House of Commons - Advanced genetic techniques for crop improvement: regulation, risk and precaution

Advanced genetic techniques for crop improvement: regulation, risk and precaution - Science and Technology Committee Contents

4 The EU regulatory environment for genetically modified organisms

EU GMO regulation

49. The import, processing and cultivation of genetically modified organisms (GMOs) in European Union (EU) Member states is closely regulated. This is achieved through four main pieces of EU legislation:

· the Contained Use Directive (2009/41/EC),[162] which lays down measures for the contained use of genetically modified micro-organisms, for example, in research;

· the Deliberate Release Directive (2001/18/EC),[163] which outlines the risk assessment required before any release of GMOs to the environment; and

· two GM food and feed regulations which set out the traceability and labelling (EC 1830/2003)[164] and assessment and authorisation (EC 1829/2003)[165] requirements for marketing of food or feed containing or derived from GMOs.[166]

Under this legislation, all GMOs must undergo risk assessment by the European Food Safety Authority (EFSA) before they can be imported or grown in the EU. Once EFSA has delivered its scientific opinion—typically stating whether or not the assessed GMO is as safe as its conventionally-bred counterpart—the European Commission formulates a draft decision on how to manage any potential risks highlighted by EFSA and whether or not to grant EU-wide permission to import or cultivate that GMO. This draft authorisation decision is voted on by a Standing Committee consisting of Member state representatives. In the event that the required qualified majority[167] is not achieved, the decision on whether or not to accept the Commission's proposal is referred to an Appeal Committee, where a second vote is taken. If the Appeal Committee vote is also indecisive, the Commission is empowered to make a final authorisation decision.

50. To date, the EU has granted approval for the import of over 40 genetically modified (GM) food and feed varieties, including cotton, maize, oilseed rape, sugar beet, yeast and soybean, which is widely used across Europe as poultry feed.[168] However, according to the Government, "since 1998 every attempt to reach an EU decision on [cultivation of] a GM crop has resulted in an inconclusive vote, with no qualified majority for or against the proposed authorisation".[169] As a result, several applications for GMO cultivation have become 'stuck' in the regulatory system for many years while others have been withdrawn. Only one GM crop is currently authorised for cultivation in the EU: a variety of insect-resistant Bt maize (see paragraph 11) approved in 1998. This accounts for approximately 30% of Spain's total maize production (more than 100,000 hectares) and is also grown in Portugal, the Czech Republic, Romania and Slovakia.[170] However, this product counters a pest not problematic in the UK and is therefore not currently grown in this country.[171]

THE PRECAUTIONARY PRINCIPLE

51. The current EU regulatory framework is generally considered to have been heavily informed by the precautionary principle. There is no single agreed definition of the precautionary principle and "considerable debate" as to what it means and how it can be implemented.[172] However, a useful definition was offered in 2005 by the UN's World Commission on the Ethics of Scientific Knowledge and Technology, which described it as follows:

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The precautionary principle has its roots in environmental law. It was first formally adopted in the German Clean Air Act of 1974 and its application was later extended through the 1992 Rio Declaration on Environment and Development.[174] Having informed EU environmental policy for several years, in 2000 the principle was the subject of a European Commission 'Communication', which outlined the Commission's "approach to using the precautionary principle" and established "guidelines for applying it", in an attempt to "avoid unwarranted recourse to the precautionary principle, as a disguised form of protectionism".[175] Its role in EU environmental policy was later enshrined in the 2007 Lisbon Treaty.[176]

52. The influence of the precautionary principle on the EU's regulatory approach to GMOs is reflected in the language of the current legislation. The Deliberate Release Directive, 2001/18/EC, states that the precautionary principle was "taken into account" in its drafting and that it must also "be taken into account" in its implementation, in relation to both risk assessment and risk management.[177] The final version of the recent amendment to this Directive—discussed later in this chapter—similarly includes a clause requiring that the precautionary principle "always be taken into account in the framework" of this Directive "and its subsequent implementation".[178] EC 1830/2003, on traceability and labelling, also stipulates that legislation should "facilitate the implementation of risk management measures in accordance with the precautionary principle" and an online summary of legislation, published by the EU's publications office, explicitly acknowledged that this legislation was adopted "in accordance with the precautionary principle".[179] Nevertheless, when questioned on the subject of the principle, Eric Poudelet, Director of Safety of the Food Chain at the European Commission, told us repeatedly that the Commission had "never implemented the precautionary principle for the authorisation of GMOs".[180]

53. It is clear to us that an interpretation of the precautionary principle has significantly influenced the EU's approach to GMO regulation and we consider the claim, made by a representative of the European Commission, that the principle has never been implemented for GMO authorisation to be, at best, disingenuous. If the precautionary principle is to avoid being used as a political tool, greater clarity is needed regarding when, and how, it has been used. In order to avoid future ambiguity, we recommend that the Commission clearly and publicly state when it has drawn on the precautionary principle in the policy formation process.

The precautionary principle is discussed further in chapter 5.

Is the current regulatory system fit for purpose?

