Australasian Biotechnology, Vol. 11, No. 5, 2001, pp. 36-39
GM ROYAL COMMISSION
ROYAL COMMISSION ON GENETIC MODIFICATION RELEASES REPORT AND RECOMMENDATIONS: PRESERVING OPPORTUNITIES
Mark Christensen and Ben Johnston
Anderson Lloyd Caudwell, Lawyers, Christchurch, New Zealand, firstname.lastname@example.org
Code Number: au01060
The New Zealand Royal Commission on Genetic Modification released its report and recommendations to the Government on 27 July 2001. http://www.gmcommission.govt.nz
New Zealand is in a position where it can benefit from a variety of technology. Some of the benefits can be derived from the selective use of genetic modification, others from existing and developing uses that do not depend on genetic modification. The Commission considered that it would be unwise to pin New Zealand irretrievably to any one approach at this time as this would limit New Zealand's future options.
The Commission noted that genetic modification technology offers many advantages, but the field is far from fully researched and continues to develop rapidly. Global trends and future consumer preferences cannot be predicted with any confidence. Thus, it would be premature to commit all New Zealand's resources to GM technology at this time.
The Commission considered that genetic modification technology should be used only in ways that are carefully managed. All opportunities to use the new technology should be seen in terms of the net contribution that it will make to New Zealand. This will allow controlled use of genetic modification with the degree of control varying with the situation.
It was the Commission's view that an appropriate regulatory and institutional framework for the controlled use of genetic modification is already provided by the Hazardous Substances and New Organisms Act 1996 (HSNO). Nevertheless, throughout the report the Commission makes a number of recommendations for additional controls to make the existing system more robust.
In reaching this overall conclusion about preserving opportunities, the Commission rejected on one hand the argument that New Zealand should become free of all genetically modified material, with no genetically modified products either in use or able to be brought into the country. This option was clearly impractical in light of the evidence presented.
In response to the evidence that the "clean green New Zealand" image and New Zealand's "natural" environment was at risk from genetic modification, the Commission found that a "clean green New Zealand" is an important image to maintain. However, although it is possible world consumer resistance may remain high, there could also be a shift towards increased tolerance to new forms of genetically modified food in particular.
The Commission considered that there are advantages to be had from using genetic modification technology selectively, in a way that does not threaten New Zealand's "clean green" image. This conforms with the Commission's preserving opportunities strategy.
Some submitters called for New Zealand to become 100% organic. Having heard and considered extensive evidence on this issue, the Commission found that this subset of a "genetic-modification-free New Zealand" is not economically viable. Organic foods may indeed attract a premium (at least at the moment). However, world markets are uncertain, and it is unlikely that organic exports will attract sufficient premium in the near or medium future to offset to any degree the contractionary effect of not allowing any genetic modification in the country.
Nonetheless, the Commission considered the organic economy important to New Zealand's future and regarded it as a key component of the preserving opportunities strategy.
Preserving Opportunities in Research
The Commission acknowledged that many submissions made stressed the contribution of GM research to the future of New Zealand. Benefits include economic benefits in building on and developing current primary industries, benefits to the "knowledge" sector and research capacity of New Zealand and environmental benefits such as GM contribution to conservation biology, pest control and bioremediation, and health benefits and medical applications.
The Commission found that much genetic research in New Zealand involves the use of GM technology to isolate, identify, and characterise genes from a wide range of species and that most of this type of research is carried out in containment and is low risk. Specific amendments to the HSNO process were recommended to reduce and streamline the approval processes where levels of risk are low, and to address current regulatory anomalies in contained research.
Conversely, many concerns about GM research were focussed on field trials or releases of GM products. The Commission recommended that at the phase where GM research is proposed for release there be a further category between development and importation of GM organisms in containment, called conditional release.
Preserving Opportunities in Food
The Commission did not accept that it is a viable option to ban the production, importation or sale of GM food in New Zealand. It was noted, however, that there is widespread public unease about the use of GM in relation to food which should be taken into account by central Government and relevant regulatory agencies.
The Commission expressed confidence in the Australian/New Zealand Food Authority Safety assessment process. The Commission recommended that the Food Administration Authority monitor research studies on stock feed and act on any that indicate a need for stock feed to be assessed in relation to human health and disseminate information on labelling for GM foods and consumer rights, as a matter of priority. The Commission recommended that the Government facilitate the development of a voluntary label indicating food has not been genetically modified.
Preserving Opportunities in Medicine
The Commission found that New Zealanders appeared to be more comfortable with the use of GM technology in medicine than with most other uses of GM. The Commission also found that GM is and has been widely used in biomedical research and the study of disease for more than two decades.
