentially unhindered, subject to two conditions:
In what may prove to be its most important legacy, the Biosafety Protocol further requires the state of import, in deciding whether to authorize the shipment, to undertake in a scientifically sound manner a risk assessment to identify and evaluate the possible adverse effects of living organisms on the conservation and sustainable use of biological diversity.100 The Protocol also establishes an internet based “Bio- Safety-Clearing-House”, intended to assist states in the exchange of scientific, technical, environmental, and the legal information about LMOs.101 Even though some assume that if the protocol is ratified, it would have a profound effect on the future of biotechnology and international trade in agricultural products,102 the protocol contains considerable gaps in its coverage: it covers only living modified organisms and it is concerned only with their effects on conservation of biological diversity. For instance all pharmaceuticals are excluded from coverage. Finally the advanced informed agreement procedure only applies to LMOs intended for introducing into the environment of the importing state, it does not cover LMOs
intended for direct use as food or feed or for processing and it does not apply to living organisms in transit.103
Another drawback of the Protocol is its ambivalence by providing that each state’s right to import LMOs is subject to existing agreements. The Preamble both emphasizes that the Protocol does not alter the rights and obligations of parties under other international agreements and agreements which are mutually supportive, while at the same time such statements are “not to be intended to subordinate this Protocol to other international agreements”.104 Other issues such as potential liability for any harm caused by the introduction of genetically modified organisms will be resolved at a later date.105 The Biosafety Protocol leaves unclear the relationship between the standards set in the Protocol and, to the extent that they may differ, the standards that would otherwise operate under trade agreements.106
The positive outcome of the Biosafety Protocol can be seen as “being a tremendous step forward in creating transparency for the highest risk category of biotechnological exports — LMOs specifically intended to be introduced into the environment”.107
(c) Agenda 21
Another brick in the international framework concerning the regulation of Biotechnology is Agenda 21 — an action plan setting out principles and goals for sustainable development. Chapter 16 of Agenda 21 deals with the environmentally sound management of Biotechnology. The “need for further development of internationally agreed principles on risk assessment and management of all aspects of biotechnology, which should build upon those developed at the national level” is recognized in paragraph 16.29. “Only when adequate and transparent safety and border control procedures are in place will the community at large be able to derive from, and be in much better position to accept the potential benefits and risks of biotechnology.”108
3. Institutional Framework for the Regulation of Genetic Engineering
(a) Ministry for the Environment (MfE)
The MfE provides policy advice to the Minister for the Environment on the HSNO Act. MfE has a policy interest in the impact of genetically modified organisms on the environment and maintains a watching brief on international activities, including research and development in this area as well as on biocontrol and bioremediation research and development. The functions of MfE are set out in section 31 of the Environment Act 1986. Policy functions include advising the Minister for the Environment on all aspects of environmental administration.
MfE administers the HSNO Act and monitors ERMA. A further function of MfE is to provide and disseminate information and services to promote environmental policies, including environmental education and mechanisms for promoting effective public participation in environmental planning. MfE has also the responsibility to advise the Minister of the Environment about the call in powers under s. 68 of the HSNO Act. Call in is possible when the Minister considers that an application made under the HSNO Act will have significant effects with respect to the economy, or the environment, or health, or internationally, or in an area in which ERMA lacks sufficient knowledge or experience. To date those call in powers have not been exercised.109 The Royal Commission recommended that the first application for release of a genetically modified crop be called in and decided by the Minister for the Environment. But Helen Clark said that it would have left the Government like “a possum in the headlights”, because it would have needed more time to research the issues raised by the commission.110
(b) Ministry of Agriculture and Forestry (MAF)
The MAF is responsible for the development and approval of important health standards for all organisms imported into New Zealand, including new organisms requiring containment. This responsibility stems from the Biosecurity Act. MAF inspectors are required to ensure that risk goods, including imported GMOs, comply with health standards and that new organisms are not given biosecurity clearance unless approved for release. The Director General of MAF may approve containment facilities and their operators.
(c) Environmental Risk Management Authority (ERMA)
ERMA exercises powers, functions and duties under the HSNO Act. The three key elements in the structure of ERMA are: the Authority, Nga Kaihautu Tikanga Taiao and ERMA New Zealand. Nga Kaihautu is the Maori Advisory Committee and has been formally established under the First Schedule to the Act. ERMA is the executive arm of the Authority and is led by the Chief Executive. ERMA was established under part IV of the Hazardous Substances and New Organism Act 1996. The Authority is a quasi-judicial body with currently eight members appointed by the Minister for the Environment. The Authority is the governing board for ERMA New Zealand. With regard to genetic modification some of the main functions of the Authority are:
(d) Crown Research Institutes (CRIs)
ERMA has the power to delegate low risk GMO applications to Institutional Biosafety Committees (IBSCs) in scientific institutions — mostly universities.