54. According to the Government, the current EU legislative framework for the cultivation of GMOs, "as written", could provide for "a pragmatic assessment and authorisation process".[181] However:

In practice, the operation of the regime is very dysfunctional because Member states do not share a common outlook on this issue. The agreed regime should mean that GM crops are cleared for planting if they pass the required safety assessment. In practice, even if a crop has received a favourable EFSA [European Food Safety Authority] assessment, a significant number of Member states still object to proposed EU approvals due to their political views on GM.[182]

55. Some of these issues were acknowledged by those involved in the process itself. Professor Joe Perry, Chair of EFSA's GMO panel, recognised that Member states tended to vote "on political grounds, in many cases ignoring the […] scientific evidence" provided by EFSA, despite this being against World Trade Organisation rules.[187] He added that aspects of the system had been "abused by Member states for political reasons that have nothing to do with science".[188] Professor Perry also acknowledged the existence of long procedural delays, although he attributed these to "political inertia once the EFSA opinion has been received" by the European Commission, rather than to flaws in the risk assessment process itself.[189] Mr Poudelet also appeared to recognise the system's weaknesses; however, like the Government, he saw "no problem in the legislative framework" and stated that "the problems" with the system came through "the process of adoption, where member states have to vote with the qualified majority system".[190] Mr Poudelet admitted that the Commission was "guilty" of failing to meet its statutory duty to adopt a draft decision within three months of receiving EFSA's opinion, but stated that this was a deliberate move to give it time to "find a solution that commands the widest possible support from member states" before forcing a vote.[191]

56. Although there was widespread agreement about the inefficiency of the current regulatory system, not everyone agreed that the politicisation of the decision-making process facilitated by the European Commission made it dysfunctional. The Advisory Committee on Releases to the Environment (ACRE) drew a distinction between risk assessment, as performed by EFSA, which "should be based on objective scientific principals", and subsequent decision-making about risk management, which might be rightly "expected" to be "influenced by non-scientific and often political considerations".[192] This distinction was also highlighted by Mr Poudelet, who stated that, as risk manager, the European Commission had to "take into account other legitimate [non-scientific] factors, which EFSA does not" —"you call that politics".[193] He continued:

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Mr Poudelet stated that "today, in most member states—maybe not the UK—GMOs are not really accepted for food".[195] He therefore saw the EU's failure to authorise GMOs for cultivation as a legitimate reflection of this position. In contrast, the Government characterised the EU regime as "dysfunctional" and argued that it imposed a "significant opportunity cost" on the UK: a country in which "most people […] are open-minded or don't feel strongly about GM crops".[196] Only eight cultivation applications now remain in the EU regulatory system while, in contrast, nearly 100 genetically modified crops have been approved for use in the US.[197] According to Professor Rosemary Hails, Chair of the Advisory Committee on Releases to the Environment, one of these applications has "been there since 1996, I think", and "12 applications have been withdrawn" because "those who submitted them have now given up".[198] Professor Sir David Baulcombe, University of Cambridge, stated that, under the current system, "the opportunity for any individual member state to take advantage of GM is being blocked by the political agenda of other member states" and added that "the decisions by Monsanto and BASF to reduce crop biotechnology investment in Europe were a direct consequence" of the regulatory regime.[199] BASF confirmed that its decision to "halt development of GM crops for the European market was to a large extent the result of the slow and unpredictable nature of a European regulatory system" and Syngenta stated that, because of the current "political impasse", it considered "the possibility to translate agricultural GM research into commercial products in the EU" to be "essentially zero".[200] A further "perverse political outcome" of the current system, according to Professor Joyce Tait, Innogen Institute, was that "the more onerous you make the regulatory system, the more difficult it is for small companies to get through that to the market", reinforcing the oligopolistic tendency that underlies some people's concerns about the genetic modification.[201]

57. Several witnesses stated that the EU regime had also damaged the UK research environment. The Government indicated that "employment in the UK crop biotechnology industry sector fell significantly" between 1996 and 2006 and highlighted that, between 2005 and 2009, there were over 4000 trials of genetically modified crops in the US, compared with just three in the UK.[202] It estimated that if UK crop biotechnology research had progressed in the way that is had done in the US, "there could have been nearly 900 additional science jobs created, with an estimated annual additional income (salaries) generated of £57 to £77 million".[203] Professor Guy Poppy, Chief Scientific Adviser to the Food Standards Agency, told us that regulatory issues were "having consequences in terms of the willingness of industry and, to some extent, the scientists in universities and research institutes to pursue work in this area".[204] The Agricultural Biotechnology Council agreed that current regulations had "resulted in companies and scientists naturally focusing investments and time in areas of the world with more predictable and workable approval systems".[205] It continued:

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58. During the drafting of this report, the EU amended the regulations with regard to GM crops. In essence, the changes recognise the delays inherent in the system and there is now provision for countries that do not wish for GM crops to be grown in their countries to ban the growth of any crops approved on an EU wide basis.

59. A regulatory system under which it takes many years—sometimes decades—to reach a decision cannot possibly be considered fit for purpose. Evidence clearly shows that the current EU regulatory regime for GMOs is not working, and has not worked for some time. We await signs of whether the recent changes will significantly change the outcome for companies seeking approval to grow GM crops in Europe.

Issues of regulatory design

60. The operational problems underlying the current stalemate in the EU stem from three fundamental issues of regulatory design.

