Chapter 4: Regulation of GM insect technologies
The current regulatory regime
76.The current regulatory framework for GM insects in the UK is underpinned by two EU directives: contained use (2009/41/EC)64, which assesses measures for the contained use of genetically modified organisms (GMOs65), for example, in research; and deliberate release (2001/18/EC)66, which outlines the risk assessment required before any release of GMOs into the environment. These directives have been transposed into UK law to create a set of national regulations. Crucially, this regime covers all transgenic GMOs created using recombinant DNA technology, including both GM crops and GM insects.
77.There is also an EU regulation (1946/2003)67 on the transboundary movement of GMOs, which provides for implementation of the international Cartagena Protocol on Biosafety. Broadly, this aims to ensure there is prior informed consent before a GMO is exported from one country to another. Companies working in this area, such as Oxitec Ltd., are also regulated under quarantine regulations and the animal feed and animal by-products regulations.68
78.These regulatory requirements, with the exception of the implementation of the Cartagena Protocol on Biosafety, only apply to trials and commercial releases within the EU. In all likelihood, the main uses of GM insect technologies, particularly for public health purposes, will occur outside of the EU. There is a dichotomy between the geographic location of the underpinning scientific research and where some of the main applications will likely be.
79.There is no consistent, internationally recognized, regulatory protocol or convention for the testing and release of GM insects. This appears to conflict with the fact that insects, unlike crops or other GMOs, are not contained by national boundaries. Indeed, increasing global import and export trade means that insects can readily be moved across the world.
80.In 2014, the World Health Organisation (WHO) produced guidelines on testing GM mosquitoes.69 Whilst they did not propose a regulatory framework, it is a clear, practical document that discusses elements that could be part of a regulatory framework i.e. case by case assessments, increasing environmental exposure in incremental steps, risk/benefit, efficacy and stakeholder engagement. The guidelines describe regulatory regimes and discuss risk assessment frameworks.
81.The immediate beneficiaries of GM insect technologies that serve to control insect-borne diseases are most likely to be in low to middle income countries (LMCs). The Institute for Science, Innovation and Society, based at the University of Oxford, highlighted the situation in Latin America where a number of ad-hoc approaches to regulation have developed. They warned:
“Regulatory jurisdictions without a central authority in charge of assessing new GMO releases have struggled to deal with the complex challenges posed by GM insects.”70
82.Professor Anthony James, Distinguished Professor of Microbiology & Molecular Genetics at the University of California Irvine, also highlighted this situation and suggested that it may serve to hold back the development of GM insect technology:
“the circumstances created by the fragmented regulatory jurisdictions of multiple international, national and local agencies, and how this lack of coherency puts at risk the development of new technologies for which specific review and approval pathways do not exist.”71
83.Professor James cited a specific example he had experienced of selecting collaborators and sites for field trials of a transgenic mosquito strain developed to control the spread of dengue:
“The issue of how to get regulatory approval for the testing of a new technology when there was no dedicated agency to receive and review our applications was not trivial. Applying our checklist criteria, we identified Mexico as the only country at the time that had a horizontally- and vertically- integrated regulatory structure that could assure complete and ethical approval. Brazil may be there now.”72
84.George Freeman MP, Parliamentary Under-Secretary of State for Life Sciences, Department for Business, Innovation and Skills and the Department of Health, also highlighted that we must “make sure that we get the international framework right.”73
85.For resource-poor countries with limited regulatory capacity—the key constituency for vector control applications of the technology—GM insects may represent a problematic area of governance and regulation.
86.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 recommend that the Government, in light of its strong commitment to international development, works through international organisations to help to address challenges of international guidance and leadership.
87.GM insect strategies for agricultural use are likely to have greater scope for application within the EU. Furthermore, there may be future uses for public health purposes that could be applicable in Europe. Hence it remains vital that the regulatory environment in the EU is fit for purpose.
88.Scientific risk assessment is currently the foundation of the EU regulatory process for GMOs. The European Food Safety Authority (EFSA) performs this assessment at the EU level and serves as the scientific advisory body that informs the European Commission. At the UK level, the Advisory Committee on Releases to the Environment (ACRE) gives statutory advice on the risks to human health and the environment from the release of GMOs. Established under the Environmental Protection Act 1990, ACRE advises the Secretary of State for Environment, Food and Rural Affairs as well as Scottish and Welsh Ministers.
89.Directive 2001/18/EC on deliberate release has arguably the most influence on the regulatory environment for GMOs and, as such, was the main focus of our inquiry. It is implemented through two parts: part B for research trials (assessed nationally—in the UK by ACRE) and part C for commercial release (assessed at the EU level by EFSA). That is to say: the regulation of trials is a national decision. Any larger scale commercial use, however, would require EU approval.