These applications are covered by the “rapid assessment” provisions of the HSNO Act (s. 35 and 42). Decisions are mostly delegated to Crown Research Institutes. The CRIs were established and empowered under the Crown Research Institutes Act 1992, the Companies Act 1955 as amended in 1993 and the Public Finance Act 1989. They are limited liability companies with their own board of directors appointed by shareholding Ministers. Each institute is based around a productive sector of the economy or a grouping of natural resources. This allows each of the nine institutions to have a clearly defined purpose. Decisions (rapid assessments) made by the delegated institutions are treated in all respect as though they were decisions made by the Authority. With regard to Institutional Biosafety Committees, the Royal Commission recommended, that they should have at least one Maori member and that approval for development of genetically modified animal cell lines be delegated to the IBSCs.
(e) Further institutions
Department of Conservation (DoC)
DoC is under control of the Minister of Conservation and has the function to advocate and promote the conservation on New Zealand’s natural and historic resources. Under the Biosecurity Act 1993, it has an operational role to monitor compliance with the regulations in place and to enhance public understanding.
Ministry of Research, Science and Technology (MORST)
The Ministry ensures that government policy development receives sound and timely technical advice and also maintains good liaison with the research community. The Ministry is also responsible for gathering and disseminating statistics and descriptive information on research, science and technology activities and for administrating international science relations at an international level.113
Independent Biotechnology Advisory Council (IBAC)
The IBAC was the predecessor of the Royal Commission on Genetic Modification and was established by the Minister of Research, Science and Technology in May 1999. IBACs key functions were to stimulate the public debate and understanding about the broad topic of biotechnology and inform the government about the environmental, economic, ethical, social and health aspects of the technology. IBAC represented a report about its findings in August 2000.
Parliamentary Commissioner for the Environment (PCE)
The PCE114 is an officer of Parliament and was established under Part I of the Environment Act 1986. The Commissioner is an independent arm of the Government.115 According to s. 16 of the Environment Act PCE’s functions include:
As Genetic Modification relates to actual or potential effects on the environment including people and communities; and the surrounding social, economic, aesthetic and cultural conditions, the PCE claims a special interest in GM.116 Following the model of a Parliamentary Commissioner for the Environment, the Royal Commission recommended the establishment of a Parliamentary Commissioner on Biotechnology. In regard to the recommendations of the Royal Commission, there may be a need for the PCE to investigate in the Government’s response to the Commission, and the efficacy of the systems of agencies and processes that the Government might set up to manage the environmental risks posed by genetically modified organisms.117
Royal Commission on Genetic Modification (RC)
The Royal Commission was an independent body established by the Government by Order in Council on May 8, 2000, to look into and report on the issues surrounding genetic modification in New Zealand. On July 27, 2001 the RC presented its report to the Governor General, Dame Silvia Cartwright. With the finishing of the report the RC came to an end. The aim of the investigation was to stimulate a broad-ranging discussion on genetic modification and consideration of the strategic options available in New Zealand, and to identify the changes considered desirable to the current legislative, regulatory, policy and institutional arrangements in regard to genetic modification. The major outcome of the report is “Preserving Opportunities”. Here the RC explicitly rejects the idea of a New Zealand free of all genetically modified material at one extreme and the unrestricted use of genetic modification at the other. It recommends a number of enhancements but was mainly satisfied with the existing regulatory and institutional framework.