1. REGULATORY TRIGGER

61. The current EU regulatory system for novel crop plants is technology-specific; genetically modified crops are regulated because of the method by which they were created rather than because of the traits that they display. Several influential UK and European bodies—including the European Academies Science Advisory Council (EASAC),[207] the Prime Minister's Council for Science and Technology,[208] the Biotechnology and Biological Sciences Research Council (BBSRC)[209] and the Advisory Committee on Releases to the Environment (ACRE)[210]—have advocated a move to a trait-based regulatory system, as is currently operated in Canada (see box 4). They have made this recommendation on the basis of two professed flaws of the current process-based system:

i) lack of evidence to support the underlying premise that genetically modified crops present higher risk than their conventionally bred counterparts; and

ii) the failure of process-based regulation to cope with advances in technology.Box 4: The Canadian regulatory system for plants with novel traits

In Canada, genetically modified and conventionally bred plants are all regulated under the same 'trait-based' system. Under this system, crops are subject to full risk assessment and regulation only if they are defined as being a 'plant with a novel trait' (a 'PNT'). In order to be classified as a PNT, a plant must display a characteristic not seen in any previously approved product. However, the system does not distinguish between technologies: a PNT may be produced by conventional breeding, mutagenesis, genetic modification or any other technique, and not all genetically modified plants will necessarily be defined as PNTs.[211]
According to the European Academies Science Advisory Council, "this approach acknowledges the fact that it is the product, and not the process, that warrants regulation because it is the presence of novel traits in a plant that potentially pose an environmental or health risk, and not how the traits were specifically introduced".[212] It added that "a key strength of the Canadian regulatory system is that while the techniques used by plant breeders continue to evolve, the regulatory trigger for PNTs will remain current and consistent".[213]
Canada is the fourth-largest global producer of genetically modified crops and has so far approved over 120 GM crop/trait combinations through this system.[214]

The relative safety of genetically modified and conventionally bred crops

62. Professor Sir David Baulcombe, University of Cambridge, explained that the EU regulatory system was initially based on process rather than trait in order to accommodate particular "concerns about hazards associated with GM" which arose when the regulation was first developed in 1990.[215] According to Professor Baulcombe, at this time "little was known about plant genomes and the mechanisms of GM" and "there were features of the GM plants that were either surprising or difficult to monitor".[216] However, he argued, "in 2014, the situation has changed" and we can now "be confident" that "the risk associated with GM crops is negligible".[217] The Society of Biology agreed and pointed out that:

Worldwide, over 175 million hectares are dedicated to GM crop cultivation, accounting for 12 percent of arable land, and no inherent risks have so far been identified to human or animal health from this consumption or to the environment from their cultivation.[218]

63. The conclusion that genetically modified crops pose no greater risk than their conventionally bred counterparts is supported by what the Science Council referred to as an "increasingly strong international body of scientific research which says that GM crops are safe for human and animal consumption".[219] A 2010 European Commission report, looking back on 130 EU-funded research projects, concluded that GMOs were not inherently any more risky than conventionally bred crops and EASAC, "the collective voice of European science", stated in 2013 that "the scientific literature shows no compelling evidence" linking genetically modified crops "with risks to the environment or with safety hazards for food and animal feed greater than might be expected from conventionally bred varieties of the same crop".[220] According to the Royal Society, "no evidence exists that GM methods, as defined in current legislation, are intrinsically more dangerous than other less regulated approaches".[221] This conclusion has been strongly echoed by voices operating within the EU establishment. Professor Anne Glover, former Chief Scientific Adviser to the President of the European Commission, has stated publicly her confidence "in saying that there is no more risk in eating GMO food than eating conventionally farmed food".[222] Professor Joe Perry, European Food Safety Authority (EFSA), also stressed his confidence in saying that those GMOs that had received a positive opinion from EFSA were "as safe as their conventional counterparts".[223] In light of such statements, Dr Paul Burrows, BBSRC, judged that "the scientific consensus" on this matter appeared "quite sound".[224] Nevertheless, Dr Doug Parr, Greenpeace UK, stated that there was "plenty of scientific opinion out there that takes a different view", citing a recent statement issued by the European Network of Scientists for Social and Environmental Responsibility, signed by 297 scientists, which contends that there is "no scientific consensus on GMO safety".[225] Peter Melchett, Soil Association, acknowledged that "the majority of scientists think it [GM] is safe" but highlighted "a relatively small amount of peer-reviewed, published science on long-term health effects of GM food" which he suggested offered "grounds for concern".[226]

64. In setting out their inherent concerns about the safety of genetic modification, several witnesses portrayed gene insertion as a random process with potentially unexpected effects. Mr Melchett, for example, characterised genetic engineering as "disruption of the genome, with unknown consequences" and made a link between this and the "inherent uncertainty" of the technology.[227] Dr Parr similarly portrayed the insertion process as a source of inherent risk and stated that this produced "unpredictable outcomes" that could "potentially lead to unpredictable effects when released into the environment".[228] GM Freeze agreed that gene insertion could produce "potentially dangerous effects".[229]

65. However, these arguments were rejected by other expert witnesses. Professor Baulcombe explained that "gene silencing", one of the "unpredictable outcomes" suggested by Dr Parr, was "now well understood as an avoidable complication" of first generation transgenic techniques.[230] "Additionally", he explained, "with advances in DNA sequencing technology, the second level of uncertainty is eliminated because it is now relatively easy to characterize the complete genome sequence and the transgene insertion sites in the recipient genome".[231] Professor Ottoline Leyser, Royal Society, stated that gene insertion happened regularly in nature and highlighted that not all genetic crop improvement techniques involved introducing genes from outside the normal gene pool.[232] According to Professor Leyser:

