Understandings of GMO and AI

'Extreme opponents of genetically modified foods know the least but think they know the most' by Philip M. Fernbach, Nicholas Light, Sydney E. Scott, Yoel Inbar and Paul Rozin in (2019) 3 Nature Human Behaviour 251–256 reports

There is widespread agreement among scientists that genetically modified foods are safe to consume and have the potential to provide substantial benefits to humankind. However, many people still harbour concerns about them or oppose their use. In a nationally representative sample of US adults, we find that as extremity of opposition to and concern about genetically modified foods increases, objective knowledge about science and genetics decreases, but perceived understanding of genetically modified foods increases. Extreme opponents know the least, but think they know the most. Moreover, the relationship between self-assessed and objective knowledge shifts from positive to negative at high levels of opposition. Similar results were obtained in a parallel study with representative samples from the United States, France and Germany, and in a study testing attitudes about a medical application of genetic engineering technology (gene therapy). This pattern did not emerge, however, for attitudes and beliefs about climate change.

The Introduction to the Monash Data Futures Institute AI For Social Good? Australian public attitudes toward AI and society report by Neil Selwyn, Beatriz Gallo Cordoba, Mark Andrejevic and Liz Campbell states 

 Artificial Intelligence is now influencing almost all aspects of society: employment; manufacturing; telecommunications; banking and finance; health services and even our national security. The abundance of research into the legal, ethical and societal implications of AI across industry and government reflects its potential for an enduring, transformative impact. However, the views of the public remain underrepresented. The Monash Data Futures Institute (in partnership with the Faculties of Law, Education and Arts), is proud to present this first major study of Australian’s attitudes to AI. We believe it to be vital to paving the way for more frequent and systematic contributions of public opinion, to the formation of public policy, shaping the future of AI technology in Australia and educating the public about AI’s benefits and risks 

The report’s findings show very strong public support for the establishment of a new regulatory body to address AI development, as well as support for the increased governance and oversight of AI development through legislation and industry guidelines. The most immediate priority arising from our findings is the development of public education efforts to enhance what might be termed ‘public understandings of AI’. Similarly, our findings point to high levels of public trust in CSIRO, university researchers and bodies such as the Office of the Chief Scientist of Australia and Australian Human Rights Commissioner – therefore suggesting the benefits of these organisations playing prominent public-facing roles in any efforts to manage and oversee AI development in the future. 

Perhaps the most immediate priority arising from our findings is the development of public education efforts to enhance what might be termed ‘public understandings of AI’. Indeed, our survey suggests that many people will change their initial opinions and preconceptions about AI when provided with further information, examples and questions. 

This survey was administered as a scoping study rather than an exercise in providing specific recommendations or agendas for further action. Nevertheless, our findings suggest that further dialog amongst policymakers and the broader Australian ‘AI community’ would be of value.

The report notes 

 The past ten years or so have seen artificial intelligence (AI) technologies become a prominent topic of discussion across Australian society. Yet, the ongoing implementation of these technologies remains a highly contested topic. This Monash Data Futures Institute report presents one of the first comprehensive pictures of Australian public understandings, attitudes and opinions relating to AI and society. 

Based on a nationally-representative public opinion survey of over 2000 Australian adults, the report examines key areas of public understanding, optimism and concern regarding the societal application of AI technologies. As industry and policy-makers continue to develop, implement and manage AI across most areas of Australian society, this report explores the often-overlooked views of the general public – in many ways, the ultimate ‘end users’ of these powerful technologies. 

Key findings from the survey include:

• While nearly nine-in-ten people are aware of the term, the majority of the Australian public consider themselves to have little knowledge of ‘artificial intelligence’. Just over one-quarter of respondents described themselves as knowing ‘a fair bit’ or ‘a lot’ about AI. These are most likely to be people with computer science or programming expertise, aged between 18–24 years, and/or from households where a language other than English is spoken. 

• People’s immediate understandings of AI are varied. The most popular ways in which AI is described reflect ideas of robots ‘taking on work’ and/or ‘taking over the world’. That said, many respondents have more sophisticated understandings – for example, making immediate associations with computers being programmed to perform tasks, learning from data, and displaying human-like thinking. 

• There are relatively high levels of support from the Australian public for the development of AI. Having completed the survey, around two-thirds of respondents (63.5%) stated that they ‘somewhat support’ or ‘strongly support’ the development of AI. In comparison, only 12% describe themselves as either ‘somewhat’ or ‘strongly’ opposed to AI. 

• Many people will change their opinions on the basis of receiving more information about AI, and being asked to think through issues relating to AI and society. Specifically, we found 43% of the respondents who initially considered themselves ‘opposed’ to the development of AI to shift subsequently to either a ‘neutral’ or ‘supportive’ stance once having engaged with all the survey questions. 

• We found consistently high levels of support for the use of AI to address social, humanitarian and environmental challenges. Particularly strong support was expressed for the use of AI to address challenges in areas such as health and medicine, alongside environmental challenges and crisis response. The only area with notably lower levels of support is the use of AI to generate culture for popular consumption (such as films, books, music or art). 

• The majority of the public agrees with the need for industry guidelines and/or new legislation to address all possible harms associated with AI. We find high levels of support for legislation and industry governance related to banning the use of lethal autonomous weapons, ensuring the safety of autonomous vehicles, and protecting data privacy. 

• The Australian public has high levels of confidence in CSIRO and university researchers to develop AI in the best interests of the public. The lowest levels of confidence to develop AI in the best interests of the public are expressed for Amazon and Facebook. 

• In terms of managing the development of AI, high levels of confidence are expressed for CSIRO, as well as independent government bodies such as the Office of The Chief Scientist, and the Australian Human Rights Commissioner. 

• There is very strong support (87.3% of respondents) for establishing a new regulatory body in Australia to govern and promote responsible innovation in the area of AI. 

• The Australian public is especially hopeful about the potential benefits of AI in healthcare and medicine for advanced diagnosis, development of medicine and disease treatments. Conversely, the prospect of the increased use of AI in the workplace is seen in mixed terms. The most prevalent fears expressed by our survey respondents relate to AI-based surveillance and loss of privacy, alongside the misuse of AI technology by governments and companies acting with malintent. 

• Notwithstanding specific concerns, our survey finds the Australian public to be generally optimistic about the impact of AI on their lives and society. The majority of the public (69.4%) agrees that AI will do more ‘social good’ than ‘social harm’. 

• While not necessarily convinced that such technology will ever exist, most people imagine that AI capable of exceeding human intelligence would have an overall ‘good’ or ‘more or less neutral’ impact on humanity. Only 5.1% of respondents see the possible future development of high-level machine intelligence as ‘extremely bad’ and/or maybe even ‘leading to human extinction’.