This outcome was very much criticized by the Green Party of New Zealand: “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.”118
The submissions in response to the inquiry of the Royal Commission revealed the controversy in the public debate: while some groups consider that the regulatory systems now in place are appropriately robust others considered them being too restrictive and lagging behind scientific advances.119 Research organizations even objected to having to release commercial information in the public arena. They were also concerned that the restrictions could seriously compromise New Zealand’s ability to compete in the international scientific area. The University of Auckland argued in its submission that in order to continue to be an internationally respected and recognized research-led institution the University requires and enhances its present range of activities in the area of genetic modification, GMOs and GM products. Regulatory restrictions would place the University at a disadvantage. Furthermore it contends that the approval process is rather rigorous and generates unnecessary information that does not assure risk assessment. “The process has ... substantially increased to unrealistic levels the workload of the University’s researchers.”120 But there are also financial issues, which matter: “The University has a considerate investment in human capital, teaching, and research infrastructure to support activities associated with genetic technologies. That investment is at considerate risk if such technologies were unavailable or unreasonably restricted.”121 David Orr describes such a link between commerce, power and academy as a “cash relationship, which began with a defence contract here and a research project there”.122
To the contrary it was argued that existing laws should be altered in a way that as to implement the recognition of the intrinsic value of nature and respect for life in all its diversity. Professor Klaus Bosselmann, Director of the New Zealand Center for Environmental Law, Auckland University, argues for an ethically informed legal framework to guide GM. “As the new ethic fundamentally challenges the prevailing tradition, governments are reluctant to review and revise regulations, statutory controls, intellectual property law, property rights and
consent procedures. The enormous pressure of industry and industry-driven research in GM is a further factor explaining this reluctance.”123 In his opinion any serious attempt to promote a framework suitable to guide GM would have to start with the respect for nature. “This notion of respect would allow for GM research within the strict parameters of the concept of human integrity, dignity and self-determination. It would not allow for GM research affecting the integrity of animals, plants, and ecosystems.”124 He argues for key strategic directions including a long term view of the potential risks and benefits for New Zealand, beyond the short-term horizon of many commercial and political interests. Accordingly, the Green Party calls for a GE Free NZ, where GMOs would be used only in contained laboratories for research reasons but there would be no release into the environment and no outdoor field trials. “Instead of trying to outstrip the US biotech multinationals in the creation of crops ... we could develop intellectual capital in sustainable management, both to support our own production and to provide knowledge to others.”125
Regarding those arguments, the Government decision could be seen as unsatisfying and the issue of a continuation of a ban on commercial release became a core point of the election held on 27 July 2002. Green co-leader Jeanette Fitzsimonis, by stating “[i]t’s tragic to think that a sustainable economy can be built on ability to juggle genes”126 indicated, the GE issue would be a condition of the party joining any future Labour-led coalition. (Following the election, that condition appeared to rule out the Green’s joining the coalition.)
IV. PRECAUTIONARY PRINCIPLE — MEANING, IMPLICATION AND APPLICATION
1. Science and Technology/ Philosophy of Science
Can anyone think of a technological invention that is needed to improve the quality of life? Even one? I think not.127
Philosophical beliefs in modern technology and progress differ in very distinct ways. Many views suppose technical progress can solve all of our problems. Others, like the German Philosopher Heidegger, regard it as the villain in modern
125 Submission of the Green Party of Aotearoa to the Royal Commission, 2001, supra note 46, at 7. 126 See Small, Vernon, Gene genie will rise again from ballot box, The New Zealand Herald, Oct.
31, 2001, at A1.
127 Hardin, quoted in Ferkiss, Victor C., Nature, Technology and Society: Cultural Roots of the current environmental Crisis, New York University Press, 1993, at 177.
life. But there are many others, who though not quite as negative, still share a basic skepticism about modern technology and what it has done to nature and society, and they contend that, if technology is left uncontrolled, it threatens the continuance of the human race, all its culture and nature.
According to von Weizsaecker the relevance of modern science goes beyond its technical application, since today our era has become “an age of science and our world a technical world”.128 Science and its application (technology) have changed every-day life everywhere on earth. Modern science has not only changed human beings’ living conditions on earth, but also human beings’ view on nature. In most western societies the confidence in science and scientific truth is omnipresent and science has the task of describing realities, of explaining the world and fulfilling human beings’ wants. But science is also being regarded a “two-edged-sword”: on the one hand it claims to liberate humankind from nature; on the other hand it leads to an exploitive use of natural resources, the loss of non-human life and the current global environmental crisis129 and to an increasing dependence on scientific progress and its implementation. Some argue that there is a danger in letting the use of technology mesmerize people so that they fail to pay attention to what really makes them human and “sacrifice their identity at the altar of technology”.130 Technology is an application — a tool — of natural sciences, which can be used for the achievement of particular goals131 and which gives human beings physical power over nature. Heidegger points out the danger of technological progress. According to him “modern technology could only arise in a world which has become “nihilistic” or forgetful of Being”.132 It is the essence of technology or its perspective that causes the environmental deterioration.133 In Heidegger’s view we must seek not to manipulate Being and to contempt it. “Western man has got to fetch Being back from oblivion into which it has fallen.”134 In Heidegger’s view it is in wondering and reflection that we find truth not in sensory data. But the attempt — particularly in the modern area of GE — to impose our ideas on the world rather than being open to the world itself, is the thrust underlying the whole technical effort to make the world over the image of our ideas. Modern technology, which seeks to master the earth rather than cooperate with it, is something radically different from traditional technologies. “Technology
is ... no mere means. Technology is a mode of revealing.”135 Freedom does not consist in choice, but in the process of revelation of what the world is really like, the “process of unconcealment”.136 With regard to nature, the new perspective prepares for total control and domination. In order to solve the crisis, it is not technology itself, but the technological view on nature that must be rejected. It is the belief of humans that technology can explain ultimate reality. The problem is that “mankind has made the world a mere object of desires: Nature appears everywhere ... as the object of technology”.137 When technology becomes total it lifts mankind to a level where it confronts problems with which technical thinking is not prepared to cope.138 Heidegger believes that the essence of technology is danger and that technology may already have taken us beyond the point of no return.139 He argues for a new Western meta-physics of a “newly experienced naturalness of nature”140 Saving the earth would require human beings to let nature be and remain what nature is. Or — as Mumford already argued in 1969
— “the gates of the technocratic prison will open automatically despite their ancient hinges, as soon as we choose to walk out”.141
2. Regulating Risks and Uncertainty
But even though ethical and philosophical critiques grow stronger — progress- driven society pushes Biotechnology further. Biotechnology is clearly an area in which those who want to use technology to change human nature to a form they deem superior will become manifest. Therefore it is essential that control is exercised over the use of biotechnology. But the key problem is whether regulation is asking the right questions and providing the right instruments.