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66. Aside from the "inherent" risk posed by the process of genetic modification, Liz O'Neill, GM Freeze, highlighted her organisation's concern about a number of specific consequences.[234] She stated, for example, that "in north and south America, where a large amount of GM is grown, we have seen a huge growth in pesticide-resistant weeds, a massive decline in the monarch butterfly, and a large number of serious contamination incidents".[235] In response to Ms O'Neill, Professor Leyser stated that "all the things that you mentioned, absolutely all of them" were not to do with the technology itself, but "the trait that has been introduced".[236] She explained:

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The Royal Society explained that process-based regulation inevitably resulted in these types of "inconsistencies", because the same phenotypic trait, for example herbicide resistance, "may fall in or out of the scope of the regulations […] simply because of the way it was introduced".[238] As a consequence, according to Professor Leyser, conventionally-bred herbicide-tolerant crops undergo "no scrutiny whatsoever before they are put in the field", despite them producing the same type of potentially harmful effects as those listed by Ms O'Neill.[239]

67. Given the balance of evidence, the Science Council stated that the Government needed "to display confidence in the scientific consensus around the safety of GM foods".[240] We saw limited evidence of this happening. In its evidence to us, the Government made clear its support for genetic crop improvement but stopped short of explicitly acknowledging that crops produced via these technologies posed no greater risk than conventionally bred crops. There is no statement to this end on the relevant policy pages on GOV.UK and it has not been a feature of recent speeches on the topic, such as that made by the Secretary of State in January 2015.[241] The Minister did acknowledge to us that the EU risk assessment process was "more than robust enough to ensure that authorised GM products will be as safe as their non-GM counterparts", but made no more generalised comment about the scientific consensus that genetically modified crops pose no inherent risk.[242]

68. The current EU legislative framework for novel plants is founded on the premise that genetically modified plants pose inherently greater risk than their conventional counterparts. The weight of peer-reviewed scientific evidence, collected over many years, has shown this to be unjustified. Where genetically modified crops have been shown to pose a risk, this has invariably been a result of the trait displayed—for example, herbicide tolerance—rather than the technology itself. We are disappointed that the Government has not more publicly argued this fact. We recommend that the Government publicly acknowledge that genetically modified crops pose no greater inherent risk than their conventional counterparts. A statement recognising this fact should be included in the Government's response to this report and relevant areas of GOV.UK should be updated to reflect this.

New techniques for genetic crop improvement

69. Current EU legislation defines a GMO as "an organism, with the exception of human beings,[243] in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination".[244] As a result of its focus on process rather than trait, a list of particular techniques considered to meet this definition are specifically included in the legislation (for example, the typical first generation process of transgenic insertion) while others are expressly excluded (for example, in vitro fertilisation and the induction of polyploidy,[245] a technique commonly used in plant breeding). In a 2013 report on new plant breeding techniques, the Advisory Committee on Releases to the Environment (ACRE) stated that it had been experiencing an increased number of enquiries "as to whether organisms produced by certain techniques are captured by the EU's GMO legislation".[246] Professor Rosemary Hails, Chair of ACRE, stated that this was leading to "a necessary but nonsensical debate" about whether particular new methods should be considered 'GM'.[247] In recognition of this issue, the Biotechnology and Biological Sciences Research Council (BBSRC) recently issued a position statement on new techniques for genetic crop improvement. This stated that "novel genetic techniques" were "advancing rapidly" and that "the boundaries between established GM and non-GM techniques" would, in the future, "become increasingly blurred", placing "even more emphasis on the advantages of a trait-based [regulatory] system".[248] It concluded that "a regulatory system based on the characteristics of a novel crop, by whatever method it has been produced, would provide more effective and robust regulation than current EU processes".[249] Professor Joe Perry, European Food Safety Authority (EFSA), stated that current EU legislation was "less and less apt" to deal with emerging genetic crop modification techniques and that the Commission was aware of this problem.[250] The Commission also acknowledged this, but was not able to tell us how it intended to resolve this issue or when a solution was likely to be found.[251]

70. The EU's process-based regulatory system for novel crops is increasingly proving itself to be incapable of dealing with advances in technology. This raises the prospect that potentially important agricultural innovations will be hindered, or even halted, by inappropriate regulation, while potentially harmful crops may escape appropriate control if they are produced using techniques not captured by GMO regulations.

71. We consider the current process-based EU legislative framework for GMOs to be fundamentally flawed and unfit for purpose.