GMO Labelling

'On the Costs and Benefits of Mandatory Labeling, with Special Reference to Genetically Modified Foods' by Cass Sunstein comments

 As a result of movements for labeling food with genetically modified organisms (GMOs) Congress enacted a mandatory labeling requirement in 2016. These movements, and the legislation, raise recurring questions about mandatory product labels: whether there is a market failure, neoclassical or behavioral, that justifies them, and whether the benefits of such labels justify the costs. The first goal of this essay is to identify and to evaluate the four competing approaches that agencies now use to assess the benefits of mandatory labeling in general. The second goal is to apply those approaches to the context of GM food. 

Many people favor labeling GM food on the ground that it poses serious risks to human health and the environment, but with certain qualifications, the prevailing scientific judgment is that it does no such thing. In the face of that judgment, some people respond that even in the absence of evidence of harm, people have “a right to know” about the contents of what they are eating. But there is a serious problem with this response: the benefits of such labels would appear to be lower than the costs. Consumers would obtain no health benefits from which labels. To the extent that they would be willing to pay for them, the reason is likely to be erroneous beliefs, which are not a sufficient justification for mandatory labels. Moreover, GMO labels might well lead people to think that the relevant foods are harmful and thus affirmatively mislead them. 

Some people think that the key issue involves the need to take precautions in the face of scientific uncertainty: Because there is a non-zero risk that GM food will cause irreversible and catastrophic harm, it is appropriate to be precautionary, through labels or through more severe restrictions. The force of this response depends on the science: If there is a small or uncertain risk of serious harm, precautions may indeed be justified. If the risk is essentially zero, as many scientists have concluded, then precautions are difficult to justify. The discussion, though focused on GM foods, has implications for disclosure policies in general, which often raise difficult questions about hard-to-quantify benefits, the proper use of cost-benefit balancing, and the appropriate role of precautionary thinking.

Productivity Commission's draft Agriculture Regulation report

The Productivity Commission has released its draft report on Regulation of the Agriculture Sector, commissioned in November last year as the Government headed towards the general election.

The Commission was directed as follows

The Australian Government has identified the agriculture sector as one of the five pillars of the economy. It is promoting the economic potential of the sector by removing unnecessary regulatory burdens and promoting improved productivity and global competitiveness. The Australian Government’s deregulation agenda has focussed on reducing Commonwealth red tape. As part of its deregulation agenda, the Government is implementing reforms in agricultural and veterinary chemicals, biosecurity and export certification. However, there is an opportunity for better national outcomes for the agriculture sector by considering regulation at all levels of government. This is particularly applicable in the areas of transport, environmental protection, native vegetation management, land tenure, animal welfare and food safety in which the states and territories have significant responsibility. 

While regulation targets valid objectives, such as protecting consumers from unsafe food, protecting the environment or supporting the export of goods, poorly implemented and administered regulation and the cumulative impact of regulation can have adverse effects on farm businesses. It can unnecessarily restrict farm management decisions and reduce investment. 

Inconsistent and overlapping regulations between jurisdictions can also create adverse effects and raise costs for faun businesses. 

Scope of the inquiry 

The inquiry will focus on regulation with a material impact on domestic and international competitiveness of farm businesses and the productivity of Australian agriculture. 

The inquiry will define priority areas for removing or reducing unnecessary regulatory burdens where doing so will/can contribute to improved productivity for farm businesses as well as the wider economy. 

The inquiry will also review regulation of farm businesses to identify unnecessary restrictions on competition. 

While focussed on the impact of regulation on farm businesses, the inquiry should also consider the material impact arising from regulation imposed along the supply chain such as regulations introduced to meet the requirements of international markets. 

Consistent with its legislative remit, the Commission is to have particular regard to:

• areas of regulation that directly affect farm businesses, including those identified as areas of concern through the white papers on agricultural competitiveness and northern Australia. This includes regulatory arrangements affecting access to new technologies, investment opportunities, land tenure, relevant environmental protection and native vegetation laws, animal welfare and the Exporter Supply Chain Assurance System 

• areas where there is greatest scope to reduce unnecessary regulatory burden and pursue regulatory objectives in more efficient (least cost) ways 

• whether the current level at which matters are regulated (national, State and local) is appropriate and whether there is scope for better coordinated action across governments to reduce unnecessary overlap 

• whether Australia’s farm export competitiveness can be improved by minimising duplication between domestic regulation and importing country requirements 

• relevant regulatory approaches adopted in other countries.

Specific requirements

In undertaking the inquiry, the Commission should:

• identify specific areas of regulation that are unnecessarily burdensome, complex or redundant 

• identify priority areas for regulatory reform 

• provide recommendations to alleviate regulatory burden identified. 

For the purposes of this inquiry, the regulatory issues affecting: 

• marine fisheries and aquaculture industries will be investigated as part of a separate Productivity Commission inquiry into the Regulation of Australian Marine Fisheries and Aquaculture Sectors.

The draft report comments

• Farm businesses are subject to a vast and complex array of regulations. Regulations are in place at every stage of the supply chain — from land acquisition to marketing — and are applied by all levels of government. The number and complexity of regulations affecting farm businesses means that the cumulative burden of regulation on farmers is substantial. 

• The need for regulation is not disputed by farm businesses. In fact, some regulations, such as biosecurity and food safety regulations, were highlighted as providing clear benefits to Australian farmers. Rather, Australian farmers want ‘better’ (or less burdensome) regulation. 

• Some regulations lack a sound policy justification and should be removed. Examples include restrictions on the use of land held under pastoral lease arrangements, state bans on cultivating genetically modified crops, recent changes to tighten foreign investment review requirements for the agricultural sector, barriers to entry for foreign shipping providers, mandatory labelling of genetically modified foods, and statutory marketing legislation relating to rice in New South Wales and sugar in Queensland. 

• Other regulations and regulatory systems need to be reformed so they can more fully achieve their objectives.

− Native vegetation and biodiversity conservation regulations need fundamental change so that risks and impacts are considered at a relevant landscape wide scale. Environmental regulatory decisions also need to take into account economic and social factors. 

− Animal welfare regulations seek to achieve welfare outcomes that (among other things) meet community expectations. However, little is known about these expectations. 

− The process for setting standards for farm animal welfare would be improved by applying scientific principles and evidence through the creation of a national, independent body responsible for building the evidence base on community expectations, as well as for developing national farm animal welfare standards. 

− The standard for the level of gluten allowed in foods labelled as ‘gluten free’ needs review. 

− International evidence could be put to greater use in assessing agricultural and veterinary (agvet) chemicals, reducing the time and cost taken to grant registration. 

• Inconsistent regulatory requirements across jurisdictions make it difficult for farmers to understand their obligations and add to the cost of doing business. A more consistent approach would improve outcomes in the areas of heavy vehicle regulation and road access, and the use of agvet chemicals. 