One of the striking aspects both of the debate about genetic technology and of its regulation is the number of different conceptualizations of the problem which genetic technology poses and thus of the solutions that should be found. Black summarizes the different perceptions towards genetic engineering as follows: “It is seen variously to be an issue of risk (to health, the environment), a question of choice (of patients, of consumers), a matter of property rights (to patents, and
individual’s DNA), of confidentiality (against employers, insurances, companies) or a question of ethics.”142 Therefore to bring the fundamentally different views into accordance, regulation of genetic engineering has a role to play in connecting the arguments of participants, in facilitating the integration of the wide range of views as to the appropriate course that the technology and its regulation should take.
The issue at which the regulation in New Zealand is addressed is that of risk. The risks from genetic engineering, both to human health and to the environment, derive from the inherent uncontrollability of the technology itself. Risk has been the defining conceptualization of the problems posed by GMOs through the development of the regulation. Particularly the scientific area of genetic engineering is one plagued with a high extent of incomplete knowledge. Uncertainties about unpredicted and uncontrolled side effects contribute to that fact. The insufficiency of knowledge ranges from the application of the scientific process itself to the impact of changes on ecosystems and the whole environment. Traditionally science has viewed risk and uncertainty as objective and unknowns, which can be understood by gaining more scientific knowledge or applying quantification techniques to work out probabilities.143 “Science is perceived as continuing to add pieces of the uncertainty puzzle and providing better risk assessment to inform decision making.”144
Uncertainty may arise from insufficient information or from lack of scientific knowledge. Disputes may arise over scientific data involving scientific judgement, over inferences to be drawn from the same data, and over “trans- science” issues or questions, which can be posed but not resolved by science. These are all science-policy issues, covering a spectrum of situations, where the “gaps” in information and knowledge are filled by policy. They sit alongside pure policy issues, including those such as whether (and if so, how) to test before use or to wait until there is actual evidence of harm.145
Especially in the field of genetic engineering, the parameters of scientific research differ from any other scientific area. David Suzuki states, “The word ‘engineering’ conjures up images of roads and bridges and buildings, all designed and constructed to precise specifications. But as a geneticist I can assure you that genetic
engineering is based on trial and error, rather than on precision.”146 Brian Goodwin, a theoretical biologist, referring to scientists, states:
[T]he problem is, this is experimenting as you go along. Nobody has any confidence any more that they exactly predict the consequences. They just hope that they are only going to get small effects, the effects they want, and that they’re not going to propagate really serious changes in the other constituent of that organism, that could be damaging to human health or dangerous for ecological systems.147
Not only is the education of bio-technologists one of the narrowest in the world and biotechnologists often do not know about organism’s physiology, whole organisms or ecosystems that they are potentially threatening – but they are simply unable to see the potential consequences of the sorts of products they are producing.148 Furthermore, as Christine von Weizsaecker, a molecular biologist, who is the president of the German Environmental Group ECOROPA, expresses it “the risk of biotechnology lies in its imprecision”.149 For every genetic engineering success there are thousands and thousands of failures. Dr Richard Strohman notes:
[I]t is impossible to follow the effect of one gene in (this) matrix of interaction. We say such things are transcalculational — that is to say, hopelessly complex
...” Molecular biologists and all biologists are revealing to us a level of complexity of life that we never dreamt was there. We’re seeing connections and interconnections and complexity that are mind-boggling. It’s stupendous. It’s transcalculational. It means that the whole science is going to have to change. And this reductionist biology of trying to locate complex things in a single anything ... is not going to work.150
Resulting from this comment it is perceivable that scientists don’t know the extent of their unknown knowledge. Science is able to define risk and uncertainty in a particular isolated context. But facing complex inter-linkages which genetic engineering encompasses this body of knowledge may not be sufficient and accurately applicable.
