22 September 2013

GMO Regulation in New Zealand

'An overview of genetic modification in New Zealand 1973-2013: the first forty years' [PDF] by Wendy McGuinness and Renata Mokena-Lodge of the McGuinness Institute (2013) argues that
strategically, New Zealand is no further ahead on public policy regarding outdoor use of GMOs than it was when the Royal Commission on Genetic Modification reported its findings in 2001. It considers New Zealand is less equipped to make a strategic decision to release GMOs in the outdoors in 2013 than it was a decade ago.The report forms part of the Institute’s flagship project, Project 2058. Forty years since the development of genetic modification, the Institute believes it is timely to reassess New Zealand’s approach to managing the benefits, costs and risks.
The report provides a comprehensive overview of policy development through four key eras: (1) the journey towards the 2001 Royal Commission on Genetic Modification; (2) the Royal Commission and its findings, (3) the response to the Royal Commission, and (4) the era of institutional change from 2008 – 2013.
The Institute’s report makes 12 recommendations on how the current system could be strengthened, stressing the need for transparency, accountability, and consideration of the interests of all New Zealanders.
The report concludes by reflecting on the proposal that ‘the most risk-adverse solution is to close down New Zealand’s only two GM outdoor experiments on the basis that they create unnecessary public risk, with little or no public benefit, and to use those funds elsewhere. Currently the only two outdoor field tests are being operated by two Crown Research Institutes, AgResearch and Scion, and could therefore be closed down by government.
The authors comment that
It is now 12 years since the report of the Royal Commission on Genetic Modification was released. After considering the options available to New Zealand, the Commissioners endorsed a compromise: a strategy to preserve opportunities and proceed with caution. It is timely to review what has essentially been an expensive and time-consuming exercise in public policy-making. The issue of genetic modification (GM) has provided a particularly interesting case study for policy development in relation to assessing and developing strategies for new technologies where the benefits and risks are uncertain.
The purpose of this report is two-fold. On the one hand it seeks to chronicle the history of GM in New Zealand and provide a record of the available data. On the other, it seeks to consider gaps in the current policy framework and provide a meaningful contribution to the continuing debate. The report consists of seven sections and is split into two main parts; the first part, comprising Sections 1 to 5, describes the historical landscape from the beginnings of the technology in the 1970s to the present day, while the second part, comprising Sections 6 and 7, looks at the Crown Research Institute (CRI) system and suggests principles to guide its future, and concludes with a set of observations, recommendations and narrative on future strategy for GM in New Zealand. Importantly the focus of this report is on public policy, it does not aim to report on scientific developments in any detail.
The context of the report and its limitations are outlined in Section 1. Sections 2–5 document the history of GM in New Zealand, breaking it into four eras: the journey to the Royal Commission; the Royal Commission’s inquiry; the response to the inquiry, and the current era of institutional change. These sections are supported by the 16 appendices and seek to collate the available data on the topic to provide a factual overview and historical commentary. The journey toward the Royal Commission (see Section 2) started in the mid-1970s with the emergence and adoption of ground-breaking new technology. As a tool it offered benefits, but arguably it came with considerable risks to an agriculture-based economy. Public concern developed accordingly, and the result was the establishment of the Royal Commission on Genetic Modification in 2000.
The Commission was charged with considering the strategic options available to New Zealand to manage genetic modification, and its conclusions were published in a report in 2001 (see Section 3). During this time a pause was put on the outdoor use of genetically modified organisms (GMOs) while a deeper understanding of the risks and opportunities was developed. The Commission’s report included 49 recommendations conceptualised to allow New Zealand to ‘preserve opportunities’ and retain optionality. In Section 4 we present an overview of the response to the report of the Royal Commission and consider the subsequent implementation of the Commissioners’ recommendations. This era saw both government acceptance of and public protest at the Commission’s findings.
The most recent era spans the last five years, during which we have witnessed unprecedented institutional change in New Zealand (see Section 5). As of 2013 only two GM field tests are in operation in New Zealand, but there have been 57 since 1988. Not one of these has resulted in any commercial benefit or tangible return on the public’s investment, while all experiments have presented a constant risk. Debates on this subject are often framed as a matter of balancing environmental protection and economic development. Could it be that in this case we have compromised environmental protection for promises of economic development and received neither?
Sections 6 and 7 are the only area of the report to draw conclusions and make suggestions going forward. In Section 6 we take a closer look at the three CRIs that have conducted the majority of GM research in the outdoors since the Royal Commission: AgResearch; Scion, and Plant & Food Research. In this section we also present five principles to drive the current system in order to deliver more effective public investment in the future. These five principles are:
1. Value for money
2. Robust assessment, decisionmaking and monitoring by regulators
3. Ethics should drive practice
4. Timely reporting on controversial experiments is essential
5. A culture of due diligence is vital across science.
The overall goal of Section 7 is to assess whether the system fulfils its purpose, and if not, what the government must do to develop a better policy landscape and operational system to manage the benefits, costs and risks of GM in the outdoors. Section 7.1 identifies ten observations that can be made about the current operational framework. Section 7.2 provides our conclusions on the policy process thus far and provides 12 recommendations in response to perceived gaps in the current framework. Lastly, Section 7.3 presents a strategic reflection, bringing the report to a close by providing a narrative and context for future debate.