• Governments could also reduce the regulatory burden on farm businesses by 

− improving their consultation and engagement practices. There is scope to better support landholders to understand environmental regulations, and to reduce duplicative and unnecessary information gathering regarding water management by farm businesses 

− doing more to coordinate their actions, both between agencies and between governments 

− ensuring that good regulatory impact assessment processes are used as an analytical tool to support quality regulation making, not as a legitimising tool or compliance exercise.

The Commission offers the following findings and recommendations

Land use regulation 

Draft Recommendation 2.1 Land management objectives should be implemented directly through land use regulation, rather than through pastoral lease conditions. State and territory governments should pursue reforms that enable the removal of restrictions on land use from pastoral leases. 

Draft Finding 2.1 Pastoral leases offer less security of tenure than freehold land, creating uncertainty for leaseholders and investors. In general, converting pastoral leases to freehold facilitates efficient land use. 

Draft Recommendation 2.2 State and territory governments should: • ensure that, where reforms to Crown lands confer additional property rights on a landholder, the landholder pays for the higher value of the land and any costs associated with the change (including administrative costs and loss of value to other parties) • set rent payments for existing agricultural leases to reflect the market value of those leases, with appropriate transitional arrangements. 

Information Request 2.1 What are the advantages and disadvantages of ‘right to farm’ legislation? Are there any other measures that could improve the resolution of conflicts between agricultural and residential land uses? 

Draft Finding 2.2 Regulation and policies aimed at preserving agricultural land per se can prevent land from being put to its highest value use. A right of veto by agricultural landholders over resource development would arbitrarily transfer property rights from the community as a whole to individual landholders. 

Environmental regulations 

Draft Recommendation  3.1 The Australian, state and territory governments, in consultation with natural resource management organisations, should ensure that native vegetation and biodiversity conservation regulations: • are risk based (so that landholders’ obligations are proportionate to the impacts of their proposed actions) • rely on assessments at the landscape scale, not just at the individual property scale • consistently consider and balance economic, social and environmental factors. 

Draft Recommendation 3.2 The Australian, state and territory governments should continue to develop market based approaches to native vegetation and biodiversity conservation. Where the community is seeking particular environmental outcomes, governments could achieve them by buying environmental services (such as native vegetation retention and management) from existing landholders. 

Draft Recommendation  3.3 The Australian, state and territory governments should review the way they engage with landholders about environmental regulations, and make necessary changes so that landholders are supported to understand the environmental regulations that affect them, and the actions required under those regulations. This would be facilitated by: • recognising and recruiting the efforts and expertise of landholders and community based natural resource management organisations • building the capability of, and landholders’ trust in, environmental regulators. 

On-farm regulation of water 

Draft Finding  4.1 Complexity and ongoing changes in water regulation contribute to the cumulative burden of regulation on farm businesses. However, the diversity of Australia’s river catchments makes streamlining and harmonising regulation difficult. More flexible governance arrangements may be needed to develop locally appropriate regulatory settings for accessing water. 

Draft Recommendation  4.1 The Australian Government should implement the findings of the Interagency Working Group on Commonwealth Water Information Provision to reduce duplicative and unnecessary water management information requirements imposed on farm businesses. 

Regulation of farm animal welfare 

Draft Recommendation  5.1 The Australian Government should take responsibility for ensuring that scientific principles guide the development of farm animal welfare standards. To do this, an independent body tasked with developing national standards and guidelines for farm animal welfare should be established. The body should be responsible for determining if new standards are required and, if so, for managing the regulatory impact assessment process for the proposed standards. It should include an animal science and community ethics advisory committee to provide independent evidence on animal welfare science and research on community values. 

Information Request5.1 The Commission is seeking feedback on: • the most effective governance structure for an independent body tasked with assessing and developing standards and guidelines for farm animal welfare • what the body’s responsibilities should include (and whether it should make decisions or recommendations and if the latter, to whom) • what processes the body should use to inform and gauge community values on farm animal welfare • how such a body should be funded. 

Draft Recommendation  5.2 State and territory governments should review their monitoring and enforcement functions for farm animal welfare and make necessary changes so that: • there is separation between agriculture policy matters and farm animal welfare monitoring and enforcement functions • a transparent process is in place for publicly reporting on monitoring and enforcement activities • adequate resourcing is available to support an effective discharge of monitoring and enforcement activities. State and territory governments should also consider recognising industry quality assurance schemes as a means of achieving compliance with farm animal welfare standards where the scheme seeks to ensure compliance (at a minimum) with standards in law, and involves independent and transparent auditing arrangements. 

Access to technologies and agricultural and veterinary chemicals 

Draft Finding  6.1 There is no economic or health and safety justification for banning the cultivation of genetically modified (GM) organisms. • The Office of the Gene Technology Regulator (OGTR) and Food Standards Australia New Zealand (FSANZ) assess GM organisms and foods for their effect on health, safety and the environment. Scientific evidence indicates that GM organisms and foods approved by the OGTR and FSANZ are no less safe than their non-GM counterparts. • The successful coexistence of GM and non-GM crops is possible and has been demonstrated both in Australia and overseas. This means that if there are any market access or trade benefits (including price premiums for non-GM products), they would be achieved regardless of whether GM crops are in the market. 

Draft Recommendation 6.1 The New South Wales, South Australian, Western Australian, Tasmanian and Australian Capital Territory governments should remove their moratoria (prohibitions) on genetically modified crops. All state and territory governments should also repeal the legislation that imposes or gives them powers to impose moratoria on the cultivation of genetically modified organisms by 2018. The removal of the moratoria and repeal of the relevant legislation should be accompanied by the provision of accurate information about the risks and benefits to the Australian community from genetic modification technologies. State and territory governments, the Office of the Gene Technology Regulator and Food Standards Australia New Zealand should actively coordinate the provision of this information. 

Draft Recommendation 6.2 The Australian Pesticides and Veterinary Medicines Authority should make greater use of international evidence in its assessments of agricultural and veterinary chemicals (including by placing greater reliance on assessments made by trusted comparable international regulators). Reforms currently underway in this area should be expedited. 

Draft Recommendation 6.3 The Australian, state and territory governments should expedite the implementation of a national control-of-use regime for agricultural and veterinary chemicals (which includes increased harmonisation of off-label use provisions), with the aim of having the regime in place in all states and territories by the end of 2018. 

Information Request 6.1 How well does the regulatory framework for technologies and agvet chemicals perform? Are the institutional arrangements and regulatory objectives underpinning the OGTR and APVMA appropriate and up to date? What improvements could be made? 

Biosecurity 

Information Request 7.1 Participants raised concerns about farm trespass, particularly as trespass can increase biosecurity risks. What strategies could be used to discourage farm trespass? Are existing laws for trespass sufficiently enforced in relation to farm trespass? 