Many submissions were received emphasising the benefits of GM in medicine from universities, scientists, medical organisations and patient groups. The recommendations made by the Commission focus on managing safety and ethical aspects of medical uses. Recommendations include requiring formal medical ethical oversight for all gene therapy and the establishment of Toi Te Taiao: the Bioethics Council to develop ethical guidelines on xeno-transplantation involving GM technology.
Preserving Opportunities in Crops and Other Field Uses
The Commission considered field uses and crops of GM technology in relation to forestry, pest and weed control and bioremediation, as well as food crops. The Commission heard evidence that potential effects of GM crops included building agricultural expertise in making commodity production more competitive, decreased chemical use, development of niche markets, expanded opportunities for New Zealand's knowledge economy.
The Commission did, however, consider that more research is needed into the environmental risks that GM crops and non-food uses might pose for ecosystems into which they may be released. In particular, the Commission recommended that prior to the release of BT-modified crops, appropriate agencies develop a strategy for the use of BT toxins and sprays and GM plants and that the appropriate agencies develop a labelling regime to identify GM seed, nursery stock and propogative material at the point of sale.
Is Compatibility of GM and non-GM Crops Possible?
The Commission identified a principal environmental risk of releasing genetically modified crops into the environment as being the physical "contamination" of other production systems. The Commission heard a great deal of evidence as to potential negative effects on organic farming from the growth of GM crops such as cross-pollination, horizontal gene transfer and seed dispersal.
Specific recommendations made by the Commission included options for growing both genetically modified and non-genetically modified crops. While the Commission encouraged farmer and specific industry cooperation and self-reliance, it considered that there needed to be an element of Government regulation to develop and maintain coexistence between production systems.
The Commission recommended that the Ministry of Agriculture and Forestry develop an industry code of practice to ensure effective separation distances between GM and non-GM crops (including those grown for seed production), such a code being established on a crop-by-crop basis, taking into account separation distances for existing seed certification, developments in international certification standards for organic farming, and emerging strategies for coexistence. It saw the use of sterilising (or "terminator") technology as potentially very useful to limit the effects of GM crops on the environment and to control the escape of modified genes.
A Shared Framework of Values
The Commission considered that values are often hidden or unnamed, and there was a danger of core values becoming lost in the debate about strategies and losing sight of what New Zealand ultimately wants to achieve. At the start of its report, the Commission identifies seven core values pertinent to the debate:
Cultural, Ethical and Spiritual Issues
The seven core values identified were derived from various sources and viewpoints presented to the Commission. These include the traditional Maori world view, the ecological world view, religious views, cultural, ethical and other beliefs.
Having identified values from various sources, the Commission addressed the issue of placing the values in a framework that allows decisions to be made.
The Commission heard a number of submissions which propose that ethically based policy decisions should be made at a higher level than the level currently addressed by the Environmental Risk Management Authority or ethics committees of various institutions. The Commission saw a "compelling need" for a body to address the "big picture" issues where new forms of technology pose societal questions that go beyond individual choice. The Commission recommended the establishment of Toi Te Taiao, the Bioethics Council whose task will be to consult with the community on significant ethical issues and to develop guidelines to assist existing ethics committees.
The Commission notes that in the absence of an effective framework for ethical decision-making, decisions about the use of biotechnology would be made by default. The Commission sees it as vital that the Bioethics Council promote continuing consultation and active choice, allowing development of biotechnology to be based on values that New Zealand holds in common.
Environmental and Health Issues
Concerning the risk of gene technology, the Commission found that the main issue was whether genetic modification could be used safely in terms of potential impacts upon human health and the environment.
The Commission acknowledged that there was clearly a high level of concern about the environmental impacts of genetic modification, not just among the public but also among the scientific community. The Commission stated that while much of the evidence it heard was about the risks of genetic modification, they also heard evidence from witnesses, particularly scientific witnesses, that the risks of adverse impacts could be assessed and managed. The Commission also noted that some of the claims of possible environmental and health damage were exaggerated or based on inconclusive research data of unproven hypotheses.
Economic and Strategic Issues
The key question for the Commission from a wider strategic perspective was whether GM technology would enhance or damage New Zealand's economic and strategic prospects in terms of international competitiveness, the knowledge economy and trade.
The Commission noted that whether or not GM modification will be of economic benefit to New Zealand will largely be determined by the degree to which consumers in New Zealand's export markets prefer, tolerate or reject GM. However, it is too early to predict consumer reaction with any certainty. Economic evidence presented suggested that it was not a realistic option for New Zealand to develop its organic sector at the expense of conventional farming and/or the use of GM techniques. This again is consistent with the Commission's theme of "preserving opportunities".
The Commission also noted that evidence was given that an important effect of an avoidance of GM technology would be a significant reduction in the skill levels of the New Zealand workforce in both research institutes and universities.