Some argue that genetic engineering isn’t even a science. “[S]cientists who use it (genetic engineering) every day admit that this technology is a blunt hammer
— used to bang genes from one species into the genetic structure of another species which has been finely balanced by millions of years of evolution.”151 The
impreciseness of the technology and the complex unpredictability of genetic modification means, that genetic engineering has inherent risks, which stem from the very heart of the technology itself and the nature of genetic expression, organisms and ecosystems. But even the awareness of this unpredictability doesn’t change scientists’ attitude to go ahead with research and experiments. Dr Bellamy, for instance, points out in his briefing paper for the Royal Commission, “[U]nless specific measures are taken to direct the foreign DNA to a particular site, integration of the foreign DNA into chromosomes is usually random and often the DNA is inserted into more than one site.”152 This means scientists cannot automatically replicate the outcomes of their experiences. Each new organism that is created by genetic engineering is unique in terms of where the new gene has lodged in the original genome. This leads to all sorts of different characteristics being demonstrated by different versions of the new organism, many of which would not have been predicted before the new organism was created.
An immense extent of uncertainty remains. And even expanding scientific knowledge will not necessarily equate better risk management. In many cases expanding scientific frontiers may reveal more uncertainties than it resolves. This failure calls for a basic re-conceptualization of science.
3. Precautionary Approach
With regard to the challenges and dangers connected with technological progress a precautionary approach to scientific uncertainty appeared within environmental law with the emergence of its legal application — the precautionary principle. Precaution tries to uphold the crucial difference between the complexity of nature and the complicity of science and technology.
The conceptual core of the principle can be loosely described as a reflection of the adage “better safe than sorry”,153 i.e., that precaution should be taken to protect human health and the environment even in the absence of clear evidence of harm and/or causal linkage with some activity, and despite the indisputable costs of taking such a conservative approach.154 In essence that means that, where there is less than clear scientific evidence, decision-makers should take extra precaution and not use that lack of evidence as a pretext to advance.
(b) International law
The Precautionary Principle is rapidly becoming one of the foremost environmental concepts in environmental law and policy, especially with the adoption of the Rio Declaration at the United Nations Conference on Environment and Development (UNCED) in 1992.155
Principle 15 of that Declaration provides:
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.156
The precautionary concept has also been included in the Preamble to the Convention on Biological Diversity:
Where there is a threat of significant reduction or loss of biological diversity, lack of full scientific certainty should not be used as a reason for postponing measures to avoid or minimize such a threat.157
Furthermore, Article 11.8 of the United Nations Cartagena Protocol on Biosafety 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 that living modified organism intended for direct use as food or feed, or for processing, in order to avoid or minimize such potential adverse effects.
The precautionary principle has been widely enshrined in international instruments and many commentators now believe the principle has crystallized into a General Principle of International Law.158
31 ILM 874.
The particular feature of the precautionary concept is not that it dictates specific regulatory measures but many different types of measures can be used to implement it. “The distinctive characteristic is the way in which and the time at which the measures are adopted.”159 The concept assumes that science does not always provide the insights needed to protect the environment effectively, and that undesirable effects may result if measures are taken only when science does provide such insights. In Wildavsky’s words, the precautionary approach is an attempt to ensure “trial without error”.160 Controls are to be put in place even in the absence of information on the extent of the risk posed. Based on the precautionary approach the praxis would entail the following:
From a legal point of view the most important facet of the principle is that positive actions to protect the environment may be required before scientific proof of harm has been provided. The new element is the timing rather than the need for, remedial action. Preventive action before damage has been determined is a long- standing requirement of international environmental law.161 “The essence of the precautionary principle is that once a risk has been identified the lack of scientific proof of cause and effect shall not be used as a reason for not taking action to protect the environment. But as mentioned above, even though the problem has been called one of scientific uncertainty and resulting risks, in reality it is one of “inappropriateness” of scientific methods in the identification of problems caused by the use of biotechnology. Brian Goodwin notes, “[T]he Precautionary Principle says that you don’t use a technology unless you have very firm safeguards and reasons to believe that there is no real hazard associated with that technology.”162
162 Suzuki, D, supra note 7, at 123.
Despite its favored reception as outlined above there is a lack of consensus over what the principle means in practice. Much of the precautionary element in decision-making will depend on the context of its application.