Transport 

Draft Finding  8.1 Despite the commencement of the Heavy Vehicle National Law and the establishment of the National Heavy Vehicle Regulator, there remain significant variations and inefficiencies in heavy vehicle regulation, including delays in processing road access permits. 

Draft Recommendation 8.1 States and territories that are participating in the Heavy Vehicle National Law should increase the number of routes that are gazetted for heavy vehicle access. Permits should only be required in locations where there are significant risks to public safety or infrastructure that must be managed on a case by case basis. There are arrangements in South Australia to allow road users to propose and undertake road route assessments for gazettal, and in Queensland to fund road assessments and gazettals on both state and local roads. These arrangements should be considered for adoption in other jurisdictions or expansion in respective states. 

Draft Recommendation 8.2 The Australian, state and territory governments should pursue road reforms to improve the efficiency of road infrastructure investment and use, particularly through the introduction of road-user charging for selected roads, the creation of Road Funds, and the hypothecation of revenues in a way that incentivises the efficient supply of roads. 

Draft Recommendation 8.3 The National Heavy Vehicle Regulator, road managers, and relevant third parties (such as utilities and railway companies) should ensure that requirements for moving oversized agricultural machinery are proportionate to the risks involved. To achieve this they should, wherever possible, make greater use of gazettal notices or other exemptions for oversized agricultural machinery, and issue permits for oversized agricultural machinery that are valid for longer periods and/or for multiple journeys. 

Draft Finding  8.2 The road safety remuneration system (including the Road Safety Remuneration Tribunal) imposed costs on businesses, including farm businesses, without commensurate safety benefits and its abolition will reduce this burden. 

Draft Recommendation 8.4 The Australian, state and territory governments should review the National Heavy Vehicle Regulator (NHVR) as part of the planned review of the national transport regulation reforms. The review should fully assess concerns over inefficiencies in heavy vehicle regulations, and identify ways in which new funds allocated following the abolition of the Road Safety Remuneration Tribunal could best be used by the NHVR to improve road safety in all states and territories. 

Draft Finding 8.3 Privatisation of major ports has the potential to increase economic efficiency, provided appropriate processes are followed to ensure that the public interest is protected through structural separation, regulation or sale conditions. Increasing the sale price of ports by conferring monopoly rights on buyers is not in the public interest. 

Draft Recommendation 8.5 The Australian Government should amend coastal shipping laws by 2018 to substantially reduce barriers to entry for foreign vessels, in order to improve competition in coastal shipping services.  

Draft Recommendation  8.6 Arrangements to support the biofuel industry — including excise arrangements and ethanol mandates — deliver negligible environmental benefits and impose unnecessary costs on farmers and the community. The Australian, New South Wales and Queensland Governments should remove these arrangements by the end of 2018. 

Food regulation 

Information Request 9.1 The Commission is seeking information on whether the new country-of-origin labelling system would deliver higher net benefits to the community as a voluntary system rather than as a mandatory system. 

Draft Recommendation 9.1 Food Standards Australia New Zealand should remove the requirement in the Food Standards Code to label genetically modified foods. 

Draft Recommendation 9.2 Food Standards Australia New Zealand should review the standard for the level of gluten allowed in foods labelled as ‘gluten-free’, taking into account scientific evidence, international standards and risks to human health, and set a maximum allowable parts per million level for foods to be labelled ‘gluten-free’. 

Information Request 9.2 The Commission is seeking information on the costs and benefits of egg stamping relative to alternative traceability systems for eggs (such as labelling on egg cartons and requiring food businesses to keep records). Are there examples where the source of an outbreak of salmonellosis caused by eggs could not have been traced in the absence of egg stamping? 

Information Request 9.3 The Commission is seeking information on whether there are opportunities to further reduce the burden of regulatory food safety audits while still achieving regulatory objectives, and if so, where these opportunities lie. 

Competition regulation 

Draft Recommendation 11.1 The New South Wales Government should repeal the Rice Marketing Act 1983. 

Draft Finding 11.1 Statutory marketing of potatoes in Western Australia has reduced consumer choice and increased the price of potatoes in Western Australia. The Western Australian Government’s plan to deregulate the industry will allow potato production in that state to respond to changing consumer preferences and reduce the cost of potatoes for consumers. 

Draft Recommendation 11.2 The Queensland Government should repeal the amendments made by the Sugar Industry (Real Choice in Marketing) Amendment Act 2015. 

Draft Finding 11.2 Existing competition regulation and oversight is adequate for managing the risk of supermarkets abusing market power in their dealings with farm businesses and wholesale merchants. Suggestions to amend exemptions that allow collective bargaining under section 45 of the Competition and Consumer Act 2010 (Cwlth) are unlikely to increase collective bargaining by farm businesses. 

Foreign investment in agriculture 

Draft Recommendation 12.1 The Australian Government should increase the screening thresholds for examination of foreign investments in agricultural land and agribusinesses by the Foreign Investment Review Board to $252 million (indexed annually and not cumulative). 

Draft Recommendation 12.2 The Australian Government should set application fees for foreign investment proposals at the level that recovers the costs incurred by the Foreign Investment Review Board in reviewing proposals, and should closely monitor the fees to ensure no over- or under recovery of costs. 

The way forward 

Information Request 14.1 The Commission is seeking feedback on possible strategies and governance arrangements for improving the incentives for policy makers to use regulatory impact assessment processes as an analytical tool to support the quality of regulation making, rather than as a legitimising tool or compliance exercise.

GMO Bugs

The House of Lords Science and Technology Committee has released its upbeat report on Genetically Modified Insects, stating

The problems caused by infectious disease and agricultural pests are real. Genetically modified (GM) insects have the potential to address both these problems. The UK is a world leader in the development of this technology. The European Union’s regulatory process, however, is likely to hold back progress. There is a moral duty to test the potential of the technology. We therefore support further research and call for action to test the efficiency of the EU process via a trial which should also be used to drive public engagement.

The world’s fastest growing insect-borne disease is dengue. The global incidence of dengue has grown dramatically in recent decades and about half of the world’s population is now at risk. Dengue can be found in tropical and sub-tropical climates across the world. The possibility of an outbreak of dengue, however, now exists in Europe. This mosquito-borne viral infection causes a flu-like illness, and can develop into a potentially lethal complication named severe dengue. Severe dengue is a leading cause of hospitalization and death among children in many Asian and Latin American countries. A recent study estimated there to be 390 million dengue infections per year.

In 2015 there have been approximately 214 million cases of malaria and 438,000 deaths. Sub-Saharan Africa is particularly affected; so far this year, the region has been home to 89% of malaria cases and 91% of malaria deaths. Malaria is both preventable and curable, and increased efforts have seen significant reductions in malaria incidence (the rate of new cases) and deaths. Nevertheless, about 3.2 billion people, nearly half of the world’s population, live in countries, territories and areas where malaria is endemic.