90.No applications have been made to release GM insects in the UK for research purposes, and across all EU Member States (MS) there has only been one national application for a trial release of GM olive flies in Spain in accordance with part B of 2001/18/EC (see Box 4). There have been no applications at an EU level for commercial release (part C of 2001/18/EC). Dr Ladislav Miko, Deputy Director-General in the DG for Health and Food Safety at the European Commission, highlighted this and emphasized that the current regulatory framework remains untested for GM insects: “we have never had any applications, so we do not have practical experience.”74 Why the regime remains untested is a question that we will return to.
Box 4: Oxitec GM olive fly (OX3097D) application75
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Oxitec Ltd. developed a GM insect approach to tackling olive fly pests based on a genetic-equivalent of the traditional SIT approach. After contained trials, the strain OX3097D of modified flies was deemed ready for a field trial. Oxitec made an application to the Spanish National Authorities under Ley 9/2003 (the implementation of part B of directive 2001/18/EC in Spain) in late 2012. The Spanish authorities, however, felt that they could not authorise the trial without additional data and significant containment measures in place. Due to the timeframes required to generate the data, Oxitec determined that the appropriate administrative approach would be to withdraw the application and re-submit at a later date. In 2015, a new regulatory submission was made to the Spanish authorities which included additional data. Despite having addressed the 2012 requirements, concerns remained with the second application regarding the confinement of the trial site. While additional confinement measures were presented, it appeared to Oxitec that only a fully-contained trial would be accepted and the application was subsequently withdrawn once again. The governments of Brazil and the USA, Oxitec report, have recently allowed environmental release approvals (outside of netted enclosures) for self-limiting GM insect plant pests based on identical technology. While risk assessment is case-by-case, and site specific considerations are unique, Oxitec highlighted to us that they find it difficult to rationalize the decision of the Spanish authorities given the internationally accepted principles of evidence-based risk analysis. The only application for a GM insect field trial in the EU failed. “We cannot even get to the first hurdle of getting a genetically modified insect in a field cage,” Oxitec told us.76 |
91.Figure 2 depicts how the EU regulatory process for GMOs should function in accordance with part C of directive 2001/18/EC.
Figure 2: The EU regulatory process for GMOs
92.While the process depicted in Figure 2 looks plausible, we were repeatedly told that there were profound problems with how the system works in practice. The Minister of State for Farming, Food and the Marine Environment, Department for Environment, Food and Rural Affairs, George Eustice MP, told us that that the principal problem for GM crops was one of implementation, and explained how a situation of deadlock had been reached:
“we do not think there is anything particularly wrong with the regime as written, but there is certainly a great deal wrong with the way it is implemented, in that if all member states followed the evidence and had a risk-based approach, there are actually lots of checks and balances in the system, but there is no reason why an application, if it were proved to be safe, should not proceed to commercial cultivation in a relatively straightforward way and in a relatively short timeframe. In practice, we have seen, frankly, political deadlock over the last 10 years between member states and an inability to get qualified majority voting to block [GM crop] cultivation, or indeed to allow cultivation, and a feeling generally from the Commission that because this is such a divisive hot potato, there are usually lots of reasons to ask for more evidence and new reviews and for outdated information to be updated. So we tend to have applications that have been stuck in limboland in most cases for many, many years.”77
93.At the insistence of the UK, an agreement was reached last year on allowing national derogations for commercial cultivation of GM crops. We acknowledge the efforts made by the Government to achieve this. George Eustice MP hoped that this “might unblock that logjam and make other member states less inclined to try to block these cultivations so that we can allow member states that want to do the commercial cultivation of crops that are shown to be safe to do so.”78
94.The Minister told us about how the process became log-jammed:
“What tends to happen is that member states that have more political objections to these technologies find reasons to question the science, to question the recommendation. Again, that is foreseen in the process, so when that happens the Commission asks the EFSA to carry out its own independent assessment. When that authority concludes, it then makes a recommendation to the Commission, and at that point the matter should go to a vote and either be carried or not under QMV.79 The difficulty is that whenever these have come back and gone to QMV, there is never a QMV to do either one thing or the other. What should happen at that stage is that the Commission can go ahead and authorise it if that is where the balance of evidence lies. I hope that it will be more inclined to do that now that we have allowed the national derogation.”80
95.This is a bleak picture. 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,81 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.
96.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.
97.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.
98.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’.”82 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.
99.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.”87
102.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.
103.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.”88
104.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.”89
In this way, the deliberate release directive is fundamentally not designed to consider self-perpetuating population replacement strategies.
105.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.”90
106.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.”91
107.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.”92
108.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.”93
109.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.
110.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.
111.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
112.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.”94
113.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?’”95
114.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.”96 From what we heard of the EU regulatory system, such efficiency would seem highly unlikely were a similar application to be received.
115.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.97 Thus, GM insects are not considered against an idealised ‘risk-free’ alternative.
116.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.”98
Furthermore they stressed that: “No political interference is allowed, at least under normal circumstances.”99
117.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
118.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.”100
119.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
120.A trait-based approach to regulation was raised as a sensible, scientifically-sound alternative to the current process-based regulatory system.101 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.”102 Dr Jeremy Sweet also highlighted that trait-based regulation is a “science-based approach”.103
121.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.