(d) National law
The precautionary principle has become enshrined within the domestic discourses on environmental management in New Zealand, where scientific uncertainty and serious environmental costs are at stake.163 The most current example of this is the 1996 Environment 2010 Strategy.164 Here, the Ministry for the Environment states:
The Precautionary Principle should be applied to resource management practice, where there is limited knowledge or understanding about the potential for adverse environmental effects or the risk of serious or irreversible environmental damage.
The document explains further:
We cannot anticipate all possible environmental effects of our action. Where there is limited information available to decision makers, or limited understanding of the possible effects resulting from an activity and there are significant risks or uncertainties (for example, over the extent of environmental damage), a precautionary approach should be applied.165
The precautionary principle has begun to be applied in New Zealand’s domestic legislation.
The HSNO Act takes a precautionary approach. This actually represents the first direct incorporation of the precautionary principle of international environmental law into New Zealand domestic legislation.166 Section 7 provides:
Precautionary approach: All persons exercising functions, powers, and duties under this Act ... shall take into account the need for caution in managing adverse effects where there is scientific uncertainty about those effects.167
163 See Ministry for the Environment, Making the Connections: An Overview of Agenda 21, (1993). 164 Ministry for the Environment, Environment 2010 Strategy: A Statement of the Government’s
Strategy on the Environment, (1995).
This section provides little elaboration on what a “precautionary approach” entails except that “caution” should be used where scientific and technical uncertainty exist.168
Williams notes, the question of the correct approach of the precautionary principle remains somewhat uncertain. “As yet there is no clear line of authority with regard to scientific uncertainty, the precautionary principle, and the relationship between these concepts and the RMA requirements to assess any actual and potential effects on the environment.”169
Section 7 of the HSNO Act provides enormous scope for interpretation to ERMA in how to apply precaution when it makes its decision. There is no clear indication in the Act as to how to balance the competing interests set out in sect. 6 and which type of values should have priority to others. The HSNO Act is neither ethically nor economically ambitious. On the one hand, the Act requires “taking into account the need for caution in managing adverse effects” (s. 7) on the other hand, it leaves to ERMA to decide what this precautionary approach means. Even the purpose of the Act as outlined above does not indicate any hierarchical values. In appointing safeguarding of the life-supporting capacity of air, water, soil and ecosystems while aiming for the maintenance and enhancement of the capacity of people and communities to provide for their economic, social and cultural well-being and for the needs of future generations,170 the purpose itself seems to be inconclusive.
A purpose of this width gives little or no guidance on how specific or unknown risks should be managed or how the priorities of the present human generation, the nature’s ecosystems and future generations are to be reconciled or valued.
In practice, much discretion is left to ERMA to determine exactly how economic values are to be weighted against potential environmental damage. Due to this discretionary power ERMA has set the HSNO Act (Methodology) Order 1998 in accordance to s. 9 HSNO Act.
(e) ERMA’s approach to risk
ERMA operates within the Methodology Order that sets out the procedure. According to the Order it is predominant to the decision-making process that a determination will be made in the most straightforward and efficient way apparent to the Authority.171 The Authority works within certain decision-paths concerning different applications.
The core concept of approaching risks is risk evaluation and risk assessment. For making determinations ERMA must evaluate risks, costs and, where applicable, benefits taking into account the nature and characteristics of the organism, and the applicant’s assessments and proposals for the management of the risks concerned.172 When evaluating risks, the Authority must begin with a consideration of the scientific evidence relating to the application, and take into account the degree of uncertainty attaching to that evidence.173 Further ERMA has to determine the level of risk and approve an application where an organism poses negligible risk to the environment or human health.174
From this procedure the question arises whether — in regard to the significant extent of existing uncertainty — it is possible to determine any level of risk.
ERMA determines risk levels (by recognizing uncertainty in many ways!) due to risk assessment, which involves several steps:
ERMA also expresses in the Order its awareness that it has to deal with uncertainty in considering applications. Uncertainty may arise from a number of different matters:
This risk assessment following certain decision paths seems to be theoretically sufficient since it addresses all kinds of possible risks and outcomes of the development or field testing of an GMO. But in regard to the extent of scientific uncertainty it is questionable if a procedural risk assessment approach embodies a precautionary approach.
(f) Critique of ERMA’s approach (risk assessment versus precautionary principle)
Although ERMA purports to entrench the precautionary approach by applying its degree of caution in determining the level of risk181 — it has to be questioned if this is possible per se.