By 2050 the world’s population will likely increase by more than a third to over 9 billion people. World food production will be required to increase by 70% to feed this larger, more urban and richer population. Insect pests affect all aspects of food production, storage, transport and waste. Agricultural losses due to insect damage are high. For example, insect pests cause an average annual loss of 7.7% in production in Brazil, a reduction of approximately 25 million tons of food, fibre and biofuels, with total annual economic losses reaching around US$ 17.7 billion. Insect-borne diseases also have a heavy impact on livestock. Research conducted at the Pirbright Institute in the UK prevented Bluetongue disease becoming endemic in UK sheep and cattle, an estimated saving to the UK economy of £480 million in 2008 alone.

The development and use of GM insects offers significant potential for both the control of infectious diseases and the management of agricultural pests. It is possible to manipulate an insect’s DNA in order to alter its function or reduce its fitness. In this way, insects which transmit diseases or damage crops can be modified. GM insect technologies are a potential form of biological control, in contrast to the use of chemical controls, such as insecticides, which can be harmful to people and the environment.

GM insect technology has already been trialled for dengue transmitting mosquitoes. Developed by the UK company Oxitec Ltd., field evaluations have seen a >90% reduction in numbers of the target species in the Cayman Islands and a 96% reduction in Brazil, which is argued to be sufficient to prevent endemic dengue fever anywhere in the world. From the evidence we heard, it may be the case that GM insect technology is more suited to tackling dengue than malaria.

In November 2015, scientists announced that they had successfully used GM insect technology so that a modified mosquito passes on genes conferring resistance to a pathogen (an organism that causes disease) to almost all of its offspring, not just half, as would normally be expected. This offers the possibility of a gene resistant to the parasite that causes malaria being able to spread quickly through a wild population of mosquitoes. In early December 2015, scientists, including Professor Austin Burt who gave oral evidence to our inquiry, announced findings that could speed up the development of techniques to suppress mosquito populations to levels that would not support malaria transmission.

The potential of GM insect technologies, however, should not be over-stated; an arsenal of strategies is required to tackle insect-borne diseases and crop pests. GM insect technologies do not represent a panacea. They are one of a number of experimental techniques being investigated in order to control insect-borne diseases and reduce agricultural pests.

Nevertheless, despite inevitable uncertainties, we conclude that GM insect technologies should be afforded an opportunity to play a complementary role in helping to meet the global challenges of disease control and food security. The UK, moreover, is a world leader in this area and hosts the only company in the world producing and distributing GM insects (Oxitec Ltd.). Unfortunately, we are very concerned that the benefits offered by GM insects may not be realised. The EU regulatory regime for genetically modified organisms (GMOs) is not functioning effectively. Although no EU-level GM insect applications have been received to date, the regime has seen many applications for GM crops. In these cases, the regime is failing lamentably. The prescribed process is not being followed and the system is gridlocked. Strenuous efforts must be made to ensure that the system operates more efficiently and that future GM insect applications are not stymied unnecessarily. To this end, the UK Government must bring pressure to bear on the European Commission to ensure that the current regime works as intended.

However, ensuring that the current system works as intended is not sufficient. The EU regulatory regime does not take into account the benefits of a technology; regulation is entirely on the basis of risk. Any rational approach to deciding whether or not to pursue a given technology should include an assessment of its net benefits. At the moment, moreover, no consideration is given to the risks of alternatives to the GM application. A potential new GM insect technology to reduce an agricultural pest population, for example, would not be compared alongside the insecticide currently used to tackle the pest. As such, GMOs are effectively considered against an idealised, risk-free alternative. For many GM insect technologies, the alternative may present a number of risks and problems, and, in many cases, such risks and problems (the use of insecticides for instance) may be the imperative behind the development of the GM insect technology in the first place. Consideration of the benefits of a technology, and acknowledgment of the control methods currently in use, should be incorporated into the regulatory regime in order to address this illogical situation.

In order to attempt to break the current impasse, we recommend that the Government invests in a GM insect field trial to test fully the science of GM insects, regulatory processes and policies. This stimulus is required in order to move beyond the current stasis induced by the failings of the EU regulatory regime. Moreover, the pursuit of such a trial should be the catalyst for a public engagement exercise. It is imperative that the public is given the opportunity to understand the development of GM insect technologies in a transparent way so that the polarised debate which has enveloped GM crop technologies is avoided.

GM insect strategies for agricultural use are likely to have greater scope for application within the EU, though there may be future uses for public health purposes that could be applicable in Europe. In all likelihood, however, the main uses of GM insect technologies, particularly for public health purposes, will occur outside the EU. In this regard, we are concerned that the application of GM insect technologies in the countries whose need is greatest may be affected by a lack of international guidance and leadership on the governance and regulation of these technologies. We therefore recommend that the Government, in light of its strong commitment to international development, actively considers how these challenges of international guidance and leadership can be fully achieved.

The application of GM insect technology, together with advances in the broad area of biotechnology, has the potential to provide additional tools for the control of insect-borne diseases and crop pests. The conceivable prize is enormous and the opportunity must not be squandered. Our concern is that unless there is change, and an injection of momentum and urgency, it will be.

The report goes on to refer to "a bleak picture", stating

The process for GM crops is clearly failing lamentably. It is not working as intended. The new national derogations for commercial cultivation of GM crops, referred to by the Minister, are to be broadly welcomed as a potential means of breaking the gridlock, but only time will tell if they can have any effect.

Concerns expressed about the regulatory regime were voluminous, and extended beyond poor implementation, and the vagaries outlined by the Minister, to fundamental misgivings about the design of the regime. We heard repeatedly, from nearly all parties involved, that the system does not work as intended and is subject to excessive political interference once the scientific risk assessment has been completed by EFSA. Policy-makers should not ignore the scientific evidence base.

Further concerns highlighted to us also included: regulation was not designed with GM insect technologies in mind, but is rather an extension of the legislation for GM crops; regulation is entirely on the basis of risk, and benefits are not considered; the process is regulated rather than the product generated; and self-limiting population replacement strategies are considered in the same way as self-perpetuating population replacement strategies.

In the paragraphs that follow, we briefly catalogue the litany of criticism that was directed towards the regulatory regime. As Dr Jack Stilgoe, Senior Lecturer at the Department of Science and Technology Studies, University College London, put it to us: “I am afraid it is one of those situations where you could say ‘you wouldn’t start from here’.” We agree, but we have, of course, no choice, and if the potential of GM insects is to be realised, then urgent actions are required.