Government policy on process- versus trait-based regulation

72. George Freeman MP, Minister for Life Sciences, expressed concern at what appeared to be "a dangerous trend towards regulating by process rather than product" and stated that his "strong preference" was "that we regulate by product".[252] However, Lord de Mauley stated that if a move was to be made towards trait-based novel crop regulation, there was "a very real possibility of ending up with the unsatisfactory GM regime simply being applied more generally to any novel crop".[253] He stated that the Government therefore needed to "tread very carefully with this idea" and explained that its "immediate focus" was "on trying to improve the existing GM regime".[254] Professor Guy Poppy, Chief Scientific Adviser to the Food Standards Agency, also pointed out that while trait-based regulation might represent an improvement to the current framework, "if the member states, through block vote, decide to vote against" genetically modified products for political reasons, "you will end up in exactly the same situation".[255]

73. We acknowledge that there is a need to "tread carefully" with regard to trait-based regulation and recognise that a change in UK policy on this issue is unlikely to pay immediate dividends. However, we consider it likely that a move to trait-based regulation at EU-level will eventually be forced by technological progress and suggest that the Government would be wise to prepare for such a change. We recommend that the Government formally adopt a move to trait-based novel plant regulation as a long-term policy goal and begin to develop its preferred framework for such a system so that this can inform EU discussions. The Government should provide our successor committee with an update on this work by the end of 2015.

74. In the meantime, we urge the European Commission to take a pragmatic and evidence-based approach to its development of policy regarding emerging techniques for genetic crop improvement. We remind it that such techniques are likely to be vital to ensuring future global food security and that inappropriate regulation may have significant negative consequences for both the UK and the EU as a whole.

2. CONSIDERATION OF RISKS AND POTENTIAL BENEFITS

75. We have seen strong evidence that the use of first generation genetically modified crops can deliver significant benefits, both to farmers and to the environment (see paragraph 13).[256] However, as many witnesses pointed out, while risks are comprehensively assessed under the EU regulatory system, potential benefits are not currently accounted for, leading to what the John Innes Centre called "a very one-sided decision making process".[257] The Advisory Committee on Releases to the Environment (ACRE) described this as a "fundamental problem with the current regulatory framework" and several witnesses agreed that "a more explicit risk/ benefit analysis, taking compensatory measures into account, would allow decision-makers to take more informed decisions".[258]

76. Professor Joe Perry, European Food Safety Authority (EFSA), confirmed that, at present, EFSA could not, "according to the legislation covering regulation of GMOs […] consider benefits, only adverse effects".[259] Consideration of both the benefits of action, and the risks of inaction, is a widely accepted principle of good risk management[260] and Professor Perry explained that "the risk managers", the European Commission and the member states, were "meant to do a detailed analysis of benefit".[261] However, he continued, whether due to "lack of resources or expertise", "quite clearly this is not being done".[262] As a consequence, he said, "potential benefits such as the possible reduction in carbon emissions associated with reduced tillage in herbicide-tolerant systems, are not formally assessed at any point in the regulatory system".[263] Eric Poudelet, European Commission, agreed that it was the Commission's role, as risk manager, to introduce "other legitimate factors" for consideration following scientific risk assessment, and stated that the Commission had "established an organisation" with this in mind.[264] He described this as:

a bureau of cost benefit where 18 member states have been asked to deliver expertise. They will issue a report, probably next year, about the cost of cultivation in particular, and whether the cultivation of GM in Europe brings some benefit for the farmer, the environment and citizens.[265]

The body to which Mr Poudelet refers is the European GMO Socio-Economics Bureau (ESEB), a technical working group of the European Commission's Joint Research Centre. ESEB's objective is to:

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77. Good risk management requires the potential benefits of an action to be thoroughly considered alongside the risks. It also requires a consideration of the risk of failing to act. Current GMO legislation fails to adequately recognise this point and the European Commission, as risk manager, has proved itself incapable of taking (or unwilling to take) these factors into account on a discretionary basis. This has led to a one-sided decision-making process and has sent a misleading message to the public about the potential value of these products, to the economy, society and the environment. We urge the Commission to give greater recognition to the full array of potential social, economic and environmental benefits offered by GMOs and the potential consequences of failing to adopt these products during EU risk assessment and risk management processes.

3. NATIONAL VERSUS COLLECTIVE DECISION-MAKING

78. European GMO regulation is currently prescribed through a series of EU Directives (see paragraph 47). The Science Council noted that while such instruments could be effective in harmonising response across member states, they "do little to recognise individual member states' scientific and political cultures, and public attitudes to the adoption and application of new science and technologies".[268] Evidence suggests that these attitudes vary widely across the EU, particularly in relation to agricultural biotechnology. A 2010 Eurobarometer survey found that, in general, Europeans did "not see benefits" of genetically modified foods and were "not in favour" of their development.[269] However, it noted that EU citizens were "divided in their optimism about biotechnology and genetic engineering" and that UK citizens were markedly more enthusiastic about the field than those from other member states.[270] According to the Government, "the available evidence suggests that most people in the UK are open-minded or don't feel strongly about GM crops".[271] Sense about Science highlighted the British public's greater appreciation of "public sector research" and the potential "non-commercial benefits" offered by GMOs compared to that of other member states, and stated that while discussion about genetic crop improvement in the UK was "now relatively balanced and evidence-related", this discussion had "not progressed in the same way […] at European level".[272] Professor Brian Wynne, University of Lancaster, downplayed these differences, stating that his own research had indicated a high degree of convergence in public attitudes across the UK, Spain, Italy, Germany and France with regard to "the factors lying behind opinions and attitudes".[273] However, he acknowledged that this was not necessarily reflected in the widely differing positions of these countries' respective governments.[274]