We found that many initiatives put in place after the Royal Commission have since been disestablished or not progressed. Since 2001, New Zealand has significantly reduced its ability to collect strategic information to make informed decisions on GM. For example, New Zealand has disestablished the Bioethics Council (2009); discontinued Futurewatch, a work programme of the Ministry of Research, Science and Technology (MoRST) (2011); discontinued the Bioscience Survey, a survey undertaken by Statistics NZ (2013); and have not reviewed or updated the Biotechnology Strategy, published in 2003 and due to expire this year.
We also found considerable evidence that the system is showing symptoms of fatigue. Largely due to the significant institutional change that has occurred in the last five years, information is not well collected or reported (see Section 7.2.5 for examples) and institutional knowledge and therefore analytical capability and linkages are likely to be significantly reduced (see in particular Figure 2 and Appendix 16). Strategically, New Zealand is no further ahead on public policy regarding outdoor use of GMOs than it was when the Commissioners reported their findings in 2001. Indeed, we consider New Zealand is less equipped to make a strategic decision to release GMOs in the outdoors in 2013 than it was a decade ago. We also identified a number of emerging issues that add to this sense of urgency:
1. Community concerns over the use of GM in food production are growing, that is now putting pressure on councils to address benefits, risks and costs in local plans. This is in line with overseas trends, particularly the European Union (see discussion in Section 7.2.6 and 7.2.11).
2. Food Standards Australia New Zealand (FSANZ) is continuing to approve increasing numbers of GM foods, raising issues over labelling and traceability (FSANZ provides a list of approved GM ingredients, but there is currently no list of food for sale in New Zealand containing those ingredients). Further, an application for conditional or full release may not necessarily trigger a ‘call-in’ by the Minister if it is a FSANZ approved GM food.
3. If the Minister did decide to ‘call-in’ an application (see s 68 of the HSNO Act 1996), the resulting process is unclear. We suggest that the government is not ready to make such a strategic decision on the first release of a GM crop or fibre.
4. There are a range of emerging molecular plant breeding technologies on the horizon that may not come under the HSNO legislation. One that local developers AgResearch and Scion have expressed interest in is zinc finger nuclease (ZFN-1). In April 2013 a decisionmaking committee of the Environmental Protection Authority (EPA), in response to an application by Scion, reached a decision that ZFN-1 was outside of HSNO regulation (despite EPA staff recommending that these techniques should be considered similar to GM techniques, and not exempt from the regulations) (EPA, 2013: 3). This decision may be appealed but, as it currently stands, there would be no assessment of the public benefits, costs and risks as required under the HSNO legislation; nor would outdoor use of food or fibre crops generated by the tecnique be subject to any controls.
5. The upcoming Trans Pacific Partnership Agreement means New Zealand needs to think deeply about its position of GM crops and other uses.
The Royal Commission purposefully created a strategic pathway for New Zealand to follow. Twelve years later, with little evidence that significant commercial benefits exist for New Zealand through outdoor research, it seems timely to revisit the Commission’s recommendation of preserving opportunities, and ask whether New Zealand would not be better to remain a GM-free food and fibre producer.
Our approach to GM crops in the outdoors would be threefold:
1. Buy time: Put in place a moratorium or require a field test before any GMO release
2 Undertake a systemic review: ensure the current system is 'fit for purpose' by implementing the Institute's 12 recommendations
3 Think strategically: revisit the original question - should NZ commit to becoming a dedicated GM-free food and fibre producer?
In the closing section of the report, Section 7.3, we reflect on the way forward. We discuss New Zealand’s current position, and argue that we have one foot in and one foot out of GM. We argue that this is a risky position, particularly when combined with the fact that there appears to be a prevailing belief that we operate the most robust regulatory system in the world. Are we putting at risk our global reputation simply because we are failing to critique our own systems? It is crucial that as a country we reflect on what is the best outcome for New Zealand and ensure we create durable public policy to deliver on that outcome. Reactive public policy delivers uncertainty to all stakeholders, creates unnecessary stress within the system for regulators, and is more likely to lead to systemic failure.
Our view is that the most risk-averse solution is to close down New Zealand’s only two GM experiments (AgResearch and Scion) on the basis that they create unnecessary public risk at little to no public benefit; the science research funds would be better spent elsewhere. In regard to GM crops and other uses, we suggest retaining optionality through buying time, undertaking a systemic review of the current system and thinking strategically about the best way forward. Most importantly we think it is timely to have a conversation about the future of GM crops and other uses; as indicated by the Royal Commission recommendations, this issue remains unresolved but has always been believed to be a necessary consideration sometime in the future, when more information was available. The time for reflection is now.
Recommendation 1: Investment programmes should be evaluated as a matter of good practice
Recommendation 2: Risk management requires a whole-of-government approach
Recommendation 3: Compliance costs should be fully recovered from applicants
Recommendation 4: Legal liability should be reviewed as coexistence with zero contamination is not possible and definitions of new organisms have become increasingly unclear
Recommendation 5: Data management requires urgent attention
Recommendation 6: Allow local authorities to regulate GMOs or amend the HSNO framework accordingly
Recommendation 7: Before the conditional release of any GMO, a field test should first be undertaken
Recommendation 8: Reviews should be tactical and regular
Recommendation 9: Memoranda of Understanding should be urgently reviewed and updated
Recommendation 10: Strategy should be revisited
Recommendation 11: A high-level foresight unit should be established
Recommendation 12: Decouple hazardous substances from new organisms, creating separate legislation for both