As we have noted, the regulatory regime covers all GMOs including both GM crops and GM insects. Although it does remain to be seen if GM insect applications would be subject to regulatory difficulties resulting from part C of directive 2001/18/EC, all the experience of GM crops would seem to point to it. Professor Rosemary Hails, Chair, Advisory Committee on Releases to the Environment (ACRE), stated: “in the EU we do not have a functioning system for GM crops.”83 Camilla Beech, Head of Regulatory Affairs at Oxitec Ltd., gave a clear view from the commercial sector: “As an applicant we believe that the European system does not work because it is just not predictable. You put an application in and you can never predict when you are going to receive a response. That is bad for innovation and it is bad for companies.”84 100.Innovate UK stressed that the deliberate release directive had not been designed with GM insect technologies in mind, but was rather an extension of the legislation for GM crops: “The current regulations pre-date the existence of GM insects and do not seem to effectively accommodate this technology.”85 George Eustice MP, however, disputed the view that the currently regulatory regime could not effectively accommodate GM insect technologies: “from a regulatory point of view, we do not see any reason why the GM process that exists for crops in the EU should not equally be applied to GM insects.”86 101.We heard repeatedly that there is currently no means to consider the potential benefits of GMOs within the regulatory regime. As such, decisions are made entirely on the basis of risk alone. The National Institutes of Bioscience (NIB) stated: “Without considering benefits, one is implicitly comparing the proposed action with a non-existent risk-free alternative—a Utopian fallacy. Benefits, and therefore risk-benefit, could be considered explicitly.”

Furthermore, we were surprised to learn that new technologies are not evaluated alongside alternative means to address the problem. For example, a potential new GM insect technology to reduce an agricultural pest population would not be compared alongside the insecticide currently used to tackle the pest.

The current EU regime operates via a system of process-based regulation. That is to say, the trigger is the process by which a product is made rather than the nature of the product itself. In this regard, Camilla Beech, Head of Regulatory Affairs at Oxitec Ltd., offered the following analogy: “It is like reviewing a book as to whether it has been written on a typewriter or a computer and not on its content.”

This process-based system would consider population replacement and population suppression GM insect strategies in the same way. John Mumford, Professor of Natural Resource Management, Centre for Environmental Policy, Imperial College London, highlighted a fundamental conflict within the current framework when population replacement strategies were considered: “there are seven large areas of technical concern within the deliberate release directive, and persistence is one of those seven. Obviously, with the self-sustaining mode of action for some of these methods, you are starting from an assumption that the whole mode of action is a concern. That is an inherent conflict within the regulation.”  In this way, the deliberate release directive is fundamentally not designed to consider self-perpetuating population replacement strategies.

The criticism directed towards the regulatory regime raises the question of whether the focus should be on making the current system work better, or seeking to overhaul it entirely. Professor Rosemary Hails argued that there would be merit in trying to make the existing system work as it should: “We ought to be proactive on trying to make the current system work more effectively. In essence, we have the evidence that it works more effectively in other countries.”

The current system is framed around the implementation of the Precautionary Principle. On the use of this Principle, Professor Rosemary Hails stated: “the Precautionary Principle properly applied would also take into account the risks of not developing a particular technology and the benefits forgone. It is a misuse of the Precautionary Principle that has led us to this place.”

The Government maintains that the best course of action is to ensure that the regulatory environment works as it is written. George Eustice MP said: “All the EU has to do is not necessarily rewrite its process but just gain some credibility by sticking to the process that it has written down.”

George Freeman MP put it in the following terms: “GM technology is taking off across the world. The question is not whether we are going to stop it; the question is whether we are going to help contribute to leading it and getting the right regulatory framework in place.”

We welcome the Government’s endorsement of the potential of GM technologies and its recognition of the importance of a functioning regulatory environment. We are concerned, however, by its view that the most appropriate course of action is only to ensure that the current system proceeds as it is written. This is not sufficient.

GM insects have the potential to help in the control of both insect-borne diseases and agricultural pests, bringing both public health and economic benefits. The UK is a world leader in the development of GM insect technologies and the public good and the commercial opportunities are tangible. However the current EU regulatory regime for GMOs risks this opportunity being squandered. The regime is failing as applied to GM crops and the full potential of GM insects will not be realised if it continues to fail to function adequately.

We accept that there is some practical merit in the Government’s decision to work to ensure that the existing regulatory regime for GMOs at least functions as written. We ask the Government to set out clearly how it intends to do so and to publish annual updates on progress made in improving the operation of the system, starting in the summer of 2016. However, we do not accept that this is sufficient and we advocate a more radical review of the regulatory framework later in this Chapter.

International regimes

By way of comparison, we explored a number of international (non-EU) regulatory frameworks for GMOs in order to ascertain the characteristics of alternative regulatory regimes. Norway was cited as a notable example. Although a non-EU country, Norway is a member of the European Economic Area (EEA). As a member of the EEA, it has incorporated EU-based regulation but has also included an additional component. Professor Rosemary Hails told us: “Norway has some additional legislation—the Gene Technology Act 1993—where it considers the benefits also of a particular element to the community and the contribution to sustainable development, but that is in addition to the other regulations.”

Outside Europe, we were told that Canada has adopted a regime of trait-based regulation. This is effectively the reverse of the system in the EU whereby process-based regulation is used. Dr Jeremy Sweet, an Environmental Consultant with Sweet Environmental Consultants and member of the EFSA GMO panel, said of the Canadian system: “they do not discriminate GMOs from other types of engineering or manipulation or technologies. They look at the novelty of a product and say, ‘Are we concerned about this and do we need to look at it and regulate it?’”

Oxitec Ltd. highlighted the regulatory environment in Brazil. This regulatory system has been tested, unlike that in the EU, and the Brazilian authorities accepted a trial release of Oxitec GM mosquitoes. Oxitec suggested that this successful release in Brazil was due to “a clear regulatory framework based on plausible scientific pathways to harm and subsequent evaluation allowed the assessment of the dossier for commercial release in approximately 9 months from submission to approval.” From what we heard of the EU regulatory system, such efficiency would seem highly unlikely were a similar application to be received.

Oxitec also highlighted the regulatory environment in the USA where, under the National Environmental Policy Act, agencies are required to issue an Environmental Assessment that takes into consideration the alternatives available alongside the GMO application. Thus, GM insects are not considered against an idealised ‘risk-free’ alternative.

The joint submission received from a grouping of eminent Brazilian scientists—Dr Amaro de Castro Lira Neto, Dr Marcia Almeida de Melo and Professor Paulo Paes de Andrade—also highlighted the US system of regulation. They suggested that the main point of success of the US system is: “the full independence of the risk assessment procedure against the other risk analysis steps, i.e., risk management and risk communication, and ultimately against political decisions.” Furthermore they stressed that: “No political interference is allowed, at least under normal circumstances.”