79. Several witnesses pointed out that these differences of political opinion had led to issues in the operation of the centralised regulatory process, both at the risk assessment and risk management stages. The European Food Safety Authority (EFSA), the organisation responsible for GMO risk assessment, is "an independent European agency" intended to operate "separately from the European Commission, European Parliament and EU Member states".[275] However, some witnesses considered its work in this area to have become increasingly influenced by EU politics. The Agricultural Biotechnology Council stated that there were "increasing concerns over a proliferation of new regulatory requirements which are a political response to anti-GM campaigns without any scientific basis addressing legitimate safety concerns".[276] It cited the example of compulsory 90-day rodent feeding studies, which were recently made a mandatory requirement through Regulation 503/2013.[277] Professor Perry, EFSA, agreed that these studies were made compulsory "for political reasons", despite his panel's "repeated advice" that there was "no good scientific reason to do so".[278] According to Food Standards Agency, "the Regulation was not supported by the UK and a number of other Member states who saw it as an unjustified increase in animal testing, contrary to agreed policies on reducing animal experimentation".[279] However, "the majority of Member states voted in favour of the Regulation and it subsequently came into effect in June 2013".[280]

80. Several witnesses argued that exaggerated claims of 'scientific uncertainty' had also been used as a political tool, both during risk assessment and risk management. Professor Perry stated that "those with an agenda against GMOs" frequently attempted to "overemphasise uncertainty for their own ends", particularly through the misuse of safeguard clauses, which he stated were often used as "a purely political ploy, containing no scientific content of any merit".[281] Syngenta agreed that "political opposition to GM products" had given rise to unjustified "claims of 'scientific uncertainty'" and offered several examples in which this tactic had been effective in delaying or preventing authorisation (see, for example, box 5).[282] Professor Joyce Tait, Innogen Institute, indicated that this was to be expected, as it was "part of the political process" for those who opposed a technology on ideological grounds to "seek to maximise the level of uncertainty in order to make a political case".[283] She contrasted this with the scientific process, which "seeks to minimise the uncertainty by doing more experiments", and argued that these two processes should therefore, as far as possible, be kept separate.[284]Box 5: Maize 1507

Maize 1507 is a herbicide- and insect-resistant crop developed by DuPont-Pioneer. It was first submitted to the European Food Safety Authority (EFSA) for risk assessment in 2000 and, following "substantial delay" due to a change in GMO legislation and requests for additional data, received its first positive safety opinion from EFSA in early 2005.[285]
In response to concerns raised during a technical meeting between the European Commission, member states, EFSA and DuPont-Pioneer, in July 2006 the Commission asked EFSA to deliver a further scientific opinion. Over the following years, maize 1507 was assessed and re-assessed multiple times, eventually receiving a total of seven positive EFSA opinions.[286] The European Commission is legally obliged to prepare a draft authorisation opinion within three months of receiving an opinion from EFSA; however, it continually failed to do so and, as a result, in 2010 DuPont-Pioneer launched a legal action against the Commission. This was successful and in a September 2013 ruling, the European Court of Justice found that the Commission had "failed to fulfil its obligations" under the relevant legislation "by failing to submit to the Council" a draft authorisation decision on maize 1507.[287]
In November 2013, thirteen years after the product first entered the regulatory process, the European Commission passed a draft opinion on maize 1507. This recommended that the product be authorised for cultivation. However, in February 2014 the European Parliament approved a Resolution calling on the Council of the European Union to "reject the Commission proposal" on the basis that "the long-term effects of GMO cultivation and the effects on non-target organisms have, thus far, not been adequately taken into account in the risk assessment framework".[288] It further called on the Commission "not to propose to authorise any new GMO variety and not to renew old ones until the risk assessment methods have been significantly improved".[289] A final authorisation decision on maize 1507 remains outstanding.

81. While Professor Tait saw a need to maintain a distinction between the scientific and political aspects of risk governance, she, and several other witnesses, acknowledged that both processes relied on subjective, value-based judgements as well as objective evidence.[290] According to Professor Andy Stirling, University of Sussex, "in order to interpret a risk assessment", for example, "even if we assume it is complete, you still have to know what level of safety you are going to require. That is a value judgment".[291] The notion of 'harm' is also a value-based concept central to the process of scientific risk assessment. The Advisory Committee on Releases to the Environment (ACRE) highlighted that environmental harm was not defined in current GMO legislation and argued that this had led to risk assessments becoming generalised "data gathering exercises" rather than focused tests of plausible risk hypotheses.[292] Professor C J Pollock, ex-Chair of ACRE, argued that, in the absence of any "formal definition of harm", "impact" was increasingly being used as a substitute—"not a sensible way to proceed", in his view, as "all agricultural systems impact on the receiving environment".[293] Professor Perry, EFSA, disputed this claim, stating that change was "not equivalent to harm" and was not treated as such by EFSA.[294] However, he acknowledged that it was often difficult to establish what level of change was likely to lead to biologically relevant effects and suggested that deciding where this line should be drawn was "probably the responsibility of the risk manager" rather than the risk assessor.[295]