Commentators criticize a risk assessment approach as an “attempt to address the issues of scientific uncertainty in a procedural manner”.182 Von Moltke explains:
By defining the process, which is acceptable to most of those concerned and which is neither accessible nor transparent to all key parties, risk assessment attempts to develop a systematic approach to bridging the gap between scientific uncertainty and legal regulation ... This creates a burdensome requirement to document each step of a decision-making process and to find specific justification for each critical decision.183
Furthermore Von Moltke doubted, whether it was possible to assess the risks of genetic modification accurately and suggested that accepted methods of assessing risk were inappropriate for genetic modification because the risk factors associated with the technology could not be known or quantified in advance. Commentators suggest there is insufficient scientific knowledge of the behavior of genetically modified organisms to allow for proper assessment of the risks. Professor Terje Traavik, a virologist from the Department of Medicine at the University of Tromsø, Norway, speaking in the context of horizontal gene transfer, said:
There is already sufficient evidence on the unpredictability of genetic engineering techniques and the interaction of genetically engineered organisms with the environment to indicate that we do not understand enough about the short, medium or long-term consequences of their release. Horizontal gene transfer from GMOs is a real option. Such events may result in extensive and unpredictable health, environmental and socio-economic problems. Under some circumstances the consequences may be catastrophic. Our present level of knowledge about horizontal gene transfer is inadequate for reliable risk assessments. This applies to GMOs in general as well as to any particular GMO.184
Risks are made up of two elements: the likelihood of something happening (probability of an impact) and the consequences if it did (magnitude). Normally, the characterization of risks associated with technology requires an aggregation of a series of different magnitudes, each corresponding with a particular form of impact.185 But the field of genetic engineering encompasses a wide range of different, disparate issues, including the environment, human health, agricultural practice, economics, social impacts and questions of fundamental ethics. Given now the uncertainties, the limited knowledge and ignorance relating to the determination of cause and effect of genetically modified organisms released deliberately into the environment or escaped from field testing, it is to assume that the risks are difficult if not impossible to perceive. Some argue that the complexities of environmental interactions are, by their very nature, not amenable to scientific understanding.186 The approach of risk assessment to the width and diversity of issues is to adopt a single major yardstick of performance and measure all the various aspects using this as a metric.
One crucial consequence from this artificial narrowing and conflation of full diversity of technical risk is effectively to exclude from consideration many classes of effects. But due to the interconnectedness and interrelatedness of those different dimensions they cannot be reduced to a single measure of performance since they are inherently multi-dimensional in nature.187 One problem inherent in the assessment of risks associated with the release of GMOs is the difficulty in simulating the enormous variety of conditions outside the “laboratory-microcosm”. The more knowledge we acquire the greater it may seem the boundaries of ignorance loom. And, although, scientific and ecological understanding is always increasing, knowledge of organisms, ecosystems and people-nature relationships will always be incomplete because of their dynamic nature, organizational
complexity and ongoing evolutionary changes. But regulatory decision-making on technological risks should be as complete and as comprehensive as possible, and be based on consideration of the full range of issues, which may reasonably be held pertinent. “Appraisals should take account of all relative additive, cumulative, synergistic and indirect effects as well as the more simple causal relationships.”188
However, no one set of assumptions or priorities may be claimed to be uniquely rational, complete or comprehensive. Therefore the analytical, systematic, and data based (quantitative) methodology of risk assessment cannot be definite. The complexity, incommensurability and multi-dimensionality of risks lead to an overall insufficiency and under-determining the nature of risks in risk assessment. The basic outcome of risk assessments is to recognize scientifically only the known uncertainties and this, concludes Brian Wynne, “totally and silently excludes from consideration the unknowns, which result in unanticipated consequences”.189 The limitations of risk assessment as a response to scientific uncertainty are therefore very obvious. It is a cumbersome approach requiring significant resources, administrative effort and depending on what is quantifiable.
Following to that it can be concluded that the risk assessment system as applied by ERMA, which seeks to classify different risk categories as well as negligible risk cannot be judged safe.