This independence of the risk assessment procedure from political decision-making presents a stark contrast to the picture painted for us of the EU regulatory system. This group of Brazilian scientists also suggested that this independence is the cause of rapid adoption of biotechnology in Brazil and, to a certain extent, in Argentina, Australia and Canada as well.

Alternative regulatory protocols

We were presented with a number of alternative regulatory models that may allow for more effective incorporation of GM insects into the general GMO regulations. A number of these have been touched on above. Warnings were issued, however, about the pursuit of a new regulatory regime. George Eustice MP stressed to us: “with any European process you always have to be conscious that by taking the lid off things and trying to play around with the wiring, you might end up with something worse. It is a terrible thing to say, but I am afraid there is a track record of trying to tamper with things in Europe that are not quite right, and they end up worse than ever.”

.Although a radical overhaul of the current regulatory process may be unlikely or undesirable at this time, a number of potential alterations to the regulatory process were highlighted to us.

A trait-based approach

A trait-based approach to regulation was raised as a sensible, scientifically-sound alternative to the current process-based regulatory system. In this case, the product, rather than the means by which it has been formed, is considered. This system is in operation in Canada. Professor Rosemary Hails indicated that ACRE would deem this approach to be more scientifically defensible and “more scientifically rational now.” Dr Jeremy Sweet also highlighted that trait-based regulation is a “science-based approach”.

.A move to a trait-based system would allow separate consideration of GM insects created via population suppression and population replacement strategies. It would also result in population suppression approaches such as Oxitec’s genetic-equivalent of the SIT being considered in the same way as traditional irradiation-based SIT approaches. This may be more rational as the nature and implications of the end products are arguably the same; it is simply that the process to create them is different.

Not all the evidence we heard suggested that trait-based regulation is superior to process-based regulation. Dr Jack Stilgoe warned us that there may be good reasons for a process-based system: “They are to do with the uncertainties that we might be unable to predict in terms of the products, whether those are the products themselves or the products of that particular innovation in terms of the consequences and ramifications of those traits, and actually paying attention to the processes might better take you into a precautionary approach to governing those uncertainties.”

New technological developments may be captured within a system of trait-based regulation. For example, both transgenic and cisgenic GMOs would be included. Dr Jeremy Sweet indicated that it is becoming increasingly difficult to draw a distinction between “GM” and “non-GM”. He emphasised to us that: “We are getting into a bigger and bigger mess by basing the regulation around the technology.”

Government Ministers also highlighted to us that new emerging technologies are serving to blur the boundaries between GM and non-GM. However, on the prospect that trait-based regulation could incorporate new (cisgenic) technologies and remove the need for such arbitrary classifications, George Eustice MP stated: “We would not want those [emerging technologies] to be treated as GM, otherwise you are going to hold back the development of a very exciting new area.” He continued: “Once you start talking about trait-based approaches to this, I think there is a danger that you start to tip some of those other novel techniques too closely to the GM regulatory regime, which is the worst of all worlds, because then you have other exciting new technologies that we hope to protect from this and to maintain an understanding that they are not GM, and get muddled up in this unsatisfactory regime as well.”

At present, cisgenic organisms, such as those created using gene-editing techniques, including CRISPR, are not considered within 2001/18/EC. We consider this to be correct. We heed the warning that a move to trait-based regulation would alter this situation. However, while we agree with the Minister that new emerging technologies should not be stifled by a failing regulatory system, we do not think it appropriate to ignore the deficiencies of the regulatory regime for other developing (transgenic) technologies.

We urge the Government to monitor the development of new genetic technologies, including GM insects, in order to ensure that the regulatory regime is fit-for-purpose. We recognise that a move to a trait-based system may not currently be appropriate. We see the risk that a move to a trait-based system may be counter-productive in the short term. We acknowledge, however, that trait-based regulation may be a valid long-term aim in order to develop a more scientifically robust, overarching regime once current regulatory barriers within 2001/18/EC have been addressed. Monitoring and surveillance of persisting GMOs

.Persistence is not currently accounted for within the directive 2001/18/EC. The Institute for Science, Innovation and Society at the University of Oxford highlighted that ‘future-proofing’ would be needed in light of the development of self-sustaining, persistent gene-drive techniques: “These ‘second generation’ varieties will present a radical challenge to existing regulatory frameworks. For one, they will likely require forms of pre-release testing and post-release monitoring yet to be developed.”

.Mechanisms will be required in order to allow for effective post-release monitoring and tracking of new genetic material promoted via gene drives, and designed to persist in the environment, particularly as these may not be included within 2001/18/EC. This could include means to implement both ecological monitoring and GM screening. The Institute for Science, Innovation and Society continued: “We need better tools for the monitoring of GM insects in the environment, and the development of these tools needs to be addressed in a public and straightforward manner by the relevant scientific and regulatory institutions.” We are persuaded by these arguments.

The ecological impact of GMOs designed to persist in the environment presents a new regulatory challenge. In light of the advances in gene-drive research, we conclude that underpinning research is required in order to allow effective monitoring and tracking of this new generation of genetic modifications. The regulatory framework should take persistence into account and stipulate appropriate monitoring requirements. Consideration of benefits and evaluation alongside alternatives

We heard a number of times that taking into account the benefits of a technology could be a desirable addition to the current regulatory process. ACRE has given thought to how this could work within the existing framework. Professor Rosemary Hails explained to us that: “For example, in the whole risk assessment process, the very last question is to characterise the overall risk of a GM organism. Additional information could be provided on context under that question and that context could include benefits also. The reason why that does not happen routinely is the questions leading up to that final question do not put in the building blocks for benefits in the same way as they do for risks.”

Although any rational approach to deciding whether or not to pursue a given technology would include an assessment of its net benefits, the key element must first be sound scientific risk assessment. Professor John Mumford stated: “the risk assessment stage should be independent of values such as benefits. Those may enter at a later stage at the risk management stage, where a decision is made, but not at the assessment stage. Assessment should be objective and management should focus on performance and benefits.”

We heard different views on how benefits might be considered. Benefits and risk are often considered as opposites. However, Sir Roland Jackson, Executive Chair, Sciencewise, questioned this linkage and stressed that benefit is not the opposite of risk. He urged that benefits and dis-benefits be considered alongside each other. Risks and dis-benefits must not be conflated. He provided us with the following clarification: “Questions of benefits encompass a much wider range of issues than the question of science-defined risk. If you are to have a system that looks at benefits as well as risk, you have to look at wider dis-benefits—things like impacts on employment, ways of farming or landscapes, which are not dealt with in a risk assessment.”

Benefits must be considered at an appropriate stage of the regulatory process and not confused with scientific risk assessment. We consider that benefits and dis-benefits should be considered after the process of scientific risk assessment has taken place, at the risk management stage.