82. Value-based considerations are also key to risk management. Professor Paul Nightingale, University of Sussex, explained that while scientific experiments such as those considered during risk assessment could "provide convincing evidence that something causes harm", they could never "fully establish [that] something is safe", so "what counts as safe is the result of a negotiated and often contested process".[296] Professor Nightingale argued that "uncertainty about safety" provided "a legal route to address non-health concerns" which were "difficult to articulate" elsewhere in the regulatory process and therefore saw the "high regulatory standards" that GMOs were required to meet as "a reflection of the operation of democracy, not a failing of science".[297] However, Professor Sir Mark Walport, the Government Chief Scientific Adviser, stated that there was a need for society to "be a bit more honest about when we are talking about science and when we are talking about values".[298] He continued:

The broader European point is that, inevitably, values about individual innovations vary between nation states. The question is: should the values of one group of countries trump the values of another? That brings us to the principle of subsidiarity on GM, which I hope we are moving to, where GM foods can be regulated at European level but individual countries can choose to opt out of growing them.[299]

The Minister stated that the Government "strongly support[ed]" decisions about whether or not to cultivate EU-approved GM crops being taken "at member state level".[300]

83. The principle of subsidiarity is defined in Article 5 of the Lisbon Treaty. This states that:

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According to a lay summary published by the EU, the principle of subsidiarity "ensures that decisions are taken as closely as possible to the citizen and that constant checks are made to verify that action at Union level is justified in light of the possibilities available at national, regional or local level".[302] It requires that "the Union does not take action […] unless it is more effective than action taken at national, regional or local level".[303]

84. Science and politics each have a role to play in both risk assessment and risk management. However, while risk management is rightly a politically-led process, risk assessment must be led by science if it is to effectively contribute to evidence-based policy-making. This distinction has not been sufficiently observed in the EU's regulation of GMOs.

85. In attempting to centralise decision-making about risk management, the current EU regulatory system limits the ability of member states to take local political factors into account. The result is undue politicisation of the risk assessment process. Those opposed to genetic modification seek to exaggerate scientific uncertainty in order to block or delay authorisation. This, in turn, leads to stalemate at the voting stage, where strongly conflicting political positions inevitably prevent agreement from being reached. To resolve this, decision-making about risk management, including the decision whether or not to cultivate an authorised GMO, must be repatriated to member states. We consider the current EU regime to be at variance with the principle of subsidiarity. We remind the Council, the Commission and the Parliament of their responsibility to observe this principle.

Recent developments

86. In October 2014, Vytenis Andriukaitis, the new Commissioner to the European Commission's Directorate General for Health and Consumers ('DG Sanco'), stated that he would "review the legislation applicable to the authorisation of genetically modified organisms" within "the first six months" of his tenure.[304] This followed an earlier pledge by the new President of the European Commission, Jean-Claude Juncker, to "make sure that the procedural rules governing the various authorisations for GMOs are reviewed".[305] In apparent reference to a February 2014 request by the European Parliament for the Commission "not to propose to authorise any new GMO variety and not to renew old ones until the risk assessment methods have been significantly improved",[306] he continued:

I would not want the Commission to be able to take a decision [on GMO authorisation] when a majority of Member states has not encouraged it to do so.[307]

Eric Poudelet, Director, Safety of the Food Chain at DG Sanco, confirmed to us that Mr Juncker intended to "review the [GMO] decision-making process, to avoid taking decisions that are against a clear majority of member states" and that the Commission would prepare a proposal to this end by April 2015.[308]

87. In addition to these planned changes to the decision-making process, an amendment to the Deliberate Release Directive, passed by the European Parliament in January 2015, is due to come into effect this spring.[309] As initially drafted by the Commission in 2010, this proposal acknowledged that GMO cultivation was "an issue with a strong local/regional dimension" and granted member states greater power to make decisions at a national level.[310] However, some of these powers were rescinded in later drafts and while the final version allows member states to prohibit cultivation of authorised GMOs on non-scientific grounds, it provides no assurance that authorisation will be granted to those crops that have received a positive safety opinion.[311] In the words of the Minister: "There is discretion to member states to stop the process. There is not the discretion to individual member states to proceed".[312]

88. Eric Poudelet, European Commission, acknowledged that the final text of this amendment "substantially modifies the proposal we made in 2011", but appeared to remain optimistic about its potential impact.[313] He explained that because those Member states opposed to GMO cultivation would now have confidence that they could prohibit cultivation in their own territories, "we expect that they will not abstain or that they will give a favourable vote when we present the [authorisation] decision to be voted on".[314] Others, however, were less confident. Dr Julian Little, Agricultural Biotechnology Council, stated that he "really doubt[ed]" that this legislation would "allow UK farmers to access GM" and expressed concern that:

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Dr Mike Bushell, Principal Scientific Adviser at Syngenta, praised the Government's "leadership" in supporting this amendment but stated that there was "uncertainty" about its "ability to unblock the regulatory process".[316] He added that the change "rather risks damaging the principles of a single market and bringing in all sorts of intra-common market trade issues".[317]

89. The Government initially described the amendment to us as a "breakthrough" which could "unblock the EU system" by allowing "more national self-determination".[318] However, the Minister later stated that he was "disappointed" with the eventual outcome of negotiations and was concerned that it would "stifle our ability to benefit from GM technology".[319] He explained:

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The Minister acknowledged that the final position was "not what the UK would ideally have liked" but stated that the Government must move on and "consider what we do now".[321] He stated that there were "several strands" to this, including continuing to "engage strongly with the three pillars of the EU institution", "pressing for the outstanding applications for EU approval to be authorised as soon as possible" and speaking to the agricultural biotechnology industry "to gauge its view on the prospects for GM developments in the UK and EU" in light of the amendment.[322]

90. The hard won amendment to the Deliberate Release Directive is intended to ease problems with the operation of the regulatory system by ceding more power to Member states. However, it does nothing to resolve underlying weaknesses in the regulations or to prevent those hostile to GMOs from voting against authorisation in order to maintain the current EU-wide 'ban' on GMO cultivation. It may also do little to attract the agricultural biotechnology industry back to Europe. We commend those Governments that have provided leadership in attempting to secure more fundamental legislative change but share their view that the agreed amendment is far from satisfactory.