The Commission considered and heard evidence on intellectual property issues including patents, plant variety rights and New Zealand's international obligations applicable to intellectual property rights.
The Commission concluded that economic benefits of intellectual property systems are generally considered to be positive. Not allowing New Zealand investors to protect their work under an intellectual property right would leave them in an invidious position against the rest of the world and would place New Zealand in breach of its obligations under major trade agreements.
The Commission recommended that certain amendments be made to the existing legislation to address valid concerns such as an amendment to the Patents Act 1953 to the effect that human beings and biological processes should not be able to be patented. The Commission also recommended that a Maori consultative committee be established by the Intellectual Property Office of New Zealand to develop procedures for assessing applications and to facilitate consultation with the Maori community where appropriate and that New Zealand be proactive in pursuing cultural and intellectual property rights for indigenous peoples internationally. It recommended that HSNO and the Agricultural Compounds and Veterinary Medicines Act 1997 be amended to ensure appropriate protection to commercially sensitive and confidential information accompanying applications.
Treaty of Waitangi
The Commission found that the Treaty principles particularly relevant to the debate on GM were the Crown's duty of active protection of Maori interests and the principle of cooperation (where each party is to act reasonably and in good faith towards each other). Cooperation requires the Crown to consult with Maori so as to make informed decisions on matters of significance.
The Commission considered that successful consultation between the Treaty partners was an important element in giving effect to the principles and the Commission envisaged that Toi Te Taiao: the Bioethics Council will have a role in drawing up a framework of principles for both Treaty partners.
The Commission also recommended that Section 8 of HSNO be amended to provide that effect is to be given to the principles of the Treaty of Waitangi.
The Commission considered that the effects of genetic modification are expected to be likely to manifest only in the long term, be diffuse in nature and involve difficulties and expense in establishing proof of cause, nature and extent of liability. The main question is who is liable for damage caused by genetic modification?
The Commission considered rules of statutory liability, common law approaches and the approaches of overseas jurisdictions. The Commission concluded that from a legal liabilities perspective they had not been persuaded that there is anything so radically different in GM as to require new or special remedies. The Commission considered that strict liability can be a barrier to innovation and progress and found that the regimes of the United States, Canada and the United Kingdom did not impose strict liability but instead relied on common law general environmental protection legislation. It found that New Zealand should follow this approach and recommended no changes to the existing liability regime.
The Commission recommended that emphasis should be placed on preventing damage or injury in the first place, rather than creating a liability regime additional to that already in place. The Commission recommended that the Bioethics Council, in association with the Human Rights Commission, address the issue of genetic discrimination.
The Biotechnology Century: Three Major Proposals
To provide for ongoing overview of biotechnological developments, the Commission made three major proposals.
The first is the establishment of a Bioethics Council. The Bioethics Council will address ethical, cultural and spiritual dimensions of genetic modification at a level higher than the ERMA case-by-case decision making process. The Council should be an expert independent body, promoting debate on matters of principle, providing a forum where issues of national significance can be addressed and developing guidelines for ERMA and other bodies.
The second major recommendation was that an Office of the Parliamentary Commissioner on Biotechnology be established. The Parliamentary Commissioner on Biotechnology would audit bodies charged with making decisions about biotechnology in New Zealand, monitor and respond to emerging developments in biotechnology in terms of their implications in the New Zealand context, and fulfil a widespread educational and consulting role with the public.
The third proposal was that the Government adopt a national biotechnology strategy. The biotechnology strategy was seen by the Commission as providing a mechanism for ongoing debate and encompassing many of the issues considered before the Commission. The aim of the strategy would be to ensure that New Zealand is kept abreast of developments in biotechnology and that these were used to national advantage, while preserving the core values identified by the Commission.
Reaction to the Commission's report and recommendations has, predictably, been mixed. Both the Labour Government and the National Opposition have applauded the comprehensive and balanced nature of the report. Labour's coalition partners in Government have been somewhat less enthusiastic, with the Green Party, which played a major role in the Inquiry as an Interested Party, rejecting the report and calling for a national referendum.
Organisations in favour of the responsible use and development of GM technology, uses and products, such as the New Zealand Life Sciences Network, have also endorsed the reports as comprehensive, balanced and strategic.
There is, of course, much work still to do. The report is merely recommendatory and there is no certainty that the Government will adopt all, or any, of the specific recommendations.
The Government has indicated that it is likely to release its response to the report and recommendations by the end of October 2001. At that time, depending on what the response is, there will no doubt be continuing activity from players on all sides of the debate to continue to have their voices heard.
At the time of writing, the voluntary moratorium on applications for field trials and release appeals is due to be lifted at the end of August. It is not yet settled what position industry will take in the event that the Government asks it to extend the voluntary moratorium for a further period.
Copyright 2001 - AusBiotech