Additionally, because errors occur in assessment of probability and magnitude as well in reliability of existing data and because scientific evaluations are affected by political and ethical assumptions, valid and reliable risk assessment cannot be carried out. In regard to the insufficiency of risk assessment and incommensurable dimensions of variability remaining implicit in risk assessment procedure, Stirling asks the serious question, whether the results associated with that costly and time consuming process “are of any practical policy use at all”.190 Accepting that there is an “unknownability” element in scientific uncertainty, poses a fundamental challenge to the science of risk assessment. There is a need to recognize the limits of science and the importance of applying the precautionary principle. Stirling concludes that:
when ignorance and incommensurability are acknowledged to be firmly grounded in the science of risk assessment, then it follows, that a more broadly based, pluralistic and epistemologically humble precautionary approach is more scientific than traditional narrow risk assessment.191
Risk assessment relies on data on the nature of risk, the consequences if the risk eventuates and the probability that it will eventuate. In the area of genetic engineering substantial data are not available. Hence, risk assessment cannot efficiently be undertaken for the release of GMOs into the wider environment and for their use in food. One reason for the missing data is the novelty of the scientific field of GE. While in other scientific fields adverse effects are quite recognizable once the research outcomes have been applied — the impact of genetically modified organisms on the earth’s biosphere might not occur within a longer period of time.
Second, little research, if any at all, is invested in effects of the application of GE. IBAC reported, that there is “little current effort directed towards identifying the effects of GM on, for example, food safety or the environment”.192 The Green Party notes, that “there has been virtually nothing invested in understanding risks to indigenous ecosystems as the economic impacts of damaging ecology are less direct, harder to predict and are shared by everyone”.193
Therefore the approach to risk assessment taken by ERMA has to be challenged in two ways:
From these challenges it has necessarily to be concluded, that scientists, regulators, and decision makers have to put more emphasis on precaution than is currently the case.
The precautionary principle provides such a different approach. Von Moltke describes that:
it realizes the reality that science will not provide clear policy prescriptions and that criteria need to be developed to systematically address the resultant uncertainties in the policy progress ... Instead of attempting (like risk assessment) to reduce uncertainty through a systematic, quasi-scientific process, it focuses on the policy process itself and seeks to extract maximum response from legal and economic structures.197
Implementation of the precautionary principle revolves around finding appropriate legal, political and economic bounds for action taking the need to act as given despite the continuing reality of scientific uncertainty. But the precautionary principle in practice is not simple to implement because policies which, are socially desirable, may involve individual “winners” and “losers” who intervene for or against a particular policy approach. Policy making therefore requires legal and economic guidance to reach useful decisions in the face of these difficulties.
(g) Application of the precautionary principle
There are basically two ways of applying the precautionary principle: a strong and a weak approach.
A weak precaution requires only to take precautionary measures where the balance of costs and benefits justifies to do so. This is more consistent with an anthropocentric stance. “Weak precaution means that we can harm nature as long as we are net gainers from doing so.”198 A cost-benefit analysis would then have to be implied. But because of uncertainty and ignorance it is not possible to know whether costs outweigh benefits or what the consequences of our actions might be. A cost-benefit analysis would have to include a weighting of uncertainty and also a weighting to allow the effect on future generations to be ranked against present costs and benefits.
The strong approach on the other side interprets the precautionary principle rigidly as seeking to prevent damage in an 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. But in our progress-driven
and technology orientated society a “stop everything” (totally restrictive) approach to the regulation of technology does not offer a valid solution.
Some commentators seek to apply the precautionary principle within “margins of tolerance” or “ecological space”. But since we have an extremely limited idea of the nature of hazards and the magnitude of the consequences, it is impossible to have realistic knowledge of what the margins of tolerance might be.
As a proper approach to the precautionary principle it is therefore encouraged to emphasize broad, system-based analysis and multi-disciplinary framing of questions. This would include:
Only when social and environmental considerations are taken into account in an integral way can the precautionary approach provide a sufficient basis to managing the risks.
No matter how broad and exhaustive the research and consultation, the task of determining the specific applicability and implications and the relative degree
of precaution is not a matter on which there can be a single definitive or even uniquely authoritative conclusion.
There are quantitative methods and specific techniques, which offer practical ways to address the deficiencies of the narrow/weak risk approaches of purely risk assessment procedures. The variety mentioned above of discursive procedures offers a systematic way of providing the vital information on values and priorities required to complement and frame the approach of risk assessment. By using these techniques alongside of risk assessment, much can be done to establish better understanding of the different forms and dimensions of technical risk and responding with adequate precaution.
Whether or not the promised benefits might outweigh the perils of genetic engineering is impossible to determine yet. The magnitude of detrimental ecological impacts is not assessable. Even if some outcomes can be identified, their probability of occurrence remains uncertain. But in most cases science is caught in ignorance since the outcomes are not known.
However, instead of recognizing the strong need for precaution to face the limitations and uncertainties, scientists, regulators, decision-makers, and politicians embark and rely on incomplete empirical, expensive and time-consuming studies to assess the risk encompassed by genetic engineering.
It was the focus of this paper to show that:
communication etc) is insufficient to deal with uncertainties and ignorance, since the necessary data concerning the outcomes of genetic engineering and their magnitude are not available.