122.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.”104
123.New technological developments may be captured within a system of trait-based regulation. For example, both transgenic105 and cisgenic106 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.”107
124.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.”108
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.”109
125.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.
126.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
127.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.”110
128.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.”111
We are persuaded by these arguments.
129.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
130.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.”112
131.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.”113
132.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.”114
133.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.
134.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.115 Hazard is frequently equated or confused with risk, and this leads to poor debate, confused communication and flawed decision-making.
135.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.”116
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.”117
136.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.”118
137.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.”119
138.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.
139.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.”120 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.
140.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.
141.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.
142.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.
143.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.”121
144.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.122 In our view, this would represent a positive means of trying to break the regulatory deadlock.
145.The fact that the current EU regulatory regime remains untested for GM insect technologies is a major barrier to progress. Only when a field trial application has been approved will we be able to move forward. We therefore conclude that action must be taken to instigate a field trial which should also be used to drive public engagement (see Chapter 5).
146.We therefore recommend that the Government actively pursues and invests in a GM insect field trial to test fully the science of GM insects, regulatory processes and policies. This trial could be considered as a GM insect counterpart to the Farm Scale Evaluations of new GM crop technologies undertaken from 1999 to 2006. Such a trial should be dual-approach in nature and investigate both an agricultural pest and a species of mosquito.
147.In order to undertake this trial, Government departments, including DEFRA, BIS and DFID, should work together to develop a proposal to be put out for tender to the UK science community. Funding should be drawn from these Government departments as well as Innovate UK (see paragraph 72).
148.Alternative regulatory approaches should be considered in the light of this trial, including those highlighted in this report, such as: consideration of benefits, evaluation against real-world alternatives and trait-based regulatory triggers.
149.Alongside this trial, with the aim of ensuring that regulation remains relevant and up to date, we recommend that the Government monitors the suitability of the regulatory environment for emerging technologies, such as GM insects, to ensure that the potential benefits they could bring are not stifled at inception due to anachronistic regulation. This includes the development of new mechanisms to allow for effective post-release monitoring and tracking of new genetic material promoted via gene drives. We recommend that the Government issues an annual statement which provides their assessment of the suitability of the regulatory environment for emerging technologies.
64 Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms
65 A GMO is an umbrella term for any organism whose genetic material has been changed.
66 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
67 Regulation (EC) No 1946/2003 of 15 July 2003 of the European Parliament and of the Council on transboundary movement of genetically modified organisms
69 World Health Organisation, Guidance framework for testing of genetically modified mosquitoes (June 2014): http://www.who.int/tdr/publications/year/2014/guide-fmrk-gm-mosquit/en/ [accessed 9 December 2015]
72 Ibid.
79 Qualified majority voting (QMV) is the most widely used voting method in the EU Council of Ministers. A qualified majority is reached if two conditions are met: 55% of Member States vote in favour—in practice this means 16 out of 28; and the proposal is supported by Member States representing at least 65% of the total EU population.
81 As of October 2015, an amendment to directive 2001/18/EC allows Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory. Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory (March 2015).
91 Q 33 (Prof Rosemary Hails). The Precautionary Principle was the focus of a recent report from our counterpart Committee in the House of Commons. As such we will not focus on it here. For further discussion of the use and misuse of this principle, we refer to their report: House of Commons Science and Technology Committee, Advanced genetic techniques for crop improvement: Regulation, risk and precaution (Fifth Report, Session 2014–15, HC 328)
97 Ibid.
98 Written evidence from Dr Amaro de Castro Lira Neto, State Institute for Agronomy (IPA), Dr Marcia Almeida de Melo, Federal University of Campina Grande, and Prof Paulo Paes de Andrade, Federal University of Pernambuco (GMI0006)
99 Ibid.
101 Our counterpart Committee in the House of Commons included consideration of the merits of a trait based approach in their Report: Advanced genetic techniques for crop improvement: Regulation, risk and precaution (Fifth Report, Session 2014–15, HC 328)
105 Modified via insertion of genetic material from another organism.
106 Modified via rearrangement of genetic material within the organism.
111 Ibid.
115 Annual Report of the Government Chief Scientific Adviser 2014, Innovation: Managing risk, not avoiding it (2014): https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/381905/14-1190a-innovation-managing-risk-report.pdf [accessed 9 December 2015]
122 For consideration of the Farm Scale Evaluations, please see: Maria Burke, GM crops: Effects on farmland wildlife (October 2003): http://cib.org.br/wp-content/uploads/2011/10/estudos_cientificos_ambiental_19.pdf [accessed 9 December 2015]. This publication, produced by the Farmscale Evaluations Research Team and the Scientific Steering Committee, and written by Maria Burke, is a summary of the scientific papers published in the Philosophical Transactions of the Royal Society (Biological Sciences), Vol. 358, Issue 149, 1775–1889.