91. In our view, decisions about access to and use of safe products should be made by national governments on behalf of the populations that elected them, not by the EU. The most significant flaw in the current EU regulatory system for GMOs is its continued failure to enable Member states to make such decisions without prejudice. We remind those in the EU who are opposed to GMO cultivation that the purpose of shared regulation should be to ensure mutual protection from unsafe products, not to unjustifiably restrict the choices available to other elected governments and the citizens whom they represent. We encourage all member states to vote in favour of authorising those products that have been deemed safe by the European Food Safety Authority so that national governments can make their own decisions about how best to act in their electorate's interests.

92. We also encourage the new President of the European Commission, Mr Jean-Claude Juncker, and the new Health and Consumers Commissioner, Mr Vytenis Andriukaitis, to bear this point in mind in their planned review of the procedural rules governing GMO authorisation.

Conclusion: the need for regulatory reform

93. This chapter has explored several significant flaws in the design and operation of the current EU regulatory process for genetically modified organisms (GMOs). These have long been recognised by the Government and it has made laudable efforts to try and resolve them, primarily by "trying to improve the current system" through small, incremental changes.[323] The Government was receptive to more wholescale changes, such as those recently supported by the Council for Science and Technology, but told us that it considered it "unlikely that in the foreseeable future EU agreement could be secured to implement such a fundamental departure from the existing GM control regime". It maintained that its "immediate focus" was on "trying to improve the existing GM regime".[324] Other witnesses challenged this approach. The Advisory Committee on Releases to the Environment acknowledged that short term solutions based on the current system may be attractive, but stated that they would "perpetuate an approach that is not consistent with the scientific evidence and that will continue to cause problems in the future".[325] The Council for Science and Technology similarly stated that the EU regulatory process needed to be "rebalanced to reflect the evidence" and stressed that "we need the right regulatory framework that will encourage continued research into solutions to current and future problems facing UK agriculture".[326] In its recent report on food security, the Environment, Food and Rural Affairs Committee stated that "the Government must continue to work within the EU to argue for a system which is more flexible for those member states that wish to take advantage of GM technology, while still ensuring that all EU consumers are protected, in the same way it does with non-GM technologies".[327] It added: "Progress towards this objective must be research and science-led".[328]

94. We understand the challenge of securing major legislative change in the EU—particularly in relation to this subject—and therefore the Government's inclination towards delivering small improvements to the current regime rather than attempting a more significant overhaul. However, fundamental flaws in the design of this legislative framework have created a regulatory process that is not fit for purpose, has driven research activity out of the EU and which is putting the UK's agricultural future at risk. Substantial regulatory reform is no longer merely an option, it is a necessity. We recommend that the Government publicly state its long-term commitment to major reform of the EU legislative framework for genetically modified organisms and other novel crops.

95. This Committee scrutinises the actions of the UK Government and the UK Government is therefore the target of most of our recommendations. However, much of the power to bring about the changes that we, and many others, advise, lies in the hands of the European Commission and its leadership. We urge the European Commission to consider the conclusions and recommendations set out in this report and provide our successor committee with a formal response, by the end of 2015, to those issues for which it has responsibility.

162 Council Directive 2009/41/EC Back

163 Council Directive 2001/18/EC Back

164 Council Regulation 1830/2003 Back

165 Council Regulation 1829/2003 Back

166 Parliamentary Office of Science and Technology, GM crops and regulation, POSTnote 482, October 2014. Note, the Contained Use Directive (90/219/EEC) referred to in this document was repealed and replaced by Directive 2009/41/EC as of 6 May 2009 Back

167 Under a qualified majority, any decision must be voted for by Member states representing at least 72% of the population of the European Union (232 votes from a possible 321). The UK has been allocated approximately 9% of these votes (29 in total). See Europa, The Council of the European Union, accessed 16 December 2014. Back

168 See the EU register of authorised GMOs, accessed 26 January 2015. Back

169 GMC051 [Gov] para 8 Back

170 David Baulcombe, Jim Dunwell, Jonathan Jones, John Pickett and Pere Puigdomenech, GM science update: a report to the Council for Science and Technology, March 2014, p.9. See also GMC029 [SCIMAC] para 34 Back

171 GMC029 [SCIMAC] para 34; GMC051 [Gov] para 12 Back

172 European Environment Agency, Late lessons from early warnings: the precautionary principle 1896-2000, 2001, p.12. Back

173 United Nations Educational, Scientific and Cultural Organization, World Commission on the Ethics of Scientific Knowledge and Technology, The Precautionary Principle, March 2005, p.14 Back