As well as confusion surrounding benefits and dis-benefits, more clarity is needed in considering hazard, exposure, risk, and vulnerability. In the Government Chief Scientific Advisor’s 2014 annual report Innovation: managing risk, not avoiding it, Sir Mark Walport argued that it is vital that these terms are understood.

Hazard is frequently equated or confused with risk, and this leads to poor debate, confused communication and flawed decision-making.

.Professor Austin Burt highlighted the potential perversity in not including consideration of the benefits of a GM insect strategy. He stated: “I would not go to a Government in sub-Saharan Africa with this idea of a genetically modified mosquito and not talk about malaria. That does not make sense.”

Professor Luke Alphey reiterated this view: “If you are not talking about the benefits and the reasons why you are doing it, how will you persuade anybody it is worth doing? At that level it does not make any sense.”

The Government do not think that considering benefits should be pursued, despite appreciating the logic behind these arguments. George Eustice MP suggested that such a move would be unlikely to make a significant change in ameliorating the current major problems at the EU level: “My argument would be if the problem is a political barrier and an overly cautious political culture, to say that we are just going to balance the risk against benefits does not do much to reassure that problem.”

Dr Ladislav Miko, Deputy Director-General in the DG for Health and Food Safety at the European Commission, corroborated this perspective: “In my view, all the experience we have shows that the position of member states which are not supporting the GMs will not be dramatically changed by any socio-economic analysis.”

Benefits were not the only additional consideration that we were told ought to be incorporated into the regulatory regime. As previously highlighted, in the current regime GMOs are effectively considered against an idealised, risk-free alternative. Obviously such an alternative does not exist. Furthermore, for many GM insect technologies, the alternative presents a number of risks and problems. In many cases, this is the imperative behind the development of the GM insect technology in the first place. A clear example is insecticides.

The Institute for Science, Innovation and Society called for evaluation of GM insects alongside alternative approaches to the problem in question. They stated that: “Application of genetic methods of insect control should be evaluated alongside alternative courses of action.” While the existing plausible pathways to harm requirements go some way towards acknowledging this, we perceive it to be vital that, on a case-by-case basis, appropriate comparators are used.

We consider the argument for including the benefits of a technology within the regulatory process to be entirely valid. Furthermore, we do not agree with the stance of the Government and the European Commission that there would be little to gain in modifying the current framework to include consideration of benefits. We recommend that consideration of benefits and dis-benefits be incorporated into the regulatory regime once the scientific risk assessment has taken place, during the risk management stage.

Furthermore it is inappropriate that new GMO technologies are considered in relation to an unrealistic, risk-free alternative. We recommend that the regulatory process should acknowledge control methods currently in use, such as insecticides, which a new technology may replace.

It is clear to us that the regulatory regime is failing as it is currently applied to GM crops. Furthermore, we envisage that these failings would likely affect GM insect applications. Views on how the regime could be improved are numerous. Action, as we recommended earlier in this chapter, needs to be taken to try and improve the current system, but this is only sufficient as a first step.

We are concerned that a situation has arisen whereby applications are not received due to concerns over the regulatory framework, yet the regulatory framework cannot be tested nor improved until such an application materialises. There are concerns that GM insect applications would likely be subjected to the considerable delays experienced by crop applications. The Minister, George Eustice MP, described such applications to us as being “stuck in limboland.”

Action needs to be taken to try and breathe new life into this policy area and provide some momentum and a focus for activity. It is with this in mind that we think the Government should initiate an insect trial akin to the Farm Scale Evaluations of new GM crop technologies. In our view, this would represent a positive means of trying to break the regulatory deadlock.

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

Not just dumb

Greenpeace Australia has proudly announced that

A mum takes action against GM wheat

Greenpeace activists, including one mother who wants to protect her family, have stopped a GM wheat experiment outside Canberra this morning.

Three women used whipper snippers to remove a controversial genetically modified (GM) wheat crop before day break.

The activists constructed a decontamination area to safely dispose of the untested and potentially unstable GM organisms.

The activity follows the revelation that Australia’s peak scientific body, CSIRO, is conducting the world’s first human feeding trials of GM wheat, without adequate safety testing.

"This GM wheat should never have left the lab", said activist and mother, Heather McCabe. "I'm sick of being treated like a dumb Mum who doesn't understand the science. As far as I'm concerned, my family's health is just too important. GM wheat is not safe, and if the government can't protect the safety of my family, then I will."

One response might be that she's not just dumb; Ms McCabe's arguably a vandal who is happy to break the law in giving effect to romantic notions about GM. I wonder whether she'll next turn her attention to the old-fashioned breeding of plants and critters.

The ABC omitted the emo in reporting that

Greenpeace protesters have broken into a CSIRO experimental farm in Canberra to destroy a crop of genetically modified wheat.

In the early hours of this morning a group of Greenpeace protesters scaled the fence of the CSIRO experimental station at Ginninderra in the capital's north.

Greenpeace says activists were wearing Hazmat protective clothing and were equipped with weed string trimmers.

The Hazmat kit is a nice touch ... presumably useful in case the wheat tries to suck out the protesters' eyeballs or lure them into a crop circle to be beamed up by bug-eyed aliens working for the CIA.

The report continues -

About half a hectare of GM wheat is being grown on the site, as part of Australia's first outdoor trials.

No genetically modified wheat strain had ever been approved for cropping in Australia before.

Last month the CSIRO received permission to conduct Australia's first trial in which humans will eat GM wheat.

The wheat's genes have been modified to lower the glycemic index and increase fibre to create a product which will improve bowel health and increase nutritional value.

Animal feeding trials of up to three months have been conducted, with human trials at least six months away.

Greenpeace says it has taken action because of concerns over health, cross-contamination and the secrecy surrounding the experiments.

That apparently justifies a spot of direct action.

Campaigner Laura Kelly says the Federal Government needs to put an end to testing GM wheat in Australia. ... "No one is looking after the health of Australians. Julia Gillard isn't standing up to foreign GM countries to protect our daily bread so Greenpeace has to," she said.

Ooh, nothing like a dash of xenophobia among the bien pensants.

ACT Greens MLA Shane Rattenbury used to work for Greenpeace and says he is not surprised the group has taken such action.

"It's always very controversial these sorts of actions, but you have to stand up for what you believe in sometimes," he said.

"Greenpeace has clearly formed a view that the best way to both draw attention to this issue and to potentially protect the human food chain in Australia is to take this action."

Heaven forbid that they should engage with the legal system and develop effective legislation rather than self-involved agitprop. Greenpeace's actions may get favourable media coverage but, irrespective of the law, are problematical. Researchers are told to conduct field trials and other tests to determine the efficacy and safety of GMO crops. At the same time, the testing is sabotaged by vigilantes who assert that the crops are not safe and that 'activists' are right to ignore the law and destroy the field trials.